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 2016 and 2017 American Proficiency Institute(API) proficiency testing results, it was determined the laboratory failed to have successful participation in proficiency testing in the subspecialty of Mycology as evidence by: Failure to achieve an overall testing event score of satisfactory performance in three of four consecutive testing events is unsuccessful performance as cited at D2046. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) 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 -- (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on review of American Proficiency Institute (API) testing results, and interviews with laboratory staff, it was determined the laboratory had a subsequent unsuccessful performance for the subspecialty of Mycology (Dermatophyte Identification) as evidenced by: Failure to achieve satisfactory performance for the subspecialty of Mycology (Dermatophyte Identification) in three out of four consecutive testing events, as cited at D2046. D2046 MYCOLOGY CFR(s): 493.827(e) 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 the review of the 2016 and 2017 American Proficiency Institute(API) proficiency testing results it was determined the laboratory had three out of four consecutive failures which constitutes unsuccessful performance for the subspecialty of Mycology (Dermatophyte Identification) as evidenced by: A. The laboratory received an overall score of 60% in the third proficiency testing event of 2016, 60% in the first proficiency testing event of 2017, and 60% in the third proficiency testing event of 2017 for subspecialty of Mycology (Dermatophyte Identification). B. In an interview at 11:28 on 1/11/2017, the laboratory technical consultant confirmed three of four proficiency test failures for Mycology (Dermatophyte Identification). 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 2016 and 2017 proficiency testing reports, it was determined the laboratory director failed to ensure that