California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 8 - ENFORCEMENT › Section 1065.5 - Principal Sanctions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
						department may impose on a clinical laboratory the principal sanctions of denial,
						revocation or suspension of a registration or license issued under chapter 3 of
						division 2 of the Business and Professions Code whenever it determines that any of
						the grounds identified in Business and Professions Code section
						1320
						exist and it has complied with the requirements of Business and Professions Code
						sections
						1267
						and
						1322.
						A clinical laboratory that has had a Statement of Issues or an Accusation filed
						against it for the denial, revocation or suspension of its license or registration
						may defend itself, its owner(s) and director(s) by filing a notice of defense in
						accordance with section
						11506 of the
						Government Code. A clinical laboratory that is dissatisfied with a final decision
						regarding a denial, revocation or suspension may seek judicial review in accordance
						with section
						11523 of the
						Government Code.
(b) The department may
						impose on a public health laboratory the principal sanctions of denial, revocation
						or suspension of the approval to operate a public health laboratory granted under
						article 5 (commencing with section
						101150) of the Health and Safety Code
						whenever it determines that the requirements identified in
						17 CCR section
						1078 are not being met and it has complied with
						chapter 5 (commencing with section
						11500) of part 1 of division 3 of title
						2 of the Government Code. A public health laboratory that has had a Statement of
						Issues or an Accusation filed against it for the denial, revocation or suspension of
						its approval to operate may defend itself by filing a notice of defense in
						accordance with section
						11506 of the
						Government Code. A public health laboratory that is dissatisfied with a final
						decision regarding a denial, revocation or suspension may seek judicial review in
						accordance with section
						11523 of the
						Government Code.
(c) The department may
						impose on a provider of service the principal sanction of suspension from further
						participation in, including reimbursement from, the Medi-Cal and Medicaid programs
						whenever it determines that any of the grounds identified in Welfare and
						Institutions Code section
						14123
						exist and it has complied with chapter 5 (commencing with section
						11500) of part 1 of division 3 of title
						2 of the Government Code, except that hearings may be conducted by departmental
						hearing officers appointed by the director. A provider of service that has had an
						Accusation filed against it for its suspension from further participation in the
						Medi-Cal program may defend itself, its owner(s) or director(s) by filing a notice
						of defense in accordance with section
						11506 of the
						Government Code. A provider of service that is dissatisfied with a final decision
						regarding suspension from further participation in the Medi-Cal program may seek
						judicial review in accordance with section
						11523 of the
						Government Code.
1. New
						  section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A
						  Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency
						  language will be repealed by operation of law on the following day.
2.
						  Certificate of Compliance as to 8-28-98 order, including amendment of subsection
						  (b), transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No.
						  7).
Note: Authority cited: Section
							 1224,
							 Business and Professions Code; Section
							 100275,
							 Health and Safety Code; Stats. 1995, c.510, Section
							 1; and Section
							 14105,
							 Welfare and Institutions Code. Reference: Stats.1995, c.510, Section
							 1; Section
							 101160,
							 Health and Safety Code; Sections
							 1265,
							 1267,
							 1280,
							 1281,
							 1282,
							 1283,
							 1284,
							 1285,
							 1286,
							 1287,
							 1288.5,
							 1289,
							 1310,
							 1320,
							 1323,
							 1324
							 and
							 1326,
							 Business and Professions Code; Sections
							 11503,
							 11504,
							 11506 and
							 11523,
							 Government Code; 42 USC, Section
							 1395x(s) [Section
							 1861(s) of the Social
							 Security Act]; 42 United States
							 Code, Section 1395w-2 [Section
							 1846 of the federal Social Security
							 Act]; 42 United States Code,
							 Section 1396a(a)(9)(C) [Section
							 1902(a)(9)(C) of the
							 federal Social Security Act]; 42
							 United States Code, Section
							 1396a(a)(30) [Section
							 1902(a)(30) of the
							 federal Social Security Act]; 42
							 USC Section 1396a(p) [Section
							 1902(p) of the Social
							 Security Act]; 42 CFR Section
							 1002.2;
							 42 CFR Sections
							 1001.201 through
							 1001.1701; Section
							 14123, Welfare and Institutions Code;
							 and 42 CFR Section
							 493.1840.