Memphis Childrens Clinic

Summary Statement of Deficiencies D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory testing records to include temperature charts, Sysmex maintenance logs, and proficiency testing results from 8/1/2021 through 1/25/2023, interview with testing personnel (TP) #1 as listed on the Centers of Medicare & Medicaid Services 209 form on 1/25/2023, and a follow-up interview with the Nurse Manager for Memphis Children's Clinics at 5:00 p.m. on 1/31/2023, the Technical Consultant (TC) had not documented as reviewed temperature records, maintenance logs and proficiency test results as detailed below. Findings Include: 1. Review of the laboratory records from 8/1/2021 through 1/25/2023 revealed the following records were not documented as reviewed by the technical consultant: a. Temperature records (room, refrigerators, humidity) from 8/1/2021 through 1/25/2023 b. Sysmex XN-330 maintenance logs from 3/1/2022 through 1/25/2023 c. Proficiency testing records for 3rd event of 2021 and 1st, 2nd, and 3rd events of 2022 2. TP #1 confirmed in an interview at 4:00 p.m. on 1/25/2023 that there was no documented review of these records by the TC. The Nurse Manager also confirmed the lack of documented review of these records in a follow-up interview at 5:00 p.m. on 1/31/2023. THIS IS A REPEAT DEFICIENCY 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 D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and the CASPER report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 10/10 /2022, the laboratory failed to maintain satisfactory performance in two of two testing events (1st event of 2022 and 2nd event of 2022) resulting in unsuccessful performance for White Blood Cell Differential (WBC Diff). Refer to D2130. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 10/10 /2022, the laboratory has not successfully performed proficiency testing for WBC Diff in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D /0155D revealed the laboratory scored the following for WBC Diff: Year 2022 - 1st Event: 16% Year 2022 - 2nd Event: 0% -- 2 of 2 --

Summary Statement of Deficiencies D0000 D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory testing records from 12/1/18 through 7/28/21 and interview with testing personnel (TP) #1 as listed on the Centers of Medicare & Medicaid Services 209 form and Nurse Manager for Memphis Children's Clinics at 1: 00 p.m. on 7/28/21, the following records had not been documented as reviewed by the technical consultant: Findings Include: 1. Review of the laboratory records from 12 /1/18 through 7/28/21 revealed the following records were not documented as reviewed by the technical consultant: a. AcT Diff hematology quality control (QC) from 12/1/18 through 7/28/21 b. AcT Diff hematology calibration records from 12/7 /18 through 6/11/21 c. Temperature records (room, refrigerators, freezers) from 1/2/19 through 7/28/21 d. Proficiency Testing result records for 3rd event of 2018, all events of 2019 and 2020, and 1st event of 2021 2. Interview with the TP #1 and the Nurse Manager at 1:00 p.m. on 7/28/21 confirmed there was no documented review of these records by the technical consultant. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory personnel records from 11/29/18 through 7/28/21, the Centers of Medicare and Medicaid Services (CMS) 209 personnel form, and interview with the Nurse Manager, the technical consultant (TC) failed to evaluate and document the performance of TP #3 responsible for performing complete blood count (CBC) testing at least semiannually during the first year of employment. Findings include: 1. Review of the personnel records for TP #3 revealed the 6 month evaluation /competency was available but not documented as performed by the technical consultant during the first year of hire. TP #3 began employment in August 2020 as testing personnel. 2. Interview with the Nurse Manager at 1:30 p.m. on 7/28/21 confirmed the 6 month evaluation/competency was not performed by the Technical consultant on TP #3 during the first year of hire. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory testing personnel (TP) records including the Centers of Medicare and Medicaid Services (CMS) 209 personnel form, lack of documentation, and interview with the Nurse Manager for Memphis Children's Clinics, the technical consultant (TC) failed to evaluate annually and document the performance of TP #1, #2 and #3 who are responsible for performing complete blood counts (CBC). Findings include: 1. Based on personnel records available for review on the day of survey, the annual evaluations/competencies performed on the TP #1 through TP #3 were performed by staff other than the TC since the last survey on 11/29/18: TP # 1 - Annual evaluation not performed by TC for 2019, 2020 or 2021 TP # 2 - Annual evaluation not performed by TC for 2019, 2020 or 2021 TP # 3 - Annual evaluation not performed by TC for 2021 2. Interview with the Nurse Manager confirmed the annual evaluation/competencies for TP #1 through #3 available the day of survey had not been documented as performed by the technical consultant. -- 2 of 2 --

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 the AcT Diff 2 analyzer records from 1/20/17 through 11/29/18 and confirmation with staff at 10:30am, the laboratory failed to retain the quality control (QC) assay sheets for the AcT Diff 2 controls for at least 2 years. 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 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 calibration records for the AcT Diff 2 hematology analyzer since the last survey on 1/19/17, and lack of documentation of calibration, 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 2 -- failed to document, as performed, calibration on the AcT Diff 2 analyzer every 6 months. Findings include: Review of calibration records for the AcT Diff 2 hematology analyzer revealed the analyzer had not been calibrated since 12/4/17. This time period exceeds the laboratory policy and the manufacturer's calibration requirement of every 6 months. -- 2 of 2 --