Overview of the New Organ Transplant Regulation

1
Overview of the New Organ Transplant Regulation

• Ed Q Japitana
• CMS Western Consortium OPO Coordinator
• Division of Survey Certification
• San Francisco Region IX
• June 6, 2007

2
General Requirements

• 482.72OPTN membership
• Abide by rules and requirements of the OPTN
• 482.74Notification of CMS
• Significant changes that could affect compliance
• Change in key staff members
• Decrease in number of transplants or survival
  rates
• Termination of agreement between hospital and OPO
• Inactivation of the transplant center

3
General Requirements

• 482.76Pediatric transplant
• A center that performs 50 or more of its
  transplants on adults in a 12-month period must
  be approved to perform adult transplants in order
  to be approved to perform pediatric transplants.
• A center that performs 50 or more of its
  transplants on pediatric patients in a 12-month
  period must be approved to perform pediatric
  patients in order to be approved to perform adult
  transplants.

4
General Requirements

• A center that performs 50 or more transplants on
  pediatric patients is not required to meet
  clinical experience requirements prior to its
  request for approval as a pediatric transplant
  center.
• A pediatric heart transplant center must
  demonstrate its ability to provide specialized
  facilities, services, and personnel required by
  pediatric heart transplant patients.

5
Transplant Center Data Submission, Clinical
Experience, and Outcome Requirements

• 482.80Data submission, clinical experience, and
  outcome requirements for initial approval of
  transplant centers
• transplant center must submit to the OPTN at
  least 95 of required data on all transplants
  (deceased and living donor) it has performed no
  later than 90 days after due date set by OPTN.
• 482.82Data submission, clinical experience, and
  outcome requirements for re-approval of
  transplant centers
• For re-approval, submission includes data for 3
  years of the approval period.

6

• Clinical Experience Requirements
• --Initial
• 10 transplants heart, intestine, liver and lung
  transplant centers
• At least 3 transplants kidney transplant centers
• No annual volume requirement for heart-lung,
  pancreas, and centers that primarily perform
  pediatric transplants
• --Re-approval
• 10 transplants heart, intestine, kidney, liver
  and lung transplant centers
• No annual volume requirement for heart-lung,
  pancreas, and centers that perform primarily
  pediatric transplants

7

• Outcome Requirements (initial and re-approval)
• Except for lung transplants, CMS will review
  adult and pediatric outcomes separately when
  requests are made for approval of both adult and
  pediatric transplant programs.
• Transplant centers patient and graft survival
  rates not acceptable if observed patient
  survival or graft survival rate is lower than its
  expected patient survival or graft survival rate
  and all 3 of the following thresholds are crossed
  over
• -O E gt3
• -O/E gt1.5
• -1 sided p-value lt0.05.
• No outcome requirements for heart-lung,
  intestinal, and pancreas transplant centers (for
  both initial and re-approval)

8
Transplant Center Process Requirements

• 482.90 Patient and living donor selection
• Must use written patient selection criteria in
  determining a patients suitability for placement
  on the waiting list or for transplantation
• If performing living donor transplants, the
  center must use written donor selection criteria
  in determining suitability of candidates for
  donation.
• Selection criteria must ensure fair and
  non-discriminatory distribution of organs.
• If possible, transplant candidate must receive a
  psychosocial evaluation .

9

• Medical record contains documentation of blood
  type determination.
• Patient selection criteria used is documented in
  the medical record.
• Living donor selection criteria consistent with
  general principles of medical ethics.
• Prospective living donor receives medical and
  psychosocial evaluation prior to donation.
• Living donors suitability for donation is
  documented in the medical record.
• Document that living donor has given informed
  consent.

10

• 482.92 Organ recovery and receipt
• Have written protocols for validation of
  donor-recipient blood type and other vital data
• Transplant surgeon is responsible for ensuring
  the medical suitability of donor organs.
• If intended recipients identity is known,
  transplant centers recovery team must review and
  compare donor data with intended recipients
  blood type and other vital data before organ
  recovery takes place.
• Transplant surgeon and another licensed health
  care professional must verify that donors blood
  type and other vital data are compatible with
  that of the intended recipient.

11

• For living donor transplants, the transplant
  surgeon and another licensed health care
  professional must verify that the living donors
  blood type and other vital data are compatible
  with transplantation of the intended recipient
  immediately before the removal of the donor
  organ(s) and, if applicable, prior to the removal
  of the recipients organs.
• 482.94 Patient and living donor management
• Have written patient management policies for
  transplant and discharge phases of
  transplantation
• If performing living donor transplants, policies
  include donor evaluation, donation, and discharge
  phases of living organ donation.

12

• Each transplant patient is under the care of a
  multi-disciplinary team coordinated by a
  physician.
• This also applies to living donors.
• Transplant centers must keep their waiting lists
  updated on an ongoing basis including
• Updating waiting list patients clinical
  information
• Removing from the list patients transplanted,
  have died, or for other reasons the patient
  should no longer be on the waiting list
• Notifying the OPTN no longer than 24 hours after
  a patients removal from the list
• Maintain updated and accurate patient records
• Make social services, nutritional assessments
  ,and dietary counseling available

13

• 482.96 QAPI
• Develop, implement, and maintain a data-driven
  QAPI program designed to monitor and evaluate all
  services including those provided under contract
  or arrangement
• Must use objective measures to evaluate
  performance regarding transplantation activities
  and outcomes
• Establish and implement written policies to
  address and document adverse events such as
  identification, reporting, analysis, and
  prevention
• Must document and conduct a thorough analysis to
  effect changes in policies and practices to
  prevent repeat accidents.

14

• 482.98 Human resources
• All individuals are qualified to provide or to
  supervise services provided including those under
  contract or arrangement.
• Transplant center is under the general
  supervision of a qualified transplant surgeon or
  qualified physician-director.
• While the director need not serve full-time,
  he/she must devote sufficient time to carry out
  responsibilities including
• coordinating with the hospital to ensure adequate
  training of nursing staff and transplant
  coordinators
• Ensuring that tissue typing and organ procurement
  services are available
• Ensuring that transplants are performed by or
  under the direct supervision of a qualified
  transplant surgeon.

15

• The transplant center identifies to the OPTN a
  primary transplant surgeon and transplant
  physician.
• Have clinical transplant coordinators to ensure
  continuity of care of patients and living donors
• Clinical transplant coordinator must be a
  registered nurse or a licensed clinician.
• CTC responsibilities include coordinating
  clinical aspects of the care of the transplant
  patient and living donor, and acting as liaison
  between a kidney transplant center and ESRD
  facility as applicable.
• If center performs living donor transplant, it
  must identify either an independent living donor
  advocate or living donor advocate team to ensure
  protection of living donors and prospective
  living donors.

16

• Living donor advocate or living donor advocate
  team must be knowledgeable of living organ
  donation, transplantation, medical ethics, and
  informed consent.
• Responsibilities include
• representing and advising the donor
• protecting and promoting the interests of the
  donor
• Respecting the donors decision and ensuring that
  donors decision is informed and free from
  coercion.
• Transplant center must identify a
  multidisciplinary transplant team and describe
  responsibilities of members.
• Transplant center must demonstrate availability
  of expertise in internal medicine, surgery,
  anesthesiology, immunology, infectious disease
  control, pathology, radiology, blood banking, and
  patient education.

17

• 482.100 Organ Procurement
• Have written agreement for the receipt of organs
  with an OPO that identifies responsibilities for
  the hospital and for the OPO with respect to
  organ recovery and allocation
• 482.102 Patient and living donor rights
• In addition to Patients rights outlined in the
  hospital regulations
• Protect and promote each transplant patients and
  living donors rights.
• Notify patients on waiting list of information
  that could impact patients ability to receive a
  transplant should an organ be available and
  procedures for ensuring availability of
  transplant team.

18

• 482. 104 Additional requirements for kidney
  transplant centers
• Kidney transplant centers must directly furnish
  transplantation and other medical and surgical
  specialty services.
• Have on-going communication with patients local
  ESRD facilities
• Must furnish inpatient dialysis services directly
  or under arrangement.
• Must cooperate with local ESRD Network in
  fulfilling the terms of the Networks current
  statement of work.

19
Application for approval

• Submit an application to CMS
• Application for approval must be submitted to CMS
  no later than December 26, 2007.
• Until CMS makes determination, transplant centers
  will continue to be approved
• Applications mailed to
• Sherry Clark
• Centers for Medicare Medicaid Services
• 7500 Security Boulevard, Mailstop S2-12-25
• Baltimore, MD 21244
• Telephone inquiries 410- 786-8476 or email
  sherry.clark_at_cms.hhs.gov

20

• Copy of the organ transplant regulations could be
  obtained at
• http//www.cms.hhs.gov/CFCsAndCoPs/Downloads/tran
  centerreg2007.pdf
• Questions
• Ed Q Japitana
• Division of Survey and Certification
• CMS Regional Office IX
• 90 7th Street, Suite 5-300 (5W)
• San Francisco, CA 94103-6707
• Tel [phone]
• email edgardo.japitana_at_cms.hhs.gov