Memorial Health Partner Foundation, Inc

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 3 of 5 patient final test results, the Centers for Medicare and Medicaid Services (CMS)-116 form and interview with the lead quality manager, the laboratory address were not correct on the final laboratory reports. The findings include: 1) Review of patients final test results dated 021218, 082418, and 021119 revealed the following address: 1949 Gunbarrel Road Suite 255, Chattanooga, TN. 2) Review of the CMS -116 form revealed the laboratory address is 7305 Jarnigan Road, Suite 125, Chattanooga, TN. 3) Interview on March 6, 2019 at 11:30am with the lead quality manager confirmed the address was incorrect on the laboratory final reports. since the laboratory's move in December 2017 until the survey date. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on review of 11 of 11 testing personnel competency documents for performing Complete Blood Counts (CBC) and upon interview with the lead quality manager, determined the technical consultants failed to ensure documented/signed annual competency evaluations including problem solving of testing personnel for 2017- 2018. The findings include: 1. There were no competency evaluations with problem solving documented/signed for 11 of 11 testing personnel in 2017-2018 for performance of CBC testing. 2. Upon interview with the lead quality manager at approximately 9:30am. on March 6, 2019, confirmed the Technical Consultants failed to document/sign competency assessments including problem solving for 11 of 11 testing persons in 2017-2018 for CBC testing. -- 2 of 2 --

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 Services CASPER Report 153 & 155 (CMS 153 & 155) and the Proficiency Testing Agency, American Proficiency Institute (API) Performance Summary determined the laboratory failed to maintain satisfactory performance for the specialty of Hematology for the Cell I.D. or White Blood cell Differential (WBC Diff) analyte in Event One and Two in 2018, resulting in the first unsuccessful occurrence. (Refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) 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 achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on Review of the CMS 153 & 155 Casper report and the API Performance Summary report the laboratory failed to achieve successful performance for the 1st and 2nd event of 2018 for the specialty Hematology for Cell I.D. or WBC Diff with a score of 67% resulting in the first unsuccessful performance in 2018. The Findings include: 1. Review of the CMS Casper report 153 & 155 revealed the laboratory failed to achieve successful performance for the 1st event score of 67% and 2nd event score of 67% for Cell I.D. or WBC Diff in 2018. 2. Review of the API Performance Summary report the laboratory failed to achieve successful performance for the 1st event score of 67% and 2nd event score of 67% for Cell I.D. or WBC Diff in 2018. -- 2 of 2 --