Over the past months, the Government of Ontario enacted multiple amendments to regulations made under the Laboratory and Specimen Collection Centre Licensing Act (the "LSCCLA"). These amendments eased certain legislative restrictions on diagnostic testing for COVID-19 and formed part of the provincial government's approach to enable rapid testing for COVID-19 in the province.
The Laboratory and Specimen Collection Centre Licensing Act
In Ontario, specimen collection centres and laboratories are governed by the LSCCLA and the regulations made thereunder.1 The LSCCLA provides for the licensing, inspection, operation, and maintenance of specimen collection centres and laboratories. There are two regulations under the LSCCLA: (1) the Specimen Collection Centres Regulation, Regulation 6832 (the "SCC Regulation") and (2) the Laboratories Regulation, Regulation 6823 (the "Lab Regulation").
In the LSCCLA, a "specimen collection centre" is defined as "a place where specimens are taken or collected from the human body for examination to obtain information for diagnosis, prophylaxis or treatment, and any other place that may be provided for in the regulations".4 The LSCCLA establishes a number of exceptions to what is deemed a specimen collection centre, including:5
- a place where a legally qualified medical practitioner is engaged in the practice of medicine or surgery; and
- a place where a registered nurse who holds an extended certificate of registration under the Nursing Act, 1991 is engaged in the practice of nursing.
These exceptions make it possible for certain healthcare providers to collect specimens outside of a licensed specimen collection centre in limited circumstances.
Furthermore, the LSCCLA defines "laboratories" as "an institution, building or place in which operations and procedures for the microbiological, serological, chemical, hematological, biophysical, immunohematological, cytological, pathological, cytogenetic, molecular genetic or genetic examination, or any examination prescribed by the regulations, of specimens taken from the human body are performed to obtain information for diagnosis, prophylaxis or treatment, and any other institution, building or place that may be provided for in the regulations".6 The Lab Regulation exempts qualified medical practitioners who perform laboratory tests exclusively to diagnose or treat their own patients in the course of their medical practice from the laboratory licensing requirements in the LSCCLA.7
In late November 2020, amendments to the SCC Regulation and the Lab Regulation came into force that exempted prescribed healthcare providers and laboratories from the licensing requirements of the LSCCLA when collecting specimens for COVID-19 testing and when performing point-of-care COVID-19 tests.
More recently, amendments to both regulations came into force that exempted any person from the licensing requirements of the LSCCLA when collecting specimens for COVID-19 rapid antigen testing and when conducting COVID-19 antigen testing as part of the Provincial Antigen Screening Program.
The COVID-19-related amendments are described in further detail below.
i. Amendments Related to Specimen Collection for COVID-19 Testing
Pursuant to amendments made in November 2020, the following persons are exempt from the provisions of the SCC Regulation and from sections 5 to 16 of the LSCCLA (which contain, in part, the licensing requirements imposed by the LSCCLA) when collecting specimens for a test performed in relation to COVID-19:8
- A legally qualified medical practitioner.
- A registered practical nurse or registered nurse, including a registered nurse who holds an extended certificate of registration under the Nursing Act, 1991.
- A person registered as a dentist under the Dentistry Act, 1991.
- A person registered as a pharmacist under the Pharmacy Act, 1991.
- A paramedic in the course of their employment with an ambulance service operator that is certified under the Ambulance Act.
- A person who provides services as part of a community paramedicine program approved by either the Ministry of Health or Ministry of Long-Term Care, and who is a paramedic within the meaning of the Ambulance Act.
ii. Amendments Related to "Point of Care" Testing
The same healthcare providers described above are also exempt from compliance with the Lab Regulation and from sections 5 to 16 of the LSCCLA when performing a point-of-care test in relation to COVID-19 only.9 "Point-of-care testing" is defined as testing performed outside a clinical laboratory at or near where a patient is receiving care.10
While the amendments to the SCC Regulation do not restrict the location where authorized healthcare providers are permitted to collect specimens for COVID-19 point-of-care tests, the amendments to the Lab Regulation do so. More specifically, as noted above, under the Lab Regulation, point-of-care testing by authorized health care providers in relation to COVID-19 must be performed outside a clinical laboratory at or near where a patient is receiving care.
Amendments to the Lab Regulation made in November 2020 also exempt laboratories from needing to submit applications for a new licence, or to renew a licence, to establish, operate or maintain a laboratory for providing point-of-care testing for COVID-19.11 However, laboratories must comply with all other requirements under the LSCCLA and any conditions or restrictions placed on their licence for any location where they provide point-of-care testing for COVID-19. In addition, no specimen collection may occur in a location where a licensed laboratory performs point-of-care testing for COVID-19 other than specimen collection in relation to COVID-19.12
iii. Amendments Related to COVID-19 Antigen Testing
In February 2021, the Government of Ontario enacted amendments to the SCC Regulation and the Lab Regulation to enable specimen collection and testing for COVID-19 antigen testing by point-of-care testing as part of the Provincial Antigen Screening Program.
The Provincial Antigen Screening Program is defined in both the SCC Regulation and Lab Regulation as a program in which persons or organizations enter into agreements with the Province of Ontario concerning COVID-19 antigen testing and where each participating person or organization agrees to comply with the conditions of the program.13 These conditions include ensuring that the COVID-19 antigen testing by point-of-care testing is used only for the purposes of the program and in accordance with the manufacturer's label and provincial guidance, complying with quality assurance requirements applicable to the program, as well as submitting requested data to the province.14
Pursuant to these amendments, any person is exempt from compliance with the SCC Regulation and from sections 5 to 16 of the LSCCLA when collecting specimens for COVID-19 antigen testing by point-of-care-testing if the person (or an organization the person is acting on behalf of) is participating in the Provincial Antigen Screening Program and complies with the program's conditions.15
Similarly, any person is exempt from the provisions of the Lab Regulation and from sections 5 to 16 of the LSCCLA when performing COVID-19 antigen testing by point-of-care-testing if the person, or an organization they act on behalf of, is partaking in the Provincial Antigen Screening Program and complies with its conditions.16
The Government of Ontario announced that it is deploying rapid testing through the Provincial Antigen Screening Program in high-priority settings to quickly identify cases of COVID-19 and to support the safe re-opening of schools.17 The government has identified seven high-priority settings where the program will be implemented:
- Long-term care homes
- Retirement homes
- Congregate living
- High-priority communities
- Land borders
- Essential industries, such as manufacturing and construction
The amendments to the SCC Regulation and Lab Regulation form part of the provincial government's strategy to enable rapid testing for COVID-19.
6 LSCCLA, section 5.
7 LSCCLA, Section 13.
8 SCC Regulation, section 9(1).
9 Lab Regulation, section 13.2.
10 SCC Regulation, section 0.1, and Lab Regulation, section 1.
11 Lab Regulation, section 4(2.1).
13 Section 10(2) and section 13.3(2), respectively.
15 SCC Regulation, section 10(1).
16 Lab Regulation, section 13.3(1).
17 See the provincial news release here.
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