Staff performing waived tests are competent.

(1)

Staff who perform waived testing have been trained for each test that they are authorized to perform. The training for each waived test is documented. Note: This includes training on the use and maintenance of instruments.

(2)

Competence for waived testing is assessed according to hospital policy at defined intervals but at least at the time of orientation and annually thereafter. Competency is assessed using at least two of the following methods per person per test: - Performance of a test on a blind specimen - Periodic observation of routine work by the supervisor or qualified designee - Monitoring of each user's quality control performance - Use of a written test specific to the test assessed This competency is documented. Note 1: When a licensed practitioner performs waived testing that does not involve an instrument and the test falls within their specialty, the hospital may use the medical staff credentialing and privileging process to document evidence of training and competency in lieu of annual competency assessment. In this circumstance, individual privileges include the specific waived tests appropriate to the scope of practice that they are authorized to perform. At the discretion of the person from the hospital whose name appears on the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) certificate or according to hospital policy, more stringent competency requirements may be implemented. Note 2: Provider-performed microscopy (PPM) procedures are not waived tests.