Obgyn West Minnetonka

Summary Statement of Deficiencies D0000 The OBGYN West Minnetonka 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 March 19, 2024. The following standard-level deficiencies were cited: 493.1253 Establishment and verification of performance specifications 493.1413 Technical consultant responsibilities . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to complete a performance verification (PV) for two of three non- waived Microbiology tests implemented by the laboratory in 2023. Findings are as follows: 1. The laboratory performed moderate complexity Microbiology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 12:35 p. m. on 03/19/24. 2. A Cepheid GeneXpert XVI test system was observed as present and available for use during the tour. The laboratory implemented this test system on 05/12/23 using the following tests: Xpert Xpress MVP - Bacterial Vaginosis, Vulvovaginal Candidiasis, and Trichomoniasis Xpert GBS - Group B Streptococcus Xpert CT/NG - Chlamydia trachomatis and Neisseria gonorrhoeae 3. PV documentation for GBS and CT/NG testing on the GeneXpert test system was not 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 -- found during review of laboratory records. The laboratory was unable to provide the PV documentation for these tests upon request. 4. Test performance verification was required when a test system was installed or replaced with the same or different model as established in the Evaluation of Test Methods procedure found in the General Laboratory Policy and Procedure Manual. 5. In an interview at 4:15 p.m. on 03/19/24, the TC confirmed the above finding. 6. In an interview at 4:40 p.m. on 03/19/24, the TC indicated 868 patients received testing since implementation on 05/12/23 through date of survey, 03/19/24. See below Test Number of patients tested GBS 148 CT/NG 720 . 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 five testing personnel (TP) was assessed semi-annually and annually through testing previously analyzed specimens, blind samples, or proficiency testing samples for three of four tests performed 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. A Cepheid GeneXpert XVI test system was observed as present and available for use during the tour. The laboratory performed the following tests on this test system in 2023: Xpert Xpress MVP - Bacterial Vaginosis, Vulvovaginal Candidiasis, and Trichomoniasis Xpert GBS - Group B Streptococcus Xpert CT/NG - Chlamydia trachomatis and Neisseria gonorrhoeae 3. Assessment of test performance using previously analyzed specimens, internal blind samples, or external proficiency samples was required semi-annually for new TP and annually for all TP as 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 TP6's 2023 semi-annual and annual competency evaluation forms for the above moderate complexity tests. 5. The laboratory was unable to provide the missing blind sample evaluation documentation upon request. 6. In an interview at 2:25 p.m. on 03/19/24, the TC confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to ensure training for two of eight new testing personnel was performed and/or documented in 2021. Findings are as follows: 1. The laboratory performed Bacteriology, Mycology, Parasitology, and General Immunology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:10 a.m. on 04/19/22. 2. BD Affirm VPIII, Cepheid GeneXpert, and Amnisure ROM testing kits were present and available for use during the tour. 3. Initial training documentation was required for new testing personnel as established in the Staff Orientation, Training, and Competency procedure found in the General Laboratory Policy and Procedure Manual. 4. Testing Personnel 10 (TP10) was hired in December 2021 and Testing Personnel 11 (TP11) was hired in July 2021 as indicated in laboratory records. 5. The following initial training documents were not found during review of personnel records: TP10: BD Affirm VPIII, Cepheid GeneXpert TP11: BD Affirm VPIII, Cepheid GeneXpert, Amnisure ROM 6. The laboratory was unable to provide the missing documents upon request. 7. In an interview at 12:00 p.m., the TC confirmed the above finding. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on observation, document review and interview with laboratory personnel, the technical consultant failed to perform each competency assessment in 2020 and 2021. Findings are as follows: 1. The laboratory performed Bacteriology, Mycology, Parasitology, and General Immunology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:10 a.m. on 04/19/22. 2. BD Affirm VPIII, Cepheid GeneXpert, and Amnisure ROM testing kits were present and available for use during the tour. 3. The TC was responsible for performing testing personnel competency assessments as established in the Laboratory Personnel Requirements and Responsibilities procedure found in the General Laboratory Policy and Procedure Manual. 4. Every competency assessment document reviewed on date of survey indicated non-TC personnel performed the semi-annual and annual competency assessments in 2020 and 2021. 5. In an interview at 11:15 a.m. on 08/26 /20, the TC confirmed the above finding. . D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to assess competency at least semi-annually during the first year of patient specimen testing for three of eight testing personnel hired in 2020 and 2021. Findings are as follows: 1. The laboratory performed Bacteriology, Mycology, Parasitology, and General Immunology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:10 a.m. on 04/19/22. 2. BD Affirm VPIII, Cepheid GeneXpert, and Amnisure ROM testing kits were present and available for use during the tour. 3. Competency evaluations were required semi-annually for new testing personnel as established in the Staff Orientation, Training, and Competency procedure found in the General Laboratory Policy and Procedure Manual. 4. Initial training was performed and documented for the following testing personnel (TP) as indicated in laboratory records: TP3: January 2021 TP4: March 2021 TP6: February 2021 5. The following semi-annual competency assessments were not found during review of personnel records: TP3: BD Affirm VPIII, Cepheid GeneXpert, Amnisure ROM TP4: BD Affirm VPIII, Amnisure ROM TP6: BD Affirm VPIII, Amnisure ROM 6. The laboratory was unable to provide the missing documents upon request. 7. In an interview at 12:00 p.m. on 004 /19/22, the TC confirmed the above finding. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to assess competency at least annually for one of two tenured testing personnel in 2021. Findings are as follows: 1. The laboratory performed Bacteriology, Mycology, Parasitology, and General Immunology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:10 a. m. on 04/19/22. 2. BD Affirm VPIII, Cepheid GeneXpert, and Amnisure ROM testing kits were present and available for use during the tour. 3. Annual competency evaluations were required as established in the Staff Orientation, Training, and Competency procedure found in the General Laboratory Policy and Procedure Manual. 4. The 2021 BD Affirm VPIII competency assessment was not found for Testing Personnel 1 during review of personnel records. 5. The laboratory was unable to provide the missing document upon request. 6. In an interview at 12:00 p.m. on 04 /19/22, the TC confirmed the above finding. -- 3 of 3 --