View all text of Subjgrp 42 [§ 493.1353 - § 493.1365]
§ 493.1359 - Standard; PPM laboratory director responsibilities.
The laboratory director is responsible for the overall operation and administration of the laboratory, including the prompt, accurate, and proficient reporting of test results. The laboratory director must—
(a) Direct no more than five laboratories; and
(b) Ensure that any procedure listed under § 493.19(c)—
(1) Is personally performed by an individual who meets the qualification requirements in § 493.1363; and
(2) Is performed in accordance with applicable requirements in this subpart and subparts H, J, and K of this part;
(c) Evaluate the competency of all testing personnel and ensure that the staff maintains their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to—
(1) Direct observations of routine patient test performance, including, if applicable, specimen handling, processing, and testing;
(2) Monitoring the recording and reporting of test results;
(3) Review of test results or worksheets;
(4) Assessment of test performance through testing internal blind testing samples or external proficiency testing samples; and
(5) Assessment of problem solving skills; and
(d) Evaluate and document the performance of individuals responsible for PPM testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations and documentation must be performed at least annually.