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Summary Statement of Deficiencies 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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: Urea Nitrogen (BUN). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for 2 of 2 consecutive testing events. Refer to 2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte: Urea Nitrogen (BUN) for 2 of 2 consecutive testing events. Findings include: Unsatisfactory performance for 2 of 2 consecutive proficiency testing events constitutes unsuccessful performance for BUN. BUN PT event Score 1st event 2023 60% 3rd event 2022 0% -- 2 of 2 --

Summary Statement of Deficiencies 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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the sub- specialty of Bacteriology. Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for 3 of 4 proficiency testing events. Refer to D2028 ***Repeat Deficiency from 5/03/2022 survey*** D2028 BACTERIOLOGY 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 -- CFR(s): 493.823(e) 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 review of the CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for sub-specialty bacteriology throat/urine and urine culture identification in three out of four consecutive testing events. Findings include: Unsatisfactory performance for three out of four consecutive PT events constitutes a subsequent unsuccessful performance for throat/urine and urine culture identification. PT Event Score 3rd event 2021 71% 1st event 2022 68% 3rd event 2022 0% ***Repeat Deficiency from 5/03/2022 survey*** 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 review of the CMS database and review of the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory director failed to provide overall management and direction in accordance with 493.1407 of this subpart. Findings include: Failure to ensure that the proficiency testing samples were tested as required under subpart H. 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: . Based on review of the CMS database and review of the American Association of Bioanalysts proficiency testing reports, the director failed to ensure that the laboratory successfully participated in a proficiency testing program as required under subpart H. Findings include: The laboratory failed to achieve satisfactory performance for the sub-specialty bacteriology. Refer to D2016 and D2028. -- 2 of 2 --

Summary Statement of Deficiencies 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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the bacteriology analyte: throat/urine culture identification. Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for 2 of 2 proficiency testing events for the bacteriology analyte: throat /urine culture identification. Refer to D2028. D2028 BACTERIOLOGY 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 -- CFR(s): 493.823(e) 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 review of the CMS database and review of the American Association of Bioanalysts (AAB) final proficiency testing program reports, the laboratory failed to achieve satisfactory performance for microbiology bacteriology throat/urine culture identification in 2 out of 2 consecutive testing events. Findings include: Throat/urine culture identification PT Event Score 1st event 2022 68% 3rd event 2021 71% -- 2 of 2 --

Summary Statement of Deficiencies 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 CMS database and the American Association of Bioanalysts (AAB) final proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte alanine aminotransferase (ALT). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for two of three proficiency testing events for the chemistry analyte: ALT. Refer to D2087 and D2096. D2087 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(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 CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the alanine aminotransferase (ALT) analyte, which is unsatisfactory performance for the testing events. Findings include: Unsatisfactory performance for two of three consecutive proficiency testing events constituting unsuccessful performance for ALT: PT event Score 3rd event 2018 60% 2nd event 2019 20% 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 review of the CMS database and the American Association of Bioanalysts (AAB) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte alanine aminotransferase (ALT) in two of three consecutive testing events. Findings include: Unsatisfactory performance for two of three consecutive proficiency testing events constituting unsuccessful performance for ALT: PT event Score 3rd event 2018 60% 2nd event 2019 20% -- 2 of 2 --