Fanno Creek Clinic Llc

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 Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D revealed the laboratory had unsuccessful participation for two (2) consecutive testing events for the analyte Aspartate Aminotransferase (AST). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) desk review of the American Proficiency Institute (API) proficiency testing and CASPER Report 0155D revealed the laboratory had unsuccessful participation for two (2) consecutive testing events for the analyte Aspartate Aminotransferase (AST). Findings include: 1. API 3rd Event 2022 = AST 60%. 2. API 1st Event 2023 = AST 20%. 3. Phone conversation with the Laboratory Manager/ Technical Supervisor on 05/22/2023 @ 10:35AM confirmed these findings. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based upon review of records and interview with the the Technical Supervisor (TS) on 04/08/2019 at approximately 1200, the laboratory failed to ensure the Laboratory Director (LD) and testing personnel (TP) performing Proficiency Testing (PT) attest in writing to the testing of PT samples. 1. The were no signed attestation forms for PT events one (1) through three (3) for 2017. 2. The were no signed attestation forms for PT events one (1) through three (3) for 2018. 3. The LD confirmed he had signed the attestation pages for 2017 and 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --