HT0014-17-R-0016_(AS_RELEASED)_DOCUMENT.pdf

SEE ADDENDUM

(No Collect Calls)

HT0014-17-R-0016 26-Oct-2017

b. TELEPHONE NUMBER

(703) 275-6329

8. OFFER DUE DATE/LOCAL TIME

10:00 AM 27 Nov 2017

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

HT00149. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

ROBERT C. SHEPHERD

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0010909308-0003

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESSX

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

DHA CONTRACTING OFFICE-(CO-NCR) HT0014

8111 GATEHOUSE ROAD

2ND FLOOR

FALLS CHURCH VA 22042

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0017 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

WALTER REED NAT. MIL. MED. CTR (WRNMMC)

WRNMMC, DEPT. OF REHAB.

8901 ROCKVILLE PIKE

BETHESDA MD 20889-5600

TEL: FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

NAICS:

339113

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF108

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

HT0014-17-R-0016

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 12 Months Upper & Lower Prosthetics – CMS Listed

FFP

Contractor shall provide prosthetic devices that fulfill Upper or Lower Extremity

Amputee Patient’s prescription(s) for post-Amputation Surgical Appliances

(NAICS 339113). The Base Period of Delivery for these devices and supplies is

31 January 2018 to 30 January 2019. Supplying these devices and supplies requires the contractor to: model the extremity by cast or scan; perform prosthesis design; fabrication; manufacture or assembly; testing; fitting; adjustment, and/or modification of existing prosthetic devices already prescribed and in use. The

Prosthetic Devices provided under this CLIN are LISTED in the Healthcare

Common Procedure Coding System’s (HCPCS), standardized code list provided by the Centers for Medicare & Medicaid Services’ (CMS), Durable Medical

Equipment, Prosthetics Orthotics & Supplies Fee Schedule; for prescription prosthetic devices.

An estimated average monthly sample of the LISTED Prosthetic Devices is found in: Table Two (2) – CMS LISTED DEVICES. This table is located in Part III;

section J – (List of Attachments) of this Solicitation. The contractor will identify and apply HCPCS (or his/her discounted HCPCS) fixed (in each CLIN) unit prices for each of the LISTED prosthetic items, found in Table Two (2) – CMS

LISTED DEVICES, where indicated in the table. Should the contractor choose to submit a discounted unit price, he/she should indicate so in the table; at each item discounted in unit price; and, indicated in parentheses, the percentage of the unit price discount.

The contractor shall compute this CLIN’s MONTHLY estimated unit price, as being equal to: the Sum, of the estimated monthly quantities of each item found in

Table Two; times the HCPCS (or his/her discounted) unit price for each prosthetic device item. The contractor shall state the HCPCS (or his/her discounted) fixed unit price for each prosthetic device, for each performance period of the contract; the Base Period, and all Option Periods.

The contractor shall only provide devices or supplies, after obtaining both the signed physician’s prescription for the patient; and, the released Delivery Order

(to fulfill the prescription) signed by the Administrative Contracting Officer

(ACO). Multiple patient prescriptions may be filled in a single Delivery Order.

FOB: Destination

PURCHASE REQUEST NUMBER: 0010909308-0003

MAX

NET AMT

PSC Code 6515

PSC Code MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

UNIT UNIT PRICE MAX AMOUNT

0002 12 Months Upper & Lower Prosthetics – un-Listed

FFP

The contractor shall provide prosthetic devices that fulfill Upper or Lower

Extremity Amputee Patient’s prescription(s) for post-Amputation Surgical

Appliances (NAICS 339113). The Base Period of Delivery for these devices and supplies is 31 January 2018 to 30 January 2019. Supplying these devices requires the contractor to: model the extremity by cast or scan; perform prosthesis design;

fabrication; manufacture and/or assembly; testing; fitting; adjustment, and/or modification of existing prosthetic devices already in service. The Prosthetic

Devices provided under this CLIN are UNLISTED in the Healthcare Common

Procedure Coding System’s (HCPCS), standardized code of the Centers for

Medicare & Medicaid Services’ (CMS), Durable Medical Equipment, Prosthetics/Orthotics & Supplies, and Fee Schedule; for fulfilling prescriptions for

The list of UNLISTED Prosthetic Devices for this CLIN is found in: Table One

(1) – CMS UNLISTED DEVICES. This table is located in Part III; Section J –

(List of Attachments) of this Solicitation. The contractor will identify and apply his fixed (in each CLIN) unit prices for each of the unlisted prosthetic items, found in Table One (1) – CMS UNLISTED DEVICES, where indicated in the table.

being the Sum, of the estimated monthly quantities of each UNLISTED item found in Table One; times the Contractor’s unit price for each UNLISTED prosthetic device. The contractor shall state his/her proposed UNLISTED fixed unit price for each item; and for each performance period of the contract; the Base

Period, and all Option Periods.

The contractor shall only provide devices or supplies, after obtaining both the signed physician’s prescription for the patient; and, the released Delivery Order

UNIT UNIT PRICE MAX AMOUNT

1001 12 Months OPTION Upper & Lower Prosthetics – CMS Listed

FFP

Contractor shall provide prosthetic devices that fulfill Upper or Lower Extremity

Amputee Patient’s prescription(s) for post-Amputation Surgical Appliances

(NAICS 339113). The Base Period of Delivery for these devices and supplies is

31 January 2019 to 30 January 2020. Supplying these devices and supplies requires the contractor to: model the extremity by cast or scan; perform prosthesis design; fabrication; manufacture or assembly; testing; fitting; adjustment, and/or modification of existing prosthetic devices already prescribed and in use. The

Prosthetic Devices provided under this CLIN are LISTED in the Healthcare

Common Procedure Coding System’s (HCPCS), standardized code list provided by the Centers for Medicare & Medicaid Services’ (CMS), Durable Medical section J – (List of Attachments) of this Solicitation. The contractor will identify and apply HCPCS (or his/her discounted HCPCS) fixed (in each CLIN) unit prices for each of the LISTED prosthetic items, found in Table Two (2) – CMS

LISTED DEVICES, where indicated in the table. Should the contractor choose to submit a discounted unit price, he/she should indicate so in the table; at each item

Table Two; times the HCPCS (or his/her discounted) unit price for each prosthetic device item. The contractor shall state the HCPCS (or his/her

UNIT UNIT PRICE MAX AMOUNT

1002 12 Months OPTION Upper & Lower Prosthetics – un-Listed

FFP

The contractor shall provide prosthetic devices that fulfill Upper or Lower

Extremity Amputee Patient’s prescription(s) for post-Amputation Surgical

Appliances (NAICS 339113). The Base Period of Delivery for these devices and supplies is 31 January 2019 to 30 January 2020. Supplying these devices requires the contractor to: model the extremity by cast or scan; perform prosthesis design;

fabrication; manufacture and/or assembly; testing; fitting; adjustment, and/or modification of existing prosthetic devices already in service. The Prosthetic

Devices provided under this CLIN are UNLISTED in the Healthcare Common

Procedure Coding System’s (HCPCS), standardized code of the Centers for

Medicare & Medicaid Services’ (CMS), Durable Medical Equipment, (List of Attachments) of this Solicitation. The contractor will identify and apply his fixed (in each CLIN) unit prices for each of the unlisted prosthetic items, found in Table One; times the Contractor’s unit price for each UNLISTED prosthetic device. The contractor shall state his/her proposed UNLISTED fixed unit price for each item; and for each performance period of the contract; the Base

Period, and all Option Periods.

The contractor shall only provide devices or supplies, after obtaining both the signed physician’s prescription for the patient; and, the released Delivery Order

UNIT UNIT PRICE MAX AMOUNT

2001 12 Months OPTION Upper & Lower Prosthetics – CMS Listed

FFP

Contractor shall provide prosthetic devices that fulfill Upper or Lower Extremity

Amputee Patient’s prescription(s) for post-Amputation Surgical Appliances

(NAICS 339113). The Base Period of Delivery for these devices and supplies is

31 January 2020 to 30 January 2021. Supplying these devices and supplies requires the contractor to: model the extremity by cast or scan; perform prosthesis design; fabrication; manufacture or assembly; testing; fitting; adjustment, and/or modification of existing prosthetic devices already prescribed and in use. The

Prosthetic Devices provided under this CLIN are LISTED in the Healthcare

Common Procedure Coding System’s (HCPCS), standardized code list provided by the Centers for Medicare & Medicaid Services’ (CMS), Durable Medical section J – (List of Attachments) of this Solicitation. The contractor will identify and apply HCPCS (or his/her discounted HCPCS) fixed (in each CLIN) unit prices for each of the LISTED prosthetic items, found in Table Two (2) – CMS

LISTED DEVICES, where indicated in the table. Should the contractor choose to submit a discounted unit price, he/she should indicate so in the table; at each item

Table Two; times the HCPCS (or his/her discounted) unit price for each prosthetic device item. The contractor shall state the HCPCS (or his/her

UNIT UNIT PRICE MAX AMOUNT

2002 12 Months OPTION Upper & Lower Prosthetics – un-Listed

FFP

The contractor shall provide prosthetic devices that fulfill Upper or Lower

Extremity Amputee Patient’s prescription(s) for post-Amputation Surgical

Appliances (NAICS 339113). The Base Period of Delivery for these devices and supplies is 31 January 2020 to 30 January 2021. Supplying these devices requires the contractor to: model the extremity by cast or scan; perform prosthesis design;

fabrication; manufacture and/or assembly; testing; fitting; adjustment, and/or modification of existing prosthetic devices already in service. The Prosthetic

Devices provided under this CLIN are UNLISTED in the Healthcare Common

Procedure Coding System’s (HCPCS), standardized code of the Centers for

Medicare & Medicaid Services’ (CMS), Durable Medical Equipment, (List of Attachments) of this Solicitation. The contractor will identify and apply his fixed (in each CLIN) unit prices for each of the unlisted prosthetic items, found in Table One; times the Contractor’s unit price for each UNLISTED prosthetic device. The contractor shall state his/her proposed UNLISTED fixed unit price for each item; and for each performance period of the contract; the Base

Period, and all Option Periods.

The contractor shall only provide devices or supplies, after obtaining both the signed physician’s prescription for the patient; and, the released Delivery Order

Part I – The Schedule

Section C – Description/Specifications/Statement of Work (SOW)

1. INTRODUCTION

1.1 The contractor shall provide post-operative specialized surgical appliances: Prosthetic Devices (consisting of their component sub-assemblies, their consumable supplies, supporting equipment, or systems), for the upper and lower human extremities. The contractor shall accomplish this through the fulfillment of Walter Reed National

Military Medical Center (WRNMMC) patient’s Physician’s original or revised prescriptions for post-Amputation

Surgical Appliances (e.g., the North American Industrial Classification System (NAICS), Code 339113), that their

Physicians deem necessary for their patients’ initial; or on-going post-operative rehabilitation, and/or continuing care. This contract envisions that the contractor will fulfill approximately 4,000 prosthetic device prescriptions over a base year, plus up to two additional option years.

1.2 The Government will issue during the life of the contract individual Delivery Orders for the delivery of prosthetic devices and supplies that arise from WRNMMC patient prescriptions and multiple patients’ prescriptions may be filled in a single Delivery Order.

2. GENERAL REQUIREMENTS FOR THE PROVISION OF PROSTHETIC DEVICES & SUPPLIES

2.1 The contractor shall only supply prosthetic devices for all levels of post-operative upper and lower human extremity amputation surgeries; as directed by written post amputation prescriptions from the patient’s amputee surgeon or other rehabilitative physician.

2.2 Concurrent with acceptance of award; the contractor shall supply the name of their Program Manager and

Program Manager – Alternate, to the Contracting Officer; designating who shall be the responsible Contracting

Official of their firm, for the fulfillment of the responsibilities of the firm; in providing prosthetic devices and supplies, through this contract.

2.3 The contractor is required to have access to the Department of Rehabilitation at WRNMMC; for access to

WRNMMC amputee patients for measurement, fitment, modification and adjustment of upper and lower extremity prosthetic devices. The contractor is required to directly enter all prosthetic device and patient fitment information into the individual patients’ record using WRNMMC’s AHLTA system for electronic medical records keeping.

Security Identification Badges: Contractor shall comply with the local installation and MTF personnel identification and access requirements. This will require the contractor to obtain and maintain qualification of Common Access

Card ID and access documents. The contractor shall immediately report any lost or stolen security badges to the

Installation Security Office.

2.4 The contractor shall obtain; and, at all times maintain, contractor identification badge access to WRNMMC, Department of Rehabilitation; and, Common Access Card (CAC) access to information technology systems at

WRNMMC; and, have qualified to access the AHLTA patient record keeping system at WRNMMC.

2.5 The contractor is not authorized to begin any work upon any prosthetic device or supplies provided thru the

Delivery Orders of this contract without being in the actual possession of both, the physician’s prescription for same; and, the released Delivery Order from this contract’s Administrative Contracting Officer, requesting such device(s) or supplies.

2.6 The contractor shall only fulfill patients’ prescriptions with those components, devices, and supplies that are already included in this contract’s Price Schedule for same as released, or as amended.

2.7 The contractor shall only utilize prosthetic devices or supplies that are commercially available to fulfill any prosthetic prescription and Delivery Orders under this contract.

2.8 The Government reserves the right to provide selected components for use by the contractor in the fabrication of prosthetic devices. However; the Government does not routinely provide component parts to the Contractor.

When components are provided by the Government, the contractor will not include any coding for Government provided components/devices in the billing for that Order.

2.9 The contractor shall not utilize any devices, supplies, or component sub-assemblies, which are undergoing alpha or beta testing; in the prosthetic device(s); or, in any supplies provided under this contract.

2.10 This contract is an indefinite delivery and indefinite quantity (IDIQ) type. The Government’s requirement for prosthetic devices and supplies cannot specify a firm quantity or uniform delivery schedule of devices and supplies

(other than a minimum and a maximum quantity) over this contract’s period of performance.

2.11 Access by the contractor to the Department of Rehabilitation, WRNMMC or its information systems is only allowed IAW the full compliance with the terms of the Crime Control Act of 1990 and Department of Defense

Instruction 1402.5 dated 19 January 1993. All contract personnel access to Government computer systems and/or providing care to children (17 years of age and under) must be subject to background investigation with a favorable adjudicated result. Background checks will be based on fingerprints of individuals obtained by a law enforcement officer and inquiries will be made, based on the Standard Form 85-P completed by the contract personnel and will be provided to the Federal Bureau of Investigation (FBI) and state criminal history repositories. All individuals who are required to complete the Standard Form 85-P Questionnaire for Public Trust Position (including individuals who will access CHCS) shall provide the SF85-P documentation, as prescribed by Security Office at WRNMMC.

3. GENERAL PROCEDURES CONTRACTOR IS TO FOLLOW IN PROVIDING PROSTHETIC DEVICES

AND SUPPLIES

3.1 Upon receipt of a contract Delivery Order for supplies or device(s); and, with the accompanying physician’s prescription for prosthetic supplies or device(s); the contractor shall formulate a plan for fulfillment of the prescription. This plan is to be based upon his (the contractor’s) assessment of the prescription’s prosthetic device requirement for the patient; and will as a minimum include; initial patient measurement (if required); device(s) fitment, device(s) specification & selection, device design, fabrication, assembly, test, mounting, and adjustment(s) as needed. The contractor will provide the Orthotic & Prosthetic Service Chief (or his/her designee) the written results of the assessment, and the plan for fulfillment of the Delivery Order, within forty-eight (48) hours of receipt of the Order. Should a problem with, or in, the Order or its fulfillment be recognized; the contractor shall immediately contact the Orthotic & Prosthetic Service Chief (or his/her designee); to consult and advise on the problem’s resolution.

3.2 Contractor shall be, and is to remain technically proficient and current with all surgical advances (i.e. Osseo integration) and associated technologies related to prosthetic devices prescribed by amputee surgeon’s and or rehabilitation physicians. The contractor is required to provide Thermolyn Steif or its equivalent sockets for use by patients in aggressive physical therapy regimens in use in WRNMMC Amputee Service. The contractor is required to provide prosthetic sockets, constructed of carbon fiber and composite acrylic laminate, and/or rolled silicon inner sockets, when residuum is determined stable; or, for special events that require a more durable connection between the socket and the other components of the prosthesis.

3.3 Contractor shall make post initial fitment adjustments to patient’s existing prosthetic devices with respect to patients’ physical and/or occupational therapy sessions. The contractor shall have the capability to make socket changes in prosthetic device(s) to address rapid volume change and pressure points associated with severe blast injuries within 48 hours of notification of such need.

3.4 Contractor shall supply prosthetic devices that incorporate the most recent advancements in powered prosthetic components; in microprocessor controlled or sensory controlled prosthetic components, and to incorporate the most advanced suspension and joint systems components, as prescribed in the written prescription of the patient’s physician.

3.5 Contractor shall supply the highest technologically developed upper extremity prostheses for the treatment of upper extremity amputees. This includes but is not limited to myoelectric terminal devices, sensor hand speed, bebionic terminal devices, advanced microprocessor elbows and advanced mind machine technological interfaces.

The contractor shall provide control systems for prosthetic devices that incorporate the most recent advancements in elbow, wrist, hand, and finger prosthetic components in accordance with the written prescription of the physician.

3.6 Contractor shall supply activity specific prosthetic devices as prescribed by the physician.

3.7 Contractor shall document the experience of the prosthetists proposed to perform work under this contract in the provision of activity specific prosthetic devices.

3.8 Contractor shall supply prosthetic devices whose designs provide solutions to prosthetic device design and fitting problems found in the co- morbidities most closely associated with blast injuries. These co-morbidities include, but are not limited to skin grafts, heterotopic ossification, abnormal suture lines, etc.

3.9 Contractor shall enter all prosthetic device and patient fitment information into the individual patients’ record using the AHLTA system for electronic medical records; and prepare and submit all monthly reports on patient devices’ deliveries inventories and other monthly reports on patient prosthetic prescription fulfillment processing procedures.

3.10 Contractor shall utilize Health Care Common Procedural Coding System (HCPCS) Schedule – Level II priced with regional (State) adjustment, as published by the Centers for Medicare and Medicaid Services (CMS), of the US

Department of Health & Human Services; in the fulfillment of patient prescriptions; where the physician’s prosthetic prescription calls for device(s) that are so listed.

SOW Appendix 1

4. DEFINITIONS AND ACRONYMS

4.1 Alpha Testing: Field testing of a component or system by actual users in an operational environment; to discover material weaknesses that cannot be found in a non-operational testing.

4.1 Armed Forces Health Longitudinal Technology Application (AHLTA): An automated medical information system that provides integrated support for the functional work centers of inpatient and outpatient care facilities, patient administration, patient appointments and scheduling, nursing, laboratory, pharmacy, radiology, and clinical dietetics.

4.2 Beta Testing: A form of external acceptance testing of a component, sub-system or system, to acquire feedback operational users.

4.3 Defense Enrollment Eligibility Reporting System (DEERS): A computerized system that maintains current eligibility status for all eligible health care beneficiaries.

4.4 Health Care Procedural Coding System (HCPCS) Schedule – Level II: A prosthetic device and procedures schedule, priced with regional (State) adjustment that is published by the Centers for Medicare and Medicaid

Services US Department of Health & Human Services.

General List of Acronyms

ACOR Alternate Contracting Officer’s Representative

ADP Automated Data Processing

AHA American Hospital Association

AHLTA Armed Forces Health Longitudinal Technology Application

AMA American Medical Association

AO Authorizing Official

AOD Administrative Officer of the Day

AR Army Regulation

ATO Authority to Operate

BCLS Basic Cardiac Life Support

BLS Basic Life Support

CAP Cloud Access Point

CDRL Contract Data Requirement List

CFR Code of Federal Regulations

CHAMPUS Civilian Health and Medical Program of the Uniformed Devices

CHCS Composite Health Care System

CIO Chief Information Officer

CJCSM Chairman of the Joint Chiefs of Staff Manual

CLIN Contract Line Item Number

CME Continuing Medical Education

CMS Center for Medicare & Medicaid Services

CND SP Computer Network Defense Service Provider

CNSS Committee on National Security Systems

CO Contracting Officer

CONUS Continental United States (excludes Alaska and Hawaii)

COR Contracting Officer Representative

CPARS Contractor Performance Assessment Reporting System

CPGs Clinical Practice Guidelines

CS Contract Specialist

CSP Cloud Service Provider ()

CUI Controlled Unclassified Information

CVS Contractor employee Verification System

DA Department of Army

DCCS Deputy Commander for Clinical Devices

DD 254 Department of Defense Contract Security Requirement List (if applicable)

DEA Drug Enforcement Administration

DFARS Defense Federal Acquisition Regulation Supplement

DHA Defense Health Agency

DISA Defense Information Systems Agency

DMHRSi Defense Medical Human Resources System Internet

DMRC Deployment Medical Readiness Clinic

DOD Department of Defense

DoDI Department of Defense Instruction

ECFMG Educational Commission for Foreign Medical Graduates

EFT Electronic Funds Transfer

EULA End User License Agreements

FAR Federal Acquisition Regulation

FedRAMP Federal Risk Authorization and Management Program

FTE Full Time Equivalent

GS General Schedule

HCAA Health Care Acquisition Activity

HCP Health Care Provider

HCPCS Healthcare Common Procedure Coding System

HIPAA Health Insurance Portability & Accountability Act of 1996

HIT Health Information Technology

HSPD Homeland Security Presidential Directive iRAPT Invoicing, Receipt, Acceptance, and Property Transfer (formerly Wide Area Work Flow)

IA Information Assurance

IAVM Information Assurance Vulnerability Management

IS Information System

JC Joint Commission

KO Contracting Officer

MEDCEN Medical Center

MEDCOM Medical Command

MEDDAC Medical Department Activity

MHS Military Health System

MTF Medical Treatment Facility

NACI National Agency Check with Inquiries

NAICS North American Industrial Classification System (NAICS)

NASW National Association of Social Workers

NCOIC Noncommissioned Officer in Charge

NDA Non-Disclosure Agreement

NIST National Institute of Standards and Technology

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska and Hawaii)

ODC Other Direct Costs

OIC Officer-in-Charge

OMB Office of Management and Budget

OTSG Office of The Surgeon General, U.S. Army

OSHA Occupational Safety & Health Association

P-ATO Provisional Authorization to Operate

PA Provisional Authorization

PAD Patient Administration Division

PDH-CPG Post Deployment Health Evaluation and Management – Clinical Practice Guidelines

PDHRA Post-Deployment health Re-Assessment

PHI Protected Health Information

PII Personally Identifiable Information

PIPO Phase In/Phase Out

PK Public Key

PKI Public Key Infrastructure

PL Public Law

PMO Program Management Office

POC Point of Contact

PoP Period of Performance

PPIMS Past Performance Information management System

PPSM Ports, Protocols, and Devices Management

PRS Performance Requirements Summary

PWS Performance Work Statement

QA Quality Assurance

QAP Quality Assurance Program

QASP Quality Assurance Surveillance Plan

QA&I Quality Assessment & Improvement

QC Quality Control

QCP Quality Control Plan

RFP Request for Proposal

RMC Regional Medical Command

RMF Risk Management Framework

SAR Security Assessment Report

SF Standard Form

SP Special Publication

SRG Security Requirements Guide(s)

SRP Soldier Readiness Processing

STIG Security Technical Implementation Guide(s)

TA Trusted Agent

TAB Therapeutic Agents Board

TE Technical Exhibit

TOS Terms of Service

WRNMMC Walter Reed National Military Medical Center

SOW Appendix 2

CMS HCPCS Level II (Device & Fee) Schedule for the States of Maryland; Virginia, And the District of Columbia

Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

(DMEPOS)

Revised January 2017 Fee Schedule (Unit of issue for all devices is each)

THE APPLICABLE CMS HCPCS LEVEL II SCHEDULE FOR MARYLAND; VIRGINIA, AND IN THE

DISTRICT OF COLUMBIA FOR PROSTHETICS ORTHOTICS, AND SUPPLIES IS INCORPORATED

HEREIN, BY REFERENCE TO THE CMS SITE (www.CMS.GOV) BELOW:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule-

Items/L-Code-Pricing http://www.cms.gov/ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule-Items/L-Code-Pricing https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule-Items/L-Code-Pricing

SOW Appendix 3

PERFORMANCE REQUIREMENTS SUMMARY (PRS)

The contractor’s required standards to be met in providing prosthetic devices and supplies called for in this contract are summarized into standards and objectives that relate directly to mission essential deliveries of such items. The performance threshold briefly describes the minimum acceptable levels of performance required for each element.

These thresholds are critical to mission success.

Performance

Objective

Standard Performance

Threshold

Consequence of

Failure to Meet

Requirement

Method of

Surveillance

SOW 2.2

Designate Program

Manager and

Program Manager –

Alternate, to the

Contracting Officer upon acceptance of award

Oral and written notification of named

PM and Alt. PM shall be received by the

CO concurrent with

KTR’s acceptance of award.

PM and Alt. PM must be named to the KO concurrent with awardee’s acceptance of Government’s award notice. Zero deviation from standard.

Government’s offer of award is held until contractor’s PM and PM – Alt. is ready to be named by the contractor.

Oral and written notification to

Contracting

Officer

SOW 3.1

Prepare and submit

Plan for fulfillment of patient prescription from a

Delivery Order and patient prescription

Written Summary of plan for fulfillment of prescription provided to COR not more than 48 hours after receipt of Del. Order and prescription.

Plan for fulfillment must be provided by contractor in response to Del Order and patient prescription within

48 hours. Zero deviation is permitted from standard.

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than one (1) occurrence in a quarter

Oral and written notification to

Contracting

Officer

SOW 3.9

Monthly Status

Reports

Due first week of every month

No more than 3 days past suspense date;

and not more than one (1) occurrence in any quarter

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than one (1) occurrence in a quarter

Written notification to the CO

SOW 3.5, 3.6

The patient is able to use the prescribed prosthesis within one week (Sat. &

Sun. included) of receiving physicians prescription

Patient is able to wear the provided device when required for therapy or personal use

Not more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than one (1) occurrence per quarter in a single year

Clinical observation and patient reporting;

contractor’s quality control plan

SOW 3.6, 3.7

The patient can function without discomfort to the remnant limb caused by the prosthetic fit

Patient wears the provided device whenever required for therapy or personal use

No more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more

Clinical observation and patient reporting;

contractor’s than two (2) occurrences per quarter in a single year.

quality control plan

SOW 3.2, 3.3, 3.4

The prosthetic device does not limit the patient from engaging in any activity after treatment that he/she engaged in prior to injury

Patient wears the provided device whenever required for therapy or personal use

No more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than two (2) occurrences per quarter in a single year.

Clinical observation and patient reporting;

contractor’s quality control plan

SOW 3.2, 3.3, 3.4

The provided prosthetic device does not limit an otherwise physically able patient from returning to active duty if he/she so desires.

Patient wears the provided device whenever required for therapy or personal use

No more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than two (2) occurrences per quarter in a single year

Clinical observation and patient reporting;

contractor’s quality control plan

SOW 3.6, 3.8

Contractor provides prosthetic devices for all applicable levels of amputation

Patients at all levels of amputation receive appropriate devices from the contractor

No more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than two (2) occurrences per quarter in a single year

Clinical observation and patient reporting

SOW 3.4

Provides prosthetic devices that incorporate the most recent advancements in prosthetic technology

Observation of device supplied based on the physician’s prescription

No more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than two (2) occurrences per quarter in a single year.

Clinical observation and patient reporting

SOW 3.8

Provide solutions to prosthetic design and fitting problems for the co-morbidities most closely associated with blast injuries

Patient wears the provided device whenever required for therapy or personal use

No more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than two (2) occurrences per quarter in a single year

Clinical observation and patient reporting

SOW 3.6

Provides appropriate activity specific prosthetic devices

Patient is able to participate in the activity for which the prosthetic device was intended

No more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than two (2) occurrences per quarter in a single year

Clinical observation and patient reporting

SOW 3.6

Solution for co-morbidities enable wear and use of the device

Patient wears the provided device whenever required for therapy or personal use

No more than one patient complaint per month

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than two (2) occurrences per quarter in a single year.

Clinical observation and patient reporting

SOW 3.10

KTR bills only for the unlisted procedures (NOC) codes L5999, provided in the PWS with

KTR correctly invoices for devices and supplies against

Delivery Orders and prescriptions for unlisted items, according to pricing proposal for unlisted items

KTR’s internal processes for invoice construction and review of invoice(s) prior to submission must result in zero

(0) invoicing errors in invoices submitted.

Zero deviation is permitted from standard.

No incorrect invoice will be accepted. An unfavorable written notice of performance is to be recorded in

CPARS for this contract for every occurrence of incorrect invoicing

COR

surveillance and

DFAS audits of

WAWF

invoicing

SOW 2.11

Combating

Trafficking in persons (awareness program)

IAW FAR 52.222-

50 and 22.1703

100% compliance

(zero tolerance) regarding trafficking in persons policy

Complete required training by suspense date

Unfavorable written notice of performance is recorded in

CPARS for this contract if more than one (1) occurrence per quarter in a single year

COR

documentation and program review. Any non-compliance must be brought to the immediate attention of the

KO

Section E – Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

1001 Destination Government Destination Government

1002 Destination Government Destination Government

2001 Destination Government Destination Government

2002 Destination Government Destination Government

Section F – Deliveries or Performance

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 31-JAN-2018 TO

30-JAN-2019

N/A WALTER REED NAT. MIL. MED. CTR

(WRNMMC)

WRNMMC, DEPT. OF REHAB.

8901 ROCKVILLE PIKE

BETHESDA MD 20889-5600

HT0017

0002 POP 31-JAN-2018 TO

30-JAN-2019

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 31-JAN-2019 TO

30-JAN-2020

N/A (SAME AS PREVIOUS LOCATION)

1002 POP 31-JAN-2019 TO

30-JAN-2020

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 31-JAN-2020 TO

30-JAN-2021

N/A (SAME AS PREVIOUS LOCATION)

2002 POP 31-JAN-2020 TO

30-JAN-2021

N/A (SAME AS PREVIOUS LOCATION)

Section G – Contract Administration Data

Contract Administration Data to be provided at time of Award.

Section H – Special Contract Requirements

CLAUSES INCORPORATED BY FULL TEXT

DHA PGI 224.1-90 - PERSONALLY IDENTIFIABLE INFORMATION (PII), PROTECTED HEALTH

INFORMATION (PHI), AND FEDERAL INFORMATION REQUIREMENTS (REVISED MAY 6, 2015)

The contractor shall comply with the document entitled, ‘Personally Identifiable Information (PII), Protected Health

Information (PHI) and Federal Information Requirements,’ that can be found at http://health.mil/Policies/2015/04/09/DHA-Standard-Contract-Language which is incorporated by reference in its entirety.”

(End of requirements language) https://mhs.health.mil/Content/DHA/procurement/downloads/atch/DHA%20PGI%20224.1-90%20Atch%202%20-%20PII%20PHI%20(Revised%2005.06.2015)%20(3).pdf https://mhs.health.mil/Content/DHA/procurement/downloads/atch/DHA%20PGI%20224.1-90%20Atch%202%20-%20PII%20PHI%20(Revised%2005.06.2015)%20(3).pdf

Part II – Contract Clauses

Section I – Contract Clauses

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984

52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(Sep 2006) -- Alternate I

OCT 1995

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

OCT 2010

52.203-17 Contractor Employee Whistleblower Rights and Requirement

To Inform Employees of Whistleblower Rights

APR 2014

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper

MAY 2011

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

OCT 2016

52.209-6 Protecting the Government's Interest When Subcontracting

With Contractors Debarred, Suspended, or Proposed for

Debarment

OCT 2015

52.219-6 Notice Of Total Small Business Set-Aside NOV 2011

52.219-14 Limitations On Subcontracting JAN 2017

52.219-16 Liquidated Damages-Subcontracting Plan JAN 1999

52.222-19 Child Labor -- Cooperation with Authorities and Remedies OCT 2016

52.222-21 Prohibition Of Segregated Facilities APR 2015

52.222-26 Equal Opportunity SEP 2016

52.222-35 Equal Opportunity for Veterans OCT 2015

52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014

52.222-37 Employment Reports on Veterans FEB 2016

52.222-54 Employment Eligibility Verification OCT 2015

52.223-3 Hazardous Material Identification And Material Safety Data JAN 1997

52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011

52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

AUG 2011

52.225-13 Restrictions on Certain Foreign Purchases JUN 2008

52.228-5 Insurance - Work On A Government Installation JAN 1997

52.232-18 Availability Of Funds APR 1984

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-3 Protest After Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.242-13 Bankruptcy JUL 1995

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013

252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By

The Government of a Country that is a State Sponsor of

Terrorism

OCT 2015

252.225-7012 Preference For Certain Domestic Commodities DEC 2016

252.225-7021 Trade Agreements--Basic DEC 2016

252.225-7048 Export-Controlled Items JUN 2013

252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business

Concerns

SEP 2004

252.227-7015 Technical Data--Commercial Items FEB 2014

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7001 Pricing Of Contract Modifications DEC 1991

252.243-7002 Requests for Equitable Adjustment DEC 2012

CLAUSES INCORPORATED BY FULL TEXT

52.203-13 CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT (OCT 2015)

(a) Definitions. As used in this clause--

Agent means any individual, including a director, an officer, an employee, or an independent Contractor, authorized to act on behalf of the organization.

Full cooperation—

(1) Means disclosure to the Government of the information sufficient for law enforcement to identify the nature and extent of the offense and the individuals responsible for the conduct. It includes providing timely and complete response to Government auditors' and investigators' request for documents and access to employees with information;

(2) Does not foreclose any Contractor rights arising in law, the FAR, or the terms of the contract. It does not require-

(i) A Contractor to waive its attorney-client privilege or the protections afforded by the attorney work product doctrine; or

(ii) Any officer, director, owner, or employee of the Contractor, including a sole proprietor, to waive his or her attorney client privilege or Fifth Amendment rights; and

(3) Does not restrict a Contractor from--

(i) Conducting an internal investigation; or

(ii) Defending a proceeding or dispute arising under the contract or related to a potential or disclosed violation.

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

Subcontract means any contract entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract.

Subcontractor means any supplier, distributor, vendor, or firm that furnished supplies or services to or for a prime contractor or another subcontractor.

United States means the 50 States, the District of Columbia, and outlying areas.

(b) Code of business ethics and conduct. (1) Within 30 days after contract award, unless the Contracting Officer establishes a longer time period, the Contractor shall--

(i) Have a written code of business ethics and conduct;

(ii) Make a copy of the code available to each employee engaged in performance of the contract.

(2) The Contractor shall--

(i) Exercise due diligence to prevent and detect criminal conduct; and

(ii) Otherwise promote an organizational culture that encourages ethical conduct and a commitment to compliance with the law.

(3)(i) The Contractor shall timely disclose, in writing, to the agency Office of the Inspector General (OIG), with a copy to the Contracting Officer, whenever, in connection with the award, performance, or closeout of this contract or any subcontract thereunder, the Contractor has credible evidence that a principal, employee, agent, or subcontractor of the Contractor has committed--

(A) A violation of Federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations found in

Title 18 of the United States Code; or

(B) A violation of the civil False Claims Act (31 U.S.C. 3729-3733).

(ii) The Government, to the extent permitted by law and regulation, will safeguard and treat information obtained pursuant to the Contractor's disclosure as confidential where the information has been marked “confidential” or

“proprietary” by the company. To the extent permitted by law and regulation, such information will not be released by the Government to the public pursuant to a Freedom of Information Act request, 5 U.S.C. Section 552, without prior notification to the Contractor. The Government may transfer documents provided by the Contractor to any department or agency within the Executive Branch if the information relates to matters within the organization's jurisdiction.

(iii) If the violation relates to an order against a Government wide acquisition contract, a multi-agency contract, a multiple-award schedule contract such as the Federal Supply Schedule, or any other procurement instrument intended for use by multiple agencies, the Contractor shall notify the OIG of the ordering agency and the IG of the agency responsible for the basic contract.

(c) Business ethics awareness and compliance program and internal control system. This paragraph (c) does not apply if the Contractor has represented itself as a small business concern pursuant to the award of this contract or if this contract is for the acquisition of a commercial item as defined at FAR 2.101. The Contractor shall establish the following within 90 days after contract award, unless the Contracting Officer establishes a longer time period:

(1) An ongoing business ethics awareness and compliance program.

(i) This program shall include reasonable steps to communicate periodically and in a practical manner the

Contractor's standards and procedures and other aspects of the Contractor's business ethics awareness and compliance program and internal control system, by conducting effective training programs and otherwise disseminating information appropriate to an individual's respective roles and responsibilities.

(ii) The training conducted under this program shall be provided to the Contractor's principals and employees, and as appropriate, the Contractor's agents and subcontractors.

(2) An internal control system.

(i) The Contractor's internal control system shall--

(A) Establish standards and procedures to facilitate timely discovery of improper conduct in connection with

Government contracts; and

(B) Ensure corrective measures are promptly instituted and carried out.

(ii) At a minimum, the Contractor's internal control system shall provide for the following:

(A) Assignment of responsibility at a sufficiently high level and adequate resources to ensure effectiveness of the business ethics awareness and compliance program and internal control system.

(B) Reasonable efforts not to include an individual as a principal, whom due diligence would have exposed as having engaged in conduct that is in conflict with the Contractor's code of business ethics and conduct.

(C) Periodic reviews of company business practices, procedures, policies, and internal controls for compliance with the Contractor's code of business ethics and conduct and the special requirements of Government contracting, including--

(1) Monitoring and auditing to detect criminal conduct;

(2) Periodic evaluation of the effectiveness of the business ethics awareness and compliance program and internal control system, especially if criminal conduct has been detected; and

(3) Periodic assessment of the risk of criminal conduct, with appropriate steps to design, implement, or modify the business ethics awareness and compliance program and the internal control system as necessary to reduce the risk of criminal conduct identified through this process.

(D) An internal reporting mechanism, such as a hotline, which allows for anonymity or confidentiality, by which employees may report suspected instances of improper conduct, and instructions that encourage employees to make such reports.

(E) Disciplinary action for improper conduct or for failing to take reasonable steps to prevent or detect improper conduct.

(F) Timely disclosure, in writing, to the agency OIG, with a copy to the Contracting Officer, whenever, in connection with the award, performance, or closeout of any Government contract performed by the Contractor or a subcontractor thereunder, the Contractor has credible evidence that a principal, employee, agent, or subcontractor of the Contractor has committed a violation of Federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations found in Title 18 U.S.C. or a violation of the civil False Claims Act (31 U.S.C. 3729-3733).

(1) If a violation relates to more than one Government contract, the Contractor may make the disclosure to the…