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

Changes in Conditions of Changes in Conditions of Participation (CoPs) and Participation (CoPs) and

Interpretive Guidelines for Interpretive Guidelines for Informed ConsentInformed Consent

Informed ConsentInformed ConsentThe New RequirementsThe New Requirements

Presented by: Presented by: City-wide Patient Consent City-wide Patient Consent

CommitteeCommittee

Changes in CoPs for Changes in CoPs for Informed ConsentInformed Consent

Objectives:Objectives:1.1. Review components of Informed Consent.Review components of Informed Consent.2.2. Provide background on Medicare Conditions Provide background on Medicare Conditions

of Participation (CoPs) for hospitals. of Participation (CoPs) for hospitals. 3.3. Provide an overview of the revised CoPs for Provide an overview of the revised CoPs for

surgical consents, treatments and surgical consents, treatments and procedures.procedures.

4.4. Solicit feedback and offer assistance in Solicit feedback and offer assistance in implementing the new process.implementing the new process.

5.5. Q&A.Q&A.

Informed Consent DoctrineInformed Consent Doctrine

Informed Consent DoctrineInformed Consent Doctrine– Two distinct componentsTwo distinct components::

1)1) A A Person’s rightPerson’s right to determine what happens to his to determine what happens to his or her body; andor her body; and

2)2) A A Physician or Practitioner’s dutyPhysician or Practitioner’s duty to provide a to provide a person with enough information to ensure that the person with enough information to ensure that the patient’s ultimate decision is based on an patient’s ultimate decision is based on an appreciable knowledge of his/her condition, the appreciable knowledge of his/her condition, the available options for treatment, known risks, available options for treatment, known risks, prognoses to make an informed consent.prognoses to make an informed consent.

Informed Consent DoctrineInformed Consent Doctrine

Informed Consent DoctrineInformed Consent Doctrine– The treating physician or practitioner is The treating physician or practitioner is

responsible to obtain the informed consent.responsible to obtain the informed consent.

– The Hospital’s or nursing staff’s duty is to The Hospital’s or nursing staff’s duty is to facilitate and validate the form is complete facilitate and validate the form is complete and present on the chart prior to the and present on the chart prior to the operation/procedure.operation/procedure.

Who is Making these Changes?Who is Making these Changes?

(CMS) the Centers for Medicare and (CMS) the Centers for Medicare and Medicaid is a Federal Government Medicaid is a Federal Government Agency who establishes standards Agency who establishes standards or regulations that regulate or regulations that regulate reimbursement of Medicare and reimbursement of Medicare and Medicaid Patients.Medicaid Patients.

CMS calls these guidelines CMS calls these guidelines “Conditions of Participation (CoP’s). “Conditions of Participation (CoP’s).

Why didn’t we know about Why didn’t we know about these CMS changes?these CMS changes?

CMS published the changes in 2005 CMS published the changes in 2005 and made the implementation date to and made the implementation date to be January 2006.be January 2006.

Physicians requested the changes be Physicians requested the changes be made city wide.made city wide.

City wide meetings have been City wide meetings have been occurring for 1 ½ years to identify the occurring for 1 ½ years to identify the best implementation processes and best implementation processes and guidelines. guidelines.


A-0392 CoP §482.51(b)(2) A-0392 CoP §482.51(b)(2) A properly executed informed consent A properly executed informed consent

form for the operation must be in the form for the operation must be in the patient’s chart patient’s chart before surgerybefore surgery, except in , except in emergencies.emergencies.

““No change in wording but the No change in wording but the interpretative guidelines were interpretative guidelines were

expanded.”expanded.”


A-0238 CoP §482.24(c)(2)(v) A-0238 CoP §482.24(c)(2)(v) Properly executed informed consent Properly executed informed consent forms for procedures and treatments forms for procedures and treatments specified by the medical staff, or by specified by the medical staff, or by Federal and State law, if applicable, to Federal and State law, if applicable, to require informed consent.require informed consent.

““No change in wording but the No change in wording but the interpretative guidelines were interpretative guidelines were

expanded.”expanded.”


Elements required Elements required prior prior toto changes changes in CoP:in CoP:

1)1) Name of patient;Name of patient;

2)2) Name of hospital;Name of hospital;

3)3) Name of procedure;Name of procedure;

4)4) Signature of patient or legal guardian;Signature of patient or legal guardian;

5)5) Date and time consent is obtained;Date and time consent is obtained;


AddedAdded CoP Elements CoP Elements 6)6) Name of the practitioner performing the Name of the practitioner performing the

procedure or important aspects of the procedure or important aspects of the procedures;procedures;

7)7) Risks;Risks;• Related to surgical procedureRelated to surgical procedure• Related to patient conditionRelated to patient condition• Related to surgery in generalRelated to surgery in general

8)8) Alternative procedures and treatments;Alternative procedures and treatments;


AddedAdded CoP Elements CoP Elements 9)9) Title(s) and specific surgical tasks that will be Title(s) and specific surgical tasks that will be

conducted by practitioners other than the conducted by practitioners other than the

primary surgeon/practitioner;primary surgeon/practitioner; Significant surgical tasks include: Significant surgical tasks include: • opening and closingopening and closing• harvesting graftsharvesting grafts• dissecting tissuedissecting tissue• removing tissue removing tissue • implanting devicesimplanting devices


AddedAdded CoP Elements CoP Elements 10)10) Statement that procedure was explained to Statement that procedure was explained to

patient or guardian;patient or guardian;

11)11) Name/Signature of person who explained the Name/Signature of person who explained the procedure the patient or guardian;procedure the patient or guardian;

12)12) Signature of person witnessing the consent;Signature of person witnessing the consent;


When circumstances require a change in When circumstances require a change in practitioners practitioners afterafter consent has been obtained – consent has been obtained – thethe post-operative note in the chart needs to post-operative note in the chart needs to reflect the change.reflect the change.

CMS’s Focus: CMS’s Focus: Is to make sure the patient is Is to make sure the patient is informed and consents to the procedure as well informed and consents to the procedure as well as other practitioners (i.e., third year resident) as other practitioners (i.e., third year resident) who may participate in his/her procedure (i.e. who may participate in his/her procedure (i.e. opening and closing).opening and closing).

How to obtain the How to obtain the Consent FormConsent Form

By the first of February offices will be By the first of February offices will be able to access the formable to access the form

1.1. Via Via Web site at Saint Elizabeth Regional Medical Center Web site at Saint Elizabeth Regional Medical Center Portal at BryanLGH Medical CenterPortal at BryanLGH Medical Center

2.2. Emailed directly to your medical officeEmailed directly to your medical office

3.3. Compact Disc- per office request Compact Disc- per office request

Timelines for Timelines for Implementation of the New Implementation of the New

Consent ProcessConsent Process February-March 2007: February-March 2007: City wide task City wide task

force members will work with physician force members will work with physician office staff members to take the proposed office staff members to take the proposed city wide form and develop office specific city wide form and develop office specific forms for individual providers which forms for individual providers which include risks, benefits, alternatives.include risks, benefits, alternatives.

February 28, 2007: February 28, 2007: Implement the new Implement the new consent processes with the new form.consent processes with the new form.

April 2, 2007April 2, 2007: : Facilities will only Facilities will only accept the new city-wide consent accept the new city-wide consent form developed for each provider.form developed for each provider.

Once the form is completed in Once the form is completed in the office where do I send the the office where do I send the

form?form?

To the pre-op office of the facility To the pre-op office of the facility where the patient is going to be where the patient is going to be admitted.admitted.

Fax the form along with the other Fax the form along with the other information, e.g. H&P, orders, etc. information, e.g. H&P, orders, etc. that you send now.that you send now.

Frequently Asked Frequently Asked Questions related to Questions related to

changes with changes with ConsentConsent

Who must obtain consent?Who must obtain consent?

The provider or practitioner who The provider or practitioner who is performing the procedure.is performing the procedure.– This includes Physicians, Surgeons, This includes Physicians, Surgeons,

Dentists, Podiatrists, Midwives, CRNAs, or Dentists, Podiatrists, Midwives, CRNAs, or Licensed Independent Practitioners, by the Licensed Independent Practitioners, by the state of Nebraska.state of Nebraska.

Who is responsible for the Who is responsible for the consent?consent?

The physician or practitioner is The physician or practitioner is responsible to obtain the consent. responsible to obtain the consent.

However, a crucial aspect of the However, a crucial aspect of the nurse advocacy role is his/her nurse advocacy role is his/her obligation to ensure that medical obligation to ensure that medical intervention does not proceed intervention does not proceed unless the patient comprehends unless the patient comprehends the details of the procedure. the details of the procedure.

Can the physician or Can the physician or practitioner obtain consent and practitioner obtain consent and

also also witness the consent?witness the consent?

Yes, but according to legal Yes, but according to legal counsel it is not advised.counsel it is not advised.

Can Physician Assistants Can Physician Assistants obtain consent?obtain consent?

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

Who can be a witness?Who can be a witness?

Any person can witness the Any person can witness the patient signature on the consent patient signature on the consent form. form.

Family members should not be a Family members should not be a witness to a consent.witness to a consent.

Does the witness have to be in the Does the witness have to be in the room during the discussion of risks, room during the discussion of risks,

benefits, and alternatives benefits, and alternatives between the physician and patient?between the physician and patient?

NoNo The witness is only validating The witness is only validating

the person’s signature. the person’s signature. The witness is validating who The witness is validating who

has signed the form not that has signed the form not that he/she understands the he/she understands the implications of the form.implications of the form.

Will all consents be Will all consents be signed in the office?signed in the office?

It is preferred that Consents be It is preferred that Consents be completed in the office and are signed completed in the office and are signed and witnessed before they are faxed. and witnessed before they are faxed.

The surgeon or practitioner must sign The surgeon or practitioner must sign the consent prior to the procedure.the consent prior to the procedure.

If the permit is not signed in the office, If the permit is not signed in the office, it can be signed and witnessed at the it can be signed and witnessed at the hospital prior to procedure. hospital prior to procedure.

How long are consent valid?How long are consent valid?

There is no state law stating the There is no state law stating the time limit on consents. The city time limit on consents. The city wide group is proposing 6 wide group is proposing 6 months unless the patient months unless the patient condition or procedure changes. condition or procedure changes.

If the patient condition changes If the patient condition changes the consent will then need to be the consent will then need to be updated or completed again.updated or completed again.

We already have material we give We already have material we give the patient regarding the the patient regarding the

procedure. procedure. Can we just use that material? Can we just use that material?

No, this information can not be No, this information can not be used as part of the consent used as part of the consent although it can be used for although it can be used for patient information.patient information.

The required information must The required information must be documented be documented onon the specific the specific consent form. consent form.

Can we change the form? Can we change the form?

The answer is yes and no.The answer is yes and no. The content and format of the text in The content and format of the text in

the form cannot be changed except the form cannot be changed except for: for:

– The Allograph section can be deleted if The Allograph section can be deleted if not applicable.not applicable.

– General procedure risks can be altered if General procedure risks can be altered if appropriate. appropriate.

– Copy can be added at the end of the Copy can be added at the end of the form as needed.form as needed.

Can the physician or Can the physician or practitioners have standardized practitioners have standardized

consents for specific or consents for specific or frequent procedures?frequent procedures?

Yes, in fact it is preferred.Yes, in fact it is preferred. Standardized consent forms Standardized consent forms

allows for:allows for:– Consistent education for Consistent education for

patientspatients– Assist with time constraints in Assist with time constraints in

the office the office

Who will help the Who will help the physician/practitioner make physician/practitioner make

these specific template these specific template consents?consents?

Members of the city wide task force Members of the city wide task force have agreed to work with physicians have agreed to work with physicians and office staff to obtain the consent and office staff to obtain the consent template and provide suggestions for template and provide suggestions for form standardization and office work form standardization and office work flows.flows.

Do we have to list every Do we have to list every adverse outcome or adverse outcome or

complication on the consent? complication on the consent?

Listing every adverse outcome Listing every adverse outcome would be impossible. The ones would be impossible. The ones that need to be listed are those that need to be listed are those most frequently associated with most frequently associated with the procedure. the procedure.

What are the three risk What are the three risk components that must be listed components that must be listed

on consent form? on consent form?

The three risk components are: The three risk components are:

1.1. Risks of surgery or procedure Risks of surgery or procedure in general (listed on the in general (listed on the form).form).

2.2. Risks of the specific surgery Risks of the specific surgery or procedure.or procedure.

3.3. Risks related to the patient Risks related to the patient and his/her condition. and his/her condition.

What if the surgeon, physician, or What if the surgeon, physician, or practitioner does not know who will practitioner does not know who will be assisting during the procedure at be assisting during the procedure at the time the consent is filled out? the time the consent is filled out?

The provider must inform the The provider must inform the patient that another provider patient that another provider (list title) will be assisting with (list title) will be assisting with the procedure. the procedure.

The provider will need to list the The provider will need to list the extent of support or activities extent of support or activities the other provider will perform.the other provider will perform.

Will the consent form allow Will the consent form allow for abbreviations?for abbreviations?

No!!! No!!! Abbreviations are not Abbreviations are not

allowed on the consent form.allowed on the consent form.

Can we fax or photocopy the Can we fax or photocopy the consent form to the hospital or consent form to the hospital or

outpatient clinic?outpatient clinic?

Yes, CMS has indicated that a Yes, CMS has indicated that a copy of the form either mailed copy of the form either mailed or faxed to the hospital is or faxed to the hospital is sufficient for CMS. sufficient for CMS.

What about patients who can What about patients who can not sign their own consent? not sign their own consent? Are telephone consents legal?Are telephone consents legal?

Yes. The physician or practitioner who is Yes. The physician or practitioner who is performing the procedure should explain performing the procedure should explain the procedure with the legal guardian the procedure with the legal guardian and review the risks, benefits and and review the risks, benefits and alternatives, and answer questions. alternatives, and answer questions.

If consent is obtained by phone, the If consent is obtained by phone, the permit should be read to the legal permit should be read to the legal guardian in total prior to obtaining guardian in total prior to obtaining consent by either the physician or consent by either the physician or witness.witness.

If the patient is unable to sign the If the patient is unable to sign the consent then note the reason.consent then note the reason.

What if the procedure is What if the procedure is incorrect?incorrect?

The form can be corrected with The form can be corrected with the physician or practitioner and the physician or practitioner and patient initialing next to the patient initialing next to the change on the consent form. change on the consent form.

A new consent form could also A new consent form could also be completed.be completed.

Will an order for the procedure Will an order for the procedure still be required prior to still be required prior to

surgery?surgery?

The city wide task force believes an order The city wide task force believes an order will continue to be needed for planned will continue to be needed for planned procedures. procedures.

Orders are used to verify the following: Orders are used to verify the following: – Appropriate procedure is scheduled.Appropriate procedure is scheduled.– Patient matches procedure scheduled.Patient matches procedure scheduled.– Appropriate procedure matches the Appropriate procedure matches the

surgery schedule. surgery schedule.

Can there be blanks Can there be blanks on the consent form?on the consent form?

No. All areas from the start No. All areas from the start through physician declaration must through physician declaration must be completed in full before sending be completed in full before sending to the hospital or outpatient center. to the hospital or outpatient center.

Areas after physician declaration Areas after physician declaration including patient signature and including patient signature and other applicable areas must be other applicable areas must be completed prior to the procedure.completed prior to the procedure.

How will consents be obtained How will consents be obtained for unplanned or unanticipated for unplanned or unanticipated

procedures?procedures?

All facilities will have generic All facilities will have generic consent forms available online for consent forms available online for physician or practitioner use. physician or practitioner use.

Clinical staff will print the form and Clinical staff will print the form and have available for the physician or have available for the physician or practitioner prior to the procedure.practitioner prior to the procedure.

In a true emergency, a consent is In a true emergency, a consent is not required prior to the procedure.not required prior to the procedure.

What if the patient gets to the What if the patient gets to the hospital or outpatient center and hospital or outpatient center and

does not understand the procedure does not understand the procedure or has questions regarding the or has questions regarding the

procedure?procedure?

Everything stops until the Everything stops until the physician or practitioner physician or practitioner completing the procedure comes completing the procedure comes to answer the questions of the to answer the questions of the patient and family patient and family PRIORPRIOR to the to the procedure start.procedure start.

What about Blood consents or What about Blood consents or Consents for PICC lines? Consents for PICC lines?

In the hospital, the Registered Nurse In the hospital, the Registered Nurse who is performing the procedure is who is performing the procedure is allowed by state law to provide consent allowed by state law to provide consent for both of these procedures and will for both of these procedures and will obtain the consent with the patient.obtain the consent with the patient.

The blood section of the general patient The blood section of the general patient consent form should be completed at consent form should be completed at the time of patient consent is obtained if the time of patient consent is obtained if it is anticipated that blood products it is anticipated that blood products may/will be administered. may/will be administered.

What about Anesthesia What about Anesthesia consent?consent?

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


For more information:For more information: The website for CoPs and The website for CoPs and

Interpretive Guidelines for Interpretive Guidelines for HospitalsHospitals: : http:\www.cms.hhs.gov/manuals/http:\www.cms.hhs.gov/manuals/

Downloads/Downloads/som107ap_a_hospitals.pdfsom107ap_a_hospitals.pdf

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