Regulation - LGIC
Proposed Amendments to Ontario Regulation 45/22 (General) under the Laboratory and Specimen Collection Centre Licensing Act to restrict which laboratories can perform Influenza and Respiratory Syncytial Virus (RSV) Testing as Part of the Provincial Respiratory Virus Testing Program
Regulation Number(s):
45/22
Instrument Type:
Regulation - LGIC
Bill or Act:
Laboratory and Specimen Collection Centre Licensing Act
Summary of Decision:
1. Ontario Regulation 45/22 is amended by adding the following section:
Restrictions re flu and RSV testing
19.1 The owner and the operator of a laboratory shall ensure that no person employed in the laboratory performs a test for influenza or respiratory syncytial virus under the provincial respiratory virus testing program unless the owner or the operator has entered into an agreement with Ontario Health respecting conditions related to the participation of the laboratory in the program.
Restrictions re flu and RSV testing
19.1 The owner and the operator of a laboratory shall ensure that no person employed in the laboratory performs a test for influenza or respiratory syncytial virus under the provincial respiratory virus testing program unless the owner or the operator has entered into an agreement with Ontario Health respecting conditions related to the participation of the laboratory in the program.
Analysis of Regulatory Impact:
If approved, the ministry anticipates no new administrative costs or burdens from the proposed amendments because, to the extent possible, these tests would be funded through similar funding agreements and funding authorities/mechanisms as currently exists. Labs authorized to perform publicly-funded influenza/RSV testing for the Program through this proposed regulatory amendment would report test results in accordance with their legal obligations and, to the extent possible, existing billing processes and systems would be leveraged.
The proposed regulatory amendments specify which labs are authorized to perform publicly-funded influenza and RSV testing as part of the Program for individuals who meet the Program's eligibility criteria. If provincial testing guidance is updated to expand the Program's eligibility criteria, there may be an increase in volumes for this publicly-funded influenza/RSV testing. These additional volumes are, however, anticipated to be low and would be managed through the funding agreements and mechanisms related to this Program, as applicable.
If approved, the proposed amendments would enable individuals who meet the Program's eligibility criteria to receive publicly-funded influenza/RSV testing, at no cost to them. This would also mean faster and easier access to a diagnosis and treatment for Ontarians across the province that need it most.
The proposed regulatory amendments specify which labs are authorized to perform publicly-funded influenza and RSV testing as part of the Program for individuals who meet the Program's eligibility criteria. If provincial testing guidance is updated to expand the Program's eligibility criteria, there may be an increase in volumes for this publicly-funded influenza/RSV testing. These additional volumes are, however, anticipated to be low and would be managed through the funding agreements and mechanisms related to this Program, as applicable.
If approved, the proposed amendments would enable individuals who meet the Program's eligibility criteria to receive publicly-funded influenza/RSV testing, at no cost to them. This would also mean faster and easier access to a diagnosis and treatment for Ontarians across the province that need it most.
Further Information:
Regulation
Proposal Number:
23-HLTC049
Posting Date:
July 7, 2023
Summary of Proposal:
Through proposed regulatory amendments to O. Reg. 45/22 (General) under the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA), the ministry proposes to restrict the performance of publicly-funded influenza and Respiratory Syncytial Virus (RSV) testing as part of the Provincial Respiratory Virus Testing Program to laboratories having agreements with Ontario Health. If approved, restricting which laboratories could perform publicly-funded influenza/RSV testing for the Program would provide a provincially coordinated approach to ensure equitable testing for Ontarians who meet the Program's eligibility criteria (which would be based on provincial testing guidance). This proposed program-based testing restriction for influenza/RSV testing would be similar to existing restrictions for certain provincial programs (e.g., colorectal cancer screening, prenatal screening, and newborn screening) in O. Reg. 45/22 under the LSCCLA.
The proposed amendments related to the Program would build on actions taken in the 2022/23 respiratory season and provide greater clarity on publicly-funded influenza/RSV testing access in the healthcare system for both patients and providers. This coordinated provincial approach would enable readiness for seasonal surges of respiratory viruses resulting in faster patient access to testing, diagnosis and treatment, and oversight for respiratory season planning in the healthcare system.
The proposed amendments related to the Program would build on actions taken in the 2022/23 respiratory season and provide greater clarity on publicly-funded influenza/RSV testing access in the healthcare system for both patients and providers. This coordinated provincial approach would enable readiness for seasonal surges of respiratory viruses resulting in faster patient access to testing, diagnosis and treatment, and oversight for respiratory season planning in the healthcare system.
Contact Address:
Ministry of Health
Laboratories and Diagnostics Branch
438 University Avenue, 4th Floor
Toronto ON M5G 2K8
Laboratories and Diagnostics Branch
438 University Avenue, 4th Floor
Toronto ON M5G 2K8
Effective Date:
August 28, 2023
Decision:
Approved