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 a review of the laboratory ' s competency records and policies and procedures, and an interview with the laboratory ' s technical consultant (TC), the laboratory failed to establish and follow written policies or procedures to, and evaluate consultant competency for one out of one TC listed on the CMS-209 form, since the laboratory ' s last survey on 03/08/2022. The laboratory performs approximately 800 tests annually. Findings include: 1. A review of the laboratory ' s policies and procedures revealed that there was no written policy or procedure to evaluate TC competency. 2. A review of the laboratory ' s competency records showed that there were no documented evaluations of TC competency. An interview with the laboratory ' s TC on 06/07/2024 at approximately 11 A.M. confirmed that the laboratory did not have a policy or procedure to evaluate TC competency and had not been doing so since the last survey on 03/08/2022. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory ' s records and an interview with the laboratory ' s 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 -- technical consultant (TC), the laboratory failed to twice annually verify the accuracy of it ' s Activated Clotting Time (ACT) and Blood Oximetry (Blood OX) tests, since the last survey on 03/08/2022. The laboratory performs approximately 800 ACT and Blood OX tests per year. Findings include: 1. A review of the laboratory ' s records failed to find any evidence of twice annual accuracy verification for ACT and Blood OX tests. 2. An interview with the laboratory ' s TC on 06/07/2024 at approximately 11 A.M. confirmed that the laboratory did not have any policy or procedure to verify the accuracy of the ACT and Blood OX tests, and had not been doing so since the last survey on 03/08/2022. -- 2 of 2 --