Obgyn West Eden Prairie

Summary Statement of Deficiencies D0000 The OBGYN West Eden Prairie laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the recertification survey performed on May 1, 2024. The following standard-level deficiency was cited: 493.1413 Technical consultant responsibilities . D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant (TC) failed to ensure one of four testing personnel (TP) in 2022 and one of five TP in 2023 were assessed annually through testing previously analyzed specimens, blind samples, or proficiency testing samples for three of three test systems in 2022 and one of three test systems in 2023. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology and Diagnostic Immunology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 12:35 p.m. on 03/19/24. 2. The following test systems were observed as present and available for use during the tour: Cepheid GeneXpert XVI test system - Group B Streptococcus and Chlamydia trachomatis/Neisseria gonorrhoeae tests BD Affirm (Trademark) VPIII microbial identification system - vaginitis panel test ROM Plus - rupture of membranes test Cepheid GeneXpert Bacterial Vaginosis, Vulvovaginal Candidiasis, and Trichomoniasis test was in use May 2023 through February 2024 as indicated in laboratory records and confirmed by the TC. 3. Assessment of test performance using previously analyzed specimens, internal blind samples, or external proficiency samples was required annually for all TP as 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 -- established in the Staff Orientation, Training and Competency procedure found in the General Laboratory Policy and Procedure Manual. 4. Blind sample competency assessments were not documented as completed on TP3's 2022 annual competency evaluation forms for the above moderate complexity tests. 5. Blind sample competency assessments were not documented as completed on TP6's 2023 annual competency evaluation forms for the Cepheid GeneXpert tests. 6. The laboratory was unable to provide the missing blind sample evaluation documentation upon request. 7. In an interview at 11:40 p.m. on 05/01/24, the TC confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document required monthly maintenance on 1 of 2 analyzers in use in 2020.. Findings are as follows: 1. The laboratory performed Bacteriology testing as confirmed by the Laboratory Manager (LM) during a tour of the laboratory at 9:20 a.m. on 12/30/20. 2. A Cepheid GeneXpert analyzer was observed as present and available for use during the tour of the laboratory. The LM indicated Chlamydia and Neisseria Gonorrhea testing on the GeneXpert was implemented on 04/24/20. 3. Manufacturer requirements for monthly maintenance of the GeneXpert analyzer were established in the Xpert CT/NG Procedure located in the Cepheid Assay Binder manual and indicated on the laboratory's Maintenance Log. 4. Documentation of monthly maintenance was not found for 5 of 9 months reviewed in the following timeframe; April 2020 through December 2020. See below. Months missed 2020 May June July August October 5. In an interview at 11:45 a.m. on 12/30 /20, the LM confirmed the above finding. 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 --