Bellmore Dermatology Pllc

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Standard Operating Procedures (SOPs), lack of Quality Assessment (QA) policies, as well as interview with the Office Manager (OM), the laboratory failed to establish written policies for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory system. FINDINGS: 1. There was no documentation of annual QA performance and review from 2023 through the survey date. 2. The current, approved SOPs did not include instructions for performing an ongoing review process that encompasses all facets of the laboratory's technical and non-technical functions and all locations/sites where on-site laboratory testing was performed. 3. The OM confirmed the findings on August 12, 2025, at approximately 11:30 A.M. Repeated deficiency from February 9, 2023. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and 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: 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 -- Based on review of SOPs, lack of QA policies, as well as interview with the OM, the Laboratory Director (LD) failed to draft, approve QA programs to assure the quality of laboratory services provided and to identify failures in quality as they occur. FINDINGS: 1. The current, approved SOPs did not include QA policies for performing and documenting such activity. 2. The OM confirmed the findings on August 12, 2025, at approximately 11:30 A.M. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of the Quality Assessment (QA) policy, the laboratory failed to establish the written policy for monitoring pre-analytic, analytic, and post-analytic systems in the laboratory. Finding: 1. Annual QA review was not performed from 2020 through the survey date. 2. Confirmed above finding on an interview with office manager on 2/9/2023 approximately 11:00A.M. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of the laboratory's Quality Assessment (QA) procedure, the laboratory failed to establish written QA for all phases for the general laboratory system. Refer D5291. 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 --