In our bulletin of February 22, 2021, titled "Recent Regulatory Amendments to the Laboratory and Specimen Collection Centre Licensing Act in connection with COVID-19", we reported on a number of amendments that have been made over the past few months to the regulations under the Laboratory and Specimen Collection Centre Licensing Act (the "LSCCLA"), which eased certain restrictions on diagnostic testing for COVID-19.
On March 3, 2021, the Government of Ontario filed additional amendments to the regulations under the LSCCLA. These new amendments further ease restrictions on point-of-care testing for COVID-19.
i. The Laboratory and Specimen Collection Centre Licensing Act
The LSCCLA and the regulations made thereunder govern specimen collection centres and laboratories in Ontario, and provide for the licensing, inspection, operation, and maintenance of specimen collection centres and laboratories.1 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").
ii. Prior COVID-19 Related Amendments to the LSCCLA
As reported in greater detail in our bulletin of February 22, 2021, Recent Regulatory Amendments to the Laboratory and Specimen Collection Centre Licensing Act in connection with COVID-19, over the preceding five months the Government of Ontario brought in amendments to the SCC Regulation and the Lab Regulation to exempt:
- prescribed healthcare providers and laboratories from the licensing requirements of the LSCCLA when collecting specimens for COVID-19 diagnostic testing and when performing point-of-care COVID-19 tests; and
- any persons from the licensing requirements of the LSCCLA when collecting specimens for COVID-19 rapid antigen testing and when performing COVID-19 antigen testing as part of the Provincial Antigen Screening Program.
However, changes to the SCC Regulation and the Lab Regulation that came into force on March 3, 2021 revoke or significantly modify these prior amendments.4 These new changes are discussed in further detail below.
iii. Redefining Point-Of-Care Testing for COVID-19
As part of amendments made last year to the Lab Regulation and the SCC Regulation with respect to COVID-19, the term "point-of-care testing" was introduced into both regulations. "Point-of-care testing" was defined as "testing performed outside a clinical laboratory at or near where a patient is receiving care".5
As of March 3, 2021, point-of-care testing in both the Lab Regulation and the SCC Regulation has been redefined to mean "testing that employs a COVID-19 medical device authorized by the Minister of Health (Canada) for point-of-care use".6
Notably, under the new definition for point-of-care-testing, there is no longer any restriction regarding the place where the point-of-care test must be performed.
iv. Amendments Pertaining to Specimen Collection for COVID-19 Testing
Pursuant to amendments made late last year, the following persons were exempted 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-19:7
- 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.
This exemption continues to be in effect.
Furthermore, amendments to the SCC Regulation made last month enabled anyone to collect specimens for COVID-19 antigen testing by point-of-care testing as part of the Provincial Antigen Screening Program.8
However, as of March 3, 2021, all provisions relating to antigen testing and the Provincial Antigen Screening Program in the SCC Regulation have been revoked. Instead, any person who collects specimens for point-of-care testing for COVID-19 is now exempted from the provisions of the SCC Regulation and from sections 5 to 16 of the LSCCLA.9 In other words, individuals who collect specimens for point-of-care tests for COVID-19 no longer need to be affiliated with the Provincial Antigen Screening Program to be exempted from compliance with the licensing requirements of the LSCCLA.
v. Amendments Pertaining to Performing Point-of-Care Testing for COVID-19
Under amendments made in November 2020, the same six types of healthcare providers described above with respect to specimen collection for COVID-19 were also exempted 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-19.10 Additionally, amendments enacted last month to the Lab Regulation enabled anyone to perform COVID-19 antigen testing by point-of-care testing as part of the Provincial Antigen Screening Program.11
As of March 3, 2021, these two amendments to the Lab Regulation have been revoked. Instead, the Lab Regulation now exempts anyone who performs COVID-19 point-of-care testing from compliance with the Lab Regulation and from the licensing requirements of the LSCCLA.12 Individuals no longer need to fall within one of the six enumerated categories of healthcare providers, nor do they need to be affiliated with the Provincial Antigen Screening Program, in order to perform COVID-19 point-of-care testing.
vi. Amendments Related to Laboratory Licensing for Point-of-Care Testing for COVID-19
Amendments to the Lab Regulation made in November 2020 exempted 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-19.13 In addition, amendments made at that time stated that no specimen collection could occur in a location where a licensed laboratory performed point-of-care testing for COVID-19 other than specimen collection in relation to COVID-19.14
These two amendments to the Lab Regulation have been revoked as of March 3, 2021.15 Now, any laboratory intending to provide point-of-care testing for COVID-19 must comply with the licensing requirements of the LSCCLA.
Footnotes
1 Laboratory and Specimen Collection Centre Licensing Act, R.S.O. 1990, c. L.1
2 R.R.O. 1990, Reg. 683: SPECIMEN COLLECTION CENTRES.
3 R.R.O. 1990, Reg. 682: LABORATORIES.
4 See ONTARIO REGULATION 156/21 and ONTARIO REGULATION 158/21.
5 SCC Regulation, section 0.1, and Lab Regulation, section 1 (previously).
6 SCC Regulation, section 0.1, and Lab Regulation, section 1.
7 SCC Regulation, section 9(1).
8 SCC Regulation, section 10(1) (previously).
9 SCC Regulation, section 10.
10 Lab Regulation, section 13.2 (previously).
11 Lab Regulation, section 13.3(1) (previously).
12 Lab Regulation, section 13.2.
13 Lab Regulation, section 4(2.1) (previously).
14 Ibid.
15 Ontario Regulation 158/21, section 2.
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