Cal. Code Regs. tit. 17 § 1230

Current through Register 2024 Notice Reg. No. 36, September 6, 2024

Section 1230 - HIV Screening Testing by Laboratories

(a) All clinical laboratories that perform waived, moderate or high complexity tests or examinations to screen for human immunodeficiency virus (HIV) shall do all of the following:

(1) Utilize United States Food and Drug Administration (FDA) approved test systems in accordance with the manufacturers' instructions. Any laboratory that modifies a non-waived FDA-approved kit shall establish and verify the performance specifications pursuant to 42 Code of Federal Regulations Section 493.1253.

(2) Confirm all reactive or indeterminate HIV test results by following the HIV diagnostic protocols recommended by the federal Centers for Disease Control and Prevention, the Clinical and Laboratory Standards Institute, the Association of Public Health Laboratories or the U.S. Department of Health and Human Services prior to reporting the result as positive.

(3) Establish and maintain a quality assurance program that includes all of the following:

(A) Evaluation and documentation of testing personnel by direct observation, training, and competency testing to ensure tests are accurately performed and reported. This shall be done prior to testing, six months later and then yearly as long as assessment of test performance is acceptable. If the testing personnel fail any assessment of test performance given in subpart (B), the testing personnel shall be removed from testing, retrained and their competency re-evaluated.

(B) Assessment and documentation of test performance by testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples at least twice yearly and monitored by the laboratory director.

(b) Failure to comply with all the requirements of this section shall subject the laboratory to sanctions pursuant to Business and Professions Code Section 1320.

Cal. Code Regs. Tit. 17, § 1230

1. New section filed 1-21-86 as an emergency; effective upon filing (Register 86, No. 6). A certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 5-21-86.
2. Change without regulatory effect of group 9 and article 1 heading filed 2-7-86; effective upon filing (Register 86, No. 6).
3. Certificate of Compliance as to 1-21-86 order including amendment of section heading and subsections (b) and (f) transmitted to OAL 5-15-86 and filed 6-12-86 (Register 86, No. 24).
4. Amendment filed 1-8-90 as an emergency; operative 1-8-90 (Register 90, No. 4). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 5-8-90.
5. Amendment filed 5-11-90 as an emergency; operative 5-11-90 (Register 90, No. 25). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed by operation of law on 9-8-90.
6. Amendment filed 9-12-90 as an emergency; operative 9-12-90 (Register 90, No. 43). A Certificate of Compliance must be transmitted to OAL by 1-10-91 or the emergency language will be repealed by operation of law on the following day.
7. Certificate of Compliance including amendment transmitted to OAL 1-9-91 and filed 2-8-91 (Register 91, No. 11).
8. Repealer and new section filed 10-15-2009; operative 11-14-2009 (Register 2009, No. 42).
9. Amendment of subsection (a)(2) filed 6-26-2013 as an emergency; operative 6-26-2013 (Register 2013, No. 26). A Certificate of Compliance must be transmitted to OAL by 12-23-2013 or emergency language will be repealed by operation of law on the following day.
10. Amendment of subsection (a)(2) refiled 12-17-2013 as an emergency; operative 12-23-2013 pursuant to Government Code section 11346.1(d) (Register 2013, No. 51). A Certificate of Compliance must be transmitted to OAL by 3-24-2014 or emergency language will be repealed by operation of law on the following day.
11. Certificate of Compliance as to 12-17-2013 order transmitted to OAL 3-14-2014 and filed 4-16-2014 (Register 2014, No. 16).

Note: Authority cited: Sections 1603.1(f), 131050 and 131200, Health and Safety Code; and Section 1224, Business and Professions Code. Reference: Sections 1220 and 1265, Business and Professions Code; and Sections 1603.1, 101160, 120895, 131050, 131051 and 131052, Health and Safety Code.