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Surviving the POCT Inspection

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Surviving the POCT Inspection. Best Practices for Ensuring Quality and Meeting ... Compliance improvement with connectivity. Quality ... GlucoWatch Biographer ... – PowerPoint PPT presentation

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Title: Surviving the POCT Inspection


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 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
5
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
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

9
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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

11
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12
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13
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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 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

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 Diabet
    es Care 2002251499-1503

18
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

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

20
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

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
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