36C10G22R0013 RFI (Amend 0001).docx

36C10G22R0013

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

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

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

04-15-2022 Darrell Williamson 2025902373 05-13-2022

EST

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

X

339113 750 Employees

NET 30 Days

N/A

See delivery orders for details

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.3 invoicing/payment) Austin TX 78714-8917 1 (877) 489-6135

See CONTINUATION Page Title: Standard Manual Wheelchairs for Home use Period of Performance (POP) from the date of award through 60 months.

Please See Section B.4 Price/Cost Schedule (Attachment D) for details

Zachary Wilcox

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

Governing Law Clause Federal law and regulations, including the Federal Acquisition Regulations (FAR), shall govern this Contract/Order. Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrink wrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

B.1

CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C10G Zachary Wilcox U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 Zachary.wilcox@va.gov Contracting Specialist Darrell Williamson U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave., Suite 400 Fredericksburg, VA 22408 Darrell.williamson@va.gov

Program Office Point of Contact (POC) – To Be Determined (TBD)

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted monthly in in arrears based upon delivery and acceptance.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: Darrell Williamson, email: Darrell.williamson@va.gov COR (Contracting Officers Representative): Kimberly Cowen-Tucker Contract/Task Order Number: TBD Purchase Order: #TBD

a. Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

b. Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-Invoice email: vafsccshd@va.gov

5. See https://www.fsc.va.gov/einvoice.asp for more information.

B.2 PAYMENT TERMS AND CONDITIONS

a) The Government is obligated only to the extent of authorized purchases made under the resultant contract/task order. The terms and conditions included in this contract apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this contract, and the Contractor’s invoice, the provisions of this contract will take precedence.

b) Purchase/Ordering Limitation:

Limited to FAR Clause 52.216-19 Order Limitations, as noted in the contract. The estimated total quantities are listed in the Schedule of Services. The quantities are estimates only, and the VA makes no guarantee regarding the actual quantities that may be purchased.

c) Delivery Tickets:

The following provisions apply to all shipments:

Inspection: Destination Acceptance: Destination Shipping: Free on Board (FOB) – Destination Ship To and Mark For : Deliveries shall be marked and shipped to various VHA locations and patient homes, as applicable, identified in each order placed against the contract.

All shipments, either single or multiple container deliveries, shall bear and contain on the delivery tickets or sales slips (external shipping labels and associated manifests or packing lists)) the following at a minimum:

(i) Name of supplier

(ii) Contract number

(iii) Date of purchase

(iv) Itemized list of supplies or services furnished

(v) Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided the invoice is itemized to show this information).

(vi) Date of delivery or shipment

In the case of multiple container deliveries, a statement readable near the VA Order number will indicate total number of containers for the complete shipment (ex. “Package 1 of 2”), clearly readable on manifests and external shipping labels.

Packing Slips/Labels and Lists shall include the following:

IFCAP PO # TBD (i.e., 166-E11234)

Total number of Containers: Package ___ of ___. (i.e., Package 1 of 3)

d) Reports:

Quarterly Report:

To track compliance, VA requires the contractor to submit the quarterly report of sales in the approved format listed in contract Attachment A – Quarterly Reporting Tool based on the Governments fiscal calendar year. See below.

The contractor agrees that they shall adhere to this requirement. The contractor shall provide a quarterly report, no later than the submission due date outlined above. Reports shall be sent electronically to the following SAC IDIQ Government points of contact until the contractor is notified, in writing, of a different point of contact as follow:

a. Project Manager;

b. Contracting Officer’s Representative;

c. Contract Specialist; and

d. Financial Management Analyst at SACPAY@va.gov;

B.3 BUSINESS ASSOCIATE AGREEMENT(S) (BAA)

A National Business Associate Agreement (BAA) shall be established within 60 days of contract award.

When the Government engages the services of contractor to create, receive, maintain, or transmit individually-identifiable health information on its behalf, the contractor becomes a business associate under HIPAA. As a result, the Government and the contractor must enter into a HIPAA-compliant Business Associate Agreement (BAA), and the contractor is both contractually liable for meeting the terms of the BAA and directly liable for compliance with the applicable requirements of the HIPAA Rules.

VHA is the only administration of the Department of Veterans Affairs (VA) that is a Covered Entity under the HIPAA Privacy Rule.

Although VHA is the Covered Entity under HIPAA, other VA Administrations and Staff Offices may have access to PHI and EPHI during performance of certain functions or activities on behalf of, or providing certain services to VHA through a Business Associate Agreement (BAA). A BAA must be in place for VHA to disclose PHI or EPHI to a VA component that is Business Associate.

Failure to comply with all aspects of HIPAA requirements applicable to Business Associates can result in non-compliance with Federal law, which carries penalties for VA and potentially for individual(s) responsible for non-compliance. All Business Associates also understand that they are subject to periodic HIPAA compliance reviews conducted by VHA.

While a BAA may be required in connection with a SAC-executed contract, as a general rule, SAC contracting officers due not have the authority to enter into a BAA. The VHA Privacy Office, VHA NDS/HIA Office, VA Facility Director, Contracting Officer, Privacy Officer, Information Security Officer, and Contracting Officer Representative work together to ensure BAAs are enacted for all Business Associates. See VHA HANDBOOK 1605.05 for more information on how BAAs are established and administered.

See RFP Attachment B – Sample Business Associate Agreement

CONTRACT MINIMUM DOLLAR VALUES

The minimum guaranteed amount is $2,500.00. Orders shall be determined by department needs. The Government has no obligation to award orders beyond the minimum guaranteed amount. The Government’s obligation for the minimum guarantee amount applies only in year one ordering period of the contract. If the Contractor receives total orders for less than the minimum amount in year one, the Government will pay the difference between the amount ordered and the minimum amount guaranteed for the year one ordering period of the contract.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of

B.4 PRODUCT DESCRIPTION

1.0 Introduction

1.1 The Veterans Health Administration’s (VHA) Prosthetic Clinical Management Program (PCMP) has identified Standard Manual Wheelchairs w/Accessories as a uniform preferred product for continued consolidated contracting. The purpose of consolidated contracting is to obtain user uniformity and quality products at competitive prices. This standardization initiative is in accordance with VHA’s PCMP Charter signed by the Under Secretary for Health on February 9, 2001.

1.2 Standard Manual Wheelchairs w/Accessories Intended Use:

Definition: The standard manual wheelchair is a basic, self-propelled wheelchair available at VA facilities as in-stock inventory. This folding wheelchair typically weighs more than 30 pounds, is available in two sizes with a 250-pound weight capacity, and one size with a 300-pound weight capacity. Most features on the wheelchair are fixed, with the exception of a detachable and adjustable length leg supports. A limited number of accessories are available.

Indications: The standard manual wheelchair is indicated for individuals with a short term or minimal physical impairment who require a manual wheelchair part-time or intermittently and who do not require wheelchair adjustment for postural support or functional skills. The individual must fit appropriately in one of the three available sizes. Examples include but are not limited to 1) Veteran requires manual wheelchair for less than three months due to temporary physical impairment; 2) Veteran requires manual wheelchair less than once per week; 3) Veteran has limited ability to self-propel and is expected to rely on a caregiver for wheelchair mobility and does not have postural support, repositioning, or skin protection needs.

Contraindications: The standard manual wheelchair is contraindicated for individuals with long term (i.e., more than three months) or significant physical impairment necessitating the use of a manual wheelchair more than once per week. It is contraindicated for those who require specific wheelchair adjustments to optimize postural support, skin protection, and/or functional skills. The standard wheelchair is contraindicated for those who do not fit one of the available three sizes.

2.0 SCOPE OF WORK

2.1 The contractor shall provide uninterrupted delivery of approved Standard Manual Wheelchairs w/Accessories as specified in the agreement and the resulting orders.

2.2 Standard Manual Wheelchairs w/Accessories will be procured through an Indefinite Delivery Indefinite Quantity (IDIQ) wherein individual VAMC facilities shall have the authority to place delivery orders against the IDIQ. The delivery order shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures.

3.0 PERFORMANCE

3.1 The base agreement-ordering period is for base year and four one-year option periods.

3.2 Agreement Effective Date: The effective date of the contract shall be 45 calendar days (or sooner) from award.

3.3 Orders issued under this agreement will be firm-fixed price. The contractor shall provide the supplies and resources necessary to accomplish the requirements described in this contract.

4.0 REQUIREMENTS

4.1 The following salient characteristics apply to all model sizes offered under this contract: Minimum Technical Requirements (MTRs):

The standard manual wheelchairs must meet all the minimum technical requirements The MTRs include:

1). Wheelchairs must be fully assembled (leg rests can be installed at time of issuance without tools).

2). U.S. Food and Drug Administration (FDA) Medical Equipment Clearance Documentation 3). Healthcare Common Procedure Coding System (HCPCs) (provide HCPC code for device(s) offered - Centers for Medicare & Medicaid Services (CMS).

4). Rehabilitation Engineering Society of North America (RESNA) Reports (provide individual RESNA reports for each device tested and submitted for solicitation (tests perform recently - version 2019). Any decompiling and recompiling of test reports shall cause offer to be rejected. https://www.resna.org/Portals/0/Documents/AT_WC1_SellSheet_8.21.19.pdf).

MTR 1

Seat Sizes (width x depth) with occupant mass (weight) capacity

1.16”x16” with 250 lbs. occupant mass (weight) capacity.

2.18"X16" with 250 lbs. occupant mass (weight) capacity.

3. 20"x18" with 300 lbs. occupant mass (weight) capacity.

A separate RESNA test report is required for model 20"x18" given the occupant mass capacity is different than the (2) other models.

**Typically, K0001 – K0003 but higher levels not excluded

MTR 2

Frame Description

Folding frame. Frame material is not designated.

MTR 3

Arm support Fixed height, detachable, reversible, with desk length padded arm support. Solid panel to serve as clothing guard.

MTR 4

Back Canes Integrated push handles with bend at superior aspect. The degree of bend is not specified. The back canes shall be padded and/or covered so that the vertical section of the back cane is fully covered (front and back) with no exposed metal or rough edges.

MTR 5

Backrest height Back height set at 16.5” But can have adjustability plus or minus (+/-) 1” (one inch).

MTR 7

Seat to floor height

19.5" plus or minus (+/-) 1/2" (one-half inch).

Wheelchairs with dual axle positions and quick release wheels will not to be excluded For adjustable rear seat to floor height, front caster housing must maintain vertical alignment.

MTR 10

Front Rigging Swing-away, detachable, adjustable length by push-button, with flip-up composite footplate with heel loop. The angle of the front rigging is not specified.

MTR 12

Anti-tip devices Adjustable length, removable, mounted on both right and left sides of frame. If alternate rear seat heights are available, adjustability of anti-tip device must support compatibility with all seat heights.

MTR 13

Overall weight of the wheelchair For 16"x16" and 18"x16" with 250 lbs. occupant mass capacity, 36 lbs. maximum device weight includes all components except front riggings.

For 20"x18" with 300 lbs. occupant mass capacity, the overall weight of the wheelchair is not specified.

MTR 14

Warranty Minimum one-year warranty for parts and labor. Associated forms must accompany proposal.

MTR 15

User Manual Consistent with requirements outlined as established standards in RESNA Volume I Section 15.

REQUIRED FOR ORDERING AS NEEDED WITH A CHAIR ORDER

MTR 17

Elevating Leg Support Swing away, adjustable length, adjustable position calf pad, flip up composite footplate. Multiple elevation positions must be available.

MTR 18

Wheel lock extensions Minimum 6” length and removable, with retention mechanism to secure the extension handle to the wheel lock.

MTR 20

Cane/Crutch Holder Designed for efficient installation with both right and left orientation available. Must be compatible with both oxygen tank older and anti-tip devices installed.

B.5 RESNA Standards Tests & Reports

A Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) test report must be included for each wheelchair model submitted. Requirements are specified for RESNA test reports.

Failure to provide a RESNA test report consistent with minimum requirements will result in the offer being summarily rejected and withdrawn from further consideration.

RESNA test reports will also be used to confirm compliance with required MTRs. Lack of compliance with MTRs will result in the offer being summarily rejected and withdrawn from further consideration.

The RESNA standards for wheeled mobility device testing are industry recognized objective measures of performance, durability and safety. These tests are developed by committees of experts from industry, research and clinical practice. The standards for wheelchair testing constantly evolve as refinements in test procedures are incorporated. RESNA has defined the device configuration for testing and clarified test protocols. All parameters and technical information needed to conduct the testing may be obtained from RESNA at:

RESNA (Rehabilitation Engineering Society of North America) 1700 N. Moore Street, Suite 1540, Arlington, VA 22209-1903 Phone (703) 524-6686

FAX (703) 524-6630

www.RESNA.org

RESNA STANDARDS REQUIREMENTS:

Each offer submitted must be accompanied by a comprehensive RESNA test report meeting the following minimum specifications. Failure to meet any of the minimum requirements will result in the offer being rejected and withdrawn from further consideration.

1. For each sample offered, all literature and test reports must be grouped together in a single, organized package. The documentation package must be provided in 2 formats: 1) electronically as a PDF; and 2) hardcopy in an organized and clearly labeled binder.

2. All devices must be tested at the maximum occupant mass specified. Products with different specified occupant mass capacities require separate test reports. Products that differ only in non-functional details such as seat size or additional accessories do not require separate test reports.

3. The testing must have been conducted in the United States.

4. The report must be prepared in English.

5. The report must be signed by a representative of the testing facility who can confirm that test results are accurate, were obtained in accordance with identified RESNA standards, and were performed on a single product sample.

6. The product sample tested must be the same model as the bid sample or clearly be a close predicate that has only cosmetic differences. A test report on a prototype is not acceptable. Photos of the product tested are required as a component of the test report.

7. The report must contain sufficient dimensional and performance measures to verify that product specifications are met.

8. The requirements for testing performed at independent test facilities vs. manufacturer facilities are not specified. However, the RESNA report will be significantly weighted as a component of the subjective technical evaluation and higher ratings will be assigned to reports completed by independent test facilities. The facilities listed below in alphabetical order have prior conducted mobility device testing and are members of the RESNA Standards Committee on Wheelchairs. The VA does not specifically endorse any of these testing facilities.

Beneficial Designs, Inc.

Peter Axelson PO Box 69 Minden, NV 89423 Phone: 775.783.8822

MET Laboratories, Inc.

Leonard Frier 914 W. Patapsco Ave.

Baltimore, MD 21230 Phone: 410.354.3300

Ammer Consulting Bill Ammer 1050 Saxonburg Blvd Glenshaw, PA 15116 Phone: 412.389.4429

9. The required RESNA tests and results to be submitted for each sample are listed below. To be consistent with current commercial standards of practice applied by other government third party payers, VA requirements are consistent with current Pricing, Data Analysis & Coding (PDAC) requirements identified by Noridian Administrative Services, LLC contracted by Centers for Medicare and Medicaid Services (CMS).

Required: RESNA test protocols for Volume 1 are listed below. Test protocols that are not required are not listed; results from any additional tests provided will be reviewed and considered when rating the RESNA report as a component of the technical evaluation.

Note: The clause numbers of some tests may have recently changed. The name of the test procedure shall take precedence.

RESNA WC-1 – American National Standard for Wheelchairs Volume 1: Requirements and Test Methods for Wheelchairs Section 1: Determination of static stability Clause 9 – Test for static stability in the forward direction Clause 10 – Test for static stability in the rearward direction

10.3 – Wheels locked and the wheelchair in the least stable configuration Wheelchair set up per table 2.

Clause 11 – Test for static stability with anti-tip devices

11.2 – Anti-tip device in the least effective configuration (tested in rearward orientation if anti-tips exist and lateral orientation if anti-tips exist).

Section 5: Determination of dimensions, mass and maneuvering space

Clause 8 – Required Measurements

0. - Length - Full overall length; Definition 3.9 - distance between the most forward and most rearward point of the wheelchair when assembled and ready for use with any leg supports, foot supports and any anti-tipping devices fitted (see Figure 8). Tested with loader gauge feet on device to verify the feet fit on device.

0. – Width - Overall width; Definition 3.21 – distance between the two outer most lateral points of the wheelchair (left and right) when assembled and ready for use (see Figure 8).

8.9 Total Mass

8.11 – Pivot width

8.15 - Required width of angled corridor; Annex E-12; Definition 3.32 minimum width of a corridor with a right angled turn in which the wheelchair can be driven in forward and rearward direction (see Figure 20).

Clause 9 – Disclosure of Information Clause 10 – Test Reports

Section 7: Method of measurement of seating and wheel dimensions Clause 7 – Measurement procedure Clause 7.3 – Measurements

0. - Dimension 1: Seat plane angle

0. - Dimension 2: Effective seat depth

0. - Dimension 3: Seat width

0. - Dimension 5: Seat surface height at front edge

0. - Dimension 6: Back support angle

0. - Dimension 7: Back support height Section 8: Requirements and test methods for static, impact and fatigue strengths (all tests) Clause 8 - Static Strength Clause 9 - Impact Strength Clause 10 – Fatigue tests Section 15: Requirements for information disclosure, documentation and labeling Clause 5 – Requirements for disclosure of test information in manufacturer's specification sheets Clause 7 – Documentation

7.1 General

7.2.3 User manual

7.3 Contents of user manual

Clause 8 – Permanent labeling (RESNA Rev.)

(End of RESNA)

B.6 HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) COMPLIANCE

a) As a covered entity, the VA is required by law to obtain satisfactory assurance of a Business Associate that the Business Associate appropriately safeguards protected health information it receives or creates on behalf of the covered entity. Contractors and any Subcontractors must adhere to the provisions of Public Law 104-191, HIPAA to include the Administrative Simplification Provisions of the law and associated rules and regulations published by the Department of Health and Human Services (HHS). The Contractor shall comply with all HIPAA-related rules and regulations to include Electronic Transactions, the Standards for Privacy of Individually Identifiable Health Information, and the Security Standards. This includes both the Privacy and Security Rules published by HHS. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities. The covered entity component of the VA is the Veterans Health Administration (VHA). Business associates must follow VHA privacy policies and practices. All Contractors and business associates must receive privacy training annually. For Contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or Contractor furnished training that meets the requirements of HHS Standards for Privacy of Individually Identifiable Health information as determined by VHA. For Contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required.

b) Any violation of HIPAA will be reported to the CO, the COR, and the PM in writing within one (1) business day of the Contractor’s discovery of an occurrence. Included in the report will be a description of the occurrence, patient names (if known), location, date and time. A copy of any filed police report will be provided by the Contractor to the CO within one (1) business day of completion.

c) Security must be designed into the system to protect patient information as required by HIPAA. All external network connects to the remote server shall be via encrypted SSL connects, VPN software and hardware. The process and method in which the transmission or routing of VA image data shall be reviewed and approved in accordance with form VA 6500.6. All patient information remains the sole property of the United States government and shall not be used for any purpose other than those stipulated in this contract. The VAMCs shall act as primary custodian of the patient information (including both the image data and the report) for all purposes related to Government records retention requirements. Patient information, including images shall be retained by the Contractor only for the minimum period of time required to comply with any applicable laws, regulations, and the retention policies stated herein. Upon request, the Contractor shall provide the Strategic Acquisition Center (SAC) CO, assigned COR for the applicable facility, Information Security Officer (ISO), or Privacy Officer (PO) with access to information pertaining to the way the Contractor maintains NPOP/VAMC patient data and the steps taken on an ongoing basis to assure the privacy and security thereof. This includes information regarding computer network architecture, configuration of firewall(s), routers, and other pieces of networking equipment, information about installed security software, and audits of patches of known security vulnerabilities. All relevant security-related patches and anti-virus updates shall be installed with seven (7) days of initial release. Patient lists, no matter how developed, shall be treated as privileged information. Lists and names of patients shall not be disclosed or revealed in any way for any use outside the contract of this PWS. Contractor must meet all VA required security restrictions and Contractor representatives shall undergo all HIPAA/confidentiality related training to comply with V15 requirements.

d) Contractors are not to retain any copies of the corresponding testing services, clinical data, even unidentified data (i.e., data that has had patient information redacted).

B.7 FACSIMILE (FAX) PRIVACY STATEMENT

Should the Contractor require the use of facsimile communication during the life of the contract, the VA requires the following statement on all fax cover sheets be included:

“This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

B.8 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a) A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or Task Order.

b) All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c) Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d) Custom software development and outsourced operations must be located within the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth.

e) The contractor or subcontractor must notify the CO immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The CO must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

B.9 VA INFORMATION CUSTODIAL LANGUAGE

a) Information made available to the Contractor or Subcontractor by VA for the performance or administration of this contract or information developed by the Contractor/Subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the Contractor/Subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b) Prior to termination or completion of this contract, Contractor/Subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/Subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the SAC CO within 30 days of termination of the contract.

c) The Contractor/Subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

d) The Contractor/Subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the contract or to preserve electronic information stored on Contractor/Subcontractor electronic storage media for restoration in case any electronic equipment or data used by the Contractor/Subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

e) If VA determines that the Contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the Contractor or third party or terminate for cause under FAR part 12.

f) If a VHA contract is terminated for cause, any associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

g) The Contractor/Subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

h) The Contractor/Subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

i) Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the Contractor/Subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval.

j) Notwithstanding the provision above, the Contractor/Subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the Contractor/Subcontractor is in receipt of a court order or other requests for the above-mentioned information, that Contractor/Subcontractor shall immediately refer such court orders or other requests to the SAC CO for response.

k) For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require Certification & Accreditation (C&A) or a Memorandum of Understanding – Information Security Officer (MOU-ISA) for system interconnection, the Contractor/Subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the assigned COR for each applicable facility

B.10 SECURITY INCIDENT INVESTIGATION

a) The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The Contractor/Subcontractor shall immediately notify the assigned COR for the applicable facility and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/Subcontractor has access.

b) To the extent known by the Contractor/Subcontractor, the Contractor/Subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the Contractor/Subcontractor considers relevant.

c) With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d) In instances of theft or break-in or other criminal activity, the Contractor/Subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The Contractor, Contractor personnel, and its Subcontractors and their personnel shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The Contractor/Subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

B.11 LIQUIDATED DAMAGES FOR DATA BREACH

a) Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b) The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c) Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) Date of occurrence;

(b) Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4)Names of individuals or groups affected or potentially affected;

(5)Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g.,…