Saint Francis Medical Partners-Germantown Rd

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records and interview with the laboratory liaison, the testing personnel and laboratory director failed to sign attestation statements for proficiency testing 2018 event two and 2019 event one for hematology. The findings include: 1) Review of the laboratory proficiency testing records revealed no signed attestation statements were present for hematology 2018 event two and 2019 event one. 2) Interview with the laboratory liaison on April 4, 2019 at 10:50 am confirmed the testing personnel and laboratory director failed to sign attestation statements for hematology 2018 event two and 2019 event one. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2018 proficiency testing performance evaluation reports, the laboratory failed to maintain satisfactory performance for the hematology specialty for two of two testing events resulting in the first unsuccessful occurrence. (Refer to D2127) D2123 HEMATOLOGY CFR(s): 493.851(c) 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 participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2018 proficiency testing (PT) reports, the laboratory failed to maintain successful participation for the hematology specialty for 2018 event one and 2018 event two, resulting in the first unsuccessful occurrence. The findings include: 1. Review of the CMS 155 revealed a testing event score of 0% for the hematology specialty for 2018 events one and two. 2. Review of the laboratory's PT performance evaluation report for 2018 event one revealed a testing event score of 0% for "Failure to Participate." 3. Review of the laboratory's PT performance evaluation report for 2018 event two revealed a testing event score of 0% for "Failure to Participate." -- 2 of 2 --