Laboratory and Specimen Collection Centre Licensing Act, R.S.O. 1990, c. L.1

CONTENTS 1. Definitions Health Facilities 5. Definitions 6. Director 8. Protection from personal liability 9. Licence required 9.1 Emergency suspension 9.2 Transfer of licence 10. Hearing re terms of licence 11. Proposal to refuse to issue, suspend, revoke or impose condition 12. Parties 13. Appeal to court 14. Tests permitted 16. Appointment of inspectors 17. Restraining orders 17.1 Personal information 18. Regulations 19. Agreement 20. Committee Fines and the Recovery Thereof 22. Offences Definitions 1 In this Act, “Minister” means Minister of Health and Long-Term Care; (“ministre”) “Ministry” means Ministry of Health and Long-Term Care. (“ministère”) R.S.O. 1990, c. L.1, s. 1; 2006, c. 19, Sched. L, s. 11 (2, 3). Section Amendments with date in force (d/m/y) 2006, c. 19, Sched. L, s. 11 (2, 3) - 22/06/2006 2-4 Repealed: 2006, c. 19, Sched. L, s. 6 (1). Section Amendments with date in force (d/m/y) 2006, c. 19, Sched. L, s. 6 (1) - 22/06/2006 Health Facilities Definitions 5 In this section and in sections 6 to 20, “Director” means the Director of Laboratory and Specimen Collection Centre Licensing appointed under section 6; (“directeur”) “inspector” means an inspector appointed under section 16; (“inspecteur”) “laboratory” means, subject to any exclusions provided for in the regulations, (a) 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 such other examinations as are prescribed by the regulations, of specimens taken from the human body are performed to obtain information for diagnosis, prevention or treatment, and (b) any other institution, building or place that may be provided for in the regulations; (“laboratoire”) “laboratory facility” means a laboratory or a specimen collection centre; (“centre de laboratoire”) “operator” means a person having charge or control of a laboratory facility; (“exploitant”) “personal information” includes personal information as defined in the Freedom of Information and Protection of Privacy Act and personal health information as defined in the Personal Health Information Protection Act, 2004; (“renseignements personnels”) “quality management program” means a quality management program provided for in section 19; (“programme de gestion de la qualité”) “regulations” means the regulations made under section 18; (“règlements”) “Review Board” means the Health Services Appeal and Review Board under the Ministry of Health and Long-Term Care Appeal and Review Boards Act, 1998; (“Commission de révision”) “specimen collection centre” means a place where specimens are taken or collected from the human body for examination to obtain information for diagnosis, prevention or treatment, and any other place that may be provided for in the regulations, but does not include, (a)-(d) Repealed 2017, c. 11, Sched. 3, s. 1 (6). (e) a laboratory that is established, operated or maintained under a licence under this Act, or (f) a place that is excluded from this definition by the regulations; (“centre de prélèvement”) “test” means a procedure for carrying out an examination in a laboratory. (“test”) R.S.O. 1990, c. L.1, s. 5; 1998, c. 18, Sched. G, s. 62 (2); 2006, c. 19, Sched. L, s. 6 (2, 3); 2007, c. 10, Sched. J, s. 2; 2009, c. 26, s. 12 (1); 2009, c. 33, Sched. 18, s. 17 (2); 2014, c. 14, Sched. 1, s. 12 (1, 2); 2017, c. 11, Sched. 3, s. 1. Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 62 (2) - 01/02/1999 2006, c. 19, Sched. L, s. 6 (2, 3) - 22/06/2006 2007, c. 10, Sched. J, s. 2 - 04/06/2007; 2007, c. 10, Sched. P, s. 18 - no effect - see 2014, c. 14, Sched. 1, s. 13 - 11/12/2014 2009, c. 26, s. 12 (1) - 15/12/2009; 2009, c. 26, s. 12 (2) - no effect - see 2014, c. 14, Sched. 1, s. 14 - 11/12/2014; 2009, c. 33, Sched. 18, s. 17 (2) - 15/12/2009 2014, c. 14, Sched. 1, s. 12 (1, 2) - 11/12/2014 2017, c. 11, Sched. 3, s. 1 (1-6) - 01/07/2022 Director 6 The Minister shall appoint an officer of the Ministry to be the Director of Laboratory and Specimen Collection Centre Licensing for purposes of sections 5 to 18. R.S.O. 1990, c. L.1, s. 6. 7 Repealed: 1998, c. 18, Sched. G, s. 62 (3). Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 62 (3) - 01/02/1999 Protection from personal liability 8 No action or other proceeding for damages shall be instituted against the Minister or the Director or anyone acting under the authority of the Director for any act done in good faith in the execution or intended execution of his or her duty or for any alleged neglect or default in the execution in good faith of his or her duty. 1998, c. 18, Sched. G, s. 62 (4); 2014, c. 14, Sched. 1, s. 12 (3). Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 62 (4) - 01/02/1999 2014, c. 14, Sched. 1, s. 12 (3) - 11/12/2014 Licence required 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 Emergency suspension 9.1 (1) If the Director is of the opinion upon reasonable grounds that a laboratory facility is being operated or will be operated in a manner that poses an immediate threat to the health or safety of any person, the Director by a written order may suspend the licence of the laboratory facility. 2017, c. 11, Sched. 3, s. 2. Order effective immediately (2) An order under subsection (1) takes effect immediately upon notice of the order being served on the licensee. 2017, c. 11, Sched. 3, s. 2. Notice requiring hearing by Review Board (3) The Director shall deliver with the order under subsection (1) notice that the licensee is entitled to a hearing by the Review Board if the licensee mails or delivers, within 15 days after the notice is served on the licensee, notice in writing requiring a hearing to the Director and the Review Board, and the licensee may so require such a hearing. 2017, c. 11, Sched. 3, s. 2. Power of Review Board where hearing (4) Section 11 applies, with necessary modifications, to a suspension under subsection (1). 2017, c. 11, Sched. 3, s. 2. Service of notice (5) The Director may serve notice of an order under subsection (1) by sending the notice by any means that produces a paper record or by any other method of delivery that is prescribed in the regulations. 2017, c. 11, Sched. 3, s. 2. Deemed receipt (6) If the Director serves notice in a manner described in subsection (5), the licensee shall be deemed to have received the notice on the day it is sent. 2017, c. 11, Sched. 3, s. 2. No stay (7) Despite section 25 of the Statutory Powers Procedure Act, a request for a hearing by the Board made in accordance with subsection (3) of this section or an appeal to Divisional Court of the Review Board’s decision under section 13 does not operate as a stay of a suspension of a licence ordered under subsection (1) of this section. 2017, c. 11, Sched. 3, s. 2. No interim order to stay (8) Despite section 16.1 of the Statutory Powers Procedure Act, the Review Board shall not make an interim order to stay the suspension of a licence ordered under subsection (1) of this section. 2017, c. 11, Sched. 3, s. 2. Powers are additional (9) For greater certainty, the powers of the Director under this section are in addition to, and not in place of, the powers of the Minister under the Health Facilities Special Orders Act. 2017, c. 11, Sched. 3, s. 2. Section Amendments with date in force (d/m/y) 2017, c. 11, Sched. 3, s. 2 - 01/07/2022 Transfer of licence 9.2 (1) A licence issued under this Act is not transferrable without the consent of the Director. 2017, c. 11, Sched. 3, s. 2. How dealt with (2) In deciding whether to consent to the transfer of a licence, the Director shall treat the proposed transferee of the licence as if the proposed transferee were an applicant for a licence and, for the purpose, section 9 applies with necessary modifications. 2017, c. 11, Sched. 3, s. 2. Limitations and conditions (3) In consenting to the transfer of a licence, the Director may attach to the licence such conditions as the Director considers necessary in the circumstances. 2017, c. 11, Sched. 3, s. 2. Section Amendments with date in force (d/m/y) 2017, c. 11, Sched. 3, s. 2 - 01/07/2022 Hearing re terms of licence 10 (1) Where the Director issues a licence under this Act and any party to the proceeding is dissatisfied with the terms and conditions thereof prescribed by the Director, the party may by written notice given to the Director and the Review Board require a hearing by the Review Board, and the Review Board shall appoint a time for and hold a hearing. R.S.O. 1990, c. L.1, s. 10 (1); 1998, c. 18, Sched. G, s. 62 (1). Decision of Review Board (2) Pursuant to a hearing under subsection (1), the Review Board may affirm the terms and conditions prescribed for the licence by the Director or may cancel such terms and conditions or may prescribe such other terms and conditions for the licence in the place of those prescribed by the Director as it considers proper and such terms and conditions shall be terms and conditions of the licence. R.S.O. 1990, c. L.1, s. 10 (2); 1998, c. 18, Sched. G, s. 62 (1). Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 62 (1) - 01/02/1999 Proposal to refuse to issue, suspend, revoke or impose condition 11 (1) Where the Director proposes to suspend, revoke or to refuse to issue or renew a licence or to impose a condition on an existing licence under this Act, the Director shall serve notice of the proposal, together with written reasons, on the applicant in the case of a proposal to refuse to issue or renew the licence and on the owner and operator in the case of a proposal to suspend, revoke or to impose a condition on the licence. 2017, c. 11, Sched. 3, s. 3. Notice (2) A notice under subsection (1) shall inform the applicant or the owner and operator that they are entitled to a hearing by the Review Board if they mail or deliver, within fifteen days after the notice under subsection (1) is served on them, notice in writing requiring a hearing by the Review Board and each of them may so require such a hearing. R.S.O. 1990, c. L.1, s. 11 (2); 1998, c. 18, Sched. G, s. 62 (1). Powers of Director where no hearing (3) Where the applicant or the owner or operator do not require a hearing by the Review Board in accordance with subsection (2), the Director may carry out the proposal stated in the notice under subsection (1). R.S.O. 1990, c. L.1, s. 11 (3); 1998, c. 18, Sched. G, s. 62 (1). Power of Review Board where hearing (4) Where an applicant or an owner or operator requires a hearing by the Review Board in accordance with subsection (2), the Review Board shall appoint a time for and shall hold the hearing and, on the application of the Director at the hearing, may by order direct the Director to carry out his or her proposal or refrain from carrying out the proposal and to take such action as the Review Board considers the Director ought to take in accordance with this Act and the regulations, and for such purposes the Review Board may substitute its opinion for that of the Director. R.S.O. 1990, c. L.1, s. 11 (4); 1998, c. 18, Sched. G, s. 62 (1). Extension of time for requiring hearing (5) The Review Board may extend the time for the giving of notice requiring a hearing by an applicant or an owner or operator under this section either before or after the expiration of such time where it is satisfied that there are apparent grounds for granting relief to the applicant or the owner or operator pursuant to a hearing and that there are reasonable grounds for applying for the extension, and the Review Board may give such directions as it considers proper consequent upon the extension. R.S.O. 1990, c. L.1, s. 11 (5); 1998, c. 18, Sched. G, s. 62 (1). Continuation of licence pending renewal (6) Where, within the time prescribed therefor or, if no time is prescribed, before the expiry of the licence, the owner or operator has applied for renewal of the licence and paid the prescribed fee, the licence shall be deemed to continue, (a) until the renewal is granted; or (b) where the owner or operator is served with notice that the Director proposes to refuse to grant the renewal, until the time for giving notice requiring a hearing by the Review Board has expired and, where a hearing is required, until the Review Board has made its decision. R.S.O. 1990, c. L.1, s. 11 (6); 1998, c. 18, Sched. G, s. 62 (1). Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 62 (1) - 01/02/1999 2017, c. 11, Sched. 3, s. 3 - 01/07/2022 Parties 12 (1) The Director, the applicant or the owner or operator who has required the hearing and such other persons as the Review Board may specify are parties to proceedings before the Review Board under this Act. R.S.O. 1990, c. L.1, s. 12 (1); 1998, c. 18, Sched. G, s. 62 (1). Notice of hearing (2) Notice of a hearing under section 11 shall afford the applicant or the owner or operator a reasonable opportunity to show or to achieve compliance before the hearing with all lawful requirements for the issue or retention of the licence. R.S.O. 1990, c. L.1, s. 12 (2). Examination of documentary evidence (3) Any party to proceedings under section 11 shall be afforded an opportunity to examine before the hearing any written or documentary evidence that will be produced or any report the contents of which will be given in evidence at the hearing. R.S.O. 1990, c. L.1, s. 12 (3). Members holding hearing not to have taken part in investigation, etc. (4) Members of the Review Board holding a hearing shall not have taken part before the hearing in any investigation or consideration of the subject-matter of the hearing and shall not communicate directly or indirectly in relation to the subject-matter of the hearing with any person or with any party or the representative of the party except upon notice to and opportunity for all parties to participate, but the Review Board may seek legal advice from an adviser independent from the parties and in such case the nature of the advice should be made known to the parties in order that they may make submissions as to the law. R.S.O. 1990, c. L.1, s. 12 (4); 1998, c. 18, Sched. G, s. 62 (1). Recording of evidence (5) The oral evidence taken before the Review Board at a hearing shall be recorded and, if so required, copies of a transcript thereof shall be furnished upon the same terms as in the Superior Court of Justice. R.S.O. 1990, c. L.1, s. 12 (5); 1998, c. 18, Sched. G, s. 62 (1); 2006, c. 19, Sched. C, s. 1 (1). Findings of fact (6) The findings of fact of the Review Board pursuant to a hearing shall be based exclusively on evidence admissible or matters that may be noticed under sections 15 and 16 of the Statutory Powers Procedure Act. R.S.O. 1990, c. L.1, s. 12 (6); 1998, c. 18, Sched. G, s. 62 (1). (7) Repealed: 1998, c. 18, Sched. G, s. 62 (5). Release of documentary evidence (8) Documents and things put in evidence at a hearing shall, upon the request of the person who produced them, be released to the person by the Review Board within a reasonable time after the matter in issue has been finally determined. R.S.O. 1990, c. L.1, s. 12 (8). Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 62 (1, 5) - 01/02/1999 2006, c. 19, Sched. C, s. 1 (1) - 22/06/2006 Appeal to court 13 (1) Any party to the proceedings before the Review Board under this Act may appeal from its decision or order to the Divisional Court in accordance with the rules of court. R.S.O. 1990, c. L.1, s. 13 (1); 1998, c. 18, Sched. G, s. 62 (1, 6). Record to be filed in court (2) Where any party appeals from a decision or order of the Review Board, the Review Board shall forthwith file in the Superior Court of Justice the record of the proceedings before it in which the decision was made, which, together with the transcript of evidence if it is not part of the Review Board’s record, shall constitute the record in the appeal. R.S.O. 1990, c. L.1, s. 13 (2); 1998, c. 18, Sched. G, s. 62 (1); 2006, c. 19, Sched. C, s. 1 (1). Minister entitled to be heard (3) The Minister is entitled to be heard, by counsel or otherwise, upon the argument of an appeal under this section. R.S.O. 1990, c. L.1, s. 13 (3). Powers of court on appeal (4) An appeal under this section may be made on questions of law or fact or both and the court may affirm or may rescind the decision of the Review Board and may exercise all powers of the Review Board to direct the Director to take any action which the Review Board may direct him or her to take and as the court considers proper and for such purposes the court may substitute its opinion for that of the Director or of the Review Board, or the court may refer the matter back to the Review Board for rehearing, in whole or in part, in accordance with such directions as the court considers proper. R.S.O. 1990, c. L.1, s. 13 (4); 1998, c. 18, Sched. G, s. 62 (1). Section Amendments with date in force (d/m/y) 1998, c. 18, Sched. G, s. 62 (1, 6) - 01/02/1999 2006, c. 19, Sched. C, s. 1 (1) - 22/06/2006 Tests permitted 14 (1) Every owner and operator of a laboratory shall ensure that no tests are performed in the laboratory other than tests authorized by the licence, and no person employed in the laboratory shall knowingly participate in such tests. R.S.O. 1990, c. L.1, s. 14 (1). Specimen taking or collecting permitted (2) Every owner and operator of a specimen collection centre shall ensure that no specimen taking or collecting is carried out in the specimen collection centre other than specimen taking or collecting authorized by the licence, and no person employed in the specimen collection centre shall knowingly participate in such specimen taking or collecting. R.S.O. 1990, c. L.1, s. 14 (2). 15 Repealed: 2017, c. 11, Sched. 3, s. 4. Section Amendments with date in force (d/m/y) 2017, c. 11, Sched. 3, s. 4 - 01/07/2022 Appointment of inspectors 16 (1) The Minister may appoint, in writing, one or more persons as inspectors for the purposes of this Act and the regulations. 2017, c. 11, Sched. 3, s. 5. Certificate of appointment (2) The Minister shall issue every inspector appointed under subsection (1) a certificate of appointment and every inspector, in the execution of his or her duties under this section and the regulations, shall produce the certificate of appointment upon request. 2017, c. 11, Sched. 3, s. 5. Director is an inspector (3) The Director is an inspector by virtue of office, and when acting as an inspector shall, on request, produce evidence of being appointed as Director instead of the certificate of appointment required under subsection (2). 2017, c. 11, Sched. 3, s. 5. Inspections (4) For the purpose of determining whether this Act and the regulations are being complied with, an inspector may, without a warrant, enter and inspect, (a) a licensed laboratory facility; (b) any business premises of a company that owns or operates one or more licensed laboratory facilities; and (c) any place that the Director reasonably believes is being operated as a laboratory facility without a licence. 2017, c. 11, Sched. 3, s. 5. Time of entry (5) The power under this section to enter and inspect without a warrant may be exercised only during the regular business hours of the laboratory facility, business premises or place. 2017, c. 11, Sched. 3, s. 5. Dwellings (6) The power to enter and inspect under this section shall not be exercised to enter and inspect a place or a part of a place that is used as a dwelling. 2017, c. 11, Sched. 3, s. 5. Use of force (7) An inspector is not entitled to use force to enter and inspect a laboratory facility, business premises or place. 2017, c. 11, Sched. 3, s. 5. Powers of inspector (8) An inspector conducting an inspection may, (a) examine records or anything else that is relevant to the inspection; (b) demand the production of a record or any other thing that is relevant to the inspection; (c) remove a record or any other thing that is relevant to the inspection for review, examination or testing; (d) remove a record or any other thing that is relevant to the inspection for copying; (e) in order to produce a record in readable form, use data storage, information processing or retrieval devices or systems that are normally used in carrying on business in the place; (f) take photographs or make any other kind of recording; and (g) question a person on matters relevant to the inspection. 2017, c. 11, Sched. 3, s. 5. Written demand (9) A demand under this section that a record or any other thing be produced must be in writing and must include a statement of the nature of the record or thing required. 2017, c. 11, Sched. 3, s. 5. Obligation to produce and assist (10) If an inspector demands that a record or any other thing be produced under this section, the person who has custody of the record or thing shall produce it and, in the case of a record, shall on request provide any assistance that is reasonably necessary to interpret the record or to produce it in a readable form. 2017, c. 11, Sched. 3, s. 5. Records and things removed from place (11) A record or other thing that has been removed for review, examination, testing or copying, (a) shall be made available to the person from whom it was removed on request and at a time and place that are convenient for the person and for the inspector; and (b) shall be returned to the person within a reasonable time, unless, in the case of a thing that has been subject to testing, the thing has been made unsuitable for return as a result of the testing. 2017, c. 11, Sched. 3, s. 5. Copy admissible in evidence (12) A copy of a record or other thing that purports to be certified by an inspector as being a true copy of the original is admissible in evidence to the same extent as the original and has the same evidentiary value. 2017, c. 11, Sched. 3, s. 5. Obstruction (13) No person shall hinder, obstruct or interfere with or attempt to hinder, obstruct or interfere with an inspector conducting an inspection, refuse to answer questions on matters relevant to the inspection or provide the inspector with false information on matters relevant to the inspection. 2017, c. 11, Sched. 3, s. 5. Personal information in records (14) For greater certainty, a reference to a record in this section includes a record that contains personal information. 2017, c. 11, Sched. 3, s. 5. Section Amendments with date in force (d/m/y) 2014, c. 14, Sched. 1, s. 12 (8-10) - 11/12/2014 2017, c. 11, Sched. 3, s. 5 - 01/07/2022 Restraining orders 17 (1) If it appears to the Director that a person is not complying with this Act or the regulations, the Director may apply to the Superior Court of Justice for an order directing the person to comply, and, upon the application, the court may make the order that the court thinks fit. 2014, c. 14, Sched. 1, s. 12 (11). Same (2) Subsection (1) applies in addition to any other procedures that may be available to the Director, whether or not the Director has exercised his or her rights under such procedures. 2014, c. 14, Sched. 1, s. 12 (11). Compliance (3) A person to whom an order under subsection (1) is directed shall comply with it according to its terms. 2014, c. 14, Sched. 1, s. 12 (11). Appeal (4) An appeal lies to the Divisional Court from an order made under subsection (1). 2014, c. 14, Sched. 1, s. 12 (11). Section Amendments with date in force (d/m/y) 2002, c. 18, Sched. I, s. 13 (1) - 26/11/2002 2011, c. 1, Sched. 6, s. 6 (1) - 30/03/2011 2014, c. 14, Sched. 1, s. 12 (11) - 11/12/2014 Personal information 17.1 (1) The Ministry may directly or indirectly collect personal information for purposes related to the administration or enforcement of this Act, subject to any requirements or conditions provided for in the regulations. 2017, c. 11, Sched. 3, s. 6. Use of personal information (2) The Ministry may use personal information for purposes related to the administration or enforcement of this Act, subject to any requirements or conditions provided for in the regulations. 2017, c. 11, Sched. 3, s. 6. Disclosure of personal information (3) The Ministry may disclose personal information for purposes related to the administration or enforcement of this Act, subject to any requirements or conditions provided for in the regulations. 2017, c. 11, Sched. 3, s. 6. Personal health information not to be used for administration (4) Despite the definition of “personal information” in section 5, “personal information” for purposes related to the administration of this Act does not include personal health information as defined in the Personal Health Information Protection Act, 2004. 2017, c. 11, Sched. 3, s. 6. Section Amendments with date in force (d/m/y) 2017, c. 11, Sched. 3, s. 6 - 01/07/2022 Regulations 18 (1) The Lieutenant Governor in Council may make regulations for carrying out the purposes and provisions of this Act. 2017, c. 11, Sched. 3, s. 7. Same (2) Without restricting the generality of subsection (1), the Lieutenant Governor in Council may make regulations, (a) providing for the issuance and renewal of licences and provisional licences and prescribing their terms and conditions; (b) excluding institutions, buildings or places from the definitions of “laboratory” and “specimen collection centre” in section 5, and providing for additional institutions, buildings or places that are laboratories and specimen collection centres for the purposes of those definitions; (c) prescribing examinations for the purpose of the definition of “laboratory” in section 5; (d) prescribing grounds for the purposes of subsections 9 (10) and 9 (20); (e) prescribing classes of tests for the purposes of this Act and the regulations; (f) respecting the officers and employees of laboratory facilities and prescribing their duties, responsibilities and qualifications; (g) prescribing the classes of persons who may perform tests in a laboratory; (h) prescribing the classes of persons who may take or collect specimens in a specimen collection centre; (i) prescribing classes of persons who shall not be owners of laboratory facilities or of any interest in a laboratory facility; (j) respecting the management and operation of laboratory facilities; (k) requiring laboratory facilities to keep any records and make any reports that are prescribed; (l) respecting and governing the promotion and advertising of laboratory facilities; (m) prescribing fees for licences, provisional licences and renewals and for laboratory services performed by the Ministry; (n) exempting laboratory facilities or any class of laboratory facilities or any class of persons from the application of any provision of this Act or the regulations; (o) prescribing tests to which this Act does not apply; (p) prescribing other duties and powers of the Director and the Review Board, including the approval of educational qualifications of officers and employees of laboratory facilities; (q) instituting a system for the payment by the Province of all or any part of the annual expenditures of laboratories in lieu of amounts payable under the Health Insurance Act; (r) prescribing fees for assessments under a quality management program; (s) designating an agency or agencies to carry out a quality management program, and permitting the agency or agencies to establish and charge fees for assessments under the quality management program; (t) requiring an agency designated under clause (s) to submit reports to the Director, and governing the contents of those reports; (u) prescribing, providing for and governing any other matter that this Act refers to as being prescribed or provided for in the regulations. 2017, c. 11, Sched. 3, s. 7. 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 (5, 6) - 22/06/2006 2011, c. 1, Sched. 6, s. 6 (2) - 30/03/2011 2014, c. 14, Sched. 1, s. 12 (12) - 11/12/2014 2017, c. 11, Sched. 3, s. 7 - 01/07/2022 Agreement 19 The Minister may enter into an agreement with an agency or agencies designated in the regulations to provide for the carrying out of a quality management program acceptable to the Director. 2006, c. 19, Sched. L, s. 6 (7). Section Amendments with date in force (d/m/y) 2006, c. 19, Sched. L, s. 6 (7) - 22/06/2006 Committee 20 The Minister may establish a committee of not fewer than five persons for the purpose of recommending to the Minister standards and procedures for assessments under a quality management program. 2006, c. 19, Sched. L, s. 6 (7). Section Amendments with date in force (d/m/y) 2006, c. 19, Sched. L, s. 6 (7) - 22/06/2006 21 Repealed: 2017, c. 11, Sched. 3, s. 8. Section Amendments with date in force (d/m/y) 2011, c. 1, Sched. 6, s. 6 (3) - 30/03/2011 2017, c. 11, Sched. 3, s. 8 - 01/07/2022 Fines and the Recovery Thereof Offences 22 (1) Subject to subsection (2), a person who contravenes any provision of this Act or of the regulations is guilty of an offence and on conviction is liable, (a) for a first offence, to a fine of not more than $25,000 for each day or part of a day on which the offence occurs or continues or to imprisonment for a term of not more than 12 months, or to both; (b) for a subsequent offence, to a fine of not more than $50,000 for each day or part of a day on which the offence occurs or continues or to imprisonment for a term of not more than 12 months, or to both. 2014, c. 14, Sched. 1, s. 12 (13). Same, corporation (2) A corporation that is convicted of an offence under subsection (1) is liable to a fine of not more than $50,000 for each day or part of a day on which the offence occurs or continues for a first offence and to a fine of not more than $200,000 for each day or part of a day on which the offence occurs or continues for a subsequent offence. 2014, c. 14, Sched. 1, s. 12 (13). Directors, officers, etc. (3) Whether or not a corporation has been convicted of an offence under subsection (1), each director, officer, employee or agent of the corporation who authorized, permitted, acquiesced in or participated in the commission of an offence by the corporation under subsection (1) or failed to take reasonable care to prevent the corporation from committing an offence under subsection (1) is a party to and guilty of the offence, and on conviction is liable to the punishment provided for under subsection (1). 2017, c. 11, Sched. 3, s. 9 (1). No limitation (4) Section 76 of the Provincial Offences Act does not apply to a prosecution under this section. 2002, c. 18, Sched. I, s. 13 (3). Provincial Judge required (5) The Attorney General or an agent of the Attorney General may, by notice to the clerk of the Ontario Court of Justice, require that a provincial judge preside over a proceeding in respect of an offence under this Act. 2017, c. 11, Sched. 3, s. 9 (2). Publication re convictions (6) If a person is convicted of an offence under this Act, the Minister may publish or otherwise make available to the general public the name of the person, a description of the offence, the date of the conviction and the person’s sentence. 2017, c. 11, Sched. 3, s. 9 (2). Restraining order not necessary (7) A person may be prosecuted under this section whether or not a restraining order has been previously made with respect to the subject matter of the prosecution. 2017, c. 11, Sched. 3, s. 9 (2). Certificates (8) In any prosecution or other proceeding under this Act, a certificate of an analyst stating that the analyst has made an analysis of a sample and stating the result of that analysis is evidence of the facts alleged in the certificate without proof of the signature or the official character of the person appearing to have signed the certificate. 2017, c. 11, Sched. 3, s. 9 (2). Section Amendments with date in force (d/m/y) 2002, c. 18, Sched. I, s. 13 (2, 3) - 26/11/2002 2006, c. 19, Sched. L, s. 6 (8) - 22/06/2006 2011, c. 1, Sched. 6, s. 6 (4, 5) - 30/03/2011 2014, c. 14, Sched. 1, s. 12 (13) - 11/12/2014 2017, c. 11, Sched. 3, s. 9 (1, 2) - 01/07/2022 ______________