Memphis Children's Clinic

Summary Statement of Deficiencies D0000 During a recertification survey on 10/8/2025, the laboratory was found out of compliance with the following condition: 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) Hematology Proficiency Testing (PT) records for Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff) and staff interview, the laboratory failed to retain proficiency testing records for a minimum of two years from the date of the proficiency testing event for four of four events reviewed. The findings include: 1. A review of the laboratory's API PT records for Hematology CBC w/Diff revealed the following: The PT program instructions were not retained for 2024 Event Two, 2024 Event Three, 2025 Event One, and 2025 Event Two. The attestation statements were not retained for 2024 Event Two and 2025 Event Two. The data submission report was not retained for 2025 Event 2. 2. The technical consultant confirmed the survey findings during an interview on 10/08/2025 at 11:40 a.m. D2128 HEMATOLOGY 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 -- CFR(s): 493.851(e) (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 a review of the laboratory's API Hematology PT records, surveyor review of the PT records, and staff interview, the laboratory failed to determine the cause of PT failures for the Hematology specialty and the Red Blood Cell, Hematocrit, Hemoglobin, and Platelet analytes and perform

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory procedure, and staff interviews, the laboratory failed to follow the procedure for the Sysmex XN complete blood count (CBC) instrument when it did not perform quality controls (QC) after reagent changes in 2023 and 2024. The findings include: 1. Observation of the laboratory on 04/18/2024 at 9:00 am revealed a Sysmex XN 330 (Serial # 14732) used for CBC patient testing. Testing persons two and four were present and asked to describe QC procedures during the observation. The testing persons stated they did not perform QC after reagent changes. 2. A review of the manufacturer's basic operation manual for the Sysmex XN 330 instrument, Chapter 3, titled "Performing Quality Control (QC)" 3.2.2 "When QC analysis is performed" revealed reagent replenishment or replacement required personnel to perform QC. 3. Interview on 04/18 /2024 at 1:00 pm with the technical consultant confirmed the laboratory failed to follow the procedure for QC after a reagent change in 2023 and 2024. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), review of the laboratory's proficiency testing records and interview with the lead testing person, the laboratory failed to ensure proficiency testing was performed by personnel who routinely perform patient testing when the lead testing person performed six of eight proficiency testing events reviewed for 2020, 2021 and 2022. The findings include: 1. Review of the form CMS 209 revealed three personnel who perform patient testing for complete blood count. 2. Review of the laboratory's proficiency testing attestation statements revealed that six of eight proficiency testing events reviewed were performed by the lead testing person. 3. Interview with the lead testing person on 09/06/2022 at 2:30 pm confirmed the laboratory failed to ensure proficiency testing was performed by personnel who routinely perform patient testing in 2020, 2021 and 2022. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- CITATION NUMBER ONE Based on review of quality control records, document request and interview with the laboratory lead, the laboratory failed to retain manufacturer quality control (QC) assay sheets for two years for nine of twelve lots reviewed for selected dates from 2020, 2021 and 2022. The findings include: 1. Review of quality control records for complete blood count the revealed the following: QC lot numbers 068000, 078000 and 088000 in use on 11/18/2020. QC lot numbers 067600, 077600 and 087600 in use on 05/20/2021. QC lot number 2070 (levels 1, 2 and 3) in use from 03/30/2022 to 06/14/2022. QC lot number 2154 (levels 1, 2 and 3) (current lot) reviewed for 08/27/2022. 2. Request made to the laboratory lead on 09/06/2022 at 1pm for the manufacturer assay sheet for the twelve QC lots reviewed revealed the manufacturer assay sheets were not retained for 068000, 078000, 088000, 067600, 077600, 087600, and lot 2070 (Levels 1, 2, and 3). Nine of twelve assay sheets were not retained for two years. 3. Interview with the laboratory lead on 09/06/22 at 2:30 pm confirmed the laboratory failed to retain the manufacturer QC assay sheets for two years for nine of twelve lots reviewed from 2020, 2021 and 2022. CITATION NUMBER TWO Based on review of quality control (QC) records, patient test records, and interview with the laboratory lead, the laboratory failed to maintain records of quality controls in use from 04/01/2022 until 09/06/2022. 1. Review of quality control records for the Sysmex XN-330 complete blood count instrument revealed the laboratory prints and reviews the insight data from Sysmex. The reports did not include the laboratory's quality control ranges that were in use during the period the lots were used. 2. Review of the laboratory's patient test records revealed patient testing on the Sysmex XN-330 began on 04/01/2022 with approximately 550 patients reported since patient testing began. 3. Interview with the lead testing person on 09/06/2022 at 2:30 pm confirmed the laboratory failed to retain quality control limits in use since patient testing began on the Sysmex XN-330 on 04 /01/2022 until the date of the survey on 09/06/2022. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to detect problems with proficiency testing failures (Refer to D5293), failed to have a procedure for use of the Sysmex XN-330 complete blood count (CBC) instrument (Refer to D5401), failed to monitor environmental conditions (humidity) for the use of the Sysmex XN-330 CBC instrument (Refer to D5413 citation #1), failed to define appropriate temperature ranges for storage of CBC quality control materials (Refer to D5413 citation #2), failed to have documentation of background checks for the Sysmex XN-330 CBC instrument (Refer to D5435), failed to perform quality control on dates when patients were tested (Refer to D5447), and failed to have an effective analytic quality assessment program (Refer to D5793). 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. -- 2 of 13 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient test records, the laboratory's testing personnel competency assessment policy, lack of documentation, and interview with the laboratory lead, the laboratory failed to follow its' own policy for assessing competency when a new laboratory test platform was introduced for patient complete blood count (CBC) testing in 2022. The findings include: 1. Observation of the laboratory on 09/06/2022 at 9 am revealed the Sysmex XN-330 in use for patient testing for complete blood count (CBC) (new since the last survey). 2. Review of patient test records revealed patient testing for CBC began on the new instrument on 04/01/2022. 3. Review of the laboratory policy for testing personnel competency revealed that employees are to be evaluated for competency when a new laboratory test or brand of laboratory test is introduced. 4. Lack of documentation of training and competency assessment for three of three testing personnel for the use of the new Sysmex XN-330 instrument. 5. Interview with the lead testing person on 09/06/2022 at 2:30 pm confirmed the laboratory failed to follow its' own competency assessment policy when it did not reassess competency for the use of the Sysmex XN-330 in 2022. 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 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 the Centers for Medicare and Medicaid Services Laboratory Personnel form (CMS 209), the laboratory's proficiency testing records and interview with the lead testing personnel, the laboratory failed to rotate proficiency among testing personnel who perform patient testing for urine colony count and throat culture in 2017 and 2018. The findings include: 1) Review of the CMS 209 form revealed the names of eight testing personnel (providers) who perform patient testing for urine colony count and throat culture. 2) Review of the laboratory's proficiency testing records revealed attestation statements for urine colony count and throat culture signed by testing personnel number eight for testing events 2017-2, 2017-3, 2018-1, 2018-2, and 2018-3. 3) Interview with the lead testing personnel on February 5, 2019 at 12:30 p.m. confirmed the laboratory failed to rotate proficiency testing for urine colony count and throat culture among all testing personnel in 2017 and 2018. _______________________________________ 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records, proficiency testing records, and interview with the lead testing personnel, the laboratory failed to retain manufacturer assay sheets for complete blood count (CBC) controls for five of twelve control lot numbers in 2017 and 2018, and failed to maintain a paper trail for provider responses for proficiency testing in 2017 and 2018. The findings include: 1) Review of the laboratory's quality control records revealed that the following lot number manufacturer assay sheets were not retained: lot numbers 069400, 079400, 089400-in use on 7.30.17; 067800, 077800-in use on 10.2.18. 2) Review of the laboratory's proficiency testing records revealed there was no paper trail for provider responses for Urine Microscopy and Pinworm Prep for 2017 events two and three, and 2018 event two. 3) Interview with the lead testing personnel on February 5, 2019 at 4:00 p.m. confirmed the laboratory failed to retain quality control and proficiency testing records for at least two years. Five of twelve manufacturer assay sheets for CBC controls in 2017 and 2018, and provider responses for microscopy proficiency testing in 2017 and 2018 were not retained. _____________________________________ 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 laboratory procedure manual, the Centers for Medicare and Medicaid Services form (CMS 209), the competency assessment policy, and interview with the lead testing personnel, the laboratory's policy for competency assessment failed to include all six criteria for assessing personnel competency, and failed to include competency assessment for providers performing urine microscopy, pinworm prep, urine colony count, and throat culture. The findings include: 1) Review of the laboratory procedure manual revealed the following six criteria were not included in the competency assessment policy: 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) Review of the CMS 209 revealed the names of eight providers who perform urine microscopy, pinworm prep, urine colony count, and throat culture. 3) Review of the laboratory policy for competency assessment revealed that the competency assessment policy did not include competency assessments for the providers performing urine microscopy, pinworm prep, urine colony count, and throat cultures. 4) Interview on February 5, 2019 at 11:30 a.m. with the lead testing personnel confirmed the testing personnel competency policy did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS), and failed to include competency assessment for providers performing moderately complex testing for urine microscopy, pinworm prep, urine colony count, and throat culture. ______________________________________ D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE -- 2 of 5 -- CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the 2018 event two microbiology proficiency testing performance evaluation report and interview with the lead testing personnel, the laboratory failed to evaulate non-graded proficiency testing scores in 2018. The findings include: 1) Review of the 2018 event two microbiology proficiency testing performance evaluation report revealed a score of Not Graded (No consensus) for urine colony count for sample number UR-10. There was no evaluation of the results to determine the laboratory's accuracy. 2) Interview with the lead testing personnel on February 5, 2019 at 12:30 p.m. confirmed the laboratory failed to evaluate non-graded proficiency testing scores for 2018 microbiology event two for sample number UR-10. ___________________________________ D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer package insert and interview with the lead testing personnel, the laboratory failed to label complete blood count (CBC) controls with corrected expiration date in 2019. The findings include: 1) Observation of the laboratory on February 5, 2019 at 9:00 a.m. revealed CBC control vials (lot numbers 069100, 079100, 089100) in use labeled "2-1-19." 2) Review of the Beckman Coulter 4C-ES manufacturer package insert revealed the CBC controls are good for 35 days after opening for a maximum of 20 samplings. 3) Interview with the lead testing personnel on February 5, 2019 at 10:00 a.m. confirmed the laboratory did not label CBC controls with corrected expiration after opening in 2019. ____________________________________ D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of patient number four test report, urine colony count patient test logs, urine colony count quality control records, and interview with the lead testing personnel, the laboratory failed to perform quality control for urine colony count media for lot number 8D20A in 2018 with 58 patient tests performed. The findings include: 1) Review of patient number four test report revealed patient testing for urine colony count on October 10, 2018. 2) Review of the urine colony count patient test log revealed media lot number 8D20A in use at the time of patient number four testing. The lot number was in use from 8.27.18 to 11.26.18 with 58 patient tests performed. 3) Review of the urine colony count quality control records revealed no quality control records were available for media lot 8D20A. 4) Interview with the lead testing personnel on February 5, 2019 at 4:00 p.m. confirmed quality control records were not located for urine colony count media lot number 8D20A, with patient testing performed. ____________________________________ D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, quality control records, and interview with the lead testing personnel, the laboratory failed to identify testing personnel and culture read dates/times for proficiency testing in 2018, and the identity of personnel performing quality control for the throat culture system in 2019. The findings include: 1) Review of the laboratory's proficiency testing records revealed the following: Microbiology 2018 Event two: Urine colony count test record log-no identity of testing personnel for any of the five samples, no record of the read date/time. Original proficiency testing results for sample numbers UR-06, UR-07, UR09 were marked through and changed with no identity of the person who changed the original results. Throat culture log-no identity of testing personnel for any of the five samples, no record of the read date/time. Microbiology 2018 Event three: Urine colony count and throat culture record log-no identity of testing personnel providing the final test result. 2) Review of the laboratory's quality control records for throat culture system revealed no identity of the personnel who performed the quality control in January 2019. 3) Interview with the lead testing personnel on February 5, 2019 at 4: 00 p.m. confirmed the laboratory failed to identify the testing personnel and culture read dates/time for proficiency testing in 2018, and the identity of testing personnel performing quality control for the throat culture system in 2019. ___________________________________ D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of -- 4 of 5 -- 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. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved