Katmai Oncology Group, Llc

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 the laboratory's 2024 College of American Pathologists (CAP) proficiency testing (PT) records and an email with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte Cell Identification/WBC Differential in two (2) out of three (3) Hematology 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 -- 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 the laboratory's 2024 College of American Pathologists (CAP) proficiency testing (PT) records and an email with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analyte Cell Identification/WBC Differential in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2024 CAP PT records revealed analyte scores of less than eighty percent for Hematology Cell Identification/WBC Differential . a. 2024 Event 2 = 60% b. 2024 Event 3 = 60% 2. In an email correspondence with the laboratory director on November 7, 2024, it was confirmed the laboratory was unsuccessful in the PT events listed above. -- 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 analyzers when performing QC for the BMP+ cartridges for 3 of 3 months since patient testing began on 5/3/2023. 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 QC records showed the laboratory failed to follow it plan to perform two levels of external QC every thirty days, and with each new lot or shipment of cartridges on each Piccolo analyzer. a. New lot QC on 8/16/23 did not include two levels of external QC on each Piccolo. b. Quality control records showed no entries for June or July 2023. 3. The lab director confirmed these findings on 8/30/2023 at approximately 11:45 AM. 4. The laboratory estimates approximately forty 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 --