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Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of Policies and Procedures and an interview with Testing Personnel #15, the laboratory failed to follow their policy for specimen labeling. This was noted from the date of the last survey, 6/8/2023, to the date of the current survey, 2/7/2024. The findings include: 1. A review of Policies and Procedures revealed the following under a section titled "Specimen Submittal": "...Patient specimens are labeled with the patient's name and chart number..." 2. During the tour of the laboratory, the surveyor inquired about the process of specimen handling prior to patient testing for Complete Blood Counts (CBCs). Testing Personnel #15 explained the samples were only labeled with the patient's chart number before performing the CBC. 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 --

Summary Statement of Deficiencies 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 a review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and an interview with Testing Personnel #10, the surveyor determined the physicians reading the Bacteriology cultures failed to sign the attestation statements as testing personnel on ten out of eleven 2019 - 2023 survey events. The findings include: 1. A review of the 2019 - 2023 MLE records revealed the physicians reading the Bacteriology cultures failed to sign the attestation statements for 10 out of 11 survey events; only the 2022 M-1 attestation statement had the signature of the Laboratory Director who signed as the testing personnel after performing the reading for Urine Colony Counts. 2. During an interview on 6/8/2023 at 1:45 PM, Testing Personnel #10 reviewed and confirmed the above noted findings. . 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 a review of the Medical Laboratory Evaluation (MLE) proficiency testing (PT) records and an interview with Testing Personnel #10, the laboratory failed to: (1) document reviews of results for five of six 2020 - 2021 survey events; and (2) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- document investigation and implementation of

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based a review of the test menu, a review of the MLE (Medical Laboratory Evaluation) proficiency testing records, and an interview with Testing Personnel (TP) #7 (also the Laboratory Manager). the surveyor determined the laboratory failed to implement and document