California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 4 - Preventive Medical Service › Subchapter 9 - Testing for Heritable Disorders › Group 3 - Newborn Screening Program › Article 2 - Testing and Follow-up Program Requirements › Section 6503 - Newborn Screening Laboratory Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
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.