Cal. Code Regs. tit. 17 § 6507.6

Current through Register 2024 Notice Reg. No. 40, October 4, 2024

Section 6507.6 - Approval of Hemoglobin Testing Laboratories

(a) All laboratories that accept specimens from an approved sickle cell counseling program shall be in compliance with the Business and Professions Code governing licensed clinical laboratory operations and personnel (commencing with Section 1200 of the Business and Professions Code) or be an approved public health laboratory operated in accordance with the California Health and Safety Code, Section 101150 et seq.

(b) All laboratories involved in sickle cell screening as specified in this Article shall use a test or combination of tests with demonstrated ability to distinguish hemoglobins including F, A, S, C, D, and E, as well as the thalassemias.

(c) The State Department of Health Services shall have the responsibility of monitoring sickle cell screening laboratories coming under the scope of this Article. Such monitoring may be accomplished by on-site inspections and proficiency testing, or any other effective method. The Department may deny, revoke, or suspend the approval of any laboratory which does not comply or continue to comply with the above qualifications.

Cal. Code Regs. Tit. 17, § 6507.6

1. New section filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code section 309(g) (Register 90, No. 4).
2. Renumbering of section 6507.6 to section 6507.5 and renumbering of section 6507.7 to section 6507.6 filed 4-20-92 as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No. 40).
4. Change without regulatory effect amending section heading, section and NOTE filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).

Note: Authority cited: Sections 124980, 125000 and 125025, Health and Safety Code. Reference: Sections 124980, 125000, 125025 and 125030, Health and Safety Code.

1. New section filed by the Department of Health Services with the Secretary of State on 12-22-89 as an emergency; operative 12-22-89. Submitted to OAL for printing only pursuant to Health and Safety Code section 309(g) (Register 90, No. 4).
2. Renumbering of section 6507.6 to section 6507.5 and renumbering of section 6507.7 to section 6507.6 filed 4-20-92 as an emergency; operative 4-20-92 (Register 92, No. 18). A Certificate of Compliance must be transmitted to OAL 8-18-92 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 4-20-92 order transmitted to OAL 8-17-92 and filed 9-28-92 (Register 92, No. 40).
4. Change without regulatory effect amending section heading, section and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).