Summary:
Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted for Charleston Area Medical Center Cancer Center on July 28, 2022, by the West Virginia Office of Laboratory Services. The laboratory proficiency testing evaluations with the American Proficiency Institute (API) were reviewed and evaluated with the laboratory CMS 0153D Unsuccessful PT Report for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. 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 American Proficiency Institute (API) failures summary report 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 -- and the CLIA 155D report for the Charleston Area Medical Center Cancer Center laboratory, the laboratory failed to successfully participate in a program approved by CMS for the analyte #0305 Bilirubin Total for two consecutive events in 2022. Findings: 1. Review of 155D revealed the following unsatisfactory scores for analyte #0305 Bilirubin Total: 1st Event 2022- 40% 2nd Event 2022- 20% 2. Review of API failures summary report confirmed the unsatisfactory scores and resulting unsuccessful performance for the analyte #0305 Bilirubin Total. 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 review of CLIA 155D report and the failures summary report from the American Proficiency Institute (API) proficiency testing (PT) evaluations, the laboratory failed to achieve satisfactory performance for the analyte #0305 Bilirubin Total in two consecutive testing events of 2022. Findings: 1. Review of 155D revealed the following unsatisfactory scores for #0305 Bilirubin Total: 1st Event 2022- 40% 2nd Event 2022- 20% 2. Review of API failures summary report confirmed the unsatisfactory scores and resulting unsuccessful performance for analyte #0305 Bilirubin Total. -- 2 of 2 --