Informed Consent for Invasive Medical Treatment

Dated: January 31, 2012

 Active Representation

 Informed Consent for “Professional Medical

Treatment” when CAB fully represents the Class

Member

 Willowbrook Considerations: Do Not Resuscitate

(DNR), Do Not Intubate (DNI), Life Sustaining

Treatment (LST)

Active Representation

Important Reference:

Willowbrook Active Representation

 Correspondence dated 9/30/2011 posted

on the

Beyond Willowbrook

website

 Updates prior memoranda related to sign

off on movements, plans of care and

treatment on behalf of Willowbrook class

members

Active Representation

Is…

Is not…

 Per the Willowbrook

Permanent Injunction,

 Correspondent

participation with the

program planning team

in planning and

evaluating the person’s

plan of services; and/or

visits the class member

at least annually

 Merely signing consent

forms sent through the

mail or receiving phone

calls initiated by staff

with no other

involvement

Representation is

first and foremost for the class member

If the family is not meeting the standard of

active representation, for whatever reason, and the

class member cannot self-advocate, then the class

member should be referred to CAB

Active Representation Status: Self-advocate

 A class member who self-advocates acts as his or her

own correspondent

 A class member who self-advocates may also have co-

representation from a family member or the CAB

 As a self-advocate, the class member gives his or her own

consent for movements, release of information, participation

in activities, routine medical/dental care, etc.

 The class member who self-advocates may also sign for

invasive medical/dental treatment when determined to be

capable of making the decision at hand

When a class member is not a self advocate…

The correspondent would be either…

A parent or legal guardian

Alternate family member

The Consumer Advisory Board (CAB)

Active Representation Status: Family full representation

 A parent/family member may act as the class member’s

correspondent

 The parent/family may also elect to have co-representation

from the CAB

 As the correspondent, the parent/family member

gives consent for movements, release of information,

participation in activities, routine medical/dental

care, etc.

 The parent/family member acting as correspondent

is also able to sign for invasive medical/dental

treatment

Active Representation Status: CAB co-representation

 CAB staff attend team meetings and visit programs

 CAB is notified along with the self advocate/family of

significant events, including medical, injuries and

incidents

 The self-advocate/family retains its responsibility as

correspondent, to review and respond to issues that

require written consent, including informed consent

 Therefore, CAB staff do NOT sign plans of care or give

consent for care and treatment for class members they co-

represent

Active Representation Status: CAB full representation

 The Board acts as correspondent for the class member

 The Board provides informed consent for surgery

and/or other invasive treatments; or end of life

decisions

 On behalf of the Board, local CAB representatives…

 attend team meetings and advocate for the class member

 visit the class member

 make recommendations to the Board

 ensure that the class member is receiving appropriate

services, and that services are consistent with his/her plans;

 follow up on identified problems; and

 report to the Board

Remember:

When CAB fully represents a class member…

 The Board acts as correspondent/ surrogate for

the class member

 The local CAB representatives provide the

eyes/ears/voice for the Board but are NOT the

correspondent/surrogate

 If a surrogate name is needed for any form or

document, enter Consumer Advisory Board (CAB)

Willowbrook Concerns

The Willowbrook parties feel that OPWDD is not

ensuring active representation for class members

 They feel MSCs and program staff are obliged to be

knowledgeable regarding active representation status for

each class member

 They feel providers are not taking timely steps to involve

CAB when class member family members retire/relocate

out of state/age and/or die

Willowbrook Concerns

The parties feel that the DDSOs and agencies do not

understand the role of CAB and the different

functions of the local representatives and the Board

itself

 The local representative serves as the point person for

DDSOs and voluntary agencies BUT the BOARD is the

deciding body

 For example, when surrogate name is requested, enter

“Consumer Advisory Board,” never name of local

representative

Willowbrook

Expectations…

 Teams should discuss active representation status for

each class member at the semi-annual update and annual

review

 The plan of services should reflect whether the class

member self-advocates or whether family member(s) or

the CAB serve as sole advocate or co-representative on

their behalf

 If family is involved, the plan of services and follow up

documentation should include the frequency of visits

and/or participation with team members

Willowbrook Expectations :

Active Representation Monitoring

 OPWDD has developed the WillowBrook CAB

Active Representation data system to

maintain information on CAB involvement on

behalf of class members

 Service coordination/case management providers

are to report active representation status to the

DDSO Willowbrook liaisons quarterly along with

caseload reporting

The Willowbrook CM/SC should adapt 1 of 2 sample

letter formats with prescribed attachments, located at

http://www.opwdd.ny.gov/willowbrook/hp_willowbrook_activerep.jsp

• 1

letter format is used when CAB is “no rep”

• 2

letter format is used when CAB already provides co-representation

Attachments:

1. ACTIVE REPRESENTATION RESPONSE FORM



Note: Active Representation options CANNOT be changed

2. Responsibilities of Correspondent

3. Definition of Willowbrook Active Representation

When offering CAB to correspondents…

 The DDSO Willowbrook liaison and CAB

Executive Director should be cc’d on the

correspondence to the correspondent

 Copies of the completed response form should

be forwarded to the DDSO Willowbrook

Liaison and CAB Executive Director

When offering CAB to correspondents…

Informed Consent When CAB Fully

Represents the Class Member

Effective 11/23/2005…

 OPWDD's regulation on informed consent for medical

treatment 14 NYCRR 633.11 was amended to include CAB on

the list of surrogate decision makers

 CAB is authorized to make informed consent decisions for a

class member who is not able to make the informed medical

decision and has no other identified surrogate

 The following is the order for surrogates:

 a legal guardian or health care agent;

 an actively involved spouse;

 an actively involved parent;

 an actively involved adult child;

 an actively involved adult sibling;

 or actively involved adult family member;

 or the CAB for class members for whom it fully

represents; OR

 a surrogate decision-making committee (SDMC) or a court

CAB is NOT authorized to give informed

consent for class members…

 who are able to give informed consent on their

own behalf;

 who have a legal guardian, health care agent

[person appointed pursuant to a health care

proxy executed by the individual] or other

actively involved family member to act as

surrogate decision maker; or

 when CAB provides co-representation.

CAB will NOT give informed consent…

When CAB is the identified surrogate

for a class member…

 Depending on the procedure, the provider

submits either the

Dental Consent Overview or

Medical Consent Overview

AND CAB Informed

Consent Submission Checklist

 Current forms dated [4/15/09] and available on

OPWDD’s website at

http://www.opwdd.ny.gov/hp_cabconsent_index.jsp

 The compiled information is submitted via

paper mail to Antonia Ferguson, Executive

Director of the CAB, at 1050 Forest Hill Road,

Staten Island, NY 10314

Requesting agencies are expected to…

 Implement a review protocol for requests for

informed consent, which includes sign off from

administrative or medical supervisory staff

 sign off is to be reflected on the CAB Informed

Consent Submission Checklist and Medical /Dental

Consent Overview

 Maintain a detailed chronology of contacts

following submission of its request for informed

consent, with local CAB reps and CAB Central

Office in SI

 include all dates of verbal or phone contact, questions

from CAB and follow up actions taken by the agency

Requesting agencies are expected to…

 Respond timely to all questions and

requests for information from the

CAB.

 Remember ~ All responses to questions

and requests for information must be

reflected in the chronology.

 Notify CAB of date of procedure/

treatment AND forward

results/findings to the Executive

Director of the CAB, 1050 Forest

Hill Road, Staten Island, NY 10314

Requesting agencies are expected to…

 Notify DDSOs of all requests for informed

consent to CAB:

 Fax the CAB Informed Consent Submission

Checklist to the DDSO Director immediately

after mailing ~ DDSO enters date received in

Box 1

 Notify the DDSO Director immediately when

the information packet is returned for

resubmission, or when the signed or declined

consent form is received from CAB ~ DDSO

enters date consent confirmed in Box 3

Requesting agencies are expected to…

 Keep the DDSO informed of status of request

 DDSO needs to know if request for informed consent

is still pending after 30 business days

 If signed or declined consent has been secured,

DDSO will note on its copy of the CAB Informed

Consent Submission Checklist

 If the request is still outstanding, the DDSO

Director or designee will contact Ms. Ferguson

to ascertain the status of the submission

WHEN will requesting agencies hear from

CAB?

 As a rule, CAB will complete a regular review,

when all required documentation is submitted,

within 21 business days.

 Expedited decisions will be made within 8

business days of submission when all required

documentation is submitted.

HOW will requesting agencies hear from

CAB?

 Once all questions are fully addressed and

information received, the signed or declined

consent will be forwarded via regular mail directly

to the originating requestor as reflected on the

CAB Informed Consent Submission Checklist

along with the local CAB representative

 On an exception basis only, CAB will fax the copy

directly to a provider if a faxed consent is accepted by

the health care provider, i.e., hospital, clinic, physician,

etc.

What if an alternate surrogate exists?

 633.11 allows the requesting agency to seek consent

from the next highest surrogate if the authorized

surrogate is “not reasonably available and willing, and

is not expected to become reasonably available and

willing to make a timely decision given the person’s

medical circumstances.” However, the agency must

document the efforts made to contact the surrogate

 IF a surrogate refuses to provide the requested

consent and the agency believes the proposed

treatment would be in the person’s best interest, the

agency should apply for court authorization for the

proposed treatment

What happens in an emergency?

 For emergency medical treatment, Section 633.11 provides

that:

 “Medical, dental, health and hospital services may be

rendered to a person of any age without seeking informed

consent when, in the physician’s judgment, an emergency

exists creating an immediate need for medical attention”

 In such cases, the supplier of treatment may accept the

authorization of the chief executive officer of the person’s

residential facility to render treatment

 Public health law defines “emergency” as when a person is

in immediate need of medical attention and an attempt to

secure consent would result in delay of treatment that

would increase the risk to the person’s life or health”

What happens in an emergency? continued

 Before declaring an “emergency”, the hospital/physician will

attempt to reach out to the appropriate surrogate to

obtain informed consent

 For a member fully represented by the CAB, the

hospital/physician would reach out to CAB Central Office in

Staten Island, to give notice of the situation

 If the CAB cannot be reached or cannot provide consent

given the circumstances, the treatment should be provided

on an “emergency” basis.

 Some hospitals/physicians will simply provide such

treatment; others will seek the director’s authorization

pursuant to Section 633.11

What happens when urgent care is needed?

 Urgent care is needed when a condition occurs suddenly and

unexpectedly; requires prompt diagnosis or treatment; and in

the absence of immediate care, the individual could reasonably

be expected to suffer chronic illness, prolonged impairment or

require a more hazardous treatment.

 When a class member fully represented by CAB is in the

hospital and requires urgent care:

1. Contact CAB directly by telephone at 718-477-8800

2. Primary health contact completes the Medical Consent

Overview form; faxes to the CAB Staten Island Office at

718-477-8805

3. All questions on the Overview

form should be answered to

prevent delays; however, responses to some questions will

be abbreviated since CAB will obtain supplemental

information directly from the physician via telephone

TIPS to facilitate requests for CAB

informed consent

 Do not use SDMC forms ~ they will be returned

to the originating requestor.

 Failure to submit all required documentation

delays the review, and will result in the return of

the information packet to the originating

requestor for resubmission.

 Piecemeal submission will also delay the review

process.

 For expedited requests only, fax submissions will

be accepted

 Please confirm that the pages received are legible

TIPS to facilitate requests for CAB

informed consent

 If sedation or anesthesia is required,

include an explanation including type of

anesthesia and risk/benefit information

 Always include recent annual medical

assessment and laboratory reports

 Provide a listing of current medication ~

remember name and dosage

 Any known medication or food allergies

 Don’t forget weight information for the

past year

TIPS to facilitate requests for CAB

informed consent

 Include a statement from the ISP/CFA or

a recent assessment by a qualified

examiner that confirms:

 the class member lacks capacity to give informed

consent for the proposed medical treatment and the

basis for the statement

 no health care agent, legal guardian, or actively

involved family member is available to grant

informed consent

 the class member is fully represented by the

Consumer Advisory Board

TIPS to facilitate requests for CAB

informed consent

 Work with local CAB representative

immediately when professional medical

treatment is recommended, and

communicate throughout the process

 Give advance notice to local CAB

representative of related appointments so

that, if possible, they can attend

 Remember to request a status from the

local CAB representative

TIPS to facilitate requests for CAB

informed consent

 If an expedited decision is needed [within 8

business days of submission], inform the

local CAB representative, and reflect on the

CAB Informed Consent Submission Checklist

and cover letter

 Remember to provide the medical

recommendation/justification for the

expedited review

TIPS to facilitate requests for CAB

informed consent

 Ensure that the primary health services contact

(RN or MD) is available to respond to CAB

questions.

 Ensure prompt response to CAB’s inquiries from

the health care provider proposing the treatment

 The secondary contact is designated by the

requesting agency ~ it may be the service

coordinator/case manager, residential director or

other agency designee. It is helpful if the

secondary contact is aware and knowledgeable of

the submission

 The local CAB rep is NEVER the secondary

contact

TIPS to facilitate requests for CAB

informed consent

 Seek a second opinion for medical/dental

treatment when questions can be

anticipated

 Include all applicable documentation from

these medical/dental consultations to

facilitate the CAB review

What if…

…there is known family who is not the

correspondent for the class member and

has not been active in care and

treatment?

 A non-correspondent family member may

be initially passed over in the chain of

surrogate decision makers. However, the

provider must include the name, address

and telephone number of any known family

member in its request to CAB for

informed consent.

What if…

…there is a family member who has served as

correspondent for the class member with CAB

co-representation; however, the family is no

longer involved and no other family is

immediately available to serve as

correspondent?

 Immediately submit a written request for full

representation to the Executive Director CAB.

CAB is unable to give informed consent until it

serves as the full representative.

 If an alternate family member subsequently

indicates a willingness to serve as correspondent,

the issue of co-representation would be revisited.

What if…

…the class member has served as his/her own

correspondent with no CAB involvement; however,

the individual is no longer able to provide his/her

own informed consent and no other family is

immediately available to serve as correspondent?

 If the class member has not executed a health care proxy,

immediately submit a written request for full

representation to the Executive Director CAB. CAB is

unable to give informed consent until it serves as the full

representative.

 If an alternate family member subsequently indicates a

willingness to serve as correspondent, the issue would be

revisited.

Is informed consent required for IV

sedation for dental services?

 Dental procedures performed under general

anesthesia must go before the CAB for

informed consent.

 For dental procedures that require

informed consent in which IV sedation is

required, the informed consent provided by

CAB will cover both the procedure and IV

sedation.

 The local representative on behalf of CAB

is able to provide consent for routine dental

procedures when IV sedation is required.

Does the primary health services contact

have to be available during evening hours?

 Agencies must ensure the primary health

services contact (RN or MD) is available by

telephone to respond to CAB questions, and

facilitate CAB’s communication directly with

the health care provider proposing treatment

 These telephone calls will be scheduled with

notice during day or evening hours

 Include all communication by the primary

health services contact in the chronology

maintained by the requesting agency

Is informed consent required for presedation

when it is required to perform the proposed

medical or dental treatment?

 Informed consent for presedation is included

in CAB’s informed consent for the underlying

professional medical treatment.

 Once the procedure/treatment is completed,

are there other steps to be taken to finalize

documentation?

 The primary health services contact should forward

the results of the procedure to the Executive

Director of the CAB, 1050 Forest Hill Road, Staten

Island, NY 10314.

Is it routine care or professional medical

treatment?

 Venipuncture, suturing of lacerations and

catheterization of the bladder are routine.

 Radiology procedures not involving contrast

are routine; however, radiology procedures

involving contrast with radiopaque dyes or

contrast media require informed consent due

to the risk of allergic reaction.

 Sigmoidoscopies, colonoscopy and

endometrial biopsies require informed

consent due to the risk of perforation.

Is it routine care or professional medical

treatment?

 Biopsies of suspicious skin lesions that

involve scraping are routine; however, those

involving excision procedures would require

informed consent due to the risk of

bleeding and infection, and due to the cuts

that compromise body integrity.

Is it routine care or professional medical

treatment?

 Reduction and casting of fractures

depends on the situation. If considered

an emergency, care would be covered

under Public Health Law 2504. Routine

recasting does not require informed

consent.

 If a break has not healed well and internal

fixation is required, informed consent is

needed for this surgical procedure.

Is it routine care or professional

medical treatment?

 Aspiration or injection of joints, tendons, or

cysts that involve a fine needle biopsy do

not require informed consent.

 Surgical biopsies; fine/core needle biopsies,

i.e., breast, liver; and transurethral biopsies

of the bladder requires informed consent

due to the invasive nature of the

procedures.

 Insertion of a central venous catheter for

venous access requires informed consent

due to the intrusive nature of the catheter.

For more about Willowbrook informed

consent…

 Reference the document,

Willowbrook Informed Consent for

Class Members Fully Represented

by the Consumer Advisory Board,

last

updated September 30, 2011

 Available on OPWDD’s website as

follows:

 Go to http://www.omr.state.ny.us/

 Select “News & Publications”

 Select “Publications”

 See “CAB Informed Consent”

Another important resource for health concerns…

 Reference the document,

HEALTH CARE CHOICES:

WHO CAN DECIDE?, issued

March 2011 to learn about…

 Informed consent for

professional medical

treatment

 health care proxies

 DNR Orders

 Health Care Decisions Act

for Persons with Mental

Retardation

 Living Wills

Willowbrook Considerations ~

Do Not Resuscitate (DNR), Do Not Intubate

(DNI), Life Sustaining Treatment (LST)

CAB is now an authorized surrogate for DNR/DNI/LST

 Effective 6/1/10, the Health Care

Decisions Act (HCDA) process was

changed for all decisions involving the

withholding or withdrawing of life-

sustaining treatment, including

Do Not Resuscitate (DNR),

Do Not Intubate (DNI) or

Life Sustaining Treatment (LST)

 HCDA created one set of medical criteria

and one surrogate list for all such

decisions, which includes CAB for class

members fully represented by the CAB

 Access additional information at

http://www.opwdd.ny.gov/health/images/hp_fhcda_

memo.pdf

 Life sustaining treatment means medical

treatment including CPR and artificial

nutrition and hydration which is sustaining

life functions and without which according to

reasonable medical judgment, the patient will

die within a relatively short time period

What is life-sustaining treatment?

Article 17-A guardian

Qualified family member [14 NYCRR section

633.10(a)(7)(iv)]

• Actively involved spouse

• Actively involved parent

• Actively involved adult child

• Actively involved adult sibling

• Actively involved adult family member

CAB

Surrogate Decision-Making Committee

Prioritized Surrogate List

Steps in securing DNR Orders and Life

Sustaining Treatment (LST)

 Step 1–Identification of Appropriate 1750-b Surrogate

from Prioritized List

 Should be the signer for the class member

 Step 2–1750-b surrogate makes decision to withhold or

withdraw LST, either orally or in writing.

 Step 3–Confirm individual’s lack of capacity to make

health care decisions.

 Step 4– Determination of Necessary Medical Criteria.

 Step 5- Notifications

 Step 6- Objections

When CAB is the 17A guardian

When CAB provides full representation for a

class member

Remember: CAB is NOT the 1750-b Surrogate

when CAB provides co-representation

 In these instances, the local representative is NOT the

authorized Surrogate and cannot consent to DNR, DNI, LST

but should be kept informed throughout the process

When is CAB the 1750-b surrogate?

 The process begins with a conversation or series of

conversations between the class member, CAB as 1750-b

surrogate, and qualified, trained health care professional

 This minimally includes diagnosis, progress, objectives for care,

treatment preferences, CAB position on DNR, DNI, LST

 When CAB is 1750-b Surrogate, the request will be made

in a letter issued by Antonia Ferguson, Executive

Director

 In lieu of a letter, the request may be made orally in

extenuating situations, i.e., a weekend or holiday

How will CAB make a request for DNR/DNI/LST?

The MOLST LEGAL REQUIREMENTS CHECKLIST for

Individuals With Developmental Disabilities is completed

first and must accompany the MOLST or DOH Nonhospital

Order

 MOLST = Medical Orders for Life Sustaining Treatment

 The MOLST LEGAL REQUIREMENTS CHECKLIST confirms

that the appropriate statutory standards have been met per the

Health Care Decisions Act (HCDA)

A Nonhospital DNR order may be documented on either

the DOH Nonhospital DNR form or on the MOLST

What documentation is required?

 The MOLST is an optional form and best used

when the person has serious health conditions

 The MOLST is the only authorized form in NYS

for documenting both DNR and DNI orders.

 Use of the MOLST should be seriously

considered when a decision has been made to

withhold or withdraw LST other than CPR

When should the MOLST be used?

 When a class member is admitted to the hospital with a DOH

Nonhospital DNR Order, it will be reviewed by the hospital

physician

 A new order will be needed when the class member

returns home

 A DNR issued on a MOLST form is transferable between

settings

 The MOLST form is effective in hospitals, nursing homes,

community settings

 Review and renewal of the DNR must be done upon

discharge from the hospital and reflected in Section F of

the MOLST

Is a DNR/DNI/LST Order transferable

between home and hospital?

 A blank MOLST form should never be sent to the 1750-b

Surrogate

 It is only appropriate to complete the MOLST after the

MOLST LEGAL REQUIREMENTS CHECKLIST has been

completed

 After the MOLST Legal Requirements Checklist has been

completed, the 1750-b Surrogate will determine whether or not

they want the MOLST completed

 If the physician will not fill out the form, a staff shall be

designated to completed the MOLST to reflect the decision of the

1750-b Surrogate for the subsequent signature of the physician

Who fills out the MOLST form?

For more information on Willowbrook

services

Go to OPWDD’s Beyond Willowbrook website

Powerpoint:

Overview of Services for Willowbrook Class Members

Accessed at

http://www.opwdd.ny.gov/willowbrook/hp_willowbrooktraining.jsp