(a)  Laboratories conducting HIV antibody testing shall be certified in accordance with this Rule.  The requirements for certification are as follows:

(1)           All laboratories, except the State Public Health Laboratory, shall be licensed under the Clinical Laboratory Improvement Act (CLIA), accredited by the College of American Pathologists (CAP), American Association of Blood Banks (AABB), or the Joint Commission on the Accreditation of Hospitals (JCAH), certified by the Health Care Financing Administration (HCFA) for Medicare or Medicaid, or accredited by a comparable program approved by the Director, State Public Health Laboratory.

(2)           Laboratories shall participate in a periodic proficiency testing program operated jointly by AABB and CAP or in a comparable periodic proficiency testing program with comparable standards of acceptable performance approved by the Director, State Public Health Laboratory.  Laboratories shall demonstrate an acceptable level of proficiency according to the standards of the testing program.

(3)           HIV antibody screening test results shall not be issued as final until all initially reactive tests have been repeated at least once, and all repeatedly reactive tests have been confirmed by the Western Blot method or a method approved by the Director, State Public Health Laboratory.  Preliminary results may be released after all initially reactive tests have been repeated but before a confirmatory test is done if the results are clearly marked as preliminary.  The results of both screening and confirmatory tests shall be transmitted to the ordering physician.

(4)           Laboratories shall perform HIV antibody tests only on specimens submitted by a physician licensed to practice medicine.

(b)  An application for certification shall be submitted to the Department of Human Resources listing the name and location of the laboratory requesting certification, the name of the laboratory director, and evidence that the laboratory meets the requirements listed in Paragraph (a).  Laboratories will be notified in writing within 45 days of the receipt of the application that they have been certified or, if certification has been denied, of the reasons for denial.

(c)  Certification must be renewed when licensing, accreditation or certification renewal is required by the program that has accredited the laboratory pursuant to Paragraph (a).  If a laboratory's license, accreditation or certification from one of these programs is suspended or revoked, the laboratory director shall immediately notify the department and the laboratory's certification under this Rule shall be revoked in accordance with G.S. 130A-23.  Certification may otherwise be suspended or revoked in accordance with G.S. 130A‑23 for violation of this Rule or for repeatedly issuing erroneous test results.  The laboratory may apply for recertification when it can provide evidence that it meets the requirements listed in Paragraph (a)‑(c).

(d)  Appeals concerning the interpretation and enforcement of this Rule shall be made in accordance with G.S. 150B.

(e)  Laboratories conducting HIV antibody testing may be certified under this Rule upon the Rule's effective date.  However, these laboratories are not required to be certified until July 1, 1988.


History Note:        Authority G.S. 130A‑148(a);

Temporary Rule Eff. February 1, 1988, for a period of 180 Days to expire on July 29, 1988;

Eff. March 1, 1988;

Transferred and Recodified from 10 NCAC 9D .0104 Eff. April 4, 1990;

Amended Eff. July 1, 1995.