Individualized Quality Control Plan (IQCP) (Or How I Spent My Summer Vacation)

Dave Warshauer, PhD., D(ABMM)

Deputy Director, Communicable Diseases

A. I’ve heard more than enough about IQCP. Let’s go on to the case study

B. Our lab has completed an IQCP

C. I’m a non-laboratorian, so I will be checking my email

D. I’m still confused about IQCP

E. I continue to procrastinate

4

Case 1

Shakespeare’s Query

IQCP

“The IQCP option offers your laboratory flexibility for meeting regulatory QC requirements appropriate for the testing you perform and when you add a new test” Allows a laboratory to reduce external control analysis to a frequency less than the limits defined in the CLIA regulations and the CAP checklists. Can be applied to all nonwaived tests. The IQCP must be approved by the laboratory director.

IQCP in Mycobacteriology

Test System IQCP

AFB Smear No CLIA-Fluorescent, Each time of use; Kinyoun, Each day of use

AFB Culture Media Yes; Exempt Media Maybe: Non-Exempt Media

AFB Identification No

AFB DST No; CLIA-Each week; Each batch of media and each lot number and shipment of antimycobacterial agent(s)

“This worksheet (Risk Assessment Worksheet)will help you update your QCP and QA activity. There is one worksheet for each of the five risk components. However, you can download or photocopy as many as you will need. There are no right or wrong answers to complete these worksheets. What is included in your plan will be specific for your laboratory testing process. Each of the five risk assessment components that you will evaluate has its own section that shows you how to evaluate that risk component based on the overarching scenario presented on page 10. Use that as a guide to develop and perform your own risk assessment”. Cindy Flacks CDR U.S. Public Health Service, Division of Laboratory Services, CMS Courtesy Ray Podzorski

Quality Control Plan (QCP)

“Risk Assessment” used to develop the Quality Control Plan

Risks identified are addressed in the QCP

How will these risks be controlled?

How often does QC need to be performed?

What QC materials are needed?

What are the criteria for QC acceptability?

MEDIA IQCP

Mycobacteriology Media

“EXEMPT”

AFB biphasic bottle mediium

Middlebrook 7H9 broth

Lowentstein-Jensen media

Middlebrook agar

Automated AFB broths

“NON-EXEMPT”

Middlebrook 7H10 agar

Middlebrook 7H11 agar

American Trudau Society (ATS) agar

Mitchison’s agar

Petragnani medium

CMS does not distinguish between exempt and non-exempt culture media

CAP Requirements

MIC.21240, MIC.31380, MIC.41200 An individualized quality control plan (IQCP), including all required elements of IQCP, may be implemented by the laboratory to allow for the acceptance of the quality control performed by the media supplier for media listed as "exempt" in the CLSI/NCCLS Standard M22-A3, Quality Control for Commercially Prepared Laboratories using exempt media that have not implemented an IQCP or are using media that do not qualify for an IQCP must continue to test each lot and shipment of media and maintain records of such testing.

For these tests –labs may do ‘default’ QC listed on this slide or IQCP

Test QC Frequency CMS/CLIA – Subpart K: 493.1256 (e) (4)

QC Frequency CAP: MIC.21240 MIC.31380 MIC.41200

Media

Each new batch, lot #, and shipment – check before or concurrent with initial use

- Sterility - Ability to support growth - Select or inhibit specific organisms - Produce biochemical response - Document…when

compromised…deterioration…

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Exempt-Media IQCP Risk Assessment-Informational Review

Documentation showing visual quality checks of media are acceptable

May include manufacturer’s quality certificates

Remel’s “Certificates of Quality” certify that media have met all performance and QC criteria

Remel has no recommendation for end-user QC of CLSI exempt media (http://www.remel.com/IFUs/TM93.pdf)

Summary of Historical In-House Data

Review data for last 12 months

Visual checks include:

Other Steps Taken to Assure Media Quality

Media is checked for contamination immediately before inoculation with specimens

Look for organisms growing on a medium and not on others when reading cultures

Statement of results---e.g.

1. CLSI Document M22-A3

Courtesy Susan Sharp

Courtesy Susan Sharp

Courtesy Susan Sharp

Courtesy Susan Sharp

Courtesy Susan Sharp

Courtesy Susan Sharp

Courtesy Susan Sharp

Courtesy Susan Sharp

Courtesy Susan Sharp

References – CLIA Brochures

• Brochure #11 - CLIA Individualized Quality Control Plan Introduction (IQCP)

• Brochure #12 - CLIA IQCP, Considerations When Deciding to Develop an IQCP

• Brochure #13 - CLIA IQCP, What is an IQCP?

• Brochure #4 - Equivalent Quality Control Procedures

• CAP Microbiology Checklist, 7-28-2015

• CAP All Common Checklist, 7-28-2015

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CMS IQCP Site 1. Step-by-Step Guide 2. Considerations When Deciding to Develop an IQCP

ASM Clinical Microbiology Portal 1. IQCP-Guidelines and Template for Getting Started—Linda Bruno

2. AST IQCP Examples 3. Disk Diffusion IQCP 4. Pulling It All together-Real Life

IQCP-Susan Sharp 5. List of Microbiology tests not

requiring IQCP-Linda Bruno

References

Acknowledgements

Linda Bruno

Susan Sharp

Ray Podzorski

Thank You

Extras

FORMS 3 Steps for IQCP

Nicole Cooney: Here is a question from Judith Bridges. All other IQCP webinars and symposiums I have attended indicate that the risk assessment includes what is the frequency of occurrence and severity of harm matrix for each possible error. There is no mention of this in the workbook. Cindy Flacks (CDR U.S. Public Health Service, Division of Laboratory Services, CMS): That’s a great question Judith, thank you. CMS does not have any such requirements.

IQCP for CLIA Laboratory Nonwaived Testing: Workbook Tool – Webcast Medicare Learning Network (MLN), July 15, 2015 Courtesy of Ray Podzorski