San Antonio Metropolitan Hlth Dist Lab

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institutes proficiency testing records from 2024 and 2024, review of the laboratory's College of American Pathologists proficiency testing records from 2024, and staff interview, the laboratory failed to have documentation of evaluating results on 5 of 5 events on which proficiency testing results were ungraded by the proficiency testing agency. The findings included: 1. A review of the laboratory's American Proficiency Institutes proficiency testing records from 2024 (Microbiology event 1, and Microbiology event 3) and 2025 (Microbiology event 2) identified proficiency testing results which were ungraded by the proficiency testing agency: a) 2024 Microbiology event 1 Gram Stain morphology Sample: GS-02 b) 2024 Microbiology event 3 Gram Stain Sample: GS- 13 c) 2025 Microbiology event 2 Gram Stain morphology Sample: GS-09 2. A review of the laboratory's College of American Pathologists proficiency testing records from 2024 (D5-A and D5-B) identified proficiency testing results which were ungraded by the proficiency testing agency: a) 2024 D5-A Sample: D5-01 Sample: D5-05 b) 2024 D5-B Sample: D5-06 3. The general supervisor confirmed the findings in an interview conducted on 12/09/2025 at 1339 hours in the office. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES 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 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 -- tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records and staff interview, the laboratory failed to have documentation of competency assessments being performed within the first year of testing for 3 of 3 testing personnel. The findings included: 1. A review of the laboratory's personnel records identified 3 testing personnel who were trained on new methodology. They were (as listed on Form CMS 209): a) Testing personnel number 1 HIV testing- Trained: 11/2023 b) Testing personnel number 7 HIV testing- Trained: 7/2023 c) Testing personnel number 10 GC gram stain- Trained: 6/2024 Dark Field microscopy- Trained: 7/2024 Urine trichomonias/Wet prep Trained: 7/2024 2. Further review of the laboratory's personnel records identified competency assessments for the listed methodologies were performed at the following times: a) Testing personnel number 1 One competency assessment performed from 11 /2023 and 11/2024 performed on: 6/2024 b) Testing personnel number 7 Zero competency assessments performed from 7/2023 to 7/2024 c) Testing personnel number 10 One competency assessment performed from 6/2024 to 7/2025 performed on: 9/2024 3. The general supervisor (as listed on Form CMS 209) on 12/09/2025 at 1125 hours in the office confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based upon observations, review of policies and procedures, manufacturer's instructions and interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for verifying the dispense volume of the needle used for delivering the reagin antigen used when testing patient samples for RPR (Rapid Plasma Reagin) in 2022 and 2023. The findings included: 1. Based upon observations made during the demonstration of the RPR antigen needle check by testing person 6 conducted January 23, 2024 at 1:21 PM, the laboratory used a serological pipette to measure the volume of 31 drops of RPR antigen dispensed into a secondary container. The volume exceeded the expected 0.5 ml. 2. Review of the laboratory's procedure titled ASI RPR CARD TEST PROCEDURE FOR SYPHILIS found at 6.6: " The needle drops must be within 30 +/- 1 drop/0.5 ml. This can be done by dispensing 29- 30 drops in the reagent vial with a 1 ml serological pipette. The volume should be approximately 0.5 ml." 3. Review of the manufacturer's instructions found under the heading HANDLING AND PROCEDURAL NOTES: "1. In order to obtain reliable and consistent results, the instructions in the package insert must be strictly followed. Do not modify the handling and storage conditions for reagents or samples. 4. The needle should deliver 60 + 2 drops of antigen suspension per milliliter when held in a vertical position. To perform accuracy check on the needle, attach the needle to a 1 or 3 ml syringe. Fill the syringe with the antigen suspension and, holding the syringe in a vertical position, count the number of drops delivered in 0.5 ml. The needle is considered satisfactory if 30 + 1 drops are obtained in 0.5 ml." 4. During interview of 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 -- the Technical Consultant conducted January 23, 2024 at 1:44 PM, she confirmed that the laboratory did not verify the needle dispense volume as per the manufacturer's instructions. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based upon observations, review of policies and procedures, manufacturer's instructions and interview of facility personnel, the laboratory director failed to ensure that testing personnel followed the manufacturer's instructions for verifying the volume of the needle used for dispensing the reagin antigen used when testing patient samples for RPR (Rapid Plasma Reagin) in 2022 and 2023. (See D 5411) D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based upon review of policies and procedures, proficiency testing records and interview of the facility personnel, the laboratory director failed to ensure there was a written procedure for performing twice annual accuracy assessment of results for Darkfield microscopy identification of Treponema pallidum spirochetes and direct smear wet mounts for Trichomonas in 2022 and 2023. The findings included: 1. Review of policies and procedures found no written procedure for the twice annual accuracy assessment of results for which there was not a CMS approved proficiency testing program. 2. Review of records provided for the assessment of accuracy of results for darkfield microscopy and wet mount examinations, found that some of the records were kept in the personnel files and some were kept in patient result notebooks. 3. During interview of the Technical Consultant conducted January 24, 2024 at 12:25 PM, she confirmed there was no written procedure for performing twice annual accuracy assessments available. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: 493.1250 D5400 Condition: Analytic systems Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were 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

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 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: 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 -- Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Association of Bioanalysts (AAB) , it was determined 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 did not successfully participate in the specialty of general immunology. Refer to D2084 D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and AAB records found the laboratory failed to attain a score of at least 80% acceptable responses for each analyte in the subspecialty of Immunology for the analyte anti-human immunodeficiency virus (HIV). Findings: 1. AAB 2017 - 3rd event the laboratory received an unsatisfactory score of 60 % for HIV. D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and AAB records found that the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of general immunology. Findings: 1. AAB 2017 - 3rd event lab received a score of 60% for general immunology testing event. 2. AAB 2018 - 2nd event lab received a score of 0% for general immunology testing event. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the review of proficiency testing results from AAB, it was found the laboratory failed to participate in the 2018 - 2nd event for General Immunology -- 2 of 3 -- resulting in unsatisfactory scores. (satisfactory score is 80% or greater). Findings: 1. AAB 2018 - 2nd event report stated "Failed to Participate" resulting in the unsatisfactory score: HIV 0% D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80 % or greater) for the same analyte in the specialty of immunology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. AAB 2017 - 3rd event laboratory received an unsatisfactory score of 60% for HIV. 2. AAB 2018 - 2nd event laboratory received an unsatisfactory score of 0% for HIV. 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 it was revealed that 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; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2084 -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the