Memphis & Shelby County Pediatric Group

Summary Statement of Deficiencies D0000 During a recertification survey performed on 03/10/2025, the laboratory was found out of compliance with the following conditions: 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. D2123 HEMATOLOGY CFR(s): 493.851(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER Report 0155D (CMS 155), the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records, lack of records, and staff interview, the laboratory failed to participate in the 2024 Event One (one of three events reviewed) for the Complete Blood Count with White Blood Cell Differential (CBC w/Diff) analytes. The findings include: 1. A review of the CMS 155 report revealed the laboratory received a 0% score for the 2024 Event One. 2. A review of the laboratory's WSLH performance evaluation report for 2024 Event One revealed "Fail" in the status column with the comment "No results received" for the samples AT-1, AT-2, AT-3, AT-4, and AT-5 which resulted in a 0% score for the event. 3. An interview with the laboratory director, testing person one, and laboratory liaison on 03/10/2025 at 2:00 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- pm confirmed that the laboratory failed to participate in the CBC w/Diff 2024 Event One and performed patient testing. 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 a review of the Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS- 209), laboratory personnel records, laboratory policy, lack of records, final patient test reports, and staff interviews, the laboratory failed to follow its policy for competency assessment for three of three new testing personnel (TP) that performed Complete Blood Count with White Blood Cell Differential (CBC w/Diff) patient testing in 2023 and 2024. The findings include: 1. A review of Form CMS-209 revealed five TP that performed CBC w/Diff patient testing. Three of the five were new since the last survey (TP three, four, and five). 2. A review of the laboratory personnel records revealed the following: TP three: The "Laboratory Competency Evaluation" form was completed on 01/05/2024, and the hire date was listed as 07/05/2023. TP four: The "Laboratory Competency Evaluation" form was completed on 08/06/2024, and the hire date was listed as 02/06/2024. TP five: The "Laboratory Competency Evaluation" form was completed on 08/26/2024, and the hire date was listed as 02/26/2024. 3. A review of the laboratory policy titled "Quality Assurance Plan" in the section "Personnel" revealed "New personnel shall undergo 2 week, 6 month, and annual, thereafter, reviews." and "Documentation of the reviews shall be available in the individual personnel jackets." 4. On the survey date (03/10/2025), the two-week review documentation was unavailable for TP three, four, or five. 5. A review of the final patient CBC w/Diff test reports revealed the following: TP three reported patient 141507 on 05/01/2024 at 12:05 pm. TP four reported patient 147120 on 08/14/2024 at 2:48 pm. TP five reported patient 146008 on 07/10/2024 at 10:59 am. 6. The laboratory director, TP one, and laboratory liaison confirmed the survey findings in an interview on 03/10/2025 at 2:00 pm. Word Key: CLIA- Clinical Laboratory Improvement Amendments D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 a review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records, lack of documentation, and staff interviews, the laboratory failed to evaluate results that the WSLH PT agency did not grade for one of three events reviewed in 2024. The findings include: 1. A review of the -- 2 of 6 -- laboratory's WSLH PT records revealed the following: 2024 Event Three: The performance evaluation report indicated "***" in the status column with a comment of "Not scored- Insufficient Peer Group" for the hematocrit (Hct) % analyte for samples AT-11, AT-12, AT-13, AT-14, and AT-15. The laboratory failed to provide documenation of a self-evaluation of the non-graded scores. 2. The laboratory director, testing person one, and laboratory liaison confirmed the survey findings in an interview on 03/10/2025 at 2:00 pm. Word Key %- percent 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 review of the Centers for Medicare and Medicaid (CMS) Casper Report 0155D (CMS 155), the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records, the Department of Health and Human Services Centers for Medicare and Medicaid Laboratory Personnel Report (CLIA) (Form CMS- 209), laboratory personnel records, final patient test reports, and staff interviews, the laboratory director failed to ensure the laboratory participated in one of three PT events in 2024 (Refer to D6017), and failed to ensure three of five testing personnel (TP) had documentation of training and competency prior to patient Complete Blood Count with White Blood Cell Differential (CBC w/Diff) testing in 2023 and 2024 (Refer to D6029). D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER Report 0155D (CMS 155), the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) reports, and staff interviews, the laboratory director failed to ensure the PT results for 2024 Event One (one of three reviewed) were submitted to the PT agency before the event deadline (Refer to D2123). The findings include: 1. A review of the CMS 155 report revealed the laboratory received a 0% score for the 2024 Event One. 2. A review of the laboratory's WSLH performance evaluation report for 2024 Event One revealed "Fail" in the status column with the comment "No results received" for the samples AT-1, AT-2, AT-3, AT-4, and AT-5 which resulted in a 0% score for the event. 3. An interview with the laboratory director, testing person one, and laboratory liaison on 03/10/2025 at 2:00 pm confirmed that the laboratory director failed to ensure the laboratory participated in 2024 Event One and performed CBC w /Diff patient testing. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) -- 3 of 6 -- (e)(4)(iv) An approved

Summary Statement of Deficiencies 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 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 laboratory records, patient test reports, and staff interview, the laboratory failed to retain complete blood count (CBC) analytic records including quality control (09/04/2020 to 10/27/2020 and 09/01/2021 to 02/28/2022), calibrator assay sheets (three of four), and quality control assay sheets (nine of twenty-one) for two years in 2020, 2021, and 2022 with patient testing reported. Approximately 343 patients were reported during the gaps in quality control records. The findings include: 1. Review of laboratory CBC analytic records revealed the following: The laboratory did not retain QC records for two years for dates ranging from 09/04/2020 to 10/27/20 and 09/01/2021 to 02/28/2022. The laboratory did not retain calibrator assay sheets for three of four calibrations reviewed (08/13/2020, 02/04/2021, 08/30 /2021). The laboratory did not retain quality control assay sheets for nine of twenty- one lots (068800, 078800, 088800, 069600, 079600, 089600, 068900,078900, and 089600). 2. Review of patient CBC reports revealed patient 000140826 reported on November 1, 2021 and patient 000142092 reported on February 1, 2022 on dates when QC records were not available. Further investigation revealed approximately 43 patients were reported during the QC retention gap from 09/04/2020 to 10/27/2020 and approximately 300 patients were reported during the QC retention gap from 09/01 /2021 to 02/28/2022 for a total of 343 patients. 3. Interview with the laboratory director on 03/17/2022 at approximately 3:30 p.m. confirmed the laboratory failed to retain all CBC analytic records for two years in 2021 and 2022. The laboratory 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 -- director stated that the QC printouts are discarded at the end of each month. There were no other records available for the dates in question. He also confirmed other records including calibrator and quality control assay sheets were not retained. 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 have an effective quality assessment process (Refer to D5293) and failed to ensure appropriate quality control ranges were used (Refer to D5439). 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 and the checklist used for performing testing personnel competency assessment, and interview with the laboratory director, the laboratory failed to have a procedure to include all six criteria for assessing testing personnel competency in 2022. The findings include: 1) Review of the laboratory procedure manual revealed the laboratory did not have a policy /procedure for assessing testing personnel competency. The checklist being used to assess competency did not include all six criteria as required by the regulations. The six criteria required for assessing testing personnel competency 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) Interview on 03/17/2022 at 3:30 p.m. with the laboratory director confirmed the laboratory did not have a policy/procedure for assessing testing personnel competency and the checklist being used did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). 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 observation of the laboratory, patient number one final complete blood count (CBC) records and interview with the laboratory director, the laboratory failed to maintain the CBC instrument printout for patient number one, in 2018. The findings include: 1) Observation of the laboratory on October 4, 2018 at 9:45 a.m. revealed the Beckman Counter AcT diff CBC instrument in use for patient testing. 2) Review of patient number one CBC records revealed on September 5, 2018 a CBC was performed and reported in the electronic medical record (EMR) with no scanned CBC instrument printout included. 3) Interview on October 4, 2018 at 11:20 a.m. with the laboratory director confirmed patient number one CBC was reported in the EMR without a scanned instrument printout. The process is the CBC is manually entered into the EMR and the CBC instrument printout is then scanned into the EMR. 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 --