Genoa Community Hospital/Ltc

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test report and interview with the laboratory director, the laboratory's results reported date and time on the test report changes on copies generated at a later time. 1. Review of 1 patient test report for comprehensive metabolic panel, draw date of 10/2/2020, revealed a draw date and time, an approval date and time, and results reported date and time. The results reported date and time changed with subsequent printing of the report. 2. Interview with the laboratory director on 10/5/2020 at 4:14 PM confirmed the results reported date and time changed with subsequent printing. 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 analytes Total Billirubin for the first and second events 2018 (see D2087) and Thyroid Stimulating Hormone (TSH) for the third event 2017 and second event 2018 (see D2098) resulting in unsatisfactory scores for the sub specialty of endocrinology for the third event 2017 and second event 2018 (see D2099). This results in the unsuccessful performance in proficiency testing for these analytes and the sub specialty of endocrinology. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2018, this laboratory had unsatisfactory performance for the routine chemistry analyte total billirubin for the first event 2018 (score 60%) and the second event 2018 (score 0%). D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2017 and 2018, this laboratory had unsatisfactory performance for the endocrinology analyte thyroid stimulating hormone (TSH) for the third event 2017 (score 0%) and the second event 2018 (score 0%). D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2017 and 2018, this laboratory had unsatisfactory performance for the sub specialty of endocrinology with the overall scores for the third event 2017 (score 0%) and the second event 2018 (score 0%). -- 2 of 2 --