CAP/POCT 2003

1. CAP/POCT2003 Carol Riley-Hunte, RRT Senior Education Specialist Bayer HealthCare

2. Point of Care Testing • Point of Care Testing Checklist must be completed and accompanied by the Laboratory General Checklist (since the contents of that checklist apply to all laboratory activity, whether occurring in dedicated space or not).

3. What is POCT/Which Checklist Do I Use? • Temporarily brought to patient care location - surgery, ICU, etc. • POCT Checklist and/or Section Specific Checklist(e.g. Hematology,Microbiology) and • Lab General Checklist

4. Point of Care Testing If records are maintained in a central location only one copy of the POC checklist need be completed. If records are not maintained centrally a POC checklist must be completed for each location. POC programs may be inspected as sections or the central laboratory if they are registered under the same CLIA-88 number.

5. Top POC Deficiencies • Following the manufacturer’s instructions • Documentation of patient results in patient records • Patient identification • Operator identification • Failure to do QC

6. Top POC Deficiencies • Failure to respond to out-of-control situations • Unauthorized tester • Using outdated/ expired reagents • Failure to observe safety requirements

7. Checklist Topics • Proficiency Testing • Quality Control and Improvement • Procedure Manual • Specimen Handling • Results Reporting • Reagents • Instruments and Equipment • Calibration and Standards • Personnel

8. Sources Of Information • CLIA ‘88 www.HCFA.gov/medicaid/clia/cliahome.htm • CAP • www.cap.org • JCAHO • www.jcaho.org • NCCLS • www.nccls.org

9. POCT-Proficiency Testing POC.03200 Is the POCT program enrolled in the appropriate available graded CAP Surveys or a CAP approved alternate proficiency testing program for the patient testing performed?

10. Proficiency Testing POC-03225 For analytes where proficiency testing is not available, are other procedures used to validate performance at least semi-annually?

11. Proficiency Testing • Labs must be enrolled • Samples integrated with normal workload • Run by personnel normally involved in patient testing • Should be handled and run as if it were a typical sample received in the laboratory

12. Proficiency Testing • Evidence of active review of survey results • suggest laboratory manager and medical director sign and date results • Evidence of evaluation and corrective action (if indicated) in response to unacceptable result • written documentation of corrective action and ongoing monitoring of problem • Response must include action taken to prevent reoccurrence

13. Quality Control • System in place to immediately detect and correct • Analytical errors • Unusual results • How? • Review by supervisor, qualified person • Automatic “traps” for improbable results

14. Quality Control • Minimum weekly review of QC results by section supervisor • review needs to be documented • Minimum monthly review by lab director or designee • review needs to be documented • If It Isn’t Documented It Isn’t Done!

15. Quality Control • A good quality control program includes: • levels run by shift, define time to be run • CLIA defines a shift in 8 hour increments • type or level of control to be run • blood gas, HcT • frequency • control limits defined by laboratory • required response to out of control situations • documentation • time, results, and employee • review by supervisor

16. Procedure Manual • Procedure manual should reflect routine review and updating of procedures as appropriate • Procedures should include but not limited to: specimen collection, processing and test procedures • review by Lab Manager and Medical Director • reference ranges, reportable ranges and critical ranges • QC procedures, maintenance procedures and calibration procedures • Etcetera, etcetera,etcetera …

17. Specimen Handling • Pre-analytical • sample preparation • sample transport • sample ID • Analytical • running the sample • Post-analytical • documentation

18. Results Reporting • POC 04500: When applicable, are all patient results reported with accompanying reference ranges?

19. Results Reporting • POC.04525: Are reference intervals (normal ranges) established or verified for the population being tested? • specific for age and sex • specific for typical patient population

20. Results Reporting • POC.04550 Are critical limits established for the results of certain tests important for prompt patient management decisions? • POC.04700 Do the records indicate who performed each test?

21. Reagents • POC 04800: Are all reagents properly labeled with the following elements, as applicable and appropriate • content and strength, concentration, or titer • storage requirements • date prepared or received • date placed in service • expiration date

22. Instruments and Equipment • Is there evidence of active review of instrument maintenance and function, temperature, etc. for routine procedures on all shifts? • routine maintenance • corrective maintenance • preventive maintenance

23. Calibration and Standards Quantitative Testing POC.08700: Are multiple instruments that perform the same assays checked at least twice a year for calibration agreement and correlation of patient results?

24. Calibration and Standards • Are upper and lower limits of the CLINICALLY REPORTABLE RANGE for all reportable parameters on instrument systems defined, so results that fall outside these limits are reported appropriately?

25. Calibration - Why? • To provide a known relationship between the response measurement and the value of the substance being measured. • Ensures instrument integrity

26. Calibration Verification The process of confirming that the current calibration settings remain valid for a method • Required biannually • POC.08300:Are criteria established for calibration verification, and it’s compliance documented?

27. Calibration Verification • “ Calibration Verification” is required: • At changes of reagent lots for chemically or physically active or critical components. • When indicated by QC data • After major maintenance or service • When recommended by the manufacturer • minimum of every six months

28. Data Management • Information Management • Instrument Control

29. Questions

30. Disclaimer • The information just presented is to provide you with some tools, and to stimulate thought processes. • Bayer Diagnostics does not claim responsibility for your inspection, this is an educational service we provide to assist our customers. • The regulations change constantly, Bayer Diagnostics recommends you check the websites for updates