To College of American Pathologists (CAP) Accredited Laboratories:
As a service to CAP-accredited laboratories, the CAP is providing the following information to help maintain continuous compliance. This is in response to changes in the Centers for Medicare & Medicaid Services (CMS) interpretive guidelines, effective January 1, 2016, that will remove the Equivalent Quality Control (EQC) option and replace it with the Individualized Quality Control Plan (IQCP) option. All laboratories performing nonwaived testing will be required to follow the default CLIA QC requirements, as written (two levels of external QC each day of testing or other specified frequency) or implement an IQCP to reduce the frequency of external quality control. IQCP is not applicable to waived testing.
To address these changes, the CAP will publish a new checklist edition in summer 2015 that will introduce new checklist requirements for nonwaived testing (CAP IQCP), and remove provisions for EQC (eg, the use of an internal electronic, procedural, or built-in control system on a daily basis in lieu of running traditional external control materials).
Effective January 1, 2016, all CAP-accredited laboratories must discontinue the use of EQC to meet daily QC requirements and implement an IQCP or utilize the default CLIA and CAP requirements, as written.
All CAP inspections occurring after January 1, 2016, will be evaluated for compliance with the revised QC requirements as published in the 2015 Checklist edition, regardless of the checklist edition being used for the inspection.
If a laboratory is located in a state that does not accept IQCP as an option for reducing the frequency of external QC, the laboratory must follow the state regulations and perform external QC each day of testing, following the frequency defined in the state regulations and yet to be published CAP 2015 checklists (whichever is more stringent).
The CAP's IQCP checklist requirements will meet or exceed the CLIA and CMS regulations for nonwaived QC performance. As with the CMS requirements, a laboratory may NOT implement an IQCP that allows QC to be performed less frequently than indicated in the manufacturer's instructions. The CAP will limit the eligibility for use of an IQCP to testing meeting both of the following criteria:
- Nonwaived tests that employ an internal (electronic/procedural/built-in) QC system
- Exception: Microbiology media and reagents used for microbial identification and susceptibility testing may implement an IQCP as defined in the checklist.
- Tests performed in specialties other than Anatomic Pathology and Cytopathology
- Exception: If an Anatomic Pathology or Cytopathology test can be assigned to a different CMS subspecialty, it may qualify (eg, FISH testing may be classified as either histopathology or cytogenetics).
The CAP checklist requirements will not require a specific IQCP format, but will allow laboratories to develop their own model or use other resources, such as the Clinical and Laboratory Standards Institute (CLSI) Guideline EP23-A, the CMS guidance, manufacturer protocols, or other commercially available products. The CAP will require laboratories to complete CAP forms that list and summarize their IQCP plans for inspector use during an onsite inspection. Additionally, the CAP is working collaboratively to produce templates for developing IQCP for microbiology. These will be available to participants on the CAP website, when available.
The CAP will provide information on IQCP requirements, including educational materials and training for laboratories and inspectors, on www.cap.org as they become available.
A complimentary IQCP webinar will be presented in August 2015, which will be available for download on the CAP website after the event. Registration for the webinar will open in June.
For now please review the following:
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