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Summary Statement of Deficiencies D0000 A recertification survey was performed on , September 19, 2024. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. CONDITION LEVELS: D5024 - Hematology - 493.1215 D6000 - Moterately Complexity Laboratory Director - 493.1403 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 A proficiency testing desk review was completed on March 14, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory 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 -- failed to successfully participate in proficiency testing (PT) in 2 consecutive testing events for WBC Diff (WBCD) resulting in the initial unsuccessful participation for WBCD. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(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 CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 2 consecutive testing events for WBC Diff, resulting in the initial unsuccessful participation for WBC Diff. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed WBC Diff on the following: 2023 Event 2 Score 67% 2023 Event 3 Score 0% 2. A review of the laboratory's API Reports confirmed the laboratory failed WBC Diff with the aforementioned scores. 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 review of the CMS CASPER 155 report and review of the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. 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 review of the CMS CASPER Report 155 and the API 2023 events 2 & 3 PT evaluation reports, the laboratory director failed to ensure successful PT participation in 2 consecutive testing events. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on February 11, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the Proficiency Testing (PT) documents from American Proficiency Institute (API) for 2019 and 2020, the Laboratory failed to document the review and evaluation of the laboratory's proficiency testing results. Findings: 1. Review of the PT documents from API, the laboratory failed to document the review and evaluation for testing of Immunology, Hematology, and Chemistry for the three events for 2020. In 2019 the laboratory failed to provide documentation of review and evaluation of Immunology for the three events, Hematology for events one and three, and for Chemistry events two and three. 2. Interview with Staff #2, #3, and the LD on February 11, 2021, at approximately 4:30 pm, in the laboratory, confirmed the lack of document review and evaluation of the profiency testing results. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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 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 -- director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 14, 2019. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st event of 2018 and 3rd event 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 3 -- 2018), resulting in the first unsuccessful occurrence for red blood cell count (RBC) analyte #775. Findings include: Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st event of 2018 and 3rd event of 2018), resulting in the first unsuccessful occurrence for red blood cell count (RBC) analyte #775. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #775, RBC on event 1 of 2018 with a score of 0% and event 3 of 2018 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from API confirmed the laboratory failed RBC on events 2 and 3 of 2018 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (1st and 3rd events of 2018), resulting in the first unsuccessful occurrence for red blood cell count (RBC). Findings include: Refer to D 6016 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory -- 2 of 3 -- maintained satisfactory performance in two of three consecutive events (1st and 3rd events of 2018), resulting in the first unsuccessful occurrence for red blood cell count (RBC). Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 775 RBC on event 1 of 2018 with a score of 0% and event 3 of 2018 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (AP)) confirmed the laboratory failed RBC on Events 1 and 3 of 2018, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August,18 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on the review of the American Proficiency Testing (API) and staff interview the laboratory failed to document