Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part I - General Health
Chapter 5 - CLINICAL LABORATORIES
PROCEDURES
Section 5.50 - Approval to provide special analytical services

Universal Citation: 28 PA Code ยง 5.50

Current through Register Vol. 54, No. 44, November 2, 2024

(a) The Department will approve qualified laboratories to perform certain specialized laboratory services. The Department's Bureau of Laboratories will, from time to time, establish prerequisite requirements for admission to approval programs based on an evaluation of the personnel, equipment and procedures employed in the applicant laboratory. After the prerequisite requirements are satisfied, admission to approval programs will require demonstration of acceptable capability in the analysis of test samples. Continued approved status will require satisfactory performance in periodic evaluations conducted to monitor the reliability of participating laboratories.

(b) Lists of laboratories approved under this section to provide special analytical services will be prepared semiannually and will contain the names, addresses and directors of the facilities. Only approved facilities are permitted to offer the specified determinations to clients in this Commonwealth. If an approval is revoked or limited for reasons of unsatisfactory performance, reinstatement of approval will require demonstration of proficiency over a testing period not to exceed 6 months.

This section cited in 7 Pa. Code §203.73 (relating to testing); 7 Pa. Code §203.74 (relating to test results); 28 Pa. Code § 5.102 (relating to equipment and methods for laboratory analysis of breath samples); 28 Pa. Code § 5.103 (relating to blood tests for blood alcohol content); 58 Pa. Code § 15.1 (relating to definitions); 58 Pa. Code §188.3 (relating to testing); and 58 Pa. Code §188.4 (relating to test results).

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