Regulation - LGIC
Proposed Amendments to Ontario Regulation 45/22 (General) under the Laboratory and Specimen Collection Centre Licensing Act to expand midwives' authority to order additional laboratory tests and allow midwives to perform certain point-of-care tests.
Regulation Number(s):
45/22
Instrument Type:
Regulation - LGIC
Bill or Act:
Laboratory and Specimen Collection Centre Licensing Act
Summary of Proposal:
Midwives - Requisitioning Additional Lab Tests and Performing Point-of-Care Testing:
The Ministry of Health ("ministry") is proposing to amend Ontario Regulation 45/22 (General) under the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA) to update the list of specific laboratory tests and include certain point-of-care tests (POCT) that midwives are able to order and perform, within their scope of practice.
The Laboratory and Specimen Collection Centre Licensing Act (LSCCLA) regulates the establishment and operation of medical laboratories and specimen collection centres in Ontario, including requirements and restrictions relating to requisitioning and performance of laboratory tests. Currently in Ontario, midwives are able to order specific laboratory tests, as identified in Schedule 2 of O.Reg. 45/22 made under the LSCCLA. Midwives are not currently authorized to perform point-of-care tests on specimens they have collected.
The proposed amendments would both expand the list of laboratory tests that midwives can requisition under Schedule 2 and identify certain point-of-care tests that midwives will be able to perform. The ability to perform POCTs will be achieved through an exemption to being a licensed laboratory to perform these tests under the LSCCLA regulation.
The ministry is proposing to make the following amendments to O.Reg. 45/22 under the LSCCLA, to better reflect current midwifery scope of practice:
• Add 35 tests to Schedule 2 Tests - Requisition by Midwife under Section 18.
• Specify 8 POCTs that midwives would be able to perform through an exemption to being a licensed laboratory
Any new tests added to Schedule 2 can also be requisitioned by Aboriginal midwives, who are practicing under an exemption to the Regulated Health Professions Act, 1991.
Prenatal and Newborn Screening Restrictions:
The ministry is also proposing the following amendments to O.Reg. 45/22 to bring outdated provisions into alignment with the current provincial and prenatal screening and newborn screening programs:
• Expand the testing that can be performed under the provincial prenatal screening program by certain laboratories, in accordance with subsection 19(1).
• Update the list of newborn screening tests specified under subsection 19(3) to include X-ALD (X-linked adrenoleukodystrophy).
• Update restriction in subsection 19(3) to authorize certain additional laboratories that have entered into agreements with the Children's Hospital of Eastern Ontario (CHEO) to perform the specified newborn screening tests.
Technical Amendments:
The ministry is proposing housekeeping amendments to Schedule 1 in O.Reg. 45/22 to make test names consistent throughout the regulation.
This proposal is not final. The ministry may refine this proposal based on feedback received through this consultation, prior to seeking final approvals.
A Consultation Draft of the proposed regulation is attached - note that the Test names highlighted in yellow are the new laboratory and Point-of-Care tests proposed to be added in the regulation.
The Ministry of Health ("ministry") is proposing to amend Ontario Regulation 45/22 (General) under the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA) to update the list of specific laboratory tests and include certain point-of-care tests (POCT) that midwives are able to order and perform, within their scope of practice.
The Laboratory and Specimen Collection Centre Licensing Act (LSCCLA) regulates the establishment and operation of medical laboratories and specimen collection centres in Ontario, including requirements and restrictions relating to requisitioning and performance of laboratory tests. Currently in Ontario, midwives are able to order specific laboratory tests, as identified in Schedule 2 of O.Reg. 45/22 made under the LSCCLA. Midwives are not currently authorized to perform point-of-care tests on specimens they have collected.
The proposed amendments would both expand the list of laboratory tests that midwives can requisition under Schedule 2 and identify certain point-of-care tests that midwives will be able to perform. The ability to perform POCTs will be achieved through an exemption to being a licensed laboratory to perform these tests under the LSCCLA regulation.
The ministry is proposing to make the following amendments to O.Reg. 45/22 under the LSCCLA, to better reflect current midwifery scope of practice:
• Add 35 tests to Schedule 2 Tests - Requisition by Midwife under Section 18.
• Specify 8 POCTs that midwives would be able to perform through an exemption to being a licensed laboratory
Any new tests added to Schedule 2 can also be requisitioned by Aboriginal midwives, who are practicing under an exemption to the Regulated Health Professions Act, 1991.
Prenatal and Newborn Screening Restrictions:
The ministry is also proposing the following amendments to O.Reg. 45/22 to bring outdated provisions into alignment with the current provincial and prenatal screening and newborn screening programs:
• Expand the testing that can be performed under the provincial prenatal screening program by certain laboratories, in accordance with subsection 19(1).
• Update the list of newborn screening tests specified under subsection 19(3) to include X-ALD (X-linked adrenoleukodystrophy).
• Update restriction in subsection 19(3) to authorize certain additional laboratories that have entered into agreements with the Children's Hospital of Eastern Ontario (CHEO) to perform the specified newborn screening tests.
Technical Amendments:
The ministry is proposing housekeeping amendments to Schedule 1 in O.Reg. 45/22 to make test names consistent throughout the regulation.
This proposal is not final. The ministry may refine this proposal based on feedback received through this consultation, prior to seeking final approvals.
A Consultation Draft of the proposed regulation is attached - note that the Test names highlighted in yellow are the new laboratory and Point-of-Care tests proposed to be added in the regulation.
Analysis of Regulatory Impact:
If the proposed regulatory amendments are approved, it is anticipated that there will not be a significant increase in overall volumes for the specified tests within the system, beyond forecasted population growth. The total volume for these tests is expected to shift across a larger set of healthcare providers.
Overall, the proposed update is not anticipated to increase the funding for community laboratory testing beyond expected utilization increases across the system due to a small growth in birth rates, which the ministry accounts for through yearly inflation-related budgetary measures.
Updating the restrictions in subsections 19 (1) and (3) of O. Reg 45/22 would bring the regulation in line with current operational realties in the administration of the provincial prenatal screening and newborn screening programs.
Overall, the proposed update is not anticipated to increase the funding for community laboratory testing beyond expected utilization increases across the system due to a small growth in birth rates, which the ministry accounts for through yearly inflation-related budgetary measures.
Updating the restrictions in subsections 19 (1) and (3) of O. Reg 45/22 would bring the regulation in line with current operational realties in the administration of the provincial prenatal screening and newborn screening programs.
Further Information:
Draft Regulation for Consultation
Proposal Number:
24-HLTC015
Posting Date:
April 10, 2024
Comments Due Date:
May 25, 2024
Contact Address:
Laboratories and Diagnostics Branch
Health Programs and Delivery Division
Ministry of Health
438 University Avenue, 4th Floor
Toronto ON M7A 1N3
Health Programs and Delivery Division
Ministry of Health
438 University Avenue, 4th Floor
Toronto ON M7A 1N3