2014 PT PROGRAM ENROLLEE REFERENCE MANUAL

CALIFORNIA THORACIC SOCIETY (CTS)
2014
PT PROGRAM ENROLLEE
REFERENCE MANUAL
Thank you for selecting the California Thoracic Society (CTS) ABG Proficiency Testing (PT) Program to help
you monitor your laboratory's performance.
CTS urges you to retain this document in a binder, and include your laboratory's PT Cycle Notes that will be
transmitted to you after each Cycle (see this year’s CTS PT Action Calendar).
— The CTS PT Program Committee
QUESTIONS?
PT Enrollment or administration questions may be directed to:
CALIFORNIA THORACIC SOCIETY
575 Market Street, Suite 2125
San Francisco, CA 94105
Phone: 415-536-0287 / Fax: 415-764-4933 / E-mail: [email protected]
Office Hours: Mon–Fri: 9:00 am – 5:00 pm Pacific Time
THE CTS MISSION is to improve respiratory health in California by promoting and advancing the science
and practice of pulmonary, sleep, and critical care medicine.
— Executive Committee, 12/08
MARK YOUR CALENDARS
[Please post in your lab]
2014 PT CALENDAR
CTS PROFICIENCY TESTING PROGRAM
Blood Gas/Electrolyte, Blood Gas Hgb/Hct, and CO-Ox Programs
FLOW
Test Event One
(Cycle 2014-1)
Test Event Two
(Cycle 2014-2)
Test Event Three
(Cycle 2014-3)
SAMPLES SHIPPED
to Laboratories (~2 day)
Mon. 3/3/2014
Mon. 7/7/2014
Mon.11/3/2014
NO SAMPLES?
Call 1-888-450-4633 by noon if
your samples have NOT arrived
or are unacceptable for testing
at Laboratories (ETA +3)
By Tues. 3/11/2014
By Tues. 7/15/2014
By Tues 11/11/2014
DATA INPUT FORMS Due:
Your data input forms MUST be
faxed/mailed to the CTS Data
Center in Wisconsin by this
date.
Fax: 608-265-1111
Address: 465 Henry Mall, #402
Madison, WI 53706-1578
Fri. 3/21/2014
Fri. 7/25/2014
Fri. 11/21/2014
Cycle Reports
Received by Labs
Mon. 5/5/2014
Mon. 9/8/2014
Mon. 1/5/2015
HHS/ State/ COLA/ CAP
Reporting Deadline
Tues. 5/20/2014
Tues. 9/23/2014
Tues. 1/20/2015
QUESTIONS?
California Thoracic Society (CTS)
575 Market Street, Suite 2125/ San Francisco, CA 94105
ph: 415-536-0287 / fax: 415-764-4933 / e-mail: [email protected] / www.calthoracic.org
CTS PT PROGRAM ENROLLEE REFERENCE MANUAL
CONTENTS
Program Purpose and Federal Regulations.................................................................................................................. Page 2
Cycle Timetable / PT Action Calendar .......................................................................................................................... Page 3
Cycle Shipments............................................................................................................................................................. Page 3
Replacement Samples ................................................................................................................................................... Page 3
Federal, State Regulatory Agency & Accredited Organization PT Reporting Requirements .................................... Page 3
Data Input Form.............................................................................................................................................................. Page 4
Data Analysis .................................................................................................................................................................. Page 5
Scoring ............................................................................................................................................................................ Page 6
Enrollment Changes ....................................................................................................................................................... Page 8
PT Cancellation............................................................................................................................................................... Page 8
Reports............................................................................................................................................................................ Page 9
Validated Ampules.......................................................................................................................................................... Page 9
PT Reinstatement Program.......................................................................................................................................... Page 10
Troubleshooting and CTS PT Program Reference Technicians ............................................................................... Page 10
Reenrollment ................................................................................................................................................................ Page 11
Sample Forms:
Blood Gases/Electrolytes+ and Hemoglobin/Hematocrit PT Sample Handling and Reporting Instructions ............ Page 15
Shipment Cover Page – Key ....................................................................................................................................... Page 18
Evaluation Report: Interpretation Guidelines .............................................................................................................. Page 19
Sample Evaluation Report ........................................................................................................................................... Page 20
Sample Cumulative Summary Report: Interpretation Guide ..................................................................................... Page 24
Sample Cycle Notes (specific for each Cycle, accompanies Reports) ..................................................................... Page 25
CTS PT Troubleshooting and Documentation Guide ................................................................................................. Page 27
CTS PT Validated Ampule Request Form .................................................................................................................. Page 28
California Thoracic Society © 2014
PROGRAM PURPOSE AND FEDERAL REGULATIONS
The California Thoracic Society (CTS) has demonstrated considerable leadership in blood gas analysis and a unique
concern for the quality care of pulmonary patients. CTS initiated the Proficiency Testing (PT) Program in 1979 to
serve blood gas laboratories. The Program involves establishing standards of excellence and accumulating data of
important scientific interest regarding blood gas (BG) measurement techniques and equipment specifications.
Prior to 1992, the CTS offered the PT Program as a voluntary program. In 1993, HCFA—which became the Center
for Medicare and Medicaid Services (CMS)—issued regulations that mandated proficiency testing for all clinical
laboratories. Operating under the Clinical Laboratories Improvement Amendments (CLIA) of 1988, these regulations
stipulate that successful participation in a CLIA approved proficiency testing program is a prerequisite for certification,
Current CLIA regulations are online at: www.cdc.gov/clia/regs/toc.aspx.
California and several other states also require PT to obtain a state lab license. For participants, the PT programs are
identical. CTS sends ALL scores and Cycle reports to CMS and the California Department of Health Care Services,
Lab Field Services Branch (DHCS LFS) for federal regulatory purposes. For laboratories outside California, CTS
sends reports to CMS, state regulatory agencies, Commission on Office Laboratory Accreditation (COLA), College of
American Pathologists (CAP) or AOA (only if requested by lab on the PT Enrollment form). Laboratories DO NOT
have the option of denying sending scores to CMS as part of fulfilling its regulatory requirements. Duplicate
transmissions to accreditation organization (COLA, CAP) must be made if requested by the Accrediting
Organization or laboratory.
The CTS PT program is a CMS-approved program for pH, pCO2, pO2, Na+, K+, Cl-, glucose, and tHb. The CLIA-CMS
regulations mandate specific methods for assessing laboratory PT performance, and the CTS PT Program scoring
system accommodates these regulations. CTS is a CAP accepted PT-Provider for the following analytes: pH, pCO2,
pO2, Na+, K+, Cl-, iCa++, lactic acid, whole blood glucose, carboxyhemoglobin, methemoglobin, oxyhemoglobin, and
tHb from CO
CTS PROFICIENCY TESTING PRODUCTS
Blood Gas / Electrolytes+ Analytes and PT Products:
The CTS Blood Gas/Electrolyte+ PT Program assesses measurement accuracy of pH, pCO2, pO2, Na+, K+, Cl-, and
glucose as required by CMS. The CTS program also assesses iCa++ and lactic acid (not required by CMS); the iCa++
and lactic acid scores are released to designated state agencies.
Consistent participation in this program is useful for monitoring the adequacy and effectiveness of your laboratory,
preventive maintenance protocols, and overall instrument performance as compared with your peers. The CTS Blood
Gas/Electrolyte+ PT Program uses a clear, aqueous, buffered solution testing material, without colored dyes (five 3
mL samples per shipment) to accommodate proficiency testing for instruments that perform Electrolyte+ analysis in
conjunction with blood gas analysis.
Blood Gas - Hemoglobin/Hematocrit Analytes and PT Products:
The CTS Blood Gas - Hemoglobin/Hematocrit PT Program assesses measurement accuracy of hemoglobin (Hb) and
hematocrit (Ht) as required by CMS. These scores are released to designated agencies. The CTS
Hemoglobin/Hematocrit PT Program uses clear, aqueous, buffered solution testing material, without colored dyes
(five 2.5 mL samples per shipment) to accommodate proficiency testing for instruments that perform hemoglobin/
hematocrit analysis, using the conductivity method, in conjunction with blood gas analysis.
CO-Oximetry Analytes and PT Products:
The CTS CO-Oximetry PT Program assesses measurement accuracy of total hemoglobin (tHb) as required by CMS.
In addition to tHb, participation in this program also allows you to assess measurement accuracy of oxyhemoglobin
(O2Hb %), carboxyhemoglobin (COHb %), and methemoglobin (MetHb %), which are not regulated under CLIA.
These scores are released to designated state agencies. The CTS CO-Oximetry PT Program uses a bovine-based
hemoglobin solution (a non-biohazardous, non-human blood-based reagent) for total hemoglobin and hemoglobin
fraction testing (five 2 mL samples per shipment). These solutions are suitable for all instruments with the
exception of Waters Oxicom.
CYCLE TIMETABLE / PT ACTION CALENDAR
The PT Action Calendar identifies specific shipping dates, data input due dates, and the dates when cycle reports
will be sent to you. YOUR ADHERENCE TO THIS PT SCHEDULE IS ESSENTIAL: CMS REQUIRES THAT
RESULTS RECEIVED AFTER A CYCLE DATA INPUT DUE DATE OR IS NON-PARTICIPANT MUST BE
SCORED "UNSATISFACTORY” AND WITH A SCORE OF “0”. FEDERAL AND STATE SANCTIONS MAY
RESULT FROM LATE SUBMISSION.
CYCLE SHIPMENTS
CTS PT Program materials are shipped three times a year (see PT Action Calendar for specific dates) to each
enrolled laboratory via Two Day UPS delivery with signature required. The CO-Oximetry materials are shipped with
an ice pack and these CO-Ox ampules require refrigeration upon receipt. The CO-Ox samples should not be
used if they are left unrefrigerated for more than 24 hours.
REPLACEMENT SAMPLES
PT samples will be replaced at no cost to enrollees if regular samples do not arrive or are damaged during shipment.
To obtain replacement samples, you must call the toll free number on the PT Action Calendar within 3 days from
expected date of receipt of original shipment §493.901 (b)(6).
If a lab misplaces or mishandles the samples, replacement samples can be ordered for a nominal fee. To order, call
the CTS Program Manager at 415-536-0287. Any request for replacement samples must occur and be prepaid
within 3 days from expected date of receipt of original shipment.
FEDERAL, STATE REGULATORY AGENCY AND ACCREDITED ORGANIZATION PT REPORTING
REQUIREMENTS
Your laboratory’s designated instrument PT score(s) are automatically released to CMS in compliance with CLIA PT
regulations, as required by HHS for Medicare and Medicaid payments. If you do not want your CTS scores sent to
CMS (that is, your CTS enrollment is for internal QC purposes only and you are enrolled in another CLIA approved
program that reports your lab PT results to CMS), you must advise the CTS office on your PT enrollment Regulatory
Agency Reporting form—or with a written addendum by the contact person prior to a Cycle’s data input due date.
For labs requesting CAP reporting: CTS will electronically transmit all scores for all PT enrolled instruments to CAP.
For labs licensed in California, Pennsylvania or Washington State: CTS automatically transmits all PT scores
electronically to the state agency, in the unique California record format as required (if you have provided CTS with
your State ID number). If you do not want your CTS scores sent to these agencies (that is, your CTS enrollment is
strictly for internal QC purposes and you are enrolled in another approved program that reports your lab PT results to
LFS, California, Pennsylvania or Washington State Agencies),you must advise the CTS office by checking the
appropriate box on the PT enrollment Regulatory Agency Reporting form and also submit a written statement for
CTS documentation purposes.
All other state regulatory agencies have access to the designated instrument results CTS submits to CMS in the
CMS required format, unless you inform CTS of other state expectations. If your state regulatory agency or
accredited organization has specific program requirements that need to be addressed by your PT provider, assure
you notify CTS in writing. CTS sends PT Cycle reports to CMS, the state regulatory agency and/or accredited
organization specified by the enrolled lab on Regulatory Agency Reporting, Part D of the CTS PT enrollment form (or
as provided on a written addendum, from the contact person prior to a Cycle’s data input due date).
The CTS Proficiency Testing Program is designed to satisfy the requirements of your regulatory agency. Proficiency
testing combined with your daily QC procedures also is an important tool for you to maintain the quality of your
clinical testing. Therefore, it is important for you to take the appropriate troubleshooting and corrective steps if
your PT results fall out of limits, even if the results were obtained on a non-designated instrument, were for a
non-regulated analyte, or received an 80% score.
In addition, failure to respond to any out of limit result could lead to problems when your laboratory is inspected.
According to a memo we received from the Joint Commission on 5/18/05, “We will review all proficiency testing
performed, regardless of its classification as a regulated analyte. A laboratory would receive a finding for failing to
follow-up on out of range results (whether they achieve a passing score or not), specifically, performing an
investigation and implementing corrective action.”
DATA INPUT FORM
A Data Input Form is provided for each Blood Gas/Electrolyte +, Hemoglobin/Hematocrit and/or CO-Oximetry
instrument you enrolled. To ensure proper grading of your test results, each Data Input Form submitted to the CTS
PT Data Center must include:
 Your CTS ID Number (ie, C-123 or A-321) that we assigned to your laboratory. (Current CTS enrollees find this
number on past reports, upper left corner.)
 Identifier that you assign, specific to each instrument. Use up to four alpha and/or numeric characters according
to location, serial number, analyst, etc (ie, ER1, ER2; NICU, ICU). You must define a distinct Identifier for each
enrolled instrument, and consistently match that instrument’s data with its Identifier on Data Input Forms.
 Method Code that is specific to your instrument model reported on that Data Input Form. Method Codes are
four-digit numbers that represent your instrument system. Please verify your Blood Gas/Electrolytes+ and COOximetry Instrument Method Codes carefully on page 14 respectively; instruments are listed alphabetically by
manufacturer, and new codes are added continually.
If your instrument is not listed, enter 9999 for your instrument: if you use this “other” code, you must identify the
instrument in the Instrument Name box or Comments section of the Data Input Form, to group your instruments
appropriately before scoring and help us update the Method Code list.
If you have changed an instrument model since the last testing Cycle, assure that you correctly identify
the Method Code for your current instrument on the Data Input Form. If you provide CTS with the wrong
method code (i.e, wrong instrument model) your result will be graded against the wrong peer group. This
could increase the likelihood that your result will fall outside of the target range.
Note: CMS requires that labs keep copies of all documents for at least two years.
DISCONTINUE ENROLLMENT
If you discontinue an enrolled analyte, be sure to notify the CTS office in writing ASAP. If you do not advise us
of the change by the Cycle data input due date, a non-respondent zero score report will be generated and the
unsatisfactory status will be sent to CMS, your state regulatory agency, and any accredited organization, as required
by CLIA.
REPORTING ERRORS BEFORE CYCLE DATA INPUT DEADLINE
If you notice an error on your copy of the Data Input Form after you have transmitted it and you notify CTS of your
corrected input in writing before the data input due date, this will not be regarded as a failure. After the data input
due date, the reporting error is considered a failure and cannot be revised, as required by CLIA.
DATA ANALYSIS
CTS suggests that laboratories analyze all the samples in the same manner to minimize differences. PT Sample
Handling & Reporting Instructions [see page 11] accompany each set of samples.
Under CLIA Code of Federal Regulations (CFR) part H § 493.801 (b), you must handle proficiency testing
specimens in the same manner as you test patient specimens.
 Testing PT samples in the same manner as you test patient specimens, testing the same number of times as
patient specimens. and at the same time as patient specimens;
 Samples must be tested by personnel who routinely perform the testing in the lab;
 Testing must be done using the laboratory’s routine methods, using the same test system that is routinely used
for the patient specimens;
 You cannot analyze the proficiency testing material multiple times, unless it is the laboratory's routine practice to
analyze all samples multiple times;
 Never send proficiency testing materials out of your laboratory for any reason, never send to another laboratory
for analysis, or to discuss your testing results with another laboratory until after the deadline for your Data Input.
If you are contacted by another lab for this purpose, you are instructed to notify CMS immediately;
 If a loaner or “mothballed” operational instrument temporarily replaces your standard instrument for patient
reporting, you must run the samples on it and submit Cycle data by the deadline.
Mode Selection:
Laboratories using instruments with both blood and aqueous (QC) sampling modes need guidance from the
instrument’s manufacturer as to which mode to use when performing aqueous PT analysis.
After PT sample analysis:
 Record your instrument results on the Data Input Form enclosed with your samples. Legibly complete all
the information requested on the Form.
 Verify your CTS ID Number, Identifier, and Method Code, recording them correctly on the Data Input Form.
 Mark the designated instrument box (see below for more information about selecting a designated
instrument) on the Form [see pages 15-18]. CMS scoring will be based only on the instrument you specify
as the Cycle’s designated instrument. We strongly recommend that you select the designated
instrument for your lab. If you do not specify your lab’s designated instrument on your Data Input
Form, a random selection will be made for you.
 Sign and date your Data Input Form where indicated and have your Laboratory Director (or it’s designee)
sign, as required by CLIA CFR § 493.801(b)5. Under CMS rules, the Laboratory Director (or it’s designee)
and the analyst (i.e. testing person) must sign an attestation statement as part of each testing Cycle. In
addition, per the California Thoracic Society’s proficiency testing protocol, laboratories doing moderately
complex tests may have the Technical Specialist or the Medical Director sign as the designee of the
Laboratory Director. This statement indicates that you used your laboratory's routine methods and protocols
to analyze the proficiency testing material.
 Fax or mail your PT analyses data to the CTS PT Data Center at the fax number or address provided on
the Form by the PT Action Calendar deadline. It is not necessary to include a cover sheet when you fax your
Data Input Forms. We strongly recommend that you program your fax machine to print a journal
report verifying data transmission details. Keep the fax journal report for documentation. Assure that you
feed the Forms into your fax machine with the appropriate side down for correct transmission of the data, to
avoid a non-respondent’s unsatisfactory report.
 Keep a file copy of your instrument printout (raw data) and the completed, signed Cycle Data Input Forms
for a minimum of two years, as required by CLIA CFR § 493.801(b)5.
Designated Instrument:
Laboratories that enroll multiple instruments need to designate one of these instruments for each module, each
testing Cycle, for regulatory purposes. Laboratories are required to rotate the primary testing instruments from
testing Cycle to testing Cycle (§ 493.801(b)(1)). If your instrument analyzes both Blood Gas and Electrolyte+
analytes, you must indicate the designated instrument(s) for both Blood Gas analytes and Electrolyte+ analytes. It is
acceptable to designate one instrument for Blood Gas analytes and a different instrument for Electrolyte+ analytes, so
long as one instrument is designated for each regulated analyte. The designated instrument and only the designated
instrument is used to determine whether the laboratory's performance is acceptable under the CMS guidelines.
Although only the designated instrument is used to define compliance with CMS regulations, it is to your advantage
to enroll all clinically used instruments in a proficiency testing program, and to involve all your techs as part of your
overall quality assurance operation.
Institutions are required to provide a representative sample of your twice annually ‘checks’ along with your annual
review submittal (CLIA CFR § 493.1236(c)(1). Internal performance-based checks include regular use of certified
reference materials and/or internal quality control using secondary reference materials; replicate tests or calibrations
using the same or difference methods; re-testing of retained items.
SCORING
Blood Gas / Electrolyte+ and Hemoglobin/Hematocrit Analytes:
You will receive a Cycle PT Evaluation Report for all instruments you enrolled. Peer group mean values and
standard deviations (SD) are calculated for each comparative peer group for pH, pCO2, pO2, Na+, K+, Cl -, iCa++,
glucose, and lactic acid for each coded sample. Each of your results receives a standard deviation index (SDI) score
that is calculated from the difference between your result and the target value [see page 8] assigned for your peer
group divided by the peer group SD. A high SDI score (greater than 3.0 in either a positive or negative
direction) indicates poor performance. If the SDI is greater than 2.0 in either direction, it suggests problematic
performance even if you have received an “acceptable” rating. The Evaluation Report for your designated instrument
includes the relevant entries in the Regulatory Status column on the right [see sample, pages 19-21].
Your Cumulative Summary Report provides further data regarding your designated instrument in each
module [see sample pages 22-23].
The CTS ABG, Electrolyte+ and CO-Ox PT Program Committee carefully reviews and monitors the PT Program
results. The data are scored both by our own CTS established inter-laboratory comparison program and by the
system mandated by CLIA. [Sample Reports similar to those you will receive are on pages 19-25].
Target Value:
As defined in the CLIA regulations (§ 493.2) target value for quantitative tests means either the mean of all
participant responses after removal of outliers (those responses greater than 3 standard deviations from the original
mean) or the mean established by definitive or reference methods acceptable for use in the National Reference
System for the Clinical Laboratory (NRSCL) by the National Committee for the Clinical Laboratory Standards
(NCCLS). In instances where definitive or reference methods are not available or a specific method's results
demonstrate bias that is not observed with actual patient specimens, as determined by a defensible scientific
protocol, a comparative method or a method group ("peer" group) may be used. If the method group is less than 10
participants, "target value" means the overall mean after outlier removal (as defined above) unless acceptable
scientific reasons are available to indicate that such an evaluation is not appropriate. § 493.2 CLIA
Acceptable Performance:
In accordance with CMS rules, the following define ACCEPTABLE performance for the analysis of a single analyte in
one of the samples:
pH:
Target value + 0.04
pO2:
Target value + 3 SD
pCO2: Target value + 5 mmHg or + 8% (whichever is greater)
Na +:
Target value + 4 mmol/L
K +:
Target value + 0.5 mmol/L
Cl :
Target value + 5 mmol/L
Glucose: Target value +6 mg/dl or +10% (whichever is greater)
Ht:
Target value + 6%
Hb:
Target value + 7%
Note: Currently iCa++ and lactic acid are not regulated by CMS. These target values are: iCa++: + 0.13 mmol/L and
lactic acid: + 2SD or 0.2 mmol/L (whichever is greater).
Scores for Each Analyte:
If at least 80% of the scores (ie, at least four of the five assays each PT Cycle) for a given analyte are
ACCEPTABLE, the performance for that analyte is scored as SATISFACTORY (if less than 80%, that analyte is
scored as UNSATISFACTORY).
Overall Score:
If at least 80% of all assays for a given specialty (eg, chemistry or hematology) within a given PT Cycle are scored as
ACCEPTABLE, the overall testing score is SATISFACTORY (if less than 80%, that analyte is scored as
UNSATISFACTORY).
According to CMS rules, if a laboratory fails to participate or to submit results by the specified due date, a
score of UNSATISFACTORY is given for the analyte's performance, with a zero (0) for the overall testing
event score.
Excused Non-submission:
If patient testing was temporarily suspended during the time when proficiency testing samples were scheduled to be
shipped (e.g. extended equipment malfunction or reagent back order of more than 2 weeks), in writing, you must
notify the CTS San Francisco office that patient testing was temporarily suspended and you are requesting for an
“excused non-submission” status for this Cycle and submit it along with the data input results. The excuse will be
valid only if your documentation is accepted by your accrediting agency’s surveyor.
UNSUCCESSFUL Performance
A laboratory's performance is considered UNSUCCESSFUL if the principle/primary instrument used for Federal
regulatory purposes fail to achieve SATISFACTORY performance for the same analyte or in the overall score for two
consecutive testing Cycles, or in two of three consecutive testing Cycles.
Under CMS rules, UNSUCCESSFUL performance may result in sanctions that could include termination, revocation,
suspension, or limitation of the laboratory's Medicare-Medicaid approval and/or licensure under CLIA ’88. It may also
result in intermediate sanctions that include remedial action, re-testing, and monetary fines.
CO-Oximetry Analytes:
All of the previous information on scoring is applicable to CO-Oximetry with one exception. In accordance with CMS
rules, the following will define acceptable performance for the analysis of a single analyte in one of the samples:
Hemoglobin:
Note:
Target value +7%
Currently, only hemoglobin in the CO-Oximetry profile is regulated by CMS.
All the other parameters tested (ie, O2Hb, COHb, and MetHb) are to enhance your laboratory's overall
program. The target value for O 2Hb, COHb, and MetHb is +3 SD.
ENROLLMENT CHANGES
If there are any changes in shipping/mailing address or contact person during the year, alert the CTS San
Francisco office IMMEDIATELY in writing, on official letterhead. This will assure you continue receiving PT items in a
timely manner, and maintain the confidentiality of your lab’s data.
Additional Instruments for a Currently Enrolled Lab: Laboratories may add an instrument to the CTS PT Program
at any time, with the cost prorated accordingly. Call the CTS office to arrange adding an instrument: it will be enrolled
for the next available PT Cycle shipment.
If you want to add an instrument when the shipping address, CLIA and State ID numbers are not exactly the same,
call the CTS office to enroll a separate lab, as described below.
Any separate mailing, different contact person, or different CLIA # are charged at the first instrument rate. Funds
cannot be transferable from one lab to another.
New Lab Enrollments: A new lab can enroll at any time by calling the CTS office for the current Cycle enrollment
forms and rates.
Instrument Model Change: If you change your instrument model during the year, you need to carefully identify the
correct Method Code for your current instrument on the Data Input Form. This ensures that your results are
processed and scored with the appropriate comparative peer group, and it keeps your lab’s CLIA reports accurate
over the next two cumulative Cycles. No additional cost is incurred for a change in instrumentation.
PT CANCELLATION
CLIA regulations require your lab to be enrolled with the same PT provider for three consecutive Cycles (12 months)
(ie, you cannot ‘switch’ PT providers within a cumulative reporting stream, defined as a minimum of three testing
events) CLIA CFR § 493.801(a)(3). Cancellation or withdrawal from the program is valid only if a lab has closed, has
merged with another lab with continuing PT service, has shut down all its testing for Blood Gas/ Electrolytes+/COOximetry, or started a new laboratory or new test starts midyear, then the laboratory may enroll in another PT
Program the next calendar year For the rest of the calendar year, please notify the CTS Program Manager in writing,
on official letterhead, of any cancellation or withdrawal and its effective date. A $100 cancellation/processing fee is
incurred. CTS issues a refund when applicable based on prorated costs of Cycle shipments consumed during the
year.
REPORTS
Each CTS enrolled laboratory receives reports of its Blood Gas, Electrolyte+ and CO-Oximetry proficiency tests from
each testing Cycle [samples, pages 19-25]. For duplicate reports, there is a prepaid $30 charge per Cycle.
All CTS enrollees will receive paper cycle reports this year. Those who chose e-reports also will receive electronic
reports at their current email address.
Blood Gas, Electrolyte+ and Hemoglobin/Hematocrit Analytes:
CTS Cumulative Regulatory Reports notify participants when an UNSATISFACTORY rating occurs. Review each
Cycle report and, if you receive an UNSATISFACTORY score, take action as soon as possible to correct the
situation, and to document your corrective action.
Each laboratory needs to keep ALL proficiency testing reports on file for at least two years, in accordance
with CLIA regulations. Any UNSATISFACTORY (individual or overall testing event score) rating needs to
have prompt attention for possible analysis problems (e.g. equipment maintenance, accuracy of calibration
liquids or gases, use of uncommon or inappropriate techniques). The CTS PT Troubleshooting and
Documentation Guide [see page 26] is a useful tool for this process.
CMS requires that, if an UNSATISFACTORY rating is received on the primary instrument for a given testing Cycle,
the laboratory must undertake appropriate training and employ the technical assistance necessary to correct
problems associated with this proficiency testing problem. All remedial action taken must be documented and
maintained by the laboratory for two years from the date of the proficiency testing Cycle, per CLIA CFR.
 It is important that you INVESTIGATE, DOCUMENT, and REMEDIATE any unacceptable, unsatisfactory, and
unsuccesful score(s) for an analyte over the last 2 or 3 cycles. Any UNACCEPTABLE result refers to a particular
analyte that has not reached the 80th percent in scoring. These types of score(s) may result in sanctions by your
inspecting agency that could include termination, revocation, suspension, or limitation of your laboratory's
medicare-medicaid approval and/or licensure under CLIA '88. It may also result in intermediate sanctions that
include remedial action, re-testing, and monetary fines. State sanctions may also apply.
Request for Report Correction: You have 30 calendar days from the event report date (listed on the bottom left
corner of your Cumulative Summary Report) to request corrections in writing from the CTS office in San Francisco.
After the 30 days, scores are sent to regulatory agencies and will not be changed. If your lab receives a “No Results
Received” statement on the report, and you feel it is in error, you must provide proof of timely response/data
submission (eg, printed fax confirmation, fax log, telephone bill) in order to request a correction. For this reason, it is
always prudent to save your fax confirmation printouts with your original result forms.
VALIDATED AMPULES
As a service to our subscribers, CTS offers validated ampules that are identical to the samples shipped in each
testing Cycle. The use of these ampules may be employed as part of the remedial measures suggested under CMS
rules pursuant to CLIA’88 when “UNACCEPTABLE,” “UNSATISFACTORY,” or “UNSUCCESSFUL” ratings are
encountered. Model-specific target values for each ampule are included in each Cycle report. The validated ampules
are numbered, so you will know the model-specific target values. We suggest validated ampules be utilized after a
thorough check of your instrument; the results will indicate if a problem persists. As these data are part of your
troubleshooting and remedial measures, you do not need to send validated ampule data back to the CTS Data
Processing Center. To order validated ampules, use the enclosed order form or retrieve it from the CTS web site
(www.calthoracic.org). Note that the order and accompanying payment must be made within 30 days of receipt
of an “UNACCEPTABLE,” “UNSATISFACTORY,” or “UNSUCCESSFUL” rating for each testing Cycle.
PT REINSTATEMENT PROGRAM
As an added service to our CTS PT enrollees, we have arranged a PT Reinstatement Program as a remedial measure
if your lab receives a second “UNSUCCESSFUL” PT Cycle report in the cumulative summary for the same analyte, or
for overall performance. An order form and instructions will accompany relevant Cycle reports.
Your regulatory agency inspector will advise you concerning the number of reinstatement set(s) needed for remedial
action. The use of the PT Reinstatement Program may be employed as part of remedial measures suggested by
CMS/your state or other regulatory agency to avoid penalties for any two of three cumulative UNSUCCESSFUL PT
Cycles.
This Reinstatement Program includes one set of reinstatement samples, with special instructions and Data Input
Forms. When you receive these samples, immediately analyze the samples and return your results to the PT Data
Center. The results will be scored manually and a Reinstatement Report issued to your lab and your inspecting
agency(s).
TROUBLESHOOTING AND CTS PT PROGRAM REFERENCE TECHNICIANS
CTS has skilled Reference Laboratory Technicians to assist our enrolled laboratories with prompt PT problem
analysis and resolution. Each reference technician has been selected by the CTS ABG, Electrolyte+ and CO-Ox PT
Program Committee on the basis of his or her expertise in blood gas analysis, a thorough working knowledge of
quality control systems, numbers theory, statistical analysis, knowledge of instruments that match with frequently
enrolled models, location, and willingness to assist participating laboratories.
Enrollee access to these Reference Laboratory Technicians is part of the CTS PT Program service. The technicians
provide supplementary data, telephone assistance, and laboratory group review of issues that need attention and
referral to the California Thoracic Society ABG, Electrolyte+ and CO-Ox PT Program Committee.
These Reference Laboratory Technicians are available to answer CTS participant's questions regarding any aspect
of the CTS PT Program.
 Feel free to contact a CTS PT Reference Technician directly with any technical questions you may have:
Michael Muth, RCP RRT MBA
Los Angeles, California
Ph: 213-977-2210
Fx: 213-977-2262
E-mail: [email protected]
Michael H. Terry, RCP RRT
Loma Linda, California
Ph: 909-558-4000 x46209
Fx: 909-558-4165
E-mail: [email protected]
CTS PT PROGRAM REENROLLMENT
CTS will mail the PT enrollment forms in September. Please watch for them. If you have not received yours by
September 26, call the CTS office at 415-536-0287 to request your CTS PT enrollment forms.
If you require a delivery receipt for your enrollment forms, send the forms to CTS via certified mail, receipt
requested. Kindly do not request that CTS call you to confirm receipt—due to the high volume of enrollments and
other patient care endeavors, CTS cannot respond to these confirmation requests.
CAP Accredited Labs
Blood Gas Hgb / Hct are not CAP accepted. Please call a program associate at 415-536-0287 if your menu includes
one more more of these analytes.
2014 CTS PT General Instructions
***READ ALL SHIPMENT PAPERWORK as there are many significant changes.***
Inspect shipment contents immediately upon receipt:
Verify the package contains the Modules and quantities (Primary and Secondary) listed on the cover page
which serves as a packing slip. Verify sample integrity for all received sets/ampules. Review result forms
for accurate instrument information. Note that Q products are web-only so results forms are not provided
for any Secondary/additional result sets.
Package discrepancies or questions? Call the CTS PT Fulfillment Center: 888-450-4633
Need to adjust your enrollment? Contact the CTS Main Office by phone: 415-536-0287.
Sample Handling, Storage, and Testing Instructions:
Store, handle, and test CTS PT samples according to the enclosed Supplemental Instructions for
your enrolled module(s). If any Supplemental Instruction documents are misplaced, copies are
available online at http://www.pt-central.com/wslhpt/cts/login.asp by logging in (Login/Password
are on cover page) and clicking on the corresponding Module number.
Prior to testing, review all shipment paperwork: Cover page, General Instructions, Module
Supplemental Instructions, and Module result forms. [Note: result forms are now double-sided.]
Test samples using routine methods, test procedures, and personnel. Report only those
analytes/procedures you normally perform in-house on patient samples. DO NOT REFER
PROFICIENCY TESTING SAMPLES.
Note that samples within any set might have shifted in transit and it is the participant’s
responsibility to match sample sets to forms, to confirm both integrity of ampules and
completeness of each set, and to re-organize any shifted ampules prior to analysis. Additionally,
we recommend use of the label ID as part of the specimen ID during analysis to minimize
transcription errors.
***NEW*** If your lab ordered multiples of any CTS PT product(s), you will find that any
additional sets were filled as “Q Product” which will arrive in the same shipment as your Primary
sets. These “Q Products” are labeled with alternate testing/resulting dates on the fluorescent “Q
Product” set label. To satisfy current regulatory requirements, Secondary (Q) instruments should
not be analyzed prior to the Primary PT result due date. See “Testing Periods and Due Dates”
section on the next page for additional information.
Replacement Samples: All requests for replacements must be made by the “Call by” date of the
scheduled shipment date [see “Proficiency Testing Action Calendar”]. Supplies may be limited. Requests
received after the “Call by” date may incur additional fees. Failure to make timely requests for
replacement samples will not be accepted or excused.
Broken or missing samples? Call the CTS PT Fulfillment Center for replacements: 888-450-4633.
Mishandled or lost samples? Submit payment with a “Replace Ampules Lab Order Form”
(available online) to the Main Office by fax: 415-764-4933.
**NEW**
Testing periods and Due Dates: To comply with current CMS requirements, there are
now different testing periods AND due dates for Primary and Secondary Modules. The intent is to avoid
any inference of comparison or referral. Only the Primary Module samples should be analyzed and
reported during the live proficiency testing cycle. See next page for details.
Primary Modules: Web submission is preferred. Samples must be tested during the normal
Cycle period, ship date through due date (as listed in the “Primary” section of the shipment cover
page. Primary set results submitted after the Primary due date will receive a 0% score.
Secondary (Q) Modules: Web submission is REQUIRED. The Q Period (for analysis and
submission of these Secondary sets) is defined on a fluorescent Q Product label on each Q set
sample bag. It begins the day following the Primary due date and ends at midnight central of the
following Friday. Additionally, the Secondary due date is listed on the shipment cover page in
the “Secondary” section. Results must be submitted online by midnight central of this date.
Reporting Results: Provide a numeric result or exception code for each sample/analyte. Blank
sample/analytes will receive a 0% score. Call 888-450-4633 with reporting questions.
**NEW** Online Data Entry:
NOTE: Do not use your browser’s back button to navigate.
1. Report your results online at www.pt-central.com/wslhpt/cts/login.asp
Log in using the assigned PT Central user name and password found on the shipment cover page
just under your account information. [During the Secondary (Q) period, start on this same login page
but click on the blue “Secondary for Q Products” link, then log into the Q page using the same login
name and password as used for the Primary site.]
2. Once logged in, verify that your modules, identifiers, and method information are correct before
continuing. Notify the CTS PT Data Processing Center of any discrepancies PRIOR to any data
entry/submission by phone (888-450-4633) or by clicking the CONTACT US link on the left side of
the screen to send us an email. Complete all fields and include any comments. Be specific when
referring to sample number, analyte or module. Click the blue NEXT link to send the message.
3. Once any needed updates (analytes, methods) have been addressed, locate the module for which you
wish to enter results and click ENTER to the right of the module/instrument to enter your results.
Enter the numeric result value in the appropriate box. Use the Tab button to move between fields.
If your result exceeds the reportable range of your instrument, select the greater than (>) or less
than (<) sign from the drop-down box above your result. A numeric value must accompany a
greater than or less than sign.
4. Exception Codes: If you will not be reporting results for any reason, an exception code must be
attached to either the entire module or the individual sample (example: Excuse Requested –
Instrument Out of Order). NOTE: You will not be able to report a result for any sample that has an
exception code.
A. Global Exception Code - located above your analyte list:
This exclusion will be applied to all analytes/samples listed. Click on the blue arrow next to
the red box to choose from a list of exceptions; the selected code will appear in the red box.
Next, click on the blue APPLY link to apply the exception code to the entire module.
Click the blue REMOVE link to remove the exception code from the entire module.
B. Individual Sample Exception - located next to OR below the associated result field:
This exception code can be applied to an individual sample/analyte. Click on the yellow E
associated with that result field, then click on the blue arrow to the right of the red box and
choose from the list of exceptions. The selected exception code will appear in the red box.
WARNING! Clicking the blue REMOVE link will remove all exception codes.
5. Comments/Questions:
A. For individual sample/analyte comments, click on the yellow C associated with that result field to
open a free text box. Such comments will be included on your Data Submission Report.
B. General comments and questions may be directly submitted to CTS PT by clicking on the
CONTACT US link on the left side of the data entry screen. Complete all fields and include any
comments. Be specific when referring to sample number, analyte or module. Click the blue
NEXT link to send the message.
C. If you have a question about your results that directly impacts your submission, or if you need to
have your instrument updated, CALL 888-450-4633 for assistance before you save your results.
6. Saving Results:
You have the option of a TEMPORARY SAVE or FINAL SAVE. Both submit into the database.
Temporary Save will submit results but keeps them available for review/edit.
Final Save submits and locks your results. Be sure to carefully review your results, check for
clerical errors and correct method information before selecting Final Save. No further edits
are allowed without coordinator assistance.
7. CLIA Record Keeping:
After saving your results, generate a Data Submission Report by clicking the REPORTS link on the
left side of the screen. Select the appropriate Year and Event (i.e.; BloodGas1), click APPLY, then go
to the Data Submission Report line under “Reports” and select BUILD to generate the report. Click
VIEW to open the pdf, print it, and keep with your PT records including the signed Attestation
Statement (found on your shipment cover page) for your records.
8. Log out of PT Central by clicking on the LOG OUT link on the left side of the screen.
**NEW** Paper Result Forms (Fax) – available ONLY for Primary set results
1. The result forms enclosed with your PT samples are customized for your laboratory and pertain only
to the Primary result set(s). Your account information is embedded in the barcode on each page; you
MUST use these forms when reporting Primary set results by fax. Refer to the instructions at the top
of each form for specific directions on how to complete correctly. A detailed form example is
provided in this packet.
2. Do NOT cross out or darken the blue box/bubble outlines on the form. Use blue or black ink to
record your results. Use block numbers for all results. For any Exception Codes you must fill in the
bubble completely; any writing other than filling in the oval or boxes will result in read/scan errors.
3. All reporting forms are double sided. Be sure to proof BOTH SIDES and enter results for all analytes
and each sample. The COMMENTS section on side two of any form should be used to add missing
analytes, instruments, results or other information, as needed.
4. Fax your completed Primary result forms to (866) 240-4687 as listed in the form’s instructions at the
upper right corner. We STRONGLY recommend reprogramming your fax it it has a pre-programmed
button for data submission. [This is a new fax number strictly for result forms submission.] Be sure
to fax all completed sides of your combined forms. If there are no analytes or comments on side 2 of
any form then you do not need to fax that blank page.
5. Do NOT include a fax cover page, attestation page, or any other information to this number. Do not
send duplicate faxes.
6. Keep a copy of your submitted results and proof of successful/timely fax transmission (confirmation
report, daily log) for your PT records. Although you should not fax your attestation to the Data
Processing Center, you must sign it and keep it with your PT records to meet CLIA requirements.
Questions? Call 888-450-4633.
SHIPMENT COVER PAGE - KEY
NHS = Non-Hazardous Samples
Shipment name = ship group + Cycle number
“(18)” = Fulfillment Center shipment reference
Sequence number within the shipment
(for Fulfillment Center use).
New web entry customer numbers; 7
digits beginning with a ‘30’ followed
by the previous shipping number (i.e.,
2013 shipping ID “20000” becomes
2014 paperwork/web ID# 3020000).
DUE DATE for the Primary Result Set(s).
The sample IDs for the included sample sets
An identifying number for enrolled base
product sample sets that need to be
included in the package. May include:
1350 = BloodGases or BloodGases/Lytes+
1380 = BloodGas Hgb/Hct
1390 = Co-Oximetry
This section is for new ‘Q’ modules
(additional sets) module numbers
followed by the additional set
quantity(-ies) for each enrolled
module that need to be included in
the package.
DUE DATE for Additional Result Set(s); only
available through web entry starting the date
AFTER the Primary Due Date. CMS no longer
allows submission of multiple result sets during
the live Primary cycle.
CLIA attestation and signature
lines for your in-house records.
CTS PT Program – Evaluation Report Interpretation Guidelines
CTS ID Number
Laboratory Supervisor
Some Institution
9999 Some Avenue
Some City, CA 99999
5
C-999
1
2 Blood Gases/Co-oximetry
Shipment Date: 7/08/09
3
4
6
7
8
Event 2009-2
Evaluation Report
10
11
12
Agencies/Consultants Reported To:
CMS CLIA ID:
10D0000000
CAP-LAP ID:
0000000
CA Dept of Health: CLF0000000
13
14
Analyte
Sample
Result
Identifier
pCO2 (mmHg)
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
ER
ER
ER
ER
ER
i-STAT
i-STAT
i-STAT
i-STAT
i-STAT
70.7
41.4
66.7
22.8
16.8
64.1 - 75.2
34.1 - 45.1
59.9 - 70.4
17.1 - 27.1
11.4 - 21.4
69.6
39.6
65.2
22.1
19.4
0.4
1.0
0.8
0.8
0.5
100%
Satisfactory
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
ICU
ICU
ICU
ICU
ICU
i-STAT
i-STAT
i-STAT
i-STAT
i-STAT
72.4
40.8
67.5
21.9
11.0 *
64.1 - 75.2
34.1 - 45.1
59.9 - 70.4
17.1 - 27.1
11.4 - 21.4
69.6
39.6
65.2
22.1
19.4
1.2
0.5
1.2
-0.2
-4.5
80%
Non-regulated result set
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Scoring Group
Your Result
9
Accepted Range
Mean
SDI
Score
CLIA
Regulatory Status
CTS identification number.
Proficiency Testing program and shipment date.
Institution name and department demographic information.
CLIA and other specified accreditation organization identification numbers
Analyte: Individual analyte reported and unit of measure.
Sample: Identification code on each sample ampule (BG = 2-letter PT program code, 06 = year, -2 = testing event/cycle, -1 = sample number).
Result Identifier: Your identification of the instrument. Your options include location, serial number, analyst, etc.
Scoring Group: Scoring group used to evaluate your results. A scoring group can consist of results from a specific instrument model, results from instrument models in the
same series, results from a group of instruments from the same manufacturer or results from all instruments.
Your Result: The result reported by your institution. An asterisk indicates an unsatisfactory result.
Accepted Range: The scoring group range of results in which your result must fall for satisfactory performance. The criteria for acceptable performance are defined by the
Center for Medicare and Medicaid Services (CMS), formerly HCFA, and are published in the Federal Register, Clinical Laboratory Improvement Amendments of 1988; Final
Rule, 42 CFR Part 405, February 28, 1992.
Mean: The average result in the scoring group by which your result was scored.
SDI: Standard deviation index is a comparison of your result to the scoring group mean, expressed in terms of the standard deviation. The SDI is calculated as follows:
SDI = Individual result – scoring group mean
Scoring group standard deviation
Score: The percentage of your results which fall within the accepted range. It is calculated by dividing your number of satisfactory results by the total number of samples in
the cycle challenge.
Regulatory Status: This column indicates whether a regulated analyte score is satisfactory (≥80%) or unsatisfactory (<80%). “Non-regulated analyte” is printed for analytes
not regulated by CMS. The regulatory status is shown only for the designated instrument results. “Non-regulated result set” is printed for results reported for analytes from
additional instruments.
Page 1 of 2
CTS Number: A-888
Event 2011-1
Evaluation Report
Blood Gases/Co-oximetry
Shipment Date: 03/01/11
REPORTuserIDinternalNum: SL20182
Some Community Health Center
Attn: Director Lab Services
Laboratory
88 Some Place
Somewhere, CA 0000
Agencies/Consultants Reported To:
CMS - CLIA ID: 00D0000000
Sample
Scoring Group
pH
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
pCO2 (mmHg)
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
pO2 (mmHg)
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
Ionized calcium (mmol/L)
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
Lactate (mmol/L)
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
Your
Result
M
PL
E
Analyte
Accepted
Range
CLIA
Mean SDI Score Regulatory Status
7.519
7.282
7.641
7.585
7.343
7.378
7.138
7.498
7.544
7.200
-
7.458
7.218
7.578
7.624
7.280
7.418
7.178
7.538
7.584
7.240
0.3
1.0
1.0
0.3
0.8
20%
Unsatisfactory
36.3
61.3
26.8
23.7
51.9
31.5
56.4
21.8
18.5
46.8
-
41.5
66.4
31.8
28.5
56.8
36.5
61.4
26.8
23.5
51.8
-0.4
-0.1
0.0
0.4
0.1
100%
Satisfactory
87.0
49.3
78.4
129.0
140.0
83.3
45.2
73.0
124.4
135.6
-
97.1
59.4
90.0
141.4
149.6
90.2
52.3
81.5
132.9
142.6
-1.4
-1.2
-1.1
-1.4
-1.1
100%
Satisfactory
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
1.29
1.74
0.88
0.71
1.10
1.18
1.64
0.74
0.55
1.00
-
1.44
1.90
1.00
0.81
1.26
1.31
1.77
0.87
0.68
1.13
-2.0
-1.0
0.5
1.0
-3.0
100%
Non-regulated analyte
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
ABL 700 series
6.40
7.20
9.40
1.80
5.50
5.67
6.27
8.06
1.58
4.75
-
6.71
7.57
9.93
2.00
5.71
6.19
6.92
9.00
1.79
5.23
0.8
0.8
0.8
0.1
1.1
100%
Non-regulated analyte
*
*
*
SA
*
8
N
!
E
~
Not scored
Nonconsensus
Excuse requested
Referred
P Pass
L Late result, automatic 0% score
* Unsatisfactory result
Report Run Date: 09/30/09
Form: PTTR0087
S Susceptible
I Intermediate
R Resistant
Page 2 of 2
Analyte
Sample
Your
Result
Scoring Group
Accepted
Range
CLIA
Mean SDI Score Regulatory Status
-2-3
BG09-2-4
BG09-2-5
130
111
133
149
116
-
138
119
141
157
124
134
115
137
153
120
-1.0
-0.8
-2.0
-1.0
-0.8
Potassium (mmol/L)
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
3.7
2.6
4.3
6.1
2.1
-
4.7
3.6
5.3
7.1
3.1
4.2
3.1
4.8
6.6
2.6
0.0
0.0
0.0
0.0
0.0
Glucose (mg/dL)
BG09-2-1
BG09-2-2
BG09-2-3
BG09-2-4
BG09-2-5
207
260
303
47
145
-
254
317
370
59
178
230
288
337
53
162
-0.1
-0.6
-0.3
0.8
0.4
Hemoglobin (g/dL)
CO09-2-1
CO09-2-2
CO09-2-3
CO09-2-4
CO09-2-5
7.8
12.8
15.7
15.6
7.7
-
9.0
14.8
18.1
18.0
8.9
8.4
13.8
16.9
16.8
8.3
0.0
0.5
0.5
0.5
1.0
Oxyhemoglobin (%)
CO09-2-1
CO09-2-2
CO09-2-3
CO09-2-4
CO09-2-5
94.0
83.0
56.5
55.0
94.2
-
97.2
85.6
58.9
57.4
97.2
95.6
84.3
57.7
56.2
95.7
-2.6
-2.8
-1.5
-1.5
-3.4
1.5
12.7
39.4
42.2
1.3
-
3.3
14.3
41.2
43.8
3.5
2.4
13.5
40.3
43.0
2.4
-1.7
-1.7
-1.7
-1.7
-0.2
0.2
0.2
2.0
1.6
0.0
-
2.0
1.9
4.2
3.4
2.0
1.1
1.1
3.1
2.5
1.0
5.3
4.0
2.8
3.7
6.0
Carboxyhemoglobin (%)
CO09-2-1
CO09-2-2
CO09-2-3
CO09-2-4
CO09-2-5
Methemoglobin (%)
CO09-2-1
CO09-2-2
CO09-2-3
CO09-2-4
CO09-2-5
Not scored
Nonconsensus
Excuse requested
Referred
SA
M
PL
E
Sodium (mmol/L)
N
!
E
~
Blood Gases/Co-oximetry
Shipment Date: 07/08/08
Event 2008-2
Evaluation Report
CTS Number: A-515
P Pass
L Late result, automatic 0% score
* Unsatisfactory result
*
*
*
*
*
Report Run Date: 09/30/09
CTS Number: C-999
1
Blood Gases/CO-Oximetry
Event: 2011-1
Shipment Date: 03/01/11
2
Agencies/Consultants Reported To:
CMS - CLIA ID: 10D0000000
CA Dept of Health Services ID: CLF0000000
CAP LAP ID: 0000000
3
Facility/Organization
Contact Name
Street Address
City State Zip Code
4
CUMULATIVE SUMMARY REPORT
2011-1
2010-3
2010-2
Score
Score
Score
Program(s)
Analyte(s)
6
Blood Gases/Electrolytes+ (BG)
pH
pCO2
5
pO2
Ionized calcium
Lactate
Sodium
Potassium
Chloride
Glucose
Co-oximetry (CO)
Hemoglobin
Oxyhemoglobin
Carboxyhemoglobin
Methemoglobin
CLIA Regulatory
Cumulative Performance
8
7
80%
100%
100%
100%
100%
100%
100%
100%
Dropped
60%
100% Excused
80%
100%
100%
60%
Not Reported
Not Reported
100%
Not Reported
0%
100%
100%
60%
100%
100%
20%
100%
Successful
Successful
Successful
Insufficient Information **
Non-regulated analyte
Insufficient Information **
Unsuccessful
Successful
Successful
0%
100%
100%
100%
100%
60%
100%
100%
Successful
Non-regulated analyte
Non-regulated analyte
Successful
100%
100%
100%
100%
CURRENT EVENT UNSATISFACTORY PERFORMANCE
Blood Gases/Electrolytes+
Potassium
Co-oximetry (CO)
Hemoglobin
99
60%
0%
** Refer to CTS PT Reference Manual if you experience an unsatisfactory (<80%) score.
11
Three events are required to assess regulatory performance.
Scores marked as voluntary are not transmitted to agencies
Reviewed By __________________________________________ Date_____________
Report Run Date: 09/03/10
(Lab Director / Designee)
10
Interpreting Your Cumulative Summary Report: File this report key with your proficiency testing (PT) records.
NOTE: The top of this report is a summary of your laboratory’s performance over 3 events. The bottom portion lists any
problem analytes on the enclosed evaluation report for the current event. Review both your current event Evaluation Report
and your Cumulative Summary Status report as soon as possible after receipt.
REMINDER: You are responsible for in-house maintenance of PT records. File all reports and other in-house
documentation for a minimum of 2 years. Refer to your inspecting agency’s guidelines for exact requirements.
CUMULATIVE SUMMARY KEY:
1. Your CTS identification number (“A” or “C” followed by the 3-digit assigned number). Refer to this number anytime
you contact us to help us identify your lab.
2. Proficiency testing program/group, year, cycle number and date samples were shipped.
3. Inspecting/accrediting agency with identification numbers [if applicable].
4. Facility/organization, contact name and mailing address for all correspondence.
5. Programs and analytes reported to us for the current and 2 previous events.
6. Analyte score is the percentage of results which fall within the accepted range.
7. Informational field indicating analyte score status. Field will be blank unless one the following apply:
Dropped
Lab has indicated that test is no longer performed
Late
Results were received after the due date
Excused
Patient testing temporarily suspended; excuse requested by lab
No Results
Results were not received for a regulated analyte; no indication from lab that testing was
dropped/suspended
Not Reported
Lab had not previously reported a regulated analyte OR results were not received for a nonregulated analyte
Not Enrolled
Lab was not enrolled in this CTS PT program for event(s) specified
Not Scored
Labs receive automatic 100%. This may not be indicative of instrument performance.
8. CLIA performance for regulated analytes over the current and 2 previous events:
Successful
Analyte has acceptable scores in at least 2 of the last 3 events
Unsuccessful
Analyte has unacceptable scores in any 2 of the last 3 events
Non-regulate
Performance criteria for analyte is not defined under CLIA
Voluntary
Lab has indicated to us that it participates for quality assurance purposes, is not
covered under CLIA, or has designated another PT provider to send analyte scores
to their accreditation agency
Insufficient Information
Analyte scores for 3 events are needed to assess performance
9. List of all analytes with unacceptable scores for the current event. Scores of 0% due to late result submissions or
missing/unreported results will not be included. More detailed information on why the failure may have occurred can be
obtained by reviewing the enclosed report. These analytes will require in-house follow-up and documentation to assure
accrediting agencies that failures were noted and actions were taken.
10. Legends to clarify regulatory performance status and the date that the report was generated.
11. Signature line and date for documenting in-house review of this report.
Blood Gases/Electrolytes+/CO-Oximetry
CTS Proficiency Testing Program
Cycle 2013-1 Notes
General Information
This "Cycle Notes" document accompanies your Evaluation Report and Statistics Summary Report for the most recent
PT cycle with a scheduled ship date of March 4th. View the footer of your reports for official report release date(s).
Report Review/Request for Correction: Review your results as soon as possible after receiving reports. You have 30
calendar days from the "report run date" listed on the bottom left corner of your "Cumulative Summary Report" to
request corrections. After 30 days, scores are sent to accrediting agencies and may become ineligible for correction.
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 If your lab receives a “No results submitted for …” statement for any product (BG, CO, etc), proof of timely data
submission (e.g. printed fax confirmation, fax log, or phone bill) must accompany your request. For this reason, it
is always prudent to save your fax confirmation printouts WITH your copy of the result forms. If your fax machine
is not currently set to print confirmations, we recommend resetting it.
 If your lab receives a 0% score for analytes that are listed with blank/missing results, it is because method
information was provided without corresponding sample/analyte results. Because instructions stated that numeric
data would be evaluated “as submitted” AND that unenrolled or unreported analytes should be left blank for all
fields, provision of method information implies intent to report and is processed as such. Contact the CTS PT Main
Office at 415-536-0287 if your enrollment requires updating. Review the paragraph “Avoid errant/stray marks on
your data input forms” in Section 5 (page 3) of the 2013 instructions for details.
 If you note a data processing error (i.e.; numeric value error, analyte data missing, etcetera), immediately contact the
CTS PT Main Office at 415-536-0287. When brought to our attention in a timely manner and IF confirmed by
review of the submitted data forms, such requests will usually result in issuance of a corrected report.
 Failures due to clerical or handling errors by the participant(s) are not eligible for correction. They should, however,
be recognized and documented with any corrective action(s) taken. If any sample was depleted or not recoverable, a
replacement request should have been submitted to the CTS PT Main Office in a timely manner. Similarly,
compromised forms could have been replaced by calling for a blank form. It is recommended that labs always
initiate proficiency testing at least 4 days prior to the due date to allow time for any needed replacements or
clarifications.
 Result set designation or omission errors are sometimes eligible for correction. If a result set reported by your lab is
not included on your Evaluation Report, contact CTS so we can determine if it is a clerical, submission, or fax error
versus a data processing error. If it is found to be a data processing error, a corrected report will be issued.
Temporary Suspension of Analyte Testing: If your lab temporarily suspended patient testing [e.g. reagent/calibrator
backorder or instrument malfunction/repair], you must have contacted CTS PT in writing prior to the due date to
request excused status for the shipment. Requests received after the due date will not be reflected on your current
Evaluation Report and are not eligible for correction without proof of timely notification. It is your responsibility to
document the reasons for any unreported analyte(s) as part of your proficiency testing records. Any Excuse Requested
flag/status will be valid only if your certifying agency concurs with the reason and is satisfied with your documentation.
Permanent Suspension of Analyte Testing: If your lab stops in-house patient testing for any analyte(s), it is your
responsibility to contact both CTS and your certifying agency. Failure to notify CTS prior to the scheduled due date
will cause a "0% No Result" score for any regulated analytes and a blank score / "Not Reported" for non-regulated
analytes on the reports. For regulated analytes, the 0% score will be sent to your certifying agency unless we are notified
in a timely manner [see above].
For additional information please refer to the current Enrollee Reference Manual.
Reports
Each participant will receive three reports (defined below) with a Validated Ampules Request Form. Examples of the
Evaluation and Cumulative reports, with keys to interpretation, are found in the Enrollee Reference Manual.
1. The Cumulative Summary Report presents an assessment of participant analyte performance for this cycle, the
two previous cycles and your current regulatory status for each analyte. If you are a new participant, the regulatory
status will state “insufficient information” until two or three cycles are completed. The CLIA ’88 regulations
define analyte performance as “Successful” when the analyte score is 80% for two of three consecutive cycles. If
the analyte score is <80% for two of three consecutive cycles, analyte performance is “Unsuccessful”. Analyte
scores that do not meet these criteria are deemed “Unsuccessful” for regulatory purposes and documented in-house
corrective action is necessary. Scores are listed only for the designated set of results regulated by CMS.
2. The current Evaluation Report includes CLIA Regulatory Status and Standard Deviation Index (SDI).
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CLIA Regulatory Status is “Satisfactory” when a regulatory analyte score is 80% and “Unsatisfactory” when
it is <80%. The column will state “Non-regulated analyte” if the scoring criteria for the analyte is not listed in
the CLIA regulations and “Non-regulated result set” if additional sets of results are reported from instruments
other than your designated instrument. Scored results are sent to CMS and other specified agencies. Since only
one set of results is sent to CMS, be sure to designate which set of results should be sent.
SDI is the number of standard deviations above (+) or below (-) the target value where your reported result lies.
This can help you assess your result’s difference (bias) from the scoring group mean independent of the analyte
concentration of that sample.
Not scored (N): The PT Program may choose to utilize this option if there are not enough participants using a
specific instrument and/or method to create a statistically significant peer group and results from that instrument
could not be combined with other related instruments to constitute a valid peer scoring group. Results are given
an automatic 100% but the score may not be indicative of instrument performance. Affected participants must
self-evaluate their performance.
In this cycle, affected CTS methods (# n, CTS) was/were: RAPIDLab 1200 series (n=1) Lactate
OPTI CCA-TS (n=1)
Sodium
cobas b 221 (n=5)
Hemoglobin (CO)
IL GEM 3000 (n=1)
Hemoglobin (BGHN)
Non-consensus: Results will be flagged as "non-consensus" if less than 80% of the results fell within the
calculated range for the peer group. Affected participants receive an automatic score of 100% but are required
to self-evaluate performance using the statistics summary provided.
3. The Qualitative Statistics Summary Report provides additional scoring information. Standard Deviation (SD) and
scoring/peer group size (n) are listed for each peer group (both specific/direct and non-specific/composite or
indirect) used for scoring purposes for all analytes by program/product. “Not Scored” peer groups are not included.
Cycle Specific Information
Performance Data: There was a combined total of 545 participants in this cycle, 123 labs from CTS PT and 422 from
the WSLH PT program. By pooling the data from the two programs we are able to provide larger and more modelspecific peer groups with more reliable statistics. Of the 5540 analytes scored, there were 151 analyte failures
experienced by 64 participants. While some failures might be attributed to sample storage and/or handling issues, it was
transcription errors, late submission, and missing/unexcused data that appeared to account for the majority of the
failures. These could be easily avoided through adherence to the instructions AND with consistent proof-reading of
result forms prior to submission. The overall analyte passing rate was 97.3 %.
Cycle 2013-2 Shipment
The next Blood Gas/Electrolytes/CO-Oximetry Cycle will be shipped via 2-day carrier on July 8, 2013 with UPS as the
default courier. Re-enrollment is required for continued participation. Result forms will be due at the CTS Data
Center by midnight (central) of July 26th. If you have any questions/concerns OR if you need to adjust your 2013
Enrollment (number of sets, analyte content, etcetera), call the CTS PT Main Office at 415-536-0287.
Have you seen CTS PT Web Education materials?
Go to http://www.calthoracic.org/content/cts-proficiency-testing-web-education
CTS PROFICIENCY TESTING TROUBLESHOOTING AND DOCUMENTATION GUIDE
Laboratory Name:
Instrument:
Your Value:
All Instrument Mean:
Your Model Mean:
Model: _______
SDI:
SD:
n:
SD:
Year:
Serial#:
Unsatisfactory Analyte:
Ampule Code #:
Cycle:
Identifier:
n:
SUGGESTED GUIDELINE FOR TROUBLESHOOTING INVESTIGATION
Directions: Review the following list of possible causes for poor Proficiency Testing (PT) performance. Check "PASS" for compliance
and "FAIL" for non-compliance indicating potential problems in your lab. Summarize you findings and implement corrective action.
Save this checklist with your PT records as documentation of your investigation, corrective action, and Medical Director review.
PASS
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FAIL
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Results suggest the possibility of room air contamination of sample contents or other pre-analytic errors.
Multiple instruments were enrolled, and all failed on the same analyte in the same direction (pos or neg).
Low n. The "all-instrument" mean was used as target value instead of the "model-specific" mean.
Scoring error. Scoring is inconsistent with CTS model-specific or all-instrument acceptable range.
Pre-existing bias. Previous PT SDI rankings are low or unacceptable.
Transcription error. Failed to transcribe PT value(s) correctly to CTS Data Input form.
Storage error. Failed to store PT material according to CTS package insert instructions.
Equilibration error. Failed to ensure temperature equilibration of PT material prior to sampling.
Sample handling error.
Analyzer mode error. Failed to introduce PT material according to instrument manufacturer's
instructions.
Sample introduction error. Failed to sample PT material according to instrument manufacturer’s
instructions.
Preventive maintenance error. Failed to follow instrument manufacturer's service interval
recommendations.
Sensor/electrode failure. Age and/or performance of the measurement electrode were unsatisfactory.
Sample chamber temperature error. Failed to follow instrument manufacturer's recommendations.
Instrument "Error Codes" displayed during PT sampling. Failed to initiate corrective action prior to
sampling.
Reagent expired. Failed to replace reagent when expired.
Reagent contaminated. External analysis or internal swapping of buffer/gas standard confirms
contamination.
Compromised reagent path. Reagent path shows signs of leakage or contamination buildup.
Contaminated sample path. Sample path/chamber shows signs of protein buildup or other contamination.
Barometric pressure error. Instrument's barometer failed to agree with laboratory standard.
Calibration error. Failed to calibrate instrument within manufacturer's specifications.
Quality control error. Failed to meet laboratory quality control standards.
Other error (describe):
Review performed by: Name:
CONSULTATION
Laboratory Medical Director: Name:
Analyzer Field Service Rep: Name:
CTS Reference Tech: Name:
Corrective Action:
Corrective Action Implemented by: Name:
Title:
Date:
Date:
Date:
Date:
Recommendation:
Recommendation:
Recommendation:
Title:
Date:
For CTS Office use:
CTS PROFICIENCY TESTING PROGRAM:
VALIDATED AMPULES REQUEST FORM
______ - _____
This order form is provided to all participating laboratories in conjunction with the Cycle Notes and reports.
You may order any needed set(s) of five Validated Ampules by faxing this completed order form with credit card
information OR sending the completed form with a check to the CTS Main Office at the address listed on the bottom
of this form. Requests will be forwarded to the Order Fulfillment Center once your prepaid order/payment has been
received and processed. Most requests are filled using 2-day UPS service. SEE REVERSE FOR MORE DETAILS.
Routine requests received after 11:00 am Wednesday (Pacific Time) are not processed until the following Monday.
Overnight delivery may be available for an additional fee. ANY requests received after 9:30AM Pacific Time on
Thursday will not ship until the first business day of the following week.
Requesting Account:
CTS ID number ____ –
__
Requestor’s Name ____________________________________
Phone ____________________________________
Ship to: Institution ____________________________________
Address ______________________________________
______________________________________
______________________ Zip ________-____
At this time, we are requesting the following Validated Ampule sets from the most recent PT Cycle:
# of
Product description
Price
Extended
sets
per set price
Blood Gas / Electrolytes+ analysis (5 BG samples, including routine s/h) $100
Blood Gas – Hgb/Hct analysis
(5 BGHN samples, including routine s/h) $100
CO-Oximetry analysis
(5 CO samples, including routine s/h) $100
Overnight delivery
$27
CALCULATED TOTAL COST:
 Prepayment Method (check one):
Visa®  MasterCard®  AmEx®
OR
 overnight check*
____ ____ ____ ____
Expiration Date: Month _ _ Year _ _ _ _
Security Code: _ _ _
Credit Card #:
Authorized Signature:
_________________________________________________________
PRINT name as it appears on card:
____________________________________
WRITE LEGIBLY TO EXPEDITE APPROVAL!
FAX credit card order to 415-764-4933
OR mail form with check* to:
CTS PT Main Office
575 Market Street, Suite 2125
San Francisco, CA 94105