Memphis Childrens Clinic

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 a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) Form CMS-209, a review of testing personnel records, a review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, a review of patient test records, and staff interview, testing personnel (TP) who routinely performed patient testing for Complete Blood Count with automated White Blood Cell differential (CBC w/Diff) failed to participate in proficiency testing in 2024 and 2025. The findings include: 1. A review of Form CMS 209 revealed nine testing personnel who performed patient testing for CBC w/Diff (four primary TP and five fill-in (float) TP). 2. A review of the four primary TP's records revealed that TP1 was hired on 08/14/24, TP2 on 07/16/24, TP3 on 05/09/25, and TP4 on 05/26/25. 3. A review of the laboratory's API proficiency testing records revealed that TP 1 had performed all PT events received since her hire date of 08/14 /24 (2024 Event Three, 2025 Event One, and 2025 Event Two). 4. A review of patient test records revealed patient testing for CBC w/Diff that was performed by other testing personnel (patient 206102 performed by TP 2 on 11/18/24, patient 190760 performed by TP 5 on 03/08/25, and patient 143127 performed by TP 3 on 08/18/25). 5. The technical consultant confirmed the survey findings during an interview on 10/07 /25 at 4 p.m. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 -- (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's API CBC w/Diff PT records and staff interview, the testing personnel and laboratory director/designee failed to sign one of five PT attestation statements from 2024 and 2025. The findings include: 1. A review of the laboratory's API PT records revealed that the attestation statement for 2024 Event Two was not signed by the testing personnel or the laboratory director/designee. 2. The technical consultant confirmed the survey findings during an interview on 10/07 /25 at 3:45 p.m. 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 laboratory procedure manual, a review of testing personnel records, a review of patient test reports, and staff interview, the laboratory failed to follow the policy for testing personnel training and competency assessment prior to patient testing for TP Two (one of four new testing personnel who performed Complete Blood Count with Automated White Blood Cell Differential (CBC w/ Diff). The findings include: 1. A review of the laboratory's policy titled "QUALITY ASSURANCE PLAN" revealed the following statement: "All testing associates are trained, and competency is evaluated prior to the initiation of patient testing and reporting patient results." 2. A review of testing personnel records revealed the following for TP 2: The date of hire was listed as 7/16/24. Initial training was not documented until 05/16/25. There was no documentation that an initial competency assessment was performed. A six-month competency was documented on 02/07/25. 3. A review of patient test reports revealed patient testing performed by TP 2 on 11/17 /24 for patient 206102 prior to documentation of initial training and documented competency assessment. 4. The technical consultant the survey findings during an interview on 10/07/25 at 4:00 p.m. -- 2 of 2 --

Summary Statement of Deficiencies 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 Laboratory Personnel Report (CLIA) (Form CMS-209), laboratory policy, personnel records, and staff interviews, the laboratory failed to follow the personnel policy for competency assessment of testing personnel that performed complete blood count (CBC) patient testing in 20223 and 2024. The findings include: 1. A review of Form CMS-209 submitted for the laboratory survey performed on 04/18/2024 revealed four testing personnel that performed CBC patient testing. 2. A review of the laboratory policy titled " Quality Assurance Plan" section "Personnel Assessment" revealed that testing personnel would have competency assessment performed prior to patient testing. 3. A review of the laboratory's personnel records revealed no documentation of competency assessment for testing person two (hired December 2023) or testing person four (hired January 2024). 4. Interview on 04/18/2024 at 4:30 pm with the technical consultant confirmed the laboratory failed to follow the policy for testing personnel competency assessment for testing persons two and four who were performing patient testing on the date of the survey (04/18/2024) hired in 2023 and 2024. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of Form CMS-209, laboratory personnel records, and staff interviews, the laboratory director failed to ensure that testing personnel (two of four reviewed) had documented training and demonstrated accuracy prior to patient CBC testing in 2023 and 2024 (Refer to D5209). The findings include: 1. A review of Form CMS-209 submitted for the survey on 04/18/2024 revealed four testing personnel that performed CBC patient testing. 2. A review of the laboratory personnel records revealed no documentation of training or demonstration of accuracy before patient CBC testing in 2023 and 2024 for testing persons two or four (two of four reviewed). 3. Interview on 04/18/2024 at 4:30 pm with the technical consultant confirmed thesurvey findings during interview on 04/18/2024 at 4:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (Form CMS-209) and the CMS ASPEN database, lack of documentation, interview with the lead testing person, search of CMS ASPEN database and review of a letter from technical consultant number two, the laboratory director ( LD) failed to notify CLIA of change in LD within 30 days of the change. The findings include: 1. Review of the Form CMS-209 and the CMS ASPEN database revealed the LD on the Form-CMS 209 did not match the LD of record in the CMS ASPEN database. 2. Request for documentation of notification to the state agency of change in LD to the lead testing person on August 23, 2022 at approximately 11:00 am revealed no documents were available. 3. During an interview on August 23, 2022 at 1:00 pm, the lead testing person stated the current LD took over shortly after the 2019 survey. 4. Search of the CMS ASPEN database revealed no evidence that the state agency had been notified of the LD change. 5. Review of a letter received on August 24, 2022 from technical consultant number two dated August 22, 2022, revealed the current LD took over responsibilities on October 7, 2020. The LD failed 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 -- to notify CLIA of change in laboratory director within 30 days of the change as required at 493.51. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, and interview with the lead testing personnel, the testing personnel performing urine colony count and throat cultures failed to sign proficiency testing attestation statements in 2017, 2018, and 2019. The findings include: 1. Review of the laboratory's proficiency testing records revealed that the attestation statements for the urine colony count and throat culture were not signed by the testing personnel performing the final read of the cultures for 2017 event two, 2018 events one, two and three, and 2019 event one. 2. Interview with the lead testing personnel on March 21, 2019 at 4:45 pm confirmed the attestation statements for urine colony count and throat culture were not signed by the testing personnel who perform the final read of the cultures in 2017, 2018, and 2019. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, patient culture logs, and interview with the lead testing personnel, the laboratory failed to test proficiency 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 -- testing samples the same number of times it tests patient samples in 2017 and 2018. The findings include: 1. Review of the laboratory's proficiency testing records revealed repeat testing of proficiency testing as follows: 2017 event two-Urine colony count performed on 6.28.2017, all five samples repeated on 7.05.2017. 2017 event three-throat culture performed on 10.09.17, two samples (TH-11 and TH-12) repeated on 10.11.17. 2. Review of random patient culture logs revealed no repeat testing of urine colony count or throat culture. 3. Interview with the lead testing personnel on March 21, 2019 at 4:45 pm confirmed the laboratory does not routinely perform repeat testing of patient urine colony count and throat culture and did not test proficiency testing samples the same number of times it tests patient samples in 2017 and 2018. 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 laboratory's proficiency testing records and interview with the lead testing personnel, the laboratory failed to maintain a copy of all proficiency testing records for a minimum of two years in 2017 and 2018. The findings include: 1. Review of the laboratory's proficiency testing records revealed no urine colony count or throat culture logs documenting all testing steps as follows: No test logs for 2018 events one, two and three. No read date and time on the log for urine colony count and throat culture for 2017 event two. 2. Interview with the lead testing personnel on March 21, 2019 at 4:45 pm confirmed the laboratory did not maintain all proficiency testing records in 2017 and 2018. 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, testing personnel competency assessment records, and interview with the lead testing personnel, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency. The findings include: 1. Review of the laboratory procedure manual revealed the following six criteria were not included in the procedure and competency documentation: direct observation of routine patient test performance; monitoring the -- 2 of 4 -- 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. The competency assessment policy was titled "POLICY FOR COMPETENCY TESTING OF MEDICAL ASSISTANTS." The policy only applied to medical office assistants and did not include testing personnel who perform the final read of the urine colony count and throat culture. 2. Review of the 2017 and 2018 competency assessment records for testing personnel performing the final read of the urine colony count and throat culture revealed the competency assessment did not include all six elements. 3. Interview on March 21, 2019 at 4:45 pm with the lead testing personnel confirmed the testing personnel competency procedure did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS) and did not include testing personnel who perform urine colony count and throat cultures. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the lead testing personnel, the laboratory failed to evaluated non-graded proficiency testing scores in 2018. The findings include: 1. Review of the laboratory's proficiency testing scores for 2018 microbiology event two revealed a score of "Not Graded" for sample number UR-10. There was no evaluation of the reported result to determine laboratory accuracy. 2. Interview with the lead testing personnel on March 21, 2019 at 4:45 pm confirmed the laboratory failed to evaluate non-graded proficiency testing scores for 2018 event two sample UR-10. 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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CMS209), the laboratory testing personnel competency assessment records, and interview with the lead testing personnel, the technical consultant failed to perform competency assessment for six of eleven personnel performing patient testing for urine colony count and throat culture, and three of four personnel performing patient testing for complete blood count (CBC). The findings include: 1. Review of the CMS209 revealed the names of eleven testing personnel who perform urine colony colony and throat culture patient testing. 2. Review of the laboratory competency assessment records revealed no documentation of competency assessment -- 3 of 4 -- for testing personnel numbers four, five, six, seven, eight and nine who perform final read of urine colony count and throat culture in 2017, 2018, and 2019. 3. Review of the laboratory competency assessment records revealed no documentation of competency assessment performed by the technical consultant for testing personnel numbers one, two, and three who perform complete blood count testing in 2018 and 2019. 4. Interview with the lead testing personnel on March 21, 2019 at 4:45 pm confirmed the technical consultant failed to perform competency assessment for six of eleven testing personnel performing urine colony count and throat culture, and three of four testing personnel performing complete blood count testing in 2017, 2018, and 2019. -- 4 of 4 --