Thompson Oncology Group

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 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 the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and College of American Pathologists (CAP) records for 2026, the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (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 Hematology for the White Blood Cell Differential (WBC DIFF) analyte. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a proficiency testing desk review of the CASPER 0155 report and the College of American Pathologists (CAP) records for 2026, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two consecutive testing events in the specialty of Hematology for the White Blood Cell Differential (WBC DIFF) analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: *Hematology 2026-1st Event: The laboratory received an unsatisfactory score of 20% for the WBC DIFF analyte. *Hematology 2026-2nd Event: The laboratory received an unsatisfactory score of 0% for the WBC DIFF analyte. 2. A review of the CAP 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 a proficiency testing desk review of the CASPER 0155 report and the College of American Pathologists (CAP) records for 2026, the laboratory director failed to provide overall management and direction for laboratory services. The laboratory director failed to ensure that proficiency testing samples were tested as required. 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 a proficiency testing desk review of the CASPER 0155 report and the College of American Pathologists (CAP) proficiency records for 2026, the laboratory director failed to ensure that proficiency testing samples were tested as required. The -- 2 of 3 -- laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130 -- 3 of 3 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, random review of environmental monitoring records, and staff interview, the laboratory failed to follow its humidity monitoring procedure for four of four months reviewed in 2023 and 2024. The findings include: 1. A review of the laboratory's "Reagent and Supply Management & Environmental Monitoring of Temperature and Humidity" policy revealed the following: - "Refrigerator, humidity and Room temperature will monitored and recorded each day of testing." - "Is the current temperature/humidity in Range as defined on the daily log? If no proceed to step 6." - Step 6: "Run QC and document if results are acceptable or not on the temperature log." - "Always document if QC was acceptable and if instrument function checks were acceptable when documenting

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's Proficiency Testing Policy, proficiency testing records, documented