Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was conducted on February 5, 2018 at Franklin Medical Center-CLIA ID # 19D0707823. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to have a policy for Proficiency Testing. Findings: 1. Review of the laboratory policy and procedure manual revealed there was no policy or detailed instructions for Proficiency Testing (PT) to include, but not limited to: *Proficiency Testing (PT): a) Ordering and ensuring that you are enrolled for Proficiency Testing. b) What to do when you receive samples from the PT Provider. c) How to handle the samples; who will test, when to test, how do you assure no inter and intra laboratory communication takes place d) How to record results to send into the PT Provider to be scored. e) What records to maintain. f) How to evaluate when you receive your scores from the PT Provider. g) what steps to take if