Katmai Oncology Group

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 policies and procedures, lack of documentation, and an interview with the laboratory director (LD), the laboratory failed to fully establish procedures and follow quality assessment activities described in the "Patient Results Review" procedure since August 2023. The findings include: 1. A review of the procedure "Patient Results Review" listed quality assessment activities to review calculations, linearity, clerical error, unusual results, critical values and provider notification, and performance of reflex testing. 2. A request for documentation of performing quality assessment activities was made but documentation was not available. 3. An on-site interview with the LD on 11/10/25 at 12:00 PM confirmed there was no documentation. 4. The laboratory reports performing 50650 tests annually. D5309 TEST REQUEST CFR(s): 493.1241(e) (e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of policies and procedures, lack of documentation, and interviews 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 -- with testing personnel one (1) and the laboratory director (LD), the laboratory failed to ensure patient orders entered from the electronic health record (EHR) into the laboratory information system (LIS) were transcribed accurately since August 2023. The findings include: 1. A review of the policies and procedures manual revealed a lack of documented process for transcribing orders from the EHR to the LIS. 2. A request for documentation of audits or activities that checked the accuracy of transcription was made but documentation was not available. 3. In an on-site interview with TP1 on 11/10/2025 at 11:30 AM confirmed no procedure was available and with LD on 11/10/2025 at 12:00 PM confirmed that no audits or activities were performed. 4. The laboratory reports performing 50650 tests annually. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on lack of procedures and documentation, record review, and an interview with the laboratory director, the laboratory failed to perform a comparison of test results twice a year for magnesium and lactate dehydrogenase (LD) performed on two of two Piccolo Express analyzers since August 2023. The findings include: 1. A review of policies and procedures failed to include procedures for comparison of magnesium and LD results between analyzers. 2. A request was made for documentation of analyzer comparisons for magnesium and LD performed on the Piccolo Xpress analyzers P06393 and P06805 but was not available. 3. An on-site interview with the laboratory director confirmed comparison of Piccolo Express analyzers P06393 and P06805 performing magnesium and LD was not done. 4. The laboratory reports performing 1588 magnesium and LD tests annually. -- 2 of 2 --

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 Individual Quality Control Plan (IQCP), Quality Control (QC) records, and an interview with the laboratory director, the laboratory did not follow their IQCP for the Abaxis Piccolo Chemistry analyzer when performing QC for the BMP+ cartridges for three of three months of QC reviewed. Findings include: 1. The Quality Control Plan states two levels of external controls are to be performed every thirty days, and with each new lot or shipment of cartridges on each piccolo analyzer. 2. A review of nine of nine QC records for June, July, and August of 2023 showed the laboratory failed to follow its plan to perform two levels of external QC on each Piccolo analyzer with each new lot or shipment of BMP+ cartridges. 3. The lab director confirmed these findings on 8/31/2023 at approximately 12:00 PM. 4. The laboratory estimates approximately 1060 chemistry tests 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 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on policy review and staff interview, the laboratory did not follow the manufacturer's instructions for reporting Hematology automated differentials. Findings: 1. The laboratory is using a Sysmex XT-2000i for complete blood counts (CBC) including automated differentials. 2. The analyzer suppresess abnormal results that potentially affect the accuracy of the test parameter resulting in an 'error' in the auto differential results. These potentially inaccurate results can be found in the 'research' screen of the analyzer. 3. According the to the Sysmex XT-2000i Instructions for use, "Parameters for research are displayed on the Research Screen. The analysis result cannot be used as data for reporting." 4. The results from the research screen were used for patient results and reported when the analyzer showed error flags on the auto differential. 5. The laboratory does approximately 7,365 CBCs annually. 6. The laboratory director confirmed these findings on 8/15/19 at 12:00 pm. D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory 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 -- director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on review of the CMS116 application, credentialing documents such as college diplomas, and staff interview, the laboratory was performing peripheral smear reviews, including the reporting of abnormal red blood cell morphology and immature white blood cells categorized by the Food and Drug Administration (FDA) as high complexity testing. The laboratory director did not qualify to be a director for high complexity testing. Findings: 1. The CMS116 application listed two physicians performing peripheral smear reviews using a microscope. 2. The smear findings were entered electronically in the patient chart notes. 3. The laboratory was unaware that smear reviews with abnormal findings are categorized by the FDA as high complexity. 4. The laboratory performs approximately 38 peripheral smear reviews annually. 5. The laboratory director has a Bachelor of Science, and does not meet the qualifications for high complexity testing. 7. The laboratory director confirmed these findings on 8/15/19 at 12:00 pm. -- 2 of 2 --