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Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Review of Proficiency Testing (PT) records and discussion with laboratory staff revealed the laboratory is NOT enrolled in HHS approved PT Provider for the regulated analytes IgA, IgG, and IgM. Finding includes: 1. Review of Proficiency Testing records revealed that the laboratory was testing IgA, IgG, and IgM in Diagnostic Immunology. 2. The laboratory had records of participation of PT through a PT provider called "Immprove Quality Assurance Scheme Binding Site"(IQASBS) which was received 03/03/2021, performed 03/11/2021 and results submitted 03/11 /2021. 3. Further investigation revealed that the PT Provider IQASBS was NOT approved by HHS. This was confirmed by phone conversation between the PT provider's Technical Representative and the General Supervisor on 03/15/2021 at 12: 30PM. 3. Discussion with the General Supervisor on 03/15/2021 @ 12:30 PM concurred with these findings. 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 --

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: Record review of the American Proficiency Institute (API) proficiency testing reveals that your laboratory has unsuccessful proficiency testing for Routine Chemistry. Refer to D2096. 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Review of the American Proficiency Institute (API) proficiency testing (PT) shows unsatisfactory performance for the same analyte in two out of three consecutive testing events. Findings include: 1. 3rd Event 2017 - Urea Nitrogen - 60%. 2. 2nd Event 2018 - Urea Nitrogen - 0%. -- 2 of 2 --