36C24420Q0305_1.docx

36C24420Q0305

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24420Q0305 06-1 -2020 Kevin Balser kevin.balser@va.gov 570-824-3521 X 09-30-2020

4:00 PM

36C244 Department of Veterans Affairs Network Contracting Office 4 Kevin Balser

X 339113 750 Employees N/A X

VISN 4

As defined at the ordering level.

36C244 Department of Veterans Affairs Network Contracting Office 4

Austin Payment Center

PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Limbs and Braces services in accordance with the statement and cost/price schedule.

This solicitation is being issued in accordance with FAR Part 13. Any reference to FAR 15 is unintended, and the Offeror should seek clarification with the Contracting Officer.

RFQ posted under 41 U.S.C. 253(c)(5) and 38 U.S.C. 8123.

(38 U.S.C. 8123) The resulting Blanket Purchase Agreement (BPA) will be a multiple award BPA to all responsible vendors to facilitate Veteran'schoice as required.

All questions/quotes concerning this solicitation must be emailed to Kevin Balser @ kevin.balser.va.gov Awards can and will be made before solicitation close date.

See CONTINUATION Page X X Frederick C. Hilliard Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

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 36C244

Network Contracting Office 4 Kevin Balser

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

Austin Payment Center Department of Veterans Affairs

PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 VISN 4 LIMBS AND BRACES STATEMENT OF WORK

1. Background The Department of Veterans Affairs (VA) provides prosthetic limbs, orthotics and related services to Veterans who are eligible for VA health care services and have medical needs for such items and services. These include, but are not limited to artificial arms, legs, related items to facilitate fit and function, and repairs to all of these items. Contractor shall provide services including the evaluation, manufacture, fitting and adjustment of orthotic devices by its qualified Orthotist. This acquisition will support the Butler, Coatesville, Erie, Lebanon, Philadelphia, Pittsburgh, WIlkesBarre and Wilmington VAMCs in providing comprehensive prosthetic and orthotic care and support to the Veterans in need. It is VA’s intent to solicit proposals and award multiple Blanket Purchase Agreements (BPAs). BPAs will be awarded to all technically capable, responsible, and price reasonable vendors as responses to the solicitation are received in order to facilitate Veteran’s Choice. Note: VA Pittsburgh Health Care will not be contracting Orthotic devices and services as a part of this contract.

2. Scope The Contractor shall provide services including evaluation, manufacture, fitting and adjustment of all prosthetic limbs in strict conformance to the prosthetic prescription that has been provided by the VA Amputee Clinic Team. The Contractor shall not add or substitute components or alter the Veteran’s limb prescription in any way without prior approval and written authorization from the Contracting Officer Representative (COR). The solicitation only includes commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized under this solicitation.

Veterans who are eligible for Bracing may be provided items to include but not limited to, KAFO, AFO, Knee and back braces.

This solicitation falls under the following authority :

806.302-5 Authorized or required by statute.

(b) Various sections of title 38 U.S.C. authorize the Secretary to enter into certain contracts and certain types of contracts without regard to any other provisions of law. When the contracting officer enters into a contract without providing full and open competition for any of the following items or services, the contracting officer must cite 41 U.S.C. 253(c)(5) and the following authorities:

1. For contracts for orthopedic and prosthetic appliances and related services including research, cite 38 U.S.C. 8123. (38 U.S.C. 8123)

3. Education and Training Requirements

3.1. General Education

The Contractor shall have a full-time American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) certified, or Board of Certification/Accreditation International (BOC) certified prosthetist(s) on staff in “good standing” at each of the proposed service locations throughout the contract period. “Good standing” is defined as participating and achieving appropriate continuing education credits and paying dues as determined by Certifying Agency such as ABC and BOC.

VA reserves the right to verify prosthetists’ credentials anytime during the term of this contract. The Contractor shall provide current copies of certifications upon request of the COR. Failure to comply with this requirement may lead to adverse actions by the Government up to, and including contract termination in accordance with the contract clauses in the contract.

3.2. Special Education Requirements for Certain Prosthetic Limb Devices/Components The fitting and alignment of prosthetic limbs device and associated services shall be performed under the supervision of a prosthetist who has met the applicable educational and training requirements covered under the manufacturing training program for that device. New technologies require proof of training and only those prosthetists specifically trained, or completing training for purposes of providing an item by the time of delivery of the item may provide the item and follow up services to a Veteran. VA reserves the right to determine which technologies require specific training. VA will notify the Contractor when current technologies require specialized training from the manufacturer in order to provide to Veterans.

4. Specific Requirements

4.1. Compliance with VA Prescription and Coding of Prosthetic Limb Devices/Components The Contractor shall not add or substitute components or alter the Veteran’s prosthetic limb prescription in any way without prior approval and written authorization from the COR. Any changes to the Veteran’s prescription, components or codes require review and approval by the VA Amputee Clinic Team and shall be authorized in writing by the COR. Contract employees must successfully complete the VAHA Privacy and Information Security, HIPAA and Rules of Behavior courses on an annual basis. Contract employees will be required to perform an electronic version and complete the requirements of each course on the Talent Management System (TMS).

Contractor and/or subcontractor shall provide to the VA COR a copy of the training certificates. In the event that the VA determines that the above requirements are not being met by the contractor, VA shall terminate the contract for cause in accordance with the applicable clauses listed in the contract.

Prosthetic Clinics are held by each Medical center. This time is subject to change and/or may vary. The members of the Clinic are the Physiatrist, the Prosthetic Representative, and Certified Prosthetists who wish to attend. The Contractor is encouraged to attend the Prosthetic Clinic but it is not required. This is, however, a privilege for Contractor which may be rescinded by the COR. Each facility will inform Contractors of the dates and times of their clinics as applicable.

4.2. Contractor Facility Locations

All Contractor facilities as well as other fabrication facilities such as commercial central fabrication facilities that will be utilized for this contract shall be listed in the proposal. All work required under this contract shall be conducted at the facility locations included in the contract. The Contractor’s facilities shall be accredited either by the Facility Accreditation Program of the ABC or the Accredited Facilities Program of the BOC at the time of proposal submission. VA reserves the right to conduct site visits of the facility and review accreditation and certification documents and standards at any time. The Contractor shall provide current copies of accreditation documents upon request of the COR. VA may conduct site visits as needed by the COR and other VA subject matter experts as determined by the COR. Throughout the duration of this contract, the Contractor shall notify VA of any facilities that are added, changed, or closed to the CO and the COR within 15 calendar days of any change. Approval for added or changed facilities must be obtained before those facilities may be used for this contract. Contractor must maintain a facility within 45 minutes’ drive of at least one of the locations see Attachment 5.

4.3. The Joint Commission and Other Special Requirements

The Contractor shall perform the required work in accordance with the Joint Commission (TJC) and ABC and/or BOC standards. All Contractor employees shall continuously meet or exceed TJC and ABC and/or BOC standards. The Contractor shall develop and maintain the following documents for each contractor employee working on this contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully, and including knowledge and skills required to provide care for certain patient populations, as appropriate); a current performance evaluation supporting ability of the contractor employee to successfully perform the work required under this solicitation; and, listing of relevant continuing education for the last two years. At the time of contract award, annually on the date of the contract award thereafter, and at any other time requested by the VA COR, the Contractor shall provide current copies of these records for each contractor employee working on this contract.

The Contractor shall be responsible for ensuring that contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

When changes in contractor personnel are approved in accordance with the “Key Personnel” clause of the contract in section 5.1, the Contractor shall provide evidence of orientation, the current competence assessment, and current performance evaluation that supports the above.

Where the contract does not require TJC accreditation or other regulatory body requirements, the Contractor shall perform the required work in accordance with TJC standards. A copy of TJC standards can be obtained from The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181 or http://www.jointcommission.org/ .

4.4. Outcome Monitoring and Utilization

VA may prescribe and authorize an automated prosthetic utilization and function monitoring device for data collection and analysis for a new lower extremity prosthetic limb (transtibial, knee disarticulation, transfemoral and hip disarticulation level; does not include socket replacements). The utilization and function monitoring device will have the ability to record intensity, endurance, gait symmetry, dynamic function, including alignment, forces and moments with proven accuracy.

The device will monitor and continuously record the following:

· Stance and swing time for gait symmetry, dynamic function including alignment, forces, and moments;

· Cadence and cadence variability;

· Step count – continuous recording of total step count;

· Number of steps per selected time interval;

· Longitudinal, historical and objective analysis;

· Peak performance index, quantifiable into baseline and faster than baseline rate of walking, distance and variable cadence;

· Functional level assessment capability; and

· Measurement of socket load during gait.

VA may request “Veteran Outcome Reports” based on the data collected. The report shall contain narrative and graphical representation of the above variables.

4.5. Semi-Annual Service

The Contractor shall provide semi-annual service to each Veteran for whom the Contractor is managing prosthetic limb care. For the purposes of this contract, semi-annual service is defined as a follow up visit for inspection of the prosthetic limb(s) and evaluation for fit and function for all VA-approved prosthetic limb(s) the patient owns and is actively using. Typically, semi-annual service includes inspection, testing, cleaning, and checking of the prosthetic limb(s) and/or residual limb(s) to include maintenance specific to the warranty of devices.

Semi-annual service shall not be incumbent upon the number of prosthetic limbs a patient owns. Two follow up visits per patient are required annually for a patient to whom the Contractor delivered a prosthetic limb(s) under this contract. The Contractor shall notify the CO for the required semi-annual service and receive written authorization prior to providing the semi-annual service to the Veteran.

The following L-Code shall be used for semi-annual service: L7520 – Repair prosthetic device, labor component, per 15 minutes (not to exceed 4 units or 60 minutes)

4.6. Warranty

The Contractor shall warrant the prosthetic limb provided against defective material and/or workmanship for a minimum of 90 calendar days from the date of acceptance by VA. The minimum warranty period shall commence after the final check out at the VAMC by the Amputee Clinic Team and deliverable acceptance by the CO. Manufacturer’s warranties of prosthetic limb and limb devices/components that extend beyond the minimum 90 calendar day period shall be in effect and be enforced. The Contractor shall furnish, without additional cost to the Government, all materials and labor necessary to correct defects that were detected during the warranty period. These conditions do not apply to adjustments incidental to wearing of the prosthetic limb, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse or alteration by anyone other than the Contractor.

Any prosthetic limb repaired or furnished as a “loaner” shall be subject to this clause to the same extent as a new prosthetic limb delivered. The warranty for a repaired limb or “loaner” limb shall be equal in duration to the term the Contractor is required to offer to a new prosthetic limb and shall run from the date of the acceptance of the repaired or “loaner” prosthetic limb by VA.

The Contractor shall warrant and imply that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract. The rights and remedies of the Government provided in this clause are in addition to, and do not limit any, rights afforded to the Government by any other clause of the contract.

4.7. Repair and Replacement

4.7.1. Minor Parts of Prosthetic Device and Labor

All parts procured or fabricated to replace existing parts or to modify a previously issued or fabricated device is considered a “repair,” regardless of who fabricated or supplied the original part. Repair and replacement of minor parts may require adjustments to a prosthetic limb required by wear or a change in the Veteran’s condition. A minor repair or replacement means repair or replacement that does not significantly alter the function or essential physical characteristics of an item or component, or change the purpose of an item or component. Factors that will be considered in determining whether a repair or replacement is minor include the value and size of the repair or replacement, and the comparative value and size of the final product. Dollar values and percentages may be used as guideposts, but are not conclusive evidence that a repair or replacement is minor. The following L-Codes shall be used for repair and replacement of minor parts and for labor:

· L7510 – Repair prosthetic device, repair or replace minor parts (not to exceed $500.00)

· L7520 – Repair prosthetic device, labor component, per 15 minutes (not to exceed 8 units or 120 minutes) Repair and replacement of minor parts and labor requires prior approval and written authorization from the COR, except for repairs provided to Veterans with VA Prosthetic Service Card (VA Form 10-2501) as described in section 4.7.2.

4.7.2. Use of Prosthetic Service Card (VA Form 10-2501)

Veterans may obtain repair services using a VA Prosthetic Service Card (PSC) VA Form 10-2501. A PSC is a pre-authorized card that can be used to receive needed repairs to the Veteran’s qualified prosthetic device up to the amount indicated on the PSC. For prosthetic limbs, Veteran may obtain repairs up to $500.00 with the PSC. For repairs or replacement of parts other than using a PSC or over $500.00 shall be completed with prior approval and written authorization from VA and in accordance with the section

The Contractor shall submit VA Form 10-2520 PSC Invoice (Attachment A) to the Prosthetic and Sensory Aids Service at the VAMC with the primary service area responsibility where the Veteran resides for reimbursement. The Contractor shall obtain the Veteran’s signature acknowledging receipt of appropriate repair for invoices for such repairs under the authority of a PSC.

4.7.3. Other than Repair or Replacement of Minor Parts of Prosthetic Device and Labor Repairs to a prosthetic limb are covered when necessary to make the prosthetic limb functional. If the expense for repairs exceeds the estimated expense of purchasing a new prosthetic limb or device, no payment can be made for the amount of the excess. Maintenance that may be necessitated by manufacturer’s recommendations or construction of the prosthetic limb shall be performed by the Contractor covered as a repair.

Replacement of a prosthetic limb or replacement of a prosthetic limb device/component requires prior approval and written authorization from the Ordering Official/CO. Replacement of a prosthetic limb or prosthetic limb device/component will be initiated if the VA provider (i.e., Amputee Clinic Team or VA provider) with granted prescription authority, and who is involved in Veteran’s amputation care, prescribes a prosthetic limb or device for the following reasons:

· A change in the physiological condition of the patient; irreparable wear of the device or part of the device; or the condition of the device, or part of the device, requires repairs and the cost of such repair would be more than 50% of the cost of a replacement device, or of the part being replaced.

· Damage to the prosthetic limb or device is not due to malicious damage, culpable neglect, wrongful disposition or use of device other than intended purposes.

4.8. Government Supplied Items

VA may provide certain supplies such as shrinkers, liners, sleeves, and socks to the Veteran at the discretion of the VA. Any items or supplies provided to the Veteran by the Contractor shall be pre-authorized by the CO.

4.9. Loaner Prosthetic Limb Requirements

The Contractor shall be qualified to furnish prosthetic devices such as, but not limited to, hydraulic knee units, micro-processor feet and knees, electronic hands and feet by completing special educational and training requirement for such devices as described in section 3.2 and the same requirement shall be applied to provision of a “loaner” unit. The Contractor shall provide a “loaner” unit in the event that a Veteran’s prosthetic limb requires repair by the manufacturer. A “loaner” is defined as a suitable prosthetic device, fit for patient use during the repair period. VA will not reimburse for loaner units.

4.10. Recalls

The Contractor shall immediately notify all affected VAMC(s) and COR(s) in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Contractor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification:

· A complete item description and identification;

· Administrative identification data including contract number, order numbers and order date;

· Removal, adjustment, or modification reasons for recall; and

· Instructions for appropriate corrective action.

4.11. Salvage

In the event that a Veteran beneficiary dies prior to delivery and acceptance of an artificial limb, VA shall pay the Contractor for the work performed up to the point that they are notified to stop work. The pricing paid shall be at the discretion of the government upon notification of the death and shall not exceed the Contract price of the limb less the salvage value of the unused limb.

5. Special Contract Requirements

5.1. Key Personnel and Temporary Emergency Substitutions

The Contractor shall assign the following key personnel to this contract: all individuals providing items and related services to Veterans and for whom information about education and training is required to be submitted as a part of the response to this solicitation including, but not limited to, those individuals who must meet the training requirements set forth in the Education and Training Requirements in Section 3.0.

During the first ninety (90) calendar days of performance, the Contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the CO, in writing, within fifteen (15) calendar days after the occurrence of any of these events and provide the following information:

· Detailed explanation of the circumstances necessitating the proposed substitution;

· Complete resume for the proposed substitute; and

· Any additional information requested by the CO.

Proposed substitutes shall have comparable qualification to those of the persons being replaced. The CO will notify the Contractor within fifteen (15) calendar days after the receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel. In the case where VA does not agree with the proposed substitutes and their qualifications, the contract may be terminated and the Contractor may not receive the minimum dollar amount specified in this contract.

For temporary substitutions where the key person will not be reporting to work for three (3) consecutive work days or more, the Contractor shall provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person being replaced temporarily. Any substitution exceeding a period of two weeks consecutively shall follow the key personnel replacement procedure described in paragraph above.

5.2. Confidentiality of Patient Records

Contractors, Contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

Access to VA Information and VA Information Systems

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.

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.

Contract does not involve connection of one or more Contractor-owned IT devices (such as a laptop computer or remote connection from a Contractor system) to a VA internal trusted (i.e., non-public) network. Therefore, certification and accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required.

Contractor personnel performing work under this Contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information belonging to or being used on behalf of the Department of Veterans Affairs. The Contractor will be responsible for the actions of those individuals they provide to perform work for the VA under this Contract. In the event that damages arise from work performed by Contractor provided personnel, under the auspices of this Contract, the Contractor will be responsible for all resources necessary to remedy the incident. Printed output containing sensitive VHA data will be stored in a secured area, and disposed of properly by shredding using a NIST compliant shredder or other VA approved method. Under the provisions of the Privacy Act of 1974 as amended, personnel performing work under this Contract have an obligation to protect VA information indefinitely.

Contractor employees are required to complete the online training classes entitled “VA Privacy and Information Security Awareness and Rules of Behavior Training” (VA Course 10176) and “Privacy and HIPAA Training” (VA Course 10203). If possible, this training should be completed in VA’s Talent Management System (TMS) https://www.tms.va.gov/plateau/user/login.jsp . Information will be obtained from the Contractor at award in order to establish TMS accounts for Contractor employees providing services under this Contract. A certificate of successful completion will be generated for each course. Copies of the certificates shall be forwarded to the COR. ). Classes should be completed within 30 days of award of Contract. Completion of these training. Courses are required on an annual basis based on the VA’s fiscal year.

If deemed required under this agreement, the Contractor shall be considered part of the Department of Veterans Affairs (VA) for purposes of 38 U.S.C. §§ 5701 and 7332. Its employees may have access to patient medical records to the extent necessary to perform this Contract. Notwithstanding any other provision of this agreement, the Contractor and its employees may disclose patient records and individually-identified patient information, including information and records generated by the Contractor in performance of this agreement, only pursuant to explicit disclosure authority from VA. The Contractor shall NOT remove any VA sensitive information from VA property.

Contractor shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality. Due to the confidential nature of medical reports, any transcription must be completed in areas that provide reasonable security. All documents are confidential and are protected under the Privacy Act of 1974, as amended. All Contractor personnel shall be required to observe the requirements imposed on sensitive data by law, federal regulations, VA statutes and policy, DM&S policy and the associated requirements to insure appropriate screening of personnel.

If deemed required under this agreement, reports provided to the Contractor by VA, event reports, and patient medical records are medical quality assurance records protected by 38 U.S.C. § 5705, it’s implementing regulations at 38 U.S.C. §§ 17.500-.511 and VHA Directive 2008-04377, Quality Management (QM) And Patient Safety Activities That Can Generate Confidential Documents. These records may be disclosed only as authorized by § 5705 and is a criminal offense under 38 U.S.C. § 5705(e).

If deemed required under this agreement, the treatment and administrative patient records created by, or provided to, the Contractor under this agreement are covered by the VA system of records entitled "Patient Medical Records - VA (24VA136).

All quality data maintained by the Contractor and/or its employees shall be shared with designated Service Line Staff.

No VA data is permitted to be stored on portable media, including but not limited to flash drives, CDs/DVDs, external hard drives, etc.

No VA data is permitted to be stored on a desktop or laptop computer hard drive. Use of any portable computer under this Contract must be approved by the ISO and the computer’s hard drive must be encrypted in accordance with FIPS 140-2.

6. Federal Privacy and Confidentiality Statutes

6.1. Health Insurance Portability and Accountability Act (HIPPA) Concerns Contractor will be given Patient information that may include Patient’s name, place of residence address, telephone number, and social security number. Patient information is confidential and is protected under the Privacy Act of 1974, and the Healthcare Insurance Portability and Accountability Act of 1996 (HIPAA). See FAR 52.224-1 and 52.224-2. Any individual making unauthorized disclosure may be criminally liable for violations under the Acts. The Contractor shall not use or further disclose Patient information in a manner that would violate the Federal privacy and confidentiality statutes.

Contractor personnel performing work under this Contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems belonging to or being used on behalf of the Department of Veterans Affairs. The Contractor will be responsible for the actions of those individuals they provide to perform work for the VA under this Contract. In the event that damages arise from work performed by Contractor provided personnel, under the auspices of this Contract, the Contractor will be responsible for all resources necessary to remedy the incident. Printed output containing sensitive VHA data will be stored in a secured area, and disposed of properly by shredding or similar methods. Under the provisions of the Privacy Act of 1974 as amended, personnel performing work under this Contract have an obligation to protect VA information indefinitely. Furthermore, it is the Contractor's responsibility to notify the Information Management staff when access to Information Management systems is no longer needed by personnel performing work under this Contract.

6.2. VA Information Custodial Language

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).

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. 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 the Contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

6.3. Security Incident Investigation

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 COR 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.

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.

6.4. Liquidated Damages for Data Breach

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.

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.

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

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

· Description of the event, including:

· Date of occurrence;

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

· Number of individuals affected or potentially affected;

· Names of individuals or groups affected or potentially affected;

· 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., unencrypted, plain text;

· Amount of time the data has been out of VA control;

· The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

· Known misuses of data containing sensitive personal information, if any;

· Assessment of the potential harm to the affected individuals;

· Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

· Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

Based on the determinations of the independent risk analysis, the Contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

· Notification;

· One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

· Data breach analysis;

· Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

· One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

· Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

7. Performance and Delivery The Contractor shall complete initial delivery of items ordered under this contract no later than 30 calendars days after receipt of a delivery order. Initial delivery means an ordered item or service is complete and the item is provided to, and accepted by the patient. The Contractor shall provide a written notification to the COR within 7 calendar days of the receipt of a delivery order to show cause in the event the Contractor is unable to deliver the required items or services in accordance with the Government’s required delivery date. Initial delivery shall not be construed as final delivery or acceptance of an item or service by the Government.

In the event the Government desires expedited delivery, the COR shall telephonically contact the Contractor and inquire into the feasibility of obtaining the device under this condition. The Contractor shall respond within 24 hours to such request and expedited delivery shall be mutually agreed upon. Expedited delivery terms and conditions, when required, shall be determined by the CO or COR and the Contractor on a case by case basis and stated in the individual task or delivery order. Any additional costs incurred by the Contractor for meeting this requirement shall be negotiated in accordance with 48 U.S.C. 52.212-4, Contract Terms and Conditions – Commercial Items. The total cost for the expedited delivery shall not exceed 1.5 times the cost of the normal delivery for the same or similar item with any applicable discounts. Failure by the Contractor to deliver the ordered items on an expedited basis, or otherwise fulfill the agreed upon requirements shall constitute an event of default, and the CO shall undertake any action authorized pursuant to the awarded contract, or otherwise in accordance with applicable statutes and regulations.

Veteran beneficiaries who are experienced orthotic wearers will normally be measured, fitted and accept delivery of their orthotics appliance at the contractor’s facility. Veteran beneficiaries who are not experienced orthotic wearers will normally be measured, fitted, and accept delivery at the ordering VA facility. The condition of and point of measurement, fitting, delivery, inspection, and acceptance of orthotic appliance shall be at the discretion of the Prosthetic Representative, Chief of Prosthetics or designee, and handled on a case by case basis.

The contractor guarantees the orthosis against defective material and/or workmanship for a minimum of 90 calendar days from the date of acceptance. Manufacture’s warranties of orthotic components that extend beyond the minimum 90 day period shall be expressed and also enforced. The contractor agree to furnish without additional cost to the government, all labor and materials necessary to correct defects that were detected during the guarantee period. These conditions do not apply to adjustments incidental to the wearing of an orthosis, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse or alteration by anyone other than the contractor.

8. Inspection and Acceptance Contractor performance shall be monitored by the Quality Assurance Surveillance Plan (QASP) located in Attachment 1. The QASP matrix details performance indicators, the standard, the acceptable quality level, the method of surveillance and incentive/disincentives. The indicators are:

· Delivery time requirement

· Limb compliant with VA physician prescription

· Workmanship free of defect (socket fits appropriately, limb correctly aligned)

· Patient education

· Patient acceptance of the device in all aspects (cosmetically and functionally)

Payment shall be rendered for a prosthetic limb or service that satisfactorily meets all of the indicators. Payment shall be delayed for any prosthetic limb or service that does not meet one or more of the indicators. The Contractor shall correct all deficiency of non-compliant prosthetic limb or service within fifteen (15) calendar days of written rejection notification from the COR. The corrected prosthetic limb or service will be re-inspected for acceptance. No invoice shall be submitted until the Government accepts the item or service.

For new prosthetic limbs or socket replacement for existing prosthetic limbs, final check-out by the VA Amputee Clinic Team at the VAMC from which the task order was generated is required. Final delivery and check out shall be conducted at the VAMC, either by in person inspection or via Tele-health capabilities at an outlying VA facility. Final acceptance or rejection and authorization for payment shall occur with the final delivery and checkout of the prosthetic limb to ensure accuracy of prescription and acceptance by the Veteran. CO will provide a written acceptance notification for any items accepted by the Government. Veteran prosthetic limb wearers may be measured and fitted and accept conditional or initial delivery of the prosthetic limb at the Contractor’s facility. However, conditional or initial delivery shall not be construed as final delivery or acceptance of an item or service by the Government and authorization for payment.

Repair or replacement of prosthetic limb components other than socket replacement does not generally require final check-out by the VA Amputee Clinic Team unless VA determines and notifies the Contractor that the final check-out is required with the issuance of the task or delivery order. VA retains sole discretion to determine whether a final check-out is necessary for the task order.

9. Patient Education Contractor will be responsible for providing training to the Veteran on the following:

· Cleaning and Maintenance Instruction.

· How to Don and Doff the Custom Orthotic including how to properly fit.

· How to inspect the skin for pressure areas, redness, irritation, skin breakdown, pain and edema.

· How and when to use an interface, such as stockinettes, socks, gloves, or shoes to accommodate the custom orthotic.

· How to report problems related to the custom orthotics to the contractor.

Training provided must be on a check sheet to be developed by the contractor. The check sheet will be completed when the Veteran is issued an orthotic device. The check sheet is to be submitted with the invoice for the orthotic device.

10. Ordering Procedures The Contractor shall not directly, or indirectly through agents, solicit eligible Veterans. VA personnel shall not direct, guide or prompt a Veteran to a specific contractor except when a physician determines that it is a medical necessary as documented in clinical notes.

Veterans are allowed to select a non-VA prosthetic limb provider from a list of VA approved contractors and this satisfies the requirement for fair opportunity. In some instances a VA clinician determines that it is medically necessary to select a certain contractor as documented in clinical notes, which would also satisfy the fair opportunity requirement of FAR 16.505(b)(1). Exceptions to the fair opportunity process are:

· The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

· Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

· The order must be issued on a sole-source basis in the interest of economy and efficiency because it is logical follow-on to an order already issued under the contract, provide that all awardees were given a fair opportunity to be considered for the original order.

· It is necessary to place an order to satisfy a minimum guarantee.

· For orders exceeding the simplified acquisition threshold, a statue expressly authorizes or required that the purchase be made from a specified source.

· In accordance with section 1331 of Public Law 111-240 (15 USC 644(4)), contracting offers may, at their discretion, set aside orders for any of the small business concerns identified in 19.000(a)(3). When setting aside orders for small business concerns, the specific small business program eligibility requirements identified in part 19 apply.

Contractor will return quotes (including an itemized list by L-code with discount taken off total of all L codes) to requestor within 2 business days of clinic. For items/services not evaluated in clinic, Contractor will contact Veteran beneficiary within 5 calendar days of request for quote to schedule an evaluation appointment and return quote as described above within 2 business days of completing evaluation appointment.

11. Pricing See Cost/Price Schedule

12. General Invoicing Instructions The Contractor shall obtain a signature and date from the Veteran at the time of delivery of the completed prosthetic limb at the Contractor’s location that certifies the Veteran’s acceptance of the prosthetic limb or service. The Veteran’s signature for the initial delivery of the prosthetic limb or service at the Contractor’s location shall not constitute final delivery or VA acceptance of the item or service for payment.

For new prosthetic limbs or socket replacement for existing prosthetic limbs, final check-out by the VA Amputee Clinic Team at the VAMC from which the task order was generated is required. After the final check-out by the VA Amputee Clinic Team and VA acceptance of the item or service, a copy of the signed and dated invoice shall be provided to the purchasing official within 30 calendar days of…