Revised Informed Consent policy: What’s new?

1. Revised Informed Consent policy:What’s new?

2. VHA HANDBOOK 1004.01INFORMED CONSENT FOR CLINICAL TREATMENTS AND PROCEDURES

3. Major changes • Signature consent • iMedConsent • HIV testing • Home telehealth • Who may obtain informed consent

4. 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

5. 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.

6. Who can obtain informed consent? “other health care professional”

7. 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.

8. Signature consent • Exception – where there is a significant change in the patient’s condition that would reasonably be expected to alter the diagnosis or therapeutic decision

9. Signature consent - witnesses • Witness signatures are no longer required for signature consent except in limited circumstances.

10. Signature consent - witnesses • Exception - when the patient’s or surrogate’s signature is indicated on the VA authorized consent form by an “X.” • Exception - when an individual cannot physically document consent.

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

12. 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

13. Signature consent – HIV testing specific oral informed consent

14. 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.

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

16. 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

17. iMedConsent ™ - Exceptions Documenting informed consent Form OF-522 is obsolete Use - VA Form 10-431a or 10-431b

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

19. 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;

20. 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.

21. 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.

22. 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 patient’s specific medical and mental health needs, and • a forensic examination to obtain all possible historical and physical evidence

23. Collecting and releasing evidentiary materials / signature consent for forensic examinations Follow the regular procedures for obtaining informed consent for treatments or procedures

24. 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.

25. 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.

26. 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.

27. Collecting and releasing evidentiary materials / signature consent for forensic examinations The emergency exception does not apply to forensic examination.

28. Collecting and releasing evidentiary materials / signature consent for forensic examinations The patient has the right to refuse an examination

29. Collecting and releasing evidentiary materials / signature consent for forensic examinations Disclosure

30. 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

31. 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

32. 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

33. Obtaining consent for testing a source patient after an occupational exposure When an employee is inadvertently exposed to a patient’s 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.

34. Obtaining consent for testing a source patient after an occupational exposure The patient has the right to refuse testing

35. 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.

36. 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.

37. Other issues “Blanket consent”

38. Other issues multiple or recurrent treatments or procedures

39. Other issues “gurney consent”

40. Other issues oral consent

41. Other issues separate consent for anesthesia

42. Other issues consent for prescribing chronic narcotics

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