Bergen Dermatology Specialists

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the lack of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to enroll in an Health and Human Serivces (HHS) approved PT program for Gram Stain tests from 1/30/24 to 12/10/25. The finding includes. 1. The laboratory was not enrolled in an HHS approved PT program for Gram Stain tests. 2. The OM confirmed on 12/10/25 at 10:30 am, the laboratory was not enrolled in PT for Gram Stain. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 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 -- 45:9-42.28. License; necessity; categories, the laboratory failed to maintain a NJCLL for Bacteriology Gram Stain testing in the calendar year 2025 or any prior years. The Office Manager (OM) confirmed on 12/10/25 at 10:30 am that the laboratory did not maintain a NJCLL for Bacteriology Gram Stain testing in the calendar year 2025 or any prior years. -- 2 of 2 --

Summary Statement of Deficiencies 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 surveyor review of Quality Control (QC) records and interview with the Clinical Supervisor (CS), the testing personnel # 3 listed on CMS form 209 failed to check and document the Immunohistochemical Stains (IS) reactions from 6/7/17 to the date of the survey. The CS confirmed on 6/11/19 at 11:25 pm that IS reactions were not checked and documented. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require