Manhattan Dermatology Pllc

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 lack of proficiency testing (PT) records and interviews with the Laboratory Director (LD) and Testing Personnel (TP), the laboratory failed to successfully enroll and participate in a histopathology specialty PT program for 2022 and 2023. FINDINGS: 1. There was no documentation of histopathology twice year verification performance for 2022 and 2023. 2. The LD and TP confirmed the findings on March 31, 2025, at approximately 12:00 P.M. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on lack of PT documentation and confirmed by interview with the TP, the LD 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 -- failed to provide overall management and direction of the laboratory services. Refer to D2000. -- 2 of 2 --

Summary Statement of 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 review of the laboratory Competency Assessment policy & records and an interview with the laboratory director, the laboratory failed to follow their established Competency Assessment policy that included the six required competency components for the Moh's technician. FINDINGS: 1. The laboratory's Competency Assessment policy requires direct observation, record review and assessment of problem solving skills, based on the duties and responsibilities of the Moh's technician. 2. The Competency Assessment form used to perform the annual competency for the Moh's technician had a written statement signed by both the Moh's technician and laboratory director stating the date the review was performed in 2020 and 2021. 3. The laboratory director confirmed on Janaury 27, 2022 at approximately 2:00 PM that the failed to follow their established Competency Assessment policy. 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 --