Crete Area Medical Center

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 surveyor off-site desk review of 2023 immunohematology proficiency testing (PT) performance reported to the CLIA database by the PT provider and phone interview with the laboratory manager, the laboratory failed to successfully participate in proficiency testing for the analyte, compatibility testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor off-site desk review of 2023 immunohematology proficiency testing (PT) performance reported to the CLIA database by the PT provider and phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for two out of three consecutive testing events for the analyte, compatibility testing. Findings are: 1. Desk review of the laboratory's 2023 PT records revealed the analyte, Compatibility Testing, scores of less than one hundred percent for the following events: 2023 first event, score 80% 2023 third event, score 0% 2. Telephone interview with the laboratory manager on 2/1/2024 at 3:30 PM, confirmed the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of quality control (QC) records, review of patient testing, and interview with the laboratory manager the laboratory failed to perform daily QC for electrolyte sedimentation rate (ESR) testing performed for one day of two months of patient testing reviewed. Findings are: 1. Review of external QC records from 8/1 /2023 - 9/28/2023 revealed level 2 of quality control was not performed on 9/5/2023. 2. Review of patient testing revealed three patients tested for ESR on 9/5/2023. 3. Interview with the laboratory manager confirmed the laboratory did not run level 2 on 9/5/2023 and three patients ESR testing was performed. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of quality control (QC) records, review of patient testing, and interview with the laboratory manager the laboratory failed to have quality control 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 -- result meet the criteria for acceptability before reporting patient test result for electrolyte sedimentation rate (ESR) testing performed for one day of two months of patient testing reviewed. Findings are: 1. Review of external QC records from 8/1 /2023 - 9/28/2023 revealed level 2 out of range on 8/28/2023. 2. Review of patient testing revealed one patient tested for ESR on 8/28/2023. 3. Interview with the laboratory manager confirmed the laboratory failed to have quality control meet the criteria for acceptability before reporting ESR patient test result on 8/28/2023. -- 2 of 2 --

Summary Statement of Deficiencies D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on lack of blood bank laboratory procedures and interview with general supervisor, the laboratory director failed to have an approved blood bank procedure manual available to personnel. Findings are: 1. No approved blood bank procedure manual was available on day of survey. 2. Interview with general supervisor on 9/11 /2019 at 9:30 AM confirmed no approved blood bank procedure manual was available to personnel. 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 --