Memorial Health Partners Foundation, Inc

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: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the Red Blood Cell (RBC) analyte resulting in the initial unsuccessful proficiency testing (PT) occurrence for RBC (Refer to D2130) =================================== 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 a desk review of the CMS CASPER Report 0155D and the laboratory's 2021 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Red Blood Cell (RBC) analyte in the 2nd event 2021 and 3rd event 2021, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory RBC analyte scores of 60% for the 2nd event of 2021 and 60% for the 3rd event of 2021. 2. A review of the laboratory's API Proficiency Testing records revealed unsatisfactory RBC analyte scores of 60% for the 2nd event of 2021 and 60% for the 3rd event of 2021, resulting in the initial unsuccessful PT occurrence. =================================== -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: _________________________________ Based on review of personnel competency procedure, employee competency records for 2016 and 2017 and interview with the Medical Laboratory Technician and Quality Manager, the laboratory failed to document 6 month competency for one new person and annual competencies for 2 of 4 testing persons as required per procedure. The findings include: 1. Review of the personnel competency procedure revealed competency reviews to be performed in 6 months after hire and annually thereafter. 2. Review of employee competency records revealed lack of 6 month competency for new person hired 4/17/17 and lack of annual competencies for testing person number one of four for 2016 and 2017 and number four of four for 2017. 3. Interview March 13, 2018 at approximately 12:00 p.m. with the Medical Laboratory Technician and Quality Manager confirmed the laboratory failed to document 6 month and annual competencies as defined in procedure, for the two year period. 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 --