Overview of the U.S. Donation System

Transcription

1 Fourth Biennial Transplant Donation Global Leadership Symposium 2016 May 22 May 26, 2016 L Auberge Del Mar, California USA Overview of the U.S. Donation System Presented by: Howard M. Nathan President & CEO

2 Challenges in Organ Donation Lack of Available Organs Authorization & Donation Rates Funding & Organizational Structure Education/Staff Training Early deceleration of care, DNI, DNR, improved trauma care, etc. affecting (lessening) the pool of potential brain dead organ donors.

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4 Gift of Life Donor Program Philadelphia, USA Gift of Life Donor Program is one of the Largest OPOs in the U.S. with 483 organ donors and 44 Donors per Million in 2015

5 Gift of Life Donor Program Philadelphia, Pennsylvania USA Non-Profit OPO/Tissue Recovery/Eye Bank Established in 1974 Largest OPO in the United States Federally designated OPO (by Medicare) for eastern PA, Southern NJ & Delaware Acute Care Hospitals - 15 Transplant Centers, 42 Programs - 11 Million Population 483 organ donors in 2015, resulting in 1,291 transplants; highest donor volume in the U.S. 44 donors/mm; 1,202 bone recoveries; 2,265 cornea recoveries and 2,546 tissue recoveries Over 40,000 organs for transplantation and over 550,000 tissue allografts Accredited by: Association of Organ Procurement Organizations (AOPO); American Assoc. of Tissue Banks (AATB) & Eye Bank Assoc. of America (EBAA); UNOS/OPTN member OPO

6 Gift of Life Donor Program Organ Donor Experience Organ Donors Based upon GLDP data through December 31, Donors Per Million

7 What I Will Discuss Today U.S. Organ Donation and Transplant System Role of UNOS Organ Procurement Organizations Staffing Donation Process (Organ and Tissue) Public and Healthcare Education

8 National Organ Transplant Act of 1984 Organ Procurement & Transplantation Network (OPTN) Private nonprofit entity by contract with HHS Public Health Service oversight National policy board Establish membership criteria and medical criteria for allocating organs National policy and system; nationwide coordination Created the current designated OPO system Slide Courtesy of Charlie Alexander, UNOS

9 The U.S. Federal Government s Oversight Role in Donation and Transplantation Department of Health and Human Services (DHHS) Advisory Committee on Transplantation (ACOT) Other Agencies Health Resources and Services Administration (HRSA) Centers for Medicare & Medicaid Services (CMS) Healthcare Systems Bureau (HSB) Division of Transplantation (DOT) SR Contractor OPTN Contractor (UNOS) CWBYCTP Slide Courtesy of Charlie Alexander, UNOS

10 Current U.S. Organ Donation & Transplantation Structure 58 Organ Procurement Organizations (OPOs) 244 Transplant Centers (Hospitals) 871 organ programs (kidney, heart, liver, lung, pancreas, intestine) United Network for Organ Sharing (UNOS) U.S. Donation & Transplantation Statistics (2015): Deceased Organ Donors = 9,080 Living Organ Donors = 5,988 U.S. Total Transplants Performed 33,530 Deceased Donor Transplants = 27,542 Living Donor Transplants = 5,988 Source: Based on OPTN data as of with donor/transplant data through December 31, 2015.

11 Involved With Organ Only

12 UNOS Headquarters Organ Allocation Center Richmond, Virginia

13 Approves New Transplant Centers & Programs Operates Computerized Organ Sharing System Manages Wait List Manages National Database Allocation Policies for Deceased Organ Donors Organ Matching via DonorNet Maintains Data on All Living and Deceased Organ Donors and Transplants Audits (OPOs and Transplant Centers)

14 UNOS Regional Map Organ allocation policies are local (OPO), then regional then national and are patient specific (not transplant center)

15 United States Waiting List Total Candidates May 2016 * 100,005 Kidney 14,772 Liver 4,120 Heart 1,909 Kidney/Pancreas 1,439 Lung 996 Pancreas 269 Intestine 41 Heart/Lung 120,746 TOTAL WAITING *Source: Based on OPTN data as of May 19, 2016 with data available through May 13, 2016.

16 1 OPO Per Service Area

17 A Donate Life Organization

18 OPOs Are Highly Regulated Federal Government Healthcare Organ & Tissue Associations Centers for Medicaid & Medicare Services (CMS) Association of Organ Procurement Organizations (AOPO) United Network for Organ Sharing (UNOS) American Association of Tissue Banks (AATB) Food & Drug Administration (FDA) Eye Bank Association of America (EBAA)

19 2015 Deceased Organ Donors 9,080 Living Organ Donors 5,988 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 U.S. National Trends in Organ Donation Living vs. Deceased Organ Donors ,080 8,596 8,017 8,085 7,989 8,022 8,126 8,143 6,622 6,631 7,150 7,593 8,268 7,943 6,828 7,004 6,895 6,731 6,561 5,985 6,315 6,218 6,609 6,023 5,867 5,988 5,824 5,4795,793 5,990 6,080 6,190 6,457 5,363 5,418 5,819 5,048 4,569 5,957 3,804 4,067 3,496 Waiting List Deaths 6,184 1,000 0 Living Donors Deceased Donors Source: Based on OPTN data as through December 31, Count based upon candidates.

20 U.S. Deceased Organ Donor Transplants 2015 (N = 27,542) Pancreas 973 (3.0 PMP) Lungs 3,577 (10.4 PMP) Intestines 139 (0.4 PMP) Hearts 2,824 (8.4 PMP) Kidneys 13,253 (39.4 PMP) Livers 6,776 (20 PMP) Source: Transplants based on OPTN data through December 31, U.S. population in million (Source US Census and World Bank)

21 30,000 25,000 20,000 19,026 19,355 U.S. Experience Deceased Organ Donor Transplants Kidney (n=180,681) Livers (n=93,859) Lungs (n=40,284) Pancreas (n=20,398) Hearts (n=37,305) Intestine (n=2,226) 20,106 20,408 21,966 23,359 24,504 24,274 23,979 24,289 24,665 25,032 24,625 25,513 26,110 27,542 15,000 10,000 5, Source: Based on OPTN data through December 31, Total Organs Transplanted: 374,753

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23 U.S. Organ Donor Experience DBD & DCD Donors Total Deceased Organ Donors = 109,659 BD (n=97,943) DCDs (n=11,716) YEAR ,062 7,036 7,304 7,069 7,586 1,206 1,107 1,057 1,292 1,494 (8,143) (8,126) 7, (7,943) 7, (8,022) 7, (7,989) 7, (8,085) 7, (8,017) 7, (7,593) (8,596) (8,268) (9,080) , (7,150) ,187 6, (6,457) (6,190) 0 2,000 4,000 6,000 8,000 10,000 Source: Based on OPTN data through December NUMBER OF ORGAN DONORS

24 Deceased Organ Donors Donors Per Million Mexico Israel Brazil Australia Argentina Canada UK Italy France USA Portugal Spain Croatia Gift of Life Donor Program Source: IRODaT.

25 U.S. Deceased Organ Donors All Organ Donors By Cause of Death 2015 CNS Tumor/Other (n=19) 0.9% CVA (n=2,671) 29.0% Trauma (n=2,709) 30.0% Anoxia (n=3,430) 38.0% (n=9,080) Source: Based on Gift of Life Donor Program data through December 31, 2015.

26 U.S. Deceased Organ Donors By Cause of Death Tumor/Oth Anoxia Trauma CVA 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1, Year Trend +3% +8% +452% +16% Source: Based on OPTN data through December 31, 2015.

27 U.S. Deceased Organ Donors By Cause of Death Trauma Only ,500 3,000 2,500 2,520 2,545 2,610 2,617 2,794 2,908 3,058 3,026 2,793 2,670 2,720 2,685 2,628 2,681 2,646 2,709 2,000 1,500 1, Source: Based on OPTN data through December 31, 2015.

28 U.S. Deceased Organ Donors By Cause of Death CVA Only ,000 3,500 3,336 3,355 3,308 3,206 3,178 3,049 3,000 2,612 2,631 2,635 2,767 3,127 2,932 2,833 2,761 2,782 2,671 2,500 2,000 1,500 1, Source: Based on OPTN data as through December 31, 2015.

29 4,000 U.S. Deceased Organ Donors By Cause of Death Anoxia Only % Increase 3,500 3,430 3,000 2,500 2,278 2,436 2,599 2,900 2,000 1,500 1, ,024 1,147 1,348 1,489 1,732 1,893 1, Source: Based on OPTN data through December 31, 2015.

30 Since 2000, the rate of deaths from drug overdoses in the U.S. has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids (opioid pain relievers and heroin). From 2000 to 2014, nearly half a million persons in the United States have died from drug overdoses. In 2014, there were approximately one and a half times more drug overdose deaths in the United States than deaths from motor vehicle crashes. In 2014, opioids were involved in 28,647 deaths, or 61% of all drug overdose deaths; the rate of opioid overdoses has tripled since 2000.

31 U.S. Deceased Organ Donors Mechanism of Death Drug Intoxication Mech of Death Drug Intox Source: OPTN data

32 U.S. Deceased Organ Donors Mechanism of Death Drug Intoxication by Gender Male (n=2,819) Female (n=2,312) Source: OPTN data

33 U.S. Deceased Organ Donors Mechanism of Death Drug Intoxication by Age yrs 18-34yrs 35-49yrs 50-64yrs 65+yrs Source: OPTN data

34 Donor Hospitals (130 Acute Care Hospitals) Gift of Life Donor Program (OPO) Transplant Centers (16) Donors & Donor Families Transplant Recipients

35 General Staffing Model for U.S. OPOs Clinical Division Transplant Coordinators Family Requestors Hospital Services Call Center Organ Preservation Eye/Tissue Recovery Administrative Division Finance Human Resources Information Systems Community Relations Family Support Services Administrative Support Quality Assurance

36 1 Employee in Employees in 2016 Governing Board Executive Leadership Clinical Division Administrative Division Transplant Information Center Transplant Coordinators Hospital Services Tissue & Preservation Quality Assurance Clinical Staff Education Community Relations Human Resources Information Technology Finance

37 How does the donation system work?

38 Ideal Process for Organ Donation Education (General Public / Healthcare Professionals) Detection/Declaration of Death/Referral to OPO Donor Evaluation by OPO Coordinator Family Approach/Consent Clinical Donor Management Matching/Allocation Surgical Recovery/Preservation/ Transportation Transplantation Case Follow-Up

39 Routine Referral Process PA Act 102 of 1994 U.S. Medicare Hospitals Conditions of Participation Policy - August 1998 (modeled after PA law) Routine referral of all patient deaths Standard educational message: Early referral of all non-recoverable, neurologically-injured, ventilatordependent patients. OPO Coordinator on site early for evaluation

40 Revised Hospital Conditions of Participation For Hospitals Receiving Medicare Funding Guidelines published: June 22, 1998 Effective date: August 21, 1998

41 Gift of Life Triage for Patient Deaths Cardio-Respiratory Death Loss of cardiac function Loss of respiratory function Non-Recoverable Brain Injury/Illness (Ventilator Dependent) Irreversible loss of all brain stem & brain stem function in absence of metabolic or pharmacologic inhibitors or Family is discussing withdrawal of lifesustaining measures Potential Tissue Donor Potential Organ & Tissue Donor Corneas, Heart Valves, Skin, Long Bones, Saphenous Veins Heart, Lungs, Liver, Pancreas, Intestine, Kidneys & Tissues Call KIDNEY-1

42 Transplant Information Center 24/7 Call Center

43 Transplant Coordinators

44 OPO Transplant Coordinator Background & Clinical Staffing Models Typical Backgrounds: All are non-physicians Critical Care Nurses Paramedics Respiratory Therapists OPO Staffing Model: Triage/Referral Coordinator Transplant/Donation Coordinators Advanced Practice Coordinators Specialized Family Requestors Hospital-based OPO Coordinators

45 Gift Of Life Donor Program Transplant Coordinator Responsibilities 9. Post Mortem Care Follow-up Letters 8. Organ Allocation & Surgical Recovery Coordination 7. OR Scheduling Communication & Prep 6. Family Support & Communication 5. Check DMV 1. Referral Intake & On-site Response 2. Clinical Assessment Diagnostic Testing Donor Management 3. Collaboration with Care Team 4. Team Huddles Real Time Education

46 UNOS Organ Allocation Process Under contract with the U.S. Department of Health and Human Services' Health Services & Resources Administration (HRSA), United Network for Organ Sharing (UNOS) maintains a centralized computer network called UNet SM Available 24 hours/day, seven days/week Matches Donor Organs With Transplant Candidates ( match run )

47 DonorNet

48 OPO Begins Organ Offer Process OPO sends an electronic notification to a selected range of potential recipients. The primary contact for each transplant center will receive a voice and text notification. OPO sends out electronic notifications on the match results page. Prominent display of donor blood type. The candidate with the primary offer is highlighted.

49 Gift of Life Team Transportation

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52 Congestion(NHBD). Kidneys on a pulsatile preservation machine

53 Hospital Development: A Systems Approach Communications referral follow-up, post-donor conferences, morbidity/mortality conferences, business correspondence, GOL clinical updates Data collection, analysis and dissemination referral tracking forms, patient referrals, death chart reviews, qualitative data sought out following every clinical interaction Hospital Strategic Plans in-depth analysis of donation process, assessment of hierarchy & points of influence, relationships, data analysis, policy updates, educational plan Performance Management accountability for donation outcomes, program guidelines for hospital development responsibilities, hospital review sessions

54 Hospital Outreach Case Debriefing Routine Education Resident Training CEO Meetings Conferences & Symposiums Donation Champion Training

55 Organ Donation Breakthrough Collaborative Background..Prior to 2001 U.S. Deceased Donor Organ Transplants Were Only Increasing 1-2% Per Year The Transplant Waiting Lists and Waiting Times Were Rapidly Growing Deaths On The Waiting List Were Increasing Sharply (from 3,512 in 1995 to 6,703 in 2001: We had more deaths than donors )

56 Monthly Number of Organ Donors Organ Donors Collaborative Starts Here Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

57 Every System is Perfectly Designed to Achieve Exactly the Results it Gets ~Donald Berwick and Paul Batalden

58 The National Organ Donation Breakthrough Collaborative An intensive, full-court press to transform performance Based on: Breakthrough Collaborative Series A learning model developed by the IHI (Institute for Healthcare Improvement) Defined, Documented, and Disseminated Good Ideas Accelerated Improvement Achieved Results

59 Organ Donation Breakthrough Collaborative GOALS: Increase the average conversion rate of eligible donors from the average of 43% to 75% in the Nation s largest 200 hospitals Increase donations by up to 1,900 donors per year Increase transplantations by 6,000 per year Help save lives of thousands of people each year and prevent up to 17 deaths per day.

60 This is an unprecedented historic opportunity to apply science, methods, systems, vigor, and energy to organ and tissue donation Rear Admiral Kenneth Moritsugu, MD U.S. Deputy Surgeon General Learning Session 2 Dallas, TX January 2004

61 Sharing of Best Demonstrated Practices OPO Referral Trigger: Refer all vent-dependent patients with a nonrecoverable neurological injury OPO Commitment: Immediate on-site response to evaluate every organ donor referral Hospital - OPO team approach to clinical management & family centered care Strong OPO emphasis on Consistency in clinical practice Timely referral Effective requestors Family empowerment Hospital Routine open dialogue w/care team; reinforcing environment of joint accountability for outcomes Family OPO

62 Create a Culture for Excellence No Credit for Effort Joint accountability Hospitals and OPOs staff must be held accountable for: Referral rates Conversion rates Consent rates Organ yield per donor Consent processes Donor management processes

63 Building a World Class Donation & Transplantation System SPREAD best practices and results to largest hospitals with 90% of potential organ donors Nurture and sustain a national learning community in action to increase donation Launched the first Annual Organ Donation National Learning Congress in May nd Annual Learning Congress Convened in October rd Annual Learning Congress Convened in October th Annual Learning Congress Convened in October th Annual Learning Congress Convened in September th Annual Learning Congress Convened in November 2010

64 Consult Gift of Life on all Vent-Dependent Patients w/a Non-Recoverable Neurologic Injury/Illness To preserve the organ donation option for patients/families, call KIDNEY-1 according to the following criteria: (regardless of age, medical history, current hospital course, hemodynamic status) 1. At the first indication the patient has suffered a non-recoverable neuro injury/illness (pt. begins to lose some neuro reflexes) 2. Prior to the first formal brain death examination 3. Prior to family discussion of DNR or withdrawal of support 4. Patient has suffered: Head Trauma, Anoxia, CVA Call Gift of Life KIDNEY-1 ( ) In collaboration with the care team, Gift of Life will initiate the first mention of organ donation (after it has been determined that the patient is a medically suitable candidate for donation).

65 Team Huddle Ensures Optimal Communication with Care Team and Family Criteria for Team Huddle: After medical suitability has been determined Shift change Family/care team are discussing DNR or withdrawal of support Family brings up donation Brain death has been determined Patient is hemodynamically unstable At the request of the care team or Gift of Life Coordinator Participants: Gift of Life Coordinator Bedside Nurse Treating Physician Resident Support Staff (when appropriate) Pastoral Care Social Work Respiratory Care Other A Gift of Life Coordinator (with a designated member of the care team) will facilitate the team huddle at important junctures of the case. Points for Discussion Patient Status, Clinical Plan, Donation Options, Family Communication/Support, Next Steps

66 High Leverage Change #7 Implement Donation After Cardiac Death (DCD) DCD Policy Roles / Responsibilities Case Debriefings Ongoing Education

67 Rear Admiral (Retired) Kenneth P. Moritsugu, M.D., M.P.H., former Acting Surgeon General, U.S. Public Health Service, Office of the Surgeon General, Office of Public Health and Science, Office of the Secretary, U.S. Department of Health and Human Services, Washington, D.C.

68 VIDEO

69 Holding the Gains.. But More Improvement is Needed Organ Donors Collaborative Starts (2003) Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Source: Based on OPTN data through December 31,

70 The Collaborative has led to major increases in conversion rates at the participating hospitals as well as to national increases in organ donation. The primary goal, a 75% conversion rate, was achieved by 21 of the 95 hospitals by the end of September In 2004, total donations in the United States from deceased donors increased by 10.8% over 2003; donations increased by 16% in the 95 hospitals participating in the Collaborative. Crit Care Nurse 2006;26:33-48; The all teach all learn approach has brought an incredible level of mutual accountability, teamwork, and spirit to the lifesaving interactions between hospitals and OPOs.

71 Transplantable Tissues Ocular (cornea) Musculoskeletal Cardiovascular Integumentary (skin) Pancreas for Islet Cells

72 Transplant

73 VCAs: More Like Organs than Tissue Tissues Organs VCAs Corneas, skin, bone, heart valves, veins, tendons Kidney, liver, heart, lungs, pancreas, small intestine, islet cells Facial grafts, hand grafts (skin, muscle, tendon, nerves, bone and blood vessels) Recovered from deceased, asystolic donors. Non-vascular; no biocompatibility requirements. No immunosuppression Processed before transplantation Recovered primarily from deceased (brain dead) heartbeating donors. However, DCD (Donation After Cardiac Death) increasing. Must be ABO-compatible; HLA compatible for some organs. Immunosuppression required. Transplanted within hours after recovery Recovered primarily from deceased (brain dead) heartbeating donors. However, DCD may be possible. Must be ABO and HLA compatible. Immunosuppression required. Transplanted within hours after recovery. No wait list > 123,000 Americans waiting Wait lists forming

74 VCA Under OPTN Oversight 42 CFR Part 121 Final Rule: July 3, 2013 Added VCA to definition of a human organ effective July, 2014 This definition identifies which body parts are now covered, while providing flexibility to allow other body parts to be covered as the field of VCA transplantation advances.

75 VCA Transplants In the U.S. (1999 thru December 2014 before and after UNOS ) 32 VCA transplant recipients were transplanted at 11 different transplant centers. 8 Face Transplants 8 Bilateral Upper Extremities 15 Unilateral Upper Extremities 1 Multiple VCA a face & bilateral upper extremity Source: AOPO and UNOS There are an additional nine transplant hospitals in the planning stages for a new VCA transplant program, with a few close to approving patients, including one children s hospital.

76 UNOS VCA Committee Formed December 2013 Develop policies and procedures for safe and efficient procurement and distribution of VCAs Establish specific donor authorization requirements. Establish VCA transplant program OPTN membership requirements Develop an OPTN VCA database Review VCA definition in Final Rule

77 VCA Policy Development OPTN directed by HRSA to establish policies for VCA transplantation within its existing policy structure, with goal of instituting basic framework for VCA transplantation prior to implementation of the Final Rule modifications on July 3, OPTN Vascularized Composite Allograft (VCA) Transplantation Committee formed Representation from U.S. transplant programs experienced in VCA transplantation and the major transplant and procurement societies Discussed/proposed policy and bylaw recommendations for the major areas identified for VCA program and allocation oversight Chair, Sue V. McDiarmid, MD Vice Chairs: L. Scott Levin, MD, FACS; Richard Luskin, New England Organ Bank

78 UNOS Approved VCA Transplant Centers By UNOS Region (as of 1/9/2015) N=21 NYMS-TX1 NYUC-TX1 MACH-TX1 MAMG-TX1 MAPB-TX1 MNSM-TX1 WICH-TX1 MIUM-TX1 ILMM-TX1 PAPT-TX1 MDJH-TX1 PACP-TX1 PAUP-TX1 MDUM-TX1 NCDU-TX1 CAUC-TX1 TXSP-TX1 TXMH-TX1 FLJM-TX1

79 Number of VCA Registrations on the UNOS Waiting List as of 5/18/2016 (N=16) Abdominal Wall 1 Upper Limb, Unilateral 5 Craniofacial 3 Other 2 Upper Limb, Bilateral 5 Source: UNOS

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82 World s first pediatric double-hand transplant performed at The Children s Hospital of Philadelphia July, 2015

83 The World s Most Extensive Face Transplant Volunteer firefighter Patrick Hardison of Senatobia, Miss., is shown in these before-and-after photos of his face transplant surgery, which was called the world s most comprehensive one to date. It was performed at New York University s Langone Medical Center. (NYU Langone Medical Center/via Reuters)

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85 The World s Most Extensive Face Transplant Patrick Hardison David Rodebaugh

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88 Public Outreach & Initiatives

89 Information-based Decision Making

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91 All 52 States (includes PR and DC) Have Drivers License Registries Pennsylvania New Jersey Delaware

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93 140,000,000 Donor Designation in the United States ,000, ,000,000 80,000,000 60,000, ,972,649 as of 12/31/15 40,000,000 20,000,000 0

94 Donor Designation Share - United States states, Washington D.C., and Puerto Rico Designated Donors Period ending 12/31/12014 DD Share: 52% 129,972,649 as of 12/31/15

95 60% 50% 40% 30% Impact on Donation, Designated Donors Among Recovered Donors 28% 25% 46% 43% 40% 36% 33% 30% 27% 37% 53% 52% 49% 50% 48% 45% 42% 42% 42% 33% 38% 20% 10% 0% Organ Donors Tissue Donors Eye Donors

96 2016 Rose Parade Treasure Life s Journey

97 National Observances

98 Family Support Services Sent within 24 hours Donor Recognition Package Offer support services information Letter to donor family within 7 days Offer support services, refer resources Follow Up Call At 1 Month & Correspondence ast 6 Months & 1 Year Between Donor Family & Recipients Letters (Anonymous) Updates on recipient health Donor Medal

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100 April 17, 2016 Philadelphia Museum of Art 10,000 Attendees 400 Teams 14 Hospital Teams

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102 Social Media

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104 Questions? More Information? Howard M. Nathan