The FDA has withdrawn its draft waiver guidance and the criteria for waiver as published in the 1995 proposed waiver rule would be used for evaluation of requests for waived status. CLIAC sent its comments on the proposed criteria for waiver to the Secretary of Health and Human Services (HHS). Dr. Cowan (FDA) presented a report on the Blood Products Advisory Committee session (6/14/01) addressing the applicability of waivers to HIV rapid tests. The FDA will update CLIAC when substantive progress is made.
The CLIAC members discussed the proposed rule for the qualification requirements for directors of laboratories performing high complexity testing and concluded that Alternative 3 in the proposed rule was vague. CLIAC recommended that a higher standard be required as provided by certification from a board approved by HHS.
CMS anticipates publication of proposed QC/QA guidelines in the Federal Register no later than December 2002.
CDC is hopeful that a Quality Institute (QI) can be established to provide a forum for defining quality laboratory systems. The QI would include representatives from all areas of healthcare. CLIAC supports the development of the QI and a National Laboratory System.
Dr. Charache updated CLIAC on the work accomplished by the Secretary's Advisory Committee on Genetic Testing (SACGT). Both SACGT and CLIAC provide advice to CDC and HHS on CLIA requirements for genetic testing.
In Vitro Devices (IVD) Regulations
Kay Setzer, a manufacturer's liaison representative on CLIAC, presented a concise overview of the regulatory process for FDA approval of IVDs.
Health Insurance Portability and Accountability Act (HIPAA)
CLIAC recommended that HHS carefully review the apparent requirement in HIPAA that CMS "deemed" organizations must set up a "business associate" relationship with all laboratories receiving accreditation inspection and proficiency testing material.