Bmg Family Physicians Group Foundation, Inc

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 procedure manual, review of testing personnel records, and a lack of records, and staff interview, the laboratory failed to follow the policy for testing personnel competency assessment when it did not perform one of the three annual testing personnel competency assessments due in 2024 for performance of CBC w/Diff. The findings include: 1. A review of the laboratory's policy titled "PERSONNEL ASSESSMENT POLICY" revealed the following statement: "At the completion of 1 year working as testing personnel, each employee will have a yearly "Competency Assessment." 2. A review of testing personnel records revealed the following: Testing Person four was hired on 09/27/2023. There was no documented annual competency assessment record in 2024. 3. The laboratory liaison confirmed the survey findings during an interview on 06/05/2025 at 4:15 p.m. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on a review of the laboratory procedure manual, a review of the laboratory's Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff) College of American Pathologists (CAP) Proficiency Testing (PT) records, a review of the laboratory's quality assessment records, and staff interview, the laboratory failed to perform

Summary Statement of Deficiencies 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 supplies and staff interviews, the laboratory failed to label the saline used for patient wet prep sample collection and transportation on the date of the survey (02/01/2024). The findings include: 1. Observation on 02/01/2024 at 1:00 pm of patient exam room supplies used by nursing personnel for patient wet prep sample collection and transport revealed clear plastic transport tubes that contained clear liquid. The tubes were not labeled. 2. Interview on 02/01/2024 at 1:00 pm with the laboratory liaison and testing person three revealed personnel aliquoted saline from a master container into the transport tubes and stored them without labels. Patient samples were collected and transported using the tubes in the exam room for vaginal wet prep testing. This confirmed the 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 --