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 record review and interview, the laboratory failed to successfully participate in proficiency testing (PT) for two consecutive events (1/2017 and 2/2017) in the specialty of Hematology for the analyte, WBC-Cell ID (Refer to D2130). Legend=WBC (White Blood Cell) Cell ID (Celllular Identification) 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 record review and interview, the laboratory failed to successfully participate in proficiency testing (PT) for two consecutive events (1/2017 and 2/2017) in the specialty of Hematology for the analyte, WBC-Cell ID. Legend=WBC (White Blood Cell) Cell ID (Cellular Identification) Findings include: 1) Review of Oscar Report 155D (Individual Laboratory Profile) indicated the following unsatisfactory scores for WBC Cell-ID: Event 1 (2017)=0% and Event 2 (2017)=67%. 2) Review of proficiency testing scores received from API (American Proficiency Institute representative), confirmed the above WBC Cell-ID scores. Staff member SP#1 (API representative) sent an email on 02/16/18 at 10:40 am, confirming the above failing scores for WBC Cell-ID. 3) In interview on 02/16/18 at 11:02 am, SP#2 (laboratory representative), confirmed the scores for Event 1/2017 (0%) and Event 2/2017 (67%) for the analyte, WBC Cell-ID. -- 2 of 2 --