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 Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory policies, competency assessments and an interview with the technical supervisor, the laboratory failed to have a policy that included competency assessments for supervisors and competencies for one (1) of one (1) technical supervisors and one (1) of one (1) general supervisors. The findings include: 1. A review of the CMS209 identified one person fulfilling the roles of technical supervisor and general supervisor. 2. A review of laboratory policies identified that the laboratory failed to have a policy that addressed supervisor competencies. 3. A review of competency assessments identified that the laboratory failed to have competency assessment for one (1) of one (1) technical supervisors and one (1) of one (1) general supervisors. 4. An interview with the technical supervisor on 7/28/2026 at 10:54 am confirmed the above findings. 5. The laboratory reports performing 399,734 tests annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) 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 -- Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a direct observation, review of manufacturer instructions for use (IFU), lack of temperature documentation, and an interview with the technical supervisor, the laboratory failed to monitor room temperature in the patient draw room and the storage room where Becton Dickinson (BD) and Greiner Bio-One tubes were stored prior to use. The findings include: 1. A direct observation of the patient draw room and storage room identified the following blood collection tubes: BD 8.5 ml SST tubes lot 6027084 expiration 2027-01-31 BD PPT plasma tubes lot 5293014 expiration 2026-10-31 Greiner Bio-One 5 ml yellow serum separator tubes lot 456018P expiration 2027-07-01 Greiner Bio-One 4 ml K2 EDTA tubes lot 454209 expiration 2027-05-03 Greiner Bio-One 4 ml lithium heparin tubes lot 456088 expiration 2027-03-11 2. A review of the manufacturer IFUs for Greiner and BD blood collection tubes list a storage temperature of 4-25 C. 3. A review of laboratory temperature logs identified that the laboratory failed to monitor and document storage temperature of blood collection tubes as required by the manufacturers. 4. An interview with the technical supervisor on 7/28/2026 at 1:59 pm confirmed that the laboratory failed to monitor storage temperatures of their blood collection tubes. 5. The laboratory reports performing 399,734 tests annually. -- 2 of 2 --