Summary:
Summary Statement of 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 review of laboratory records and discussion with the Office Manager / Medical Assistant (MA #1), the laboratory failed to ensure that a current Quality Assurance (QA) plan was written and being followed with QA activities being documented in writing at least twice per year. Findings include: 1. Upon request for a copy of the laboratory's QA plan, none could be provided in writing or digitally. 2. Upon request for written documentation of QA activities for the years 2021, 2022 and 2023 to date, none could be produced. 3. The Office Manager / MA#1 confirmed that neither a written QA plan or written evidence of QA activities at least twice per year for 2021, 2022, and 2023 to date could be produced during interview at 2:30 pm on 08 /23/2023. 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