Fallon Medical Complex

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. 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 director failed to provide overall management and direction for preventing proficiency testing failures for three of four events (2018 event 3, 2019 event 1, and 2019 event 3) resulting in subsequent unsuccessful proficiency testing performance. See D2096. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies D0000 Based on an off-site proficiency testing desk review conducted on 3/20/19, deficiencies were cited for Fallon Medical Complex in Baker, MT. 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 chloride for two consecutive events (2018 event 3 and 2019 event 1), resulting in unsuccessful proficiency testing performance. See D2096. D2096 ROUTINE CHEMISTRY 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 -- 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 proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for chloride in two consecutive events in 2018 and 2019, resulting in unsuccessful performance. The findings include: 1. During a review on 3 /18/19 at 11:30 a.m. of the CMS-153 Unsuccessful Proficiency Testing Report included Fallon Medical Complex with unsuccessful proficiency testing scores for chloride. 2. During a review on 3/20/19 at 8:00 a.m. of the CMS-155 report, the American Proficiency Institute (API) chloride score for event 3 of 2018 was 60%. 3. During a review on 3/20/19 at 8:00 a.m. of the CMS-155 report, the API chloride score for event 1 of 2019 was 40%. 4. On 3/20/19 at 9:00 a.m., the laboratory manager stated the failures occurred and