Smg Pediatric Clinic Seymour

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interviews, the laboratory failed to ensure it did not use heel incision devices for blood collection and blood collection tubes for patient testing past their expiration date on the survey date, 11.06.2025. The findings include: 1. Observation of the laboratory on 11.06.2025 at 9:05 a.m. revealed a Sysmex XP-300 (Serial Number B5909) hematology analyzer used for complete blood count (CBC) patient testing and an Advanced Instruments Advanced Bilirubin STAT-analyzer (serial number 19060893C) used for neonatal bilirubin patient testing. Also observed were the following: - Two Cardinal Health GentleHeel incision devices, lot number: 200821F, expiration date of 08.20.2025. - Four bags (containing 50 tubes per bag) 125 microliter (L) RAM Scientific Safe-T-Fill Capillary Blood Collection System, Lithium Heparin tubes (used for collecting heel stick neonatal bilirubin samples), lot number: 23J4032, expiration date of 10.31.2025. -One 500L Becton Dickinson (BD) Dipotassium Ethylenediaminetetraacetic Acid (EDTA) microtainer capillary blood collector tube (used for collecting fingerstick/heel stick CBC with automated differential samples), lot number: 2161933, expiration date of 11.30.2023. 2. An interview with the laboratory supervisor and lead testing person on 11.06.2025 at 9:15 a.m. confirmed the above survey findings. D5781

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 14, 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 --