NEW HANSENS DISEASE CONTRACT.PDF

1. THIS CONTRACT IS A RATED ORDER )o, RATING PAGE OF PAGES
AWARD/CONTRACT UNDER DPAS (15 CFR 700) 1 1 43
2. CONTRACT (Proc. Inst. !dent.) NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
HHSH258201300005C 09/01/2013 HRS115216
5. ISSUED BY CODE I NHDP 6. ADMINISTERED BY (If other than item 5) CODE
ERSA/OAMP/NHDP
Office of Acquisition
Management and Policy
National Hansens Disease Program
Baton Rouge LA 70816
7. NAME AND ADDRESS OF CONTRACTOR (No., Street, City, Country, State and 71P Code) 8. DELIVERY
E FOB ORIGIN K OTHER (See below)
COUNTY OF MARTCOPA 151577 9, DISCOUNT FOR PROMPT PAYMENT
MARTCOPA, COUNTY OF 1645 E ROO .
1645 E ROOSEVELT
PHOENIX AZ 850063638
10. SUBMIT INVOICES ITEM
(4 copies unless otherwise specified) Illo.
TO THE ADDRESS SHOWN IN
CODE 151577 FACILITY CODE
It SHIP TO/MARK FOR CODE NHDP/ADM/CONTRACTS 12. PAYMENT WILL BE MADE BY CODE NHDP/FMO
National Hansen's Disease Program A NHDP/FMO
1770 Physicians Park Drive 1770 Physicians Park Drive
Baton Rouge LA 70816 Financial Management Office
Baton Rouge LA 70816
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 14. ACCOUNTING AND APPROPRIATION DATA
ii 1 0 u.s.c. 2304 (G) ( ) 11141 U.S.C. 253 (c) ( ..2013.3280075.25627
15A. ITEM NO 150. SUPPLIES/SERVICES 15C, 15D. 15E, UNIT PRICE 15F, AMOUNT
QUANTITY UNIT
Continued
150. TOTAL AMOUNT OF CONTRACT 10, $12,836.00
16. TABLE OF CONTENTS
(X) I SEC. DESCRIPTION I PAGE(S) (X) I SEC- I DESCRIPTION PAGE (S)
PART I THE SCHEDULE PART II - CONTRACT CLAUSES
X A SOLICITATION/CONTRACT FORM 1 X ' t CONTRACT CLAUSES 122
X B SUPPLIES OR SERVICES AND PRICES/COSTS 5 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
X C DESCRIPTION/SP ECS.NVORK STATEMENT 7 X J LIST OF ATTACHMENTS 126
X D PACKAGING AND MARKING a PART IV - REPRESENTATIONS AND INSTRUCTIONS
X E INSPECTION AND ACCEPTANCE 9 K REPRESENTATIONS, CERTIFICATIONS AND
X F DELIVERIES OR PERFORMANCE 10 OTHER STATEMENTS OF OFFERORS
X 0 CONTRACT ADMINISTRATION DATA 13 L INSTRS., CONDS., AND NOTICES TO OFFERORS
X H SPECIAL CONTRACT REQUIREMENTS 17 M EVALUATION FACTORS FOR AWARD
CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-HIP OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE
•
17. CONTRACTOR S NEGOTIATED AGREEMENT (Contractor is required to sign this 18. 0 SEALED-BID AWARD (Contractor is not required to sign this document.) Your hid a
document and return 1 copies to issuing office.) Contractor agrees to Solicitation Number
furnish and deliver all items or perform all the services set forth or otherwise identified including the additions or changes made by you which additions or changes are set forth
above and on any continuation sheets for the consideration stated herein. The rights and in full above, is hereby accepted as to the items listed above and on any continuation
obligations of the parties to this contract shall be subject to and governed by the following sheets. This award consummates the contract which consists of the following
documents: (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, documents: (a) the Government's solicitation and your hid, and (b) this award/contract.
representations, certifications, and specifications, as are attached or incorporated by No further contractual document is necessary. (Mock 18 should be checked only when
reference herein. (Attachments are listed herein.) awarding a sealed-bid contract.)
19A, NAME AND TITLE OF SIGNER (Type or print) 20A. NAME OF CONTRACTING OFFICER
DIANE L. COGER
19B. NAME OF CONTRACTOR 190. DATE SIGNED 20B, UNITED STATES OF AMERICA 20C. DATE SIGNED
BY BY
(Signature of person authorized to sign) (Signature of the Contracting Officer)
STANDARD FORK 26 (Rev. 512011)
AUTHORIZED FOR LOCAL REPRODUCTION Prescribed by GSA - FAR (48 CFR) 53.214(a)
Previous edition is NOT usable

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
CONTINUATION SHEET HHSH258201300005C 2 1 43
NAME OF OFFEROR OR CONTRACTOR
COUNTY OF MARICOPA 151577
ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
(A) (B) (C) (D) (B) (F)
Tax ID Number: 86-6000472
DUNS Number: 602062515
Delivery: 12/31/2013
Appr. Yr.: 2013 CAN: 3280075 Object Class: 25627
FOB: Destination
Period of Performance: 09/01/2013 to 12/31/2013
Title: Outpatient Clinical Treatment Services
for Hansen's Disease
Type of Contract: Firm Fixed-Price
1 Procurement Plan Number NHDP 181 C 1886 12,836.0
The Contractor shall provide all services related
to Outpatient Clinical Treatment Services for
Hansen's Disease for the National Hansen Disease
Program in accordance with the Statement of Work
as attached.
Obligated Amount: $12,836.00
2 Option Period One 0.0
Amount: $40,305.00(Option Line Item)
12/31/2013
3 Option Period Two 0.0
Amount: $40,740.00(Option Line Item)
12/31/2014
4 Option Period Three 0.0
Amount: $41,135.00(Option Line Item)
12/31/2015
5 Option Period Four 0.0
Amount: $41,580.00(Option Line Item)
12/31/2016
Contracting Officer Representative (COB):
Irma E. Guerra, BSN, MPH
Director, Ambulatory Care
National Hansen's Disease Program
1770 Physician Park Drive
Baton Rouge, LA 70816
Telephone: 1-800-642-2477
Fax: 225-756-3806
Email: IGuerra@hrsa.gov
Contracts Office Point of Contact:
Continued ...
ALITHOPiZED FOR LOCAL REPRC OPTIONAL FORM 336 (446)
Spormared by GSA
FAR (48 CFR) 63.110

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF
CONTINUATION SHEET H11SH258201300005C 3 1 43
NAME OF OFFEROR OR CONTRACTOR
COUNTY OF MARICOPA 151577
ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
(A) (E) (C) (D) (E) (F)
Charisse Whitney
National Hansen's Disease Program
1770 Physician Park Drive
Baton Rouge, LA 70816
Telephone: 225-756-3785
Fax: 225-756-3786
The total amount of award: $176,596.00. The
obligation for this award is shown in box 15G.
AUTHORIZE() FOR LOCAL REPR( OPTIONAL FORM ne {4-86)
Sponsored by GSA
FAR (48 CFR) 51110


SECTION A — STANDARD FORM (SF) 26
This page is left blank intentionally.
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SECTION B — SUPPLIES OR SERVICES AND PRICES/COSTS
B.1 Purpose of Contract
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 their contacts.
B.2 Compensation Cost/Price
1. In consideration of the satisfactory performance of the services and tasks detailed in Section J—
Attachment A-Statement of Work, the Contractor shall be compensated in accordance with the following
amounts:
a) Base Period (September 1, 2013 — December 31, 2013)
The price for full performance of the base period under this contract will be $12,836.
b) Option Period One (January 1,2014- December 31, 2014)
It is estimated that the cost to the Government for full performance of Option Period One, if
exercised, under this contract will be $40,305.
Price for Four (4) Three (3) month intervals:
$10,076.25
$10,076.25
$10,076.25
$10,076.25
c) Option Period Two (January 1, 2015- December 31, 2015)
It is estimated that the total cost to the Government for full performance of Option Period Two, if
exercised, under this contract will be $40,740.
Price for Four (4) Three (3) month intervals:
$10,185
$10,185
$10,185
$10,185
d) Option Period Three (January 1, 2016- December 31, 2016)
It is estimated that the total cost to the Government for full performance of Option Period Three, if
exercised, under this contract will be $41,135.
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Price for Four (4) Three (3) month intervals:
$10,283.75
$10,283.75
$10,283.75
$10,283.75
e) Option Period Four (January 1, 2017- December 31, 2017)
It is estimated that the total cost to the Government for full performance of Option Period Four, if
exercised, under this contract will be $41,580.
Price for Four (4) Three (3) month intervals:
$10,395
$10,395
$10,395
$10,395
2. The total Firm Fixed Price (FFP) for the Base Period is $12,836. The total FFP for Option Period One
(1), Option Period Two (2); Option Period Three (3); and Option Period Four (3) is $163,760.
B.3. Wage Determination
This contract is subject to the Wage Determination No. 2005-2023, Revision No. 17, date of revision
06/19/2013.
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SECTION C — DESCRIPTION/SPECIFICATIONS/ STATEMENT OF WORK
C.1 Statement of Work
Independently and not as an agent of the Government, the Contractor shall furnish all personnel, material,
facilities, services, and equipment as needed to perform the Statement of Work set forth in Section Jr
(Attachment A) attached hereto and made part of this document.
C.2 Incorporation of Contractor's Proposal
It is understood and agreed that the Contractor shall, in meeting the requirements of this contract, perform
the work in accordance with the Contractor's proposal to the Health Resources and Services
Administration originally dated March 8, 2013, revised June 27, 2013 and July 23, 2013, provided
however, that to the extent that any clauses of the articles of this contract are in conflict or inconsistent
with any clauses of said proposal, the provisions of the articles of this contract shall control and shall
supersede the provisions of said proposal; therefore, the contractor's proposal is hereby incorporated into
the resultant contract.
7

SECTION D - PACKAGING AND MARKING
PAGE LEFT BLANK INTENTIONALLY
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SECTION E – INSPECTION AND ACCEPTANCE
E.1 Inspection and Acceptance
The Contracting Officer Representative (COR), as a duly authorized representative of the Contracting
Officer, shall assume the responsibilities for monitoring the Contractor's performance, evaluating the
quality of services provided by the Contractor and performing final inspection and acceptance of all
deliverables.
E.2 52.246-4 Inspection of Services—Fixed Price (AUG 1996)
(a) Definition. "Services," as used in this clause, includes services performed, workmanship, and material
furnished or utilized in the performance of services.
(b) The Contractor shall provide and maintain an inspection system acceptable to the Government
covering the services under this contract. Complete records of all inspection work performed by the
Contractor shall be maintained and made available to the Government during contract performance and
for as long afterwards as the contract requires.
(c) The Government has the right to inspect and test all services called for by the contract, to the extent
practicable at all times and places during the term of the contract. The Government shall perform
inspections and tests in a marmer that will not unduly delay the work.
(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor,
the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price,
all reasonable facilities and assistance for the safe and convenient performance of these duties.
(e) If any of the services do not conform with contract requirements, the Government may require the
Contractor to perform the services again in conformity with contract requirements, at no increase in
contract amount. When the defects in services cannot be corrected by re-performance, the Government
may—
(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract
requirements; and
(2) Reduce the contract price to reflect the reduced value of the services performed.
(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure
future performance in conformity with contract requirements, the Government may—
(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the
Government that is directly related to the performance of such service; or
(2) Terminate the contract for default.
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SECTION F – DELIVERIES OR PERFORMANCE
F.1 FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)
The contract incorporates one or more clauses by reference with the same force and effect as if they were
given in full text. Upon request, the Contracting Officer will make their full text available. In addition, the
full text of a clause may be accessed electronically at www.amet.gov/far.
F.2 FAR 52.242-15 Stop-Work Order (AUG 1989)—Alternate I (APR 1984)
F.3 Observance of Federal Holidays
Official Holidays
New Year's Day January 1st
Martin Luther King's Birthday 3rd Monday in January
Inauguration Day 3rd Tuesday in January (every 4 th year)
Presidents' Day 3rd Monday in February
Memorial Day Last Monday in May
Independence Day July 4th
Labor Day 1st Monday in September
Columbus Day 2nd Monday in October
Veterans' Day November 11th
Thanksgiving Day 4th Thursday in November
Christmas Day December 25th
Inauguration Day Every fourth year, Washington, DC
For work to be performed at Government site(s):
1. No services or deliveries shall be performed, nor shall HRSA reimburse a contractor for
work performed on Saturdays, Sundays, Federal legal holidays, holidays set forth by Presidential
Executive Order and any other Government closures, including for inclement weather, unless
otherwise provided for in the terms of the contract. The contractor may not bill for hours not
worked.
2. When the Government site is closed, there may be a rare emergency situation or a necessity
for critical work to continue where the Contracting Officer or the Head of Contracting Activity
may authorize work at the fixed hourly rate set forth in the contract.
F.4 Period of Performance/Place of Performance
The period of performance shall be a base period of twelve (12) months with four (4) twelve (12) month
option periods from effective date of contract award. The period of performance under this contract shall
commence with the effective date of the contract (EDOC). The place of performance is at the
contractor's site.
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F.5 Articles or Services to be Furnished
1. All reports, processes, and product deliverables are subject to approval of the Contracting Officer
Representative (COR).
2. All reports and documents shall have, at a minimum in the document header, the contract number,
and the COR' s name. All reports and documents shall have, at a minimum in the document
footer, the author in the lower left corner, the page # of total # of pages in the center bottom of the
page, and the date and /or version of the document (not the auto date) in the lower right corner.
F.6 Schedule of Deliverables
a. The Contractor shall submit all items in the quantities and by the dates indicated to the COR.
(Base and Option Periods)
Deliverable Quantity Due Date
Outpatient Treatment As required Upon patient presentation in
clinic
Hansen's Disease Surveillance Report As requested Upon confirmed HD
Diagnosis
Semi-Annual Reports 2 1 NLT 30 days after June
30
1 NLT 30 days after
December 31
In addition to the number of copies to be submitted as shown above, one copy of the final
report shall be mailed directly to:
National Hansen's Disease Programs
Attn: Contracts Office
1770 Physicians Park Drive
Baton Rouge LA 70816
b. Reporting Requirements And Deliverables
1. The contractor shall submit the items in quantities and during the time periods indicated
above to the following address:
National Hansen's Disease Programs
1770 Physicians Park Drive
Baton Rouge LA 70816
2. The Contractor shall deliver all items labeled per instructions, and in the quantity
cited, and at the time indicated or before the time indicated in this Article.
a. All deliverable reports are to carry at the top of the first page the following
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information:
1) Contract number
2) Deliverable item number
3) Deliverable item delivery due date
4) Date of submission
b. All deliverables items are to be separate physical entities.
e. All deliverables are subject to the review and approval of the COR.
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SECTION G — CONTRACT ADMINISTRATION DATA
GA Designation of Contracting Officer Representative (COR)
The person identified below is hereby designated as the Contracting Officer Representative (COR) for
this contract. The responsibility of the COR is to ensure that the Government's technical objectives are
met. To this end, the COR will provide necessary information, direction, coordination, etc., within the
contractual work description. Issuance of changes which affect the articles, terms, or conditions of this
contract will be accomplished through the Contracting Officer who is the only party authorized to bind
the Government to contract:
Irma Guerra
Health Resources and Services Administration
National Hansen's Disease Program (NHDP)
1700 Physicians Park Drive
Baton Rouge, LA 70816
Phone Number: 225-756-3764
Fax Number: 225-756-3806
Email: iguerra@hrsa.gov
G.2 Contracting Officer's Representative's Responsibility
Technical Direction — The COR will provide the necessary information, direction, and coordination
within the confines of the existing contractual work description in order for the contract to have a
successful outcome for the government.
This includes providing technical direction to the Contractor to guide the contract effort in order to
accomplish the contractual statement of work. This may include providing information to the Contractor
for assistance in the interpretation of government provided information, specifications or technical
portions of the work description, and where required by the contract, review and approval of product
deliverables of the Contractor to the Government under the contract.
Contract Progress and Performance Management — The COR should prepare a performance report
semiannually on the contractor's performance on this Contract. The minimal requirement is an annual
performance report. Performance reporting on this Contract follows established government guidelines
and is submitted to the Contractor and Contracting Officer with supporting documentation.
G.3 Restrictions on the Contracting Officer's Representative's Authority
Direction given by the COR to the Contractor must be within the parameters of the Statement of Work as
stated in the Contract.
The COR may not issue any direction to the Contractor that:
1. Solicits a proposal, OR
2. Constitutes an assignment of additional work outside the Statement of Work of this Contract, OR
3. In any manner causes an increase in the total contract cost or the time required for contract
performance, OR
4. Changes any of the express terms, conditions, or specifications of the Contract (i.e., changes in
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the price or scope of work, instructions to start or stop work, approval of any actions that will
result in additional charges to the government).
Issuance of changes that affect the articles, terms, or conditions of this Contract will be accomplished
through the Contracting Officer, who is the only party authorized to bind the Government to contract and
the only party who can determine if a direction is within the Statement of Work.
G.4 Key Personnel
Pursuant to the Key Personnel clause (111-1SAR 352.242-70) referenced in SECTION I of this contract, the
following individual(s) is (are) designated as Key Personnel and considered to be essential to the work
being performed under this contract:
Title Name
Program Manager - Refugee, Angelito Bravo
TB and Adult Immunizations
Contact Information for key personnel:
1645 E. Roosevelt St.
Phoenix, AZ 85006
Telephone No. (602) 372-1013
Fax No. (602) 372-0342
Email: AngelitoBravo t,mail.maricopa.gov
The person identified as the Key Personnel shall direct the necessary work and services toward fulfillment
of the contractual requirements. Prior to removing, replacing, or diverting the specified individual(s), the
Contractor shall notify the Contracting Officer in writing and reasonably in advance, and shall submit
justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on
the contract. No diversion shall be made by the Contractor without the written consent of the Contracting
Officer, provided that the Contracting Officer may ratify in writing changes made due to events beyond
the control of the Contractor, and such ratification shall constitute the consent of the Contracting Officer
required by this clause. Examples of events beyond the control of the Contractor are: (1) prolonged
sickness, (2) termination of employment, and (3) death. Key personnel, with the consent of the
Contracting Officer, may be amended from time to time during the course of the contract to either add or
delete personnel, as appropriate.
G.5 Submission of Invoices and Place of Payment
1. The Contractor shall submit monthly invoices. The monthly invoice shall be
determined by dividing the total annual amount for services by 12 months.
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2. The Contractor shall submit an original copy to the COR and one (1) copy to the
below address:
Health and Resources Services Administration
National Ilansen's Disease Programs
1770 Physicians Park Drive
Baton Rouge LA 70816
Attn: Financial Management Office
Reference Contract Number: 1IHS1125820 I 300005C
INVOICES WITHOUT ALL REQUIRED INFORMATION WILL BE DENIED UNTIL
THE PROPER INFORMATION IS SUBMITTED.
3. For inquiries regarding receiving, inspection and acceptance, rejections, or technical issues,
call your respective COR.
4. The Contractor agrees to include the following information on its invoice:
• Name and address of the Contractor same as on the contract;
• DUNS number;
• Invoice or voucher number;
• Invoice or voucher date;
• Dollar amount;
• Contract number ; order number ; Date of Delivery or Service;
• Description, quantity, unit of measure, unit price, and extended price of supplies
delivered or services performed;
• Information that supports request for payment; and
• Name and complete mailing address where payment is sent.
5. Receiving Payment under this contract
a. You must be able to accept electronic payments.
b. Have a valid TIN and DUNS Number and be registered in the System for Award
Management (SAM) database (http://www.sam.gov ). The Contractor shall maintain
registration during performance and through final payment of this contract.
c. Keep in mind if your bank merges with another bank or you change banks you are
responsible for updating the data in the SAM database. For inquiries regarding payment,
contact the Financial Management Office at (225) 756-3769.
G.6 Electronic Funds Transfer
The Contractor shall designate a financial institution for receipt of electronic funds transfer payments and
it shall be reported in Systems for Award Management (SAM) and shall be submitted in writing to the
finance office set forth in Section G.5.5. All data stored in the CCR and ORCA has been
transferred to the new Systems for Award Management (SAM) and can be found at
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www.sam.gov. Contractors are encouraged to periodically review their file for accuracy and are
required to re-reregister before their expiration date, which is the same date as their CCR
expiration date. SAM will notify users by e-mail that their file is due to expire beginning 60
days prior to expiration, then 30 days and finally 15 days before expiration. Directions on how
to navigate SAM can be found on the site's Home Page by clicking Help in the navigation bar at
the top of the page.
G.7 Evaluation of Contractor's Performance
Interim and final evaluation of Contractor performance on this contract shall be conducted in accordance
with FAR Subpart 42.15, and HHSAR 342.7001(d). Upon contract completion, a final evaluation of the
Contractor's performance shall be completed by the Government; see Section1, Attachment D.
The Government will conduct an evaluation of Contractor's performance based on the completion of the
tasks stated in the SOW. HRSA documents contractor performance using the Contractor Performance
Assessment Rating System (CPARS) (www.cpars.gov ). The evaluation shall be conducted by the COR
and be comprised of an evaluation of contractor performance completed by the Contractor and Federal
staff, and a review of progress reports and financial reports (deliverables).
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SECTION II — SPECIAL CON'IRACT REQUIREMENTS
H.1 Communication
Any HRSA communication products developed under this contract will require an additional separate
clearance on an ITHS-615 (for text and/or graphic publications arid products that will be printed, posted
on the Web, or disseminated through other electronic methods, such as by email) or an HI-IS-524A (for
audiovisual products, including those that will be posted on the Web). Communication clearance for this
contract itself does not satisfy the requirement to seek clearance of the specific HRSA communication
products.
H.2 Printing and Duplicating
The printing of government documents must be accomplished through the Government Printing Office
(GPO). Contractors and grantees shall not be used as sources of printing for the Department or OPDIVS.
Therefore, the inclusion of printing in contracts and grants is prohibited unless authorized by the Joint
Committee on Printing (ICP). All requests for waivers must go through the HHS Department Printing
Officer. Contractors may prepare copy, illustrative material (forms etc.) and for camera ready copy for the
purpose of producing publications.
The Contractor shall not engage in, nor subcontract for, any printing (as the term is defined in Title 1 of
the Government Printing and Binding Regulations in effect on the effective date of this contract) in
connection with the performance of work under this contract; except that performance of a requirement
under this contract involving less than 25,000 production units in the aggregate of multiple pages will not
be deemed to be printing. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only,
and one color.
Regarding the use of private funds for printing, the regulations state that when appropriated funds are to
be used to create information for publication, the printing of that information cannot be made available to
a private publisher for publication without prior approval of the congressional Joint Committee on
Printing by way of the office offlUIS Department Printing Officer. For any questions, please contact the
Ef_HS Department Printing Officer at 301-594-3185.
H.3 Clearance/Production of Information Products/Services
The U.S. Department of Health and Human Services (HI-IS), Office of the Assistant Secretary for Public
Affairs, requires clearance for any external communication products, which includes publications,
audiovisual products, multimedia products, exhibits (including exhibit structures), conferences (including
program/agenda books and other meeting materials), or public affairs services produced for or by HRSA
through this contract as a deliverable. An external communication product is one that will be distributed
outside of HRSA in any quantity. This clearance, which takes approximately 4 weeks, is obtained by the
project officer through FIRSA's Office of Communications.
It is the policy of HEIS that HHS must be prominently and dominantly identified as the primary
publisher/producer, to include the name of MIS and placement of the MIS logo, on all
communication materials, including those produced for Government publications and
Government printed matter by contractors.
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The name of the U.S. Department of Health and Human Services and the Health Resources and
Services Administration must be spelled out on the front cover of publications and on the opening
and closing frames of audiovisual products. The FIRS and URSA logos must be displayed in
addition to spelling out the names of the Department and the Agency. Use of the MIS and
HRSA logos that include the names of the Department and the Agency as part of the graphics in
the logos does not satisfy the requirement to spell out the names of HHS and HRSA. All
publications and audiovisual products must display the month and year of issuance. The HHS
and HR SA logos must be displayed on the front cover of any publications and on the opening and
closing frames of any audiovisual products. The requirement for placement of the logos may be
satisfied by displaying the HI-IS logo on the bottom left corner and the HRSA logo on the bottom
right corner. The HHS logo should be larger than the URSA logo. Government publications or
other Government printed matter may not include the contractor's logo unless specifically
authorized in accordance with agency policy and procedures
(http://www.hhs.gov/web/policies/webpolicies/logopolicies/logos contractors.html)
Communication products are any and all products intended for audiences outside the Agency,
including but not limited to:
• reports, booklets, manuals, fact sheets, newsletters, brochures, flyers
• Internet publications
• press releases, advisories, other media materials (including press kits)
• exhibits, exhibit structures
• conferences, meeting materials (including program/agenda books)
• summaries, monographs, proceedings
• slides, overhead transparencies, posters
• audio and videotapes, films, CDs, DVDs, and other audiovisual products
• multimedia products, educational or information modules
• advertisements and/or scripts for radio, TV, Web, or other venue
Internal publications (no copies will be distributed outside of the Agency in print; electronically
•by any means, including by email or listserv; and will not be posted on the Internet) are exempted
from this requirement. Where appropriate, the words Health Resources and Services
Administration, Bureau ..., Office of, Division of ..., shall be included above the HRSA logo.
Title 44 of the U.S. Code requires that the printing of any publication developed under this
contract shall be done by the Government Printing Office. Printing shall be coordinated through
the Contracting Officer Technical Representative.
NOTE: OMB clearance must be obtained if you (the contractor) intend to survey or interview
more than 9 people outside of HRSA and/or the Department, including grantees. Failure on the
part of the Contractor to comply with the printing and duplicating, and publication clearance
requirements stated above will be deemed unauthorized services and reimbursement will be
denied.
H.4 Language Disclaimer
The views expressed in written conference materials, publications, audiovisual products, and by speakers
and moderators at HHS-sponsored conferences, do not necessarily reflect the official policies of the U.S.
-18

Department of Health and Human Services nor does mention of trade names, commercial practices, or
organizations imply endorsement by the U.S. Government.
H.5 Rights in Data
The Contractor will be prohibited from copyrighting, publishing or disseminating information resulting
from work performed under this contract, and/or, using data produced or obtained under this contract,
and/or any other information or products provided by the Government, or which the Contractor develops,
for any purpose other than performance under this contract without prior written approval from the
Contracting Officer.
Ownership of Documents, Materials and Records: All documents, materials (including any computer
code) or records provided to the Contractor, developed or maintained by the Contractor in the
performance of this contract are deemed to be property of the Government.
H.6 Limited Use of Data
Performance of this effort may require the Contractor to access and use data and information proprietary
to a Government agency or Government Contractor which is of such a nature that its dissemination or use,
other than in performance of this effort, would be adverse to the interests of the Government and/or
others.
Contractor and/or Contractor personnel shall not divulge or release data or information developed or
obtained in performance of this effort, until made public by the Government, except to authorize
Government personnel or upon written approval of the Contracting Officer (CO). The Contractor shall
not use, disclose, or reproduce proprietary data that bears a restrictive legend, other than as required in the
performance of this effort. Nothing herein shall preclude the use of any data independently acquired by
the Contractor without such limitations or prohibit an agreement at no cost to the Government between
the Contractor and the data owner which provides for greater rights to the Contractor.
1-1.7 Disclosure of Information
Information made available to the Contractor by the Government for the performance or administration of
this effort shall be used only for those purposes and shall not be used in any other way without the written
agreement of the Contracting Officer.
The Contractor agrees to assume responsibility for protecting the confidentiality of Government records,
which are not public information. Each Contractor or employee of the Contractor to whom information
may be made available or disclosed shall be notified in writing by the Contractor that such information
may be disclosed only for a purpose and to the extent authorized herein.
11.8 Confidentiality Agreement Requirement
The Contractor shall implement a confidentiality agreement related to all data provided by the
Government staff: All Contractor staff that work with the Federal Government and are provided
information and access to databases shall sign such an agreement and a copy of the signed agreement for
each relevant staff member shall be submitted to the COR prior to receipt of relevant documents.
19

H.9. Homeland Security Presidential Directive-12
To perform the work specified herein the Contractor personnel may require access to sensitive data,
regular access to HEIS-controlled facilities and/or access to HHS information systems, the Government
may require that this effort entail a background investigation.
• Upon receipt of the Government's notification of applicable Suitability Background Investigation
required, the Contractor shall complete and submit required forms within 30 days of the
notification. Additional submission instructions can be found at the NCI Information Technology
Security Policies, Background Investigation Process: (http://ais.nci.nih.gov/).
• The Contractor shall submit a roster, by name, position and responsibility, of all staff working under
the contract. The roster shall be submifted to the Contracting Officer Representative (COR), with a
copy to the HRSA Division of Workforce Management and Contracting Officer, within 14 days of
the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be
submitted within fifteen (15) calendar days of the change. The COR will submit the list to the HRSA
Personnel Security Officer for determination of the appropriate level of suitability investigations to be
performed.
Contractors should ensure that the employees whose names they submit have a reasonable chance for
approval. While delays in performance caused by successful investigations will be the Government's
responsibility, delays associated with rejections will be the Contractor's responsibility. Typically, the
Government conducts investigations and checks at no cost to the Contractor. Multiple investigations for
the same position, whether- resulting from rejections or resulting from an employee's move to another
position(s) or company, may at the Contracting Officer's discretion, justify reductions(s) in the contract
price of no more than the cost of the extra investigation.
H.10. Food
It is the Department's policy that OPDIVs and STAFFDIVs shall not use appropriated funds
(whether from an annual appropriation, multi-year appropriation, appropriated user fee,
mandatory appropriation, gift funds, or reimbursements from such appropriations, etc.) to
purchase food (whether for conferences or meetings; for meals, light refreshments, or beverages;
or for Federal or non-Federal participants). Food and meals are not to be provided and are an
unallowable expense.
H.11. System for Award Management (SAM)
The Contractor must be registered in the SAM database at www.sam.gov . "Registered in the SAM
database" means that (1) the Contractor has entered all mandatory information, including the DUNS
number or the DUNS+4 number, into the SAM database; and (2) The Government has validated all
mandatory data fields and has marked the record "Active".
By submission of an offer, the Offeror acknowledges the requirement that a prospective awardee shall be
registered in the SAM database prior to award, during performance, and through final payment of any
contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this
20

solicitation. If not registered in the SAM database within the time prescribed by the Contracting Officer,
the Contracting Officer will proceed to award to the next otherwise successful registered Offeror
H.12. Medical Records
The contractor shall ensure the confidentiality of the record under the Privacy Act of 1974 and HIPAA as
it relates to the release of medical information.
H.13. Quality Assurance
The contractor shall perform all the requirements identified in this contract. The contractor shall supervise
the reviews in accordance with Government Auditing Standards. The COR shall review and approve all
work products and deliverables submitted by the contractor in accordance with the terms and conditions
identified under the contract.
HRSA reserves the right to obtain and review working papers from the contractor for the period
beginning with the effective date of the contract through its termination. These reviews shall be conducted
at HRSA's discretion at either the contractor's site or at the appropriate HRSA office. When reviewed at
the HRSA's site, the working papers will be sent to the HRSA office for review and evaluation by HRSA
staff. After completion of the review, HRSA may hold a conference with the contractor to discuss any •
issues. HRSA may choose to visit the contractor or subcontractor site during the audit to assess
performance of the review. The contractor shall maintain an internal quality control program adequate to
ensure that the requirements of the contract are met. As with the working paper review, HRSA reserves
the right to obtain and review all working papers associated with the contractor's internal quality control
program. These reviews shall be conducted at HR.SA's site, the working papers will be sent to the HRSA
office for review and evaluation by URSA staff. After completion of the review, HRSA may hold a
conference with the contractor to discuss any issues. HRSA may choose to visit the contractor and/or the
subcontractor's site during the review to assess performance of the reviews.
21

SECTION I — CONTRACT CLAUSES
I.1 Federal Acquisition Regulation (FAR) (48 CFR Chapter I) Contract Clauses
A. FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998) —This contract incorporates one or
more clauses by reference, with the same force and effect as if they were given in full text. Upon
request, the Contracting Officer will make their full text available. Also, the full text of a clause
may be accessed electronically at www.acquisition.gov/far.
Clause No. Title Date
52.202-1 Definitions JAN 2012
52.203-3 Gratuities APR 1984
52.203-5 Covenant Against Contingent Fees APR 1984
52.203-6 Restrictions on Subcontractor Sales to the Government SEPT 2006
52.203-7 Anti-Kickback Procedures OCT 2010
52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal JAN 1997
or Improper Activity
52.203-10 Price or Fee Adjustment for Illegal or Improper Activity JAN 1997
52.203-12 Limitation on Payments to Influence Certain Federal OCT 2010
Transactions
52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber MAY 2011
Content Paper
52.204-6 Data Universal Numbering System (DUNS) Number APR 2008
52.204-7 Central Contractor Registration (now System for Award AUG 2012
Management (SAM))
52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011
52.204-10 Report of Executive Compensation and First Tier AUG 2012
Subcontractor Awards
51209-6 Protecting the Government's Interest When Subcontracting DEC 2010
with Contractors Debarred, Suspended, or Proposed for
Debarment
52.215-2 Audit and Records—Negotiation OCT 2010
52.215-8 Order of Precedence—Uniform Contract Format OCT 1997
51215-10 Price Reduction for Defective Cost or Pricing Data OCT 1997
52.215-18 Reversion or Adjustment of Plans for Postretirement JUL 2005
Benefits (PRB) Other Than Pensions
52.215-20 Requirements for Certified Cost or Pricing Data OCT 1997
52.215-21 Requirements for Cost or Pricing Data or Information Other OCT 1997
Than Cost or Pricing Data — Modifications
52.219-14 Limitations on Subcontracting NOV 2011
52.222-1 Notice to the Government of Labor Disputes FEB 1997
52.222-3 Convict Labor JUN 2003
52.222-17 Nondisplacement of Qualified Workers Under Service
Contracts JAN 2013
52.222-21 Prohibition of Segregated Facilities FEB 1999
52.222-26 Equal Opportunity MAR 2007
52.222-35 Equal Opportunity for Veterans SEP 2010
52.222-36 Affirmative Action for Workers with Disabilities OCT 2010
22

Clause No. Title Date
52.222-37 Employment Reports Veterans SEP 2010
52.222-38 Compliance with Veteran's Employment Reporting SEPT 2010
Requirements
52.222-41 Service Contract Act of 1965 NOV 2007
52.222-42 Statement of Equivalent Rates for Federal Hires MAY 1989
52.222-43 Fair Labor Standards Act and Service Contract Act-Price SEPT 2009
52.222-54 Adjustment Employment Eligibility JUL 2012
Verification
52.223-3 Hazardous Material Identification and Material Safety Data JAN 1997
52-223-5 Pollution Prevention and Right-to-Know Information MAY 2011
52.223-6 Drug-Free Workplace MAY 2001
52.223-10 Waste Reduction Program MAY 2011
52.224-1 Privacy Act Notification APR 1984
52.224-2 Privacy Act APR 1984
52.225-13 Restrictions on Certain Foreign Purchases JUN 2008
52.227-1 Authorization and Consent DEC 2007
52.227-14 Rights in Data-General DEC 2007
52.227-17 Rights in Data-Special Works DEC 2007
52.228-7 Insurance-Liability to Third Persons MAR 1996
52.229-3 Federal, State and Local Taxes APR 2003
52.230-2 Cost Accounting Standards MAY 2012
52.230-3 Disclosure and Consistency of Cost Accounting Practices MAY 2012
52.230-6 Administration of Cost Accounting Standards JUN 2010
52.232-1 Payments APR 1984
52.232-9 Limitation on Withholding of Payments APR 1984
52232-13 Notice of Progress Payments APR 1984
52.232-17 Interest OCT 2010
52.232-18 Availability of Funds APR 1984
52.232-23 Assignment of Claims JAN 1986
52.232-25 Prompt Payment OCT 2008
52.232-33 Payment by Electronic Funds Transfer-Central Contractor OCT 2003
Registration (now known as System for Award Management
(SAM)
52.232-38 Submission of Electronic Funds Transfer Information with
Offer MAY 1999
52.232-99 Providing Accelerated Payment to Small Business
Subcontractor AUG 2012
52.233-1 Disputes JUL 2002
52.233-2 Service of Protest SEPT 2006
52.233-3 Protest After Award-Alternate I (JUN 1985) AUG 1996
52.233-4 Applicable Law for Breach of Contract Claim OCT 2004
52.237-3 Continuity of Services JAN 1991
52.237-7 Indemnification and Medical Liability Insurance JAN 1997
52.239-1 Privacy or Security Safeguards AUG 1996
52.242-17 Government Delay of Work APR 1984
52.242-13 Bankruptcy JUL 1995
52.243-1 Changes-Fixed Price (AUG 1997) Alternate I APR 1984
23

Clause No Title Date
52.244-2 Subcontracts OCT 2010
52.244-5 Competition in Subcontracting DEC 1996
52.244-6 Subcontracts for Commercial Items DEC 2010
52.246-25 Limitation of Liability—Services FEB 1997
52.249-2 Termination for Convenience of the Government (Fixed
Price) MAY 2004
52.249-8 Termination (Fixed Price) APR 1984
52.253-1 Computer Generated Forms JAN 1991
A. Department of Health and Human Services Acquisition Regulation (HHSAR) (48 CFR Chapter
3) (http://www.hhs.gov/policies/hhsar/subpart301-1.html)
Clause No. Title Date
352.201-70 Paperwork Reduction Act JAN 2006
352.202-1 Definitions JAN 2006
352.224-70 Privacy Act JAN 2006
352.227-70 Publications and Publicity JAN 2006
352.228-7 Insurance - Liability to Third Persons DEC 1991
352.231-70 Salary Rate Limitation JAN 2010
352.233-71 Litigation and Claims JAN 2006
352.242-71 Tobacco-free Facilities JAN 2006
352.242-70 Key Personnel JAN 2006
352.242-73 Withholding of Contract Payments JAN 2006
352.242-74 Final Decisions on Audit Findings APR 1984
352.270-10 Anti-Lobbying (applies if contract exceeds JAN 2006
$100,000)
352.270-1 Accessibility of Meetings, Conferences, and JAN 2001
Seminars to Persons with Disabilities
1.2. Options
a. FAR 52.217-8, OPTION TO EXTEND SERVICES (NOV 1999)
The Government may require continued performance of any services within the limits and at the
rates specified in the contract. These rates may be adjusted only as a result of revisions to
prevailing labor rates provided by the Secretary of Labor. The option provision may be
exercised more than once, but the total extension of performance hereunder shall not exceed 6
months. The Contracting Officer may exercise the option by written notice to the Contractor
within the period specified in the Schedule
24

b. FAR 52.217-9, OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)
(a) The Government may extend the term of this contract by written notice to the Contractor
within twelve (12) months, provided that the Government shall give the Contractor a
preliminary written notice of its intent to extend at least sixty (60) days before the contract
expires. The preliminary notice does not commit the Government to an extension.
(b) If the Government exercises these options, the extended contract shall be considered to
include this option provision.
(c) The total duration of this contract, including the exercise of any options under this clause,
shall not exceed sixty (60) months.
25

SECTION J— LIST OF ATTACHMENTS
J.1 The following attachments are made part of this solicitation:
Attachment Title No. of Pages
A Statement of Work 11
Billing Instructions . 2
CPARS Information Sheet 1
A Manual for the Care of Hansen's
Disease in the United States 49
Wage Determination No. 2005-2023 8
Revision No. 17; Date of Revision
06/19/2013
26

ATTACHMENT A - STATEMENT OF WORK
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 DI-IRS 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 HID 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.
II. PURPOSE/GENERAL DESCRIPTON
The purpose of this contract is to provide Hansen's Disease (RD) 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 HD ruled out as a diagnosis, or has been diagnosed as having
RD, is eligible for care under this contract.
27

2. HD contact Any person who has lived in the same household with a new ED 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 HD 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 HD 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
i. 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
28

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 FED 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 HD and its related conditions. Services to be provided through this
contract, according to the following protocol include:
Task I. Patient Assessment:
Evaluation of a patient with suspected or confirmed FIB 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
29

2" 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 infoimative 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 HD under this contract.
The Treatment Protocol for Hansen's Disease in the U.S. is multi-drug therapy which includes the
drugs Dapsone, Rifatnpin and Clofazimine. Medications used for the treatment of reaction in HD
are prednisone, clofazimine, and thalidomide. Alternative anti-microbial agents include
minocycline, and elarithromyein, (See NE1DP website, www.hrsa.gov/hansensdisease.)
30

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
ITuberculoid (TT & BT) (WHO classification Paucibacillary, "PB")
lAgent Dose Duration
iDapsone
100 mg daily
1 1 12 months, and then therapy discontinued
TRifampicin
600 mg daily
Adults
Lepromatous (LL, BL, BB) (WHO classification Multibacillary, "MB")
Agent Dose Duration '
Dapsone
100 mg daily
24 months, and then therapy discontinued
Rifampiein
600 mg daily
Clofazimine b
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 HD 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 BD in the U.S.
In order for physicians to obtain the drug for treating HD, they will have to be registered as an
31

investigator under the NHDP END. This will require submitting a signed FDA form 1572, providing a
curriculum vitae, and obtaining and maintaining local Institutional Review Board (IRE) 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 708 I 6
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 1 mg/ Kg daily
12 months, and then therapy discontinued
Rifampicin 1-2 mg/ Kg daily
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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33

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 11 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 NHDP 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 HD shall incorporate physical therapy, occupational therapy, pedorthies, 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,
34

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 neeessaiy.
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.
35

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 N1TDP — Physicians at NHDP in Baton Rouge, Louisiana
may authorize referrals on a ease-by-case basis
B. Patient Transportation — Reimbursement for travel to the BID 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 necessaty 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, TM Manual, Forms and
Procedure)
A. Leprosy Surveillance Form —The NHDP maintains a National HD Registty 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.govihansens, 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
36

B. The contractor shall submit, semi-annually, a password-protected electronic
report on CD generated with the use of Microsoft Access or compatible database,
with the following information:
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
it. 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
I) 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
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
37

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, www.hrsa.gov/hansens or by calling 1-800-642-2477.
D. The online course, "Lower Extremity Amputation Prevention and Treatment of
the Neuropathie Foot," is highly recommended for physicians, nurses, and
therapists providing services through this contract. This course can be found at
www.hrsa.gov/leap/brochure.htm.
38

ATTACHMENT B - BILLING INSTRUCTIONS
A. RECEIVING PAYMENT UNDER ATTACHED AWARD
1. You must be able to accept electronic payments.
2. Have a valid TIN and DUNS Number and be registered in the System for Award Management (SAM)
database (http://vvvvw.sam.gov). The Contractor shall maintain registration during performance and
through final payment of this contract.
Keep in mind if your bank merges with another bank or you change banks you are responsible
for updating the data in the SAM database. For inquiries regarding payment, call the Financial
Management Office at (225) 766-3769.
B. SUBMITTING INVOICES
Before submitting an invoice, you should make sure that the invoice contains the following information:
1. The Contractor shall submit invoices/vouchers in Microsoft Word or PDF format using
Standard Form SF1034 "Public Voucher for Purchases and Services Other than Personal"
and include the following information:
• Name and address of the Contractor same as on the contract;
• DUNS number;
• Invoice or voucher number;
• Invoice or voucher date;
• Dollar amount;
• Contract number ; order number ; Date of Delivery or Service;
• Description, quantity, unit of measure, unit price, and extended price of supplies delivered or
services performed;
• Information that supports request for payment; and
• Name and complete mailing address where payment is sent.
2. Inquiries:
Regarding payment, call (225) 756-3769;
Regarding receiving, inspection and acceptance, or technical issues, call your Contracting
Officer Representative;
Regarding suspension or rejection call your Contract Specialist.
INVOICES WITHOUT ALL REQUIRED INFORMATION WILL BE DENIED UNTIL THE PROPER
INFORMATION IS SUBMITTED.
Note: Your respective COR does not have the authority to (1) solicit proposals, (2) modify the stated
terms of the award (i.e. change in price, change in scope of work), (3) issue instructions to the contractor
to start or stop work, or (4) approve any action that will result in additional charges to the government.
These changes are the sole responsibility of the Contracting Officer. The Government will not be
responsible for cost overruns or unauthorized procurements made by the vendor.
39

Standard FOrM 1034 VOUCHER NO.
Revised October 19137 PUBLIC VOUCHER FOR PURCHASES AND
Department of the Treasury
1 TFM 4-200-0 SERVICES OTHER THAN PERSONAL
1(134-122
U.S.DEPARTMENT, BUREAU, OR ESTABLISHMENT AND LOCATION DATE VOUCHER PREPARED SCHEDULE NO.
CONTRACT NUMBER AND DATE I. PAID BY
REQUISITION NUMBER AND DATE
A. PAYEE'S DATE INVOICE RECEIVED
NAME
AND
ADDRESS DISCOUNT TERMS
' PAYEE'S ACCOUNT NUMBER
GOVERNMENT B/L NUMBER
SHIPPED FROM TO WEIGHT
NUMBER DATE OF ARTICLES OR SERVICES UNIT PRICE AMOUNT
AND DATE DELIVERY OR (Enter description, item number of contract or Federal supply QUAN- TITY
OF ORDER schedule, and other information deemed necessary) COST PER (1)
SERVICE
(Use continuation sheets if necessary) (Payee must NOT use the space below) TOTAL
PAYMENT: APPROVED FOR EXCHANGE RATE DIFFERENCES
El PROVISIONAL 4 41.00
El COMPLETE BY2
El PARTIAL
D FINAL Amount verified; correct for
El PROGRESS TITLE (Signature or inifials)
El ADVANCE
Pursuant to authority vested in me, I certify that this voucher is correct and proper for payment,
(Date) (Authorized Certifying orficeo2 (Title)
ACCOUNTING CLASSIFICATION
CHECK NUMBER ON ACCOUNT OF U.S. TREASURY CHECK NUMBER ON (Name of bank)
CASH DATE PAYEE°
$
i When slated in foreign currently, insert name of currency. PER
211 the ability to certify and authority to approve are combioed in one person, one signature only Is necessary; otherwise the
approving oMcer will sign In the space provided, over his official tille.
3 When a voucher is recaipted In the name of a company or corporation, the name of the peach writing the company Or cOrpOrate TITLE
name, an well as the capacity In which he signs, must appear. For example: 'John One Company, per John Smith, Secretary" or
"Treasurer, as the case may be.
Previous edition usable NSN 750-00-634-4206
40

PRIVACY ACT STATEMENT
The information requested on this form is required under the provisions of 31 U.S.C. 82b and 82c, for the purpose of disbursing Federal money. The information requested is to identify the
particular creditor and the amounts to be paid. Failure to furnish this information will hinder discharge of the payment obligation.
41

ATTACHMENT C — CPARS INFORMATION SHEET
The Contractor Performance Assessment Reporting System (CPARS) is the Department of
Defense (DoD) Enterprise Solution for collection of contractor Past Performance Information
(PPI) as required by the Federal Acquisition Regulation (FAR). CPARS is a web-enabled
application that collects and manages a library of automated contractor report cards. A report
card assesses a contractor's performance and provides a record, both positive and negative, on a
given contract for a specific period of time. Each report card is based on objective facts and is
supported by program and contract management data. Use of CPARS promotes report card
consistency, increases data integrity, and motivates improved contractor performance. For more
information, see www.cpars.gov
42

ATTACHMENT D - A Manual for the Care of Hansen's Disease in the United States
43

A MANUAL FOR THE CARE OF
IHANS171TE OISEzt
IN THE
UNITED STATES
National Hansen's Disease Programs
Ambulatory Care Program
1770 Physicians Park Drive
Baton Rouge, Louisiana 70816
Phone: 1-800-642-2477
Website: www.hrsa,gov/hansensdisease
NHDP1ACP
Rev. 8/2012

TABLE OF CONTENTS
Page
Introduction 1
Mission
Eligibility
Objective
Background
Epidemic logy 2
Bacteriology 2
Management of Hansen 's Disease 2
Clinical Aspects 2
Effects of 14ansen's Disease on Peripheral Nerves 3
The Peripheral Nerves 3
Surgery 4
Silent Neuritis 4
HD and Pregnancy 5
HD and Children 5
Testicular I-1D 6
Diagnostic Criteria 6
Schedule of Services 6
Patient Assessment 7
Laboratory Monitoring
Treatment of I ID in the U.S. 8
Reactions in HD 13
Rehabilitation Services 15
Consultant Services 16
Contact Follow-UP 16
Reporting Requirements 17
Patient Education 17
Referrals to NHDP 17
Ambulatory Care Program 17
Private Physician Program 17
Resources 18
Forms and Procedures

NATIONAL HANSEN'S DISEASE PROGRAM
A MANUAL FOR THE CARE OF HANSEN'S DISEASE
IN THE UNITED STATES
INTRODUCTION
MISSION
The National Hansen's Disease Program (NHDP) is an activity in the Department of Health and
Human Services (DHHS), Health Resources and Services Administration (HRSA), and the
Healthcare Systems Bureau. It is authorized by Public Law 99-117, Section 2.. (a), Section 320
and is guided by DHHS regulations. The NHDP is charged with the responsibility of providing
Hansen's disease (HD) treatment for individuals with this disease through the NHDP, in Baton
Rouge, Louisiana, and through its Ambulatory Care Program.
ELIGIBILITY
Any individual living in the United States and Puerto Rico may receive outpatient medical care
for the diagnosis and treatment of HD and its complications. Contacts of these patients are also
eligible for services as described by NHDP policy (see "Contact Surveillance" in this Manual)
OBJECTIVE
The goal of the National Hansen's Disease Program is to prevent deformity and disability from
HD through early diagnosis and treatment. The purpose of this Manual is to serve as a resource
for the diagnosis, care, and treatment of I ID in the United States (U.S.).
BACKGROUND
The NHDP in the United States has a 100-year history of caring for people diagnosed with this
disease. It began in 1896 in Carville, Louisiana, with the Daughters of Charity of St Vincent de
Paul who provided basic services to a small group of patients from New Orleans. In 1921 it
became the federally-funded Gillis W. Long Hansen's Disease Center and the only inpatient
facility for HD in the country.
In the early 40's, the use of sulfone therapy by Dr. Guy Paget at the Center resulted in the
development of dapsone as a bactericidal agent against Mycobacterium loprae, the organism that
causes the disease. This led to the greatest change in patient care, for patients could now be
discharged from "Carville" and new patients could be treated on an outpatient basis.
The year 1960 Dr. Paul Brand, FRCS, FACS, an orthopedic surgeon, initiated rehabilitative
procedures at Carville which effectively decreased the frequency of amputation of the lower
extremities. These procedures have been incorporated into what is now LEAP, or Lower
Extremity Amputation Prevention, the core of the Foot Seminars at the NHDP.
1

In 1981, the Federal Government initiated the Ambulatory Care Program (ACP), which provides
HD medical care through Outpatient Clinics in the U.S. and Puerto Rico. Services provided by
these Clinics include diagnosis and treatment of HD and related conditions, laboratory
monitoring, consultant services, and patient and community education.
In January, 2000, the NHDP relocated its services at Carville to Oehsner Medical Center campus
in Baton Rouge, LA, and now functions as the primary Outpatient Referral Center for the
diagnosis and treatment of HD.
EPIDEMIOLOGY
The NHDP has responsibility for the National Hansen's Disease Registry, which is maintained
through the submission of HD Surveillance Forms by private providers, and from the Outpatient
HD clinics. California, Florida, Hawaii, Louisiana, Massachusetts, New York, and Texas
collectively accounted for the largest number of the total reported cases. Although the number of
cases reported annually is affected considerably by immigration patterns, the average number of
annual cases reported over the past decade is 130.5.
Hansen's disease occurs in all age groups with a U.S. median age at diagnosis of 35.0 years. The
disease exhibits a gender bias with twice as many male cases as female. A race/ethnicity
breakdown shows that three fourths of the reported cases are represented by the Asian/Pacific
Islander and White Hispanic groups, but fully 50% of the endemic cases are classified as White,
Not Hispanic. (See "Data & Statistics" at www.lirsa.govihansensdisease
3 for more information)
BACTERIOLOGY
HD is caused by Mycobacterium leprae, a slow-growing, acid-fast bacillus. The incubation
period for HD may be two-five years, although it can be as long as 15-20 years or more. The
disease is probably spread through airborne droplets from the nasal mucosa and upper airways of
a person with untreated disease, or through prolonged skin contact with this person. Armadillos
may also carry the disease. The communicability of HD is very low, however, and about 95% of
the world's population has a natural immunity to this bacillus. A person with HD becomes non-
communicable within one week of starting treatment.
MANAGEMENT OF HANSEN'S DISEASE
CLINICAL ASPECTS OF HANSEN'S DISEASE
IlD affects the skin, peripheral nerves, eyes, and mucous membranes of the upper respiratory
tract, especially the nose. Nerve damage caused by the bacillus may result in anesthesia and
deformities of the hands and feet and lagophthalmos of the eyes. In leprornatous HD there may
be frills, direct invasion of the anterior part of the eye by the bacilli, and in males, it may cause
testicular atrophy and gynecomastia. A complete physical assessment of the patient is necessary.
2

In most people, resistance develops to infection with M.leprae. The body's defenses kill the
invading bacteria, or contain the infection so disease does not develop. In persons with limited
or no resistance to the disease, the bacteria grow slowly, eventually leading to the appearance of
symptoms. Presence of the bacteria will be demonstrated with skin smears or biopsy.
Hypo- or hyper-pigmented, flat or raised lesions appear, which are insensitive to light touch.
These are most commonly found on the buttocks, thighs, trunk, and lateral aspect of the upper
and tower extremities. There may be anhidrosis, loss of hair on the skin, and changes in skin
texture. The earlobes may be swollen and pendulous.
Patients may experience inflammation of the eyes, excessive or decreased tearing, loss of corneal
sensation and lateral eyebrows, and incomplete closure of the eyelids.
Muscle strength of the hands and feet may be affected. There may be dryness, decreased
sensation, muscle atrophy, deformity such as clawing of fingers or toes, wounds, and ulcers.
Male patients may have painful, swollen testicles or gynecomastia.
Peripheral nerves may be enlarged or tender. The ulnar, median, radial cutaneous, posterior
tibial, peroneal, and greater auricular are most commonly affected. Some patients complain of
pain in the extremities, and a burning sensation in the soles of the feet, Abnormal nerves will
feel sclerosed.
Effects of Hansen's Disease on Peripheral Nerves
Disability and deformity in HD are primarily due to nerve damage. The damage is caused by
bacilli in the perineurium, the influx of inflammatory cells, the sheer bulk of bacillary material in
both Schwarm cells and invading macrophages, and by fibrosis occurring in the inflamed nerve.
In addition to sensory loss or muscle paralysis, other effects of this denervation are anhydrosis
and decreased oil production in the skin. This causes the skin to become dry and inelastic,
leading to difficulties in healing when trauma occurs. The functionally important nerves most
commonly damaged are the facial, ulnar, median, radial, peroneal, and posterior tibial.
Most of the disability and deformity in HD is secondary due to repetitive trauma and infection of
insensitive areas. These secondary effects of nerve damage are preventable. Persons with normal
sensation rely on the sense of pain to warn them of possible trauma and are able to prevent
serious injury. Those who have lost sensation have to learn other methods to protect insensitive
areas from injury. The specific psychological effects associated with a significant loss of
sensation also need to be considered.
The Peripheral Nerves
a The Facial Nerve - The orbicularis muscle, innervated by the facial nerve, is sometimes
affected in persons with RD. Damage to this nerve results in lagophthahnos, exposing the
cornea to possible damage, especially during sleep. Loss of corneal sensation will
compound the problem because the blink reflex may be compromised.
3

• Ulnar, Median, and Radial Nerves - Most commonly, the ulnar nerve is involved at the
elbow and the wrist, and the median nerve is damaged just proximal to the wrist and in
the carpal tunnel. Early signs are dryness of the hands, callus formation, and signs of
trauma due to insensitivity, such as burns. The result of severe nerve damage will be
atrophy of the intrinsic muscles of the hand, including the hypothenar and thenax areas.
There may be clawing of the digits and weakness of pinch (ulnar) loss of opposition of
the thumb (median), and wrist drop (radial).
Peroneal and Posterior Tibial Nerve - Damage to the peroneal nerve causes anesthesia in
the lateral aspect of the lower extremities and dorsum of the feet. The motor deficit is in
the peroneal muscles and dorsiflexors of the foot; the earliest sign is difficulty in
dorsiflexion or eversion of the foot against pressure. The result of a full motor deficit in
this area is foot drop. Damage to the posterior tibial nerve will result in anesthesia of the
plantar surface of the tbot, and claw toes. Observe for a high-stepping, inverted gait,
callus formation on the toes and plantar surface, and erythematous or warm pressure
areas on the foot.
• Sensory Testing of Hands and Feet - Sensory testing of hands and feet with nylon
filament should be done at the time of diagnosis and periodically during treatment to
detect evidence of nerve damage at the earliest possible stages, This is an important part
of disability prevention. Early detection of problems makes it possible to take steps which
can prevent further nerve damage.
Surgery
Most patients with I ID do not require any surgery but there are occasional situations in which the
following surgical procedures may assist in therapy or rehabilitation:
• Incision and Drainage
• Tendon transfer procedure
• Surgical release of nerves
• Procedures for stabilization of Charcot foot.
Silent Neuritis
There are some patients who have no signs of reaction or nerve pain, but continue to have
progressive sensory or motor loss in hands or feet. Such patients need to be assessed to
determine that they are receiving appropriate chemotherapy since noncompliance with drug
intake could contribute to this problem. However, there are still some patients who are taking
their medications regularly and still have deteriorating nerve function. The cause of this
deterioration is not known, but some of these patients will have improvement if they receive
steroid treatment. If the loss of function has been 3 months or less, they should be given a course
of steroids in the dose range for reactions. If the loss has been present for longer than 3 months
the chance of recovery is diminished. Therefore, it is important to monitor all patients under
treatment for any changes in nerve function and treat accordingly.
4

HD and Pregnancy
A female with HD who is pregnant is rare in the U.S., but a few cases occur each year. The
majority of these pregnancies are uneventful as far as HD is concerned, but there are a number of
potential problems and risks that should be considered when advising female HD patients of
childbearing age, and when managing patients who are already pregnant and have HD.
All female patients of childbearing age should be advised to avoid pregnancy during early stages
of the disease, at least until MDT has been completed and preferably until the disease is
completely inactive. The postponement of pregnancy is especially important for patients who
have evidence of reaction or neuritis since these problems will be exacerbated during pregnancy
and the postpartum period. There may also be a very small risk of transmission of the disease
from mother to infant in those eases where the pregnancy occurs before treatment or early in the
course of treatment.
There are alterations in the immune response during all pregnancies, causing a depression of the
cell-mediated immune system. This immune suppression during pregnancy and its recovery in
the postpartum period appears to play a role in the clinical manifestations of in women. It is
common for the first symptoms of HD in young women to occur during pregnancy or the
postpartum period. An increased risk of relapse during pregnancy has also been reported.
ENL is more common during pregnancy when the Mil is depressed, while reversal reaction is
more common during the postpartum period when the CMI is recovering.
The risk of reactions or neuritis during pregnancy will vary considerably with the type of disease
and the amount of treatment a patient has received prior to the pregnancy. If a reaction occurs
during a pregnancy, it should be managed as in non-pregnant patients with the use of prednisone
sufficient to control the reaction and prevent nerve damage. Thalidomide cannot be used.
For patients who are or become pregnant during the early stages of the disease, chemotherapy
should generally continue during pregnancy with some modification of the regimens in some
eases. We avoid the use of rifampin during pregnancy if possible. Dapsone can be continued
throughout the pregnancy.
Patients who have had HD sometime in the past, who have been adequately treated, and whose
disease is now completely inactive, can be expected to have essentially normal pregnancies.
There is no risk of the mother transmitting the disease to infants in such cases.
HD and Children
HD in children is uncommon in the U.S., but does occur and is usually indeterminate or
tuberculoid type disease. It is usually a benign disease with very few deformities reported.
Management of the disease is generally the same as for adults except for the adjustment of drug
dosages to be determined by the physician. Transmission of HD to children should not occur
after the adult patient starts on treatment that includes rifampin. Preventive treatment is not
generally recommended for child contacts. The presence of new cases in children usually
indicates that HD is still being transmitted in the general population.
5

Testicular HD
Direct invasion of the testicles probably occurs in most cases of Borderline and Lepronaatous
disease, although testicular dysfunction is most common in Lepromatous disease. The testicles
are a cool part of the body and are preferentially affected. If HD is not treated early, there is
progressive destruction of testicular tissue and eventually testicular atrophy with sterility and a
decrease in testosterone production.
Gynecomastia usually develops relatively late and is an indication of advanced disease. Acute
orchitis may develop during ENL and may be an indication for prednisone therapy. Testicular
atrophy is usually permanent. After testicular function is destroyed, the only treatment is
testosterone replacement. This does not restore fertility but is helpful in restoring sexual potency.
Injectables are the preferred route for replacement therapy. Oral androgens are not recommended
for long-term therapy because of potential liver toxicity.
• DIAGNOSTIC CRITERIA
In the U.S., HD is diagnosed through biopsy of a skin lesion associated with loss of sensation.
SCHEDULE OF SERVICES
New Patient
A. Patient Interview
B. HD Monitors
C. Medical Assessment
D. Biopsy
E. Skin Smears (optional)
F. Baseline laboratory studies
a. Hand and Foot Screens
H. HD Surveillance Form
HD Patient Education
IL Follow-Up Visit
A. Patient Interview
B. HD Monitors
C. Medical Assessment
D. Laboratory monitoring (See Lab Monitoring below for schedule)
E. Annual biopsy is recommended
F. Skin Smears annually (optional)
a Hand and Foot Screens (See Frequency of Performance in Appendix)
H. Patient Education every clinic visit
6

PATIENT ASSESSMENT
I. Patient Interview
A, Family History of HD
13. Presenting Symptoms
1. No pain reported with injuries such as cuts or burns
2. Recurrent nosebleeds
3. Chronic nasal congestion
4. Burning sensation on soles of feet or hands
5. Painful / tender peripheral nerves
C. Psychological considerations
1. Stiginaimyths
2. Living with the diagnosis-family, friends, boss, colleagues
3. Common concerns-cause, treatment, contagiousness,
sexual relations, deformities
II. Physical Assessment
A. Skin-It is important to perform a complete examination of the skin in good
light. Hypo-pigmented of hyper-pigmented flat or raised lesions may be
found on the face, trunk, extremities, buttocks, or thighs. Absence of
sweating, hair loss, or changes in texture of the skin may also be present.
Ask male patients about pain or swelling of the testicles and examine for
erythematous nodules.
13. Eyes-Examine the eyes for inflammation, incomplete closure of the
eyelids, and pupil size. In patients with borderline lepromatous disease, an
ophthalmological exam should be done to rule out eye involvement.
C. Nerves-A peripheral nerve assessment should be done to determine if
nerves are enlarged or tender (See Appendix).The ulnar, median, radial
cutaneous, posterior tibial, and peroneal nerves are commonly affected. In
patients with anesthesia of the hands or feet, ulcerations, 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.
D. Hands and Feet-Hands and feet should be examined for dryness,
diminished sensation, muscle weakness or muscle atrophy, wounds, and
ulcers.
HD Monitors-The purpose of this exam is to perform a visual inspection
and assessment of motor function of the eyes, hands, and feet of a patient
with HD. It is an excellent venue for teaching patients about the
prevention of complications. (See Appendix for procedure)
7

LABORATORY MONITORING
I. Recommended Laboratory Tests and Frequene
Initial 2" visit
visit (1-2 months) 3 in 6 in 12 In 18 In 24 m
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
B lirubin X
G6PD X
1-lepatitis B*
Hepatitis C*
*Screen for these or other co-morbidities if patient requires preduisone for reaction
II. Other tests
A. UA should be done annually with these studies for all patients.
B. PCR Assay (Polymerase Chain Reaction)
In a non-endemic population, the sensitivity and specificity of PCR assay
recommend its use primarily to identify M.leprac when acid-fast
organisms are discernible but atypical clinical or histopathologie 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
l998; 109:642-646) To further determine whether this Assay would be
clinically appropriate, contact Dr. David Scollard, Chief, Clinical Branch
NILIDP, at 225-756-3713.
TREATMENT OF HD IN THE U.S.
Clinical Spectrum of HD
The clinical features of HD cover a wide range, from a single hypo-pigmented
skin maeule to generalized disease. Wide differences are seen in the pathological
features, immunological status, treatment required, and types of complications
that develop. For treatment purposes, the NHOP uses the WHO two-group
classification, into which the Ridley-Jopling five-group classification is
incorporated.
A. Indeterminate (I) HD is the earliest stage of disease, and consists of one or
two vague hypo-pigmented macules, slightly dry in texture, with
anhidrosis, and generally, no IVEleprae in the lesion. Over half of these
cases resolve without treatment, others progress eventually into one of the
other forms of HD.
8

B. Tuberculoid (TT) is limited disease with few, well-defined hypo-pigmented
skin lesions which have marked sensory loss. Loss of hair in the lesion is
common and there is often central healing. Without treatment, lesions may
enlarge slowly, or self-heal. M.leprae are few or hard to find, but
peripheral nerve involvement is common, leading to severe disabilities if
nerve damage occurs.
C. Borderline (BT, BB, BL) disease has features of both the tuberculoid and
lepromatous types of HD. Skin lesions occur in small and large sizes and
may be hypo- or hyper-pigmented. These lesions may or may not be
anesthetic.
D. Lepromatous (LL) type disease is characterized by lesions which are
numerous, small, and symmetrically distributed. They may be hypo- or
hyper-pigmented. The skin, nerves, bones, eyes, and nasal area are most
often affected; however, all organs may become involved. There may
be elongated oar• lobes with partial or complete loss of the eyebrows,
and anhidrosis of some parts of the body.
II. Treatment
Treatment of HD involves more than simply prescribing medication. Good health
education at the time of diagnosis and during the course of treatment will make it
more likely that the patient will have a better outcome. Thus, an important part of
the management of HD is providing accurate information to patients and families
regarding the expected course and prognosis of the disease.
A. Recommended Treatment Regimens
Following are the general NHDP recommendations for the treatment of persons
with HD in the U.S. NHDP recommendations are for daily rifampin, and for
longer duration of treatment than the WHO recommendations. 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 corticosterod use,
etc.) are as follows:
Adults
Tuberculoid (TT & ST) (WHO classification Paucibacillary, "PB")
Agent Dose Duration
Dapsone 100 mg daily
12 months, and then therapy discontinued
Rifampicin
600 mg daily
9

Adults
Lepromatous (LL, BL, BB) (WHO classification Multibacillaty, "MB")
Agent Dose Duration
Dapsone
100 mg daily
24 months, and then therapy discontinued
Rifampicin
600 mg daily
Clofazimine
50 mg daily
For immunologically compromised patients, these protocols may be modified, and
consultation with the NHDP is recommended.
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.
b. 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 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 HD in the U.S.
B. In order for physicians to obtain the drug for treating HO, they will have to be
registered as an investigator under the NHDP IND. This will require submitting a
signed FDA form 1572 and a curriculum vitae to the NHDP. A packet of information
including the form 1572 as well as consent forms, etc., will be provided. An
Institutional Review Board (IRB) of the Centers for Disease Control has agreed to act
as the central IRB for the use of Clofazimine for Hansen's Disease, so that individual
physicians do not need to arrange this themselves. For further information, or to
request investigator status to use Clofazimine, please call the NI-IDP at 1-800-642-
2477.
C. ALTERNATIVE ANTI-MICROBIAL AGENTS
1. Minocycline, 100 mg daily, can be used as a substitute for Dapsone inindividuals
who do not tolerate this drug. It can also be used instead of Clofazimine,
although evidence of the efficacy of its anti-inflammatory activity against Type 2
reactions is not as substantial as the evidence for Clofazimine.
2. Clarithromycin, 500 mg daily is also effective against M. leprae, and can be used
as a substitute for any of the other drugs in a multiple drug regimen.
3. Ofioxacin, 400 mg daily, may also be used in place of Clofazimine, for adults.
This is not recommended for children.
D. In the United States, the occurrence of leprosy in children is rare. We strongly
recommend contacting the NHDP for management of leprosy in children; the
following are general guidelines.
10

Treatment for children
Tuberculoid (rr & BT) (WHO Paucibacillary, "PB")
Agent Dose Duration
Depsone 1 mg/ Kg daily
12 months, and then therapy discontinued
Rifampicin 10-20 mg/ Kg daily
(not > 600)
Treatment for children
Lepromatous (LL, BL, BB) (WHO Multibaciliary, "MB")
Agent Dose Duration
Dapsone 1 mg/ Kg daily 24 months, and then therapy discontinued
Rifampicin 10-20 mg/ Kg daily
(not > 600)
Clofazimine C 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.
E. Common Side-effects of HD medications
1. Dapsone
a. Contraindications-prior allergy to dapsone, 6PDdeficiency,
breast-Feeding
b. Side effeets-hemolysis
2. Rifampin
a. Contraindications-prior allergy to rifampin
b. Side effects-abnormal liver function, thrombocytopenia,
drug interactions with oral contraceptives and anticoagulants,
reddish discoloration of urine, stools, saliva, tears, and sweat
11

3. Clofazimine
a. Contraindications-none indicated
b. Side effects-discoloration of skin, diarrhea, abdominal pain, and less
commonly, bowel obstruction
On November 1, 2004, Novartis Pharmaceuticals Corporation
ceased distribution of lamprene (clofazimine) in the U.S. through
its usual distribution channels. It is only available now through
Investigational New Drug (IND) protocol. To receive clofazimine
for treatment of HD, you must be enrolled as an investigator under
the IND held by CDC. To enroll, contact Catherine Cmko at:
Catherine Cmko, Administrative Officer
National Hansen's Disease Programs
cernk91(1hrsa.gov
1770 Physician Park Drive
Baton Rouge, LA 70816
Phone: (225) 756-3709, Fax (225) 756-3819
"Clofazimine has been safely used in children and pregnant
women for years. For questions regarding this process, please call
Barbara Stryjewska,MD, Principal Investigator/Sponsor, at 1-800-
642-2477.
New Drugs
Several new drugs have been studied and undergone small clinical
trials. Larger clinical trials are now in progress. The most
promising of these are ofloxacin, minocycline, and clarithromycin.
Although these drugs are already marketed and available for other
uses, at present there is only limited information on the use of
these drugs in the treatment of HD. Therefore, they are not
recommended as routine or first line anti-leprosy drugs at present
The main indication for their use at present would be in
patients with drug intolerance for the currently recommended
drugs or cases of documented drug resistance. It is important to
make the best use of the drugs that are available to avoid
increasing the problem of drug resistance,
D. Follow-Up after Completion of Treatment
Clinical examinations should be done at the following intervals:
I. Paucibacillary (PB) - Annually for three years
2. Multibacillary (MB)
a, Every six months for two years
b. Annually for eight years
3. Skin biopsies are recommended annually
12

REACTIONS IN HD
Although M.leprae is almost non-toxic, some patients develop acute hypersensitivity "reactions"
to the organism. These are known as "lepra reactions". Reports of the frequency of reactions
indicate that 25% to 50% of all HD patients will have a reaction 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 have reactive episodes. Reactions are also 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. For guidance
on management of reaction, call the NHDP at 1-800-642-2477.
I. Symptoms of Reaction
A. Neuritis-Enlarged or tender peripheral nerves; changes in sensation or
strength
B. Muscle weakness
C. Tender, painful, erythematous nodules which may ulcerate
D, Development of new lesions
E. Malaise
F. Fever-low-grade to moderate
G. Red, painful eyes
H. Orchids in patients with multibacillary disease
I. Edema of hands and feet
II. Treatment of Reactions
Reactions are a major cause of nerve damage, so the focus of management should
be on the prevention of nerve damage. Damage to the nerves is caused by the
tissue response within the nerves to intraneural M. leprae and is similar to the
process seen in the skin. In untreated HD without reaction, nerve damage is more
insidious, while in reaction, nerves may be damaged more rapidly. Skin reactions
and acute neuritis often occur together. Antibacterial treatment should be
continued at full dosage.
Patients with mild reaction may be treated symptomatically. Those with moderate
to severe reaction may require steroids, thalidomide, or clofazimine. Patients with
severe reaction, especially those with evidence of nerve damage, require treatment
with cortieosteroids. Some patients may require high doses of corticosterokis to
control reaction and prevent nerve damage. They should have a baseline Bone
Density test prior to initiating extended therapy with high doses of corticosteroids.
A. Treatment with steroids
Contraindications
a. Inadequately treated infection
b. Situation where medically supervised stoppage of
medication is not possible
13

c. Prolonged usage without close medical supervision
2. Side effects
a. Weight gain or potassium loss
b. New infection or exposure to an infectious person
c. Poor response to some immunizations
d. Interaction with laboratory or medical procedures such as
blood sugar and TB skin tests
e. Withdrawal effects
B. Thalidomide is very effective in controlling ENL, and is the drug of first
choice if not contraindicated. This 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.
Male patients taking this medication must use prophylactics during sexual
intercourse. Pregnancy tests at regular intervals are required for female
patients of childbearing age.
1. Contraindications
a. Pregnancy
b. No unauthorized person may take this medication
2. Side effects
a. Fetal developmental defects
b. Constipation
c. Drowsiness
d. Dizziness
C. Clofazimine can be given in a dose of 300mg daily for four to six weeks,
reduced to 200 mg daily for several months, and then reduced to 100mg
daily. The addition of clofazimine at these doses will usually make it
possible to reduce the dose of steroids required, but not eliminate them
entirely. Clofazimine is not quick acting and it may take six weeks or
more for the full effect on the reaction to be noted. Patients receiving
larger doses of clofazimine will have more severe skin pigmentation and
more frequent gastro-intestinal side effects.
When the patient has required no steroids for approximately three months,
the dosage of clofazimine can be reduced to 50mg daily. If clofazimine is
not required for antibacterial treatment, it can be discontinued when no
steroids have been required for an additional three months.
For consultation on the treatment of reaction, call the NHDP at 1-800-642-
2477.
14

REHABILITATION SERVICES
I. Hand and Foot Rehabilitation Services
An efficient and comprehensive rehabilitation program in the management of
insensitive limbs shall incorporate physical therapy, occupational therapy,
pedorthics, and patient education. Rehabilitation goals aimed at minimizing loss
of function, ulceration, amputation, and ultimate disability, can be satisfactorily
achieved utilizing the following interdisciplinary rehabilitation practices: hand and
foot care, exercise, wound care, splinting, casting, recommending assistive
devices, follow-up therapy for HD orthopedic procedures, and in collaboration
with the medical staff, identifying candidates for reconstructive surgery.
Disability prevention is promoted by the visual inspection of the hands, and feet
of the patient at each encounter. If the hand or foot requires further evaluation, a
hand or foot screen and palpation of the nerves shall be done. (See appendix, HD
Manual for procedures.)
For patients scheduled to receive care at the NTIDP in Baton Rouge, the
Ambulatory Care therapist coordinates care with the NHDP therapists.
Preoperative casting, wound care and postoperative rehabilitation provided by the
therapist in the Ambulatory Care setting decreases the length of stay required for
care at the NHDP,
A. Occupational Therapy
1. Hand Screens — These are a means of assessing the T-ID patient's risk
category for hand problems, and for developing a care plan for their
prevention and treatment.
2. The sensory testing device used with the Hand Screen is 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.
B. Physical Therapy
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 sensory testing device used with the Foot Screen is a nylon
filament mounted on a holder designed to deliver a 10 gram force
when properly applied. Our research has shown that a patient can feel
the 10 gram filament in the selected sites will not develop ulcers.
15

(3) 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.
CONSULTANT SERVICES
Due to the multi-faceted aspects of this disease, patients may need referral to the
following ancillary medical services for complications. Not all consultant
services will be needed in every case and some will be indicated only rarely.
Consultation with NHDP staff is also available by calling 1-800-642-2477.
A. Physical Therapy
B. Occupational Therapy
C. Podiatry
D. Orthotics
E. Orthopedics
F. Ophthalmology
G. ENT
II. Consultation with N1-[DP staff is also available by calling 1-800-642-2477.
CONTACT FOLLOW-UP
In the U.S., a Hansen's disease contact is identified as a person living in the same household with
a new patient in the three year period prior to the diagnosis and the beginning of treatment. These
contacts should be examined as follows:
Contact examination
A. Exam of the entire skin
B. Nerve function assessment of the peripheral nerves, focusing primarily on the
eyes, hands, and feet (See Appendix).
C. The contact exam should also include patient education on the disease, and what
symptoms a contact should report to the health care provider.
D. An individual with symptoms of HD may be referred to one of the Outpatient I-1D
Clinics or to the NI-1DP by physicians or healthcare agencies. These persons will
be provided with the services required to rule out the diagnosis of HD as
described above.
16

11. Follow-Up of Contacts
A. Contacts of a paucibacillary case with a negative initial exam do not need follow-
up as long as the patient has been educated about the symptoms of HD.
B. In contacts of a multibacillary case, exams should be done annually for five years,
including patient education about the disease and its symptoms
C. The NHDP does not recommend chemoprophylaxis with dapsone or any other
drug for contacts of patients.
REPORTING REOUIFtEMENTS
The NI1DP maintains a National HD Registry in the U.S. for all patients
diagnosed with Hansen's disease.. A Hansen's Disease Surveillance Form is
required on all newly-diagnosed patients. The Form can be found on the NHDP
website, www.hrsa.aovibansens, and should be sent to NHDP as soon as the
diagnosis is confirmed. The HD Surveillance Form should be mailed or faxed to:
NI-ID?
ATTN: Medical Records,
1770 Physicians Park Drive,
Baton Rouge, LA 70816
Fax: 225-756-3706
PATIENT EDUCATION
Appropriate treatment of a stigmatizing disease like HD involves more than merely
prescribing medications. Many patients fear they will become severely disabled and will
infect their families. They also fear social isolation if others become aware of their
diagnosis. Awareness of these patient concerns at the time of diagnosis and during the
course of treatment will more likely ensure patient compliance with treatment and
achieve its objective, which is the prevention of deformity and disability.
REFERRALS TO NHDP
Physicians at the NHDP may authorize a referral to the NHDP on a case-by-case
basis.
AMBULATORY CARE PROGRAM
The Ambulatory Care Program provides HD outpatient care through
Outpatient Hansen's Disease Clinics located where most of the patients live in
the U.S. and Puerto Rico. Services provided by these Clinics include diagnosis
and treatment of HD and related conditions, laboratory monitoring,
consultant services, patient and community education.
17

PRIVATE PHYSICIAN PROGRAM
HD medications can be provided to patients living in an area not served by an HD clinic
through the NHDP. Their private physician can order the HD medications (dapsone,
rifampin, clofazimine) from the NHDP at no charge to the patient. Consultant and biopsy
processing services are also provided to the physician.
RESOURCES
Resources available from the NHDP for HD are:
A. Consultation on treatment and management guidelines
B. Medications for 11D: dapsone, rifampin, clofazimine
C. Processing biopsies for histopathology
D. HD and Foot Seminars for Physicians, Nurses, Occupational Therapists,
Physical Therapists, Orthotists, and Podiatrists
E. NI-ID? Website-www.hrsa.gov/hansensdisease
Information regarding these services is available from the NHDP, 1770 Physicians Park
Drive, Baton Rouge, LA, 70816, Phone: 800-642-2477; Fax: 225-756-3806.
Other Resources
A. American Leprosy Missions
1 ALM Way
Greenville, SC 29601
Phone: 800-543-3131
B. IDEA (International Association for Integration, Dignity,
And Economic Advancement)
U.S. Headquarters
P.O. Box 651
32 Fall Street-Suite A
Seneca Falls, NY 13148
Phone: 315-568-5838 Fax: 315-568-5891
E-rnail:alaw@idealeprosydignity.org
C. Support for People with Hansen's Disease/Leprosy
Phone: 1-866-637-1525
Website: littp://www.hansensdisease.orp,
E-mail: niholmes@hansensdiseaseorg,
N I DP
Rev, 7/2012
18

FORMS AND PROCEDURES
APPENDIX A: Hansen's Disease Monitors
APPENDIX B: Peripheral Nerves
APPENDIX Skin Biopsy
Protocol for Submitting Specimens
APPENDIX D: Skin Smears
Skin Smears for Acid-Fast Bacilli
Procedure for Obtaining Smears
Skin Smear/Biopsy Chart
Staining of Skin Smears
Microscopic Examination of Skin Smears
APPENDIX E: Hand and Foot Screens
Standards for Performance of the Hand Screen
Hand Screen Instructions
Hand Screen Record
Standards for Performance of the Foot Screen
Foot Screen Encounter Form
Foot Screen Record
WHO Grading of Disabilities Hands and Feet
APPENDIX F: Hansen's Disease Medication Chart
English
Spanish
APPENDIX G: Surveillance Form
Instructions for Surveillance Form
HD Surveillance Form
APPENDIX H: Hansen's Disease Outpatient Clinic Listing
APPENDIX I: Hansen's Disease Outpatient Clinic Listing

APPENDIX

Appendix A
Hansen's Disease Monitors
The Hansen's disease (HD) monitors are a system of assessment which includes a visual inspection
and assessment of motor function of the eyes, hands, and feet of a patient with HD. These
procedures can be used to teach patients about prevention of complications.
1. Visual Inspection
a.. Eyes
1. Examine the eyes for inflammation
2. Check the pupil size, shape, and reaction to light
3. Ask the patient to close their eyes and check for incomplete closure
b. Hands
1. Inspect the palms and dorsum of the hands for dry skin
2. Check for muscle atrophy and injuries
e. Feet
1. Inspect for dry skin, erythema, calluses, and injuries
2. Cheek socks and shoe wear for signs of drainage from ulcers or injuries
2. Motor Function Assessment
Those assessments should be done with the application of resistance by the examiner,
otherwise early signs of weakness may be missed. (See attachment)
3. Moment* Assessment for Insensitive Feet
a. Extra-depth shoes with removable insoles
b. Rounded or square toe box
C. Leather upper
d. A half-inch length beyond longest toe
e , No seams at the toe
f. Soft wedge sole
A patient with a positive eye exam should be evaluated by an ophthalmologist; hand and foot
problems need follow-up with a hand or foot screen and referred as necessary.

HANSEN'S DISEASE MONITORS
FACIAL NERVE
Have patient close eyes as in ULNAR NERVE
sleep. Look for incomplete '— Have patient abduct little
closure of eyelids. finger against resistance
applied by examiner.
MEDIAN & ULNAR NERVES
Have patient approximate little
finger and thumb with hand in prone
position.
PERONEAL NERVE
Ask the patient to bring foot up. Apply
resistance when foot is up. There will
be weakness or paralysis when patient
Is unable to resist the downward
movement that is applied to the foot.
These assessments are to be done with application of resistance by examiner;
otherwise early signs of weakness may be missed. A patient with a positive eye
exam should be evaluated by an ophthalmologist. Positive hand or foot
assessments shall be further evaluated through a hand or foot screen and
referred.
NHDP/ACP
Rev. 8/2012

Appendix B
PERIPHERAL NERVES
Greater auricular-with the patient's head turned to one side, palpate the
nerve as it stretches across the stemomastoid muscle.
Ulnar-palpate above the ulnar groove.
Radial cutaneous-palpate at the lateral border of the radius proximal to
the wrist joint.
Posterior tibial-posteriorly and inferiorally to the medial malleolus.
Common peroneal-palpate the popliteal fossa just medial to the biceps
femoris tendon, and around the neck of the fibula.

Appendix C
SKIN BIOPSY
A proper site is the single most important factor in the skin biopsy to be evaluated for leprosy. The
pathologist will be unable to make a definite diagnosis if bacilli cannot be demonstrated by means of
the biopsy. A general rule is that the biopsy should be taken entirely within the lesion, preferably
from the active margin if there is one; this is especially important in the non-lepromatous forms of
leprosy. There is no necessity to include any normal tissue in the biopsy. When no definite lesion
can be found, the site for biopsy should be guided by information from skin scrapings and clinical
findings such as decreased sensation and decreased sweating.
The skin biopsy should be made with a biopsy punch or by surgical excision. In all instances, the
biopsy should be deep enough to include subcutaneous fat; this depth of biopsy is very important, for
often the most prominently involved nerves will be found in the upper portion of the subcutaneous
tissue. A 4 mm or larger biopsy punch should be used; a 2 or 3 ram punch biopsy can be made on
the face, if necessary. Surgical excision is made 1 cm by 3 mm, with a cold knife; removal of
specimens by cautery is to be entirely avoided. A proper fixative should be employed for specimen
fixation and transfer; 10% neutral buffered formalin is used routinely. At least five volumes of
fixative per volume of tissue should be used.
For his to pathological consultation, at no charge, mail specimens in 10% neutral buffered forrnalin
to:
National Hansen=s Disease Programs
Attention: Clinical Laboratory
1770 Physicians Park Drive
Baton Rouge, Louisiana 70816
For questions regarding these procedures, please call 1-800-642-2477.
PROTOCOL FOR SUBMITTING SPECIMENS FOR HISTOLOGICAL
EVALUATION OF HANSEN'S DISEASE
National Hansen's Disease Programs
Baton Rouge, Louisiana
The following are the requirements needed before sending a biopsy for routine histological
evaluation:
I. A biopsy collected with a 4 — 5 mm punch (2 mm if on face) or surgical excision, which should be
deep enough to include subcutaneous fat. This depth is important because often the most
prominently involved nerves will be found in the upper portion of the subcutaneous fat. As a
general rule, the biopsy should be taken entirely within the lesion, preferably from the active
margin if there is one.
2. Place in 10% buffered formalin, at least 5 volumes of fixative per volume of tissue. Label container
with patient's name and biopsy site.
3. A brief clinical history including number of lesions, changes in sensation, previous diagnosis and
present clinical impressions.
4. The patient's name, sex, race and social security number if available.
5. The patient's date of birth.

6. The submitting doctor's name and the address where the report is to be sent.
7. Send biopsy in leak-proof container.
The following specimens may also be submitted for evaluation (listed in order of preference):
1. Paraffin blocks.
2. Slides of unstained sections - preferably at least 4 slides,
3. Stained slides to include H&E and Fite.
Specimens should be placed in protected mailing containers such as screw-cap cardboard cylinders or
padded mailing envelopes to prevent damage.
Specimens are then sent to:
National Hansen's Disease Programs
Clinical Laboratory
1770 Physicians Park Drive
Baton Rouge, LA 70816
Attn: George Reed or Steve Kees
Phone: 1-800-642-2477

Appendix D
SKIN SMEARS FOR ACID-FAST BACILLI
PURPOSE:
The skin smear is a valuable, cost-effective tool in the routine management of the Harisen=s disease
patient. The smear is a means of estimating the number of acid-fast bacteria present, reported as the
bacterial index (RI), and is important in determining the type and severity of disease as well as
assessing the response to treatment.
GENERAL:
1. Initial skin smears are usually taken from 6 Aroutine sites@ (both earlobes, elbows, and
knees) as well as several typical lesions from the patient
Repeat smears are obtained from 3 to 4 of the most active sites previously tested to evaluate
progress.
2. The time interval between repeat smears is determined by the physician but in general,
annual smears are adequate for monitoring response to treatment and during the follow-up
period to detect any evidence of relapse.
3. They may be sent in protective mailers to:
National Hansen=s Disease Programs
Attention: Clinical Laboratory - Skin Smears
1770 Physicians Park Drive
Baton Rouge, Louisiana 70816
Phone: (225) 756-3733
PROCEDURE FOR OBTAINING SMEARS:
1. Universal precautions should be observed in obtaining skin smears.
2. All microscopic slides on which skin smears are made should be precleaned in 70% alcohol,
acetone, or alcohol-acetone to remove amorphous debris. The slides are wiped dry with a clean
hand towel. Blades that are used in smear taking are likewise cleaned.
3. The skin is cleansed with 70% alcohol and air dried or wiped dry with cotton, (Zepharin tends
to make the skin too slippery and is not recommended.)
4. A fold of skin is made relatively avascular by pinching. If the skin cannot be grasped by
pinching, it can be compressed. A surgeon's glove may aid in grasping.
5. Local anesthesia is generally unnecessary. (If there is not adequate decrease in sensation,

obtain local anesthesia with 1% Xylocaine, or Ethyl Chloride spray can be carefully applied.)
The compression of the skin by pinching aids in the anesthesia.
6. An incision 3-5 mm long and 2-3 mm deep is made with an alcohol-cleansed single-edge razor
blade or a scalpel with a #15 Bard-Parker blade may also be used. The blade or scalpel should
be used for only one site and then discarded. Mild pressure to maintain relative avascularity
is continuously applied to the area until an adequate smear has been obtained.
7. A small amount of blood does not interfere with the reading, but large amounts should be
avoided and can usually be controlled by the amount of pressure of the pinch. If excessive
bleeding occurs, it can be wiped away with a cotton swab.
8. After the incision is made, and before the blade is withdrawn, the inner surface of the wound is
scraped with the blade held at a right angle to the incision. Upon scraping, tissue fluid and
dermal tissue are obtained.
9. The material is transferred to the cleaned microscope slide. A moderately thick smear, with a
visible uniform opacity is made. The smear is made in a circular manner on the slide, no
larger than a pencil eraser (5-7 mm) in diameter, beginning peripherally and ending in the
center, leaving a central "button" (2-4 mm) which can be easily focused upon with the
microscope. Slides should be properly labeled as shown in the sample diagram for 3 routine
sites.
Name
1. R -knee
2 .R-elbow
3. R - ear
Date
10. Slides should be air-dried and NEVER heat fixed.
11. A Band Aid is generally sufficient to protect the smear site.
12. A single technician takes all smears to provide for more uniform and consistent results.
13. The smears may be sent to the National Hansen's Disease Programs for reading.
14. A chart to diagram sites of the skin smears or biopsy is attached to "Skin Biopsy" in the
appendix. It can be copied for your convenience.
141-0Pat.I. REV. RtZOIZ

NATIONAL HANSEN'S DISEASE PROGRAMS SKIN SMEAR I BIOPSY CHART DATE'
Patients Name (Last, First, Middle* HID ID NO:
Dale of Birth . Social Security No.: Phone results to
. _
Skin Smear Sites
( 1 ) -
; (2) -
(3) -
(4) -
, (5) -
(6) -
\
Biopsy Sites
(1) -
(2) -
(3) -
(4) -
(5) -
(6) -
Private Physician:
Name:
Address'
NHOR PQRM 155 REV SEPT 2012
SKIN SMEAR I BIOPSY CHART

STAINING OF SKIN SMEARS,
1. Dry the slide with smear at room temperature. DO NOT HEAT FIX.
2. Place slides on a staining rack and flood with 10% formalin for 15 minutes for fixation.
3. Rinse with tap water.
4. Flood slides with Ziehl-Neelsen carhol-fuchsin for twenty minutes. (Always filter stain
before each use.)
5. Rinse with tap water.
6. Decolorize with 2% acid alcohol for I minute.
7. Rinse slides thoroughly with tap water.
8. Counterstain with alkaline methylene blue for 30 seconds to 1 minute.
9. Rinse with tap water and air dry.
NOTE: Positive and negative control slides must be used each day for quality control
purposes.
Z-N Carhol Fuchsin Stain:
Basic fuchsin 1.0 gm.
Phenol crystals 5.0 gms.
95% ethanol 10.0 nits.
Water, to make 100.0 rids.
Acid alcohol:
Cone. HCI 2.0 mls.
95% ethanol 98.0 mls.
Alkaline Methylene Blue:
KOH (10%) 10.0 mls.
Methylene blue 0,35 gms.
95% ethanol , 16.0 mls.
Water to make 100.0 mls.
NHDP/ACP
Rev. 812012

MICROSCOPIC EXAMINATION OF SKIN SMEARS:
The stained smears are examined with a quality microscope using the oil immersion objective
(x.100) to determine the total number of bacilli. The same individual should read all smears for
the purpose of consistency. The smear will have similar numbers of bacilli throughout, however,
four separate quadrants of the smear are examined and averaged to establish the Bacterial Index
(BI).
REPORTING THE BACTERIAL INDEX (ED:
The results are reported on a 0 to 6 + semi-logarithmic scale using a descriptive phrase or
numerical code. This is an indicator of the total bacillary load of the patient. It falls about I
point per year during effective treatment as dead bacilli undergo lysis and are absorbed.
Very Numerous (+6) - over 1000 bacilli per oil immersion field.
Numerous (+5) - 100 to 1000 bacilli per oil immersion field.
Moderate 10 to 100 bacilli per oil immersion field.
Few 1 to 10 bacilli per oil immersion field.
Very few I to 10 bacilli per 10 fields.
Rare 1 to 10 bacilli per 100 fields.
None found No AFB seen on entire site.
N 14 DP/AC P
Rev. 812012

Appendix E
STAINDARDS FOR PERFORMANCE OF HAND SCREEN
The hand screen is intended to record the baseline and risk assessment of patients requiring acute
care, or receiving health education, and it helps identify patients in need of treatment to prevent
progressive nerve damage (decrease in sensory and muscle function). The majority of patients
may not have sensory or muscle involvement of the hands or will have long-standing
involvement that is not changing.
Long standing sensory and muscle loss that is unchanging does not need treatment of the nerve,
however, the patient may benefit from deformity prevention techniques (splinting/education/
adaptive devices).
The sensory testing device used with the Hand Screen is a set of five (5) calibrated nylon
filaments mounted on a small rod, which measures levels of coetaneous touch and pressure on a
scale of 2.83 to 6.65. The normal threshold level is 2.83.
WHEN TO PERFORM THE SCREEN
• A baseline hand screen is performed on all new patients at the time of diagnosis.
• Screens are performed on a quarterly basis as patients are scheduled for laboratory
monitoring during chemotherapy for HD.
• Screens shall also be performed as clinically necessary on any patient
complaining of muscle weakness, decrease in sensation, or change in function.
PATIENTS WITH NERVE CHANGES:
Patients whose sensory and muscle function has deteriorated over the last 6-12 months are
experiencing reaction in the nerves; these are considered "acute" nerves,
Patients with "acute" nerves need immediate attention in order to prevent progression in nerve
involvement, and examination by the physician for treatment of the nerve with corticosteroids or
other anti-inflammatory agents.
Referral to an occupational therapist may be warranted for patient education in reducing stress on
the acute nerve, protection of the nerve, or temporary immobilization.

HAND SCREEN INSTRUCTIONS
PATIENT DATA:
Use middle initial or middle name if available.
Use patient's social security number.
SECTION I SENSORY TEST:
A. Perform the test with the patient's eyes closed or averted.
B. Select the sites to be tested as indicated on the Hand Screen form.
C. Use Filament #1, the lightest, first. If equates to normal sensation (0.05
gram).
D. Apply the filament slowly to bending (just before bending to the heaviest),
hold 1.5 seconds, remove slowly.
• MeiC•SIPP-172:1,77777,2770.
E. Apply the filament three times (slowly) in succession and record if the
patient feels any of the three applications.
F. If the first filament is not felt, proceed to the next heavier filament,
repeating the process until a filament is felt.
G. Record the number of the filament first felt in the appropriate blank, next
to the appropriate number. If no filament is felt, put a zero in the blank to
indicate the test was completed for that site, but the patient did not
respond.
H. Do not allow the filament to slide across the skin.
I. Ask the patient to reply "yes" when the filament is felt.
J. Apply the filament along the margin of and NOT on an ulcer site, callous
Or scar.

SECTION II SKIN INSPECTION:
Use initials indicated on form to mark hand map and for lesions and observations
made of the condition of the patient's hands.
SECTION III MUSCLE TESTING:
Results of muscle testing are graded as strong, weak, or paralyzed.
Strong — Normal ROM and full resistance
Weak — Reduced ROM with reduced or no resistance
Paralyzed — No contraction palpable.
1. Abduction of index finger (ulnar).
Index finger should be abducted with some slight flexion in the knuckle
joint, with all other joints straight. Apply resistance at the base of the
index finger. Thumb of supporting hand can palpate for possible muscle
contraction.
2. Abduction of little finger (ulnar).
Ask patient to move little finger out and slightly up, palm side up, keeping
all the joints of the finger straight. Apply resistance at the base of the little
finger. Fingers of your supporting hand will be able to palpate for
possible muscle contraction.
Abduction of the thumb (median).
Move thumb away from palm of hand at right angles to the plane of the
palm of the hand. Resistance is applied at the base of the thumb, pushing
it in to the index finger.
4. 0 position of the thumb (median).
Have patient make ring with thumb and little finger, try to push thumb out.
5. Wrist extension (radial).
Ask the patient to make a fist, and. try to push the wrist down on the radial
side. If weakness is present, patient may not be able to resist or wrist may
deviate to unaffected side.
SECTION IV PERIPHERAL NERVE RISK:
Weakness or paralysis is usually not present wherever normal sensation or
sweating is found. Loss of sensation and weakness may occur at the same time or
sometimes months or years later.
Peripheral nerve involvement of short duration is more apt to be responsive to
treatment. Acute nerve involvement may be successfully minimized or reversed
by treatment with cortieosteroids, anti-inflammatory agents, immobilization,

Section I. SENSORY TESTING: Use first filament (A) at site Indicated (apply three times). If no response, use next
heavier filament to determine level of loss.
Filament Force, gms interpretation (Grade Pts.)
A Green (283) 0.05 Normal (5)
B Blue (3.01) 0.20 Residual Texture (4)
O Purple (4.31) 2.00 Residual Protective. &mullion (3)
0 Red (4.50 4.00 Loss of Protective Sensation (2)
E Orange (8.05) 300.00 Residual Deep Pressure ...., (1)
Right Left
Section II. SKIN INSPECTION: Draw and label (above): IN - Wound, C - Callus, S - Swelling, R - Redness,
- Dryness, T Temperature, NI - Missing, i - Contracture, 0 - Other
Section III. MUSCLE TESTING: Mark (below): S = Strong, W = Weak, P = Paralysis (or Grade 5 to 0)
(Ulnar Nerve) (Median Nerve) (Radial Nerve)
L R L R R L
1) Index finger 2) Little Finger 3) Thumb Abduction 4) Thumb to Little 5) Radial Wrist
Abduction (FDI) MP Joint Flex. (L) Out of Palm (APB) Finger (OP) Extension (ECR)
Section IV, PERIPHERAL NERVE RISK: Mark: U, M, R (or combination)
Radial Cutaneous
On Dorsum
1) Enlarged or swollen nerve
2) Tender / painful on stretch or compression
3) Sensory change in the last 12 months
4) Muscle change in the last 12 months
Ulnar High Risk (acute or changing nerve): Yes No
(roterto physicianItherapist)
Section V. DEFORMITY RISK: (Check if present)
1) Loss of Protective Sensation R L 4) Injuries (wounds, blisters, etc.) R L
2) Clawed but Mobile Hand R L 5) Contracted or Stiff Joints R L
3) Fingertip Absorption (mild severe R L 6) Wrist Drop (radial nerve)
High Risk (any of the above): Yes No
(refer for appropriate treatment)
Has there been a change in the hand since any previous exam? Yes No
Examined by:
(1(4DP FORM 130 HANDSCREEN RECORD

wrapping to keep it warm, or possibly surgery (nerve transfer).
Classification is graded on a scale of 1 to 4.
Risk Category 1:
A patient in this category may need to be followed for the possibility of further
problems.
Risk Category 2:
Tender nerve on stretch or compression, with the ulnar nerve in the area of the
oleeranon process in the elbow. May be tender on flexion of arm or if pressure
applied to area. To palpate for an enlarged nerve, use the four fingers of one hand
and gently roll the nerve under them. A normal nerve is slightly thick or may not
be palpable at all. A hard, sclerosed nerve is abnormal.
Risk Category 3:
Sensory change in the last 12 months.
Risk Category 4:
Muscle change in the last 12 months.
Section V DEFORMITY RISK:
This is classitied from a range of 1 to 5, which lists types of disability which may
be present in a patient.
1I11-1DP
Rev. 8/2012

STANDARDS FOR PERFORMANCE OF THE FOOT SCREEN
The initial foot screen is intended to record the baseline status of patient subjective data and
clinical signs and symptoms of neurological impairment. The foot screen evaluates history or
presence of plantar ulceration, strength of specific muscles, plantar foot sensation, and
deformities which can place the foot at risk of injury. After the initial evaluation, screens are
performed annually to monitor or pick up any undetected changes by the patient and are
indicated more often if the patient perceives any change in sensory, motor or functional status.
The screen is a tool to bring up any treatment issues such as wound, callus, and toenail care,
footwear and orthotic needs.
The Screen is also used to place the patient in a Risk Category. The foot screen assessment
section or risk category serves as a guideline for routine foot checks. This check up is for
monitoring and trimming plantar callus and toenails and for checking on appropriateness of
patient footwear and ortholics.
The sensory testing device used with the Foot Screen is a nylon filament mounted on a holder
and is designed to deliver a 10 gram force when properly applied. Our research has shown that a
patient who can feel the 10 gram filament in the selected sites will not develop ulcers.
Rating categories are based on the objective data and are defined as follows:
Category 0 No Loss of Protective Sensation (LOPS)
Category 1 - LOPS but no deformity
Category 2 LOPS and deformity
Category 3 LOPS and history of ulceration
Category 4 Charcot foot
WHEN TO PERFORM THE SCREEN
• A baseline hand screen is performed on all new patients at the time of diagnosis.
o Screens are performed on a quarterly basis as patients are scheduled for laboratory
monitoring during chemotherapy for HD.
• Screens shall also be performed as clinically necessary on any patient
complaining of muscle weakness, decrease in sensation, or change in function.

FOOT SCREEN ENCOUNTER FORM
Instructions for sensory testing on the foot:
1. Use the 10 gram filament provided to test sensation.
2. Select the sites to be tested based on the Foot Screening Form,
3. Apply the filament peipendicular to the skin's surface. (See diagram A)
4. The approach, skin contact and departure of the filament should be approximately I V2
seconds duration.
5. Apply sufficient force to cause the filament to bend (See diagram B)
Diagram A Diagram 13
6. Do not allow the filament to slide across the skin or make repetitive contact at the test
site.
7. Randomize the selection of test sites and time between successive tests to reduce the
potential for patient guessing.
8. Ask the patient to respond "yes" when the filament is felt.
9. Apply the filament along the perimeter of and NOT on an ulcer site, callous, scar or
necrotic tissue.
10. Foot screens are performed annually. If the patient has symptoms of neuritis, e.g.,
burning on the soles of the feet, pain in the lower extremities, or is on treatment for
neuritis, the foot screen should be done more frequently to monitor progress or to refer to
the clinician.
11. A copy of the Foot Screen must be sent to the NI-LDP.

Fill in the following blanks with and R. L. or B to indicate positive findings on the right, left or both feel
Has there been a change in the foot since last evaluation? Yes No
Is there a feat ulcer now or history of foot ulcer? Yes No
Does the foot have an abnormal shape? Yes No
Is there weakness In the ankle or foot? Yes N o
Are the nails thick, too long or Ingrown? Yes No
Label: Sensory level with a '+' in the circled areas of the toot It the patient Can feel the 10 gram (5,07 Semmes
Weinstein) nylon filament and "-" If he/she can not feel the 10 gram filament.
RIGHT LEFT
Clinical Appearance Of Skin;
Does the patient use footwear appropriate for his/het category? Yea No
RISK CATEGORY:
0 No protective sensory loss
Loss of protective sensation (no deformity, or plantar ulcer history).
2 Loss of protective sensation and deformity (no plantar ulcer history).
3 History of plantar ulcer.
PATIENT EDUCATION: Skin care, Inspection, footwear
REFERRALS:
Date of Next Evaluation: Category 0 One Year
Category 'I — One Year
Category 2 — Six Months
Category 3 — One — Three Months
WHOP FORM t53
ACP 1,DOT SCHkEll HELIC)R0

WHO GRADING OF DISABILITIES
HANDS AND FEET
Grade 0: No anesthesia, visible deformity, or damage
Grade 1: Anesthesia present, but no visible deformity or damage
Grade 2: Visible deformity or damage present
Each hand and foot should be assessed and graded separately. Damage in this context includes
ulceration, shortening, disorganization, stiffness, or loss of part or all of the hand or foot. If any
disability found in the patient is due to causes other than leprosy, this fact should be noted.

Append ix F
HANSEN'S DISEASE MEDICATIONS
DRUG NAME DRUG DOSAGE HOW fo TAKE " COMMON SIDE EFFECTS I
RIFAIVIPIN TAKE AS DIRECTED BY TAKE ON AN EMPTY May color urine, sweat, sputum, tears red.
300 mg - PHYSICIAN STOMACH May upset stomach or give you flu-like
1 HOUR BEFORE MEALS OR 2 symptoms Often Interferes with other
HOURS AFTER MEALS medicine. Inform us if you are taking any
, LY new medicines, even birth control pills.
, DIRECTIONS:
DAPSONE TAKE AS DIRECTED BY CAN TAKE ON EMPTY OR FULL May cause muscles weakness or give you
PHYSICIAN STOMACH a sore throat and fever. If this happens,
stop the drug and call HO clinic nurse.
25 mg
DIRECTIONS;
100 mg
CLOFAZIMINE TAKE AS DIRECTED BY TAKE WITH FOOD May color skin, urine, sweat, sputum or
PHYSICIAN whites of eyes brown.
50 mg
Skin may become dry; use lotion on skin
at least twice a day.
DIRECTIONS:
PREDNISONE TAKE AS DIRECTED BY TAKE WITH FOOD Drug must be gradually decreased.
(drug may vary in PHYSICIAN NEVER ABRUPTLY STOP DRUG! Take
calms / nfzes) as directed by MD.
May have Increased appetite or increased
5 mg DIRECTIONS: energy.
..I
20 mg
M1NOCYCLINE TAKE AS DIRECTED BY MAY BE TAKEN ON AN EMPTY Wear sunscreen in sunlight.
PHYSICIAN OR FULL STOMACH
100 mg Dizziness can occur. Stop medicine if
hives develop. Women can get yeast
Infections. Call HD nurse It you develop
DIRECTIONS: DO NOT TAKE ANTACIDS OR any symptoms of a yeast infection:
IRON SUPPLEMENTS WHILE Vaginal discharge or vaginal
TAKING THIS MEDICINE itching/burning.
" NOTE All medications should de taken with a full glass of water.
NHDP RSV. 08i24H2
For frflormaTiva: 1-800442-241?

Appendix F
MEDICINAS PARA LA ENFERMEDAD DE HANSEN
--1
DROGA DOSIS COMO SE TOMA** EFECTOS SECUNDARIOS I
RIFAMPIN TOME COMO INDICADO TOME EN AYUNAS Puede enrojecer la wine, esputo, a
300 mg FOR SU MEDICO i HORA ANTES DE COMER 0 lw.3grimas. Puede irritarie el estcrimago o
2 HORAS DESPUES DE COMER causerie sintomas de parecidos a los de la
NO TOME ANTA, ,C1DOS (-rums, gripe. Puede interred( con otras
uce med cines, Avlsenos si es quo 05 05th
D1RECCIONES: Durant° una bora de !lobe 'meta tornado tOrnando cualquler medicine incluyendo
pastillas anticoneeptivas.
DAPSONE TOME COMO INDICADO TOME EN AYUNAS 0 DESPUES Puede provocar debIlIclad muscular, dolor
PAR SU ME DICO DE COMER de garganta y fiebre. En dado case,
descontinue la droga y Ham a la
25 mg enfermera de la clinica HO
DIRECCIONES:
•
100 mg
CLOFAZUVIINE TOME COMO INDICADO TOME CON COMIDA Puede alterar el color de la piel, thine,
POR SU ME DICO sudor, y esputo, o la parte blanca de los
50 mg ajos.
Puede resecarte la piel. Use una !cola n
DIRECCIONES; pare la piel por lo menos dos veces al dia.
PREDNISONE TOME COiv10 INDIC/NM] TOME CON COMIDA Se debe- disminuvir gradualmente Is dosis
(puede varier FOR SU ME, DICO de eats droga, NO SE DEBE DETENER
de coloritemano) BRUSCAMENTE! Tome como le indique
su DOCTOR,
5 mg DIRECCIONES:
20 mg Puede aumentar su apetito o energla.
MINOCYCL1NE TOME COMO INDICADO SE PUEDE TOMAR EN AYUNAS AplIquese bloqueador de sol.
POR SU ME :DICO 0 DESPUES DE COMER
100 mg Puede causar mareos. Detenga Is
NO TOME ANTA , CIDOS NI medicine silo salon ronchas. Las nnujeres
SUPLEMENTOS DE HIERRO pueden sufrir infecciones de clertos
DIRECC1ONES: DURANTE DOS HORAS ANTES hongos. Llarrie a la enfermera de la
0 DESPUES DE TOMAR ESTA clinica HD si sufre cualquier slntoma de
MEDICINA infeccio n: flujo vaginal, comezontardor.
"r NOTE Tomo toda Medicrna con un vaso de agua
NHDP REV, 08/2012
FCc infOrinallo 1-800-612-2477

Appendix G
Instructions for Completi ig the
Hansen's Disease (Leprosy) Surveillance Form
The Hansen's Disease or Leprosy Surveillance Form (LSF) is the document used to report leprosy cases to the U.S.
National Hansen's Disease Registry. These data are used for epidemiological, clinical, and basic research studies
throughout the National Hansen's Disease Program (NHIDP), and are the official source for information on leprosy cases in
the U.S.
The information requested on the LSF is used by many clinicians and researchers, and collection of all information is highly
desirable. However, the fields that are boldfaced on the form and in the instructions below are considered to be the
minimal information needed to register a patient. Failure to provide this information will result in the form being returned
which creates additional work and may cause delays in obtaining program seneces for the patient.
1. Reporting State: Use the abbreviation of the state from which the report is being sent. This is usually the state of
the clinician's office and not necessarily the patient's resident state.
2. Date of Report; This is date of the initial LSF completion. if patient was previously reported and has relapsed,
write the word "RELAPSE" next to the date.
3. SOC181 Security Number: self-explanatory.
4. Patient Name: Self-explanatory.
5. Present Address: Please include the county and zip code which are used to geographically cluster patients.
6. Place of Birth: include state and county, if born in the U.S., or the country, if foreign born.
7. Date of BirthfSex: Self-explanatory.
8. ReceeEthnicity: This Information should be voluntarily provided by the patient. If the patient refuses or indicates a
race/ethnicity category not listed, check the "Not Specified' box.
9. Date Entered the U.S; For patients who have immigrated to the U.S., provide the month and year of entry.
10. Date of Onset of Symptoms: This information is usually the patient's recollection of when classic leprosy symptoms
(rash, nodule formation, paresthesia, decreased peripheral sensation, etc.) were first noticed.
11. Date Leprosy First Diagnosed: Provide the month and year a diagnosis was made. This usually coincides with a
biopsy date if one was performed.
12. Initial Diagnosis: Was the patient diagnosed in the U.S. or outside the U.S.
13. Type of Leprosy: Classify the diagnosis based on one of the ICD-9-CM diagnosis codes, (NHDP Clinic
physicians: Please circle specific classification, if possible)
030.0 Lepromatous Leprosy (macular, diffuse, infiltrated, nodular, neuritic — includes Ridley-Jopling [R.11,
Lepromatous XL] and Borderline lepromatOuS (1314): A form marked by erythematous macules, generalized
papular and nodular lesions, and variously by upper respiratory infiltration, nodules on conjunctiva or sclera, and
motor loss.
030.1 Tuberculoid Leprosy (macular, mactiloanesthetic, major, minor, neuritic — includes RJTuberculold
ITT] and Borderline tuberculoid IBM: A form marked by usually one lesion with well-defined margins with scaly
surface and local tender cutaneous or peripheral nerves.
030.2 Indeterminate (uncharacteristic, macular, neuritic): A form marked by one or more macular lesions,
which may have slight erythema.
030.3 Borderline (dimorphous, infiltrated, neuritic — includes RJ Borderline IBM or true mid disease only):
A form marked by early nerve involvement and lesions of varying stages.
030.8 Other Specified Leprosy: Use this aode when the diagnosis is specified as a "leprosy" but is not listed
above (030.0-030.3),
030.9 Leprosy, Inactive: Use this code when the diagnosis is identified as a "leprosy' but inactive.
14. Diagnosis of Disease: Enter INMAL biopsy and skin smear dates and results.
'15. Residence (Pre-diagnosis): List all cities, counties, and states in the U.S. and all foreign countries a patient
resided in BEFORE leprosy was diagnosed. This information is used to map all places where U.S. leprosy cases
have resided,
18. Disability: Indicate any sensory abnormalities or deformities of the hands and feet or lagophthalmos of the eyes.
17. Current Household Contacts: Self-explanatory.
18. Current Treatment for Leprosy: Date treatment started and indicate all drugs used for initial treatment.
'19, Name and Address of Physician or Investigator: Self-explanatory.
NMP/Ai:
Ray. 8/2012

HANSEN'S DISEASE (LEPROSY) SURVEILLANCE FORM
NATIONAL HANSEN'S DISEASE PROGRAMS
1770 PHYSICIANS PARK DRIVE
BATON ROUGE, LA 70816
1-800442-2477
-I Reporting Slate 2 Date of Report 3 Social Security Number (optional)
Day Yr-
I 1 Li fin n
4 Patient Name: gas0 (Pirst) (Middle)
5 Present Address: Street
City
County State Zip
6 Place of Birth: .1.-11[*M.Y.111 7 Date of Birth: Sex:
No. Day Yr, 0 Male
State County t LII -10 LJLJ
Country Female
8 RacelEthnic8 Y: Whl, rini Hispanic ri White, flisnanic n American Iidkiit, Alaska Native Indian, Middle Easterner
1 Black, riot Flispanlo I Blault, Hispanic Asian, Pacific Islander El Not Specified
9 Date Entered U.S.: I 10 Uate of Onset or Symptoms: 11 Data Leprosy First Diagnosed 2 initial Diagnosis in:
Me, 1
nri ELI I Eli 1 1 Fl I Outside U.S.
'13 Type of Leprosy: (100-9-CM Code) (NHDP Clinic physicians: Please circle specific classification, if possible)
0 Lepromatous (030.0 • LL, LK) 0 indeterminate (030_2 CI Other Specified Leprosy (030.8)
0 Tuberculoid (030.1 - Tr, ST) 0 Borderline (030.3 - 013) 0 Leprosy, Unspecified (030.9)
14 Olagnosis of Disease: 1$ List all places in pie U.S.A. end all foreign countries a PATIENT resided
Was biopsy performed In U.S. „ Yes (IAGIuding Milllary Service) BEFORE leprosy was diagnosed.
Na rowN ,:-GUNTY COU/1/11? INCLUSIVE DATES
rm. wow. To blo/Yr.
Result
D Yes
Skin Smear
Date _ ./ Ho
DI: Positive - Negative _
16 Disability; Hands Eell' g_y_q
Yes I no rag I Ho
J•meofy L.ne LI El El tagnplillialooe?
Oeforrnity
17 Current Household Contacts: B Current Treatment for Leprosy: (ow all mar apply)
Namellielationship
Date Treatment Started:
Mn. Yr-
Dapsone
2
E Rlfampin
3 E Clafazimine
4 0 Other WV)
5
-.-,5eniaascsumawreemea......wener
19 Name and Address of Physician:
investigator:
This form may be FAXED to NHOP at (225} 756-3706 Isftelmassmax, mei?
A copy of this form should be sent to your local or state health department. emetten?

Appendix H
HID CLINIC CHANGE OF INFORMATION DATE
Last Name, First name, Middle Initial
Date of Birth: Social Security No.
Ii Check box if there are any changes in the above information.
In accordance with the national Hansen's Disease Program Policy, the following
change is reported:
The above patient has:
0 Relocated To:
City State Zip
Hansen's Disease Clinic
o Left the Country
LI Deceased:
Date
NHL/PAU/kW
Rev. 8/2012

Appendix I
HANSEN'S DISEASE CLINICS
National Hansen 's Disease Programs
Ambulatory Care Program
IVehpage: auvw.hrsa.gavihan.vonviivra.s*: Toll Free Phone Number: R00.642-2477
ATLANTA HD CLINIC MARTINEZ HD CLINIC
Emory MidTown Hospital Contra Costa Regional Medical Center
550 Peachtree Street NE Outpatient Specialty Clinic
711' Floor MOT 2500 Alhambra Avenue
Atlanta, GA 30308 Martinez, CA 94553
PH: (404) 686-5885 PH: (925) 370-5868
Fax: (404) 6864508 Fax: (925) 370-5529
Primary Physicians — Dr. Jessica Fairley/Dr. Phyllis Kozarsky Primary Physician - Drs, Sutherland/Saffier
email: jessica.fairleymmory (NM email: ssialleriamtalistloo.compa-costaca.as
email: pkoza s .edu PH: (925) 370-5867
PH: (404) 686-5885 • ksaffier(d.:yalloo.com
Public Health Nurse: Roberta Dismukes, RN P11: (925) 370-5200 Ext.:4743
Public Health Nurse — Barbara Hobson, RN
email: roberta_dis111ukes02emoryhealtheare.org PH: (925)313-6757
PH: (404)320-6662 email: Barbara. Ho& on@fis dr, ce.couniy.lts
PH: (404) 686-7668 Community Health Worker Sebastian Basalic
BOSTON HD CLINIC • Sebrafkm.Basolic(iihs .deccomay,us
Lahey Medical Center MIAMI HD CLINIC
41 Mall Road Jackson Memorial Hospital
Burlington, MA 01805 1611 N.W. 12th Avenue
PH: (781) 744-5670 ACC East — 2 nd Floor
Fax: (781) 744 -5687 Department of Dermatology
Primary Physician - Dr. Samuel Moschella Miami, FL 33136-1096
email: 6).11n toeLLIttoschellird).1ahei ,.org PH: (305) 585-7348
Public Health Nurse - Ms. Stephanie Burns, RN, D.N.C. Fax: (305) 585 -6397
email: stephorfie.u.burns@lahey.org Primary Physician - Dr. Anne Burdick
CHICAGO HD CLINIC • Aburtilelea)nett miamLecht
Public Health Nurse - Gail Chepenik, RN
University of Illinois email: ii,ichepe1ikt017smicani,org
College of Medicine at Chicago
Department of Dermatology, (MC 624) NEW YORK HD CLINIC
808 S. Wood, RM 176 CMF Bellevue Hospital Center
Chicago, IL 60612 Department of Dermatology
PH: (312) 996-0734 462 First Avenue, Room I 7-N-7
Fax: (312) 355-0870 New York, NY 10016
Primary Physician - Dr_ Carlotta Hill PH: (212) 562-5670
ch h if I (Ouic.cd Fax: (212) 263-6423
Public Health Nurse — Gladys Lee, RN Primary Physician - Dr. William Levis
email: FIA,celauic.edu email: william levisAawhoo,com
Public 1 icalth Nurse Lydia Macwan, RN
LOS ANGELES HD CLINIC PH: (212) 562-6096
LAC-FUSC Medical Center email: L%'tha,JSi c1tu bIivun,mcIthc.oPg
1200 N. State St_ Physical Therapist - Louis intlUZZi. P.T., C.Ped.
Clinic Tower A5 B123 email: [-al ......
Los Angeles, CA 90033 PHOENIX HD CLINIC
PH: (323)409-5240 Maricopa County Health Department
Fax: (323) 441 -8152 64$ East Roosevelt Street
Primary Physician - Dr. Maria T, Ochoa Phoenix, Arizona 85006
email: urculatocqusc.edu PH: (602) 372-2039
PH: (323) 226-3373 Fax: (602) 372-3862
Public Health Nurse - Helen Mora, RN Primary Physician - Dr. Ronald Pust
email: Innora(a)tilmiaemady,goi, Tucson Office: (520) 626-5650
Occupational Therapist Rob Jerskey Cell: (520) 668-6441
email: roNirwskeyiiyahoo.cow email: IplesqemmiLiirizoikr.edu
Public Health Nurse - Eileen Smith, RN
PH: (602) 372-2039
email: eileensalit*irlaiLm1rfrova.01,
Physical Therapist - Tracy Carroll, MPH
OMItme email: r.c.q.0:0.141:20ail.arb,Da.erla

SAN DIEGO HD CLINIC
HEISA, North Central Regional Center Dallas Commy Health & Human Services
5055 Ruffin Road, Mail Stop: N-513 2377 N. Stemmons Freeway, Suite 522
San Diego, CA 92123 Dallas, TX 75207-2710
PH: (858)573-7338 PH: (214) 819-2010
Pax: (858) 573-7325 Fax: (214) 819-6095
Primary Physician - Dr. Erik 0. Gilbertson Physicians - Dr. Jack Cohen/Dr. Sharon Nations
email: erik.iAberlsollAstleuttntv,ea.goi , email: jbc:oheralexii!aol.cont
Public Health Nurse Gina Sandoval, RN, PUN PH: (817) 753-6633 (private practice)
email: ?.eghta.sandovaMP,stleautriv.ea.gay email: sharonmallons(iOrtspythwesteriteciu
PH: (214) 645-8800
SAN JUAN HI) CLINIC Public Health Nurse - Nancy Bernstein, RN, BSN
University of Puerto Rico • ithemstebkilduliascounir.orx
Medical Sciences Campus
School of Medicine - Dept, of Dermatology Houston Hansen !s Disease Clinic
P. 0. Box 365067 Northside Health Center
San Juan, PR 00936-5067 8504 Schuller Street
PH: (787) 765-7950 Houston, TX 77093
Fax: (787) 767-0467 PH: (832) 393-4804
Primary Physician - Dr. Pablo Almodoivar Fax: (832) 393-5247
• delmatullowilnipreda Physician - Dr. Terry Williams/Dr, Steven Mays
Mlle Health Nurse - Sonia Santos-Expo'sito, RN, BSN email: Tinivill3502(a)cio1.co»,
PH: (787) 758-2525, Ext. 5503 PH: (281) 332-8571
email: sonia.saniosqiwpr.odu email: St eveu. Alax.vt4W t)/. tow. edu
PH: (713) 500-8329
SEATTLE IID CLINIC Public Health Nurse Marion Matsu, RN, CCM
Harborview Medical Center • Marion.itiamn&nonsewitx.gov
2 West Clinic — 359930, 325 Ninth Avenue Main: (832) 393-4798
Seattle, WA 98 1 04 Cell: (832) 248-7150
PH: (206) 520-5000
Toll Free th 1-877-520-5000 Texas Center for Infections Disease
Fax: (206) 744-5109 2303 S. C.. Military Drive
Primary Physician - Dr. James 1-lamisch San Antonio, TX 78223
• jiyharnischfii;:comettyt.net PH: (210) 53 1-4526 ,
Public Health Nurse — Angela Bartels, RN Fax: (210) 531-4508
email: horte1s46iiutv.ethr Physician - Dr. Adriana Vasquez
PH: (210) 531-4565
SPRINGDALE HD CLINIC email: ark lana,vaseple.7fii,dsirs.state.tx.us
Joseph H. Bates Outreach Clinic of Washington County Physician - Dr: Lynn Horvath
614 E. Emma Avenue, Suite 247 PH: (210) 531-4524
Springdale, AR 72 764 email: lynn.horvathOdshs.state.tx.tis
PH: (479) -751 -3630 Public Health Nurse - Debbie Mata, RN
Fax: (479)-751-4838 PH: (210) 531-4576
Primary Physician: Linda McGhee, MD PH: (210) 531-4295
PH: (4 79) 521-0263 Cell: (210) 389-3568
PH: (479) 973-8450 (office) Appointment Secretary: (2 1 0) 53 1-452 6
email: Int e Oteeki)Ltams.ecit, email: debbk.ntarViedslis.gtale,fx,us
Public Health Nurse - Sandy 1-lainline Williams, RN
P1-I: (479) 751-3630 Department of Stale Hkh Services Region (MR) 11
Cell: (479) 422-0190 601 W. Sesame Drive
email: sancira,liairliiileagl:arisas.gov Harlingen, TX 78550
P1-I: (956) 423-0130
TEXAS HD CLINICS Fax: (956)444-3295
Department of State Health Services Physician - Dr. Richard Wing
Hansen's Disease Program email: '10141,71ml» ggdyirs.stamix.us .
P. 0. Box 149347, Mail Code 1939 Public Health Nurse — Grace Flores, RN
Austin, TX 78714-9347 PH: (956) 423-0130, Ext. 5573
PH: (800) 252-8239 • gracejlotesWshs.stote.tx.us
Fax: (512)365-7824-primary fax
Fax: (512) 533-3167-secondary fax
Nurse Consultant: Linda Brown, MS, RN
PH: (512) 533-3144
• Iliuldbrown(60&. state. ix. us
Officer Administrator: Kirbi Woods
PH: (512) 739-1876
• kirbi.ivowr1s(aW4u.strote. tuts

Other Clinks
HAWAII HD CLINIC
Hawaii State Department ofIlealth
Hansen's Disease Community Program
3650 Maunalei Avenue
Honolulu, HI 96816
PH: (808) 733-9'831
Fa t (808) 733 -9836
Program Manager: Lori Ching, RN
Direct Line/Voice Mail: (808) 733-4663
email: lor.i.chine,dolLhaivirii,z0v
Office Physical Address:
Diamond Head Health Center
3627 Kilauea Avenue Room 102
Honolulu, HI 96816
WWI" DEIMMIldh


Page 1 of 10
WD 05-2023 (Rev.-17) was first posted on www.wdol.gov on 06/25/2013
************************************************************************************
REGISTER OF WAGE DETERMINATIONS UNDER U.S. DEPARTMENT OF LABOR
THE SERVICE CONTRACT ACT EMPLOYMENT STANDARDS ADMINISTRATION
By direction of the Secretary of Labor WAGE AND HOUR DIVISION
WASHINGTON D.C. 20210
Wage Determination No.: 2005-2023
Diane C. Koplewski Division of Revision No.: 17
Director Wage Determinations Date Of Revision: 06/19/2013
State: Arizona
Area: Arizona Counties of Apache, Coconino, Gila, Maricopa, Navajo, Pinal,
Yavapai
**Fringe Benefits Required Follow the Occupational Listing**
OCCUPATION CODE - TITLE FOOTNOTE RATE
01000 - Administrative Support And Clerical Occupations
01011 - Accounting Clerk I 14.85
01012 - Accounting Clerk II 16.68
01013 - Accounting Clerk III 18.65
01020 - Administrative Assistant 25.36
01040 - Court Reporter 16.73
01051 - Data Entry Operator I 12.52
01052 - Data Entry Operator II 13.66
01060 - Dispatcher, Motor Vehicle 16.40
01070 - Document Preparation Clerk 13.55
01090 - Duplicating Machine Operator 13.55
01111 - General Clerk I 12.53
01112 - General Clerk II 13.67
01113 - General Clerk III 15.34
01120 - Housing Referral Assistant 20.78
01141 - Messenger Courier 12.33
01191 - Order Clerk I 12.32
01192 - Order Clerk II 14.86
01261 - Personnel Assistant (Employment) I 14.98
01262 - Personnel Assistant (Employment) II 16.76
01263 - Personnel Assistant (Employment) III 18.69
01270 - Production Control Clerk 20.26
01280 - Receptionist 12.58
01290 - Rental Clerk 14.97
01300 - Scheduler, Maintenance 16.66
01311 - Secretary I 16.66
01312 - Secretary II 18.64
01313 - Secretary III 20.78
01320 - Service Order Dispatcher 14.32
01410 - Supply Technician 25.36
01420 - Survey Worker 16.63
01531 - Travel Clerk I 13.28
01532 - Travel Clerk II 14.46
01533 - Travel Clerk III 15.61
01611 - Word Processor I 13.82
01612 - Word Processor II 15.78
01613 - Word Processor III 17.54
05000 - Automotive Service Occupations
05005 - Automobile Body Repairer, Fiberglass 20.34
05010 - Automotive Electrician 20.30
05040 - Automotive Glass Installer 19.42
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05070 - Automotive Worker 19.42
05110 - Mobile Equipment Servicer 16.62
05130 - Motor Equipment Metal Mechanic 22.69
05160 - Motor Equipment Metal Worker 19.62
05190 - Motor Vehicle Mechanic 21.59
05220 - Motor Vehicle Mechanic Helper 15.12
05250 - Motor Vehicle Upholstery Worker 18.14
05280 - Motor Vehicle Wrecker 19.62
05310 - Painter, Automotive 22.12
05340 - Radiator Repair Specialist 19.58
05370 - Tire Repairer 14.21
05400 - Transmission Repair Specialist 21.59
07000 - Food Preparation And Service Occupations
07010 - Baker 12.03
07041 - Cook 10.50
.07042 - Cook II 12.16
07070 - Dishwasher 8.60
07130 - Food Service Worker 10.17
07210 - Meat Cutter 16.58
07260 - Waiter/Waitress 9.75
09000 - Furniture Maintenance And Repair Occupations
09010 - Electrostatic Spray Painter 16.50
09040 - Furniture Handler 10.88
09080 - Furniture Refinisher 16.50
09090 - Furniture Refinisher Helper 12.16
09110 - Furniture Repairer, Minor 14.59
09130 - Upholsterer 16.50
11000 - General Services And Support Occupations
11030 - Cleaner, Vehicles 9.97
11060 - Elevator Operator 9.97
11090 - Gardener 12.96
11122 - Housekeeping Aide 11.10
11150 - Janitor 11.10
11210 - Laborer, Grounds Maintenance 10.31
11240 - Maid or Houseman 9.59
11260 - Pruner 10.14
11270 - Tractor Operator 12.53
11330 - Trail Maintenance Worker 10.31
11360 - Window Cleaner 12.00
12000 - Health Occupations
12010 - Ambulance Driver 13.87
12011 - Breath Alcohol Technician 18.71
12012 - Certified Occupational Therapist Assistant 24.60
12015 - Certified Physical Therapist Assistant 18.94
12020 - Dental Assistant 16.61
12025 - Dental Hygienist 34.70
12030 - EKG Technician 21.08
12035 - Electroneurodiagnostic Technologist 21.08
12040 - Emergency Medical Technician 13.87
12071 - Licensed Practical Nurse 16.73
12072 - Licensed Practical Nurse II 18.71
12073 - Licensed Practical Nurse III 20.87
12100 - Medical Assistant 14.39
12130 - Medical Laboratory Technician 19.61
12160 - Medical Record Clerk 13.11
12190 - Medical Record Technician 15.57
12195 - Medical Transcriptionist 17.02
12210 - Nuclear Medicine Technologist 33.98
12221 - Nursing Assistant I 10.25
12222 - Nursing Assistant II 11.53
12223 - Nursing Assistant III 12.58
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12224 - Nursing Assistant IV 14.12
12235 - Optical Dispenser 15.39
12236 - Optical Technician 14.85
12250 - Pharmacy Technician 14.15
12280 - Phlebotomist 14.12
12305 - Radiologic Technologist 24.34
12311 - Registered Nurse 26.93
12312 - Registered Nurse II 33.08
12313 - Registered Nurse II, Specialist 33.08
12314- Registered Nurse III 40.02
12315 - Registered Nurse III, Anesthetist 40.02
12316 - Registered Nurse IV 47.96
12317 - Scheduler (Drug and Alcohol Testing) 23.09
13000 - Information And Arts Occupations
13011 - Exhibits Specialist 17.08
13012 - Exhibits Specialist II 21.08
13013 - Exhibits Specialist III 25.71
13041 - Illustrator I 18.79
13042 - Illustrator II 23.18
13043 - Illustrator III 28.27
13047 - Librarian 23.06
13050 - Library Aide/Clerk 14.20
13054 - Library Information Technology Systems 20.92
Administrator
13058 - Library Technician 14.08
13061 - Media Specialist I 15.03
13062 - Media Specialist II 16.81
13063 - Media Specialist III 18.75
13071 - Photographer I 14.99
13072 - Photographer II 17.27
13073 - Photographer III 21.32
13074 - Photographer TV 26.01
13075 - Photographer V 31.55
13110 - Video Teleconference Technician 16.68
14000 - Information Technology Occupations
14041 - Computer Operator I 15.04
14042 - Computer Operator II 17.51
14043 - Computer Operator III 20.13
14044 - Computer Operator IV 22.75
14045 - Computer Operator V 24.82
14071 - Computer Programmer I 23.00
14072 - Computer Programmer II 24.90
14073 - Computer Programmer III (see
14074 - Computer Programmer IV (see
14101 - Computer Systems Analyst (see
14102 - Computer Systems Analyst II (see
14103 - Computer Systems Analyst III (see
14150 - Peripheral Equipment Operator 15.04
14160 - Personal Computer Support Technician 22.75
15000 - Instructional Occupations
15010 - Aircrew Training Devices Instructor (Non-Rated) 29.46
15020 - Aircrew Training Devices Instructor (Rated) 36.56
15030 - Air Crew Training Devices Instructor (Pilot) 40.22
15050 - Computer Based Training Specialist / Instructor 29.46
15060 - Educational Technologist 21.91
15070 - Flight Instructor (Pilot) 40.22
15080 - Graphic Artist 21.68
15090 - Technical Instructor 20.91
15095 - Technical Instructor/Course Developer 25.58
15110 - Test Proctor 16.87
15120 - Tutor 16.87
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16000 - Laundry, Dry-Cleaning, Pressing And Related Occupations
16010 - Assembler 9.06
16030 - Counter Attendant 9.06
16040 - Dry Cleaner 11.32
16070 - Finisher, Platwork, Machine 9.06
16090 - Presser, Hand 9.06
16110 - Presser, Machine, Drycleaning 9.06
16130 - Presser, Machine, Shirts 9.06
16160 - Presser, Machine, Wearing Apparel, Laundry 9.06
16190 - Sewing Machine Operator 12.05
16220 - Tailor 12.81
16250 - Washer, Machine 9.86
19000 - Machine Tool Operation And Repair Occupations
19010 - Machine-Tool Operator (Tool Room) 16.74
19040 - Tool And Die Maker 22.78
21000 - Materials Handling And Packing Occupations
21020 - Forklift Operator 13.52
21030 - Material Coordinator 19.58
21040 - Material Expediter 19.58
21050 - Material Handling Laborer 11.91
21071 - Order Filler 12.24
21080 - Production Line Worker (Food Processing) 13.52
21110 - Shipping Packer 14.52
21130 - Shipping/Receiving Clerk 14.52
21140 - Store Worker I 9.13
21150 - Stock Clerk 14.39
21210 - Tools And Parts Attendant 13.52
21410 - Warehouse Specialist 13.52
23000 - Mechanics And Maintenance And Repair Occupations
23010 - Aerospace Structural Welder 26.77
23021 - Aircraft Mechanic I 25.34
23022 - Aircraft Mechanic II 26.77
23023 - Aircraft Mechanic III 28.40
23040 - Aircraft Mechanic Helper 17.74
23050 - Aircraft, Painter 24.07
23060 - Aircraft Servicer 21.28
23080 - Aircraft Worker 22.80
23110 - Appliance Mechanic 18.79
23120 - Bicycle Repairer 12.92
23125 - Cable Splicer 29.26
23130 - Carpenter, Maintenance 17.36
23140 - Carpet Layer 15.63
23160 - Electrician, Maintenance 20.14
23181 - Electronics Technician Maintenance I 18.00
23182 - Electronics Technician Maintenance II 23.29
23183 - Electronics Technician Maintenance ITT 25.37
23260 - Fabric Worker 14.70
23290 - Fire Alarm System Mechanic 19.80
23310 - Fire Extinguisher Repairer 15.17
23311 - Fuel Distribution System Mechanic 29.33
23312 - Fuel Distribution System Operator 20.70
23370 - General Maintenance Worker 17.48
23380 - Ground Support Equipment Mechanic 25.34
23381 - Ground Support Equipment Servicer 21.28
23382 - Ground Support Equipment Worker 22.80
23391 - Gunsmith I 15.17
23392 - Gunsmith II 18.14
23393 - Gunsmith III 21.09
23410 - Heating, Ventilation And Air-Conditioning 19.83
Mechanic
23411 - Heating, Ventilation And Air Contditioning 20.95
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Mechanic (Research Facility)
23430 - Heavy Equipment Mechanic 21.55
23440 - Heavy Equipment Operator 21.23
23460 - Instrument Mechanic 24.18
23465 - Laboratory/Shelter Mechanic 19.62
23470 - Laborer 11.55
23510 - Locksmith 19.50
23530 - Machinery Maintenance Mechanic 25.00
23550 - Machinist, Maintenance 17.73
23580 - Maintenance Trades Helper 13.00
23591 - Metrology Technician I 24.18
23592 - Metrology Technician II 25.25
23593 - Metrology Technician III 26.51
23640 - Millwright 23.72
23710 - Office Appliance Repairer 19.75
23760 - Painter, Maintenance 16.50
23790 - Pipefitter, Maintenance 20.86
23810 - Plumber, Maintenance 19.81
23820 - Pneudraulic Systems Mechanic 21.09
23850 - Rigger 21.09
23870 - Scale Mechanic 18.14
23890 - Sheet-Metal Worker, Maintenance 17.99
23910 - Small Engine Mechanic 16.52
23931 - Telecommunications Mechanic T 22.60
23932 - Telecommunications Mechanic II 26.99
23950 - Telephone Lineman 18.23
23960 - Welder, Combination, Maintenance 17.37
23965 - Well Driller 21.09
23970 - Woodcraft Worker 21.09
23980 - Woodworker 14.71
24000 - Personal Needs Occupations
24570 - Child Care Attendant 10.73
24580 - Child Care Center Clerk 16.79
24610 - Chore Aide 10.71
24620 - Family Readiness And Support Services 15.56
Coordinator
24630 - Homemaker 18.38
25000 - Plant And System Operations Occupations
25010 - Boiler Tender 23.78
25040 - Sewage Plant Operator 22.71
25070 - Stationary Engineer 23.78
25190 - Ventilation Equipment Tender 14.81
25210 - Water Treatment Plant Operator 22.71
27000 - Protective Service Occupations
27004 - Alarm Monitor 18.73
27007 - Baggage Inspector 11.01
27008 - Corrections Officer 19.52
27010 - Court Security Officer 20.49
27030 - Detection Dog Handler 16.13
27040 - Detention Officer 19.52,
27070 - Firefighter 21.80
27101 - Guard 11.01
27102 - Guard II 16.13
27131 - Police Officer I 25.69
27132 - Police Officer II 28.53
28000 - Recreation Occupations
28041 - Carnival Equipment Operator 13.84
28042 - Carnival Equipment Repairer 15.17
28043 - Carnival Equpment Worker 9.89
28210 - Gate Attendant/Gate Tender 14.95
28310 - Lifeguard 11.90
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28350 - Park Attendant (Aide) 16.73
28510 - Recreation Aide/Health Facility Attendant 12.21
28515 - Recreation Specialist 17.99
28630 - Sports Official 13.33
28690 - Swimming Pool Operator 19.72
29000 - Stevedoring/Longshoremen Occupational Services
29010 - Blocker And Bracer 19.45
29020 - Hatch Tender 19.45
29030 - Line Handler 19.45
29041 - Stevedore I 17.16
29042 - Stevedore II 21.45
30000 - Technical Occupations
30010 - Air Traffic Control Specialist, Center (HFO) (see 2) 35.77
30011 - Air Traffic Control Specialist, Station (HFO) (see 2) 24.66
30012 - Air Traffic Control Specialist, Terminal (UFO) (see 2) 27.16
30021 - Archeological Technician I 17.49
30022 - Archeological Technician II 19.58
30023 - Archeological Technician III 24.25
30030 - Cartographic Technician 24.59
30040 - Civil Engineering Technician 21.56
30061 - Drafter/CAD Operator I 17.49
30062 - Drafter/CAD Operator II 19.84
30063 - Drafter/CAD Operator III 22.12
30064 - Drafter/CAD Operator IV 26.82
30081 - Engineering Technician I 16.02
30082 - Engineering Technician II 17.98
30083 - Engineering Technician III 21.48
30084 - Engineering Technician IV 25.33
30085 - Engineering Technician V 30.27
30086 - Engineering Technician VI 34.64
30090 - Environmental Technician 22.20
30210 - Laboratory Technician 22.92
30240 - Mathematical Technician 24.69
30361 - Paralegal/Legal Assistant I 21.19
30362 - Paralegal/Legal Assistant II 25.09
30363 - Paralegal/Legal Assistant III 30.61
30364 - Paralegal/Legal Assistant IV 37.15
30390 - Photo-Optics Technician 24.69
30461 - Technical Writer 22.49
30462 - Technical Writer If 27.51
30463 - Technical Writer III 31.24
30491 - Unexploded Ordnance (UX0) Technician I 22.74
30492 - Unexploded Ordnance (UXO) Technician II 27.51
30493 - Unexploded Ordnance (UX0) Technician III 32.97
30494 - Unexploded (UXO) Safety Escort 22.74
30495 - Unexploded (UXO) Sweep Personnel 22.74
30620 - Weather Observer, Combined Upper Air Or (see 2) 22.12
Surface Programs
30621 - Weather Observer, Senior (see 2) 24.12
31000 - Transportation/Mobile Equipment Operation Occupations
31020 - Bus Aide 8.17
31030 - Bus Driver 17.45
31043 - Driver Courier 13.84
31260 - Parking and Lot Attendant 10.32
31290 - Shuttle Bus Driver 15.35
31310 - Taxi Driver 10.88
31361 - Truckdriver, Light 15.35
31362 - Truckdriver, Medium 18.71
31363 - Truckdriver, Heavy 19.29
31364 - Truckdriver, Tractor-Trailer 19.29
99000 - Miscellaneous Occupations
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99030 - Cashier 11.86
99050 - Desk Clerk 10.74
99095 - Embalmer 24.27
99251 - Laboratory Animal Caretaker I 10.57
99252 - Laboratory Animal Caretaker II 13.33
99310 - Mortician 28.19
99410 - Pest Controller 14.44
99510 - Photofinishing Worker 13.44
99710 - Recycling Laborer 18.15
99711 - Recycling Specialist 23.31
99730 - Refuse Collector 17.29
99810 - Sales Clerk 12.38
99820 - School Crossing Guard 8.69
99830 - Survey Party Chief 26.46
99831 - Surveying Aide 15.94
99832 - Surveying Technician 22.46
99840 - Vending Machine Attendant 14.89
99841 - Vending Machine Repairer 18.88
99842 - Vending Machine Repairer Helper 14.89
ALL OCCUPATIONS LISTED ABOVE RECEIVE THE FOLLOWING BENEFITS:
HEALTH & WELFARE: $3.81 per hour or $152.40 per week or $660.40 per month
VACATION: 2 weeks paid vacation after 1 year of service with a contractor or
successor; 3 weeks after 5 years, and 4 weeks after 15 years. Length of service
includes the whole span of continuous service with the present contractor or
successor, wherever employed, and with the predecessor contractors in the
performance of similar work at the same Federal facility. (Reg. 29 CFR 4.173)
HOLIDAYS: A minimum of ten paid holidays per year, New Year's Day, Martin Luther
King Jr's Birthday, Washington's Birthday, Memorial Day, Independence Day, Labor
Day, Columbus Day, Veterans' Day, Thanksgiving Day, and Christmas Day. (A
contractor may substitute for any of the named holidays another day off with pay in
accordance with a plan communicated to the employees involved.) (See 29 CFR 4174)
THE OCCUPATIONS WHICH HAVE NUMBERED FOOTNOTES IN PARENTHESES RECEIVE THE FOLLOWING:
1) COMPUTER EMPLOYEES: Under the SCA at section 8(b), this wage determination does
not apply to any employee who individually qualifies as a bona fide executive,
administrative, or professional employee as defined in 29 C.F.R. Part 541. Because
most Computer System Analysts and Computer Programmers who are compensated at a rate
not less than $27.63 (or on a salary or fee basis at a rate not less than $455 per
week) an hour would likely qualify as exempt computer professionals, (29 C.F.R. 541.
400) wage rates may not be listed on this wage determination for all occupations
within those job families. In addition, because this wage determination may not
list a wage rate for some or all occupations within those job families if the survey
data indicates that the prevailing wage rate for the occupation equals or exceeds
$27.63 per hour conformances may be necessary for certain nonexempt employees. For
example, if an individual employee is nonexempt but nevertheless performs duties
within the scope of one of the Computer Systems Analyst or Computer Programmer
occupations for which this wage determination does not specify an SCA wage rate,
then the wage rate for that employee must be conformed in accordance with the
conformance procedures described in the conformance note included on this wage
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determination.
Additionally, because job titles vary widely and change quickly in the computer
industry, job titles are not determinative of the application of the computer
professional exemption. Therefore, the exemption applies only to computer employees
who satisfy the compensation requirements and whose primary duty consists of:
(1) The application of systems analysis techniques and procedures, including
consulting with users, to determine hardware, software or system functional
specifications;
(2) The design, development, documentation, analysis, creation, testing or
modification of computer systems or programs, including prototypes, based on and
related to user or system design specifications;
(3) The design, documentation, testing, creation or modification of computer
programs related to machine operating systems; or
(4) A combination of the aforementioned duties, the performance of which
requires the same level of skills. (29 C.F.R. 541.400).
2) AIR TRAFFIC CONTROLLERS AND WEATHER OBSERVERS - NIGHT PAY & SUNDAY PAY: If you
work at night as part of a regular tour of duty, you will earn a night differential
and receive an additional 10% of basic pay for any hours worked between 6pm and 6am.
If you are a full-time employed (40 hours a week) and Sunday is part of your
regularly scheduled workweek, you are paid at your rate of basic pay plus a Sunday
premium of 25% of your basic rate for each hour of Sunday work which is not overtime
(i.e. occasional work on Sunday outside the normal tour of duty is considered
overtime work).
HAZARDOUS PAY DIFFERENTIAL: An 8 percent differential is applicable to employees
employed in a position that represents a high degree of hazard when working with or
in close proximity to ordinance, explosives, and incendiary materials. This
includes work such as screening, blending, dying, mixing, and pressing of sensitive
ordance, explosives, and pyrotechnic compositions such as lead azide, black powder
and photoflash powder. All dry-house activities involving propellants or explosives.
Demilitarization, modification, renovation, demolition, and maintenance operations
on sensitive ordnance, explosives and incendiary materials. All operations
involving regrading and cleaning of artillery ranges.
A 4 percent differential is applicable to employees employed in a position that
represents a low degree of hazard when working with, or in close proximity to
ordance, (or employees possibly adjacent to) explosives and incendiary materials
which involves potential injury such as laceration of hands, face, or arms of the
employee engaged in the operation, irritation of the skin, minor burns and the
like; minimal damage to immediate or adjacent work area or equipment being used.
All operations involving, unloading, storage, and hauling of ordance, explosive, and
incendiary ordnance material other than small arms ammunition. These differentials
are only applicable to work that has been specifically designated by the agency for
ordance, explosives, and incendiary material differential pay.
** UNIFORM ALLOWANCE **
If employees are required to wear uniforms in the performance of this contract
(either by the terms of the Government contract, by the employer, by the state or
local law, etc.), the cost of furnishing such uniforms and maintaining (by
laundering or dry cleaning) such uniforms is an expense that May not be borne by an
employee where such cost reduces the hourly rate below that required by the wage
determination. The Department of Labor will accept payment in accordance with the
following standards as compliance:
The contractor or subcontractor is required to furnish all employees with an
adequate number of uniforms without cost or to reimburse employees for the actual
cost of the uniforms. In addition, where uniform cleaning and maintenance is made
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the responsibility of the employee, all contractors and subcontractors subject to
this wage determination shall (in the absence of a bona fide collective bargaining
agreement providing for a different amount, or the furnishing of contrary
affirmative proof as to the actual cost), reimburse all employees for such cleaning
and maintenance at a rate of $3.35 per week (or $.67 cents per day). However, in
those instances where the uniforms furnished are made of "wash and wear"
materials, may be routinely washed and dried with other personal garments, and do
not require any special treatment such as dry cleaning, daily washing, or commercial
laundering in order to meet the cleanliness or appearance standards set by the terms
of the Government contract, by the contractor, by law, or by the nature of the work,
there is no requirement that employees be reimbursed for uniform maintenance costs.
The duties of employees under job titles listed are those described in the
"Service Contract Act Directory of Occupations", Fifth Edition, April 2006,
unless otherwise indicated. Copies of the Directory are available on the Internet. A
links to the Directory may be found on the WED home page at http://www.dol.
gov/esa/whd/ or through the Wage Determinations On-Line (WDOL) Web site at
http://wdol.gov/.
REQUEST FOR AUTHORIZATION OF ADDITIONAL CLASSIFICATION AND WAGE RATE {Standard Form
1444 (SF 1444)}
Conformance Process:
The contracting officer shall require that any class of service employee which is
not listed herein and which is to be employed under the contract (i.e., the work to
be performed is not performed by any classification listed in the wage
determination), be classified by the contractor so as to provide a reasonable
relationship (i.e., appropriate level of skill comparison) between such unlisted
classifications and the classifications listed in the wage determination. Such
conformed classes of employees shall be paid the monetary wages and furnished the
fringe benefits as are determined. Such conforming process shall be initiated by
the contractor prior to the performance of contract work by such unlisted class(es)
of employees. The conformed classification, wage rate, and/or fringe benefits shall
be retroactive to the commencement date of the contract. {See Section 4.6 (C) (vi))
When multiple wage determinations are included in a contract, a separate SF 1444
should be prepared for each wage determination to which a class(es) is to be
conformed.
The process for preparing a conformance request is as follows:
1) When preparing the bid, the contractor identifies the need for a conformed
occupation(s) and computes a proposed rate(s).
2) After contract award, the contractor prepares a written report listing in order
proposed classification title(s), a Federal grade equivalency (FGE) for each
proposed classification(s), job description(s), and rationale for proposed wage
rate(s), including information regarding the agreement or disagreement of the
authorized representative of the employees involved, or where there is no authorized
representative, the employees themselves. This report should be submitted to the
contracting officer no later than 30 days after such unlisted class(es) of employees
performs any contract work.
3) The contracting officer reviews the proposed action and promptly submits a report
of the action, together with the agency's recommendations and pertinent
information including the position of the contractor and the employees, to the Wage
and Hour Division, Employment Standards Administration, U.S. Department of Labor,
for review. (See section 4.6(b) (2) of Regulations 29 CFR Part 4).
4) Within 30 days of receipt, the Wage and Hour Division approves, modifies, or
disapproves the action via transmittal to the agency contracting officer, or
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notifies the contracting officer that additional time will be required to process
the request.
5) The contracting officer transmits the Wage and Hour decision to the contractor.
6) The contractor informs the affected employees.
Information required by the Regulations must be submitted on SF 1444 or bond paper.
When preparing a conformance request, the "Service Contract Act Directory of
Occupations" (the Directory) should be used to compare job definitions to insure
that duties requested are not performed by a classification already listed in the
wage determination. Remember, it is not the job title, but the required tasks that
determine whether a class is included in an established wage determination.
Conformances may not be used to artificially split, combine, or subdivide
classifications listed in the wage determination.
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