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: The laboratory failed to successfully participate in proficiency testing (PT) by failing to achieve satisfactory scores of at least 80% in two consecutive or two out of three consecutive PT events for Red Blood Cell Count and Hemoglobin. (See D2130) 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. 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 -- This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) results review and confirmation by staff, the laboratory failed to achieve satisfactory performance for Red Blood Cell Count (RBC) in two out of three consecutive testing events (events 1 and 3 of 2017) and for Hemoglobin (Hgb) in two consecutive testing events (events 2 and 3 of 2017) constituting unsuccessful performance. Finding include: 1. A PT score of less than 80% constitutes unsatisfactory performance 2. API PT records document unsatisfactory RBC scores of 60% for event 1 of 2017 and 40% for event 3 of 2017. 3. API PT records document unsatisfactory Hgb scores of 60% in the 2nd and 3rd events of 2017. 4. The technical consultant confirmed the unsatisfactory scores by email on 12/29/2017. -- 2 of 2 --