A2

Department of Health and Human Services OMB No. 0915-0184

Health Resources and Services Administration Expiration Date: xx/xx/201x

Part 1: Section A – Transplant Hospital

1. The bylaws require that an applicant has in force medical liability insurance with a minimum of $1,000,000 coverage limit per occurrence. Coverage must be provided by an insurer that is either:

• Licensed

• Approved by the insurance regulatory agency of the state in which the applicant's principal office is located.

In lieu of commercial insurance coverage, evidence of equivalent coverage through a funded, self-insurance arrangement will suffice.

1. Is your hospital insured for the required professional liability with a minimum of $1,000,000 coverage limit per occurrence?

Yes
No

2. If no, and you have a funded self-insurance program; provide the name of the fund administrator, the amount of the self-insurance fund, and a description of the coverage available to your institution.

Fund Administrator	Amount of Self Insurance Fund	Describe Coverage

3. Will you require transplant surgeons and transplant physicians on your medical staff to carry professional liability insurance or to participate in a funded self-insurance program beyond what is described in “a” or “b” above? If yes, describe the amount of coverage or funded self-insurance that you will require.

	Response Required (check one)	Amount of Self Insurance Coverage
Yes
No

Part 1: Section B – Donation after Circulatory Death (DCD) Protocols

Donation after Circulatory Death (DCD). In accordance with the bylaws, transplant hospitals must develop, and once developed must comply with, protocols to facilitate the recovery of organs from DCD donors. Transplant Hospital DCD recovery protocols must address the model requirements set forth in the policies.

Certification Statement

The undersigned, as the duly authorized Chief Executive Officer, hereby certifies after investigation that to the best of his or her knowledge, a Donation after Circulatory Death (DCD) organ recovery protocol has been developed, adopted and implemented in accordance with OPTN Bylaws; and that the DCD organ recovery protocol addresses the requirements.

Signature:

Date:

Name:

Part 2: Section A – Program Description

Duplicate this section for each organ application that is being submitted

Indicate below all programs and components for which the hospital is applying.

Application (Check)	Program Type	Application (Check)	Program Type
	Kidney		Pancreas
	Living Donor Kidney Recoveries		Pancreas Islet Cell
	Liver		Heart
	Living Donor Liver Recoveries		Lung

1. Indicate below the anticipated start date that the transplant program will become operational.

[Insert detailed response here. Table will expand automatically]

2. Will this program perform transplants in patients under age 18?

Yes
No

2. Is this a stand-alone pediatric hospital?

Yes
No
No, we are affiliated with:

2. Is this program certified by Medicare?

If yes, submit evidence of certification and complete the table below:

CMS provider number:

Certification date:

2. If a Certificate of Need (CON) is required by your state prior to initiation of this transplant program, provide the below information.

Date Application Made	Application (Actual or Anticipated) Approval Date

Part 2: Section B – Facilities

Transplant programs require extensive facilities and commitment of resources. Consequently, transplant hospitals must allocate sufficient operating and recovery room resources, intensive care resources, and surgical beds to the transplant program. Describe below how this hospital satisfies these requirements.

Operating Room(s):
Recovery Room(s):
ICU:
Surgical Intensive Care (SICU):
Step-Down Unit/Floor:
Outpatient Transplant Clinic:
Total # of Days/Hours Available for Outpatient Transplant Clinic:
Additional information:

Part 2: Section C – Human Resources

1. Clinical Nursing: Describe the nursing support that will be provided to the transplant program.

1. Patient to nurse ratio:

ICU

NON-ICU

2. Describe training/orientation for clinical nursing staff caring for transplant patients. Include details regarding competencies required before a nurse is given responsibility for care of transplant patients.

[Insert detailed response here, table will expand automatically.]

3. Will a transplant nurse specialist be actively involved in the care of patients on the transplant unit? If so, describe responsibilities.

[Insert detailed response here, table will expand automatically.]

2. Transplant Program Personnel: OPTN Bylaws require that transplant programs have support personnel on staff to ensure quality patient care. For details regarding roles and responsibilities for these positions, reference the bylaws. In the table below, indicate if individuals in these positions are designated members of the transplant team or serve as consultants to support the transplant program.

Position	Designated Member of Transplant Team	Consultative, available as needed
Clinical Transplant Coordinator
Financial Coordinator
Clinical Transplant Pharmacist
Mental Health and Social Support
Radiology
Infectious Disease
Pulmonary Medicine
Pathology
Immunology
Physical Therapy
Rehabilitation Medicine
Dietary & Nutritional Support

3. Other Medical Discipline Involvement: Indicate in the table if the transplant program has immediate access to the following services and their location:

Specialty Area	In-House	Offsite
Microbiology
Clinical Chemistry
Immunological Monitoring
Blood Bank
Hepatology
Pediatrics
Nephrology (with dialysis capability)
Pulmonary Medicine (with respiratory therapy support)

4. Anesthesiology Commitment: All transplant hospitals must show evidence of collaborative involvement with experts in the field of anesthesiology.

a) Is there a director of transplant anesthesiology and/or an anesthesiology service chief for the organ transplant program covered in this application?

Yes
No

b) Does the department of anesthesiology or the hospital medical staff have a credentialing process for transplant anesthesiologists?

Yes
No

c) Select the statement that best describes the anesthesiology care.

Care for transplant procedures will be provided exclusively by members of a transplant anesthesiology team
Care for transplant procedures will be provided by members of a transplant anesthesiology team and other non-team members
Care for transplant procedures will be distributed among anesthesiology department members

4. How many anesthesiologists, including the director, will participate in transplant care?

[Insert detailed response here. Table will expand automatically]

5. Is there a written protocol for the conduct of anesthesia in transplant cases?

Yes
No

6. In what way do the anesthesiologists participate in transplant patient care?

Phase of Patient Care	Yes	No	If Requested
See patients preoperatively
Participate on the Selection Committee
Consultation preoperatively with subspecialists (e.g. cardiologists, pulmonologists) as needed for specific cases
Participate in M&M Conferences
Other (describe)

5. Staffing Resources – Planning:

Using the chart below, show the expected transplant volume and staffing levels (FTEs) for year 1 through year 3 of the program.

	Year 1	Year 2	Year 3
Workload Volume
Projected Transplant Volumes
Projected # of Candidates Waitlisted
Expected # of New Evaluations Each Year
Projected # of Patients Followed Post-transplant
Staffing/Personnel Projections (FTEs)
Surgeons – Primary/Additional
Surgeons – Other
Surgeons – Transplant Fellow
Physician – Primary/Additional
Physician – Other (Organ Specific)
Physician – Fellow (Organ Specific)
Physician Extenders(s)
Transplant Pathologists
Transplant Coordinators
Dietary/Nutritional Counselors
Financial Counselors
Social Workers
Transplant Program Administrative Management
Administrative Assistants
Data Coordinators
Transplant Pharmacists
Transplant Psychiatrist/Psychologist

Part 2: Section D - Program Administration:

1. Describe administrative relationships of the transplant program with the hospital (include an organizational chart).

[Insert detailed response here, table will expand automatically.]

2. Describe the institutional commitment to this program including hospital resources to be dedicated to this program for the next two years.

[Insert detailed response here, table will expand automatically.]

3. Describe oversight and management of the transplant program, including if the program is part of a designed comprehensive transplant center or service line, and how this transplant program fits into the overall hospital structure.

[Insert detailed response here, table will expand automatically.]

4. Describe the role of the transplant administrator and areas of oversight (including non-transplant duties).

[Insert detailed response here, table will expand automatically.]

5. Describe in detail the transplant program’s quality assurance/performance improvement protocol or process, and how the transplant program will review its performance. Indicate the method, frequency of reviews, and participants (by title). Expand or duplicate table as needed.

Individuals Involved:

(Name and title)

Methods:

Frequency of reviews:

Metrics/Data Tracked:

Detailed response:

6. Will specialty representatives participate with the transplant team in patient specific reviews post-transplant (i.e. morbidity and mortality meetings, etc)?

Individuals Involved:

(Name and title)

Methods:

Detailed response:

7. Will hospital administration receive periodic reports for the transplant program? If so, indicate frequency and data reported. Expand table as needed.

Frequency of reports:

Metrics/Data Tracked:

Detailed response:

8. Describe the process for ensuring compliance with OPTN obligations. Include who is responsible (name and title/position) and how this process is integrated with other transplant programs and institution wide.

Name/Title:

[Insert detailed response here, table will expand automatically.]

9. Data Collection and Submission: In accordance with the OPTN policies, members must submit data on candidates, recipients, and donors.

a) Describe the methods that will to be used to collect, verify, and submit data on a timely basis.

[Insert detailed response here, table will expand automatically.]

b) Describe the training/orientation for the data coordinator(s) supporting the transplant program. Include details regarding competencies measured as part of the training.

[Insert detailed response here, table will expand automatically.]

Part 2: Section E –Protocols/Methods/Procedures

1. Are there written policies and procedures for transplantation and patient management?

Yes, individual physician/surgeon specific
Yes, program specific for all team members
No

How often will these be reviewed and who participates in the review?

[Insert detailed response here, table will expand automatically.]

2. Describe below how patients (additional explanation for living donors when applicable) will move through the pre-, peri-, and post-transplantation process (from identification and referral, selection committee review process, patient notification, post surgery/post transplant care and plan/policy for transitioning patients back to referring doctors post-transplant) as applicable. The description should include:

• resources involved with each step (address expected average volume of patients moving through the system at any given time)

• the process for continuous review of patients currently waitlisted for transplant

[Insert detailed response here, table will expand automatically.]

3. Describe existing or anticipated development of outreach programs for facilitating referrals.

[Insert detailed response here, table will expand automatically.]

4. Describe the approach for responding to patient inquiries and emergencies.

Routine patient calls:

Outpatient emergencies:

5. What provisions are made for patient assistance/funding for temporary housing, medications, etc.?

[Insert detailed response here, table will expand automatically.]

6. Describe types of transplant team meetings and who participates in them. Are rounds conducted with a multi-disciplinary team? Who participates in them? Duplicate or expand table as needed.

Meeting Type:

Attendees (role, not name):

Multi-disciplinary team rounds:

Participants:

7. Who oversees and directs the outpatient transplant clinic? Which physicians and surgeons regularly participate in the transplant clinic?

Transplant Clinic Oversight:

Transplant Clinic Participation:

8. Patient Selection Criteria: Transplant programs must establish procedures for selecting transplant candidates and distributing organs in a fair and equitable manner.

a) Describe the patient evaluation protocol for this transplant program.

[Insert detailed response here, table will expand automatically.]

b) Are there formal exclusion criteria for acceptance?

[Insert detailed response here, table will expand automatically.]

c) Who gives final approval for adding patients to the waiting list?

Single Individual
Committee of (list titles of participants):

9. Immunosuppression: Answer the questions below regarding immunosuppression:

1. Is there a standard immunosuppression protocol?

Yes, individual physician/surgeon specific
Yes, program specific for all team members
No

2. Indicate who (role/title) manages immunosuppression at various stages of the transplant process:

Initial hospitalization
First 3 months post-transplant
Long term (after 3 months)

Describe the interactions of team members in providing immunosuppression management.

10. Off-site Transplant-related Services: In the space below, summarize plans for any transplant-related services provided outside of the transplant hospital. Provide a letter of support or agreement from each off-site provider.

[Insert detailed response here, table will expand automatically.]

Part 2: Section F – Business/Implementation Plan

The existence of a business/implementation plan is a critical element for any successful transplant program. The OPTN requests verification that such a business/implementation plan exists in support of this application.

Verification of this plan is requested when:

• applying for institutional membership

• establishing a new transplant program

• the MPSC requires it as a condition for reactivating a transplant program

Certification Statement

The undersigned, as the duly authorized Chief Executive Officer, hereby certifies after investigation that to the best of his or her knowledge, a Business/Implementation Plan has been developed, adopted and will be consulted regarding the institutional commitments being made and acknowledge in the this transplant program application.

Signature:

Date:

Name:

Part 2: Section G – Organ Procurement Arrangements

As part of the application submission, include a letter of agreement or contract with your OPO that specifically indicates it will provide the organ for which the hospital is applying.

1. Describe the process for organ acceptance, including who (role/title) is involved in taking organ offer calls. Elaborate if you utilize a hired offer screening service.

[Insert detailed response here, table will expand automatically.]

2. Describe any regional transplant agreements below.

[Insert detailed response here, table will expand automatically.]

Part 2: Section H – Histocompatibility Testing Arrangements

1. Each transplant program must have a written agreement with a histocompatibility laboratory(ies) that will be providing testing services. Select the statement below that best describes how this transplant program will meet this requirement.

a) This hospital already has an OPTN approved in-house histocompatibility laboratory
b) This hospital is also submitting a separate OPTN application for histocompatibility testing services to be provided by its in-house laboratory
c) This hospital will be entering into a contract with an OPTN approved outside histocompatibility laboratory to provide testing services to this program

2. If the answer to question 1(c) above is “yes,” list the names and addresses of the histocompatibility laboratory(ies) and submit each written agreement. The agreement must include all of the elements required in the OPTN Bylaws. Expand rows as needed.

Histocompatibility Laboratory Name	Address	Functions Performed

Version pending General - 6