Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 7, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency test (PT) records and interview with the Quality Team, the laboratory testing personnel failed to sign the attestation form. The Findings include: 1. Review of PT records(American Associates of Bioanalysts) revealed the laboratory testing personnel failed to sign the attestation form for Chemistry Q1 in 2020. 2. During an interview with the Quality Team on October 7, 2021 at approximately 3:15 PM, in their conference room, confirmed that the testing personnel failed to sign the attestation form. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on laboratory records review and interview with the Quality Team, the laboratory failed to establish a written quality assessment plan (QA) to monitor, assess, and correct problems in the general laboratory. The laboratory did not have a written quality assessment policy that encompasses all of the laboratory's technical and non-technical functions. The Findings include: 1. The laboratory failed to have a QA plan to assess specimen identification and integrity, complaint investigations, personal competency, proficiency testing performance, and