Statutes, codes, and regulations
California Code Of Regulations
Title 17 - Public HealthDivision 1 - State Department of Health ServicesChapter 2 - LaboratoriesSubchapter 1 - Service LaboratoriesClinical 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

Cal. Code Regs. tit. 17 § 1053

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Current through Register 2024 Notice Reg. No. 23, June 7, 2024
Section 1053 - Clinical Laboratory Improvement Amendments (CLIA) Record Retention Regulations Determined to be Less Stringent than California Law
(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 TYPECA REQUIREMENTCA LAWFEDERAL REQUIREMENTFEDERAL LAW 42 CFR § 493.1105(a)COMPLY WITH
Test requisition and authorization records3 yearsCBPC § 1265(j)(2)2 yearsSubdivision (1)State Law
Test procedure records3 yearsCBPC § 1265(j)(2)2 yearsSubdivision (2)State Law
Quality control and patient test records3 yearsCBPC § 1265(j)(2)2 yearsSubdivision (3)State Law
Test system performance specifications3 yearsCBPC § 1265(j)(2)2 yearsSubdivision (3)(i)State Law
Immunohematology, blood, blood product, and transfusion records10 yearsCLIA 200310 yearsSubdivision (3)(ii)CLIA 2003
Proficiency testing records2 yearsCLIA 20032 yearsSubdivision (4)CLIA 2003
Quality systems assessment records3 yearsCBPC § 1265(j)(2)2 yearsSubdivision (5)State Law
Test reports3 yearsCBPC § 1265(j)(2)2 yearsSubdivision (6)State Law
Immunohematology test reports10 yearsCLIA 200310 yearsSubdivision (6)(i)CLIA 2003
Pathology test reports10 yearsCLIA 200310 yearsSubdivision (6)(ii)CLIA 2003
Cytology slides and blocks5 yearsCLIA 20035 yearsSubdivision (7)(i)(A)CLIA 2003
Histopathology slides10 yearsCLIA 200310 yearsSubdivision (7)(i)(B)CLIA 2003
Pathology specimen blocks2 yearsCLIA 20032 yearsSubdivision (7)(ii)CLIA 2003
TissueUntil diagnosedC¶ 2003Until diagnosedSubdivision (7)(iii)CLIA 2003

Cal. Code Regs. Tit. 17, § 1053

1. New section filed 6-11-2020; operative 10-1-2020 (Register 2020, No. 24). For prior history, see Register 96, No. 25.

Note: Authority cited: Sections 1208 and 1224, Business and Professions Code; and Section 131200, Health and Safety Code. Reference: Sections 1220, 1225 and 1265, Business and Professions Code; and Sections 131050, 131051 and 131052, Health and Safety Code.

1. New section filed 6-11-2020; operative 10/1/2020 (Register 2020, No. 24). For prior history, see Register 96, No. 25.