Laboratory and Specimen Collection Centre Licensing Act

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Sections55

• 1Definitions

  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

• 1.
• 2-4

  2-4 Repealed: 2006, c. 19, Sched.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

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• 2.-4.
• [s2]

  Health Facilities

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• 4.
• 5Definitions

  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 labora…

• [s4]
• 6Director

  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.

• 5.
• 7Repealed

  7 Repealed: 1998, c. 18, Sched.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

• 6.
• 8Protection 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

• 7.
• 9Licence 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 lic…

• 8.
• 9 #8Licence required
• 9.1Emergency 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…

• 9.
• 9.2Transfer 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

• 10Hearing 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…

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• 11Proposal 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…

• 11.
• 12Parties

  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 he…

• 12.
• 13Appeal 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.
• 14Tests 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).

• 14.
• 15Repealed

  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

• 15.
• 16Appointment 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 warran…

• 16.
• 17Restraining 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…

• 17.
• 16 #18Appointment of inspectors
• 17.1Personal 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, “persona…

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• 18Regulations

  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 …

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• [s20]
• 19Agreement

  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

• 20.
• 20Committee

  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.
• [s22]
• 18 #22Regulations
• 21Repealed

  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

• [s23]

  Fines and the Recovery Thereof

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• 22Offences

  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 …

• [s26]