Qmentum Program. Organ Donation Standards for Living Donors STANDARDS. For Surveys Starting After: January 01, Accredited by ISQua

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1 STANDARDS Organ Donation Standards for Living Donors For Surveys Starting After: January 01, 2014 Date Generated: August 13, 2014 Ver. 9 Accredited by ISQua

2 Published by Accreditation Canada. All rights reserved. No part of this publication may be reproduced, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without proper written permission from Accreditation Canada. Ver. 9 Organ Donation Standards for Living Donors

3 Accreditation Canada would appreciate your feedback on these standards Your Name: Organization Name: address or telephone number where an Accreditation Canada Product Development Specialist may contact you about your feedback: Feedback: Please indicate the name of the standard, as well as the criterion number in your comments. Please be as specific as possible in your comments. For example: I would like to provide comments on the Long-Term Care standards, criterion Clients should be included in this process. I suggest you change the wording to "The team engages staff, service providers, and clients in the process to plan services." You may also submit your feedback online at: [YOUR COMMENTS HERE] Thank you for your input! Please send this page to: Program Development Accreditation Canada 1150 Cyrville Road Ottawa, ON K1J 7S9 Fax: ProgramDevelopment@accreditation.ca

4 The Organ Donation Standards for Living Donors apply to acute care organizations that have a living donation team and program. The standards pertain to living organ donation only, including living kidney, liver, lung, intestine, and pancreas donation; they cover caring for living organ donors through all phases of the living donation continuum, from suitability assessment to organ recovery and follow-up care. The standards include references to the Canadian Standards Association (CSA) standards entitled Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements (Z ) and the subset standards: Perfusable Organs for Transplantation (Z ). The Organ Donation Standards for Living Donors comply with Health Canada s of Human Cells, Tissues and Organs for Transplantation Regulations (1). This standard section covers the following subsections: Making a commitment to living donation services at the leadership level Engaging prepared and proactive staff Guiding potential living donors through the informed decision-making process Assessing the medical and psychosocial suitability of potential living donors Performing living donation procedures safely and effectively Caring for living donors following organ recovery Maintaining accessible and efficient clinical information systems Monitoring quality and achieving positive outcomes 1) of Human Cells, Tissues and Organs for Transplantation Regulations, S.O.R./ to 152 and SI/ to 69 (Canada Gazette, June 27, 2007, Part II). 2) of Human Cells, Tissues and Organs for Transplantation Regulations, S.O.R./ to 152 and SI/ to 69 (Canada Gazette, June 27, 2007, Part II). References Attachment 1 to Appendix B of UNOS Bylaws: Designated Transplant Program Criteria. United Network for Organ Sharing. Canadian Standards Association (CSA) (2003). Z , Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements. Canadian Standards Association (CSA) (2003). Z , Tissues for Transplantation. Canadian Standards Association (CSA) (2003). Z , Perfusable Organs for Transplantation. Enhancing Living Donation: A Canadian Forum: Report and Recommendations. February 9-12, Vancouver, British Columbia. Ethical for the Evaluation of Living Organ Donors. University Health Network Bioethics Program, updated December Pruett, T.L. et al. (2006). The Ethics Statement of the Vancouver Forum on the Live Lung, Liver, Pancreas, and Intestine Donor. Transplantation. 81 (10). The Consensus Statement of the Amsterdam Forum on the Care of the Live Kidney Donor Ver. 9 1 Organ Donation Standards for Living Donors

5 (2004).Transplantation, 78 (4). The Organ Procurement and Transplantation Network. Guidance for the Informed Consent of Living Donors. The Organ Procurement and Transplantation Network. Living Liver Donor Evaluation. of Human Cells, Tissues and Organs for Transplantation Regulations, S.O.R./ to 152 and SI/ to 69 (Canada Gazette, June 27, 2007, Part II). 2

6 Organ Donation Standards for Living Donors MAKING A COMMITMENT TO LIVING DONATION SERVICES AT THE LEADERSHIP LEVEL 1.0 The living donation program delivers services based on established values and policies. 1.1 The living donation program has policies that specify which organs are recovered as part of the program. 1.2 The living donation program sets measurable goals and objectives for its services. Goals and objectives should include participating in national and international programs, registries, and research aimed at both optimizing opportunities for organ transplant, and improving the safety and effectiveness of living donation and transplant. 1.3 The living donation program has an ethical framework or guidelines that are upheld throughout the living donation process. The framework or guidelines are in place to prevent and manage conflict of interest among staff, prevent coercion of potential living donors, and maintain confidentiality and fairness for potential and actual living donors. Continuity of 1.4 The living donation program collaborates with organizations managing clients with organ failure and primary care providers to coordinate living donation services across the continuum. 3

7 Open communication and collaboration with these organizations improves patient flow, makes donation referrals and transfers more efficient, and contributes to achieving positive donation and transplant outcomes. Organizations that manage clients with organ failure may include dialysis centres and other hospitals. 2.0 The organization provides the living donation program with the necessary resources to deliver efficient, high quality services. Efficiency 2.1 The living donation program has a sufficient number of staff members across all relevant disciplines to respond when living donation opportunities arise, and to complete the services within the time frames that the program has established. Each living donation program may have its own defined acceptable lengths of time to complete certain services, such as donor work-ups. 2.2 The living donation team has adequate physical space to properly function and carry out its living donation activities. Efficiency 2.3 The living donation team has private space to meet with potential living donors to provide information and education about the living donation process. Private space may include an office where potential living donors can meet with members of the living donation team to discuss the process, complete aspects of the suitability assessment and have their concerns addressed. Efficiency 2.4 The living donation team has standards in place and monitors those standards for timely access to the necessary diagnostic and consultative services required to complete its medical suitability assessments. Consultative services may include laboratory, HLA laboratory, diagnostic, and specialist services. 4

8 2.5 The living donation team has timely access to operating rooms, ICU beds, and ward beds to carry out organ recovery and provide follow-up care. Efficiency 3.0 The organization has standard operating procedures (SOPs) for all aspects of the living donation process. 3.1 The organization has an SOP manual that is available to all members of the living donation team. CSA Reference: Z , 6.1, The SOP manual is dated and signed by the Medical Director of the living donation program or designate. CSA Reference: Z , Each SOP contains the title and purpose, a unique identification number, the date it was implemented or revised, the signature of the authorizing person(s), the date of authorization, the steps to be followed in the procedure, and who is responsible for checking, reviewing, and approving the SOP. CSA Reference: Z ,

9 3.4 The living donation team has specific SOPs on the qualifications and responsibilities of living donation team members and the protocols that address all phases of the living donation process including patient care plans; guidelines for providing potential living donors with information and obtaining an informed decision; components of the living donor suitability assessment including work-ups for living donor exchange; methods used to prevent donor coercion; time intervals for retrieving, preserving, and storing organs; living donor follow-up; exceptional distribution; retrieving and transporting organs; and record keeping for organs. CSA Reference: Z , The living donation team annually reviews and evaluates the effectiveness of the SOPs and based on the results, the team changes the SOPs, training activities, or monitoring processes as necessary. CSA Reference: Z , The living donation team reviews the relevant SOPs following a sentinel or adverse event, changes in regulatory or legal requirements, internal or external audits, and other situations as defined in the program's policies. 3.7 The living donation team tracks all changes to the SOPs and documents the version numbers. 3.8 The Medical Director of the living donation program or designate approves new or revised SOPs. CSA Reference: Z ,

10 3.9 The Medical Director of the living donation program, or designate provides information and/or training to the living donation team members before implementing a new or revised SOP. CSA Reference: Z , The living donation team members indicate in writing that they have read, understood, signed off on and received training, where necessary, on the SOPs. CSA Reference: Z , The living donation team maintains records of compliance and implementation of the SOPs The organization conducts an independent audit by a neutral individual every two years to verify that the living donation team is following the SOPs. The person carrying out the audit has no direct responsibility for the living donation activities that are being audited. 7

11 ENGAGING PREPARED AND PROACTIVE STAFF 4.0 The living donation team uses an interdisciplinary approach to deliver services. 4.1 The living donation team includes living donation coordinators; donor surgeons; donor physicians; and clinical social workers or psychiatrists or psychologists. Clinical social workers, psychiatrists and psychologists provide information, counselling, and emotional support to living donors. 4.2 The living donation team members have clearly defined roles, responsibilities, and scope of practice. The roles and responsibilities of team members may vary depending on the type of donation or phase of the donation process in which they are involved. 4.3 The living donation team evaluates its interdisciplinary team functioning and makes improvements as necessary. Depending on the type of donation, the team may identify different areas for improving the way it functions and delivers living donation services. 5.0 The living donation team members are experienced, trained, and skilled in the delivery of living donation services. 5.1 A qualified Medical Director or designate supervises the living donation program. The Medical Director or designate of the living donation program is a licensed physician or surgeon with expertise in living donation, critical care, organ recovery or transplantation. 8

12 5.2 The living donation social workers, psychiatrists and psychologists have expertise and experience in living donation. The living donation team members that are responsible for providing information, counselling and emotional support services to living donors should be familiar with the issues, stresses, and psychosocial challenges that living donation involves. 5.3 The living donation team provides each living donor with an opportunity to discuss their intentions about living donation with a donor advocate who promotes the best interests of donors, ensures protection of their rights, and assists them in obtaining information on the living donation process. The donor advocate may be a physician, nurse, living donation coordinator, or clinical social worker. The donor advocate should not be involved in the recipient's care (evaluation and decision to transplant) and should be knowledgeable about living donation and transplant. 5.4 The living donation team has access to an ethicist whom they can consult on ethical matters related to living donation. Access to an ethicist is important in protecting the interests of living donors and developing an ethical framework or guidelines to guide the living donation process. The ethicist may be consulted in cases where team members who have completed the medical and psychosocial assessments cannot reach a consensus on a donor's suitability, e.g. team members may question the donor's capacity or suspect the presence of coercion to donate. 5.5 Living donation coordinators are licensed physicians, registered nurses, or health care professionals with two years of experience in a donation program or clinical health care environment. CSA Reference: Z ,

13 5.6 The organization orients and trains newly recruited living donation team members on the living donation program and standard operating procedures. CSA Reference: Z , 4.2. The orientation and training program for new team members facilitates their understanding of their duties so that they can safely perform them. 5.7 The organization provides living donation team members with regular training and education about living donation. CSA Reference: Z , 4.2. The organization trains and educates the team on all phases of the living donation process, including pre- and post- operative living donor care, standards, best practices, laws and regulations, and delivering client-centered care. 5.8 The Medical Director or designate monitors the education and training and verifies that skills are kept up to date with advancements in the field. 5.9 The Medical Director or designate regularly evaluates and documents each living donation team member's performance in an objective, interactive, and positive way. A performance evaluation is usually done before the probationary program is complete; annually thereafter or as defined by the organization; when new SOPs, technology, equipment, and technical skills are introduced; and when the team member has been away from the workplace for an extended period of time. The evaluation process includes addressing the individual's ability to carry out responsibilities and assigned duties, and considers the individual's contributions to client safety, worklife, and other areas. It may include feedback from clients or peers. Performance evaluations for physicians and surgeons may be carried out by different divisions or departments. 10

14 5.10 Living donation team members demonstrate their competence as a part of their performance evaluation. CSA Reference: Z , The organization documents performance evaluations in the personnel files. 11

15 GUIDING POTENTIAL LIVING DONORS THROUGH THE INFORMED DECISION-MAKING PROCESS 6.0 The living donation team has a written disclosure policy that is used to provide potential living donors with information on living donation. 6.1 The living donation team has a comprehensive disclosure policy that specifies the process for facilitating informed decision-making. The policy may include the timing of the discussions and who is responsible for providing information, answering questions and obtaining the decision. 6.2 The disclosure policy includes a list of key elements of information that must be provided to the potential living donor. CSA Reference: Z , Living donors require information on potential risks and complications (medical, psychosocial, and financial); international, national, and program-specific outcomes of the surgery (where available and appropriate); and the nature and intended use of the organ being recovered. They require a comprehensive description of the assessment process; the surgical procedure and recovery period, including follow-up care and testing, and the process to obtain long-term follow-up health outcomes information. They need to be advised about the possibility of discovering unexpected medical findings during the suitability assessment and the process for handling them. Information should be provided on resources that are available to the donor and on alternative treatments that are available to the recipient. Donors should be reminded that donor information is confidential, including reasons for not proceeding with donation. Non-Canadian donors need to be informed that in the event of an unexpected medical finding, their ability to receive care in Canada for that medical condition may be limited for insurance reasons. The living donor needs to know that the outcome of the transplant may not be successful despite donation; that they are free to change their mind about becoming a living donor at any time during the process; and that their decision, as well as all aspects of their assessment, will remain confidential. 6.3 The living donation team provides the living donor with materials that are easy to understand and explain the phases of the living donation process. To be easy to understand, written materials should be provided in the potential donor's native language and at an appropriate reading level. 12

16 6.4 When required, the organization assists the living donor with accessing professional interpretation services. Family members should not act as interpreters to minimize the risk of coercion. 6.5 The living donation team provides the living donor with information on living donation in a private and confidential manner. The information may be provided in a private room, separate from the transplant program and recipient preparation areas. 6.6 The living donation team verifies that the information provided is understood by the living donor. The team can verify that living donors understand the information provided by, for example, requesting that they repeat it back to them. Other methods include itemizing the consent form, or having two physicians or living donation team members see all patients. 7.0 The living donation team respects the potential living donor's decisionmaking process and choice. 7.1 Consenting to living organ donation is an ongoing process and the living donation team informs the potential living donor that they can withdraw at any time. 13

17 7.2 The team provides every potential living donor with the option of time between donor consent and the scheduled donation operation to contemplate their decision to donate and prevent them from feeling coerced or pressured. Time for reflection allows potential living donors that require it, adequate time to consider their choice. 7.3 The living donation team obtains and documents the potential living donor's informed consent at two points in the process: prior to completing the medical suitability assessment and prior to carrying out the organ recovery procedure. The potential living donor must give informed consent to the medical suitability assessment and work-ups because that assessment may reveal a medical condition or issue of which the donor is unaware. 7.4 When potential living donors withdraw from the donation process, the living donation team maintains confidentiality about the decision and reasons for the withdrawal. 8.0 The living donation team treats living donors with respect and sensitivity. 8.1 The living donation team informs living donors about their rights and investigates and resolves any claims that their rights have been violated. Living donor rights include the right to have their privacy and confidentiality protected; be treated with respect and care; maintain cultural practices; pursue spiritual beliefs; be free from abuse, exploitation, and discrimination; have consent obtained in a way that is free from coercion; and to raise concerns about the quality of service. 8.2 The organization has policies specifying the methods used to minimize the potential for donor coercion, and for determining that no illegal material reward is given to potential living donors in the selection and consent processes. 14

18 While donors may be reimbursed for their expenses associated with the living donation process, the living donation program should take steps to monitor and prevent coercion and reward for donation. Steps may include verbally informing potential donors of the policies and laws regarding material reward and coercion or conducting further assessments when team members suspect that illegal material rewards may be involved in the donation. 8.3 The organization has a process to identify and address ethical issues related to living donation. The process for handling ethics issues is established at the organization level. Staff and service providers receive training on making ethical decisions, including guidelines for handling disagreements between donors and service providers and among service providers on ethics-related questions. Training also includes mechanisms to share information with donors and families and identify client needs resulting from ethical questions. Ethical issues related to living donation may include persuasion or coercion to donate; illegal compensation for donation; confidentiality; fairness and justice; or handling exceptional distribution requests. Ethics-related issues may be addressed by an ethics committee or consultation team which may include health service professionals, clergy, or ethicists. In addition to clinical consultation, the ethics committee may be involved in policy review and ethics education. Ethics-related issues involving particular living donors are recorded in the client record. 8.4 The living donation team responds to complaints in an open, fair, and timely way. Living donors should feel comfortable raising concerns or issues. For example, the organization may provide access to a neutral, objective resource person from whom clients can seek advice or consultation. 15

19 ASSESSING THE MEDICAL AND PSYCHOSOCIAL SUITABILITY OF POTENTIAL LIVING DONORS 9.0 The living donation team conducts a comprehensive medical and surgical suitability assessment of potential living donors. 9.1 The living donation team conducts and documents a comprehensive living donor medical and surgical suitability assessment to assess and limit the risks to the potential living donor post-donation, and determine the suitability of the donated organ. CSA Reference: Z , The living donation team opens a formal medical record for potential living donors when the medical assessment begins. Opening a medical record as soon as the assessment begins ensures the program has an accurate record of all potential donors, including those that do not proceed beyond the early stages of the assessment. This record should be separate from the recipient's record. 9.3 The living donor medical suitability assessment is conducted by a neutral physician or surgeon with experience in living donation who is not involved in the intended recipient's pre-transplant assessment. CSA Reference: Z , The neutral physician may act as the donor advocate to prevent conflict of interest in the living donation process. 9.4 The living donation team conducts the necessary serological, blood, and infectious disease laboratory testing for potential living donors within one month of surgery. CSA Reference: Z , 14.2; Z , See CSA Z , for organ-specific testing. 16

20 9.5 The living donation team obtains and documents potential living donor information and history for the suitability assessment. CSA Reference: Z , The team obtains donor information and history (both medical and psychosocial) using standardized questionnaires that capture factors such as age, medical history, family history of disease, behavioural risk, exposure risks, immunizations, or transfusions. 9.6 The living donation team conducts and documents a timely physical examination for potential living donors as part of the suitability assessment. CSA Reference: Z , 13.2; Z , 12.2 and The physical examination is carried out to look for risk factors for surgery, organ disease, infection and malignancy. Potential living donors must also be assessed based on the risks associated with anaesthetic and the surgical procedure as well as a determination of the health of the organ. 9.7 The living donation team has procedures for potential donors who do not complete testing or repeatedly miss appointments for testing. When potential donors fail to show up for required testing, the living donation program follows procedures such as setting a maximum number of missed testing appointments or sending a letter indicating that the program questions whether the donor wants to proceed. 9.8 In the case of a seriously ill recipient, the living donation team upholds the same standards for comprehensive donor suitability assessments and workups. A rapidly deteriorating condition in the intended recipient is not a justifiable reason for less than thorough assessments and workups. 17

21 10.0 The living donation team conducts a comprehensive psychosocial suitability assessment of potential living donors The living donation team's licensed clinical social worker or psychiatrist, who is independent of the intended recipient's pre-transplant assessment, conducts and documents a living donor psychosocial assessment The living donation team's licensed clinical social worker or psychiatrist uses a semi-structured interview to carry out the psychosocial suitability assessment The team's psychosocial assessment evaluates the potential living donor's psychological, emotional and social stability; decision-making capacity and competency; ability to cope with possible psychosocial and financial consequences and risks; relationship with the recipient; reason for donation; and the degree to which the expectations of the donation and transplant are reasonable and the decision to donate is made freely without pressure or coercion. The assessment may explore how the donor decided to consider donation and reached the decision to donate; possible declining family power dynamics; their expectations of the donation and transplant, e.g. in terms of their relationship with the donor and the fact that the transplant may not be successful despite donation As part of the living donor psychosocial assessment, the team verifies that the donor will be able to access appropriate future medical and psychosocial care such as post-operative care, care for complications, long-term medical followup, and psychosocial supports. Psychosocial supports may include support for psychological and emotional conditions such as anxiety and depression, as well as social supports such as employment insurance or other appropriate financial resources. 18

22 10.5 Following the medical and psychosocial assessments, the living donation team meets to discuss all aspects of the interdisciplinary suitability assessments and create a plan for surgery if consensus is reached If the living donation team cannot reach a consensus about the medical and psychosocial suitability of a potential donor, they follow a process to reach a decision about whether or not to proceed with the donation. The process may involve consulting other medical experts, a bioethicist, legal counsel, hospital administration or other external resources to assist them in their decisionmaking The living donation team offers to make arrangements for appropriate medical care for potential donors that are deemed unsuitable due to medical reasons. Making arrangements may include advising the potential donor's primary care provider of the results and recommending follow-up If the potential living donor is deemed unsuitable, the team reassures the potential donor that reasons for not proceeding with donation will be kept confidential The living donation team facilitates access to counselling from a social worker or psychologist to help clients deal with the discovery of an unexpected medical problem or issue such as non-paternity. 19

23 11.0 The living donation team prepares the potential living donor for the donation procedure by providing education and making arrangements for follow-up The living donation team has specific members responsible for educating and counselling potential living donors on the requirements for short -and long-term follow-up post-donation. Short-term follow-up may be provided by the living donation team while long-term follow-up may be provided by the donor's primary care provider. Follow-up care may vary depending on the type of living donation (e.g. blood pressure, blood sugar, urinalysis and serum creatinine for kidney donors; liver function tests and ultrasound for liver donors; and lung function measurements, oxygen saturation, and chest x-ray for lung donors). Education is interactive. Resources may include information about donor and caregiver information sessions (individual or group); written materials on community resources, home care services, and rehabilitation The living donation team provides education to potential living donors on recovering from the donation procedure, potential changes in lifestyle, and the need for maintaining a healthy lifestyle post-donation. After donation, living donors, families and caregivers may experience changes, e.g. returning to work or needing caregiver support. Information should be provided on possible issues or changes, potential strategies to address these changes, and resources and contact information. Information should also be provided about a healthy lifestyle The education and resources provided by the living donation team are appropriate to the potential living donor's type of donation, readiness, and needs. Education and resources are provided in a variety of languages and formats (written, oral, group, counselling), and specific to the donor's needs The living donation team documents in the potential living donor's medical record that education was provided prior to discharge. 20

24 The documentation describes the timing of the education, the type of education provided, materials shared and content reviewed, family members that were present, duration of session and who provided the education Prior to the donation procedure, the living donation team establishes how communication between the donor and recipient will occur after the procedure in order to maintain confidentiality. Depending on the relationship between the donor and recipient, they may want to communicate or be kept informed of each other's progress. How this will happen needs to be established prior to the procedure so that confidentiality is maintained, where appropriate The living donation team responds to requests for exceptional distribution of organs only in circumstances where it has been appropriately justified The organization has a documented procedure for responding to requests for exceptional distribution of organs. Health Canada defines exceptional distribution as the release of organs to a transplant program from a donor whose donor suitability assessment has identified an increased risk for disease transmission. Exceptional distribution may be permitted only in circumstances where it is medically justified and the potential benefit outweighs the potential risk to the recipient If divulging information to the recipient about any unspecified high-risk behaviour or reasons for the exceptional distribution, the living donation team obtains the living donor's informed consent The Medical Director or living donation coordinator records in the donor client record the circumstances, date and time of the exceptional distribution, and names of the physicians from the donation program and transplant centre involved in the exceptional distribution. CSA Reference: Z ,

25 Population Focus 12.4 The notice of the exceptional distribution includes the organ name, tests not completed or the conditions not met, reasons justifying the exceptional distribution, name of the organization and signature of the transplant physician or surgeon authorizing the organ release, physicians involved in the exceptional distribution, and date of the authorization. CSA Reference: Z , Following the exceptional distribution, the living donation team completes the donor suitability testing and informs the transplant program of the results The organization minimizes the need for an exceptional distribution by making sure that the appropriate testing is available to properly release the organs. 22

26 PERFORMING LIVING DONATION PROCEDURES SAFELY AND EFFECTIVELY 13.0 The living donation team safely and effectively carries out the living donation surgical procedure REQUIRED ORGANIZATIONAL PRACTICE: The team identifies medical and surgical clients at risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) and provides appropriate thromboprophylaxis. Venous thromboembolism (VTE) is the collective term for deep vein thrombosis (DVT) and pulmonary embolism (PE). VTE is a serious and common complication for clients in hospital or undergoing surgery. Evidence shows that incidence of VTE can be substantially reduced or prevented by identifying clients at risk and providing appropriate, evidence-based thromboprophylaxis interventions. Currently, the American College of Chest Physicians Evidence-Based Clinical Practice (8th edition) are the generally accepted standard of practice for the prevention of VTE. The widespread human and financial impact of thromboembolism is well documented. Development of VTE is associated with increased patient mortality, and is the most common preventable cause of hospital death. In addition, both hospital costs and median length of stay are greatly increased for patients developing VTE. Note: This ROP is not a requirement for pediatric hospitals. The ROP applies to clients 18 years of age or older. Test(s) for Compliance Major The organization has a written thromboprophylaxis policy or guideline. Major The team identifies clients at risk for venous thromboembolism (VTE), [(deep vein thrombosis (DVT) and pulmonary embolism (PE)] and provides appropriate evidence-based, VTE prophylaxis. Minor The team establishes measures for appropriate thromboprophylaxis, audits implementation of appropriate thromboprophylaxis, and uses this information to make improvements to their services. Minor The team provides information to health professionals and clients about the risks of VTE and how to prevent it REQUIRED ORGANIZATIONAL PRACTICE: The team uses a safe surgery checklist to confirm safety steps are completed for a surgical procedure. 23

27 Surgical checklists play an important role in the provision of effective and safe surgery. Evidence demonstrates that the use of safe surgery checklists reduces the likelihood of complications following surgery, and may improve surgical outcomes. The purpose of a safe surgery checklist is to initiate, guide, and formalize communication among the team members conducting a surgical procedure and to integrate these steps into surgical workflow. Surgical procedures are increasingly complex aspects of health services, and carry a significant risk of potentially avoidable harm. Data show substantial cost savings if surgical checklists are widely used; Semel et al. estimate resultant savings in the USA of billion dollars. Safe surgery checklists have been developed by and are available from Canadian (Canadian Patient Institute) and international (World Health Organization) sources. Each checklist has three-phases: i. Briefing: Before the induction of anesthesia ii. Time out: Before a skin incision is made iii. Debriefing: Before the patient leaves the operating room. Test(s) for Compliance Major The team has agreed on a three-phase checklist to be used in the operating room. Major The team uses the checklist for every surgical procedure. Major The team has developed a process for ongoing monitoring of compliance with the checklist. Minor The team evaluates the use of the checklist and shares results with staff and service providers. Minor The team uses results of the evaluation to improve the implementation of and expand the use of the checklist The living donation team conducts an intraoperative assessment to check for presence of infection, malignancy and assess the physical quality of the organ being donated. CSA Reference: Z ,

28 13.4 The living donation team reports any unsuspected infections, malignancies, or abnormalities that are found during the intraoperative assessment. CSA Reference: Z , The living donation team reviews the donor medical and surgical suitability assessment information before recovering the organs The living donation team recovers organs using aseptic techniques to maintain the safety of the living donor and prevent contamination of recovered organs. CSA Reference: Z , The living donation team inspects the recovered organs for anomalies and documents the findings in the medical record for the transplant team. 25

29 CARING FOR LIVING DONORS FOLLOWING THE SURGICAL PROCEDURE 14.0 The living donation team provides living donors with immediate follow-up care following their donation procedure The living donation team provides living donors with prompt access to the appropriate interdisciplinary services following the donation procedure. Interdisciplinary services may include those provided by surgeons, physicians, nurses, pain specialists, nurse practitioners, nutritionists, rehabilitation therapists, social workers, and psychologists The living donation team tells living donors what is contained in the postoperative care plan. The post-donation care plan includes post-operative care that the donor will receive while in hospital The living donation team monitors the living donor for pain and complications immediately following surgery. Complications vary depending on the type of organ donation procedure and may include reactions to anaesthesia, organ-specific complications, blood clots, pneumonia, infection, pain and discomfort In cases where the recipient experiences an adverse event, the living donation team offers psychosocial support services to the donor, where appropriate. 26

30 15.0 The living donation team prepares living donors for transition to another service team or setting, service provider, or end-of-service The living donation team develops and shares with the living donor a postdonation immediate and long-term follow-up care plan. Continuity of The living donation team provides living donors with information about follow-up care and how to access services once they have left the facility. Short-term post-operative follow-up by a medical or surgical transplant team member is recommended between 4-12 weeks and at 12 months for all living donors. If the team cannot provide these services (e.g. the donor lives a significant distance from the program), they assist living donors in accessing the services elsewhere, or the services may be provided by primary care providers. For long-term follow-up, it is recommended that donors be responsible for accessing care (e.g. through their primary care provider) beyond the first year The living donation team provides living donors with written instructions preparing them for discharge. Continuity of Continuity of care is enhanced when living donors have comprehensive information about end-of-service. Information provided to the donor and family includes the donor's service plan, goals, and preferences; a summary of the care provided; an updated list of outstanding issues, clinical or otherwise; what to expect at end-of-service; possible diet and activity restrictions; contact information for the living donation team and details on when donors should contact them, e.g. if donors notice any warning signs or symptoms of adverse reactions The living donation team tells the donor how to access follow-up support services that address psychosocial issues related to donation. Continuity of 15.4 The living donation team communicates with the living donor's primary care physician to arrange for long-term follow-up care. Continuity of 27

31 The donor's primary care physician needs to know that the donor will require follow-up testing at regular intervals, as well as check-ups that cover exercise, diet and weight Following discharge, the living donation team contacts the donor or primary care provider to transfer donor information and gather health outcomes data. 28

32 MAINTAINING ACCESSIBLE AND EFFICIENT CLINICAL DONATION INFORMATION SYSTEMS 16.0 The living donation team keeps living donor records accurate, up-to-date, and secure The living donation team maintains an accurate, up-to-date record for each potential living donor that is separate from the recipient's record. CSA Reference: Z , 7.3. The living donor record includes the donor's consent, written reports by those carrying out the medical and psychosocial suitability assessments, tests completed, test results, notes on the retrieval, labelling, and the identity of those performing the steps, records on adverse events or problems, and dates for each step of the process The living donation team assigns each living donor a unique identification number. CSA Reference: Z , 7.2. The unique identification number maintains donor confidentiality and traceability between donors, donated organs, and recipients The organization is able to trace organs between the donor and recipient. Keeping comprehensive documentation and using unique identification numbers allows the organization to trace organs between living donors and recipients. Some information required to trace organs between donors and recipients may be collected and maintained by Organ Procurement Organizations (OPOs) The living donation team shares living donor information and coordinates its flow among other teams or organizations with the consent of the living donor. Continuity of Other organizations include primary care providers, transplant centres, and follow-up support services. The sharing of living donor information respects applicable provincial privacy legislation. 29

33 16.5 The organization retains records for a minimum of 30 years after the living donation. CSA Reference: Z ,

34 MONITORING QUALITY AND ACHIEVING POSITIVE OUTCOMES 17.0 The living donation team uses the latest research, evidence-based guidelines, and best practice information to improve the quality of its living donation services The living donation program has a process to select evidence-based guidelines for living donation services. Evidence-based guidelines may be established internally by the living donation program, a council, or an individual who develops tools and makes recommendations to the team. Organizations such as the Organs and Tissues Division of Canadian Blood create consensus documents on best practices. The Canadian Medical Association publishes best practice guidelines, as does the Canadian Institute for Health Information (CIHI) that publishes guidelines as well as outcomes through CORR (Canadian Organ Replacement Register). from other organizations or associations may be adopted by the team. The process for selecting guidelines should be standardized and formalized. It may include using content experts, a consensus panel, the Appraisal of Research and Evaluation (AGREE) instrument, or the Cochrane Collaboration's systematic reviews The living donation team reviews the guidelines to make sure they are up to date and reflect the current research and best-practice information. The team's review process includes ways to access the most up-to-date research and information, e.g. through literature reviews, content experts, national organizations or associations, or the Cochrane Collaboration. Research information may include intervention research, program evaluations, and clinical trials The living donation team consistently follows the selected evidence-based guidelines The living donation team follows Health Canada's regulations for the of Human Cells, Tissues and Organs for Transplantation. 31

35 17.5 The living donation team's research activities meet applicable research and ethics standards. The team may participate in research initiatives to improve the quality of care to living donors and their families such as clinical trials, assessments of new interventions, or changes to existing ones. Research and ethics protocols and standards include those for client consent to participate in research activities The living donation team shares benchmark and best practice information with its partners and uses the information to make improvements to its services. Benchmarking data may include process or outcome measures. The team may share its data across different levels of the organization or partner organizations such as other living donation facilities. CIHI's CORR publishes benchmark and best practice information. Teams may use this information to compare themselves to national trends and make improvements to their service delivery accordingly The living donation team regularly monitors safety and addresses areas of risk The living donation team is trained to identify, reduce, and manage risks to donors, their families, recipients, and staff safety. Risks to recipients may include donor-recipient mismatching; positive infectious disease results; and problems with handling, storing, or dispensing medications. Risks to donors may include emotional and psychological factors associated with persuasion or coercion to consent to donation The living donation team participates in regular safety briefings. 32

36 Regular opportunities to proactively share information about potential safety issues and review actual incidents, e.g. Morbidity and Mortality conferences or debriefing sessions after each living donor case, can reduce risk and the likelihood of an incident occurring or recurring The living donation team has verification processes for high-risk activities. High-risk activities include donor-recipient mismatching, infectious disease testing, donor exclusionary criteria testing and assessments, post-surgical complications and maintaining organ traceability The living donation team makes special arrangements to maintain the longterm health and safety of living donors that are at high-risk for complications or isolated medical abnormalities The living donation team investigates all sentinel and adverse events and notifies the individuals who are effected in a timely way. In event of sentinel and adverse events, the team must quarantine the recovered organs, notify all implicated individuals and organizations, and initiate an investigation. Adverse events include accidents, errors, and adverse reactions The living donation team discloses the sentinel or adverse event and results of the investigation to Health Canada, the Public Health Agency of Canada, and donors. 33

37 The team discloses sentinel and adverse events and investigations to Health Canada in the form of a preliminary report within 24 hours of beginning of the investigation. A more detailed report of the suspected error or adverse event is submitted within 15 days of the start of the investigation and every 15 days after the event until the final report is submitted. This criterion reflects Health Canada's Regulations for the of Human Cells, Tissues and Organs for Transplantation The living donation team takes steps to prevent the adverse event, error, or accident from occurring again The team collects and uses indicator data to guide its quality improvement initiatives. As of January 01, 2015, this criterion comes into effect and will be assessed during on-site surveys The team collects information and feedback from clients, families, staff, service providers, organization leaders, and other organizations about the quality of its services to guide its quality improvement initiatives. The team gathers information and feedback in a consistent manner from its key stakeholders about the quality of its services. Feedback, in the form of client and family satisfaction or experience data, complaints, indicators, outcomes, scorecards, incident analysis information and financial reports, may be gathered by a variety of methods, including surveys, focus groups, interviews, meetings, or records of complaints. As of January 01, 2015, this criterion comes into effect and will be assessed during on-site surveys The team uses the information and feedback it has gathered to identify opportunities for quality improvement initiatives. The team uses feedback as well as other forms of information, and observation and experience, to identify and prioritize areas for quality improvement initiatives. This is done using a standardized process based on criteria such as client-reported outcomes, risk, volume, or cost. As of January 01, 2015, this criterion comes into effect and will be assessed during on-site surveys. 34