Bradley P Grant Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Bradley P Grant on June 11, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on interview and review of chemical and surgical case logs, the laboratory failed to use non-expired reagents in their Hematoxylin and Eosin stain for staining patient's histopathology slides from 04/04/2023 to 04/11/2023 and 06/04/2024 to 06/18 /2024. Findings: 1. Review of the Chemical Expiration Dates log for April 2023 listed the Clarifier lot #104693 expired on 3/2023, and Clarifier lot #125131 expired on 11 /2024 and was opened on 06/19/2024. 2. Review of the Mohs Surgical Case Log revealed there were seven surgical procedures on 04/04/2023, and seven surgical procedures on 04/11/2023. 3. Review of the Chemical Expiration Dates log for June 2024 listed the Clear-Rite lot #2015108 expired on 06/02/2024, and Clear-Rite Lot #2412323 expiring on 05/06/2028 was opened on 06/19/2024. 4. Review of the Mohs Surgical Case Log revealed there were seven surgical procedures on 06/04/2024, seven surgical procedures on 06/11/2024, and seven surgical procedures on 06/18 /2024. 5. During an interview on 06/11/2025 at 11:45 AM, the Mohs Technician confirmed the Clear-Rite and Clarify were on back order and expired reagents were used. 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 A recertification survey was conducted on January 19, 2021. Bradley P Grant MD PA 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 Hematoxylin and Eosin (H&E) stain at least twice annually in 2019. Findings: The laboratory used peer review to verify the accuracy of the reading and interpretation H&E stains. Review of the laboratory's records showed that peer review for the Laboratory Director was only done once during 2019, on 2/11/19. During an interview on 1/19/21 at 2:41 PM, the Mohs Technician acknowledged that peer review was performed only once during 2019. 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, the laboratory failed to record the humidity of the room where testing was performed from 2/12/17 to 2/12/19. Findings: The manual for the Leica CM1510S cryostat noted that the relative humidity of the laboratory should be a "relative humidity max. 60%." A review of the laboratory's logs showed that the laboratory failed to record the humidity of the room where testing was performed On 2/12/19 at 2:25 PM, Histotechnologist/Mohs Technician acknowledged 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 --