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 (PT) data report and review of the comparative evaluation summary from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to successfully participate in the MLE PT program for hematology testing, in which the laboratory is certified under CLIA (D2130 and D2131). D2121 HEMATOLOGY CFR(s): 493.851(a) 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 attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to attain a score of 80% for each analyte in the MLE PT program for hematology testing. The following analyte was noted as failed in the 2020 3rd event. Findings: 1. MLE 2020 3rd event Hematocrit 20% D2123 HEMATOLOGY CFR(s): 493.851(c) 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 (PT) data report and review of the comparative evaluation summary from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to participate in the MLE 2020 2nd event for hemoglobin. Findings: 1. MLE 2020 2nd event Hemoglobin 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 (PT) data report and review of the comparative evaluation summary from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to achieve satisfactory performance for the same analyte in 2 out of 3 consecutive hematology testing events. The following analyte was noted as failed in the 2020 1st and 3rd events. Findings: 1. MLE 2020 1st event Cell Identification or White Blood Cell Differential 66% 2. MLE 2020 3rd event Cell Identification or White Blood Cell Differential 0% D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the Medical Laboratory Evaluation (MLE) PT program, the laboratory failed to achieve an overall testing event score of satisfactory performance for 2 consecutive hematology testing events. Findings: 1. MLE 2020 2nd event overall Hematology 77% 2. MLE 2020 3rd event overall Hematology 60% 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 (PT) data report and review of the comparative evaluation summary from the Medical Laboratory Evaluation (MLE) PT program, the laboratory director failed to ensure that the laboratory successfully participated in the MLE PT program for hematology testing, in which the laboratory is certified under CLIA (D6019). D6019 LABORATORY DIRECTOR RESPONSIBILITIES 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