Midnight Sun Oncology Partners

Summary Statement of Deficiencies 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 an off-site desk review of American Proficiency Institute (API) proficiency testing (PT) records and a telephone interview with the testing personnel (TP), the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte of hematocrit in two (2) out of three (3) testing events resulting in unsuccessful PT performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of American Proficiency Institute (API) proficiency testing (PT) records and telephone interview with the testing personnel (TP), the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte of hematocrit in two (2) out of three (3) testing events resulting in unsuccessful PT performance. The findings include: 1. A desk review of the laboratory's proficiency testing results revealed hematocrit scores of less than eighty percent. 2. The laboratory obtained an unsatisfactory score of 40 percent for the hematocrit in the first testing event of 2025. 3. The laboratory obtained an unsatisfactory score of 60 percent for the hematocrit in the second testing event of 2025. 4. A telephone interview with the TP on 09/17/25 at 3:10 PM confirmed the laboratory failed to achieve satisfactory performance for the hematocrit. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of 2023 and 2024 proficiency testing (PT) records and an interview with the testing person, the laboratory failed to include five (5) of seven (7) PT attestation forms indicating the PT samples were tested in the same manner as patient samples. Findings include: 1. A request was made to review the PT attestations for Hematology PT for 2023 and 2024, and the attestations for the second and third events of 2023 and all three events for 2024 could not be provided. 2. The testing person confirmed these findings during an in-person interview on 11/20/2024 at 12:00 PM. 3. The laboratory reports performing approximately 3,900 complete blood counts (CBCs) annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on a procedure review, review of competency records, and an interview with the Testing Person (TP), the laboratory failed to establish and follow written policies and procedures to assess employee competency for one (1) of two (2) testing persons. Findings include: 1. The Laboratory General Policy states "Each laboratory testing personnel file will have documentation of training, experience and yearly competency review." The policy did not establish instructions for semiannual assessment during the first year of testing. 2. A request was made to review competency assessments for TP1, hired in April 2023, and semiannual and annual competency assessments could not be provided. 3. The testing person confirmed these findings during an in-person interview on 11/20/2024 at 12:00 PM. 4. The laboratory reports performing approximately 3,900 complete blood counts (CBCs) annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory did not establish or have written policies and procedures to assess the Technical Consultant's competency. Findings: 1. The Technical Consultant was hired on 7/15/16. 2. A review of the laboratory personnel's training and competency records for 2016, 2017, and 2018 revealed there was no training or competency assessment for the Technical Consultant. 3. During an interview on 6/12/18 at 10:00 am, the laboratory testing person confirmed the above findings. 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 record review and staff interview, the laboratory did not verify the 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 -- reportable range on the Beckman Coulter AcT Diff 2 Hematology Analyzer prior to testing patients. Findings: 1. A review of the verification documentation showed the Beckman Coulter AcT Diff 2 Hematology Analyzer was put into use for patient testing on 8/31/16. 2. The reportable ranges for White Blood Cell counts, Red Blood Cell counts, Hemoglobin, and Platelet counts were verified on 10/28/16 and reviewed by the Laboratory Director on 11/8/16. 3. The laboratory does approximately 285 Complete Blood Counts per month on the analyzer. 4. During an interview on 6/12/18 at 1:00 pm, the laboratory testing person confirmed the above findings. -- 2 of 2 --