Russel S Glaun Md Pa

Summary Statement of Deficiencies D0000 A recertification survey was completed on 6/10/2022 at Russel S Glaun MD PA. The laboratory was not in compliance with 42 CFR Part 493, Requirements for 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 interview, the laboratory failed to perform peer review twice annually for Scabies testing in 2020 and 2021. Findings included: Review of Scabies proficiency testing log revealed no documentation of Scabies peer-review performed twice annually in 2020 and 2021. Review of Scabies log revealed 6 patients had been tested for scabies from 2020 to 2021. During an interview on 6/10 /2022 at 3:55 PM, the laboratory director and technologist confirmed that the laboratory failed to perform peer review twice annually for Scabies testing in 2020 and 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 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 with the laboratory director, the laboratory failed to document the room temperature and humidity from 2016 to 2018. Findings include: Review of the cryostat manual Leica CM1850 indicated a requirement for room temperature with a operational range of 18 C to 40 C and humidity lower than 60 %. Quality control records of laboratory room revealed that there is no documentation of the humidity neither room temperature done from 2016 to 2018 During an interview on 09/17/18 at 12:00 p.m., the laboratory director confirmed that there was no record of room temperature or humidity for the period of reference. 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 --