Oleg Volchonok Md Pc

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 of the laboratory, lack of documentation, and interview with the office manager (OM), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 1 of 1 Fisher Brand Traceable thermometer/humidity monitor used for monitoring room temperature and humidity in the histopathology laboratory from 04/26/2023 to the day of the survey. Findings include: 1. On the day of the survey, 03/26/2025 at 10:15 am, observation of the laboratory revealed the following thermometer used for room temperature and humidity monitoring in the histopathology laboratory was due for maintenance: - 1 of 1 VWR Traceable Thermometer (S/N 200657483) due 10/2022. 2. The laboratory failed to provide maintenance/functions checks records for the Fisher Brand Traceable thermometer/humidity monitor from 04/26/2023 to 03/26/2025. 3. The laboratory performed 2400 histopathology examinations in 2024 (CMS 116, estimated annual volume). 4. The OM confirmed the findings above on 04/26/2025 at 10:25 am. 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 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 review of a sampling of 2017 and 2018 peer review records and interview with the Laboratory Director (LD), Office Consultant, and Office Manager, the laboratory failed to retain at least twice annually, verification accuracy of general histology slides read on site, which are not included in subpart I for 2017. Findings include: 1. The Laboratories Quality Assurance/ Peer Review Procedure, Subheading B. states, "A 2% of randomly selected slides will be sent for peer review every six months". 2. On the date of survey, 08/15/2018, a sampling of six pathology reviews sent out in 2017 and six in 2018, revealed that all cases sent for review stated, "Date Reviewed: 07/24/2018." 3. The laboratory could not provided documentation to prove 2017 (6 of 6) slides were sent out for pathology review in 2017. 4. The LD and Office Consultant confirmed the findings above on 08/15/2018 around 9:30 am. 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 --