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 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for Bacteriology for two consecutive events (2019 Event 3 and 2020 Event 1), resulting in unsuccessful proficiency testing performance. See D2025. 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 scores and interview, the laboratory failed to achieve a score of 80 percent for Bacteriology in two consecutive events in 2019 and 2020, resulting in unsuccessful performance. The findings include: 1. During a review on 5-28-20 at 8:00 am of the CMS-153 Unsuccessful Proficiency Testing Report included Mountain View Medical Group with unsuccessful proficiency testing scores for Bacteriology. 2. During a review on 5-28-20 at 8:00 am of the CMS-155 report, the American Proficiency Institute (API) Bacteriology score for event 3 of 2019 was 0%. 3. During a review on 5-28-20 at 8:00 am of the CMS-155 report, the American Proficiency Institute (API) Bacteriology score for event 1 of 2020 was 0%. 4. On 5-28- 20 at 10:00 am, laboratory practice manager stated that "the 1st event was not submitted on time and the second was completed, but it seems that it did not submit." -- 2 of 2 --