Published on New York State Department of Health, Wadsworth Center (https://wadsworth.org)

Clinical Laboratory Evaluation Program - Laws & Regulations

Clinical Laboratory Statute and Regulations

Statute - Public Health Law
Article 5, Title V: Clinical Laboratory and Blood Banking Services

  • Follow the link[1], click "PBH" from the list, click "Title 5" under "Article 5"

Article 31: Human Blood and Transfusion Services  

  • Follow the link[2], click "PBH" from the list, click "Article 31"

Regulations - Title 10, NYCRR

Patient Access of Laboratory Test Results 

Regulatory revisions were adopted effective December 23, 2015 to allow direct patient access to laboratory test results. The revised Sections of Title 10 of NYCRR are 58-1.8[9], 58-1.9[10], 58-8.4[11] and 34-2.11[12]

Genetic Testing

Statute - Civil Rights Law
Confidentiality of Genetic Testing, Section 79-L    

  • Follow the link[16], enter "79-L" in the search box, then click "79-L"

HIV Testing

Statute - Public Health Law
Article 27-F: HIV and AIDS Related Information - Effective 09/01/2010      

  • Follow the link[17], enter "27-F" in the search box, then click "27-F"     

Amendments to HIV Law[18]            

Regulations - Title 10, NYCRR

Laboratory Business Practices

Statute - Public Health Law
Article 2, Title II-D: Health Care Practitioner Referrals

  • Follow the link[20], click "PBH", click "Title II-D" under "Article 2"           

Article 5, Title VI: Laboratory Business Practices       

  • Follow the link[21], click "Title 6" under "Article 5"

Regulations - Title 10, NYCRR

Public Health Reporting Requirements

Statute - Public Health Law Title I: Communicable Diseases        

  • Follow the link[25], click "PBH", click "Title 1" under "Article 21", then click "2102" 

Regulations - Title 10, NYCRR

Communicable Diseases Reporting Guidelines 2020

Regulated Medical Waste

Statute - Public Health Law Article 13, Title XIII: Regulated Medical Waste        

  • Follow the link[33], click "PBH", click "Title 13" under "Article 13"

Regulation - Title 10, NYCRR