1. Surviving the POCT Inspection Best Practices for Ensuring Quality and Meeting Regulatory Requirements. A Laboratory Perspective. Frederick L. Kiechle, MD, PhD Chairman, Department of Clinical Pathology Medical Director, Beaumont Reference Laboratory William Beaumont Hospital Royal Oak, MI

2. Outline Compliance improvement with connectivity Quality management program for unit use devices Continuous glucose monitors: pre- analytical, analytical and post-analytical factors Plastic capillary tubes

3. *Post RALS Plus implementation with the operator lockout feature.

4. Unauthorized operators on all 61 nursing units before and after connectivity: Costs Expenses Before Connectivity After Connectivity POCT time spent on creating and issuing reports/3 mos 36 hrs0 hrs Nursing time spent responding to reports/3 mos 4.5 hrs0 hrs TOTAL unauthorized operators associated labor cost/3 mos $847.80$0.00

5. Quality control failures: Costs POCT Cost Before Connectivity After Connectivity Time spent troubleshooting/ 3 mos 3 hrs15 min TOTAL troubleshooting labor cost/3 mos $58.53$4.88

6. Reduction in labor costs after interface of the Inform with the LIS: 3 month period Expenses Before Connectivity After Connectivity Manual result LIS entry: Average time/single result Average number results/3 mos Labor cost 1 min 84,858 $32,627.90 0 84,858 $0.00 Performing manual audits: Time required/3 mos Labor cost 24 hrs $468.24 0 $0.00 TOTAL labor costs related to manual result entry and audits $33,096.14$0.00

7. Conclusion Point of care connectivity reduces user error, increases program compliance and decreases POCC and nursing costs Point of care connectivity resulted in a total annual cost saving of $119,092

8. Quality Management Program The Quality Management Program is built around sources of error based on the: Device Operator Staffing

10. Quality Management for Unit-Use Testing Proposed Guideline: NCCLS Document EP- 18-P release for review (about 8/99) QC should be performed periodically to access: Reagent storage conditions Operator competency Electronic QC should be performed when possible

14. So – Here We Are! The continuous measurement of glucose for a subset of difficult to control insulin- treated diabetes in a hospital is very appealing in the face of a shortage of MTs and nurses to perform POCT glucoses. However, the current continuous measurement devices are dependent on capillary glucose values for calibration.

15. MiniMed Continuous Glucose Monitoring System Interstitiul fluid glucose; 40–400 mg/dL measures every 10 sec and averages over 5 min for 72 hour (288/24hr) Calibration: 4 SMBG throughout the day retrospective) which compares glucose meter/CGMS sensor data pairs of results by linear recognition Data downloaded to computer: cannot calculate area under curve No alarms

16. GlucoWatch Biographer Transdermal extraction of interstitial fluid glucose; 40 – 400mg/dL using low-level electric current Extracts for 3 min; measures glucose, 7 min Cycle time between measurements: 20 min Periodic calibration with SMBG Alarm for perspiration +/or hypoglycemia Glucose oxidase and amperometric sensor (hydrogen peroxide)

17. Uses of CMGS – Type I DM Determine the number of episodes of nonsystomatic nocturnal hypoglycemia/hyperglycemia Reportable range 40 – 400mg/dL Calibration: 4 comparisons with SMBG device throughout this range Tightly controlled type I values do not vary enough for adequate calibration falsely low CMGS results which may lead to inappropriate decrease in overnight insulin dose Diabetes Care 2002;25:1499-1503

18. Uses of CGMS – Type I DM Validate use of SMBG as a proxy for integrated blood glucose level Diabetes Care 2002;25:1203-6 Good correlation with HgbA1c Mean glucose for 3 days Ann Clin Biochem 2002;39:516-7 Area under glucose curves for 3 days, Diabetes Care 2002;25:1840-4

19. Preanalytical Factors Arterial vs. venous vs. capillary blood- SMBG Inadequate instrument cleaning- SMBG Incorrect QC procedure- SMBG/Cont Sweat on body temp extremes - Cont - nocturnal hyperemia (vasodilation) Systolic bp < 80mm Hg- SMBG/Cont - CPR, ICU ICU poor correlation in 1 st 6hr due to stress Scand J Clin Lab Invest 2002;62:285-92

20. Analytical Factors Glucose extremes: 400 mg/dL - SMBG/Cont Hematocrit extremes - SMBG/Cont Improper technique - SMBG/Cont IV dopamine: inhibits GO Rx - SMBG/Cont Low total fraction - SMBG/Cont Oxygenation status (PO 2 ) - SMBG/?Cont Premature sensor failure with loss of data - Cont

21. Analytical Factors (cont.) Direct oxidation of electroactive - SMBG/Cont species - ascorbate, urate, acetominophen Implantation side inflammation: - Cont decreased sensitivity of sensor – catalase/ myeloperoxidase from granulocytes Protein coating sensor surface- Cont

22. Postanalytical Factor Data entry Calculation errors

23. Future Internal calibration system which would detect potential interferences with direct oxidation of electroactive species at the amperometric sensors, inflammation at the implementation site and/or protein coating of the sensor surface – alarms Wireless connectivity to LIS/HIS Software to calculate area under the curve

24. CAP Gen.71032 – Phase I Has the laboratory discontinued the use of plain glass capillary tubes for specimen collection and specimen handling?

25. Plastic capillary tubes Roche microsampler, 240 l RAM Scientific, 230 l

26. POCT Future Noninvasive techniques Transcutaneous bilirubin Pulse oximetry Connectivity Greater number of applications Decrease in size of immediate response lab