Laurelwood Pediatrics

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 American Proficiency Institute (API) proficiency testing (PT) records and staff interview, testing personnel failed to sign two of five attestation statements from 2022 and 2023. The findings include: 1. Review of the laboratory's 2022 and 2023 API PT records revealed attestation statements were not signed by testing personnel for 2022 event two (sample 09) and 2022 event three (sample 13). 2. The laboratory director confirmed the survey finding during interview on 2/7/24 at 4:00 PM. 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's testing personnel competency assessment policy, review of testing personnel records and staff interview, the laboratory failed to follow its' own policy for annual competency assessments for three of six established testing personnel who performed patient testing for Complete Blood Count (CBC) in 2022, 2023 and 2024. The findings include: 1. Review of the laboratory's testing personnel 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 -- competency assessment policy revealed "Annual competency assessment will be performed for all established personnel." 2. Review of the laboratory's testing personnel competency assessment records revealed annual competency assessments were not performed for testing person three in 2022, 2023 or 2024, testing person five in 2022 or testing person six in 2022. 3. During an interview on 2/7/24 at 4:00 PM, the laboratory director confirmed the laboratory did not follow its own testing personnel policy when annual competencies were not performed for established personnel in 2022, 2023 or 2024 for three of six established testing personnel. 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 D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of patient SARS-CoV-2 test records and email communication with the laboratory director, the laboratory failed to report SARS-CoV-2 test results as required for 13 of 27 days in January, 2022. The findings include: 1. SARS-CoV-2 patient test logs and documentation of test reporting documentation was reviewed for the dates of January 10, 2022 and June 8, 2022. 2. Documentation revealed that positive SARS-CoV-2 were not reported as required on January 10, 2022 for 18 of 20 positive SARS-CoV-2 results. 3. Further review for the month of January 2022 revealed that results were not reported as required for 13 of 27 days. 45 of 376 positive SARS-CoV-2 results were not reported. 4. The laboratory director confirmed via email communication on July 26, 2022 at 1:18 pm that not all SARS-CoV-2 results were reported as required. 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 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 form used for assessing employee compentency, and interview with the laboratory director, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency in 2017, 2018 and 2019. The findings include: 1) Review of the laboratory procedure manual revealed no procedure was present that defined the methods used for determing testing personnel competency. The required six criteria are: 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 form used for assessing testing personnel competency revealed evaluation of blind testing was not included in 2017, 2018, and 2019. 3) Interview on April 10, 2019 at 12:20 p.m. with the laboratory director confirmed the laboratory did not have a procedure defining the methods for assessing testing personnel competency and did not include all six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). Evaluation using blind testing was not included on the competency assessment form in 2017, 2018, and 2019. 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 --