Ontario Laboratory Licensing: What the Laboratory and Specimen Collection Centre Licensing Act Requires for Specimen Handling

A specimen collection centre in Ontario is not licensed by its landlord, its accreditation body or the network it feeds. It holds a licence issued by the Director under the Laboratory and Specimen Collection Centre Licensing Act, and the conditions attached to that licence decide what the site may collect and where each specimen may go.

What does the Laboratory and Specimen Collection Centre Licensing Act license?

The Act covers two kinds of site. A laboratory performs tests on specimens taken from the human body, and a specimen collection centre is a place where specimens are taken or collected for examination elsewhere. Section 9 is the hinge: no person may establish, operate or maintain a laboratory facility except under a licence issued by the Director. That licence is scoped rather than general: the Director may issue it for one or more classes of tests or specimens, or for named tests within a class.

Which regulation sets the specimen rules today?

The regulation most older manuals quote, R.R.O. 1990, Reg. 683, was revoked on 1 July 2022; its content sits in O. Reg. 45/22: General, which is the instrument an inspector now reads alongside the Act.

Who may requisition a collection?

Section 17 of O. Reg. 45/22 is a closed list. No person employed at a specimen collection centre may take a specimen unless the requisition comes from one of the practitioners named in the regulation, which includes physicians, dentists, midwives, aboriginal midwives, extended class registered nurses, and naturopaths for the tests listed in Schedule 1. Public health orders under the Mandatory Blood Testing Act, 2006 are dealt with separately in the same section.

What records must a specimen collection centre keep?

Section 22(2) sets five fields: the name of each individual attending for a specimen, the specimens taken or scheduled to be taken, the name of the person who made the requisition, the date and time the specimen was submitted to a laboratory, and the name and address of that laboratory. The facility layer adds records covering employee duties and qualifications, services offered, service timelines, emergency procedures and any incident of injury or hazardous event.

What does an inspector actually look at?

Under section 16 of the Act an inspector may enter a licensed laboratory facility and its business premises without a warrant during regular business hours, examine and demand records, remove records for copying or testing, take photographs and question staff. Penalties under section 22 reach $25,000 for a first offence, per day the offence continues, and $50,000 for a subsequent offence or for a corporation.

What does that mean for the consumables on the bench?

Section 21 restricts where specimens may go: only to a laboratory licensed under the Act, or one run by an Ontario ministry. Because the record has to name that laboratory and the time of submission, the container carries part of the evidence. A 95 kPa rated transport bag keeps a leak from becoming a paperwork problem, a 3-wall specimen bag keeps the requisition and the specimen together without contact, and a graduated screw-cap specimen container keeps the collection volume readable at the bench where the label is written.

Ordering for a clinic, lab or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers. A laboratory running its own sterilization programme can start with a five-vial biological indicator trial before committing to case quantities.

References

1. Government of Ontario (e-Laws) — Laboratory and Specimen Collection Centre Licensing Act, R.S.O. 1990, c. L.1, current consolidation (checked 25 September 2026)
2. Government of Ontario (e-Laws) — O. Reg. 45/22: General, under the Laboratory and Specimen Collection Centre Licensing Act (checked 25 September 2026)

Related Reading

• Specimen Bag Labeling Requirements for Canadian Laboratories
• MDEL vs Provincial Laboratory Licence: What Buyers Must Verify
• Does TDG Apply to Specimen Collection in Canada?
• RCDSO-compliant sterilization records

Frequently Asked Questions

What does the Laboratory and Specimen Collection Centre Licensing Act require for specimen handling?

A site must hold a licence from the Director before it collects specimens, may collect only the classes of specimens named on that licence, must have a requisition from one of the practitioners listed in O. Reg. 45/22 before each collection, must keep a record of every specimen, and may send specimens only to a laboratory licensed under the Act.

Who may requisition a specimen collection in Ontario?

O. Reg. 45/22 section 17 lists Ontario and out of province physicians, Ontario and out of province dentists, midwives, aboriginal midwives, extended class registered nurses, naturopaths for the tests in Schedule 1, medical officers of health under the Mandatory Blood Testing Act, 2006, and the Consent and Capacity Board.

How long can an Ontario laboratory licence run?

A licence other than a provisional licence expires no later than five years from the date it is issued or renewed, and a provisional licence expires within 12 months, with one renewal of up to 12 months possible.

What records must a specimen collection centre keep?

Five fields: the name of each individual attending for a specimen, the specimens taken or scheduled, the name of the requisitioning practitioner, the date and time each specimen was submitted to the laboratory, and the name and address of that laboratory.

Last updated: September 2026. CliniEco Medical is a licensed medical device establishment (MDEL #35334).