Summary:
Summary Statement of Deficiencies D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to notify Centers for Medicare & Medicaid Services (CMS) of their enrollment in an approved proficiency testing program for the specialty in chemistry for five (#1-#3 2017 and #1-#2 in 2018) of five testing events. Findings include: 1. On August 2, 2018 while preparing the file for survey, the surveyor pulled the 155D report to review the proficiency testing scores. The following statement appeared on the screen: "Your retrieval arguments did not pass validation and had the following error(s): The CCN entered was not found or did not meet entered criteria." 2. On August 16, 2018 at 10:47 AM, record review of the American Association of Bioanalysts (AAB) final proficiency testing reports revealed the laboratory was enrolled in an approved program for the routine chemistry and endocrinology testing for five (#1-#3 2017 and #1-#2 in 2018) of five testing events. 3. During the interview on August 16, 2018 at 10:47 AM, testing personal #1 as listed on the CMS-209 confirmed the facility was enrolled in an approved proficiency testing program but CMS was not notified. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --