§ 1053. Clinical Laboratory Improvement Amendments (CLIA) Record Retention Regulations Determin...
17 CA ADC § 1053Barclays Official California Code of Regulations
17 CCR § 1053
§ 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:
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 |
Credits
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.
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 1053, 17 CA ADC § 1053
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