Cal. Code Regs. tit. 17, § 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. (1) 42 C.F.R. § 493.1105(a)(1)
2. (2) 42 C.F.R. § 493.1105(a)(2)
3. (3) 42 C.F.R. § 493.1105(a)(3)
4. (4) 42 C.F.R. § 493.1105(a)(3)(i)
5. (5) 42 C.F.R. § 493.1105(a)(5)
6. (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
  CLIA 2003
  Until diagnosed
  Subdivision (7)(iii)
  CLIA 2003

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.

History

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