ontario regulation 23/21
made under the
Laboratory and Specimen Collection Centre Licensing Act
Made: January 22, 2021
Filed: January 22, 2021
Published on e-Laws: January 22, 2021
Printed in The Ontario Gazette: February 6, 2021
Amending Reg. 683 of R.R.O. 1990
(SPECIMEN COLLECTION CENTRES)
1. Regulation 683 of the Revised Regulations of Ontario, 1990 is amended by adding the following section:
0.1 In this Regulation,
“point-of-care testing” means testing performed outside a clinical laboratory at or near where a patient is receiving care.
2. Subsection 5 (2) of the Regulation is revoked.
3. (1) The Regulation is amended by adding the following section:
10. (1) A person who collects specimens for COVID-19 antigen testing by point-of-care testing is exempt from sections 5 to 16 of the Act and from the provisions of this Regulation if the person or an organization that the person is acting on behalf of is participating in the Provincial Antigen Screening Program and is in compliance with its conditions.
(2) In this section,
“Provincial Antigen Screening Program” means a program in which persons or organizations enter into agreements with the Province of Ontario or an agent of the province concerning COVID-19 antigen testing and where each participating person or organization agrees to comply with the conditions of the program, including conditions that they shall,
(a) ensure that COVID-19 antigen testing by point-of-care testing is used only,
(i) for the purposes of the program, and
(ii) in accordance with the manufacturer’s label and provincial guidance,
(b) submit data in the form and manner requested by the Province of Ontario, and
(c) comply with the quality assurance requirements that are applicable to the program.
(2) Section 10 of the Regulation, as made by subsection (1), is revoked.
Commencement
4. (1) Subject to subsection (2), this Regulation comes into force on the day it is filed.
(2) Subsection 3 (2) comes into force on March 31, 2022.