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 1065.10 - Intermediate Sanctions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) The
						department may impose on a clinical laboratory the intermediate sanction of
						temporary suspension of a registration or license issued under chapter 3 of division
						2 of the Business and Professions Code based on a departmental finding of immediate
						jeopardy or other grounds identified in Business and Professions Code section
						1323.
						The intermediate sanction becomes effective upon the serving of an Accusation. A
						clinical laboratory that has had an Accusation filed against it for temporary
						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
						1323
						of the Business and Professions Code. Regardless of a notice of defense being filed,
						the temporary suspension remains in effect at least until the hearing is completed
						and the department has made a final determination on the merits. A clinical
						laboratory that is dissatisfied with a final determination on the merits may seek
						judicial review in accordance with section
						11523 of the
						Government Code.
(b) The department may
						impose on a public health laboratory the intermediate sanction of temporary
						suspension of the approval to operate a public health laboratory granted under
						article 5 (commencing with section
						101150) of the Health and Safety Code
						based on a departmental finding of immediate jeopardy. The intermediate sanction
						becomes effective upon the serving of an Accusation. A public health laboratory that
						has had an Accusation filed against it for temporary suspension of its approval may
						defend itself, its owner(s) and director(s) by filing a notice of defense in
						accordance with section
						11506 of the
						Government Code. Regardless of a notice of defense being filed, the temporary
						suspension remains in effect at least until the hearing is completed and the
						department has made a final determination on the merits. A public health laboratory
						that is dissatisfied with a final determination on the merits may seek judicial
						review in accordance with section
						11523 of the
						Government Code.
(c) The department may
						impose on a provider of service the intermediate sanction of temporary suspension
						from participation in, including reimbursement from, the Medi-Cal and Medicaid
						programs based on a departmental finding of immediate jeopardy or condition level
						deficiencies and when in the opinion of the director of the department such action
						is necessary to protect the public welfare or the interests of the Medi-Cal program.
						The intermediate sanction becomes effective upon the serving of an Accusation. A
						provider of service that has had an Accusation filed against it for temporary
						suspension from participation in the Medi-Cal program may defend itself, its
						owner(s) and director(s) by filing a notice of defense in accordance with section
						11506 of the
						Government Code. Regardless of a notice of defense being filed, the temporary
						suspension remains in effect at least until the hearing is completed and the
						department has made a final determination on the merits. A provider of service that
						is dissatisfied with a final determination on the merits 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.