Ogi - Edina

Summary Statement of Deficiencies D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform quality control on new test kits prior to testing patient specimens. Findings are as follows: 1. The laboratory performed Bacteriology, Mycology, and Parasitology testing as confirmed by Testing Personnel 8 (TP8) during a tour of the laboratory at 1:10 p.m. on 09/04/19. 2. A BD Affirm Microprobe processor was observed as present and available for use during the tour. The laboratory performed Trichomonas, Gardnerella, and Candida testing using this processor. 3. Quality control (QC) testing was required with every new test kit as established in the BD Affirm VP III Microbial Identification Test procedure found in the un-named procedure manual. 4. In June 2018 through August 2018, the laboratory failed to perform QC on four of eight new test kits prior to testing patient (Pt) samples which potentially affected 7 patients. See below. Lot Pt testing date Pts QC date 8072819 6/29/18 3 7/2/18 6/30/19 1 7/2/18 8075689 7/17/18 1 7/18/18 8108857 7/30 /18 1 7/31/18 8072822 8/6/18 1 8/7/18 5. In an interview at 3:30 p.m. on 09/04/19, TP8 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 --

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 on document review and interview with laboratory personnel, Testing Personnel failed to attest to the integration of proficiency testing samples into the routine patient workload on 2 of 6 events. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by General Supervisor (GS) during a tour of the laboratory on 2/22/18 at 9:05 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) as the PT provider. 3. Testing Personnel failed to attest to the integration of API proficiency testing samples into the routine patient workload as follows: - Microbiology, 2016, 1st PT event. - Microbiology, 2016, 2nd PT event. 4. In an interview on 2/22/18 at 10:45 a.m., the GS confirmed the above findings. . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing records for at least 2 years on 2 of 6 events. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by General Supervisor (GS) during a tour of the laboratory on 2/22/18 at 9: 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 -- 05 a.m. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute (API) as the PT provider. 3. The PT records for Microbiology, 1st Event, 2017 were missing the Documentation of Review by Laboratory Director (LD), or designee. 4. The PT records for Microbiology, 2nd Event, 2017 were missing the Result Evaluation Report and Documentation of Review by Laboratory Director (LD), or designee. 5. The laboratory was unable to provide the required records upon request. 6. In an interview on 2/22/18 at 10:45 a.m., the GS confirmed the above findings. . 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 document review and interview with laboratory personnel, the Technical Consultant (TC) failed to assess the competency of 1 of 7 new Testing Personnel at least twice annually during the first year of testing. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by General Supervisor (GS) during a tour of the laboratory on 2/22/18 at 9:05 a.m.. 2. Testing Personnel 11 (TP- 11) was listed on Form CMS-209 Laboratory Personnel Report (CLIA) as a new employee performing moderate complexity testing. Laboratory records indicated TP- 11 began working in the lab on 1/30/17 and was initially assessed for competency in December, 2017. 3. A semi-annual competency assessment for TP-11 was not found during review of laboratory records. The laboratory was unable to provide the required documentation upon request. 4. In an interview on 2/22/18 at 10:45 a.m., the GS confirmed the above findings. . -- 2 of 2 --