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 the CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to successfully participate in Hematology testing for two of three consecutive events (Event #2 and Event #3 of 2020). The failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored sixty percent (60%) for Event #2 2020 and zero percent (0%) for Event #3 2020 for RBC (Hematology). 2. A review of the API proficiency testing records revealed the laboratory failed to successfully participate in testing, resulting in a score of sixty for 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 -- RBC in Event #2 of 2020. Also, the review revealed the laboratory failed to participate in testing, resulting in a score of zero in Event #3 2020 for RBC. 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. This STANDARD is not met as evidenced by: Based on the CMS CASPER reports and a review of the American Proficiency Institute (API) proficiency testing reports, the surveyor determined the laboratory failed to successfully participate in Hematology testing for two of three consecutive events (Event #2 and Event #3 of 2020). The failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the CASPER reports for proficiency testing revealed the laboratory scored sixty percent (60%) for Event #2 2020 and zero percent (0%) for Event #3 2020 for RBC (Hematology). 2. A review of the API proficiency testing records revealed the laboratory failed to successfully participate in testing, resulting in a score of sixty for RBC in Event #2 of 2020. Also, the review revealed the laboratory failed to participate in testing, resulting in a score of zero in Event #3 2020 for RBC. -- 2 of 2 --