Womens Health Center Of Southern Oregon

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 review of the attestation forms for 2023 and 2024 Proficiency Testing (PT) events from American Proficiency Institute (API) and interview with the office manager, the laboratory failed to ensure that the Laboratory Director (LD) and the testing personnel (TP) attested to the performance of these PT samples. Findings include: 1. Upon review of the PT records from API for 2023, for the specialty Bacteriology, it was noted that the person signing off as the LD on the attestation form was not the LD, but a Medical Assistant (MA), with a high school (HS) diploma (also TP#4) for events one (1), two (2) and three (3) in 2023. 2. Upon review of the PT records from API for 2024, for the specialty Bacteriology, it was noted that there was no LD or TP signature for any of three (3) events in 2024. 3. The Office manager confirmed during interview at 1:30pm that the signature on the attestation forms for the three (3) events in 2023 belonged to TP #4 and not the LD. 4. The Office manager confirmed during interview at 1:30pm that the signature on the attestation forms for the three (3) events in 2024 were lacking for both the LD and the TP performing testing. 5. The laboratory reports performing 3000 moderate complexity Bacteriologic assays annually. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the test report for the five (5) bacteriologic infectious agents tested for using the Cepheid Gen-Xpert instrument, and interview with the Office manager (also listed on the CMS 209 form as the Technical Consultant (TC) and Testing personnel (TP #1), the laboratory failed to ensure the final patient test report included pertinent information. Findings include: 1. The name and address on the test report is incomplete and reads as WHC 1075 SW Grandview. There is no city, state or zip code. 2. The tests performed are stated in vague acronyms, with no key included on the test report for interpretation of these acronyms. Atop gp - meaning unknown Mega1- meaning unknown Cgroup - standing for Candida species Cglab-krus- standing for Candida species TV - standing for Trichomonas vaginalis Rule 1 - meaninng unknown CT1 standing for Chlamydia trachomatis NG2 - standing for Neisseria gonorrhea NG4 - Standing for Neisseria gonorrhea 3. There is no ordering provider on the test report. 4. There is no specimen source or time of collection on the test report. 5. Interview with the Office manager (also listed as the TC and TP #1 on the current CMS 209 form) at 2:00 pm confirmed that the test report did not include the items stated above. 6. The laboatory reports performing 3000 tests annually for bacteriologic infectious agents. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of Personnel and training records and interview with the technical Consultant (TC) the Laboratory Director failed to ensure that prior testing patients' specimens, all testing personnel (TP) have the required documentation of education and experience required prior to patient testing. Findings include. 1. Two (2) out of seven (7) TP performing moderately complex Becton Dickinson (BD) Affirm VPIII Microbial Identification System did not have copies of their diploma or transcript of records on file at the time of survey. 2. Interview with the TC on 07/17/2023 at 10:30 AM confirmed these findings. 3. The laboratory performs approximately 1,792 specimens for BD Affirm Microbial Identification System annually. 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 --