Surviving the POCT Inspection

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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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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

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Post RALS? Plus implementation with the operator
lockout feature.
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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 hrs 0 hrs
Nursing time spent responding to reports/3 mos 4.5 hrs 0 hrs
TOTAL unauthorized operators associated labor cost/3 mos 847.80 0.00
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Quality control failures Costs
POCT Cost Before Connectivity After Connectivity
Time spent troubleshooting/ 3 mos 3 hrs 15 min
TOTAL troubleshooting labor cost/3 mos 58.53 4.88
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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
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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

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Quality Management Program

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

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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

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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.

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MiniMed Continuous Glucose Monitoring System

• Interstitiul fluid glucose 40400 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

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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)

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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 Diabet
  es Care 2002251499-1503

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Uses of CGMS Type I DM

• Validate use of SMBG as a proxy for integrated
  blood glucose level
• Diabetes Care 2002251203-6
• Good correlation with HgbA1c
• Mean glucose for 3 days
• Ann Clin Biochem 200239516-7
• Area under glucose curves for 3 days,
• Diabetes Care 2002251840-4

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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 lt 80mm Hg - SMBG/Cont
• - CPR, ICU
• ICU poor correlation in 1st 6hr due to stress
• Scand J Clin Lab Invest 200262285-92

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Analytical Factors

• Glucose extremes lt40 gt400 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

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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

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Postanalytical Factor

• Data entry
• Calculation errors

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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

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CAP Gen .71032 Phase I

• Has the laboratory discontinued the use of plain
  glass capillary tubes for specimen collection and
  specimen handling?

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Plastic capillary tubes
Roche microsampler, 240 ?l
RAM Scientific, 230 ?l
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POCT Future

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