Monica K Bedi Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Monica K Bedi PA on 9 /17/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, interview, and review safety data sheets (SDS), the laboratory failed to ensure protection from chemical hazards used for Histopathology testing of Hematoxylin and Eosin (H&E) stain from 06/28/24 to 9/17/26. Findings: 1. During a tour of the laboratory on 9/17/2026 at 10:55 AM, the fume hood in the laboratory to provide protection from respiratory chemical hazards was observed not used for H & E testing for Mohs staining. 2. The SDS sheets for Eosin Solution, Reagent Alcohol 100%, and Reagent Alcohol 95%, all included hazard statements regarding inhalation precautions. 3. The Laboratory Policy Manual last approved by the Laboratory Director 10/06/2025 included a document titled Safety Policy indicating the Laboratory Director would ensure that the laboratory is a safe working environment to include all hazards. 4. Histotech A stated on 9/17/2026 at 10:55 AM the hood in the laboratory was used for the staining of frozen H&E staining but not for the Mohs staining to ensure respiratory protection from chemical hazards used for H & E staining. 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 announced CLIA recertification survey was conducted at Monica K Bedi MD PA dba Dermatology Associates on 06/28/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems in the analytic systems for 11 of 12 months reviewed for 2023. Findings included: 1. Review of the Quality Assurance (QA) program approved by the Laboratory Director on 10/24/2023, showed Monthly QC [Quality Control] - This form should be completed at the end of each month and signed by the lab director..." 2. Review of the Monthly QC Worksheets for 2023 revealed 11 (January, February, March, April, May, June, July, September, October, November, and December) of the 12 months were signed and dated by the Laboratory Director prior to the worksheets being filled out. There was no documentation of QC on the worksheets. 3. The Chief Administrative Office confirmed on 6/28/2024 at 10:50 AM the laboratory had not followed the written QA policy for 11 of 12 months in 2023. 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 --