Fillable Tissue Banks Application 4 (Kinsale Insurance)

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Tissue Banks Application 4 (Kinsale Insurance)

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Page 1 of 7
APPLICATION FOR TISSUE BANKS, BLOOD BANKS AND ORGAN PROCUREMENT
Instructions to the Applicant – please complete this application in ink and answer all questions completely.
Attach extra sheets as necessary should you run out of space provided. An incomplete or illegible application cannot
be processed. Completion of this application neither binds coverage nor guarantees that a policy will be issued.
Provide a fully completed application, signed and dated by the owner, partner, or officer not earlier than 45 days
before the proposed effective date of coverage.
If a question is not applicable, then state “N/A”.
The following information must be submitted with the completed application:
- Copy of your current professional liability insurance Declarations Page (claims made
policies must reflect the retroactive date)
- Copy of your Informed Consent documents
- Copy of all contracts between you and any Principal Investigators or trial sponsors
- Copy of your advertisements
- Copy of your current Financial Statement
- 5-year company loss runs, valued within the last 60 days
GENERAL INFORMATION
Applicant Name:____________________________________________________________________________________________
List of Any Previous Names or Organizations:_____________________________________________________________________
Date Established:____________________________ Website:_______________________________________________
Mailing Address:____________________________________________________________________________________________
Additional Locations: ________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
Applicant is: Corporation Partnership Joint Venture Not For Profit
Limited Liability Company Individual Other
Audit Contact: _______________________________ __ Phone Number: _________________________________________
Kinsale Insurance Company
P. O. Box 17008
Richmond, VA 23226
(804) 289-1300
www.kinsaleins.com
Page 2 of 7
Description of Operations:____________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
_________________________________________________________________________________________________________
Locations
Name and Address
Description
Retro Date
FDA License
Revenues and Anticipated Number of Donors
Donors
Upcoming Year
________________
Current Year
________________
First Prior Year
________________
Second Prior Year
________________
Third Prior Year
________________
STAFFING
1. Please indicate the number of employed professionals or independent contractors
Staff:
Full Time
Part Time
Contracted
Medical Director
Physician
RN/LPN
Nurse Practitioners
Phlebotomist
Technicians
Compliance/QA
Other (specify)
Check the hiring procedures that apply or are performed:
Page 3 of 7
Criminal Background Checks
Drug, alcohol and sexual abuse screening or testing
Verification of certification or professional licensing
Reference Checks
Questioning of employees in their previous involvement as defendants in professional malpractice litigation.
SERVICES
1. Annual Exposure (Percentage)
Paid Donations
________________
Volunteer Donations
________________
Autologous Donations
________________
Foreign Donations
________________
Pheresis Donations
________________
Postmortem Donations
________________
2. Annual Exposure (Percentage)
Blood
________________
Tissue
________________
Organ
________________
Cord Blood
________________
Sperm
________________
Embryo
________________
Bone Marrow
________________
Other (describe):
________________
OPERATIONS
1. List all of the applicable accreditation or industry trade organization memberships:
Accredited by the American Association of Blood Banks
Accredited by the American Association of Tissue Banks
Accredited by FACT
Member of the American Blood Center
Other: _________________________________________
Other: _________________________________________
2. Describe in detail all processing, quarantine and testing procedures (please attach a separate sheet if necessary):
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
Page 4 of 7
3. Is testing performed by a subcontractor?
i. Do you require a Certificate of Insurance from the subcontractor?
ii. Are you included as an Additional Insured?
iii. What are the minimum limits required? __________________
Yes No
Yes No
Yes No
4. Do you provide testing services for other facilities?
i. Revenue: __________________
ii. Do you sign a contract with the other facilities?
If yes, please attach.
Yes No
Yes No
5. Since what date have you continuously tested for the following:
i. HIV? _____/_____/______
ii. HTLV-I? _____/_____/______
6. When was your last FDA, regulatory authority or accreditation organization inspection? ______________
Please attach the report.
7. Do you conduct research activities?
Yes No
If yes, explain:
____________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
8. Do you follow a written quality control program?
i. Do you have a full-time risk manager?
ii. How often do you audit your procedures? ________________
iii. How often do you perform maintenance of equipment? ________________
Yes No
Yes No
9. Do you offer mobile blood units or similar off premises services?
i. Estimated annual number of events: _______________
ii. Estimated annual number of donors: _______________
Attach a copy of your contract.
Yes No
LOSS HISTORY
1. How many adverse events have been reported to you, the FDA and/or any other regulatory authority concerning your
clinical trials in the last 5 years?
Please provide details.
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
2. Has any license or accreditation ever been suspended or revoked?
Yes No
If yes, explain:
___________________________________________________________________________________________
_____________________________________________________________________________________________________
_____________________________________________________________________________________________________
3. Has any claim been made against any person or organization proposed for this insurance during the last
five (5) years?
Yes No
If yes, please provide five (5) year loss history for all claims, including any predecessor. Attach a description of any loss
greater than $10,000.
Page 5 of 7
Year
No. of Claims
Total Amounts Paid
Amounts Reserved
Total Incurred
Date of Loss Info.
4. Is any person or organization proposed for this insurance aware of any fact, incident, circumstance,
situation, condition, defect or suspected defect which may result in a claim, such that would fall under
the proposed insurance?
Yes No
If yes, please provide details
. _________________________________________________________________________________
_____________________________________________________________________________________________________
INSURANCE INFORMATION
1. Has any insurer declined, canceled, or nonrenewed any General Liability, Professional Liability or similar
insurance on behalf of any person or organization proposed for this insurance?
Yes No
If yes, please provide details.
__________________________________________________________________________________
2. Provide the following insurance information for the prior five (5) years:
Year
Limits of Liability
Deductible/SIR
Premium
Effective Dates
Retroactive Date
3. Indicate the limits of liability and deductible requested:
i. General Liability Limits - $__________________/$_________________ Deductible - $__________________
ii. Professional Liability Limits - $__________________/$_________________ Deductible -$_______________
iii. Products Liability Limits - $__________________ /$__________________ Deductible - $________________
Page 6 of 7
FRAUD WARNING
NOTICE TO ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, CONNECTICUT, DELAWARE, GEORGIA, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS,
MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NORTH
CAROLINA, NORTH DAKOTA, OREGON, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TEXAS, UTAH, VERMONT, WASHINGTON, WEST VIRGINIA,
WISCONSIN, AND WYOMING APPLICANTS: In some states, any person who knowingly, and with intent to defraud any insurance company or other
person, files an application for insurance or statement of claim containing any materially false information, or, for the purpose of misleading, conceals
information concerning any fact material thereto, may commit a fraudulent insurance act which is a crime in many states.
NOTICE TO COLORADO APPLICANTS: It is unlawful to knowingly provide false, incomplete or misleading facts or information to an insurance company for
the purpose of defrauding or attempting to defraud the company. Penalties may include imprisonment, fines, denial of insurance and civil damages. Any
insurance company or agent of an insurance company who knowingly provides false, incomplete or misleading facts or information to a policy holder or
claimant for the purpose of defrauding or attempting to defraud the policyholder or claiming with regard to a settlement or award payable for insurance
proceeds shall be reported to the Colorado Division of Insurance within the Department of Regulatory Agencies.
NOTICE TO DISTRICT OF COLUMBIA APPLICANTS: WARNING: It is a crime to provide false or misleading information to an insurer for the purpose of
defrauding the insurer or any other person. Penalties include imprisonment and/or fines. In addition, an insurer may deny insurance benefits if false
information materially related to a claim was provided by the applicant.
NOTICE TO FLORIDA APPLICANTS: Any person who knowingly and with intent to injure, defraud or deceive any insurance company files a statement of
claim containing any false, incomplete or misleading information is guilty of a felony of the third degree.
NOTICE TO HAWAII APPLICANTS: For your protection, Hawaii law requires you to be informed that presenting a fraudulent claim for payment of a loss or
benefit is a crime punishable by fines or imprisonment, or both.
NOTICE TO KENTUCKY APPLICANTS: Any person who knowingly and with intent to defraud any insurance company or other person files an application for
insurance containing any materially false information or conceals, for the purpose of misleading, information concerning any fact material thereto
commits a fraudulent insurance act, which is a crime.
NOTICE TO LOUISIANA APPLICANTS: Any person who knowingly presents a false or fraudulent claim for payment of a loss or benefit or knowingly
presents false information in an application for insurance is guilty of a crime and may be subject to fines and confinement in prison.
NOTICE TO MAINE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the purpose
of defrauding the company. Penalties may include imprisonment, fines, or denial of insurance benefits.
NOTICE TO NEW JERSEY APPLICANTS: Any person who includes any false or misleading information on an application for an insurance policy is subject to
criminal and civil penalties.
NOTICE TO NEW MEXICO APPLICANTS: Any person who knowingly presents a false or fraudulent claim for payment of a loss or benefit or knowingly
presents false information in an application for insurance is guilty of a crime and may be subject to civil fines and criminal penalties.
NOTICE TO NEW YORK APPLICANTS: Any person who knowingly and with intent to defraud an insurance company or other person files an application for
insurance or statement of claim containing any materially false information, or conceals, for the purpose of misleading, information concerning any fact
material thereto, commits a fraudulent insurance act, which is a crime and shall also be subject to a civil penalty not to exceed $5,000 and the stated value
of the claim for each such violation.
NOTICE TO OHIO APPLICANTS: Any person who, with intent to defraud or knowing that he/she is facilitating a fraud against an insurer, submits an
application or files a claim containing a false or deceptive statement is guilty of insurance fraud.
NOTICE TO OKLAHOMA APPLICANTS: WARNING: Any person who knowingly, and with intent to injure, defraud or deceive any insurer, makes a any claim
for the proceeds of an insurance policy containing any false, incomplete or misleading information is guilty of a felony.
NOTICE TO PENNSYLVANIA APPLICANTS: Any person who knowingly and with intent to defraud any insurance company, or other person, files an
application for insurance or statement of a claim containing any materially false information or conceals for the purpose of misleading, information
concerning any fact material thereto commits a fraudulent insurance act, which is a crime and subjects the person to criminal and civil penalties.
NOTICE TO TENNESSEE APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the
purpose of defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.
NOTICE TO VIRGINIA APPLICANTS: It is a crime to knowingly provide false, incomplete or misleading information to an insurance company for the purpose
of defrauding the company. Penalties include imprisonment, fines and denial of insurance benefits.
Page 7 of 7
The Applicant acknowledges that the answers provided herein are based on a reasonable inquiry and/or investigation. The Applicant warrants that the
above statements and particulars together with any attached or appended documents are true and complete and do not misrepresent, misstate or
omit any material facts.
The Applicant agrees to notify us of any material changes in the answers to the questions on this questionnaire which may arise prior to the effective
date of any policy issued pursuant to this questionnaire and the Applicant understands that any outstanding quotations may be modified or withdrawn
based upon such changes at our sole discretion.
Completion of this form does not bind coverage. Applicant’s acceptance of the company’s quotation is required prior to binding coverage and policy
issuance.
All written statements and materials furnished to the company in conjunction with this application are hereby incorporated by reference into this
application and made a part of this application.
Applicant:
_____________________________________
Title:
________________________________
FEIN #:
_____________________________________
Applicant’s Signature:
___________________________
Date:
________________________________
Agent / Broker Name:
_____________________________________________________________________
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Tissue Banks Application 4 (Kinsale Insurance)

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Completed 20 July 2020

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