Knoxville Pediatric Associates

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), College of American Pathologists (CAP) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that nine of ten testing personnel (TP) who routinely performed patient Complete Blood Count (CBC) testing also participated in proficiency testing in 2024. The findings include: 1. Observation of the laboratory on 04.03.2025 at 9:30 a.m. revealed a Sysmex XN-330 analyzer (serial number 14606) for patient CBC testing. 2. A review of Form CMS-209 revealed ten testing personnel (TP10 through TP19) who perform moderately complex patient testing for CBC. 3. A review of the laboratory's CAP PT attestation statements revealed that TP10 was the only testing personnel who participated in hematology proficiency testing in 2024. 4. An interview with the Nurse Manager on 04.03.2025 at 11:15 a.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 D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: ================================== Based on the laboratory's 2022 Proficiency Testing (PT) performance summary report from the College of American Pathologisits (CAP) Proficiency testing program and interview with the Nurse Manager, the laboratory failed to review and document remedial action for Unsatisfactory hemoglobin analyte results first event 2022. Finding Include: 1. Review of the laboratory's 2022 CAP Proficiency Testing summary report for Hemoglobin analyte revealed the laboartory failed to review and document remedial action for failed hemoglobin analyte results first event 2022. 2. Interview with the Nurse Manager on April 7, 2022 at 12:30 pm confirmed the laboratory failed to review and document remedial action for failed hemoglobin analyte results PT first event 2022. ================================== 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 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 -- 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 review of the Cell-Dyn Emerald instrument operator's manual for complete blood count (CBC), CBC instrument calibration records, and interview with the Nurse Manager, the laboratory failed to follow manufacturer's requirements for CBC instrument calibration frequency in 2020. The findings include: 1. Review of the Cell-Dyn Emerald instrument operator's manual for CBC revealed that calibration is to be performed "At least every six months." 2. Review of CBC instrument calibration records revealed the calibration was not performed in 2020. 3. Interview with Nurse manager on April 7, 2022 at 12:30 pm confirmed lack of calibration performance in 2020. =================================== -- 2 of 2 --

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 review of 2018 Hematology Proficiency Testing (PT) attestation sheets and upon interview with the Nurse Manager, determined the PT samples were not tested by 15 of 16 testing personnel as listed on the Laboratory Personnel Report Form 209. The findings include: 1. Review of the Hematology PT records for 2018 revealed only one of sixteen testing personnel's signature on the attestation sheets. 2. Interview with the Nurse Manager January 8th, 2019 at approximately 1:30 p.m. confirmed the attestation sheets for 2018 Hematology PT were signed by only one of sixteen testing personnel. ==================================== 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 review of three patient CBC (Complete Blood Count) reports manually entered in Electronic Medical Records (EMR) for 2018, lack of CBC instrument printouts and upon interview with 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 -- the Nurse Manager, the laboratory failed to retain CBC instrument printouts for the last 2 years. The findings include: 1. Review of three patient CBC reports for January 26, 2018, February 28, 2018 and November 21, 2018 revealed manually entered results in the Electronic Medical Records. 2. CBC instrument printouts for manually entered CBC's into EMR for dates in January, February and November of 2018 were not retained. 3. Interview with Nurse Manager January 8th, 2019 at approximately 1: 30 p.m. confirmed the laboratory was not able to retrieve CBC instrument printouts for the dates of review in 2018 and also had not been retained for 2017. ===================================== 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)