Immunization Regulation

Immunization Regulation, M.R. 36/2009 The Public Health Act , C.C.S.M. c. P210 Regulation 36/2009 Registered February 20, 2009 bilingual version (HTML) Table of Contents Section 1 Definitions 2-4 Reportable events 5 Immunization records 6 Consent if adult patient not competent to consent 7 Coming into force Definitions 1 The following definitions apply in this regulation. "Act" means The Public Health Act . («  Loi  ») "director" means the director responsible for communicable disease control. (« directeur ») REPORTABLE EVENTS Reportable event 2(1) For the purposes of the definition "reportable event" in section 56 of the Act, a reportable event means an adverse event set out in subsection (2) that is temporally associated with an immunizing agent, cannot be attributed to a co-existing condition, and that meets at least one of the following criteria: (a) the event is life-threatening, could result in permanent disability, requires hospitalization or urgent medical attention, or for any other reason is considered to be of a serious nature; (b) the event is unusual or unexpected, including, without limitation, (i) an event that has not been previously identified, or (ii) an event that has been previously identified but is being reported at an increased frequency; (c) at the time of the report there is nothing in the patient's medical history — such as a recent disease or illness, or the taking of medication — that could explain the event. Adverse events 2(2) The following are "adverse events" for the purpose of subsection (1): (a) a local reaction at or near the injection site; (b) anaphylaxis; (c) an allergic reaction of any of the following types: (i) skin or mucosal, either at or near the injection site or generalized, (ii) cardiovascular, (iii) respiratory, (iv) gastrointestinal; (d) one or more of the following: (i) seizures, (ii) meningitis*, (iii) Guillain-Barré Syndrome*, (iv) Bell's Palsy*, (v) paralysis other than Bell's Palsy*, (vi) encephalopathy* or encephalitis*, (vii) hypotonic or hyporesponsive episode (age less than two years), (viii) persistent crying (continuous and unaltered for more than three hours), (ix) rash, (x) arthritis, (xi) intussusception*, (xii) thrombocytopenia*, (xiii) parotitis, (xiv) oculo-respiratory syndrome; * as diagnosed by a physician (e) a serious event not described in clauses (a) to (d). Report to be made to the director 3 A report under section 59 of the Act about a reportable event must (a) be in a form approved by the minister; and (b) be submitted to the director. Additional information about a reportable event 4 A health professional who reports a reportable event must provide the director, or the director's designate, with such additional information about the reportable event as may be requested by the director or designate, in the time and form specified by the director or designate. IMMUNIZATION RECORDS Information to be recorded on patient's health record 5 Immediately after administering an immunizing agent, the health professional administering it must record the following information on the patient's health record: (a) the date of administration; (b) the name of the health professional who administered the immunizing agent; (c) the name of the immunizing agent, its lot number, dosage, route of administration and the location on the body where the agent was administered. CONSENT IF ADULT PATIENT NOT COMPETENT TO CONSENT Person authorized to consent 6(1) For the purposes of subsection 57(3) of the Act, the following persons are authorized to consent to the administration of an immunizing agent on behalf of an adult patient in accordance with the authority granted to them by law: (a) a proxy appointed by the patient under The Health Care Directives Act ; (b) a committee appointed for the patient under The Mental Health Act if the committee has the power to make health care decisions on the patient's behalf; (c) a substitute decision maker for personal care appointed for the patient under The Adults Living with an Intellectual Disability Act if the granting of consent relates to the powers and duties of the substitute decision maker. Relatives and others who may consent 6(2) If the health professional administering the immunizing agent reasonably believes that no person described in clauses (1)⁠(a) to (c) exists, or that no such person is readily available, the person authorized to consent is the adult person listed first in the following clauses who has had contact with the patient in the preceding 12-month period and is readily available and willing to make the decision as to whether or not to consent on the patient's behalf: (a) a spouse, with whom the individual is cohabiting, or a common-law partner; (b) a son or daughter; (c) a parent; (d) a brother or sister; (e) a person with whom the individual is known to have a close personal relationship; (f) a grandparent; (g) a grandchild; (h) an aunt or uncle; (i) a nephew or niece. Two or more persons of the same ranking 6(3) If there is more than one person described in any clause in subsection (2) who has had contact with the patient in the preceding 12-month period and is readily available and willing to make the decision as to whether or not to consent on the patient's behalf, the person authorized to consent is (a) the person who, in the opinion of the health professional, is most involved in the patient's care; or (b) if the health professional is unable to form an opinion as to who is most involved in the patient's care, the eldest. Meaning of "readily available" 6(4) In this section, "readily available" , in relation to a person, means that it is possible to communicate with the person in a time that is reasonable in the circumstances, and the person has the capacity to understand the nature and consequences of the decision as to whether or not to consent on the patient's behalf. M.R. 115/2025 COMING INTO FORCE Coming into force 7 This regulation comes into force on the same day that The Public Health Act , S.M. 2006, c. 14, comes into force. February 11, 2009 Minister of Health/ 11 février 2009 La ministre de la Santé, Theresa Oswald