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 Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209), laboratory policy, personnel records, and staff interview, the laboratory failed to follow the Quality Assurance policy for competency assessment of testing personnel who performed complete blood count (CBC) patient testing in 2023 and 2024. The findings include: 1. A review of Form CMS-209 provided by the laboratory on 08.18.2025 revealed two testing personnel (TP) who performed CBC patient testing. 2. A review of the laboratory policy titled "Quality Assurance - Employee Competency" revealed that "Evaluating and documenting the performance of individuals responsible for moderate complexity testing will be completed at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations will be completed at least annually." 3. A review of the laboratory's personnel records revealed no documentation of annual competency for TP1, as listed on the Form CMS-209, in 2024, and no semiannual competency assessment for TP2 in 2023. 4. An interview with the Chief Financial Officer on 08.18.2025 at 12:30 p.m. confirmed the above survey findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 observation and staff interview, the laboratory failed to ensure it did not use blood collection tubes for reference laboratory testing past their expiration date on the survey date, 08.18.2025. The findings include: 1. Laboratory observation on 08.18.2025 at 9:17 a.m. revealed the following: - 89 3.0 milliliter (mL) Becton Dickinson (BD) no additive blood collection tubes, lot number: 3222710, expiration date of 02.28.2025 -97 3.5mL BD Serum Separator Tube (SST) blood collection tubes, lot number: 3126854, expiration date of 04.30.2024 - 44 4mL Greiner Bio-One Lithium Heparin (LH) blood collection tubes, lot number: B24033NB, expiration date of 07.03.2025 - 11 4mL Greiner Bio-One LH blood collection tubes, lot number: B240333X, expiration date of 07.01.2025 - One 4mL Greiner Bio-One LH blood collection tube, lot number: B22063MB, expiration date of 10.08.2023 - One 4mL Greiner Bio-One LH blood collection tube, lot number: B230637N, expiration date of 10.04.2024 2. An interview with the Chief Financial Officer on 08.18.2025 at 9:25 a. m. confirmed the above survey findings. -- 2 of 2 --