Edward A Gross Md Pa D/B/A

Summary Statement of Deficiencies D0000 A recertification survey was conducted on November 20, 2024. EDWARD A GROSS MD D/B/A clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 record review and staff interview, the laboratory failed to stop using expired reagent. Findings included: 1-During the laboratory tour on 11/20/2024 at 8:45 AM the surveyor found in use one 4 oz bottle of Optic Mount 1 with Lot number 45034, this bottle had an expiration date of 01/31/2024. No other bottle of this reagent was found. 2-Review of the procedure manual signed by the Laboratory Director on 03/08 /20219 revealed that on section "Reagent Storage, Use and Handling" stated: "Do not use reagents after expiration." On 11/20/2024 at 9:30 AM, the office Nurse confirmed that the expired reagent was in use. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have documentation of the acceptability of the Quality Control (QC) slide for Hematoxylin & Eosin (H&E) stain for 1 out of 4 testing dates January 2024. Findings included: The laboratory uses the "HEMATOXYLIN & EOSIN STAINING QUALITY CONTROL WORKSHEET" to record the acceptability of the H&E stain. Review of the testing date column revealed that the laboratory recorded the evaluation of the QC slide for three testing dates In January: 01/04/2024, 01/11/2024 and 01/25/2024. Review of the QC slides for January 2024 revealed that the laboratory had QC slides for 01/04/2024, 01/11/2024, 01/18/2024 and 01/25/2024. During an interview on 11/20/2024 at 09:30 AM the office Nurse confirmed that the laboratory failed to document the acceptability of the Daily QC slide for H& E Stain for the day listed above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 03/23/2021 found that the EDWARD A GROSS MD PA D/B/A SOUTH FLORIDA SURGICAL DERMATOLOGY clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation, record review and testing personnel A (TP A) interview, the laboratory failed to use Eosin Y Stain Solution 1 % that was not expired for Hematoxylin and Eosin stains from 6/6/2020 to 3/23/2021. Findings Include: During laboratory tour on 03/23/2021 at 9:30 am, found in a fire safety cabinet was a 1 liter bottle with approximately 400 ml of Eosin Y Stain Solution 1 %, with lot number 1815019 that expired on 06/05/2020. Patient logs review revealed that the laboratory performed Hematoxylin and Eosin stains from 6/6/2020 to 3/23/2021 on 58 patients. During an interview on 03/23/2021 at 10:00 am, the TP A confirmed the laboratory had used expired Eosin Y Stain Solution for Hematoxylin and Eosin stains during 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 --

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 for 2 out of 2 years reviewed. Findings include: Review of the cryostat manual Leica CM1510S indicated a requirement for room temperature no more than 35 C and humidity not above 60 %. Quality control records of histopathology room revealed that: there was no documentation of the humidity and room temperature during 2017 and 2018. During an interview on 03/08/19 at 2:00 p.m., the laboratory director confirmed that there was no record of room temperature or humidity for the years 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 --