Summary:
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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Associates of Bioanalyst (AAB) proficiency testing (PT) program, the laboratory failed to successfully participate in the AAB PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2123 and D2130) 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 3 -- 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Associates of Bioanalyst (AAB) proficiency testing (PT) program, the laboratory failed to successfully participate in the AAB PT program for hematology testing, in which the laboratory is certified under CLIA. Findings: 1. The laboratory failed to satisfactorily participate in the AAB PT program for hematology. 2. American Association of Bioanalysts 2019 2nd event overall hematology score 0% D2130 HEMATOLOGY CFR(s): 493.851(f) 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 federal proficiency testing data report and review of the comparative evaluation summery from American Associates of Bioanalyst (AAB) proficiency testing (PT) program, the laboratory failed to successfully participate in the AAB PT program for hematology testing, in which the laboratory is certified under CLIA. The following analyte was noted as failed in the 2019 second and third event. Findings: 1. American Association of Bioanalysts 2019 2nd event WBC 0% 2. American Association of Bioanalysts 2019 3rd event WBC 40% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Association of Bioanalyst (AAB) proficiency testing (PT) program, the laboratory director failed to ensure that the laboratory successfully participated in the AAB PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2123 and D2130) D6019 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved