Summary:
Summary Statement of Deficiencies D0000 Based on evidence of unsuccessful proficiency testing performance for the Sodium analyte, the following Condition level deficiency was deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. . 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 proficiency testing review for calendar year 2019 (three testing events), the laboratory failed to successfully participate (achieve a score of 80 percent or more) in the College of American Pathologists (CAP) proficiency testing program for the Sodium analyte. Refer to D2096. . 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 an off site desk review of the laboratory's 2019 and 2020 College of American Pathologists (CAP) proficiency testing (PT) records the laboratory failed to achieve satisfactory performance for the Sodium analyte for two out of three testing events resulting in unsuccessful performance for the analyte as evidenced by the following: 1. Desk review of the laboratory's 2019 and 2020 CAP PT records revealed the laboratory achieved a score for Sodium of less than eighty percent for the following Routine Chemistry testing events: 2019 third testing event - Sodium score of forty (40) percent; and, 2020 first testing event - Sodium score of sixty (60) percent. 2. Review of CAP reports for the two testing periods above confirmed that the above PT scores were correct. -- 2 of 2 --