STANDARD 11: Patient’s Rights

11.1 General

1. The healthcare organization shall protect and promote each patient’s rights, and shall ensure that the staff understand and respect these rights.

2. The healthcare organization shall provide a patient or their legal guardian or representative written notice of patient rights and responsibilities. When possible, this notice shall be provided prior to initiating care and in a language which the patient or legal representative understands. Additionally, all patent’s rights shall be published and displayed publicly in the healthcare facility.

3. The patient responsibilities shall include but are not limited to:

a) providing accurate information to care providers;

b) facilitating the delivery of care;

c) respecting the rights of staff.

4. The patient or the patient’s legal representative has the right to participate in the development and implementation of his or her plan of care. These rights shall include and specifically require:

a) patient participation in making decisions regarding his/her plan of care;

b) adequate and accurate information shall be provided to the patient and family regarding care and treatment to include the following:

i. requesting specific treatment;

ii. refusing specific treatment;

iii. understanding their health status;

iv. protection from processes determined to be medically unnecessary;

v. when medically indicated and possible, the healthcare organization shall make every effort to inform patients of risk associated with discharge against medical advice.

5. When the patient has an advanced directive the healthcare organization shall attempt to place a copy of this said directive on the medical record. There shall be a written policy documenting this process (See requirements of 4.1.3–4.1.5).

6. Decisions regarding planned treatment including transfer and discharge shall be provided to the patient or their legal representatives. When a patient is incapacitated or otherwise unable to communicate his or her wishes, and there is no written advance directive available the healthcare organization shall be expected to honor the decisions of family or legal representatives.

7. The healthcare organization shall ensure that all persons are treated with respect and dignity. The healthcare organization shall recognize cultural, dietary, and spiritual sensitivities of patients and their communities and provide support as required.

8. The healthcare organization shall have written policies and procedures addressing the visitation right of its patients. 

9. Staff members shall be trained on the policies and procedures and their role in supporting patient and family participation in care processes.

11.2 Informed Consent

1. The healthcare organization shall have a documented process for obtaining informed consent throughout its scope of services.

2. The healthcare organization shall identify procedures that require a written informed consent to include but not limited to:

a) surgery;

b) high-risk procedures;

c) sedation and anesthesia;

d) blood transfusion;

e) participation in research projects;

f) filming or videotaping;

g) organ procurement.

3. Risks, benefits, and alternatives shall be explained to the patient by the attending physician or other competent person within that scope of practice if allowed by legislation, in a language that the patient understands. This explanation shall be documented on the medical record by that physician (signed, dated, and timed).

4. Informed consent shall document and contain at least the following:

a) name of patient, and when appropriate, patient’s legal guardian;

b) name of healthcare organization;

c) name of specific procedure(s) or medical treatment);

d) name of the responsible practitioner who is performing the procedure(s) or administering the medical treatment;

e) a statement by the patient that risks, benefits, and alternatives to the procedure have been explained by their practitioner and that their questions have been answered to their satisfaction;

f) date and time informed consent is completed by the patient or the patient’s legal representative to include an appropriate signature;

g) date and time the informed consent is completed by practitioner including an appropriate signature.

5. The process shall address how the rights of mentally incompetent patients shall be protected, and how decision making for these patients shall be addressed (e.g. proxy informed consent, best interest decisions, etc.).

NOTE 1 Patients have a fundamental legal and ethical right to determine what treatments they receive. Valid informed consent to treatment is fundamental in all forms of healthcare from providing personal care to undertaking surgical procedures. Such informed consent shall be considered valid when it is demonstrated that it is made:

a) voluntarily;

b) with reasonable information to make an informed, purposeful decision;

c) by a mentally competent person.

See requirements of 4.1.3.–4.1.5.

6. In the event of a medical emergency, the healthcare organization is not required to obtain a written informed consent. A timely effort shall be made to obtain an informed written consent from the patient’s authorized representative where permitted by national and regulatory requirements.

7. If anesthesia is required, an anesthesia informed consent by the appropriate authority shall be completed as per requirements above. NOTE 2 For the purpose of this document "informed consent" means the patient or patient representative is given (in a language or means of communication he/she understands) the information, explanations of risks, benefits, and alternatives, needed in order to provide an informed consent to a procedure or treatment. For surgery, informed consent should include that the patient is informed as to who will actually perform planned surgical interventions. When practitioners other than the primary surgeon will perform important parts of the surgical procedures, even when under the primary surgeon’s supervision, the patient shall be informed of who these other practitioners are, as well as what important tasks each will carry out. It is however recognized that at the time of the surgery, unforeseen circumstances may require changing which individual practitioners actually are involved in conducting the surgery.

11.3 Patient Grievance

1. The healthcare organization shall establish a process for prompt resolution of patient complaints including a method for informing each patient and/or the patient’s legal representative of how to submit same. This process shall be publicly available.

2. This process shall include providing the patient/and or representative contact information for the Ministry of Health, Medical Chamber, or other regulatory authority including AACI. 

3. This healthcare organization process shall define when the status of a complaint changes to a grievance.

NOTE 1 A complaint may be from a patient, or a patient’s representative regarding the care provided, abuse, neglect, or the healthcare organization’s compliance with applicable laws and regulations. Complaints may be written or verbal. For the purposes of this requirement, an email or fax is considered ‘written’. Billing issues are seldom considered in this requirement.

NOTE 2 A complaint does not constitute a grievance until it cannot be resolved in a satisfactory manner. as describe by the policy of the healthcare organization. A complaint is considered resolved when the patient is satisfied with the actions taken on their behalf.

4. The healthcare organization shall approve and be responsible for the timely review and resolution of the complaint or grievance.

5. The healthcare organization shall provide the patient with written response (s) in the patient’s language that contain:

a) the healthcare organization contact person;

b) steps to being taken on behalf of the patient to investigate the complaint/grievance;

c) any results achieved;

d) a reasonable estimated date of completion according to organizational policy.

NOTE 3 A reasonable timeframe is within 14 working days.

6. If resolution cannot occur within this timeframe, the patient shall continue to be informed of the status of the complaint/grievance in a timely manner.

11.4 Language and Communication

1. The healthcare organizations shall ensure that it has access to competent individuals who have knowledge of medical terms to interpret for patients’ who do not speak the predominant language.

2. The healthcare organization shall provide alternative communication aids for those who are hearing impaired, vision impaired or have other specific needs.

11.5 Family Member Notification

1. The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to a healthcare organization.

2. For every inpatient admission, the organization shall ask the patient whether the organization should notify a family member or representative about the admission. If the patient requests such notice and identifies the family member or representative to be notified the healthcare organization shall provide such notice promptly to the designated individual.

3. The explicit designation of a family member or representative by the patient takes precedence over any non-designated relationship.

4. The healthcare organization shall ask the patient whether the organization shall or shall not notify his/her own physician.

NOTE 1 In the case of scheduled admissions, the patient’s own physician likely is already aware of the admission. However, if the patient requests notice to and identifies the physician, the healthcare organization shall provide such notice promptly to the designated physician, regardless of whether the admission was scheduled in advance or emergent.

11.6 Right to Personal Privacy

1. The patient has the right to personal privacy.

2. The patient has a basic right to respect, dignity, and comfort. "The right to personal privacy" includes at a minimum, that patients shall have privacy during personal hygiene activities, during medical/nursing treatments, and when requested as appropriate.

3. The right to personal privacy shall also include limiting the release or disclosure of patient information such as the patient’s presence in the facility or location in the healthcare organization, or personal information such as:

a) name;

b) age;

c) address;

d) health information – without prior informed consent from the patient.

11.7 Safety

1. The patient has the right to receive care in a safe setting.

2. Each patient shall receive care in an environment that a reasonable person would consider to be safe.

3. The healthcare organization shall protect vulnerable patients, including newborns and children.

4. Respect, dignity, and comfort shall be components of an emotionally safe environment.

11.8 Abuse, Harassment and Mobbing

1. The patient has the right and the healthcare organization shall ensure that to be free from all forms of physical or mental abuse, corporal punishment, harassment, and mobbing.

11.9 Patient Property

1. The healthcare organization shall exercise care with property belonging to patient while it is under the healthcare organization’s care.

2. An accurate and descriptive inventory of the patient’s belongings shall be made upon admission.

3. The healthcare organization shall verify, protect, and safeguard patients’ property.

4. When the property of a customer is lost, damaged, or otherwise found to be unsuitable for use, the healthcare organization shall report this to the patient or his family and retain documented information on what has occurred.

NOTE 1 A patient’s property can include personal belongings, medical equipment, medications, intellectual property, and personal data.

11.10 Confidentiality of Patient Records

1. The healthcare organization shall ensure the confidentiality of patient records as per STANDARD 23.

2. The healthcare organization shall notify the patient accordingly.

NOTE 1 The right to confidentiality means safeguarding the content of information, including patient paper records, video, audio, and/or computer stored information from unauthorized disclosure without the informed consent of the individual, parent of a minor child, or legal guardian. 

NOTE 2 Confidentiality applies to both central records and clinical record information that may be kept at other locations in the healthcare organization, such as patient units, radiology, laboratories, patient clinics, record storage area, and data systems.

11.11 Restraint and/or Seclusion

1. All patients shall be free from restraint, seclusion, any form of impose coercion, discipline, convenience, or retaliation by the healthcare organization.

2. Restrain or seclusion shall only be used in order to protect the patient or other from harm when less restrictive interventions have been considered, tried, or found to be ineffective.

3. Restraint or seclusion shall only be imposed to ensure the immediate physical safety of the patient, a staff member, or others. Restraint or seclusion shall be discontinued at the earliest possible time.

4. When restraint intervention is utilized the patient care staff shall document the following:

a) restraint is based on patient assessment;

b) the restraint is a result of physician order or competent RN in the case of emergency;

c) de-escalation techniques have been considered in the process;

d) the restraint protects the patient and staff;

e) the least restrictive restraint has been utilized.

5. When a drug or medication is used to restrict or manage patient behavior, or to restrict patient freedom of movement, and is not a standard treatment or dosage for the patient’s condition it shall be considered a chemical restraint, and all requirements for restraint use shall apply.

6. The condition of a patient who is restrained for nonviolent behavior shall be monitored by trained staff who have completed training criteria as determined by the healthcare organization. The frequency and interval of monitoring shall be determined by the organization and standard of care parameters for nonviolent behavior.

7. A summary of daily monitoring shall be recorded in the patient care record. The patient’s nursing plan of care shall be updated to reflect restraint needs and condition and the patient’s attending physician shall be notified of the summary content.

8. When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient shall be seen face-to-face within 1 hour after the initiation of the intervention by a physician or registered nurse who has been trained in accordance with the requirements.

9. When the simultaneous use of restraint and seclusion is employed, there shall be adequate documentation that justifies the decision for simultaneous use as well as vigilance in continuously monitoring the patient so that the patient’s care needs are met.

NOTE 1 The requirements contained in this standard are not specific to any treatment setting within the healthcare organization. They are not restricted to patients on psychiatric units or those with behavioral/ mental health care needs. Instead, the requirements are specific to the patient behavior that the restraint or seclusion intervention is being used to address.

NOTE 2 In summary, these restraint and seclusion regulations address these concepts:

a) the decision to use a restraint or seclusion is not driven by diagnosis, but by a comprehensive individual patient assessment. For a given patient at a particular point in time, this comprehensive individualized patient assessment is used to determine whether the use of less restrictive measures poses a greater risk than the risk of using a restraint or seclusion;

b) healthcare organization leaderships responsible for creating a culture that supports a patient’s right to be free from restraint or seclusion.

NOTE 3 Restraint – Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. This restraint definition applies to all uses of restraint in all healthcare organization care settings. Under this definition, commonly used healthcare organization devices and other practices could meet the definition of a restraint, such as:

a) tucking a patient’s sheets in so tightly that the patient cannot move;

b) use of a "net bed" or an "enclosed bed" that prevents the patient from freely exiting the bed;

c) use of "freedom" splints that immobilize a patient’s limb;

d) using side rails to prevent a patient from voluntarily getting out of bed; or

e) geri chairs or recliners, only if the patient cannot easily remove the restraint appliance and get out of the chair on his or her own.

NOTE 4 Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior.

11.12 Order for Restraint or Seclusion

1. The use of restraint or seclusion shall be in accordance with the order of a physician or other qualified licensed practitioner who is responsible for the care of the patient as specified by the healthcare organization and standard of care.

2. An order for nonviolent behavior restraint or seclusion shall be obtained prior to the application of restraints, except in emergency situations when the need for intervention may occur quickly. This order shall be renewed on a 24-hour basis if required.

3. An order for restraint or seclusion is never to be written as a standing order, or on an as needed basis (PRN).

4. If the restraint is not ordered by the patient’s attending physician, the attending physician shall be consulted and notified as soon as possible.

5. Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours:

a) 4 hours for adults 18 years of age or older;

b) 2 hours for children and adolescents 9 to 17 years of age;

c) 1 hour for children under 9 years of age.

6. After 24 hours, before writing a new order for the use of restraint or seclusion for the management of violent or self-destructive behavior, a physician who is responsible for the care of the patient and authorized to order restraint or seclusion by the healthcare organization policy in accordance with applicable laws or regulations shall see and assess and document the findings on the patient record.

7. Healthcare organizations have the flexibility to determine time frames for the renewal of orders for restraint of the non-violent, non-self-destructive patient. These time frames shall be addressed in healthcare organization policies and procedures.

8. A patient may only be removed from restraints by an individual authorized by training and competence to do so. If a patient is removed from restraints, subsequent restraint shall require a physician’s order except in a case of emergency.

NOTE 1 Standard of care recommends at most a 24-hour renewal timeframe as the majority of behavioral restraint is ended prior to that time.

11.13 Staff Training for Restraint and/or Seclusion

1. The patient has the right to safe implementation of restraint or seclusion by trained staff.

2. The healthcare organization shall require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in:

a) techniques to identify patient behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion;

b) the use of nonphysical intervention skills;

c) choice of the least restrictive intervention based on an individualized assessment of the patient’s medical, or behavioral status or condition;

d) safe application and use of all types of restraint or seclusion used in the healthcare organization, including training in how to recognize and respond to signs of physical and psychological distress;

e) in clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary;

f) monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by healthcare organization policy associated with the one-hour face-to-face evaluation;

g) in the use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification.

3. Individuals providing staff training shall be qualified as evidenced by education, training, and experience in techniques used to address patients’ behaviors.

4. The healthcare organization shall document in the staff personnel records that the training and demonstration of competency were successfully completed.

5. Staff personnel records shall contain documentation that the training and demonstration of competency were successfully completed initially during orientation and on a periodic basis consistent with healthcare organization policy.

6. Physicians who order restraints shall have a working knowledge of the healthcare organization policies and procedure for restraint applications orders. This shall include knowledge of monitoring and measuring, order for restraint and requirements for patient assessment. This shall be required in the medical staff orientation program.

11.14 Quality Monitoring

1. The healthcare organization shall define "prolonged restraints". Aggregate data shall be analyzed and reviewed in order to minimize and reduce the incidents of prolonged restraints. This information shall be reported regularly to the healthcare organization management system.

2. This information shall also be shared with the Utilization Review Committee when "prolonged restraints" compromise resource availability within the healthcare organization.

3. Corrective actions as a result of this analysis shall be documented and retained. Follow-up review for effectiveness of these corrective actions shall be done to ensure the intended result.