Form B16 a B16 a B16 a VCA_Other_Updated

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

Health Resources and Services Administration Expiration Date:  xx/xx/xxxx

Part 3: Other VCA Transplant Program

Table 1: OPTN Staffing Report

Member Code:	Name of Transplant Hospital:
Main Program Phone Number:	Main Program Fax Number:	Hospital URL: http://www
Toll Free Phone Number for Patients:	Hospital Number:

Refer to the staffing audit sent with this application and complete the table below for staff that are not captured on the staffing audit or to update information for current staff, including deleting (DEL) an individual. If you did not receive an audit with this application, complete the entire staffing report. Add additional rows as necessary. Make sure to use individuals’ full, legal names (middle name/initial also included when possible) to prevent duplicate entries within the UNOS Membership Database and UNet.

Identify the transplant program medical and/or surgical director(s).

DEL	Name	Address	Phone	Fax	Email

Identify the primary surgeon and additional surgeon(s) who perform transplants for the program.

DEL	Name	Address	Phone	Fax	Email

Identify other surgeon(s) who perform transplants for the program.

DEL	Name	Address	Phone	Fax	Email

Identify the multidisciplinary surgical team who participate in this transplant program.

DEL	Name	Address	Phone	Fax	Email

Identify the primary physician and additional physicians (internists) who participate in this transplant program.

DEL	Name	Address	Phone	Fax	Email

Identify other physicians (internists) who participate in this transplant program.

DEL	Name	Address	Phone	Fax	Email

Identify the transplant program administrator(s)/hospital administrative director(s)/manager(s) who will be involved with this program. The * denotes the primary transplant administrator.

DEL	Name	Address	Phone	Fax	Email
	*

Identify the clinical transplant coordinator(s) who will be involved in this transplant program.

DEL	Name	Address	Phone	Fax	Email

Identify the data coordinator(s) who will be involved in this transplant program. The * denotes the primary data coordinator.

DEL	Name	Address	Phone	Fax	Email
	*

Identify the social worker(s) who will be involved with this program.

DEL	Name	Address	Phone	Fax	Email

Identify the pharmacist(s) who will be involved with this program.

DEL	Name	Address	Phone	Fax	Email

Identify the financial counselor(s) who will be involved with this program.

DEL	Name	Address	Phone	Fax	Email

Identify the anesthesiologists who will be involved with this program. The * denotes the director of anesthesiology.

DEL	Name	Address	Phone	Fax	Email
	*

Identify the QAPI team members who will be involved with this program.

DEL	Name	Address	Phone	Fax	Email

Identify any other transplant staff who will be involved with this program.

DEL	Name	Title	Address	Phone	Fax	Email

Part 3A: Personnel – Other VCA Transplant Program Director(s)

1. Identify the transplant program surgical and/or medical director(s) of the other VCA transplant program and submit a C.V. for each program director. Briefly describe the leadership responsibilities for each individual.

Name	Date of Appointment	Primary Areas of Responsibility

Part 3B, Section 1: Personnel – Surgical – Other VCA Primary Transplant Surgeon

1. Identify the primary other VCA transplant surgeon:

Name:

1. Provide the following dates (use MM/DD/YY):

Date of employment at this hospital:

Date assumed role of primary surgeon:

b) Does the surgeon have FULL privileges at this hospital?

Yes
No

If the surgeon does not currently have full privileges:

Date full privileges to be granted (MM/DD/YY):

Explain the individual’s current credentialing status, including any limitations on practice:

c) How much of the surgeon’s professional time is spent on site at this hospital?

Percentage of professional time on site:

Number of hours per week:

d) How much of the surgeon’s professional time is spent on site at other facilities (hospitals, health care facilities, and medical group practices)?

Facility Name	Type	Location (City, State)	% Professional Time On Site

e) List the surgeon’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If individual has been recertified, use that date, also provide a copy of certification(s).

Certification Type	Certificate Effective Date (MM/DD/YY)	Certificate Valid Through Date (MM/DD/YY)	Certification Number

Table 2: Primary Surgeon – Relevant Clinical Experience Log (Sample)

Organ:
Name of proposed primary surgeon:
Name of hospital where procedures were performed:
Date range of surgeon’s appointment/training: MM/DD/YY to MM/DD/YY

List cases in date order. Add rows as needed. Patient ID should not be name or Social Security Number.

Multi-organ Procurements Observed

#	Date of Observation	Medical Record/ OPTN ID #	Role of Surgeon	Multi-organs
1
2
3

Pre-operative Evaluations of Potential Transplant Patients Observed

#	Date of Observation	Medical Record/ OPTN ID #	Role of Surgeon	Hospital
1
2
3
4
5

Director’s Signature	Date
Print Name

Table 3: Primary Surgeon – VCA Experience Log (Sample)

Organ:
Name of proposed primary surgeon:
Name of hospital where procedures were performed:
Date range of surgeon’s appointment/training: MM/DD/YY to MM/DD/YY

List cases in date order. Add rows as needed. Patient ID should not be name or Social Security Number.

#	Date of Procedure	Procedure	Medical Record/ OPTN ID #	Role of Surgeon
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15

Director’s Signature	Date
Print Name

Part 3B, Section 2: Personnel – Additional Surgeon(s)

Complete this section to describe surgeons involved in the program that are not designated as primary. For each surgeon, they should be designated as additional as described below. Duplicate this section as needed.

Additional transplant surgeons must be credentialed by the transplant hospital to provide transplant services and be able to independently manage the care of transplant patients, including performing the transplant operations and organ procurement procedures.

1. Identify the additional transplant surgeon:

Name:

a) Provide the following dates (use MM/DD/YY):

Date of employment at this hospital:

b) Does the surgeon have FULL privileges at this hospital?

Yes
No

If the surgeon does not currently have full privileges:

Date full privileges to be granted (MM/DD/YY):

Explain the individual’s current credentialing status, including any limitations on practice:

c) How much of the surgeon’s professional time is spent on site at this hospital?

Percentage of professional time on site:

Number of hours per week:

d) How much of the surgeon’s professional time is spent on site at other facilities (hospitals, health care facilities, and medical group practices)?

Facility Name	Type	Location (City, State)	% Professional Time On Site

e) List the surgeon’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If the surgeon has been recertified, use that date.

Board Certification Type	Certification Effective Date/ Recertification Date (MM/DD/YY)	Certification Valid Through Date (MM/DD/YY)	Certificate Number

Part 3C, Section 1: Personnel – Medical – Primary Other VCA Transplant Physician

1. Identify the primary transplant physician:

Name:

Check which membership criteria the primary VCA physician will use to qualify. Next steps are within the criteria box selected.

Membership Criteria	Check One
(1) Currently designated as the primary transplant surgeon or primary transplant physician at an active solid organ transplant program. Which solid organ transplant program? ______________________________ Proceed to Table 8, Certificate of Investigation.
(2) Meets the requirements of a primary transplant surgeon or primary transplant physician in the OPTN Bylaws. Which solid organ transplant program? _____________________________ Complete the rest of the application.
(3) Meets the requirements found in Appendix J.2. Fellowship Hospital: __________________________ Dates: _________________________ Fellowship Program Director: ___________________ Medical or Surgical Specialty: ___________________ Complete 1a) – e) below.

a) Provide the following dates (use MM/DD/YY):

Date of employment at this hospital:

Date assumed role of primary physician:

b) Does the physician have FULL privileges at this hospital? (check one)

Yes
No

If the physician does not currently have full privileges:

Date full privileges to be granted (MM/DD/YY):

Explain the physician’s current credentialing status, including any limitations on practice:

c) How much of the physician’s professional time is spent on site at this hospital?

Percentage of professional time on site:

Number of hours per week:

d) How much of the physician’s professional time is spent on site at other facilities (hospitals, health care facilities, and medical group practices)?

Facility Name	Type	Location (City, State)	% Professional Time On Site

e) List the surgeon’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If individual has been recertified, use that date, also provide a copy of certification(s). If the surgeon does not have current American or Canadian board certification, provide letters of recommendation requesting this exception and provide the plan for continuing education as described in the OPTN Bylaws.

Board Certification Type	Certification Effective Date/ Recertification Date (MM/DD/YY)	Certification Valid Through Date (MM/DD/YY)	Certificate Number

Answer if qualifying by the primary intestine physician requirements: If the physician is not a pediatric gastroenterologist and the program serves predominately pediatric patients, please identify a pediatric gastroenterologist who will be involved in the care of transplant recipients. Provide C.V.

Name	Board Certification	% Professional Time on Site

f) Check the pathway through which the primary VCA transplant physician will be proposed. Refer to the Appendices E-I in the OPTN Bylaws for the necessary qualifications and more specific descriptions of the required supporting documents.

Membership Criteria	Check one
Residency Pathway
Transplant Fellowship Pathway
Pediatric Fellowship Pathway
Combined Pediatric Training and Experience Pathway
Clinical Experience Pathway
Full (Intestine only)
Conditional (Intestine only)

g) Transplant Experience (Post Fellowship) and Training (Fellowship): List the name(s) of the transplant hospital(s), applicable dates, and program director name(s) from either fellowship training or experience post fellowship. If a surgeon is being proposed to serve as the primary physician, also document the number of transplants and procurements performed. If a physician, document the number of patients that were provided substantive patient care (pre-, peri- and post-operatively from the time of transplant).

Tr Training and Experience	Date (MM/DD/YY)		Transplant Hospital	Program Director	# Transplants as Primary or 1st Assist (Surgeon)	# Procured as Primary or 1st Assist (Surgeon)	# Patients Followed (Physician)
	Start	End					Pre	Peri	Post
Fellowship Training
Experience Post Fellowship

h) Training/Experience: List how the physician fulfills the criteria for participating as an observer of procurements and transplants. For procurements, the physician must have observed the evaluation, donation process, and management of the donors. This table is only applicable if you are applying as a primary transplant physician.

Date From - To (MM/DD/YY)	Transplant Hospital	# of Procurements Observed	# of Transplants Observed

i) Describe in detail the proposed primary physician's level of involvement in this transplant program as well as prior training and experience under All Organs. Then also complete the organ specific section for which you are applying through (heart, lung, kidney, liver, pancreas, or intestine).

Describe Level of Involvement in This Transplant Program		Describe Prior Training/Experience
All Organs
Donor Selection
Recipient Selection
Transplant Surgery (surgeon only)
Pre-operative management/care of patients with acute, chronic disease or end stage organ failure
Long term outpatient follow-up care
Immunosuppressive therapy including side effects of drugs and complications of immunosuppressive
Histological interpretation and grading of allograft biopsies for rejection
Fluid and electrolyte management (peds only)
Effects of transplantation and immunosuppressive agents on growth and development (peds only)
Manifestation of rejection in the pediatric patient (peds only)
Heart, Lung
Use of mechanical circulatory support devices/ cardiopulmonary bypass
Pre-operative hemodynamic/ ventilator care
Post-operative hemodynamic/ ventilator care
Kidney, Liver, Pancreas, Intestine
Differential diagnosis of organ dysfunction in the allograft recipient
Histocompatibility and tissue typing
Interpretation of ancillary tests for organ dysfunction

Table 4: Primary Physician - Transplant Log (Sample)

Only complete this table if applying as the primary VCA transplant physician by qualifying as a primary transplant surgeon.

Organ:
Name of proposed primary surgeon:
Name of hospital where transplants were performed:
Date range of surgeon’s appointment/training: MM/DD/YY to MM/DD/YY

List cases in date order. Add rows as needed. Patient ID should not be name or Social Security Number.

#	Date of Transplant	Medical Record/ OPTN ID #	Primary Surgeon	1st Assistant
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

Director’s Signature	Date
Print Name

Table 5: Primary Physician - Procurement Log (Sample)

Only complete this table if applying as the primary VCA transplant physician by qualifying as a primary transplant surgeon.

Organ:
Name of proposed primary surgeon:

List cases in date order. Add rows as needed. Patient ID should not be name or Social Security Number.

#	Date of Procurement	Donor ID Number	Comments (LD/CAD/Multi-Organ)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

Director’s Signature	Date
Print Name

Table 6: Primary Physician - Recipient Log (Sample)

Only complete this table if applying as the primary VCA transplant physician by qualifying as a primary transplant physician.

Organ:
Name of proposed primary physician:
Name of transplant hospital where transplants were performed:
Date range of physician’s appointment/training: MM/DD/YY to MM/DD/YY

List cases in date order. Add rows as needed. Patient ID should not be name or Social Security Number.

#	Date of Transplant	Medical Record/ OPTN ID #	Pre-Operative	Peri-Operative	Post-Operative	Comments
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

Director’s Signature	Date
Print Name

Table 7: Primary Physician - Observation Log (Sample)

Only complete this table if applying as the primary VCA transplant physician by qualifying as a primary transplant physician.

Organ:
Name of proposed primary physician:

In the tables below, document the physician’s participation as an observer in transplants and procurements. For procurements, the physician must have observed the evaluation, donation process, and management of the donors.

List cases in date order. Add rows as needed. Patient ID should not be name or Social Security Number.

Transplants Observed

#	Date of Transplant	Medical Record/ OPTN ID #	Donor Type	Age	Hospital
1
2
3
4
5

Procurements Observed

#	Date of Procurement	Medical Record/ OPTN ID #	Living Donor or Deceased
1
2
3
4
5

Part 3C, Section 2: Personnel – Additional Physician(s)

Complete this section to describe physicians involved in the program that are not designated as primary. For each physician, they should be designated as additional as described below. Duplicate this section as needed.

Additional transplant physicians must be credentialed by the transplant hospital to provide transplant services and be able to independently manage the care of transplant patients.

1. Identify the additional physician:

Name:

a) Provide the following dates (use MM/DD/YY):

Date of employment at this hospital:

b) Does the physician have FULL privileges at this hospital? (check one)

Yes
No

If the physician does not currently have full privileges:

Date full privileges to be granted (MM/DD/YY):

Explain the physician’s current credentialing status, including any limitations on practice:

c) How much of the physician’s professional time is spent on site at this hospital?

Percentage of professional time on site:

Number of hours per week:

d) How much of the physician’s professional time is spent on site at other facilities (hospitals, health care facilities, and medical group practices)?

Facility Name	Type	Location (City, State)	% Professional Time On Site

e) List the physician’s current board certification(s) below. If board certification is pending, indicate the date the exam has been scheduled. If the physician has been recertified, use that date. Also provide a copy of the certification(s).

Board Certification Type	Certification Effective Date/ Recertification Date (MM/DD/YY)	Certification Valid Through Date (MM/DD/YY)	Certificate Number

Table 8: Certificate of Investigation

1. List all transplant surgeons and physicians currently involved in the program.

a) This hospital has conducted its own peer review of all surgeons and physicians listed below to ensure compliance with applicable OPTN/UNOS Bylaws. Expand rows as needed.

Names of Surgeons

Names of Physicians

2. If prior transgressions were identified, has the hospital developed a plan to ensure that the improper conduct is not continued?

Yes
No
Not Applicable

If yes, what steps are being taken to correct the prior improper conduct or to ensure the improper conduct is not repeated in this program? Provide a copy of the plan.

I certify that this review was performed for each named surgeon and physician according to the hospital’s peer review procedures.

Signature of Primary Surgeon	Date
Print Name
Signature of Primary Physician	Date
Print Name

Table 9: Program Coverage Plan

1. Provide a copy of the current Program Coverage Plan and answer the questions below. The program coverage plan must be signed by either the:

a. OPTN/UNOS Representative;

b. Program Director(s); or

c. Primary Surgeon and Primary Physician.

	Yes	No
Is this a single surgeon program?
Is this a single physician program?
If single surgeon or single physician, submit a copy of the patient notice or the protocol for providing patient notification.
Does this transplant program have transplant surgeon(s) and physician(s) available 365 days a year, 24 hours a day, 7 days a week to provide program coverage?
If the answer to the above question is “No,” an explanation must be provided that justifies why the current level of coverage should be acceptable to the MPSC. Please use the additional information section below.
Transplant programs shall provide patients with a written summary of the Program Coverage Plan at the time of listing and when there are any substantial changes in program or personnel. Has this program developed a plan for notification?
Is a surgeon/physician available and able to be on the hospital premises to address urgent patient issues?
Is a transplant surgeon readily available in a timely manner to facilitate organ acceptance, procurement, and implantation?
A transplant surgeon or transplant physician may not be on call simultaneously for two transplant programs more than 30 miles apart unless circumstances have been reviewed and approved by the MPSC. Is this program requesting an exemption?
If yes, provide explanation:
Unless exempted by the MPSC for specific causal reasons, the primary transplant surgeon/primary transplant physician cannot be designated as the primary surgeon/primary transplant physician at more than one transplant hospital unless there are additional transplant surgeons/transplant physicians at each of those facilities. Is this program requesting an exemption?
If yes, provide explanation:
Additional information:

Other VCA-3

Xx/xx/xx Version