Reliance Pathology Partners Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Reliance Pathology Partners LLC on 01/13/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3001 FACILITIES CFR(s): 493.1101(a)(1) (a) The laboratory must be constructed, arranged, and maintained to ensure the following: (a)(1) The space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observations and interview the laboratory failed to ensure an adequate ventilation system to remove vapors and fumes. Findings include: 1. During the laboratory tour on 01/13/2025 at 9:55 AM to 10:35 AM, a gallon jug of Reagent Alcohol with a label/pictogram with the words "FUME HOOD" was observed. A tissue processing and staining work station was present. No fume hood was present. Photographic evidence was taken. 2. Interview with the Lead Technologist on 01/13 /2025 at 10:35 AM confirmed the lab utilized the Reagent Alcohol and did not have a fume hood. 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 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 maintenance log record review and interview with the Histotechnologist, the laboratory failed to document cleaning for the cryostat and microscope for two out of two years reviewed (2017-2018). Findings included: A review of the maintenance logs revealed no documentation of cleaning of the cryostat and microscope for two out of two years (2017 - 2018). An interview on 06/19/18 at 12:15 pm with the Histotechnologist confirmed that documentation had not been made for cleaning the cryostat and microscope for two out of two years (2017-2018). 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 --