Nj Cd Dba Dedicated Dermatology

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's Mohs procedure manual, quality control (QC) log and interview with the Regional Supervisor (RS), the laboratory failed to establish and document the laboratory's criteria for intended reactivity (493.1273(a)) to ensure acceptable staining characteristics of Hematoxylin & Eosin (H&E) stains used for histopathology examinations performed from 11/12/2024 to the date of survey. Refer to D5601 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 procedure review, lack of documentation and interview with the Regional Supervisor (RS), the laboratory failed to follow the established competency assessment (CA) procedure to assess the competency of 1 of 2 Technical Supervisors (TS), and 1 of 2 General Supervisor (GS) for their supervisory responsibilities and 5 of 6 Testing personnel (TP) who performed histology examinations from 11/12/2024 to 06/18/2026. Findings Include: 1. On the day of survey, 06/18/2026 at 10:30 am, 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 -- review of the SOP Manual stated, "23. Personnel Training and Competency - Initial training documented-Competency assessed at 6 months, 12 months, then annually - Rececords maintained - Competency includes: Directo observation of testing-Review of QC documentation-Blind slide review- Documentation of results. Competency is assessed and documented by the LD or qualified designee. 2. On the day of survey, 06 /18/2026 at 10:30 am, the laboratory failed to provide CA records for 1 of 2 TS and 1 of 2 GS (CMS 209 TS/GS #2, dated 6/16/2026) for their supervisory responsibilities performed from 11/12/2024 to 06/18/2026. 3. The laboratory failed to provide CA records for 5 of 6 TP (CMS 209, TP #2, 3, 4, 5, and 6) that performed macroscopic histopathology (grossing and inking) examinations from 11/12/024 to 06/18/2026. 4. The laboratory performed 160 Mohs examinations in 2025 (CMS 116 estimated annual volume, dated 06/16/2026). 5. The RS confirmed the findings above on 06/18 /2026 at 10:45 am. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on observation of the laboratory, lack of documentation, and interview with the Regional Supervisor (RS), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 1 of 1 timer used for staining histopathology slides in the laboratory from 11/12/2024 to the day of the survey. Findings include: 1. On the day of the survey, 06/18/2026 at 10:00 am, observation of the laboratory revealed the following timer used to aid in the staining of histopathology slides was past due for calibration: - McKesson Timer S/N 51631, due 09/19/2025 2. The laboratory failed to provide maintenance/functions checks records for 1 of 1 McKesson timer from 9/19/2025 to 06/18/2026. 3. The laboratory performed 160 Mohs histopathology slide examinations in 2025 (CMS 116, estimated annual volume, dated 06/16/2026). 4. The RS confirmed the above findings on 06/18 /2026 at 10:10 am. B. Based on review of maintenance logs, lack of documentation, and interview with the Regional Supervisor (RS), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 1 of 1 Avantix QS12 cryostat used for histopathology slides in the laboratory from 11/12 /2024 to the day of the survey. Findings include: 1. On the day of the survey, 06/18 /2026 at 9:30 am, the laboratory failed to provided the maintenance logs for 1 of 1 Avantix QS12 cryostat for the following months: - 2024-December - 2025-June, October, November, December - 2026-Janurary, February 2. The laboratory performed 160 Mohs histopathology slide examinations in 2025 (CMS 116, estimated annual volume, dated 06/16/2026). 3. The RS confirmed the above findings on 06/18 /2026 at 10:10 am. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's Mohs procedure manual, quality control (QC) log and interview with the Regional Supervisor (RS), the laboratory failed to establish and document the laboratory's criteria for intended reactivity to ensure acceptable staining characteristics of Hematoxylin & Eosin (H&E) stains used for histopathology examinations performed for 2 of 2 years from 11/12/2024 to the date of survey. Findings include: 1.The laboratory's "Mohs CLIA Laboratory Standard Operating Procedure Manual states, "12. Quality Control (QC) Daily stain control slide performed and reviewed. Qc result documented as Acceptable -Unacceptable. If QC fails: 1. Testing is halted; 2. Root cause identified (reagent, equipment, technique); 3.

Summary Statement of Deficiencies 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 lack of documentation and interview with the medical assistant (MA), the laboratory failed to verify twice annually the accuracy of macroscopic histopathology examinations performed from 11/08/2022 through the date of the survey. Findings include: 1. On the day of survey, 11/12/2024, the laboratory could not provide documentation of the twice annual verification of accuracy for macroscopic histopathology examinations (grossing and inking) performed from 11/08/2022 to 11 /12/2024. 2. The laboratory could not provide a procedure for the verification of accuracy for macroscopic histopathology examinations (grossing and inking). 3. The MA confirmed the findings above on 11/12/2024 at 10:45 a.m. 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 review of the laboratory's Mohs procedure manual, quality control (QC) log 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 -- and interview with the medical assistant (MA), the laboratory failed to establish and document the laboratory's criteria for intended reactivity to ensure acceptable staining characteristics of Hematoxylin & Eosin (H&E) stains used for histopathology examinations performed from 11/08/2022 to the date of survey. Findings include: 1. The laboratory's "Mohs procedures" (SOP S-1) states, "If the control slide is unacceptable, the MOHS tech will make any necessary adjustments and stain another H&E control slide and continue with the process until the surgeon deems the control acceptable." 2. On the day of survey, 11/12/2024, a review of the laboratory's "QC Mohs staining logs" revealed the laboratory failed to establish and document the laboratory's criteria for intended reactivity to ensure acceptable H&E staining characteristics when Histopathology slides were examined from 11/08/22 to 11/12/24. 3. The laboratory performed an annual volume of 150 histopathology examinations in 2023. (CMS 116) 4. The MA confirmed the findings above on 11/12/24 at 10:45 am. -- 2 of 2 --

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on, the review of Laboratory Procedures and interview with Testing Personnel (TP) #2, the laboratory failed to ensure that quality assessment programs are maintained and documented to assure the quality of laboratory from 2017 to the date of survey. Findings: 1. On the day of survey, 06/05/2018, the laboratory provided a Quality Assurance Procedures, that was implemented in February of 2018. 2. The laboratory could not provide a Quality Assurance Procedure, signed by the Director before February 2018. From January 2017 to February 2018 (13 months) a Quality Assurance Procedures was not available on site. 3. TP#2 confirmed the findings above, on 06/05/2018 around 10:15 am. 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 --