Section 6503 - Newborn Screening Laboratory Requirements(a) The Department shall designate laboratories and tests to be used for Department required newborn tests. Such laboratories shall be either laboratories operated by the Department for quality control confirmatory and emergency testing or contractor laboratories licensed as clinical laboratories under the Business and Professions Code.(b) Perinatal licensed health facilities and birth attendants shall submit required specimens to the newborn screening laboratory designated by the Department.(c) Contract newborn screening laboratories shall be limited to laboratories that shall have submitted a bid acceptable to the Department on a competitive contract to provide laboratory services in sufficient volume to cover all of the newborns born in a geographical area, as defined by the Department, plus an appropriate emergency capacity. The Department will define not more than six areas and may combine areas if necessary to reduce costs or assure statewide coverage.(d) Notwithstanding (c) above a comprehensive prepaid group practice direct health care service plan with 20,000 or more births in the last completed calendar year for which complete statistics are available may have a laboratory serving a comprehensive prepaid group practice health care service plan designated a newborn screening laboratory under terms of a written agreement as defined in Section 6508(b) or may provide services in conformity with the terms of a mutually acceptable contract for services.(e) Newborn screening laboratories shall participate in a proficiency testing program conducted by the Department's laboratory and shall maintain levels of performance acceptable to the Department.(f) Newborn screening laboratories contracting with the Department shall be subject to on-site inspections and review of laboratory performance of tests and laboratory records.Cal. Code Regs. Tit. 17, § 6503
1. New section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15).
2. Amendment filed 8-29-80 as an emergency; effective upon filing (Register 80, No. 35). A certificate of compliance must be filed within 120 days or emergency language will be repealed 12-28-80.
3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81 (Register 81, No. 3).
4. Amendment filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).
5. Amendment of subsections (d) and (e) 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).
6. Change without regulatory effect amending section heading 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 and 125000, Health and Safety Code. Reference: Sections 124980, 125000 and 125001, Health and Safety Code.
1. New section filed 4-11-80; designated effective 9-1-80 (Register 80, No. 15).
2. Amendment filed 8-29-80 as an emergency; effective upon filing (Register 80, No. 35). A certificate of compliance must be filed within 120 days or emergency language will be repealed 12-28-80.
3. Certificate of Compliance transmitted to OAL 12-15-80 and filed 1-12-81 (Register 81, No. 3).
4. Amendment filed 11-21-86; effective thirtieth day thereafter (Register 86, No. 47).
5. Amendment of subsections (d) and (e) 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).
6. Change without regulatory effect amending section heading and Note filed 10-12-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 41).