Memorial Community Hospital

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the CMS-209 testing personnel report, review of 2021 and 2022 testing personnel annual competencies, and an interview with the technical consultant, the technical consultant failed to perform competencies on five out of nineteen testing personnel performing moderate complexity testing. Findings are: 1. Review of CMS- 209 form and 2021 and 2022 testing personnel competencies revealed the following competencies missing: a. Testing personnel #11 missing 2022 annual competency. b. Testing personnel #14 missing 2021 annual competency. c. Testing personnel #15 missing 2021 and 2022 annual competency. d. Testing personnel #16 missing 2021 annual competency. e. Testing personnel #19 missing 2021 and 2022 annual competency. 2. No documentation of annual competency was presented for the testing personnel listed above. 3. Interview with the technical supervisor on 3/7/2023 at 11:45 AM confirmed the competencies listed above were not available. 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 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's list of tests performed, lack of documentation, and interview with the general supervisor the laboratory failed to have a system that twice annually evaluated the relationship between test results using different methodologies for white blood cell (WBC) differentials for 2020. Findings are: 1. Review of the laboratories list of tests performed revealed the laboratory was performing WBC differentials by automated instrument and by manual method. 2. No documentation could be presented at the time of survey to demonstrate the laboratory evaluated the relationship between these different methodologies. 3. Interview with the general supervisor on 7/1/2021 at 1:35 PM confirmed patient testing was being performed using both methods, but no semi annual evaluations had been documented for 2020 comparing these two methodologies. 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 --

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: The laboratory failed to achieve satisfactory scores for the hematology analyte Cell Identification/White Blood Cell Differential for the 2020 second event and 2020 third event. See D2130. This results in the unsuccessful performance in proficiency testing for this analyte. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 proficiency testing for 2020 and the laboratory's graded Proficiency Testing results from College of American Pathologists, this laboratory had unsatisfactory performance for the analyte Cell Identification/White Blood Cell Differential. Findings are: 1. 2020 second event, analyte - Cell Identification/White Blood Cell Differential, score 60%. 2. 2020 third event, analyte - Cell Identification /White Blood Cell Differential, score 60%. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) policy and interview with general supervisor on 3/20/2019 at 1:10 PM the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems indentified in the general laboratory systems. Findings include: 1. No QA policies for the general lab system was presented for review during the survey. 2. Review of 2017 competency assesments revealed 4 out of 14 moderate complex testing personnel missing their competency assesment. 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 --