George S Sidhom Md Pa D/B/A Brandon Pain Clinic

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at George S Sidhom MD PA dba Brandon Pain Clinic on 12/23/25 through 12/24/25. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform and document calibration verification at least once every 6 months for the speciality of Chemistry and Toxicology performed from 2/13/24 to 12/23/2025. Findings included: 1. Calibration Verification reports for speciality of Chemistry and Toxicology which 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 -- used two point calibration performed from 2/13/24 to 12/23/2025 was requested. No documentation was presented for review. 2. The Technical Supervisor on 12/23/2025 at 11:11 a.m. confirmed the laboratory had not performed and documented calibration verification from 2/13/24 to 12/23/2025 every 6 months for the speciality of Chemistry and Toxicology. D6080 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(c) (c) The laboratory director must: (c)(1) Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and (c)(2) Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to establish a policy to be onsite once every six months and failed to document any onsite visits from 1/1/2025 to 12/23/2025. Findings included: 1. The Laboratory Policy and Procedure signed by the Laboratory Director on 7/07/2020, failed to contain a policy to be onsite once every six months and to document any onsite visits. 2. On 12/23 /2025 at 11:31 a.m., the Technical Supervisor confirmed the laboratory failed to have an established policy for the Laboratory Director to be onsite once every six months and failed to have documention of any onsite visits from 1/1/2025 to 12/04/2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 09/17/19 thru 09/19/19 at George S Sidmon MD DBA Brandon Pain Clinic. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Clinical Laboratories. Based on the survey findings an Immediate Jeopardy situation was identified and the laboratory was notified at 3:59 PM on 09/18/19. The laboratory reported patient test results without two levels of acceptable quality control (D5400). The following Conditions were not met: D5200 - 493.1230 General laboratory systems D5400 - 493.1250 Analytic systems D6076 - 493.1441 Laboratories performing high complexity testing: laboratory director D6141 - 493.1459 Laboratories performing high complexity testing: general supervisor 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 American Proficiency Institute (API) proficiency testing attestation statements and interview with the General Supervisor the Laboratory Director failed to sign 4 (1st testing event 2019, 1st, 2nd testing event 2018, and 2nd testing event 2017) out of 4 testing event attestation statements. Findings Included: API proficiency testing was reviewed for the 1st testing event 2019, 1st, 2nd testing event 2018, and 2nd testing event 2017. Review of API proficiency testing attestation statements revealed no signature of the Laboratory Director on the 1st testing event in 2019, 1st, 2nd testing event in 2018, and the 2nd testing event in 2017. Interview on 09 /17/19 at 11:35 AM with the General Supervisor confirmed the lack of Laboratory Director signature on the attestation statements. 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 -- D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the General Supervisor the laboratory failed to have documentation of competency and training for 2 out of 2 years (2017- 2019) reviewed (See D5209). 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 record review and interview with the General Supervisor the laboratory failed to have documentation of competency and training for 2 out of 2 years reviewed (2017-2019). This is a repeat deficiency from the 10/24/17 recertification survey. Findings Included: Review of the CMS 209 signed by the Laboratory Director on 09 /17/19 revealed two Testing Personnel: Testing Person #A (who is also the General Supervisor) and Testing Person #B. Review of Testing Person/General Supervisor #A's personnel file revealed she worked with the laboratory since it opened on 06/12 /14. There were no competency evaluations for being a Testing Person or General Supervisor in the file. Review of Testing Person #B's personnel file revealed that the first day of work was 07/15/19. There was no documentation of training or competency signed off prior to performing patient testing. Review of the undated Policy and Procedure titled Laboratory Requirements (not signed by the Laboratory Director) revealed that "Only trained personnel, as defined by laboratory regulating bodies, are to perform tests in the laboratory." There were no competency polices. Interview on 09/17/19 at 11:21 AM with the General Supervisor confirmed that there were no competencies or training in the personnel binder. Review of the CMS 2567 from the 10/24/17 recertification survey revealed that this was a repeat deficiency. The