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Regulatory Affairs - Statutes and Regulations

Blood and Tissue Banks Statutes and Regulations

Statutes - Public Health Law
Article 5, Title V: Clinical Laboratory and Blood Banking Services PDF  
Article 31: Human Blood and Transfusion Services PDF HTM
Article 43-B: Organ, Tissue and Body Parts PDF HTM

Regulations - Title 10, NYCRR
Subpart 58-2: Blood Banks PDF HTM
Subpart 58-5: Hematopoietic Progenitor Cell Banks PDF  
Part 52: Tissue Banks and Nontransplant Anatomic Banks PDF  

Guidance
Index for Subpart 58-2: Blood Banks PDF  


Clinical Laboratory Statute and Regulations

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

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

On-Site Survey Standards
Clinical Laboratory Standards of Practice   HTM

Guidance
Persons authorized to order tests and receive results PDF  
Electronic Health Records and Access to Laboratory Results FAQ PDF  
Update 2/19/14 - Electronic Health Records and Access to Laboratory Results FAQ PDF  


Genetic Testing

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


HIV Testing

Statute - Public Health Law
Article 27-F: HIV and AIDS Related Information - Effective 09/01/2010 PDF  
Document showing specific changes to HIV law   HTM

Regulation
Part 63: AIDS/HIV Testing, Reporting and Confidentiality   HTM


Laboratory Business Practices

Statute - Public Health Law
Article 2, Title II-D: Health Care Practitioner Referrals PDF  
Article 5, Title VI: Laboratory Business Practices PDF HTM

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

Guidelines
Prohibited Items Under Subpart 34-2 PDF  
Authorized Ordering Source FAQ PDF  


Public Health Reporting Requirements

Statute - Public Health Law
Title I: Communicable Diseases PDF  

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

Guidelines
Communicable Disease Reporting Guidelines 2010 PDF  


Environmental Laboratory Statute and Regulations

Statute - Public Health Law
Article V, Title I: Environmental Laboratories PDF HTM

Regulations - Title 10, NYCRR
Subpart 55-2: Laboratories Performing Environmental Analysis PDF  
Subpart 55-3: Environmental Laboratory Approval Fee PDF HTM


Regulated Medical Waste

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

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


Use of Living Animals

Statute - Public Health Law
Article 5, Title I: Laboratories; Scientific Tests on Living Animals PDF  

Regulation - Title 10, NYCRR
Subpart 55-1: Use of Living Animals in Laboratories PDF  


Vehicle and Traffic Alcohol Testing

Regulation - Title 10, NYCRR
Part 59: Chemical Analysis of Blood, Urine, Breath or Saliva for Alcohol PDF  


Archive

Regulations   HTM