Memphis Childrens Clinic

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on laboratory observation and a staff interview, the laboratory failed to ensure that tubes used for collecting fingerstick Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff) samples were not expired on the survey date (06/11/25). The findings include: 1. Laboratory observation on 06/11/25 at 9:00 a. m. revealed multiple lot numbers of fingerstick collection tubes with multiple expiration dates used for collecting CBC w/Diff samples in a basket. Seven expired collection tubes were noted with dates of 03/31/24, 10/31/24, and 01/31/25. The tubes were discarded on the survey date. 2. The technical consultant confirmed the survey finding during an interview on 06/11/25 at 9:15 a.m. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of quality control reports, patient test reports, quality assessment reports, and a staff interview, the laboratory failed to document

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 laboratory's proficiency testing (PT) records, review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), and staff interview, the laboratory failed to ensure PT was performed by personnel who routinely perform patient testing for Complete Blood Count (CBC) in 2022 and 2023. The findings include: 1. Review of the laboratory's PT attestation statements from 2022 and 2023 revealed that three of five PT events were performed by testing person two (2022 event three, 2023 event two, and 2023 event three). 2. Review of the Form CMS-209 revealed five testing personnel who perform patient testing for CBC. 3. During an interview on 01/24/24 at 1:30 pm the lead testing person stated the laboratory doesn't have a process in place to ensure the PT is rotated among all testing personnel, and confirmed that PT was not rotated among all testing personnel who perform patient testing for CBC in 2022 and 2023. 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: 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 -- Based on review of the laboratory procedure manual, employee personnel records for 2022 and 2023, and interview with the laboratory lead, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency, resulting in competency assessments performed without including all six required criteria for four of five testing personnel, eight of nine competency assessments reviewed. The findings include: 1. Review of the laboratory procedure manual revealed the following six criteria were not included in the procedure for assessing testing personnel competency: 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 2022 and 2023 employee personnel records revealed the following: Testing person number two: Competency assessment dated 05/2022-no assessment of blind testing. Competency assessment dated 05/31/23-no assessment of blind testing. Testing person number three: Competency assessment dated 03/29/23-no assessment of blind testing. Competency assessment dated 09/19/23-no assessment of blind testing. Testing person number four: Competency assessment dated 08/25/22-no assessment of blind testing. Competency assessment dated November 2022-no assessment of blind testing. Competency dated 02/24/23-No assessment using blind testing. Competency dated 8 /28/23-No assessment of blind testing. Testing person number five: Competency assessment dated 09/30/22-No assessment of blind testing. 3. Interview on 01/24/24 at 1:45 pm with the laboratory lead 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), resulting in competency assessments performed that did not include all six required criteria for four of five testing personnel (eight of nine competency assessments reviewed). D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with the laboratory lead, the laboratory failed to have policies or procedures that defined quality activities related to proficiency testing. The findings include: 1. Review of the laboratory procedure manual revealed no policy or procedure related to proficiency testing. 2. Interview with the laboratory lead on 01/24/24 at 1:45 pm confirmed the laboratory failed to have proficiency testing policies and procedures. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when -- 2 of 5 -- appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation of the laboratory, staff interview, review of the laboratory procedure manual, and interview with the laboratory lead, the laboratory failed to follow its' own policy for labeling of patient CBC samples. The findings include: 1. Observation of the laboratory on 01/24/24 at 9 am revealed the Sysmex XN 330 (serial # 14732) used for performing patient testing for Complete Blood Count with automated white blood cell differential (CBC w/Diff). 2. On 01/24/24 at 9 am, testing person number three was asked to describe how patient samples are labeled. She stated she did not label patient CBC samples at any point during the collection and testing of the sample. 3. Review of the laboratory procedure titled "LABELING, HANDLING AND STORAGE OF SPECIMENS POLICY" revealed the following statement: "Correct and timely labeling of each specimen is critical. The correct labeling system includes: patient's full name + last 4 digits of the SS# or DOB, date of collection (in some cases)." The procedure titled "SPECIMEN COLLECTION" revealed the following statement "Labeling of the collected specimen must take place immediately after collection and be legible, indelible, accurate, and firmly affixed to the specimen container." 4. During an interview on 01/24/24 at 1:45 pm, the laboratory lead confirmed the laboratory failed to follow its' own policy for labeling of patient specimens, when testing person three stated she did not label patient CBC samples. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on observation of the laboratory, interview with testing person number three, review of the laboratory's quality asessment monitoring form and interview with the laboratory lead, the laboratory's quality assessment process did not include monitoring for pre-analytic laboratory activities. The findings include: 1. Observation of the laboratory on 01/24/24 at 9 am revealed the Sysmex XN 330 used for performing patient testing for CBC. 2. During an interview on 01/24/24 at 9 am, with testing person three, the testing person stated she never labels a patient CBC specimen. 3. Review of the laboratory's monthly quality assessment form revealed pre-analytic activities were not monitored. 4. Interview with the lead testing person on 01/24/24 at 1:45 pm confirmed the laboratory's quality assessment process did not include monitoring for pre-analytic activities. 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 -- 3 of 5 -- 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 D0000 493.51 Notification requirements for laboratories issued a certificate of compliance Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory ' s certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance. This requirement is not met as evidenced by: Based on review of the laboratory's specialties in the Aspen Web 116, observation of the laboratory, review of the Centers for Medicare and Medicaid Services Application for Certification (Form CMS-116), request for documentation, and interview with the lead testing person, the laboratory failed to notify the State Agency of change in specialties within six months of the change. The findings include: 1. Review of the laboratory' specialties in the Aspen Web 116 revealed the specialty of bacteriology. 2. Observation of the laboratory on 06 /02/2022 at 8:30 am revealed no evidence of testing in the specialty of bacteriology. 3. Review of the laboratory's Form CMS-116 completed as part of the survey revealed bacteriology was not listed as a specialty. 4. Request on 06/02/2022 at 9:30 am for documentation of State Agency notification of change in specialties revealed no documentation was available. 5. Interview with the lead testing person on 06/02/2022 at 9:30 am confirmed the laboratory had ceased testing for the bacteriology specialty. She was unsure, but believed it was sometime in 2019. She further confirmed notification there was no documentation the State Agency had been notified of the change. The laboratory failed to notify the State Agency of change in specialties within six months of the change. 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 4 -- 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 American Proficiency Institute (API) proficiency testing attestation statements and interview with the lead testing person, the laboratory director and testing personnel failed to sign attestation statements for four of six proficiency testing events reviewed in 2020, 2021 and 2022. The findings include: 1. Review of the laboratory's API Hematology/Coagulation proficiency testing attestation statements revealed attestation statements that were not signed by the lab director/testing personnel as follows: Not signed by lab director: 2020 event three, 2021 event one Not signed by testing personnel: 2021 event two and 2022 event one 2. Interview with the lead testing person on 06/02/2022 at 1pm confirmed four of six proficiency testing attestation statements were either not signed by the lab director or the testing personnel in 2020, 2021, and 2022. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the lead testing person, the laboratory failed to protect its' patient from potential biological hazards when it stored patient medication in the same refrigerator as quality control vials and patient blood samples in 2022. The findings include: 1. Observation on 06/02/2022 at 8:30 am of the laboratory refrigerator revealed the storage of over-the-counter children's medication in the same refrigerator as quality control vials and patient blood samples. 2. Interview with the lead testing person on 06/02/2022 at 1 pm confirmed the laboratory failed to ensure its' patients were protected from biological hazards when it stored patient medications in the same refrigerator with quality control material and patient specimens in 2022. 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 patient test reports, document request, and interview with the lead testing person, the laboratory failed to have a written procedure for use of the Sysmex SN-330 Complete Blood Count instrument beginning 04/07/2022 until survey date on 06/02/2022. The findings include: 1. Observation of the laboratory on 06/02/2022 at 8:30 am revealed the Sysmex SN-330 -- 2 of 4 -- CBC instrument (serial #14731) on the counter in use for performing patient complete blood count (CBC) testing. 2. Review of the first patient reported (patient #2) revealed patient testing began on 04/07/2022. 3. Request made to the lead testing person on 06 /02/2022 at 11:30 am for Sysmex XN-330 instrument procedure manual revealed no written and approved procedure was available. 4. Interview with the lead testing person on 06/02/2022 at 2 pm confirmed the laboratory began patient testing for CBC on 04/07/2022 until the date of the survey on the Sysmex XN-330 without a written procedure for use. 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 manufacturer complete blood count (CBC) quality control package insert and interview with the lead testing person, the laboratory failed to label complete blood count quality control vials with open date and corrected expiration date on the date of the survey (06/02/2022). The findings include: 1. Observation of the laboratory on 06/02/2022 at 8:30 am revealed the Sysmex XN-330 CBC instrument (serial #14731) in use for patient testing. Observation of the control vials in use revealed no labeling to indicate when they were opened or the corrected expiration date. 2. Review of the manufacturer quality control package insert revealed the following statement: "Open vials and vials which have been sampled by cap piercing will retain stability for 15 days if stored at 2-8 degrees C after being re-capped." 3. Interview with the lead testing person on 06/02/2022 at 1 pm confirmed the laboratory had not labeled CBC quality control vials with open date and corrected expiration date on the date of the survey (06/02/2022). D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require