Twelve Clans Unity Hospital

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 Partial Thromboplastin Time (aPTT) for the 2019 second event and 2019 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 2019 and the laboratory's graded Proficiency Testing results from American Proficiency Institute, this laboratory had unsatisfactory performance for the analyte Partial Thromboplastin Time (aPTT). Findings are: 1. 2019 second event, analyte - Partial Thromboplastin Time (aPTT), score 20%. 2. 2019 third event, analyte - Partial Thromboplastin Time (aPTT), score 60%. -- 2 of 2 --

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 review of the laboratory's list of tests performed, lack of documentation, and interview with the technical consultant at 1:10 PM on 9/19/2019, the laboratory failed to verify the accuracy for micro albumin. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performing moderate complexity micro albumin testing for the past 2 years. 2. No documentation could be presented through proficiency testing or laboratory comparison to verify the accuracy of this testing. 3. Interview with the technical consultant revealed the laboratory had not enrolled the laboratory in proficiency testing or had comparison testing performed for this analyte. 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: 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 -- Based on review of patient test report and interview with the technical consultant at 3: 08 PM on 9/19/2019, the laboratory failed to have the address of the testing location on the patient test report. Findings are: 1. Review of 1 patient test report revealed no testing location address on the report. 2. Interview with the technical consultant confirmed no testing location address was indicated on the report. -- 2 of 2 --