Summary:
Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 6/21/19. The Bison Community Clinic laboratory was found not in compliance with the following requirement: D5291. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of quality assurance (QA) activities, QA policies, and interview with the laboratory director, the laboratory failed to follow their QA policy to ensure problems within general laboratory systems had been identified, assessed, and corrected for 12 of 12 months reviewed (January 2018 through December 2018). Findings include: 1. Review of the laboratory's 2018 fourth quarter QA activities report revealed: *Personnel competency had not been marked as acceptable or unacceptable. *Proficiency testing (PT) had not been marked as acceptable or unacceptable. *Communications had not been marked as acceptable or unacceptable. *Safety Compliance Review had not been marked as acceptable or unacceptable. *Laboratory staff had not signed the QA forms. *The laboratory director had signed the QA forms on 3/27/19. Review of the current QA policy signed by the laboratory director in March 2018 stated requirements were: *A mechanism would be in place to document and assess problems identified during QA review. *Staff reviewed and signed the QA reports. *