IQCP

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Category: Best Practices

Last Updated on Wednesday, 20 January 2021 11:08

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Updated 12/14/15

ASM together with CAP and CLSI have coordinated preparation of materials to help you address the CMS requirement for implementation of IQCP (Individualized Quality Control Plan) by January 1, 2016.

Below please find:
Examples of IQCPs for several clinical microbiology test systems. Please note that these are examples only and there are many ways you can develop your IQCP; CMS is not prescriptive on how your IQCP can best be done.

Links to those sites which we feel are most pertinent to clinical microbiology.

New Items

New! Microbiology Tests That do NOT Need an IQCP (12/14/15)

AST IQCP Example – Word version added (9/2/15)

Disk Diffusion IQCP Example – Word version added (9/2/15)

New! Streamlined ID System IQCP Example – Word and PDF versions (9/2/15)

New! CLSI-Exempt Media IQCP Example – Word and PDF versions (9/2/15)

CAP Common Checklist Items That Refer to IQCP (7/31/2015)

Materials Developed Collaboratively by ASM, CAP, and CLSI

Antimicrobial Susceptibility Testing

AST IQCP Introduction (5/31/2015)

AST IQCP Q&A (5/31/2015)

AST IQCP Template – PowerPoint and PDF versions (5/31/2015)

AST IQCP Example– PDF verson (9/2/2015)

AST IQCP Example– Word verson (9/2/2015)

Disk Diffusion IQCP Example– PDF version (9/2/15)

Disk Diffusion IQCP Example– Word version (9/2/15)

Other Tests

New! Streamlined ID System IQCP Example – PDF version (9/2/15)

New! Streamlined ID System IQCP Example – Word version (9/2/15)

New! CLSI-Exempt Media IQCP Example – PDF version (9/2/15)

New! CLSI-Exempt Media IQCP Example – Word version (9/2/15)

PowerPoint Presentations (6/8/2015)

Overview of CMS’ Vision for IQCP in Clinical Microbiology - Nancy Anderson, MMSc, MT(ASCP)

IQCP - Guidelines and Template for Getting Started - Linda C. Bruno, M.A., MT(ASCP)

Pulling It All Together - Real Life IQCP Examples - Susan E. Sharp, Ph.D., (D)ABMM, F(AAM)

List of Microbiology tests not requiring IQCP - Linda C. Bruno, M.A., MT(ASCP)

Audio for the preceding presentations can be purchased at https://www.pathlms.com/asm/events/375.

Materials Available from CMS

CMS Webpage Describing IQCP
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html

Letter Informing Laboratories about the IQCP option that contains significant detail about the program
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-54.pdf

Letter Informing Laboratories of the Removal of References to the Clinical Laboratory Standards Institute (CLSI) and to CLSI Documents from CLIA Survey Interpretive Guidelines (10/31/14)
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-07.pdf

CDC/CMS “Developing an IQCP Step-by-Step Guide”
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-Workbook.pdf

CMS FAQs – FAQs # 39-43 are specifically for microbiology
(revised April 2015) (see #39-42 which are specific for microbiology)
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/FAQs-IQCP.pdf

CLIA Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (1/9/15)
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-17.pdf