Brio Clinical Inc

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on August 22, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 laboratory 2023 and 2024 American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the technical consultant and the laboratory manager, the laboratory failed to ensure that the analysts performing the testing signed the attestations. Findings include: 1. A review of the 2023 API PT Hematology/Coagulation test event three records revealed that the testing personnel who performed the testing for the event did not sign the attestation. 2. A review of the 2024 API PT Immunology/Immunohematology test event one records revealed that the testing personnel who performed the testing for the event did not sign the attestation. 3. The findings were confirmed during an interview with the technical consultant and the laboratory manager conducted on August 23, 2024 at approximately 2:30 PM. The laboratory performs approximately 1,000 hematology tests and 1,300 diagnostic immunology tests annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) 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 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the laboratory 2023 and 2024 American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the technical consultant and the laboratory manager, the laboratory failed to ensure that the results that were not graded by the proficiency testing agency were evaluated and documented. Findings include: 1. A review of the 2023 API PT Immunology/Immunohematology test event one revealed that there was no documentation of evaluation for the ungraded results for the Herpes Simplex Virus (HSV) 1/2. 2. A review of the 2023 API PT Hematology/Coagulation test event two revealed that that there was no documentation of evaluation for the ungraded results for the educational blood cell identification samples. 3. A review of the 2023 API PT Hematology/Coagulation test event three revealed that there was no documentation of evaluation for the ungraded results for the educational blood cell identification samples. The laboratory reported a result of 2% for "Lymphocyte, reactive." The expected result stated to see the data summary. The data summary was not available at the time of the survey to evaluate consensus with other laboratories. The laboratory reported a result of 2% for "Neutrophil, seg or band." The expected result was listed as 12-38%. For sample ECI- 15, the laboratory reported a result of "Plasma cell." The expected result stated, "See commentary." The commentary was not available at the time of the survey to evaluate the reported result. 4. A review of the 2023 API PT Immunology/Immunohematology test event three revealed that there was no documentation of evaluation for the ungraded result for the C-Reactive Protein (CRP) sample CRP-05. 5. The findings were confirmed during an interview with the technical consultant and the laboratory manager conducted on August 23, 2024 at approximately 2:45 PM. The laboratory performs approximately 1,300 diagnostic immunology tests and 1,000 hematology tests annually. 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 on a review of the manufacturer's package insert, observation of the Sysmex CS-2500 programming for the INR calculation, and an interview with the Technical Consultant and the Laboratory Manager, the laboratory failed to ensure that the ISI was updated in the instrument when the current lot number of Dade Innovin reagent was placed in use for the Prothrombin Time (Protime) test. Findings include: 1. A review of the Dade Innovin package insert revealed that the ISI value for lot number 564603 for use on the Sysmex CS-2500 coagulation instrument was 1.08. 2. Observation of the current programming in the Sysmex CS-2500 analyzer revealed -- 2 of 3 -- that the ISI in the instrument was 1.03. 3. The findings were confirmed during an interview with the General Supervisor numbers one and two conducted on August 22, 2024 at approximately 2:15 PM. The laboratory performs approximately 1,000 hematology tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review conducted off-site for your laboratory on 9/29/2023. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 desk review of federal database CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms on 9/29/2023, 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 -- the laboratory failed to maintain successful participation with the American Proficiency Institute (API) PT program. Findings include: 1. The laboratory failed to achieve an overall satisfactory proficiency testing event performance for two out of three testing events for the analyte partial thromboplastin time (PTT). 2. The laboratory received a score of 0% in the third testing event of 2022 and a score of 60% in the second testing event of 2023, resulting in unsuccessful proficiency testing performance for the analyte PTT. Refer to D2131. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 federal database CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms on 9/29/2023, the laboratory failed to successfully participate in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for partial thromboplastin time (PTT) in the third testing event of 2022 and second testing event of 2023. 2. CASPER Report 0155D and the API PT evaluation both reported a score of 0% in the third testing event of 2022 and a score of 60% in the second testing event of 2023 for the analyte PTT. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of federal database CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms on 9/29/2023, the Condition: Laboratories Performing High Complexity Testing: Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1445. Findings include: The laboratory director failed to ensure that the laboratory successfully participated in a PT program approved by CMS; as described in 42 CFR subpart I for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on desk review of federal database CASPER Report 0155D and American Proficiency Institute (API) proficiency testing (PT) evaluation forms on 9/29/2023, the laboratory director failed to ensure that the laboratory successfully participated in a proficiency testing program. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for partial thromboplastin time (PTT) in the third testing event of 2022 and second testing event of 2023. 2. CASPER Report 0155D and the API PT evaluation both reported a score of 0% in the third testing event of 2022 and a score of 60% in the second testing event of 2023 for the analyte PTT. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review, conducted off-site for your laboratory on July 14, 2023. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 review of the federal database CASPER Report 0155D on July 14, 2023, the laboratory did not successfully participate in a proficiency testing program. 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 -- American Proficiency Institute (API) proficiency testing (PT) evaluation forms were requested from the laboratory on July 14, 2023. As of August 15, 2023, these forms were not provided. The laboratory's failure to achieve an overall satisfactory proficiency testing event performance for two consecutive testing events for the first and second testing events of 2023 with a score of 20% in the first event of 2023 and a 0% in the second event of 2023 resulted in unsuccessful proficiency testing performance for the analyte amylase. Findings include: The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for amylase in the first and second testing events of 2023. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 the federal database CASPER Report 0155D on July 14, 2023, the laboratory did not successfully participate in a proficiency testing program. The American Proficiency Institute (API) proficiency testing (PT) evaluation forms were requested from the laboratory on July 14, 2023. As of August 15, 2023, these forms were not provided. Findings include: 1. The laboratory failed to maintain successful participation with the API PT program shown by the unsuccessful performance for amlyase in the first and second testing events of 2023. 2. CASPER Report 0155D reported a score of 20% for the first event and 0% for the second testing event of 2022. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of federal database CASPER Reports 0153D and 0155D, the Condition: Laboratories Performing High Complexity Testing; Laboratory Director was not met. The laboratory director failed to provide overall management and direction in accordance with CFR 493.1445 of this subpart. Findings include: 1. The laboratory director failed to ensure that the laboratory successfully participated in a PT program, approved by CMS; as described in subpart 1 of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. Refer to D6089. 2. The American Proficiency Institute (API) proficiency testing (PT) evaluation forms were requested from the laboratory on July 14, 2023. As of August 15, 2023, these forms were not provided. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) -- 2 of 3 -- The laboratory director must ensure 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 the federal database CASPER Report 0155D on July 14, 2023, the laboratory director failed to ensure that proficiency testing samples were tested as required. The American Proficiency Institute (API) proficiency testing (PT) evaluation forms were requested from the laboratory on July 14, 2023. As of August 15, 2023, these forms were not provided. Findings include: 1. The laboratory failed to achieve satisfactory performance for amylase in the first and second proficiency testing events of 2023, resulting in unsuccessful PT performance. 2. CASPER Report 0155D reviewed reported 20% for the first testing event and 0% for the second testing event of 2023 for amylase. -- 3 of 3 --