Update on Waived Testing, December 2001
Problems with the CLIA Enrollment and Certification Process
In September 2001, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a report that identified vulnerabilities in the program enrollment and certification process of the CLIA program (see Lab Update, 2001-B P.O.L. Insight). The report states that significant vulnerabilities exist in the oversight of Waived and PPM labs, particularly due to the lack of routine visits. The report further states vulnerabilities also exist in Moderate and High complexity labs. The OIG made several recommendations to the Centers for Medicare and Medicaid Services (CMS), including:
- Provide educational outreach to lab directors of Waived and PPM labs.
- Require labs applying for Waived and PPM certificates to identify the tests they plan to conduct and the methods they will use.
- Establish a mechanism whereby Medicare claim denials can be used to inform surveyors about labs performing testing outside the scope of their certificate.
- Use periodic paper self-assessment tools to ensure compliance for labs that are not routinely inspected.
- Encourage CMS to conduct random surveys of some waived and PPMA labs each year.
- Review the Waived and PPM tests conducted in Moderate and High complexity labs during routine surveys to ensure CLIA compliance.
- Shorten the length of time between the application and survey for new labs.
- Establish a workgroup to develop methods that can be used to identify uncertified labs.
In its response, CMS concurred with the recommendations and stated that it already had plans to conduct random onsite surveys of some Waived and PPM labs, along with including surveys of Waived and PPM testing performed in Moderate and High complexity labs. While CMS concurred, it was noted that its ability to implement change would be impeded by a lack of resources, program priorities and funding.
The OIG's 2002 Work Plan includes monitoring lab compliance with their CLIA certificates, specifically monitoring whether the labs are performing tests outside their certificates and whether they are following manufacturer instructions and CLIA standards when performing tests.
The OIG's 2002 Work Plan includes monitoring lab compliance with their CLIA certificates, specifically monitoring whether the labs are performing tests outside their certificates and whether they are following manufacturer instructions and CLIA standards when performing tests.
FDA Withdraws Draft Waiver Guidance
The FDA has announced the withdrawal of its "Guidance for CLIA 88 Criteria for Waiver: Draft Guidance for Industry and FDA." This draft was originally intended to offer alternative criteria to be used in place of the proposed criteria published as a Notice of Proposed Rulemaking in the Federal Register on September 13, 1995, and outlined a systematic approach to the criteria for CLIA Waiver. As CMS has the authority to establish the criteria for waived tests, the FDA will continue to work with both CMS and the CDC to determine the next steps. In the interim, the FDA will use the criteria published in the 1995 Federal Register. The result could be a slow-down in the number and types of tests being granted waived status.
Physician Office Laboratory Topics
Update on Waived Testing, December 2001
