Tennessee Pediatric & Adolescent Center

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 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 six of seven testing personnel (TP) who routinely performed patient Complete Blood Count (CBC) testing also participated in proficiency testing in 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on 05/21/2024 at 8:30 a.m. revealed a Horiba ABX Micros 60 analyzer (ID: 506CS94848) used for patient CBC testing. 2. A review of the FORM CMS-209 revealed seven persons (TP-1, 2, 3, 4, 5, 6, and 7) who perform moderately complex patient testing. 3. A review of the laboratory's API PT attestation statements revealed that TP-1 was the only signature on all attestation pages for completing proficiency testing. 4. An interview with the Office Manager and TP-1 on 05/21/2024 at 1:00 p.m. confirmed that TP-2, 3, 4, 5, 6, and 7 did not complete testing in any CBC PT events in 2022, 2023, and 2024. 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. 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 -- This STANDARD is not met as evidenced by: Based on laboratory observation, review of the Clinical Laboratory Improvement Amendments Application for Certification (Form CMS-116), review of the laboratory's policy and procedure manual, and staff interview, the laboratory failed to establish a written policy for complete blood count (CBC) testing, with an average of 10175 hematology tests performed annually. The findings include: 1. Observation of the laboratory on 05/21/2024 at 8:30 a.m. revealed a Horiba ABX Micros 60 analyzer (ID: 506CS94848) used for patient CBC testing. 2. A review of the laboratory's Form CMS-116 revealed the laboratory performed approximately 10175 hematology tests annually. 3. A review of the laboratory's policy and procedure manual revealed that no written procedure for performing CBC testing on the Horiba ABX Micros 60 analyzer was available for reference. 4. An interview with the Office Manager and TP-1 on 05 /21/2024 at 1:00 p.m. confirmed that the laboratory did not have a written policy for CBC testing. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory observation, review of the laboratory policies and procedures, quality control (QC) records, and staff interviews, the laboratory failed to monitor QC performance over time for complete blood count (CBC) testing in 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on 05/21/2024 at 8:30 a. m. revealed a Horiba ABX Micros 60 analyzer (ID: 506CS94848) used for patient CBC testing. The laboratory used Minotrol-16 Hematology Reference Control (Lot: MX447) to verify the daily performance of the instrument. 2. A review of the laboratory's policies revealed the following: - The "QC Highlights" policy states, "The laboratory must establish the number, type, and frequency of testing control materials that monitor the complete analytical process: Must monitor over time the accuracy, precision of test performance that may be influenced by changes in test system performance and environmental conditions and operator performance." - The "Quality Control" policy states, "Quantitative QC results are graphed to show shifts or trends that indicate problems prior to them being out of range." 3. On 05/21/2024 at 11:00 a. m., TP-1 was requested to provide the Levy-Jennings graphs used by the laboratory to monitor QC shifts and trends. No records were available. 4. An interview with the Office Manager and TP-1 on 05/21/2024 at 1:00 p.m. confirmed the laboratory did not monitor Levy-Jennings graphs and document shifts or trends in hematology QC for the last two years. -- 2 of 4 -- 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (Form CMS-209) and Clinical Laboratory Improvement Amendments Application for Certification (Form CMS-116), testing personnel (TP) competency assessment records, and staff interview, the laboratory's technical consultant (TC) failed to document all six required criteria for assessing personnel competency for seven of seven testing personnel performing complete blood count (CBC) patient testing in 2022, 2023, and 2024. The findings include: 1. A review of Form CMS-209 and Form CMS-116 provided by the laboratory on 05/21/2024 revealed seven TP who performed CBC patient testing. 2. A review of 2022, 2023, and 2024 personnel records revealed that competency assessments completed annually for the TP failed to include documentation of the six required competency elements (1. direct observation of routine patient test performance; 2. monitoring the recording and reporting of test results; 3. review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records; 4. direct observation of the performance of instrument maintenance and function checks; 5. assessment of test performance through previously analyzed specimens, internal blind testing samples, or external proficiency testing samples; 6. evaluation of problem-solving skills). 3. An interview with the Office Manager and TP-1 on 05/21/2024 at 1:00 p.m. confirmed that the laboratory's competency assessment failed to include the six criteria for evaluating testing personnel competency in 2022, 2023, and 2024. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), testing personnel (TP) records, the laboratory's Quality Assurance (QA) policy, and staff interviews, the technical consultant failed to evaluate the semiannual competency for two of three new testing personnel who began complete blood count (CBC) patient testing in 2022 and 2023. The findings include: 1. A review of the FORM CMS-209 revealed seven persons (TP- 1, 2, 3, 4, 5, 6, and 7) who performed CBC patient testing. TP-5, 6, and 7 were new testing persons listed. 2. A review of the laboratory's testing personnel records revealed the following: - TP-5 began testing on 10/29/2022. The laboratory documented competencies on 07/14/2023 and 03/12/2024. - TP-6 began testing on 10 /10/2022. The laboratory documented competencies on 07/14/2023 and 03/9/2024. 3. A review of the section titled "Personnel" in the laboratory's QA policy revealed the following statement: - "Personnel are evaluated semiannually during the first year of -- 3 of 4 -- employment or when new methodologies are incorporated. Thereafter, evaluations are performed yearly." 4. An interview with the Office Manager and TP-1 on 05/21/2024 at 1:00 p.m. confirmed that the laboratory did not document semiannual competencies for TP-5 and TP-6. -- 4 of 4 --

Summary Statement of Deficiencies 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 Office Manager, it was determined the laboratory failed to maintain copies of the instrument printouts, Attestation sheets and Performance summaries for 2020 PT,1st, 2nd and 3rd events. The findings include: 1. There were no 2020 PT instrument printouts, Attestations sheets and Performance Summaries available for review. 2. An interview with the Office Manager on September 27th at 11:00am, confirmed the laboratory failed to maintain copies of PT instrument printouts, Attestation sheets and Performance Summaries for 2020 PT 1st, 2nd and 3rd events. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) temperature records for 2017-2019, and an interview with the office manager, the laboratory failed to retain one year of temperature logs for 2018. Findings include: 1. Review of QC records disclosed that temperature logs were not retained for 2018. 2. In an interview, on June 18, 2019, at 11:30am, the office manager confirmed the temperature logs were not retained for one year in 2018 as required. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of