1. CMS Informed Consent and Patient Rights Regulations: Ensure Compliance and Reduce Risk Progressive Healthcare Conferences John R. Rosing, MHA, FACHE Vice President and Principal Patton Healthcare Consulting

2. What is Informed Consent?  Informed consent is much more than a signature on a form that gives a caregiver permission to treat a patient.  Informed consent is when a patient (or an individual legally authorized to act for the patient) receives a complete discussion of the intended procedure and also understands the information that they have been given.

3. What is Informed Consent? Each patient may be asked to give informed consent many times from the moment they are admitted to the hospital throughout their hospital stay. Hospitals have many situations that warrant an informed consent acknowledgement from a patient. Here are a few examples….  Administration of blood of blood products  Autopsy  Blood/Organ/Tissue Donation and Transplantation  DNR Orders  HIV Testing Patients also need to complete a consent form if they want to refuse treatment (Informed Refusal).

4. The general guideline for written consent is that procedures which involve medically significant risks and/or where medically significant alternatives exist, written consent is necessary. Often defined as procedures that have a surgical billing code. The following are examples: consent for anesthesia procedures done under general anesthesia, deep or moderate sedation procedures performed in operating rooms, delivery rooms, and cystoscopic rooms, ECT procedures which might involve such a risk or result that the patient would attach significance to the risks, and/or results when deciding whether or not to proceed with the proposed procedure blood product transfusion Interventional radiology / cardiac cath/ EP procedures Consents are usually valid for 60-90 days. When is a Written Informed Consent Form Required?

5. Who may obtain an Informed Consent? A Qualified Practitioner (for obtaining informed consent)may be: A physician (MD or DO) or supervising physician if he/she is not performing the procedure, fellow, resident, Physician assistant (PA), certified registered nurse anesthetist (CRNA), certified nurse midwife (CNM), nurse practitioner (NP), Or other healthcare provider, who is qualified to perform the particular treatment and who is credentialed or permitted by the facility in which the treatment will be provided, or are allowed through their training program, or as part of a contractual arrangement, as applicable, is responsible for obtaining the patient’s informed consent.

6. Obtaining of Informed Consent First Step- Explanation of the Procedure The first step in obtaining informed consent is the explanation of the procedure (as well as the risks and alternatives) and should always be given by the Qualified Practitioner. This explanation shall include, but is not limited to: Patient’s condition Planned procedure including risks, benefits and possible consequences, who may be participating Procedure purpose and nature Reasonable alternatives including risks, benefits and possible consequences Possible Consequences of Remaining Untreated Potential Problems Related to Recuperation Likelihood of Success

7. Blood? The Consent for Procedure form typically discusses blood transfusion related to a procedure and, along with the informed consent for the procedure discussion, serves as a written blood transfusion consent. The Consent for Procedure blood consent is effective for any blood given related to the specific patient’s surgery, from the date of surgery throughout the patient’s hospitalization.

8. Obtaining Informed Consent Second Step – Assess Patient’s understanding and confirm their consent The next step in obtaining informed consent is the assurance of understanding by the patient or their representative. The Qualified Practitioner should ask for questions and confirm that the answers were understood. Once the Qualified Practitioner has completed the explanation and obtained consent to proceed, he or she will document the informed consent.

9. Documenting Informed Consent Completing the INFORMED CONSENT FOR SURGERY OR OTHER PROCEDURE form also requires the patient’s signature, date and time. This can be obtained by the Qualified Practitioner » or by placing an order for the specific procedure in the patient's medical record and for the nurse to facilitate completion by presenting the form to the patient for signature.

10. Form Content CMS minimum requirements for procedures or other types of medical treatment requiring informed consent: Name of the hospital where the procedure is to take place. Name of the specific procedure for which consent is being given. Name of the responsible practitioner who is performing the procedure. Statement that the procedure, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient’s legal representative. (Material risks could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but high degree of severity. Hospitals are free to delegate to the responsible practitioner, who uses the available clinical evidence as informed by the practitioner’s professional judgment, the determination of which material risks, benefits and alternatives will be discussed with the patient.) Signature of the patient or the patient’s legal representative. If there is applicable state law governing the content of the informed consent form, then the hospital’s form must also comply with those requirements.

11. Form Content M ight also include the following additional information: Name (NOTE: not necessarily a signature!) of the practitioner (typically the physician) who conducted the informed consent discussion with the patient or the patient’s representative. Date, time, and signature of the person witnessing the patient or the patient’s legal representative signing the consent form (the witness is often the physician him/herself.) Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient’s representative. Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner. Statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of the surgery or administration of anesthesia will be performing only tasks that are within their scope of practice, as determined under state law, and for which they have been granted privileges by the hospital.

12. Informed Consent: The Bedside Nurse’s Role When the bedside nurse receives an order to have the patient sign the consent form, your role is one of VALIDATION. Below are examples of the information you are validating…. Has the Qualified Practitioner documented the specific procedure or surgery in the medical record, on the MY INFORMED CONSENT form or on the history and physical? Is the procedure listed on the MY INFORMED CONSENT form the same procedure noted in the informed consent documentation? Has the patient or their representative(s) had all questions for the physician regarding the procedure, risks, benefits or alternatives answered? If you can validate ‘yes’ to these questions, you may ask the patient to complete the MY INFORMED CONSENT form with their signature, date and time.

13. Informed Consent: The Bedside Nurse’s Role If the nurse can validate ‘yes’ to the aforementioned questions, the nurse may ask the patient to complete the INFORMED CONSENT form with their signature. If the answer to one or more of the questions is ‘no’, acting as an advocate for the patient, the nurse should notify the physician before the consent form is signed. The patient’s signature on the consent form indicates that the patient has had a discussion with the practitioner about the procedure. The patient may withdraw consent at any time prior to the procedure. A competent patient has the right to refuse treatment. Remember, the nurse is only validating that the information on the form is correct; that the documentation of attaining informed consent is present and that the patient has no further questions for the Qualified Practitioner. Obtaining informed consent (explanation and assurance of understanding) is the responsibility of the Qualified Practitioner, not the bedside nurse.

14. Who May Consent to a Procedure? Any adult (18 years of age or older) may consent to his or her own medical treatment unless in the opinion of the attending physician the individual is incapable of making a decision regarding the proposed treatment. A minor patient (one under the age of 18 years) in general must be accompanied by a legally authorized adult. – Certain treatments, such as reproductive services, may have specific informed consent requirements. Please check with your facility.

15. Who May Consent to a Procedure? Incapacitation If the patient is incapacitated, any of the following may consent to a procedure: For the short term, in priority, the following may act as the patient’s representative: patient’s spouse, adult child, parent, adult sibling, grandchild, grandparent, or an adult who has exhibited concern for the patient (no compensated healthcare provider). Those designated in a court appointed guardianship, or healthcare agent If the practitioner is unable to find any of the above, staff should check with administration or risk management to start the guardianship process.

16. Who May Consent to a Procedure? Telephone consent When a telephone consent is necessary: The Qualified Practitioner should have the conversation with the patient or legal guardian that is witnessed by another member of the health care staff. Both the Qualified Practitioner and the healthcare team member should sign the consent form. In place of the patient signature on the form, there should be a statement indicating that the patient or legal guardian agreed to the procedure, and the date and method by which the consent was obtained.

17. Who May Consent to a Procedure? Emergency In the case of an emergency where informed consent cannot be obtained in a timely manner: A Practitioner may proceed with a medical screening examination and/or treatment necessary to alleviate an Emergency Medical Condition without the patient’s/representative’s consent if the attempt to secure informed consent would result in an unacceptable delay in treatment. In such cases, two Qualified Practitioners, when possible, should verify the urgency and both should document the urgency of the problem in the medical record. This process would also pertain to a patient who suddenly became unable to give informed consent. At the next available time after the above situations, it is desirable to contact the patient or person legally authorized to consent for the patient and obtain consent after the fact.

18. Informed Refusal Process similar to the informed consent process except the patient refuses care When a patient refuses recommended care: -Inform them of the risks and benefits of refusing care -Advise them of any alternatives to the refused care -Execute the hospitals Informed Refusal Form Informed Refusal Form can be used for Refusal of assessment, care or treatment -Refusal of transfers -Leaving against medical advise -For patients who leave without being seen

19. Withdrawal of Consent A patient may withdraw consent for treatment at any time: – After Treatment Initiated Stop the treatment as soon as reasonably possible Discuss consequences of withdrawal with patient Document the withdrawal and discussion of impact of withdrawal in the patients medical record – Prior to Initiation of Treatment Document withdrawal in the medical record Inform the appropriate practitioners/departments

20. Patient Rights Updates Tag A-0117 – The hospital must inform each patient, or when appropriate, the patient’s representative as allowed by state law of the patient’s rights. 20

21. TAG A-0117 Incapacitated patient with designee orally or in writing Incapacitated patient who presents with Medical Power of Attorney (MPA) or similar Incapacitated patient unable to communicate wishes, no MPA or similar, with loved one who asserts authority including same sex domestic partners 21

22. TAG A-0117 Hospital action: Provide the designee with your statement of patient’s rights In the case of those who “assert authority” – Don’t demand written proof unless: More than 1 person asserts authority Acceptance would violate state law The hospital has reasonable cause to believe this authority is false 22

23. TAG A-0117 Hospital actions: Develop P+P that facilitate expeditious and non discriminatory resolution of disputes. If the hospital refuses to recognize a request, document the specific basis for the refusal in the medical record. Also be sure to give the IM, “important message” from Medicare to the rep 23

24. SOM ALSO INCLUDES SURVEY PROCEDURES TO PREPARE FOR Surveyors should ask to see your policy for implementing this directive. Review records and interview staff to determine how the hospital ID’s the representative and if the notice of patient’s rights is provided to the rep. 24

25. SAME STREAM OF THOUGHT, DIFFERENT CONTENT AREA: PLANS OF CARE TAG A-0130 Representatives as allowed by state law have a right to participate in the development and implementation of care plans, discharge plans and pain management plans. 25

26. TAG A-0130 SURVEY PROCEDURES See P+P to involve reps in the development and implementation of care plans, discharge plans, pain mgmt plans Review records, interview staff, reps, patients to determine how the hospital… 26

27. SIMILAR CONTENT, TAG A-0131 The patient or rep has a right to make informed decisions regarding care. The rights include being informed about health status, being involved in care planning and being able to request or refuse treatment. Not to be construed as a means to demand the provision of treatment or services deemed medically unnecessary or inappropriate. 27

28. TAG A-0132 The patient has a right to formulate advance directives and to have the hospital staff and practitioners who provide care comply with these directives. – The patient may use the AD to designate a “support person” for purposes of exercising visitation rights. The AD takes precedence over any non designated relationship unless withdrawn by the patient. 28

29. TAG A-0132 Notice of written policies for advance directives must be provided to inpatients and ED patients in observation status, and same day surgery patients who may become incapacitated. Not required for routine outpatients who are unlikely to become incapacitated. If the hospital will refuse to honor the AD based on conscience must include a statement of limitation. Conscience cannot be used to limit the patients right to choose a designee or support person. 29

30. TAG A-0133 The patient has a right to have a family member or representative or physician notified promptly of the admission to the hospital. This explicit designation takes precedence over any non designated relationship. The MR must document that the patient was asked. Document date, time and method of notification. Notice may be oral in person, phone, email, or other electronic, but not US mail. 30

31. TAG A-0215 The hospital must have written P+P regarding visitation rights including setting forth any clinically necessary or reasonable restriction or limitation. Policies must address in and outpatients Any restrictions on visitation rights must be necessary and reasonable. 31

32. 32 TAG A-0215 Examples of reasonable restrictions: – Infection control issues – Visitation interferes with care of other patients – Existing court order restricting contact – Visitors engage in disruptive, threatening or violent behaviors – Protocols for substance abuse treatment – Patient is undergoing care interventions, unless patient specifically requests support person to remain. – Number of visitors, or age of visitors

33. TAG A-0215 SURVEY PROCEDURES Verify the hospital has P+P that address the rights of patients to have visitors. Review for any limitations or restrictions to determine if there is rationale. Look for documentation how the hospital trains staff who play a role in controlling access to visitors. Interview staff, can they correctly verbalize the policy? 33

34. TAG A-0216 In the visitation policies: – 1. Inform each patient or support person of visitation rights including any restrictions – 2. Inform each patient or support person of the right, subject to their consent to receive visitors they designate including, but not limited to a spouse, domestic partner including same sex partner, another family member, or friend and the right to withdraw that consent at any time. 34

35. TAG A-0216 INTERPRETIVE GUIDANCE Patients support person is not necessarily the same as the representative. In the absence of an advance directive if someone asserts they are the support person, accept the assertion and provide the notice of visitation rights. If more than one person claims to be the support person, it “would not be inappropriate to ask for documentation”. 35

36. TAG A-0216 INTERPRETIVE GUIDANCE A refusal by the hospital to accept the support person with respect to visitation rights should be documented in the medical record, along with the specific basis for the refusal. If the support person and the representative are different, provide both with the notice of visitation rights. If they disagree, defer to the representative. Document provision of visitation rights notice in the medical record. 36

37. TAG A-0217 In the visitation policies: – 1. State you don’t restrict or deny visitation privileges on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation or disability. – 2. State you ensure all visitors enjoy full and equal visitation privileges consistent with patient preferences. 37

38. TAG A-0217 SURVEY PROCEDURES Review the policies to make sure there are no restrictions on a prohibited basis. Ask the hospital how they educated staff to assure that policies are implemented on a nondiscriminatory basis. Ask the staff to discuss their understanding of the circumstances under which visitors may be restricted. Ask patients or support persons if the hospital has restricted visitors against their wishes. If yes, verify that the medical record documents a clinical rationale. 38

39. QUESTIONS? John R. Rosing, MHA, FACHE Vice President and Principal Patton Healthcare Consulting email: johnrosing@pattonhc.comjohnrosing@pattonhc.com web: www.pattonhc.com www.pattonhc.com Milwaukee Wisconsin Office 262-242-3631 (Office) 39