Consolidated Medical Practices Of Memphis Pllc11/2

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) Plan, lack of documentation and an interview with the technical consultant (TC), the laboratory director failed to follow the written policies and procedures to access the TC competency in 2021 and 2022. The findings include: 1. Review of the QA Plan, Personnel Competency section, states that all testing personnel are trained initially and six months later. "At least annually, the laboratory director and/or TC will review the performance of each employee working in the laboratory to assure employee competency. This includes employees responsible for specimen collection and processing (other than testing personnel) and the TC if applicable". 2. Review of the TC personnel file revealed no documentation of competency performed in 2021 and 2022. 3. Interview with the TC on 01.11.2023 at 12:35 pm confirmed the laboratory director failed to follow the personnel policy for performing TC competency in 2021 and 2022. 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 maintain satisfactory participation in two out of three proficiency testing (PT) events for the automated white blood cell (WBC) differential, resulting in the first unsuccessful PT occurrence for the WBC Differential. (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 a desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2020 and 2021 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the automated white blood cell (WBC) differential in two out of three PT events, resulting in the first unsuccessful PT occurrence for the WBC differential. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the WBC differential: 2020 event three: 0% 2021 event two: 0% 2) Review of the laboratory's proficiency testing records revealed the following: 2020 event three: WBC differential scored as 0% for "Failure to Participate." 2021 event two: Sample numbers HEM-06, HEM-07, HEM-08, HEM-09 and HEM-10 all scored as unacceptable for Lymphocytes %, Monocytes/Mids, and Granulocyte %, resulting in an overall score of 0% for the WBC differential, and the first unsuccessful PT occurrence for the WBC differential analyte. -- 2 of 2 --