On February 1, 2022, the Ontario Ministry of Health announced a new regulation (Reg.) 45/22 - General, made under the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA). The new regulation will regulate the licensing and operations of “laboratory facilities”. O. Reg 45/22 revokes and replaces Reg. 682, (laboratories), and Reg. 683, (specimen collection centres) (SCC). The new regulation comes into effect on July 1, 2022, except for the reporting requirement related to the Ontario Laboratories Information System (OLIS), which will come into effect on January 1, 2023.

The key changes to the new regulation include:

• Reducing the sector’s burdens by making it easier to apply for a laboratory facility license, simplifying the licensing fee structure from 18 to 6 categories of licensing fees and streamlining licensing processes for administrative efficiency. 
• Permitting laboratory facilities to advertise their services, but prohibiting any false, misleading, or deceptive advertisements, to ensure patient safety and consumer protection.
• Strengthening administration and enforcement of the LSCCLA by enabling the collection, use, and disclosure of personal information. 
• Ensuring public health and safety by granting the Director of Laboratory and Specimen Collection Centre Licensing the power to suspend a license, on an emergency basis.
• Addressing the changing labour needs of the sector and reducing administrative burden by updating the qualifications for laboratory personnel to ensure laboratories are appropriately staffed.  

IQMH has been invited and will participate in a focus group geared at improving the Laboratory Inspection and Licensing Information (LILI) system and its supporting processes to align with O. Reg 45/22 (LSCCLA), and the amendments to the LSCCLA that will come into effect on July 1, 2022. 

O. Reg. 45/22: GENERAL can be viewed here: https://www.ontario.ca/laws/regulation/r22045