Summary:
Summary Statement of Deficiencies D0000 An onsite recertification survey conducted 11/14/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of laboratory policy, quality assurance (QA) documentation, and confirmed in interview, the laboratory failed to follow its own QA policy for monthly QA review for 10 of 10 months in 2023 (January - October). Findings included: 1. Review of laboratory policy, "Quality Assurance Program" (Approved by the Laboratory Director on 02/17/2022) revealed the following: "Quality Assurance Checklist Monthly, a Quality Assurance form will be filled out by the histology technician in order to help identify any immediate issues to be addressed in the laboratory. The Laboratory Director will review this checklist monthly." 2. Review of provided QA documentation revealed no monthly QA forms were included. The surveyor requested the monthly QA forms for 10 of 10 months in 2023 (January - October), and none were provided. 3. During an interview in the facility breakroom on 11/14/2023 at 10:22 a.m., the histotechnician confirmed the laboratory failed to follow its own QA policy for monthly QA review for 10 of 10 months in 2023 (January - October). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --