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 |
Cal. Code Regs. Tit. 17, § 1053
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.