GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Blood Regulations — 69
Criteria — collecting establishment 69 (1) An establishment that collects blood must store the blood in accordance with the following: (a) in the case of a licensed establishment, its authorization; and (b) in the case of a registered establishment, the storage and expiration criteria specified in Table 2 of the standard. Criteria — receiving establishment (2) An establishment that receives blood from another establishment must store it in accordance with the directions on its label and with any other directions that are specified in writing by the establishment that collected it.
Blood Regulations — 70
Storage location 70 An establishment that stores blood must do so in a location that has appropriate environmental conditions that maintain the safety of the blood and that is secure against the entry of unauthorized persons.
Blood Regulations — 71
Segregation — autologous, designated and directed donations 71 An establishment that stores blood must ensure that blood that is intended for autologous, designated or directed use is segregated from blood that is intended for other allogeneic use.
Blood Regulations — 72
Segregation — untested or positive or reactive test results 72 An establishment that stores blood must segregate all of the following blood from blood that has been determined safe for distribution or autologous transfusion under section 73 : (a) blood that is untested; (b) blood for which the testing is incomplete or for which all of the test results are not yet available; and (c) blood for which the test results on blood samples are positive or repeat reactive for transmissible disease agents or markers.
Blood Regulations — 73
Determination of safety — allogeneic blood 73 (1) An establishment that collects allogeneic blood must, before distributing it for transfusion or for use in the manufacture of a drug for human use, determine that it is safe for distribution once the establishment is satisfied that the blood has been processed in accordance with these Regulations. Determination of safety — autologous blood (2) An establishment that collects autologous blood must, before distributing it for transfusion, determine that it is safe for autologous transfusion once the establishment is satisfied that the blood has been processed in accordance with these Regulations.
Blood Regulations — 74
Verification 74 (1) Before distributing blood for transfusion or for use in the manufacture of a drug for human use, an establishment must examine the container to verify all of the following: (a) the information on the label is legible; (b) the integrity of the container is intact; (c) there are no signs of deterioration or contamination of the blood; and (d) any frozen blood components show no signs of thawing. Prohibition — distribution (2) An establishment must not distribute blood for transfusion or for use in the manufacture of a drug for human use if the verification carried out under subsection (1) indicates any of the following: (a) the donation code is missing or illegible; (b) any information — other than the donation code — that is required by these Regulations to appear on the label of blood is missing or is illegible, unless the missing or illegible information can be retrieved from the establishment’s records; (c) the container is defective or damaged to the extent that it does not protect the blood against external conditions; or (d) there are signs of deterioration or contamination of the blood.
Blood Regulations — 75
Shipping containers 75 An establishment that ships blood must (a) examine the blood containers before shipping to verify the integrity of the container and the legibility of the labels; and (b) use shipping containers that are capable of resisting damage and maintaining the safety of the blood.
Blood Regulations — 76
Storage during transportation 76 An establishment that ships blood for transfusion must ensure that the blood is stored during transportation in accordance with the criteria specified in Table 2 of the standard.
Blood Regulations — 77
Transformation methods 77 An establishment that transforms blood must do so using safe and effective methods.
Blood Regulations — 78
Washing 78 (1) An establishment that washes blood must do so in accordance with sections 7.5.2.3 and 7.5.3 of the standard. Labels (2) An establishment that washes blood must amend the label to add to it a mention of the washing and any new expiry date and time.
Blood Regulations — 79
Pooling 79 (1) An establishment that pools blood components must do so in accordance with sections 7.11.1 and 7.11.3 of the standard. Labels (2) An establishment that pools blood components must ensure that all of the information specified in sections 10.8.2 and 10.8.3 of the standard appears on the label of the pooled components.
Blood Regulations — 80
Irradiation 80 An establishment that irradiates blood must do so in accordance with sections 7.12.2 to 7.12.6 of the standard.
Blood Regulations — 81
Conditions 81 An establishment may distribute or transfuse allogeneic blood for transfusion for which the test results for ABO group, Rh factor and transmissible diseases or disease agents are not yet available if both of the following conditions are met: (a) blood that has been determined safe for distribution is not immediately available; and (b) the recipient’s physician requests the blood for use in the emergency treatment of their patient.
Blood Regulations — 82
Notice of exceptional distribution 82 (1) An establishment that distributes blood under section 81 must complete a notice of exceptional distribution that contains all of the following information: (a) the name of the establishment and the signature of the medical director; (b) the donation code; (c) a statement of whether the blood was whole blood or a blood component, and if it was a component, its name; (d) a list of the test results that were not available at the time of the distribution; (e) the name and signature of the recipient’s physician; (f) the justification for the distribution; (g) the name of the establishment to which it distributed the blood; and (h) the date and time of the distribution. Notice in establishments’ records (2) The establishment must keep the notice in its records and send a copy of it to the establishment to which it distributed the blood. Notice to be forwarded (3) If the establishment to which the blood is distributed does not perform the transfusion, it must send a copy of the notice to the establishment where the transfusion is performed. Notice in recipient’s file (4) The establishment where the transfusion is performed must keep the notice in the recipient’s file.
Blood Regulations — 83
Labelling 83 An establishment that distributes blood under section 81 must label it to indicate that the testing required by these Regulations is incomplete or that all of the test results are not yet available, as the case may be.
Blood Regulations — 84
Follow-up 84 (1) An establishment that distributes blood under section 81 either before the testing is complete or before the test results are all available must, after the distribution, conduct any remaining testing and provide the establishment to which it distributed the blood with all of the relevant test results as soon as they become available. Results to be forwarded (2) If the establishment to which the blood was distributed did not perform the transfusion, it must send a copy of the test results to the establishment where the transfusion was performed.
Blood Regulations — 85
When blood not transfused 85 If blood that is the subject of an exceptional distribution is not transfused into the intended recipient in the emergency, the establishment that was to perform the transfusion must not store the blood or transfuse it into another recipient.
Blood Regulations — 86
Program characteristics 86 An establishment that has a pre-assessed donor program must ensure that the program has both of the following characteristics: (a) it is carried out under the supervision of a medical director; and (b) it is used only when (i) no other alternative source of blood appropriate for the recipient is available, and (ii) the recipient’s physician requests the blood for use in the emergency treatment of their patient.
Blood Regulations — 87
Donor identification code 87 An establishment that has a pre-assessed donor program must assign a donor identification code at the time of the donor’s acceptance into the program.
Blood Regulations — 88
Regular donor assessment and testing 88 (1) An establishment that has a pre-assessed donor program must take both of the following steps every three months: (a) assess the suitability of every donor in the program in accordance with sections 40 to 44 ; and (b) take blood samples from every donor and test them for all of the following: (i) the transmissible diseases and disease agents listed in sections 8.4.1 and 8.4.2 of the standard, (ii) the ABO group, (iii) the Rh factor, including weak D testing when appropriate, and (iv) clinically significant antibodies. Comparison of results (2) The establishment must compare the results of the tests conducted under subparagraphs (1)(b)(ii) and (iii) with the last available results, if any, for that donor. Discrepancies (3) If the comparison indicates a discrepancy, the establishment must repeat the tests and must not collect any blood from that donor until the discrepancy is resolved.
Blood Regulations — 89
At each collection 89 An establishment that collects blood from a pre-assessed donor must take all of the following steps at each collection: (a) assess the suitability of the donor; (b) assign a donation code to the blood collected and link the code in its records to the donor identification code; and (c) take a sample of blood from the donor and test it within 72 hours for all of the following: (i) the transmissible diseases and disease agents listed in sections 8.4.1 and 8.4.2 of the standard, (ii) the ABO group, (iii) the Rh factor, including weak D testing when appropriate, and (iv) clinically significant antibodies.
Blood Regulations — 90
Labelling 90 An establishment that collects blood from a pre-assessed donor must ensure that at least the donation code and the ABO group and, when appropriate, the Rh factor appear on the label of the blood.
Blood Regulations — 91
When blood not transfused 91 If blood that is collected from a pre-assessed donor is not transfused into an intended recipient in the emergency, the establishment that was to perform the transfusion must comply with the requirements of section 16.2.5 of the standard.
Blood Regulations — 92
Information — before importation 92 (1) An establishment may, in urgent circumstances, import allogeneic blood that was not processed in accordance with an authorization if it provides the Minister with all of the following information before the importation: (a) the information required by paragraphs 6 (1)(a) and (j) with respect to each foreign establishment that processes blood that it proposes to import; (b) a copy of the circular of information for the blood that is proposed to be imported, or an equivalent document; (c) a copy of the donor screening questionnaire that is used by each foreign establishment that processes blood that it proposes to import, including a document that indicates how that questionnaire differs from the one referred to in section 41 ; (d) a description of how post-donation information described in paragraph 44 (1)(b) is evaluated in the foreign jurisdiction; (e) a description of the conditions of storage and transportation of the blood that is proposed to be imported, both before and after its importation; (f) a description of how the establishment proposes to identify the blood as having been imported in urgent circumstances; and (g) a description of how errors, accidents and adverse reactions are investigated and reported in the foreign jurisdiction. Information — at each importation (2) At the time of each importation described in subsection (1), the establishment must provide the Minister with the following information: (a) a written justification that demonstrates the existence of urgent circumstances; and (b) a description of any further processing or labelling that may need to be done to the blood before its transfusion. Meaning of urgent circumstances (3) In this section, urgent circumstances means that there is an insufficiency of allogeneic blood in Canada that poses an immediate and substantial risk to public health.
Blood Regulations — 93
Organizational structure 93 (1) A licensed or registered establishment must have an organizational structure that sets out the responsibility of management for all activities that the establishment conducts. Oversight (2) The establishment must have an effective quality management system, and must name an individual who has responsibility for it. Periodic review (3) The establishment must review its quality management system at regular intervals that are specified in the operating procedures, to ensure its continuing suitability and effectiveness.
Blood Regulations — 94
Requirements 94 (1) The quality management system must include all of the following elements: (a) a quality assurance unit; (b) a quality control program; (c) a change control system; (d) a process control program, within the meaning of section 3.1 of the standard; (e) a system for process improvement through complaint monitoring and the implementation of corrective and preventive actions; (f) a system for the identification and investigation of post-donation information, errors, accidents and adverse reactions, including the implementation of corrective action and the conduct of recalls; (g) a program for the training and competency-evaluation of personnel; (h) a proficiency testing program for the evaluation of the accuracy and reliability of test results; (i) a document control and records management system; (j) an internal audit system; (k) emergency contingency plans; (l) a system that uniquely identifies all critical equipment and supplies; (m) written specifications for all critical equipment, supplies and services; (n) a program for the preventive maintenance of critical equipment; and (o) a program for process validation. Separation of functions (2) The establishment’s quality assurance unit must be a distinct organizational unit that functions and reports to management independently of any other functional unit. Exception (3) Subsection (2) does not apply in the case of a licensed establishment that only tests allogeneic blood or a registered establishment if the establishment ensures that any individual who conducts an internal audit does not have direct responsibility for the activities being audited
Blood Regulations — 95
Operating procedures required 95 An establishment must have operating procedures for all of the activities that it conducts with respect to human safety and the safety of blood.
Blood Regulations — 96
Requirements 96 The operating procedures must meet all of the following requirements: (a) be in a standardized format; (b) be approved by a senior executive officer; (c) be readily accessible at all locations where the activities to which they relate are conducted; and (d) be kept up to date.
Blood Regulations — 97
Documented evidence 97 An establishment must have documented evidence that demonstrates that the operating procedures that it uses in processing and transforming blood will consistently lead to the expected results.
Blood Regulations — 98
Personnel 98 (1) An establishment must have sufficient personnel, who must be qualified by their education, training or experience to perform their respective tasks, to conduct the establishment’s activities. Competency (2) An establishment must have a program for the orientation and training, both initial and ongoing, of personnel and for the evaluation of their competency.
Blood Regulations — 99
Facilities 99 A licensed or registered establishment must have facilities that permit all of the following: (a) the conduct of all of its activities; (b) the performance by personnel of their respective tasks using proper hygiene; (c) the cleaning of the facilities in a way that maintains sanitary conditions; (d) environmental controls that are appropriate to all areas where its activities are conducted; (e) controlled access to all areas where its activities are conducted; and (f) donor screening to be conducted in privacy.
Blood Regulations — 100
Equipment 100 (1) A licensed or registered establishment must ensure that the critical equipment that it uses is cleaned and maintained and, as appropriate, validated for its intended purpose and calibrated. Repair or change (2) The establishment must, whenever necessary after it repairs or makes any change to critical equipment, revalidate and recalibrate the equipment, as appropriate.
Blood Regulations — 101
Storage equipment 101 An establishment must use equipment to store blood that enables the establishment to meet the requirements of sections 69 to 72 .
Blood Regulations — 102
Supplies 102 A licensed or registered establishment must ensure that the critical supplies that it uses are validated or qualified, as applicable, for their intended use and must store them under appropriate environmental conditions.
Blood Regulations — 103
Error or accident of another establishment 103 (1) An establishment that has reasonable grounds to believe that the safety of blood may have been compromised by the occurrence of an error or accident during an activity conducted by another establishment must immediately take all of the following actions: (a) determine the donation codes of the implicated blood; (b) identify and quarantine any implicated blood in its possession; and (c) notify all of the following establishments: (i) the establishment that collected the implicated blood, (ii) the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and (iii) any establishment to which it distributed implicated blood. Contents of notice (2) The notice must include all of the following information: (a) the donation codes of the implicated blood; (b) a statement of whether the implicated blood is whole blood or blood components, and the names of the implicated blood components; and (c) the reason for the establishment’s belief that the safety of the blood may have been compromised. Action on receipt of notice (3) An establishment that is notified under subparagraph (1)(c)(iii) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood and quarantine all implicated blood in its possession. Written notice (4) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.
Blood Regulations — 104
Establishment’s own error or accident 104 (1) An establishment that receives a notice under subparagraph 103 (1)(c)(i) or (ii) or suspects that an error or accident that occurred during an activity it conducted may have compromised the safety of blood must immediately take all of the following actions: (a) determine the donation codes of the implicated blood; (b) identify and quarantine any implicated blood in its possession; and (c) determine whether there is sufficient evidence to warrant proceeding to an investigation into the suspected error or accident. When no investigation — notice (2) If the establishment determines that an investigation is not warranted, it must notify the establishment that sent it the notice under subparagraph 103 (1)(c)(i) or (ii) that it will not be conducting an investigation and provide its reasons for that decision. Action on receipt of notice (3) An establishment that is notified under subsection (2) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood. Notice of investigation (4) If the establishment determines that an investigation is warranted, it must begin the investigation, notify every establishment and other person to which it distributed implicated blood, and include the following information in the notice: (a) the donation codes of all implicated blood; and (b) a description of the suspected error or accident and an explanation of how the safety of the implicated blood may have been compromised. Action on receipt of notice (5) An establishment that is notified under subsection (4) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood and quarantine all implicated blood in its possession. Written notice (6) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.
Blood Regulations — 105
Requirement to cooperate 105 (1) An establishment must, on request, provide any establishment that is conducting an investigation with any relevant information in its possession in respect of blood that it distributed or transfused. Communication (2) When more than one establishment is affected by an error or accident or the investigation of one, each establishment must ensure that every other establishment that is so affected is kept informed of all relevant information and of all developments and issues that arise during the investigation.
Blood Regulations — 106
Investigation results 106 (1) An establishment that is conducting an investigation must notify in writing every establishment and other person to which it distributed implicated blood of the results of the investigation and of any action that is required to be taken. Notice to be forwarded (2) An establishment that is notified under subsection (1) or under this subsection must send a copy of the notice to every establishment to which it distributed implicated blood.
Blood Regulations — 107
Reports to Minister 107 (1) An establishment that is conducting an investigation into a suspected error or accident that is thought to have occurred during an activity that it conducted and that is identified after the blood is distributed or transfused must file the reports described in subsection (2) with the Minister if there is a reasonable probability that the error or accident could lead to a serious adverse reaction. Contents and timing (2) The reports must include the following information and be filed at the following times: (a) a preliminary report that includes all relevant information that is available, within 24 hours after the start of the investigation; and (b) a written update on any new information about the suspected error or accident, on the progress made in the investigation since the last report and on the steps taken to mitigate further risks, (i) within 15 days after the start of the investigation, and (ii) on request of the Minister at any time after the preliminary report. Written notice (3) If the report under paragraph (2)(a) is given verbally, a written report must be filed as soon as possible afterwards. Final report to Minister (4) On completion of an investigation, the establishment must file a final report with the Minister that contains all of the following information: (a) the results of the investigation; (b) the final disposition of the blood that was the subject of the investigation and the reasons for that disposition; and (c) any corrective actions taken and any other changes that are recommended to be made to relevant processes.
Blood Regulations — 108
Annual report 108 (1) An establishment must prepare an annual report that summarizes all of the error and accident investigations that it conducted in the previous 12 months, including a concise critical analysis of those investigations, and must file it with the Minister on request. When to notify Minister (2) If the analysis reveals a previously unidentified risk to the safety of blood, the establishment must notify the Minister immediately. Additional reports (3) An establishment must, on the Minister’s request, file additional reports described in subsection (1) in respect of the period specified in the request.