Human Blood Sample Collection for Research Purposes

'Phlebotomy', the collecting of blood from humans by venipuncture is regulated in Ontario as a 'controlled act' under the Regulated Health Professions Act. As a controlled act, phlebotomy may only be performed by members of a regulated health profession whose governing legislation authorizes them to practice phlebotomy (including a physician or registered nurse; a medical lab technologist when the procedure is ordered by a physician or dentist) or by a person to whom authorization has been delegated by such a member as outlined in the Interprofessional Guide of the Use of Orders, Directives and Delegation for Regulated Health Professionals in Ontario.

An exemption to this requirement is under the Laboratory and Specimen Collection Centre Licensing Act, which allows an employee in a laboratory or specimen collection centre that is licensed under that act to collect blood without a physician or dentist’s authorization. This exemption does NOT apply to the University’s facilities.

There are generally two options available to those who wish to collect blood as part of a research study.

1. Involve a physician with the study to perform the blood collection, or to authorize another trained individual to perform the blood collection
2. Contract out the blood collection to a licensed laboratory or specimen collection centre, in which case a physician’s authorization is NOT required

Any room used for blood collection must be separated from any active manipulation of infectious biological agents and active work with hazardous agents.

Blood that is collected in spaces outside of clinical care areas should be conducted in a room that is separated by a door from bench space, biological safety cabinets or other laboratory equipment that is used to handle or store biological or infectious agents.

The room must have a handwashing sink, and all surfaces and interior coatings, including, but not limited to, floors, walls, doors, frames, casework and benchtops must be cleanable, non-absorbent, and resistant to repeated decontamination.

Phlebotomy chairs and other furniture must be made of a material that can easily be disinfected and cleaned.