2001D-0044 Clinical Laboratory Improvement Amendments of 1988
FDA Comment Number : EC16
Submitter : Dr. Jan King Date & Time: 12/07/2005 09:12:05
Organization : Los Angeles County,Office of AIDS Programs
Category : Local Government
Issue Areas/Comments
This letter is to provide comment for the Draft Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications (Docket No. 2001D-0044).

The Los Angeles County, Department of Health Services, Office of AIDS Programs and Policy (OAPP)would like to submit strong concerns and comments regarding the Draft Guidance for CLIA Waiver Applications.

OAPP has extensive experience in implementing innovative approaches to diagnose new HIV cases and reduce the impact of the disease within our highly impacted communities of Los Angeles County. In addition, point of care testing serves as a rubric in our HIV Prevention Plan and response given its accessibility, scope, and high need. As we embrace and encourage the expansion of HIV counseling and testing services, these new recommendations would 1)drastically impact our ability to diagnose individuals with HIV and 2)possibly contribute to the increase of HIV transmission in Los Angeles County and the nation by reducing access to services.

More specifically,the impact of the proposed provisions to 1)exclude reportable diseases from being CLIA waived,2)re-defining the simple criteria for a CLIA wavier and 3) revise requirements for qualitative testing without regard to low prevalence disease such as HIV will create long-term detrimental effects on HIV prevention and case finding. For instance, from our informal communications with the Centers for Disease Control and Prevention the waiver trial will would require 2,100(prevalence 5%) to 6,000 patients(prevalence 2%)to obtain the required positive patient samples. In the case of HIV, this would be a larger clinical trial than that required for approval of the device. The proposed Guidance does not provide reasonable arguments to implement this shift in policy.

OAPP manages the largest testing program within the State of California, given this role, we have developed several systems to ensure the highest quality HIV, Sexually Transmitted Disease (STD), and Hepatitis C testing program. OAPP follows the intensive State Quality Assurance requirements including State mandated training for certified HIV counselors,competency assessment and laboratory proficiency protocols,and quality management processes.Additionally, County contracts with community-based providers include the ability to closely monitor the entire process of conducting HIV and STD tests by certified staff. OAPP also maintains a close working relationship with vendors to obtain ongoing technical assistance, education and training materials.

In addition,as a partner in the federal Advancing HIV Prevention Initiative, OAPP has encouraged new technologies and testing methods as encouraged through this Administration. Introducing and implementing new testing approaches is central to this partnership and to the goals of the AHP Initiative.

With the implementation of HIV rapid testing, OAPP-funded programs have diagnosed and counseled individuals who would never have been diagnosed with HIV if a community based rapid testing program was not able to implement a CLIA waived test. In addition, current rates of disclosure of HIV test results have increased drastically which decreases the spread of HIV.These recommendations would greatly reduce the opportunity for OAPP to help diagnose the almost 15,000 individuals in Los Angeles County who have HIV but do not know their status. Lastly,
access to the most current testing technologies within the populations that we serve will be greatly impacted through the current form of the Guidance. The cost of removing a highly accepted and community-routed intervention is immeasurable. OAPP is discouraged with this proposed reversal of current progressive policies that enhance HIV testing.

We appreciate the opportunity to comment on these recommendations and hope that the FDA strongly reconsiders their guidance. If you have any questions,please contact me.