HL7 v.2 Consent Directive Use Cases

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HL7 v2.5 Chapter 9 Medical Records, Consent Segments

9.9 CONSENT INFORMATION

• 9.9.1 Short Description

This segment identifies patient consent information relating to a particular message. It can be used as part of existing messages to convey information about patient consent to procedures, admissions, information release/exchange or other events discussed by the message. It may also be used in messages focusing on recording or requesting consent and for consents related to employees or service providers. The segment will be used in conjunction with various other segments to identify the practitioner (PRA/STF) or patient (PID) the consent is for, the various individuals involved in the consent (ROL) as witnesses, consenting person (not always the patient), translators, consulting providers, etc., and the specific procedures being proposed (PR1). 9.9.2 Justification

• 9.9.2.1 Segment

The issue of patient consent has become more important, particularly in the tracking of consent for the release of or exchange of information. The pieces of information recorded when dealing with a patient consent tend to be similar, regardless of the purpose of the consent. This segment combines these pieces of information so that they can be used for consents of any type.

• 9.9.2.2 Fields
• Consent Type: In concert with giving consent, some programs may allow patients to request varying degrees of participation in a given program. I.e. if consent program relates to a patient’s entire medical record being available online they might have the opportunity to only reveal certain portions of that history such as the drug history only..

Consent Form ID: Some institutions may have a set of pre-defined consent forms. Identifying the specific form identifies the details the subject is consenting to, as well as what information is on the form.

• Consent Text: When recording consents electronically it is important to know the specific text that was presented to the consenting person.

Subject-specific Consent Text: Sometimes consent forms have areas where details of the procedure or information distribution that are specific to a given consent instance are recorded, i.e. a variation on a common procedure, or an explicit listing of documents to be released. As this is part of the consent document, it needs to be recorded. It is helpful to keep this information separate from the standard ‘template’ consent text, as in most circumstances people viewing the consent will want to know “What’s different from usual”.

• Background Text: In most cases in the health field, consent must be “informed” consent. This means that the consenting individual must understand and appreciate the implications of what they are consenting to. Most consent processes involve providing background material describing the reasons for the proposed service, expected benefits and potential risks. It is important to have a record of what information was presented to the subject at the time of consent.
• Subject-specific Background Text: The reasons, expected benefits and risks may vary from subject to subject. It may be necessary to inform the subject of background information that only applies to their particular circumstance.
• Subject-imposed Limitations: At the time of consent, the subject may wish to make modifications or add limitations to their consent. These modifications and limitations must be recorded.
• Consent Mode: The manner in which consent can be given may vary greatly within a specific program, from program to program, or from organization to organization. Therefore, the standard must allow applications to identify how consent was obtained (i.e. verbally, written, etc.).
• Consent Status: Consent can be pending (subject hasn’t been asked yet), given, refused, revoked or even completely bypassed. Consent Status identifies what the status of a subject’s consent is (or was at a given point in time).

Consent Discussion Date/Time: For informed consent, a knowledgeable person must discuss the ramifications of consent with the subject. In some instances, this discussion is required to take place prior to the provision of consent. This ensures that the subject has sufficient time to consider the ramifications of their decision. To ensure that guidelines are followed, it is imperative to record when the consent information was initially discussed with the subject.

• Consent Decision Date/Time: Related to the above, there also needs to be a record of the time the subject actually made their consent decision.
• Consent Effective Date/Time: Not all consents take effect at the time the consent decision is made. They may not become effective for some time, or in certain circumstances they may even be retroactive. Use this field to record the effective time. .
• Consent End Date/Time: For most programs requiring voluntary participation, the decision to participate is not final and therefore may be revoked in the future. Therefore, when a patient makes the decision to revoke their consent, the date and time on which the decision was made must be recorded in order to provide a complete history of the consent. Alternatively, the initial consent may only have been granted for a limited period of time (i.e. 24 hours, 1 week, 1 year). If Consent End Date/Time is null, this should be interpreted as ‘indefinite’.
• Subject Competence Indicator: One of the issues involved in informed consent is whether the subject is judged to be competent to provide consent on their own behalf. Factors involve age, mental capacity, and current state of health/awareness. A professional judgment about whether the subject is deemed competent must be made and recorded.
• Translator Assistance Indicator: To obtain informed consent, the patient must understand what they are consenting to. For subjects who do not understand the commonly used language of the institution, or who are unable to hear/read/speak, translation services may be required.
• Translation Type: To obtain informed consent, the patient must understand what they are consenting to. For subjects who do not understand the commonly used language of the institution, or who are unable to hear/read/speak, translation services may be required. An indication of what type(s) of translation were/will be performed is required.

Informational Material Supplied Indicator: As part of the informed consent process, additional material in the form of pamphlets, books, brochures, videos, etc. may be provided to the patient. An indication of whether this has been done is required. (Details on the materials provided will be sent using a separate segment.)

• Consent Bypass Reason: There may arise situations in which an action must be performed without patient consent (i.e. retrieving an unconscious patient’s drug history, performing life saving surgery, etc.). This field indicates the rationale for accessing information without obtaining the required consent.
• Consent Disclosure Level: Identifies whether the subject was provided with information on the full background information on the procedure, the subject is giving consent to, i.e. has all information needed for ‘informed’ consent been provided.
• Consent Non-disclosure Reason: Identifies why information was withheld from the patient (i.e. telling the patient may cause a worse outcome than performing the procedure).

9.9.3 Use Case(s)

1. A patient decides to participate in a voluntary electronic drug history program. The patient records this decision in writing (Consent Mode) on a pre-designed consent form (Consent Form ID and Version) after their health care service provider has explained the benefits and drawbacks of their participation. In providing consent, the patient can also decide on the degree to which they will participate in the program (Consent Type). The consent decision (Consent Status) is recorded under the patient’s name (use ROL segment) and the number of the paper-based form that the patient signed is recorded in the electronic consent gathering function (Consent Number). The patient’s consent is effective from the day of the decision (Consent Effect Date/Time), but this consent can be terminated at the patient’s discretion at a given date in the future (Consent End Date/Time). Several months later the patient is rushed into an emergency health care facility with what appears to be a drug reaction. While checking the patient’s drug history, health care service providers find that the patient’s drug history has controlled access. The patient is unable to provide access to this information given their physical state, so the health care service provider circumvents the consent process (Non-consent Access Reason) in the interests of the patient’s immediate well-being.
2. A patient is seeking a therapeutic abortion. Because she is under 18, the practitioner must evaluate her competence to provide consent. The patient is deemed to be competent (Patient Competence Indicator). Local legislation mandates that the patient be counseled at least 24 hours prior to receiving the procedure. The patient is counseled, and the time recorded (Consent Discussion Date/Time). They are also given a pamphlet to take home and read (Informational Material Supplied Indicator). They return the following day and sign the consent form (Consent Decision Date/Time)
3. A deaf patient is admitted for labor and delivery. It becomes apparent the patient will require a cesarean section. A translator is required (Translator Assistance Indicator) who can translate sign language (Translation Type). The translator explains the details of the procedure the patient is being asked to consent to (Consent Text), the intention to use epidural anesthetic (Subject-specific Consent Text), the general risks associated with doing the procedure, as well as those with not doing the procedure (Background Text) and benefits associated with the epidural (Subject-specific Background Text). The patient agrees to the procedure, subject to the condition that she not be given any blood products for religious reasons (Subject-imposed Limitations).
4. An employee signs a consent form authorizing (Consent Status) a hospital to request their driving records from the local Department of Motor Vehicles (Consent Type).
5. A patient signs a consent form to have basic diagnostic and billing information sent to their insurer. The consent indicates that information may only be given to parties that are bound by HIPPA guidelines (Trust Agreement Restriction Type)

HL7 v2.8 Chapter 9 Medical Records Consent Segments

9.4 CONSENT INFORMATION

• Example 1:

A patient decides to participate in a voluntary electronic drug history program. The patient records this decision in writing (Consent Mode) on a pre-designed consent form (Consent Form ID and Version) after their health care service provider has explained the benefits and drawbacks of their participation (Consent Discussion Date/Time). In providing consent, the patient can also decide on the degree to which they will participate in the program (Consent Type). The consent decision (Consent Status) is recorded under the patient’s name (use ROL segment) and the number of the paper-based form that the patient signed is recorded in the electronic consent gathering function (Consent Number). The patient’s consent is effective from the day of the decision (Consent Effect Date/Time), but this consent can be terminated at the patient’s discretion at a given date in the future (Consent End Date/Time). Several months later the patient is rushed into an emergency health care facility with what appears to be a drug reaction. While checking the patient’s drug history, health care service providers find that the patient’s drug history has controlled access. The patient is unable to provide access to this information given their physical state, so the health care service provider circumvents the consent process (Non-consent Access Reason) in the interests of the patient’s immediate well-being.

• Example 2: A patient is seeking a therapeutic abortion. Because she is under 18, the practitioner must evaluate her competence to provide consent. The patient is deemed to be competent (Patient Competence Indicator). Local legislation mandates that the patient be counseled at least 24 hours prior to receiving the procedure. The patient is counseled, and the time recorded (Consent Discussion Date/Time). They are also given a pamphlet to take home and read (Informational Material Supplied Indicator). They return the following day and sign the consent form (Consent Decision Date/Time).
• Example 3: A deaf patient is admitted for labor and delivery. It becomes apparent the patient will require a cesarean section. A translator is required (Translator Assistance Indicator) who can translate sign language (Translation Type). The translator explains the details of the procedure the patient is being asked to consent to (Consent Text), the intention to use epidural anesthetic (Subject-specific Consent Text), the general risks associated with doing the procedure, as well as those with not doing the procedure (Background Text) and benefits associated with the epidural (Subject-specific Background Text). The patient agrees to the procedure, subject to the condition that she not be given any blood products for religious reasons (Subject-imposed Limitations).
• Example 4: An employee signs a consent form authorizing (Consent Status) a hospital to request their driving records from the local Department of Motor Vehicles (Consent Type).
• Example 5: A patient signs a consent form to have basic diagnostic and billing information sent to their insurer. The consent indicates that information may only be given to parties that are bound by HIPPA guidelines (Trust Agreement Restriction Type).