Clinical Network
Clinical Center of Excellence
Application Cover Sheet
Institution:
Respondent:
Position/Title:
Department:
Address (Street):
City, State/Province, Zip Code:
Phone:
(
)
Fax:
(
)
Email:
(
)
Email:
Administrative Assistant (for Applicant)
Phone:
(
)
Fax:
Institutional Official to be Notified if Accepted (if different from above):
Name:
Title:
Phone:
Email:
1
FARE CLINICAL CENTER OF EXCELLENCE MEMBERSHIP APPLICATION
FARE’s mission is to improve the quality of life and the health of individuals with food allergies,
and to provide them hope through the promise of new treatments.
FARE believes that every food allergic individual deserves the best care and treatment possible. To that
end, we are creating the FARE Clinical Network (“FCN”) to raise the quality of care for food allergic
patients nationwide, to reduce discrepancies in care among providers and to make comprehensive care
accessible and available for all food allergic patients. FARE believes that parents, caregivers, and
patients should know which clinics provide and maintain the highest standards in clinical and subspecialty food allergy services, which clinics are leaders in rapidly applying new evidence based
knowledge, and who is accountable for delivering the care patients should expect. FARE intends to
make its educational materials available to, and/or co-brand those materials with, FCN members. FARE
seeks to be inclusive, not exclusive, in this program. FARE will encourage collaboration and resource
sharing among members. FARE believes that through collaborative efforts, the FCN will provide benefits
to its members for the benefit of its patients.
Our efforts are modeled on the work of other successful organizations that have moved their fields
forward.
FARE has invited select institutions to apply as inaugural members to the FCN. Over the coming year, we
intend to award membership to other qualified centers.
Application Process
FARE will consider an application for membership to become a Clinical Center of Excellence (“CCE” or
“Center”) in the FCN if a Center meets all of the minimum criteria for care, teaching and clinical
research.
The application consists of 18 questions. You have the option of answering questions 14 and 15 in your
initial application, or upon notification of provisional acceptance to the FCN.
Required for Provisional Acceptance: Questions 1-13; 16-18.
Required for Final Consideration: Questions 14 and 15.
In order to become a member, a CCE must certify to FARE that it has met the mandatory criteria for its
food allergy programs as described in the application. If a CCE fails to maintain these criteria, it will be
subject to loss of membership. Centers will certify to FARE in their application that they meet, and then
reconfirm annually that they continue to meet, the minimum requirements for membership. A FAREorganized and -supervised FCN Center Review Committee (“Review Committee”) will review each
Center’s application to become a member of the FCN, as well as its annual renewal. The Review
Committee will work with Centers on any needed remediation efforts, but will not assess whether the
2
certification made by the CCE of its compliance with the minimum criteria for membership is accurate.
Information submitted in an application or annual update will only be reviewed by the Review
Committee and will not be shared without the prior permission of the applicant.
FARE strongly encourages patients to meet with Center personnel to discuss their chosen Center’s
qualifications as they make personal food allergy care decisions. FCN membership is not a substitute for
an evaluation by patients and FARE relies entirely on a Center’s self-reporting in making membership
decisions.
3
FARE Clinical Center of Excellence (“CCE”) Membership Application
Please be complete in responses. The page limits are limits, not goals. As appropriate, please crossreference responses (e.g., responses contained in CVs). Do not repeat information. Attach
documents, e.g., SOP’s, MOP’s as evidence that criteria are met.
A. PERSONNEL
 A CCE must have a minimum of two board certified allergists and one board certified
gastroenterologist as members of its practice group, present in clinics at least one day per week
(although not necessarily simultaneously). The gastroenterologist(s) can either be a member of
the practice group or a member(s) of affiliated groups that the food allergy team can access on
an as needed basis.
 1. Please provide CVs and clinic schedule for each of the personnel listed above.

A CCE that cares for both adults and children can have separate or dedicated care teams for its
pediatric and adult programs. Some members, including physicians, may be shared between
pediatric and adult programs, where appropriate board or other certification exists.
 2. Please provide a listing of the physicians on each care team, their responsibilities, and
their credentials.



A CCE must also have a designated Director and Associate Director, who fulfill the following
criteria:
Director Qualifications and Responsibilities
Qualifications
The Director must be board certified in Allergy and Clinical Immunology or Gastroenterology.
In addition, he/she should have at least 3 years’ post-fellowship clinical experience in the care of
food allergy patients.
 3. Please provide a copy of the CV for the designated Director.
Care/Administrative Responsibilities of Director
 All CCEs are expected to adhere to the AAAAI and ACAAI Clinical Practice Guidelines
for diagnosing and treating food allergies.
 4. Please discuss how these clinical practice guidelines are implemented at your site.
(1-2 pages)
 A Center Director is responsible for providing oversight of the operation of the
Center. This may entail coordinating with other entities within a specific Center.
 5. Please describe the types of operational oversight measures that are in place,
how often they are reviewed, and who participates in the review. (1-2 pages)
4
 He/she also provides quality assurance for all aspects of patient diagnosis and
care in the operation of the CCE.
 6. Describe the quality of care assurance procedures that are in place, how
often they are reviewed, and who participates in the review. (1-2 pages)
 The Director must also be involved on a day-to-day basis with patient care and be
knowledgeable about the administrative aspects of the CCE. Without limitation, the Center
Director must ensure that:
a) Quality food testing (prick and blood assays) and clinical practice guidelines, continued
quality improvement, and all other membership criteria are developed and maintained.
 7a. Describe and document the procedures above. (1-2 pages)
b) Annual recertification material, including efforts to ensure that patient
registry data is input to a (to be created) FARE Patient Registry, are submitted on a
timely basis.
 7b. Please describe and document how the requirements above are met. (1
paragraph)
c) The institution is providing adequate facilities and ancillary support to the FCN program.
 7c. Please describe facilities for both the adult and pediatric patients and any
additional areas of specialization that the teams utilize. Please describe the
state-of-art of your facilities. (1-2 pages; note that a separate section focuses on
facilities.)
d) CCE personnel (physician and non-physician) are of the highest quality and
maintain expertise in the area of food allergy.
 7d. Please describe: a) the performance review system in place at your Center and state the
number of physicians attaining highest level performance rating; and b) the professional
training provided (or that can be accessed): seminars, conferences, classes, accredited
courses that are offered (or that can be accessed) for staff participation. (1-2 pages)
e) Personnel time allotted to care of CCE patients is appropriate for the patient
population.
 7e. Please describe how your Center meets these criteria. For example, you can provide data
on full-time equivalent personnel to the number of new and returning patients annually.
You can also site, for example, the number of hours, on average, for initial visits, food
challenges.
Teaching Responsibilities
 The Director must be an acknowledged expert in food allergy and share his/her expertise
through teaching activities for:
5
a)
b)
c)
d)
e)
f)
g)
Center personnel
Physician trainees and staff
Medical students
Allied health professionals
Community
Lay groups
Presentations at national meetings, etc.
 8. Please list and describe the topics and seminars offered in 2014 by you to the
groups above. List (or site CV for) research papers and published articles. (3-4 pages)
Research Responsibilities
 The Director should be an acknowledged expert in clinical research and
demonstrate his/her expertise through activities including:
a)
b)
c)
d)
e)
f)
Collaboration with other investigators within the institution and FCN members.
Participating in nationally or locally funded clinical research performed by FCN staff.
The involvement of trainees and fellows in food allergy-related research areas.
Involvement in collaborative or multicenter projects, including those within the FCN.
Providing education throughout the institution or affiliated medical school to
researchers in the most recent advances in food allergy research, as well as clinical
correlations.
Directors must attend the annual FARE research conference a minimum of every
other year. It is strongly suggested that the either the CCE Director or Associate
Director attend every annual meeting to ensure that each CCE is aware of advances
in the field of food allergy.
 9. Please include an itemized list for the items above (a-f) and provide a description of each
project and its duration. In your opinion, which programs have been most successful and
why? (1-2 pages)
Associate Center Director (“ACD”) Qualifications and Responsibilities
 With the exception of Clinical Research experience, the Associate Center Director should have
the same or comparable qualifications and experience as the Center Director so that he/she is
fully capable of assuming directorship in the Center Director’s absence. Therefore, he/she must
be board certified (Allergy and Clinical Immunology, Pediatrics, Internal Medicine, or
Gastroenterology) with at least three years’ post fellowship-training and/or clinical experience
in the care of food allergic patients. In addition, this person must be involved on a day-to-day
basis with patient care and be knowledgeable about the administrative aspects of the CCE.
 10. Please provide CV for the designated ACD. Discuss specific duties that demonstrate how
the ACD is involved in daily patient care and administration. (CV plus 1-2 pages)
6
B. FACILITIES AND SERVICES
 A CCE is required to have adequate clinical facilities to provide appropriate care and diagnostic
services for food allergy patients. This includes:
a) dedicated facilities for food allergy diagnosis, including food challenges
b) an appropriate space (or kitchen) to support food challenges
c) adequate office space to support physicians involved in the care of patients
d) an appropriate tertiary care hospital facility where inpatient care can be provided as
necessary (during anaphylaxis or other severe health issue).
 11. Please provide a description for each of the items above (a-d) and discuss areas
that may need improvement. How many incidents of anaphylaxis were treated in 2014
YTD? Were there any reported deaths? How many food challenges were done 2014
YTD? How many patients are seen annually for initial examinations in 2014 YTD? (1-5
pages)

Clinical Program Criteria
The following specific clinical program criteria must be met:
a) The CCE team has significant food allergy experience and routinely interfaces with
the physicians who treat food allergic patients.
b) Outpatient care is provided in clinic areas where food exposure is controlled.
c) The Center Director, Assistant Director or other associated physician is available 24
hours a day for emergencies.
d) Phone calls are received by the Center Director or Assistant Director, fellows or
trained coordinator.
e) A full range of associated adult and pediatric subspecialists provide inpatient and
outpatient care, e.g., dietician, dermatology, psychology, gastroenterology.
f) Electronic patient records must include (but need not be limited to):
Documentation of definitive diagnosis
Copies of outpatient clinic visits
Discharge summaries
Growth chart
Laboratory data
All outpatient clinic reports and discharge summaries are sent to referring
physician
g) Minimum equivalent of a full day food allergy clinic every week
h) Team meetings on a regular basis
i) Minimum of 200 food allergic patients, seen annually
j) Research Coordinator, if appropriate
 12. Please respond to each item above (a-j). Quantify as appropriate and discuss
each item. In addition, please describe the systems used to capture patient data
(registry/database, excel file, etc. (1- 4 paragraphs for each item) plus back-up, if
appropriate)
 13. Please describe the extent to which you keep blood serum, DNA samples, etc. (1-2
paragraphs). Please note that FARE intends to build a patient registry and will ask
7
members to input data to the registry for the benefit of the overall community. It also
intends to build biorepositories and make those tools shared resources to FCN members.
Hospital Support Criteria (for inpatient care; must be JCAHO approved)
a) Defined age-appropriate service, i.e., Pediatrics, Adolescent Medicine, and/or
Internal Medicine
b) House officers
c) Intensive care unit
d) Respiratory Care Department
e) Nutrition or Dietary Support
f) Social Work Department
g) Identifiable Clinical Laboratories
h) Dietitian/Nutritionist (R.D.)
 14. (Optional for initial application.) In Part II of the application, please respond to each item
above (a-h). Provide descriptions, responsibilities and CVs for appropriate staff, and
quantify the number of patients treated (c, d, e, f, h). (1-4 paragraph-description for each
item plus CVs)

Teaching Requirements
To maintain status as a CCE, FARE believes teaching activities are necessary and an important
part of the CCE activity. Therefore a minimum of 2 of the 7 activities listed below must be
maintained.
a) Formal teaching program for pediatric and adult house officers involved in care of
food allergic patient or fellowship programs.
b) Integrate food allergy into the core curriculum of your medical school and create
opportunities for medical students to be involved in food allergic patient care.
c) Allied health personnel teaching and training in food allergy care.
d) Conduct of food allergy-related support groups, community/lay group activities.
e) Food allergy-related presentations at area hospitals, medical meetings, national
conferences.
f) Non peer-reviewed, food allergy-related articles and book chapters, and
development of special educational materials.
g) Committee activities for extramural organizations, i.e., FARE, AAAAI, ACAAI,
AAP, ACP.
 15. (Optional for initial application.) In Part II of the Application, for the items selected from
above (minimum 2), please identify the personnel involved, their credentials (CVs) and
responsibilities, how the material was developed and quantify as appropriate. (1-4
paragraphs per item)
C. RESEARCH
 FARE feels that one of the major activities for a CCE is the performance of clinical research.
FARE expects that the CCE would be a major site of clinical food allergy research as well as the
source of subjects for patient registries and repositories of clinical material. Therefore, a
minimum of 3 of the following 7 activities must have been accomplished within the past three
8
years and the proposed CCE must be involved in some IRB-approved research involving food
allergies.
a) Nationally approved and extramurally funded food allergy-related research project
by core Center staff.
b) Peer-reviewed and funded food allergy-related projects by other members of the
institution who have a working relationship with the Center.
c) Two food allergy-related articles by Center staff published in refereed journals.
d) Two food allergy-related articles by other investigators with acknowledged
participation or facilitation by CCE staff.
e) Active participation in a FARE-sanctioned multicenter research studies (counts as
two activities)
f) Industry-sponsored clinical trials.
g) Participation in Phase IV studies conducted under an IND filed with the FDA.
h) Participation in investigator-initiated, IRB-approved food allergy clinical studies.
 16. Please list, discuss and attach articles/documentation, as appropriate for
at least 3 items listed above (a-g). (1-5 pages plus attachments, if appropriate)
 17. Please describe any patient satisfaction surveys you conduct and remedial
efforts taken to address concerns. (1-2 paragraphs).
 18. Please describe efforts to capture Quality of Life data in practice and/or trials (1-2
paragraphs).
9
Please compile your information as follows:
Print Format:
Please use an easy to read 10-12 point font.
Order
1. Complete the Application Cover Page
2. Follow the application order:
Section A: Personnel
 Responses 1 - 10
Section B: Facilities & Services  Responses 11 - 15
Section C: Research
 Responses 16 - 18
Forward the package of information via email or hard copy to:
Research Department – FARE New York Office
515 Madison Avenue, Suite 1912
New York, NY 10022-5403
212-207-1974 phone 917-338-5130 fax
Email mjmarchisotto@foodallergy.org
10