Changes in Conditions of Participation (CoPs) and Interpretive Guidelines for Informed Consent

1. Changes in Conditions of Participation (CoPs) and Interpretive Guidelines for Informed Consent Informed Consent The New Requirements Presented by: City-wide Patient Consent Committee

2. Changes in CoPs for Informed Consent Objectives: • Review components of Informed Consent. • Provide background on Medicare Conditions of Participation (CoPs) for hospitals. • Provide an overview of the revised CoPs for surgical consents, treatments and procedures. • Solicit feedback and offer assistance in implementing the new process. • Q&A.

3. Informed Consent Doctrine • Informed Consent Doctrine • Two distinct components: • A Person’s right to determine what happens to his or her body; and • A Physician or Practitioner’s duty to provide a person with enough information to ensure that the patient’s ultimate decision is based on an appreciable knowledge of his/her condition, the available options for treatment, known risks, prognoses to make an informed consent.

4. Informed Consent Doctrine • Informed Consent Doctrine • The treating physician or practitioner is responsible to obtain the informed consent. • The Hospital’s or nursing staff’s duty is to facilitate and validate the form is complete and present on the chart prior to the operation/procedure.

5. Who is Making these Changes? • (CMS) the Centers for Medicare and Medicaid is a Federal Government Agency who establishes standards or regulations that regulate reimbursement of Medicare and Medicaid Patients. • CMS calls these guidelines “Conditions of Participation (CoP’s).

6. Why didn’t we know about these CMS changes? • CMS published the changes in 2005 and made the implementation date to be January 2006. • Physicians requested the changes be made city wide. • City wide meetings have been occurring for 1 ½ years to identify the best implementation processes and guidelines.

7. Changes in CoPs for Informed Consent A-0392 CoP §482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. “No change in wording but the interpretative guidelines were expanded.”

8. Changes in CoPs for Informed Consent A-0238 CoP §482.24(c)(2)(v) Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal and State law, if applicable, to require informed consent. “No change in wording but the interpretative guidelines were expanded.”

9. Changes in CoPs for Informed Consent Elements required prior to changes in CoP: • Name of patient; • Name of hospital; • Name of procedure; • Signature of patient or legal guardian; • Date and time consent is obtained;

10. Changes in CoPs for Informed Consent Added CoP Elements • Name of the practitioner performing the procedure or important aspects of the procedures; • Risks; • Related to surgical procedure • Related to patient condition • Related to surgery in general • Alternative procedures and treatments;

11. Changes in CoPs for Informed Consent Added CoP Elements • Title(s) and specific surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner; Significant surgical tasks include: • opening and closing • harvesting grafts • dissecting tissue • removing tissue • implanting devices

12. Changes in CoPs for Informed Consent AddedCoP Elements • Statement that procedure was explained to patient or guardian; • Name/Signature of person who explained the procedure the patient or guardian; • Signature of person witnessing the consent;

13. Changes in CoPs for Informed Consent • When circumstances require a change in practitioners after consent has been obtained – the post-operative note in the chart needs to reflect the change. • CMS’s Focus: Is to make sure the patient is informed and consents to the procedure as well as other practitioners (i.e., third year resident) who may participate in his/her procedure (i.e. opening and closing).

14. How to obtain the Consent Form By the first of February offices will be able to access the form • Via • Web site at Saint Elizabeth Regional Medical Center  • Portal at BryanLGH Medical Center • Emailed directly to your medical office • Compact Disc- per office request

15. Timelines for Implementation of the New Consent Process • February-March 2007: City wide task force members will work with physician office staff members to take the proposed city wide form and develop office specific forms for individual providers which include risks, benefits, alternatives. • February 28, 2007: Implement the new consent processes with the new form. • April 2, 2007: Facilities will only accept the new city-wide consent form developed for each provider.

16. Once the form is completed in the office where do I send the form? • To the pre-op office of the facility where the patient is going to be admitted. • Fax the form along with the other information, e.g. H&P, orders, etc. that you send now.

17. Frequently Asked Questions related to changes with Consent

18. Who must obtain consent? • The provider or practitioner who is performing the procedure. • This includes Physicians, Surgeons, Dentists, Podiatrists, Midwives, CRNAs, or Licensed Independent Practitioners, by the state of Nebraska.

19. Who is responsible for the consent? • The physician or practitioner is responsible to obtain the consent. • However, a crucial aspect of the nurse advocacy role is his/her obligation to ensure that medical intervention does not proceed unless the patient comprehends the details of the procedure.

20. Can the physician or practitioner obtain consent and also witness the consent? • Yes, but according to legal counsel it is not advised.

21. Can Physician Assistants obtain consent? • The Physician Assistant can provide information and answer questions with the patient but the Physician or Practitioner who is doing the procedure ultimately has owness for patient informed consent and must sign the permit.

22. Who can be a witness? • Any person can witness the patient signature on the consent form. • Family members should not be a witness to a consent.

23. Does the witness have to be in the room during the discussion of risks, benefits, and alternatives between the physician and patient? • No • The witness is only validating the person’s signature. • The witness is validating who has signed the form not that he/she understands the implications of the form.

24. Will all consents be signed in the office? • It is preferred that Consents be completed in the office and are signed and witnessed before they are faxed. • The surgeon or practitioner must sign the consent prior to the procedure. • If the permit is not signed in the office, it can be signed and witnessed at the hospital prior to procedure.

25. How long are consent valid? • There is no state law stating the time limit on consents. The city wide group is proposing 6 months unless the patient condition or procedure changes. • If the patient condition changes the consent will then need to be updated or completed again.

26. We already have material we give the patient regarding the procedure. Can we just use that material? • No, this information can not be used as part of the consent although it can be used for patient information. • The required information must be documented on the specific consent form.

27. Can we change the form? The answer is yes and no. • The content and format of the text in the form cannot be changed except for: • The Allograph section can be deleted if not applicable. • General procedure risks can be altered if appropriate. • Copy can be added at the end of the form as needed.

28. Can the physician or practitioners have standardized consents for specific or frequent procedures? • Yes, in fact it is preferred. • Standardized consent forms allows for: • Consistent education for patients • Assist with time constraints in the office

29. Who will help the physician/practitioner make these specific template consents? • Members of the city wide task force have agreed to work with physicians and office staff to obtain the consent template and provide suggestions for form standardization and office work flows.

30. Do we have to list every adverse outcome or complication on the consent? • Listing every adverse outcome would be impossible. The ones that need to be listed are those most frequently associated with the procedure.

31. What are the three risk components that must be listed on consent form? The three risk components are: • Risks of surgery or procedure in general (listed on the form). • Risks of the specific surgery or procedure. • Risks related to the patient and his/her condition.

32. What if the surgeon, physician, or practitioner does not know who will be assisting during the procedure at the time the consent is filled out? • The provider must inform the patient that another provider (list title) will be assisting with the procedure. • The provider will need to list the extent of support or activities the other provider will perform.

33. Will the consent form allow for abbreviations? • No!!! • Abbreviations are not allowed on the consent form.

34. Can we fax or photocopy the consent form to the hospital or outpatient clinic? • Yes, CMS has indicated that a copy of the form either mailed or faxed to the hospital is sufficient for CMS.

35. What about patients who can not sign their own consent? Are telephone consents legal? • Yes. The physician or practitioner who is performing the procedure should explain the procedure with the legal guardian and review the risks, benefits and alternatives, and answer questions. • If consent is obtained by phone, the permit should be read to the legal guardian in total prior to obtaining consent by either the physician or witness. • If the patient is unable to sign the consent then note the reason.

36. What if the procedure is incorrect? • The form can be corrected with the physician or practitioner and patient initialing next to the change on the consent form. • A new consent form could also be completed.

37. Will an order for the procedure still be required prior to surgery? • The city wide task force believes an order will continue to be needed for planned procedures. • Orders are used to verify the following: • Appropriate procedure is scheduled. • Patient matches procedure scheduled. • Appropriate procedure matches the surgery schedule.

38. Can there be blanks on the consent form? • No. All areas from the start through physician declaration must be completed in full before sending to the hospital or outpatient center. • Areas after physician declaration including patient signature and other applicable areas must be completed prior to the procedure.

39. How will consents be obtained for unplanned or unanticipated procedures? • All facilities will have generic consent forms available online for physician or practitioner use. • Clinical staff will print the form and have available for the physician or practitioner prior to the procedure. • In a true emergency, a consent is not required prior to the procedure.

40. What if the patient gets to the hospital or outpatient center and does not understand the procedure or has questions regarding the procedure? • Everything stops until the physician or practitioner completing the procedure comes to answer the questions of the patient and family PRIOR to the procedure start.

41. What about Blood consents or Consents for PICC lines? • In the hospital, the Registered Nurse who is performing the procedure is allowed by state law to provide consent for both of these procedures and will obtain the consent with the patient. • The blood section of the general patient consent form should be completed at the time of patient consent is obtained if it is anticipated that blood products may/will be administered.

42. What about Anesthesia consent? Anesthesia will obtain their own consent with a special anesthesia consent form that has been approved by the city anesthesia groups.

43. Changes in CoPs for Informed Consent For more information: • The website for CoPs and Interpretive Guidelines for Hospitals: http:\www.cms.hhs.gov/manuals/ Downloads/som107ap_a_hospitals.pdf