SOW_Guam_HD_Ambulatory_Care_Clinic_ATTCH_A_06092016.pdf

ATTACHMENT A (SOW)

STATEMENT OF WORK (SOW)

1. BACKGROUND

The legislative authority for the National Hansen’s Disease Programs (NHDP) is Public Law 33 99-117, Section 2. (a.), Section 320, and is guided by Department of Health and Human Services (DHHS) regulations. The Ambulatory Care Program was initiated in 1981 as a consequence of the closing of United States Public Health Service (U.S.P.H.S.) hospitals. Historically, persons with Hansen’s Disease (HD) were provided care by those facilities in the United States (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, the Territory of Puerto Rico, Washington, and Texas.

HD 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 HD, increasing the detection of its’ early signs, and initiating treatment early in the disease process.

2. GENERAL REQUIREMENTS/TASKS

About 150 to 200 new HD cases are diagnosed each year in the United States. The number of HD patients in the service area of the Territory of Guam is approximately 110, with an estimated annual increase of 9 new patients per year. Patients in the active phase of treatment (Multi Drug Therapy (MDT) or reactions) require a minimum of 4 visits annually. Patients are who are not in the active phase of the disease shall be seen at least annually and as needed as determined by the healthcare provider. The patient population with HD in the U.S. is multi-ethnic and will require culturally sensitive healthcare.

Initial assessments of newly diagnosed cases may average 60 to 120 minutes. Routine, uncomplicated patient visits for HD services can be completed in an average of 30 minutes and complicated cases can be completed in an average of 45 minutes. It 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.

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• Hospital and/or Healthcare Facility – The facility should be accredited by the Joint Commission for Accreditation or certified by an accredited agency. Any conditional accreditation will be accompanied with a copy of the evaluation report.

• Availability – Hours of operation should be adequate to support the HD patient population in the service area of the Territory of Guam. The contractor shall provide standard facility and clinic hours for HD care as well as provide emergency and after hour provisions.

• Accessibility – The facility shall be handicap accessible, and shall be in close proximity to and accessible to public transportation.

• Multidisciplinary Team – A multidisciplinary team shall be utilized for performance of services under this 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 for all key personnel.

Performance of this contract typically requires the following labor categories:

Registered Nurse Occupational Therapist Ophthalmologist Orthopedist Orthotist Otolaryngologist (ENT) Physical Therapist Physician Podiatrist Project Director

Specific Tasks

• Task 1. Patient Assessment and Management

A. Assess eligibility for services.

The contractor shall validate patient eligibility before rendering services. When the eligibility status of an individual patient is unclear, the contractor shall obtain guidance and approval from the Contracting Officer Representative (COR) or NHDP physician.

Patients are considered eligible under the following circumstances:

• HD Patient – Any individual in the continental United States and its Territories who needs to have HD ruled out as a diagnosis or has been diagnosed with HD.

• HD contact – Any person shall be examined who has lived in the same household with a new HD patient in the three year period prior to the diagnosis or at the start of treatment (See HD Manual “Contact Follow-Up”).

B. History and Physical.

The contractor shall perform a complete history and physical on patients with suspected or confirmed HD as outlined in the HD Manual (see Appendices A-E, and G under “Forms and Procedures”). HD can affect the skin, peripheral nerves, anterior parts of the eye, and nasal area. The advanced forms can also cause gynecomastia and testicular atrophy in males. The physician who is providing primary HD care shall perform initial assessments on all HD patients and may identify patients in higher risk categories who require services of other labor categories covered under this contract (dermatologist, ENT, ophthalmologist, orthopedist, orthotist, podiatrist, physical therapist, and occupational therapist). It is estimated that 20% of the HD population will fall in the higher risk category where the other healthcare providers are needed.

C. Diagnostic Studies and Lab Monitoring.

The contractor shall perform a biopsy (4 mm punch or larger) for diagnostic purposes as outlined in the HD Manual (see Appendix C, “Biopsies,” under “Forms and Procedures”). Laboratory tests shall be performed in accordance with the following chart:

Laboratory Tests and Frequency

Initial Visit

2nd Visit (1-2 months)

Months

Months

12 Months Or Every 3

Months Until

Active Treatment Completed

Annually Or As

Needed After

Active Treatment Completed

Complete Blood Count + platelets X X X X X X

Aspartate Aminotransferase X X X X X

Alanine Aminotransferase X X X X X Creatinine Reactive Protein X X X X X X

Basic Metabolic Panel X X Creatinine X Bilirubin X Glucose-6-Phosphate dehydrogenase X

Hepatitis B* X Hepatitis C* X *Screen for these if patient requires prednisone for reaction.

D. Medication Management.

The contractor shall use the HD Manual as a comprehensive guide to determine the recommended treatment of HD for adults and children. Overviews of the recommendations are listed below.

• Recommended Treatment Regimens – Adults

Treatment for Hansen’s Disease under this contract shall follow NHDP treatment guidelines. The treatment is specified below, and includes daily rifampin. NHDP recommended treatment protocols are medically preferable because they are more intensive than World Health Organization (WHO) protocols.

Treatment guidelines for immunologically competent individuals, (e.g. those without immunodeficiency, immunosuppression, and 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

12 Months, And Then Therapy Discontinued

Adults Lepromatous (LL, BL, BB) (WHO classification

Multibacillary "MB") Agent Dose Duration

Dapsone 100 mg Daily

24 Months, And Then Therapy Discontinued

Rifampicin 600 mg Daily

24 Months, And Then Therapy Discontinued

Clofazimine 50 g Daily

24 Months, And Then Therapy Discontinued

1. The recommended durations of treatment are sufficient, even though large numbers of dead bacilli may remain in the tissues for several years, before being 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.

2. Clofazimine, used for decades to treat HD around the world, is no longer available on the open market. Because it is no longer distributed commercially, the only way the contractor 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 HD in the U.S.

In order for physicians to obtain Clofazimine, they must be registered as an investigator under the NHDP Investigational New Drug (IND) Program. This will required submitting a signed FDA form 1572 and curriculum vitae to NHDP. A packet of information including form 1572 and consent forms will be provided. An institutional review board (IRB) of the Centers for Disease Control and Prevention has agreed to act as the central IRB for the use of Clofazimine for Hansens Disease, so individual physicians will not need to arrange this for themselves. For further information or to request investigatory status, please call NHDP at 1-800-642-2477.

• Recommended Treatment Regimens – Children

The occurrence of Hansen’s Disease in children in the United States and its Territories is rare. The contractor shall contact NHDP for the management of Hansen’s Disease in children. The following are the guidelines for treatment:

Children

Tuberculoid (TT & BT) (WHO Classification Paucibacillary "PB")

Agent Dose Duration

Dapsone 1 mg/Kg Daily

12 Months, And Then Therapy Discontinued

Rifampicin 1 to 2 mg/Kg 600 Daily

12 Months, And Then Therapy Discontinued

Children Lepromatous (LL, BL, BB) (WHO classification

Multibacillary "MB") Agent Dose Duration

Dapsone 1 mg/Kg Daily

24 Months, And Then Therapy Discontinued

Rifampicin

10 to 20 mg/Kg Daily, not greater than 600

24 Months, And Then Therapy Discontinued

Clofazimine 1.0 mg/Kg Daily

24 Months, And Then Therapy Discontinued

E. Management and Treatment of Reaction.

Overview of Reactions:

The contractor shall monitor patients for reactions during and after treatment.

Reactions or acute hypersensitivity “reactions” to the M. leprae organism may occur in 20% of all HD patients at any time during the course of the disease. There are no predictors for 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. For guidance on management of Reaction, call the NHDP at 1-800-642-2477; or email Dr. David Scollard at dscollard@hrsa.gov, or Dr. Barbara Stryjewska at bstryjewska@hrsa.gov.

Treatment of Reactions:

The contractor shall treat reaction in HD with the medications commonly used, which are corticosteroids, clofazimine, and thalidomide.

Thalidomide is very effective in controlling ENL, and is the drug of choice if not contraindicated. This medication 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, contract customer service at 888-423-5436.

F. Patient Education.

The contractor shall be responsible for educating patients and their families regarding HD, appropriate treatment, stigma, deformity, disability, isolation, job loss, and being a source of infection to their families.

The contractor shall educate patients regarding the purpose of screening tools and the importance of completing the recommended course of treatment.

G. Patient Outreach.

The contractor shall conduct outreach efforts to retain all patients in treatment during the active phase of the disease. Patients who are lost to follow-up and individuals who have relocated must be reported as soon as the contractor is knowledgeable. Outreach efforts must be documented on the Semi-annual report.

• H. Rehabilitation Services.

The contractor shall provide a comprehensive rehabilitation program in the management of insensitive limbs secondary to HD. The goal of the rehabilitation program is to prevent or minimize loss of nerve function, ulcerations, amputations, and disabilities, as best achieved through utilizing evidenced based interdisciplinary rehabilitation practices.

Services required for performance of this contract shall include performing hand and foot screens, reporting changes in sensory and motor function to the physician, teaching prevention of disability, wound management, nail and callus care, splinting and casting, providing orthotics and appropriate footwear, 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.

Patients with HD related loss of protective sensation and deformities such as muscle atrophy in the hands or feet, clawing in the fingers or toes, contractures in fingers, foot drop, charcot deformity, wounds and injuries, shortening of the digits or amputations in the hands and feet shall be treated by the appropriate healthcare professional.

Hand Screens:

1. The contractor shall perform a hand screen to monitor sensory and motor function. The results of the hand screen are to identify patients with HD related hand problems and to develop a plan of care for treatment and prevention of disabilities. Hand screens shall be performed on a quarterly basis and as clinically necessary (reactions, muscle weakness, decrease in sensation, or change in function).

2. The contractor shall perform sensory testing using the Semmes-Weinstein

Monofilaments for sensory threshold detection. The Hand Screen shall 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.

Foot Screens:

1. The contractor shall perform a Foot Screen to monitor sensory function and identify patients who are at risk of developing deformities as a result of insensitivity. Foot screens shall be performed on a quarterly basis and as clinically necessary (reactions, muscle weakness, decrease in sensation, or change in function).

2. The contractor shall perform a sensory testing with the Semmes-Weinstein

Monofilaments. The monofilaments are designed to deliver a 10 gram force when properly applied. Filaments shall consist of three calibrated nylon filaments including 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.

Semmes-Weinstein Monofilaments for the Ambulatory Care Clinics may be obtained by calling 1-800-642-2477, or email CAPT. John Figarola at JFigarola@hrsa.gov. The NHDP Rehabilitation Department Staff are also available for consultation with Ambulatory Care Clinic staff as necessary.

• Task 3. Patient Transportation

The contractor shall provide reimbursement to indigent HD patients for travel via ground transportation within the Territory of Guam to the HD Clinic or other facility where contractor personnel may also be providing services under this contract, up to 1600 miles per 12 month period of performance. The reimbursable rate shall be in accordance with the Federal Travel Regulations for mileage.

• Task 4. NHDP Consultations

The contractor shall consult with the National Hansen’s Disease Programs for patients whose care may not be covered under this contract. If it is determined that their care is not covered under this contract then NHDP will coordinate with the HD patient to assist them in obtaining the care that is needed.

• Task 5. Reporting Requirements

A. Hansen’s Disease Surveillance Form – The contractor shall complete and submit the

Hansen Disease Surveillance Form (Appendix G) for new patients. These forms assist NHDP in fulfilling a mandate imposed by the federal government for NHDP to maintain a National HD Registry for all patients diagnosed in the U.S. and its mailto:JFigarola@hrsa.gov

Territories. 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 should be done to establish clinical status and need for further medical treatment for HD.

This form can be found at Appendix G and should be sent to NHDP within 10 business days of the diagnosis of HD. Also, a copy of the form should be sent to the local and/or State Health Department. The HD Surveillance Form should be sent by secure fax to NHDP Medical Records Department at 1-225-756-3706.

B. NHDP Annual Follow-Up Form – The contractor shall complete and submit the

NHDP Annual Follow –up form by the 5th of the month. The form shall be completed each year on the date which closely corresponds to the patient’s date of diagnosis.

C. Semi-Annual Report – The contractor shall complete and submitted the Semi-Annual

Reports twice for every 12 month period of performance, using Microsoft Access or compatible database and shall provide the following information for HD patients:

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:

i. A – Active (Attends Clinic for Services)

ii. C – Contact (Household Member of Patient)

iii. D – Deceased

iv. LF – Lost to Follow-Up (Unable to Contact After Several

Attempts)

v. RS – Refused Supervision (Contacted and Nonresponsive)

vi. R – Relocated (Relocated from Area of Service)

vii. S – Suspect (Pending Rule/Out of HD)

2. Medications:

a. Start and Stop Dates

b. Type of Medication Protocol

i. Recommended Regimen (Dapsone, Rifampin, Clofazimine)

ii. Other MDT (List Medications)

iii. 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:

a. Date and Grade According to WHO Disability Scale Specified in the

HD Manual

5. Clinic Visit:

a. Clinic Visit and Date

6. Consult Visit:

a. Consult Visit and Date

7. Referral to NHDP:

a. Referral to NHDP and Date

8. Hard Copy of the following documents, used during the reporting

a. Hand Screens

b. Foot Screens

c. Change of Information Form

d. Quality Assurance Survey

D. Quarterly Hand and Foot Screen – The contractor shall complete Hand and Foot

Screens on a quarterly basis for HD patients. These forms shall be submitted to NHDP on a monthly basis.

E. Periodic Data Report - The contractor shall be required to complete and submit Periodic Data Reports as requested by the COR for evaluation of patient care and services provided under this contract. The quantity of these reports shall range from 1 to 2 per 12 month period of performance. This report is due within 5 business days of request by COR.

• Task 6. NHDP Meetings

Key personnel identified in the contract shall be required to travel to NHDP in Louisiana to attend an Administrative/Clinical Management Meeting. NHDP will provide at least 120 days of notice prior to meeting occurrences. This meeting will occur annually. This meeting will be 2 days long and allow for 2 travel days.

3. KEY PERSONNEL

Key personnel proposed by the contractor to perform services under this contract are subject to review and concurrence by the Contracting Officer prior to their placement. Any desired replacement or removal of key personnel by the contractor is subject to review and concurrence of the Contracting Officer prior to their replacement or removal.

The Contracting Officer may request that the contactor exclude form work such personnel as the Contracting Officer deems incompetent, careless, and or unsuitable or whose continued employment is inconsistent with the best interest of the Federal Government. The Contracting Officer reserves the right to exclude from work any personnel previously barred from NHDP.

The Federal Government may request that the contractor immediately remove personnel from the place of performance should it be determined that the individual being assigned to duty is not qualified or is found to be unfit for performing services under this contract.

For clarification, a determination of unfit may be made from, but is not limited to incidents involving the most identifiable types of misconduct or delinquency as set forth below:

• Violation of rules and regulations.

• Disorderly conduct, use of abusive or offensive language, quarreling, intimidation by words or actions of fighting. Participating in disruptive activities, which interfere with the normal and efficient operations of the Federal Government, is also considered disorderly conduct.

• Theft, vandalism, immoral conduct, or any criminal action.

• Possessing, selling, consuming or being under the influence of intoxicants, illegal drugs or substance that produces similar affects.

• Unauthorized use of Federal Government property.

• Possession of weapons while on duty.

In the event of a dispute, the contractor Officer will make the final determination.

The contractor shall remind their personnel that the place of performance is a Federal Government facility.

The following key personnel shall be identified by the contractor.

• Project Director

Education/Licensure/Experience:

The project director shall have a degree in a social science field, public health, health management, health policy and planning, or other health and human services-related specialty. The program directory shall a minimum of three year of specialized experience of preparing reports and other written correspondence; diagnosing and resolving administrative problems; and devising new processes for managing the work of an office.

Duties/Responsibilities:

• The project director shall assists with planning, coordinating and implementing activities associated with administrative management, operations, equipment, space management, logistics, budget, travel and other areas for the performance accountability and management, and work collaboratively with NHDP to ensure task described under the contract are performed.

• Physician

The physician shall have a degree in medicine or an equivalent degree from a course of education in medicine with a permanent, full, and unrestricted license to practice medicine in a State, Territory or Commonwealth (i.e., Puerto Rico) of the United States, or the District of Columbia. The physician shall have a minimum of three years of independent practicing experience. The physician shall have a minimum of three years of experience as a fulltime physician. The physician shall possess a current, full and unrestricted license to practice medicine in a State, Territory or Commonwealth (i.e., Puerto Rico) of the United States, or the District of Columbia.

• Shall provide medical screenings, evaluations, and treatment of HD and reactions.

• Shall provide medical oversight and coordinate overall HD care utilizing special labor categories identified in the SOW to manage higher risk clients.

• Shall document care provided in the medical records.

• Shall collaborate with NHDP physicians as needed regarding medical care of HD patients as needed.

• Registered Nurse

Education /Licensure/Experience:

The nurse shall be a graduate of a school of professional nursing approved by the appropriate State-accrediting agency and accredited by one of the following accrediting bodies at the time the program was completed; The Accreditation Commission for Education in Nursing (ACEN) or The Commission on Collegiate Nursing Education (CCNE). The registered nurse shall have a current, full, active, and unrestricted registration as a graduate professional nurse in a State, Territory or Commonwealth (i.e., Puerto Rico) of the United States, or the District of Columbia. The nurse shall have a minimum of three years of experience as a fulltime nurse.

• Screen, assess, manage, and coordinate healthcare and services for HD patients.

• Plan and coordinate comprehensive care to individuals, families and communities, in the healthcare setting.

• Provide patient teaching and assist with understanding, accepting and adjusting to the implications and responsibilities of HD medical care, diagnosis and treatment (also includes addressing psychosocial issues with stigma associated with HD).

• Physical Therapist

The physical therapist shall be a graduate from a degree program in physical therapy from an approved college or university approved by the Commission and Accreditation in Physical Therapy Education (CAPTE). The CAPTE is the only accreditation agency recognized by the United States Department of Education (USDE) and the Council for Higher Education Accreditation (CHEA) to accredit entry-level physical therapy programs. The physical therapist must have a full, active, and unrestricted license to practice physical therapy in a State, Territory or Commonwealth (i.e., Puerto Rico) of the

United States, or the District of Columbia. The physical therapist shall have a minimum of three years of full time experience.

• Evaluate the lower extremity sensory-motor function following NHDP Guidelines.

• Determine risk category, provide patient education, training and assistive devices.

• May perform callus and nail care, wound management foot wear selection and off-loading of foot.

• Podiatrist

The podiatrist shall have a Doctor of Podiatric Medicine (D.P.M.) from a school of podiatric medicine accredited by the Council of Podiatric Medical Evaluation in the year in which the degree was granted. The podiatrist shall be currently licensed to practice podiatric medicine in a State, Territory or Commonwealth (i.e., Puerto Rico) of the United States, or the District of Columbia. The podiatrist shall have a minimum of three years of experience working in the field of podiatry.

• Diagnose foot disorders and determine the best course of treatment (foot drop).

• Educate patients on disease process and course of treatment.

• The podiatrist shall complete the NHDP's online Neuropathic Foot Course within

90 days of the contract award.

• Occupational Therapist

The occupational therapist shall possess a degree in occupational therapy approved by the Accreditation Council for Occupational Therapy Education (ACOTE). The ACOTE is the only accreditation agency recognized by the United States Department of Education (USDE) and the Council for Higher Education Accreditation (CHEA). The occupational therapist shall hold a full and current unrestricted state Occupational Therapist License and possess written documentation that the individual has passed the entry-level certification examination for occupational therapists which is administered by the National Board for Certification in Occupational Therapy (NBCOT). The occupational therapist shall have a minimum of three years of full time experience in an acute, chronic, rehabilitative, or outpatient facility managing patients with hand problems. A certified hand therapist is preferred.

• Evaluate upper extremity sensory-motor function. For patients with loss of protective sensation or Hansen's disease related deformities, evaluate the performance of activities of daily living, recommend adaptive devices to prevent injuries and maximize function, fabricate splints and casts, provide wound management and provide patient education.

• Otolaryngologist (ENT)

The otolaryngologist must have a doctor of medicine or an equivalent degree resulting from a course of education in medicine or osteopathic medicine. Possess a current, full and unrestricted license to practice medicine or surgery in a State, Territory or Commonwealth (i.e., Puerto Rico) of the United States, or the District of Columbia.

• The ENT shall manage care for HD patients as medically necessary who present with complex ear, nose, and throat disorders which exceed the scope of care which can be provided by the primary HD physician (persistent hoarseness, perforated nasal septum, etc.).

• Ophthalmologist

The ophthalmologist shall have a degree of doctor of medicine or an equivalent degree resulting from a course of education in medicine or osteopathic medicine. The ophthalmologist shall possess a current, full and unrestricted license to practice medicine or surgery in a State, Territory or Commonwealth (i.e., Puerto Rico) of the United States, or the District of Columbia, and be board certified in Ophthalmology. The ophthalmologist shall have a minimum three years of experience in the field of ophthalmology.

• The ophthalmologist shall provide eye care as medically necessary for high risk HD patients who may present with lagophthalmos, asymmetrical closing of eyelids, photophobia, painful red eyes, etc.

• Orthopedist

The orthopedist shall have a doctor of medicine degree or equivalent degree resulting from a course of education in medicine or osteopathic medicine. The orthopedist shall possess a current, full and unrestricted license to practice medicine or surgery in a State, Territory or Commonwealth (i.e., Puerto Rico) of the United States, or the District of Columbia. The orthopedist shall maintain current registration in the State of licensure if this is a requirement for continuing active, current licensure. The orthopedist shall have a minimum of three years of experience of practice as an orthopedist.

• The orthopedist shall provide a full range of diagnostic, therapeutic and minor procedures for HD patients who may present with loss of protective sensation of the extremities, sensory and motor loss, nerve damage, neuropathic wounds.

• The orthopedist shall provide offloading, orthotics, and footwear.

• Orthotist

The orthoptist shall have knowledge of current professional orthotic and/or prosthetic principles and practices. The orthoptist must have a minimum of three years of experience working in the field of orthotics.

• The orthoptist shall provide orthotics, foot wear and orthotic devices to patients with loss of protective sensation or deformities related to HD. The orthotist will provide services in a timeframe appropriate to the patients need.

• Consults with physicians, caregivers, therapist and/or staff members to obtain and understand the prescription for orthotic devices.

• Measures foot and limb segments appropriate to the item being fitted.

• Selects items appropriate for the patients' loss of sensation and deformities of the feet.

• Applies items to body and limb segment, adjusting as required and confirms device fit and proper function.