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 5 - California Prenatal Screening Program › Article 5 - Requirements for State-Approved Comprehensive and Satellite Prenatal Diagnosis Centers and Laboratories to Perform Follow-up Services › Section 6548 - Suspension and Revocation of Laboratory Approval to Perform Follow-Up Services

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Approval for laboratories to perform cytogenomic and/or
						  cytogenetic tests on amniotic fluid and/or chorionic villus samples from
						  State-approved Comprehensive or Satellite Prenatal Diagnosis Centers for California
						  Prenatal Screening Program referrals may be suspended or revoked by the Department
						  if the laboratory:
(a) Knowingly makes a
						false statement of fact or omits to state a fact on an application that would have
						resulted in the denial of approval.
(b)
						Fails to comply with the provisions of the Prenatal Diagnosis Center Standards and
						Definitions 2022, incorporated by reference.
(c) Fails to operate and furnish services in
						compliance with all other applicable state laws, regulations, and local
						ordinances.
1. New
						  section filed 12-20-2019 as an emergency; operative 12-20-2019 pursuant to Health
						  and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2019, No. 51). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
2. Statement of Compliance pursuant to Health and Safety Code
						  section
						  124977(d)(1)
						  as to 12-20-2019 order filed 12-11-2020. Exempt from OAL review pursuant to Health
						  and Safety Code section
						  124977(d)(2).
						  Submitted to OAL for filing and printing only pursuant to Government Code section
						  11343.8
						  (Register 2020, No. 50).
3. Amendment of subsection (b) filed 7-18-2022
						  as an emergency; operative 7-18-2022 pursuant to Health and Safety Code section
						  124977(d).
						  Submitted to OAL for filing and printing only pursuant to Health and Safety Code
						  section
						  124977(d)
						  (Register 2022, No. 29). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
4. Amendment of subsection (b) refiled 9-9-2022 as an
						  emergency; operative 9-9-2022 pursuant to Health and Safety Code section
						  124977(d)
						  (Register 2022, No. 36). Pursuant to Health and Safety Code section
						  124977(d)(2),
						  these regulations shall remain in effect until revised or repealed by the
						  department.
Note: Authority cited: Sections
							 124977,
							 124980,
							 124996,
							 125000,
							 125065
							 and
							 131200,
							 Health and Safety Code. Reference: Sections
							 124975,
							 124980,
							 124990,
							 125000,
							 125001,
							 125050,
							 125055
							 and
							 125065,
							 Health and Safety Code.