Title: i-STAT Operations and Testing Procedure

1 POCT ProgramMassachusetts general hospital - Pathology Service55 fruit Street, Boston, MA 02114 Title: i-STAT Operations and Testing ProcedureCross References: i-STAT Operator Training Checklisti-STAT INR Fingerstick Training and Assessment Recordi-STAT Competency Assessment 6-month and Annuali-STAT Instrument Competency-Written Testi-STAT Cartridge Temperature Storage Logi-STAT Instrument Corrective Action Logi-STAT Instrument Validation Logi-STAT Record of Receipt-QC Documentation Logi-STAT Training GuideMGH POCT Inter-Laboratory Correlation ProcedureMGH POCT QC Storage Ordering and Documentation GuidePOCT Proficiency Testing ProcedurePOCT Proficiency Testing Evaluation Worksheeti-STAT CLEW update formTitle (with LTR): i-STAT Operations and Testing Procedure (LTR19694)Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 8/11/2014 3:04:44 PM)1 Contents:Purpose.

2 2 Scope .. 2 Policy and Procedure 2 Proficiency Testing (For G3+, CG8+, CG4+, ACT, PT/INR and Troponin cartridges) .. 2 Regulatory Requirements .. 3 Competency Assessment .. 3 Limitations/Interferences .. 3 Test Kit/Supplies/Equipment .. 6 Calibration .. 7 Calibration Verification .. 7 Electronic Quality 7 Liquid Quality Control .. 8 Barcode 9 Reporting results .. 9 Preventive 9 Instrument Replacement Policy .. 10 Connectivity and LIS / HIS Down Time Procedure - OR .. 10 Connectivity and LIS / HIS Down Time Procedure - Imaging .. 12 Troubleshooting .. 13 Alternative method .. 13 References .. 13 Reference Ranges .. 14 ACT (Kaolin) Cartridge Procedure .. 16CG8+, CG4+, and G3+ Cartridges Procedure .. 20 Creatinine Cartridge Procedure .. 24PT/INR Cartridge Procedure .. 27 Troponin I Procedure .

3 31 Written By: Kim Gregory MT(ASCP)Date: 7/08 Nancy Toscano MT (ASCP)Date: 12/09 Title (with LTR): i-STAT Operations and Testing Procedure (LTR19694)Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 8/11/2014 3:04:44 PM)2 PurposeThis document outlines policies and procedures pertaining to Testing on the i-STAT . In an effort to be concise, some information from the manufacturer s recommended Procedure may be excluded. It is recommended that operators familiarize themselves with the manufacturer s product information that accompanies each package and their manual, if one of Personnel: All RN s, Catheterization lab techs, Perfusionists, Respiratory Therapists, Laboratory Technologists, and MD s who have successfully completed initial training and fulfilled the specific competency requirements for the complexity level of each cartridge.

4 Testing Site: Clinical sites approved and on file with the Pathology service s POCT Cartridges: G3+, CG8+, CG4+, Creatinine, ACT (Kaolin), PT/INR, Troponin IPolicy and Procedure StatementThe i-STAT is a portable clinical analyzer used in conjunction with i-STAT cartridges to obtain definitive quantitative measurements of ACT, blood gas parameters, lactate, creatinine, PT/INR and Troponin I utilizing i-STAT cartridges. The disposable cartridge contains all of the system s components (reagents, sensors, and waste container).Proficiency Testing (For G3+, CG8+, CG4+, ACT, PT/INR and Troponin cartridges)The College of American Pathologists (CAP) sends unknown samples to the laboratory for analysis several timesper year. Results are submitted to the CAP within 10 days of survey receipt. If a site fails 2 out of 3 events or twoconsecutive events according to federal law, it may be required to discontinue Testing .

5 All Survey results are to be handled and reported in the same manner as clinical results following the directions on the CAP Survey package insert. The samples are not to be analyzed in duplicate unless clinical specimens are analyzed in duplicate. Actions or decisions must be documented. Participation must be random and not assigned to specific individuals. Successful participation may be used as demonstrating successful competency for that year. Upon receiving the survey: The POCT program will contact the participating departments regarding the survey and the timeline of the survey to be performed. The departments must be available within the period identified by POCT. The Key operators must make sure of the following:oInstruments are in good working select staff to participate, but ensure that subsequent surveys are rotated among different staff ( document in a log)oMaintain original CAP survey form with the results the signed Attestation addition, retain copies of above in the files of Testing personnel.

6 Once results are obtained, they should be given to the POCT Coordinators who will send them to CAP via mail, fax or electronic entry on the CAP website. Site Director and CLIA certificate Director or designees shall review survey results to assess performance and ensure compliance with the standard and comment. Scores of 100% minimally requires documentation of review by the Director or designee. Scores between 100% and 80% requires a comprehensive investigation and remedial action documented of unsuccessful challenges. Scores less than 80% requires a comprehensive investigation and documentation of remedial action of unsuccessful challenges. Scores of less than 80 percent may jeopardize a sites ability to continue to perform Testing . Should a site fail proficiency, they will be required to immediately perform a comprehensive investigation and document remedial action.

7 Operator re-training may be required. In order to avoid cessation of Testing , a site failing a challenge will be expected to develop and implement a more aggressive plan for performance improvementTitle (with LTR): i-STAT Operations and Testing Procedure (LTR19694)Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 8/11/2014 3:04:44 PM)3 Each site is responsible for completing survey challenges when they Survey Periods:AQ3 (Blood Gases), & PCARM (Cardiac Markers)WP3 (PT/INR)CT-1/CT5 (Activated Clotting Time)Product ReceiptEvaluation receiptProduct ReceiptEvaluation receiptProduct ReceiptEvaluation receiptMarchAprilFebruaryMarchJanuaryFeb ruaryJuneJulyMayJuneJulyAugustOctoberNov emberSeptemberOctoberRegulatory RequirementsI.

8 Each Testing site must have a documented quality control program, which is developed in collaboration with or has been approved by the MGH Pathology All test results must be maintained in patient records with all required information for four years Required information:1. Patient s name2. Medical Record Number3. Patient s gender4. Patient s age or date of birth5. Date & time test collected, performed and reported6. Ordering Physician7. Responsible physician (if not 6)8. Reference or Target Range9. Test Performed10. Test units11. Lab name III. Additional information that must be retained for four years:1. Testing personnel records2. Quality control results 3. Product information ( serial number, lot numbers, expiration dates, etc.), information on quality control and any remedial action4.

9 QC charts, maintenance sheets, reference and critical rangesIV. Other 1. Universal precautions must be observed when handling any patient A physician s order or standing order is required prior to performing The hospital Hand Hygiene policy must be adhered to at all Linearity/Calibration VerificationThe POCT program will perform and document linearity/calibration verification checks every six months for non -waived cartridges if AssessmentTesting personnel must demonstrate competency prior to direct patient Testing . Refer to the individual cartridge procedures for specific competency requirements. All operators must read the Procedure manual and complete the Operator Training Checklist after initial training and Competency Assessment Checklist after completing the competency Operators:Operators that fail to meet competency requirements within 365 days will be locked out of the system.

10 They will be required to undergo retraining and competency assessment according to InterferencesTitle (with LTR): i-STAT Operations and Testing Procedure (LTR19694)Last Approved: Gregory, Kimberly (Electronic Signature Timestamp: 8/11/2014 3:04:44 PM)4An interferent is a substance, which, if present at significant levels in the blood specimen being analyzed, will produce an error in the result of the analyte being measured. For example, in the table below, -hydroxybutyrate at sample concentration level of 16 mmol/L would decrease the measured sodium by 5 Concentration/Effect on Analyte ResultACTI ncorrect handlingExogenously added heparin, citrate, oxalate or EDTAA nalyzer not maintained on a level surface during testingHeparinized syringeResults may be affected by >10%Will interfere with resultsCreatinineAcetaminophenAscorbateB romideCO2 CreatineN-acetylcysteineHydroxyurea1 mmol/L100 mg/dLWhen Creat < 2mg/dL:pCO2 >40 mmHgpCO2 < 40 mmHgWhen Creat >2mg/dL.