Summary:
Summary Statement of Deficiencies D0000 An onsite announced CLIA initial certification survey was conducted by the South Carolina Department of Public Health's (SC DPH) Bureau of Healthcare Systems and Services on July 1, 2024, at Keystone Substance Abuse Service's clinical laboratory. The laboratory was found to be out of compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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 lack of documentation and staff interview, the laboratory failed to establish and follow an ongoing process for quality assessment of the laboratory. Findings included: 1. No Quality Assessment plan or procedure available at the time of survey. 2. Interview on July 1, 2024 in the laboratory at 11:30am with the laboratory director (LD), the findings were confirmed. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of