Smg Pediatric Clinic Hardin Valley

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), American Proficiency Institute (API) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that two of five testing personnel (TP) who performed hematology patient testing also participated in proficiency testing in 2024. The findings include: 1. An observation of the laboratory on 10.02.2025 at 8:45 a.m. revealed that it used a Sysmex XP-300 hematology analyzer (Serial Number: B5476) for complete blood count (CBC) patient testing. 2. A review of the FORM CMS-209 revealed a total of five persons (TP1, TP2, TP3, TP4, and TP5) who perform moderately complex patient testing. 3. A review of the laboratory's API PT attestation statements revealed that TP4 and TP5 did not participate in any hematology PT events (0 of 3 reviewed) in 2024. 4. An interview with the facility laboratory lead (TP2) on 10.02.2025 at 10:30 a.m. and a subsequent phone interview with the laboratory team lead (TP1) on 10.06.2025 at 1:45 p.m. confirmed the above survey findings. 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 D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer's instruction manual, laboratory records, and interview with the laboratory liaison, the laboratory failed to follow manufacturer's instructions for calibration in 2022. The findings include: 1. Observation of the laboratory on December 14, 2023 at 9:30 a.m. revealed the Advanced Instruments BR2 Bilirubin Stat Analyzer on the counter in use for pediatric patient testing for total bilirubin. (Serial number 19060894C). 2. Review of the manufacturer's instruction manual revealed the following, "The BR2 requires calibration upon installation and at least every six months, unless quality control data indicates the need for earlier calibration". 3. Review of laboratory records revealed that calibration was due April 2022 and was not performed. 4. Interview with the laboratory liaison on December 14, 2023 at 12:20 p.m. confirmed the laboratory failed to follow the manufacturer's instructions for calibration of the BR2 Bilirubin Stat Analyzer every six months in 2022. 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 D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: ================================== Based on review of employee personnel records for 2020 and 2021 and interview with the lead testing person, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for all testing personnel (TP). The findings include: 1) Review of employee personnel records for 2020 and 2021 failed to include documentation of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills. 2) An interview with the lead testing person on December 9, 2021 at 10: 00 a.m. confirmed all TP evaluated during 2020 and 2021 were not evaluated using the six criteria for competency required by Centers for Medicare and Medicaid (CMS). ================================== 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 --