Proposed Amendments to Regulation 683 under the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA)
Regulation - LGIC
Bill or Act:
Laboratory and Specimen Collection Centre Licensing Act
Summary of Decision:
Proposed amendments to Regulation 683 (Reg. 683) under the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA) have been approved and are effective immediately.
Published on the e-Laws website (https://www.ontario.ca/Laws) November 18, 2016, O. Reg.362/16 amends s. 1(1) and s. 5 of Reg. 683 making it a condition of licensing that specimen collection centres (SCCs) meet the requirements of a Quality Management Program (QMP). The amendment was reflected in the Ontario Gazette, Volume 149, Issue 49, published on December 3, 2016.
The QMP is delivered by Institute for Quality Management in Healthcare (IQMH) through a new program called Integrated Accreditation Program (IAP). The IAP will integrate the assessments of licensed SCCs with the regularly-scheduled on-site conformity assessments of licensed laboratories.
September 8, 2016
Summary of Proposal:
The Ministry of Health and Long-Term Care (ministry) is committed to ensuring patient's access to Ontario laboratories and SCCs is safe, effective and patient-centered.
A quality management program for licensed laboratories exists in the Laboratory and Specimen Collection Centre Licensing Act (Act) and Regulation 682 (Reg. 682). It is a condition of every laboratory licence that the laboratory meet the requirements of a QMP. The QMP includes an accreditation component.
The ministry is proposing amendments to Reg. 683 under the Act to strengthen quality oversight in Ontario's licensed SCCs (hospital-owned and community-based) by making it a condition of licensing that SCCs meet the requirements of a QMP. Institute for Quality Management in Healthcare (IQMH) is designated in Reg. 682 to carry out a QMP.
The proposed amendments to Reg. 683 would make it a condition of licensing for SCCs to be accredited. Combined with the existing accreditation program for licensed laboratories, both licensed laboratories and SCCs would be subject to a new program called the Integrated Accreditation Program (IAP). Under the IAP, IQMH would assess accreditation for a testing laboratory. The accompanying scope of accreditation for that testing laboratory would also list all of its associated SCCs.
The proposed regulation amendments are subject to the prior review by the Minister of Health and Long-Term Care and the approval of the Lieutenant Governor in Council.
The proposed amendments to Reg. 683 would not impact:
1. A hospital's obligations under the Public Hospitals Act and associated regulations;
2. Public Health Laboratories and Canadian Blood Services as they do not own or operate SCCs;
3. Health regulatory colleges and associated regulations.
November 18, 2016