Pediatric Center Of Tullahoma Pc The

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, review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records and staff interviews, the laboratory failed to ensure that three of four testing personnel (TP) who performed hematology patient testing also participated in PT testing in 2025 and 2026. The findings include: 1. Laboratory observation on 04/29/2026 at 09:30 a.m. revealed a Sysmex pocH-100i (Serial Number: A4176) used for complete blood count (CBC) testing. 2. A review of the Form CMS-209 revealed a total of four testing personnel (TP1, TP2, TP3, and TP4) who routinely perform moderately complex CBC patient testing. 3. A review of the laboratory's AAB-MLE proficiency testing records revealed that TP2, TP3 and TP4 did not participate in any hematology PT events (0 of 4 reviewed) in 2025 and 2026. 4. The laboratory director and nursing supervisor confirmed the survey findings in an interview on 04/29/2026 at 12:00 p.m. . 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 3 -- This STANDARD is not met as evidenced by: Based on laboratory observation and staff interviews, the laboratory failed to ensure it did not use blood collection tubes for reference laboratory patient testing past their expiration date on the survey date, 04/29/2026. The findings include: 1. Laboratory observation on 04/29/2026 at 09:30 a.m. revealed the following: - (3) 2.7 milliliter (mL) Becton Dickinson (BD) Vacutainer light blue top Sodium (Na) Citrate (0.109M, 3.2%) blood collection tubes, lot number: 4222854, expiration date: 2025-05-31. - (1) 6 mL BD Vacutainer royal blue top K2EDTA (dipotassium ethylenediaminetetraacetic acid) Trace Element blood collection tube, lot number: 4229079, expiration date: 2025-07-31. 2. The laboratory director and nursing supervisor confirmed the survey findings in an interview on 04/29/2026 at 12:00 p.m. . D5781

Summary Statement of Deficiencies D0000 Based on a desk review of the proficiency testing (PT) scores obtained from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and verified with the American Association of Bioanalysts/Medical Laboratory Evaluation (AAB/MLE) PT program for 2025, the laboratory was found to be out of compliance with the conditions of the Clinical Laboratory Improvement Amendments (CLIA) program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016- 493.803 Condition: Successful participation. (Proficiency Testing) D6000- 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This CONDITION is not met as evidenced by: Based on a desk review of PT records from the CASPER 0155 report and the AAB /MLE PT records, the laboratory failed to successfully participate in a PT program approved by Health and Human Services (HHS), for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the Hematocrit (HCT) analyte. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CASPER 0155 report and the AAB/MLE PT records for 2025 events one and three, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte for three consecutive testing events in the specialty of Hematology for the HCT analyte. The Findings Include: 1. A review of the CASPER 0155 report revealed the following: Hematology 2025- Event One: The laboratory received an unsatisfactory score of 0% for the HCT analyte. Hematology 2025- Event Three: The laboratory received an unsatisfactory score of 60% for the HCT analyte. 2. A review of the AAB/MLE PT records revealed the following: Hematology 2025- Event One: The laboratory received an unsatisfactory score of 0% for the HCT analyte. Hematology 2025- Event Three: The laboratory received an unsatisfactory score of 60% for the HCT analyte. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a PT desk review of the CASPER 0155 report and the AAB/MLE 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure PT samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a PT desk review of the CASPER 0155 report and the AAB/MLB 2025 -- 2 of 3 -- records, the laboratory director failed to ensure PT samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved PT program. Refer to D2130. -- 3 of 3 --

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 2018 and 2019 and interview with the lead testing person, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency. The findings include: 1) Review of employee personnel records for 2018 and 2019 did not reveal 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 January 14, 2020 at 12:00am confirmed 5 of 5 testing personnel evaluated during 2018 and 2019 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 --