Natural Image Skin Center

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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for Mycology tests from January 2025 to 8/5/25. The TP confirmed on 8/6/25 at 1:40 pm the laboratory was not enrolled in PT for Mycology. 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 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 interview with the Laboratory Manager (LM) and 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. 45:9-42.28. License; necessity; categories, the laboratory failed to obtain a NJCLL to perform Mycology testing from 9/1/22 to 2/21/24. The findings include: 1. The laboratory was performing Potassium Hydroxide (KOH) for fungal elements from 9/1/22 to 2/21/24. 2. The laboratory failed to obtain a NJCLL to perform Mycology testing. 3. The laboratory performed approximately 75 KOH tests annually. 4. The LM confirmed on 2/21/24 at 2:15pm, the laboratory failed to obtain a NJCLL for perfoming Mycology tests. 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 --