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 Directly the Results of Certain Laboratory Tests June 2023
- 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"
Regulations - Title 10, NYCRR
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
Communicable Diseases Reporting Guidelines 2020
- Guidelines for New York City
- Guidelines for New York State
- Letter to laboratory directors highlighting major changes
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