Document 6538135

575 Market Street, Suite 2125, San Francisco, CA 94105 ph:415-536-0287
Blood Gases (BG)
Blood Gases / Electrolytes+ (BGP)
Blood Gases – Hemoglobin/Hematocrit (BGHN)
Co-Oximetry (CO)
2013 Sample Handling and Reporting Instructions
1. Inspect samples upon receipt. Your package should contain a packing slip, this instructions document (with
method code list), the appropriate data input form(s), and at least one corresponding set of five samples for BG, BG+,
BGH and/or CO based on your current enrollment.
Package temperature: BG and BGHN samples are stable (short-term) at ambient temperatures. They are shipped with a
soft/refrigerated gel pack that is intended to act as a cushion (against physical jarring) and temperature buffer (against
temperature extremes). CO samples are more sensitive and are shipped with one or more frozen cold packs which
protect the CO samples from extreme heat during shipping. None of the CTS samples should be compromised if the
cold packs have warmed during the shipping process; stability studies have shown that short-term exposure to ambient
temperatures does not affect sample performance if samples are equilibrated properly on receipt. Follow the storage and
handling instructions in Section 2 of this document to obtain optimal results.
Your packing slip indicates both the type AND number of forms and sample sets that should be found in your shipment.
Your shipment content reflects the current enrollment information on file with CTS. A single data input form and
corresponding sample set is provided for each program enrollment. If you need to add or drop a program because of
changes in your in-house test menu, or if you need to increase/decrease your set quantities to reflect the current number
of analyzers/analysts, call the CTS PT Main Office (415-536-0287).
If your shipment is incomplete (missing forms and/or samples), or if any forms or samples are damaged on receipt,
you must request replacement(s) by the current “Call by” date. Such requests after that date may be subject to
additional fees. Call the CTS Fulfillment Center (888-450-4633) to determine availability of needed item(s).
Replacement requests for damaged or mishandled samples can be made after the “Call by” date, but may be subject
to additional replacement fees and limited by product availability. Request paid replacement samples by submitting
a completed Replacement Ampule Order form (with payment) to the CTS PT Main Office by fax (415-764-4933)
or mail. Requests submitted in the final 3 calendar days of the live Cycle may incur additional charges for priority
shipping on top of the standard replacement fees. Failure to make timely calls for replacement of missing or
mishandled samples will not be accepted/excused.
[Refer to the “Proficiency Testing Action Calendar” for important action dates of the current Cycle. Per CLIA
regulations, the laboratory is responsible for contacting the PT vendor if a scheduled shipment is not received in a
timely manner. If any expected shipment is not received within 5 business days of the scheduled ship date, call the
CTS Fulfillment Office (888-450-4633) to initiate an investigation.]
2. Store samples appropriately on receipt. Storage in a closed, light-protected, refrigerated environment is optimum
between shipment receipt and testing. Note that storage and handling requirements are not the same for all sample
types; disregard handling instructions that do not pertain to your enrollment. Appropriate storage/handling is the
customer’s responsibility:
CO -- store unopened CO samples in a refrigerator at 2-8ºC (36-46ºF).
BG -- refrigerated storage is recommended for optimal performance, especially if testing will be delayed more than
2-3 days from receipt); however, unopened BG samples can be stored at room temperature on receipt.
BGHN – follow same recommendations as for BG samples.
3.
Prepare samples for testing.
***Safety reminder*** All participants must follow basic safety guidelines when breaking ANY glass ampules.
Although these proficiency samples are not a biological hazard, they should be considered a potential SHARPS
hazard. Glass ampules should never be opened with bare/unprotected hands. Use of protective safety sleeves
(available commercially), several layers of gauze or paper towel, or some other physical barrier to protect yourself
from sharps injury is necessary. Neither vinyl nor latex gloves are, on their own, a sufficient sharps barrier.
A. Products BG (Blood Gases) and/or BG+ (Blood Gases/Lytes+) use samples “BG” and handle as follows:
1) If samples were refrigerated, allow to equilibrate at room temperature at least 4 hours.
2) Just prior to testing, hold ampule by the top and bottom (with forefinger and thumb); shake 15 to 20 times (about 10
seconds) to mix. Do not hold the ampule in the palm of your hand for shaking!
3) Gently tap the ampule to restore all of the liquid to the bottom.
575 Market Street, Suite 2125, San Francisco, CA 94105 ph:415-536-0287
4) With fingers protected, hold the ampule so the red dot is facing up. 
Hold bottom of ampule steady & carefully snap top down (away from
red dot) to open. Discard top in sharps container.
5) Immediately introduce the liquid from the ampule to the analyzer.
When direct aspiration from the ampule into the analyzer is not possible, do the following:
a) Use a clean, gas-tight syringe attached to a clean blunt syringe needle.
b) Prime the syringe by slowly aspirating a small amount (0.2-0.3 mL) of solution. Discard this liquid and aspirate
the entire solution into the primed syringe, avoiding foaming and bubbles.
c) Expel one or two drops, detach the needle, and immediately inject the sample into the instrument.
6) If you will be testing an(y) additional analyzer(s) using the same samples/set, it is recommended that the analyzers
be in close proximity so cumulative open vial time can be minimized. Delays in testing of any open vial allows gas
exchange which may cause sample/analyte failure(s).
7) When testing has been completed on any sample, discard the open vial following in-house safety procedures.
B. Product BGH (Blood Gases-Hgb/Hct) uses samples “BGHN” with the following handling instructions:
1) If samples were refrigerated, allow samples to equilibrate at room temperature at least 4 hours before using.
2) Just prior to testing, hold ampule by the top and bottom (with forefinger and thumb) and shake 15 to 20 times
(about 10 seconds) to mix the solution. Do not hold the ampule in the palm of your hand for shaking!
3) Gently tap the ampule to restore all of the liquid to the bottom.
4) With fingers protected, carefully snap open the first ampule. Discard ampule top in sharps container.
5) Immediately introduce the liquid from the ampule to the analyzer.
When direct aspiration from the ampule into the analyzer is not possible, do the following:
a) Use a clean, gas-tight syringe attached to a clean blunt syringe needle.
b) Prime the syringe by slowly aspirating a small amount (0.2-0.3 mL) of solution. Discard this liquid and aspirate
the entire solution into the primed syringe, avoiding foaming and bubbles.
c) Expel one or two drops, detach the needle, and immediately inject the sample into the instrument.
6) Analyze BGHN samples for only hemoglobin/hematocrit by conductivity method on “blood gas” analyzers.
7) When testing has been completed on any sample, discard the open vial following in-house safety procedures.
C. Product CO (Co-Oximetry) uses samples “CO” with the following sample handling instructions:
1) Allow CO samples to equilibrate in the refrigerator for at least 4 hours before beginning any testing.
Samples should be analyzed immediately after removal from refrigeration. If testing is interrupted, and
samples begin to warm, return unopened vials to the refrigerator and allow them to re-equilibrate before
resuming testing.
2) Just prior to testing, holding ampule at either end (between thumb and index finger), gently invert the ampule
to mix the solution. Do not hold the ampule in the palm of your hand or shake it!
3) Gently tap the ampule to restore all of the liquid to the bottom/barrel of the ampule.
4) With fingers protected, carefully snap open the ampule. Discard top in sharps container.
5) Immediately introduce the liquid from the ampule to the analyzer.
When direct aspiration from the ampule into the analyzer is not possible, do the following:
a) Use a clean gas-tight syringe attached to a clean, blunt syringe needle.
b) Aspirate the entire solution into the syringe, avoiding foaming and bubbles.
c) Expel one or two drops, detach the needle, and immediately inject the sample into the instrument.
d) Radiometer ABL 700 and 800 series users: Analyze CO proficiency samples in the patient mode with the
analyzer set to correct for hemoglobin F (FHb) at >20%. Some laboratories may experience oximetry
measuring errors with question marks. These errors can be disregarded and the PT results reported to CTS.
6) If you will be testing an(y) additional analyzer using the same sample, it is recommended that the analyzers be
in close proximity so cumulative open vial time can be minimized. Delays in testing of any open vial allows
sample warming and gas exchange which may cause sample/analyte failure(s).
7) When testing has been completed on any sample, discard the open vial following in-house safety procedures.
575 Market Street, Suite 2125, San Francisco, CA 94105 ph:415-536-0287
4. Test samples as you do patient specimens. Use routine test procedures and personnel but DO NOT REFER
proficiency testing samples to any core or reference laboratory and DO NOT COMPARE your proficiency testing
results with any other department or lab prior to the due date.
Bayer RAPIDLab 800 series systems require the use of a Quick Adapter P/N 673395 to facilitate direct aspiration of
CTS survey materials. If an ampule does not fit into the adapter properly, use the syringe-transfer procedure
described above, the aspiration adapter (sipper tube), or modify the quick adapter to accommodate the ampule.
Roche Omni users: Analyze the proficiency testing samples in the blood mode of your Omni instrument.
Abnormal result(s) suppression: If a PT sample runs but no results are reported out, check the internal instrument
settings for suppression of abnormal results. If enabled, adjust the settings so PT values can be retrieved/reported.
5. Record your test results. Verify your CTS ID number, institution name, and address printed at the top of the data
input form(s). Your CTS ID (A- or C- number) must be included on each submitted form. Complete your forms
following the instructions in this document. Note that CLIA regulations require that data be evaluated “as submitted”
and suspected clerical errors cannot be corrected by the PT provider during data processing. If you have questions
about the forms, call prior to submission.
You must report each enrolled analyte in at least one result set. Enrolled analytes left blank will receive a 0% score
unless they have been pre-approved by CTS PT. Include the appropriate method, result fields, and identifier for each
enrolled analyte (i.e.; pH, pCO2, K+, Cl-, Lactic Acid, Carboxyhemoglobin).
Enrollment changes or requests for excused status on any analyte(s)/program(s) must be made prior to the due date
by contacting the CTS PT Main Office at 415-536-0287.
Result Set designations: All submitted results/sets will be evaluated and reported back on your Evaluation Report.
For any enrolled product, analyte scores from your “Primary Result Set” will be sent to your agency(-ies), while
analytes resulted on any “Additional Result Set” forms MAY be transmitted to agency(-ies) if appropriate.
NOTE: All forms sent in your package are pre-numbered and you should report any analyte under the “Primary
Result Set” before reporting additional result sets for that same analyte under any “Additional Result Set”. This
numbering indicates agency transmission precedence and DOES NOT necessarily correlate with in-house analyzer
designations. If you have designated different analyzers/sites as “primary” for the current cycle (i.e.; a blood gas
only analyzer for pH, pCO2, pO2 with a second analyzer for Sodium, Potassium, Chloride, and a third analyzer for
Ionized Calcium, Lactate, and/or Glucose), you will need to combine the “primary” results from each analyzer to
complete your single “Primary Result Set 1” form for each affected product. Similarly, if your in-house designated
instrument is down for one or more analytes, run the instruments separately and then be sure one set of results for
each enrolled analyte is reported under your “Primary Result Set” before reporting any subsequent sets under the
appropriate “Additional Result Set” form(s). Submit each Data Input Form even if there are no numeric results.
Identifier boxes: You may identify your instrument by location, serial number, analyst, etc. Your identifier is limited
to 4 alpha-numeric characters, is reported back on your Evaluation Report, and helps identify the source of any result
set data. If you report more than one set of results (both “Primary” and one or more “Additional” sets), you should
identify each analyte under each set of results using the appropriate identifier box(-es). Leave these boxes blank for
any non-enrolled analyte/set.
Avoid errant/stray marks on your data input forms. Do not make any marks/entries in any fields associated with
analytes for which your lab did not enroll in this Cycle (i.e.; Na+, iCa++, Glucose). If, under BG+, you enrolled for
4 of Glucose but only 2 of Ionized Calcium, leave the Ionized Calcium fields (including the Identifier, Method, and
result boxes) blank on 2 of your “Additional” set forms. Data in these fields is evaluated “as submitted” and
method codes submitted without results will be processed as “No results received” with an automatic 0% score.
Comments do not take precedence over result-related fields.
Instrument code boxes: Report your instrumentation using the CURRENT codes table provided these instructions.
Check the codes table carefully for updates; instruments are listed alphabetically by manufacturer and new codes are
continually added. If your instrument is not listed, enter 9999 for your instrument BUT then define your “other”
method by including the manufacturer and model names in the “Comments” section of the corresponding form(s).
**i-STAT users**: All i-STAT systems must be reported using the single instrument code 3670 PLUS the
cartridge name (i.e. G3+, CG4+, etc) for each reported analyte. Use the COMMENTS area of the results form to
record the i-STAT cartridge name that corresponds to the analyte results on that page.
If a result falls outside of your instrument’s reportable range, report the upper or lower limit of your range in the
result boxes and fill in the bubble that corresponds to the “less than” (<) or “greater than” (>) sign (e.g. <2.0).
Honor the PT reporting units indicated on the Data Input Forms. Perform any conversions if/as needed.
575 Market Street, Suite 2125, San Francisco, CA 94105 ph:415-536-0287
Honor the result format (presence/absence of decimal points) as listed on the Data Input Forms. If the form does not
include a preprinted decimal point for any given analyte, you may not write/insert one in the result boxes. Manually
inserted/added decimal points will invalidate the results and will receive zero percent scores.
Honor the result field length as listed on the Data Input Forms. Your reported result(s) may not exceed the number
of decimal places provided on the forms for any analyte. If you report patient values to the tenths but the PT form
requests a whole number, it is YOUR responsibility to round your results according to your in-house protocols.
However, do not report non-significant trailing zeroes. If we provide a decimal point on the form (i.e.; provide
boxes for reporting to the tenths or hundredths) and you do not routinely report patient values out that far, you should
leave the unused decimal place box(-es) blank…do not include any extraneous/non-significant trailing zeroes in your
reported results. If you report patients to the whole number but record a zero in the tenths place on the form, we
must assume your instrument is measuring/reporting to the tenths for scoring purposes.
Do not report any negative values on the data form(s). For analytes where negative values are sometimes obtained,
such as Methemoglobin (CO), see specific instructions on the Data Input Form. Any results submitted as negative
values will be processed as Invalid and will receive a 0% score.
6. SUBMIT completed data input form(s) to the CTS PT Data Center at (608) 265-1111 by midnight (central) of the
scheduled due date. Any faxed results received at the Data Center after midnight central of the scheduled due date
will be flagged as “Late” as will any mailed results postmarked by the post office after the due date. Late submissions
receive an automatic 0% score.
For fax submission, a cover sheet is not needed AND you do not need to mail the original data input form(s). You
SHOULD print and retain a copy of your fax activity log or transmission report as proof of timely submission. Also,
verify transmission page count AND transmission status (that all intended pages were included in the scan and that
transmittal status shows success in delivery). NOTE: It is preferred that your fax be programmed to identify your
institution name and fax number at the top of each page for auditing purposes.
If you do not have fax capabilities, mail the original Data Input Form(s) to: Proficiency Testing - Rm 402, 465 Henry
Mall, Madison, WI 53706.
BG, BG+, BGHN, and/or CO INSTRUMENT CODES
Code
Instrument
Code Instrument
Code Instrument
2176
AVL Omni/Omni S
--call-- Nova STAT Profile series ##
4868
Roche cobas b221
2171
2181
AVOXimeter 1000/1000E
AVOXimeter 4000
2182
2184
3206
Epocal EPOC
3150
ITC IRMA TRUpoint
3603
3618
4064
4072
IL 682
OPL
GEM Premier 3000 series
GEM Premier 4000 series
4752
Radiometer ABL 5
4760
ABL 700 series
4765
ABL 800 series
--call-ABL 800 FLEX
4766
ABL 80 series
4768
ABL 80 FLEX series
4767
ABL 90 FLEX
4763
NPT 7 series
2832
2843
2838
2845
2847
2852
2834
2835
2850
Siemens 238/248
348
600 series
RAPIDPoint 400
RAPIDPoint 405
RAPIDPoint 500 series
RAPIDLab 840/850/860
RAPIDLab 845/855/865
RAPIDLab 1200
Osmetech OPTI CCA series
Osmetech OPTI CCA-TS
Other Instruments (define manufacturer
and instrument name/model in the
3670
i-STAT (requires reagent code)*
Comments area of your result form.)
* i-STAT users MUST also provide their cartridge name (i.e.; G3+) in the COMMENTS of the appropriate Data Input Form(s).
## Nova system users must call the Data Center (888-450-4633) with their model name to receive correct method coding.
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9999
General Tips for Completing Result Forms
To ensure proper recording of results your CTS ID must be recorded on every submitted Data Input Form.
Use a fine tipped black or blue pen. Do not use pencil.
Result boxes for unenrolled analytes should be left blank. Do not mark blank boxes or pages with “x” or “n/a.”
Numbers should be printed using block style. Do not cross zeros or sevens. Do not allow pen-marks to touch or cross any of
the box lines.
Numbers and letters should be printed with solid connected lines.
Enter your results in the boxes provided, no more than one digit per box, using the units requested.
Sample or form questions? Call (888) 450-4633
Enrollment updates or questions? Contact the Main Office at 415-536-0287 or [email protected]