Risk Assessed QC Plan i-STAT Lactate POC Forum July 31, 2014 Lou Ann Wyer, MS, MT(ASCP), CQA (ASQ) Sentara Healthcare

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Case Study for Risk Assessed QC Plan Sentara POC Program  350 i-STATs  12 facilities  Lactate, POC method  Lactic acidosis - forerunner of major medical illnesses 



High mortality rate 

values > 4mmol/L 2

Measuring System Information Medical Requirements for the Test Results

Regulatory and Accreditation Requirements

Measuring System Information: •Provided by the manufacturer •Obtained by the Laboratory

Information about Health Care and Test Site Setting

PROCESS: Risk Assessment Corrective and Preventive Action and Continual Improvement

OUTPUT: Quality Control Plan

PROCESS: Post-implementation Monitoring

CLSI. Laboratory Quality Control Based on Risk Management; Approved Guideline. CLSI document EP23-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.

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Types of QC in our QC Toolbox Quality Program Element

Strengths

Weaknesses

Does My System Have This?

LQC Liquid based quality control materials

Readily available Sequestered lot number Long out-date Ranges already established Know if performance is acceptable

Cost

Yes, LQC materials provided by the manufacturer Establish in-house ranges Perform 1H/1L each analyzer monthly

Function Checks

Internal and automatic Monitors electronics of test system Quality checks prevent reporting of results

May not monitor the entire process (i.e., sample) Does not detect hemolysis or interferences

Yes, except for hemolysis index and interferences

Calibration Verification

Identifies that calibrators, reagents, instrument, and calibration algorithm are working

Labor intensive

Yes, material provided by manufacturer Perform with each new/replacement device Perform on each cartridge type twice per year

Proficiency Testing

Confirms proper technique by testing personnel Confirms proper operations of test system

Does not carry over to individual patient samples

Yes, provided by CAP 40 measurements (2011)

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Types of QC in our QC Toolbox Internal ProficiencyMethod Comparisons

 

Identification of Implausible Values

New employee orientation

 

    

Confirms comparison of methods for random selected tests Ensures POC method is aligned with lab method or another analyzer



Informs operator/POCC of results outside established ranges Software rules stop values from automatically posting to the chart



All new employees who will be using test system Direct observations Conducted by POCC for consistency Identify learners who need more 1:1 First impressions of POCT



Does not carry over to each patient test (unit-use)



 



Yes, conducted by POCC Perform patient sample for each sensor type monthly Perform LQC for each analyzer monthly

Does not determine reason for value (operator, specimen, etc) May delay results from getting to chart



POCC monitors daily

Resource heavy



Yes, conducted by POCC

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Information for Risk Assessment Regulatory and Accreditation Standards  Measuring system  Literature Search  Lab and testing unit information  Medical requirements for test results  Known interferences 

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Process Map Method Validation: precision, accuracy, methods, reference ranges, procedures

Medical Director approval

Test System Ready

Operator training and competency

MD order/protocol in EMR Equipment and supply acquisition and storage Collect Venipuncture Sample

Patient identification

Label Specimen

START

Charge cartridge

Evaluate Results

Yes

No

Evaluate Results

Scan operator, patient ID and cartridge pouch Select test/panel

Troubleshoot

System quality check code? No

Repeat test

Send specimen to the Laboratory for testing

Match clinical picture? Yes

Release results to EMR

END

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Fishbone Diagram – POC Lactate Samples

Sample Integrity: -Collection Technique -Hemolysis -Correct tube/fill -Time to test -Specimen Labeling -Interferents

Operators Operator Capacity: Sample Preparation: -Orientation/Training -Competency -Mix well prior to loading -Correct cartridge type Data Entry: -Sample type -Bubbles -Test Select -Over/under fill -Cartridge handling Operator Staffing

Identify Potential Hazards Cartridge, QC Materials: -Shipping -Storage -Expired -Preparation/handling -Acceptance -Availability Cal Ver Materials: -Shipping -Storage -Expired -Preparation/handling

Reagents

Measuring System Instrument Failure: -Dead Battery -EQC failure -Software failure -Quality check codes

Maintenance Failure: -Pin Conditioning -Blood/liquid contamination

Incorrect/Delayed Test Result

Atmospheric Environment: -Temperature -Humidity -Dust

Utility Environment: -Electrical -IT/networks

Instrument availability

Lab Environment

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TEST SYSTEM: Point-of-Care Whole Blood Lactate

Means of Failure Detection

Engineering Controls Operator Training Are there Can operators reduce manufacturer checks or detect failures to reduce the through training? probability of failure?

General Comments or Other LaboratoryImplemented Monitor What other processes can the laboratory implement to detect failure?

Mandatory Observations Operator ID during training required for trained sessions staff

Operator Lockout/warning

PLMS modules Certified trainers

PLMS transcripts POCT Database

Mandatory Safety Habits Operator ID Direct required for trained Observations staff

Operator Lockout/warning

PLMS modules Certified observers/Skills Operator ID

PLMS transcripts Skills Fairs POCT Database

Steps List the stage or aspect of the test system’s process under investigation.

Failure Mode List all manners in which failure could occur in this step.

Causes List all causes of the failure mode that have the potential to produce incorrect test results.

Internal Controls Are there internal biological or procedural controls to detect failure?

Operator Training and Competency

Capacity

Orientation/ Training

Competency

External Controls Can external controls increase the probability to detect failure?

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TEST SYSTEM: Point-of-Care Whole Blood Lactate

Means of Failure Detection

Steps List the stage or aspect of the test system’s process under investigation.

Failure Mode List all manners in which failure could occur in this step.

Measuring Instrument System Failure Error Message or Malfunction

Engineering Causes Internal Controls External Controls Controls Operator Training List all causes of the Are there internal Can external controls Are there Can operators reduce failure mode that biological or increase the manufacturer checks or detect failures have the potential to procedural controls to probability to detect to reduce the through training? produce incorrect test detect failure? failure? probability of failure? results.

General Comments or Other LaboratoryImplemented Monitor What other processes can the laboratory implement to detect failure?

Electronic instability

Internal QC performed every 8 hrs. FAIL message displays on screen

External electronic simulator performed as needed

Lock-out for failures

Train operators to perform external simulator when needed. Contact POCC for assistance.

POCC’s review EQC results daily

Dead Battery

Battery status displayed on analyzer screen

NA

Battery status displayed on analyzer screen

Train operators to routinely observe battery status.

Two 9-volt lithium batteries, or rechargeable battery available in the laboratory

Quality Check Codes

Each code is indicative of a type of error

No

Guardian reports

Contact POCC for assistance. Review troubleshooting tips with operators.

Train POCC's on software applications and identification/followup to quality check codes. Review quality check codes monthly for trending.10

Residual Risk Assessment TEST SYSTEM: Point-of-Care Whole Blood Lactate

Targeted Failure Mode (Hazard)

Measuring System Feature or Recommended Action

Known Limitation of Feature or Recommended Action

Control Process Effective?

The IQCP Actions Required to Address Known Limitations

Residual Risk Acceptable? (Yes/No)

Operator Competency

Operator Lock-out (mandatory Operator ID required for trained staff)

Provide multiple forms of competency to address testing & QC procedures, maintenance, troubleshooting, proficiency samples

Y

Y

Temp control card with a four-window indicator to monitor temp during transit.

Perform LQC with each shipment

Y

Operator Lock-out QC Lock-out Transmission Lockout Skills Fairs PLMS interactive modules Direct Observations Proficiency testing Results review Perform LQC # and patient samples with each shipment

Shipping (Cartridges)

Y

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Data to Justify QC Plan LQC  Old lot vs. new lot  Acceptance studies  Internal proficiency with patient samples  CAP acceptable limits 

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Delta Lactate

Scatterplot of Delta Lactate vs Lactate Old Lot 1.0

1

0.5

0.5

0.0

0

-0.5

-0.5

-1.0

-1 2

4

6

8 10 12 Lactate Old Lot

14

16

Old Lot Number T10330 Y10352 Y11074 Y11167

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i-STAT Lactate QA by Risk Management Power Analysis Power Curve for Paired t Test 1.00 0.95

Sample Size 3 4 5 6

0.80

A ssumptions A lpha 0.05 S tDev 0.13 A lternativ e N ot =

Power

0.60

0.40

0.20

0.00

-1.0

-0.5

0.0 Difference (mmol/L)

0.5

1.0 14

i-STAT Lactate Proficiency Testing with Laboratory Instrument 16

Fits Regress Lowess

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Lot Number T10330 W11245 Y10352 Y11074 Y11146 Y11167

i-STAT (mmol/L)

12 10

OLS

Lowess

8 6 4 2 0 0

2

4

6 8 10 12 Laboratory Method (mmol/L)

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16 15

i-STAT Lactate QA by Risk Management Power Analysis Control Level 1 Power Curve for 2-Sample t Test 1.00 0.95

Sample Size 3 6

0.80

A ssumptions A lpha 0.05 S tDev 0.2 A lternativ e N ot =

Power

0.60

0.40

0.20

0.00

-1.0

-0.5

0.0 Difference

0.5

1.0 16

Lactate Testing – QCP QC Toolbox Electronic QC

Acceptance studies

Monthly LQC Calibration Verification

QC Plan 

Every 8 hours  QC, Operator, Transmission Lock-outs  2H/2L, 5 patients with each shipment 

4H/4L (min), each cartridge type  3 levels in triplicate, every 6 months 17

Lactate Testing – QCP QC Toolbox

QCP

Internal proficiency for comparative methods



External Proficiency program



New/replacement devices



1 patient monthly for each sensor type vs Lab analyzer CAP survey sets

LQC (2 H/2 L x10)  Patient sample (1)  Calibration verification (3 levels in triplicate) 18

Lactate Testing – QCP QC Toolbox Orientation/Training Competency

QCP 

Provided by POCCs  Interactive PLMS  Direct Observations  Proficiency surveys  Skills Fairs  Results review

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Post-Implementation Monitoring Evaluate the effectiveness  Unacceptable findings? 

Troubleshoot  Determine cause  Assess the risk to the patient  Corrective action 





Modify QC Plan to prevent recurrence

Document, document, document 20

Lessons Learned Start early  Consider all current processes  Review current data  Monitor for effectiveness 

Q&A

Questions?

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