36C24418R0074-001.docx

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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

36C24418R0074 12-26-2017 Stanley Kwasny +1 (412) 822-3781 01-26-2018

12:00 PM

36C244 Department of Veterans Affairs NCO 4 (Medical Support Services - MED 2)

X

339113 750 Employees

N/A

Determined at Task Order Level

00244

Network Contracting Office 4

Austin Payment Center http://www.tungsten-network.com/ customer-campaigns/veterans-affairs

Contractor to provide Prosthetic Limb devices and support services to Veteran beneficiaries of the VA Medical Centers listed in Section B.4. All work is to be performed in accordance with the Statement of Work, Section B.4, which shall be incorporated into any resulting contract(s).

Offeror must clearly state what VA site(s)they are requesting.

Offeror must provide all supporting documents and comply with all items in each evaluation factor as outlined in Section E.

Refer to Section E.2 for specific items which are required to be submitted.

Offeror is responsible for adhering to Service Contract

Act wage determination rates, upon award.

The government anticipates one or more IDIQ contracts will be awarded as a result of this solicitation.

Anticipated Period of Performance:03/26/2018–03/25/2023.

Nancy L. Porter NCO 4 Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR PERSONNEL:

Contract Manager designated with full authority to act for the Contractor on all Contract matters.

Program Supervisor designated to communicate with the COR regarding the day-to-day, technical requirements and to receive government orders.

Telephone:

e-mail: ___________________________________

Alternate Program Supervisor designated all supervisory authority during any Supervisor absence.

Telephone:

e-mail: ___________________________________

b. GOVERNMENT: Contracting Specialist Stanley F. Kwasny / Contracting Officer Nancy L. Porter Department of Veterans Affairs NCO 4 (Medical Support Services – Med 2) 1010 Delafield Rd Pittsburgh, PA 15215

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:

Other [X] following issuance of individual task orders.

4. GOVERNMENT INVOICE ADDRESS: All Invoices and payment receipts from the Contractor shall be submitted to: the purchase card holder at the local VA Medical Center who submitted the purchase order.

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

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-14 Limitations on Subcontracting. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

36C24418R0074

B.4 STATEMENT OF WORK

B.4.1 Multiple Awards The Government intends to award one or more Indefinite Delivery Indefinite Quantity (IDIQ) fixed price contract(s) pursuant to this solicitation for commercial items. The contract shall be for a base period of five (5) years from the effective date on the SF 1449 (Box 3). The Contracting Officer shall determine the individual proposals evaluated to be most advantageous to the Government based on the evaluation of each offeror’s proposal in accordance with section E.15.

Locations:

Philadelphia VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104

· Coatesville VA Medical Center, 1400 Blackhorse Hill Road, Coatesville, PA 19320

· Wilmington VA Medical Center, 1601 Kirkwood Highway, Wilmington, DE 19805 Wilkes-Barre VA Medical Center, 1111 East End Blvd., Wilkes-Barre, PA 18711 Lebanon VA Medical Center, 1700 South Lincoln Avenue, Lebanon, PA 17042 B.4.2 Background The Department of Veterans Affairs (VA) provides prosthetic limbs and related services to eligible Veterans. It is VA’s intent to solicit proposals and award one or more fixed-unit-price indefinite delivery/indefinite quantity (IDIQ) type contracts on a competitive basis under the authority of FAR.

The Government intends to provide prosthetic limb coverage to Veterans for the following counties through this solicitation, including, but not limited to:

Delaware Counties: New Castle, Kent, Sussex Maryland Counties: Cecil, Wicomico New Jersey Counties: Atlantic, Burlington, Cape May, Cumberland, Gloucester, Salem New York Counties: Tioga Pennsylvania Counties: Adams, Berks, Bradford, Bucks, Carbon, Chester, Cumberland, Dauphin, Delaware, Franklin, Juniata, Lackawanna, Lancaster, Lebanon, Lehigh, Luzerne, Lycoming, Mifflin, Monroe, Montgomery, Montour, Northampton, Northumberland, Perry, Pike, Schuylkill, Snyder, Sullivan, Susquehanna, Union, Wayne, Wyoming, York For the purposes of this solicitation, a county is considered to have coverage by the Contractor if the county is within 20 miles from a contractor’s location.

· In fiscal year 2015 (FISCAL YEAR 2015), the VA Medical Centers (VAMCs) listed as participating VA facilities in this solicitation, on a combined basis, have requested a total number of 577 new prosthetic legs, and a total number of 43 new prosthetic arms. During the same time period, these VAMCs recorded a total number of 1244 incidences of repair to prosthetic legs, and a total number of 104 incidences of repair to prosthetic arms. The following is the breakdown by the participating VA facilities:

· The Philadelphia VA Medical Center, in fiscal year 2015, requested 257 new prosthetic legs, 182 repaired prosthetic legs, 17 new prosthetic arms, and 9 repaired prosthetic arms. The numbers provided are estimates based on FISCAL YEAR 2015 prosthetic limb data and include the limb componentry and associated items needed for limbs from the limb vendors.

· The Coatesville VA Medical Center, in FISCAL YEAR 2015, requested 39 new prosthetic legs, 38 repaired prosthetic legs, 2 new prosthetic arms, and 27 repaired prosthetic arm. The numbers provided are estimates based on FISCAL YEAR 2015 prosthetic limb data and include the limb componentry and associated items needed for limbs from the limb vendors.

· The Wilmington VA Medical Center, in FISCAL YEAR 2015, requested 85 new prosthetic legs, 57 repaired prosthetic legs, 1 new prosthetic arm, and 21 repaired prosthetic arms. The numbers provided are estimates based on FISCAL YEAR 2015 prosthetic limb data and include the limb componentry and associated items needed for limbs from the limb vendors.

· The Wilkes-Barre VA Medical Center, in fiscal year 2015, requested 107 new prosthetic legs, 884 repaired prosthetic legs, 17 new prosthetic arms, and 22 repaired prosthetic arms. The numbers provided are estimates based on fiscal year 2015 prosthetic limb data and include the limb componentry and associated items needed for limbs from the limb vendors.

· The Lebanon VA Medical Center, in fiscal year 2015, requested 89 new prosthetic legs, 83 repaired prosthetic legs, 6 new prosthetic arms, and 25 repaired prosthetic arms. The numbers provided are estimates based on fiscal year 2015 prosthetic limb data and include the limb componentry and associated items needed for limbs from the limb vendors.

B.4.3 Scope The Contractor shall fabricate all prosthetic limbs in strict conformance to the prosthetic prescription that has been provided by the VA Amputee Clinic Team IAW VA Directive 1045. The VA will provide a list of approved L Codes for work to be provided by the Contractor for the specific prescription. 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 VA Amputee Clinic Team Prosthetic Representative or designee. This 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.

B.4.4 Education and Training Requirements B.4.4.1 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.

The 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.

B.4.4.2 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.

At a minimum, the training shall include CAD/CAM, Longs Technique, NSNA, and/or educational seminars specific to the fabrication and servicing of these components that were presented by organizations such as National Association for the Advancement of Orthotics and Prosthetics (NAAOP), American Academy of Orthotics and Prosthetics (AAOP), American Orthotic and Prosthetic Association (AOPA), International Association of Orthotics and Prosthetics (IAOP), or a formal program which is specifically designed to train Prosthetist in the fabrication of these socket.

B.4.5 Specific Requirements B.4.5.1 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 VA Amputee Clinic Team. 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 VA Amputee Clinic Team Prosthetic Representative or designee.

B.4.5.2 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.

B.4.5.3 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 B.4.9.1, 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/.

B.4.6 Outcome Monitoring and Utilization B.4.6.1 Monitoring 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.

B.4.6.2 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 COR or VA Prosthetics Representative 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) B.4.7 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 COR or VA Prosthetics Representative. 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.

B.4.8 Repair and Replacement B.4.8.1 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 $2,500.00) L7520 – Repair prosthetic device, labor component, per 15 minutes (not to exceed 8 units or 120 minutes) as described in the Medicare rates.

Repair and replacement of minor parts and labor requires prior approval and written authorization from the CO.

B.4.8.2 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 COR or VA Prosthetics Representative. 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 60% 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.

B.4.9 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 COR or VA Prosthetics Representative.

B.4.9.1 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.

B.4.9.2 Recalls The Contractor shall immediately notify all affected VAMC(s) and COR or VA Prosthetics Representative 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 initial notification should be via telephone to the Supervisor of Prosthetics and COR followed by written notification to ensure all necessary actions are completed. 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.

B.4.10 Special Contract Requirements B.4.10.1 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 4.4.

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 résumé 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.

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.

B.4.10.2 Confidentiality of Patient Records The Contractor shall develop or operate a system of records on individuals, to accomplish an agency function subject to Title 5 United States Code (USC) 552a. Violation of the law may involve the imposition of criminal penalties. The Contractor is not required to enter into a Business Associate Agreement (BAA). Contractor personnel (Orthotists and Prosthetists) who attend the Philadelphia, Coatesville, or Wilmington VAMC Amputee clinics gather PHI related to the prescription of an artificial limb or similar device for a specific patient. Said PHI is verbally related to the Orthotist or Prosthetist by VA staff or by the patient themselves. Contractor personnel will not have access to VA systems such as LAN or CPRS. PHI disclosures are made to Contractor personnel in their capacity as healthcare providers, resulting in contracts not requiring BAA’s. HIPAA and Privacy Act requirements will be incorporated into the solicitation and any resulting contracts. Contractor personnel will be subject to CRISP requirements and a Low Risk NACI Background Investigation.

The Contractor is a VA Contractor and shall assist the patient in seeking such care from or through the VA. The Contractor is considered to be a VA Contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA Contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provision of the contract, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA. The records referred to above shall be an remain the property of the VA and shall not be removed or transferred from VA except in accordance with U.S.C. 552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records), 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, and rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA’s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. Records created by the Contractor in the course of treating VA patients under this contract are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations. Upon the expiration of this contract or termination of the contract, the Contractor shall promptly provide the VA with the individually identified VA patient treatment records. In any instance where the Contractor transmits patient or sensitive data of any sort to the VA, the Contractor shall encrypt the data and provide it in an encrypted/secured manner.

B.4.10.3 VA Sensitive Information VA sensitive information is all Department data, on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, records about individuals requiring protection under various confidentiality provisions such as the Privacy Act and the HIPAA Privacy rule, and information that can be withheld under the Freedom of Information Act.

All paragraphs of the VA 6500.6 HB, Appendix B Clauses and appropriate security language from Appendix C will be incorporated into the solicitation and contract. Applicable sections of Appendix C that will be included into the solicitation and contract include the following: Paragraphs 1, 2a, 2b, 2e, 3a, 3b, 3c, 3d, 3e, 3f, 3g, 3h, 3j, 3k, 6, all paragraphs, 7 all paragraphs Section 7: Data Breach and Section 9.

B.4.10.3 Additional Contract Information The Contractor shall fabricate all prosthetic limbs in strict conformance to the prosthetic prescription provided by the VA Prosthetics Representative or designee.

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 statute 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 FAR Part 19.000(a)(3).

B.4.11 Performance, Delivery, Inspection and Acceptance B.4.11.1 Performance and Delivery The Contractor shall complete initial deliveries and repairs of items ordered under this contract no later than 30 calendars days after receipt of an 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 or the VA Prosthetic Representative 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 52.212-4, Contract Terms and Conditions – Commercial Items.

B.4.11.2 Inspection and Acceptance Contractor performance shall be monitored by the Quality Assurance Surveillance Plan (QASP) located in Section D1. The QASP matrix details the method of surveillance.

Payment shall be rendered for a prosthetic limb or service that satisfactorily meets all of the indicators. Payment shall not be made for noncompliant limbs/services. 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. 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.

B.4.11.3 Ordering Procedures The basic ordering process.

1 The patient is initially evaluated for a prosthetic limb/brace at the VA Amputee clinic and a prosthetic consult is entered as a Clinical order/RX.

2 The consult is converted into a quote by the Prosthetics Staff using the appropriate L-codes and faxed to the contractor selected directly by the patient.

3 Purchase order is generated based upon the quote and sent to contractor as approval for fabrication.

NOTE: If the order is under $3,500 the local Prosthetics staff initiates the purchase order process.

If order is over $3,500, an acquisition plan is entered into FORCE for Prosthetics Contracting Team initiates the purchase order process.

4 The prosthetic device is fabricated by the contractor according to the quote based on the patient’s evaluation at the VA Amputee clinic.

5 The patient is scheduled for an appointment in the VA Amputee clinic for final check ensure the prosthetic device is exactly as ordered with proper fit and function.

6 If approved by VA Physician, the contractor is authorized to charge the purchase card attached to order. If not approved, contractor makes the necessary changes and Step 5 is repeated.

B.4.12 Abbreviations

DEFINITIONS:

GOOD STANDING: participates and achieves appropriate continuing education credits and pays dues as determined by Certifying Agency such as ABC or BOC.

B.5 Price Schedule The Centers for Medicare and Medicaid Services Healthcare Common Procedure Coding System L-Codes for fabrication and repair of prosthetic limbs, the prices proposed shall not exceed the established Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) L-Code fee schedules applicable to the geographic area subject to this solicitation and at the time of performance. It should be noted that repair rates for 15 minute increments are now part of the L-Code pricing baseline.

Please apply the best percentage discount that you offer against the L-Code fee schedule baseline. Offerors are to propose a discount on all L-Codes applicable to this solicitation such as prosthetic limbs, prosthetic limb devices/components and labor rates for repairs and devices.

Offerors are encouraged to submit their best discounts off of the L-Code pricing to be considered for contract award. The Government reserves the right to make contract award without discussions thus making it in the offeror’s best interest to submit the greatest possible discount in the original offer.

Year 1 - CLIN 0001 - L-Code Pricing less _________% discount Year 1 - CLIN 0002 - Not Otherwise Classified (NOC) L-Codes less _______% discount Year 2 - CLIN 0004 - L-Code Pricing less _________% discount Year 2 - CLIN 0005 - Not Otherwise Classified (NOC) L-Codes less ________% discount Year 3 - CLIN 0007 - L-Code Pricing less _________% discount Year 3 - CLIN 0008 - Not Otherwise Classified (NOC) L-Codes less ________% discount Year 4 - CLIN 0010 - L-Code Pricing less _________% discount Year 4 - CLIN 0011 - Not Otherwise Classified (NOC) L-Codes less ________% discount Year 5 - CLIN 0013 - L-Code Pricing less _________% discount Year 5 - CLIN 0014 - Not Otherwise Classified (NOC) L-Codes less ________% discount

* It should be noted that L-Code pricing is subject to economic price adjustments and are generally modified on an annual basis and released in December for the following year. The L-Code pricing at the time when the authorization for an item or service was issued shall be used to invoice the Government.

It should be noted that L-Code pricing are published by HCFA’s Common Procedure Coding System (HCPCS). The website for the L-Code Pricing: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/DMEPOS-Fee-Schedule.html (DME, Orthotics and Prosthetics) to download the most current fee schedule. L-Codes are updated every year and are released in December, for the following year. Updates occasionally occur during the year.

B.5.1 Reimbursement for Items Not Otherwise Classified or Specified (NOC) L-Codes

Reimbursement…