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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 4/14/20, the laboratory failed to successfully participate in proficiency testing for Bacteriology in two of three consecutive testing events. See the deficiency cited at D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 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. This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 4/14/20, the laboratory failed to successfully participate in proficiency testing for Bacteriology in two of three consecutive testing events. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gardnerella vaginalis samples, resulting in a score of 60% for Bacteriology on the 2019 Microbiology 2nd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate in the 2020 Microbiology 1st event, resulting in a score of 0% for Bacteriology. 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 4/14/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 4/14/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 Gardnerella vaginalis samples, resulting in a score of 60% for Bacteriology on the -- 2 of 3 -- 2019 Microbiology 2nd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory failed to participate in the 2020 Microbiology 1st event, resulting in a score of 0% for Bacteriology. -- 3 of 3 --