You are here

Laws & Regulations

Clinical Laboratory Statute and Regulations

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

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

Article 31: Human Blood and Transfusion Services  

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

Regulations - Title 10, NYCRR
Part 19: Clinical Laboratory Directors           
Part 58: Clinical Laboratories and Blood Banks        
Subpart 58-1: Clinical Laboratories   
Subpart 58-2: Blood Banks
Subpart 58-3: Inspection and Reference Fees           
Subpart 58-8: Human Immunodeficiency Virus Testing        

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, 58-1.9, 58-8.4 and 34-2.11

Persons authorized to order tests and receive results September 14, 2011 
Electronic health records and access to laboratory testing results: Ensuring compliance with 10 NYCRR 58-1.8 FAQ January 17, 2014
Electronic health records and access to laboratory testing results: Ensuring compliance with 10 NYCRR 58-1.8 FAQ February 19, 2014    

Genetic Testing

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

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

Amendments to HIV Law            

Regulations - Title 10, NYCRR
Part 63: AIDS/HIV Testing, Reporting and Confidentiality              

Laboratory Business Practices

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

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

Article 5, Title VI: Laboratory Business Practices       

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

Regulations - Title 10, NYCRR
Subpart 34-1: Health Care Practitioner Referrals    
Subpart 34-2: Laboratory Business Practices 

Prohibited Items Under Subpart 34-2

Public Health Reporting Requirements

Statute - Public Health Law Title I: Communicable Diseases        

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

Regulations - Title 10, NYCRR
Part 2: Communicable Disease Reporting    
Part 22: Environmental Diseases - Reporting of Pesticide Poisoning       
Part 63: AIDS/HIV Testing, Reporting and Confidentiality          
Subpart 67-3: Reporting of Blood Lead Levels         

Guidelines
Communicable Disease Reporting Guidelines 2016
2016 Changes in Reporting Communicable Diseases

Regulated Medical Waste

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

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

Regulation - Title 10, NYCRR
Part 70: Regulated Medical Waste