Gordon T Connor Md

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the Laboratory Manager (LM) who is also the Testing Personnel (TP), the laboratory failed to ensure the Laboratory Director (or designee) signed the proficiency testing attestation statements. This was noted for six of the six PT events reviewed in 2024- 2025. The findings include: 1. A review of the AAB-MLE PT records revealed the Laboratory Director (or designee) failed to sign the attestation statements for the following PT events: a) 2024 M1-M3 Events (Urine Sediment) b) 2025 M1-M3 Events (Urine Sediment) 2. The LM/TP confirmed the above findings during exit conference on 02-04-2026 at 11:13 PM. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the 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 -- Laboratory Manager (LM) who is also the Testing Personnel (TP), the laboratory failed to document review and evaluation of PT performance. This was noted for six of the six 2024-2025 PT events reviewed. The findings include: 1. A review of the AAB-MLE PT records revealed no documentation of review on the graded evaluations by the Laboratory Director, or designee, for the following events: a) 2024 M1-M3 Events (Urine Sediment) b) 2025 M1-M3 Events (Urine Sediment) 2. The LM /TP confirmed the above findings during exit conference on 02-04-2026 at 11:13 PM. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the centrifuge maintenance records and an interview with the Laboratory Manager (LM) who is also the Testing Personnel (TP), the laboratory failed to ensure centrifuge maintenance was performed and documented annually. This was noted from the last 2023 survey to the current 2026 survey. This is a repeat deficiency. The Findings include: 1. A review of the maintenance records revealed centrifuge maintenance was performed and documented 10-11-2023 after the facility was cited for non-compliance during the last survey on 10-10-2023. However, at the time of the current survey on 02-04-2026, no documentation of the 2024 and/or 2025 maintenance was available for review. 2. The LM/TP confirmed the above findings during exit conference on 02-04-2026 at 11:13 PM. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of the Personnel records and an interview with the Laboratory Manager (LM) who is also the Testing Personnel (TP), the laboratory failed to ensure the Laboratory Director specified in writing the duties and responsibilities of all personnel listed on the CMS 209 (Laboratory Personnel Report). This was noted for one out of one employee from the date of the last survey (10-10-2023), through the current survey (02-04-2026). This is a repeat deficiency. The Findings include: 1. A review of the Personnel records revealed no evidence of job description for the Testing Personnel, Technical Consultant and Clinical Consultant. 2. A further review of the Personnel records revealed the only job description available for review was for the Laboratory Director. 3. LM/TP confirmed the above findings during exit conference on 02-04-2026 at 11:13 PM. -- 2 of 3 -- D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the Laboratory Manager (LM) who is also the Testing Personnel (TP), the Laboratory Director (LD), who is also the Technical Consultant (TC), failed to assess and document the annual competency assessment of TP responsible for the Urine sediment examination. This was noted for one out of one employee listed on the CMS-209 Form (Laboratory Personnel Report). The findings include: 1. A review of personnel records for TP listed on the CMS-209 Form (Laboratory Personnel Report) who performed urine sediment examinations revealed the LD/TC failed to document the annual competency assessments for the TP due in January 2026. 2. The LM/TP confirmed the above findings during exit conference on 02-04-2026 at 11:13 PM. -- 3 of 3 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of Maintenance records and interviews with Testing Personnel #1, the laboratory failed to ensure maintenance for the centrifuge was documented. This was noted from the date of the last survey, 8/20/2023, to the date of the current survey, 10/10/2023. The findings include: 1. A review of Maintenance records revealed centrifuge maintenance records dated in 2013. No current documention of maintenance for the laboratory's centrifuge was available for review. 2. During an interview on 10/10/2023 at 11:00 AM, Testing Personnel #1 explained a Southeast Clinical Laboratories representative came annually to perform maintenance, and retained those records. After reaching out to Southeast Clinical Laboratories, Testing Personnel #1 informed the surveyor no maintenance records were available for review. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with Testing Personnel #1, the Laboratory Director failed to specify in writing the job duties and responsibilities of all laboratory personnel as listed on the Laboratory Personnel Report (CMS-209). This was noted from the date of the previous survey, August 20, 2023, to the date of the current survey, October 10, 2023. The findings include: 1. A review of the Personnel records revealed no evidence of a job description for the Laboratory Director, Testing Personnel #1, or Testing Personnel #2. 2. During an off site interview on 10/12/2023 at 9:50 AM, Testing Personnel #1 confirmed the above findings. -- 2 of 2 --