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§ 1051. Proficiency Testing Services.

17 CA ADC § 1051Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 2. Laboratories (Refs & Annos)
Subchapter 1. Service Laboratories
Group 2. Clinical Laboratory Regulations
Article 5. Clinical Laboratory Operations
17 CCR § 1051
§ 1051. Proficiency Testing Services.
A service may be approved by the department for proficiency testing laboratories providing the service:
(a) Makes available to each participating laboratory
(1) Materials not less than four times during each calendar year for testing those procedures which have been designated by the department for evaluation,
(2) Acceptable forms for reporting results of proficiency testing,
(3) An evaluation of test results reported by the participating laboratory showing acceptable results based on a reference system approved by the department, and
(4) A summary of results reported by all participating laboratories prepared at least annually.
(b) Provides the department with an adequate description of acceptable procedures for
(1) The preparation and distribution of test materials,
(2) The determination of limits of acceptable test results, and
(3) The reporting of results of performance to the laboratories subscribing to the service.
(c) Establishes and maintains an adequate reference system for each procedure evaluated. The names and addresses of all laboratories used as reference or referee laboratories by the service must be provided to and approved by the department.
(d) Maintains records of proficiency testing including reports for participating laboratories for a period of not less than five years, such records being available to the department for reference upon request. These records must include:
(1) The names and addresses of laboratories subscribing to the service,
(2) The test procedures evaluated,
(3) The results of performance reported by each laboratory, and
(4) The results or range of results which were considered acceptable performance by the service.
(e) Makes application for approval on forms provided by the department.

Credits

History
1. New section filed 12-28-71; effective thirtieth day thereafter (Register 72, No. 1).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 1051, 17 CA ADC § 1051
End of Document