9 (1) No person shall establish, operate or maintain a laboratory facility except under the authority of a licence issued by the Director under this Act. 2017, c. 11, Sched. 3, s. 2. Issuing licences (2) The Director may issue a licence for a laboratory facility to, (a)  perform one or more classes of tests specified in the licence; (b)  perform tests specified in the licence within one or more classes of tests; (c)  take or collect specimens or one or more classes of specimens specified in the licence; or (d)  take or collect specimens specified in the licence within one or more classes of specimens. 2017, c. 11, Sched. 3, s. 2. Conditions (3) A licence is subject to the conditions, if any, specified by the Director in the licence. 2017, c. 11, Sched. 3, s. 2. Issuance of licence (4) Subject to subsection (10), any person who applies in accordance with this Act and the regulations for a licence to establish, operate or maintain a laboratory facility and who meets the requirements of this Act and the regulations and who pays the prescribed fee is entitled to be issued the licence. 2017, c. 11, Sched. 3, s. 2. Where proposal not in public interest, issuance of licence (5) Despite subsection (4), the following applies where an application is made for a licence and the Minister states in writing to the Director that it is not in the public interest to issue a licence to establish, operate or maintain the laboratory facility in the area where the applicant proposes to establish, operate or maintain the laboratory facility: 1.  Section 11 does not apply. 2.  The Director shall not issue the licence to the applicant. 3.  The Director shall give written notice to the applicant of the refusal and of the Minister’s statement. 2017, c. 11, Sched. 3, s. 2. Where proposal not in public interest, tests, specimens, etc. (6) Despite subsection (4), where an application is made for a licence and the Minister states in writing to the Director that it is not in the public interest to issue a licence, either, (a)  in the case of a laboratory, for any classes of tests or any of the tests within a class or classes of tests in respect of which the application is made; or (b)  in the case of a specimen collection centre, to take or collect any specimens or class or classes of specimens in respect of which the application is made: then, (c)  sections 10 and 11 do not apply; (d)  where the Director issues a licence to the applicant upon the application, the Director shall give written notice to the applicant of the Minister’s statement; and (e)  the licence shall not be for the classes of tests or the tests within a class or classes of tests or for taking or collecting the specimens or class or classes of specimens that are set out in the Minister’s statement. 2017, c. 11, Sched. 3, s. 2. Matters to be considered by Minister (7) In making a decision as to what is in the public interest for the purposes of subsection (5) or (6), the Minister may consider any matter the Minister regards as relevant, including, without being limited to, (a)  the number and type of laboratory facilities that operate under the authority of licences issued under this Act, (i)  in the area, or (ii)  in the area and any other area; (b)  the tests and classes of tests performed or the specimens or class or classes of specimens taken or collected in the laboratory facilities, (i)  in the area, or (ii)  in the area and any other area; (c)  the utilization of existing laboratory facilities and their capacity to handle increased volume; (d)  the availability of facilities for the transportation of persons and specimens to laboratory facilities, (i)  in the area, or (ii)  in the area and any other area; or (e)  the funds available to provide payment for laboratory tests that are insured services under the Health Insurance Act. 2017, c. 11, Sched. 3, s. 2. Blood collection facilities (8) Despite subsection (4), where an application is made for a licence to establish, operate or maintain a laboratory facility which will operate as a blood collection facility within the meaning of the Voluntary Blood Donations Act, 2014 and the Minister states in writing to the Director that it is not in the public interest to issue such a licence, section 11 shall not apply and the Director shall not issue the licence to the applicant and shall give written notice to the applicant of the refusal and of the Minister’s statement. 2017, c. 11, Sched. 3, s. 2. Same (9) In making a decision in the public interest in subsection (8), the Minister may consider any matter the Minister regards as relevant, including, without being limited to, the principles set out in the Voluntary Blood Donations Act, 2014. 2017, c. 11, Sched. 3, s. 2. Grounds for refusal (10) Subject to section 11, the Director may refuse to issue a licence where in the Director’s opinion, (a)  the past conduct of the applicant or, where the applicant is a corporation, of its officers or directors affords reasonable grounds for belief that the laboratory facility will not be operated in accordance with the law and with honesty and integrity; (b)  the proposed laboratory facility or its operation would contravene this Act or the regulations or any other Act or regulation or any municipal by-law respecting its establishment or location; (c)  the applicant is not competent to operate a laboratory facility in accordance with this Act and the regulations; (d)  the equipment and premises are not suitable for the performance of the tests or the taking or collecting of the specimens for which the licence is sought; or (e)  any other ground for refusal that is prescribed in the regulations exists. 2017, c. 11, Sched. 3, s. 2. Provisional licence (11) Where the applicant for a licence does not meet all the requirements for issuance of the licence and requires time to meet such requirements, the Director may issue a provisional licence for the laboratory facility. 2017, c. 11, Sched. 3, s. 2. Expiration and renewal of provisional licence (12) A provisional licence expires on the date specified on the licence, which shall not be later than 12 months after the date of its issue, but the provisional licence may be renewed for one further period of no more than 12 months where, in the opinion of the Director, sufficient progress in complying with the requirements for issuance of a licence has been made. 2017, c. 11, Sched. 3, s. 2. Expiration and renewal of licence (13) A licence that is not a provisional licence expires on the date specified on the licence, which shall not be later than five years from the date of its issue or renewal. A renewal shall be issued where the applicant is not disqualified under subsection (20). 2017, c. 11, Sched. 3, s. 2. Transitional (14) Despite subsections (12) and (13), a licence or provisional licence that is in existence immediately before section 2 of Schedule 3 to the Protecting Patients Act, 2017 comes into force expires when it would have otherwise expired. 2017, c. 11, Sched. 3, s. 2. Stay of refusal to renew (15) Where the Director refuses to renew a licence, the laboratory facility shall be deemed to continue to be licensed until an order is made by the Review Board or until the time for requiring a hearing by the Review Board expires, whichever occurs first. 2017, c. 11, Sched. 3, s. 2. Operator to be named in licence (16) It is a condition of a licence that the operation of the laboratory facility be under the charge and control of the operator named in the licence as operator and that the ownership of the laboratory facility be only in the person or persons named in the licence as owners. 2017, c. 11, Sched. 3, s. 2. Conditions re quality management (17) It is a condition of a licence for a laboratory facility that, (a)  the operation of the laboratory facility meet the requirements of a quality management program; (b)  the owner and the operator of the laboratory facility permit an agency designated in the regulations to carry out a quality management program; and (c)  the owner of the laboratory facility pay the fees for an assessment under a quality management program, if any, that are prescribed by the regulations or established by an agency designated in the regulations. 2017, c. 11, Sched. 3, s. 2. Failure to meet program requirements (18) Where an agency designated in the regulations to carry out a quality management program reports to the Director that the operation of a laboratory facility does not meet the requirements of the program, the Director may impose any conditions upon the laboratory facility’s licence that the Director considers necessary or advisable in order that the health of the public be protected. 2017, c. 11, Sched. 3, s. 2. Notice of changes (19) Where the operator or the owner named in the licence is a corporation, the corporation shall notify the Director in writing within 15 days of any change in the officers or directors of the corporation. 2017, c. 11, Sched. 3, s. 2. Revocation, suspension, renewal refusal (20) The Director may revoke, suspend or refuse to renew a licence where, (a)  any person has made a false statement in the application for the licence or its renewal or in any report, document or other information required to be furnished by this Act or the regulations or any other Act or regulation that applies to the laboratory facility; (b)  any test authorized by the licence is incompetently performed; (c)  any specimen taking or collecting authorized by the licence is incompetently carried out; (d)  there is a breach of a condition of the licence; (e)  the owner or the operator does not comply with this Act or the regulations or any other Act or law relevant to the operation or maintenance of a laboratory facility; (f)  the services that can be provided by the laboratory facility are misrepresented; (g)  a change in the officers or directors of any corporation which is an operator or owner of a laboratory facility named in the licence would afford grounds for refusing to issue a licence under clause (10) (a); or (h)  any other ground for revoking, suspending or refusing renewal that is prescribed in the regulations exists. 2017, c. 11, Sched. 3, s. 2. Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 62 (1) - 01/02/1999 2006, c. 19, Sched. L, s. 6 (4) - 22/06/2006 2014, c. 14, Sched. 1, s. 12 (4-7) - 11/12/2014 2017, c. 11, Sched. 3, s. 2 - 01/07/2022