Indian River Pathology Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on May 10, 2021. Indian River Pathology LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the accuracy of the reading and interpretation of the Methylene Blue stain at least twice annually in 2020. Findings: The laboratory used peer review to verify the accuracy of the reading and interpretation of Methylene Blue stain. Review of the laboratory's records showed peer review for the Laboratory Director was not performed in 2020. During an interview on 5/10/21 at 2:05 PM, Testing Personnel B stated peer review for 2020 was performed in 2021. 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 D0000 An initial certification survey was conducted on November 6, 2019. Indian River Pathology LLC clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to record the humidity of the room where testing was performed from 11/6/17 to 11/6/19. Findings: Review of the operations manual for the laboratory's Avantik cryostat noted that the maximum relative humidity should be 60%. A review of the laboratory's logs showed that the laboratory failed to record the humidity of the room where testing was performed. During an interview on 11/6/19 at 3:09 PM, the Histology Technician stated that they did not record the humidity of 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 1 --