F154: RESIDENT RIGHT TO BE INFORMED OF HEALTH STATUS, CARE AND TREATMENT

1. F154: RESIDENT RIGHTTO BE INFORMED OF HEALTH STATUS, CARE AND TREATMENT Informed Consent Process in NCU

2. OBJECTIVES: After completing this learning module, the learner will be able to: • Discuss process of obtaining and documenting informed consent • Identify the role of the attending physician and licensed staff in the informed consent process

3. Why obtain an informed consent? Because residents have a … • right to be “fully informed in a language that he or she can understand of his or her total health status, including but not limited to, his or her medical condition” §483.10(b)(3) State Operations Manual (SOM), 2011

4. Why obtain an informed consent? Because residents have a … • right to “be fully informed in advance about care and treatment and of any changes in that care or treatment that may affect the resident’s well-being” §483.10(d)(2) SOM, 2011

5. Examples of Procedures/ Treatment Requiring an Informed Consent • Complex procedures- surgeries and invasive procedures • Special procedures- blood transfusion, HIV tests, physical restraint, psychotropic medications Community Hospital of San Bernardino (CHSB), 2011

6. Physician’s Role • Provide resident or responsible party with necessary information to make an “informed decision” • Discuss nature of procedure, treatment, or medication

7. Physician’s Role • Discuss benefits, risks or side effects including potential problems that may occur after the procedure • Discuss alternatives if any are available • Discuss likelihood of achieving goals of treatment The responsibility of the informed consent being fully explained to the patient rests on the resident’s physician. CHSB, 2011

8. Physician’s Role • Document in the resident’s record that information necessary to make an informed decision was discussed with resident or responsible party • Include signature, date and time of conversation and whether a consent was given or not CHSB, 2011

9. Physician’s Role • Complete and sign physician’s section of the consent form and the telephone order as soon as they are received and return forms to the unit (via fax) • If present in the unit, sign the verbal order and complete and sign consent form in the resident’s medical records

10. Licensed Staff Role • Facilitate informed consent process • Call MD and responsible party (conference call) • Witness telephone or personal conversation between MD and responsible party • Inform responsible party that conversation is being witnessed by a third party

11. Licensed Staff Role • Obtain a telephone order or verbal order when conversation is complete • Initiate the consent form (affix resident’s label) • Fax telephone order AND consent form to MD office ASAP

12. Licensed Staff Role • Document in the nurses’ notes • Include nurse’s signature, date and time of conversation between MD and responsible party, name of MD and responsible party, and whether informed consent was given or not

13. Licensed Staff Role • If MD is in the unit, ensure that he/she completes his/her portion of the consent form • Complete “Informed Consent Log” each time informed consent process is completed

14. Informed Consent Process • Licensed staff to initiate conference call between MD and responsible party • Licensed staff to witness and inform responsible party that conversation is being witnessed by a third party • MD to provide all necessary information to responsible party

15. Informed Consent Process • Licensed staff will obtain a telephone or verbal order reflecting that an informed consent was obtained by the MD via conference call. Document the order as ff: Informed consent for (name of procedure or treatment) was obtained by MD from responsible party via conference line on (date and time). May proceed with (name of procedure of treatment). TORB

16. Informed Consent Process • Licensed staff will fax the telephone order and consent form to MD office • MD to sign the verbal or telephone order and will complete and sign the consent form • MD to document in resident’ medical record whether informed consent was given or not

17. Informed Consent Process • Licensed staff will complete the “Informed Consent Log” (in the 24 hour report book) once process is complete

18. References Community Hospital of San Bernardino (2011). Informedconsent [PowerPoint slides]. Interpretive Guidelines (2011). F 154. State Operations Manual. Retrieved from http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf