O'Bryon Family Medicine Inc

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of maintenance records, and interview with the Technical Consultant (TC), the laboratory failed to assess the maintenance and function checks as defined by the manufacturer for 1 of 1 VWR traceable thermometer used to monitor temperature in the chemistry laboratory from 10/23 /2023 to 10/20/2025. Findings include: 1. On the day of survey, 10/20/2025 at 2:15 pm, observation of the laboratory revealed 1 of 1 VWR traceable thermometer (serial number 130767722) was due for calibration on 12/19/2015. 2. The laboratory failed to provide documentation of maintenance and function checks for 1 of 1 VWR traceable thermometer used to monitor refrigerator temperature in the chemistry laboratory from 10/23/2023 to 10/20/2025. 3. The TC confirmed the above findings on 10/20/25 at 2:35 pm. D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on record review, and interview with the Technical Consultant (TC), the TC failed to assess the test performance of 1 of 2 testing personnel (TP) through testing previously analyzed specimens, internal blind testing samples or external proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing samples for routine chemistry tests performed from 10/23/23 to 10/20/2025. Findings Include: 1. On the day of the survey, 10/20/2025 at 1:15 pm, review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) attestation records for routine chemistry analyses revealed TP # 2 (CMS 209, dated 10/07/2025) performed all of the PT samples for the events in 2024 and 2025. 2. The laboratory failed to provide documentation for the evaluation of test performance through internal blind testing or external PT samples for routine chemistry for 1 of 2 TP (CMS 209, TP # 1) that did not perform PT testing from 10/23/2023 to 10/20/2025. 3. The laboratory performed 830 routine chemistry and endocrinology tests in 2024 (CMS 116, estimated annual volume, dated 10/06/2025). 4. The TC confirmed the findings above on 10/20/2025 at 2:35 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's IQCP procedure, lack of quality control (QC) records, and interview with the Technical Consultant (TC) and Testing Personnel (TP) #2 (CMS 209), the laboratory failed to perform and document QC procedures using the number and frequency established by the laboratory for chemistry testing performed from 11/09/2021 to the day of the survey. Findings include: 1. According to the laboratory's Fast Pack IQCP procedure manual, QC should be performed each week of patient testing and after calibration. 2. On the day of the survey, 10/23/2023, at 01:00 PM, the laboratory failed to provide QC documentation for chemistry testing performed using the Fast Pack Analyzer System for each week of patient testing from 11/09/2021 to 10/23/2023. 3. The laboratory's estimated 2022 annual volume for chemistry is 1142 (CMS 116). 4. The TC and TP#2 confirmed the above findings on 10/23/2023 at 02:00 PM. 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 laboratory personnel interview with the Technical Consultant, and review of the competency records, at the time of the survey, laboratory failed to establish written policies and procedures to assess consultant competency for 1 of 1 Technical Consultants. Findings: 1. The laboratory could not produce written policies and procedures to assess Technical Consultant competency from 04/09/2019 through the date of the survey 11/09/2021. 2. Review of the competency records revealed no documentation of Technical Consultant competency for 1 of 1 Technical Consultants from 04/09/2019, through the date of the survey. 3. During the survey (11:00 11/09 /2021), the Technical Consultant confirmed, the above 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 --