Specimen Collection Act Flashcards
What is the definition of ‘laboratory’ according to the Act?
An institution where operations for examination of specimens from the human body are performed
Includes microbiological, serological, chemical, and other examinations as prescribed by regulations.
What must a licence specify for a laboratory facility?
Classes of tests, specimens, or conditions specified by the Director
Licences are tailored to the specific capabilities of the laboratory.
True or False: A laboratory facility can operate without a licence.
False
The Act explicitly requires that all laboratory facilities operate under a valid licence.
What is the purpose of a quality management program as defined in the Act?
To ensure quality management standards are met in laboratory operations
This program is crucial for maintaining the integrity and accuracy of laboratory testing.
What happens if an application for a licence is deemed not in the public interest?
The Director shall not issue the licence, and the applicant will be notified
This protects the community from potentially harmful laboratory practices.
What is the significance of ‘regulations’ in the context of the Act?
They provide detailed rules and guidelines for the implementation of the Act
Regulations are essential for ensuring compliance and standards in laboratory operations.
What is a provisional licence?
A provisional licence is issued when the applicant does not meet all requirements but needs time to comply.
This allows continued operation while the applicant works towards meeting the necessary standards.
How long does a provisional licence last?
A provisional licence expires no later than 12 months after issuance but may be renewed for one additional 12-month period if sufficient progress is made.
This renewal is subject to the Director’s discretion.
What is the maximum duration for a standard laboratory licence?
A standard laboratory licence expires no later than five years from the date of its issue or renewal.
Renewals are contingent upon the applicant not being disqualified.
What are the conditions related to quality management for a laboratory licence?
- The facility must meet quality management program requirements
- The owner and operator must allow assessment by a designated agency
- The owner must pay prescribed assessment fees
These conditions help maintain high standards in laboratory operations.
What can happen if a laboratory facility fails to meet quality management program requirements?
The Director may impose additional conditions on the laboratory facility’s licence.
This action is taken to protect public health.
What is the effect of an emergency suspension of a laboratory licence?
The licence is suspended immediately if the Director believes the facility poses an immediate threat to health or safety.
This is a protective measure for public health.
What tests are permitted in a laboratory according to the Act?
Only tests authorized by the licence may be performed.
This is stated in R.S.O. 1990, c. L.1, s. 14 (1).
