Art: 714262-00AA
Rev. Date: 17-Mar-11
2
6+, and CHEM8+ cartridges as waived when testing is performed using venous whole blood samples
collected in sodium or lithium heparin evacuated tubes. Other venous whole blood samples, capillary, and/
or arterial samples tested using these same cartridges on the i-STAT 1 System are categorized by the FDA
as moderate complexity.
CodIng i-STAT ReSuLTS
Proficiency Testing providers use different methods for coding results. The information below should be
used to select the correct code(s).
Periodically, Abbott Point of Care (APOC) makes cartridge manufacturing changes which may affect the
results for non whole-blood samples, such as proficiency testing (PT) material. Cartridge generations are
identified by the prefix letter preceeding the cartridge lot number.
Miscoding your results can cause PT failures. Continued PT failures may result in the loss of your
permission to report results. Furthermore, miscoding may cause inaccurate peer group means,
resulting in unnecessary failures for some participants.
APOC recognizes that it may be difficult for PT providers and customers to ensure proper coding. We are
working the PT providers to prevent unnecessary PT failures and will continue to work with customers and
providers when we suspect failures are due to miscoding or inappropriate peer groups.
Therefore, it is
important for troubleshooting purposes to record the cartridge type and lot number used to report PT
results.
Note 1: pH and
P
CO
2
results from EC8+ cartridge lots with prefix letters F, G, H, J, and K will not agree with
pH and
P
CO
2
results from other cartridges. When reporting results, look for a separate peer group for these
cartridge lots.
Note 2:
For creatinine results, select IDMS-Traceable Calibration, if available. If not available, make your
selection based upon the cartridge type and lot number.
Note 3:
When reporting results with the < or > symbol, you must record the lowest or highest reportable
value. Make sure the symbol is legible and cannot be interpreted as a number.
Follow the proficiency testing survey instructions for reporting results. Double check the coding as well
as the CLIA number, test results, and any additional information required before submitting result forms to
your provider.
Record and retain the cartridge type and lot number used to test samples. If you have
any questions, contact your provider or APOC Technical Support at 1-800-366-8020, option 1.
uSe The PRofICIenCy TeST PAThWAy
It is recommended that the Proficiency Test path be used on the i-STAT Portable Clinical Analyzer and the
i-STAT 1 Analyzer when testing proficiency samples, especially those that include hematocrit or ACT. The
Proficiency Test path uses K
3
EDTA standardization coefficients for hematocrit and disables the CPB mode
.
It also uses the
PrEWArM mode for ACT. Use of the Proficiency Test path will ensure that the results
from analyzers customized for K
2
EDTA, CPB-Always, or ACT
NONWARM
will match results from analyzers
customized for K
3
EDTA, CPB-Never and ACT PrEWArM
for survey reporting purposes. If the patient
sample test path is used instead of the Proficiency Test path, do not select CPB, and if the analyzer is
customized for K
2
EDTA, divide the hematocrit results by 1.0425 before reporting. There is no reliable way
of converting NONWARM ACT results to
PrEWArM
ACT results.
• To access the Proficiency Test path on the Portable Clinical Analyzer:
1. Insert the Electronic Simulator and wait for PASS to be displayed.
2. Hold down the DIS key and press the MENU key to access the
Utility menu.
3. Press 5 for Proficiency.
• To access the Proficiency Test path on the i-STAT 1 Analyzer
1. Press the On/Off key.
2. Press the MENU key.
3. Press 3 for Quality Tests.
4. Press 2 for Proficiency.
Summary of Contents for i-STAT 1
Page 1: ...i STAT 1 System Manual Rev Date 20 Jan 12 Art 714336 00L ...
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Page 627: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 6 REV DATE 16 Oct 12 ART 714446 00L ...
Page 628: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 7 REV DATE 16 Oct 12 ART 714446 00L ...
Page 629: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 8 REV DATE 16 Oct 12 ART 714446 00L ...
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