Genesee Hematology Oncology

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the technical consultant, the laboratory failed to label its hematology control materials with the expiration date reflecting its opened container stability for three of three opened control materials observed. Findings include: 1. The surveyor observed the three levels of hematology control with "11/1/24" written on each container on 11/4/24 at 9:02 am. 2. A review of the laboratories package insert for the current lot of hematology controls revealed a section stating, "8 consecutive day open-vial Stability." 3. An interview on 11/14/24 at 9:02 am with the technical consultant revealed the date on the vials was the open date and the laboratory did not included the expiration dates on the vials. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: 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 -- . Based on record review and interview with Technical Consultant, the laboratory failed to ensure background checks for the Abbott Celldyn Ruby hematology analyzer were within established limits prior to testing and reporting patient results for 5 (4/25 /2024, 04/26/2024, 1/10/2024, 1/11/2024, 1/26/2024, 1/29/2024) of 61 days in 2024. Findings include: 1. A review of the laboratory's Abbott Celldyn Ruby hematology analyzer background count records revealed the background counts failed on the following days: 4/25/2024, 04/26/2024, 1/10/2024, 1/11/2024, 1/26/2024 and 1/29 /2024. 2. An interview on 11/04/2024 at 12:15 pm with the Technical Consultant revealed that

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation and interview with the Technical Consultant (TC), the laboratory failed to perform and document thermometer calibrations and/or replace an expired thermometer for 1 (S/N 130041895) of 1 thermometers in use. Findings include: 1. During a tour of the laboratory on 11/29/2022 at 9:00 am the surveyor observed a thermometer in the Frigidaire refrigerator with an expiration date of unable to read the month/23/2015. 2. When queried on 11/29/2022 at 9:00 am, the TC was not able to provide the surveyor documentation to show the thermometer had been calibrated. 3. An interview on 11/29/2022 at 9:00 am, the TC confirmed the laboratory failed to perform and document thermometer calibrations and/or replace the expired thermometer. 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 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the hematology analyte: White Blood Cell Differential. Findings include: Review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for the hematology analyte: White Blood Cell Differential. Refer to D2130. D2130 HEMATOLOGY 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 -- CFR(s): 493.851(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 review of the CMS database and review of the American Proficiency Institute (API) graded proficiency testing reports, the laboratory failed to achieve satisfactory performance for the hematology white blood cell differential (WBC) for 2 of 2 consecutive testing events. Findings include: Unsatisfactory performance for 2 of 2 consecutive proficiency events constitutes unsuccessful performance for WBC differential: White Blood Cell Differential PT Event Score 1st event 2022 60% 3rd event 2022 76% -- 2 of 2 --