[Federal Register Volume 62, Number 177 (Friday, September 12, 1997)]
[Notices]
[Pages 48065-48073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24225]
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DEPARTMENT OF ENERGY
Office of Environment, Safety and Health; Notice of Availability
of Funds and Request for Applications To Deliver Special Medical Care
in the Marshall Islands
AGENCY: Office of Environment, Safety and Health, Department of Energy.
ACTION: Request for applications.
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SUMMARY: The Department of Energy (DOE) Office of Environment, Safety
and Health (EH) is requesting applications to provide special medical
care to a specific group of citizens of the Republic of the Marshall
Islands (RMI). This Notice of Availability of Funds and Request for
Applications to Deliver Special Medical Care in the Marshall Islands is
a follow-on to a more general, annual notice of potential availability
of grants and cooperative agreements for epidemiology and other health
studies published in the Federal Register on October 16, 1996.
DATES: The deadline for receipt of applications is October 27, 1997.
ADDRESSES: Applications may be submitted to Mr. Neil Barss at the U.S.
Department of Energy, Office of International Health Programs, EH-63/
270CC, 19901 Germantown Road, Germantown, Maryland 20874-1290.
FOR FURTHER INFORMATION CONTACT: Requests for application forms, the
additional program information described below, and any other requests
for information in response to this Notice should be directed to Mr.
Barss, U.S. Department of Energy, Office of International Health
Programs, EH-63/270CC, 19901 Germantown Road, Germantown, Maryland
20874-1290; telephone: (301) 903-4024; facsimile: (301) 903-1413; or
email: [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. Purpose
III. Background
IV. Program Requirements
V. Applications
VI. Application Format and Instructions
VII. Application Review, Evaluation Criteria and Award Information
VIII. DOE's Role
IX. Applicants
I. Introduction
A Draft Notice of Availability of Funds and Request for
Applications for the Department of Energy Medical Program in the
Republic of the Marshall Islands was published in the Federal Register
on May 29, 1997 (62 FR 29125). A public meeting was held July 8, 1997
to receive comments and questions on the Draft Notice. A Notice of
Potential Applicant Visit to Honolulu, Hawaii, and the Republic of the
Marshall Islands was published in the Federal Register on September 5,
1997 (62 FR 46954). In addition, the following information will be made
available in conjunction with the application forms:
(1) A transcript of the public meeting;
(2) Answers to questions of general interest raised at and
submitted in written form after the public meeting;
(3) The ``Memorandum Of Understanding Between The U.S. Army Space
And Strategic Defense Command (USASSDC) U.S. Army Kwajalein Atoll/
Kwajalein Missile Range (USAKA/KMR) And The U.S. Department of Energy
Office Of International Health Programs'';
(4) A tabulation of DOE medical equipment used currently by
Brookhaven National Laboratory and associated location and functional
status;
(5) Marshall Islands Medical Program reports provided to the U.S.
Congress by DOE for the last five years;
(6) A table illustrating distribution of DOE's Marshall Islands
program budget for FY 1990 through FY 1997, which includes the DOE's
special medical care program;
(7) A list of predominant diseases observed in DOE patients by
Brookhaven National Laboratory and the ICD-9 code associated with each
disease;
(8) The forms required by the Office of International Health
Programs for budget planning, program progress and activity reporting,
in addition to those specified in 10 CFR part 600; and
(9) A report entitled, ``Medical Status of Marshallese Accidentally
Exposed to 1954 Bravo Fallout Radiation: January 1988 through December
1991'', DOE/EH-0493 and BNL-52470, July 1995.
As noted above, DOE has arranged a site visit to Honolulu and the
Republic of the Marshall Islands for potential applicants. Anyone who
intends to participate in the site visit and has not contacted Mr.
William Jackson for details and arrangements should do so immediately.
Mr. Jackson can be reached by telephone at (808) 422-9211 or 422-9203,
by facsimile at (808) 422-9217, or by e-mail at
[email protected].
II. Purpose
DOE provides a special medical care program for a specific group of
RMI citizens in accordance with section 103(h) of the Compact of Free
Association Act of 1985, as amended, which mandates that the United
States ``shall continue to provide special medical care and logistical
support thereto for the remaining * * * members of the population of
Rongelap and Utrik [sic] who were exposed to radiation resulting from
the 1954 United States thermonuclear `Bravo' test, pursuant to Public
Laws 95-134 and 96-205.'' Section 104(a)(4) of Public Law 95-134,
enacted in 1977, directed the Secretary of the Interior to provide for
the populations residing on Rongelap and Utirik Atolls on March 1,
1954, ``adequate medical care and treatment * * * of any radiation
injury or illness directly related to the [''Bravo''] thermonuclear
detonation * * *'' Section 104(a)(4) goes on to state that, ``The costs
of such medical care and treatment shall be assumed by the
Administrator of the Energy Research
[[Page 48066]]
and Development Administration,'' a precursor agency to DOE. Pursuant
to this congressional mandate, DOE provides a special medical care
program consisting of:
Medical screening, diagnosis and treatment for radiation-
related diseases or illnesses (see Appendix A for definition) in an
economically disadvantaged tropical environment in the central Pacific.
Medical care and treatment of other diseases or illnesses
as time and resources permit.
Administrative management, cognizance and oversight of
patients and patient records, clinical referrals and followups as
medically appropriate.
DOE is soliciting applications to provide medically appropriate
care to the exposed population and a comparison group within applicable
legal, financial and logistical constraints. By so doing, DOE is
seeking ways to more effectively and efficiently deliver special
medical care services in the Marshall Islands to an aging population.
As used in this Notice, primary medical care means the community based
medical services provided locally at each Atoll by medically trained
individuals. Secondary medical care means those medical services
provided at the U.S. Army Hospital at Kwajalein Atoll or by other
providers, as described below. Tertiary medical care means medical
services that are not currently available in the Marshall Islands and
that must be provided to the patients outside the Marshall Islands.
Subject to available funding, DOE intends to award one (1)
cooperative agreement in support of the RMI special medical care
program in FY 1998. The cooperative agreement award will be for a one
(1) year budget period, and subject to available funding, may be
negotiated and extended annually as continuation awards for up to four
(4) additional years.
The funding level for the implementation of the current DOE primary
and secondary special medical care program is $1.1 million annually.
III. Background
As a result of the 1954 United States' thermonuclear ``Bravo'' test
in the Marshall Islands, approximately 253 Marshallese people
(hereinafter referred to as patients) on Rongelap and Utirik Atolls
were exposed to high levels of radioactive fallout. Since 1956, DOE and
its predecessor agencies have provided medical care to these patients.
Within DOE, this special medical care program is currently administered
by the Office of International Health Programs for the Assistant
Secretary for Environment, Safety and Health.
Currently, there are three programs providing medical care in the
RMI:
The RMI Ministry of Health national medical care program
for approximately 60,000 people.
This care is delivered at primary and secondary care facilities on
Ebeye and Majuro islands, with smaller facilities in the remote outer
islands that function as first aid stations, providing limited primary
care and pharmaceutical capabilities (see Appendix B for details). Two-
way radio is the primary means of inter-atoll communications, and
medical emergencies are transported by air from the outer islands to
Ebeye or Majuro.
The 177 Health Care Program (177 HCP), described in
section 103(j) of the Compact of Free Association Act of 1985 as the
Four Atoll Health Care Program.
This program provides medical care for the people of the Atolls of
Bikini, Enewetak, Rongelap, and Utirik who were affected by the
consequences of the 1946-1958 U.S. nuclear testing program in the
northern Marshall Islands, and their descendants. The program is
administratively overseen by the Department of the Interior (DOI), is
funded by the U.S. Congress through the DOI, and is currently
implemented by Mercy International, Inc., under contract to the RMI
Ministry of Health. The program serves approximately 10,600 individuals
(see Appendix C for additional details) and provides primary medical
care, secondary care referrals to the hospitals at Ebeye and Majuro,
and tertiary care referrals to the Queen's Medical Center and Group in
Honolulu, Hawaii.
Since 1986, DOE patients have been referred to the 177 HCP for
primary and continued medical care during the time between Brookhaven
National Laboratory screening visits and for non-radiation related
disease or injuries. Currently, the 177 HCP has not been able to
adequately meet all the medical needs of the DOE patients.
The special medical care program provided by DOE to
approximately 238 patients in the Rongelap and Utirik communities.
DOE's special medical care program currently provides biannual
medical screening visits and full medical care for radiation-related
conditions for the remaining 131 members of the original patient
population, as well as medical treatment for approximately 107 people
in a comparison group. From the inception of DOE's program, medical
treatment has been delivered biannually by teams consisting of
Brookhaven National Laboratory (BNL) employees supplemented with
volunteer medical specialists. Logistical support for DOE's special
medical care program has also been provided by a contractor, which is
currently Bechtel Nevada Corporation.
In 1995, DOE transitioned from biannual vessel-based medical
missions to biannual land-based medical missions located at Kwajalein
Island. Vessel-based missions were handicapped by the inability to keep
a vessel equipped with state-of-the-art medical equipment. The land-
based approach has improved the quality of medical care delivery for
the patient populations in Rongelap and Utirik and will also effect
cost efficiencies. This approach makes available at the U.S. Army
Hospital on Kwajalein Island in the Marshall Islands secondary medical
care facilities and more sophisticated diagnostic equipment and
improved laboratory capabilities, for example: use of ultrasound
equipment; ability to perform immediate fine needle aspiration or
thyroid surgery; availability of certified mammography equipment and
other medical equipment that permits immediate followup, additional
tests, and surgery when needed.
As with vessel-based care, the land-based system includes visits to
infirm patients in their homes at Mejatto and Utirik. Land-based
medical assets have also added the ability to provide full diagnostics
and tests of samples taken right after the visit to these remote
islands, rather than (as previously) shipping such samples for analysis
to the U.S. mainland.
Those DOE patients with medical conditions that can be effectively
managed in the Marshall Islands are either treated by the BNL medical
personnel at the U.S. Army hospital on Kwajalein Island or are referred
to the 177 HCP. Those DOE patients with radiation-related medical
findings that cannot be managed in the Marshall Islands are referred to
Straub Hospital and Clinic in Honolulu for tertiary evaluation and
medical treatment.
In January 1997, the RMI requested the DOE to compete the current
special medical care program due to problems being experienced by the
177 HCP and the RMI's desire to have more of the allocated budget spent
on medical care services rather than on logistical support services.
IV. Program Requirements
A. General
Note: The terms ``application'' and ``proposal'' are used
synonymously herein.
[[Page 48067]]
(1) The awardee will be required to execute a special medical care
program within DOE requirements and budget; provide continuity with the
medical program conducted since 1956; and operate in a highly visible
international political environment and under rigorous oversight by the
U.S. Congress.
(2) A Primary Application (see definition in section VI. A.,
herein) shall describe the applicant's approach to the primary and
secondary clinical medical elements, as well as the other elements of
the special medical care program identified in section IV.B. herein,
based on a budget of $1.1 million annually over a 5-year period. In
preparing applications to deliver DOE's special medical care program in
the RMI, potential applicants should consider innovative ways to:
(a) Provide full-time medical services in the Marshall Islands to
the Rongelap and Utirik communities, sufficient to cover the medical
needs of the affected Marshallese citizens.
(b) Collaborate and coordinate medical care delivery with local
Marshallese health care providers.
(c) Use telemedicine and other electronic technologies that enhance
professional communications and maximize cost savings.
(d) Use recruited volunteer medical professionals to maximize cost
savings.
(e) Provide medical services as much as possible within the
Marshall Islands, thus reducing the need for expensive tertiary medical
referrals.
(f) Use current DOE contractor, subcontractor and interagency
support (i.e., Bechtel Nevada Corporation, the Straub Hospital and
Clinic, and the U.S. Army Hospital at Kwajalein; see Appendices D, E,
and F, respectively, for currently provided services).
(3) In addition, the applicant may submit an Optional Application
(see definition in section VI.A., herein) for an alternative approach
to replace a part or all of the following being provided by current DOE
providers:
(a) Tertiary medical care services for an annual average of 13
patients, and/or
(b) Related logistical support for an annual average of 13 patients
receiving tertiary medical care services, and/or
(c) Related logistical support for the primary and secondary
medical care services of all the DOE patients within the Marshall
Islands. Such an application should be based on an annual budget that
does not exceed $800,000.
For example, in FY 1996, DOE spent $259,000 on 13 patient referrals
to the Straub Hospital and Clinic. For each patient, this cost involved
both the medical services provided at the Straub Hospital and Clinic
and the concomitant logistical services provided by Bechtel Nevada
Corporation. Examples of patient logistical support costs include, as a
minimum, the following:
Patient travel costs to and from his/her local atoll to
Majuro Atoll;
Patient travel costs to and from Majuro Atoll to the
tertiary care facility located outside the RMI (currently Straub
Hospital and Clinic);
Patient travel costs to and from Kwajalein Atoll for the
medical services currently provided at the U.S. Army Hospital;
Marshallese translator salaries and travel costs and/or
patient family member escort travel costs; and
Associated lodging, meal, and living expenses incurred for
all individuals while the patient is in transit or being treated at any
location.
B. Project Description
For the approximately 238 patients, whose general medical and
demographic information is summarized in Appendix G, the awardee shall
either itself implement or use subcontractors for the following special
medical care program requirements:
The DOE Clinical Medical Program
For this program element:
(a) Conduct and implement a primary, secondary and tertiary
clinical medical program for patients with radiation-related diseases
and illnesses in a tropical and under-developed area of the world,
together with the treatment of as much non radiation-related disease as
medically indicated and as resources permit. The clinical medical
program should be implemented by primary care medical professional(s)
augmented by physicians with specialties including, but not limited to
oncology, diagnostic radiology, gynecology, internal medicine, and
endocrinology, as appropriate.
(b) Provide the services of other medical specialists, as indicated
by patient condition, including but not limited to the fields of:
allergy/immunology, cardiology, dentistry, dermatology, emergency
medicine, family practice, gastroenterology, geriatrics, hematology,
infectious diseases and parasitology, nephrology, neurology, nuclear
medicine, obstetrics, ophthalmology, pathology, physical medicine,
pulmonary medicine, rheumatology, surgery, tropical medicine and
therapeutic radiology.
(c) Provide, in addition to the physician services specified in
this section, nursing, pharmacy, radiology (including nuclear
medicine), clinical laboratory, histology and pathology, inpatient,
outpatient and technical medical support services.
(d) Institute appropriate ethical safeguards to ensure patient
informed consent in writing.
(e) Provide appropriate gender medical personnel to accommodate
Marshallese cultural sensitivities.
(f) Conduct medical examinations in accordance with medical
screening recommendations, published guidelines or standards (e.g.,
American Cancer Society, American College of Physicians, U.S.
Preventive Services Task Force of the Department of Health and Human
Services, etc.).
(g) Provide radiology services that include:
(1) Mammography utilizing a unit that is certified by the American
College of Radiology and complies with U.S. Food and Drug
Administration regulations.
(2) Diagnostic equipment that has been inspected for radiological
safety and approved for operation (e.g., chest x-ray, nuclear medicine
imaging or therapy, mammography).
(3) Therapy as clinically prescribed for the treatment of cancer.
(h) Conduct examinations of the thyroid gland including:
(1) Thyroid ultrasound measurements.
(2) Palpation of the thyroid by a physician skilled in such
technique.
(3) Appropriate blood and chemistry tests of thyroid function
(e.g., TSH, T3, T4).
(i) Provide diagnostic and clinical laboratory services, as
appropriate.
(j) Utilize laboratory testing capabilities and services that
comply with the requirements specified in the Clinical Laboratory
Improvement Amendments of 1988 (documentation required).
(k) Provide appropriate immunizations, as indicated by patient
needs.
(l) Provide pharmaceuticals, medical supplies or equipment based on
the needs of the patients.
(m) Provide pathological services for the identification of cancer.
Administrative Support
For this program element:
(a) Obtain insurance (and documentation thereof) for medical
malpractice and comprehensive general liability, for $1 million per
occurrence and $3 million aggregate for each insurance type for any
U.S. licensed individual.
(b) Implement non-medical administrative functions in support of
the special medical care program, which shall at a minimum include the
following:
[[Page 48068]]
(1) Provision of non-medical personnel and administrative staff
services to adequately support the medical personnel and services.
(2) If the awardee intends to use DOE's contractors or the services
of the U.S. Army Hospital at Kwajalein, the awardee will be required
to:
(i) Establish and maintain a working programmatic relationship with
Bechtel Nevada Corporation.
(ii) Establish and maintain a working programmatic relationship
with the current secondary or tertiary referral facilities (U.S. Army
Hospital at Kwajalein and Straub Hospital and Clinic in Honolulu).
These services are currently provided pursuant to a Memorandum of
Understanding between DOE and the U.S. Army Space and Strategic Defense
Command at Kwajalein Atoll and a subcontract between Bechtel Nevada
Corporation and Straub Hospital and Clinic, respectively.
(3) As applicable, establish and maintain a working programmatic
relationship with existing medical providers in the Marshall Islands
and/or the 177 HCP (using the capabilities listed in Appendix C), to
help implement the DOE special medical care program.
(4) Provide current state-of-the-art methods for the consolidation,
storage, management and retention of current and historical patient
medical records and medical program operational records, which will
include receipt of approximately 30 cubic feet of all hardcopy medical
records, a similar volume of records compressed onto compact discs and
an Oracle database of current
patients.
(5) Protect the confidentiality of patient medical information and
records.
(6) Implement a continuing quality control and assurance program
for all clinical medical and recordkeeping aspects of the program
necessary to maintain compliance with applicable medical standards.
(7) Develop and implement a transition phase with Brookhaven
National Laboratory.
Direct Marshallese Involvement
For this program element:
(a) Interface, establish and maintain a working relationship with
Marshallese appointed spokespersons and/or citizen advisory committees
in the Rongelap and Utirik communities to:
(1) Consult and inform before implementing any changes in the DOE
special medical care program.
(2) Establish a regular process that receives community and patient
input and feedback on DOE special medical care program activities.
(3) Consider Marshallese patient concerns and recommended
improvements in the special medical care delivery;
(4) Work with DOE to accommodate Marshallese concerns and
improvements within a framework of DOE's legal mandate, funding and
sound medical practice.
(b) Develop and implement a Rongelap and Utirik community health
outreach educational program that:
(1) Develops educational materials (e.g., videotapes, brochures
and/or handouts) that include DOE and Marshallese community
representative input, to be used by health care providers that strive
to accentuate awareness of, increase sensitivity to, and accommodate
Marshallese traditional perceptions and attitudes towards the practice
of ``Western-style'' medicine in the Marshall Islands.
(2) Helps patients and their family members learn about the special
medical care program activities and findings by preparing, distributing
and explaining the annual medical activity report, which is required to
be sent to DOE.
(3) Utilizes Marshallese public health educational materials and
brochures.
(4) Develops public health and educational materials (e.g.,
handouts, brochures or videotapes) for Marshallese use that describes
the types of special medical care being provided by the awardee.
(5) Advises on the known relationships between radiation dose and
health effects.
(c) Develop and implement a training program for Marshallese
medical and para-medical, and/or technical support professionals for
the special medical care program that includes:
(1) A needs assessment as to the types and number of professionals
(physicians, physician assistants, nurses, support-service
technicians).
(2) Means to provide training and ``on-the-job'' practical
experience in the Marshall Islands.
(3) Consideration of available regional educational resources to
meet these objectives.
(d) Develop and implement a plan to build an infrastructure in the
Marshall Islands for the special medical care program including:
(1) Partnerships with local health care providers.
(2) Facilitating the training of Marshallese health care
professionals.
(3) Acquisition, use, and maintenance of medical equipment.
Development of Procedures and Documentation
The awardee will be required to provide the following:
(a) Written protocol(s) and/or manuals describing procedures and
associated forms to be used by the medical professionals for medical
examinations, patient referrals, and overall administrative
implementation of the special medical care program that includes:
(1) Identities, qualifications, and biographies of medical or
medical program experience for all persons providing medical,
technical, nursing, and administrative support services.
(2) The awardee's selection and qualification criteria for all
personnel who will participate in or implement the program.
(3) Involvement of local Marshallese medical, health, and support
personnel, including:
(i) Participation of medical and other health care or technical
professionals.
(ii) As applicable, selection and qualification criteria by which
these personnel will be made eligible to participate.
(iii) Provision of bilingual Marshallese/English speaking
individuals for adequate communication, translation and the
interpretation of examination results, and meaning between the patients
(or their designated guardians) and the medical care providers.
(4) Frequency and types of patient examinations.
(5) Method(s) of patient examinations and treatments that afford
personal privacy.
(6) Method(s) by which patient informed consent and medical release
will be obtained for any medical examination or treatment modality in a
way that ensures patient understanding in Marshallese.
(7) As applicable, method(s) by which a special medical care
program physician will interface with existing medical care providers
in the Republic of the Marshall Islands or the Pacific region and
provide tertiary medical referrals as needed.
(8) Method(s) by which medical services will be provided to those
patients (currently, approximately 25) who habitually reside in the
United States, such as other medical care insurance options in lieu of
awardee provided medical services.
(9) Method(s) by which the program referring physician will consult
with and remain continually cognizant of the medical condition and
results of a patient referred to another medical
[[Page 48069]]
professional or organization identified in items (7) or (8).
(10) Method(s) to inform all patients (or their designated
guardians) in Marshallese of individual medical results and any
additional followup actions necessary.
(11) Method(s) by which pharmaceuticals will be obtained,
inventoried, managed, and dispensed.
(12) Method(s) for retaining, storing, maintaining, or releasing
(to honor a lawful request), patient tissue samples and specimens used
for pathological classification of disease.
(13) As applicable, method(s) by which the awardee will implement
the working programmatic relationships with any current DOE provider of
services or regional health care provider.
(b) An annual summary report (in English and Marshallese) on the
following:
(1) Program activities, medical conditions, and statistical
analyses of the findings.
(2) Number of individuals remaining in the patient and comparison
populations.
(3) The overall health of the two populations and the
identification of any special risks to their health.
(4) Identification of all medical, nursing, technical
practitioners, and support personnel that performed provider services.
(5) Identification of patient related medical problems with
recommendations for improvement or resolution.
(6) Progress made on strategic plan initiatives.
(7) Recommendations to improve programmatic functions.
(c) A strategic plan that proposes and details ways to advance the
special medical care program to:
(1) Achieve partnership and coordination with the RMI medical and
health care organizations.
(2) Evolve medical partnerships and coordinate the awardee's
resources, to the greatest extent possible, with local Marshallese or
other U.S. Federal resources, to advance the DOE's special medical care
program as follows:
(i) Strengthen local health care delivery.
(ii) Involve local personnel in medical activities.
(iii) Share new skills and technical knowledge.
(iv) Strengthen local land-based assets, such as radiologic,
pathologic, and laboratory support services.
(3) Maintain a cost effective special medical care program as the
patient population ages and incurs greater needs for medical services.
Cost and Reporting Requirements
(a) The awardee shall implement cost containment measures,
maximization of financial savings, and negotiation of subcontracted
services to maintain a high quality special medical care program in
accordance with DOE budgetary constraints. At a minimum, the cost
reporting requirements that will be required under the cooperative
agreement will include, but not be limited to providing:
(1) Budget, financial and programmatic activity reports. The
contents and formats are to be specified and revised as necessary by
DOE.
(2) A monthly report of all program expenditures.
(3) Fiscal planning and budget information in the format prescribed
by DOE.
(4) A separate itemized price list (detailing both direct and
indirect costs) for all clinical medical examinations, treatments,
services, or supplies to conduct and implement the special medical care
program.
(5) A separate itemized price list for the direct and indirect
medical program and non-clinical administrative and program management
aspects, salaries, and supplies for the proposed support services.
(6) A separate itemized price list for any service that is
anticipated to be subcontracted.
(7) A separate itemized price list for any capital equipment that
must be purchased to implement the special medical care program.
(8) The formula or estimated cost for each of the following non-
priced listed items:
(i) Special DOE requests (e.g., record duplication, statistical
analysis of medical findings, special topical reports in response to
RMI or congressional inquiries).
(ii) Non-stocked medical or administrative items and supplies.
(iii) Cost of any other service or expense that the provider
intends to charge but does not appear on a price list.
V. Applications
This Notice of Availability of Funds and Request for Applications
is issued pursuant to DOE regulations contained in 10 CFR part 602:
Epidemiology and Other Health Studies Financial Assistance Program, as
published in the Federal Register on January 31, 1995 (60 FR 5841). The
Catalog of Federal Domestic Assistance number for 10 CFR part 602 is
81.108, and its solicitation control number is EOHSFAP 10 CFR part 602.
10 CFR 602 contains the specific requirements for applications,
evaluation, and selection criteria, except as modified herein. Only
those applications complying with the criteria and using the forms
specified in 10 CFR 602 will be considered. Application forms may be
obtained at the address previously cited. Applications will be peer
reviewed by evaluators apart from DOE employees and contractors as
described under section 10 CFR 602.9(c) and in section VII. of this
Notice, and submission of an application constitutes agreement that
this is acceptable to the care provider(s) and the submitting
organization.
VI. Application Format and Instructions
A. General
An application shall contain a proposal for the following:
The primary and secondary clinical medical program;
The other elements of the special medical care program
(i.e., administrative support, direct Marshallese involvement, the
development of procedures and documentation, the cost and reporting
elements);
Any proposed replacement for part or all of the secondary
medical services provided at the U.S. Army Hospital on Kwajalein Island
in the Kwajalein Atoll.
For the purposes of this Notice, the proposal containing the above
components will be referred to as the Primary Application and shall
contain two volumes, one providing technical details and the other the
costs.
In addition, an Optional Application may be submitted for an
alternative approach to replace a part or all of the following being
provided by current DOE providers:
Tertiary medical care services for an annual average of 13
patients, and/or
Related logistical support for an annual average of 13
patients receiving tertiary medical care services, and/or
Related logistical support for the primary and secondary
medical care services of all the DOE patients within the Marshall
Islands.
The Optional Application shall also contain two volumes, one for
the technical details and the other for the cost. The technical volumes
for both the Primary and Optional Applications shall be:
No more than one hundred (100) pages in length;
One-sided, 12-point font size; and
Submitted in black and white.
Resumes of key personnel should be submitted as an appendix to the
technical application(s) and will not be
[[Page 48070]]
counted against the page limit. Cost proposal volume(s) have no page
limit and either one or both application(s) will be structured to
include a five (5) year project period consisting of five one (1) year
budget periods.
The application(s) shall not merely offer to perform work in
accordance with the program requirements but shall outline the actual
work proposed as specifically as possible.
B. Specific Application Instructions
All applicants must submit a Primary Application for the special
medical care program, as described herein, based on a budget of $1.1
million annually over a 5 year period. An Optional Application for an
alternative approach as described herein may also be submitted, based
on a budget that does not exceed $0.8 million annually over a 5-year
period. If an Optional Application is not submitted, the DOE will
assume that the applicant plans to utilize the current DOE provider
logistical support, and the secondary and tertiary medical care
services referenced herein. However, an applicant can propose in the
Primary Application any replacement for the secondary medical services
currently provided at the U.S.Army Hospital at Kwajalein Island (see
paragraph (1)(n), as follows).
(1) The technical volume of the Primary Application must include
technical details and information that:
(a) Demonstrate that the applicant has the experience and
capability to plan, organize, implement, and manage the primary and
secondary medical care services and all the other elements of the
special medical care program described herein. This includes
organizational structure, plans for self-assessment of the special
medical care program, and envisioned relationship with DOE.
(b) Demonstrate the competency of the applicant's personnel and the
adequacy of its resources.
(c) Identify technical and administrative staff, and detail their
professional experience, as well as their level of program involvement.
In the event that any of the proposed personnel are not currently
employed by the applicant, letters of commitment from those individuals
shall be submitted.
(d) Itemize the medical diagnostic or laboratory equipment that the
applicant intends to use for this special medical care program, and how
the applicant will integrate such equipment with the Federal Government
owned equipment listed in Appendix H.
(e) Specify the location(s) where services will be obtained or
performed.
(f) Identify the recommendations or standards to be used to satisfy
the requirements of section IV.B., paragraph (f) under the special
medical care program element, DOE Clinical Medical Program, and any
reason for exception(s) taken by the applicant to those standards.
(g) Contain initial concepts for the training program development
requirements of paragraph (c) under the special medical care program
element, Direct Marshallese Involvement.
(h) Contain initial concepts for the development and implementation
of the applicant's plan to meet the Marshall Islands infrastructure
requirements of paragraph (d) under the special medical care program
element, Direct Marshallese Involvement.
(i) Contain a short-term plan detailing milestones and deadlines
stating:
(i) Applicant's requirements for a transition phase with Brookhaven
National Laboratory.
(ii) When independence will be achieved to implement all elements
of the special medical care program.
(j) Contain initial concepts for the strategic plan required by
paragraph (c) under the special medical care program element,
Development of Procedures and Documentation, that includes milestones
and deadlines for implementation.
(k) Provide evidence of medical malpractice insurance for any
individual licensed in the United States, required by paragraph (a)
under the Administrative Support element of the special medical care
program.
(l) Provide applicant's plan to obtain malpractice insurance for
any non-U.S. health care provider that the applicant intends to hire or
provide.
(m) Propose a plan to provide medical care services and associated
logistical support for those Marshallese patients who do not habitually
reside in the Marshall Islands.
(n) Identify and propose, if the applicant desires, a replacement
for any or all of the secondary medical care services provided at the
U.S. Army Hospital on Kwajalein Island.
(2) The cost volume of the Primary Application must include the
following information that:
(a) Provides a cost proposal for the first budget period year (year
1) detailing expenses to implement the following:
(i) The primary and secondary medical services of the DOE Clinical
Medical program element of the special medical care program;
(ii) The Administrative Support element of the special medical care
program;
(iii) The Direct Marshallese Involvement element of the special
medical care program;
(iv) The Development of Procedures and Documentation element of the
special medical care program;
(v) Establishment and maintenance of a working relationship with
DOE providers of medical and logistics services;
(vi) The medical care services, in combination with associated
logistical support, for those Marshallese patients who do not
habitually reside in the Marshall Islands;
(vii) The costs to replace any or all of the secondary medical
services currently provided at the U.S. Army Hospital on Kwajalein
Island; and
(viii) The identification and magnitude of any other cost the
applicant intends to charge.
(b) Contains estimated cost information supporting the applicant's
special medical care project description for budget years 2 through 5.
(3) If an Optional Application is submitted, the applicant shall
demonstrate its approach to replacing the logistical support for the
primary and secondary clinical medical program in the Marshall Islands,
and/or the approach to replacing the tertiary medical care for an
annual average of 13 patients currently provided by Straub Hospital and
Clinic, as specified in Appendix E, and/or the logistical support of
such tertiary medical care for the annual average of 13 patients. The
technical volume of the Optional Application must include the following
information that:
(a) Demonstrates that the applicant has the experience and
capability to plan, organize, implement, and manage the tertiary
medical care services and logistical support requirements. This
includes organizational structure, plans for self-assessment of the
special medical care program, and envisioned relationship with DOE.
(b) Demonstrates the competency of the applicant's personnel and
the adequacy of its resources.
(c) Identifies technical and administrative staff, and details
their professional experience, as well as their level of program
involvement. In the event that any of the proposed personnel are not
currently employed by the applicant, letters of commitment from those
individuals shall be submitted.
(d) Itemizes the medical diagnostic or laboratory equipment that
the applicant intends to use for tertiary medical care
[[Page 48071]]
services, and how the applicant will integrate such equipment with the
Federal Government owned equipment listed in Appendix H.
(e) Specifies the location(s) where tertiary medical care services
will be obtained or provided. The applicant is free to propose tertiary
referral locations of its choosing within or outside of the Marshall
Islands.
(f) Identifies the standards to be used to satisfy the requirements
of section IV.B., paragraph (f) under the special medical care program
element, DOE Clinical Medical Program, and any reason for exception(s)
taken by the applicant to those standards.
(g) If applicable, contains initial concepts for any tertiary
medical care training program development requirements of paragraph (c)
under the special medical care element, Direct Marshallese Involvement.
This also includes any proposal to use local Marshallese individuals or
companies to perform logistical support requirements.
(h) Contains initial concepts for the development and
implementation of the applicant's plan to meet the infrastructure
requirements of paragraph (d) under the special medical care element,
Direct Marshallese Involvement.
(i) Contains a short-term plan detailing milestones and deadlines
stating:
(i) If applicable, applicant's requirements for a transition phase
with Straub Hospital and Clinic and Bechtel Nevada Corporation,
(ii) When independence will be achieved to implement all elements
of the tertiary medical care services and the associated logistical
requirements.
(j) Contains initial concepts for the strategic plan required by
paragraph (c) under the special medical care program element,
Development of Procedures and Documentation, that includes milestones
and deadlines for long-term implementation of any proposals to replace
the tertiary medical and associated logistical support services.
(k) Provides evidence of medical malpractice insurance for any
individual licensed in the United States, required by paragraph (a)
under the Administrative Support element of the special medical care
program.
(l) Provides applicant's plan to obtain malpractice insurance for
any non-U.S. health care provider that the applicant intends to hire or
provide.
(4) The cost volume of the Optional Application must include the
following information that:
(a) Provides a cost proposal for the first budget period year (year
1) detailing expenses to implement the following:
(i) Tertiary medical care services for an annual average of 13
patients, and/or
(ii) Logistic support for an annual average of 13 patients
receiving tertiary medical care services, and/or
(iii) Logistic support for the primary and secondary medical
services of all the DOE patients provided in the Marshall Islands.
(iv) The identification and magnitude of any other tertiary medical
service or logistical support cost the applicant intends to charge.
(b) Contains estimated cost information supporting the applicant's
special medical care program project description for budget years 2
through 5.
VII. Application Review, Evaluation Criteria and Award Information
Primary Applications will be subject to merit review (peer review)
and will be evaluated against the following criteria, all of which are
of equal importance. The peer review will be conducted by the Division
of Research Grants (DRG) of the National Institutes of Health (NIH),
utilizing standard NIH peer review procedures. The following criteria
constitute a single case deviation from the Office of Environment,
Safety and Health's merit review system (57 FR 55524, November 25,
1992) and EH's program rule at 10 CFR 602.
(a) The medical and technical merit of the proposed special medical
care program.
(b) The appropriateness of the proposed program.
(c) Competency of the program personnel.
(d) Organizational structure, plans for self-assessment and
envisioned relationship with DOE.
(e) Adequacy of equipment and associated physical resources.
(f) Reasonableness and appropriateness of the proposed budget.
In accordance with 10 CFR 602.9(e) and 10 CFR 600.8(c)(13), a
program policy factor which DOE will consider in making an award is the
merit of an applicant's Optional Application for an alternative
approach to the provision of logistics for primary and secondary
medical care services and the tertiary medical care services and
associated logistic services as addressed in the ``Specific Application
Instructions'' (see section VI., B, paragraphs (3) and (4)). The NIH
will conduct the peer review and score any Optional Application using
the identical procedure for evaluating the Primary Application.
However, the resulting score will not be added to the applicant's score
for the Primary Application, because the merit of the Optional
Application is a program policy factor. The DOE selecting official will
give the Primary Application predominant consideration, with lesser
consideration being accorded the Optional Application.
The resulting award may be for the Primary Application only, or for
the Primary Application and all or any part of the Optional
Application. An award will not be made for only an Optional
Application.
One cooperative agreement will be awarded for the first budget year
only and may be negotiated and extended annually as continuation awards
for up to four (4) additional years based on the following:
Availability of appropriated funds;
The awardee's continuation application, which will be
submitted not later than 120 days before the end of each budget period,
and
The results of the DOE evaluations of the awardee's
performance as described in section VIII., below.
VIII. DOE's Role
In order for DOE to maintain appropriate oversight of the special
medical care program, there must be substantial interaction between DOE
and the awardee. DOE established the core requirements for this program
and prepared this Notice of Availability of Funds and Request for
Applications. DOE will conduct the selection and award process, which
will include evaluations by persons outside the Federal Government. DOE
will utilize the results of these evaluations and make one initial
award. Continuation awards may be made based upon the availability of
funds and other DOE performance criteria that will be set forth in any
initial award. DOE will consult with program medical professionals and
will coordinate meetings between medical care provider(s) and
Marshallese community members. DOE will consult with representatives
from the RMI national and local governments, the Department of the
Interior, the Department of State and the Department of Health and
Human Services on the special medical care program. To help evaluate
program effectiveness, DOE will establish a program coordination
committee as part of the cooperative agreement consisting of
representatives from the awardee's organization, the DOE contracting
office, the DOE Office of International Health Programs, and the
Rongelap and Utirik communities. This committee will meet on a semi-
annual basis at a mutually agreed location.
[[Page 48072]]
Finally, DOE will monitor and evaluate the performance and delivery
of the special medical care program by conducting program reviews and
considering the patients' level of satisfaction.
IX. Applicants
Applicants for the cooperative agreement could include domestic or
international nonprofit and for profit organizations, universities,
medical centers, state or local government health care organizations,
labor unions and other employee representative groups, small, minority
and/or women-owned businesses, or other domestic or international
health care organizations. Consortiums of interested organizations are
encouraged to apply. Awardee(s) for the special medical care program
will work cooperatively with Marshallese health care providers, current
DOE providers (as applicable), other regional health care providers and
designated Marshallese community representatives.
Issued in Washington, D.C., on September 8, 1997.
Paul J. Seligman,
Deputy Assistant Secretary for Health Studies.
Appendix A--Definition of Radiation Related Diseases or Illnesses
For the purposes of this Notice, applicants shall consider the
following to be radiation related diseases or illnesses:
(a) Any thyroid cancer, other tumor or thyroid nodule that has
been found as a result of medical evaluation.
(b) In accordance with the ``Radiation Exposure Compensation
Act'', 42 U.S.C. 2210 note, the following are considered latently
expressed diseases attributed to radiation:
(1) Leukemia (other than chronic lymphocytic leukemia).
And the following diseases, provided onset was at least 5 years
after the first exposure to radiation:
(2) Multiple myeloma.
(3) Lymphomas, other than Hodgkin's disease.
(4) Primary cancer of the thyroid, provided that the initial
exposure occurred by age 20.
(5) Primary cancer of the female breast, provided that the
initial exposure occurred prior to age 40.
(6) Primary cancer of the esophagus, provided low alcohol
consumption and not a heavy smoker.
(7) Primary cancer of the stomach.
(8) Primary cancer of the pharynx, provided not a heavy smoker.
(9) Primary cancer of the small intestine.
(10) Primary cancer of the pancreas.
(11) Primary cancer of the bile ducts.
(12) Primary cancer of the gall bladder.
(13) Primary cancer of the liver, except if cirrhosis or
hepatitis B is indicated.
Appendix B--RMI Medical Program Information
Available RMI medical facilities and services include:
(a) Local dispensaries at Utirik and Mejatto provide limited
medicine and first aid, and are staffed by medical personnel with
MEDEX level training and experience (i.e., between a regional nurse
and nurse-practitioner). Short-wave radio communications are
maintained between the dispensaries and the off-island medical
health care providers (up to 300 miles distant) to discuss serious
medical conditions.
(b) A small 34 bed community hospital is available with limited
capabilities in a community of 12,000 living on Ebeye (an island of
approximately 4 square miles located 2 miles from Kwajalein Island
where the U.S. Army contractor-operated hospital facility that
serves the base personnel is located).
(c) A 75 bed hospital is available with limited capabilities to
serve 29,000 living on the capital island of Majuro. This hospital
also receives referrals from the entire national population of
60,000.
Appendix C--The RMI 177 Health Care Program (HCP)
For the DOE patients:
(a) Currently implements DOE patient care in absence of
Brookhaven National Laboratory.
(b) Provides all non radiation-related care of DOE patients.
(c) Provides access to DOE patient records.
For the non-DOE patients:
(a) Provides general medical care for the people of Rongelap,
Utirik, Enewetak, and Bikini.
(b) Serves a total population of approximately 10,600 (which
includes the 238 DOE patients)
(c) Refers its tertiary patients to the Queen's Medical Center
and Group in Honolulu, Hawaii.
Appendix D--Bechtel Nevada Corporation Logistical Capabilities to
Support DOE'S Special Medical Care Program
(a) Provides all logistics to transport and support medical
program personnel to the Marshall Islands twice a year, which is
currently limited to travel, lodging and per diem costs west of
Honolulu.
(b) Provides all logistics to transport and support ambulatory
patients and their authorized medical escorts to medical facilities
at Kwajalein.
(c) Provides all logistics to transport medical personnel for
subsidiary home visits to non-ambulatory infirm patients at Mejatto,
Ebeye, Utirik, and Majuro.
(d) Provides transportation and support to RMI medical personnel
assigned to participate in the DOE special medical care program.
(e) Operates and provides all logistics and support services for
patients referred to the Straub Hospital and Clinic located in
Honolulu, Hawaii, by Brookhaven National Laboratory. The services
provided include:
(1) Bilingual Marshallese/English speaking escorts to accompany
patients.
(2) Coordination of patient travel and medical appointment
schedules.
(3) Lodging and per diem arrangements and expenses.
(4) Coordination between Brookhaven National Laboratory and the
Straub Hospital and Clinic on medical services, as required.
(f) Conducts market research on the availability of marine
assets in the U.S. and Central Pacific Area to support a limited,
sea-based medical program.
(g) Issues and monitors the Straub Hospital and Clinic medical
services subcontract.
(h) Implements terms and conditions, including the making of
payments and collections under DOE's agreements with other agencies,
and instrumentalities of the RMI.
(i) Implements requirements as directed by DOE during the course
of the year.
(j) Interfaces and coordinates with the U.S. Army at Kwajalein
Island to provide the following in accordance with a Memorandum of
Understanding between DOE and the U.S. Army:
(1) Marine craft (currently a LCU) used to transport patients to
and from Mejatto.
(2) Hospital services as delineated in Appendix F.
(3) Trailer rentals for medical use (currently 2, each 660
square feet).
(4) Housing, lodging, and dining facilities for patients and
medical team members.
(5) Maintenance of facilities and equipment.
(6) Aircraft services limited to within Kwajalein Atoll at no
cost.
(7) Automotive services used to transport patients at Kwajalein
Island.
(8) Recreational services for medical team use.
(9) Public services used to announce medical team activities at
Kwajalein Atoll.
(10) Ferry services between Kwajalein and Ebeye Islands at no
cost.
Appendix E--Services Provided by the Straub Hospital and Clinic Located
in Honolulu, Hawaii
(a) Complete and comprehensive medical services for DOE patients
that have radiation-related diseases, including but not limited to,
nuclear medicine diagnostic imaging and techniques, diagnostic and
radiation therapy facilities, chemotherapy, pathological and
advanced surgical services.
(b) Refers diseases diagnosed as non radiation-related back to
the 177 HCP.
(c) Provides certified and accredited medical personnel.
(d) Provides price list as basis for charges.
Note: Straub Hospital and Clinic is accredited by the Joint
Commission for Accreditation of Health Care Organizations.
Appendix F--Secondary Medical Services Provided by U.S. Army Hospital
on Kwajalein Island in the Kwajalein Atoll in the RMI
In accordance with the Memorandum of Understanding between DOE
and the U.S. Army, the following medical services are provided at
the U.S. Army Hospital on Kwajalein Island:
(a) Laboratory Services.
(b) Mammography Screening.
(c) X-ray Screening.
(d) Proctosigmoidoscopy.
(e) Limited Surgery (e.g., appendectomy, amputations for
advanced diabetic conditions).
[[Page 48073]]
(f) Professional Services (physicians, nurses, technicians).
(g) Safety inspection and certification of mammography and x-ray
equipment by Trippler Army Hospital technical staff.
(h) Inpatient care and treatment.
Note: Brookhaven National Laboratory is responsible to ensure
that proper and current certification for the special medical
equipment and services are in place prior to receiving services.
Appendix G--DOE Special Medical Program Information
1. Summary of Clinical Findings
After 41 years of medical monitoring, the most prevalent health
effect has been related to thyroid function and the appearance of
thyroid-related nodules and cancer. There has been one case and
death due to radiation-related leukemia, two pituitary tumors and
two cases of basal cell carcinoma. The major non radiation-related
diseases seen in the Rongelap and Utirik people have been Type II
diabetes, hypertension, cardiovascular diseases, and their
associated complications.
The above information has been summarized from the report
entitled, ``Medical Status of Marshallese Accidentally Exposed to
1954 Bravo Fallout Radiation; January 1988 Through December 1991,''
by Brookhaven National Laboratory/Department of Energy, DOE/EH0493
and BNL-52470, July 1995.
2. Patient Population Description
------------------------------------------------------------------------
Age range Male Female
------------------------------------------------------------------------
30-39................................................. 1 1
40-49................................................. 57 59
50-59................................................. 28 35
60-69................................................. 15 19
70-79................................................. 8 12
80+................................................... 1 2
------------------------------------------------------------------------
3. Summary of Patient Location
Patients in the Rongelap and Utirik populations are combined in
the table below and represent approximate estimates of total
patients in each location:
------------------------------------------------------------------------
Location Female Male Total
------------------------------------------------------------------------
Ailinglaplap................................. 1 1 2
Ailingnae.................................... 2 0 2
Arno......................................... 1 0 1
Ebeye........................................ 40 33 73
Hawaii....................................... 9 4 13
Kili......................................... 1 0 1
Lib.......................................... 1 0 1
Mainland USA................................. 4 2 6
Majuro....................................... 41 46 87
Mejatto...................................... 19 12 31
Mejit........................................ 1 1 2
Ujae......................................... 1 1 2
Unknown...................................... 1 0 1
Utirik....................................... 6 8 14
Wotje........................................ 1 1 2
--------------------------
Total.................................... 129 109 238
------------------------------------------------------------------------
Appendix H--DOE Equipment Used by Brookhaven National Laboratory
(a) Johnson & Johnson
Ektachem DT60 II-DTSC II Module Chemistry Analyzer
K-Number 339 4116, Serial Number 60029378
(b) Kodak-Ektachem DT60 DTSC Module Chemistry Analyzer
K-Number 337 0137
(c) Ektachem DT60 Module Chemistry Analyzer
K-Number 322 1695
(d) Calposcope
(e) Ultramark 4 Plus with transducers
(f) Nikon Microscope
(g) Sereno Baker 9118c Blood Analyzer Machine
(h) Ektachem DT60II System
(i) Biorad Micromat Model 415
(j) Beckman TJ6 Centrifuge
(k) Portable defibrillator
(l) Hoag-Streit Slip Lamp system
(m) Sun computer workstation
[FR Doc. 97-24225 Filed 9-11-97; 8:45 am]
BILLING CODE 6450-01-P