Main Body
Regulatory Affairs - Statute and Regulations
Blood and Tissue Banks Statute and Regulations
Statute
- Article 5, Title V Clinical Laboratory and Blood Banking Services (PDF 41K)
- Article 31 Human Blood and Transfusion Services
- Article 43B Organ, Tissue and Body Parts
Regulations
- Subpart 58-2 Blood Banks
- Index for Subpart 58-2 Blood Banks
- Subpart 58-5 Hematopoietic Progenitor Cell Banks
- Part 52 Tissue Banks and Nontransplant Anatomic Banks (PDF 240K)
Clinical Laboratory Statute and Regulations
Statute
Regulations
- Part 19, Clinical Laboratory Directors - Title 10, NYCRR
- Part 58, Clinical Laboratories And Blood Banks - Title 10, NYCRR
- Subpart 58-1 Clinical Laboratories (PDF 71K)
- Subpart 58-3 Inspection and Reference Fees - Title 10, NYCRR
- Subpart 58-8 Human Immunodeficiency Virus (HIV) Testing - Title 10, NYCRR
Standards
Guidance
Genetic Testing
Statute
- Confidentiality of Genetic Testing (PDF 81K)
HIV Testing
Statute
- Article 27F HIV and AIDS Related Information (PDF 104K)
Regulations
Laboratory Business Practices
Statute
- Title II-D Health Care Practitioner Referrals (PDF 81K)
- Article 5, Title VI Laboratory Business Practices
Regulations
- Subpart 34-1 Health Care Practitioner Referrals (PDF 23K)
- Subpart 34-2 Laboratory Business Practices (PDF 32K)
Guidelines
- Prohibited Items Under Subpart 34-2 (PDF 58K)
Public Health Reporting Requirements
Statute
- Title I Communicable Diseases (PDF 10K)
Regulations
- 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 (PDF 59K)
Guidelines
Environmental Laboratory Statute and Regulations
Statute
Regulations
- Subpart 55-2 Approval of Laboratories Performing Environmental Analysis (PDF 72K)
- Subpart 55-3 Environmental Laboratory Approval Fee
Regulated Medical Waste
Statute
Regulations
- Part 70 Regulated Medical Waste (PDF 96K)
Use of Living Animals
Statute
- Article 5, Title I General Provisions: State Laboratories; Approved Laboratories Regulation (PDF 56K)
Regulations