Ayass Laboratory, Llc

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel 493. 1487 Condition: Laboratories Performing High Complexity Testing; Testing Personnel 493. 1441 Condition: Laboratories Performing High Complexity Testing; Laboratory Director D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the laboratory's test menu, the laboratory's records, and staff interview, the laboratory failed to have documentation of verifying the accuracy of one of twenty-eight antibodies tested on the Thermo Fisher Phadia 250 analyzer at least twice annually in 2023. Findings include: 1. A review of the laboratory's test menu revealed the following non-regulated analyte RNP-70 antibody was tested by the laboratory using the Thermo Fisher Phadia 250 analyzer in 2023. 2. A review of the laboratory's records from 2023 revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for the RNP-70 antibody. 3. In an interview on 7/25/24 at 10:50 a.m. in the conference room, after review of the records, the general supervisor confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiency, 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 certification is recommended. 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 Laboratory representatives were present at the entrance conference conducted 05/03 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 05/05 /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 the ACCESS SARS-CoV-2 IgM and ACCESS SARS-CoV-2 IgG test instructions for use, patient records, and interview with facility personnel, the laboratory failed to report SARS-COV-2 antibody test results as required for 79 of 79 days testing was performed between February 1, 2021 and May 4, 2021. The findings included: 1. Based on review of the ACCESS SARS-CoV-2 IgM test instructions for use (Ref C58957), under Intended Use on page 2 of 12, the instructions state "Laboratories within the United States and its territories are required to report all 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 -- results to the appropriate public health authorities." 2. Based on review of the ACCESS SARS-CoV-2 IgG test instructions for use (Ref C69057), under Intended Use on page 2 of 12, the instructions state "Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities." 3. Based on review of the laboratory's policy "DXI 600 Procedures Manual (3)", on page 1 of 11 under Intended Use, the policy states "Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities." This procedure was signed by the laboratory director on 11-01-2020. 4. Based on review of patient records, the laboratory performed patient tests 79 days between February 1, 2021 and May 4, 2021. 3 days in May 2021 26 days in April 2021 26 days in March 2021 24 days in February 2021 5. In an interview on May 4, 2021 at 10:38 hours in the office, General Supervisor 1 (as listed on the CMS-209 Laboratory Personnel Report) stated the laboratory had not reported ACCESS SARS-CoV-2 IgM or ACCESS SARS-CoV-2 IgG test results to HHS. General Supervisor 1 stated "we are uploading the PCR tests daily to the DSHS portal, but we do not upload the antibody tests." D5781

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 05/03 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 05/05 /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 the ACCESS SARS-CoV-2 IgM and ACCESS SARS-CoV-2 IgG test instructions for use, patient records, and interview with facility personnel, the laboratory failed to report SARS-COV-2 antibody test results as required for 79 of 79 days testing was performed between February 1, 2021 and May 4, 2021. The findings included: 1. Based on review of the ACCESS SARS-CoV-2 IgM test instructions for use (Ref C58957), under Intended Use on page 2 of 12, the instructions state "Laboratories within the United States and its territories are required to report all 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 -- results to the appropriate public health authorities." 2. Based on review of the ACCESS SARS-CoV-2 IgG test instructions for use (Ref C69057), under Intended Use on page 2 of 12, the instructions state "Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities." 3. Based on review of the laboratory's policy "DXI 600 Procedures Manual (3)", on page 1 of 11 under Intended Use, the policy states "Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities." This procedure was signed by the laboratory director on 11-01-2020. 4. Based on review of patient records, the laboratory performed patient tests 79 days between February 1, 2021 and May 4, 2021. 3 days in May 2021 26 days in April 2021 26 days in March 2021 24 days in February 2021 5. In an interview on May 4, 2021 at 10:38 hours in the office, General Supervisor 1 (as listed on the CMS-209 Laboratory Personnel Report) stated the laboratory had not reported ACCESS SARS-CoV-2 IgM or ACCESS SARS-CoV-2 IgG test results to HHS. General Supervisor 1 stated "we are uploading the PCR tests daily to the DSHS portal, but we do not upload the antibody tests." D5781

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, College of American Pathologists (CAP). 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 Laboratory Director, Moderate Complexity 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, 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 Immunology for the analyte Immunoglobulin M (IgM). 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 0155 and College of American Pathologists (CAP) records, the laboratory failed to attain a satisfactory score of at least 80% acceptable responses for each analyte in the specialty of Immunology for the analyte Immunoglobulin M (IgM). Findings included: 1. Review of the CMS 0155 report revealed the following results: General Immunology 2020 - 2nd Event laboratory received an unsatisfactory score of 20% for IgM immunology analyte. General Immunology 2020 - 3rd Event laboratory received an unsatisfactory score of 40% for IgM immunology analyte. 2. A proficiency desk review from College of American Pathologists (CAP) 2020 proficiency testing records confirmed the laboratory received the following results: CAP Diagnostic Immunology 2020 - S- B Event laboratory received an unsatisfactory score of 20% Immunology for the analyte Immunoglobulin M (IgM). CAP Diagnostic Immunology 2020 - S-C Event laboratory received an unsatisfactory score of 40% Immunology for the analyte Immunoglobulin M (IgM). 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 a review of proficiency testing (PT) records from 2020 (1st, 2nd, and 3rd Events) it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Immunology for the Immunoglobulin M (IgM) analyte. Two out of three consecutive testing event unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: General Immunology 2020 - 2nd Event laboratory received an unsatisfactory score of 20% for IgM immunology analyte. General Immunology 2020 - 3rd Event laboratory received an unsatisfactory score of 40% for IgM immunology analyte. 2. A proficiency desk review from College of American Pathologists (CAP) 2020 proficiency testing records confirmed the laboratory received the following results: CAP Diagnostic Immunology 2020 - S-B Event laboratory received an unsatisfactory score of 20% -- 2 of 3 -- Immunology for the analyte Immunoglobulin M (IgM). CAP Diagnostic Immunology 2020 - S-C Event laboratory received an unsatisfactory score of 40% Immunology for the analyte Immunoglobulin M (IgM). 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 --