Proficiency Testing on the i-stat System

Transcription

1 i-stat TECHNICAL BULLETIN Proficiency Testing on the i-stat System Please read this Technical Bulletin in its entirety before participating in a Proficiency Testing (PT) event as there are reminders and helpful information to enhance your probability of successful performance. Pay special attention to the Coding i-stat Results section since coding information may change periodically. Proficiency testing provides a snapshot in time of the analytic performance for a given test. The use of inter-laboratory comparison, provided by PT, allows laboratories to ensure that their instruments are performing at a level comparable to their peers. Peer performance is enhanced by following the instructions of the manufacturer. Moderate Complexity Tests CLIA REQUIREMENTS FOR PROFICIENCY TESTING CLIA regulation Subpart H Participation in Proficiency Testing requires a laboratory to enroll in a proficiency testing program approved by the Centers for Medicare and Medicaid Services (CMS) for its primary test system or that system used at its primary site. The laboratory must participate successfully as defined by the criteria defined in Subpart I Proficiency Testing Programs. A primary testing system is defined as the only method or the primary method for performing and reporting tests under a CLIA certificate. The i-stat System may be a primary testing system when: A hospital has separate CLIA certificates for the main laboratory and point of care testing; A hospital owns a clinic, same-day surgery, kidney dialysis unit, etc., which requires a separate CLIA certificate; The i-stat System is the hospital s primary laboratory testing system; or The i-stat System is the main testing system in a physician s office, skilled nursing facility, unaffiliated patient transport service, home healthcare agency, etc. For CLIA regulated analytes, proficiency testing (PT) programs must provide three separate shipments during the year that include five challenges for each analyte or test. Laboratories must comply with the CLIA requirements and those of their accrediting organization when testing PT samples. Waived Tests Proficiency Testing for waived tests is not a CLIA requirement nor is it a requirement from The Joint Commission. COLA recommends PT testing and will issue an educational citation for noncompliance. The College of American Pathologists (CAP) requires proficiency testing for waived tests. Check with your state regulatory agency for state requirements. Abbott Point of Care Inc. 100 & 200 Abbott Park Road Abbott Park, IL USA Art: AI Rev. Date: 22-APR-18

2 With the i-stat 1 System, the FDA has categorized the tests included on the i-stat G, Crea, E3+, EC4+, 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 with 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 PCO 2 results from EC8+ cartridge lots with prefix letters F, G, H, J, and K will not agree with ph and PCO 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. For CAP participants, fill in the <\> bubble. For WSLH PT participants, select the appropriate symbol from the drop-down field. 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 , option 1. USE THE PROFICIENCY TEST PATHWAY It is recommended that the Proficiency Test path be used on 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 before reporting. There is no reliable way of converting NONWARM ACT results to PREWARM ACT results. 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. 2 Art: AI Rev. Date: 22-APR-18

3 SAMPLE HANDLING It is especially important not to expose aqueous samples for blood gases and Ionized Calcium to air. The instructions in the Quality Control section of the i-stat System Manual under Transfer with Capillary Tube or Transfer with Syringe should be followed. Take care not to draw air bubbles into the transfer device. If there is only one ampule per level, the opened ampule may be exposed to air for too long to fill a second transfer device. Exposure to air could affect ph, PCO 2, PO 2 and ionized calcium results. If air is trapped between the leading edge of the solution and the syringe plunger, do not invert the syringe to expel it. Air trapped near the plunger will not affect results from the solution near the tip of the syringe, but may affect the sample as it passes through the syringe when being expelled. One or two drops should be expelled from a syringe before filling a cartridge. PROFICIENCY TEST FAILURES Certain PT survey samples are not compatible with i-stat System sensors and may contain interfering substances that could affect results. Fluorocarbon samples for blood gases and fixed-cell samples for hematocrit are not compatible with the sensors. Occasionally, results from non-whole blood samples may differ between older and newer generations of cartridges. These differences may be significant. Abbott Point of Care will work with PT providers to prevent i-stat System users from being unfairly penalized for PT failures that can be attributed to manufacturing changes. This is why it is important to record the cartridge type and lot numbers used to test samples. Note: the CLEW software prevents manufacturing changes from affecting results when testing patient samples. PROFICIENCY TESTING SURVEY PROVIDERS Note 1: This list may not include all providers and is not intended as an endorsement of any particular provider. Abbott Point of Care no longer evaluates surveys and assumes that for those surveys that list the i-stat System, compatibility has been confirmed by third-party testing or a history of adequate results. Note 2: Select a Proficiency test for Hematocrit which is formulated for a conductometric method. Proficiency Provider College of American Pathologists (CAP) 325 Waukegan Road Northfield, IL or College of American Pathologists (CAP) CAP AQI AQ3 Survey for blood gases and electrolytes: includes ica, Cl, Hct, Hb, Lac, PCO 2, ph, PO 2, K, Na, and TCO 2 CAP AQI AQ4 Survey for blood gases and electrolytes: includes all AQ3 analytes plus Glu, BUN, and Crea. Note: CAP does not include measured TCO 2 as a reportable value for AQI AQ3/ AQ4 surveys. PO 2 results should not be corrected for barometric pressure. CAP CT5 Survey for Activated Clotting Time (ACT) CAP Plasma Cardiac Markers (PCARM) Survey Samples are reconstituted with calcium chloride supplied by CAP. For use with i-stat ctni, CK-MB, and BNP cartridges. Whole Blood PT/INR (WP3) Rev. Date: 22-APR-18 Art: AI 3

4 Proficiency Provider (CAP) continued American Association of Bioanalysts (AAB) AAB Proficiency Testing Service 205 West Levee St. Brownsville, Texas CAP C Survey for General Chemistry and Therapeutic Drug Monitoring hcg, Serum (Immunology) American Association of Bioanalysts (AAB) Activated Clotting Time ( ) - (2 samples) Whole Blood Prothrombin Time ( ) - Chemistry, i-stat ( ) - Chemistry, i-stat, Waived ( ) - (2 samples) The CAP C Survey is a quantitative survey comprised of five liquid serum specimens. The only i-stat cartridge that the C Survey is recommended for is the i-stat Total ß-hCG cartridge. Qualitative/Quantitative Survey comprised of five liquid serum specimens. American Proficiency Institute (API) 1159 Business Park Drive Traverse City, MI American Proficiency Institute (API) i-stat Chemistry (including Blood Gases) - Catalog #145 - Catalog #A45 Verification Program - Catalog #945 Waived (2 samples) - Catalog #J45 Waived, Verification Program (2 samples) i-stat ACT (Activated Clotting Time) - Catalog #215 (2 samples) - Catalog #B15 Verification Program (2 samples) i-stat Protime/INR - Catalog #216 - Catalog #B16 Verification Program Cardiac Markers - Catalog #140 - Catalog #A40 Verification Program - Catalog #920 (2 samples) - Catalog #J20 Verification Program (2 samples) Calcium Chloride is included to reconstitute the samples. Calcium Chloride is included to reconstitute the samples. For use with i-stat ctni, CK-MB, and BNP cartridges. If additional sample is required for testing multiple cartridge types, please add on #165. HCG, Quantitative - Catalog #409 (5 serum samples) For use with the i-stat Total ß-hCG cartridge. 4 Art: AI Rev. Date: 22-APR-18

5 Proficiency Provider WSLH Proficiency Testing (WSLH PT) 2601 Agriculture Dr. Room 233 Madison, WI AccuTest Inc. P.O. Box Hayrick Lane Westford, MA oneworldaccuracy.com WSLH PT Activated Clotting Time (PT2030) Blood Gases / Electrolytes / Metabolites (PT01050) Blood Gas / Hemoglobin / Hematocrit, Add-on (PT01570) Blood Gases / Lytes / Metabolites with Hgb / Hct (PT01345) Electrolytes / Metabolites with Hgb / Hct Waived Methods (PT01400) Protime / INR Whole Blood (PT02370) Cardiac Markers 5 samples (PT01260) Cardiac Markers 3 samples (PT01230) Chemistry / Endocrinology / Therapeutic Drugs (CET) 5 samples (PT01310) AccuTest Inc. and Oneworld Accuracy Canada i-stat Blood Gas / Electrolytes / Hematocrit: - IBGH435 and - IBGH432 (2 samples - for waived testing.) Cardiac Markers - CARM432 (2 Samples) - CARM435 (5 Samples) Calcium chloride included. Includes PCO 2, ph, PO 2, Na, K, Cl, TCO 2, Crea, Glu, ica, Lac, BUN Same analytes as PT01050 plus Hgb & Hct. Calcium Chloride diluent included. For use with i-stat BNP, CK-MB, and ctni cartridges only. For use with i-stat Total β-hcg cartridges only. Includes ph, PCO 2, PO 2, Na, K, Cl, TCO 2, Glu, Lac, ica, Crea, Urea, Hct, Hgb Calc. Includes Cardiac Troponin I (ctni) and BNP. Oneworld Accuracy Canada (Canada Only) Fraserwood Court Burnaby, BC V5J 5H7 Canada oneworldaccuracy.com Chemistry/Immunoassay - BCHE435 - BCHE433 and 443 (3 samples) - BCHE432 (2 samples) Human Chorionic Gonadotropin - SHCG435 - SHCG432 (2 samples) For use with the i-stat Total β-hcg cartridge only. For use with the i-stat Total β-hcg cartridge only. Rev. Date: 22-APR-18 Art: AI 5

6 Proficiency Provider ACP-Medical Laboratory Evaluation (MLE) 25 Massachusettes Ave., NW Suite 700 Washington, DC , option mle@acponline.org American College of Physicians - Medical Laboratory Evaluation (MLE) i-stat Chemistry 1 - Catalog #817 (includes #818 & 847) i-stat Chemistry 2 - Catalog #818 i-stat Chemistry -Waived - Catalog #832 (Same as #818 above, but with 2 samples per shipment) Includes Cl, TCO 2, Crea, Glu, Hct, Hb, ica, K, Na, and BUN. Blood Gases and Lactate - Catalog #847 Includes Cl, ica, PCO 2, ph, PO 2, K, and Na. i-stat Protrombin Time/INR - Catalog #328 American Academy of Family Physicians - Proficiency Testing Program (AAFP - PT) American Academy of Family Physicians Proficiency Testing Program (AAFP-PT) Tomahawk Creek Parkway Leawood, Kansas pt@aafp.org Module i-stat Chemistry - (5 specimens) Module i-stat Chemistry/Blood Gas Combo - (5 specimens) Module i-stat Chemistry-Waived - (1 specimen) For G, Crea, E3+, EC4+, CHEM8+, and 6+ cartridges. For all cartridges listed for Module 700 plus EG6+, EG7+, CG8+, and EC8+. For CHEM8+, 6+, EC4+, E3+, G, and Crea cartridges. Module i-stat Blood Gases - (5 specimens) For G3+ and CG4+ cartridges. Module i-stat Protime/INR 6 Art: AI Rev. Date: 22-APR-18