Oregon Fertility Institute

Summary Statement of Deficiencies D0000 Based on desk review of proficiency testing (PT) from 2024 through 2025, the laboratory failed to meet the following conditions, resulting in noninitial unsuccessful PT participation: D2016 - 42 CFR 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 CFR 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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: Based on a desk review of proficiency testing (PT) records from that Certification and Survey Provider Enhance Reporting (CASPER) 0155D report and AAB Medical Laboratory Evaluation (AAB-MLE) proficiency testing records, the laboratory failed 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 -- to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Endocrinology. Refer to D2099. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) (b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review of CASPER 0155D report and AAB-MLE proficiency testing 2024 and 2025 records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the specialty of Endocrinology for two out of three consecutive testing events. Findings included: 1. A review of the CASPER 0155D report revealed the following results: Endocrinology 2024- 2nd Event the laboratory received an overall score of 100%. Endocrinology 2024- 3rd Event the laboratory received an overall score of 40% Endocrinology 2025- 1st Event the laboratory received an overall score of 76% 2. A review of the AAB-MLE proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing desk review of CASPER 0155D report and AAB- Medical Laboratory Evaluation 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review of CASPER 0155D report and AAB- Medical Laboratory Evaluation 2024 and 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency program. Refer to D2099. -- 2 of 2 --

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 upon review of Proficency Testing (PT) records and interview with the Laboratory Director (LD), the laboratory failed to ensure the attestation forms for PT were signed by the LD and testing personnel. Findings include: 1. No completed and signed attestation forms by testing personnel and the LD could be produced during the survey 4/16/2019 for Event #3 (2017) or Events 1 & 2 (2018). 2. During an interview with the LD 4/16/2019 at approximately 1230, she confirmed that she was unaware of this CLIA requirement. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based upon inspection of the laboratory area during survey and discussion with staff, 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 -- it was noted that reagents for testing patient samples were not being stored according to manufacturer's requirements. Findings include: 1. Two boxes of Vidas test packs were noted to be stored on top of one of two refrigerators (at Room Temperature or RT) in the lab area when the manufacturer requires storage at 2 - 8 degrees Celcius. Lot # 1006840100 Expires 9/25/2019. 2. Upon review of the refrigerator temperature logs for January 2 through April 16, 2019, it was noted that Refrigerator #1 had been out of the established range of 2 - 8 degrees Celcius nineteen days (19) out of seventy eight (78) days of clinic operation. The Laboratory Director (LD) confirmed there was no written documentation for