Southside Medical Clinic

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 following CONDITION LEVEL DEFICIENCIES of the CLIA program: D2016 - 42 C.F.R. 493.803 Condition: Successful participation 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 proficiency testing desk review of Centers for Medicare and Medicaid Services (CMS) 0155 report and American Association of Bioanalysts 2024 and 2025 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 -- proficiency testing (PT) records, the laboratory failed to successfully participate in the specialty of Hematology in the WBC Diff (White Blood Cell Differential) analyte for two of three events in 2024 and 2025, resulting in an initial PT failure. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155 Individual Laboratory Profile, American Association of Bioanalysts (AAB) proficiency testing (PT) records from 2024 and 2025, and confirmed in interview, the laboratory failed to achieve satisfactory performance (80% or greater) for the WBC Differential (WBC Diff) analyte in two out of three proficiency testing events in 2024 and 2025, resulting in an initial PT failure. Findings Included: 1. Review of the CASPER 0155 report revealed the following results: a. Hematology 2024-Third Event: Laboratory received an unsatisfactory score of 20% for WBC Diff analytes. b. Hematology 2025-Second Event: Laboratory received an unsatisfactory score of 56% for WBC Diff analytes. 2. Review of the AAB Proficiency Testing records confirmed the laboratory received the above results for the WBC Diff analyte in two out of three proficiency testing events in 2024 and 2025. 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 proficiency testing desk review of CMS 0155 report and American Association of Bioanalysts 2024 and 2025 records, 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) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS 0155 report and American Association of Bioanalysts 2024 and 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director -- 2 of 3 -- failed to ensure successful participation in an HHS approved proficiency testing program for the WBC Diff (White Blood Cell Differential) analyte for two of three events in 2024 and 2025. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory policies, patient test records, and confirmed in staff interview, the laboratory failed to ensure one of ten patient CBC test records reviewed were accurate and reliable in November 2024 (random review). Findings included: 1. Review of the XN-L series XN-530/XN-430 /XN-330 Basic Operation manual stated: "Chapter 5 Checking Analysis Results (Sample Explorer) ... 5.11.2 Display of analysis result data When an analysis result could not be obtained due to an error or other problem, the result is masked. When an analysis is determined to be abnormal, a mark appears ... Marks Display [*] Meaning Low reliability Description Indicates that the reliability of the data is low." Review of the XN-L series XN-530/XN-430/XN-330 Troubleshooting manual stated: "Chapter 5 IP Messages With respect to the following IP messages, when a sample judgement is Positive, the analysis results are regarded as having a low reliability due the abnormality, and "*" is displayed to the right of the data ..." 2. Review of the laboratory's policies stated: "Tab 7 Post Analytical Policies and Procedure ... 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 -- Procedures for: Interpreting Results Once a result is obtained, examine the report. Items to look for are: Are there low or high flags? Is the automated diff flagged for any cell type ... When patient results are flagged repeat the sample after 10-30 minutes. If he repeated sample has no flags, give that result to the physician. If the flags repeat, refer to Troubleshooting and Diagnostics Section of the Operations Manual [sic] Suspect a problem CBC when ... Asterisk "*" appears next to results data [sic] Alert messages pertaining to specimens, either patient or QC, are displayed in place of or next to the affected result(s) ...The parameter result is printed with an asterisk (*) on the ticket printout. The name of each flag, location of the flag on the display, the cause of the flag, and the action to be taken are given in the Operational Messages and Data Flagging section of the Operators Manual." 3. A random review of ten patient reports from November 2024 revealed one of ten patient CBC reports with an "*" for the following analytes and differential parameters: WBC, PLT, MPV, NEUT, LYMPH, MONO, EO, BASO, IG Note: The laboratory did not have a LIS, therefore CBC reports were manually scanned into the patient's electronic medical record and then placed into the paper medical record. 4. During an interview on 11/12 /2024 at 11:48 a.m., laboratory representatives after a review of records, confirmed the laboratory failed to ensure patient CBC test records were accurate and reliable. Word Key: CBC - complete blood count diff - differential WBC - white blood cell PLT - platelet MPV - mean platelet volume NEUT - neutrophil LYMPH - lymphocyte MONO - monocyte EO - eosinophil BASO - basophil IG - immature granulocyte LIS- laboratory information system -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, training documents, and interview, the laboratory failed to provide documentation of training on the Abbott ID NOW COVID-19 test for four out of ten testing personnel. Findings follow. A. Review of the Abbott ID NOW COVID-19 package insert, Rev. 6 09/2020, stated, "The ID NOW COVID-19 test is intended for use by medical professionals or trained operators who are proficient in performing tests using the ID NOW Instrument. The ID NOW COVID-19 test is only for use under the Food and Drug Administration's Emergency Use Authorization." B. Review of training documents showed no documentation of training for testing personnel #1, 2, 4, and 7. C. Interview with the Clinic Coordinator on October 4, 2022, at 1110 hours in the office confirmed she could not locate the training documents when the test was introduced to the laboratory in 2020. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it 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 -- can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of laboratory records, interview, and pre-survey paperwork, the laboratory failed to ensure the validation on the Sysmex XN-330 was performed and evaluated for the accuracy, precision, and verifying patient normal ranges for the Complete Blood Count prior to patient testing on March 01, 2022. A. Review of the Sysmex documentation showed there was no validation folder, or documentation of performance specifications except for the reportable range study. B. The validation records were requested on October 4, 2022, at 1130 in the office. Interview with the technical consultant on October 4, 2022, at 1130 in the office acknowledged the instrument was replaced in Nov 2021. The technical consultant called tech support for the validation, but tech support did not have a copy of the validation. Interview with the provider on October 4, 2022, at 1255 in the office acknowledged the first patient test was reported March 1, 2022. C. Review of the CMS form 116 showed an estimated 27000 tests were performed annually. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on review of laboratory records, interview, and pre-survey paperwork, the technical consultant failed to ensure the validation on the Sysmex XN-330 was performed and evaluated for the accuracy, precision, and verifying patient normal ranges for the Complete Blood Count (CBC) prior to patient testing on March 01, 2022 (refer to D5421). D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on review of the pre-survey paperwork, interview, and competency evaluations the technical consultant failed to include direct observation of patient testing as part of the evaluation of the competency of testing personnel for 10 of 10 testing personnel performing Complete Blood Counts (CBC) for two of two years reviewed. Findings follow. A. Review of the CMS form 209 showed there were 11 testing personnel. B. Interview with the technical consultant on October 4, 2022, at 0930 in the office as to whether direct observations of patient testing were part of his competency evaluations, -- 2 of 3 -- his response was he watched them [testing personnel] while he was here throughout the year. When asked how do you keep up with who you've observed his response was "I don't know how to answer that" and confirmed he used nothing to keep track of who he's observed, or when. C. Review of competency evaluations showed there were 11 current employees performing testing. D. Interview with the Clinic Coordinator on October 4, 2022, at 1230 acknowledged testing personnel #10 on the CMS form 209 was a scribe and verified with the employee via phone call during the survey that she had never performed laboratory testing at this site. E. Review of competency evaluation showed testing personnel #10 had at least three competency evaluations performed 01/17/2022, 01/18/2021, and 01/20/2020, but had never performed any laboratory testing at the site, including for competency. F. Review of the CMS form 116 showed an estimated 27000 tests were performed annually. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for 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 competency evaluations and interview, the technical consultant failed to evaluate and document the performance of individuals responsible for performing Complete Blood Counts (CBC) at least semiannually during the first year the individual tests patient specimens for one of three new employees (see D6047). Findings follow. A. Review of competency evaluations showed one of three employees hired from 07/23/2020 - 07/06/2021 had one semiannual competency evaluation. Testing personnel # 1 as listed on the CMS Form 209 was hired 02/01 /2021, was trained 02/16/2021, and had a semiannual competency evaluation on 07/30 /2021. The next competency evaluation was performed on 07/25/2021, one year later. B. Interview with the technical consultant on October 4, 2022, at 1020 in the office stated he had not heard of performing two semiannual competency evaluations from the date of hire/training. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 02/23 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 02/23 /2021. 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 State Health and Human Services Commission, Health Facility Compliance Arlington Group. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of laboratory SARS-Co-V-2 patient testing records, review of laboratory SARS-Co-V-2 result reporting records, and staff interview, it was revealed that the laboratory failed to report SARS-Co-V-2 negative test results for 33 of 33 days reviewed from 01/08/2021 through 03/25/2021. Findings: 1. Review of SARS- Co-V-2 patient tests records (test performed using the Abbott ID NOW COVID-19 Test kit and instrumentation) from 01/08/2021 through 03/25/2021 revealed 117 patients tested for SARS-CoV-2. 2. Further review of the SARS-Co-V-2 patient tests 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 -- results revealed of the 117 patients tested for SARS-Co-V-2, 49 patients tested negative. 3. Review of the laboratory's SARS-Co-V-2 result reporting documentation revealed the laboratory faxed SARS-Co-V-2 positive patient results Sunday through Saturday from 01/08/2021 through 03/25/2021 to the County Health Department. Further review of the laboratory's SARS-Co-V-2 reporting documentation revealed the laboratory failed to report the 49 negative test results to the County Health Department or to the Department of State Health Services. 4. During an interview on 03/26/2021 at 12:04 pm, the Technical Consultant and Compliance Officer confirmed that only positive SARS-Co-V-2 results were reported. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, manufacturer's instructions for CDS 3PD Hematology Control, quality control (QC) records, and confirmed in interview, the laboratory failed to establish its own mean and acceptability ranges for complete blood count (CBC) controls for 3 of 3 lot of control materials used from January 2021 through March 2021. Findings: 1. Review of the laboratory policy "Analytic Policies and Procedures" revealed: "Verifying New Lot Numbers of Control At least one day before the current lot number of controls expires, verify the acceptability of the new lot number. Run the current quality control material as usual and use these QC results to judge whether or not to accept patient test results. During the same run, run all 3 levels of the new control material in PATIENT mode, 1 to 5 times each. Examine results by verifying that all control values are within the manufacturer's stated range. If the data are acceptable, the new lot number of controls is now ready to use. Print the results and attach to the manufacturer's assay sheet. Mark "OK" on the new lot numbers of controls and sign and date this approval. Do the same on the assay sheet to document that the new lot number of controls has been verified." 2. Review of CDS 3PD Hematology Control instructions for use stated: "INSTRUCTIONS ... (9) Before expiration of the current lot, good laboratory practice requires that a new lot of cell control be analyzed in parallel with the existing lot until a laboratory mean is established on the new lot." 3. Review of CDS 3PD Hematology Control assay sheet and CBC QC records revealed the laboratory was utilizing the range of means from the assay sheet for the acceptability of QC. The laboratory did not establish its own means and limits for each parameter for the following lots: Low Control Lot 320111, expiration date: 04/09/2021, date put into use: 01/13/2021 Normal Control Lot 320112, expiration date: 04/09/2021, date put into use: 01/13/2021 High Control Lot 320113, expiration date: 04/09/2021, date put into use: 01/13/2021 4. During an interview on 03/26/2021 at 10:34 am, the Technical Consultant stated that the laboratory did not establish its own mean and ranges for complete blood counts and the assay sheets were used for QC acceptability, confirming the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 02/23 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 02/23 /2021. 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 State Health and Human Services Commission, Health Facility Compliance Arlington Group. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of laboratory SARS-Co-V-2 patient testing records, review of laboratory SARS-Co-V-2 result reporting records, and staff interview, it was revealed that the laboratory failed to report SARS-Co-V-2 negative test results for 33 of 33 days reviewed from 01/08/2021 through 03/25/2021. Findings: 1. Review of SARS- Co-V-2 patient tests records (test performed using the Abbott ID NOW COVID-19 Test kit and instrumentation) from 01/08/2021 through 03/25/2021 revealed 117 patients tested for SARS-CoV-2. 2. Further review of the SARS-Co-V-2 patient tests 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 -- results revealed of the 117 patients tested for SARS-Co-V-2, 49 patients tested negative. 3. Review of the laboratory's SARS-Co-V-2 result reporting documentation revealed the laboratory faxed SARS-Co-V-2 positive patient results Sunday through Saturday from 01/08/2021 through 03/25/2021 to the County Health Department. Further review of the laboratory's SARS-Co-V-2 reporting documentation revealed the laboratory failed to report the 49 negative test results to the County Health Department or to the Department of State Health Services. 4. During an interview on 03/26/2021 at 12:04 pm, the Technical Consultant and Compliance Officer confirmed that only positive SARS-Co-V-2 results were reported. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, manufacturer's instructions for CDS 3PD Hematology Control, quality control (QC) records, and confirmed in interview, the laboratory failed to establish its own mean and acceptability ranges for complete blood count (CBC) controls for 3 of 3 lot of control materials used from January 2021 through March 2021. Findings: 1. Review of the laboratory policy "Analytic Policies and Procedures" revealed: "Verifying New Lot Numbers of Control At least one day before the current lot number of controls expires, verify the acceptability of the new lot number. Run the current quality control material as usual and use these QC results to judge whether or not to accept patient test results. During the same run, run all 3 levels of the new control material in PATIENT mode, 1 to 5 times each. Examine results by verifying that all control values are within the manufacturer's stated range. If the data are acceptable, the new lot number of controls is now ready to use. Print the results and attach to the manufacturer's assay sheet. Mark "OK" on the new lot numbers of controls and sign and date this approval. Do the same on the assay sheet to document that the new lot number of controls has been verified." 2. Review of CDS 3PD Hematology Control instructions for use stated: "INSTRUCTIONS ... (9) Before expiration of the current lot, good laboratory practice requires that a new lot of cell control be analyzed in parallel with the existing lot until a laboratory mean is established on the new lot." 3. Review of CDS 3PD Hematology Control assay sheet and CBC QC records revealed the laboratory was utilizing the range of means from the assay sheet for the acceptability of QC. The laboratory did not establish its own means and limits for each parameter for the following lots: Low Control Lot 320111, expiration date: 04/09/2021, date put into use: 01/13/2021 Normal Control Lot 320112, expiration date: 04/09/2021, date put into use: 01/13/2021 High Control Lot 320113, expiration date: 04/09/2021, date put into use: 01/13/2021 4. During an interview on 03/26/2021 at 10:34 am, the Technical Consultant stated that the laboratory did not establish its own mean and ranges for complete blood counts and the assay sheets were used for QC acceptability, confirming the above findings. -- 2 of 2 --