Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's personnel competency evaluation documents, and interview with the laboratory manager on February 9, 2024, at 1:30 pm, the laboratory failed to establish and follow written policies and procedures to assess employees. The findings include: 1. The laboratory did not have any competency records for the testing person #1 for the years 2022 and 2023. The testing person #2 had competency evaluation, however it was incomplete and did not cover all the 6 items listed in the subpart M. Therefore, the accuracy of the laboratory's test results cannot be assured and may have potential to harm patients. 2. The laboratory manager on February 9, 2024, at 1:30 pm, affirmed that the laboratory did not evaluate testing person #1 competency in 2022 and 2023. 3. The laboratory's testing declaration form stated that the laboratory performed approximately 648 tests, annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing records, and interview Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- with the laboratory manager on February 9, 2024, at 1:10 pm, the laboratory failed to review and evaluate the proficiency testing results. The findings include: 1. The laboratory participated in the CAP proficiency testing program in 2022 and 2023. The laboratory's % CD34+ result for the sample FL4-03 was unacceptable. The laboratory did not review the unacceptable result and did not take any action. Furthermore, some results from 2022 was reviewed on August 30, 2023, by an unauthorized individual but no action taken when the bacterial culture test result for the sample CBT-02 lacked the consensus for the evaluation. Therefore, the accuracy of the laboratory's test results cannot be assured and may have potential to harm patients. 2. The laboratory manager on February 9, 2024, at 1:10 pm, affirmed that the laboratory did not review and evaluate the 2022 and 2023 proficiency testing results by the appropriate staff. 3. The laboratory's testing declaration form stated that the laboratory performed approximately 648 tests, annually. 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 Surveyor review of laboratory's policy and procedure, personnel competency evaluation documents, proficiency testing records, and interview with the laboratory manager on February 9, 2024, at 1:30 pm, the laboratory failed to establish the quality assessment for the general laboratory system. The findings include: The laboratory did not have a system in place to assess the quality of its work. Quality assessment is an ongoing review process that encompasses all facets of the laboratory's technical and non-technical functions at all location/sites where testing is performed. When the laboratory discovers an error or identifies a potential problem, actions must be taken to correct the situation. This correction process involves identification and resolution of the problem, and development of policies that will prevent recurrence. QA of the Analytic System includes assessing: Test procedures; Accurate and reliable test systems, equipment, instruments, reagents, materials, and supplies; Specimen and reagent storage condition; Equipment/instrument/test/system maintenance and function checks; Establishment and verification of method performance specifications; Calibration and calibration verification; Control procedures; Comparison of test results;