Bmg Family Physicians Group Foundation

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 observation of the laboratory, review of the laboratory procedures, laboratory personnel records, final patient test reports, and staff interviews, the laboratory failed to follow its procedure for personnel competency assessment when the annual competency assessment did not include vaginal wet prep and potassium hydroxide (KOH) testing for one of two testing personnel that performed wet prep and KOH patient testing in 2024. The findings include: 1. Observation of the laboratory on 03/07/2025 at 9:45 a.m. revealed the microscope used to perform vaginal wet prep and KOH patient testing. 2. A review of the laboratory personnel policy titled "Personnel Assessment Policy" revealed that testing personnel competency assessments were required following a training period, then after six months, and annually thereafter. 3. A review of the laboratory ' s personnel records for testing person eight revealed that the competency assessment completed on 10/04/2024 did not include vaginal wet prep and KOH testing. 4. A review of final patient test reports revealed testing person eight performed vaginal wet prep testing for patient 11651320 on 12/27/2024. 5. The survey findings were confirmed in an interview with the laboratory liaison, technical consultant, and office manager on 03/07/2025 at 2:00 p. m. 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 laboratory was found NOT to be in compliance with the following 42 CFR Part 493, Requirements for Laboratories for the specialties/subspecialties for which it was surveyed: 493.1250 Analytic systems 493.1409 Laboratories performing moderate complexity testing; technical consultant D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of procedure manuals, validation records, lack of records, manufacturer package insert, patient test reports, and staff interviews the laboratory failed to have an approved procedure for use of the Sysmex XN430 CBC instrument that met the regulatory requirements (Refer to D5403), the laboratory director failed to approve the procedure for the Sysmex XN430 (Refer to D5407), the laboratory failed to monitor room temperature and humidity in the area where the Sysmex XN430 was being used for patient testing (Refer to 5413), failed to label controls with open date and corrected expiration date (Refer to D5415), failed to verify the normal ranges used for CBC performed on the Sysmex XN430 (Refer to D5421), failed to establish performance specifications for the urine microscopic, wet prep and potassium hydroxide (Refer to D5423), and failed to have quality assessment procedures for the Sysmex XN430 (Refer to D5791). D5403 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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)