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 5 - Clinical Laboratory Operations › Section 1053 - Clinical Laboratory Improvement Amendments (CLIA) Record Retention Regulations Determined to be Less Stringent than California Law

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All clinical laboratories licensed or
						registered by the Department shall comply with those federal regulations adopted
						under the CLIA of 1988 (42 C.F.R.
						§
													493 et seq.), effective January 24, 2003,
						and published in the California Regulatory Notice Register 2016, Number 41-Z, pages
						1825-26, which became effective by operation of law as a state regulation adopted
						under Division 2, Chapter 3 of the Business and Professions Code on January 5, 2017,
						in accordance with Business and Professions Code section
						1208(c).
(b) In accordance with Business and Professions
						Code section
						1208(b),
						the department, in consultation with the Clinical Laboratory Technology Advisory
						Committee, has determined that the following subparts of the federal regulations
						adopted under the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. §
													493 et seq.), and effective January 24, 2003, are
						less stringent than California law. All clinical laboratories licensed or registered
						by the Department shall comply with applicable state law regarding retention of
						records and shall not comply with the following subparts of the above-referenced
						federal regulations, as indicated in Table 1:
Comparison of California and
						Federal Clinical Laboratory Record Retention Requirements
:
(1)
													42 C.F.R. §
														493.1105(a)(1)
(2)
													42 C.F.R. §
														493.1105(a)(2)
(3)
													42 C.F.R. §
														493.1105(a)(3)
(4)
													42 C.F.R. §
														493.1105(a)(3)(i)
(5)
													42 C.F.R. §
														493.1105(a)(5)
(6)
													42 C.F.R. §
														493.1105(a)(6)
TABLE 1
Comparison of California and Federal Clinical
						  Laboratory Record Retention Requirements
RECORD
								  TYPE
CA
								  REQUIREMENT
CA
								  LAW
FEDERAL
								  REQUIREMENT
FEDERAL LAW
								  42 CFR §
																				493.1105(a)
COMPLY WITH
Test requisition and authorization records
3
								  years
CBPC §
																	1265(j)(2)
2
								  years
Subdivision (1)
State Law
Test procedure records
3 years
CBPC
								  §
																	1265(j)(2)
2
								  years
Subdivision (2)
State Law
Quality control and patient test records
3
								  years
CBPC §
																	1265(j)(2)
2
								  years
Subdivision (3)
State Law
Test system performance specifications
3
								  years
CBPC §
																	1265(j)(2)
2
								  years
Subdivision (3)(i)
State Law
Immunohematology, blood, blood product, and
								  transfusion records
10 years
CLIA 2003
10
								  years
Subdivision (3)(ii)
CLIA 2003
Proficiency testing records
2
								  years
CLIA 2003
2 years
Subdivision (4)
CLIA
								  2003
Quality systems assessment records
3
								  years
CBPC §
																	1265(j)(2)
2
								  years
Subdivision (5)
State Law
Test reports
3 years
CBPC §
																	1265(j)(2)
2
								  years
Subdivision (6)
State Law
Immunohematology test reports
10
								  years
CLIA 2003
10 years
Subdivision (6)(i)
CLIA
								  2003
Pathology test reports
10 years
CLIA
								  2003
10 years
Subdivision (6)(ii)
CLIA 2003
Cytology slides and blocks
5
								  years
CLIA 2003
5 years
Subdivision (7)(i)(A)
CLIA
								  2003
Histopathology slides
10 years
CLIA
								  2003
10 years
Subdivision (7)(i)(B)
CLIA 2003
Pathology specimen blocks
2 years
CLIA
								  2003
2 years
Subdivision (7)(ii)
CLIA 2003
Tissue
Until diagnosed
C¶
								  2003
Until diagnosed
Subdivision (7)(iii)
CLIA 2003