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 a review of the CASPER Report 155 report and performance evaluations from the proficiency testing organization College of American Pathologists (CAP), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Magnesium, which is of the specialty Routine Chemistry. The laboratory had unsatisfactory scores for the 3rd event of 2017 and the 1st event of 2018. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and performance evaluations from the proficiency testing organization College of American Pathologists (CAP), the laboratory failed to successfully participate in a proficiency testing program approved by CMS for the analyte: Magnesium, which is of the specialty of Routine Chemistry in which the laboratory is certified under CLIA. The laboratory had unsatisfactory scores for the 3rd event of 2017 and the 1st event of 2018. Findings include: 1. CAP 2017 Event 3 for Magnesium, the score was 0%. 2. CAP 2018 Event 1 for Magnesium, the score was 0%. -- 2 of 2 --