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 2019 chemistry proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with the laboratory director, the laboratory failed to successfully participate in PT. See D-tag 2096, unsatisfactory performance in three consecutive total cholesterol PT challenges. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of chemistry proficiency testing (PT) results for 2019 and phone interview with the laboratory director, the laboratory failed to achieve satisfactory performance for the total cholesterol analyte testing in three consecutive PT events. Findings: 1. Review of the chemistry PT results for the first event of 2019 revealed the laboratory obtained an unsatisfactory score of 40 percent for the analyte, total cholesterol. 2. Review of the chemistry PT results for the second event of 2019 revealed the laboratory obtained an unsatisfactory score of 60 percent for total cholesterol. 3. Review of the chemistry PT results for the third event of 2019 revealed the laboratory obtained an unsatisfactory score of 60 percent for total cholesterol. 3. Phone interview with the laboratory director on October 24, 2019 at 3:30 PM confirmed the laboratory failed to achieve satisfactory performance for total cholesterol testing in three consecutive events for 2019. -- 2 of 2 --