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