Regulation Number(s):
682
683
Instrument Type:
Regulation - LGIC
Bill or Act:
Laboratory and Specimen Collection Centre Licensing Act
Summary of Proposal:
The regulatory framework for the lab sector has not been significantly updated since the 1990s. Certain provisions in Reg. 682 (Laboratories) and Reg. 683 (Specimen Collection Centres) under the LSCCLA have not kept up with the pace of change in the lab sector, and would therefore benefit from regulatory modernization.

The ministry has made progress outside the regulatory framework in improving lab licensing processes by streamlining administrative and operational aspects for applicants and lab licence holders.

To modernize the regulatory framework, the ministry is proposing the following:

Seek approval to proclaim amendments to the LSCCLA, made under the Protecting Patients Act, (PPA) 2017 (Schedule 3), into force.

Seek approval to revoke Reg. 682 and Reg. 683 and replace them with a new consolidated regulation to support the proclamation of amendments made to the LSCCLA. The proposed new regulation would include provisions that apply to both labs and specimen collection centres. It would modernize the lab licensing framework in Ontario by streamlining regulatory requirements, while maintaining public protection, reducing administrative burden for licensed labs and licensed specimen collection centres, and ensuring alignment with health system priorities.

For example:
-Introducing and implementing the concept of a 'laboratory facility' (a term that applies to either a lab or a specimen collection centre).
-Revising licensing fees for laboratory facilities.
-Exempting certain health care providers from the requirement to obtain a licence for specimen collection to maintain historical exemptions in the LSCCLA that would be removed if the PPA, 2017 amendments are proclaimed into force.
-Regulating the advertising and promotion of laboratory facilities.
-Updating the role and qualifications for laboratory facility personnel to reflect current needs.
-Updating conflict of interest rules for a laboratory facility to improve compliance.
-Supporting implementation of the fecal immunochemical test in the Colon Cancer Check program.
-Requiring a laboratory facility to report all lab test results to the Ontario Laboratories Information System.
-Ensuring alignment with how lab tests are ordered under the Mandatory Blood Testing Act, 2006.
-Removing duplication in existing regulations and simplifying the language for ease of interpretation; undertaking short and long-term system improvements that support the ministry's quality, safety and oversight goals.

Operational changes that support the proposed regulation described above, including simplifying operational processes by consolidating administrative functions (e.g.: invoicing, licensing, and renewals) for organizations that own or operate multiple laboratory facilities.
Analysis of Regulatory Impact:
The regulatory proposal would reduce existing administrative burdens for regulatory compliance and streamline licensing fees. There will be a one-time upfront or administrative cost related to learning about the regulatory changes. The ministry will be undergoing further stakeholder engagement in Summer 2021 to inform its approach to the new fee structure and will update once internal approvals are received on the proposed new set of fees. Regarding direct compliance costs, the ministry will have further information about a final fee structure after consultations are completed.
Further Information:
Proposal Number:
21-HLTC017
Posting Date:
September 1, 2021
Comments Due Date:
October 16, 2021
Contact Address:
438 University Avenue
4th Floor
Toronto, Ontario
M5G 2K8