HANSENS SCOPE OF WORK.PDF

ATTACHMENT A - STATEMENT OF WORK
Revised
Dated: February 1,2016
TITLE: AMBULATORY CARE PROGRAM
I. BACKGROUND
The legislative authority for the National Hansen's Disease Programs is Public Law 99-117, Section 2.
(a.), Section 320, and is guided by DHHS regulations. The Ambulatory Care Program was initiated in
1981 as a consequence of the closing of the U.S.P.H.S. hospitals. Historically, persons with HD were
provided care by those facilities in the U.S. In order to continue the mandate of the legislative authority, a
Contract Care Program was developed to provide these services in communities where the majority of
people with HD live. The current Outpatient HD Clinics are located in the states of Arizona, Arkansas,
California, Georgia, Florida, Illinois, Massachusetts, New York, Puerto Rico, Washington, and Texas.
Hansen's disease is a chronic infectious disease of low communicability, caused by the acid-fast
Mycobacteria, M. leprae. It affects the skin and peripheral nerves in the cooler parts of the body. It is
effectively treated by multidrug therapy consisting of Dapsone, Rifampin, and Clofazimine. Untreated, it
can lead to loss of sensation in the affected areas, leading to trauma, infection, and eventually to
deformity and disability. It is the goal of the National Hansen's Disease Program to prevent deformity
and disability by raising awareness about Hansen's disease, increasing the detection of its' early signs,
and initiating treatment early in the disease process.
PURPOSE/GENERAL DESCRIPTON
The purpose of this contract is to provide Hansen's Disease (HD) diagnosis, outpatient treatment, case
management, and follow-up of persons diagnosed with HD and screening of its contact in Phoenix, AZ
area. The number of patients expected for the service area is identified below. It is estimated that these
patients will require 4 outpatient visits annually during the period of this contract. The patient population
with HD in the U.S. is multi-ethnic. It is expected that the Contractor be conversant with an accepted
multi-cultural approach in the provision of patient care services.
Service Area: Number of Patients
Phoenix 57
A. Eligibility for Services
The contractor shall be responsible for providing outpatient care as described herein to those
persons designated as eligible for treatment. The contractor shall validate the patient's eligibility
before rendering services. When the eligibility status of an individual patient is unclear, the
contractor shall obtain guidance and approval from the Project Officer. Patients are considered
eligible under the following circumstances:
1. HD Patient — Any individual in the continental United States and Territory of Puerto
Rico who needs to have HID ruled out as a diagnosis, or has been diagnosed as having
HD, is eligible for care under this contract.
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2. HD contact — Any person who has lived in the same household with a new HD patient in
the three year period prior to the diagnosis and the beginning of treatment, shall be
examined. (See HD Manual "Contact Follow-Up.")
B. The Contractor shall provide all personnel, material, adequate and accessible facilities,
services, and equipment required to meet the requirements of this Contract.
1. Hospital and/or Health Care Facility — The facility shall JCAHO accredited or certified
by an accredited certifying agency. Any conditional accreditation will be accompanied
with a copy of the evaluation report.
2. Availability - Hours of operation should be adequate to support the 1-1D patient
population in the area. The contractor shall provide the facility hours and the clinic hours.
Also include emergency and after hour provisions.
3. Accessibility — The facility shall be handicap accessible, including access through public
transportation.
4. Quality Assurance - The facility shall provide a brief description of their Quality
Assurance Plan. A sample of the satisfaction survey must be included in the response to
this proposal
5. Key Personnel
Key personnel in this Contract are considered essential to the work being performed. This
includes Project Director; Primary Physician; and RD Clinic RN.
6. Multidisciplinary Team
The multidisciplinary team shall provide services through the HD Contract. These
Providers shall be licensed to practice, certified in their specialty, culturally competent,
experienced in caring for the targeted population, and have appropriate consultative
backup. Resumes and proof of professional licensure shall be provided. This team
shall include:
a. Physician (part-time)
b. Nurse (part-time)
c. ENT
d. Ophthalmologist
e. Occupational Therapist
f. Physical Therapist
g. Orthopedist
h. Orthotist
1. Podiatrist
It is estimated that a routine, uncomplicated patient visit for HD services can be
completed in 20 minutes, and visit frequency for the monitoring of chemotherapy is an
average of four times a year. New cases may require 40 minutes to an hour for
assessment. About 150 — 200 new cases are diagnosed each year in the United States. It
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is estimated that 20% of the patient population may have complications such as reaction,
eye, hand, or foot problems which require more time during a clinic visit.
C. The Contractor shall serve as HD consultant and resource in the community and in the
geographic area identified in Attachment A, Statement of Work.
III. SPECIFIC TASKS
The purpose of the Outpatient Hansen's Disease Program is to provide outpatient medical and
diagnostic services for FrD and its related conditions. Services to be provided through this
contract, according to the following protocol include:
Task 1. Patient Assessment:
Evaluation of a patient with suspected or confirmed HD shall include a complete history and
physical exam as outlined in the HD Manual (Page 7, Patient Assessment).
Hansen's disease affects the skin, peripheral nerves, anterior part of the eyes, and the nasal area.
In the advanced form of the disease (Lepromatous leprosy), it can cause gynecomastia and
testicular atrophy in males. A complete physical assessment of the patient is necessary.
Diagnostic criteria include the presence of anesthetic lesions with M. leprae in skin smears or
biopsies, and sometimes, peripheral nerve enlargement.
Eyes: Examine the eye for inflammation, complete closure, and pupil size. In patients with
borderline lepromatous or lepromatous disease, an ophthalmological exam shall be done
to rule out eye involvement in this disease.
Skin: Hypo- or hyper-pigmented flat or raised lesions, are most commonly found on the face,
extremities, buttocks, or thighs. Absence of sweating, hair loss,
thinning of eyebrows, nodular thickening of earlobes, or changes in texture of the skin
may also be present.
Nerves: Peripheral nerves may be enlarged or tender. The ulnar, median, radial cutaneous,
posterior tibial, and peroneal nerves are most commonly affected. In patients with
anesthesia of the hands or feet, ulcerations, wounds or scars without history of pain,
muscle atrophy, or deformity may be present. A common complaint is pain in the
extremities and a burning sensation in the soles of the feet.
Task 2. Diagnostic Studies:
Punch Biopsy: A 4 mm punch biopsy or larger is needed for diagnosis.
Skin Smears: These may be done on initial exam on all patients if experienced personnel
are available. (See HD Manual, Forms and Procedures, Appendices C and D
(Attachment D.)
Task 3. Laboratory Monitoring:
I. Recommended Laboratory Tests and Frequency
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2nd visit
Initial (1-2 months) 3 m 6 m 12 m 18 m 24 m
visit
CBC + platelets X X X X X X X
AST X X X X X X
ALT X X X X X X
CRP X x X X X X X
BUN X
Creatinine X
Bilirubin X
G6PD X
Hepatitis B*
Hepatitis C*
*Screen for these if patient requires prednisone for reaction
PCR Assay (Polymerase Chain Reaction)
In a non-endemic population, the sensitivity and specificity of PCR assay recommend its use
primarily to identify M.leprae when acid-fast organisms are discernible but atypical clinical or
histopathologic features are obscuring the diagnosis. The Assay is not highly informative when
acid-fast bacilli are not detectable by light microscopy. (Am J Clin Pathol 1998; 109:642-646) To
further determine whether this Assay would be clinically appropriate, contact Dr. David Scollard,
Chief, Clinical Branch, NHDP, at 225-756-3713
Task 4. Treatment
The HD Manual in the Appendix provides guidelines which shall be used to determine treatment
of I-ED under this contract.
The Treatment Protocol for Hansen's Disease in the U.S. is multi-drug therapy which includes the
drugs Dapsone, Rifampin and Clofazimine. Medications used for the treatment of reaction in HD
are prednisone, clofazimine, and thalidomide. Alternative anti-microbial agents include
minocycline, and clarithromycin, (See NHDP website, www.hrsa.gov/hansensdisease.)
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A. Recommended Treatment Regimens-Adults
Following are the general NHDP treatment recommendations. The recommendations are for daily
rifampin, and for longer duration of treatment than the WHO protocols, largely due to WHO's cost
considerations for developing countries. Treatment that is more intensive and of longer duration is
medically preferable.
Treatment guidelines for immunologically competent individuals, (e.g. those without
immunodeficiency, immunosuppression, prolonged corticosteroid use, etc.) are as follows:
Adults
Tuberculoid (TT & BT) (WHO classification Paucibacillary, "PB")
Agent Dose .Duration
Dapsone
!100 mg daily
12 months, and then therapy discontinued
Rifampicin
600 mg daily
Adults
Lepromatous (LL, BL, BB) (WHO classification Multibacillary, "MB")
Agent ;Dose Duration a
Dapsone
100 mg daily
_ 24 months, and then therapy discontinued
Rifampicin
600 mg daily
Clofazimine
50 g daily
a.The recommended durations of treatment are sufficient, even though large numbers of dead bacilli
may remain in the tissues for several years, before they are eliminated by physiological
processes. There is no evidence that additional, prolonged treatment hastens the elimination of these
dead organisms. For immunologically compromised patients, these protocols may be modified, and
consultation with the NHDP is recommended.
b.Clofazimine, used for decades to treat I-11) around the world, is no longer available on the open
market. Because it is no longer distributed commercially, the only way we can obtain the drug in the
U.S. is to once again treat it as an investigational new drug (IND). The NHDP holds this IND for its
use in treating RD in the U.S.
In order for physicians to obtain the drug for treating HD, they will have to be registered as an
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investigator under the NHDP IND. This will require submitting a signed FDA form 1572, providing a
curriculum vitae, and obtaining and maintaining local Institutional Review Board (1RB) approval. A
packet of information will be provided including everything that is needed for submission to the local
IRB, e.g. treatment protocol, sample consent form and prescribing information. The NHDP provides
guidance in this process but cannot obtain approval for physicians at any other clinic in the United
States. Further information about this process can be obtained from :
Renee Painter
Administrative Officer, Clinical Branch
National Hansen's Disease Programs
1770 Physicians Park Drive
Baton Rouge, LA 70816
B. Recommended Treatment-Children
The occurrence of leprosy in children In the United States is rare. We strongly recommend contacting
the NHDP for management of leprosy in children; the following are general guidelines:
Treatment for children
Tuberculoid (TT & BT) (WHO Paucibacillary, "PB")
Agent !Dose Duration
Dapsone mg/ Kg daily
-:12 months, and then therapy discontinued
Rifampicin
Treatment for children
Lepromatous (LL, BL, BB) (WHO Multibacillary, "MB")
Agent Dose Duration
Dapsone 1 mg/ Kg daily
Rifampicin 10-20 mg/ Kg 24 months, and then therapy discontinued
daily (not > 600)
Clofazimine 1.0 mg/ Kg daily'
c. As there is no formulation less than 50 mg, and the capsule should never be cut open, alternate
day dosing may be used at 2 mg/kg.
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Task 5. Reaction
Lepra reactions are acute hypersensitivity "reactions" to the M. leprae organism
which may occur in 25% to 50% of all HD patients sometime during the course
of the disease. There are no predictors of which patients will develop reaction,
other than patients with tuberculoid disease do not develop reactive episodes,
and these are less frequent in patients taking clofazimine. There are two types
of reaction, Reversal Reaction, or Type I Reaction, and Erythema Nodosum
Leprosum, or ENL, which is Type II Reaction.
Reactions are a major cause of peripheral nerve damage, so the goal of
management in treating reaction is preventing nerve damage. Drugs commonly
used are corticosteroids, clofazimine, and thalidomide. (For guidance on
management of Reaction, call the NI-IDP at 1-800-642-2477.)
Thalidomide is very effective in controlling ENL, and is the drug of choice if not
Contraindicated. The drug is very teratogenic and causes severe birth defects if
taken by women during pregnancy.
In the U.S., Thalidomide is available to the prescribing physician and the dispensing pharmacist
by registering with Celgene's System for Thalidomide Education and Prescribing Safety (STEPS)
program.
Task 6. Ancillary Services
Due to the multi-faceted aspects of this disease, patients shall be referred to the following
ancillary medical services for treatment of complications as necessary:
a. Dermatology
b. ENT
c. Ophthalmology
d. Orthotics
e. Podiatry
f. Orthopedics
Task 7. Rehabilitation Services
An efficient and comprehensive rehabilitation program in the management of insensitive limbs
secondary to 1-1D shall incorporate physical therapy, occupational therapy, pedorthics, and patient
education. Rehabilitation goals aimed at minimizing loss of nerve function, ulceration,
amputation, and ultimate disability, are best achieved utilizing interdisciplinary rehabilitation
practices.
A. Occupational Therapy — Services required for the performance of this Contract include
performing hand screens and reporting changes in sensory and motor function to the
physician, teaching prevention of disability, providing wound care, splinting and casting,
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recommending assistive devices and safety equipment, pre-and post-surgical therapy for
HD orthopedic procedures, and in collaboration with the medical staff, identifying
candidates for reconstructive surgery.
1. Hand Screens — These are a means of assessing the HD patient's risk category
for hand problems, and for developing a care plan for their prevention and
treatment.
2. The sensory testing device uses the Semmes-Weinstein Monofilaments for
sensory threshold detection. The Hand Screen consists of a set of five (5)
calibrated nylon filaments mounted on a small rod, which measure levels of
cutaneous touch and pressure on a scale of 2.83 to 6.65. The normal threshold
level is 2.83. The motor system is tested through a standard Manual Muscle Test.
B. Physical Therapy services include the following:
1. Foot Screens — The Foot Screen has been proven to accurately identify patients
who are at risk of developing deformities as a result of insensitivity, and also
provides a baseline for determining the extent of foot disabilities.
2. The Semmes-Weinstein Monofilaments for the Foot Screen are designed to
deliver a 10 gram force when properly applied. The foot set of filaments consist
of a set of three calibrated nylon filaments include the following: 4.17 (normal
sensation), 5.07 (protective sensation), 6.03 (deep pressure). The motor system is
tested through a standard Manual Muscle Test.
C. Frequency of Performance:
1. Hand and foot screens shall be done for new patients at the time of diagnosis, and on
a quarterly basis as patients are scheduled for laboratory monitoring during
chemotherapy.
2. Screens should also be performed as clinically necessary on any patient complaining
of muscle weakness, decrease in sensation, or change in function.
The hand and foot filament sets for the Ambulatory Care Clinics may be obtained by
calling 1-800-642-2477. The NHDP Rehabilitation Department Staff are also available
for consultation as necessary.
Task 8. Patient and Professional Education
Appropriate treatment of stigmatizing disease like HD involves concerns about
deformity, disability, isolation, job loss, and being a source of infection to their families.
Awareness of these patient concerns will more likely ensure patient compliance with
treatment.
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In order to achieve its objective, which is the prevention of deformity and disability, the
patient assessment, hand and foot screens, HD monitors, and contact exam shall be used
to educate patients and family about HD.
The majority of healthcare providers in the U.S. are not aware of HD in the population.
Providers serving populations from endemic areas shall be targeted for educational
services on HD in order to increase their index of suspicion for the disease.
Educational materials are available from the NHDP (See Appendix, HD Manual,
"Resources").
Task 9. Other Services
A. Referrals to NHDP — Physicians at NHDP in Baton Rouge, Louisiana
may authorize referrals on a case-by-case basis
B. Patient Transportation — Reimbursement for travel to the HD Clinics may be
provided for indigent patients through this contract when it is deemed necessary
by the HD clinic staff
C. Subcontractors - The contractor shall provide all necessary health services
related to HD either directly or through subcontractors. The contractor is
responsible for payments to subcontractors.
D. Third Party Reimbursement — The contractor shall screen all patients for any
type of medical coverage to obtain third party reimbursement.
Task 10. Reporting Requirements (See Appendix, HD Manual, Forms and
Procedure)
A. Leprosy Surveillance Form —The NHDP maintains a National HD Registry for
all patients diagnosed in the U.S.A. The Hansen's Disease Surveillance Form is
required on all newly-diagnosed patients. Cases diagnosed outside the U.S. must
be evaluated for previous HD treatment, and if necessary, a biopsy done to
establish clinical status and need for further medical treatment for HD.
The Form can be found on the NHDP website, www.hrsa.gov/hansens, and
should be sent to NHDP as soon as the diagnosis is confirmed. Also, a copy of
the form should be sent to the local and/or State Health Department. The HD
Surveillance Form should be mailed or faxed to:
NHDP
ATTN: Medical Records
1770 Physicians Park Drive
Baton Rouge, LA 70816
Fax: 225-756-3706
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B. The contractor shall submit, semi-annually, a Microsoft Access or compatible
database, including the below required information, through Secure Email File
Transfer (SEFT), or Secure Zip. The use of SEFT is available at no charge. The
Contractor must call the NHDP at 1-800-642-2477 to request an email with
instructions to access SEFT. Secure Zip must be purchased by the Contractor.
Further information on Secure Zip may be found on their website:
http://www.pkware.com/store . Hand and Foot Screen Forms shall be sent,
double-pouched, via FEDEX to the following address:
National Hansen's Disease Programs
Attn: Irma Guerra, Ambulatory Care Program
1770 Physicians Park Drive
Baton Rouge, LA 70816
1. Demographics:
a. Name of patient
b. Birth date
c. Gender
d. Social Security number
e. Type of disease
f. Date of diagnosis
g. Address
h. Clinic activity status of patient:
A-Active (attends clinic for services)
C-Contact (household member of patient)
D-Deceased
LF-Lost to Follow-Up (unable to contact after several attempts)
RS-Refused Supervision (contacted and nonresponsive)
R-Relocated (relocated from area of services)
S-Suspect (Pending rule/out of HD)
2. Medication:
a. Start and stop date
b. Type of medication protocol
1) Recommended regimen (Dapsone, Rifampin, Clofazimine)
2) Other MDT (list medications)
3) Treatment completed, a or b above; continues on monotherapy
(specify continued medication)
3. Reaction
a. Type
b. Medication start and stop dates
4. Hand and Foot Screens-date and grade ( per WHO recommendations)
5. Clinic visit and date
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6. Consult visit and date
7. Referral to NHDP and date
8. Hard copy of the following documents performed during the reporting
period: (See HD Manual, Forms and Procedures)
a. Hand Screens
b. Foot Screens
c. Change of Information Form
d. Quality Assurance Form
Other reports and information requested by the Project Officer for Program Evaluation
of the services provided under this Contract.
Task 11. Reference Material
A. The HD Manual in the appendix provides guidelines for treatment of Hansen's
disease in the U.S.
B. Reporting forms are available from the National Hansen's Disease Program or
the website listed below.
C. Questions regarding treatment regimens shall be directed to the Clinical Branch
at NHDP. More information is available about HD and our services on the
NHDP website, vvww.hrsa.gov/hansens or by calling 1-800-642-2477.
D. The online course, "Lower Extremity Amputation Prevention and Treatment of
the Neuropathic Foot," is highly recommended for physicians, nurses, and
therapists providing services through this contract. This course can be found at
WWW hrsa. goy/ 1 e ap/b roc hu re . htm
Task 12. NHDP Physicians Meeting
The primary HD Physician providing Hansen's Disease services to patients and identified
as key personnel under this contract shall travel to Carville, Louisiana for an
administrative/clinical management meeting. The meeting will occur on April 16 th and
17th, 2016 with travel days on April 15 th and 18th, 2016. Authorized air travel from place
of performance to meeting location and return, ground transportation to and from airports
and to/from meeting location (no public ground transportation available), and
lodging/meals will be reimbursed by the Government at a Firm Fixed Price and in
accordance with the Federal Travel Regulations.
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