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 routine desk audit of CMS-153 and CMS-155 reports of proficiency testing (PT) scores and staff confirmation, the laboratory failed to achieve successful PT performance for two consecutive testing events in the specialty of Bacteriology in 2020. See D2025 and D2028." D2025 BACTERIOLOGY CFR(s): 493.823(c) Failure to return proficiency testing results to the proficiency testing program within 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 -- 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 review of proficiency testing (PT) scores and staff confirmation, the laboratory failed to return PT results for 2020 Event 2 to the American Proficiency Institute (API) within the specified timeframe resulting in a score of zero. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for 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 proficiency testing (PT) scores and staff confirmation, the laboratory failed to achieve a score of 80 percent for bacteriology in two consecutive events in 2020, resulting in unsuccessful performance. The findings include: 1. During a review on 12-28-20 of the CMS-153 Unsuccessful Proficiency Testing Report included Avista Women's Care with unsatisfactory proficiency testing scores for bacteriology. 2. During a review on 12-28-20 of the CMS-155 report, the American Proficiency Institute bacteriology score for event 2 of 2020 was 0%. 3. During a review on 12-28-20 of the CMS-155 report, the American Proficiency Institute bacteriology score for event 3 of 2020 was 0%.4. On 12-28-20, office staff confirmed that both events received scores of 0% and were unsuccessful. -- 2 of 2 --