Northeast Dermatology Associates, Pllc

Summary Statement of Deficiencies D0000 A CLIA recertifiaction survey was conducted on April 09, 2025 for the Northeast Dermatology Assocaites, PLLC laboratory pursuant to the Clinical Laboratory Improvement Act (CLIA) of 1988 and CLIA regulations at 42 CFR CFR 493. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on record review and interview with the Histotech (HT) the Laboratory Director (LD) failed to attest that Proficiency Testing (PT) samples are routinely integrated into the laboratory workload. Findings include: 1. Review of American Proficiency Institute (API) results for 2023, 2024 and 2025 to date on 04/09/2025 revealed attestation sheet was not signed by the LD for the 2025 Microbiology module Event 1 (KOH). 2. Staff interview with the HT on 04/09/2025 at 10:30 AM confirmed the above PT attestation sheet was not signed by the LD. 3. The laboratory performs 5 KOH tests annually. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) review and interview with Histotech (HT) and 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 -- Practice Manager (PM) on 4/09/2024, the laboratory failed to document and maintain a copy of all PT records as evidenced by the following: 1. The surveyors reviewed the American Proficiency Institute (API) PT records for calendar years 2023, 2024 and 2025 to date. The review revealed: 1. The coding report was not available for a. API Chemistry 2023 (Urinary Human Chorionic Gonadotropin - UHCG) Event 3 b. API Chemistry 2024 (UHCG) Events 1, 2 and 3 c. API Microbiology (KOH) 2025 Event 1. 2. The final reports were not present and not signed by the Laboratory Director for API Chemistry Module for 2024 Events 1, Event 2 and Event 3. 2. TP1 and TP2 confirmed in an interview on 4/9/2025 at 11:00 AM that the coding reports and final result reports were not present or reviewed and signed by the laboratory director /designee. 3. The labratory performs 342 UHCG tests and 5 KOH tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Northeast Dermatology Associates, PLLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 a control slide of known reactivity with each patient slide or group of patient slides when differential or special staining was performed as evidenced by the following: Surveyors reviewed Mohs histopathology quality control (QC) records for calendar years 2017 and 2018. The review revealed that the laboraory failed to document the hematoxilyn and eosin (H&E) stain QC on five (5) days of testing, 10/10/17, 10/16 /17, 10/17/17, 10/23/17, and 10/24/17. The histopathology technician confirmed in an interview on 2/8/19 at 10:20 AM that the H&E stain QC was not documented for five (5) days in 2017. Twenty-seven (27) Mohs surgeries were performed between 10/10 /17 and 10/24/17. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 -- either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to indicate on the test report the name of the laboratory where the test was performed as evidenced by the following: Surveyors reviewed eight (8) Mohs test reports between 3/21/17 and 11/20 /18. The review revealed the name of the laboratory on the test reports was NEDA - North Andover- Turnpike. The laboratory's name is Northeast Dermatology Associates, PLLC. The training manager confirmed on 2/8/19 at 12:15 PM that the test report did not indicate the name of the laboratory where the test was performed. -- 2 of 2 --