Surviving the POCT Inspection
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Transcript of 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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Operator Lockout Monitored for Three Random Units
8 8
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45
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May June July October*
Month
Num
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Una
utho
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Use
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5 North 6 East 9 North
*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
ExpensesBefore
ConnectivityAfter
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 min84,858
$32,627.90
084,858$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; 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
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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
Diabetes Care 2002;25:1499-1503
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Uses of CGMS – Type I DM
Validate use of SMBG as a proxy for integrated blood glucose level
Diabetes Care 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
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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 < 80mm Hg - SMBG/Cont
- CPR, ICU ICU poor correlation in 1st 6hr due to stress
Scand J Clin Lab Invest 2002;62:285-92
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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
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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 entryCalculation 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