Smg Pediatric Clinic West

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 laboratory observation, a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), American Proficiency Institute (API) proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that two of six testing personnel (TP) who performed hematology patient testing also participated in proficiency testing in 2024. The findings include: 1. An observation of the laboratory on 10.08.2025 at 9:30 a.m. revealed that it used a Sysmex XP-300 hematology analyzer (Serial Number: B5128) for complete blood count (CBC) patient testing. 2. A review of the FORM CMS-209 revealed a total of six persons (TP1, TP2, TP3, TP4, TP5, and TP6) who perform moderately complex patient testing. 3. A review of the laboratory's API PT attestation statements revealed that TP4 and TP5 did not participate in any hematology PT events (0 of 3 reviewed) in 2024. 4. An interview with the facility laboratory lead (TP1) on 10.08.2025 at 10:30 a.m. and a subsequent phone interview with the laboratory team lead (TP1) on 10.10.2025 at 11:15 a.m. confirmed the above survey findings 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 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 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 employee personnel records for 2020 and 2021 and interview with the lead testing person, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for all testing personnel (TP). The findings include: 1) Review of employee personnel records for 2020 and 2021 failed to include documentation of the six required criteria of competency that 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) An interview with the lead testing person on December 13, 2021 at 10:00 a.m. confirmed all TP evaluated during 2020 and 2021 were not evaluated using the six criteria for competency required by Centers for Medicare and Medicaid (CMS). ================================== 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 --