Dialogix Laboratories

Summary Statement of Deficiencies D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, and interview with the Technical Supervisor (TS) on July 17, 2025, it was determined that the laboratory failed to return proficiency testing results for Routine Chemistry to the proficiency testing program within the time frame specified by the program and received a score of 0 for the testing event. The findings included: 1. The laboratory enrolled in the American Proficiency Institute (API) proficiency testing (PT) program for Routine Chemistry testing in 2024 and 2025. According to the API evaluation report, the laboratory received a score of 0 for Q1-2025. 2. On July 17, 2025, at approximately 9:20 am, the Technical Supervisor affirmed that the laboratory did not submit PT results for Routine Chemistry tests to API within the specified time frame. 3. The laboratory's testing declaration form, signed by the laboratory director on July 10, 2025, stated that the laboratory performed approximately 50,930 Routine Chemistry tests annually. Thus, the accuracy and reliability of patient test reports cannot be determined. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) (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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, and interview with the Technical Supervisor (TS) on July 17, 2025, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Endocrinology analyte Estradiol. The findings included: 1. The laboratory participated in the American Proficiency Institute (API) proficiency testing (PT) program for endocrinology using the DiaSorin Liaison XL. According to the API evaluation report, the laboratory received an unsatisfactory score of 40% for Q2-2025. 2. On July 17, 2025, at approximately 9:00 am the Technical Supervisor affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on July 10, 2025, stated that the laboratory performed approximately 5,700 endocrinology tests annually. D2104 ENDOCRINOLOGY CFR(s): 493.843(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, and interview with the Technical Supervisor (TS) on July 17, 2025, it was determined that the laboratory failed to return proficiency testing results endocrinology to API within the time frame specified by the program and received a score of 0 for the testing event. The findings included: 1. The laboratory enrolled in the American Proficiency Institute (API) proficiency testing (PT) program for endocrinology testing in 2024 and 2025. According to the API evaluation report, the laboratory received a score of 0 for Q1-2025. 2. On July 17, 2025, at approximately 9:10 am, the Technical Supervisor affirmed that the laboratory did not submit PT results for endocrinology tests to API within the specified time frame. 3. The laboratory's testing declaration form, signed by the laboratory director on July 10, 2025, stated that the laboratory performed approximately 5,700 endocrinology tests annually. Thus, the accuracy and reliability of patient test reports cannot be determined. D2121 HEMATOLOGY CFR(s): 493.851(a) (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 review of the laboratory's proficiency testing (PT) records, and interview with the Technical Supervisor (TS) on July 17, 2025, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte for the specialty Hematology in 2025. The findings included: 1. The laboratory enrolled in the American Proficiency Institute (API) proficiency testing (PT) program for hematology using the DxH 560 Analyzer. According to the API evaluation report, the laboratory received unsatisfactory scores in the first event of -- 2 of 4 -- 2025 as below: Erythrocyte Count: 60% Hematocrit: 40% Partial Thrombin Time (APTT): 40% 2. On July 17, 2025, at approximately 9:30 am the Technical Supervisor affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on July 10, 2025, stated that the laboratory performed approximately 14, 280 hematology tests annually. Thus, the accuracy and reliability of patient test reports cannot be determined. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on the review of Quality Control (QC) records of routine chemistry, endocrinology and general immunology, and an interview with the Technical Supervisor (TS) on July 17, 2025, the laboratory failed to verify the stated values of the commercially assayed QC materials prior to their use. The findings include: 1.It was the practice of the laboratory to utilize Randox QC materials for monitoring chemistry, endocrinology and general immunology tests with Beckman Coulter AU 680 and Beckman Access 2 analyzers. The 2. On July 17, 2025, at approximately 12: 00 pm, the TS stated that the laboratory did not verify the stated values of the commercially assayed QC materials prior to their use. 3. The laboratory's testing declaration form, signed by the laboratory director on July 10, 2025, stated that the laboratory performed approximately 50,930 routine chemistry, 5,700 endocrinology, and 4,066 general immunology tests annually. Thus, the accuracy and reliability of patient test reports cannot be determined. 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 the review of policies and procedures manuals, laboratory records, and an interview with the Technical Supervisor (TS) on July 17, 2025, at approximately 11: 00 am, it was determined that the laboratory supervisor did not review the monthly maintenance checklists for laboratory instruments to verify their proper functioning and acceptable performance parameters thus failing to implement a system to ensure continuous improvement. The findings included: 1. On July 17, 2025, at approximately 11:00 am, the Technical Supervisor (TS) affirmed that the laboratory -- 3 of 4 -- supervisor had not reviewed the monthly maintenance checklists for tests conducted in the laboratory. 2. The laboratory's testing declaration form, signed by the laboratory director on July 10, 2025, stated that the laboratory performed approximately 96,960 tests annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on interview with Technical Supervisor (TS), review of Proficiency Testing, Quality Assessment and QC records on July 17, 2025, the laboratory Director failed to provide overall management and direction in accordance with 493.1445 of this subpart. The findings included: 1. The LD failed to ensure the proficiency testing samples were tested as required under subpart H of 42 CFR 493. See D2093, D2098, D2121, D2104 2. The LD failed to ensure that quality assessment programs were maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5791 3. The LD failed to ensure the stated values of the commercially assayed Quality Control (QC) materials verified by the laboratory prior to their use. See D5469 -- 4 of 4 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/15/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful American Proficiency Institute participation; and 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation records (2024-3, 2025- 1, and 2025-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Thyroid Stimulating Hormone resulting in subsequent unsuccessful performance.See D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for three events (2024-3, 2025-1, and 2025-2) for the analyte Thyroid Stimulating Hormone (TSH). The findings include: TSH 0% - 2024 third testing event; TSH 0% - 2025 first testing event; TSH 20% - 2025 second testing event. A review of the 2024 & 2025 scores from American Proficiency Institute (API) confirmed the above findings. 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 the CASPER 0155D report and American Proficiency Institute records for 2024-3, 2025-1, and 2025-2 events, 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 the CASPER 0155D report and American Proficiency Institute records for 2024-3, 2025-1, and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 3/25/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing. 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 review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report and American Proficiency Institute (API) records (for the laboratory's 2024-1, 2024-2, 2024-3, and 2025-1 proficiency testing 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 -- events), the laboratory failed to successfully participate in an approved HHS proficiency testing program for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA. See D2084 and D2096. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) (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 review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER) 0155D report and the American Proficiency Institute (API) records, the laboratory failed to achieve satisfactory performances for the analyte AFP (Tumor Marker). The findings include: AFP (Tumor Marker) 20% - 2024 first testing event; AFP (Tumor Marker) 20% - 2024 third testing event; AFP (Tumor Marker) 0% - 2025 first testing event. The above 2024 & 2025 American Proficiency Institute (API) scores resulted in subsequent unsuccessful AFP (Tumore Marker) performance. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 review of the laboratory's Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D report and laboratory's American Proficiency Institute (API) records, the laboratory failed to achieve satisfactory performance for the analytes: Cholesterol, HDL and Triglycerides. The findings include: Cholesterol, HDL 0% - 2024 second testing event: Cholesterol, HDL 20% - 2024 third testing event: Cholesterol, HDL 0% - 2025 first testing event: Triglycerides 60% - 2024 first testing event; Triglycerides 0% - 2024 third testing event; Triglycerides 0% - 2025 first testing event. The above 2024 & 2025 American Proficiency Institute (API) scores resulting in subsequent unsuccessful Cholesterol, HDL and Triglycerides performances. 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 the laboratory's CASPER 0155D report -- 2 of 3 -- and API records for 2024-1, 2024-2, 2024-3, and 2025-1 proficiency testing events, 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 the laboratory's CASPER 0155D report and American Proficiency Institute records for 2024-1, 2024-2, 2024-3, and 2025-1, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2084 and D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on - 3/25/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2024-2, 2024- 3, and 2025-1), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte ALT (SGPT), AST (SGOT) Cholesterol, Total, Triglyerides, TSH, and Cell ID resulting in unsuccessful performances. See D2096 and D2130. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for three consecutive events (2024-2, 2024-3, and 2025-1) for the analytes ALT (SGPT), AST (SGOT), Cholesterol-Total, TSH, and Cell ID. The finding include: 1. ALT (SGPT) 60% - 2024 second testing event; ALT (SGPT) 0% - 2025 first testing event; 2. AST (SGOT) 0% - 2024 third testing event; AST (SGOT) 0% - 2025 first testing event; 3. Cholesterol, Total 0% - 2024 third testing event; Cholesterol, Total 0% - 2025 first testing event. 4. TSH 0% - 2024 third testing event; TSH 0% - 2025 first testing event. 5. Cell ID 72% - 2024 first testing event; Cell ID 52% - 2024 second testing event. A review of the 2022 & 2023 scores from American Proficiency Institute (API) confirmed the above findings. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for three consecutive events (2024-1 and 2025-1) for the analyte TSH (specialty Endocrinology): The finding include: TSH 0% - 2024 third testing event; TSH 0% - 2025 first testing event. A review of the 2024 & 2025 scores from American Proficiency Institute (API) confirmed the above findings. 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 review of the Certification and Survey Provider Enhanced Reporting -- 2 of 3 -- (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for three consecutive events (2024-1 and 2024-2) for the analyte Cell ID (specialty Hematology): The finding include: Cell ID 72% - 2024 first testing event; Cell ID 52% - 2024 second testing event. A review of the 2024 scores from American Proficiency Institute (API) confirmed the above findings. 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 the CASPER 0155D report and (Proficiency Testing Programs) records for 2024-1, 2024-2, 2024-3 and 2025-1 events, 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 the CASPER 0155D report and (Proficiency Testing Program) records for 2024-1, 2024-2, 2024-3, and 2024-1 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096, D2107, and D2130 deficiencies. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 12/19/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES 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 review of the Certificate and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute records (2024-1 and 2024-3), the laboratory failed to successfully participate in a proficiency testing program 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 -- approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte AFP (Tumor Marker) resulting in unsuccessful performance. Refer to D2084. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute program report, the laboratory failed to achieve satisfactory performance for two consecutive events (2024 first & third testing events) for the analyte AFP (Tumor Marker): The findings include: 1. AFP (Tumor Marker)Bacteriology - 20% 2024 first testing event, 2. AFP (Tumor Marker)Bacteriology - 20% 2024 third testing event. American Proficiency Institute confirmed the above findings. 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 the CASPER 0155D report and American Proficiency Institute program records for 2024-1 and 2024-3 proficiency events, 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 proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute program records for 2024-1 and 2024-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2084. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 11/12/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; and 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (2024-1, 2024- 2 and 2024-3), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analytes Cholesterol, HDL and Triglycerides (TRIG) resulting in unsuccessful performances. 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API evaluation reports, the laboratory failed to achieve satisfactory performance for two of three events proficiency events in 2024 for analytes Cholesterol, HDL and Triglycerides (TRIG). The finding include 1. The laboratory received the following scores: 0% on the 2024 Cholesterol, HDL second event 20% on the 2024 Cholesterol, HDL third event 60% on the 2024 Triglycerides (TRIG) first event 0% on the 2024 Triglycerides (TRIG) third event 2. A review of the 2023 and 2024 proficiency testing scores from American Proficiency Institute confirmed the above findings. 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 the CASPER 155 report API records for 2024-1, 2024-2 and 2024-3 events, the laboratory director failed to provide overall management and a 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 proficiency testing desk review of CASPER 155 report API records for 2024-1, 2024-2 and 2024-3 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 2 of 2 --