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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. - PowerPoint PPT Presentation
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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
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
Operator Lockout Monitored for Three Random Units
8 8
3
00
45
01
0
2
00
2
4
6
8
10
May June July October*
Month
Num
ber
of
Una
utho
rized
Use
rs
5 North 6 East 9 North
*Post RALS Plus implementation with the operator lockout feature.
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
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
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
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
Quality Management Program
The Quality Management Program is built around sources of error based on the:
Device Operator Staffing
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
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.
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
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)
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
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
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
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
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
Postanalytical Factor
Data entryCalculation errors
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
CAP Gen .71032 – Phase I
Has the laboratory discontinued the use of
plain glass capillary tubes for specimen
collection and specimen handling?
Plastic capillary tubes
Roche microsampler, 240 l
RAM Scientific, 230 l
POCT Future
Noninvasive techniques Transcutaneous bilirubin Pulse oximetry
Connectivity Greater number of applications Decrease in size of immediate response
lab