Summary:
Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted on 6/26/19 for the AFC Urgent Care laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 the Proficiency Testing (PT) data report, (Report 155) report and graded results from, American Proficiency Institute (API), the laboratory failed to successfully participate in White blood cell Differential PT. See D2130. D2127 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's 2019 American Proficiency Institute (API) proficiency testing (PT) records and phone interview, the laboratory failed to submit their testing results to API within the specific time frame resulting in an unsatisfactory score for the automated White Blood Cell (WBC) Differential PT survey. Findings include: 1. Desk review of the laboratory's API PT final testing results for the automated WBC Differential on 6/26/19 revealed the laboratory achieved a score of zero (0) for the first event of 2019. 2. Desk review of the laboratory's