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Surviving the POCT Inspection

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.

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Surviving the POCT Inspection

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  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

  5. Quality control failures: Costs

  6. Reduction in labor costs after interface of the Inform with the LIS: 3 month period

  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

  9. 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

  10. 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.

  11. 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

  12. 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)

  13. 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

  14. 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

  15. 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 1st 6hr due to stress Scand J Clin Lab Invest 2002;62:285-92

  16. Analytical Factors • Glucose extremes: <40; >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 (PO2) - SMBG/?Cont • Premature sensor failure with loss of data - Cont

  17. 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

  18. Postanalytical Factor • Data entry • Calculation errors

  19. 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

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

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

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

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