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 proficiency testing (PT) record review and interview with the technical consultant, the laboratory failed to successfully participate in PT for Hematocrit by failing to achieve successful scores of at least 80% in two consecutive testing events. (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) results review and notification by staff, the laboratory failed to achieve satisfactory performance for Hematocrit (Hct) in 2 consecutive PT testing events (events 2 and 3 of 2017) constituting unsuccessfully PT performance. Finding include: 1. Failing to achieve a score of at least 80% constitutes unsatisfactory performance. 2. API record review documents unsatisfactory Hct scores of 60% for the event 2 of 2017 and 40% for event 3 of 2017. 3. The technical consultant notified the CLIA program on 12/28 /2017, by email, of the 2 consecutive failures. -- 2 of 2 --