Summary:
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 surveyor review of the laboratories New Jersey (NJ) State License, Proficiency Testing (PT) and interview with the General Supervisor (GS) the laboratory failed to be in compliance with NJ Administrative code N.J.A.C. 8:44-2.5 (b)3. for calendar years 2023 and 2024. The finding includes: 1. N.J.A.C. 8:44-2.5(b) 3. states Laboratories shall: iii. Maintain records of all proficiency testing results in surveys in which they participate and make such records, including results, interpretations and cumulative performance data routinely available to the Department of Health and Senior Services. 2. Review of the PT records for all PT events performed with the College of American Pathologists (CAP) in 2023 and 2024 revealed that the reports were only copied to Centers for Medicare and Medicaid Services (CMS) Department and not the NJ Department of Health and Senior Services. 3. The GS confirmed on 10/16/24 at 12:30 pm the laboratory failed to make PT performance data for Immunology, Chemistry and Hematology routinely available to the NJ Department of Health and Senior Services. 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 --