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Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on laboratory observation, a review of patient test records, and staff interviews, the laboratory failed to retain 2 of 5 complete blood counts (CBC) instrument test reports. The findings include: 1. Observation of the laboratory on 03/20/2025 at 10:45 a.m. revealed a Medonic hematology analyzer (ID: 49409) performing patient CBC testing. 2. A random review of five patient test records in 2024 and 2025 revealed that the laboratory did not retain the Medonic test reports for patients 20800 (04/05/2024) and 17341 (09/24/2024). 3. An interview with the practice manager, nurse manager, and laboratory director on 03/20/2025 at 12:30 p.m. confirmed the findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as 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 -- established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 During a recertification survey that was completed on 12/13/2023, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and staff interview, the laboratory failed to ensure the laboratory director signed the attestation statements for events two and three in 2023 (two of seven reviewed). The findings include: 1. Review of the laboratory's API PT records revealed the attestation statements for 2023 events two and three lacked the laboratory director's signature. 2. Interview on 12/13/2023 at 3:30 pm with the office manager, office supervisor, testing person two, and the laboratory director, confirmed the laboratory failed to ensure the laboratory director signed the API PT attestation statements for 2023 events two and three. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's API PT records, and staff interview the laboratory failed to retain PT documents for a period of two years for two events (two of seven reviewed) in 2022 and 2023. The findings include: 1. Review of the laboratory's API PT records revealed the following were not retained for a period of two years: 2022 Event one- Performance evaluation documents provided by API 2023 Event two- Instrument printouts for the samples that were performed on the Medonic hematology analyzer 2. Interview on 12/13/2023 at 3:30 pm with the office manager, office supervisor, laboratory director, and TP two confirmed the laboratory failed to ensure the PT documents were retained for a period of two years when the performance evaluation documents were not retained in 2022 and the Medonic instrument printouts were not retained in 2023 . 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 review of the Form CMS-209, laboratory policy, personnel records, and staff interview, the laboratory failed to follow it's own policy for competency assessments for personnel that perform CBC patient testing in 2021 and 2022. The findings include: 1. Review of the Form CMS-209 revealed TP three (new since last survey) listed as performing moderately complex CBC patient testing. 2. Review of the laboratory policy titled "Personnel" section one "Competency Assessment" revealed "New hires will be assessed at their 6 month anniversary the first year of employment and yearly thereafter." 3. Review of the laboratory's personnel records revealed TP three was hired on 09/07/2021 and completed competency assessments on 07/22/2022 and 11/27/2023. The competency assessment was not completed at six months and annually according to the laboratory policy. 4. Interview on 12/13/2023 at 3:30 pm with the office manager, office supervisor, TP two, and laboratory director, confirmed the laboratory failed to follow it's own personnel policy when TP three did not have completed competency assessments according to the policy in 2021 and 2022. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory's policy, operator's manual review, and staff interviews, the testing personnel (TP) failed to follow the laboratory's procedures for labeling patient samples for complete blood count (CBC) testing in 2023. The findings include: 1. Observation of the laboratory on 12/13/2023 at 10:35 am revealed a Medonic hematology instrument (Serial 49409) in use for patient CBC testing. Specimens were observed and were not labeled with any identifiers. TP two stated at 11:05 am the patient samples are not labeled during the collection or testing process. 2. Review of the laboratory policy titled "Specimen Labeling and Rejection Policy" revealed specimens submitted to the laboratory for testing must be accurately labeled with the patient's name and collection information at the time of collection. 3. Review of the Medonic Operator's manual section "Specimen Identification/Causes for Specimen Rejection" revealed "specimens must be labeled with both first and last name of patient as well as one more unique identifier (Medical Record Number, Date of Birth, social security number (SSN), etc.)". 4. Interview with the office manager, office supervisor, laboratory director, and TP two on 12/13/2023 at 3:30 pm confirmed the laboratory TP failed to follow the laboratory's procedures for specimen labeling in 2023. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 a review of the American Proficiency Institute Proficiency Testing (PT) attestation statement's for all 3 event's in 2020, 1st event 2021and interview with the primary testing person, determined that the PT samples were not tested with three out of four testing personnel listed on the Laboratory Personnel Report Form 209. The findings include: 1. A review of the attestation PT records revealed lack of testing personnel signatures on the PT attestation statements for all 3 events in 2020 and 1st event 2021. 2. Interview with primary testing person on 10:00 am on June 8, 2021, confirmed that the PT samples was not performed by three out of four testing personnel as listed on the Laboratory Personnel Report Form 209. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) attestation statement's for all 3 events of 2020, 1st event 2021 and interview with the primary testing person, determined the attestation statements were not signed by the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Laboratory Director and the testing personnel. Findings include: 1. Review of API attestation sheets for all 3 events of 2020 and 1st event 2021 revealed the Laboratory Director and testing personnel did not sign the API PT attestation statements. 2. Interview with primary testing person on June 8, 2021 at 10:00 am confirmed that the Laboratory Director and testing personnel did not sign the API PT attestation statements. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the Proficiency Testing (PT) records and interview with the Practice Manager it was determined the laboratory failed to maintain all copies of the instrument printouts, attestation sheets and performance summaries for the PT 1st, 2nd and 3rd events of 2019. The findings include: 1. There were no 2019 PT records available for review to include the instrument printouts, attestation sheets and performance summaries sheets. 2. An interview with the Practice Manager on June 8, 2021 at 10:00 am confirmed the laboratory failed to maintain all copies of instrument printouts, attestation sheets and the performance summaries for the PT 1st, 2nd and 3rd events of 2019. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Intakes: TN00054407 Based on lack of SARS CoV2 reporting documentation and interview with the Practice Manager, the laboratory failed to report all SARS CoV2 performed to the Public Health Department between Jan 6, 2021 through June 8, 2021. Findings include: 1. Lack of documentation available for review determined the laboratory failed to report 280 SARS CoV2 test results between Jan.6, 2021 through -- 2 of 4 -- June 8, 2021. 2. Interview with the Practice Manager confirmed the laboratory failed to report 280 SARS CoV2 test results performed between Jan.6, 2021 through June 8, 2021 to the Public Health Department. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory Quality Assurance Plan (QA) and interview with Practice Manager, the laboratory failed to follow the laboratory's written QA plan for 2019, 2020 and January through May 2021. Findings include: 1. Review of the laboratory's QA Plan state's the laboratory will perform quarterly evaluations of the laboratorys set of systems to include: Patient test management Quality control and instrumentation Proficiency testing Comparison of test results Personnel assessment Communications Laboratory errors Complaints 2. Interview June 8, 2021 at 11:00 am with the Practice Manager confirmed that the laboratory failed to perform quarterly evaluations of the laboratory set of services for 2019, 2020 and January through May 2021. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 lack of laboratory room temperature and humidity logs and interview with the Practice Manager, the laboratory failed to define and monitor the laboratory room temperature and humidity for 2019 and 2020. Findings: 1. There were no room temperature or humidity logs available for review for 2019 and 2020. 2. Interview with Practice Manager on June 8, 2021 at 08:30 am confirmed the laboratory failed to to define and monitor the laboratory room temperature and humidity for 2019 and 2020. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory -- 3 of 4 -- director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Proficiency Testing (PT) records, personnel records and lack of quality assessment (QA) records and interview with the practice manager, the Laboratory Director failed to oversee the overall operations of the laboratory for 2019, 2020 and January through May 2021. The findings include: 1. Review of the PT records revealed the laboratory director failed to sign the attestation statements attesting to the routine integration of PT the samples among all testing personnel for 2019, 2020 and January through May 2021. 2. Review of the personnel records revealed the laboratory director failed to ensure the testing personnel competency assessments included the six criteria for competency assessment required by Centers for Medicare and Medicaid (CMS) in 2019 and 2020. 3. Lack of quality assessment records available for review revealed the laboratory director failed to ensure the laboratory follow the written QA plan for 2019 and 2020 and January through May 2021. 4. Interview with the practice manager on June 8, 2021 at 12:30 pm confirmed the laboratory director failed to oversee the overall operations of the laboratory for 2019, 2020 and January through May 2021. 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 2019 and 2020 and interview with the practice manager, the laboratory's Technical Consultant failed to observe and document the six required criteria for assessing personnel competencies of 4 of the 4 testing personnel. The findings include: 1) Review of employee personnel records for 2019 and 2020 revealed the six required criteria of competencies was not documented to 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 practice manager on June 8, 2021 at 10:00 am, confirmed 4 of 4 testing personnel were not evaluated by the Technical Consultant using the six criteria for competency assessment required by Centers for Medicare and Medicaid (CMS) in 2019 and 2020. -- 4 of 4 --

Summary Statement of Deficiencies D2007 Based on a review of the American Proficiency Institute Proficiency Testing (PT) attestation statement's for all 3 event's in 2020, 1st event 2021and interview with the primary testing person, determined that the PT samples were not tested with three out of four testing personnel listed on the Laboratory Personnel Report Form 209. The findings include: 1. A review of the attestation PT records revealed lack of testing personnel signatures on the PT attestation statements for all 3 events in 2020 and 1st event 2021. 2. Interview with primary testing person on 10:00 am on June 8, 2021, confirmed that the PT samples was not performed by three out of four testing personnel as listed on the Laboratory Personnel Report Form 209. D2009 Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) attestation statement's for all 3 events of 2020, 1st event 2021 and interview with the primary testing person, determined the attestation statements were not signed by the Laboratory Director and the testing personnel. Findings include: 1. Review of API attestation sheets for all 3 events of 2020 and 1st event 2021 revealed the Laboratory Director and testing personnel did not sign the API PT attestation statements. 2. Interview with primary testing person on June 8, 2021 at 10:00 am confirmed that the Laboratory Director and testing personnel did not sign the API PT attestation statements. D2015 Based on review of the Proficiency Testing (PT) records and interview with the Practice Manager it was determined the laboratory failed to maintain all copies of the instrument printouts, attestation sheets and performance summaries for the PT 1st, 2nd and 3rd events of 2019. The findings include: 1. There were no 2019 PT records available for review to include the instrument printouts, attestation sheets and performance summaries sheets. 2. An interview with the Practice Manager on June 8, 2021 at 10:00 am confirmed the laboratory failed to maintain all copies of instrument printouts, attestation sheets and the performance summaries for the PT 1st, 2nd and 3rd events of 2019. D3000 Intakes: TN00054407 Based on lack of SARS CoV2 reporting documentation and 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 -- interview with the Practice Manager, the laboratory failed to report all SARS CoV2 performed to the Public Health Department between Jan 6, 2021 through June 8, 2021. Findings include: 1. Lack of documentation available for review determined the laboratory failed to report 280 SARS CoV2 test results between Jan.6, 2021 through June 8, 2021. 2. Interview with the Practice Manager confirmed the laboratory failed to report 280 SARS CoV2 test results performed between Jan.6, 2021 through June 8, 2021 to the Public Health Department. D5291 Based on review of the laboratory Quality Assurance Plan (QA) and interview with Practice Manager, the laboratory failed to follow the laboratory's written QA plan for 2019, 2020 and January through May 2021. Findings include: 1. Review of the laboratory's QA Plan state's the laboratory will perform quarterly evaluations of the laboratorys set of systems to include: Patient test management Quality control and instrumentation Proficiency testing Comparison of test results Personnel assessment Communications Laboratory errors Complaints 2. Interview June 8, 2021 at 11:00 am with the Practice Manager confirmed that the laboratory failed to perform quarterly evaluations of the laboratory set of services for 2019, 2020 and January through May 2021. D5413 Based on lack of laboratory room temperature and humidity logs and interview with the Practice Manager, the laboratory failed to define and monitor the laboratory room temperature and humidity for 2019 and 2020. Findings: 1. There were no room temperature or humidity logs available for review for 2019 and 2020. 2. Interview with Practice Manager on June 8, 2021 at 08:30 am confirmed the laboratory failed to to define and monitor the laboratory room temperature and humidity for 2019 and 2020. D6004 Based on review of the laboratory's Proficiency Testing (PT) records, personnel records and lack of quality assessment (QA) records and interview with the practice manager, the Laboratory Director failed to oversee the overall operations of the laboratory for 2019, 2020 and January through May 2021. The findings include: 1. Review of the PT records revealed the laboratory director failed to sign the attestation statements attesting to the routine integration of PT the samples among all testing personnel for 2019, 2020 and January through May 2021. 2. Review of the personnel records revealed the laboratory director failed to ensure the testing personnel competency assessments included the six criteria for competency assessment required by Centers for Medicare and Medicaid (CMS) in 2019 and 2020. 3. Lack of quality assessment records available for review revealed the laboratory director failed to ensure the laboratory follow the written QA plan for 2019 and 2020 and January through May 2021. 4. Interview with the practice manager on June 8, 2021 at 12:30 pm confirmed the laboratory director failed to oversee the overall operations of the laboratory for 2019, 2020 and January through May 2021. D6046 Based on review of employee personnel records for 2019 and 2020 and interview with the practice manager, the laboratory's Technical Consultant failed to observe and document the six required criteria for assessing personnel competencies of 4 of the 4 testing personnel. The findings include: 1) Review of employee personnel records for 2019 and 2020 revealed the six required criteria of competencies was not documented to 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 -- 2 of 3 -- specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills. 2) An interview with the practice manager on June 8, 2021 at 10:00 am, confirmed 4 of 4 testing personnel were not evaluated by the Technical Consultant using the six criteria for competency assessment required by Centers for Medicare and Medicaid (CMS) in 2019 and 2020. -- 3 of 3 --