G Scot Johnson Md Pa

Summary Statement of Deficiencies D0000 The laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The condition not met was: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel 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 review of the laboratory's American Association of Bioanalysts/Medical Laboratory Evaluation (AAB/MLE) proficiency testing records from 2023 and 2025, and staff interview, the laboratory failed to have documentation of testing personnel signing 6 of 6 attestation statements. The findings included: 1. A review of the laboratory's American Association of Bioanalysts/Medical Laboratory Evaluation Non-Chemistry proficiency testing records from 2023 (M1, M2 and M3) and 2024 (M1, M2 and M3) determined the laboratory failed to have documentation of testing personnel signing 6 of 6 attestation statements. They were: 2023 Non-Chemistry M1 2023 Non-Chemistry M2 2023 Non-Chemistry M3 2024 Non-Chemistry M1 2024 Non-Chemistry M2 2024 Non-Chemistry M3 2. The technical consultant confirmed the findings in an interview conducted on 01/22/205 at 1244 hours in the break room. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures, review of the laboratory's hematology quality control records from 2024, and staff interview, the laboratory failed to have documentation of following its policy for the verification of new lots of quality control material for 4 of 4 lots. The findings included: 1. A review of the laboratory's procedure titled "Hematology CBC Quality Control" stated the laboratory required testing new lots of quality control material a minimum of 10 times prior to placing the lot into use to verify the control. 2. A review of Mindray BC-3D hematology quality control records from 2024 identified 4 of 4 new lots which were placed into use without documentation of the minimum of 10 runs. They were: Lot: B0224 expiration: 5-5-2024 tested one time Lot: B0524 expiration: 8-5-2024 tested one time Lot: B0824 expiration: 11-5-2024 tested one time Lot: B1124 expiration: 2-5-2025 tested one time 3. The technical consultant confirmed the findings in an interview conducted on 01/22/2025 at 1244 hours in the break room. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration records for the Mindray 3600 hematology analyzer from 2023 and 2024, and staff interview, the laboratory's quality assurance plan failed to identify that calibration factors were changed without documentation of calibrations being performed for 3 of 3 calibrations. The findings included: 1. A review of the laboratory's calibration records for the Mindray 3600 hematology analyzer from 2023 and 2024 revealed the instrument documented the calibration factors in use prior to the calibration and the new calibration factors determined as a result of the calibration. Thus, the new calibration values should be the same as the old calibration values documented at the next calibration. 2. Further review of the calibration records showed: a) Calibration: 2/6/2023 New Calibration Factors: WBC: 101.09 RBC: 100.60 HGB: 104.07 MCV: 94.75 PLT: 98.45 b) Calibration: 7/26/2023 Old Calibration Factors: WBC: 101.57 (changed) RBC: 100.58 (changed) HGB: 103.90 (changed) MCV: 94.84 (changed) PLT: 100.09 (changed) New Calibration Factors: WBC: 102.22 RBC: 102.39 HGB: 105.13 MCV: 95.24 PLT: 101.68 c) Calibration: 01/22/2024 Old Calibration Factors: WBC: 101.09 (changed) RBC: 100.60 (changed) HGB: 104.07 (changed) MCV: 94.75 (changed) PLT: 98.45 (changed) New Calibration Factors: WBC: 99.02 RBC: 99.67 HGB: 98.32 MCV: 98.83 PLT: 96.09 d) Old Calibration Factors: WBC: 102.22 (changed) RBC: 102.39 (changed) HGB: 105.13 (changed) MCV: 95.24 (changed) PLT: 101.68 (changed) 3. The laboratory did not have documentation of calibrations being performed to support the change of calibration factors. 4. The technical consultant reviewed the records and confirmed the findings in an interview conducted on 01/22 /2024 at 1300 hours in the break room. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES -- 2 of 4 -- CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of the technical consultant performing a competency assessment twice within the first year for 1 of 1 testing personnel. The findings included: 1. A review of the laboratory's submitted Form CMS 209 determined the laboratory identified 1 testing personnel. 2. A review of the laboratory's personnel records for testing personnel number 1 identified she started performing moderate complexity testing on the Mindray 3600 hematology analyzer in January 2024. The file contained a single competency assessment performed in January 2025. 3. The technical consultant confirmed the findings in an interview conducted on 01/22/2025 at 12:44 hours in the break room. She reviewed the entire personnel record and did not see documentation of two competency assessments being performed. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of training to qualify 1 of 1 testing personnel to perform moderate complexity testing (refer to D6066). D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of training to qualify 1 of 1 testing personnel to perform moderate complexity testing. The findings included: 1. A review of the laboratory's submitted Form CMS 209 determined the laboratory identified 1 testing personnel. 2. A review of the laboratory's personnel records for testing personnel number 1 identified she started performing moderate complexity testing on the Mindray 3600 hematology analyzer in January 2024. The laboratory failed to have documentation of testing personnel number 1 being trained on the Mindray 3600 analyzer. 3. The technical consultant confirmed the findings in an interview conducted on 01/22/2025 at 12:44 hours in the break room. She reviewed the entire personnel record and did not see documentation of training on the Mindray 3600 hematology analyzer. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts Medical Laboratory Evaluation (AAB- MLE), the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory had unsuccessful participation in the specialty of hematology for the analyte White Blood Cell Differential (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CMS 155 report and proficiency testing records from American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to successfully participate for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Hematology for the analyte White Blood Cell Differential resulting in an initial proficiency testing failure. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the analyte White Blood Cell Differential: Third testing event 2023 33% Second testing event 2024 0% 2. A desk review of the laboratory's American Association of Bioanalysts/Medical Laboratory Evaluation (AAB/MLE) results from the third event of 2023 and the second event of 2024 confirmed the proficiency testing scores: Third testing event 2023 33% Second testing event 2024 0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance, the laboratory director failed to provide overall management and direction of the laboratory services (refer to D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program (refer to D2130). -- 3 of 3 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the