Lab manual - Palmetto Health

Transcription

DEPARTMENT OF ANATOMICAL AND CLINICAL PATHOLOGY
PALMETTO HEALTH RICHLAND LABORATORY MANUAL
The purpose of this manual is to provide information about daily operations of Palmetto Health
Laboratory Services. This manual is also located on MYPAL
https://www.palmettohealth.org/Document-Library/Laboratory/Hospital_Info
Test Information can be accessed by choosing the beginning letter of the test name on the
Laboratory Test Directory keypad on the top left of the Palmetto Health Richland Laboratory
Home Page.
General phone numbers:
Rapid Care Lab Richland………………………………………………………...434-7471
Central Lab……………………………………………………………………….434-7770
Paul L. Guerry, M.D.
Professional Director of Laboratories…………………………………..……….434-6405
Rebecca Walters MA, MT (ASCP) DLM
Administrative Director, PH Rapid Care Labs…………………………………...434-2234
Mary Sue Sawyer, MBA, MT (ASCP)
Administrative Director, PH Central Lab and Outreach Services…………….…..434-7619
Deanne Piester
Laboratory Manager Rapid Care Richland Lab………………………………..…434-2296
TABLE OF CONTENTS
GENERAL PHONE NUMBERS: ............................................................................................................................................................................. 1
PATHOLOGY DEPARTMENT ORGANIZATION ................................................................................................................................................ 4
LABORATORY HOURS OF OPERATION ............................................................................................................................................................ 4
ANATOMIC PATHOLOGY .................................................................................................................................................................................... 5
ROUTINE HOURS .......................................................................................................................................................................................... 5
ROUTINE SECTIONS .................................................................................................................................................................................... 6
BIOPSIES OF LYMPH NODES, SPLEEN, AND OTHER RES TISSUES .................................................................................................... 6
PATHOLOGICAL EXAMINATION .............................................................................................................................................................. 6
PREPARATIONS OF SPECIMENS ................................................................................................................................................................ 7
SPECIMEN EXCEPTION/REQUEST FORMS FOR PATHOLOGY ............................................................................................................. 8
AUTOPSY ................................................................................................................................................................................................................ 9
TRANSFER OF BODY TO MORGUE ........................................................................................................................................................... 9
NOTIFICATION TO PATHOLOGY DEPARTMENT OF AUTOPSY ........................................................................................................ 10
NOTIFICATION OF SECURITY.................................................................................................................................................................. 10
GROSS DISSECTION FOR AUTOPSY ....................................................................................................................................................... 11
TISSUE REMOVED AND SAMPLED AT AUTOPSY ................................................................................................................................ 11
1
WRITTEN AUTOPSY PROTOCOL ............................................................................................................................................................. 12
CYTOLOGY ........................................................................................................................................................................................................... 12
NON-GYN CYTOLOGY: ...................................................................................................................................................................................... 13
CLINICAL LABORATORY SECTION GUIDELINES ........................................................................................................................................ 15
SPECIMEN TRANSPORT: ........................................................................................................................................................................... 15
PEVCO PNEUMATIC TUBE SYSTEM SP 2.012.06 ................................................................................................................................... 15
ORDER PRIORITY EXPLANATIONS: ....................................................................................................................................................... 18
DUPLICATE ORDERS ................................................................................................................................................................................. 18
DOWNTIME ORDER SLIPS ........................................................................................................................................................................ 18
COLLECTION OF URINE ............................................................................................................................................................................ 18
TIMED URINE INSTRUCTION ................................................................................................................................................................... 20
TIMED URINE COLLECTION CONTAINER DISTRIBUTION SP 2.009.06 ............................................................................................ 20
TIMED URINE COLLECTIONS FORMS…ENGLISH AND SPANISH .................................................................................................... 21
SPECIMEN LABELING AND HANDLING ................................................................................................................................................ 23
RELABELING OF CRUCIAL SPECIMENS Q1.031.06.............................................................................................................................. 23
VIRAL AND RICKETTSIAL REQUESTS ................................................................................................................................................... 24
BLOOD/BONE MARROW COLLECTIONS FOR CHROMOSOME ANALYSIS ..................................................................................... 24
ORDERS FOR PATIENTS ADMITTED AS TRAUMA M (MALE) AND F (FEMALE) ........................................................................... 25
STAT TEST LIST .......................................................................................................................................................................................... 26
BLOOD COLLECTION TUBE TYPES ........................................................................................................................................................ 28
MINIMUM SPECIMEN REQUIREMENTS FOR PEDIATRICS ................................................................................................................. 29
LEGAL BLOOD ALCOHOLS Q1.032.05.................................................................................................................................................... 33
FLUID PROCESSING ................................................................................................................................................................................... 34
CRITICAL TESTS OR SIGNIFICANT Q1.018.08 ..................................................................................................................................... 34
CRITICAL VALUES ..................................................................................................................................................................................... 36
COLLECTION PROCESS
PH1.005.13 ...................................................................................................................................................... 40
CORRECT ORDER FOR DRAWING TUBES PH1.016.07 ........................................................................................................................ 44
CORRECT ORDER FOR DRAWING TUBES PH1.016.07 ........................................................................................................................ 45
BLOOD COLLECTION: VENIPUNCTURE PH1.010.07 ........................................................................................................................... 45
COLLECTION AND HANDLING OF COAGULATION SPECIMENS PH1.017.09 .................................................................................. 47
VENIPUNCTURE QUALITY ASSURANCE ............................................................................................................................................... 48
BLOOD COLLECTION FROM INFANTS ................................................................................................................................................... 49
BABYLANCE HEELSTICK LANCET PH 1.025.04 .................................................................................................................................. 52
LINE COLLECTION PROCEDURE PH1.044.04 ......................................................................................................................................... 54
NEEDLELESS TRANSFER SYSTEM PH1.014.05 ..................................................................................................................................... 55
UNACCEPTABLE SPECIMEN PROTOCOL .............................................................................................................................................. 56
URINE SPECIMENS ..................................................................................................................................................................................... 57
PH1.027.10 BACT/ALERT®BLOOD CULTURE COLLECTION .............................................................................................................. 58
CR1.033.01 NEWBORN SCREENING PANEL ........................................................................................................................................... 63
BLOOD BANK PROCEDURES ............................................................................................................................................................................ 67
B8.018.03 LABELING AND COLLECTION OF SPECIMENS FOR BLOOD BANK ................................................................................ 67
PROTOCOL FOR USE/TRANSFUSION OF BLOOD PRODUCTS............................................................................................................ 70
EMERGENCY RELEASE OF BLOOD PRODUCTS B8.033.09................................................................................................................ 73
MASSIVE TRANSFUSION PROTOCOL B8.034.04 ................................................................................................................................. 78
PICKING UP BLOOD COMPONENTS FROM BLOOD BANK ................................................................................................................. 81
RETURN OF BLOOD PRODUCTS TO BLOOD BANK ............................................................................................................................. 82
IDENTIFICATION OF THE PATIENT BEFORE STARTING TRANSFUSION ........................................................................................ 82
INFUSION OF BLOOD AND BLOOD COMPONENTS: ............................................................................................................................ 83
AFTER THE TRANSFUSION ...................................................................................................................................................................... 83
TRANSFUSION REACTION INVESTIGATION ........................................................................................................................................ 83
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HOLDING BLOOD FOR PATIENTS ........................................................................................................................................................... 84
DETERMINING IF BLOOD PRODUCTS ARE IN BLOOD BANK ........................................................................................................... 84
CIRCULAR OF INFORMATION (AMERICAN RED CROSS) .................................................................................................................. 84
GLUCOSE TOLERANCE TESTING..................................................................................................................................................................... 84
ORAL GLUCOSE TOLERANCE TEST CCH2.402.06 ............................................................................................................................. 85
GESTATIONAL DIABETES SCREEN (GDS) CCH2.401.04 .................................................................................................................... 87
TWO HOURS POST PRANDIAL GLUCOSE CCH2.403.06 ..................................................................................................................... 88
MICROBIOLOGY SPECIMENS ........................................................................................................................................................................... 90
CULTURE HANDLING M1.027.07 ........................................................................................................................................................... 90
SPECIMEN COLLECTION FOR MICROBIIOLOGY M1.026.07 ............................................................................................................... 91
SPECIMEN COLLECTION MYCOLOGY
M5.001.07............................................................................................................................ 103
MYCOBACTERIOLOGY SPECIMEN COLLECTION M4.002.08 ......................................................................................................... 105
COLLECTION AND PRESERVATION OF FECAL SPECIMENS M6.001.04 ....................................................................................... 109
RAPID TESTING IN MICROBIOLOGY LAB .................................................................................................................................................... 111
STREP. PNEUMONIAE ANTIGEN M2.043.03 ....................................................................................................................................... 111
INFLUENZA A+B
GROUP A STREP
FIA M2.046.01 ...................................................................................................................................................... 112
M2 .047.01 ................................................................................................................................................................. 113
RSV TEST M2.048.01 .............................................................................................................................................................................. 114
GASTROINTESTINAL (GI) PCR PANEL ................................................................................................................................................. 114
RAPID HIV–1/2 AG/AB COMBO FOR EXPOSURES M2.051.01 ......................................................................................................... 115
FECAL LACTOFERRIN M2.035.02 ......................................................................................................................................................... 116
LEGIONELLA ANTIGEN, URINE M2.034.02 ....................................................................................................................................... 116
ADENOVIRUS TEST M2.032.04 ............................................................................................................................................................ 117
ID OF H. PYLORI FOR GASTRIC BIOPSIES M2.029.03 ........................................................................................................................ 118
REJECTION OF MICROBIOLOGY SPECIMENS M1.025.06 ................................................................................................................ 118
MOLECULAR PATHOLOGY SPECIMENS ...................................................................................................................................................... 119
CHLAMYDIA AND N. GONORRHOEAE BY PCR.................................................................................................................................. 119
A.
ENDOCERVICAL SAMPLE- BD SWAB #441357 ..................................................................................................................... 119
B.
URETHRAL SAMPLE- BD SWAB #441358............................................................................................................................... 120
C.
CONJUNCTIVAL SAMPLE - BD SWAB #441358..................................................................................................................... 120
D.
URINE SAMPLE ............................................................................................................................................................................... 120
E.
THIN PREP SPECIMENS FOR CHLAMYDIA AND N. GONORRHOEAE .................................................................................... 120
HSV DNA BY PCR – BODY FLUIDS AND SWAB SPECIMENS ........................................................................................................... 121
HSV DNA BY PCR (PERIPHERAL BLOOD) , FACTOR V LEIDEN MUTATION, PROTHROMBIN GENE MUTATION ,MTHFR
AND HIV DNA QUAL............................................................................................................................................................................... 121
BORDETELLA PERTUSSIS/PARAPERTUSIS BY PCR .......................................................................................................................... 121
HIV VIRAL LOAD/HIV GENOTYPE ........................................................................................................................................................ 121
HCV VIRAL LOAD/HCV GENOTYPE ..................................................................................................................................................... 122
CD4, T-HELPER/SUPPRESSOR, T & B CELL ENUMERTAION PANEL, FETAL HEMOGLOBIN .................................................... 122
POINT OF CARE TESTING ................................................................................................................................................................................ 123
POINT OF CARE TESTING Q1.026.12.................................................................................................................................................... 123
PC1.035.01 FREESTYLE PRECISION GLUCOMETER FSP GLUCOMETER STRIPS .......................................................................... 127
I-STAT PROCEDURE PC1.025.04 .......................................................................................................................................................... 143
PC1.028.01 AMNISURE ROM PROCEDURE ........................................................................................................................................... 165
MICROTAINER IS A REGISTERED TRADEMARK OF BECTON, DICKINSON AND COMPANY ............................................................ 171
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PATHOLOGY DEPARTMENT ORGANIZATION
The Department of Anatomical and Clinical Pathology of Palmetto Health Richland
provides pathological investigations and clinical laboratory tests for hospital patients, private
outpatients, and Ambulatory Care Center patients.
The Anatomical Pathology Department is composed of Histology (Surgical Pathology), and
the Autopsy Service. For general information, call extension 434- 6405.
The Clinical Pathology Department is composed of Specimen Processing, Blood Bank, Core
Lab: (Hematology, Coagulation, Chemistry, Urinalysis, Immunology), Point of Care Testing,
Client Services, Microbiology/Parasitological, Molecular Pathology, Reference Lab (Send Out)..
For general information, call extension 434-7770.
PROFESSIONAL DIRECTOR OF PATHOLOGY SERVICES
Paul L. Guerry, MD, Medical Director
Jacqueline A. Emery, MD
Darren J. Monroe, MD
Ronald G. Burns, MD
Geoffrey Turner, MD
Atwell Coleman, MD
Lawrence D. Grant, MD
Paul L. Guerry, MD
Bradley J. Marcus, MD
Robert F. Bradley, MD
Sarah G. Williams, MD
Michael J Hayes, MD
Amy M. Durso, MD
ADMINISTRATIVE DIRECTORS
Mary Sue Sawyer, MBA, MT (ASCP), Palmetto Health Central Lab and Outreach
Rebecca Y. Walters, MA, MT (ASCP) DLM, Palmetto Health Rapid Care Labs
LABORATORY HOURS OF OPERATION
Departments
Anatomic Pathology
Autopsy
Blood Bank
Histology
Immunology
Microbiology/Mycobacteriology/
Parasitology/Mycology
Core Lab Chemistry, Hematology
Urinalysis, ER Lab
Reference Lab (Send outs)
Hours
7:00am-6:00pm (Mon-Fri)
8:30am-4:00pm (on call evenings/weekends)
24hr. coverage
(Frozens til 5:00 PM & on call evenings/weekends)
7:00am- 15:30 pm (M-F) Sat Sun close at 2pm
24hr. coverage
24hr. coverage
9:00am-1:00Ppm (Sat.)
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Molecular Pathology
Rapid Care Lab Richland
Closed Sundays and Hospital Holidays
8:00am-4:30pm (Mon-Sat)
Closed Sunday
24 hr coverage
Outpatient Draw Stations:
Rapid Care Richland…………..7 am – 6 pm M-F
7am-3:30pm Saturday & Sunday
Rapid Care Baptist…………… 7am-5pm M-F
PH Baptist POB …………….. 8am- 5pm M-F
PH Partridge MOB ………… 8am- 5pm M-F
2 MP…………………….…….8am- 5pm M-F
7 MP…………………………..7am-5:30 pm M-F (closed 12-1pm)
14 MP…………………………8am- 5pm M-F
ANATOMIC PATHOLOGY
Routine Hours
Routine Hours of Operation are from 7:00AM to 6:00PM, Monday through Friday.
In general, specimens received by 4:30 PM, Monday through Thursday will be examined grossly
on the day received, processed overnight, and have sections available for interpretation on the
following day.
Specimens received on Friday by 4:30 PM will be processed over the weekend and sections will
be available for interpretation the following Monday.
Certain specimens received on Friday deemed essential for earlier processing by special
request (RUSH) or at the option of the pathologist may be processed Friday night and
have section available for interpretation on Saturday.
Specimens received in the laboratory on weekends will be processed on Monday and sections
will be available for interpretations on Tuesday.
Specimens received on holidays will be processed the day following the holiday unless the
holiday precedes a weekend. Generally, there will be a one-day delay due to any holiday falling
on the usual work days (Monday through Thursday).
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Routine Sections
Pathology should be notified when a frozen section is obtained between the hours of 7:30AM
and 6:00PM, Monday through Friday (ext.434- 6405).
If there is a need for a frozen section after 6:00PM or on weekends or holidays, please call the
laboratory charge tech (434-2228) so that he/she can notify the pathologist-on-call. After
6:00PM, a pathologist may not be physically present in the department. Therefore, some delay
must be expected for his/her arrival.
Biopsies of Lymph Nodes, Spleen, and Other RES Tissues
Diagnostic lymph node biopsies, spleen and other RES tissue, are examined fresh between the
hours of 7:30AM and 6:00PM, Monday through Friday. After 6:00PM and on weekends and
holidays, call the laboratory charge tech (434-2228).
Pathological Examination
Requests for pathological examinations should contain:
1. patient’s full name
2. age/DOB
3. Race
4. Sex
5. social security number is helpful
6. Medical record number
7. billing number
8. insurance information
9. patient’s address if outpatient
10. ordering physician’s name
11. source of specimen
12. post-op diagnosis
13. Clinical data……Abortions and products of conception should also have the last
menstrual period, if known, included in the clinical data section of the requisition.
Specimens received by 4:30PM Monday through Thursday, will be examined grossly on the day
received, processed overnight, and have sections available for interpretation the following day.
Specimens received on Friday by 4:30PM will be processed over the weekend and sections will
be available for interpretation the following Monday.
Certain specimens received on Friday and deemed essential for earlier processing by
special request (RUSH) or at the option of the pathologist, may be processed Friday night
with sections available for interpretation on Saturday. [Note: There will be an additional
charge for any specimen requested RUSH.]
Small specimens received by 8AM will be run on short cycle and may be ready by that
afternoon.
Specimens received in the laboratory on weekends will be processed on Monday and sections
will be available for interpretation on Tuesday.
Specimens received on holidays will be processed the day following the holiday unless the
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holiday precedes a weekend. Generally, there will be a one-day delay due to any holiday falling
on the usual work days (Monday through Friday).
Preparations of Specimens
1.
Specimen containers and pathology requisitions should be labeled with
a. patient’s names
b. medical record number,
c. billing number,
d. physician name,
e. Date and identification of contents.
2.
The pathologist on call should be consulted when any fresh unfixed specimen comes
to the lab.
3.
Specimens (not for frozen sections) should be completely covered with 10% formalin
fixative as soon as possible. At least nine (9) volumes of formalin per one unit of
specimen should be used.
NOTE: Formalin is available from the Histology Section (ext.4 6710) or
Morgue (ext.4 2285). If formalin is not available, contact Histology.
4.
Air drying of specimens prevents proper processing and accurate diagnosis. This is
especially true of placenta. DO NOT ALLOW PLACENTA TO REMAIN
UNFIXED. Autolysis occurs at a very rapid rate.
5.
MUSCLE BIOPSIES should be obtained in a muscle clamp available in the O.R. or
submitted held by muscle biopsy forceps. The specimen should be sent immediately
to the laboratory WITHOUT FIXATIVE. Call Histology (ext. 46710) one day in
advance of performing a muscle biopsy.
6.
Shared Specimens that require BACTERIAL CULTURES must be collected in a sterile
container. These specimens should not be covered with any fixative until smears and/or
cultures are taken.
7.
Specimens for FROZEN SECTION should be submitted WITHOUT fixative and
brought immediately to the Histology Section. (Pathology ext. 46405) should be notified
when a frozen section is obtained between the hours of 7:30AM and 6:00PM, Monday
through Friday). If there is a request for a frozen section after 6:00PM or on weekends or
holidays, please call the laboratory (ext 47471) and inform the charge tech so that he/she
can notify the pathologist-on-call. After 6:00PM, a pathologist may not be physically
present in the department. Therefore, some delay must be expected for his/her arrival.
8.
DIAGNOSTIC LYMPH NODES as well as SPLEEN and other RES tissues are
examined fresh between the hours of 7:30AM and 5:00PM, Monday through Friday.
After 6:00PM and on weekends and holidays, call the laboratory (ext.47471) and inform
the charge tech so that he/she can notify the pathologist-on-call. These specimens should
be submitted WITHOUT fixative.
9.
For all MASTECTOMY SPECIMENS FOR BREAST CANCER, forms designated
Palmetto Richland Memorial Hospital Surgery Data Form for Cancer Staging and
7
Pathology Data Form for Cancer Staging is to be filled out.
The form entitle Surgery Data Form for Cancer Staging (Form No. 74-2070-6) is to
be filled out by the pathologist responsible for the pathology report or protocol. In
addition, a copy of this form is forwarded to the Tumor Registry for their files and
records.
11.
RENAL BIOPSIES should be scheduled with the Histology Section (ext. 6710). As
soon as possible the histologist will be available to assist/instruct for special handling.
12.
After 5:00PM, all specimens for Histology must be delivered to the Stat Laboratory.
Information concerning the specimen must be entered in the correct log book by the
person delivering the specimen. This information will be checked and signed by a
laboratory technologist while the nursing personnel are still in the department.
13.
be certain that all specimens are placed immediately in the proper fixative unless special
handling is requested by the attending physician. If there are any questions concerning
any of these procedures, please ask the attending physician or call the Histology
Department (ext. 6710) for advice.
ANATOMIC PATHOLOGY REQUEST FORMS
Specimen exception/request forms for Pathology
HISTOLOGY (Surgical Pathology Requisition: #75-1417)
All specimens must be accompanied by the Surgical Pathology Requisition, properly completed,
and brought to the Histology Section (ext. 6710, 2284).
If using a pen, USE PRESSURE, since there are several copies that must be legible after
separation of the form. If any of the basic information is not present on the Surgical Pathology
Requisition or if it is illegible, the requisition will be returned for clarification of the missing or
illegible items.
All “RUSH” requests are brought to the attention of one of the histologists (ext. 6710, 2284).
For Inpatients, Fill in the Form as Follows
1.
Enter patient’s name, unit record number, and account number, date of birth, sex, social
security number, and race in space labeled NAME/ADDRESS using the patient’s
addressograph plate.
2.
Enter date specimen obtained in the space labeled DATE OF SURGERY.
3.
Enter place (e.g., OR, ER Nursing Unit, etc) from which the specimen originated in space
labeled ADDRESS/LOCATION.
4.
Enter specimen identification (e.g. node, appendix, spleen, etc) in space labeled
SPECIMEN (SOURCE).
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5.
Enter specimen identification (e.g., node, appendix, spleen, etc.) in space labeled
SPECIMEN (SOURCE).
6.
Enter pertinent postoperative diagnosis/clinical data in space labeled RELEVANT
CLINICAL INFORMATION AND/OR DIAGNOSIS.
7.
Place an “X” in the appropriate box to indicate FROZEN or ROUTINE handling of the
specimen.
For Outpatients Fill in the Form as Follows
1.
Enter patient’s name, unit record number, and social security and account number in
space labeled NAME/ADDRESS for all hospital outpatients using the patient’s
addressograph.
2.
Print patient’s name and address in space labeled NAME/ADDRESS for all outpatients
from private physicians’ offices.
3.
Enter place (e.g., FP, Clinic, Physician’s Office, etc.) from which the specimen originated
in the space labeled ADDRESS/LOCATION.
4.
Enter name of physician performing surgical procedure in space labeled REQUESTING
PHYSICIAN. THE ATTENDING PHYSICIAN’S NAME MUST BE PROVIDED
WITH A RESIDENT’S NAME.
5.
Enter the date the specimen was obtained in space labeled DATE OF SURGERY.
6.
Enter specimen identification (e.g., skin lesion, cervical biopsy, etc.) In space labeled
SPECIMEN (SOURCE).
7.
Enter any pertinent clinical information and/or post op diagnosis in space labeled
RELEVANT CLINICAL INFORMATION AND/OR DIAGNOSIS.
Place an “X” in the appropriate box to designate ROUTINE or FROZEN handling of
the specimen.
8.
9.
Enter COMPLETE billing (to include insurance information) information.
10.
An ICD-9 Code must be submitted on a Pathology Form to avoid delay in specimen
processing.
AUTOPSY
Transfer of Body to Morgue
1.
When an Autopsy Consent Form has been secured with signed legal permission, the body
should be labeled “FOR AUTOPSY” and transferred to the morgue in the usual manner
as soon as possible.
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2.
When an autopsy is pending, the body should be labeled “POSSIBLE AUTOPSY” and
transferred to the morgue in the usual manner as soon as possible.
3.
If deceased is known to have serious infection, such as hepatitis, tuberculosis, AIDS, etc.
label as “CONTAMINATED”.
Notification to Pathology Department of Autopsy
1.
Autopsy Consent Form (#75-0090) must be properly completed. In order for the
Autopsy Consent Form to be legal, it must be signed by the next of kin *and two
witnesses. It is also essential to indicate whether or not there are any RESTRICTIONS
by checking either “none”, one of the designated organs, or “other” and listing what other
restrictions.
NOTE: *Signing as Next of Kin Must Be:
a) BOTH parents if examination of stillborn or infant (BOTH grandparents if
mother is unmarried minor); b) BOTH parents if examination of minor; c) Spouse if
married (or legal guardian, or person(s) responsible for hospital/funeral
arrangements).
2.
From 7:30AM to 6:00PM, notify pathology (ext. 6405) that an Autopsy Consent Form
has been obtained.
3.
Immediately bring the Autopsy Consent Form and patient’s chart to the Pathology Office.
4.
From 6:00PM to 7:30AM and on weekends and holidays, call the laboratory (ext. 7471)
and notify the charge tech that the Autopsy Consent Form has been obtained.
Immediately bring Autopsy Consent Form and patient’s chart to laboratory and deliver to
charge tech. The charge tech will notify the pathologist-on-call.
When an autopsy is to be performed on a fetus for which one or both of the parents want
the hospital to take responsibility of disposal, the Disposal of Fetus Permit (Form #740360-7) must accompany the Autopsy Consent Form and mother’s chart to the Pathology
Department.
5.
6.
NO AUTOPSY REPORT IS ISSUED TO THE FAMILY BY THE PATHOLOGY
DEPARTMENT. A copy of an autopsy report may be secured from Medical Records or
the Attending Physician.
7.
Autopsies performed every day of the week including holidays during daytime hours.
Notification of Security
1.
When autopsies are completed, designated Pathology personnel fills out release form 750091-2 and notify hospital Security. Security is responsible for releasing body to
appropriate party.
2.
For disposal of fetus from autopsy, Security calls Pathology to inquire if autopsy or
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surgical is completed.
1.
Monday through Friday from 7:30AM to 5:00PM, call ext. 6405 to notify the Pathology
Office that the autopsy permission has been obtained.
Immediately bring the autopsy consent form and the patient’s chart to the
Pathology Department.*
2.
From 6:00PM to 7:30AM and on weekends and holidays, call the laboratory (ext. 4347471) and notify the charge tech that the autopsy consent forms has been obtained.
Immediately bring the autopsy consent form and the patient’s chart to the laboratory and
deliver it to the charge tech who will notify the pathologist on call.
3.
The actual time of performance of an autopsy depends upon scheduling and is at the
discretion of the prosector (pathologist).
Usually, no autopsies are begun after 4:00PM: therefore, if all paperwork is not in order and the
body is not in the morgue prior to 4:00PM, the autopsy may be delayed until the following
morning.
NOTE: Additional information concerning Histology (Surgical Pathology), Cytology and
Autopsy Service may be found in this manual under the listing of Anatomic Pathology Section
Guidelines.
*If Pathology Office personnel have gone for the day, follow procedure #2 above.
Gross Dissection for Autopsy
Actual performance of the autopsy and the responsibility for recording of tentative and final
interpretation rests with the pathologist who functions as the prosector. Portions of the gross
dissection and certain ancillary procedures may be delegated to and carried out by the pathology
assistant under the guidance and supervision of the pathologist.
The extent of the anatomical dissection may vary from case to case depending upon the
limitations of the autopsy permit, if any, nature of the clinical situation, and suspected or actual
gross findings. Decisions relative to the extent of dissection are left to the judgment of the
pathologist performing the autopsy.
In most cases, when no limitations of consent exist, a complete autopsy is performed which
includes examination of the organs of the neck thorax, abdomen, and pelvis and removal of the
brain.
Tissue removed and Sampled at Autopsy
All gross unfixed tissues remaining after appropriate sampling for histological examination, etc.
are placed in a red plastic bag, sealed and returned with the body. These organs and tissues are
taken with the body to the funeral home. Otherwise, unfixed tissues are incinerated by the
hospital Environmental Services.
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At the time of gross dissection, appropriate gross material is removed and kept for approximately
one year. The actual amount of tissue saved or retained in this manner will depend on the
suspected or actual findings at the time of the autopsy. Representative tissue from all organs
examined should be included in this specimen container. Organs may be saved for diagnostic or
teaching purposes indefinitely.
From the material retained, tissue sections for histology are prepared and processed. The number
of sections required or submitted in each case will vary depending on the findings or suspected
findings and the custom in performance of the pathologist. However, in practically every case,
sections from all major viscera are submitted even if they are grossly normal. In general, all
significant gross observations are documented or represented by a histological section. Fixed
gross material is retained for one year, unless portions or all are felt to be useful for diagnostic or
teaching purposes.
Written Autopsy Protocol
Within one working day following completion of the gross dissection, the Provisional
Anatomical Diagnosis, based on gross observations, is rendered and sent to the Attending
Physician and to the Medical Records Department for inclusion in the permanent record of the
deceased.
The basic final autopsy report will contain the following elements:
1.
2.
3.
4.
5.
6.
Name of the deceased, unit record #, date and time of death, date and time of autopsy,
autopsy number, prosector’s name, attending physician’s name.
Gross description (external, internal [upon opening], description of organ systems or
individual organs).
Provisional Anatomical (PAD).
Description of microscopic slides.
Final Anatomical Diagnoses.
Final note or summary of pertinent findings (optional).
The style and format may vary somewhat in individual cases, and may vary relative to the
custom and preference of the prosector.
CYTOLOGY
Specimens for cytology are sent to a reference lab by the specimen processing area.
All specimens should be brought directly to the specimen processing area; unless it is a fluid or
bronchial washing (then it should go to Rapid Care Chemistry first and be signed in the book.
Information/instructions on how to complete the Cytology form can be obtained from the Send
out dept. at x7609 or the Specimen Processing Department at x4650.
The following is a list of cytology tests that can be performed... See Alphabetical Listing of Tests
for information concerning these tests.
TESTS
12
Abdominal Washings
Aspirations
Breast Smears
Bronchial Washings
Brushings
Buckle Smears for Barr Bodies
Esophageal Brush
Esophageal Washing
Fluid Cysts
Gastric Brush
Gastric Washing
Misc. fluids (must list source)
Needle Biopsies
Peritoneal Fluid
Pleural Fluid
Spinal Fluid
Sputum
Thyroids
Urines
NON-GYN CYTOLOGY:
PLEASE ORDER # 15900 IN HBO. Completed form MUST accompany the specimen before it
can be sent to reference lab.
PLEASE REFERENCE PAP SMEARS FOR ORDERING INFORMATION ON GYN
CYTOLOGY.
For Inpatients Fill in the Forms as Follows:
1.
Enter the patient’s name, address, unit record number, billing number, age, and room
number in spaces labeled NAME AND ADDRESS using the patient’s addressograph
plate.
2.
Enter the name of the physician ordering the test in the space labeled REQUESTING
PHYSICIAN.
Enter date specimen was collected in space labeled ORDERS/SAMPLE DATE.
3.
4.
Enter any pertinent information in space labeled RELEVANT CLINICAL
INFORMATION AND/OR DIAGNOSIS.
5.
For pap smears fill in appropriate spaces concerning patient’s history in spaces labeled:
AGE, LMP, PREGNANT, POSTPARTUM-WKS, POSTMENOPAUSAL-YRS.,
EXOGENOUS ESTROGENS, EXOGENOUS PROGESTERONE, IUD,
PREVIOUS PAP (results and cytology number), PREVIOUS BIOPSY (results and
pathology number), and PREVIOUS X-RAY THERAPY (when completed).
Indicate area from which smears were taken by placing an “X” in the appropriate space
beside SMEARS TAKEN FROM.
6.
For Non-Genital Cytology check the correct box to indicate SOURCE OF SPECIMEN.
7.
Use a typewriter or black ball point pen to complete the form. If writing, USE
13
PRESSURE and write legibly since there are several copies which must be legible
after separation of the form.
For Outpatients Fill in the Form as Follows
1.
Enter patient’s name in space labeled NAME.
2.
Enter patient’s address in space labeled ADDRESS.
3.
Enter COMPLETE billing information.
4.
Fill out remainder of information as described for inpatients listed above.
14
CLINICAL LABORATORY SECTION GUIDELINES
Specimen transport:
Blood and replaceable fluids may be transported to the lab via pneumatic carriers lined with
foam inserts following lab protocol (Refer to Appendix). Fluids that are considered nonreplaceable (example: spinal fluid, pleural fluids etc) cannot be sent through the pneumatic tube
system. They must be brought to the Rapid Care Richland lab accessioning area after orders are
placed.
Effective Date: 5/21/2013
Pevco Pneumatic Tube System SP 2.012.06
1.0
Purpose: The Pevco Tube System provides transport of patient specimens to and
From the specimen processing in the laboratory and various other locations throughout
the hospital. The different tube stations have been assigned a station number and their
pneumatic tubes are labeled by station number. The main tube system in specimen
processing has the ability to receive specimens from four areas and to send specimens to
two areas at the same time. The Medical Park 14
Tube system has 4 stations, each capable of sending or receiving tubes.
2.0
Equipment
2.1
Bio Hazard Bags
2.2
Pneumatic Tube Carriers
3.0
Procedural Steps
3.1
Laboratory Tube Stations
3.1.1 Specimen Processing Main Tube Stations: 35, 3A, 3B, and 3C
3.1.2 Medical Park 14 Tube Stations
3.1.3 Tube Station: 06
3.2
Carriers
3.2.1 The different color carriers represent different things.
3.2.1.1 Black carriers are for forms.
3.2.1.2 Red carriers are for biohazard specimens.
3.2.1.3 Blue carriers are for STU and PICU stat specimens.
3.2.1.4 Green /White carriers are for Emergency Room
3.2.1.5 Yellow carriers and Green/White carriers are for the Point to Point
tube system.
3.3
Incoming Carriers
3.3.1 The red carriers are designed for biohazard specimens only.
3.3.2 The blue carriers are only assigned to STU and are to be considered
STAT. These should be opened and processed immediately. Bags should
be clear with yellow stripe.
3.3.3 The carriers are labeled with their assigned tube station.
3.3.4 The specimen processing area are alerted to the carrier arrival by an alarm
if the specimen is urgent and sent in Point to Point station...
3.3.4.1 Remove the carrier from the arrival station.
15
3.4
3.5
3.3.4.2 Press the clear button to silence the alarm.
3.3.4.3 Remove the biohazard specimen bags from the carriers being sure
to check for specimen leaks or breakage. Open the biohazard bags
and place specimens in the designated area in specimen processing
for receipt in the computer system. Discard the empty biohazard
bags into a biohazard trash can.
3.3.4.4 The empty pneumatic tube is returned to the original station
number.
Outgoing Carriers
3.4.1 The main tube system and the Med Park 14 tube system are also used to
send specimens and supplies to other areas in the hospital.
3.4.1.1 Specimens are placed into appropriately marked biohazard bags
and sealed securely. All specimen lids and tops need to be
completely closed and tightened.
3.4.1.1.1
If any specimen is sent covered in paradigm, the
paradigm has to be adequate to prevent the
specimen from leaking.
3.4.1.1.2
Specimens with snap on lids or in glass containers
are not to be sent through the tube system.
3.4.1.1.3
Any documents or slips that need to be sent with the
specimens should be placed into the outer pocket on
the bag.
3.4.1.2 The sealed biohazard bags are placed in the foam lined red
biohazard carriers to be sent to an assigned station through the tube
system. Do not over fill the carrier.
3.4.1.2.1
Blood culture bottles are to be sent one patient at a
time in individual red carriers to prevent breakage.
3.4.1.2.2
Biohazard specimens are not to be sent through the
tube system in black unlined carriers. The black
carriers are to be used only to send forms or other
documents to other areas within the hospital.
3.4.1.3 Make sure that the carriers are securely closed and the catch locked
into place to prevent the carrier from opening during transport
through the tube system. The carriers are placed on the sending
dock in the main tube system or Med Park 14 Core Lab tube
system and the designation station entered on the keypad.
3.4.1.4 Press SEND and wait for the accepted signal. The carrier will
leave shortly after the signal is “ACCEPTED.”
3.4.1.5 A new station may be selected by pressing “CLEAR” and a new
station selected.
Troubleshooting
3.5.1 Carrier sent to Incorrect Station
3.5.1.1 If the carrier is sent to an incorrect station, call the area and ask
them to return the carrier to the lab.
3.5.1.2 If the incorrect station is not known, call engineering at extension
6521 to track the carrier’s destination. The maintenance engineer
will be able to determine the station the carrier was sent to, and
then the area can be notified to return the carrier to the lab.
16
3.5.2
3.6
3.7
3.8
Specimen/Biohazard us Spill
3.5.2.1 If the carriers arrive contaminated with blood or body fluids,
between the hours of 0730 and 1630, Monday through Friday, call
engineering immediately at extension 46521 to report the spill.
3.5.2.2 If the system contamination occurs any other time other than
engineering normal working hours, beep them at 1530.
Engineering will need to shut down the system and perform the decontamination procedure.
3.5.2.3 Discontinue using the tube system until engineering tells you
otherwise.
Tube System Unavailable for Use
3.6.1 In the event the main tube system is non-operational, each floor (if
decentralized) and each phlebotomist is responsible for transporting their
specimens to the laboratory.
3.6.2 If the areas have access to the Point to Point System, that system can be
used to transport specimens.
3.6.3 In the event that either tube system is down, Med Park 14 or Hospital,
departments will communicate with each other to ensure that all STAT
specimens get transported to the resulting departments as soon as possible.
3.6.4 Any unreasonable downtimes or contamination of the system needs to be
documented in each department’s tube system QA log or Specimen
Processing Problem Log.
3.6.5 Notify engineering at extension 6521 between the hours of 0730 and 1430,
Monday through Friday, of any tube system problem or downtime. After
engineering’s normal working hours, beep them at 1530.
Point to Point Pevco Tube System
3.7.1 Tube Stations
3.7.1.1 ER
station 81
3.7.1.2 OR
station 82
3.7.1.3 NICU
station 83
3.7.1.4 OPS
station 84
3.7.1.5 L&D
station 85
3.7.1.6 Main Lab
station 86
Medical Park 14 Core Laboratory has 4 send/receive stations.
3.7.1.7 Core Laboratory station 111
Body fluids and other difficult to collect specimens should not be sent through the
tube system.
3.8.1 All spinal fluids and other body fluids are to be walked down to the Rapid
Response lab and signed in the fluid book to ensure delivery to the
laboratory.
17
Order Priority Explanations:
Palmetto Health Laboratories will process all samples as soon as possible, with the first
scheduled analytical run, or without undue delay in analysis to assure the optimal specimen
accuracy.
Note: Due to the nature of testing, not all assays qualify for STAT, ASAP and timed turnaround
times. Refer to Laboratory Test Directory.
General definitions of Priorities available:
1. Routine – test usually resulted within 4-6 hrs from receipt in the lab unless batched
2. Timed - two (2) hour lead time for orders - collect by time specified.
3. STAT - resulted within one (1) hour after receipt in lab
4. ASAP - resulted within two (2) hours of receipt in lab.
5. CRISIS – Tests necessary when the patient is in an immediate “life or death” situation.
These requests receive priority over all (including STAT) work in the laboratory.
CRISIS labs must be collected on the nursing unit and walked to the Rapid Care Richland
Lab and are signed in a Crisis Log. These labs are processed immediately. Results will
be called, please give appropriate contact.
6. ADD-To be used only “to add on” to orders that have already been COLLECTED AND
RECEIVED in the lab. Barcode labels will print in the main laboratory and laboratory
personnel will check to see if the specimens are adequate for testing. Lab will call the
unit if not adequate.
7. ADDS-To be used only “to add on” for STAT orders that have already been
COLLECTED AND RECEIVED in the lab. Barcode labels will print in the main
laboratory and laboratory personnel will check to see if the specimens are adequate for
testing. Lab will call the unit if not adequate.
Duplicate Orders
An order inquiry should be checked before orders for laboratory procedures are entered into the
computer. This will ensure that duplicate entries, resulting in duplicate charges to the patient, are
not made. If duplicate orders are entered, floor must cancel. Lab personnel are allowed to cancel
exact duplicates.
Downtime Order Slips
http://mypal/documents/Richland%20Departments/Laboratory/_downtime%20organization.pdfy
Collection of Urine
To ensure accuracy of urinalysis results, the urine must be properly collected. Improper
collection may invalidate the results, no matter how skillfully the tests are performed.
18
Methods of obtaining freshly voided urine samples:
A freshly voided urine specimen is adequate for most urinalysis testing except the bacterial
examination (urine culture and sensitivity).
The patient should be instructed to void directly into a clean, dry container or into a clean
dry bedpan and then transfer the specimen directly into an appropriate container.
Specimens from infants and young children can be collected in a disposable pediatric
collection device, consisting of a plastic bag with an adhesive backing around the pening
to adhere to the child so that he voids directly into the bag.
All specimens should be covered immediately, labeled with the patient’s name, hospital
number, date and time of collection, etc. and brought or sent without delay to Specimen
Processing area of the laboratory.
Mislabeled specimens cannot be processed.
The specimen is then received into the laboratory computer system by laboratory
personnel and taken to the appropriate department(s).
Methods of obtaining a clean voided (“clean catch”) specimen:
Use this technique for a specimen likely to be contaminated with vaginal discharge or menstrual
blood, or when collecting a specimen for bacteriological examination.
The most commonly used procedure for obtaining a suitable specimen for bacteriological
examination is the collection of a clean voided midstream specimen. Bladder catherization and
percutaneous suprapubic aspiration of the bladder may be used, but only in unusual
circumstances, i.e., infants). Collection of clean voided specimens is the method of choice unless
specific contradictions exist.
To avoid contamination of the voided urine organisms in the area adjacent to the meatus, this
area must be cleaned thoroughly before patient voids. To avoid contamination of the specimen
with organisms often harbored normally in the distally urethra, the first urine is discarded and
subsequent midstream urine is collected.
A satisfactory technique for female patients consists of:
Spreading the labia and cleansing the area with a towelette. The washing is
accomplished by making a single front to back motion with three separate areas of
the towelette. One motion is used to cleanse the area on one side of the meatus,
one area for the other side and the last area for the center of the meatus.
While the labia are held apart, a small amount of urine is passed into the toilet or
bedpan (to be discarded).
A midstream specimen is collected in the sterilized container which is
immediately closed with the appropriate lid.
A comparable technique is used for males:
Retracting the foreskin of the penis, cleansing the glands and particularly the area
surrounding the meatus, with three different areas of the towelette.
With the foreskin still retracted, a small amount of urine is passed into the toilet or
19
bedpan (to be discarded). From the subsequent midstream urine a specimen is
collected in the sterilized container.
For infants and children who have not yet been toilet trained sterilized disposable
collection devices can be used to obtain specimens after the perianal area has been
suitably cleaned.
Timed Urine Instruction
Containers for 24 hour urine collections must be obtained from the Specimen Processing Section
in the laboratory. Laboratory Staff will check for inpatient orders for the 24 hour collection and
will label the container with patient’s name and MR# with a permanent marker. Instructions are
printed on forms attached to the container at the time of pick-up from the laboratory. Floors
must enter the patient’s height and weight in metric units as an order for Creatinine Clearance is
placed in Cerner. In addition, all information on the data form must be complete, to include
proper patient identification and times of collection. Height and weight in metric units are also
required on creatinine clearances. Specimens cannot be processed until lab has information
on data tag (See Appendix for form).
Effective Date: 4.1.15
Timed Urine Collection Container Distribution SP 2.009.06
1.0 Purpose: To properly fill out form 2.009. F accompanying 24 hour urine containers that
are distributed to the floors and to outpatients.
2.0
Equipment:
2.1
24 hour urine jug
2.2
Form 2.009. F1
3.0
Procedure
3.1
Using Pathnet ,Order Result Viewer, find orders for
24 hour urine.
3.1.1 For inpatients, the floor will bring the patients chart label to the lab.
3.1.2 Jugs are not to be given out for inpatients without the written
request.
3.2
Write patient’s name, Med Rec number, test requested and today’s date on jug.
3.3
Fill out the bottom portion of form 2.009. 1
3.3.1
3.3.2
3.3.3
3.3.4
3.3.5
3.3.6
3.3.7
3.3.8
Patient’s name
Medical Record number
Room number
Test ordered
Physician
Date container given to nursing staff.
Tech number of the lab personnel completing form.
Place completed form in the plastic bag attached to the jug
20
Timed Urine Collections forms…English and Spanish
ENGLISH FORM
HOW TO COLLECT SPECIMEN
1. Empty bladder at the start of collection and discard the urine. Write the start time and
date on this form.
2. From the start time on, collect all urine and pour into the provided container. If more than
one container is needed, obtain from the laboratory and continue collection in the new
container. Do not interrupt urine collection. Refrigerate the container(s) until it is
transported to the laboratory.
3. Continue to collect urine until the designated end date and time. Empty your bladder and
include this specimen in the collection container. Write this time and date on this form.
4. Bring the specimen to the laboratory as soon as possible after termination of
collection.
ALL INFORMATION BELOW MUST BE COMPLETED TO ENSURE PROPER
PROCESSING
TO BE COMPLETED BY PATIENT OR NURING STAFF
DATE STARTED______TIME STARTED________DATE ENDED______ TIME ENDED________
PATIENT HEIGHT:______(centimeters) PATIENT WEIGHT __________(kilograms) # Containers_____
(Inches times 2.54 = cm)
(Pounds divided by 2.2 = kg)
PERSON COMPLETING FORM ___________________________________________________________
TO BE COMPLETED BY LABORATORY STAFF
PATIENT NAME ____________________________MR#________________________ROOM #_________
TESTS ORDERED (ensure they are entered into the computer)__________________Dr._________________
Laboratory Staff completing form:____________________ Date container
given____________________
21
SPANISH FORM:
RECOLECCIONES DE ORINA CRONOMETRADAS...CÓMO RECOGER LA MUESTRA:
1. Desocupe la vejiga antes de recoger la muestra y deseche la orina.
2. De este momento en adelante recoja toda la orina y viértala en este recipiente. (Si
necesita otro recipiente, obténgalo del laboratorio y continúe. No interrumpa la
recolección de orina y comience de nuevo. Es muy importante recoger toda la orina
dentro del tiempo especificado.) Mantenga el recipiente refrigerado hasta que sea
llevado al laboratorio.
3. Siga recogiendo la orina hasta el punto final designado. En ese momento desocupe su
vejiga e incluya esta muestra en el recipiente recolector. Anote la hora y fecha en esta
solicitud.
4. Lleve la muestra al laboratorio tan pronto haya terminado de recogerla completamente.
TODA LA SIGUIENTE INFORMACIÓN DEBE SER DILIGENCIADA ANTES DE
PROCESAR UNA MUESTRA.
A SER DILIGENCIADO POR EL PACIENTE O EL PERSONAL DE ENFERMERÍA.
(POR FAVOR LLENE TODOS LOS ESPACIOS EN BLANCO):
FECHA DE INICIO________________HORA DE INICIO____________FECHA DE
TERMINACIÓN________________HORA DE TERMINACIÓN____________
ESTATURA DEL PACIENTE_____________cm
NÚMERO DE RECIPIENTES_____________
PESO DEL PACIENTE______________Kg
NOMBRE DE LA PERSONA QUE DILIGENCIA EL FORMATO:
___________________________________________
A SER DILIGENCIADO POR EL PERSONAL DEL LABORATORIO:
Laboratorio Nombre:__________________________________________
Personal del
Nombre del Paciente:
________________________________________#ID__________________________________Habitación______
___________
Exámenes Ordenados:___________________________________Dr.____________________________
Fecha del recipiente
22
Specimen Labeling and Handling
FOR SPECIMENS COLLECTED ON NURSING UNITS:
Specimens which are collected on the nursing unit should have the following information
included on the specimen label and, during downtime situations, on the computer request form in
the appropriate spaces:
1. Time and date specimen collected.
2. Cerner Log In of person collecting specimen
3. Notation of all laboratory tests to be performed on the specimen and on the back up
request form if in downtime.
4. Complete patient name, account number, and unit record number.
5. Source of specimen on specimen and back up request form during downtime.
6. Identification must be verified at time of drawing by matching patient’s name, unit record
number and the account number on the armband with request or lab label or other source
of patient identification. Out Patient identification may be verified with patient’s name
and birth date if arm-banding is not available. Positive patient ID and labeling at the
bedside is critical to the collection process.
7. Specimens that are delivered to the lab mislabeled will be automatically discarded once
floor has been notified by lab personnel.
8. All body fluid specimens except urine must be hand delivered to the Rapid Care
Lab and orders logged into the body fluid log.
In accordance with the Universal/Standard Precautions Policy in effect at PHR:
1. Specimens should be received in sealed plastic transparent bags, including all urine,
stool, fluids, cultures or blood.
2. Specimens that are leaking, spilled, broken, or otherwise damaged, or that have
containers that have been contaminated will not be accepted.
3. Urine specimens from the hospital floors that are received spilled or leaking will be
discarded and the floor notified to recollect specimen.
4. Specimens in syringes with needle attached will not be accepted.
5. Mislabeled specimens will be discarded unless attending physician requests relabeling and proper form is signed in the laboratory.
RELABELING OF CRUCIAL SPECIMENS Q1.031.06
1.0
Policy Statement
1.1
The standard policy of Palmetto Health Laboratories is to obtain new specimens
when an improperly labeled specimen is received.
1.1.1 Relabeling is permitted only as outlined in this policy
1.2
Refer to department policies for relabeling protocols for Blood Bank, Histology,
or Cytology Specimens.
23
2.
Guidelines
2.1.
The Laboratory will not return any specimens to units or clients without the
approval of the manager or supervisor.
2.2.
Definitions:
2.2.1. Mislabeled Specimens:
2.2.1.1.Specimens on which the identification label on the container does
not match the true identity of the patient from which the specimen
was obtained.
2.2.1.2.Specimens sent to the lab labeled with identifiers from multiple
patients.
2.2.2. Unlabeled Specimens: Specimens that are sent to the lab without any
patient identification.
2.2 Irreplaceable Specimens
2.2.2 Examples of irreplaceable specimens may include, but are not limited to:
2.2.2.1 Body fluids
2.2.2.2 Infant collections
2.2.2.3 Cerebrospinal fluid
2.2.3 The attending physician may authorize specimen relabeling if he/she
determines that the specimen cannot be recollected.
2.2.3.1 The attending physician must sign the Palmetto Health Report
Error Form Q1.017:F3
2.2.4 A record of all relabeling is maintained on the result.
2.2.4.1 Refer to Q1.017 Report Errors Policy
2.2.5 Refer to Palmetto Health Corporate Policy B.11 Occurrence Reporting and
Follow-Up
Viral and Rickettsial Requests
Call the Send-Out Department for specifics #7609
Blood/Bone Marrow Collections for Chromosome Analysis
The units will order a chromosome analysis on a patient exhibiting abnormalities or deficiencies.
The patient’s nurse or physician will collect the blood and have the specimen brought to the
laboratory.
Specimen requirements:
1. 2-3cc of peripheral blood collected in a sodium heparin tube only.
2. 2-3cc of bone marrow drawn through a sodium heparin coated syringe and placed in a
sodium heparin tube.
The Blood/Bone Marrow specimen is taken to Send Outs to be sent to the Genetics Lab.
Specimens that are collected on off business hours should be kept a room temperature until
delivery to the Lab the next day. A specimen should never be allowed to sit in the laboratory
over the weekend. In the event a specimen should be collected on Friday or Saturday, then
Genetics Lab personnel should be notified.
Forms to be completed by the ordering physician are available from Send Outs. This completed
24
form must accompany specimen.
Orders for Patients admitted as Trauma M (male) and F (female)
1. Once specimens have been collected and labeled as Trauma Male or Female with
sequential number and sent to the laboratory, orders in the computer should not be
canceled and re-entered when the person’s identity is obtained. The unit record number
will stay the same.
2. When patient’s identification is obtained, registration is up-dated, the Trauma Male or
Female is replaced with patient’s name. The unit record and account numbers remain the
same. Be sure to say “Y” to keep previous name in MPI file.
3. Additional requests entered under the person’s name should be noted in the comments
section of the request slip that they were previously identified as Trauma Male or Trauma
Female, the assigned number, and old unit record number. (Example: Trauma Male #3,
UR#01-21-67-2).
25
STAT Test List
The following tests are those which will be performed on a STAT basis. The time listed for the
performance of each test is the MINIMUM time required for completion of the test after the
specimen is received in the laboratory and when the laboratory is fully-staffed with all equipment
in working order. When multiple requests are received at the same time, some tests may take
longer to complete.
TEST
 ABO/Rh Type
 Acetaminophen
 Betahydroxybutyrate
 Adenovirus,Rapid
 Albumin
 Alcohol (Diagnostic Only)
 Alkaline Phosphatase
 Ammonia, Plasma
 Amylase
 Basic Metabolic Screen
 Bilirubin, Direct
 Bilirubin
 Bilirubin, Total
 Blood Culture, Broth (See Culture Blood Broth)
 Blood Urea Nitrogen (BUN)
 BNP
 Calcium
 C Difficile Rapid PCR
 Cell Count and Diff,CSF
 Cell Count and Diff, Extravascular Fluids
 Chemical Screen, Urine
 Chloride
 CKMB
 CO2 (Carbon Dioxide)
 Complete Blood Count Without Differential
 Complete Blood Count/Auto Differential
 Complete Blood Count/Manual Differential
 Coombs, Direct
 CPK, Total
 Creatinine, Phosphokinase (CPK)
 Creatinine
 D-Dimer
 Differential
 Digoxin
 Dilantin
 Electrolytes
 Electrolytes, Urine (excluding chloride)
 Fibrinogen
TIME
15 Minutes
45 Minutes
20 Minutes
30 minutes
45 Minutes
45 Minutes
45 Minutes
30 Minutes
45 Minutes
30 Minutes
45 Minutes
45 Minutes
45 Minutes
Collected Stat
30 Minutes
90 Minutes
30 Minutes
60 Minutes
60 Minutes
60 Minutes
60 Minutes
30 Minutes
60 Minutes
30 Minutes
30 Minutes
40 Minutes
90 Minutes
20 Minutes
45 Minutes
45 Minutes
30 Minutes
45 Minutes
90 Minutes
45 Minutes
45 Minutes
30 Minutes
30 Minutes
30 Minutes
26





Fresh Frozen Plasma
GGT
Glucose, Extravascular Fluids
Glucose
Gram Stain (Smears)


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




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

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
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
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

Hematocrit
Hemoglobin
Hemoglobin/Hematocrit
HIV-1 Screen (Rapid test)
India Ink Prep
Iron
Ketones, Urine
Lactic Acid, Plasma
Lactic Dehydrogenase (LDH)
Lipase, Serum
Magnesium
Osmolality
Osmolality, Urine
Phenobarbital
Phosphorus
Platelet Count
Potassium
Pregnancy Test, Urine
Protein, Extravascular Fluids
Protein, Total
Prothrombin Time
Prothrombin Time and PTT
PTT (Partial Thromboplastin Time)
Rapid Adenovirus Test
Rapid Influenzae A & B Test
Rapid RSV Test
Rapid Strep Test
Reticulocyte Count
Salicylate
Serum Iron
SGOT/AST
SGPT/ALT
Sickle Cell Test
Sodium
Sodium, Urine
TEG
Tegretol/Carbamezepine
Theophylline
Thrombin Time
Troponin I
Type/Crossmatch Packed Cells/Whole Blood
45 Minutes
45 Minutes
30 Minutes
30 Minutes
30 Minutes ER/OR
60 Min other areas
30 Minutes
30 Minutes
30 Minutes
45 minutes
30 Minutes
45 Minutes
20 Minutes
30 Minutes
45 Minutes
45 Minutes
45 Minutes
30 Minutes
30 Minutes
45 Minutes
45 Minutes
30 Minutes
30 Minutes
20 Minutes
45 Minutes
45 Minutes
30 Minutes
30 Minutes
30 Minutes
30 Minutes
30 Minutes
30 Minutes
30 minutes
45 Minutes
45 Minutes
45 Minutes
45 Minutes
45 Minutes
60 Minutes
30 Minutes
30 Minutes
30 Minutes
45 Minutes
45 Minutes
60 Minutes
45 Minutes
60 Minutes
27




(if blood available at PRMH)
Type/Screen
Uric Acid
Valproic Acid-Stat
White Blood Cell Count
40 Minutes
45 Minutes
1 Hour
30 Minutes
Blood Collection Tube Types
Vacutainer® tubes are used for the drawing of blood, with a few exceptions. They are coded as
to content by different colored tops (rubber stoppers or hemoguard tops). Some contain
anticoagulants required by specific tests and others contain no anticoagulant. When stocked on
floors or in units expiration dates on tubes must be monitored.
The Laboratory Test Directory provides information on the type of tube required and the amount
of blood needed for tests performed in this laboratory and for tests which are sent to reference
laboratories.
Listed below are the types of blood collection tubes available in the laboratory.
BLUE TOP:
This tube type contains 3.2% of Buffered Sodium Citrate as the anticoagulant. The tubes are
available in different sizes. The 2 mL tube contains 0.2 mL of anticoagulant and will be filled
with 1.8 mL of blood. This is considered a neonate draw tube. The 3.0 mL tube contains 0.3 mL
of anticoagulant and takes 2.7 mL of blood. It is used for prothrombin time and other coagulation
studies. Because of the ratio of blood to anticoagulant required for accuracy, tubes must be
90% full. Short draws will only be used with physician permission. Moderate and marked
hemolysis will warrant recollection.
GREEN HEMOGUARD TOP:
The inside wall of this tube is coated with lithium heparin as the anticoagulant. These are required for
the collection of certain tests and may be used for a large number of tests where whole blood or plasma
is required. Green top cannot be used for amylase, lipase, troponin, AST, LIVP, CMP, and HCG.
GOLD HEMOGUARD TOP SST
This tube is available in 3.5 and 6 mL size. It contains a clot enhancer and a silicone barrier
which forms a seal between the cells and serum when it is centrifuged. DO NOT USE THIS
TUBE TO COLLECT SAMPLES FOR BLOOD BANK, THERAPEUTIC DRUG
LEVELS OR SERUM DRUG TESTING.
GRAY TOP:
This tube type contains Sodium Fluoride Potassium Oxalate. It is available in a 2 mL and 4 mL
draw tube. It is used for lactic acid and glucose testing.
LAVENDER TOP:
This tube contains EDTA (ethylenediamintetra-acetate) as the anticoagulant and is used for most
hematological procedures. This tube available in 2 mL size.
PINK:
28
This tube type contains EDTA(ethylenediamintetra-acetate) K2 and is used for all Blood Bank
testing. This tube is available in 6 ml and 2 ml size. NOTE: 2ml FOR NEONATES ONLY
RED TOP:
Red top tubes contain no anticoagulant and are used for tests which require serum for analysis.
They are available in 5ml size and do not have a silicone barrier. These tubes are exceptable for
some Blood Bank procedures and all therapeutic drug levels.
WHITE TOP:
This tube type contains EDTA (ethylenediamintetra-acetate) K2 and is used for collection of HIV
Viral Load specimens. It may also be used for collection of specimens for Hepatitis C PCR testing
(both Qualitative and Quantitative) and HIV-1 Genotyping. This tube is available in a 5 mL size.
PEDIATRIC MICROTAINER® TUBES:
MICROTAINER® BLOOD COLLECTION DEVICES are the tubes of choice when collecting
small amounts of specimens. The Microtainer® tubes come in red tops, lithium heparin green
tops and lavender tops.
NOTE: Before substituting a different type tube than the one listed, contact Phlebotomy (ext.
7216). Some substitutions may be made.
Minimum Specimen Requirements for Pediatrics
MOST COMMONLY ORDERED TESTS
*NOTE: Whole blood requirements aor Pt with normal HCT’s, high HCT’s may require more
blood
TEST NAME
WHOLE BLOOD REQUIREMENTS
Albumin
0.6 mL Green Microtainer® tube
Amylase
0.6 mL Gold Microtainer® tube
Ammonia
2.0 mL Green (Lithium Heparin) on ice delivered to lab
immediately
Bilirubin Direct
Bilirubin, Fractionated
Bilirubin, Total
Calcium
CO2
Cholesterol
Chloride
Creatinine
Digoxin
1.0 mL Plain Red Microtainer® tube
Fibrinogen
1.8 mL Blue (Full)
Gentamicin
Glucose
Hepatitis A Total
Hepatitis A IgM
Hepatitis B Core IgM
Hepatitis B Surface Antigen w/ Confirmation
Hepatitis C Antibody w/ reflex
29
Hepatitis Acute Panel
HIV Antibody
IgA
IgE
IgG
IgM
Iron/TIBC
Lactic Acid
LDH
Lidocaine
Lipase
Magnesium
Osmolality
Osmolality, Urine
Phenobarbital
Phenytoin (Dilantin)
Phosphorus
Potassium
2.0 mL Gray on ice
2.0 mL Red Microtainer® tube
0.5 mL Urine
TEST NAME
Salicylate
Sodium
Theophylline
Total Protein
Tobramycin
TSH
Urea Nitrogen
Uric Acid
Vancomycin
0.6 mL Gold Microtainer® tubes (2)
CHEMISTRY PANELS
Electrolytes - Na, K, Cl, CO2
Basic Metabolic Panel (BMP)
Renal Panel (RENAL)
Comprehensive Metabolic Panel (CMP)
1.0 mL in a Gold tube or 2 full Gold Microtainer® tubes
Lipid Profile
1.0 mL Green tube (Lithium Heparin)
FT4 or T4 ordered with TSH
Drug Screen Urine
1.0 mL Urine (minimum requirement)
BLOOD BANK
Direct Coombs
1.0cc Purple Cone
Indirect Coombs
1.0cc Red Cone
Type & Rh (pt less than 4 mos old)
1.0cc Purple Cone
(pt greater than 4 mos old)
1.0cc Purple Cone
Crossmatch (pt with no history of transfusion)
1.5cc in 2ml Pink tube Pediatric Red Top Tube acceptable.
(pt with history of transfusion)
5.0ccin 6ml Pink tube, RedTop Tube acceptable
IMMUNOLOGY
RPR
1.5 mL Red Top
30
COAGULATION
PT Full
PTT Full
PT/PTT Full
Fibrinogen Full
DDI Full
AT III Full
1.8 mL Blue
1.8 mL Blue
1.8 mL Blue
1.8 mL Blue
1.8 mL Blue
1.8 mL Blue
TEST NAME
HEMATOLOGY
HBG
0.5 mL Lavender Microtainer® tube
HCT
HGB/HCT
Platelet Count
WBC
CBC with diff
CBC
Retic Count
Sed Rate
2.0 mL Lavender Tube
(Microtainer® tubes are not acceptable)
MICROBIOLOGY
Blood Cultures
Routine BacTAlert Adult Set
BacTAlert Pediatric Vial
8 - 10cc per vial (optimal)
1 - 3cc (optimal)
Palmetto Health Richland Children’s Hospital Weight-based Guide Lines for Blood
Culture Volumes
Patient’s Wt
Volume of Blood
Vial Size
0 - 2 Kg
1 mL
3 mL
2.1 - 10 Kg
1.5 mL
3 mL
10.1 - 20 Kg
3 mL
3 mL
20.1 - 39.9 Kg
5 mL
10 mL
>= 40 Kg
10 mL
10 mL
Fungal/AFB Isolator Tube
HIV-1 Screen
1.5cc - Pediatric (under 35lbs)
1.0cc Red Top
SEND OUT
Renin
Urine Viral Isolation
Chromosome Studies
Amino Acid Quant Plasma
3 mL Lavender
1.0 mL Urine
3.0 mL Sodium Heparin Green Tube
3.0 mL Sodium Heparin Green Tube
31
Metabolic Screen
Amino Acid Quant, Urine
5.0 mL urine
5.0 mL urine
32
Legal Blood Alcohols Q1.032.05
1.0
Policy Statement
1.1
Palmetto Health Laboratory employees may be asked to collect legal blood
alcohol specimens for law enforcement.
1.2
Testing for legal blood alcohol is not preformed at Palmetto Health Laboratories.
2.
Guidelines
2.1.
Phlebotomy may be performed at Palmetto Health for legal blood alcohol testing.
2.1.1. Emergency Room (ER) staff normally performs the phlebotomy.
2.1.2. Testing is performed at the State Law Enforcement Division (SLED).
2.2.
When ER staff is unable to perform the phlebotomy, the law enforcement officer
should bring the chain of custody paperwork and client permission to the lab.
2.2.1. The permit must be obtained prior to the specimen being collected.
2.2.2. These forms are provided by the law enforcement officer.
2.3.
Permission for the test must be obtained from the client or guardian without any
coercion or misrepresentation.
2.3.1. The client should be aware of the purpose and possible consequences of
the test.
2.5.2 The person performing the phlebotomy should ask the client if they
understand what is being done.
2.4.
The specimen is collected in two 10 cc Red top tubes
2.4.1. DO NOT USE alcohol to cleanse the site.
2.4.1.1.Betadine, Zepharin, or other non alcohol cleaner should be used.
2.5.
The person drawing the sample must sign the permit after the blood is collected.
2.6.
After proper labeling, the tube tops are sealed with liquid paraffin.
2.6.1. Paraffin is found in the Emergency Department.
2.7.
One of the labeled sealed tubes is given to the patient and the other tube is given
to the law enforcement officer.
2.8.
The permit form is given back to the officer.
2.8.1. One copy is kept for a lab record and for billing purposes.
2.8.1.1.This form should be left with the Staff Assistant for the
Administrative Lab Director.
2.9.
If a client inquires about having their own testing, you may tell them that private
laboratories (ex Quest, Lab Core) may perform legal testing as Palmetto Health
Laboratories do not perform legal blood alcohol testing.
33
Fluid Processing
PURPOSE: To facilitate fluid processing by providing guidelines that will allow the accurate
and timely processing of fluid specimens.
PROCEDURE:
1.
Enter all orders into the computer. Order spinal fluids (CSF) as such; order all other
fluids as extra-vascular fluids. If no code is specified for the test needed order the blood
code and enter the specimen type in the comment section.
2.
Label specimen with patient name, unit record number, fluid type, tests ordered on each
tube, and date collected. Deliver specimen to Rapid Care Lab Urinalysis where you will
sign the fluid in and check off testing to be performed (exception for CPOE orders).
Fluid specimens which are not easily replaced cannot be transported to the laboratory
through the tube system.
3.
In Rapid Care Lab Urinalysis section, log the fluid on the log provided to include all
orders for the fluid specimen. An extra addressograph label can be brought to the
laboratory and applied to the Fluid Log-In Sheet. All information required on the Fluid
Log-In Sheet must be accurately completed. Orders placed via CPOE do not require the
testing to be performed to be checked.
4. If additional orders are requested after the fluid is logged onto the log, a call must be
placed to the laboratory in order for the add-on orders to be processed.
Critical Tests or Significant Q1.018.08
1.0
Policy Statement
1.1
Panic values are results that warrant immediate attention due to potential life
threatening consequences, independent of order priority. Alert or critical results
are those results that may require rapid clinical attention to avert significant
patient morbidity or mortality.
1.2
Tests that are deemed critical (life or death) in nature by the provider or caregiver
based on the patient clinical condition can be ordered as CRISIS priority and
delivered to the lab.
3.
Guidelines
2.1
Reporting Panic / Critical results
2.1.1 All critical results are reviewed by the resulting tech before being accepted
in the Laboratory Computer System (LIS).
2.1.2 GenLab LIS will flag critical values in red and a comment box will
require addition of comment and documentation. Letters of “c” or
“p” may also appear indicating critical results depending on
application.
2.1.3 Blood Bank and Microbiology results that are considered critical
or significant in nature are defined in the department procedures,
34
2.2
and will follow this policy for notification.
2.1.3 Panic values are determined by the Technical Supervisor, Pathologists,
and physicians in consultation with the clinicians served.
2.1.4 Panics may be reflected by the reference lab when test is not performed on
site. Agreements with Reference Labs for notifications
2.1.4.1 These results will be called and documented by Send Out (SO)
department upon releasing the results daily.
2.1.4.2 If Send Out department is closed, the Central Lab Charge Tech
will receive the critical results and follow policy for notification
and documentation
2.1.5 Specimen characteristics are noted on the report where appropriate.
2.1.6 Panics by ordering location:
2.1.6.1 Inpatient panic values are called to the physician or clinical
provider, charge nurse, or nurse assigned to the patient.
2.1.6.2 Outpatient panic values are called to the physician or clinical
provider, or nurse at the physicians’ office.
2.1.6.3 Out Reach panics are called to the client as soon as possible
according to the agreements by their Medical Director and PH
Central Laboratory.
2.1.7 Panic results are called to the appropriate individual immediately upon
resulting, with exceptions as outlined above for Outreach
2.1.8 Do not give results to the answering service or leave on answering
machines.
2.1.9 Have the person receiving results read back the panic value to verify
accuracy to include:
2.1.9.1 Full name and MR# and/or date of birth of the patient
2.1.9.2 Test name
2.1.9.3 Panic result with units of measure
2.1.10 Note the last name of the person receiving results and the time the
results were called as a comment in the LIS
2.1.11 At the discretion of the Senior Tech, the pathologist may be notified.
2.1.11.1
Results indicated an unusual condition
2.1.11.2
Results are questionable
2.1.11.3
Tech is unable to contact responsible party
2.1.12 Any attempts to notify the appropriate person of critical results must be
documented per department procedure.
2.1.12.1
Action should be taken to prevent recurrence of the
communication problem.
Critical Need Tests
2.2.1 If patients are in life or death situations, test may be ordered under CRISIS
priority in Cerner.
2.2.2 Samples will be hand delivered to the laboratory and given to the charge
tech who will be responsible for the sample until completion of testing.
2.2.2.1 If the sample cannot be delivered to the lab, a call can be made to
the supervisor or charge tech to alert that the sample(s) will be
tubed to the lab.
2.2.2.2 Supervisor or charge tech will go to the tube system immediately
to retrieve the sample(s).
2.2.3 Samples will be logged into the CRISIS lab log book
35
2.2.4
2.3
2.4
Tests will be run and resulted as soon as possible before any other testing,
with a goal of less than 15 minutes TAT.
2.2.5 Crisis test results will be called.
Reportable Condition Reporting
2.3.1 PH will comply with all state and national reportable disease
notification listings.
2.3.1.1 Results that require immediate notification to DHEC will
be called immediately
2.3.1.2 Results that require Urgent notification to DHEC will be
reported within 24 hours.
2.3.1.3 All other Reportable Conditions Results will be reported to
DHEC within 3 days
Significant or Unexpected Surgical Pathology Findings
2.4.1 When the Pathologist discovers significant or unexpected surgical
pathology findings they will immediately notify the submitting
physician as indicated, either by telephone or pager. Findings may
include, but are not limited to
2.4.1.1 unexpected malignancy
2.4.1.2 discrepancies between frozen sections diagnosis and
permanent section findings
2.4.1.3 significant findings on special stains
2.4.2 This notification is documented as a comment in the surgical
pathology report.
CRITICAL VALUES
CHEMISTRY
CHEMISTRIES
Ammonia:
0-17 Yrs.
>/= 18 Yrs.
Total Bilirubin:
0 Day:
1-2 Days:
3-30 Days:
>=1 Mos:
Calcium
Ionized Calcium
CO2 >/= 1 mos.
<1 month
Creatinine
>/=19 Yr.
LESS THAN/EQUAL TO
GREATER THAN/EQUAL
TO
NA
NA
109 umol/L
200 umol/L
NA
NA
NA
NA
6.0 mg/dL
0.78 mmol/L
10 mmol/L
9 mmol/L
8.0 mg/dL
15.0 mg/dL
18.0 mg/dL
15.1 mg/dL
13.0 mg/dL
1.58 mmol/L
40 mmol/L
NA
NA
15.0 mg/dL
36
0-18 Yr.
Direct Bilirubin
Glucose
0-60 days
61 days- 17 Yr.
>/=18 Yr.
Lactic Acid
Magnesium
Male >/= 18 Yr.
Male 0-17 Yr.
Female >/= 18 Yr.
Female 0-17 Yr.
Osmolality (Serum)
Phosphorus:
Potassium:
0-5 mos.
>/= 6 mos.
Procalcitonin
Sodium:
0-30 Days
31 Days - 12 years
>/=13 years
Troponin
Acetaminophen
Alcohol
Amikacin Peak
0-17 years
Amikacin Trough
3m-17yrs
0-2months
Carbamazepine(Tegretol)
Cyclosporine
Dilantin
Digoxin
Gentamicin Peak
0-17 years
Gentamicin Trough
3m-17yrs
0-2 months
Lithium
Phenobarbital
Salicylate
Tacrolimus
NA
NA
4.0 mg/dL
9.0 mg/dL
40 mg/dL
40 mg/dL
40 mg/dL
NA
201 mg/dL
400 mg/dL
501 mg/dL
5.0 mmol/L
1.0 mg/dL
1.0 mg/dL
1.0 mg/dL
1.0 mg/dL
240 mOsm/kg
1.2 mg/dL
6.0 mg/dL
5.0 mg/dL
7.0 mg/dL
5.0 mg/dL
350 mOsm/kg
8.9 mg/dL
2.5 mmol/L
2.5 mmol/L
0 ng/mL
7.0 mmol/L
6.5 mmol/L
2 ng/mL
125 mmol/L
125 mmol/L
120 mmol/L
150 mmol/L
160 mmol/L
160 mmol/L
0.60 ng/mL
201 ug/mL
300 mg/dL
40.00 ug/mL:
12.00 ug/mL
7.00 ug/mL
20.1 ug/mL
500 ng/mL
40.0 ug/mL
2.6 ng/mL
15.0 ug/mL
2.5 ug/mL
1.2 ug/mL
2.1 mmol/L
61 ug/mL
41 mg/mL
25.0 ng/mL
37
Theophylline
Tobramycin Peak
0-17 years
Tobramycin Trough
0-2 Mos.
3 Mos.-17 Yrs.
Valproic Acid
Vancomycin Trough
0-17 years
25.1 ug/mL
15.0 ug/mL
1.2 ug/mL
2.5 ug/mL
201 ug/mL
25.0 ug/mL
HEMATOLOGY
HEMATOLOGY
Hemoglobin
(0-1 mos)
(>1 mos)
Hematocrit
(0-3 mos)
(> 3 mos)
WBC
(0-3 mos)
(> 3 mos)
Platelet Count
(0-2 mos)
(> 2 mos)
LESS THAN/ EQUAL TO
GREATER THAN/EQUAL
TO
9.6 g/dL
5.5 g/dL
NA
NA
25%
18%
65%
60.00%
2.0 K/uL
1.0 K/uL
50.1 K/uL
75.0 K/uL
50 K/uL
1,000 K/uL
20 K/uL
1,000 K/uL
LESS THAN/ EQUAL TO
50%
100 mg/dL
NA
NA
GREATER THAN/EQUAL
TO
NA
NA
4
150.0 seconds
COAGULATION
COAGULATION
Antithrombin III
Fibrinogen
INR
PTT
PARASITOLOGY
Positive Malaria Smears
Presence of all pathologic parasites from O&P exam
38
MICROBIOLOGY
Positive Smear/Culture from CSF, Blood or Body Cavity
Fluids.
Positive India Ink Prep
Positive Blood Cultures
Positive Rapid Bacterial Antigen Detection Test for Legionella urinary antigen and Streptococcus pneumonia
antigen
Positive AFB (acid-fast bacterial) smears or cultures
Postive Cultures for Neisseria Gonorrheae or N. Meningitidis, Listeria,
Haemophilus Influenzae (Invasive), Streptococcus Pneumoniae (Invasive)
Positive Stool Cultures for Salmonella, Shigella, Campylobacter or Ecoli O157:H7.
Positive Stool Cultures for Parasites
Positive PCR test/cultures for Bordetella
Positive Rapid HIV test
Positive Smear/Culture from Tissue Samples from OR, to include bone and cornea samples
Positive Carbapenemase Isolates
Positive Bordetella pertussis PCR
IMMUNOLOGY
Positive Cryptococcal Antigen (CSF or Serum)
Positive Heparin Induced Platelet Antibody
Positive C Difficile Toxin A/B
REFERENCE LAB
Positive Western Blot
Panic value results as determined by the reference lab will be called by the reference lab to the
Palmetto Richland Lab. Palmetto Richland Lab will then call the panic value result per lab
policy.
39
Collection Process
1.0
2.0
PH1.005.13
General Information
1.1 Scan the patient’s armband and have them verify their name and Date of Birth.
1.1.1 If the patient does not have an armband, DO NOT collect any
blood work until an armband is placed on the patients arm by the nursing
staff.
1.1.2 If discrepancies are found during the identification process such as
account number or MR# that does not match, do not draw the patient’s
blood until a new armband can be placed on the patient by the nursing
staff.
1.2
Verify proper collection tubes and quantity for unfamiliar tests with coordinator
or computer system (i.e. Cerner) before start of collection.
Inpatients
2.1
Check tray and requisitions before leaving lab to insure all necessary equipment is
available for proper blood collection.
2.2
Check on sample requirements before you leave the lab if you have any doubts
about what to draw.
2.3
Knock on patient’s door and announce your arrival by introducing yourself and
continue with AIDET (A – Acknowledge, I – Introduce, D – Duration, E –
Explaination, and T – Thank You) scripting for Excellent Service.
2.3.1 Acknowledge: the patient by name.
2.3.1.1 Hello Mr(s) _______ (while making eye contact with the patient.
2.3.2 Introduce: yourself, your reason for entering room, and your experience.
2.3.2.1 (My name is _______and I am here from the lab to draw blood
your physician has ordered for your care. I have been drawing
blood for _____years and will make this as pleasant as possible.
2.3.3 Duration: Give an estimate of time it will take you to complete the
blood draw while you are identifying the patient and gathering
your supplies.
2.3.3.1 Mr(s)________, I do apologize for the interruption and will be
finished in about five minutes.
2.3.4 Explanation: Explain what you are doing as your go through the steps .
2.3.4.1 I must verify you are the patient I am to draw (for your safety).
2.3.4.2 I will place a tourniquet on your arm to find the best vein to insure
to collect the best specimen possible.
2.3.4.3 I do need to collect____tubes so you will see me changing tubes,
but, will not feel the change.
2.3.4.4 Once the draw is complete, I will hold pressure to the site until the
bleeding has stopped. I will then tape gauze to the site to apply
continued pressure to insure no bleeding occurs.
2.3.4.5 If you have any questions or concerns, you can reach me at x7216.
2.3.5 Thank You: Thank the patient (and family members if in the room).
2.3.5.1 Thank you Mr(s)_______for allowing me to help you feel better.
2.3.5.2 For Family Members: Thank you for supporting Mr(s) ______and
your cooperation during collection.
2.4
If the patient insists on knowing what you are drawing always get the patient’s
nurse to answer the question(s) before proceeding with the blood collection.
40
2.5
2.6
2.7
2.8
2.9
2.10
2.11
3.0
Ask the patient to repeat his/her name and date of birth.Compare the name and
date of birth with the information found on the Pathnet barcode label.
Do not rely on labels at the foot of the patient’s bed or on the bed’s arm rail
Perform venipuncture or capillary stick according to instructions in this manual.
Label all specimens before leaving the room with the patient’s name, hospital
number, Cerner login and the time and date of collection. Document the collect
time and workload on your collection sheet.
Refer to B8.018.02 Labeling Specimens for Crossmatch/Type and Screenfor these
tests.
Apply bandage to the puncture site before leaving room; if patient is alert and
requests that you not bandage the site, make sure he/she understands that pressure
must be applied for several minutes to prevent bruising.
If you were unable to collect the specimen, notify the nurse in charge of the
patient and also indicate “can’t stick” or “C/S”, your tech number, time and date
on your collection sheet.
2.10.1 You must notify the Coordinator of the C/S and it will be assigned to
another phlebotomist.
2.10.2 The unsuccessful phlebotomist is expected to accompany the reassigned
phlebotomist to observe their attempt to collect the specimen.
2.10.3 If reassigned phlebotomist is unsuccessful, notify the patient’s nurse and
she will notify the patient’s physician.
2.10.4 The general rule is 2 phlebotomists to attempt and each attempt 2 times
each.
Specimens are promptly sent to the accessioning area to be received in the
computer with proper collect time.
2.11.1 If specimen is your last collection, hand deliver the specimen to the
laboratory for receiving.
2.11.2 If other collections are needed, tube the specimen to the laboratory for
receiving.
2.11.3 It is your responsibility to ensure your specimens are received by clearing
pendings.
Outpatients
3.1
Outpatients should be accommodated immediately.
3.1.1 Although there is usually a person assigned specifically to outpatient
coverage, it is the responsibility of any phlebotomist who is available at
the time to assist with outpatient collections.
3.2
Check the labels you have versus the prescription carefully and draw all blood
needed. Failure to do this may result in the patient’s having to return to the
hospital due to lab error
3.2.1 If patient has to return to the hospital for recollection, it is the
responsibility of the phlebotomy department to notify the patient.
3.2.2. The recollection must be documented in the outpatient Call Back log
immediately along with who called the patient and when the patient will
return.
3.3
Always ask the patient to state his/her full name and their date of birth/age.
This is the only assurance you have that ensure you have the proper labels to
collect the proper patient.
3.3.1 If patients are not able to give you the information, check to see if
someone accompanying the patient can give the information.
41
3.3.2
3.3.3
3.4
3.5
3.6
3.7
3.8
Never give the information and then ask if that is correct.
If the patient is reluctant to give you the information, explain that it is for
their protection and identification safety.
Place an aliquot label on the outpatient log sheet after the venipuncture or
fingerstick is performed and document the date and time the specimen was drawn,
tubes collected and your tech code.
Make sure bleeding has stopped before allowing the patient to leave the lab. This
is especially important with patients on anticoagulant therapy or those with
special bleeding disorders. Always place a bandage on the puncture site before the
patient leaves.
All STAT priority patients must have a STAT label placed on each tube.
All collected outpatient samples are to be delivered to accessioning and handed
directly to the STAT Processor.
3.7.1 Stat priority collections are to be announced to the STAT processor upon
delivery.
Be sure patient collects urine specimen when indicated.
4.0
Emergency Room Patients
4.1
The Emergency Room staff collects its own specimens. In cases where a patient is
very difficult to draw and in certain other special situations, the lab may be called
to assist with specimen collection.
4.2
All blood work from the Emergency Room should be collected immediately.
4.3
Often the ER physicians add last-minute orders for blood collection. Be sure that
all orders have been prepared before beginning blood collection.
5.0
Decentralized Areas
5.1
Most of the areas of the hospital are decentralized so they collect their own blood
work. In cases of a very difficult draw the lab may be called to assist with the
specimen collection.
5.2
Ask what tests need to be collected. If they can be done by fingerstick, suggest
this to them. If not, explain to the caller that we will be there as soon as we
possibly can.
5.3
Phlebotomists are not authorized to:
5.3.1 Perform arterial sticks
5.3.2 Perform venipuncture on lower extremities — must have physician’s order
to do so
5.3.3 Draw from a central line
5.3.4 Draw above an IV site, insert IV catheters or manipulate IV infusions
5.3.5 Instill heparin
5.3.6 Draw from patient with no ID bracelet
5.3.7 Collect blood from arm with an active fistula, shunt, etc.
5.3.8 Stick more than twice
5.4
Areas the phlebotomist should avoid:
5.4.1 Above an IV site
5.4.2 Patient’s receiving transfusions unless directed to do so by the caregiver
5.4.3 Do not draw from heparin locks, central lines, IVs or fistulas
5.4.4 Side of a mastectomy
5.4.5 No feet extremities
5.4.6 Swollen or badly bruised extremities
5.4.7 Scarred areas (excessively) — can be difficult to puncture
42
5.4.8 Bruising indicates a previous hematoma and is usually painful (erroneous
results may be obtained due to excess tissue fluid
5.4.9 Use care with edematous patients — excess fluid can alter test results by
diluting constituents.
5.4.10 Never stick more than 2 times
5.4.11 DO NOT PROBE WITH NEEDLE!
6.0
Other Considerations
6.1
6.2
6.3
6.4
6.5
Patients on IV:
6.1.1 Ask nurse to turn off IV for at least 2 minutes if drawing from same arm.
Perform venipuncture below IV.
6.1.2 Apply tourniquet, select vein other than one with IV
6.1.3 Perform the stick
6.1.4 Draw a red top tube or waste tube ( approximately 5ml of blood)
6.1.5 Collect the blood
6.1.6 Document the collect time and workload on your collection sheet
Incomplete/No collection:
6.2.1 Move needle slightly forward
6.2.2 Move needle slightly backward
6.2.3 Adjust angle
6.2.4 Release tourniquet— if it is too tight can restrict blood flow into arm
6.2.5 Try another tube
6.2.6 Re-anchor the vein in case it has rolled
Blood Stops:
6.3.1 Vein collapse — try smaller tube
6.3.2 Needle pulled out — start over
6.3.3 Try new tube
Difficult Patients/Patient Refusal:
6.4.1 Try to persuade the patient to permit the blood collection. Emphasize that
the physician wants this done.
6.4.2 Do not discuss or explain ordered test.. This is the physician’s
responsibility.
6.4.3 If gentle persuasion does not work, report problem to the
nurse. The nurse may be able to persuade the patient.
6.4.4 If patient still refuses, obtain the nurse’s name, document
on the lab log and return to the lab. Share this information on to the
coordinator.
Other Problems:
6.5.1 Hematoma formation — abort immediately
6.5.2 Arterial stick hold extended pressure and document
6.5.3 Patient refusal — try to convince, notify nurse and document
6.5.4 Fainting— stop, inform nurse (if outpatient, notify pathologist on
clinicals)
6.5.5 Convulsions stop, call for help (same as above)
6.5.6 Communication problems — ask for assistance
6.5.7 Tremors — ask for assistance
6.5.8 Do not stick where there are casts, dressings, fraction
6.5.9 Do not stick when there are no signs of life
43
6.5.10 ALWAYS observe special precautions
Correct Order for Drawing Tubes PH1.016.07
1.0
Purpose: An order of draw is used during the collection process to reduce the effects of
cross-contamination. Cross-contamination occurs during the tube exchange when a drop
of blood mixed with tube additives enters the following tube. Cross-contamination can
result in the patient being redrawn due to the contamination
2.0
Examples of additive tubes:
2.1 Green top – Lithium Heparin, Sodium Heparin
2.2 Gray top – Fluoride, Oxalate
2.3 Purple/Pink top – EDTA
2.4
Blue top – Citrate
2.5 Gold/Red – SST
3.0
RECOMMENDED order of draw
3.1
Blood cultures
3.2
Blue
3.3
Gold/Red SST
3.4
Green
3.5
Lavendar/Pink
3.5.1 Other additive tubes (gray, etc.)
4.0 Reasoning behind this order of draw:
4.1 The blood culture tubes are drawn first to avoid contamination.
4.2 The coagulation tubes (blue) may be drawn first for PT/INR or aPTT
testing with syringe or Vacutainer® tube collections.
4.2.1 A blue top partially filled discard tube must be drawn for all coagulation
tests collected with a winged collection set to prime the tubing of the
collection set.
4.3
Additive tubes are drawn last to prevent contamination of the non-additive
tubes.
44
Correct Order for Drawing Tubes PH1.016.07
1.0
Purpose: An order of draw is used during the collection process to reduce the effects of
cross-contamination. Cross-contamination occurs during the tube exchange when a drop
of blood mixed with tube additives enters the following tube. Cross-contamination can
result in the patient being redrawn due to the contamination
2.0
Examples of additive tubes:
2.6 Green top – Lithium Heparin, Sodium Heparin
2.7 Gray top – Fluoride, Oxalate
2.8 Purple/Pink top – EDTA
2.9
Blue top – Citrate
2.10
Gold/Red – SST
3.0
RECOMMENDED order of draw
3.1
Blood cultures
3.2
Blue
3.3
Gold/Red SST
3.4
Green
3.6
Lavendar/Pink
3.6.1 Other additive tubes (gray, etc.)
5.0 Reasoning behind this order of draw:
5.1 The blood culture tubes are drawn first to avoid contamination.
5.2 The coagulation tubes (blue) may be drawn first for PT/INR or aPTT
testing with syringe or Vacutainer® tube collections.
5.2.1 A blue top partially filled discard tube must be drawn for all coagulation
tests collected with a winged collection set to prime the tubing of the
collection set.
4.3
Additive tubes are drawn last to prevent contamination of the non-additive
tubes.
Blood Collection: Venipuncture PH1.010.07
1.0
Principle: A patient’s veins are the main source of blood for laboratory testing as well
as a point of entry for IVs and blood transfusions. Since only a few veins are easily
accessible to both laboratory and other medical personnel, it is important that everything
be done to preserve their good condition and availability.
2.0
Equipment
2.1
Tourniquet
2.2
2.3
2.4
2.5
2.6
70 % alcohol prep pads
Dry gauze pads
Appropriate evacuated tubes for test ordered
Evacuated blood collection system holder or syringe
Plastic adhesive pressure strip
45
2.7
2.8
PPE – gloves (goggles, face shield, and gown as needed)
Honeywell Handheld Device
3.0
Procedure
3.1
Be sure to knock on the patient’s door before you enter the room.
3.2
Properly identify the patient by scanning the patients armband and have them verify their
name and date of birth.. This is the most important step in the performance of a
venipuncture. Do not draw a patient if he/she is not wearing an armband.
3.3
Use AIDET (Acknowledge, Introduce, Duration, Explanation, and Thank You)
3.4
If the patient wants to know more information, refer his/her questions to the nurse.
3.5
Check for diet restrictions
3.6
Check above the patient’s bed for any restrictions concerning the collection of blood.
3.7
Properly position the patient.
3.8
Always wash hands before and after each patient. Always wear new gloves with each
new patient.
3.9
Prepare your equipment before you apply the tourniquet.
3.9.1 Select the proper size needle. Needle choice depends on the size of the vein.
3.9.2 The most frequently used needle is the 21 gauge. The higher the gauge number,
the smaller the diameter or bore.
3.9.3 For extremely small veins, use a 22 or 23 gauge needle.
3.9.4 The length of the needle (1 to 1.5 inches) is an individual choice
3.10 Select the tubes needed for patients orders displayed on Handheld scanner.
3.11
Select site for venipuncture. DO NOT DRAW BLOOD ABOVE AN INTRAVENOUS
INFUSION.
3.12
Application of Tourniquet: Wrap the tourniquet around the arm approximately 3 to 4
inches above the area where you are going to “feel” for a vein. Hold one end taut and
tuck a portion of the end under the taut end to form a loop.
3.13
Clean venipuncture site with 70% alcohol after locating the vein of choice to stick. Dry
with a dry gauze pad.
3.14
Grasp the patient’s arm approximately 1 to 2 inches below the venipuncture site. Pull the
skin tight with your thumb to keep the vein from rolling.
3.15
Perform the venipuncture.
3.15.1 The needle should be held at approximately a 15 degree angle to the
patient’s arm and in a direct line with the vein.
3.15.2 The syringe or tube should be below the venipuncture site to prevent backflow,
and the arm (or other venipuncture site) be placed in a downward position.
3.15.3 Turn the needle so that the bevel is in an upward position.
3.15.4 Puncture the vein. The puncture of the skin and vein should be done, if
possible, in one motion.
3.15.5 If a syringe is used, care must be taken not to pull on the plunger too rapidly or
forcefully.
4.0
Quality Assurance
4.1
Do not attempt to stick a patient more than two (2) times. If after the second attempt you
are
unsuccessful, obtain help from another phlebotomist.
4.2
DO NOT STICK ABOVE AN IV. If an IV is running in both arms, and no other vein is
available except in the arm of the IV administration, specimens may be drawn below the
IV as follows:
4.2.1 Speak with the patient’s nurse to see if he/she will turn off the IV for no less than
2 minutes before venipuncture.
4.2.2 Apply the tourniquet below the IV site. A vein other than the one with the IV
should be used.
4.2.3 After performing the venipuncture, draw 5mL of blood. Discard this blood then
draw the blood sample to be used for testing.
46
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
Make sure that all blue top tubes have a “full draw.” Improperly filled tubes will not be
accepted for testing.
A discard tube must be drawn before the blue top tube if the phlebotomist s collecting the
sample with a winged collection set. The discard tube must
be a plain red or blue top tube.
Label all tubes AFTER you have stuck the patient, NEVER BEFORE.
If swelling occurs around the venipuncture site during collection, immediately
release the tourniquet, remove the needle, and apply pressure with the gauze pad.
USE NEEDLES AND LANCETS ONLY ONCE AND DISCARD IN A SHARPS
CONTAINER
NEVER DISPOSE OF USED NEEDLES IN THE WASTE BASKET
NEVER RECAP A USED NEEDLE.
NEVER CUT A USED NEEDLE.
Do not keep the tourniquet on a patient’s arm for more than 1 to 2 minutes.
The order of tube draw is important for obtaining accurate values and preventing the risk
of contaminating a subsequent tube with the additive from a tube just collected.
4.12.1 If a tube containing the potassium salt of EDTA is collected prior to a tube for
electrolyte evaluation, it is possible the potassium value could be falsely
increased.
4.12.2 The order in which blood is added to tubes when a syringe is used is important,
because of the possibility of micro clots, which can cause erroneous coagulation
and hematologic results.
4.12.3 Please follow the correct order of draw as described in CLSI H3-A6.
Collection and Handling of Coagulation Specimens PH1.017.09
1.0
Purpose: Specimens collected for coagulation studies must be drawn properly to ensure
a good sample is obtained. Special attention must be given to patients who are on IV
heparin to avoid specimen contamination
2.0
Drawing Procedure
2.1
All coagulation tests must be drawn as the second tube if the collection is with a
winged collection set and mixed immediately.
2.1.1 The discard tube must be used to prime the tubing of the collection set.
2.2
PT/INR and aPTT coagulation tests can be drawn as the first tube with collections
by syringe or Vacutainer® tube and mixed immediately.
2.3
If the patient is receiving IV heparin:
2.3.1 The best collection is a peripheral stick in the opposite arm. The nurse
should turn off the IV for 10 minutes prior to this collection.
2.3.2 If a line draw is performed, the nurse should turn off the IV for 10
minutes prior to the collection.
2.3.2.1 Then perform a 10cc flush before collecting the sample in a
separate syringe.
2.3.2.2 Then transfer the appropriate amount of blood from the syringe to
the 3.2% Sodium Citrate tube.
2.4
Mix collected tube immediately and send to Specimen Processing.
3.0
Collection Tubes
47
3.1
3.2
4.0
BD 3.2% Sodium Citrate
For normal hematocrits, collect the following amounts:
3.2.1 Tube volume 3.0 ml = 0,3 ml Citrate and 2.7ml Blood
3.2.2 Tube volume 2.0 ml = 0.2 ml Citrate and 1.8ml Blood
Unacceptable Specimens
4.1
Coagulation tubes less than 90% full.
4.2
FSP tubes that are filled more than the required 2 mL volume.
4.3
Clotted specimens.
4.4
Coagulation specimens that are moderately or grossly hemolyzed are
unacceptable for testing.
4.5
Prothrombin Time (PT) over 24 hours old if unopened. Over 8 hours old if
opened.
4.6
PTT over 4 hours old.
Venipuncture Quality Assurance
BLOOD COLLECTION: VENIPUNCTURE
1.
Do not attempt to stick a patient more than two (2) times, if after the second attempt you
are unsuccessful, obtain help from another phlebotomist.
2.
DO NOT STICK ABOVE AN IV. If an IV is running in both arms, and no other vein is
available except in the area of the IV of the administration, specimens may be drawn
below the IV site as follows: (1) Speak with the patients nurse to see if he/she will turn
off the IV for no less than 2 minutes before venipuncture. Never turn off IV yourself!
Notify nurse to restart IV after you finish and document!
3.
Make sure that all blue top tubes have a “full draw”, or appropriately filled. Partial draws
will not be accepted for testing. Always draw another tube, preferably a red tube, before
collecting the specimen in the blue tube.
4.
Label all tubes AFTER you have stuck the patient, NEVER BEFORE.
5.
If you notice the venipuncture area beginning to swell while you are drawing the blood,
immediately release the tourniquet, remove the needle, and apply pressure with the gauze
square.
6.
NEVER DISPOSE OF USED NEEDLES IN THE WASTE BASKET.
7.
Do not keep the tourniquet on patient’s arm more than 1 to 2 minutes.
8.
The order of tube draw is important for obtaining accurate values. This is suggested
especially when using the evacuated tube system, because there is a risk of contaminating
a subsequent tube with the additive from a tube just collected. For example, if a tube
containing the potassium salt of EDTA is collected prior to a tube for electrolyte
evaluation, it is possible that the potassium value could be falsely increased. Likewise,
the order in which blood is added to tubes when a syringe is used is important because of
the possibility of micro clots, which can cause erroneous coagulation and hematologic
48
results. The recommended order of draw is outlined on the following page.
Blood Collection from Infants
PRINCIPLE:
To obtain adequate and accurate blood specimens from infants with the least amount of trauma
while maintaining good isolation techniques. Routine venipuctures are not performed on
patients under 12 months of age unless an experienced phlebotomist is comfortable with
performing venipunture.
EQUIPMENT:
Gloves, gauze pads, alcohol swabs, sterile lancet, microcollection tubes, 4x4 gauze pads to wrap
the foot.
PROCEDURE:
1.
Observe the safety regulations required for entrance into the infant care facility.
2.
Review the request for type of test(s) ordered and prepare the required equipment,
including labeling materials.
3.
Use only blood collection tray designed for the nursery units.
4.
Remove all jewelry.
5.
Wash hands with supplied soap using aseptic technique. (See section on proper hand
washing for nursery units).
6.
Put appropriate personnel protective safety gown.
7.
Sleeves must be pushed above the elbows at all times while in the nursery units.
8.
Approach the patient.
9.
Observe feet for any unusual marks, bruising, skin tears or abrasions and notify nursing
personnel immediately. Document name of the staff nurse notified.
10.
Identify the patient by matching the request label ( full name and MR # ) with the
patient’s ankle bracelet. Account numbers are essential for glucose screen testing
11.
Apply a heel warmer to the site for 3 minutes.
12.
Cleanse the site with alcohol and allow to air dry. The presence of alcohol will quickly
hemolyze the blood.
13.
Mix all additive tubes properly. Failure to mix immediately after collection will cause
clots to form.
14.
Properly label all samples collected for transport to the laboratory to the laboratory
specimen processing center.
49
15.
Properly dispose of all contaminated collection materials.
16.
Wash hands using aseptic technique.
QUALITY ASSURANCE NOTES:
1.
Make sure the area for the skin puncture is completely dry before carrying out the
procedure.
2.
Remember not do squeeze heel too tightly to avoid diluting the blood with tissue juices.
3.
On all laboratory labels, note whether the specimen is from a skin puncture.
4.
Because platelets have a tendency to clump, it is a good idea, particularly if a number of
different tests are ordered, to collect the anti-coagulated blood first.
5.
Do not stick a baby more than twice to obtain a specimen at any given time.
6.
Do not puncture a foot if there are bruises, abrasions, or sloughing skin present. Call this
to the attention of the nurse.
7.
To help obtain a free-flowing puncture wound from a baby who does not bleed freely,
wrap the baby’s heel in a heel warming device for 5 minutes.
8.
Use only gentle massage when obtaining blood. Excessive massaging dilutes the blood
with tissue fluids and may cause hemolysis.
9.
NEVER re-puncture old puncture wounds.
10.
NEVER remove a baby from its bassinet or change its position in any way without the
approval of a nurse.
11.
Age limit for pediatric heel sticks: Pediatrics that are of the age of pulling themselves up
on their feet (usually around 6 to 7 months of age) are too old to have heelsticks
performed. Fingersticks should be performed at this age and older.
12.
Properly secure the puncture site.
PROCEDURE FOR HOLDING THE INFANT FOOT:
When doing a heelstick on an infant, hold the heel gently but firmly. This may be done in one of
two ways: (1) place the forefinger around the ankle, and thumb over the arch of the foot or (2)
place the forefinger over the arch of the foot and the thumb below the puncture site at the ankle.
13.
Use only lancets with a maximum tip length of 2.50 mm. Make the puncture in one
continuous, deliberate motion perpendicular to the puncture site. Punctures should be
made on the most medial or most lateral portion of the plantar surface (shaded areas in
the diagram of an infant’s foot below). It is also recommended that you do not perform
skin punctures on the posterior curvature of the heel.
NOTE: The depth of the skin puncture in the heel is important in infants, particularly neonates. It
50
must not exceed 2.5 mm. Penetration of the calcaneus bone, osteomyelitis, and sepsis have all
been reported as potential complications.
14.
Perform the skin puncture smoothly and quickly. Hold the lancet across the skin grain as
this will allow the blood to form in a well rounded drop. If the puncture is made with the
grain of the skin then the blood will run along the grains and not form a rounded drop.
15.
Maintain the pressure on the site, a needed. Do not hold continuous pressure as this will
not allow a free flow of blood to accumulate at puncture site. Apply gently pressure again
to form another rounded drop of blood.
16.
Wipe the first drop off since excess tissue fluid will dilute and/or cause clumping of the
specimen.
17.
Collect an adequate sample for each request and follow the correct order for draw.
18.
Apply the direct pressure to the site until the bleeding stops. A pressure pad should be
applied along with a bootie wrap to aid in the puncture site to clot.
19.
If more than one microcollection tube is needed, always collect additive tubes first. Good
blood flow is more critical for anti-coagulated specimens than serum specimens. Also,
never “scoop” the blood from the surface of the skin. This can cause platelet clumping,
which can make a hematology or blood bank specimen unsuitable for analysis. Instead,
drops of blood should be allowed to flow freely into the collection top and down the
walls of the tube. Clumps or hemolysis in a specimen will cause rejection of the specimen
by the laboratory and necessitate a re-draw.
20.
Skin puncture blood is neither venous or arterial blood. It is a mixture of blood from
arterioles, venules, and capillaries and also contains a small amount of tissue fluid. No
clinically important differences are found between skin puncture serum and skin puncture
plasma. However, there are important clinical differences between skin puncture blood
and venous serum in four constituents - glucose, potassium, total protein, and calcium.
Except for glucose, concentrations in venous serum are higher. These differences do not
diminish the value of the specimen but indicate that the origin of the specimen must be
taken into account when interpretating test results.
21.
Osteochondritis, or bone cartilage infections, of the heel of newborns can be complication
of skin puncture. To avoid this, follow these guidelines:
a.
b.
c.
d.
Punctures should be made on the most medial or lateral portions of the plantar or
flat surface of the heel.
Puncture should NOT be made on the posterior curvature of the heel where the
bone is closet to the skin.
Punctures should NOT be made deeper than 2.5 mm.
Punctures should NOT be made through previous puncture sites because hidden
infection may be present.
A proper area for heelstick can be determined by imaging a line drawn posteriorly from the
middle of the big toe to the heel and another drawn posteriorly from the 4th and 5th toes to the
heel. The puncture should be medial to the 1st line or lateral to the 2nd line. The arch is
51
unacceptable due to the potential for tendon, cartilage and/or nerve injury.
babyLance Heelstick Lancet PH 1.025.04
1.0
Principle:
All babyLance lancets are automated, producing a standardized surgical quality incision
for sampling blood from preemies and newborns. The skin of humans, especially babies,
has unique stress-strain characteristics that result in remarkable skin compression and
indentation from even minor pressure. Any pressure from a device on the infant’s heel
will indent the skin, causing the skin cells to elongate and compress in a distinct,
stratified manner. The degree of skin indentation increases the depth of any wound. If
the skin indent is 2.0 mm when using a lancet device that punctures to 2.4 mm, the
puncture depth will surpass a hazardous 4.0 mm.
The babyLance principle is to assure an incision of uniform depth and length with a
large, flat blade-slot surface which the blade protracts, enabling it to be flush against the
child’s heel without undue pressure or skin indentation. The penetration depth is 1.0 mm
with Newborn babyLance and 0.85 penetration depth for Preemie babyLance.
2.0
Equipment
2.1
Personal Protection Equipment
2.2
Gauze
2.3
70% Alcohol Pads
2.4
Microtainer® tube collection tubes
2.5
Heelwarmers
2.6
babyLance Heelstick Lancet
3.0`
Procedure
3.1
Follow the proper patient identification protocol before collection.
3.2
Review the test(s) ordered and prepare the required collection supplies.
3.3
Apply all required Personal Protection Equipment before contact with
infant.
3.4
The heelstick should be obtained from the proper collection area.
3.4.1 One area is determined by a line extending posteriorly from a point
between the 4th and 5th toes and running parallel to the lateral
aspect of the heel
3.4.2 Next area is determined by a line extending posteriorly from the
middle of the great toe running parallel to the medial aspect of the
heel.
3.5
Proper collection position for infant.
52
3.5.1
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
3.15
3.16
3.17
The baby should be placed in a supine (lying on back) position with the
knee at open end of the support surface.
3.5.1.1
This allows the foot to hang lower than the torso,
improving blood flow
Place infant heel warmer over heel for 5 minutes.
Clean the incision area of the heel with a 70% alcohol swab.
3.7.1 Allow to air dry or wipe with a clean dry gauze pad.
3.7.2 Do no touch the incision site or allow the heel to come into contact
with any non-sterile item or surface.
Remove the babyLance device from its blister pack taking care not to rest
the blade slot end on any non-sterile surface.
Remove the safety clip and Do Not push the trigger or touch the blade
slot.
Raise the foot above the infant’s heart level and select a safe incision site.
3.10.1 Avoid any edematous area or site within 2.0 mm of a prior wound.
Place the blade-slot surface of the device flush against the heel so that its
center point is vertically aligned with the desired incision site.
Ensure both ends of the instrument have made light contact with the skin,
and depress the trigger.
Immediately remove the instrument from the infant’s heel and lower the
heel to a position level with or below the baby.
Using only a dry sterile gauze pad, gently wipe away the first droplet of
blood that appears at the wound site.
Collect blood in the proper collection Microtainer® tube and fill to the
appropriate specimen volume without making direct contact to wound site.
Gently press a dry sterile gauze pad to the incision site until bleeding has ceased.
3.16.1 Pressure held on incision site will help prevent a hematoma from forming.
Place a pressure pad over the incision site and wrap the foot in a bootie wrap
made of 4x4 gauze.
4.0
Conditions affecting the procedure
4.1
Heel edema
4.2
Re-incision of prior wound site
4.3
Inflamed heel
4.4
Excessive pressure and skin indentation from placing the instrument on
the heel, resulting in deep and hazardous wound depths.
5.0
Limitations of the procedure
5.1
Care and proper procedure must always be followed to avoid injury.
5.2
Poor vascularization may cause inadequate blood flow.
5.2.1 Warming heel to 42 degrees to 44 degrees will improve blood
flow.
5.2.2 Temperatures above 44 degrees will burn the heel.
53
Line Collection Procedure PH1.044.04
1.0
Purpose: Phlebotomy is responsible for the accurate and timely collection of specimens
on specified units. Some patients have arterial lines which can be used to obtain blood
samples without requiring venipuncture. Phlebotomy does not have the authorization to
access arterial or any other direct patient lines. Access can only be obtained by
registered nursing staff. In the event a patient has a line from which blood can be
obtained, the following procedure will apply.
2.0
Patients with Line Access
2.1
The 3rd shift Phlebotomy Coordinator will send line draw sheets to the floors of
laboratory responsibility at the beginning of their shift on a daily basis.
2.2
Each floor will complete the line draw sheet by listing patients with working line
access in the appropriate room number on the sheet.
2.2.1 Patient information to include
2.2.1.1 Patient Name
2.2.1.2 Patient Medical Record Number
2.3
Each floor will send the completed Line Draw Sheet to the laboratory by 1:00 am
each day.
2.4
Phlebotomist will not be in attendance for patients listed on Line Draw Sheet
during blood collections.
3.0
Lab Orders for Patients with Line Access
3.1
All patients with line access will be collected by nursing staff.
3.1.1 Laboratory will provide common laboratory supplies to obtain appropriate
collections from patients will line access.
3.1.1.1 Tubes Stocked on floor
3.1.1.1.1
Gold
3.1.1.1.2
Green – Lithium Heparin
3.1.1.1.3
Lavender 3.1.1.1.4
Pink – Blood Bank orders only
3.1.1.2 Supplies Stocked on floor
3.1.1.2.1
10ml Syringes
3.1.1.2.2
Transfer Device (transfer blood from
syringe to appropriate tube).
3.1.2 Laboratory Supplies Storage Location
3.1.2.1 6W – Nurses Station
3.1.2.2 7E – Medication Room
3.1.2.3 7W – Medication Room
3.1.3 Other collection supplies should be requested from laboratory if
appropriate for line collection.
3.2
Labels for Timed laboratory tests print two (2) hours prior to scheduled
collection. Printed laboratory labels will be delivered to appropriate
designee on each floor by the assigned phlebotomist.
54
4.0
3.3.1 6W – Unit Secretary
3.3.2 7E – Charge Nurse
3.3.3 7W – Charge Nurse
3.3.4 8E – Charge Nurse
3.3.6 10E – Charge Nurse.
3.3
All STAT and ASAP orders collected by line access will be labeled with patient’s
chart labels.
3.3.1 The Coordinator will call the Charge Nurse with each STAT and ASAP
order.
3.3.2 Laboratory labels will be tubed to the unit upon Charge Nurse
request.
Inaccessible Lines
4.1
When lines are no longer accessible, the patient’s nurse will contact the
Phlebotomy Coordinator at 434-4650 to inform the lab that venipuncture will
need to be performed until further notice.
4.1.2 The phlebotomist will document on the Line Draw Sheet the request for
venipuncture on all laboratory orders until further notice.
4.1.2.1 The phlebotomist will document the name of the calling nurse and
time of call.
4.2
All orders received after notification of inaccessible lines, will be collected by a
phlebotomist via venipuncture.
Needleless Transfer System PH1.014.05
1.0
Principle:
This system has been devised to assure a safe transfer of blood using a
syringe collection method to a Vacutainer® tube. It is to protect the health care worker from
needlesticks and exposure to HIV and HBV. It is an approved OSHA methodology and has been
instituted through Palmetto Health Richland under the guidance of the Nursing Safety
Coordinators.
2.0
Equipment:
2.1
Syringe
2.2
Syringe needle protection device
2.3
BD Blood Transfer Device
2.4
Vacutainer® Tubes
3.0
Procedure: ***Wear Gloves At All Times***
3.1
Prepare the Needleless Transfer System before beginning the venipuncture
procedure to ensure specimen integrity.
3.2
After venipuncture is performed and the venipuncture site has been dressed, the
safe transfer of blood from the syringe to Vacutainer® tube is needed. The
collection person/phlebotomist must work quickly to prevent micro-clots from
forming.
3.3
Safety lock the syringe needle with the protection device and remove from
syringe.
55
3.4
3.5
3.6
3.7
3.8
3.9
Dispose of the needle in the biohazard sharps container.
Attach the syringe to the BD blood transfer device.
Follow the Order of Draw before transferring blood.
Place Vacutainer® tubes in the holder and push to penetrate the needle through
the rubber stopper.
3.7.1 Aliquot blood as appropriate to the tests needed.
3.7.2 Change Vacutainer® tubes as needed (tubes will fill automatically).
Label tubes appropriately.
Dispose of Needleless Transfer device in biohazard sharps container.
Unacceptable Specimen Protocol
BLOOD SPECIMENS
Acceptable: Positive patient ID requires the matching of a patient armband with a lab label /
collection list / Cerner list with pt full name, MR#, and account # where applicable.
All blood specimens are to be received in the lab properly labeled with complete patient
information.
This is to include:
1-the patient’s full name
2-unit record / MR number
3-time of specimen collection
4-date of specimen collection
5-initials or tech number of person collecting specimen.
Unacceptable:
I. If a blood specimen is improperly labeled, i.e.:
a-name only
b-incorrect unit record / MR number
c-wrong name and unit record number
d-no labeling information at all
The specimen will be rejected and a request for a new specimen will be initiated.
In the event the specimen cannot be recollected due to the time frame or difficulty of obtaining a
new specimen (see recollection protocol), the patient’s physician MUST be notified by the nurse
in charge. The unit who performed the original collection will have to come to the laboratory and
correctly label the specimen and documentation MUST be performed with the person’s signature
making the correction. Documentation will be made in the Laboratory Sunquest Computer
stating the specimen was relabeled.
NOTE: See Lab Policy per Relabelling of CRUCIAL Specimens .
SPECIMEN WILL NOT BE SENT BACK TO THE UNIT FOR CORRECTION.
II. Blood tubes have cracks or have been broken in transit.
56
Specimen recollections will be requested.
III. Blood specimens have not met special draw requirements causing inaccurate results.
Special draw requirements means:
a. not placed on ice
b. not delivered to the lab in a designed time frame for that test
c. collected in a improper tube/anticoagulant, etc.
A recollection will be requested.
Urine Specimens
Acceptable:
All urine specimens are to be received in the lab in a sealed biohazard bag. Urine specimens are
to be completely labeled with:
1-patient’s full name
2-unit record / MR number
3-physician
4-TESTS DESIRED WRITTEN ON THE LABEL
The addressograph label is acceptable.
Specimens will be accepted in a tightly sealed urine cup or a syringe that has been capped off.
All 24 hour urine specimens MUST have complete patient information written on the container
to match the request form as well as completion of test request form information for time and
date of start and completion and patient’s height and weight for creatinine clearance requests.
Unacceptable:
I.
Any urine container that is sent to the lab leaking in the bag will be rejected. A recollect
will be requested.
If a recollect is not possible, the unit will be notified and a unit employee will be
responsible for cleaning the specimen container making it suitable for handling.
II.
Any urine syringes received with needles attached will be rejected. Either a recollection
must be performed or a unit employee will have to come to the lab making the specimen
suitable for handling.
III.
Any urine sample sent to the lab mislabeled will be discarded. The unit will be notified
prior to discard and documented. In the event a urine sample can not be obtained on the
patient, the same protocol will apply as with the blood specimen on re-labeling the
specimen.
IV.
Any urine specimen received in the lab with no patient information will be discarded.
Documentation MUST be kept in the event a call comes to the department inquiring
about results.
57
PH1.027.10 BacT/Alert®Blood Culture Collection
1.0
Policy Statement
Blood Cultures are collected whenever the physician has reason to suspect
clinically significant bacteremia. Blood Cultures are one of the most important cultures
performed in the Microbiology Department. Blood Cultures help to indicate the severity and
extent of spread of an infection. They provide for the identification and antimicrobial
susceptibility of the etiological agent causing a severe or life-threatening disease. Therefore,
the technique and procedure used in the collection and processing of these specimens are
important for proper patient care.
2.0
Skin Antisepsis
2.1
The most important procedure during the collection process is proper skin antisepsis.
Although variable from person to person, many bacteria, both gram positive and
gram negative, are present on the skin.
2.1.1 Gram-negative organisms and yeast are less common inhabitants on normal,
healthy skin but are not uncommon on the skin of hospitalized patients or
hospital personnel.
2.1.1.1
There is a high risk of blood culture contamination from the
skin of the patients and from the skin of the collecting
phlebotomist.
2.1.1.2
The significance of these organisms, although usually
nonpathogenic in nature, may be difficult to establish when
they are isolated from a blood culture because of their role in
causing endocarditis from implanted prosthetic material
infections.
2.2
The laboratory must report all microorganisms isolated from the blood cultures.
2.3
The physician must interpret the report and decide whether the isolate is clinically
significant or whether the isolate is a contaminant.
2.3.1 If the isolate is interpreted as clinically significant, a designated treatment
protocol is indicated.
2.3.2 The patient could be committed to additional hospitalization for treatment at
considerable expense and some risk because of possible adverse toxic effect
due to antibiotics.
2.4
The role the phlebotomist, by his/her expertise or lack of it, either contributes to the
patient's welfare or possibly causes misleading information to be reported.
3.0
Equipment
3.1
BacT/Alert® Blood Culture Bottles
3.2
Butterfly Collection Set (with luer adapter and holder) or
Syringe System (BD)
3.3
ChloraPrep® One-Step 1.5 ml Frepp®Applicators (Medi Flex)
3.4
70% Alcohol Pads
3.5
PPE: All proper PPE to include gloves, gowns and masks (if applicable),
4.0
Reagents
4.1
ChloraPrep®One-Step 1.5 ml Frepp®Applicators
4.1
Chlorhexidine gluconate 2% (w/v) and Isopropyl alcohol 70% (v/v)
58
4.2
4.2
4.3
4.4
Warnings
4.2.1 For external use only.
4.2.2.1 Flamable: Keep away from fire or flame.
4.2.2.2 Use with care in premature infants or infants under 2 months of age.
These products nay cause irritation or chemical burns.
4.2.2.3 Do not use on patients with known allergies to cholorhexidine
gluconate or isopropyl alcohol.
BacT/Alert® PF (Pediatric: Yellow) Ingredients and Volume:
4.2.1 Complex Media 16 ml
4.2.2 8.5 % Charcoal Suspension 4ml
4.2.3 Soybean-Casein Digest 2.00% w/v
4.2.4 Brain Heart Infusion Solids 0.1% w/v
4.2.5 Sodium Polyanetholesulfonate 0.025% w/v
4.2.6 Pyridoxine HCI 0.001% w/v
4.2.7 Menadione 0.0000625% w/v
4.2.8 Hemin 0.0000625% w/v
4.2.9 L-Cysteine 0.025% w/v
BacT/Alert® FA (Aerobic: Pale Green) Ingredients and Volume:
4.3.2 6.5% Charcoal Suspension 8 ml
4.3.3 Soybean-Casein Digest Broth 2.0% w/v
4.3.7 Menadione 0.0000725% w/v
4.3.8 Hemin 0.0000725% w/v
4.3.9 L-Cysteine 0.03% w/v
BacT/Alert® FN (Anaerobic: Orange) Ingredients and Volume:
4.4.2 8.5% Charcoal Suspension 8 ml
4.4.3 Soybean-Casein Digest Broth 2.0% w/v
4.4.7 Menadione 0.0000625% w/v
4.4.8
4.4.9
5.0
Hemin 0.0000625% w/v
L-Cysteine 0.025% w/v
BacT/Alert Blood Culture Bottle Warnings
5.1 Prior to use, each vial should be examined. Do not use Bottles if you observe
any of the following:
5.1.1 Damage or deterioration (discoloration)
5.1.2 Contamination such as cloudiness
5.1.2.1 A contaminated vial could contain positive pressure.
5.1.2.2 If contaminated vial is used for direct draw, gas or
contaminated culture media could be refluxed into the
patient’s vein.
5.1.3 Excessive gas pressure (bulging septum)
5.1.4 Leakage
59
6.0
5.1.4.1 If spillage or leakage occurs after the vial has been
inoculated, treat the leak or spill with caution as pathogenic
organisms/agents maybe present.
5.1.5 Always check expiration date before collection. Never use expired
bottles for patient collection.
5.1.6 Observe the bottom of each bottle before use.
5.1.6.1 Do not use bottle if the bottom disk displays a yellow
fluorescence. The yellow fluorescence indicates bottle
contamination.
Procedure
6.1
Preparation of Site. The site or source of blood collection influences the
contamination rate of blood cultures. Cultures of blood from the umbilical
or femoral vein are more likely to be contaminated than are those of blood
from the antecubital vein. Indwelling intravascular catheters become
colonized with bacteria when left in place for longer than 48 hours. Cultures
of blood taken from such catheters are more likely to become contaminated
than are those of blood collected by percutaneous venipuncture.
6.1.1 An antiseptic agent (Chloraprep) requires at least 1 to 2 minutes
before they exert any significant activity against most skin bacteria.
6.1.2 The Chlorsprep must be allowed to completely air dry.
6.1.3 Once the venipuncture site has been prepared aseptically, it should
never be touched unless the fingers used for palpitation have also
been disinfected (in the same manner as the venipuncture site).
6.2
Preparation of BacT/Alert Bottles
6.2.1
Remove the plastic flip top from culture bottle and disinfect with
an alcohol pad. Do not use betadine.
6.3
Method of Specimen Collection
6.3.1
Blood can be drawn with a butterfly transfer set consisting of
sterile tubing with a needle at either end. This is the
recommended Collection Process.
6.3.1
Blood can be drawn with a sterile needle and syringe.
6.4
Specimen Collection – Butterfly
6.4.1 Wash hands thoroughly and don gloves.
6.4.2 Identify the patient with the full name and medical record number.
6.4.2.1 Step 4 may be done before Step 2. While you prepare your
equipment the Chloraprep may be given the appropriate
amount of time to air dry.
6.4.3 Assemble and prepare the equipment.
6.4.4 Perform AIDET (Acknowledge, Introduce, Duration, Explanation
and Thank you)
6.4.5 Pinch the wings on the Chloraprep scrub applicator to break the
ampule and release the antiseptic.
6.4.4.1 Do not touch the sponge.
6.4.4.2 Wet the sponge by pressing and releasing the sponge
against the venipuncture site until liquid is visible on the
skin.
6.4.6 Apply Choloraprep with back and forth strokes of the applicator for 2
minutes to thoroughly disinfect the selected site.
6.4.7 Allow the area to air dry for approximately 60 seconds. Do not blot
or wipe away.
60
6.4.8
6.4.9
6.4.10
6.4.11
6.4.12
6.4.13
6.4.14
6.4.15
6.4.16
6.4.17
Reapply tourniquet without touching the venipuncture site. Place
the patient’s arm in a flat position on a solid surface.
Without touching the site, pull tight on the skin and insert the needle
from the butterfly with luer adapter and tube holder (bevel up) into
the vein.
Once blood begins to flow through the rubber tubing, attach bottles
(pale green aerobic bottle first) to the holder to collect the blood.
6.4.10.1 Blood culture bottle must remain in an upright position to
prevent reflux of reagent into patient.
6.4.10.2 Maintain control of the luer connector by securing it
between the thumb and forefinger.
Blood culture bottles are filled directly using the needleless
adapter, not allowing any broth from the bottle to contaminate the
butterfly line.
Remove needle from the vein smoothly and apply pressure.
Label each bottle with a barcode label, collection time, and
collector identification..
6.4.12.1 Do not place labels over barcode on bottles!
6.4.12.2 Use the clear area length wise to place patient label on.
6.4.12.3 Include the site of collection on the label.
Check site to ensure bleeding has stopped and apply pressure
bandage.
Discard collection device in sharps container and all other
supplies in trash.
Wash hands thoroughly.
Blood Culture specimens are sent to Specimen Processing to be
received and delivered to Microbiology.
6.5
7.0
Specimen Collection Syringe (with butterfly or syringe needle)
6.5.1
Follow steps 6.4.1 through 6.4.8
6.5.2
Without touching the site, pull tight on the skin.
6.5.3
Insert the needle (bevel up) into the vein and fill syringe
6.5.4
Remove needle smoothly from arm and activate safety device
6.5.5
Apply pressure
6.5.6
Attach needleless transfer device to syringe
6.5.7
Fill Blood Culture bottle (Orange Anaerobic bottle first to prevent
oxygen entering the bottle – only if maximum quantity is
collected)
6.5.8
Add tube holder adapter to fill other blood tubes using correct
blood draw order as outlined in Order of Draw.
6.5.9 Follow steps 6.4.13 through 6.4.17
6.5.10 Fungal and AFB Blood Cultures can not be collected by this
method. Continue to use the Isolator Tubes for Fungal and
AFB. See Isolator Fungal/AFB Procedure.
Collection Requirements
7.1
Adult Requirement
7.1.1 Collect one Pale Green (Aerobic ) and one Orange (Anaerobic)
bottle for each culture ordered.
61
8.0
9.0
7.1.1.1 Insert 5 – 10 mls of blood to each bottle, optimal is 8-10 ml
per vial.. Do not deviate from these volumes. Volumes less than
the recommended amount may compromise organism recovery.
7.1.1.2 If your patient is a difficult draw and can only obtain a small
amount of blood, please place the collection in the pale
green Aerobic bottle only. Must be at least 5 mls.
7.1.1.2 Children 30-80 lbs ; 5-10 mls per culture. Children >80 lbs
and adults 10-20mls divided between anaerobic and aerobic vials.
7.2 Pediatric Requirements
7.2.1 Collect one Yellow pediatric bottle for each culture ordered.
7.2.1.1 Insert 4 mls of blood into the pediatric bottle.
7.2.1.2 If your patient is a difficult draw and can only obtain a small
amount of blood, please place a minimum of 2 mls
in the yellow pediatric bottle.
7.2.1.3 Neonates to 1 yr.(<4kg):0.5-1.5ml/vial (1ml is
preferred)*Note:2 separate cultures are generally not possible.
7.2.1.4 Children 1 to 6: 1ml per year of age,divided between 2
cultures(i.e.,0.5ml to 3ml per culture)Physician should always be consulted
concerning the amount,especially if the child is below normal weight or
has had previous venipunctures.
Labeling
8.1
Label each bottle with a barcode label, collection time and collector
identification. Do not place labels over barcode on bottles! Use the
clear area length wise to place patient labels.
References
9.1
Package Insert BacT/Alert®, bioMerieux, S. A., December 2007
9.2
Clinical and Laboratory Standards Institute, H3-A6 Procedure for the
Collection of Diagnostic Blood Specimens by Venipuncture; Sixth
Edition
10.0
Initial Date of Policy
11.0
Author
7.26.1995
J.Dixon
Revised by Dee Dailey 8.5.1997
Revised by Rachele Bosley 11.24.1998
Revised by Kendal Ringer
8.7. 2003
Revised by Angela McCrea 8.1.2005,
12.22. 2005
Revised by Paula Lundy 11.3.2006,
3.14.2008, 2.26. 2010
Toni Aversa 7.27.2015
62
Effective Date: May 19, 2015
CR1.033.01 NEWBORN SCREENING PANEL
1.0
Principle:
1.1 All infants born in a Palmetto Health nursery are screened for detection of
some of the more common congenital disorders.
1.2 Testing is performed at the South Carolina Department of Health and Environmental
Control (DHEC) and includes testing for:
1.2.1 Amino Acid Profile including PKU
1.2.2 Galactosemia (GAO and GALT)
1.2.3 T4 and TSH for Congenital Hypothyroidism (CH)
1.2.4 Congenital Adrenal Hyperplasia (CAH)
1.2.5 Hemoglobinopathies (Sickle varaints,etc)
1.2.6 Acylcarnitine (including MCADD)
1.2.7 Biotinidase Deficiency
1.2.8 Immuno Reactive Trypsin (IRT) for Cystic fibrosis
1.2.9 Succinylacetone (SUAC) for Tyrosinemia, Type I
1.2.10 Severe Combined Immunodeficiency (SCID)
2.0 Procedure
2.1 Palmetto Health nursery staff is responsible for the ordering and collection of the
newborn screens.
2.2 The Newborn Screening Panel is ordered in Cerner Powerchart.
2.3 A capillary blood collection by heel stick is performed as outlined in 3.0 below
following instructions provided by DHEC and in accordance with Clinical and
Laboratory Standards Institute (CLSI) document BNS01.
2.4 The filter paper to be used in the collection of the specimen for the initial testing is
attached to DHEC form 1327.
2.4.1 It is the responsibility of the nursery staff to ensure that the supplies for
the collection of the Newborn Screen are used within their expiration date.
3.0Collection Instructions
3.1 Blood should be collected at least 24 hours after birth or as closely as possible to the
time of discharge from the hospital.
3.1.1 If discharged early, specimens collected from infants receiving only nonlactose containing feedings must be clearly marked as such.
3.2 Cord blood is NOT acceptable for newborn screening in SC and should never be
applied on the filter paper collection form.
3.3 To aid in getting sufficient circulation to collect an adequate sample, you may place
the infant’s foot in warm water (no higher than 104ºF) for 3 minutes, or wrap in a
warm moist towel or diaper.
3.3.1 Precaution: Wear gloves and liquid resistant lab coat or apron while
collecting and preparing blood for shipment.
3.3.2 Cleanse infant’s heel with 70% isopropyl alcohol
3.2.2.1 Use only rubbing alcohol
3.3.3 Allow heel to air dry
3.3.4 The puncture should be within the area shown.
63
3.4 Using lancet, perform puncture while holding the infants limb in a dependent
position.
3.5 Gently wipe off first drop of blood with sterile gauze or cotton ball as the initial drop
contains tissue fluid.
3.6 Wait for spontaneous flow of blood
3.7 Allow the drop of blood (not the heel) to touch the printed side of the filter paper.
3.7.1 Allow the blood to soak through and completely fill circle with
SINGLE application of LARGE blood drop.
3.7 Apply blood to one side of filter paper.
3.8.1 Do NOT layer successive drops of blood in one circle.
3.9 Allow blood specimen to AIR dry thoroughly on level non absorbent surface such as
a plastic coated test tube rack at least 4 hours at room temp.
3.9.1 DO NOT stack or heat to dry.
3.10Place dried filter paper forms into mailing envelope provided and deliver as
outlined in 6.0 Specimen Transport below.
64
4.0 Special Circumstances
4.1 If the infant is to undergo a transfusion of blood products, a specimen should be
obtained prior to the transfusion.
4.1.1 If this is not possible, collect the specimen and mark the form “Transfused
Yes” indicating the date of the most recent or last transfusion.
4.1.2 Infants who receive transfusions should have a repeat hemoglobinopathy,
Biotinidase, and GALT screening 120 days after the date of the last
transfusion.
4.1.3 Do not mark the “Transfused yes” box if the transfusion took place > 120
days before the collection date.
4.2 In premature infants, the results can be falsely abnormal.
4.2.1 If the infant is on a lactose containing feeding, the specimen should be
collected at least 24 hours after birth.
4.2.2 If the infant is receiving only IV fluids (NPO) or total parenteral nutrition
(TPN), the specimen may be collected at least 24 hours after birth and the
lab slip marked “TPN” or “NPO”
4.2.3 All premature infants should receive their initial screening by 7 days of
age regardless of their health status.
5.0 Limitations
5.1 Failure to wipe off alcohol residue may dilute the specimen and adversely affect test
results.
5.2 Puncturing the heel on posterior curvature will permit blood to flow away from puncture,
making proper spotting difficult.
5.2.1 DO NOT LANCE ON PREVIOUS PUNCTURE.
5.3 Milking or squeezing the puncture may cause hemolysis and a mixture of tissue fluids
with the blood.
5.4 Capillary tubes may be used; however, we do not recommend this procedure since
application of blood with a capillary tube results in scratching the surface of filter paper,
adversely affecting test results.
5.5 Avoid touching area within filter paper circles before blood is applied.
5.6 Do not:
5.6.1 Allow water, feeding formulas, antiseptic solutions, etc. to come in contact
with the sample.
5.6.2 Place filter paper in the envelope until thoroughly dry as insufficient
drying adversely affects test results.
5.6.3 Mash blood into filter paper.
5.6.4 Staple or tape flap over blood spots.
5.6.5 Ship dried blood spot specimens in plastic bags.
6.0 Specimen Transport
6.1 Specimens collected in a Palmetto Health hospital that are ready for transport to DHEC
may be delivered to the Rapid Care labs on each of the Palmetto Health campuses to be
taken by laboratory courier to DHEC.
6.1.1 Date and Time are stamped on the specimen envelope when courier picks
specimen up from the Palmetto Health laboratory.
6.1.2 DHEC sends a quarterly report by email to the Laboratory Directors and
the Vice-President over the Laboratories to ensure that specimens are
delivered to DHEC within 24 hours of collection.
65
6.1.3
6.1.2.1 The Laboratory Directors for each campus review the report and
investigate delays for specimens collected in Palmetto Health
hospitals.
Specimens collected in a physician’s office should be mailed to DHEC in
the mailer envelop provided by DHEC within 24 hours.
6.1.3.1 Mail by first class mail
7.0 Results
7.1Are mailed by DHEC to the Palmetto Health laboratory that the infant was born and to the
infant’s pediatrician.
7.2 Reports for Palmetto Health Richland are mailed to the Send Outs Department in the
Central Laboratory.
7.2.1 Reports for infants that are still inpatients are delivered to the
nursery by the Send Outs staff.
7.2.2 The nursery staff scans the reports into the patient’s chart.
7.2.3 For discharged newborns the reports are sent by the Send Outs to
Health Information Management (HIM) to be scanned into the patient’s
chart.
7.2.4 Nursery staff reviews all results and notifies pediatricians of tests
needing to be repeated due to unacceptable specimens being submitted.
7.3 Reports for Palmetto Health Baptist are mailed to the administrative assistant for the lab
director.
7.3.1 Reports are sent to HIM to be scanned into the patient’s chart.
7.3.2 A list of infants needing repeat testing is provided to the nursery
staff by the administrative assistant.
7.3.3 Nursery staff notifies the pediatrician of recollects.
7.4 Reports for Palmetto Health Parkridge are mailed directly to the nursery staff.
7.4.1 Nursery staff sends reports to HIM to be scanned into the patient’s
chart.
7.4.2 Nursery staff reviews results and notifies pediatricians of tests
needing to be repeated.
8.0 Charges
8.1 Charges are generated when the initial screen is ordered.
8.2 DHEC does not charge for repeat testing.
8.3 For Palmetto Health Richland, Send Outs (SO) staff reviews charges as results are
received from DHEC to ensure that no charges have been generated from repeat testing
on Palmetto.
8.4 For Palmetto Health Baptist, nursery staff reviews charges to ensure that there are no
duplicate charges.
8.5 For Palmetto Health Parkridge, nursery staff reviews charges to ensure that there are no
duplicate charges.
9.0 References
9.1 Clinical Laboratories Standards and Institute NBS01-A6 Blood Collection on Filter
Paper for Newborn Screening Programs; Approved Standard- Sixth Edition July 2013
9.2 South Carolina Department of Health and Environmental Control Bureau of
Laboratories Services Guide –Tenth Edition 2006
10.0 Initial Author/Date: Ann Shuler BS, MT (ASCP) 04.17.2015
66
Blood Bank Procedures
B8.018.03 LABELING AND COLLECTION OF SPECIMENS FOR BLOOD BANK
Proper identification of patient, patient’s sample and blood
products is crucial to safe transfusion. A correctly labeled specimen is the
first step in transfusion safety. Verification of all patient information prior
to transfusion is the final crucial step in transfusion safety.
For other Blood Bank tests, proper identification of patients and correct
labeling of specimens is also imperative in obtaining accurate test results.
1.0
Principle
2.0
Safety Precautions
2.1
Refer to PH 1.005 Collection Process for requirements applicable to
collection of samples for testing.
3.0
Equipment
3.1
Computer order labels or patient ID labels (chart labels)
3.2
Blood Bank armbands, if applicable
Collection and Labeling of Samples For Crossmatch/Type and Screen
4.0
Sample Requirements
4.1
Pink-stoppered tubes (K2 EDTA) are preferred.
4.1.1 Plain red-stoppered tube (no additive) are acceptable
4.1.2 Lavender-stoppered EDTA tubes are acceptable.
4.2
Samples used for compatibility testing must be collected within 3 days of
transfusion. The day of collection is Day 0.
4.3
For information on specimens for other Blood Bank tests, refer to 6.0.
4.4
The patient’s hospital bracelet and the computer order label must match
exactly for patient name, medical record number and date of birth.
Palmetto Health Richland Only 4.4.1 – 4.4.3
4.4.1 Specimens drawn by an outside source may use a unique identification
system other than a Palmetto Health Richland medical record number.
4.4.2 Specific requirements for outside samples are described in SOPs specific
for those facilities.
4.4.3 For outside samples, Palmetto Health Richland Laboratory staff will enter
patient information into the computer system and document the assigned
medical record number.
4.5
Allowable minor corrections to items listed in 4.4 are;
 Date of collection
 Time of collection
4.5.1 Corrections are NOT allowed for any discrepancy in patient name,
medical record number or date of birth.
4.5.2 Discrepancies in name, medical record number or date of birth require
recollection of sample.
5.0
Specimen Collection
5.1
Ask patient to verify name and date of birth, if able
67
5.2
5.3
Compare order label to hospital armband on the patient.
5.2.1 Verify patient name, medical record number and date of birth.
5.2.2 Patient must have an identification bracelet on before drawing
blood.
5.2.3 Any discrepancy (ies), must be resolved before obtaining the
sample.
Blood Bank identification bracelets are available for certain patient care
situations.
5.3.1 For emergencies, unknown name or if a discrepancy cannot be resolved in
a reasonable amount of time, a Blood Bank armband may be placed on the
patient and must be used to establish a positive identification link between
patients and red blood cell products for transfusion.
5.3.2 All emergency patients with no known identification will be registered
as “Trauma Male (Female)”, “STEMI”, “John (Jane) Doe” or “Neuro
Male (Female)”. The blood bank armband will remain on the patient until
actual patient identification has been determined.
5.3.3 Should patient identification be unavailable the original blood bank
armband will remain on the patient for the duration of the current hospital
stay. New blood bands are not required for testing of subsequent samples
if transfusion is needed. After patient identification has been determined
and new identification bracelet placed on patient, the blood bank armband
should be removed after
72 hours (3 days) following the collection of the sample.
5.3.4 Blood Bank armbands will be used in the following situations.
5.3.4.1 Palmetto Health Richland, Baptist, and Parkridge
● Emergency Dept. (Trauma, Stemi, Neuro, John or Jane
Doe)
5.3.4.2 Outpatient and Offsite Transfusions: Palmetto Health Richland
Only
5.3.5
 Sickle Cell/Infusion
 Pediatric Oncology
 Health South
 Dept. of Corrections (KCI)
 Columbia Care Center (CCC)
5.3.4.3 Palmetto Health Baptist and Parkridge
● Outpatients (with no hospital bracelet) and offsite – Baptist
and Parkridge
● Intermedical (7th floor) – Baptist only
● Rehabilitation – Baptist only
Collect specimen according to PH 1.005 Collection Process.
Label all tubes at the patient’s bedside. If all information on patient’s
order label matches exactly with the patient’s armband, place on tube and
label with date, time, and collector’s (laboratory and non-laboratory)
FIRST and LAST name. Printed name must be legible.
5.3.7 Before leaving the patient, the information on the labeled samples must be
verified. Refer to Palmetto Health “Final Check” procedure.
To eliminate the need for a second sample draw for non-group O patients who
do not have a historical blood type on file in the Blood Bank, samples collected
5.3.6
5.4
68
5.5
5.6
5.7
by OR staff, OR holding, and Labor & Delivery must be labeled using the
following process.
5.4.1 When a Type and Screen/Type and Crossmatch is ordered for a patient
in the OR and Labor & Delivery, the entire process must be witnessed by
two licensed staff (RNs, Preop RNs Holding Room, OR RNs, CRNAs
Anesthesiologist), one of which is obtaining the blood sample. Obtain
blood sample with the witness present in the patient’s room for the entire
process.
5.4.1.1 Same Day Surgery patients in OPS – It is permissible for an
approved phlebotomist to draw a crossmatch in OPS and have a
nurse witness and sign the specimen without needing a second
sample for ABO/Rh verification.
5.4.2 A chart label/patient ID label will be placed on the tube after
verification of patient information on the patient’s armband.
5.4.3 The label will include the date and time drawn and the first and
last name (no initials) of TWO patient care staff members; the person
who draws the sample and a witness to the draw. The names must be
legible. Example: Amanda Moore, CRNA and Shari Altman, RN.
5.4.4 Both patient care staff members must verify patient name, medical
record number, and date of birth. Have patient verbalize patient name
and date of birth (when possible) as the staff are verifying information
with the patient ID bracelet and chart label/patient ID label. Any
discrepancies must be resolved before moving forward. There will be
ZERO TOLERANCE on any discrepancy in patient name,
medical record number, date of birth, and legibility of collectors’
information. All tubes must be labeled
at the patient’s bedside.
5.4.4.1 Place the labeled sample tube in a small transport bag and
transport to the Blood Bank.
5.4.4.2 If the specimen does not have two legible patient care staff
member’s signature on the label, the tubes will not be accepted.
NO EXCEPTIONS! The sample must be recollected.
A second sample may need to be drawn for ABO verification if there is no
previous history on the patient and the patient is non-group O. Refer to
section 5.4 for exceptions.
5.5.1 Blood Bank staff will notify floor when second sample is needed.
5.5.2 Blood Bank will order ABO verification (ABO/Rh type).
5.5.3 Blood Bank will send computer order label and tube to the floor in a
small biohazard bag.
5.5.4 Sample shall be drawn and labeled as outlined in sections 5.1-5.3.6.
5.5.4.1 Place the labeled sample tube in the small biohazard bag and
send directly to the Blood Bank.
Blood Bank staff will verify that patient information matches and that all
other information (date, time, collector, etc.) is on the sample prior to
performing compatibility testing.
When applicable, Blood Bank staff will:
5.7.1 Enter the Blood Bank ID Number (on barcode blood band) as the result
for LIS (Laboratory Information System) test code in the applicable field
when testing is performed.
69
Collection and Labeling For Non-Crossmatch/Type and Screen Blood Bank Tests (i.e. Cord
Blood, Rhogam, ABO/Rh, etc,)
6.0
Sample and Labeling Requirements
6.1 Tube type
6.1.1 Pink-stoppered tubes (K2 EDTA) are preferred.
6.1.2 Plain red-stoppered tube (no additive) are acceptable
6.1.3 Lavender-stoppered EDTA tubes are acceptable.
6.3
Information on patient’s armband and specimen labels must match exactly the
corresponding information in the LIS.
6.4
For collection and labeling requirements of tests, other than crossmatch/type and
screen and cord bloods, refer to 5.3.5 to 5.3.7.
6.5
Labeling of Cord blood specimens
6.5.1 Cord blood specimens must be labeled with 2 distinct labels.
6.5.1.1 One label will contain the mother’s name and medical record
number.
6.5.1.2 One label will contain the baby’s name and medical record
number.
6.5.1.3 Either label must include date and time of collection, identification
of the person collecting the sample and a notation that the sample
is cord blood.
6.6
Samples received in Blood Bank -- for allowable minor corrections on the label,
refer to 4.5 to 4.5.2.
6.6.1 The sample tube does not leave the Blood Bank. The person
making the correction must come to the Blood Bank to do so.
6.6.2 If corrections are not allowed, or cannot be made, the sample must
be recollected.
Protocol for Use/Transfusion of Blood Products
COMPONENT REQUESTS
The component must first be ordered by the physician and carefully ordered by the unit secretary
or designee to the computer system by proper computer codes.
When autologous or directed-donor units are needed, they must be ordered as such. Do not order
packed cells and expect the Blood Bank to know that the patient has autologous or directeddonor units. These units may not be in inventory yet.
NOTE: This would be a good time to ask the patient if they have autologous or directeddonor blood they are expecting to be used for them.
Patient diagnosis is often vitally important to the Blood Bank staff in securing the proper product
for the patient. The prime example is when blood is ordered for people with sickle cell disease.
These units must be screened for sickle cell trait. Blood Bank must be notified since this
screening is not routine and since Sickle Cell is not usually listed as the diagnosis in HBO.
NOTE: All units to be used for babies are routinely screened for sickle cell.
70
BLOOD COMPONENTS
PACKED RED BLOOD CELLS
1. A routine crossmatch must be performed, blood will be held for 3 days.
2. Each unit of packed red cells contains approximately 250-300 ml.
3. This product is prepared as leukoreduced from the Blood Supplier – The American Red
Cross.
WHOLE BLOOD
1. Whole blood is only available as an autologous unit.
2. Whole blood must be crossmatched.
WASHED RED CELLS
1. Washed red blood cells must be ordered 24 hours advance.
2. Washed cells must be crossmatched.
3. Once washed the red cells have a 24 hour expiration period.
4. Each unit contains approximately 250ml.
AUTOLOGOUS/DIRECTED DONATED BLOOD
1. Autologous blood is the patient’s own blood withdrawn before surgery in order to
provide blood during the procedure.
2. Arrangements must be made in advance with the Columbia American Red Cross to
schedule blood collections. Special Donation Department - Tel. #251-6078. NOTE:
The American Red Cross will notify the PHR Blood Bank of scheduled
donations, listing the amount and type units ordered.
3. Neither Directed Donations or Autlogous Blood is available in emergency situations.
Processing takes 3-5 days from collection for directed-donor and autologous units to
be available to PHR. All blood must be fully tested and this process takes
approximately three working days from collection.
4. Directed donation units must be crossmatched, and will be held for 3 days.
Autologous units must be crossmatched, and will be held until the patient is
discharged.
PLASMA
1. Plasma is not crossmatched but an ABO/RH blood type from the patient’s current
admission is necessary to give type-compatible plasma.
2. Fresh Frozen Plasma (FFP; frozen within 8 hours of collection) and Plasma, Frozen
Within 24 Hours of Collection (FP24) are used interchangeably for most patients.
3. Neonates (babies up to 4 months old) are transfused with fresh FFP only ( thawed < 24
hours).
4. Fresh plasma (thawed < 24 hours) is available for patients with known isolated
coagulation factor deficiencies. Include the comment “Fresh plasma only” with requests
for these patients.
5. Plasma is stored frozen and thawed plasma is not routinely available. Notify the Blood
Bank one hour prior to transfusion to allow time to thaw plasma products.
6. Each product contains 200-300 mls of plasma.
CRYOPRECIPITATE
71
1. Cryoprecipitate is not crossmatched, but a current ABO/RH type from the patient’s
current admission is necessary. ABO compatible is given when possible.
2. Each unit contains approximately 15 ml.
3. Allow at least 20 minutes notice to thaw cryoprecipitate. Notify Blood Bank when to
thaw the cryoprecipitate.
4. Once thawed, it must be transfused within 4-6 hours.
PLATELETS
1. Platelets are not crossmatched, but a current ABO/RH type from the patient’s current
admission is necessary. They are given ABO compatible, when possible.
2. Platelets must be ordered 24-48 hours before transfusion to insure that they will be
available.
3. All platelets are ordered on an as needed basis from the American Red Cross.
4. Platelets have an expiration period of 5 days, the time held for each patient depends on
the time remaining before expiration of product.
PLATELETS PHERESIS
1. Platelet pheresis is a platelet product equivalent to 6-10 single platelet units drawn from
one donor through the pheresis process.
2. Pheresis units are used to provide platelet support to patients while limiting the donors
they are exposed to.
3. Pheresis units are not usually crossmatched unless they contain a large amount of
contaminating red cells. They are given ABO compatible, when possible.
4. The Blood Bank keeps an inventory of Platelet Pheresis products in-house.
5. This product is prepared as leukoreduced from the Blood Suppliers – The American Red
Cross and The Blood Connection
LEUKOCYTE PHERESIS (Granulocyte Pheresis)
1. Leukocyte pheresis with or without platelets are a special product obtained by the
pheresis process from a single donor to provide white blood cells for patients.
2. Leukocyte pheresis units must be crossmatched because they contain a large amount of
red blood cells.
3. These products are a special order from the American Red Cross, and are usually released
before complete donor testing.
4. Leukocyte pheresis units must be infused within 24 hours of collection, preferable ASAP
within 8 hours.
VOLUME REDUCING PLATELETS
1. Floor needs to call Blood Bank when patient needs a platelet product volume reduced.
2. Product will be ready in 2 hours.
3. Product will expire in 12 hours or the original expiration date, whichever is first.
POOLED CRYOPRECIPITATE
1. SIM #: 15442. Only one order needed.
2. Please call Blood Bank when ordering cryoprecipitate.
3. Only cryoprecipitate orders of 4 or greater will be pooled
4. After cryoprecipitate is pooled, it expires in 4 hours.
72
POOLED PLATELETS
1.
2.
3.
4.
SIM #: 15441
Please call Blood Bank when ordering pooled platelets.
Only platelet orders for 4 or more units will be pooled
After platelets pooled, expiration time is 4 hours.
IRRADIATED BLOOD PRODUCTS
A. These must be requested when blood or blood component is ordered.
B. Indication for use:
i. Irradiation of blood components (except fresh frozen plasma and
cryoprecipitate) prior to transfusion is an attempt to prevent Graft
vs. Host Disease in immunosuppressed patients and first degree
donors.
C. Where products are irradiated:
i. This procedure is done in the Blood Bank Dept.
D. Procedure:
i. When irradiation of a product is requested, Blood Bank will irradiate with
25 GY (2500cGY).
E. Labeling:
i. All irradiated products will be labeled “Irradiated” and the date, time and
tech initials.
Emergency Release of Blood Products B8.033.09
1.0
Purpose
In emergency situations, delay of transfusion in order to provide
completely tested products may be detrimental to a patient’s survival.
Expedited issue of products is necessary when transfusion is required prior
to receipt of patient specimen, completion of compatibility testing or
completion of donor testing. Applicable testing is initiated immediately
upon receipt of a suitable specimen in the Blood Bank.
Products for emergency release to treat trauma cases are maintained in a
designated blood storage refrigerator located in the Emergency
Department (ED) and the Operating Room (OR). Products for patients
other than trauma cases must be obtained from the Blood Bank. Platelets
and cryoprecipitate are not included in this process and must be requested
using the standard ordering procedure.
Products that are out of a controlled temperature environment
may not be suitable for transfusion and must be returned to the Blood
Bank. If the products are not acceptable, they must be discarded.
2.0
Equipment
2.1
2.2
2.3
2.4
Blood storage refrigerator
LIS computer system
Gloves, when applicable
Mask or face shield, when applicable
73
3.0
Supplies
3.1
3.2
3.3
3.4
4.0
Form B8.033.09:F2 Emergency Release of Blood Products (Emergency
Release form 20805r10 REV 07/07)
Form “Transfusion Product Tag” –see attachments 1
Plastic ziplock bags
Labels: UNCROSSMATCHED BLOOD,” blue dots, and pink dots
Procedure
Note: If there is a shortage of type O blood or type AB plasma, Emergency
release blood products will not be stocked in the OR emergency release
refrigerator until the type O or AB supply is replenished to stock in both
4.1
Blood Bank staff prepares products for issue.
4.1.1 Select the freshest O Neg and O Pos units of packed red blood cells from
the red blood cell inventory.
 Eight O, Rh positive packed RBCs for male patients.
 Eight O, Rh negative packed RBCs for female patients
 Four AB, Rh positive or Rh negative plasma units, thawed
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
Remove 2 segments from each RBC product and label with the donor
identification number and place them in the appropriate cup labeled
“Trauma Segments” and store in appropriate blood bank refrigerator.
For each product, record the following information in the indicated
section of a Transfusion Report form:
 Donor Unit/Pool #
 Component
 Donor ABO/Rh
 Expiration Date/Time
Apply labels on the front of each RBC product and the Transfusion Report
form. See examples of labels below.
 UNCROSSMATCHED BLOOD
 Blue dot to O positive units only
 Pink dot to O negative units only
Attach each Transfusion Report form to its corresponding
blood product.
Place the appropriate number of products for each set in a plastic ziplock
bag.
4.1.6.1 Trauma products; Trauma Bay 1 Refrigerator
 Two (2) sets of two (2) O positive RBC units
 Two (2) sets of two (2) O negative RBC units
 Two AB plasma units
4.1.6.2 Trauma products; Trauma OR Refrigerator
 Two (2) sets of two (2) O positive RBC units
74


4.1.7
4.2
Two (2) sets of two (2) O negative RBC units
Two AB plasma units
Fill in unit ID numbers, product type and blood type in the unit
information section of form B8.033:F2; complete a separate form for each
set of products. Place forms in designated file at issue workstation.
4.1.8 Place products in the appropriate storage location.
4.1.8.1 Trauma products: place appropriate blood products in the
refrigerator located in Trauma Bay 1 and Trauma OR refrigerator
located outside of OR 12.
Issue products for transfusion.
4.2.1 Group-specific blood may be issued during an emergency release
only after the patient’s ABO/Rh type has been determined on a
current blood sample. Previous records must not be used to determine
which blood group to issue.
4.2.2 Trauma cases: Emergency Department (ED)
4.2.2.1 ED staff calls Blood Bank (4-7611) and requests release of
products.
4.2.2.2 Blood Bank staff releases the remote lock on the ED refrigerator.
4.2.2.3 ED staff selects the appropriate set of products for the intended
patient:
 O positive RBCs for male patients
 O negative RBCs for female patients
 AB plasma products as needed for male or female patients.
4.2.2.4 ED staff supplies required information to BB,
BB staff retrieves the form B8.033.09:F2 and documents
required information on forms used.
4.2.2.4.1 Required information for Emergency Release
forms (B8.033.09:F2)
 Patient name and medical record number
 Patient location
 Requesting physician
 Person placing the request
 Nature of emergency
 Blood product identification number
 ABO/Rh of blood product
 Product Type
4.2.2.5 ED staff documents required information on
Transfusion Report form.
4.2.2.6 BB staff completes all documentation
4.2.2.6.1 Do not delay transfusion in order to obtain
physician’s signature. Send Emergency form
for physician’s signature as soon as reasonably
possible.
4.2.2.7 Maintain control of blood products under appropriate
temperature and storage conditions.
4.2.2.7.1 Products transported to operating rooms with
a patient should be placed in the OR blood
75
4.3
storage refrigerator.
4.2.2.7.2 Products transported to other areas should be
placed in a validated cooler with ice, which
may be obtained from the Blood bank. Validated
thermometers will remain in coolers with products.
4.2.3 Trauma Cases: Operating Room (OR)
4.2.3.1 OR staff calls Blood Bank (4-7611) and requests release of
products.
4.2.3.2 Blood Bank staff releases the remote lock on the OR
refrigerator.
4.2.3.3 OR staff selects the appropriate set of products for the intended
patient:
 O positive RBCs for male patients
 O negative RBCs for female patients
 AB plasma products as needed for male or female patients.
4.2.3.4 OR staff supplies required information. BB staff retrieves the
Form B8.033:F2 and documents required information on forms
used. Refer to step 4.2.2.4.1
4.2.4 Cases Other Than Trauma
4.2.4.1 Once a physician order is given, patient care staff requests
emergency release of blood products.
4.2.4.1.1Call Blood Bank at 4-7611.
4.2.4.1.2 Request number of packed RBCs and/or plasma
products.
4.2.4.1.2.1Unless otherwise specified, 4 units of
packed red cells and 4 plasmas are
standard release for emergency release
products.
4.2.4.1.3 Supply the following information for the order:
 Patient name
 Patient medical record number
 Requesting physician’s name
 Nature of emergency
 Name of person placing the request
4.2.4.2 Immediately dispatch a clinical staff member to Blood
Bank to pick up the requested products.
 In emergent situations, Emergency Release products should
not be issued via the pneumatic tube system.
 Only clinical employees may pick up blood products.
Emergency use of group A plasma when patient’s blood group is not known, for
example in massive trauma protocols.
4.3.1 Group A plasma is acceptable for emergency use, pathology approval is
required in all circumstances.
4.3.2 Once a specimen is received and the patient’s ABO group and Rh type are
determined, the patient can begin receiving group-specific blood
components.
4.3.3 If there is any question about the patient’s true ABO/Rh type , continue
with group A plasma.
76
4.4
4.5
4.6
4.7
Blood Bank staff: Upon release of products to ED and/or OR staff.
4.4.1 Assign and dispense products to the patient electronically.
4.4.2 Begin compatibility testing immediately upon receipt of a properly
labeled patient specimen.
4.4.3 If an antibody (ies) is detected, red cells units must be tested for
corresponding antigen and crossmatch testing performed through
the antiglobulin phase to ensure confirmation of compatibility.
4.4.3.1 Enter the patient test results in the LIS.
4.4.4 Notify attending physician and BB Medical Director or Pathologist on
call of any incompatibility discovered on completion of an incomplete
crossmatch.
4.4.4.1 Documentation of notification is done by entering the call/date
and time and name of attending physician under the appropriate
accession number, called/date/time field in LIS.
4.4.5 Blood Bank staff prepares and dispenses products.
4.4.5.1 On form B8.033.09:F2, document the information supplied
in step 4.5.1.1.2.
4.4.5.2 Assign and dispense the products to the patient in LIS.
4.4.5.3 Begin compatibility testing immediately upon receipt of a
properly labeled patient specimen. If an antibody (ies) is
detected, follow steps as outlined in sections 4.4.3 and 4.4.4.
Palmetto Health Richland staff will comply with all blood supplier
requirements for any products that must be transfused prior to completion
of donor testing.
Blood Bank staff: upon return of products,
4.6.1 Inspect returned products to determine suitability for transfusion.
4.6.2 Check product temperature using the thermometer attached to the
container.
4.6.3 Blood Bank procedure B2.011 Visual Inspection of Blood
Products apply to emergency release products.
Emergency Release of serologically incompatible Donor Units:
4.7.1 Occasionally, transfusion of RBCs may be necessary when
no serologically compatible units are available for a patient. This
most often occurs in patients with:
4.7.1.1 Serological problems with Autoantibodies that typically are
reactive with cells from all donors.
 Cold and warm- reactive autoantibodies
4.7.1.2 HTLA (high titer low avidity) antibodies
4.7.2 Notify attending physician and Blood Bank Medical Director
or designee of incompatibility discovered on completion of crossmatch.
4.7.3 The requesting physician (or physician designee) is responsible
for signing the Emergency Release of Blood Products Form.
4.7.3.1 If the physician requests blood immediately prior to
Pathologist notification, contact Pathologist after release.
4.7.4 Once a physician approval is given, Blood bank staff documents required
information on the form used. Required information for Emergency
Release form (B8.033.09:F1)
77
4.7.5
5.0
 Requesting physician
 Reason for transfusion of incompatible donor unit(s)
 Blood product identification number(s)
 ABO/Rh of blood product
 Product Type
Once Emergency Release form has been signed by physician (or physician
designee), products can be issue as needed via pneumatic tube station or
pick up by clinical staff.
Procedural Notes
5.1
5.2
5.4
This protocol is primarily for emergent provision of blood; occasionally,
physicians must transfuse a patient for whom no serologically compatible donor
units are available.
Blood Bank Medical Director or Pathologist on call and the attending physician
(or physician designee) must be notified of any incompatibility discovered upon
completion of an incomplete crossmatch and/or the need to transfuse serologically
incompatible donor units.
5.3
File Emergency Release of Blood Products form in the Emergency
Release folder along with any completed crossmatch reports, when
applicable.
After 10 units of blood have been transfused to an adult patient in less than 24
hours. Refer to SOP B8.035 Compatibility for Massive Transfusion Cases for
further details.
Massive Transfusion Protocol B8.034.04
1.0
Principle
To provide a consistent method of expediting the preparation and
issue of blood products for patients experiencing massive hemorrhage. This Massive
Transfusion Protocol (MTP) is written according to requirements of Palmetto Health Trauma
Institute and the Blood Bank; it is used primarily for trauma cases, but may be used as needed for
other massive transfusion (MTP) needs that may be called by a physician at any time. The
numbers of products prepared for each batch should not deviate from those defined in this
protocol.
The Blood Bank staff is responsible for Maintaining the levels of products outlined in this
policy.
Placing appropriate orders in the LIS so that provision of products is not delayed.
 Preparing products for transfusion
 Notifying patient care staff that products are ready for issue.
 Asking if subsequent batches are needed
2.0
Procedure
78
2.1
In order to activate the MTP:
2.1.1 The patient must have a current valid computer order.
2.1.2 There must be a current valid specimen for the crossmatch in the Blood
Bank.
2.1.3 If any of the following conditions apply, RBC and Plasma products will be
issued according to protocol B8.033 Emergency Release of Blood
Products.
2.1.3.1 Pretransfusion testing has not been completed on a current valid
patient sample.
2.1.3.2 Pretransfusion testing has been completed on a current valid
patient sample and the patient has a positive antibody screen.
2.1.3.3 The patient has a history of one or more clinically significant blood
group antibodies.
2.1.3.4 Adult Massive Trauma Protocol Only
2.1.3.4.1Trauma Female (1st Choice)
o O neg rbcs and AB plasma
2.1.3.4.2Trauma Male (1st Choice)
o O pos rbcs and AB plasma
2.1.3.4.3 MTP initiated and the patient’s blood group is not
known or group AB plasma is not available.
2.1.3.4.3.1Group A plasma and O red blood cells
shall be released. Pathology approval
required in all circumstances.
2.1.4
2.2
2.3
2.4
2.5
Blood Bank staff will notify the physician and the BB Medical
Director or designee if 2.1.3 is applicable.
2.1.5 Blood Bank staff will initiate, immediately, procurement and appropriate
testing of products if the patient has a positive antibody screen or a history
of a clinically significant antibody.
2.1.5.1 Issue of products for emergency transfusion will not be delayed in
order to obtain antigen-tested products unless approved by the
attending physician.
The physician, or designee, will notify the Blood Bank directly and state, “Initiate
the massive transfusion protocol on (patient name).”
2.2.1 Trauma Pager will also receive a trauma alert page.
The Blood Bank staff will enter orders for products in LIS. See Computer Manual
for details.
The Blood Bank staff will place all subsequent product orders in LIS for the
duration of the MTP.
2.4.1 Crossmatch RBC Products.
2.4.2 Plasma Products.
2.4.3 Plateletpheresis Products.
The Blood Bank staff will immediately begin preparing products in batches as
follows:
2.5.1 If the patient is NOT in the Trauma Bay or OR when
initiated:
Initial batch: (Cooler # 1)
 Packed red blood cells- 10 units
 Plasma- 6 units
79
2.9
 Plateletpheresis- 1 unit
2.5.1.1 If patient is in the Trauma Bay or OR when initiated:
Then Emergency Release products used from refrigerators
in either the ED and/or OR are included in the initial batch.
For example, if 4 RBCs and 2 plasma units from the ED or
OR refrigerator are used, Blood Bank will issue:
6 RBCs, 4 plasma products and 1 plateletpheresis product
in the initial batch.
2.5.2 Subsequent batches: (Coolers # 2, 3, 4, 5, and 6)
 Packed red blood cells- 6 units
 Plasma- 6 units
 Plateletpheresis- 1 unit
2.5.3 Batches should be prepared and sequentially issued in
coolers within 20 minutes.
2.5.3.1 Blood Bank staff will notify the physician/designee
if a request differs from the designated MTP batch.
2.6
Cryoprecipitate is not included in any product batches.
2.6.1 Cryoprecipitate must be requested as needed.
2.7
If there is an increased need for immediate blood products, the OR
staff will call the blood bank and request additional Emergency
Release Blood products from the OR Trauma refrigerator.
2.8
Blood Bank staff will continue to prepare and dispense subsequent
batches until the physician/designee notifies the Blood Bank to
stop preparing units.
2.8.1 The physician/designee will notify the Blood Bank directly
and state, “Discontinue the massive transfusion protocol on
(patient name)”.
2.8.2 The MTP is valid only for the 3 days that the original
crossmatch specimen is valid. After the original specimen
expires, a new specimen must be collected and fully tested.
2.8.3 The Blood Bank staff will notify patient care personnel
when a new sample must be collected so that the
appropriate number of units will always be available.
2.8.4 Compatibility testing may be abbreviated if a patient is
massively transfused in a 24 hour period. Refer to B8.035
Compatibility Testing Following Massive Transfusion.
All products must be assigned/dispensed to the patient in the LIS.
2.9.1 Attach the completed crossmatch reports to the Emergency Release
of Blood Products form and file the paperwork in the Emergency
Release folder.
2.10 Products issued for MTP shall be packed in coolers on ice for
transport and temporary storage during the emergency.
2.10.1 Blood Bank will validate and maintain coolers used for
transport and/or temporary storage.
3.0
Procedural Notes:
3.1
This protocol is primarily for adult trauma purposes; this protocol is not
for emergency release blood in non-massive transfusion situations or
80
3.2
pediatric patients.
Pathologist must be notified in all circumstances for approval of group A plasma
for emergency release to adult trauma patients when the patient’s blood group is
not known or group AB plasma is not available.
Picking Up Blood Components From Blood Bank
1).
IN PERSON
Blood will be released to representatives of the nursing units who present a “Form
for Picking Up Products from the Blood Bank”. This form is stamped with the
patient’s addressograph and the product needed.
ONE CARRIER WILL BE ALLOWED TO PICKUP BLOOD PRODUCTS
FOR ONE PATIENT AT A TIME. Refer to Appendix for form example.
2).
VIA PNEUMATIC TUBE SYSTEM:
To provide blood products in a timely efficient manner without requiring nursing
to leave unit.
Blood will be released to the units upon receiving a properly filled out “Form for
Picking Up Products in the Blood Bank: through the tube system. Refer to
Appendix for form example.
Nursing Unit will phone Blood Bank that the form has been sent via tube system.
Release Form will have:
a.
b.
c.
d.
e.
f.
Name of patient
Medical Record Number
Requesting unit location and phone number
Product requested, number required, special instructions (irradiate, etc.)
Name of person that will accept product from tube system
Signature of nurse administering the product
Blood Bank will:
a. Get form from tube system
b. Select appropriate units
c. Compare information on units and form with another person using standard issue
protocol with verbal callback
d. Place product in sealed biohazard plastic bag (must not be sealed without removing most
of air first)
e. Call person designated on form to accept product and notify them to wait at tube station
for product.
Blood Bank will then go to tube station and complete section for released date, time and initials
of issuing tech on the Release Form. Form will be tucked in outer flap of plastic bag. Product
will be tubed immediately.
81
Person in nursing unit accepting product from tube system will:
a. Check name and product/products
b. Note on form number of products received. Multiple products will be sent one
after the other.
c. Note time last product received
d. Note their name on Release Form
e. Immediately send completed form back in tube system
Blood Bank tech will expect return of form within 15 minutes.
Failure to do this in a prompt manner may result in loss of tube privileges for that floor.
Blood Bank tech will note time form returned via tube system on log. Completed Release Form
will be stored in Blood Bank.
NOTE: If a product is lost in tube system, contact Engineering Services immediately!! Notify
Blood Bank of product status.
Return of Blood Products to Blood Bank
If a blood product cannot be infused, for any reason, it must be returned to the Blood Bank
within 30 minutes of the time it was issued. DO NOT store blood products in refrigerators on the
nursing units. Blood products must be kept within strict temperature ranges in a monitored
refrigerator for patient safety. Blood that has been warmed cannot be returned for re-issue.
Identification of the Patient before Starting Transfusion
Accurate identification of the donor’s blood and the intended recipient may be the single
most important step in insuring transfusion safety. Most fatal hemolytic transfusion
reactions occur because ABO-incompatible blood was inadvertently administered. Strict
adherence to the following steps is required:
It is necessary for two people to verify the patient identification information at the patient’s
bedside.
The following information should be checked:
1. the patient’s full name
2. the patient’s medical record number
3. the Fenwal Typenex Armband number, if applicable
4. the donor unit number
5. the ABO/RH type listed
6. the expiration date of the product
7. color and appearance of blood bag
All these items must agree on the Blood Transfusion Record, the Compatibility Sticker, and the
patient’s armband.
If there is a discrepancy, DO NOT transfuse the blood product. Return it immediately to the
Blood Bank.
The transfusion of one red cell unit should be accomplished within 2-4 hours. If the units are not
82
completely transfused within 4 hours, discontinue the transfusion. The blood units provide an
excellent growth medium for bacteria and extending the transfusion time greater than 4 hours is
not safe. If a longer transfusion time is necessary due to the patient’s condition, the blood unit
may be divided by the Blood Bank personnel and the two halves transfused for up to four hours
each.
Infusion of Blood and Blood Components:
Each transfusion area should have its own protocol for patient preparation, etc. for infusion in
addition to these notes.
All blood and blood components must be given through an administration set with a filter. The
choice of sets and filters is the responsibility of nursing service.
Nursing should also check:
a. vital signs
b. check the chart or with the Blood Bank for the need of warming coils
c. recheck orders to make sure the proper products are being given (i.e.
Autologous, Directed-Donors. Autologous units are specially marked with
green stickers,Directed –Donor units are specially marked with orange tag).
d. CAREFULLY FOLLOW PATIENT IDENTIFICATION PROCEDURES
ABOVE BEFORE STARTING TRANSFUSION
After the Transfusion
The Transfusion Record should be completed and one copy placed on the patient’s chart, and the
second returned to the Blood Bank promptly.
IMPORTANT: The slip attached to the product must be returned to Blood Bank and is
critical for maintaining an accurate history for the patient in case a look back is
required if problems are discovered later with the product the patient received.
Empty blood product bags are to be disposed of on the nursing units according to established
policy.
Transfusion Reaction Investigation
It is the responsibility of the transfusionist to observe the patient for signs or symptoms of
transfusion reactions. There are many different types of transfusion reactions possible;
1. Immediate reactions
a. Hemolytic symptoms include pain in the lumbar region of the back or along the
arm where blood is being administered, rapid elevation of temperature and pulse,
chills, flushing of skin, nausea, vomiting and occasional blood pressure drop.
Blood in the urine and oozing from wounds may also be observed.
b. Febrile symptoms include rise in temperature (greater than 3 degrees F) chills.
c. Allergic reaction symptoms include rash, itching and flushing of the skin. These
are the only symptoms that transfusion may be continued (after the administration
83
of antihistamines) with the physicians orders.
2. Delayed reactions: incompatible transfusions may manifest themselves after several days
by the appearance of jaundice and increasing anemia with or without other clinical
symptoms. If this is suspected contact the blood bank immediately.
If a transfusion reaction is suspected follow the directions on the back of the Transfusion Record
attached to the product. See Appendix.
Holding Blood for Patients
Physicians orders to “keep blood on hand at all times are the responsibility of the nursing units.
The nurse taking care of the patient must enter orders as necessary to assure adequate blood is
available.
Determining if Blood Products are in Blood Bank
1. Check the physician’s order.
2. Check the HBO computer using Order Inquiry.
The laboratory results displayed will list:
a. The Blood component type
b. The units ordered
c. The armband number
d. The patient’s ABO/RH (D)
e. The units allocated (available for transfusion)
f. The units issued
Blood crossmatched will be held for 3 days, expired crossmatches are released at 6AM on the
third day.
Do not call the Blood Bank to see if your patient has blood available, the information is in the
HBO system.
The medical reasons for every transfusion must be carefully evaluated and should be
monitored for therapeutic effectiveness.
Circular of Information (American Red Cross)
The current circular of information from the ARC on the use of human blood and blood
components is posted on the MYPAL (MyPal/myCampus/Richland/Laboratory
Services/Laboratory Manual). This circular is to be available for the physicians and
transfusionist. The circular is prepared by the American Red Cross and the American
Association of Blood Banks. It has the approval of the Center of Biologics Evaluation and
Research, Food and Drug Administration, and is consistent with the use of uniform labeling.
A list of Blood Components and the indications for transfusion are also in the packet. This list
describes the component, the composition of each component, the approximate volume, and the
indication for transfusion in an abbreviated form. Please see appendix for the list.
Glucose Tolerance testing
84
Oral Glucose Tolerance Test
1.0
CCH2.402.06
Principle
1.1
1.2
1.3
1.4
1.5
The oral glucose tolerance test (OGTT) is a serial measurement of glucose before
and after a specific amount of glucose is given orally.
The OGTT should be scheduled to begin in the morning as glucose
tolerance exhibits a diurnal rhythm with a significant decrease in the
afternoon.
The 2 hour OGTT
1.3.1 Identifies non-pregnant patients with either Impaired Fasting Glucose
(IFG) or impaired glucose tolerance (IGT) and includes:
1.3.1.1 Fasting Glucose
1.3.1.2 2 Hour Glucose
1.3.2 In the absence of unequivocal hyperglycemia, a positive 2 hour OGTT
should be confirmed on a subsequent day with
1.3.2.1 A Fasting Plasma Glucose (FPG)
1.3.2.2 A Casual Plasma Glucose or
1.3.2.3 2 hour OGTT
1.3.3 The standard dose for children is 1.75 grams of glucose per kilogram of
body weight, to a maximum dose of 75 grams.
The 3 hour OGTT
1.4.1 Identifies pregnant women with Gestational Diabetes
Mellitus (GDM) and includes:
1.4.1.1 A Fasting Glucose
1.4.1.2 A One Hour Glucose
1.4.1.3 A Two Hour Glucose
1.4.1.4 A Three Hour Glucose
In some instances physicians will request a 4 and 5 hour Glucose Tolerance. The
ADA (American Diabetes Association) provides no recommended reference
range for the 4th and 5th hours.
2.0
Definitions
2.1
Fasting: No caloric intake >/= 8 hours
2.2
Gestational Diabetes Mellitus: glucose intolerance with onset or first
recognition during pregnancy.
2.2.1 Diabetic women who become pregnant are not included in this category.
2.3
Diabetes Mellitus: a group of metabolic disorders of carbohydrate
metabolism in which glucose is underutilized, producing hyperglycemia.
3.0
Instructions for Patient
3.1
Medications known to affect glucose tolerance should be stopped
by patient's physician at least 3 days prior to test.
3.2
Testing should be performed between the hours of 0700 and 0900.
3.3
Perform after 3 days of unrestricted diet (containing at least 150 g of
carbohydrate/day) and activity.
3.4
Perform the test after an 8-14 hour fast in ambulatory subjects.
3.5
Testing should not be performed on hospitalized, acutely ill, or inactive
individuals.
3.6
During test the Patient should:
85
3.6.1
3.6.2
3.6.1
3.6.2
Remain seated
Not smoke cigarettes
Not eat (water is allowed).
Avoid physical exertion, emotional stress, and stimulants such as tobacco,
alcohol, coffee and tea
4.0
Specimen
4.1
Specimen should be centrifuged to separate immediately as glucose level
decreases rapidly in whole blood.
4.2
Lithium heparin plasma from a venous collection should be used.
4.3
Capillary specimens are not recommended.
4.4
The specimen type and collection container should remain constant throughout
the test.
5.0
Required Supplies
5.1
Two Hour Glucose Tolerance
5.1.1 Glucola 75g bottle
5.1.1.1 See 6.3.3 for pediatric patient
5.1.2 Venipuncture supplies
5.2
3 Hour Glucose Tolerance
5.2.1 Glucola 100g bottle
5.2.2 Venipuncture equipment
6.0
Procedure
6.1
Identify patients following lab procedure PH1.006
6.2
3 Hour Glucose Tolerance orders:
6.2.1 Verify that female patient is pregnant
6.3
2 Hour Glucose Tolerance orders:
6.3.1 Verify that the patient is NOT pregnant
6.3.2 Determine the age of the patient.
6.3.3 Pediatric patients and patients less than 83 lbs
6.3.3.1 The correct dosage of Glucola is 1.75 grams of glucose per kg of
body weight and is calculated as follows:
6.3.3.1.1
Find the weight of the child in pounds (lbs).
6.3.3.1.2
Convert lbs to kgs by dividing lbs by 2.2 (2.2 lbs =
1 kg)
6.3.3.1.3
Calculate dosage by multiplying body weight in kg
X 1.75
6.3.3.1.4
Convert grams of glucose to Ounces by dividing by
10
6.3.3.1.5
Example: 35 lb child
35 lb divided by 2.2 = 15.9 kg
15.9 kg body weight x 1.75 grams
glucose = 28 grams glucose
28 grams divided by 10 = 2.8
ounces glucola
6.3.3.1.6
DO NOT EXCEED ONE 75 g BOTTLE
6.4
6.5
Perform venipuncture to obtain fasting glucose specimen in a Lithium Heparin
green top tube.
Give patient proper amount of chilled Glucola.
86
6.5.1
6.5.2
6.5.3
6.6
6.7
6.8
6.9
7.0
Non-Pregnant Adults: 75g (whole bottle of 75g)
Pregnant Adult Female: 100g (whole bottle of 100g)
Children: See above to determine appropriate number of ounces to
be given.
Document the time the patient takes the first swallow
6.6.1 The patient should drink the full amount within 5 minutes of starting to
drink.
6.6.2 Write proper collections times down on labels
6.6.2.1 1 hour: 1 hour from 1st swallow of glucola
6.6.2.2 2 hour: 2nd hour from 1st swallow of glucola
6.6.2.3 3 hour: 3rd hour from 1st swallow of glucola
Collect the next glucose specimens at the appropriate time and label
per policy PH1.005.
Deliver sample to Specimen Processing for receipt and prompt
centrifugation.
Sample once received will be given to the Chemistry Dept.
Safety Precautions
7.1
If during testing patient suffers nausea, fainting, sweating or other symptoms, the
pathologist on Clinical is to be notified immediately.
7.2
Test will be discontinued after physician is consulted if needed.
7.3
In the case that the tolerance is canceled, patient may need to be given
something to eat or drink before leaving the lab.
Gestational Diabetes Screen (GDS) CCH2.401.04
1.0
Purpose
1.1
Screening for Gestational Diabetes Mellitus is performed by glucose
measurement in plasma 1 hour after a 50 gram oral glucose load administered
without regard to the time of day or last meal.
1.2
Screening should be performed between 24 and 28 weeks of gestation on all
pregnant women not known to have prior diabetes.
1.3
A positive result should be confirmed with a 3 hour glucose tolerance test
performed on a subsequent day.
1.4
Gestational diabetes is associated with an increased incidence of congenital
malformations and complications of pregnancy.
2.0
Definitions
2.1
Gestational Diabetes Mellitus: glucose intolerance with onset or first
recognition during pregnancy.
2.1.1 Diabetic women who become pregnant are not included in this
category.
Specimen
3.1
3.0
4.0
Patient Instructions
4.1
Patient is not to eat during test.
4.2
Patient should avoid:
87
4.2.1 Physical exertion
4.2.2 Emotional stress
4.2.3 Stimulants such as tobacco, alcohol, coffee, tea during testing.
5.0
Required Equipment
5.1
Glucola, 50g bottle
5.2
Venipuncture equipment
6.0
Procedure
6.1
Identify patient following procedure PH1.006
6.2
Give patient 50 grams of Glucola to drink.
6.3
Timing starts with the first swallow and the patient should drink
the full amount within 5 minutes of starting to drink.
6.4
Write proper collection time for 1 hour specimen on label.
6.5
Draw the 1 hr glucose 1 hour after the first swallow of glucola.
6.6
Label specimen following policy PH1.005
6.7
Glucose levels decrease rapidly in whole blood.
6.7.1 Samples should be delivered promptly to Specimen Processing
6.7.2 Samples should be centrifuged promptly to avoid decreasing
glucose levels
6.8
Sample once received can be given to Chemistry.
7.0
Safety
7.1
If during testing patient suffers nausea, fainting, sweating or other symptoms, the
pathologist on “Clinicals” should be notified immediately.
7.2
Test will be discontinued after the ordering physician is consulted.
7.3
The patient should be given something to eat or drink before leaving the lab.
8.0
Reference Range
8.1
>/=140 identifies approximately 80% women with GDM
8.2
>/=130 identifies approximately 90% women with GDM
8.3
The following comment is included with all results
8.3.1 The Gestational Diabetes screen in pregnancy involves a 50 g
glucose load and glucose measurement at 1 hour post load.
Abnormal values indicate the need to perform a diagnostic 3 hour
Gestational Glucose Tolerance.
9.0
Panic Value
9.1 </= 40 mg/dL
9.2
>/= 501 mg/dL
Two Hours Post Prandial Glucose CCH2.403.06
1.0
Principle
1.1
The two hour postprandial blood sugar is a test which measures the body's
ability to metabolize carbohydrates and produce insulin.
88
1.2
1.3
1.4
This test is administered two hours following a meal to
1.2.1 Screen for diabetes
1.2.2 To diagnosis diabetes
1.2.3 To monitor glucose control
1.2.4 To evaluate the effectiveness of medication or dietary therapy in those
already diagnosed with diabetes
Other conditions which may result in an elevated result include
1.3.1 Pancreatitis
1.3.2 Cushing's syndrome
1.3.3 Liver or kidney disease
1.3.4 Eclampsia
1.3.5 Other chronic and acute illnesses.
A lab result below the normal range can indicate problems such as
1.4.1 Reactive hypoglycemia
1.4.2 Renal or hepatic insufficiency
1.4.3 Hypopituitarism
1.4.4 Malabsorption syndrome
2.0
Definitions:
2.1
Postprandial: after meal
3.0
Special Patient Instructions
3.1
Patient should eat a normal meal.
3.2
Record time when patient ate a meal.
4.0
Specimen
4.1
4.2
Centrifuge to separate immediately as glucose level decreases rapidly in
whole blood.
5.0 Procedure
5.1
Identify patient per procedure PH1.006.
5.2
Draw the glucose exactly 2 hours after the meal was eaten.
5.3
Label properly per procedure PH1.005.
5.4
Deliver sample to Specimen Processing for immediate centrifugation as
glucose levels decrease rapidly in whole blood.
6.0 Performance Specifications
6.1 The American Diabetes Association recommended glycemic goals for postprandial
glucose are as follows:
6.1.1 <180 mg/dL for Non-Pregnant Adults with Diabetes
6.1.2 Values >/=200 mg/dL indicate diabetes.
6.1.2.1 Further lab tests may be required to confirm this diagnosis.
6.2 Panic Values
6.2.1 Less Than or Equal to 40 mg/dL
6.2.2 Age 0-60 days Greater than 200 mg/dL
6.2.3 Age 61 days to 18 years old Greater than 399
6.2.2 Age 18 years and older Greater Than 500 mg/dL
89
MICROBIOLOGY SPECIMENS
Culture Handling M1.027.07
1.0
2.
PURPOSE AND/OR PRINCIPLE
Many species of bacteria are vulnerable to delays in processing, temperature changes and
decreased moisture. If transport is delayed, rapidly growing bacteria may overgrow more
fastidious pathogens. If a delay is anticipated, or if cultures are sent from outpatient
sources transport media should be used. Dry swabs are unacceptable.
It is important that culture specimens be processed as soon as possible after
collection, preferably within 2 hours.
1.1
ALL SPECIMENS SHOULD BE DELIVERED PROMPTLY TO THE
LAB TO ENSURE MINIMUM DELAY AND PROMPT PROCESSING.
1.2
FOLLOW STANDARD PRECAUTIONS. TREAT ALL SPECIMENS
AS IF THEY ARE POTENTIALLY HAZARDOUS.
TRANSPORTATION of Microbiology specimens
2.1
All specimens must be promptly delivered to the lab, within 2
hours of collection. If specimen processing is delayed please follow the
guidelines in this procedure for storage. These conditions should be
followed for transport by courier.
2.2
Do not store specimens for bacterial culture for more than 24 hours.
2.3
Viruses usually remain stable for 2 to 3 days at 4C. It is optimal to transport in
viral transport media.
2.4
Optimal transport of clinical specimens, including anaerobic cultures,
depends primarily on the volume of material collected.
2.4.1
2.4.2
Small amounts of specimens should be submitted to the lab within
15 to 30 minutes.
Tissue from biopsies may be held for up to 24 hours, if stored at
25C in an anaerobic transport system.
2.5
Environmentally sensitive organisms include:
2.5.1 Shigella spp. which should be processed immediately.
2.5.2 N. gonorrhoeae, Neisseria meningitidis and Haemophilus
influenzae which are sensitive to cold temperatures.
2.5.3 Never refrigerate spinal fluid, genital, eye or internal ear
specimens or specimens suspected of containing these agents.
2.6
The integrity of the specimens must be maintained during transportation. If for
some reason there is a delay in transport, (2 hours or greater) specimens should
be handled in the following manner:
Refrigerate
Leave at room temp
Frozen
90
Urines
Spinal fluids
Serum for serologic studies (-20)
Respiratory exudates
Body fluids
Tissue for long term storage(-20)
Wounds
Blood specimens
Stools
Genital/cervical for gonococcus
Bronchial wash
All other sources
Lung biopsy material
Viral cultures
2.7
Cultures for gonorrhoeae should be placed directly on transport media and
held at room temp. Microbiology supplies transport media to the
floors for samples to be inoculated immediately.
2.8
Transport media should be used for the collection of exudates.
2.9
Liquid stools should be placed in a preservative if not brought down in
one hour.
Specimen Collection for Microbiiology M1.026.07
1.0
Generally, a report from the microbiology laboratory can indicate only what has been found
by microscopic and cultural examination. An etiologic diagnosis is thus confirmed or
denied. Failure to isolate the causative organism may be due to faulty collecting or transport
technique. Also contaminants or normal microbiota maybe recovered, which may lead to
improper treatment of the patient. There are general considerations regarding collection.
1.1
When possible, specimens should be obtained before antimicrobial agents
have been administered.
1.2
Select the correct anatomic site from which to obtain the specimen. The
specimen should be collected where the suspected organism is most likely to
be found, with as little external contamination as possible. All mucosal
surfaces and skin have indigenous flora. Patients may acquire a transient
flora or become colonized for extended periods with potential pathogens
from the hospital environment. The skin surface should be cleansed with a
germicide using enough friction for mechanical cleansing.
1.3
Culture only for a specific pathogen.
1.4
The stage of the disease is an important contributing factor.
1.5
Patients need to be given full instructions when participating actively in
collection. Collect the specimens using the proper technique and supplies.
1.6
Specimens should be of a sufficient quantity. Inadequate amounts of
specimen may yield false-negative results.
1.7
Prompt delivery is a must.
1.8
Collect specimens in sturdy, sterile, screw-cap, leak-proof containers with
lids that do not create an aerosol when opened.
1.9
Clearly label the specimen container with the patient’s name and
identification number and with the date and time of collection and source.
1.10 Transport all specimens to the laboratory promptly to ensure the survival and
isolation of fastidious organisms and to prevent overgrowth by more hardy
bacteria. Rapid transport is necessary to shorten the duration of specimen
Contact with some local anesthetics used in collection procedures that may
have antibacterial activity.
2.0
Specific Instruction per Specimen Type:
91
2.1
BLOOD: The method of collection and the amount of blood drawn directly
influence the success of recovery of isolates and the interpretation of results.
There is no difference in yield whether blood samples obtained during a 24hr
period were drawn simultaneously or at spaced intervals (usually 15 minutes
apart). Most cases of bacteremia are detected by using 3 sets of separately
collected blood cultures. More than three sets of blood cultures yield little
additional information. Conversely, a single blood culture may miss intermittently
occurring bacteremia and make it difficult to interpret the clinical significance of
certain isolated organisms.
2.1.1 Acute sepsis, meningitis, osteomyelitis, arthritis, pneumonia
Collect two or three cultures from separately prepared
sites prior to starting therapy.
2.1.2 Endocarditis
2.1.2.1 Acute: Obtain three sets of blood cultures with three separated
Venipunctures over 1 to 2 hr, and begin therapy.
2.1.2.2 Subacute: Obtain 3 blood cultures in 24 hours. Collect two
at start of fever spikes. Collect three more if the first
three are negative after 24 hours.
2.1.2.3 Antimicrobial therapy 1 to 2 weeks before admission
obtain 2 separate blood cultures on each of 3successive
days.
2.1.3 Fever of unknown origin: Obtain 2 separate blood cultures at least 1
hr apart. If these are negative, then 24 to 36 hr later, obtain two more
Blood cultures 1 hr apart. The yield of information beyond 4 cultures
is usually minimal.
2.1.4 Younger children: 1 to 2mL samples. Two cultures are usually
adequate for diagnosing bacteremia in newborns.
2.1.5 Low-grade intravascular infection: Three cultures in 24 hours.
Space collections at least 1 hour apart. Collect two at first sign of
febrile episode.
2.1.6 Collection of blood through a peripheral or indwelling central venous
catheter is often fraught with error because of contamination by
commensal flora. Culture results for blood from catheter collection
need accompanying results for a venous-collected specimen to aid in
interpretation.
2.1.7 See the blood culture processing procedure for collection
instructions.
2.1.8 No more than 3 sets of cultures are accepted in a 24 hour period.
2.2
Cerebrospinal Fluid: Obtain specimen under conditions of strict asepsis.
The skin should be disinfected with iodine. Specimens of at least 2mL
should be placed in sterile containers. Bring to lab immediately. Store at
35 C if not set up immediately. DO NOT REFRIGERATE
2.2.1 1 - 5 mL recommended volume for culture.
2.2.2 CSF- Lumbar puncture or reservoir fluid
2.2.3 Draw CSF at L3 to L4 or lower to avoid spinal cord damage.
2.2.4 Draw up at L4 to L5 in children because the conus medullaris
extends lower in children than in adults.
2.2.5 Bacteria - require 1 mL send cloudiest specimen to Micro
92
2.2.6
2.2.7
2.2.8
Immediately. Tube 2 is preferred.
Fungi- recommend 2 mL
Mycobacteria - recommend 2 mL
Aspirates of brain abcess or a biopsy may be necessary to detect anaerobic
bacteria or parasites.
2.3
Pleural-Thoracentesis Fluid: Fluid accumulation may cause pain,
dyspnea, and other symptoms of pressure. With (congestive heart failure)
transudative effusions may issue from the heart or kidneys or may be the
result of vascular disease; exudative effusions are associated with
inflammatory conditions such as parapneumonia and tuberculous
emphysema. Fluid can also be associated with lung infections.
2.3.1 Obtain specimens under conditions of strict asepsis.
2.3.2 The skin should be disinfected with iodine.
2.3.3 An aspirate of 10mL of chest fluid is optimum.
2.3.4 Specimens of at least 2mL should be placed in sterile containers.
2.3.5 Bring to lab immediately. Do not refrigerate.
2.4
Cellulitis:
2.4.1 Cleanse area, aspirate area of maximum inflammation with fine
Needle and syringe.
2.4.2 Draw small amount of sterile saline into the syringe and aspirate into
a sterile screw-cap tube.
2.4.3 Send to the lab immediately.
2.5
Decubitus Ulcer:
2.5.1 Cleanse the surface with sterile saline.
2.5.2 If a biopsy sample is not available aspirate inflammatory material from the
base of the ulcer.
2.5.4 Decubitus swab provides little clinical information. The collection of
this sample should be discouraged.
2.5.5 Tissue biopsy sample or needle aspirate is the specimen of choice.
2.5.6 A swab specimen is not the specimen of choice.
2.6
Dental Culture: Gingival, periodontal, periapical, Vincent’s stomatitis
2.6.1 Carefully cleanse gingival margin and supragingival tooth
Surface to remove saliva, debris and plaque.
2.6.2 Using periodontal scaler, carefully remove subgingival lesion
material and transfer it to anaerobic transport system.
2.7
Ear:
2.7.1
2.7.2
2.7.3
2.7.4
Inner- Tympanocentesis is reserved for complicated, recurrent,
Or chronic persistent otitis media.
For intact ear drums, clean ear canal with soap solution, and collect
fluid via syringe aspiration technique.
For ruptured ear drums, collect fluid on flexible shaft swab via
auditory speculum. (aerobic culture only)
Deliver to the lab immediately or store at room temperature.
Outer ear: Use moistened swab to remove any debris or crust from
the ear canal. Obtain sample by firmly rotating swab in outer
canal. Bring to the lab immediately if necessary store at 4C.
93
2.7.5
2.7.6
For otitis externa, vigorous swabbing is required because surface swabbing may miss streptococcal cellulitis.
Smears are not performed on these samples.
2.8
Respiratory tract
2.8.1 Lower (BAL, BBW, and tracheal aspirate). Lower respiratory
specimens include bronchoalveolar lavage, bronchial brushings,
tracheal aspirate and transbronchial biopsy specimens.
2.8.2 Place specimens in sterile tightly capped containers.
2.8.3 Place brush in sterile container with saline.
2.8.4 Collect >1mL of sample.
2.8.5 BAL 40 to 80 mL of fluid is needed for quantitative analysis.
2.8.6 Usually collected by respiratory therapy.
2.9
Sputum
2.9.1 Collect specimen resulting from a deep cough.
2.9.2 The mouth should be rinsed with water or gargle immediately before
the sample is collected (this is to reduce number of contaminating
bacteria).
2.9.3 Induced specimens or transtracheal aspirates are recommended for
adult patients who cannot produce sputum and pediatric patients.
2.9.4 Do not collect saliva.
2.9.5 Do not collect 24 hour specimens.
2.9.6 Place in sterile container. Close tightly and bring to laboratory as
soon as possible.
2.9.7 Unacceptable sputum specimens will be rejected and the floors are
asked to recollect within a time frame.
2.9.8 Best specimen should have <= 10 squamous cells/LPF fields.
2.10
Upper Respiratory tract
2.10.1 Oral- Remove oral secretions or debris from surface of lesion
with swab, and discard.
2.10.1.1
Using a second swab vigorously sample lesion,
avoiding any areas of normal tissue.
2.10.2 Nasal- Use swab premoistened with sterile saline. Insert ~ 2cm
into nares.
2.10.2.1
Rotate swab against nasal mucosa.
2.10.2.2
Anterior nose cultures are reserved for detecting
staphylococcal and streptococcal carriers or for nasal
lesions.
2.10.3 Nasopharyngeal specimens should be obtained with a Dacron,
cotton, or calcium alginate swab on a flexible wire which is
gently passed through the nose into the nasopharynx, rotated,
removed, and inoculate directly to media or place into a
suitable transport medium for isolation.
2.10.3.1 Do not use calcium alginate swabs for RSV testing.
2.10.4 Throat: Tongue should be depressed with a tongue blade or spoon to
minimize contamination of swab with oral secretions which may
dilute, overgrow, or inhibit the growth of pharyngeal flora.
94
2.10.4.1 Obtain cultures under direct visualization with swab
by vigorously swabbing tonsillar areas, the
posterior pharynx, and any areas of inflammation,
ulceration, exudation, or capsule formation.
2.10.4.2
Use transport system and bring to laboratory.
2.10.4.3
DONOT OBTAIN THROAT SAMPLES IF
EPIGLOTTIS IS INFLAMED, AS SAMPLING
MAY CAUSE SERIOUS RESPIRATORY
OBSTRUCTION.
2.11
Tissue, Deep Wounds and Aspirates
2.11.1 Tissues- always submit as much tissue as possible.
2.11.1.1
Never submit a swab that has simply been rubbed
over the surface.
2.11.1.2
Quantitative tissue 1 gram of tissue is needed.
2.11.2 Bite wounds: Aspirate pus from the wound or obtain it at the time
of incision, drainage, or debridement of infected wound.
2.11.3 Bone: Obtain during surgery.
2.11.3.1
Submit in sterile container.
2.11.3.2
Sterile saline may be used to keep it moist.
2.11.4 Deep wounds or abscesses
2.11.4.1
Disinfect surface, aspirate the deepest portion of the
lesion, avoiding contamination by the wound surface.
2.11.5 Punch skin biopsies
2.11.5.1
Disinfect and aspirate the deepest portion of the
lesion or sinus tract.
2.11.5.2
Specimen should be obtained aseptically and placed
in a sterile screw-topped jar.
2.11.5.3
Add several drops of sterile saline to keep moist. Do
not allow tissue to dry out.
2.11.5.4
Bring to lab immediately.
2.12
URINE: Verbal or written clean catch instructions should be given to
patient to ensure collection of good specimen.
2.12.1 Use special sterile container from clean catch or catheter tray set.
2.12.2 Cap tightly and send to laboratory immediately or refrigerate
until it can be sent.
2.12.3 Female midstream-Thoroughly clean urethral area
with soap and water. Rinse area with wet gauze pads.
While holding labia apart, begin voiding. After
several mL have passed, collect midstream portion
without stopping the flow of urine. Collect in a
sterile wide mouth container >=1mL or in a urine
transport kit (preferred).
2.12.4 Male midstream-Clean the glans with soap and water.
Rinse area with wet gauze pads. While holding the
foreskin retracted, begin voiding. After several mL
have passed collect midstream portion without
stopping the flow of urine. Collect in sterile wide
mouth container or urine transport kit. (preferred)
95
2.12.5 Straight Catheter-Thoroughly clean urethral area with
soap and water. Rinse area with wet gauze pads.
Aseptically insert catheter into bladder. Allow ~
15mL to pass, then collect urine to be submitted in a
sterile container. This is not recommended for
routine urine culture because of potential
contamination problems. The procedure may
introduce urethral flora into the bladder.
2.12.6 Indwelling Catheter- Disinfect catheter collection
port with 70% alcohol. Use needle and syringe to
aseptically collect 5-10mL of urine. Transfer sample
to sterile tube or container.
2.13
WOUND, ABCESS: Surface lesions should be opened and the advancing
edge firmly sampled. Use transport system as directed on package.
Unopened wounds should be aspirated with needle and syringe.
2.13.1 Superficial wound
2.13.1.1
Syringe aspiration is preferable to swab collection.
2.13.1.2
Disinfect and aspirate from the deepest portion of the
lesion.
2.13.1.3
If vesicle is present, collect both fluid and cells from
the base of the lesion.
2.13.1.4
If the initial aspiration fails to obtain material, inject
sterile, nonbacteriostatic saline subcutaneously and
repeat aspiration.
2.13.2 Superficial lesions, fungal
2.13.2.1
Cleanse the surface with sterile water, and use a
sterile scalpel blade, scrap the periphery of the lesion
border.
2.13.2.2
Samples from scalp areas should include hair. If
there is nail involvement, obtain scrapings of debris
or material beneath the nail plate.
2.13.2.3
Transport in sterile container or sterile petri dish.
2.13.3 Ulcers and nodules: Cleanse the area; remove overlying debris,
curette the base of the ulcer or nodule.
2.13.4 Nails
2.13.4.1
Wipe with 70% alcohol using gauze, not cotton.
2.13.4.2
Clip away generous portion of affected area, and
collect material or debris from under the nail.
2.13.4.3
Place material in clean container -enough scraping to
cover head of a thumb tack.
2.14
Gastrointestinal Tract: The gastrointestinal tract includes the esophagus,
stomach, duodenum, small intestine, and colon.
2.14.1 Fecal specimens: Send freshly passed or collected specimen in
screw capped container.
2.14.1.1
For stool culturing transport to Micro lab within l
hour of collection, or transfer to enteric transport
system.
96
2.14.1.2
2.14.1.3
2.14.1.4
Swabs cannot be used for Parasitology testing.
Keep stool specimens cool, do not incubate.
Do not collect more than two specimens per
patient, because of the limited yield provided by
additional specimens. Do not perform stool
cultures for patients whose length of stay was
> 3 days and admitting diagnosis with
gastroenteritis without consultation.
2.14.2 Rectal swabs: Reserved for N. gonorrhoeae, enteric pathogens, herpes
simplex virus and anal carriage of Group B Streptococcus
and for patients unable to pass a specimen. (usually children)
2.14.2.1
Feces should be visible on swab for detection of
pathogens.
2.14.2.2
Pass the tip of a sterile swab approximately 1 inch
beyond the anal sphincter.
2.14.2.3
Carefully rotate the swab to sample the anal
cyst, and withdraw the swab.
2.14.2.4
Send the swab in transport media.
2.14.2.5
Rectal swabs for detection of N. gonorrhoeae.
They should be placed on GC transport bottles/
plates ASAP.
2.14.3
Gastric aspirates (Specimen must be processed promptly.
Micro should be notified prior to specimen collection.)
2.14.3.1
Gastric lavages are submitted primarily for the
detection of Mycobacterium tuberculosis in patients
(most frequently children) unable to produce quality
sputum.
2.14.3.2
This should be performed after the patient wakes in
the morning so that sputum swallowed during sleep is
still in the stomach.
2.14.4 Duodenal aspiration
2.14.4.1
Pass a tube orally though the duodenum, to aspirate
for giardiasis, the tube should be in the third portion
of the duodenum.
2.14.4.2
Submitted primarily for the detection of Giardia
species and the larvae of Strongyloides stercoralis and
Ascaris lumbricoides.
2.14.5 Ecoli 0157:H7
2.14.2.1
Pass liquid and/or bloody stool into a clean dry
container.
2.14.2.2
Bloody or liquid stools should be collected within 6
days of onset among patients with abdominal cramps
have the highest yield.
2.15
Ocular Specimens:
2.15.1 Swabs for culture should be taken prior to anesthetic, whereas
corneal scrapings can be obtained afterward.
2.15.2 Do not refrigerate.
2.15.3 Conjunctiva- sample both eyes with separate swabs (pre-moistened with sterile saline) by rolling a swab over each con97
2.15.4
2.15.5
2.15.6
2.15.7
2.15.8
2.16
junctiva.
Inoculate directly to medium. Sample both conjunctiva to determine
indigenous microflora.
The uninfected eye will serve as the control.
Obtain samples on swabs.
Inoculate directly to media. (Blood and Chocolate agar plates)
Some samples include conjunctival scrapings, corneal scrapings,
and intraocular fluid.
2.15.8.1
Corneal scrapings: Scrape multiple areas of
ulceration and suppuration with a sterilized spatula.
Inoculate directly to media. Prepare smears
immediately also.
2.15.8.2
Vitreous fluid aspirates(are to be ordered and setup like
body fluids). Use a needle aspiration technique to
collect. Inoculate media immediately or transport
immediately.
2.15.8.3
Contact the Microbiology Lab at 434-7623 for
Acanthamoeba culturing.
GENITAL
2.16.1 DO NOT REFRIGERATE ANY OF THE FOLLOWING
SAMPLES
2.16.2 FEMALE:
2.16.2.1
Amniotic- Aspirate via amniocentesis,
cesarean section or intrauterine catheter.
Transfer fluid to anaerobic transport,
collect >1mL within 15 minutes.
Swabbing or aspiration of vaginal membrane
is not acceptable because of vaginal
contamination.
2.16.2.2
Bartholin- disinfect skin with iodine preparation
Aspirate >1ml of fluid from ducts.
Transport in anaerobic system.
2.16.2.3
Cervix-visualize cervix with speculum
without lubricant. Remove mucus and/or
secretions from cervix with swab, and
discard swab. Firmly yet gently, sample
endocervical canal with sterile swab.
2.16.2.4
Cul-de-sac- submit aspirate or fluid >1mL in
anaerobic transport system.
2.16.2.5
Endometrium- collect transcervical aspirate
via telescoping catheter. Transfer entire
amount to anaerobic transport system.
Collect >1mL.
2.16.2.6
Products of Conception- submit portion of
tissue in sterile container. If obtained by
cesarean section, immediately transfer to
anaerobic transport.
2.16.2.7
Urethra- Collect 1 hour after patient has
urinated. Do not refrigerate. Remove exudates
98
2.16.2.8
2.16.3 MALE
2.16.3.1
2.16.3.2
from urethral orifice. Collect discharge
material on swab by massaging urethra
against pubic symphysis through the vagina.
If no discharge can be obtained, wash external
urethra with betadine soap, and rinse with
water. Then insert urethrogenital swab 2-4
cm into urethra, and rotate the swab for 2
seconds. The specimen should be directly
inoculate to Thayer-Martin medium or to a
GC transport system if gonrohoeae is
suspected.
Vagina- wipe away excessive amount of
secretion or discharge. Obtain secretions from
mucosal membrane of vaginal vault with
a sterile swab. Inoculate directly to MTM
agar or GC transport system if gonorrhoeae is
suspected. For intrauterine devices, place
entire device into sterile container, and submit
at room temperature.
Prostate- clean glans with soap and water.
Massage prostate through rectum. Collect
fluid on sterile swab or in sterile tube.
Urethra- insert urethrogenital swab 2-4 cm
into urethral lumen, rotate swab and leave in
place for at least 2seconds.
2.16.4 GENITAL: MALE AND FEMALE: Lesion- Clean lesion with
sterile saline, and remove lesion’s surface with sterile scalpel blade.
Allow transudate to accumulate. While pressing base of lesion,
firmly sample exudates with sterile swab.
2.16.5 CHLAYMDIA CULTURE
Specimens should be collected as early in the infection as possible. It is
essential that epithelial cells be collected in conjunctival and genital
specimens. Vigorously swab or scrap the area after removal of the exudate.
The transitional zone of the cervix should be sampled. Sputa or throat
washings are suitable for respiratory infection. Collect in VTM media and
transport on ice. Send out test.
2.16.6 HERPES CULTURE
Specimens should be collected from the site of infection as soon as possible
after onset of disease. The specimen of choice is vesicular fluid aspirated
from the fresh (not crusted) lesions with a 26 or 27 gauge needle in a
tuberculin syringe. Collect in VTM media and transport on ice. Send out
test.
2.17
BETA HEMOLYTIC STREPTOCOCCI
2.17.1 Transport swab system used as directed.
99
3.0
2.18
INTRAVASCULAR CATHETERS
2.18.1 They are important potential source of bacteremia and fungemia as
well as local infectious complications at sites of catheter insertion.
2.18.2 Quantitative culturing of catheter tips is useful in assessing the
relationship between catheters and sepsis.
2.18.2.1
Aseptically remove and clip 5-cm distal tip of
catheter directly into sterile tube.
2.18.3 Semi quantitative culture: central, CVP, Hickman, broviac,
peripheral, arterial, umbilical, hyperalimentation, Swan-Ganz.
2.18.3.1
A 2-inch distal segment of catheter should be
submitted to the laboratory by aseptically clipping off
the end of the catheter directly into a screw-cap,
large-mouth sterile container at the time the catheter
is removed. Send to the lab as soon as possible.
2.18.4 Add a few drops of non-bacteriostatic sterile saline.
2.18.4 FOLEY - DO NOT CULTURE, SINCE GROWTH
REPRESENTS DISTAL URETHRAL FLORA.
2.19
GONORRHOEAE: Inoculate directly to MTM agar when possible. Use
swab transport system as directed. (NEVER REFRIGERATE).
2.20
EPIDEMIOLOGICAL CULTURES: Do only with approval of Infection
Control.
2.21
SPECIAL MICROBIAL ISOLATES: Because of special media and
differences in processing necessary to achieve maximum recovery, the
Microbiology lab must be notified in advance if any of the following are
requested:
2.21.1 Brucellosis (Always notify lab of suspicion)
2.21.2 Leptospirosis
2.21.3 Mycoplasmosis
2.21.4 Pertussis
2.21.5 Pneumocytosis
2.21.6 Tularemia
2.21.7 Diphtheria
2.21.8 Acanthamoeba infection
2.21.9 Cell wall defective organisms
2.21.10 See chart
RAPID PCR TESTING
3.1
MRSA Screen
3.1.1 Ask the patient to tilt his/her head back. Insert dry swab approximately
1–2 cm into each nostril.
3.1.2 Rotate the swab against the inside of the nostril for 3 seconds. Apply
slight pressure with a finger on the outside of the nose to help assure good
100
contact between the swab and the inside of the nose.
3.1.3 Using the same swab, repeat for the second nostril, trying not to touch
anything but the inside of the nose.
3.1.4 Remove the plastic transport tube. Twist off the tube cap and discard it.
3.1.5 Using the second swab collect a throat sample as in 2.11.4 of this
procedure.
3.1.7 Place the swabs into the plastic transport tube. The swabs should go all the
way into the tube until they rest on top of the sponge at the bottom of the
tube. Make sure the red cap is on tightly.
Note: The swabs should stay attached to the red cap at all times.
3.1.8 Label the plastic transport tube with patient ID and send to the laboratory.
3.1.9 Store swab specimen at room temperature (15–30 °C) if it will be
processed within 24 hours, otherwise store swab at 2–8 °C.
3.1.10 The swab specimen is stable up to 5 days when stored at 2–8 °C.
4.0
3.2
GROUP B
3.2.1 Using the Cepheid Collection Device, collect specimens according to
CDC recommendations. The following procedure should be
used:
 Wipe away excessive amounts of secretion or discharge.
 Remove both marked swabs from the transport container.
 Carefully insert both marked swabs into the patient's vagina.
Sample secretions from the mucosa of the lower one-third part of
the vagina. Rotate the swabs three times to ensure uniform sample
on both swabs.
 Using the same marked swabs, carefully insert both swabs
approximately 2.5 cm beyond the anal sphincter, and gently rotate
to sample anal crypts.
 Place both marked swabs in the transport container.
3.2.2 If the specimens will be processed within 24 hours, store at room
temperature. If the specimens will be tested after 24 hours, refrigerate until
testing is performed.
3.2.3 Specimens stored at 2–8º C are stable for up to six days.
3.3
CLOSTRIDIUM DIFFICILE
3.3.1 Collect the unformed stool specimen in a clean container. Follow the
institution’s guidelines for collecting samples for C. difficile testing.
3.3.2 Label with Sample ID and send to the laboratory.
3.3.3 Store specimen at 2 – 8 °C. The specimen is stable for up to 5 days when
stored at 2 – 8 °C. Alternatively, specimens can be kept at room
temperature (20 – 30 °C) for up to 24 hours
SPECIAL TESTING
ORGANISM
Brucella
SPECIMEN OF CHOICE
TRANSPORT
Blood
Transport at room
Bone marrow
temperature
COMMENTS
Hold blood culture up to 30
days
101
Francisella spp.
(tularemia)
Cat Scratch Fever
Bartonella
Mycoplasma or
Ureaplasma
Viral specimens
Lymph node
aspirate
Scrapings
Lesion biopsy
Blood(use isolator)
Sputum
Respiratory (throat
or early morning
sputum), vaginal
swab, cervical,
urine, endometrial
washing, placenta
Various areas
Collect isolator tube
Rapid transport to the lab or Send to reference lab or
freeze
Do in house on
Chocolate agar
Hold for 30 days
Store at 2C for up to 6
hours and freeze after.
Transport mycoplasma
growth media, viral
transport
Send to reference lab
Collect in viral transport
and send immediately with
cold pack or on ice. Tissue
and fluid should be in
sterile containers.
Volume 1-2mL, sterile
leak proof containers, keep
on cold pack or ice, freeze
if not sending day of
receipt.
Legionella Culture /
DFA
Sputum,bronch
washing, pleural
fld, lung tissue,
other body fluids,
abscesses, bacterial
isolates
Acanthamoeba/
Naegleria culture
CSF or tissue
submitted in Page’s
amoeba saline
Bordetella pertussis
CULT/DFA/PCR
NP swab
Collect with
calcium alginate
swabs for
Culture or DFA
Use Copan Eswab,
NP flocked swab
for PCR
DO NOT USE
calcium alginate
for PCR.
Throat swab, isolate Culturette at room
temperature, isolate agar
slant screw capped
Corynebacterium
diphtheriae
5.0
DFA- send 2 slides
1mL CSF or small piece of
tissue sterile screw capped
tube, store at room
temperature
Culture: Inoculate media
Immediately after
collection
or submerse swab in
Regan-Lowe transport.
DFA: Prep slides
immediately
PCR:Place swab in sterile
container
Contact lab in advance
for media
Contact lab in advance
for media. PCR
performed in MP. DFA
sent to Reference Lab
ANAEROBIC CULTURES
5.1
Bring fluids to lab immediately in syringes.
5.2
Swabs in anaerobic transport media may be used.
5.3
102
Suitable specimens
Properly collected abscess material
Blood (venipuncture)
Bone marrow
Lung aspirate and transtracheal asp
Suprapubic urine
Endometrial or endocervical material
collected by direct visualization through a
speculum
Aseptically collected tissue
"Sulfur granules" from sputum or
other materials when actinomycosis
is suspected.
Body fluids (ascitic, cerebrospinal
pericardial, pleural, synovial)
Bile
Nasal sinus aspirate
Fallopian tube fld. or tissue
Stool for C. difficile
IUD for Actinomyces spp.
Placenta tissue (via cesarean )
Unsuitable specimens
Throat, nasopharyngeal, material
endotracheal secretions.
Sputum (Expectorated or induced),
tracheotomy aspirate bronchoscopic
washings, bronchoalveolar lavage
washings(BAL)
Voided or bladder catherization urine
Vaginal,vulvar, cervical, or lochia secretions
(swabs)
Material from superficial abscesses or
lesions improperly collected
Specimens contaminated, with feces
(draining fistulae, colostomy, bowel
contents, rectal abscesses, perinea swabs)
* Feces or rectal swabs
Prostatic or seminal fluid, urethral,
lochia, or cervical secretions.
*There are a few exceptions; for example when botulism, C. perfringens
foodborne disease, or antibiotic associated pseudomembranous colitis is
suspected, it is appropriate to test stool specimens.
5.4
Miscellaneous test - Please contact the Microbiology Laboratory for others
not listed.
5.5
Some samples are routinely sent to reference labs. Please refer to their individual manuals
for test not listed.
Specimen Collection Mycology
1.0
M5.001.07
PRINCIPLE
Following the proper procedure for collecting, transporting and storing specimens are
extremely important for providing rapid and accurate results for the diagnosis and
management of Mycoses. The best specimen for determining the etiologic agent is at
103
active infection site. Specimens must be collected under aseptic conditions or after
appropriate hygienic preparation to optimize the significance of the mycology results.
All specimens for mycology studies should be handled as potentially hazardous.
Transportation to the laboratory should be rapid and kept at room temperature. Only if
processing is delayed, may specimens be stored at 4  C; however, there are rare
exceptions. Culturette swabs should not be stored before culturing, since Histoplasma
capsulatum, Blastomyces dermatitidis, and Cryptococcus neoformans may be inhibited.
2.0
SPECIMENS
Most specimens for fungal culture are collected as you would bacterial cultures. Swabs
are not recommended for collecting fungal specimens except when used to swab the
vagina for yeast or to swab sporotrichotic chancres. Pediatric specimens should be
collected in the same manner. The presence of more material for primary inoculum and
concentration of large volumes of fluid greatly increases the likelihood of recovery of
fungal species.
2.1
HAIR, SKIN AND NAILS
Usually submitted for dermatophyte culture
2.1.1 Abnormal hairs should be removed with forceps and scalp scales collected
by scraping.
2.1.2 If nail polish is present remove before sampling. Wipe with 70% alcohol
on gauze. Do not use cotton. Nail specimens should be obtained by
clipping a portion of the affected area and scraping off the excess keratin
produced beneath the nail.
2.1.3 Skin specimens should be obtained by scraping off the active borders of
the lesions with a scalpel after cleaning the affected area with an alcohol
swab.
2.14 All skin, hair, and nail specimens may be placed in an envelope or sterile
culture dish for transport. Cultures may be stored at room temperature.
2.2
URINE
Urine specimens should be collected in sterile containers and sent to the
laboratory immediately, if not, specimens may be stored at 4  C for up to 12
hours. Twenty-four hour and catheter bags are not acceptable for mycology
studies. Centrifuge and plate sediment.
2.3
STERILE BODY FLUIDS (CSF, Pericardial, Peritoneal, Synovial, and Vitreous
Humor)
Body fluids should be obtained under aseptic conditions with the use of a sterile
syringe. The fluid can be transferred to a sterile tube for safe transport to the
laboratory. Specimens should be stored at 4 C.
2.4
EYE SPECIMENS
An Ophthalmologist should obtain specimens. After the surface of the cornea is
scraped several times, the kimara scalpel should be streaked on X’s of C’s
designated on the bottom of appropriate fungal media in petri dishes. Another
portion of the scraping should be fixed on glass microscope slides for
examination. Inoculated plates should be kept at room temperature if transit time
104
to the laboratory may be delayed.
2.5
VAGINAL SPECIMENS
Vaginal specimens are collected on two swabs in order to culture and make a
smear, or a slide may be sent along with one swab for culture. Specimens should
be transported in a closed container and may be stored at 4  C if needed.
2.6
RESPIRATORY SECRETIONS
Most respiratory specimens are collected through the upper respiratory tract. The
first morning specimens are preferred after proper oral hygiene of brushing teeth
and rinsing the mouth. All specimens should be collected in wide mouth
containers with leak proof lids; 5 to 10 ml is more than adequate. Specimens may
be stored at 4  C if necessary.
2.7
TISSUE SPECIMENS
Tissue specimens should be collected by an experienced person. Specimens
should be placed in a small sterile container and sent to the laboratory
immediately.
2.8
STOOL SPECIMENS
Stool cultures should be submitted in a sterile container or on two rectal swabs.
Specimens may be stored at 4  C.
2.9
BLOOD CULTURES
Blood specimens should be collected in Isolator tubes. See the specimen
collection and blood culture processing procedures for the details of this
procedure.
3.0
SPECIMEN TRANSPORT
Appropriate transport and storage of specimens are necessary for fungal elements to
remain viable. Fungal viability may be affected by excessive heat and cold.
3.1
Room temperature transport and storage, ideally within 2 hours of collection is
recommended.
3.2
Exceptions 30°C for central nervous system specimens and 4ºC for extended
storage of specimens likely to be contaminated with bacteria.
4.0
PRECAUTIONS
4.1
For systemic infections consider the need for acute and convalescent- phase sera.
4.2
4.3
Always sample the periphery of a skin lesion.
Keep biopsy material moist by placing it between pieces of sterile,
moistened gauze in a small dish.
Mycobacteriology Specimen Collection M4.002.08
1.0
The efficiency of any laboratory procedure used to culture Mycobacteria from clinical
specimens depends on the manner in which the specimen is obtained and handled.
105
Specimens should be collected with the utmost care and promptly transported to the
laboratory. The proper procedure for collecting, transporting and storing specimens are
extremely important for providing rapid and accurate results for the diagnosis and
management of Mycobacteria. The successful isolation of the organism depends on the
quality of the specimen obtained and appropriate processing and culture techniques used
by the mycobacteria laboratory.
2.0
SPECIMEN COLLECTION AND HANDLING
For optimal results, obtain specimens under the following conditions:
2.1
Collect specimen before chemotherapy is started because just a few days
of therapy may kill or inhibit sufficient numbers of acid-fast bacilli to
leave confirmation of disease in doubt.
2.2
Collect specimens in clean, leak proof, sterile, one-use, plastic disposable
containers with a screw cap. Make sure it is sealed to avoid leakage or breakage in
transit.
2.3
Waxed containers must not be used because they may yield false-positive
AFB smear results.
2.4
Specimens should be collected aseptically, or the collection method should
bypass areas of contamination as much as possible in order to minimize
contamination with indigenous flora.
2.5
Avoid contamination with tap water or other fluids that may contain either
viable or nonviable environmental mycobacteria, since saprophytic
mycobacteria may produce false-positive culture and or smear results.
2.6
On successive days, collect a series of three early morning specimens.
2.7
Swabs are not optimal for recovery of AFB since they provide limited
material and the hydrophobicity of the mycobacterial cell envelope often
compromises a transfer from swabs onto solid or into broth media.
3.0
SPECIMEN TRANSPORT
3.1
3.2
3.3
3.4
4.0
Transport media, fixatives or preservatives are not necessary because of
the robust nature of mycobacteria.
3.1.1 Transport to the lab immediately to avoid overgrowth by
contaminating bacteria and fungi.
Transport specimens to the lab as soon as possible (within 30 minutes).
3.2.1 Refrigerate specimens if delivery is delayed to discourage the
multiplication of rapidly growing non-acid fast organisms that reproduce
at room temperature and sometimes make decontamination of the
specimen impossible in the laboratory.
Seal specimen containers carefully to avoid leakage or breakage in transit.
Once in the lab keep refrigerated until processed.
SPECIMEN LABELING
4.1
The specimens must be labeled with the following:
4.1.1 Patient's name
4.1.2 Patient's room number, unit record number, date of birth
4.1.3 Specimen source
4.1.4 Date and time of collection
4.1.5 Test to be performed on specimen
106
5.0
SPECIMENS
5.1
NOTE: Samples are incubated at 35-37°C, unless otherwise
specified by type.
5.2
Many different types of clinical specimens may be collected for
mycobacteriologic analyses.
5.3
The majority of the specimens originate from the respiratory tract (sputum, or
induced sputum, tracheal aspiration, bronchial aspirates; bronchoalveolar lavage
fluid specimens).
5.2
Other common specimens include:
5.2.1 Urine
5.2.2 Gastric aspirates
5.2.3 Tissues
5.2.4 Biopsy specimens
5.2.5 Sterile body fluids
5.2.6 Blood and fecal specimens are usually submitted from
immunocompromised patients only.
5.3
Sputum and aerosol induced sputum:
5.3.1 Sputum, expectorated or induced, is the principal specimen obtained for
the diagnosis of pulmonary tuberculosis.
5.3.2 To obtain a desirable specimen, the patient should be instructed to
rinse the mouth with water before sputum is collected to minimize
residual food particles, mouth wash, and oral drugs that might
contaminate the specimen or inhibit growth of any acid fast bacilli
present.
5.3.3 Have the patient take a deep breath, hold it momentarily and then
Cough deeply and vigorously. Collect only the exudative material
brought up from the lungs after a deep, productive cough. The
patient should cover their mouths carefully while coughing and to
discard tissues in an appropriate receptacle.
5.3.3.1 Specimens should be collected in laboratory approved containers,
clearly labeled with patient name and identification number.
5.3.4 These specimens should be a series of 3 single early morning
samples.
5.3.4.1 A first morning specimen is superior to a pooled specimen
primarily because of the higher contamination rate of the pooled
specimen.
5.3.4.2 Pooled (24 hour) specimens are not acceptable for AFB
processing.
5.3.5 A volume of 5 to 10 ml is adequate for each sample.
5.3.6 If there is a delay in the delivery of the specimens to the lab, they
should be refrigerated.
5.3.7 For patients who have neither a cough nor spontaneous
expectoration, suitable specimens may be obtained by the
induction of a cough by the inhalation of warm, aerosolized, sterile
sodium chloride (5% to 10%).
6.4.7.1 Because these specimens resemble saliva, it is important they be
labeled "induced" specimens.
5.3.8 Saliva and nasal secretions are not to be collected.
107
5.4
Gastric lavage
5.4.1 Aspiration of swallowed sputum from the stomach by gastric lavage
maybe necessary for infants, young children, senile and nonambulatory
patients.
5.4.2 Samples of 5 to 10ml adjusted to neutral pH, should be collected on 3
consecutive days.
5.4.3 The collection should be made early in the morning before the patient
arises, has eaten or taken oral drugs. It is preferable to use commercially
prepared sterile distilled water for parenteral injection to avoid introducing
saprophytic acid-fast organisms which may be present in tap water.
5.4.4 Gastric contents are toxic to tubercule bacilli so they must be processed
immediately after collection.
5.4.5 Notification of the Microbiology department prior to collection is
necessary to ensure adequate and prompt processing.
5.5
Urine
5.5.1 First morning urine midstream specimens are superior to 24 hour
collections because organisms accumulate in the bladder overnight. They
should be collected for at least 3 consecutive days.
5.5.2 Twenty-four hour collections are unacceptable because they have a higher
contamination rate and yield a smaller number of positive cultures because
of dilution and contamination.
5.5.3 Keep the specimen refrigerated before processing.
5.5.4 Also before specimens are collected external genitalia should be
washed.
5.5.5 Do not use bottles containing preservatives, as they can kill
Mycobacteria.
5.5.6 At least 40 ml of urine is required for culture.
5.5.7 Catheterization should be used only if a midstream sample cannot
be obtained.
5.6
Tissue( Note: Tissue samples initial smears positive will be ordered
and tested by TBPCR on the Cepheid GeneXpert by the
Molecular Pathology department.
5.6.1 Aseptically collected tissue specimens, suspected to contain Mycobacteria,
are placed in sterile containers without fixatives or preservatives.
5.6.2 Do not immerse in saline or other body fluids.
5.6.3 Do not place or wrap in gauze.
5.6.4 Minute quantities of biopsy material may be immersed in a small amount
of physiological saline.
5.6.5 For cutaneous ulcers collect biopsy material from the periphery of the
lesion.
5.6.6 When delay is necessary, freeze the tissue, and transport to the laboratory
in frozen state.
5.6.7 Specimens received in formalin are unacceptable.
5.7
Blood
5.7.1 Collect as would blood culture in a 10 ml Isolator tube or (If Pediatric
108
5.7.2
patient 1.5 ml isolator tube). See Blood Culture Specimen Procedure for
Blood culture collection.
Store at room temperature and send to the lab promptly.
5.8
Skin Lesions
5.8.1 Cleanse the skin with alcohol before aspirating the sample.
5.8.2 In cutaneous lesions, material is aspirated from beneath the margin
of the lesion.
5.8.4 Swabs that are collected should be a last resort for they are not
good sources for optimum growth.
5.8.5 Negative results from swab specimens are not reliable.
5.8.6 Dry swabs are not acceptable.
5.9
Body fluids
5.9.1 Cerebrospinal fluid, pleural, peritoneal, pericardial, joint fluids,
ascetic fluid, bone marrow should only be collected after proper
cleansing.
5.9.2 Collect in a sterile container or syringe.
6.10.2.1 Remove the needle before bringing to the lab.
5.9.3 Larger volumes increase culture yields because organisms are in
low numbers from body fluids. At least 10ml of CSF should be
submitted and 10 to 15 ml of other body fluids.
6.0
Stool specimens
6.0.1 Stool specimens should be greater than 1 gram. Collect in sterile,
leak proof, wax free container without preservative or diluent.
6.10.1.1 Initially only a smear is performed on stool samples. If the AFB
smear is positive, then the specimen is cultured for AFB. An order will
have to be entered by the physician or nurse to get results back to the
patient’s chart.
6.0.2 They are recommended for the detection of MAC involvement in
gastrointestinal tracts of immunocompromised patients.
Collection and Preservation of Fecal Specimens M6.001.04
1.0
PRINCIPLE
One of the most important steps in the diagnosis of intestinal parasites is the proper
collection of specimens. Improperly collected specimens can result in inaccurate results.
Fresh specimens are mandatory for the recovery of motile trophozoites. Trophozoites
will not survive if the stool specimen begins to dry-out. Cysts will not form once the
specimen has been passed. Strict collection and delivery times must be adhered to or
the specimen may have little value for diagnostic testing.
2.0
SPECIMEN
109
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
2.11
2.12
2.13
Collect in a clean, wide-mouthed container with a tight fitting lid.
Avoid contamination with urine or water from the toilet. If specimens are to
be collected in a bedpan, the patient should urinate into a separate container
before the specimen is collected.
Preserved or unpreserved specimens are acceptable. Several commercial kits are
available.
Specimens should be transported to the lab as soon as possible or kept
refrigerated until transport is possible. Refrigeration will delay deterioration of
the parasitic organism. Freezing of the fecal specimen is not recommended, as
characteristic morphology of the parasitic organism may be altered. Never
incubate fecal specimens.
There is no maximum amount to collect. As a minimum amount, collect several
grams.
Reject any specimen that appears to be dry on the surface or edges.
Do not receive more than 3 specimens without consultation.
Do not accept specimens from inpatients after the fourth hospital day.
A patient who has received treatment for a protozoan infection should be
checked 3 to 4 weeks after therapy.
Patients treated for helminth infections may be checked 1 to 2 weeks after
therapy and those treated for Taenia infections 5 to 6 weeks after therapy.
Fresh passed specimens are mandatory for the detection of trophic amebae or
flagellates.
Reject samples contaminated with barium.
If 3 specimens are collected, it is recommended they be 1 to 2 days apart; other
wise the series of 3 specimens should be submitted within no more than 10 days.
3.0
PRESERVATION
3.1
Specimens that cannot be processed and examined in the recommended time
should be place in an appropriate preservative.
3.2
Preservatives will prevent the deterioration of any parasites that are
present.
3.3
A number of fixatives for preserving protozoa and helminths are available.
Each preservative has specific limitations, and no single solution enables all
techniques to be performed with optimal results.
3.4
Liquid specimens should be received and examined or preserved by the lab
within 30 minutes of passage.
3.5
Soft or semi-formed specimens should be received and examined or
preserved by the lab within 1 hour of passage.
3.6
Formed specimens should be received and examined or preserved by the lab on
the same day of passage.
4.0
PRECAUTIONS
4.1
Collect all fecal specimens prior to the administration of antibiotics or antidiarrheal agents.
4.2
Avoid the use of mineral oil, bismuth, and barium prior to fecal collection since
these substances interfere with the detection or identification of intestinal
parasites.
4.2.1 Barium causes feces to be light tan to white.
4.2.2 Barium causes an excess of crystalline material in the stool specimen
making it impossible to detect intestinal protozoa for at least a week after
110
4.3
use.
Anti-malarials may also prevent the detection of intestinal protozoa.
5.0
HAZARDS
5.1
Specimens collected should be transported to the laboratory in such a way that no
one handling the container comes in direct contact with the specimens.
5.2
The unpreserved specimens should be considered as potentially infectious and
gloves should be worn.
5.3
Protozoan cyst, Cryptosporidium oocysts, eggs of Taenia solium, Enterobius
vermicularis, Hymenolepsis nana, and larvae of Strongyloides stercoralis may be
infective.
5.4
The fresh specimen may also contain Salmonella sp., Shigella sp., or other
bacterial pathogens.
5.5
Bloody stools may pose a special hazard as potential carriers of Hepatitis A and B
virus, HIV, and enteric non A, non B viruses.
6.0
PROCEDURE NOTES
6.1
The number of specimens required to demonstrate intestinal parasites will vary
depending on the quality of the specimen submitted, the accuracy of the
examination performed, and the severity of the infection.
6.2
For routine examination for parasites before treatment, a minimum of three fecal
specimens is recommended. If 3 specimens are collected, it is recommended they
be 1 to 2 days apart: otherwise the series of 3 specimens should be submitted
within no more than 10 days.
6.3
Protozoan trophozoites will not survive if the stool specimen begins to dry out
and cysts will not form once the specimen has been passed
6.4
A patient who has received treatment for a protozoan infection should be checked
3 to 4 weeks after therapy.
6.5
Patient treated for helminth infections may be checked 1 to 2 weeks after therapy and
those treated for Taenia infections 5 to 6 weeks after therapy.
6.6
Ingested iron and some anti-diarrheal compounds may cause the specimen to be dark
and black.
6.7
Yellowish specimens may be noted in cases of fat malabsorption, which commonly
seen in infections with Giardia lamblia.
6.8
Fresh passed specimens are mandatory for the detection of trophic amebae or
flagellates.
6.9
All stools for Ova and Parasite examination are concentrated and stained
with a permanent stain. (trichrome)
6.10 Ova and parasite testing is only done on patients with travel history and
previous positive results. Antigen testing is performed on other samples first.
RAPID TESTING IN MICROBIOLOGY LAB
Strep. Pneumoniae Antigen M2.043.03
1.0
Streptococcus pneumoniae Test is an immunochromatographic membrane assay used to
detect pneumococcal soluble antigen in human urine and cerebral spinal fluid (CSF).
111
2.0
PRIMARY SAMPLE SYSTEM
2.1
Specimen: Acceptable: Urine, CSF. Unacceptable: Specimens collected from
other sources.
2.2
Urine Collection Container: Use standard urine collection container. Boric Acid
may be used as a preservative. Unacceptable: Use of other preservatives
2.3
Urine Specimen Storage: Samples may be stored at room temperature if assayed
within 24 hours. Alternatively, samples may be refrigerated or frozen for up to 14
days before testing.
2.4
CSF: collect CSF according to standard protocols, submit sample in scew top
CSF container.
2.5
CSF Storage: CSF may be stored at room temperature for up to 24 hours before
testing. Alternatively CSF may be refrigerated (2-8°C) or frozen
(-20°C) for up to one week before testing.
Influenza A+B
FIA M2.046.01
1.0 PURPOSE AND/OR PRINCIPLE
The Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B
viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal
aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is
intended for use as an aid in the rapid differential diagnosis of acute influenza A and
influenza B viral infections. A negative test is presumptive and it is recommended these
results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay.
Negative results do not preclude influenza virus infections and should not be used as the sole
basis for treatment or other management decisions. Influenza viruses are causative agents of
highly contagious, acute, viral infections of the respiratory tract.
2.0 PRIMARY SAMPLE SYSTEM
2.1 Nasal Swab Sample- Immediate testing only.
2.1.1 Use the nasal swab supplied in the kit.
2.1.2 To collect a nasal swab sample, carefully insert the swab (provided in the kit)
into the nostril that presents the most secretion under visual inspection. Using gentle
rotation, push the swab until resistance is met at the level of the turbinates (less than
one inch into the nostril). Rotate the swab several times against the nasal wall, and
then remove it from the nostril. Place the swab back into the paper wrapper and label
with the patient information and transport immediately to the laboratory.
2.1.3 This specimen is only acceptable for testing less than 1 hour from collection.
If testing cannot be done within 1 hour collect specimen with Universial Transport
Medias as below.
2.1.4 DO NOT use red top dual swab culturettes.
2.2 Nasal Swabs- for specimens that must be transported.
Use regular-tip flocked swabs contained in the collection kit with a 1mL vial of
Universal Transport Media (UTM).
2.2.1 BD Universal Viral transport for Viruses, Chlamydiae, Mycoplasma and
Ureaplasmas.
2.2.2 Puritan UTM-RT Transport system.
2.2.3 DO NOT use eSwabs with Amies media
112
2.2.4 DO NOT use red top dual swab culturettes.
2.2.5 To collect a nasal swab sample, carefully insert the swab (provided in the kit)
into the nostril that presents the most secretion under visual inspection. Using gentle
rotation, push the swab until resistance is met at the level of the turbinates (less than
one inch into the nostril). Rotate the swab several times against the nasal wall, then
remove it from the nostril.
Place the swab into the viral transport media, snap off the handle. Label the vial of
UTM.
2.3 Nasopharyngeal Swab Sample: Preferred for specimens that must be transported.
2.3.1 Use mini-tip flocked swabs contained in the collection kit with a 1mL vial
of Universal Viral Transport Media.
2.3.2 BD Universal Viral transport for Viruses, Chlamydiae, Mycoplasma and
Ureaplasmas.
2.3.3 Puritan UTM-RT Transport system.
2.3.4 DO NOT use eSwabs with Amies media.
2.3.5 To collect a nasopharyngeal swab sample, carefully insert the swab into the
nostril that presents the most secretion under visual inspection. Keep the swab near
the septum floor of the nose while gently pushing the swab into the posterior
nasopharynx. Rotate the swab several times, then remove it from the nasopharynx.
Place the swab into the viral transport media, snap off the handle. Label the vial of
UTM.
2.4 Nasopharyngeal Aspirate/Wash Sample: Follow your institution’s protocol for obtaining
nasopharyngeal aspirate/wash specimens. Use the minimal amount of saline that your
procedure allows.
2.5 Specimen Transport and Storage:
2.5.1 Nasal Swab Samples collected without UTM- transport at room temperature,
test within 1 hour.
2.5.2 Nasal Swabs or Nasopharyngeal swabs collected with UTM- transport at room
temperature and test within 72 hours.
2.5.3 Nasopharyngeal Aspirate/Wash Sample-transport refrigerated (2-8°C)
Test within 24 hours.
Group A Strep
M2 .047.01
1.0
PURPOSE AND /OR PRINCIPLE
Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal
antigens from throat swabs of symptomatic patients. Group A Streptococcus is one of the
most common causes of acute upper respiratory tract infection. Early diagnosis and
treatment of Group A Streptococcal pharyngitis has been shown to reduce the severity of
symptoms and serious complications such as rheumatic fever and glomerulonephritis.
Conventional procedures for identification of Group A Streptococcus from throat swabs
involve the culture, isolation, and subsequent identification of viable pathogen at 24 to 48
hours or longer for results.
2.0
SPECIMEN COLLECTION AND PREPARATION
2.1
A Double rayon swab containing modified Stuart’s liquid medium is the
preferred specimen for this test.
113
2.1.1
2.2
2.3
Two throat swab specimens should be obtained and be placed in the
culturette with the liquid Stuart’s media
2.1.2 If a Group A Strep with reflex to culture has been ordered, use the second
swab for culture.
Swab the posterior pharynx. Tonsils and other inflamed areas. Avoid touching
the tongue, cheeks and teeth with the swab.
Testing should ideally be performed immediately after the specimens have been
collected. Specimens can be stored/transported for 24 hours at room temperature
or 48 hours at 2-8˚C.
RSV Test M2.048.01
1.0
RSV is a causative agent of highly contagious, acute, viral infection of the respiratory
tract in pediatric and elderly populations. Respiratory syncytial virus is a single-stranded
RNA virus. In an analysis of U.S. viral surveillance and mortality data, respiratory
syncytial virus (RSV) was reported as the most common viral cause of death in children
younger than 5 years when compared to influenza A (H1N1), influenza A (H3N2), and
influenza B.
2.0
2.1
Preferred specimen: Nasopharyngeal Swab Sample in VTM.
2.1.1 Use mini-tip flocked swabs contained in the collection kit with a 1mL vial
of Universal Viral Transport Media.
2.1.1.1 BD Universal Viral transport for Viruses, Chlamydiae,
Mycoplasma and Ureaplasmas.
2.1.1.2 Puritan UTM-RT Transport system.
2.1.1.3 eSwabs with Amies media are also acceptable.
2.1.2 To collect a nasopharyngeal swab sample, carefully insert the swab into
the nostril that presents the most secretion under visual inspection. Keep
the swab near the septum floor of the nose while gently pushing the swab
into the posterior nasopharynx. Rotate the swab several times, then
remove it from the nasopharynx. Place the swab into the viral transport
media, snap off the handle. Label the vial of UTM.
2.3
Nasopharyngeal Aspirate/Wash Sample: Follow your institution’s protocol for
obtaining nasopharyngeal aspirate/wash specimens. Use the minimal amount of
saline that your procedure allows.
2.4
Specimen Transport and Storage:
2.4.1 Nasopharyngeal swabs collected with UTM- transport at room
temperature and test within 24 hours.
2.4.3 Nasopharyngeal Aspirate/Wash Sample-transport refrigerated (2-8°C)
Test within 24 hours.
2.5
Unacceptable specimens: Nasal Swabs.
Gastrointestinal (GI) PCR Panel
114
1.0
PRINCIPLE:
The FilmArray GI is a multiplexed nucleic acid test intended for use with the
FilmArray Instrument for the simultaneous qualitative detection and identification
of nucleic acids from multiple bacteria, viruses, and parasites directly from stool
samples in Cary Blair transport media obtained from individuals with signs and/or
symptoms of gastrointestinal infection.
2.0
SPECIMEN REQUIREMENTS:
2.1
Human stool collected in Cary Blair transport medium. Stool specimens
should be collected in Cary Blair transport media according to
manufacturer’s instructions.
2.2
200 µL of sample is required for testing.
2.3
Specimens in Cary Blair should be processed and tested as soon as
possible, though they may be stored at room temperature or under
refrigeration for up to four days.
2.4
Store specimens 2-30°C during transport.
3.0 The panel includes the following:
DTA
CAMPYLOBACTER
ORGANISM
Campylobacter
C.DIFF
C.diff toxin A/B
P.SHIGELLOIDES
SALMONELLA
VIBRIO
Y. ENTEROCOLITICA
E.COLI (EAEC)
E.COLI (EPEC)
E.COLI (ETEC)
E.COLI (STEC)
E.COLI(EIEC)
CRYPTOSPORIDIUM
C. CAYETANENSIS
E. HISTOLYTICA
GIARDIA LAMBLIA
ADENOVIRUS
ASTROVIRUS
NOROVIRUS
ROTAVIRUS
SAPOVIRUS
Plesiomonas shigelloides
Salmonella
Vibrio
Yersinia enterocolitica
Enteroaggreative E.coli (EAEC)
Enteropathogenic E. coli (EPEC)
Enterotoxigenic E. coli (ETEC)
Shiga-like toxin-producing E.coli (STEC)
Shigella/Enteroinvasive E.coli (EIEC)
Cryptosporidium
Cyclospora cayetanensis
Entamoeba histolytica
Giardia lamblia
Adenovirus F 40/41
Astrovirus
Norovirus GI/GII
Rotavirus A
Sapovirus
Rapid HIV–1/2 Ag/Ab Combo for Exposures M2.051.01
115
1.0
Purpose and/or Principle
HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the
simultaneous detection of Human Immunodeficiency Virus Type 1 (HIV-1) p24 antigen
(Ag) and antibodies (Ab) to HIV Type 1 and Type 2 (HIV-1 and HIV-2) in human serum,
plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
2.0
Specimen Requirements
2.1
For serum or plasma samples: 50 μL of sample is needed for this test.
2.2
Purple Top EDTA tubes or gold top serum tubes can be used.
2.3
Specimens should be stored at 2-8°C for up to 7 days.
Fecal lactoferrin M2.035.02
1.0 PRINCIPLE OF THE ASSAY:
Diarrheal diseases may be classified into inflammatory and non-inflammatory diarrhea.
Non-inflammatory diarrheas include those caused by viruses and most parasites and are for
the most part treated with simple oral rehydration. Inflammatory diarrheas tend to be more
serious and need to be followed up with more extensive testing. In inflammatory diarrhea,
fecal leukocytes are found in the feces in large numbers.
2.0
SPECIMEN COLLECTION:
2.1 Collect fecal specimens into a clean airtight container with no
preservatives. Liquid, semi-solid and solid fecal specimens may
be tested. Swabs are not acceptable.
2.2 Specimens are stored between 2-8°C or room temperature for up to
2 weeks from time of collection then stored at -20°C or lower.
Legionella Antigen, Urine M2.034.02
1.0
The Legionella Urinary Antigen Test is an immunochromatographic membrane assay for
the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine.
2.0
2.1 Specimen:
Acceptable: Urine.
Unacceptable: Specimens collected from other
sources.
116
2.2 Urine Container:
2.3 Urine Preservative:
2.4 Specimen
Transport:
2.5 Specimen Storage:
2.6 Handling
Precautions:
Adenovirus Test
1.0
Acceptable: Standard Urine Collection Container.
Acceptable: Boric Acid may be used as a
preservative.
Unacceptable: Use of other preservatives.
Transport in a leakproof container.
Samples may be stored at room temperature if assayed
within 24 hours, or at 2-8°C for up to 14 days, or –10°
C to –20° C for longer periods before testing.
Specimens should be at room temp before testing.
Patient samples, controls, and test devices should be
handled as though they could transmit disease.
Observe established precautions against microbial
hazards.
M2.032.04
Human Adenoviruses are non-enveloped, double-stranded DNA viruses. There are 51
adenoviruses, separated into six subgenera, that cause human infections. Adenoviruses
can be transmitted via direct contact, fecal-oral transmission, and waterborne
transmission. These viruses are highly stable and may survive for prolonged periods of
time outside the body, contributing to their infectivity.
Adenovirus illnesses are endemic throughout the year. They are commonly known for
their ability to cause respiratory disease primarily in children, but are also the causative
agent of various clinical syndromes such as conjunctivitis, gastroenteritis, cystitis, and
rash illness. The Adeno Test is a membrane-based immunogold assay for the qualitative
detection of the group reactive hexon antigen present on all known serotypes of
adenoviruses.
2.0
2.1 Specimens should be collected as soon as possible after the onset of
symptoms (preferably within 7 – 10 days).
2.2
The area should be thoroughly swabbed for optimal recovery of the virus.
2.3
Any specimen that must also be used for culture should be transported in
1.0mLof viral transport media, placed on ice, and vortexed before testing.
2.4
Specimens should not be frozen unless a delay in testing is expected. In
this case, quickly freeze the specimen using dry ice, and keep frozen at
-20° C or colder until ready for testing.
2.5
Acceptable specimens are as follows:
2.5.1 Eye Swabs: Sterile swab of the lower palpebral conjunctiva
2.5.2 Nasal and Pharyngeal Secretions: 2-3mL of nasopharyngeal secretions,
aspirates, or washes (in sterile saline).
2.5.3 Nasopharyngeal or Tonsilopharyngeal Swabs: The swab should
be inserted in one or both nostrils and allowed to remain for a few
seconds, rotated, and withdrawn. Alternatively, rub the tonsils and
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2.5.4
the posterior pharynx thoroughly. Note: The use of separate
swabs may increase specimen volume.
Fecal Samples Minimum of 40- 50mg Fresh stool specimens or
rectal swabs may be used. Loose and formed stool specimens are
acceptable. Note: Optimal specimens are those collected during
the acute gastroenteritis phase, in which excretion of viral
particles and antigens are increased.
ID of H. Pylori for Gastric Biopsies M2.029.03
1.0
Helicobacter pylori has now been shown to be the causative agent in most instances of
acute type B gastritis. The test detects the urease enzyme for the presumptive
identification of Helicobacter pylori in gastric mucosal biopsies.
2.0
2.1
Gastric mucosal endoscopic biopsy
2.2
Patient should not have antibiotics or bismuth therapy several weeks
before test is done.
2.3
Patient should not have received proton pump inhibitors such as omeprazole or
iansoprazole because they have a bacteriocidal effect on the organisms.
Rejection of Microbiology Specimens M1.025.06
1.0
Although the primary responsibility of the bacteriology lab is to accept specimens for
routine culture and carry out the requested test on them, there are times when it is necessary
to reject a specimen. At times specimens arriving in the lab may have been improperly
selected, collected, or transported. An immediate request should be made for a recollection,
especially in instances where antimicrobial therapy has been indicated. Processing and
reporting of results for these specimens to physicians may provide misleading information
that can lead to misdiagnosis and inappropriate therapy. Samples with gross external
contamination, inadequate specimens, samples on dry swabs and incorrect use of transport
media should be rejected.
118
2.0 Some possible reasons and details for rejection are as follows:
2.1
The specimen is not labeled with the patient's name, hospital number and type of
specimen.
2.2
The specimen is in a non-sterile container.
2.3
Prolonged transport.
2.4
Specimen not adequate for the test requested.
2.5
Specimen collected incorrectly or stored incorrectly upon arrival in the lab.
2.6
Specimen collected in such a way as to make handling hazardous for laboratory
personnel.
2.7
Duplicate specimens on same day for the same request should not be processed.
Second specimens obtained from the same site within 24 hours should not be
processed unless there are specific orders from the physician or special circumstances.
(Except blood and tissues) Sputum - only one sputum for AFB will be processed daily
and should be an early morning specimen. Stool - duplicate stool specimens will be
set up daily only from pediatrics. Only one specimen will be cultured daily for adults.
2.8
2.9
2.10
Stool guidelines for routine bacterial culturing. Do not accept more than 2 specimens
per patient without prior consultation with an individual who can explain the limited
yield provided by additional specimens. Do not accept specimens from inpatients
after the third hospital day, without consultation. Do not accept repeat stools for C.
difficile by PCR , until the 7th day. Do not accept formed stools for C.difficile, unless
ileus due to C. difficile is suspected.
Specimens with needles.
Specimens with questionable microbial information – foley catheters, vomitus,
gastric aspirate of newborn, bowel content, colostomy discharge or lochia.
3.0 Specimens should be discouraged and other requested:
5.1 Superficial oral and periodontal lesion,swab request tissue or aspirate
5.2 Decubitus, swab
request tissue or aspirate
5.3 Varicose ulcer, swab
5.4 Burn wound, swab
5.5 Superficial gangrenous lesion, swab
5.6 Perirectal abscess, swab
MOLECULAR PATHOLOGY SPECIMENS
Chlamydia and N. Gonorrhoeae by PCR
(BD PROBETEC METHOD
Note: Use only the swabs supplied in the Collection Kit
The unopened collection kit may be stored at room temperature until expiration date.
A. Endocervical Sample- BD Swab #441357
1.
Remove excess mucus with white cleaning swab and discard this swab.
2.
Insert the female (pink) endocervical swab into the cervical canal and rotate
for 15-30 seconds.
3.
Withdraw collection swab.
119
4.
5.
6.
7.
Fully insert pink endocervical swab into the CT/GC diluent tube.
Break the shaft of the swab at the score mark. Use care to avoid splashing of
contents. DO NOT REMOVE SWAB FROM TUBE.
Cap tube tightly and label tube with patient information.
Transport to laboratory at 2-30 degrees C.
B. Urethral Sample- BD Swab #441358
1.
Insert the male urethral swab 2 to 4 cm into urethra. Rotate clockwise for 3 to
5 seconds to ensure contact with all urethral surfaces.
2.
3.
Fully insert urethral swab into the CT/GC diluent tube.
4.
5.
6.
C. Conjunctival Sample - BD Swab #441358
1.
Use sterile swab to clean away any discharge present. Do not scrape the
conjunctiva while cleaning.
2.
Use urethral (male) swab kit. If both eyes are affected, swab the lower
affected eye first.
3.
Thoroughly swab the lower then upper conjunctiva two to three times each
with the supplied swab.
4.
5.
Fully insert urethral swab into the CT/GC diluent tube.
6.
7.
8.
D.
Urine Sample
1. Patient should not urinate one hour prior to collection of specimen. Cannot
be performed on catheterized, mid-strem or clean catch urines.
2. Collect 10-15 mL of first catch urine (the first part of the stream) in a sterile,
plastic, preservative free specimen collection cup.
3. Seal the specimen container and label with patient information.
4. Transport unpreserved urine at 2-8 degrees C.
a.
Urine samples may be aliquotted into Urine Preservative Transport Kit
(UPT) BD # 441362 by using the transfer pipet provided to aspirate urine
from container into the UPT.
b.
Fill UPT between the black lines on the fill window located on the UPT
label.
c.
Transport samples in UPT at 2-30 degrees C.
E.
Thin Prep Specimens for Chlamydia and N. Gonorrhoeae
NOTE: use only Cytyc PreservCyt Solution ThinPrep media
1.
The Patient’s gynecologic sample is collected by the clinician using either a
broom type collection device or cytobrush/spatula combination cervical
120
2.
3.
sampling device which is rinsed in a vial of PreservCyt Solution.
The PreservCyt sample is then tightly capped, labeled, and sent to the
laboratory for testing.
Transport the Thin Prep Specimen to laboratory at room temperature.
HSV DNA by PCR – Body fluids and swab specimens
A. All body fluids should be collected in sterile, well-stoppered tubes.
B. Swabs collected for HSV DNA testing should be inoculated into transport media (M4
media).
C. Collect grossly bloody, or specimens prone to clotting in Lavender top EDTA tubes.
D. Place samples on ice and transport to the laboratory as soon as possible for processing
HSV DNA by PCR (Peripheral Blood) , Factor V Leiden Mutation, Prothrombin Gene
Mutation ,MTHFR and HIV DNA Qual
A. Collect in one 2 ml EDTA Lavender top tube.
B. HIV DNA Qual testing on pediatric patients, two full lavender Microtainer® tubes
are required.
C. HSV DNA by PCR testing on pediatric patients, two full lavender Microtainer®
tubes are required.
D. Ensure specimens are not clotted. No shared specimens or added on to blood in Lab.
E. HIV DNA Qual and MTHFR are send out tests.
F. Place on ice and transport to the laboratory as soon as possible for processing.
Bordetella Pertussis/Parapertusis by PCR
A. Nasopharyngeal swabs are the only acceptable source for this test.
B. Collect using Copan E-swabs
C. Copan E-swabs are available in supply and can be ordered by using PMM #29510.
D. Transport to the laboratory as soon as possible for processing.
Respiratory Panel by PCR
A. Nasopharyngeal swabs are the only acceptable source for this test.
B. Collect using Puritan UniTranz-RT Transport System (product # UT-116) - 1 mL
OR BD Universal Viral Transport for Viruses, Chlamydiae, Mycoplasma and
Ureaplasmas Product # 220526 - 1 mLUniversal transport Media (UTM)
C. Transport to the laboratory as soon as possible for processing.
HIV Viral Load/HIV Genotype
A. For HIV-1 viral load collect blood in 2 White Top (PPT )tubes and 1 lavendar.
B. For HIV-1 Genotype collect blood in 2 White Tip tubes (PPT).
C. Transport sample at room temperature immediately to the laboratory. Specimens
with prolonged transport times may be rejected due to strict processing guidelines.
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HCV Viral Load/HCV Genotype
A. For Hepatitis C RNA Viral Load testing or Hepatitis C Genotype testing, collect
blood in 1 White Top (PPT).
B. Transport sample at room temperature immediately to the laboratory. Specimens
with prolonged transport times may be rejected due to strict processing guidelines.
Acute leukemia Panel, Lymphoma Panel, Extended Leukemia/Lymphona Panel
A.TISSUE SPECIMENS FOR FLOW CYTOMETRY
1. All tissue specimens for Flow Cytometry must be placed in RPMI media in 15
mL conical tubes. These are available in the Histology Labs as well as the
Molecular Pathology Laboratory.
2. THESE SPECIMENS MUST BE KEPT AT REFRIGERATOR
TEMPERATURE.
3. All testing must be started within 24 hours after collection of the sample.
4. NOTE: Do not tube these samples.
B. BLOOD AND BONE MARROW SPECIMENS FOR FLOW CYTOMETRY
1. Collect at least one 2ml Lavender or Sodium Heparin (green) tube or one
Heparinized syringe (Bone Marrow).
2. All specimens of these types MUST BE KEPT AT ROOM TEMPERATURE.
3. All testing must start within 24 hours after collection of sample.
4. NOTE: Do not tube these samples.
CD4, T-Helper/Suppressor, T & B Cell Enumertaion Panel, Fetal Hemoglobin
A. Collect in one 2 ml lavender tube.
B. All specimens for these tests MUST BE KEPT AT ROOM TEMPERATURE.
C. All testing must start within 24 hours after collection of sample.
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POINT OF CARE TESTING
Point of Care Testing Q1.026.12
1.0
Policy Statement
To assure the quality of patient results on any laboratory test; to
comply with regulatory standards, including CLIA, JCAHO, OSHA; and to maintain
CAP accreditationstandards, PH Laboratories will monitor all units performing point of
care testing. Authorization of personnel and standards for compliance, performance,
quality assurance, instrumentation, quality control, safety and action taken for noncompliance is the responsibility of the Medical Director of the PH Laboratories.
2.0
Training and Competency Guidelines
2.1
All personnel performing POC testing must have documented training and
meet acceptable competency standards prior to testing.
2.1.1 Personnel performing waived testing must have documented initial
training and meet acceptable competency standards prior to performing
testing.
2.1.2 All personnel performing moderate level point of care testing must have
earned a high school diploma or equivalent as a minimum, documented
training approved by the laboratory, and meet acceptable competency
standards, before performing patient testing.
2.1.3 Waived testing training and competency may include, and moderate level
training and competency will include:
2.1.3.1 Direct observations of routine patient test performance, including,
as applicable, patient identification and preparation, specimen
collection, handling, processing and testing performance
2.1.3.2 Monitoring the recording and reporting of test results, including, as
applicable, reporting critical results
2.1.3.3 Review of intermediate test results or worksheets, quality control
records, proficiency testing results, preventive maintenance records
2.1.3.4 Direct observation of performance of instrument maintenance and
function checks, as applicable
2.1.3.5 Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples or external
proficiency testing samples
2.1.3.6 Evaluation of problem-solving skills, potentially by written exam
2.1.3.7 Reassessment when competency or performance are not acceptable
2.1.4 Waived testing competency must be reassessed at least annually.
2.1.5 Non-waived testing must have competency assessed twice during
the first year that an individual is performing patient testing
(initially and @ 6 months), competency must be assessed annually
thereafter.
2.2
Testing personnel must be competent to perform testing and comply to:
2.2.1 Users of non-waived testing must provide the laboratory certification of
education, diploma (of HS or higher) or transcript
2.2.2 Reviews may be done as often as quarterly, depending on performance
2.2.3 All users must have knowledge of the procedures
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2.2.4
3.
Quality Control Guidelines
3.1
4.
Staff are evaluated for color blind testing through PH HealthWorks as
applicable
Quality control is an essential component of all laboratory testing. The
following criteria are required
3.1.1. Quality Control must be performed and evaluated by the user to be within
acceptable limits before patient testing is done per instrument used.
3.1.1.1.For quantitative tests, 2 levels at different concentrations daily
3.1.1.2.For coagulation tests controls per every 8 hours
3.1.1.3.This may be electronic, internal or external.
3.1.1.4.System lockouts are used where available, auto programming
3.1.2. QC is run the same as patient testing
3.1.3. All users must periodically perform QC, waived or non-waived testing
3.1.3.1.Glucometer users must have performed QC within 6 months of
their certification date
3.1.4. QC will be reviewed on a periodic basis, at least monthly by designated
laboratory and testing staff and assessed for significant changes
3.1.4.1.Trends for QC, means, SD’s and CV’s are addressed.
3.1.4.2.Troubleshooting will be done as indicated
3.1.5. QC will be accessed daily by the staff performing and monthly by POC
designee.
3.1.5.1 Proper corrective actions must be done if required prior to patient
testing.
3.1.6. New lots of strips for the glucometer are evaluated and QC ranges set or
confirmed when placed into use
3.1.7. Urine QC is verified by the Urinalysis department, and aliquots are sent to
the unit.
3.1.8. i-STAT QC is run
3.1.8.1.Automatically with internal simulators every 8 hrs
3.1.8.2.External simulator at least every 6 months or when indicated
(CLEW updates)
3.1.8.3.LQC is run with new lot#, new shipments, and monthly by the unit
users at a minimum
3.1.9. After maintenance of software upgrades for all testing
3.1.10. When troubleshooting instruments or issues
3.1.11. Acceptable limits for QC are defined or verified
Testing Guidelines
4.1.
Point of Care Testing will follow the same standards as the laboratory for proper
4.1.1 Orders, physician written or verbal orders, or standing orders in defined
cases
4.1.2 Patient identification
4.1.3 Accurate collection procedures
4.1.4 Complete specimen identification and labeling
4.1.4.1 including the date and time of collections
4.1.4.2 identification of the person collecting sample and/or testing
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4.1.5
Laboratory procedures are available on the intranet, or units, and followed
for each test performed.
4.1.5.1 Procedures follow manufacturer’s instructions without
modifications
4.1.6 Complete recording and documentation of patient results in the designated
patient record to include
4.1.6.1 Initials / identification of performing personnel
4.1.6.2 Documentation of results in the patient permanent record.
4.1.6.2.1 Laboratory LIS
4.1.6.2.2 Patient care system EMR
4.1.6.2.3 Flow sheet or other method
4.1.7 Completed loop involvement with the laboratory and confirmatory testing,
when applicable.
4.2 Testing personnel and providers are responsible for the daily review and assessment
of patient results.
4.2.2 Any problems will be investigated by the laboratory, possible
confirmatory testing or consultation. Charge Techs or POC staff are
contacts for troubleshooting
4.2.3 This review will cover the
4.2.3.1 Technical aspects of the testing
4.2.3.2 Analytical issues
4.2.3.3 Improbability of unusual or unexpected patient results.
4.3 Panic and or Critical patient results must be documented with proper notification of
physician/provider by POC testing staff in the patient record
4.4 Reference ranges will be reported with each patient test result in
4.4.2 the LIS, with patient results
4.4.3 posted on the units if applicable (not interfaced in LIS, EMR)
4.4.4 available in the Laboratory Manual on intranet
4.5 The extent to which the POCT is used to treat patients is authorized by the Medical
Director of Laboratory Services
4.5.1
Use of test results are defined as screening purpose only or for
monitoring patient status, unless designated in procedures
5.
Method Guidelines
5.1.
The performance of instruments and equipment if verified when placed into use
5.1.1. performance is verified after repairs
5.1.2. performance is verified after troubleshooting when applicable
5.1.3. performance is verified after upgrades (software, etc)
5.2.
Procedures define AMR and / or reportable limits per each analyte.
5.2.1. Procedures include the linear range, and definitions for the verification
5.3.
The laboratory will be responsible for performing
5.3.1. linearity checks
5.3.2. calibrations and calibration verification checks
5.3.2.1.change of reagent lots
5.3.2.2.shift or trending of QC values
5.3.2.3.major maintenance or service
5.3.2.4.manufacturers recommendations
5.3.2.5.minimum of every 6 months
5.3.3. Software upgrades according to manufacturer
125
5.4.
5.5.
5.6.
5.7.
5.8
5.9
5.10
5.11
6.
Units will be responsible for any required function checks or daily preventative
maintenance, temperature checks per procedure where applicable and results must
be within defined limits
Refer to manufacturers service manual or technical bulletins for troubleshooting
instructions
Assayed QC will have established target ranges.
External Proficiency Testing will be performed in all applicable areas
5.7.1. The laboratory is enrolled in CAP surveys, or other CAP approved
vendors for the testing performed
5.7.2. The laboratory policy for Proficiency Testing is applicable for POCT areas
Changes in lot # of reagents will be confirmed with proper QC
documentation
before or concurrently with being placed into use.
5.8.1 New lots are QC’d with shipments, and or initial use
5.8.2 New lots are QC’s with manufacturer, method specific and reagent
specific target ranges
All reagents and supplies must be used based on manufacturer’s
instructions
5.9.1 dated, with the new expiration date marked if required
5.9.2 stored properly used by expiration date (either new or
manufacturer)
5.9.3 labeled as to content, quantity, concentration or titer
5.9.4 date prepared
5.9.5 discarded appropriately
Thermometers in use are certified NIST standards or traceable to NIST
standards
5.10.1 Temperatures are checked and recorded daily, with identity of
recorder
5.10.2 Acceptable limits are defined for all temperature dependent
equipment or reagent storage
5.10.3 Documentation of corrective action for all temperatures out of
acceptable limits to include evaluation/verification of equipment or
reagents
Initial performance validation studies are approved by the medical director
prior to implementation
5.11.1 PV will be reviewed for analytical sensitivity, specificity,
accuracy, and precision
5.11.2 Interfering substances are addressed in either PV or procedures
Safety Guidelines
6.1.
Safety procedures and Universal / Standard Precautions are required when POCT
is performed, PH and laboratory policies
6.1.1. Disinfection of POC instruments between patients is required to prevent
transmission of infections
6.1.2. Proper Hand Hygiene must be used, to include
6.1.2.1.use of gloves, changed between patients
6.1.2.2.proper hand washing or hand sanitizers according to PH policy
6.1.3. Use of retractable/safety lancets for blood collections, single use
6.1.4. Any concerns with operator or patient safety should be immediately
reported
6.1.4.1.to the laboratory
126
6.1.4.2.hospital administration
6.1.4.3.CAP
6.1.4.4.JCAHO respectively if issues are not resolved
7.0
POC Program Guidelines
7.1
Dr. Paul Guerry, Professional Director of PHR Laboratory is responsible
for the compliance to regulatory requirements, and the quality of any
laboratory testing performed at Palmetto Health.
7.2
The POC program performs only tests that are FDA approved/cleared, and
follows manufacturer instructions without modification.
7.3
Any problems or questions should be referred to the POCT Coordinator of
the Laboratory or the POC Techs, or laboratory Charge Techs.
PC1.035.01 FREESTYLE Precision GLUCOMETER FSP Glucometer Strips
1.0
Principle
1.1
The FreeStyle Precision Pro Blood Glucose Testing System (FSP) is intended for
the quantitative measurement of glucose in fresh capillary whole blood from the
finger, and from venous, arterial and neonatal whole blood.
1.2
The Freestyle Precision Pro Blood Glucose Monitoring System is intended for
testing outside the body (in vitro diagnostic use) and is intended for multiplepatient use in professional healthcare settings as an aid to monitor the
effectiveness of a diabetes control program.
1.3
The system should not be used for the diagnosis of or screening for diabetes.
1.4
The Freestyle Precision Pro Blood Glucose Test Strips are for use with the
Freestyle Precision Pro Blood Glucose Meter to quantitatively measure glucose in
fresh capillary whole blood samples drawn from the fingertips and from venous,
arterial, and neonatal whole blood.
1.5
When blood is applied to the test strip, the glucose in the blood reacts with
chemicals on the strip producing a small electrical current. FSP uses a proprietary
glucose specific chemistry that includes the glucose dehydrogenase enzyme, NAD
cofactor and PQ mediator (GDH-NAD). The current is measured and a result
displays on the meter based on the amount of glucose in the blood.
1.6
Freestyle Precision Pro Blood Glucose Monitoring System enables automatic
transmission of stored data to a data management system using the docking
station (optional), a data upload cable (optional), or wirelessly (optional) in a
WiFi enabled facility when the meter and data management systems are properly
configured.
2.0
Safety Precautions
2.1
Always wear gloves, proper PPE, and follow safety and biohazard policies when
performing testing with blood.
2.4
Use the FSP glucometer properly
2.4.1 Do not allow blood or other solutions to run down the test strip and
into the glucometer. No liquid should enter the meter at any time
2.4.2 Do not use the FSP glucometer without the port protector
2.4.3 Operate the Precision FSP system within the temperature and humidity
127
2.4.4
2.4.5
2.4.6
2.4.7
3.0
ranges, see Equipment
Check FSP glucometer for damage or blood before using. Clean and
disinfect daily, when soiled, and between patients with approved cleaners,
see Maintenance section for specific cleaning instructions
Use scanner properly with laser precautions
2.4.5.1 Hold barcode 2.5- 7 inches from scanner, and at a 50-130 degree
angle to scan.
2.4.5.2 Never look into the scanner laser or point it toward anyone’s
eyes.
2.4.5.3 If you hold the scanner for three seconds, the scanner stops.
Reposition the scanner and try again.
2.4.6.4 Audible beep will occur when successfully scanned
This system should only be used with single-use, auto-disabling lancing
devices. Dispose of lancets or needles in approved sharps containers.
Dispose of wastes and strips in Biohazardous containers.
Equipment
3.1
Precision FSP Glucometer system
3.1.1 FSP meters 7.85 x 2.93 x 1.92 inches
3.1.2 Weight 10.58 oz
3.1.3 AA Alkaline, Lithium, or NiCad batteries
3.1.4 Battery life typically 30 days
3.1.5 Operating Temp - 59 to 104 F (15 to 40 C)
3.1.6 Humidity 10 – 90%
3.1.7 Altitude up to 7,200 feet
3.1.8 Memory
3.1.8.1 2500 pt tests
3.1.8.2 1000 QC
3.1.8.3 Operators 6,000
3.1.8.4 20 PT
3.1.8.5 20 Linearity
3.1.8.6 Pt ID# 6,000
3.1.8.7 Strip lots – 36 lot# (18 glucose / 18 Ketone)
3.1.9 Abbott Docking Station
3.1.10 Lancets or phlebotomy supplies
128
4.0
4.1
4.2
4.3
4.4
4.5
4.6
4.7
Required Reagents
FSP Glucometer test strips
4.1.1 Glucose dehydrogenase (GDH-NAD) >0.03 U
4.1.2 NAD+ (as sodium salt) > 1.0 ug
4.1.3 Phenanthroline quinone >0.02 ug
4.1.4 Non-reactive ingredients >16.3 ug
Precision or Medisense Quality Controls
4.2.1 Low & High Ranges
4.2.1.1 Store 39 to 86 F room temp
4.2.1.2 do not freeze
4.2.1.3 Date bottle with new expiration date when opening
4.2.1.4 NEW EXPIRATION DATE MUST BE ON THE
VIALS once opened, vials are good for 90 days after opening
Precision FSP Precision Pro strips are individually wrapped and sealed in foil
packets, use properly.
4.3.1 Store at room temperatures between 39 and 86 F and out of direct sunlight.
Do not use strips that are improperly stored
4.3.2 Do not freeze or refrigerate!
4.3.3 Strips are stable until expiration date printed on the packet (in
barcode information ) when stored as recommended.
4.3.3.1 The FSP system will not accept strips that are beyond their
expiration date.
4.3.3.2 After opening the strip, use immediately.
4.3.4 Do not handle strips with wet or dirty hands.
Do not use strips that are
4.4.1 WET, BENT, SCRATCHED, or DAMAGED
4.4.2 PUNCTURED or have a TEAR in the package,
Use each strip only once. Do not reuse strips. Do not cut strips in half or alter in
any way.
Use only the strip that you scan, do not scan one strip and use another strip.
Do not touch the strip after application of blood
129
4.8
4.9
5.0
Use only FSP Precision Pro strips in the FSP glucometer
Observe caution when using around small children, potential choking hazard for
small parts
Performance Specifications and Method Limitations:
5.1
Meter and strips must be at room temperature.
5.1.1 If meter is moved from one temperature extreme to another, please allow
time reach to new temperature before using
5.1.2 Operate the Precision FSP system within the temperature and humidity
ranges
5.2
Use only QC solutions specified on insert to control the glucometer.
5.3
Use only FSP Precision Pro glucometer strips on the FSP glucometer with proper
storage and reagent use requirements
5.4
Apply blood to the target area from either the top or end/side, following proper
collection procedures
5.5
Do not place FSP meter in liquid, or near where it could fall into liquid. Do not
allow blood or other solutions to run down the test strip and into the glucometer.
5.7
FSP will automatically turn off if left unattended for 4 minutes.
5.8
Check date and time accuracy each time glucometer is used
5.9
Check the units of measure each time the glucometer is used (mg/dL)
5.10 Check FSP glucometer for damage or blood before using.
5.10.1 Return meter to the lab if problems are noted
5.10.1.1
POC staff M-F day shift
5.10.1.2
Charge Tech evenings, nights, weekends, etc
5.11 The Precision FSP Glucose Testing system is designed for use with fresh whole
blood samples.
5.11.1 Do no use collection tubes that contain fluoride or oxalate.
5.12 System is not for use on Critically ill patients (example: patient actively coding)
5.13 Extremes in hematocrit may affect the results, do not use if patient has
5.16.1 Hematocrit range is from 15-65%
5.14 Test results may be lower
5.14.1 Severely dehydrated patients
5.14.1.1 Severe dehydration may have symptoms of little or no
urination, sunken eyes, muscle cramps, nausea and vomiting,
fever and chills, sweating may stop, rapid breathing, heart
palpitations, lightheadedness, in the most serious cases
delirium orunconsciousness
130
5.14.2 Severely hypotensive patients
5.14.2.1 Severe hypotensive patients may have symptoms of severe chest
pain, severe headache, accompanied by confusion and blurred
vision, nausea and vomiting, severe anxiety, shortness of breath,
seizures, and unresponsiveness
5.14.3 Patients in shock
5.14.3.1 Shock is the end stage of all diseases, and symptoms will often
be dependent on the underlying cause. Depending on the
specific cause and type of shock, symptoms may include one or
more of the following: extremely low blood pressure, anxiety or
agitation, restlessness, bluish lips and fingernails, chest pain,
confusion, faintness cool clammy skin, profuse sweating, rapid
weak pulse, shallow breathing
5.14.4 Patients in a hyperglycemic-hyperosmolar state
(with or without ketosis)
5.14.4.1 Symptoms may include blood sugar level over 600 mg/dL, dry,
parched mouth, extreme thirst, warm dry skin that does not
sweat, fever >101F, sleepiness or confusion, loss of vision,
hallucinations, weakness on one side of the body
5.15 Providers and Staff must be aware of these limitations and not rely on the
glucometer results for patient care and treatment when these conditions
apply to patient testing
5.16 Use proper capillary or venipuncture techniques
5.16.1 No water or alcohol is remaining on the puncture site
5.16.2 Excessive squeezing of the finger
5.16.3 It is best to wipe away first drop of blood from capillary collection
5.16.4 Incomplete clearing of the lines before collection
5.16.5 If collected in heparinized syringe or green top tube, mix well and test
within 30 minutes
5.17 Always repeat test if results are not clinically expected, correlate with
laboratory glucose testing, and potentially
5.17.1 Notify lab POC staff if glucometer results are inaccurate (causes may be
from operator error or poor specimen quality)
5.17.2 And/ or perform laboratory assay if results are questionable (obtain a
provider order)
5.17.3 and /or follow glycemic protocols
5.18 FSP system exhibit no interferences from the following substances above
therapeutic levels:
5.18.1 beta-hydroxybutyrate
5.18.2 bilirubin
5.18.3 cholesterol
5.18.4 creatinine
5.18.5 triglycerides
5.18.6 pyruvate
5.18.7 uric acid
5.18.8 anoxicillin
5.18.9 captopril
5.18.10 soduim
5.18.11 gentisic acid
5.18.12 lactate
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5.19
5.20
5.21
6.0
5.18.13 Galactose
5.18.14 Acetominophen
5.18.15 ascorbic acid
5.18.16 dopamine
5.18.17 ephedrine
5.18.18 ibuprophen
5.18.19 L-dopa
5.18.20 maltose
5.18.21 methyldopa
5.18.22 salicylate
5.18.23 tetracycline
5.18.24 tolazamide
5.18.25 tolbutamide
Ascorbate concentrations > 2.5 mg/dL and xylose concentrations > 50 mg/dL may
interfere with the accuracy of test results and
In run precision vary no more than 3.0 to 3.6% CV
Precautions before using FSP Glucometer
5.21.1 Use the equipment only for the purpose described in the procedure
5.21.2 Do not use accessories that are not supplied by Abbott
5.21.3 Do not use FSP glucometer if it is not working properly, or has suffered
damage such as but not limited to dropping or dropping into liquid or
splashing.
5.21.3.1
Return to lab for replacement (see 5.10)
5.21.5 Do not let the FSP glucometer come into contact with surfaces that are too
hot to touch.
5.21.6 Do not use the FSP outdoors
5.21.7 Do not insert anything into any opening or port of the glucometer other
than strips
Primary Sample System
6.1
FSP Precision Pro system is designed for use with fresh whole blood. The FSP
system is not for testing serum or plasma samples.
6.2
Allow entire target area to fill with blood.
6.3
Do not re-apply blood to the strip if test does not initiate testing
6.4
After applying blood to the strip, do not touch the strip.
6.5
Obtain capillary samples with proper safety lancing device
6.5.1 Follow proper fingerstick procedures and avoiding excessive
squeezing.
6.5.2 Best to wipe away first drop, use/test immediately
6.5.3 Hold the finger on the target area while the drop of blood is drawn
into strip. Strip uses 0.6 uL of blood to perform testing
6.5.4 For neonate / heelstick collections allow a hanging drop of blood to form
from the heel and apply to target area of strip. It is ok to gently touch the
strip to the heel during application
6.5.5 Remove the finger when the test starts.
6.6
Collect venous samples in either heparin or EDTA properly filled tubes.
6.6.1 Do not use samples from oxalate or fluoride tubes.
6.6.2 Mix samples gently before testing to insure uniform distribution, use a
disposable transfer pipette to obtain blood from the tube.
6.6.3 Test within 30 minutes of collection
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6.7
Collect arterial samples
6.7.1 Clear the arterial line before collecting blood sample from heparinized
syringe.
6.7.2 Allow drop to form at the tip of syringe to apply sample to strip.
6.7.3 Test immediately, or mix well and test within 30 minutes of collection
(delay is not recommended)
7.0
Type of Container Additives
7.1
Use fresh whole blood not in a collection tube or container
7.2
Collect venous samples in either heparin or EDTA tubes
7.3
Use arterial blood collected in heparinized syringe
8.0
Maintenance
8.1
Instruments must be kept clean and free of body fluids.
8.1.1 Health care professionals should wear gloves and follow Infection Control
(IC) procedures for PH
8.1.2 Avoid getting dust, dirt, blood, QC, water (any fluid) or any other
substance in the meter strip or data ports
8.1.3 Turn off the glucometer when cleaning.
8.1.4 Use Dispatch (bleach) based cleaner or approved IC cleaner (Cavicide 1)
8.1.3.1 Cavicide wipes are acceptable, follow instructions for use
8.1.3.2 Clean meter over counter or surface to minimize
damage if meter is dropped
8.1.5 Cleaning – removal of organic soil from the meter surface and should be
done daily or when visibly dirty.
8.1.6 Disinfection – process that destroys pathogens on the meter surfaces.
Disinfection should be done after use with each patient. This is done with
a second wipe, separate from cleaning.
8.2
8.3
8.4
8.5
Instruments must be checked for damage each time they are used.
Return meter to the lab if problems are noted.
8.3.1 M-F day shift to POC technologists
8.3.2 Evening, night, weekends or holidays to Charge Tech
Laser window must be kept clean in order to scan barcodes correctly.
FSP runs on two AA alkaline, lithium, or nickel cadmium batteries.
8.5.1 New batteries must be installed within 24 hours after the old batteries are
removed to maintain the correct date and time
8.6.2 Display of battery life is bottom right hand corner of FSP screen when
glucometer is ON. Check battery voltage under MENU, Review Setup
option #2, #2 System Status.
Recommended voltage is 2.5 for optimum performance.
133
9.0
8.6
See below for battery change instructions
8.6.1 turn meters OFF
8.6.2 Turn meter to back and press down the cover at the finger grip area firmly
8.6.3 Push the cover off, when slid as far as possible, lift the cover up and away
from the meter
8.6.4 Pull tab to remove batteries (discard according to regulations)
8.6.5 Insert new batteries using the + and – symbols
8.6.6 Align the battery cover with slots on the FSP meter and slide back into
place
8.7
Port Protector Replacment – LAB USE ONLY
8.7.1 Turn meter off
8.7.2 Remove single screw on back top of meter with Phillip head screwdriver
8.7.3 Pull port module away from meter, discard along with screw in
biohazardous trash
8.7.4 Place new port module in meter by sliding into position
8.7.5 Screw into place with new screw
8.7.6 Perform QC
Calibration Procedures - LAB USE ONLY
9.1
Calibration is checked with each scan of barcoded FSP Precision Pro test strip,
based on the lot number.
9.2
Calibration Verification / Linearity is performed with RNA Medical Calibration
Verification Control (CVC) Kits upon installation
9.3
Problems such as a major shift in QC, when major maintenance is performed, or
as required by manufacturer or CAP may warrant repeating the linearity testing.
9.4
Procedure to perform linearity studies:
9.4.1 Prepare vials of calibration verification material as described in the
product insert.
9.4.1.1 Mix vials completely before testing.
9.4.1.2 Use all kits within expiration dates.
9.4.2 Press the Menu button
9.4.3 Select the #4 Linearity prompt
9.4.4 Enter operator ID and enter.
9.4.5 Scan or enter the Linearity lot # for the kit.
9.4.6 If New Panel screen appears choose either #1 ReEnter Kit Lot or #2
Replace Panel
9.4.7 Select the level of test to run.
9.4.8 The number to the right side will display the number of tests that have
been run at the test level, FSP will allow up to 4 replicates of each level.
9.4.9 If you press #6 for a New Panel, the FSP will prompt to confirm that you
wish to replace the existing panel.
9.4.10 Scan the strip lot #.
134
9.5
9.6
9.7
9.4.11 Open foil strip and insert electrode at the prompt.
9.4.12 At apply Level 1 prompt, place one drop of the well mixed vial of Level
1 solution to the target area.
9.4.12.1
Wait for testing to complete.
9.4.13 Remove electrode strip and select 2 for other replicates at the same level,
or 1 for running a test at a different level.
9.4.14 When 4 replicates have been tested the level is considered full and will
only display other level options.
9.4.15 Select other levels until all levels of reportable ranges have been run.
9.4.16 Press Menu button to return to Menu mode, or On/Off
9.4.17 Print linearity under Report Tab QCM3
Calibration verification may be done with
9.5.1 change of lot# of strips
9.5.2 overall QC fails to meet criteria
9.5.4 or whenever major problems are encountered, troubleshooting
9.5.5 Calibration verification is performed with at least 3 levels (across the
AMR or reportable range).
9.5.5.1 QC at three levels, or a low/mid/high level of thCalibration
Verification kits can be used.
Test at least Level 1, 3, and 5 in duplicate for new meters
Test at least Level 1, 3, and 5 in single replicates for replacement meters
10.0 Quality Control Procedures
10.1 Quality control is performed on the Low, and High FSP / Medisense Control
Solutions.
10.1.1 Two levels of QC are required per instrument / per 24 hour (when
patient testing is performed)
10.1.2 QC lockout is utilized on the gluocometers
10.1.3 QC requirements will be monitored and evaluated periodically
10.2 QC solutions should be stored
10.2.1 from 39 to 86 F
10.2.2 between 10 and 90% humidity
10.2.3 do not freeze
10.2.4 keep tightly capped
10.2.5 and use within 90 days of opening
10.2.6 date vials when opened with the new expiration date (90 days)
10.2.7 Solutions should be well mixed before using.
10.3 Lot numbers of QC solutions should be entered / scanned in the system when
prompted.
10.3.1 FSP Precision Pro does not accept QC that has passed its
manufacturer expiration date, adhere to written expiration date
10.3.2 Scan barcoded lot# on QC vial to enter
10.3.3 Manual entry of lot# is acceptable if barcode is not readable
10.4
Follow procedure for Control testing
135
10.4.1 Turn the meter ON, Select #2 Control Test
10.4.2 Enter operator ID, press enter.
10.4.3 Scan or enter the Low Level Solution.
10.4.3.1
If level other than the Low solution is scanned, the
meter gives the option of Unexpected Level XXX
Level entered, 1- ReEnter Lot or 2- Continue.
10.4.4 Scan barcode strip.
10.4.5 Open foil and insert strip at the prompt.
10.4.6 Apply well mixed QC solution to the target zone of strip at the prompt,
tightly recap solution.
10.4.6.1
Results in 5 seconds.
10.4.7 Results will display if PASS or FAIL, the barcoded strip contains the
expected ranges
10.4.7.1
If results FAIL, a comment code must be entered
(use
either the barcode for the comment code or the numeric
code)
10.4.7.1.1
Code 01
Repeat Test
10.4.7.2
Repeat QC with a well mixed drop from same vial
10.4.7.3
Try new vial of QC if FAILed twice from same vial
10.4.7.3.1
Code 02
New Vial QC
10.4.7.4
Contact the lab if QC fails repeatedly on original and new
vials of in date QC
10.4.8 Select 1- Next level to go on to the next test.
10.4.9 Repeat above steps for High QC solution.
10.4.10 If QC is unacceptable, do not perform patient testing.
Troubleshoot by the following
10.4.10.1
check that no air bubbles are in the bottle tip
10.4.10.2
calibrate system using barcode for the test strip used
10.4.10.3
enter or scan for the correct level of QC
10.4.10.4
check storage temperature of reagents, and humidity
10.4.10.5
check WRITTEN expiration date on vials
10.4.10.6
use new strip for each test
10.4.11 QC Lockout is in place, per 24 hours
11.0 Patient Testing Procedural Steps
11.1 Use of the Precision FSP glucometer system falls under the federal guidelines for
laboratory testing, and must comply with hospital and regulatory, and
136
11.2
11.3
11.4
accreditation standards.
11.1.1 The glucometers are not to be used for patient assessments, but for
physician ordered testing or approved care protocols
11.1.2 They are screening devices, used for monitoring, not diagnosing diabetes
11.1.3 The meters are laboratory instrumentation and fall under the direction and
responsibility of the laboratory Medical Director
Obtain fresh whole blood samples following PH collection procedures for venous,
line draws, or capillary samples.
11.2.1 Venous collections must be sampled from a EDTA or heparinized
tube with a disposable pipette within 30 minutes of collection.
11.2.2 Do not test venous bloods directly from collections.
11.2.3 Properly clear arterial lines before collections are obtained.
Each glucose screen test is to have an order in Cerner, or per protocol
Follow procedure for patient testing
11.4.1 Turn on meter, check date and time displays.
11.4.2 Select 1- Patient Test.
11.4.2.1
Patient testing may only be performed on
glucometer that has passed QC
11.4.3 Enter operator ID by scanning badge barcode
11.4.3.1
Your operator ID must be defined in the FSP system with a
current certification date in order to use the meter.
11.4.3.1.1
Operator not on List will display on meter
if ID does not have a current certification
11.4.3.2
Never use another operators ID
11.4.3.3
Never give your ID to another to use.
11.4.4 After properly identifying patient, operator should confirm that the patient
is wearing the current valid armband for the facility and visit. Patient
identification is performed by matching the full name and DOB on the
armband with a source of patient identification and using the Final Check
process. Scan the PH Patient ID Link ARMBAND for the glucose screen
test for the patient ID. Barcode is the 10 digit account number
11.4.4.1
The only way for the patient results to transfer
automatically to the LIS and EMR is by use of the
correct pt ID Link ARMBAND account number.
11.4.4.2
Linear or Aztec barcodes from the patient armbands will
scan on the FSP meter
11.4.5 For units with TRUE ID activated, the FSP will display
11.4.5.1
the patient name
11.4.5.2
the patient ID number
11.4.5.3
the patient DOB
11.4.5.4
the patient sex
11.4.5.5
prompt for the operator to enter the patient’s Year of Birth
(2 digits) to CONFIRM this is the correct patient to be
tested. (A)
137
(A)
(B)
11.4.5.6
If the FSP does not display patient identification
information (B) (Patient Data Not Found is displayed)
11.4.5.6.1
turn off and gain new wireless connection or
dock the glucometer to gain the latest ADT
registration information
11.4.5.6.2
check patient account# is active
11.4.5.6.3
check registration information in computer
with armband
11.4.5.6.4
If patient ID is not found in the FSP, the
glucometer will prompt the to 1-Re-Enter
ID
11.4.5.6.5
Upon re-entry of the patient ID#, the
operator will be prompted to either
11.4.5.6.5.1 1-ReEnter ID
11.4.5.6.5.2 2- Continue to perform test
11.4.5.6.5.3 #2 Continue if ID is accurate
11.4.6 If downtime for the ID Link system, you may use the patients 10
digit account # for pt identification.
11.4.6.1
Follow Cerner downtime procedure Nursing orders.
11.4.7 Prep meter and perform proper collection
11.4.8 Scan the strip lot #.
11.4.8.1
Never scan a lot# of strip and use another lot# strip
11.4.8.2
Open foil packaged strip (use notch on side) and insert strip
at the prompt.
138
11.4.9 At apply sample prompt place a drop of blood to the target zone.
11.4.9.1
Hold the strip to the blood sample until testing
starts.
11.4.9.2
Allow target area to fill completely.
11.4.9.3
Do not smear sample.
11.4.9.4
You may NOT reapply blood if test fails to start
11.4.9.5
Strip fills from top or side application. Do not fill
from bottom of the strip
11.4.9.6
If the test fails to start, sufficient blood may not
have been applied
11.4.9.6.1
discard the current test strip
11.4.9.6.2
repeat with new test strip
11.4.10 Results display in 5 seconds.
11.4.11 Results will display with the time and date, and pt ID
11.4.11.1
Confirm that test date and time are correct
11.4.11.2
Confirm that unit of measure is mg/dL
11.4.12 Results outside the reportable range will display as less
than (<) or greater than (>).
11.4.12.1
Reportable range for patient results is 45 to 450
mg/dL for adults, and 45 to 200 mg/dL for NICU
and NBN.
11.4.12.2
Patient test results above or below these levels are
to be addressed by caregiver, provider, and/or protocol.
Treat patient accordingly
11.4.12.2.1
Confirmatory tests ordered as
requested by provider (person authorized to
place orders
11.4.13 Results outside the Action Range limits will prompt for operator
entry of coding
11.4.13.1
Action Range limits are set per Nursing request
11.4.13.2
Action Range <70 mg/dL
11.4.13.3
Code 13
Physician Notified
Code 09
Nurse Notified
Code 18
Hypoglycemic Protocol followed
11.4.14 You will be prompted for 1 - Next Patient or 2 - Patient History
11.4.15 FPS meters will attempt wireless connection to transmit testing
139
11.5
11.6
11.7
11.4.16 Dock meter for results to file to EMR if wireless connections were
not completed
11.4.16 Follow downtime procedures if system or network connections are
down, chart results manually
If the blood glucose result appears to be inconsistent (lower or higher than
expected), there may be a problem with the test strip or blood sample, or
the patient may have limiting conditions
Results that are incorrect may have serious medical consequences.
Consult the order set or prescribing physician before making any changes
to diabetes medication plans if:
11.7.1 The blood glucose results are not consistent with the physical
symptoms AND you have ruled out common errors in technique.
Collection technique can affect results
12.0 Reference Intervals
12.1 Fasting Normal
12.2 Impaired
12.3 Random
70-99 mg/dL (POC and Lab)
100-125 mg/dL (Lab)
70-139 mg/dL (Lab)
13.0 Alert and/or Critical Values
13.1 The FSP Glucometer system does not report panic / critical results
14.0 Glucometer Configuration
14.1 Meters are programmed within the FSP System for options with
14.1.1 operator identification and certification,
14.1.2 meter QC and QA,
14.1.3 upload requirements,
14.1.4 and strip lot numbers.
14.2 Meters are set with programming options before they are issued to the
units, and each time they transmit the information in the meter itself is
updated to reflect current status of the UNIPoc database.
14.2.1 Operator certification
14.3 The Precision FSP System will allow you to review any of the data stored
in the instrument.
14.3.1 You must be a valid user to access the stored data.
14.3.2 Patient data can be retrieved with the following options
14.3.2.1
Patient by OperID
14.3.2.2
Patient by PatID
14.3.2.3
All Patient data
14.3.2.4
Control Data
14.3.2.5
Proficiency Data
14.3.2.6
Linearity Data
14.3.3 To review data
14.3.3.1
go to the MENU button,
14.3.3.2
select #1 Data Review,
14.3.3.3
Enter your Oper ID#,
14.3.3.4
Choose category to review
14.3.3.5
Under Patient data reviews you may choose
Previous or Next.
14.3.4 Press Clear to return to the MENU mode.
140
15.0 Downloading of FSP Glucometers
15.1 FSP glucometers will attempt to connect wirelessly each time they are turned on
and each time a test is completed. Sideways arrows at the bottom left of the
display screen indicate when the meter is trying to connect.
15.2
The following applies if the optional Wireless Communication is enabled:
When the meter turns off with test results still pending to send (Data
Transmission Pending), it will automatically attempt to send those results. This
will occur when the monitor is turned off by pressing and holding the power
button for 2 seconds or if it shuts itself off automatically. The Data Uploading
screen shown here will display until the meter completes transferring pending
results and then it will power off automatically. The Operator does not need to
take any action for this to occur. While Data Uploading screen is displayed, the
Operator can turn the meter off immediately by pressing ‘1 - Turn Off’. If the
Operator does press ‘1 - Turn Off’, wireless communication will stop and pending
results will not be transmitted. Pending results will be transferred the next time
the meter establishes wireless communication or the meter is docked, whichever
comes first.
15.3
The Precision FSP System offers an optional docking station or cable that
provides for hands-free automatic data transfer upload/download
between the FSP Monitor and a PC running the UNIPoc software.
15.4
The docking station or cable must be plugged into a networked PC, with the
STLB software installed.
FSP Meters should be placed in the docking station when turned OFF, and
will upload automatically when first placed in dock/ or cable connector.
15.5.1 The meter will indicate downloading with the Abbott logo first, the
arrowed rotation and the message “Please Wait Data Uploading”.
15.5
141
15.5.2 “Upload Successful meter Turning OFF” is displayed briefly when
complete.
15.5.3 If meter does not display the arrowed rotation and “Upload” message, then
15.5.3.1
check that the networked PC is ON
15.5.3.2
hardboot the PC and try docking again
15.5.3.3
check that the docking station is not physically damaged
15.5.3.4
that PH is not experiencing Network connectivity issues
15.5.3.5
After completing the above troubleshooting, you may
contact IT helpdesk or POC techs
15.5.4 If the meter is removed from the docking station before the upload
is complete, then no information will transfer, and potential meter
programming may be lost (i.e. operator list).
15.3.4.1
The information will complete in the next
docking/upload transmission.
15.6
15.7
15.8
15.5.5 If problems occur in the data upload, a display error message will
appear on the monitor, refer to the troubleshooting section.
FSP glucometer should be turned OFF before docking.
The docking station is not a charger
The FSP meter docks when initially place in docking station, it does not dock
continuously.
16.0
Entry of Results
16.1 Once the FSP glucometer is docked, results will post
16.1.1 in the Cerner / PathNet
16.1.2 other interfaced systems
16.2 Follow nursing downtime procedures if network or POC systems are down
17.0
References:
17.1 Abbott Freestyle Precision Pro Operators Manual for Healthcare Professionals,
Abbott 2012, Rev A 9/2013
17.2 UNIPoc Configuration Guide, Conworx Technology GmbH, Version V1, 3/2015
17.3 UNIPoc User Manual, Conworx Technology GmbH, Version V1B, 1/2015
17.2 Abbott Freestyle Precision Pro Glucose Test Strip Product Insert, Abbott 2012,
Rev A 9/2013
17.3 Medisense Glucose and Ketone Control Solutions Product Insert, 2013 Abbott,
Rev A 01/15
142
17.4
17.5
17.6
RNA Medical Calibration Verification Control (CVC) Kit Insert, RNA Medical,
Division of Bionostics, Inc, F6181 Rev 7/13
American Diabetes Association Clinic Practice Recommendations:
Diagnosis and classification of diabetes mellitus, Diabetes Care 2005: 28
(supl) 537-542
Freesyle Precision Pro Wireless Setup Utility User’s Guide, Abbott 2012, Rev B
3/2013
Initial Author/Date:
I-STAT Procedure
1.0
2.0
Written by Karen W. Sullivan, MT (ASCP) 4/18/2016
PC1.025.04
Principle
The I-STAT analyzer is intended for use with i-STAT cartridges for in
vitro quantification of various analytes in whole blood by trained and certified health care
professionals in accordance with the manufacturer and PHR procedures. The The iSTAT® System incorporates comprehensive components needed to perform blood
analysis at the point of care. The System consists of the following primary components:
1.1
Anaylzer: Analyzer is the handheld i-STAT Analyzer. When a sample-filled iSTAT cartridge is inserted into an analyzer for analysis, the analyzer
automatically controls all functions of the testing cycle including fluid movement
within the cartridge, calibration and continuous quality monitoring. Results are
reported in approximately 120-200 seconds for cartridges with sensors for
electrolytes, chemistries, and hematocrit. Results are reported in approximately
10 minutes for immunochemical cartridges such as Troponin I. Results are
reported in actual seconds dependent on results for ACTk cartridges up tp 1000
seconds.
1.2
Cartridges: A single-use disposable cartridge contains microfabricated sensors,
a calibrant solution, fluidics system, and a waste chamber. Sensors for analysis of
sodium, potassium, chloride, ionized calcium, glucose, creatinine, urea nitrogen
(BUN), and hematocrit are available in a variety of panel configurations. (Table
2). A whole blood sample of approximately 1 to 3 drops is dispensed into the
cartridge sample well and the sample well is sealed.
1.3
Point-of-Care QCM3 Data System: The i-STAT QCM3 server provides the
primary information management capabilities for the i-STAT System.
Downloaders for the i-STAT Analyzers allow for transmission of patient records
from a widely distributed network of analyzers to the patient’s medical record.
Some i-STAT models can transmit data wirelessly. Data is stored, organized,
edited, and transferred to the laboratory and hospital information system.
Cartridge usage and efficiency reports can be generated for QCM3 management
of the system.
Safety Precautions
2.1
Always wear gloves, proper PPE, and follow safety and biohazard policies
when performing testing with blood.
2.2
i-STAT analyzer and cartridges must be at room temperature for testing
2.2.1 If analyzer is moved from one temperature extreme to another, please
allow time reach new temperature before using
2.2.2 Operate the i-STAT within the temperature and humidity ranges
143
2.3
3.0
Store and use cartridges properly
2.3.1 Cartridges should be refrigerated and should be used before the box
expiration date.
2.3.2 Most cartridges are good for 14 days after removal from the refrigerator.
CG8+ cardridges are good for 2 months after removal from the
refrigerator.
2.3.3 If cartridges have been at room temperature for 5 minutes they cannot
be returned to the refrigerator. Never put cartridges back in the
refrigerator after they are at room temperature.
2.3.4 Cartridges are good for only one use
2.3.5 Do not allow cartridges to freeze
2.3.6 Do not expose cartridges to temperatures above 86F (30C)
2.4
i-STAT analyzers should remain still and on flat surface while testing is in
progress
2.5
Only i-STAT cartridges are approved for testing with the i-STAT instrument
2.5.1 Do not touch the cartridge sensors while handling the cartridge
2.5.2 Do not hold the cartridge with finger pressure
2.5.3 Take care not to crush silver circle while handling the cartridges
2.5.4 NEVER attempt to remove a cartridge while the monitor screen shows
“Cartridge Locked”
2.5.5 Do not overfill the cartridge.
2.5.6 Only fresh whole blood samples obtained in the approved containers may
be used to perform i-STAT testing
2.6
Verify patient identification before testing using the two identifiers required by
collection, PH and lab procedure
2.6.1 Verify 10 digit account number on armband before testing
2.7
Follow Standard Blood and Body Fluid Precautions and all safety
requirements
2.8
Questionable results should be repeated with a new sample and or confirmed by
laboratory tests
2.9
Use scanner properly with laser precautions
2.9.1 Hold barcode 3-12 inches from scanner, and at a 30-135 degree
angle to scan.
2.9.2 Never look into the scanner laser or point it toward anyone’s eyes.
2.10 Check i-STAT for damage or blood before each use
2.10.1 Clean when soiled
2.10.2 Clean between each patient
2.10.3 Clean with alcohol or ammonia based cleaners (Cavicide)
2.11 Call lab POC staff if problems are noted with the i-STAT analyzer
2.12 Dispose of lancets or needles in approved sharps containers.
2.13 Dispose of wastes and cartridges in Biohazardous containers.
2.14 All specimens must be properly labeled with the patient full name, MR#,
Account# (chart label), the date and time of collection, and the initials of the
collector
Equipment
3.1
i-STAT analyzer
3.1.1 3.04 in x 9.25 in x 2.85 in (7.68 cm x 23.48 cm x 7.24 cm)
3.1.2 22.9 ounces / 650 grams
3.1.3 Rechargable batteries or 2 9 volt lithium
3.1.4 Memory/clock backup power – Lithium battery
144
4.0
3.1.5 Analyzer Storage Temperature 14-115 F (-10-46 C)
3.1.6 Operating Temperature 61-86 F (16-30 C)
3.1.7 Relative humidity 90% maximum
3.1.8 Display – dot matrix supertwist liquid crystal
3.1.9 Calibration – Factory: electronic, mechanical, thermal, pressure
3.1.10 Communication Link – Infared light-emitting diode (LED)
Required Reagents
4.1
Cartridges are sealed in individual pouches.
4.2
Store the main supply of cartridges at a temperature between 2 to 8°C
(35 to 46°F).
4.3
Do not allow cartridges to freeze. (Freezing will cause higher than expected
ionized calcium results).
4.4
Cartridges may be stored at room temperature (18 to 30°C or 64 to 86°F) for 14
days, CG8+ may be stored at room temperature for 2 months
4.5
Cartridges should not be returned to the refrigerator once they have been at
room temperature for 5 minutes, and should not be exposed to temperatures above
30°C (86°F).
4.6
When you remove a cartridge from the box, stamp or write Expires and the date
14 days from the day/ or 2 months for the CG8+ it is removed. Do not use
after the manufacturer or new RT expiration date. All cartridges at room temp
should have new expiration date recorded. Staff obtaining cartridges from the
laboratory are responsible for dating supplies.
4.7
Cartridges should remain in pouches until time of use.
4.8
An individual cartridge may be used after 5 minutes out of the refrigerator. An
entire box should stand at room temperature for one hour before cartridges are
used.
4.9
Electronic Simulator
4.9.1 Used for instrument failure or maintenance, the electronic simulator is
stored in the laboratory
4.9.2 Store at room temperature and protect contact pads from contamination by
replacing the plastic cap and placing the Electronic Simulator in its
protective case after use.
4.10 Controls
4.10.1 i-STAT Controls for blood gases, electrolytes, and chemistries
4.10.1.1
Store at 2 to 8°C (35° to 46°F) good until
manufacturers expiration date
4.10.1.2
Warm to room temperature (at least 4 hours) prior to using.
Controls may be stored at room temperature (18 to 30°C or
64 to 86°F) for five days. Date when taken out of
refrigerator with new expiration
4.10.1.3
Do not use after expiration date on the box and ampules.
4.10.2 i-STAT Controls for ACT
4.10.2.1
Store at 2 to 8°C (35° to 46°F)
4.10.2.2
Do not use after expiration date on the box and vials.
4.10.2.3
Controls should be warmed to room temperature (for up to
4 hrs) before reconstitution, test immediately after
reconstitution.
4.10.3 i-STAT Controls for cTnI and BNP
4.10.3.1
Store unopened @ 2 to 8°C (35° to 46°F) until the
145
5.0
manufacturer expiration date on vial label.
4.10.3.2
Once opened, vials are stable for 30 days when stored
tightly capped @ 2 to 8°C (35° to 46°F). Date with new
room temperature expiration date.
4.10.4 Eurotrol GAS-ISE-HCT QC / CueSee VeriSTAT
4.10.4.1
One vial measures pH, gases, electrolytes,
metabolites, and hematocrit in a single ampule
4.10.4.2
Shelf life refrigerated (2 to 8°C) for 25 months
4.10.4.3
Ampules are stable at room temperature for 10 days
unopened. Date with new expiration date for room
temperature
4.10.4.4
Warm to room temperature for a minimum of 1
hour prior to opening. Do not put ampules back into
the refrigerator once exposed to room temperature.
4.10.4.5
After opening the vials, the product is stable for 30
sec for ABG’s
5.1
Cartridges and analyzers must be at room temperature.
5.2
Test specimen collection and sample application timing
5.2.1 Samples for ACTk must be tested immediately after collection and
collected in plastic syringes without anticoagulants
5.2.2 Samples for blood gases or ICa must be tested within 10 minutes of
collection and collected in completely filled lithium heparin tubes
anticoagulated tubes or syringes with balanced heparin anticoagulant filled
to labeled capacity. Remix blood in tubes thoroughly before testing.
5.2.3 Samples for electrolytes, glucose, or creatinine must be tested within 30
minutes of collection and collected in completely filled lithium heparin
tubes or immediately without anticoagulated tubes. Remix blood in tubes
thoroughly before testing.
5.2.4 Samples for Troponin I must be tested within 30 minutes of collection and
collected in completely filled lithium heparin tubes (green top). Remix
blood in tubes thoroughly before testing.
5.2.5 See attached chart for interfering substances: Table 1
Potential Interfering Substances
Table 1
ANALYTE
INTERFERENT
INTERFERENT CONCENTRATION
EFFECT ON ANALYTE
RESULT
Sodium
Bromide
37.5 mmol/L
Increase () Na by 5 mmol/L
Ionized Calcium
Acetominophen
1.32 mmol/L
Decrease () iCa
Magnesium
1.0 mmol/L
Increase () iCa by 0.04 mmol/L
Acetylcysteine
10.2 mmol/L
Decrease () iCa
Bromide
37.5 mmol/L
Increase () iCa
Lactate
6.6 mmol/L
Decrease () iCa by 0.07 mmol/L
Salicylate therapeutic
0.5 mmol/L
Decrease () iCa by 0.03 mmol/L
Salicylate
4.34 mmol/L
Decrease () iCa
146
ANALYTE
INTERFERENT
EFFECT ON ANALYTE
RESULT
Glucose
Acetominophen
10.2 mmol/L
Decrease () glucose
(Cartridge)
Bromide
37.5 mmol/L
Decrease () glucose
Bromide theraputic
2.5 mmol/L
Decrease () glucose by 5 mg/dL
pH
pH: per 0.1 pH units below 7.4 @ 37°C
Decrease () glucose by 0.9
mg/dL (0.05 mmol/L)
pH: per 0.1 pH units above 7.4 @ 37°C
Increase () glucose by 0.8
mg/dL (0.04 mmol/L)
Oxygen
PO2 less than 20 mmHg @ 37°C
May decrease () glucose
Hydroxyurea
0.92 mmol/L
Increase () glucose
Thiocyanate
6.9 mmol/L
Decrease () glucose by approx. 7
mg/dL
Acetaminophen
1.32 mmol/L
Increase () creatinine
Ascorbate
0.34 mmol/L
Increase () creatinine by 0.3
mg/dL
Bromide
37.5 mmol/L
PCO2
Above 40 mmHg
Increase () creatinine by 6.9%
per 10 mmHg PCO2
Below 40 mmHg
Decrease () creatinine by 6.9%
per 10 mmHg PCO2
Above 40 mmHg
Decrease () creatinine by 3.7%
per 10 mmHg PCO2
Below 40 mmHg
Increase () creatinine by 3.7%
per 10 mmHg PCO2
Hydroxyurea
0.92 mmol/L
Increase () creatinine, use
another method
Acetylcysteine
10.2 mmol/L
White Blood Count
(WBC)
Greater than 50,000 WBC/L
May Increase () hematocrit
Total Protein
For measured Hct<40%
For each g/dL below 6.5
For each g/dL above 8.0
Decrease () Hct by 1% PCV
Increase () Hct by 1% PCV
For measured Hct40%
For each g/dL below 6.5
For each g/dL above 8.0
Decrease () Hct by 0.75% PCV
Increase () Hct by 0.75% PCV
Abnormally high
Increase () Hct
Creatinine
<2 mg/dL
>2 mg/dL
Hematocrit
PCO2
Lipids
Celite ACT
Aprotinin
Falsely extends Celite ACT times
PCO2
Propofol (Diprovan®)
For patients administered
propofol or thiopental sodium, iSTAT recommends the use of
Thiopental Sodium
147
ANALYTE
INTERFERENT
EFFECT ON ANALYTE
RESULT
G3+, CG4+, CG8+, EG6+, and
EG7+ cartridges, which are free
from clinically significant
interference at all relevant
therapeutic doses. i-STAT does
not recommend the use of EC8+
cartridges for patients receiving
propofol or thiopental sodium.
Diprivan is a registered trademark of the AstraZeneca group of companies.
6.0
6.1
Always wear gloves and proper PPE when collecting and testing blood
samples.
6.2
Always properly identify patients before collections
6.2.1 All specimens must be properly labeled with the patient full name, MR#,
Account#, the date and time of collection, and the initials of the collector
(units may use chart labels with collection information noted)
6.3
In-Dwelling Line
6.3.1 Back flush line with sufficient amount of blood to remove intravenous
solution, heparin, or medications that may contaminate the sample.
Recommendation: five to six times the volume of the catheter, connectors,
and needle.
6.3.2 If collecting sample for ACT, clear the line first with 5mL saline and
discard the first 5mL of blood.
6.4
Arterial Specimens
6.4.1 For cartridge testing of blood gases, electrolytes, chemistries, and
hematocrit, fill a plain syringe or fill a blood gas syringe, labeled for the
assays to be performed, to the recommended capacity, or use the least
amount of liquid heparin anticoagulant that will prevent clotting.
6.4.2 Under-filling syringes containing liquid heparin will decrease results due
to dilution and will decrease ionized calcium results due to binding.
6.4.3 For ionized calcium, balanced or low volume heparin blood gas syringes
should be used.
6.4.4 Do not expose sample to air or PCO2 may decrease, pH may increase and
PO2 may decrease if the value is above or increase if the value is below
the PO2 of room air (approximately 150 mmHg).
6.4.5 For cartridge testing of ACT, use only a plain, plastic syringe without
anticoagulant.
6.4.6 Mix blood and anticoagulant by rolling syringe between palms for at least
5 seconds each in two different directions, then invert the syringe
repeatedly for at least 5 seconds. Discard the first two drops of blood.
6.4.7 For blood gas testing, avoid or remove immediately any air drawn into
syringe to maintain anaerobic conditions.
6.4.8 Test samples collected without anticoagulant immediately.
6.4.9 Test samples for ACT, PT/INR and lactate immediately.
6.4.10 For pH, blood gases, TCO2 and ionized calcium, test within 10 minutes of
collection. If not tested immediately, remix the sample and discard the
first two drops of blood from a syringe before testing. Note that it may be
difficult to properly remix a sample in a 1.0 cc syringe.
148
6.5
6.6
6.7
6.4.11 For other cartridge tests, test sample within 30 minutes of collection.
Venous Specimens
6.5.1 For cartridge testing of electrolytes, chemistries, and hematocrit, collect
sample into an evacuated blood collection tube or a syringe containing
sodium, lithium, or balanced heparin anticoagulant.
6.5.2 For ionized calcium measurements, balanced heparin or 10 U of sodium or
lithium heparin/mL of blood is recommended. Fill tubes to capacity; fill
syringes for correct heparin-to-blood ratio. Incomplete filling causes
higher heparin-to-blood ratio, which will decrease ionized calcium results
and may affect other results. The use of partial – draw tubes (evacuated
tubes that are adjusted to draw less than the tube volume, e.g. a 5 mL tube
with enough vacuum to draw only 3 mL) is not recommended for blood
gas or CHEM8+ cartridges because of the potential for decreased PCO2,
HCO3 and TCO2 values.
6.5.3 For cartridge testing of ACT, use only a plain, plastic syringe or collection
tube containing no anticoagulant. Use a plastic capillary tube, pipette, or
syringe to transfer sample from a tube to a cartridge.
6.5.4 Mix blood and anticoagulant by inverting a tube gently at least ten times.
Roll a syringe vigorously between the palms for at least 5 seconds each in
two different directions, then invert the syringe repeatedly for at least 5
seconds, then discard the first two drops of blood. Note that it may be
difficult to properly mix a sample in a 1 cc syringe.
6.5.5 Test Sample collected without anticoagulant immediately.
6.5.6 Test samples for ACT, and lactate PT/INR immediately.
6.5.7 Test samples for pH, PCO2, TCO2 and ionized calcium within 10 minutes
of sample draw. If not tested immediately, remix the sample before
testing and discard the first two drops of blood from a syringe before
testing.
6.5.8 For other cartridge tests, test sample within 30 minutes of collection.
Capillary Collections
6.6.1 Direct application from capillary collections is not acceptable
6.6.2 Use either plastic heparinized capillary collection tubes or collect
in a Microtainer® tube for transfer to i-STAT cartridge
6.6.3 Test capillary samples immediately after collection
Specimen Rejection Criteria DO NOT USE:
6.7.1 Evidence of clotting – DO NOT USE
6.7.2 Specimens collected in vacuum tubes with anticoagulant other than
lithium or sodium heparin
6.7.3 Specimens for ACT collected in glass syringes or tubes or with
anticoagulant of any kind
6.7.4 Syringe for pH, PCO2, PO2 and TCO2 with air bubbles in sample
6.7.5 Incompletely filled vacuum tube for the measurement of ionized calcium,
PCO2, HCO3 or TCO2
6.7.6 Other sample types such as urine, CSF, and pleural fluid
6.7.7 Avoid collections with the following:
6.7.7.1 Drawing a specimen from an arm with an I.V.
6.7.7.2 Stasis (tourniquet left on longer than one minute before
venipuncture)
6.7.7.3 Extra muscle activity (fist pumping)
6.7.7.4 Hemolysis (alcohol left over puncture site, or a traumatic draw)
149
6.7.7.5 Icing before filling cartridge
6.7.7.6 Time delays before filling cartridge, especially lactate, ACT, and
PT/INR
6.7.7.7 Exposing the sample to air when measuring pH, PCO2, PO2 and
TCO2
See Table 2 Cartridge Panel Configurations and Blood Volume
7.0












Hb

BE


SO2

TCO2

HCO3

cTnI

ACT




TCO2




Hct




Creat




Glu

iCa






(Shading denotes calculated values)
Cl






PO2
PCO2
pH






K
CG8+
EG7+
EG6+
CG4+
G3+
EC8+
6+
EC4+
E3+
G
Crea
ACT
PT/INR
cTnI
CK-MB
BNP
95
95
95
95
95
95
65
65
65
65
65
65
40
20
17
17
17
Na
CHEM8+
Vol.
L
Cartridge
Table 2: Cartridge Panel Configurations and Blood Volume



































Type of Container Additives
7.1
Cartridges for Blood Gas/Electrolytes/Chemistries/Hematocrit
7.1.1 Skin puncture: lancet and capillary collection tube (plain, lithium heparin,
or balanced heparin for electrolytes and blood gases)
7.1.2 Venipuncture: lithium or sodium heparin collection tubes and disposable
transfer device (e.g., 1cc syringe and a 16 to 20 gauge needle).
7.1.3 Arterial puncture: Plain syringe or blood gas syringe with heparin and
labeled for the assays performed or with the least amount of heparin to
prevent clotting (10 U heparin/mL of blood)
7.1.4 Fresh whole blood collected in a plain capillary collection tube or
capillary collection tube with balanced heparin.
7.1.5 Fresh whole blood collected in a collection tube with lithium or sodium
heparin anticoagulant. Fill collection tubes to capacity.
7.1.6 Fresh whole blood collected in a plain plastic syringe or in a blood gas
syringe labeled for the assays to be performed. Fill syringes for correct
150
8.0
blood-to-heparin ratio.
7.2
Cartridges for ACT
7.2.1 Skin puncture/ capillary samples are not acceptable
7.2.2 Venipuncture and arterial puncture: plain plastic syringe without
anticoagulant
7.2.3 Fresh whole blood without anticoagulant collected in a plastic syringe. If
from an indwelling line, flush the line with 5mL saline and discard the
first 5mL of blood or three to six dead space volumes of the catheter.
7.2.4 Fresh whole blood collected in a plastic tube without anticoagulant, clot
activators, or serum separators. Device used to transfer sample to cartridge
must be plastic.
7.3
Cartridges for Troponin I/ cTnI and CK-MB
7.3.1 Skin puncture/ capillary samples are not acceptable
7.3.2 Venipuncture: lithium or sodium heparin collection tubes and disposable
transfer device (e.g. 1 cc syringe and a 16 to 20 gauge needle).
7.3.3 Fresh heparinized whole blood or plasma samples collected in syringes or
evacuated tubes containing lithium or sodium heparin. Collection tubes
must be filled at least half full.
Maintenance / Instrument Operations Schedules
8.1
Instruments must be kept clean and free of body fluids. Check i-STAT for
damage or blood before each use. Contact lab if instrument is damaged
8.1.1 Clean when soiled
8.1.2 Clean between each patient
8.1.3 Clean with alcohol (preferably not on rubber) or Cavicide cleaner
8.1.4 Turn off instrument before cleaning
8.1.5 Do not use straight bleach or hydrogen peroxide based cleaners.
8.1.6 Do not get moisture into the instrument
8.1.7 Exercise standard safety precautions at all times when handling the
analyzer, cartridges, and peripherals to prevent exposure to blood-borne
pathogens.
8.1.8 The analyzer is NOT designed to be sterilized or autoclaved by any
method, including those using gas, (e.g. steam, ethylene oxide, etc) high
heat, bead, radiation, or other chemical processes. The analyzer is splash
resistant, but should not be immersed in any liquids.
8.1.9 If the analyzer is placed on a wet surface or if any liquid is spilled onto it,
dry the analyzer immediately. If liquid enters the compartments, the
analyzer may be damaged
8.2
Daily Maintenance
8.2.1 Internal Electronic Simulator will be run at least every 8 hrs of instrument
use
8.2.2 Instruments should be downloaded at a minimum
8.2.2.1 Daily, or
8.2.2.2 After every patient test, or
8.2.2.3 After every patient surgery case
8.3
Monthly Maintenance
8.2.1 All instruments will all have appropriate liquid QC run
8.3
6 Months Maintenance
8.3.1 CLEW updates as dictated by Abbott and laboratory
8.3.2 External Electronic Simulator, Thermal Probe
8.3.3 Liquid QC will be run after updating
151
9.0
10.0
8.3.3 Calibration Verification (3 levels) will be run after updating
8.3.4 Semiannual comparisons
8.4
As needed Maintenance
8.4.1 Placing the i-STAT in a downloader/recharger will automatically initiate
recharging of the rechargeable battery. Use only i-STAT rechargeable
batteries
8.4.1.1 The indicator light on top of the downloader/recharger will be
green (trickle charge), red (fast charge) or blinking red (fast charge
pending)
8.4.2 Exchange rechargeable batteries from the downloader to the instrument,
replacing the spent battery in the downloader
8.4.2.1 Placing a rechargeable battery in the recharging compartment on
the downloader will initiate a trickle recharge as indicated by green
indicator light
8.4.3 Use of wireless i-STAT will result in a 30% reduction in the life of
the battery (in terms of cartridge usage) due to wireless downloads
8.4.4 External Electronic Simulator for troubleshooting
8.4.5 Other troubleshooting procedures as recommended by Abbott
8.5
Proficiency Testing
8.5.1 According to lab policy Q1.016 Proficiency Testing, per analyte
8.6
Installing the battery pack, note the orientation labels
8.6.1 Install rechargeable battery pack with the large centrally located red dot
facing the front of the i-STAT
8.6.2 Install rechargeable battery pack with the small off center red dot located
to the bottom left of the downloader (make sure that the pack is locked
into position)
Calibration Procedures
9.1
For cartridges, calibration is automatically performed as part of the test cycle on
each cartridge type, except coagulation and immunoassay cartridges. Operator
intervention is not necessary.
9.2
Laboratory will perform validation for all new i-STAT instruments before being
placed into use according to Abbott validation procedures. (see procedure
PC1.026)
9.3
Laboratory will perform semi-annual correlation studies for all i-STAT
instruments in use where applicable
9.4
External Electronic Simulator will be used by the laboratory for troubleshooting
problems
9.5
CLEW updates as dictated by Abbott
9.6
Calibration Verifications (3 levels) semi annual
Quality Control Procedures
10.1 Daily Procedures - Analyzer Verification
10.1.1 Verify the performance of each handheld analyzer or Blood Analysis
Module in the i-STAT System using the internal electronic simulator at a
minimum every 24 or 8 hours of use, or as needed for regulatory
compliance
10.1.2 Verification using the internal electronic simulator is required every 8
hours for blood gases, hematocrit, ACT, cTnI.
10.1.3 Note: If the internal Electronic Simulator is used, the “PASS” message
will not be displayed on the analyzer screen.
152
10.2
10.3
10.4
10.5
10.1.4 The “PASS” record will appear in the analyzer’s stored results for
transmission to the system.
Daily refrigerator check:
10.2.1 All locations storing iSTAT Cartridges will verify the refrigerator storage
temperature daily and follow POC Policy for temperature requirements
10.2.2 Refrigerator temperatures must be maintained at 2 to 8 degrees C (35 to
46 degrees F)
10.2.3 If the temperature is outside the range of 2 to 8°C (35 to 46°F), quarantine
the cartridges in the storage refrigerator.
10.2.3.1
Notify the i-STAT System Coordinator immediately.
10.2.3.2
DO NOT USE the cartridges from refrigerator.
10.2.3.3
Record the QC failure in the i-STAT QC Log along with
the action taken.
New shipment of cartridges:
10.3.1 Verify that the transit temperature was satisfactory using the four window
temperature indicator strip.
10.3.1.1
Write ok in the appropriate block matching temperature
window to column.
10.3.2 Enter the date and time received. Initial
10.3.3 Temperature records will be kept on site for 2 years.
10.3.4 Cartridges from each lot number received should be tested using
10.3.4.1
Minimum of 2 levels of liquid QC, or as appropriate
10.3.5 Units will be required to sign out reagents obtained from the lab to track
inventory
Monthly quality control (liquid QC):
10.4.1 All i-STAT testing locations will participate in performing quality control
using liquid controls monthly by the users for each i-STAT.
10.4.2 Liquid QC will be rotated among users in each area
10.4.3 All cartridge types will be included in the monthly quality control check.
Performing i-STAT quality control using liquid quality control
(Performed by testing personnel)
10.5.1 Handle all control products using the same safety precautions used when
handling any infectious material.
10.5.2 Controls should be removed from the refrigerator along with iSTAT
cartridges to be tested and brought to room temperature.
10.5.2.1
For CG8+ (containing ICa) the contents of one ampule
must be used immediately to fill cartridges, i.e. multiple
instruments, or a separate ampule will be required
10.5.2.2
Ampules for testing ABG’s and Chem must stand at room
temperature for at least 1 hour before use (or according to
manufacturer instructions)
10.5.2.3
For CG8+ immediately before use, shake the ampule
vigorously for 5-10 seconds to equilibrate the liquid and
gas phases, holding the ampule at the tip and bottom with
forfinger and thumb to minimize increasing the temperature
of the solution.
10.5.2.4
For ACT LQC warm to room temperature for at least 45
minutes. Pour entire contents of calcium chloride vial into
the lyophilized plasma vial and replace stopper. Allow
reconstituted vial to sit for 1 minute, mix by swirling gently
153
for 1 minute, and then invert slowly for 30 seconds. Test
within 30 seconds of completed processing
10.5.2.5
For cTn1 LQC, remove vials from refrigerator and bring to
room temperature for 15 minutes. Mix completely by
swirling contents and avoiding foaming.
10.5.2.6
For Eurotrol LQC allow the ampule to equilibrate at room
temperature for at least 1 hour prior to use. (ampules are
stable for 10 days at room temp unopened). Shake
vigorously for at least 15 seconds to re-equilibrate the gases
(thumb and forefinger hold). Pop top carefully and load
cartridge within 30 seconds (for gases).
10.5.3 Point of Care will distribute the quality control material LQC to be tested
to the units.
10.5.4 Turn iSTAT on.
10.5.5 Press menu.
10.5.6 Press 3, Quality Test.
10.5.7 Press 1, Control.
10.5.8 Scan or enter operator ID.
10.5.9 Enter control Lot #, press enter.
10.5.10 Enter cartridge Lot #, by scanning barcode on package.
10.5.11 Immediately before use, shake the control ampule vigorously for
5 to 10 seconds for ABG, Chem testing
10.5.11.1
To shake, hold the ampule at the tip and bottom with
forefinger and thumb to minimize increasing the
temperature of the solution.
10.5.12 Protect fingers w/ gauze, tissue, or glove to snap off ampule neck
10.5.13 Use a syringe or pipette to immediately transfer solution to
cartridge
10.5.14 Immediately seal the cartridge and insert it into the analyzer.
10.5.15 Do not remove cartridge when locked message is displayed
10.5.16 When results display, compare the result to the allowable ranges
VAS (provided by laboratory Point of Care staff)
10.5.17 Results that exceed the target values must be repeated.
10.5.17.1
Obtain a new vial of QC material and repeat QC steps
10.5.17.2
If QC fails again, notify Point of Care immediately.
10.5.17.3
No testing can be performed on the iSTAT until
troubleshooting is done.
10.6
Troubleshooting out-of-range results:
10.6.1 Verify that the following conditions are met, and then repeat the test.
10.6.2 The correct expected values insert is being used, and the correct cartridge
type and lot number listing is being used.
10.6.3 Expiration date printed on the cartridge pouch and control ampule or vial
have not been exceeded.
10.6.4 Room temperature date for cartridge and control has not been exceeded.
10.6.5 Cartridge and control have been stored correctly.
10.6.6 The control material has been handled correctly.
10.6.7 The analyzer being used passes the electronic simulator test.
10.6.8 If the results are still out of range, repeat the test using a new box of
control solutions and cartridges.
154
10.6.9 If the results are still out, call Point of Care; and someone will call Abbott
Support Services.
Cartridge redesign features to be introduced summer 2014
Old Design
New Design
Cart and fill well
Cart and fill well
Fill line indicator
Fill line indicator
Sample latch design
Sample latch design
Thumbwell hold for easier handling and removal
155
11.0 Procedural Steps
(other than Tropnin I/cTnI)
11.1 An individual cartridge may be used after standing 5 minutes, in its pouch, at
room temperature. An entire box should stand at room temperature for one hour
before cartridges are used.
11.2 Turn the analyzer on and press 2 for i-STAT Cartridge.
11.3 Scan or enter the operator ID
11.4 Scan or enter the patient ID. Repeat if prompted.
11.5 Scan Cartridge Lot number from the cartridge portion pack.
11.6 Remove the cartridge from its pouch. Avoid touching the contact pads or exerting
pressure over the calibrant pack in the center of the cartridge. Hold the cartridge
only by the sides!
11.7 Following thorough mixing of the properly labeled sample, direct the dispensing
tip or device containing the blood into the sample well.
11.7.1 Dispense the sample until it reaches the fill mark on the cartridge and the
well is about half full.
11.7.2 Avoid exposing sample to air when testing venous blood for ICa and pH.
11.7.3 A full Vacutainer® tube must be drawn for the ionized calcium and pH.
Partial draws are not acceptable specimens for testing ICA and pH.
11.8 Close the cover over the sample well until it snaps into place. (Do not press over
the sample well.)
11.9 Insert the cartridge into the cartridge port on the analyzer until it clicks into place.
11.9.1 Message will appear that states “Identifying Cartridge”
11.9.2 When using an ACT cartridge, the analyzer must remain horizontal during
the testing cycle.
11.10 Choose the number corresponding to the type of sample used when prompted at
the Sample Type field, this must be entered to obtain results
11.10.1
1-Arterial
11.10.2
2-Venous
11.10.3
3-Capillary
11.11 Never attempt to remove a cartridge while the LCK or “Cartridge Locked”
message is displayed. This will damage the i-STAT
11.12 Instrument automatically corrects for CBP.
11.13 Press the  key to return to the results page.
11.14 View results shown on the analyzer’s display screen.
11.15 Enter Comment Code if prompted.
11.16 Remove the cartridge after “Cartridge Locked” message disappears. The analyzer
is ready for the next test immediately.
(Troponin)
12.1 Only acceptable sample is a properly labeled green top (Li Heparin) tube that is
properly filled, not clotted, and well mixed
12.1.1 Retain green top tubes in the ER area until the second i-STAT Troponin
has been performed
12.2 The i-STAT cTnI cartridges can only be used with the i-STAT1Analyzer bearing
the
symbol. This symbol is located on the grey casing next to the lower right
corner of the analyzer display screen. Before testing cTnI cartridges on the iSTAT 1 Analyzer, the analyzer must be customized through the software systems
by the
156
12.2.1 Cartridge Information Required & Cartridge Lot Number Required, or
12.2.2 Cartridge Barcode Required.
12.3 Press the On/Off key to turn analyzer on.
12.4 Press 2 for i-STAT Cartridge from the Test Menu.
12.5 Scan or Enter Operator ID.
12.6 Scan or Enter Patient ID. Repeat if prompted.
12.7 Scan Cartridge Lot number from the cartridge portion pack.
12.8 Remove cartridge from portion pack.
12.8.1 Handle the cartridge by its edges.
12.8.2 Avoid touching the contact pads or exerting pressure over the center of the
cartridge.
12.9 Following thorough mixing of the properly labeled sample, discard 1-2 drops
whole blood from the delivery device to clear unseen bubbles. Hang drop(s)
slightly larger than the round “target well”. Touch the drop to the well allowing
cartridge to draw sample in. Do NOT load cartridge with a needle..
12.10 Close the cTnI cartridge:
12.10.1
First anchor the cartridge in place by using the thumb and index
finger of one hand to grasp the cartridge from its side edges away
from the sample inlet.
12.10.2
Use the thumb of the other hand to slide the plastic closure clip to
the right until it locks into place over the sample well.
12.10.3
Note: When sliding the closure clip, the index finger of that same
hand should not be placed directly across from the thumb, as this
could result in the sample being pushed onto the user’s glove. This
index finger should be placed just above the position of the sliding
clip during closure or not at all.
12.11 Insert cartridge into cartridge port. Grasp the cartridge “slide cover” between
your first finger and thumb, using the thumb recess. Hold the analyzer in place
with one hand. With the other gently guide the cartridge into the analyzer,
releasing the cartridge only after it is fully inserted.
12.11.1
The analyzer must remain on a level surface with the display
facing up during testing. Motion of the analyzer during testing
can increase the frequency of suppressed results or quality
check codes.
12.11.2
Do not move the i-STAT while testing is engaged
12.11.3
You may place i-STAT in the docking station while testing is
running (after initiation) and results will auto download when
completed
12.12 Choose the number corresponding to the type of sample used when prompted at
the Sample Type field
12.12.1
1-Arterial
157
12.12.2
2-Venous
12.12.3
3-Capillary
12.13 The Time to Results countdown bar will then be displayed. Once time has
elapsed, view results on analyzer’s display.
12.13 Remove cartridge after Cartridge Locked message disappears. The analyzer is
ready for the next test immediately.
13.0
Results Reporting
13.1 Calculations: The i-STAT handheld contains a microprocessor that performs all
calculations required for reporting results.
13.2 Displayed Results: Results are displayed numerically with their units.
13.2.1 Electrolyte, chemistry and hematocrit results are also depicted as bar
graphs with reference ranges marked under the graphs.
13.3 Suppressed Results: There are three conditions under which the i-STAT System
will not display results:
13.3.1 Results outside the System’s reportable ranges are flagged with a < or > or
< > indicating that the result is below the lower limit or above the upper
limit of the reportable range respectively. (See the table of Reportable
Ranges.) The < > flag indicates that the results for this test were
dependant on the result of a test flagged as either > or <.
13.3.1.1
Action: Send specimen(s) to the laboratory for analysis, if
necessary
13.3.2 Cartridge results which are not reportable based on internal QC rejection
criteria are flagged with *** (sensor errors or interfering substances)
13.3.2.1
Action: Analyze the specimen again using a fresh sample
and another cartridge. If the result is suppressed again,
send specimen(s) to the laboratory for analysis in
accordance with the Laboratory Procedure Manual.
13.3.3 A Quality Check message will be reported instead of results if the
handheld detects a problem with the sample, calibrator solution, sensors,
or mechanical or electrical functions of the handheld during the test cycle.
13.3.3.1
Action: Take the action displayed with the message that
identifies the problem. Refer to the i-STAT or i-STAT 1
System Manual’s Troubleshooting if needed
13.4 Results that are above or below the action ranges are flagged with up  or down 
arrows.
13.4.1 Validate test results by either repeating or confirming clinically
13.4.2 Enter appropriate comment code (required) 12 Physician Notified
13.4.3 Send testing to the lab when appropriate, always match results to patient
clinical conditions. Perform lab testing on any questionable results
See Table 3
15.0 Alert and/or Critical Values
See Table 3
15.1 Critical results are test results that fall outside high and low critical limits that
define the boundaries of life-threatening values for a test. Critical results represent
an emergency condition and must be reported immediately to the patient’s
attending physician or nurse.
15.1.1 Critical Panic results notifications must be documented in EMR with
158
15.2
15.3
15.4
15.5
15.6
15.7
15.8
appropriate information including patient ID, operator ID, date time, provider,
test, result, and read back if notification is phoned to provider
Test results considered as Panics, will display an up arrow  for increased results
and down arrow  for decreased test results.
15.2.1 It is always good laboratory practice to verify Panic values by repeat
testing before treatment is administered or clinical correlation.
If the results obtained on the iSTAT are questioned for any reason a second
sample should be drawn (draw enough to fill tubes to send to the Laboratory if
necessary) and a repeat test done on the iSTAT.
15.3.1 Send sample to the lab if i-STAT results are still questionable
15.3.2 Should the results still be questioned order the appropriate Laboratory test
in Cerner.
ENTER COMMENT CODE 1 REPEAT TEST. Unit must notify the POC
Coordinator if tests should be credited and reasons noted
Star outs **** indicate the electronic sensors were compromised. Obtain a new
sample and perform the test again.
Tests that show the < or > are outside the cartridge reportable range. These tests
may need to be verified by having the test performed in the Laboratory.
A comment code corresponding to the action taken when panic results are
obtained will be requested by the i-STAT. You will not be able to perform
another test on the i-STAT until the comment code is entered.
Enter the number corresponding to the action taken:
15.7.1
0 - No Action Required
15.7.2
1 - Repeat Test
15.7.3
2 - Procedure Error
15.7.4
12 - Dr. Notified (required entry for Panic results)
15.7.5
10 - Lab Verification Requested
Warning Message, if testing is disabled due to a warning message, the condition
must be corrected and the analyzer must be turned off and back on again before
testing is enabled.
15.8.1 Remove the cartridge after Cartridge-Locked message disappears
15.8.2 The i-STAT is ready to perform next test
Table 3
Analytes Reference Ranges, Panic Values, Technical Limits
ANALYTE
UNIT
AGE RANGE
REFERENCE
RANGE
PANIC
RESULTS
REPORTABLE
RANGE
Sodium
mmol/L
0-6 mos
131 - 142
< 125 - > 150
100 - 180
>6 mos to adult
136 - 145
< 120 - > 160
0-6 mos
3.2 – 6.2
< 2.5 - > 7.0
>6 mos to adult
3.5 – 5.1
< 2.5 - > 6.5
Potassium
Chloride
mmol/L
mmol/L
97 – 108
2.0 – 9.0
65 - 140
159
CO2
mmol/L
BUN
Creatinine
mg/dL
0-6 mos
13 – 21
< 10
>6 mos to adult
14 - 32
< 10 - > 40
0-6 mos
1 – 16
>6 mos to adult
4 - 21
0-6 mos
0.1 – 0.8
> 4.0
>6 mos to adult
0.6 – 1.3
> 15.0
5 - 50
0 - 140
0.2 – 20.0
>60.0
GFR
< 40 - > 201
mg/dL
0-6 mos
>6 mos to adult
50 – 80
Glucose
70 – 99 fasting
< 40 - > 500
20 - 700
Ionized Calcium
mmol/L
0-6 mos
1.00 – 1.50
< 0.78 - > 1.58
0.25 – 2.50
>6 mos to adult
1.16 – 1.32
> 0.60
0.00 – 50.00
Troponin I
ng/mL
< 0.08
Kaolin ACT
seconds
82 – 152 (NONWRM)
Hematocrit
%PCV
cTnI
Hemoglobin
g/dL
*Calculated
pH
PCO2
PO2
mmHg
mmHg
TCO2
*Calculated
mmol/L
HCO3
mmol/L
0-6 mos
30.5 – 54.0
< 25 - > 65
>6 mos to adult
31.0 – 43.5
< 18.0 - > 60.0
0-6 mos
10.0 – 20.0
0-1 mos < 9.6
>6 mos to adult
10.1 – 14.5
Adult < 5.5
7.35 – 7.45
< 7.25 - > 7.60
6.50 – 8.20
35 - 45
< 20 - > 60
5 - 130
80 - 100
< 55 - > 500
5 - 800
10 - 75
3.4 – 25.5
5 - 50
22 - 26
< 11 - > 40
-2 to +2
BE
*Calculated
sO2
*Calculated
50 - 1000
%
Table 4
95 - 101
< 85
CLINICAL SIGNIFICANCE
160
Analyte
Some Causes of
Increased Values
Some Causes of
Decreased Values
Sodium
Dehydration
Diabetes insipidus
Salt poisoning
Skin losses
Hyperaldosteronism
CNS disorders
Dilutional hyponatremia (cirrhosis)
Depletional hyponatremia
Syndrome of inappropriate ADH
Potassium
Renal glomerular disease
Adrenocortical insufficiency
Diabetic Ketoacidosis (DKA)
Sepsis
In vitro hemolysis
Renal tubular disease
Hyperaldosteronism
Treatment of DKA
Hyperinsulinism
Metabolic alkalosis
Diuretic therapy
Ionized
Calcium
Dehydration
Hyperparathyroidism
Malignancies
Immobilization
Thiazide diuretics
Vitamin D intoxication
Hypoparathyroidism
Early neonatal hypocalcemia
Chronic renal disease
Pancreatitis
Massive blood transfusions
Severe malnutrition
Glucose
Diabetes mellitus
Pancreatitis
Endocrine disorders (e.g. Cushing’s syndrome)
Drugs (e.g. steroids, thyrotoxicosis)
Chronic renal failure
Stress
IV glucose infusion
Insulinoma
Adrenocortical insufficiency
Hypopituitarism/Massive liver disease
Ethanol ingestion/Reactive
hypoglycemia
Glycogen storage disease
Creatinine
Impaired renal function
pH
Respiratory alkalosis
Respiratory acidosis
Metabolic alkalosis
Metabolic acidosis
Acute Respiratory Acidosis:
Respiratory alkalosis:
 Depression of respiratory center
 Increased stimulation of respirator
center
PCO2
 Suppressed neuromuscular system
 Pulmonary disorders
 Hypermetabolic states
 Inadequate mechanical ventilation
 Mechanical hyperventilation
Chronic respiratory acidosis
Compensation in metabolic acidosis
 Decreased alveolar ventilation
 Hypoventilation
Compensation in metabolic alkalosis
161
Analyte
Some Causes of
Increased Values
Some Causes of
Decreased Values
PO2
Breathing oxygen-enriched air
Carbon-monoxide exposure
Pulmonary disorders
Myocardial infarction
Congestive heart failure
HCO3 and
TCO2
Primary metabolic alkalosis
Primary metabolic acidosis
Primary respiratory acidosis
Primary respiratory alkalosis
Hematocrit
Dehydration
Hemolytic anemias
Burns
Iron deficiency
Impaired ventilation
Marrow depression
Renal disorders
Blood loss
ACT Kaolin
Administration of heparin for medical or surgical
procedures.
cTnI
Myocardial Infarction
Coronary vasospasm
Cardiac contusion/trauma
Rhythm disturbance (SVT, AF)
Chemotherapy (ex. Adriamycin)
Myocarditis/pericarditis
Infiltrative diseases (ex. Amyloidosis, sarcoidosis,
hemochromatosis, connective tissue disease)
Congestive heart failure
Heart transplantation
Cardiac procedures (PTCA, DC cardioversion)
Intracranial hemorrhage/stroke
Pulmonary embolism
Pulmonary hypertension
Chronic renal insufficiency
Sepsis
Strenuous exercise
Certain drug ingestions
Rare antibodies to troponin or its
circulating complexes
16.0 i-STAT Configuration
16.1 See PC1.026 procedure for management of i-STAT system
17.0 Downloading i-STAT instruments
17.1 Transmitting Results from the i-STAT 1 Analyzer to the Data Manager
17.1.1 Place handheld in a Downloader or Downloader/Recharger.
17.1.2 Do not move handheld while the message “Communication in Progress” is
displayed.
17.1.3 i-STAT instruments should remain in the downloaders when not in use
17.1.4 Tests such as Troponins can be run while the i-STAT instrument is in the
downloader, provided the instrument is placed in the downloader prior to
the cartridge insertion
17.1.5 Wireless i-STAT (blue face) have the ability to transmit results wirelessly,
by operator prompt, or if wireless connections fail they can transmit
through the downloaders
162
17.1.5.1
Handheld must remain at least 20 cm (appx 8 inches) from
the body when the radio is ON. Radio is ON when:
17.1.5.1.1
the handheld is tramsmitting
17.1.5.1.2
the operator is using the Wireless
Utility Menu
17.1.5.1.3
during the first 2 minutes following a
testing cycle
17.1.5.2
When placed in a downloader/recharger the wireless
i-STATs will attempt to download wirelessly first,
and if unsuccessful the i-STAT will send results
through the downloader automatically
17.1.6 Operators may transmit results wirelessly to the data management system
17.1.6.1
Directly following an individual test cycle using the
Test Options Menu
17.1.6.1.1
When new test results appear on the
display press “1” (Tests Options)
17.1.6.1.2
Press “4” (Transmit Data). A
Waiting to Send message will appear
on the screen
17.1.6.1.3
The “State” line will display a series
of messages “Off” / “Booting” /
“Joining” / “Associated” /
“Connected”
17.1.6.1.4
Once the “Connected” state is
reached, a “Communication in
progress” display appears. When
this meassage disappears and the
display returns to the Test Menu, the
transmission is successful.
17.1.6.2
On-demand using the Transmit Data menu
17.1.6.2.1
Press the “1” key
17.1.6.2.2
Press the menu key
17.1.6.2.3
Press the “6” key Transmit Data
17.1.6.2.4
Press a number key of the data you
want to transmit
17.1.6.2.5
The same sequence of messages as
above will display
17.1.7 If there are unsent results remaining in the wireless handheld at the
completion of a transmission attempt, a “Communication Ended” message
will appear on the display, and the number of unsent result
17.1.8 Users can expect a approximate 30% reduction in the life of the battery
based on cartridge use due to the wireless downloads
18.0
Troubleshooting
see Table 6
18.1 Do not open the instrument, or any other i-STAT product, or perform
unauthorized procedure to resolve a problem.
18.2 The i-STAT performs a self-check when it is turned on. If a condition that should
be corrected in the near future, but will not affect results, is detected, a warning is
displayed. The operator should turn the i-STAT off and back on to attempt to
resolve.
163
18.3
18.3
Contact the lab when if an i-STAT is dropped or damaged in any way.
18.3.1 Lab will check error codes for the instrument
18.3.2 Lab will perform CCC or other troubleshooting action as recommended
18.3.3 Lab will contact Abbott for troubleshooting recommendations
Error code listings can be found in the Technical Bulletin section of the Abbott iSTAT procedure manual
Table 6
Troubleshooting Error Messages/Codes
MESSAGE DISPLAY
EXPLANATION
ACTION / RESPONSE
Electronic Simulator Test
required
Scheduled simulator test is due
Run External Electronic Simulator
Stored Memory Low
Memory space for 50 unsent test
records available before “Stored
Memory Full” message is displayed
Download i-STAT
Sored Memory Full
Memory for unsent records is full,
potential for unsent records to be
deleted
Download i-STAT
Upload required
Scheduled for uploading/downloading
Download i-STAT
Battery Low
Voltage dropped to 7.4 volts, enough
for only a few more tests
Change or charge the rechargeable
batteries
CLEW expiring
Message appears 15 days before
software expires
Lab initiate CLEW update
Date invalid, check clock
Will not allow date that precedes or
exceeds the 6 mos lifetime of the
CLEW update
Download i-STAT, contact lab
Temperature out of range
Temperature internally in instrument is
not acceptable
Check temperature of the i-STAT on the
Administrative Menu. Warm or cool the
instrument. Allow time for the
instrument to equilibrate to the new
temperature
Analyzer Interrupted, use
another cartridges
Last cartridge run was not completed
Check battery pack for proper insertion,
turn instrument on and off, check battery
voltage
Cartridge Error
Multiple reasons including sample
related, user, cartridge related,
contacts, etc
Use another cartridge
Cartridge Preburst
Fluid reached sensors before they
should have – potentially caused by
freezing or user error putting too much
pressure on cartridge
Sample positioned short of fill
mark
Under filled cartridge
Sample positioned beyond fill
mark
Overfilled cartridge
Insufficient sample
Insufficient sample or bubbles
164
MESSAGE DISPLAY
EXPLANATION
ACTION / RESPONSE
Cartridge not inserted properly
Cartridge not pushed in all the way
Test cancelled by operator
No response made to mandatory
prompt, instrument timed out
Retest, potentially retrain operator
Analyzer Error, use External
Electronic Simulator
Usually recovers. Can be caused by
angled insertion of cartridges or
simulator
Run external Electronic Simulator
properly
Analyzer Error
Mechanical or electrical failures
Use external Electronic Simulator twice,
and run QC. If issue continues call
support services @ Abbott
Cartridge type not recognized
Cartridge not compatable
No display, blank
Batteries dead, keypad not responding,
internal start switch broken
Change or recharge batteries. If not
resolved return to lab for repair or
replacement
Cartridge locked, not removed
Mechanical issue or dead batteries
Change battery pack. Turn instrument
off and back on. If cartridge is still not
released, contact lab
PC1.028.01 AmniSure ROM Procedure
1.0
1.1
The AmniSure ROM™ Test is a rapid non-instrumented, qualitative
immunochromatographic test used for the in vitro detection of amniotic
fluid in vaginal secretions of pregnant women.
1.2
AmniSure ™ detects PAMG-1 (placental microglobulin) protein marker
of the amniotic fluid in vaginal secretions. Diagnosis of ruptured fetal
membranes is of crucial importance at any term in a pregnancy for prompt
hospitalization of a pregnant woman and for timely and proper treatment.
1.3
Placental microglobulin is used as a marker of fetal membrane rupture,
due to its high level in the amniotic fluid, low level in blood, and
extremely low level in cervico-vaginal secretions when the membranes
are intact.
1.2
AmniSure® detects trace amounts of PAMG-1, one of the amniotic fluid
proteins that appear in vaginal secretion after the membranes rupture.
With intact fetal membranes, the test does not normally detect PAMG-1,
due to its low background concentration..
2.0
Definitions
2.1
PAMG-1 placental alpha microglobulin-1 protein. PAMG-1 is a protein
expressed by the cells of the decidual part of placenta.
2.2
ROM Rupture of fetal membranes
3.0
Safety Precautions
165
3.1
Follow standard precautions when performing any testing
3.2
Always wear gloves, proper PPE, and follow safety and biohazard policies
when performing testing with body fluids
3.3
Dispose of wastes and strips in Biohazardous containers
4.0
Equipment
4.1
Collection supplies including PPE and gloves
4.2
AmniSure Test packages
4.3
Timer
4.4
Biohazard container
5.0
Required Reagents and Instructions for Preparation
5.1
Sterile Dacron vaginal swab (included in kit)
5.2
Solvent vials that contain 0.9% NaCl, 0.01% Triton x100, and 0.05% NaN
5.3
AmniSure Test strips
5.3.1 AmniSure® is a one-step immunochromatographic assay.
5.3.2 Three monoclonal antibodies are used to detect PAMG-1.
5.4
A sealed AmniSure® must be stored in a dry place at room temperature or
refrigerated 40°F to 68°F (+4°C to +20°C),
5.4.1 Do not freeze.
5.4.2 Do not us beyond expiration date stamped on the product.
5.5
AmniSure® must be used within 6 hours after opening.
5.6
Do not reuse the test kit components
5.7
Do not damage strips or pouches, do not bend or fold strips
5.8
AmniSure Positive Control (1 Positive Control vial and 1 AmniSure
solvent vial)
5.8.1 Store in dry place @ 2-25C (35-77F)
5.8.2 Positive control contains 10 ng of PAMG-1 protein that has been
purified, lyophilized with buffered saline. (freeze dried)
5.8.3 Solvent is solution of distilled water, 0.9% NaCl, 0.01% Triton
X100, and 0.05% NaN.
5.8.4 When stored as recommended the test is stable until the expiration
date indicated on the storage vial
6.0
6.1
Directions must be followed carefully to get an accurate reading
6.2
Each test is a single use disposable unit and cannot be reused
6.3
Amnisure test is qualitative, no quantitative interpretation should be made
based on the test results.
6.4
A false positive result may occur in the case of bleeding in a woman with
a pathological pregnancy.
6.5
It is not recommend conducting the test when there is a discharge of
blood.
6.5.1 In this case, another sample without considerable discharge of
blood should be taken and tested.
6.6
A false negative result may occur when the sample is taken 12 or more
hours after a presumed fetal membrane rupture has occurred.
6.6.1 If 12 hour or longer rupture is suspected, it is recommended to use
other clinically available means of testing for ROM.
6.7
AmniSure® should not be used within 6 hours after the removal of any
166
disinfectant solutions or medicines from the vagina.
6.8
The Amnisure test should be used to evaluate patients with clinical
signs/symptoms suggesting of fetal rupture.
6.8.1 Results should be used in conjuction with other clinical
information
6.9
Placenta previa, and performing digital exams prior to sample collection
can lead to inaccurate results.
6.10 Failure to detect membrane rupture does not assure the absence of
membrane rupture.
6.11 Estimation of Binomial Parameter (PI), the positive and negative
agreements between the AmniSure® test and classic control were
estimated as follows:
6.11.1 Positive Agreement = 97.2% (69/71) with 95% Confidence
Interval (CI) = (90.2%, 99.7%)
6.11.2 Negative Agreement = 97.6% (81/83) with 95% (CI) = (91.6%,
99.7%)
6.12 AmniSure® works within a wide range of PAMG-1 concentrations in
vaginal secretion (from 5 ng/ml to 100 mcg/ml).
6.13 The performance of the AmniSure ROM test has not been established in
the presence of the following contaminants: meconium, antifungal creams
or suppositories, K-Y jelly, Monistat, baby powder (starch or talc),
Replens, and baby oil.
7.0
Specimen Requirements
7.1
The AmniSure® assay does not require speculum examination.
7.2
Use the Dacron vaginal swab provided with the AmniSure kit
7.2.1 Remove the sterile swab from its pack following instructions on
the pack.
7.2.2 The Dacron tip should not touch anything prior to its insertion into
the vagina.
7.3
Hold the swab in the middle of the stick, and while the patient is lying flat
on her back, carefully insert the Dacron tip of the swab into the vagina
until the fingers contact the skin no more than 2-3 inches (5-7 cm) deep
7.4
Withdraw the swab from the vagina after 1 minute.
7.5
Whenever possible, the AmniSure® test should be performed immediately
after sample collection.
7.5.1 If necessary samples can be stored in a refrigerator (at +4°C) for
six hours.
7.6
All specimen should be labeled appropriately
8.0
8.1
Vaginal fluid
8.2
Use only the sterile Dacron swab provided with AmniSure
9.0
Quality Control Procedures
9.1
Do not use a swab for External LQC testing
9.2
Uncap the AmniSure solvent vial and add entire contents (1 ml) to the
Positive Control vial (lyophilized)
9.3
Recap control vial and mix solution for 30 seconds and ensure full
reconstitution
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9.3.1 You may shake vigorously or vortex
9.3.2 The reconstituted control solution may be refrigerated for up to 24
hours @ 4-8C (39-46F), do not freeze
9.3.3 The reconstituted control solution can be aliquoted into 0.2 ml
vials for up to 5 positive controls to be run from each Positive
control
9.4
Carefully tear open foil pouch containing the AmniSure test strip and
insert the white end of the test strip (marked with arrows) into the
reconstituted positive control vial, start timer
9.5
Remove the strip at exactly 10 minutes by placing strip on clean flat
surface
9.5.1 Do not read results after 15 minutes
9.6
Intensity of lines may vary, interpret as follows:
9.6.1 Two lines = Positive result
9.6.2 One line = Negative result
9.6.3 No line = Invalid test, repeat
9.7
Expected results are Positive
9.7.1 AmniSure ROM test strip will indicate a positive result at
concentrations of 1.0 ng/mL or higher
9.7.2 The concentration of the reconstituted control is 10 ng/mL
9.8
External Controls will be run by testing personnel
9.8.1 on each new shipment
9.8.2 when there is suspicion that product performance has been
compromised
9.8.3 or if the test kit has not been stored according to instructions
9.8.4 at least every 30 days
9.9
If controls fail to yield expected results, do not perform patient testing
until resolved
9.9.1 contact the POC laboratory tech
9.10 External Control testing will be documented on the reagent validation
form provided by the laboratory
9.10.1 completed forms are to be sent to the laboratory
9.10.2 NM or designee will keep copy of the QC forms on the unit
9.11 Internal Procedural Controls are built into to the testing strip to assure
accurate reading and test performance
10.1 Perform AmniSure testing by provider order placed in Cerner
10.2 From the AmniSure Log sheet, obtain one form
10.2.1 Complete information on the form/label to include:
10.2.1.1
Patient identification lab label
10.2.1.2
test date and time
10.2.1.3
employee login identification
10.2.1.4
test strip lot#
10.2.1.5
test strip expiration date
10.2 Positively identify patient to be tested
10.3 Have the AmniSure Log sheet form at the testing site
10.4 Shake the solvent vial well to assure that the liquid in the vial is mixed and
settled at the bottom of the vial
10.4.1 place vial in vertical position
168
10.4.2 open vial
10.5 Sample collection is to be done with the sterile Dacron swab provided
10.5.1 do not allow the swab to touch anything prior to insertion in the
vagina
10.5.2 hold the swab in the middle of the stick, and while the patient is
lying flat on her back
10.5.3 carefully insert the Dacron tip of the swab into the vagina until the
fingers contact the skin, no more than 2-3 inches (5-7 cm)
10.5.4 withdraw the swab after 1 minute
10.6 Place the Dacron tip swab into the open vial of solvent and rinse by
rotating for 1 minute
10.7 Remove and dispose of swab in biohazard container
10.8 Open the AmniSure test strip foil pouch by tearing at the notches
10.9 Insert the white end of the test strip (strip is marked with arrows) into the
solvent vial for no less than 5 minutes and no longer than 10 minutes
10.10 Set and start timer for 10 minutes
10.11 Strong leakage of amniotic fluid will make the test results visible early (5
minutes), while small leaks will take the full 10 minutes of reaction time
10.12 If 2 stripes are clearly visible on the strip after 5 minutes, the test strip may
be removed prior to full 10 minutes, otherwise remove the test strip after
10 minutes
10.13 Read the results by placing the test strip on a clean dry, flat surface
immediately after removing from the solvent vial
10.13.1
Do not read result after 15 minutes from placing the test
strip into the solvent vial
10.14 Result Interpretation
10.14.1
One line = NO MEMBRANE RUPTURE (Negative)
Result is indicative of absence of amniotic fluid
10.14.2
Two lines = MEMBRANE RUPTURE (Positive)
Result is indicative of the presence of amniotic fluid
10.14.3
No lines = INVALID TEST, repeat testing
Do not interpret results
10.14.4
The degree of darkness of the lines may vary, even lines
that are faint or uneven are considered lines
10.14.4.1
Do not interpret the test based on darkness of lines
10.15 Mark the result obtained on the AmniSure Log sheet form
10.16 Send /Tube the completed AmniSure Log sheet form to the POC
laboratory
10.16.1
Make sure that all required information is clearly marked
on the form prior to sending including the internal
procedural control
10.16.2
Make sure that the results obtained are clearly indicated
10.17 Laboratory will report results in PathNet
10.18 Nurse is to document the results (either as Positive or Negative AmniSure
test) and any interventions as appropriate on the Labor and Delivery
Flowsheet in EMR.
There are three possible results: (a) Positive Result (b) Negative Result (c) Invalid Result
One line, NO MEMBRANES RUPTURE: NEGATIVE
169
Two lines, THERE IS A RUPTURE:
POSITIVE
No lines, TEST IS INVALID, take another test:
The darkness of the lines may vary. The test is valid even if the lines are faint or
uneven. Do not try to interpret the test result based on the darkness of the lines.
11.1 Clinical trials of patients presenting with signs/symptoms of membrane
between 15-42 weeks gestation demonstrated a
11.1.1 sensitivity of 98.9%,
11.1.2 specificity of 98.1%,
11.1.3 positive predictive value of 100%,
11.1.4 and negative predictive value of 99.1%
rupture
12.0 Laboratory Interpretation
12.1 AmniSure has FDA approval for use of the test by health care
professionals
to aid in the detection of ROM in pregnant women at >34 weeks gestation when
patients report signs, symptoms, or complaints
suggesting of ROM
12.2 Failure to detect membrane rupture does not assure the absence of membrane
rupture.
12.3 Negative results should be followed up with further confirmation tests
(Ultrasound and/or speculum exam) in cases where clinical suspicion of
membrane rupture is present.
13.0
LIS Entry of Results
13.1 Orderable = Amnisure
13.2 Identify accession number in PathNet
13.2.1 For patients that have discharged and no longer have valid order,
check PowerOrders to confirm initial order was placed
13.2.2 Place order in DOE in PathNet if initial order was placed and
system auto canceled on discharge of patient
13.2.3 If there is no order, then the lab will check the notations in the
Flow Chart and / or call the unit for orders
13.3 Laboratory should receive AmniSure orders in Specimen Login
13.3.1 Use operator identification when given
13.3.2 Use generic identification GNURCOL when unable to identify
who performed the testing
13.3.3 Use date and time given on form
13.4 Use function ARE to enter results by accession number
13.4.1 Select Positive or Negative results from drop down box options
13.4.2 Do not report results if test was invalid
13.5 Use VERIFY button to accept results after confirming that the correct
result
170
was selected
Microtainer is a registered trademark of Becton, Dickinson and Company
171

Lab manual - Palmetto Health

Transcription

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