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Consent to Treatment/Procedure

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1 Consent to Treatment/Procedure
AHS Clinical Policy Consent to Treatment/Procedure

2 Overview Purpose of Consent Policy Consent to Treatment/Procedures
Forms Resources Case Scenarios Questions In this presentation we will cover the following: purpose of the consent policy there are 5 consent procedures Forms Resources Case scenarios Questions – we know that you have many questions and would ask that you hold them until the end of this presentation. 2

3 Suite of Associated Procedures
Consent Policy Suite AHS CONSENT POLICY (Broad Principles) Suite of Associated Procedures This slide provides a “picture” of the various consent documents and their relationships to one another. In addition to a policy and 5 procedures, it also highlights forms and additional resources that are needed to fully implement the policy and procedures. This overview make it easy for clinicians to identify and find what they need for a particular patient group It provides supplementary tools for clinicians and patients e.g. patient / family guides to consent We encourage clinicians to read the full policy suite, especially the definitions which are capitalized throughout the documents. The focus of this training session will be the policy and first three procedures. Adults with Capacity Adults with Impaired / Lack of Capacity Mature Minors & Minors Mental Health Formal Patients & Community Treatment Orders Human Tissue & Organ Donation Consent Form(s) As per national & international requirements Consent Form(s) (limited # of forms: needs-based) RESOURCES e.g. patient guides, clinical algorithm etc. 3 3

4 Introduction Purpose of a new consent policy:
Consistency of consent process within AHS Legislative compliance Informed consent Obtaining consent from patients is undertaken across the province in many varied settings every day but with differing approaches and forms depending on where you live. This policy and five procedures provide a consistent approach and does away with the majority of the 1100 consent forms currently in use, many of which have had no legal oversight. On the Consent Resources website there is a list of those policies in former regions that have been replaced by these new documents. 4

5 Legislative Compliance
Adult Guardianship and Trustee Act Human Tissue and Organ Donation Act Mental Health Act Family Law Act There are at least 4 provincial Acts that inform the new AHS consent policy and procedures. The most recent is the Adult Guardianship and Trusteeship Act which came into effect October 30, AHS put a directive in place until this consent work could be completed. With so much legislation informing this work it presents significant challenges to ensure compliance with all applicable legislation together with a consistent approach to the consent process.

6 Informed Consent Reflects good practice Contributes to Patient safety
Enhances patient experience Consent by a patient must be informed – this is a cornerstone principle within the policy and is reflected in both: the Health Professions Act Standards of Practice, January 1, 2010, College of Physicians and Surgeons of Alberta Consent, A Guide for Canadian Physicians, 4th edition, Canadian Medical Protective Association 6

7 Substitute Decision-Maker
Give Consent Withdraw Consent Refuse Treatment Voluntary Informed Specific Shared Decision-Making & Accountability This is our attempt at a high-level representation of the key concepts for the consent process Starting in the arrow, this represents the principles and the players. The first step in the process is to determine capacity. If the person does not have full capacity, then there are, as we know, provisions for substitute decision-makers and emergency situations. Moving to the upper left, people have the right to give consent, withdraw consent or to refuse treatment. Whatever their choice, the consent process must be voluntary and informed. Specific as a concept (i.e. related to a specified procedure) is part of the informed consent process. The central premise is that both the individual and the health care provider are part of a shared decision-making process and both have accountability within that process. PRINCIPLES Patients / Partners Practitioners Capacity Substitute Decision-Maker Emergency 7 7

8 Consent Process The consent process, when clinically safe to do so, consists of adhering to the following five steps: Determine capacity: as per continuum Commence dialogue: as per rights & principles Verify understanding: address barriers Decision-making: patient/alternate & provider Document process & outcome: verbal or written as required, or noted in health record. These five steps constitute the core elements that are articulated in the policy and procedures, and that facilitate the participation of the patient - in true partnership with the clinician - in achieving a good informed consent process. 8 8

9 When Consent is Required
Before a procedure or treatment is provided there must be express or implied consent Unless a valid exception applies e.g. in an emergency 9

10 Most Responsible Health Practitioner
Means the Health Practitioner who has responsibility and accountability for the specific Treatment/Procedure(s) provided to a Patient and who is authorized by Alberta Health Services to perform the duties required to fulfill the delivery of such a Treatment/Procedure(s) within the scope of his/her practice. Only the Most Responsible Health Practitioner may now obtain informed consent from the patient In most cases, the MRHP is a physician but could be a midwife, dentist or nurse practitioner. In some AHS clinics providing care in the community, the MRHP could be a nurse or pharmacist. Consent is valid across zones and within group practices; that is it travels with the patient. If there is any uncertainty by the receiving physician, the consent discussion with the patient can be undertaken again and another form signed. 10

11 Informed Consent Duty of Most Responsible Health Practitioner to inform the Patient: Nature of Treatment/Procedure Risks Benefits Alternatives Consequences 11

12 Implied Consent Consent inferred from the Patient
or Alternate Decision-Maker (if applicable) Presumed by actions and surrounding circumstances Example: Presents voluntarily for an examination Minor or less invasive treatment/procedure Implied consent must still be informed. If there is any doubt that there is implied consent, the MRHP must obtain express consent either verbal or written 12

13 New Criteria for Consent
“The Most Responsible Health Practitioner is responsible for ensuring that there is valid and informed consent for any given Treatment/ Procedure(s) …… Informed Consent may be expressed verbally or in writing, or be implied.” The policy and procedures do not provide a list of procedures for which written consent is required with the exception of blood and blood products and human tissue and organ donation. The latter is required in legislation. The CMPA Guide to Consent advises that consent in written form should be obtained for surgical operations and invasive investigative procedures. It goes on to say that it is prudent to obtain written consent also whenever analgesic, narcotic or anesthetic agents will significantly affect the patient’s level of consciousness during the treatment. Many facilities and settings do have lists of procedures for which written consent is required and you can continue to use them as long as they are consistent with the new Consent policy and procedures. However, with the introduction of the new Consent policy, clinicians are re-examining their consent processes or re-visiting consent issues that have been unresolved for some time. Additional Treatment/Procedure(s) that have nothing to do with the original Treatment/Procedure(s), must not be performed without prior consent except in the case of an emergency. 13

14 New Criteria for Consent
“Express written consent shall be obtained for the transfusion of blood and blood products.” (PRR-01, Section 1.3) Obtaining informed consent for the transfusion of blood and blood products is a national requirement. Blood and blood products carry their own benefits and risks and may have medically appropriate alternatives. Provision of this information to patients is necessary to inform their choices. The Krever Inquiry made it clear that consent for blood should not be assumed under the “umbrella” of the larger care plan without first discussing this information with the patient. Alberta is behind the rest of the country in requiring written consent for a blood transfusion. Consent can be for a single transfusion or for a series of transfusions, for example in a treatment plan. During the conversation to obtain informed consent the discussion should include whether it is one time only or a series of transfusions and that information should be captured on the consent form. In the event of an unexpected need for a transfusion written consent is still required but the actions taken will depend on the circumstances and different aspects of the Consent policy might then provide direction, for example an emergency. Several FAQs have been developed in collaboration with Transfusion Medicine and will be posted on the Consent resources website this week. 14

15 Documenting Consent Outcomes
The MRHP is responsible for ensuring appropriate documentation of the consent process and outcomes on the patient health record. Specifically, the following outcomes shall be recorded: a. Agreement to treatment/procedures b. Refusal of treatment/procedures c. Withdrawal of consent previously given (PRR ) The new Consent form is intended to replace existing forms and is a way of documenting the patient’s agreement to a treatment or procedure. If the patient changes his mind, there is space on the form to indicate that consent has been withdrawn which is dated and initialed by the patient. The new Consent form is not intended to document the patient’s refusal to consent to a particular treatment or procedure. This should be documented in the usual space in the patient’s health record. We’ll have a look at the new form in just a few slides from now….

16 Adults with Capacity An Adult Patient is presumed to have Capacity and is able to make decisions until the contrary is determined Capacity for a particular Patient can change depending on changes to his/her mental and physical health. The Adult Patient’s entitlement to make decisions based on his or her values and beliefs should be supported. 16

17 Adults with Capacity Scenario:
The patient arrives at the office of Dr. X and needs a bowel resection. “I generally obtain written consent for surgical procedures from patients in my office In some cases a blood transfusion is needed and I generally discuss the possibility with the patient Typically in the past where I work I would witness the patient’s signature. What do I do now?” A few general comments: We will work with clinicians, programs, departments to resolve issues encountered. These are varied from zone to zone, and we are committed to work with leaders such as Elizabeth Mackay in Calgary zone. For example we know there is awkwardness and difficulties in managing issues around patient testing in needlestick injuries; however, there is work occurring with WHS, policy, Legal and clinicians that will work out the best solution overall. If necessary we will create a new policy or procedure or form. Re the basket of procedures issues, there appear to be some forthcoming solutions through the good work of all, and collaboration with government departments. We will comment further in a scenario and the OPG experts will speak to this. Blood transfusions: There is legislation in most of the rest of the country that mandates informed consent for blood and blood products. This policy requires written consent. There are logistical issues, similar in other provinces, and we are working to make processes workable and as practical as we can. We will speak more about transfusions in a scenario ahead. Anaesthesia: When do we obtain consent aand how do we document? Again, as a result of its experience with negligence litigation against physicians, the Canadian Medical Protective Association continues to believe that specific consent, except where required by a statute, is unnecessary for the administration of anaesthesia for surgery. The need for written consent for anaesthesia is seen as limited because ordinarily it should be implicit in the documentation of the pre-anaesthetic examination by the anaesthetist that the patient was properly informed. The pre-anaesthetic visit by the anaesthetist or the anaesthetist's delegate provides an opportunity for discussion about alternative forms of anaesthesia which might be offered, any exclusions imposed by the patient and any particular risks which the examining anaesthetist feels may be appropriate to mention in the particular case. Although usually the record of the pre-anaesthetic examination will adequately confirm the dialogue which occurred between anaesthetist and patient, if specific consent for anaesthesia is included on a form, care should be taken to avoid provision on the document inviting exclusions to be stated by the patient. Any such exclusions should have been agreed upon at the preanaesthetic examination. Failing such discussion and decision, and particularly with a form that offers opportunity for the patient to stipulate exclusions, there is greater risk the patient could impose last minute restrictions on the anaesthetist with the possibility that these might be overlooked.

18 Obtaining the Consent Form
Form Name: Consent to Specific Treatment/Procedure Form #09741 Where do I get the form? Obtain the form the way previously obtained or on Insite Access on Insite: This is the name and number of the new consent form – it is to document consent for a specific treatment or procedure. For those of working in Calgary it means we are no longer obtaining consent for admission and assessment. Please note the form is double-sided and available in hard copy through your usual print channels. It is also available in the Forms Library on Insite. We’ve recently learned that the new Consent form has been made available for POSP and we are hopeful the vendors will make it available to physician’s offices shortly. The new form is NOT appropriate for obtaining consent for such things as release of health information or consent for photography. Questions regarding this type of consent should be directed to Corporate Policy. Work is underway to develop a form to meet the unique needs of the community and public health programs.

19 Here is a screen shot of the Forms Library on Insite.

20 Consent Policy: Blood The MRHP is responsible for obtaining the consent for blood and blood products. Per Consent Policy: “Express written consent shall be obtained for the transfusion of blood and blood products.” Consent for blood and blood products may be obtained in conjunction with a procedure, for example, “bowel resection and possible blood transfusion” without specifying a particular product as several different products might be used in the surgical setting. However, whenever possible, be as specific as you can when obtaining consent for the transfusion of blood and blood products. For example, if you are intending to give RH immune globulin then that should be written in the Details of Treatment section of the form.

21 Name of procedure/treatment e.g. “Bowel resection” (No abbreviations)
Patient Witness Completing the form: Name of procedure/treatment e.g. “Bowel resection” (No abbreviations) Could also add “Possible Blood Transfusion” and/or “Blood Products” – be specific of the type of blood component or product if possible This is a two-sided form so for a patient with capacity you only need to complete side 1. The MRHP signs the consent form, usually before the procedure is undertaken. Exceptions include emergencies but the expectation is that the MRHP would sign the attestation ASAP. MRHP 21 21

22 Witnessing a Consent Written Consent should be witnessed:
a) Any person, other than a relative of the Patient, the Most Responsible Health Practitioner or the interpreter for the Patient, may witness the signing of a Consent Form. From CMPA …, there is some benefit to having an independent person witness signing of the consent form by the patient. It is important to appreciate that the witness is not attesting to the adequacy of the consent explanations that have been given by the physician. The role of the witness is solely to confirm the identity of the patient who signed the form and the fact that the person's mental state was consistent with an understanding a to the purpose of the form. The role of the witness has no other legal significance. There is some utility in having someone other than the Most Responsible Health Practitioner witness the patient's signature. It is preferable if another health care provider, such as a nurse, witnesses a patient consent form after the physician has had the informed consent discussion with the patient. This not only reduces the administrative burden on the physician, but it also provides additional protection in that it enables the patient to voice concerns to someone other than the treating physician. Some patients are more comfortable expressing concerns and asking questions about a treatment to someone other than the physician who proposes the treatment. The witness can also confirm with the patient that he or she has understood the explanations and information provided during the consent discussion with the physician. If the health care provider who witnesses the signing of the consent form considers that the patient requires further information, he or she can then contact the physician, who can then discuss the procedure again with the patient. This further protects the physician by providing additional evidence that proper consent was obtained.

23 Witnessing a Consent Written Consent should be witnessed:
c) In the event that the Patient expresses doubt about the Consent Process and requests further explanation, the witness shall not sign the Consent Form and the Most Responsible Health Practitioner shall be notified. PRR Section 5.6

24 Procedure: Adults with Capacity
Scenario: Dr. X is now proceeding with surgery on a patient and consent was obtained over a year ago on the old consent form. Do I need to do the consent process again? There is no time limit in the policy or procedures but the procedures do provide for 3 criteria which would indicate that a new consent is needed. These criteria are on the next slide.

25 Duration of Consent New consent is needed if:
a) The Patient’s condition has materially changed; b) The medical knowledge about the Patient’s condition or the Treatment available has materially changed; or c) There has been a refusal to a portion of the Treatment/Procedure(s) originally planned or a refusal regarding the involvement of particular individuals in the Treatment/Procedure(s) (e.g. medical trainees). The Most Responsible Health Practitioner is responsible for confirming the validity of consent prior to providing the Treatment/Procedure(s)

26 Duration of Consent Dr. X determines that he does not need to obtain a new consent. Does Dr. X need to complete the new form? No, the old form should be honoured. Consents obtained on the previous consent forms should be honoured unless one of the criteria apply.

27 Consent Policy Dr. X requests clarification:
“In my facility written consent is required for some procedures yet in other facilities my colleagues tell me that verbal consent is obtained. Does AHS have a list of procedures that require written consent?” We believe that clinicians and programs are in the best position to determine which treatments or procedures require written consent. Some criteria that we suggest to help with that determination are: how risky is the procedure how invasive is the procedure how likely are side effects how likely is the patient to experience pain This is not an exhaustive list but it gives you an idea of some things that need to be considered when deciding whether written consent is needed. As we indicated earlier, settings or facilities that have existing lists of procedures that require written consent may continue to use them but this would be a good time to revisit and update them.

28 Procedure: Adults with Capacity
Scenario: The patient was admitted to hospital for treatment of a medical condition but now requires surgery. The resident from the service usually completes the consent form with the patient. Is this permitted now? MRHP can delegate obtaining consent to equivalent within own profession who is competent to perform the procedure. However, an MRHP who is a physician cannot “delegate” obtaining consent to a nurse for example. The nurse may witness the patient’s signature. Resident OK but not the clinical clerk.

29 Adults with Capacity Dr X sees 2 people are waiting for him in his office. He is surprised when the person accompanying the patient requests to see the lab work. Does this person have the right to see the health record? The patient identifies this person as a supportive decision maker. How do I know that this person is the supportive decision maker? Can he/she sign the consent form? See next slide for answers

30 Supported Decision Maker
Means a trusted person that the capable adult appoints pursuant to the Adult Guardianship and Trusteeship Act to: Assist him/her with accessing, collecting or obtaining information, making decision(s) and communicating his/her decision(s). Form obtained from the Office of the Public Guardian website Supported Decision Maker can see the health record and communicate with health care professionals; It is important to note that the Adult in this case HAS capacity but has chosen to name someone to support their decision making. The Supported Decision Maker has NO authority to sign the consent form. The form naming the supporting person is on the next slide

31 Form obtained from the Office of the Public Guardian (ATGA) on their forms section. Link on Insite.

32 Adults with Impaired Capacity
Scenario: Dr. X walks into his office and sees 2 people sitting there. The person with the patient says he is the co-decision maker. Dr X asks: What do I do? Next slide…

33 Co-Decision-Maker A Patient who is assessed as having significant capacity impairment, but who is able to make decisions with appropriate guidance, or an interested party, may apply to the court for an order appointing a Co-Decision-Maker to be a partner with the Patient in decision-making for personal matters, including health care. The application process for co-decision-making is similar to that for guardianship. The decision to grant a co-decision-making order is made by the Court and the physician may ask for the certificate from the court as evidence that the person is in fact a “co-decision maker” under the Adult Guardianship and Trusteeship Act.

34 Co-decision Maker Decisions are made jointly by the patient and the Co-decision Maker, and both individuals sign the consent form. What do I do if they disagree on whether to go ahead with the proposed procedure? The adult patient’s decision takes precedence and he/she can sign without the co-decision maker. At any time the adult patient or the co-decision maker may end the co-decision making agreement. Often the Office of the Public Guardian will follow up to determine if another type of decision support is needed.

35 Patient Print names of both Patient and Co-decision Maker
Check Co-decision Maker Co-decision Maker Patient Patient and Co-decision Maker both sign Enter the name of the patient – check the patient box Enter the name of the co-decision-maker – check the co-decision maker box As you can see, there are two spaces for signatures to permit both the patient and the co-decision-maker to sign. 35 35

36 Adults who Lack Capacity
Who may give consent for an adult patient who lacks capacity? An Agent named in a Personal Directive A Guardian appointed by the Court A Specific Decision-Maker under the Adult Guardianship and Trusteeship Act

37 Adults who Lack Capacity
Scenario: Mrs. B., a 60 year old woman presents to the Emergency department with acute stroke and has had a bleed requiring emergency surgery. How do we obtain consent for surgery?

38 As you can see from this algorithm, there are options to deal with emergency situations when their is no obvious alternate decision maker or time to obtain consent from an alternate decision-maker. In the absence of an Agent or a guardian, the MRHP would look to family and identify a specific-decision maker in accordance with the requirements under the Adult Guardianship and Trusteeship Act. If there is no family, then the specific decision maker would be the Public Guardian.

39 Adults who Lack Capacity
Scenario: Mrs. B goes to ICU post surgery and over the next few days will require a variety of invasive procedures that are typical in the ICU setting How do we obtain consent now? Assuming there is no agent or guardian and no specific decision-maker identified at time of surgery, now is the time to identify one. The procedure provides for consent for a treatment plan or “basket” of procedures so that consent does not need to be obtained each time one is performed. The challenge is to determine what is included and what requires specific consent and we have been meeting with critical care physicians and the Public Guardian to work through some of these issues.

40 Specific Decision Maker
Mrs B has no designated agent or guardian Dr X knows that A physician, nurse practitioner, or dentist (for dental care only) may choose the nearest relative* to act as a specific decision maker for a time sensitive health care decision or temporary admission/discharge for a residential facility Dr X meets Mrs. B’s eldest daughter Next slide 40

41 Specific Decision Maker List
Ranked order: spouse or adult interdependent partner adult son or daughter father or mother adult brother or sister Grandfather or grandmother adult grandson or granddaughter adult uncle or aunt; or adult nephew or niece Office of the Public Guardian Contact the Office of the Public Guardian if there is a dispute as to who should be selected or when no person meets the criteria. Dr X must first determine if Mrs. B’s husband is available. Unfortunately he suffers from dementia and is now a resident in a nursing home and is unable to act as a specific-decision-maker Mrs. B’s daughter is willing to act as her mother’s specific decision maker. In order to confirm her in this role, Form 6 from the Office of the Public Guardian needs to be completed. A link to the form is available on the Consent resources website. 41

42 Specific Decision Maker is chosen in the ranked order
In addition to signing on the first page of the consent form, the specific decision-maker needs to confirm their role by signing to that effect on Page 2 of consent form. Also Form 6 from the Office of the Public Guardian needs to be completed. 42 42 42 42

43 Specific Decision Maker
May not: Make health care decisions where a decision respecting the provision of, withdrawal of or withholding of health care would be likely to result in the imminent death of the Adult (PRR-01, Section 8.2) We have flagged the difficulty with this requirement especially when the patient is at the end of life or “brain” dead. For now, the decision is made by physicians in consultation with the family. Disputes do arise and work is under way on a clinical policy to address the prevention and resolution of disputes in critical care settings.

44 Adults who Lack Capacity
Scenario: Mrs. B. recuperates from the surgery and goes to rehab. Despite her physical progression she appears to lack capacity. A formal capacity assessment is planned. Who can do a formal capacity assessment? In addition, Mrs. B needs to go to a long term care facility. What happens now? Since Mrs B’s lack of capacity appears to be permanent and likely progressive a formal capacity assessment is needed to confirm that initial assessment in order for appropriate care decisions are made on her behalf and an application for guardianship can be initiated. Refer to algorithm next page


46 Minors / Mature Minors Who may give consent Who may not give consent
Mature minor assessment Emergency health care These are some of the topics covered in the Consent procedure for minors and mature minors. 46

47 The Consent resources website includes an algorithm to assist with some of the complexities of consent decisions with this group of patients.

48 Mature Minor Patient Scenario:
A 13 year old teen comes to an STD clinic requesting care. How do we confirm this 13 year old is a mature minor? The policy and minors/mature minors procedure does not provide specifics about how this determination is made. Rather it is left to the MRHP to determine if the minor has the maturity to understand the benefits and risks of what is being proposed and the consequences of not undertaking the treatment both in the short term and longer term. It is up to clinicians and programs to determine how that is undertaken.

49 Minor Patient Scenario:
A 6-year old girl needs surgery but neither of her parents is in town but the mother is available by telephone. How should I complete the consent form? Let’s use this scenario to show how to complete the form on the next slide.

50 This highlighted version of the consent form is available on the website as an example of how to complete the form for a minor with a parent providing consent in person. The first page is fairly intuitive but a portion of the second page needs to be completed as well. When you are obtaining consent by telephone, an additional section on the lower part of page 1 should be used. Since the procedure requires that the form be read to the person providing consent by telephone, we suggest the MRHP complete the form, sign and date where appropriate and the form be left on the health record for the parent to sign when they arrive at the hospital. 50

51 Forms Questions Our previous form included consent for admission and assessment. Should we still use it? When do we need to replace our old forms? What do we do with the old forms? No. These situations can be considered implied consent because the patient presents for assessment and/or treatment and/or admission. In cases of minor treatments with low risk to patients, verbal or implied consent may be sufficient. We spoke earlier of the criteria that can be used to determine what type of consent is needed When do we need to replace our old forms? The policy came into effect on October 31, New forms should be introduced into practice now. Transition to the new forms will occur after consultation with the zone operations but should be complete by May 1, 2011. What do we do with the old forms? When you receive stock of the new forms, please destroy all old consent forms. Until your new stock arrives, you may continue to use existing consent forms. 51

52 Let’s review the two pages of the form.
Patient OR alternate decision maker as described in PRR ,1.3 The MRHP explains the benefits, risks, consequences and alternatives to the patient before signing the consent Patient Witness is over 18, and not a relative, interpreter or MRHP Witness Let’s review the two pages of the form. We’ve highlighted key aspects with coloured bubbles MRHP MRHP should be capable of performing procedure and sign prior to the patient 52 52 52

53 Specific decision makers are chosen in the ranked order
Double Dr consent now only permitted if Alternate Decision Maker not available AND situation is an emergency procedure as described 53 53 53 53

54 Consent Policy Resources
Resources on Insite: Summary Sheets Algorithms FAQs Forms Scenarios These resources supplement the policy and procedure which are the “source of truth”. We again encourage people to refer to them for direction. 54

55 Add webpage link 55 55 55

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61 Contact Us Further Questions:
Suggest revisions: Professional Practice Consultation Service: Within such a large organization we could not anticipate issues that might arise in every practice setting so we committed to Executive to return in six months time with revisions. Here is a way to send forward your suggestions and rationale.

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