Horizon Health Martin Medical

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 proficiency testing (PT) record review and interview with the technical consultant, the laboratory failed to achieve successful performance for the test method white blood cell differential. Unsatisfactory results had been received in two of three PT events (Hematology/Coagulation 2021 1st and 2nd events) resulting in unsuccessful PT performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(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 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 CASPER Reports and interview with the technical consultant, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the white blood cell (WBC) differential test method in two out of three events (Hematology/Coagulation 2021 1st and 2nd events) resulting in unsuccessful performance. Findings include: 1. Review of the laboratory's CASPER Reports 153D and 155D revealed the American Proficiency Institute (API) PT scores for the WBC differential test method were less than the 80% required to pass the WBC differential test per CLIA requirements found at CFR 493.861(a): a. API Hematology /Coagulation 2021 1st event WBC differential score = 0% (survey results had not been submitted prior to the PT result due date). b. API Hematology/Coagulation 2021 2nd event WBC differential score = 20% *The neutrophil/granulocyte results for HSY- 06, 07, 09, and 10 were graded as unacceptable. *The lymphocyte results for HSY 06, 08, and 10 were graded as unacceptable. *The monocyte results for HSY 06, 07, 08, 09, and 10 were graded as unacceptable. 2. Interview with the technical consultant on 9/28/21 confirmed the failures. He stated he was aware of the issues. During the first testing event, the laboratory had failed to submit their results prior to the PT result due date. Results for the 2nd testing event had been entered under the incorrect analyzer code. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 5/18/21. The Martin Community Health Center laboratory was found not in compliance with the following requirement: D2015. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the laboratory failed to maintain a copy of the submitted results for twelve of twelve proficiency testing (PT) events (American Proficiency Institute [API] 2019 Hematology/Coagulation first, second, and third PT events; 2020 Hematology/Coagulation first, second, and third PT events; 2019 Chemistry-Core second and third PT events; 2020 Chemistry-Core first, second, and third PT events; and 2021 Chemistry-Core first PT event) submitted to API for grading. Findings include: 1. Observation and review of the records for PT events identified above revealed the PT result forms had not been printed after the results had been submitted electronically. These forms would have documented the results 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 2 -- laboratory submitted to API for evaluation. Interview on 5/18/21 at 11:00 a.m. with laboratory personnel A revealed she was not aware the PT result forms should have been printed after the results were electronically submitted. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 8/8/18. The Martin Community Health Clinic laboratory was found not in compliance with the following requirement: D5437. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Medonic hematology analyzer maintenance records, Medonic Operator's manual, test volume form, and interview with laboratory personnel A, the laboratory failed to perform and document the calibration of the hematology analyzer every 6 months of patient testing for 23 of 23 months (August 2016 through July of 2018) reviewed. Findings include: 1. Review of the Medonic maintenance records revealed no documentation of a calibration had been performed in 23 months of 23 months reviewed. Review of the Medonic Operator's manual revealed under section 7 Calibration: "It is recommended to calibrate the instrument every 6 months." Review of the test volume form revealed 818 patient samples had been tested on the hematology analyzer in 2017. Interview with laboratory personnel A on 8/8/18 at 12: 20 p.m. revealed he was not aware calibrations had not been performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --