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THE MEDICAL AND

LEGAL ISSUES SURROUNDING ORGAN

DONATION Prepared in connection with a Continuing Legal Education course presented at New York County Lawyers’ Association, 14 Vesey Street, New York, NY

scheduled for May 1, 2014

Program Co-sponsor: NYCLA’s Health Law Committee

Faculty: Dr. Amy L. Friedman and Natalie Benavides, NY Organ Donor Network;

Christina Strong, Esq.

Moderator: Michele Clayton Lucas, Esq., NY Organ Donor Network

This course has been approved in accordance with the requirements of the New York State Continuing Legal Education Board for a maximum of 2 Transitional and Non-Transitional credit hours; 1 Ethics; 1 Professional Practice.

This program has been approved by the Board of Continuing Legal education of the Supreme Court of New Jersey for 2 hours of total CLE credits. Of these, 1 qualifies as an hour of credit for ethics/professionalism, and 0 qualify as hours of credit toward certification in civil trial law, criminal law, workers compensation law and/or matrimonial law.

ACCREDITED PROVIDER STATUS: NYCLA’s CLE Institute is currently certified as an Accredited Provider of continuing legal education in the States of New York and New Jersey.

Information Regarding CLE Credits and Certification

The Medical and Legal Issues Surrounding Organ Donation May 1, 2014; 6:00 PM to 8:00 PM

The New York State CLE Board Regulations require all accredited CLE providers to provide documentation that CLE course attendees are, in fact, present during the course. Please review the following NYCLA rules for MCLE credit allocation and certificate distribution.

i. You must sign-in and note the time of arrival to receive your

course materials and receive MCLE credit. The time will be verified by the Program Assistant.

ii. You will receive your MCLE certificate as you exit the room at

the end of the course. The certificates will bear your name and will be arranged in alphabetical order on the tables directly outside the auditorium.

iii. If you arrive after the course has begun, you must sign-in and note the time of your arrival. The time will be verified by the Program Assistant. If it has been determined that you will still receive educational value by attending a portion of the program, you will receive a pro-rated CLE certificate.

iv. Please note: We can only certify MCLE credit for the actual time

you are in attendance. If you leave before the end of the course, you must sign-out and enter the time you are leaving. The time will be verified by the Program Assistant. Again, if it has been determined that you received educational value from attending a portion of the program, your CLE credits will be pro-rated and the certificate will be mailed to you within one week.

v. If you leave early and do not sign out, we will assume that you left at the midpoint of the course. If it has been determined that you received educational value from the portion of the program you attended, we will pro-rate the credits accordingly, unless you can provide verification of course completion. Your certificate will be mailed to you within one week.

Thank you for choosing NYCLA as your CLE provider!

New York County Lawyers’ Association

Continuing Legal Education Institute 14 Vesey Street, New York, N.Y. 10007 • (212) 267-6646

The Medical and Legal Issues Surrounding Organ Donation

Thursday, May 1, 2014, 6:00 PM - 8:00 PM

Program Co-sponsor: NYCLA's Health Law Committee

Moderator: Michele Clayton Lucas, Esq., NY Organ Donor

Network

Faculty: Dr. Amy L. Friedman and Natalie Benavides, NY Organ Donor Network; Christina Strong, Esq.

AGENDA 5:50 PM – 6:00 PM Registration 6:00 PM – 6:10 PM Introduction and Announcements 6:10 PM – 8:00 PM Presentation and Discussion

4/30/2014

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Organ & Tissue Donation:A Collaborative Effort 

• Federally designated not for profit Organ Procurement Organization (OPO)

• Evaluate & recover organs and tissue for transplantation & research

What is the New York Organ Donor Network?

• Professional & public education

• Aftercare services for donor families

4/30/2014

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DID YOU KNOW?

More than 118,940 people in the US are currently waiting for life‐saving organ & tissue transplants

Nearly 12,000 of these people live in the New York Metro area

18 US citizens die each day while waiting for these life‐saving transplants

Organs• Heart• Lungs• Liver• Kidneys• Pancreas• Small intestine

What Can Be Donated?

Tissues• Corneas (eyes)• Heart valves• Skin• Bone• Veins• Connective tissue

ligamentstendons cartilage

4/30/2014

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Clinical trigger met, referred to NYODN

8 Steps to Save 8 Lives:The Organ Donation Process

EvaluationClinical trigger met, referred to NYODN

8 Steps to Save 8 Lives:The Organ Donation Process

4/30/2014

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Care Team Brief

EvaluationClinical trigger met, referred to NYODN

8 Steps to Save 8 Lives:The Organ Donation Process

ApproachEvaluationClinical trigger met, referred to NYODN

Care Team Brief

8 Steps to Save 8 Lives:The Organ Donation Process

4/30/2014

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Donor

Mgmt.Evaluation Approach

Clinical trigger met, referred to NYODN

Care Team

Brief

8 Steps to Save 8 Lives:The Organ Donation Process

Donor

Mgmt.Evaluation Approach

Clinical trigger met, referred to NYODN

Care Team

Brief

Organ Allocation

8 Steps to Save 8 Lives:The Organ Donation Process

4/30/2014

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Evaluation ApproachClinical trigger met, referred to NYODN

Care Team

Brief

Recovery

Donor

Mgmt.

Organ Allocation

8 Steps to Save 8 Lives:The Organ Donation Process

Lives

SavedRecovery

Donor

Mgmt.

Organ Allocation

Evaluation ApproachClinical trigger met, referred to NYODN

Care Team

Brief

8 Steps to Save 8 Lives:The Organ Donation Process

4/30/2014

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Organ Donor

Donation After Brain Death

Donation After Cardiac Death

Tissue Donor

All Hospital Deaths

Who is a Potential Donor?

• Exam consistent with brain death

• Death pronounced

• Support family

• Offer the opportunity of donation    to the family

• Maintain hemodynamic support

• Patient remains on vent until cross clamp in the OR

• Surgical recovery • Vent withdrawal occurs in OR

• Family permitted in OR until   cardiac arrest

• Surgical recovery begins 5 min. of asystole

• Patient is not brain dead 

• Grave prognosis given to the family

• Family opts to withdraw the vent

• Maintain hemodynamic support

Brain Death DCD

• Support family

• Offer donation opportunity to family 

Neuro Exam

4/30/2014

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Donor Designation(First Person Consent)

• Effective July 23, 2008: New York State changed its organ donor registry from a “registry of intent” to a “registry of consent” 

• Upon the individual’s death, their family will be informed of the individual’s decision and given information concerning the donation process

• Family’s permission is not required

• Does not apply to DCD

Improve the Donation Process

• Early referral to optimize organ function

• Care Team Brief:  Improved communication between hospital staff and the NYODN team

• Effective Requesting by a designated requestor

4/30/2014

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The Effective Request

Team work

Communication

Collaboration

Assessment of the family

Only a trained designated requestor may approach for donation

Effective Requests & Conversion Rates

4/30/2014

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Questions?

donatelifeny.org

Register as a Donor

1‐866‐NYDONOR

(1‐866‐693‐6667)

www.health.ny.gov/donatelife

Spread The Word@SAVELIVESNY/NewYorkOrganDonorNetwork

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BYC H R I S T I N A W O O D WA RD S T R O N G , E S Q .

f o rB A L A N C I N G A C T:

A C Q U I S I T ION &A L L O C AT I O N I N O R G A N D O N AT I O N

N e w Yo r k O r g a n D o n o r N e t w o r k

Anatomical Gifts in New York: A Brief Overview of Law and Process

Sources of Law

Federal- National Organ Transplant Amendments

Medicare-- OPOs are governed by Medicare, because of reimbursement for end stage renal disease

Hospitals and OPOs must comply with Medicare Conditions of Participation

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NOTA Nat’l Organ Transplant Act

Established Organ Procurement Transplant Network (OPTN) and UNOS was awarded contract

Established Scientific Registry of Transplant Recipients (SRTR) to track organ recipient outcomes and develop survival data

Established an entity within the US Public Health Service to administer the law – “Division of Transplantation”

Prohibits the buying and selling of organs Established American Board of Transplant Coordination to

certify Clinical and Procurement Transplant Coordinators (CCTC and CPTC)

Required OPOs to establish agreements with hospitals in donation service area.

What is OPTN/UNOS?

OPTN defined in 1984 part of NOTA legislation

UNOS currently holds the contract to provide this service

Contact is up for renewal every 3 years

OPTN/UNOS is a unique public-private partnership that links all of the professionals involved in the donation and transplantation system

U.S. is divided into 11 Regions

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OR

WA

MT ND

WY SD

NE

KSCO

NV

UT

NM

TX

AZ

CA

MN

IA

WI

ILMO

OK

AR

LA

MSAL

GA

FL

TN

KY

INOH

MINY

WVVA

SC

NC

MD DE

DC

CTRI

NHVT

ME

PA

PR

HI

AK

OPTN/UNOS REGIONS

MAID

NJ

OPTN / UNOS Responsibilities Develop organ specific allocation policies

Maintain a National Transplant Waiting List

Collect, validate and report transplant data

Assist with organ placement

Monitor policy compliance

Initiate Professional and Public Education

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1986 - Omnibus Budget Reconciliation Act

Mandated participation of organ procurement Organizations (OPO) and transplant centers with the OPTN

Mandated all hospitals receiving Medicare/Medicaid reimbursement to have a working relationship with an OPO

1998 - Conditions of Participation ”

Hospitals must notify the OPO, or a third party designated by the OPO, when a patient has died or death is imminent (all deaths)

The OPO will determine medical suitability for donation (organ, eye, tissue)

The hospital must have an agreement with at least one tissue bank and one eye bank to cooperate in the recovery of tissues

The hospital must ensure that, in collaboration with the designated OPO, the family of each potential donor is informed of its options for donation

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Sources of Law

State

Uniform Anatomical Gift Act

Hospital Licensing Regulations

Disposition of Body Statutes

Coroner Laws

Common Law

Sources of Law

Contract

Affiliation Agreement

Authorization is a contract

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Uniform Anatomical Gift Act (UAGA)

Adopted in 1969, amended through the years, most recently in 2009

Contains guidance on Who may give

To whom gift is given

How the gift is given and documented

How the gift is revoked

Who is immune from liability

Who May Give under UAGA?

Donor him or herself…

…If they have signed a valid document of gift, including a donor card, an advance directive, a will, their drivers license,

…or any other document with clear wishes;

…or if they are in a registry, except for the some part of the NYS registry at present.

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The Wishes of the Donor are Irrevocable

Family members are informed, and supported, but no one can overrule the donor.

S 4301. .. 1. Any individual of sound mind and eighteen years of age or more may give all or any part of his body for any purpose specified… In any case where the donor has properly executed an organ donor card, driver`s license authorization to make an anatomical gift, or has otherwise given written authorization for organ or tissue donation, authorization for donation shall not be rescinded… except upon a showing that the donor revoked the authorization

What is Authorization?

Not medical consent

More like making a charitable donation Who am I giving gift to?;

For what purpose?

How will it impact me?

There is no payment

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What Does Document Authorize

Testing

Disclosure for Purposes of Transplant

Release of Info from others (coroners)

To Whom the Gift is Given

Generally, the gift is given to the OPO, which shares the gift according to the waiting list, and to tissue banks and eye banks, as appropriate.

One may make a directed donation, to a specified recipient.

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Who May Give if Donor Dies Silent

(a) decedent's health care agent(b) Burial agent(c) the spouse, if not legally separated from the patient, or the domestic partner,(d) Adult son or daughter eighteen years of age or older,(e) either parent,(f) adult brother or sister (g) a guardian of the person(h) any other person authorized or under the obligation to dispose of the body, including hospital administrator.

Authorization to dispose of the body

“(6) any other person authorized or under the obligation to dispose of the body.”

Is defined by regulation to include, but not be limited to: … a person in the will, a commissioner of a social services

district, a coroner, m.e., or hospital administrator.

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Who is Immune from Liability

Anyone who acts in good faith in accordance with this act.

Special Issues, con’t

County Medical Examiner Law “…the coroner, the coroner`s physician or the medical examiner

who has notice of such donation shall only perform an autopsy and/or analysis of tissues or organs in a manner and within a time period compatible with the preservation for the

purposes of transplantation of said donation.”

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Tissue Issues

Tracking

Safety

Authorization

Funeral Directors

Wadsworth Licensing

Donate Life America Issues

Use of Data

Use of Trademark

Source of Info, Support

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Special Issues: ‘What Makes People Give?’

“Presumed Consent”

Worthy Recipient

Financial Incentives

Altruism

Need for Reciprocity

Presumed Consent

ConcernsConcerns

Diminishes Altruistic Benefit

A Government Taking

Unequal Access

Requires system to Record NO

ResponsesResponses

What Altruistic Benefit?

So is Taxes and Eminent Domain

Duh.

…

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Presumed Consent Bottom Line

We achieve around 75% authorization now; how much better are we going to do through an Opt OutSystem?

Living Donation

ConcernsConcerns

Only Incentivizes the Poor

Risk to Health of donor

Might get sicker organs

Diminishes altruism

ResponsesResponses

We allow this in free market, question is fairness

Make up for it with free care

We have good testing now (sic)

Prove it! And it Saves Lives

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Status of NYS Registry-S 4310

The “donate life registry”, a listing of all donors who have declared their consent to make an anatomical gift.

An anatomical gift can be made through (a) license, (b) non-driver identification card (c) enrolling in the registry website maintained by the department, which may include using an electronic signature under regulations of the commissioner (d) indication made on a voter registration form

The registration shall take effect upon the department sending written notice of the registration to the person enrolling in the registry.

The registry shall provide persons enrolled the opportunity to specify which organs and tissues they want to donate and if the donation can be used for transplantation, research, or both.

A person registered in the organ and tissue registry before the effective date of this subdivision shall be deemed to have expressed intent to donate, until and unless he or she files an amendment to his or her registration or a new registration expressing consent to donate.

The commissioner shall contact each person registered before the effective date of this subdivision in the organ and tissue registry in writing to inform him or her that at the time he or she registered, the registry was that of intent and that the registry is now one of consent, to explain in clear and understandable terms the difference between intent and consent, and to provide opportunity for the person to change his or her registration to provide consent by amending his or her current registration or executing a new registration.

Additional Information for attorneys is available at:

http://www.donatelifeny.org/just-for-you/lawyers/

In addition the New York Organ Donor Network maintains an Ethics Hotline. The Ethics Helpline is a convenient way for New York Organ Donor Network employees, volunteers, partners, vendors and other entities to seek assistance, make a suggestion, and report on specific issues that pertain to ethical matters. The Helpline is hosted by a third party, EthicsPoint, in order to maintain confidentiality and anonymity when requested, to the extent possible.

This comprehensive third party tool helps to address potential ethical matters in the conduct of business, while cultivating a positive work environment and a relationship of mutual respect and trust.

- See more at: http://www.donatelifeny.org/about-us/ethics-helpline/#sthash.wbcyVfp1.dpuf

Faculty Biographies

Michele Clayton Lucas Michele has a Bachelor's degree in biology from Fordham University and an M.B.A. in Healthcare Administration from Baruch College, both in New York. She received a law degree from Rutgers University School of Law- Newark in 2012. Michele has held the position of Human Resources Director at the New York Organ Donor Network for the past 14 years where she is responsible for recruitment, retention, labor relations, benefits and compensation. Prior to entering the field of organ and tissue donation, she held several administrative positions at New York Presbyterian hospital. She recently served as a member of the Bioethics Committee of the NYC Bar Association.

Amy L. Friedman, M.D. is the Medical Director of The New York Organ Donor Network. She is primarily responsible for overseeing all organ and tissue donor management and allocation activities in the greater New York metropolitan area. Dr. Friedman directs performance improvement efforts to maximize the quantity and quality of transplantable organs and tissues in the region and also manages the research component of the organization, which includes data analysis and performance improvement in addition to the development of a robust clinical research program.

Dr. Friedman came to the New York Organ Donor Network with a depth of experience in the field of organ donation and transplantation. Most recently, she served as a Medical Director of the Finger Lakes Donor Network. Concurrently, Dr. Friedman was a Professor of Surgery and the Director of Transplantation with the kidney transplant program at SUNY Upstate Medical University, Syracuse, NY. Prior to these roles, from 2002-2007, Dr. Friedman was an Assistant Medical Director at New England Organ Bank.

Earlier in her career, Dr. Friedman held several positions in academia, including serving as an Assistant and Associate Professor of Surgery from 1994-2007 at the Yale School of Medicine and as an Assistant Professor of Surgery at the University of Pennsylvania earlier in her career.

Dr. Friedman is a native New Yorker, having been raised in Brooklyn, NY. She received her AB in Biology from Princeton University, and her MD at SUNY Downstate Medical Center.

Christina Strong is an attorney in private practice who concentrates in healthcare law and policy, representing numerous non-profit and provider organizations, as well as trade groups, medical societies, and individual providers and practices. Ms. Strong has particular expertise in the areas of organ and tissue donation for transplant, education and research, and has been closely involved in state and national law and policy development concerning donation, privacy, informed consent, biotechnology and research.

She chaired the national Task Force on Consent Related Policies for the American Association of Tissue Banks, 2010-2011and served as Observer to National Council of Commissioners on Uniform State Laws, Uniform Anatomical Gift Act Committee, 2004-2006. A frequent educator and speaker on Anatomical Gift Law, Ms .Strong co-authored with Sheldon Kurtz, JD and David Gerasimow, The 2006 Revised Uniform Anatomical Gift Act-A Law to Save Lives, Health Lawyers News, February 2007.

She received a BA in Sociology from Skidmore UWW and a JD from Rutgers University School of Law.

Natalie Benavides joined the New York Organ Donor Network as the Director of Hospital Services in July, 2012. She carries over 10 years of nonprofit development experience with a particular specialization in the field of organ, eye and tissue donation. Previous to joining NYODN, Natalie was the Executive Director of Donate Life Maryland; the organization awarded the state contract to provide and maintain an official donor registry for the State of Maryland. She was both a Hospital Services Specialist and Donation Specialist for Washington Regional Transplant Community, the federally designated organ procurement organization for the Washington, DC metropolitan area. In addition to her work on a local level, she has contributed to national forums established to respond to the ever increasing need for transplantable organs. She was elected to Faculty for Donate Life America and served a term of three years. Likewise, she was appointed the State Team Development Chair for the Donor Designation Collaborative. Recently Natalie was asked to serve as a Producer for the Association of Organ Procurement Association’s annual meeting. Her work, extending beyond the community of donation and transplantation, includes serving as Director of Corporate Relations for the American Heart Association in Baltimore, MD and was a member of the H*Works Team of the Advisory Board Company. She is a graduate of The American University in Washington, DC.