Community Hospital Laboratory

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of list of tests performed, surveyor review of proficiency testing (PT) records, a lack of verification records, and an interview with the general supervisor, the laboratory failed to have a system for verifying the accuracy of testing for neonatal, bilirubin and direct antiglobulin test (DAT). Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory had performed two hundred and forty six neonatal, biliruin tests in 2020 and one hundred and four DAT tests in 2020. 2. The laboratory's proficiency test results for 2020 did not include testing for neonatal, bilirubin and DAT. 3. Interview with the general supervisor on 6 /23/2021 at 11:50 AM confirmed the laboratory had not enrolled in PT for neonatal, biliruin or DAT, nor had the laboratory performed accuracy verification on these analytes. 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: Based on desk review of proficiency testing for 2019 and 2020, the laboratory failed to achieve satisfactory scores for the chemistry analyte, alanine aminotransferase (ALT), for the third event 2019 and first event 2020. See D2096. 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2019 and 2020, the laboratory had unsatisfactory performance for the analyte alanine aminotransferase (ALT). Findings are: 1. 2019 third event, score 60% 2. 2020 first event, score 60% -- 2 of 2 --