Eli Cohen Md Pa

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on observation, review of the laboratory procedure manual, review of safety data sheets (SDS), and interview, the laboratory failed to ensure protection from chemical hazards used in their Hematoxylin and Eosin (H&E) stain from 03/30/2026 to 04/16/2026. (See D3011) 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 Eli Cohen MD PA on February 24, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5400 493.1250 Condition: Analytic Systems D6076 493.1441 Condition: Laboratory Director 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, review of the laboratory procedure manual, and safety data sheets (SDS), the laboratory failed to ensure protection from chemical hazards used in their Vacuum Infiltration Processor (VIP) and Hematoxylin and Eosin (H&E) stain from 01/17/2024 to 02/24/2026. Findings Included: A1. During a tour of the laboratory on 02/24/2026 at 9:44 AM, two containers used to store the chemical waste used in their H&E stain and in the VIP was seen on the floor of the laboratory. A2. Review of the VIP 3000 Tissue Processor log noted the laboratory used the following chemicals in their VIP:10% Buffered Neutral Formalin, 75% Alcohol, 95% Alcohol 100% Alcohol, and Xylene Substitute. A3. Review of the H&E Stain Line log noted the laboratory used the following chemicals in their H&E stain: Xylene Substitute, 100% Alcohol, 95% Alcohol, Hematoxylin, Bluing reagent, and Eosin A4. Review of the SDS for 10% Neutral Buffered Formalin, XS-3, Xylene Substitute, and Avantik Eosin Working Solution showed the symbol for flammable reagents. A5. Review of the SDS for 10% Neutral Buffered Formalin noted "Store locked up." A6. Review of the SDS for Stat Lab XS-3, Xylene Substitute noted, "Keep in fireproof place." A7. Review of the SDS for Avantik Eosin Working Solution noted, "Store locked up." A8. During an interview on 02/24/2026 at 9:40 AM, the Mohs Technician Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- A acknowledged the chemical waste had been stored on the floor of the laboratory. B1. During a tour of the laboratory on 02/24/2026 at 10:00 AM, no fume hood was observed in the laboratory and the Mohs Technician B was not wearing a respirator. B2. Review of the H&E Flow Chart for Mohs surgical procedures noted the laboratory used the following chemicals in their H&E stain: 100% Reagent Alcohol, Hematoxylin, Bluing reagent, Eosin and Histo-Clear. B3. Review of the SDS for Stat Lab 100% Reagent Alcohol noted, "Do not breathe mist, spray, vapors, gas" and "Use NIOSH (National Institute for Occupational Safety and Health) approved full phase negative pressure respirator equipped with approved cartridges or canisters within the use limitations of the device." B4, Review of the SDS for Avantik Harris Hematoxylin noted, "If ventilation hood not available wear respirator." B5. Review of the SDS for Stat Lab Bluing reagent noted, "Use NIOSH-approved air-purifying or supplied air respirator where airborne concentrations of vapor or mist are expected to exceed exposure limits." B6. Review of the SDS for Avantik Eosin Working Solution noted, "Do not breathe mist, vapors spray" and "Where exposure through inhalation may occur from use, respiratory protection equipment is recommended." B7. Review of the SDS for 100% Reagent Alcohol, Hematoxylin, Bluing reagent, and Eosin showed the symbol for respiratory health hazard. B8. During an interview on 02/24/2026 at 3:35 PM, the Mohs Technician A acknowledged there was no fume hood in the Mohs laboratory. C1. Review of the H&E Flow Chart for Mohs surgical procedures noted the laboratory used the following chemicals in their H&E stain: 100% Reagent Alcohol, Hematoxylin, Bluing reagent, Eosin and Histo-Clear. C2. Review of the SDS for Stat Lab 100% Alcohol and Stat Lab Vintage Bluing noted, "Disposal of waste material in accordance with all local, regional, national, provincial, territorial, and international regulations" and "Avoid release to the environment. This material is hazardous to aquatic environments. Keep out of sewers and waterways." C3. Review of the SDS for Avantik Harris Hematoxylin noted, "Do not dispose of in drains, check with local waste authorities." C4. Review of the SDS for Stat Lab Vintage Bluing noted, "Disposal of waste material in accordance with all local, regional, national, provincial, territorial, and international regulations." C5. Review of the SDS for Avantik Eosin Working Solution noted, "Disposal in safe manner in accordance with local/national regulations. Disposal of contents/container to comply with local, state, and federal regulations" and "Avoid release to the environment." C6. Review of the SDS for Avantik Histo-Clear noted, "This material and its container must be disposed of as hazardous waste. Avoid release to the environment" and "Observe all national state and local regulations regarding disposal." C7. In accordance with Rule 62-730, Florida Administrative Code Hematoxylin & Eosin (H&E) stain reagents, which often contain hazardous chemicals like Xylene, Alcohols, and Formalin, must be managed as hazardous waste in accordance with Rule 62-730, Florida Administrative Code. Dumping these reagents down the drain, on the ground, or in regular trash is prohibited; they must be collected in properly labeled, sealed containers and disposed of by a licensed hazardous waste transporter. C8. During an interview on 02/24/2026 at 3:25 PM, the Mohs Technician A stated Mohs Technician B dumped the H&E reagent used for the staining of the slides for the Mohs surgical procedures down the sink drain. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the -- 2 of 6 -- overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to label 14 reagent bottles with preparation and expiration dates for reagents used on the Tissue- Tek Vacuum Infiltration Processor (VIP) instrument. (See D5415) D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to label 14 reagent bottles with preparation and expiration dates for reagents used on the Tissue- Tek Vacuum Infiltration Processor (VIP) instrument. This is a repeat deficiency from the recertification survey on 01/17/2024. Findings Included: 1. During a tour of the laboratory on 02/24/2026 at 9:44 AM, revealed the VIP instrument in the laboratory had 2 reagent bottles that were not labeled with preparation and expiration dates, 11 reagent bottles used were not labeled with expiration dates, and one reagent bottle had no label on it. 2. During a tour of the laboratory on 02/24/2026 at 9:48 AM, revealed the flammable cabinet did not contain any 75% Alcohol or 95% Alcohol. 3. Review of the procedure title Quality Control Program, signed and date by the Laboratory Director on 09/01/2025, noted "All reagents, solutions, culture media, control materials, calibration materials and other supplies will be labeled to indicate: 1. Identity and when significant titer, strength, or concentration. 2. Recommendation storage requirements 3. Preparation and expiration dates 4. Safety data 5. Other pertinent information." 4. Review of the labels on 13 bottles showed no dates were recorded for Date Changed and the Reagent Expiration listed only the year the reagent expired. Review of one bottle showed there was no label on the bottle. 5. Review of the VIP 3000 Tissue Processor log noted the laboratory used the following chemicals in their VIP:10% Buffered Neutral Formalin, 75% Alcohol, 95% Alcohol, 100% Alcohol, and Xylene Substitute. 6. Review of

Summary Statement of Deficiencies D0000 Recertification survey was conducted from 1/9/2024 to 1/17/2024. Eli Cohen Md PA clinical laboratory was not in compliance with 42 CFR Part 493, requirements for clinical laboratories. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on record review and interview with office manager and histotechnician, the laboratory failed to complete their twice annual Mohs (microscopically controlled) surgery verification for 2022 and 2023 and failed to have it reviewed by another qualified Mohs surgeon. Findings Included: Review of Proficiency and Consultation policy read," it is policy of the Mohs laboratory that Mohs surgeon sends 2 random cases to a qualified consultant for proficiency testing as required by CLIA. The Mohs surgeon may also seek consultation to make an accurate diagnosis in difficult cases. For proficiency testing the Mohs surgeon will select 2 random cases every 6 months." The policy did not include where specimen would be sent for secondary review, and which qualified professional would perform it. Review of 2022-2023 Proficiency Testing (PT) worksheets revealed the following: a. PT was performed on 9/22/22 and with no documentation of Mohs surgeon for case review. b. PT was performed on 12/1 /22 and with no documentation from the Mohs surgeon for case review. c. PT was performed on 6/30/23 and with no documentation of Mohs surgeon for case review. d. PT was performed on 12/15/23 and with no documentation from the Mohs surgeon for case review. On 1/9/2024 at 4:04 PM, the office manager and histotechnician confirmed laboratory failed to complete their twice annual Mohs (microscopically controlled) surgery verification for 2022 and 2023 and have it reviewed by another qualified Mohs surgeon. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to label 14 reagent bottles in use with preparation and expiration dates on Tissue-Tek VIP instrument. Findings Included: On 1/9/2024 at 12:40 PM Tissue-Tek VIP instrument in the laboratory had 14 reagent bottles that were not labeled with preparation and expiration dates. Review of Quality Control Program: Test methods, equipment, reagents materials and supplies read, "All reagents, solutions, culture media, control materials, calibration materials and other supplies will be labeled to indicate: 1. Identity and when significant titer, strength, or concentration. 2. Recommendation storage requirements 3. Preparation and expiration dates 4. Safety data 5. Other pertinent information." On 1/9/2024 at 4:04 PM, office manager and histotechnician confirmed laboratory failed to label 14 reagent bottles in use with preparation and expiration dates on Tissue-Tek VIP instrument. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview, The laboratory failed to document positive stain quality control for Periodic Acid Schiff (PAS) and Tissue biopsy Hematoxylin and eosin (H&E) testing in 2022 and 2023 for 3 of 5 patient records reviewed (#3, #4, and #5). Findings included: Review PAS Quality Control signed by Laboratory director on 8/23/23 read, "all PAS stains that are performed will have a known positive control slide stained when patient specimens are processed for the PAS Stain. The positive control slide will be screened by the reading physician prior to screening the patient slides. The doctor will then sign off on the PAS quality control form stating whether the stain is satisfactory or not." Review of Quality Control Policies signed by laboratory director on 8/23/23 read, "before any microscopic slides are reviewed, a control slide is cut and stained for evaluated for section thickness, section completeness and staining quality. This protocol applies to both paraffin embedded tissue as well as Mohs sections. The slides are reviewed by the physician and are signed off on the H&E quality control form." Review of 2022-2023 Histology Test requisition and Report log revealed no documentation of control slides and slide quality for PAS and H&E. Review of Patients' slides revealed the following: A. Patient #3 received H&E biopsy test on 12/30/2022 with no control slide. B. Patient -- 2 of 3 -- #4 received H&E biopsy test on 6/16/2023 with no control slide. C. Patient #5 received H&E biopsy and PAS test on 9/ 30/2022 with no control slide. Review of CMS-116 application for certification revealed 13,001 patients were tested for histopathology. On 1/9/2024 at 4:04 PM, office manager and histotechnician confirmed laboratory failed to document positive stain quality control for Periodic Acid Schiff (PAS) and Tissue biopsy Hematoxylin and eosin (H&E) testing for 2022 and 2023. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 9/10/21 at Eli Cohen Md Pa, a clinical laboratory in Delray Beach, Florida. Eli Cohen Md Pa is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the standard level deficiencies: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on competency record review and interview with consultant, the laboratory failed to perform competency assessments on one (#B) out of two Testing Personnel (#B and #D) for the two out of two years (2019-2021). The findings included: A review of the CMS 209 Laboratory Personnel Report revealed Staff #B and #D worked at the laboratory as Testing Personnel (TP). A review of personnel records from 2019 - 2021 revealed no competency evaluations were found for TP #B. Interview on 9/10/21 at 10:50 a.m., consultant stated he did not know that the dermatopathologist (TP #B) needed competency assessment and thought peer reviews were competency assessments. 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 --