South Nassau Dermatology

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 the standard operating procedures (SOPs) as well as interview with the Mohs Surgeon (MS), the laboratory failed to draft, approve, and implement Quality Assessment (QA) criteria for ongoing laboratory performance evaluation. FINDINGS: 1. The current, approved SOPs did not include instructions for performing such activity. 2. Confirmed findings by interview with the MS on April 9, 2024, at approximately 12:00 P.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: 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 the SOPs as well as interview with the Laboratory Director (LD), the LD failed to draft, approve, and implement QA instructions for all phases of the general laboratory system. Refer to D5291. -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the manufacturer's packet inserts for the BD Veritor Plus System for Covid-19 and interview with the laboratory director and the medical provider/testing person, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls with each new kit of BD Veritor opened. FINDINGS: 1. The laboratory is using the BD Veritor Plus System kit for Covid-19. The manufacturer of the BD Veritor requires that external positive and negative controls (provided in the kits) be performed with each new kit. 2. On December 30, 2020 at approximately 11:30 AM the medical provider/testing person confirmed surveyor's findings that documentation for the required external control testing was not available at survey from September 14, 2020 when testing was initiated up to survey date. 3. Approximately 40 patient specimens were tested and reported for covid-19 testing during the above time frames. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible 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 -- case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of records, interview with the medical provider/testing person and the laboratory director, the laboratory director failed to ensure that all positive and negative covid-19 results were reported to the New York State Department of Health via the Electronic Clinical Laboratory Reporting System (ECLRS). Findings: The laboratory has tested approximately 40 Covid-19 tests from September 14, 2020 when testing was initiated through the date of this survey. The Covid-19 results have not been reported to the New York State Department of Health as required. Note: As part of their response the laboratory must provide documentation that reporting to the Department of Health is either in process or completed. -- 2 of 2 --