Summary:
Summary Statement of Deficiencies D0000 A CLIA complaint investigation and an initial inspection was performed on February 22, 2022. The complaint findings were not substaniated. Based on the CLIA initial survey this facility was found not to be in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493. 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 the laboratory procedure manual (SOP), quality assurance (QA) policy and interviews with staff and laboratory director, the laboratory failed to have an adequate (QA) policy to assess, evaluate, monitor and correct problems in the laboratory as required by CLIA. The findings include: 1. Review of QA records revealed that the laboratory's current QA policy does not indicate the necessary steps to identify and correct problems.