Revised Informed Consent policy: What’s new?

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Revised Informed Consent policy Whats new?
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VHA HANDBOOK 1004.01 INFORMED CONSENT FOR
CLINICAL TREATMENTS AND PROCEDURES
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Major changes

• Signature consent
• iMedConsent
• HIV testing
• Home telehealth
• Who may obtain informed consent

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Clarified procedures for

• obtaining consent for forensic or evidentiary
  exams
• informed consent and disclosure of PHI related to
  7332-protected info (i.e., HIV, alcohol/substance
  abuse
• Informed consent when testing patients following
  an occupational exposure to bodily fluids

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Who can obtain informed consent?

• Any physician, dentist, or health care
  professional granted specific clinical privileges
  to perform the treatment or procedure.
• Medical and dental residents, regardless of
  whether they have been granted specific clinical
  privileges.
• Other health care professionals whose scope of
  practice agreement or other formal delineation of
  job responsibility specifically permits them to
  obtain informed consent, and who are
  appropriately trained and authorized to perform
  the procedure or provide the treatment for which
  consent is being obtained.

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Who can obtain informed consent?

• other health care professional

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Signature consent

• A properly executed VA authorized consent form is
  valid for a period of 60 calendar days from the
  date signed, instead of 30 days.

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Signature consent

• Exception where there is a significant change
  in the patients condition that would reasonably
  be expected to alter the diagnosis or therapeutic
  decision

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Signature consent - witnesses

• Witness signatures are no longer required for
  signature consent except in limited
  circumstances.

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Signature consent - witnesses

• Exception - when the patients or surrogates
  signature is indicated on the VA authorized
  consent form by an X.
• Exception - when an individual cannot physically
  document consent.

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Signature consent HIV testing

• Signature consent is no longer required for
  Human Immunodeficiency Virus (HIV) testing.
• Instead specific oral informed consent

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Signature consent HIV testing

• specific oral informed consent applies to tests
  for
• illicit drug use,
• ETOH,
• HIV,
• Hepatitis B and C,
• MRSA,
• STDs,
• inheritable genetic abnormalities

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Signature consent HIV testing

• specific oral informed consent

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Specific oral informed consent - HIV

• Mandatory includes written educational material
  which includes a description of
• HIV disease, HIV testing
• expected benefits/known risks associated with HIV
  testing
• reasonable alternatives to HIV testing,
  consequences of choosing no HIV testing,
  availability of anonymous testing.
• meaning of a positive and a negative HIV test
• how HIV is transmitted and
• measures to be taken for prevention of HIV
  transmission.

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iMedConsent

• The iMedConsent software program must be used
  to document the informed consent process except
  in specific circumstances

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iMedConsent - Exceptions

• a. The patient declines to sign using the
  electronic signature pad
• b. There is a temporary system failure that
  prohibits proper use of the program
• c. The patient (or surrogate) is giving consent
  over the telephone or by fax or
• d. Use of the equipment that supports the
  iMedConsent software program would present
  introduce infection control issues

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iMedConsent - Exceptions

• Documenting informed consent
• Form OF-522 is obsolete
• Use - VA Form 10-431a or 10-431b

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Signature consent home telehealth

• Signature consent is not required
• Exception - unless the medical care delivered
  meets the usual requirements for signature
  consent.

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Signature consent when is it required?

• Signature consent must be obtained for treatments
  and procedures that
• Can be reasonably expected to produce significant
  pain or discomfort to the patient
• Can be reasonably expected to produce pain or
  discomfort to the patient that is substantial
  enough to require sedation, anesthesia, or
  narcotic analgesia
• Can be reasonably considered to have a
  significant risk of complication or morbidity

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Signature consent when is it required?

• Signature consent must be obtained for treatments
  and procedures that
• Require injections of any substance into a joint
  space or body cavity (excluding the intravascular
  space) or
• Are listed in Appendix A of the informed consent
  policy.

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Consent home telehealth

• The practitioner must ensure that the patient is
  informed about
• a. The likely differences between receiving
  care delivered using telehealth technologies and
  face-to-face care, and
• b. That patients are free to choose among
  available comparable treatments or procedures
  that use telehealth and those that do not.

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Collecting and releasing evidentiary materials /
signature consent for forensic examinations

• If a patient is suspected of criminal wrongdoing
  or is the victim of a suspected crime presents
  for medical care at a VHA facility, the patient
  may undergo two types of treatments or
  procedures
• treatments or procedures that are designed to
  address the patients specific medical and mental
  health needs, and
• a forensic examination to obtain all possible
  historical and physical evidence

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Collecting and releasing evidentiary materials /
signature consent for forensic examinations

• Follow the regular procedures for obtaining
  informed consent for treatments or procedures

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Collecting and releasing evidentiary materials /
signature consent for forensic examinations

• A separate signature informed consent is required
  to perform a forensic exam on a patient.

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Collecting and releasing evidentiary materials /
signature consent for forensic examinations

• A separate signature informed consent is required
  to perform a forensic exam on a patient.

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Collecting and releasing evidentiary materials /
signature consent for forensic examinations

• Informed consent to an examination for
  evidentiary collection needs to be obtained by a
  practitioner
• trained in conducting forensic evidentiary
  examinations.

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Collecting and releasing evidentiary materials /
signature consent for forensic examinations

• The emergency exception does not apply to
  forensic examination.

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Collecting and releasing evidentiary materials /
signature consent for forensic examinations

• The patient has the right
• to refuse an examination

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Collecting and releasing evidentiary materials /
signature consent for forensic examinations

• Disclosure

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Informed consent requirements and procedures for
disclosure of 7332-protected information

• Includes VA-generated records related to
• drug abuse,
• alcoholism or alcohol abuse,
• infection with HIV infection, or
• sickle cell anemia

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Informed consent requirements and procedures for
disclosure of 7332-protected information

• Special written consent for disclosure
• VA Form 10-5345
• Request For and Authorization to Release Medical
  Records

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Informed consent requirements and procedures for
disclosure of 7332-protected information

• Includes VA-generated records related to
• drug abuse,
• alcoholism or alcohol abuse,
• infection with HIV infection, or
• sickle cell anemia

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Obtaining consent for testing a source patient
after an occupational exposure

• When an employee is inadvertently exposed to a
  patients bodily fluids, tissues, or excretions
  (e.g., blood, urine, sweat, saliva, pus, fecal
  matter) there may be transmission of infectious
  pathogens (e.g., HIV, Hepatitis C, Hepatitis B,
  MRSA), contaminants (e.g., radiated isotopes),
  toxins, or other agents.

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Obtaining consent for testing a source patient
after an occupational exposure

• The patient has the right to refuse testing

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Obtaining consent for testing a source patient
after an occupational exposure

• Informed consent for source patient testing may
  only be obtained after the occupational exposure
  has occurred.

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Obtaining consent for testing a source patient
after an occupational exposure

• Who can obtain informed consent?
• an employee who does not have a personal
  relationship with the exposed employee (e.g.,
  friend, family member, former spouse) and,
• whenever possible, by an employee who is not
  professionally related to the employee or the
  patient.

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Other issues

• Blanket consent

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Other issues

• multiple or recurrent treatments or procedures

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Other issues

• gurney consent

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Other issues

• oral consent

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Other issues

• separate consent for anesthesia

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Other issues

• consent for prescribing chronic narcotics

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