36C24123Q0883.docx

36C24123Q0883 Section M

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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.

UEI:

EFT:

PHONE:

FAX:

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

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

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

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

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

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

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

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

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C241-23-AP-0830

36C24123Q0883 09-29-2023 Tyler Kenyon tyler.kenyon@va.gov 11-01-2023 2pm

EDT

Department of Veterans Affairs Network Contracting Office (NCO) 1

X 339113 800 Employees N/A X Department of Veterans Affairs Veterans Integrated Services Network (VISN) 1, New England

VISN 01 Prosthetics Government Purchase Card

See CONTINUATION Page In accordance with the authority of Title 38, U.S.C.

Section 8123, Procurement of Prosthetic Appliances, the Contractor shall furnish artificial limbs to those Veterans that require artificial limbs and are eligible for assistance. This solicitation shall establish a Firm-Fixed-Price (FFP) Blanket Purchase Agreement (BPA) contract to create a list of vendors.

The VA Medical Center (VAMC) facilities are located in Augusta, ME; Portland, ME; Manchester, NH; Bedford, MA:

Brockton, MA; Leeds, MA; White River Junction, VT;

Jamaica Plain, MA; West Roxbury, MA; West Haven, CT;

Newington, CT; and Providence, RI. Eligible vendors must have vendor facilities with 50 miles of these facilities.

This BPA is intended to establish the list of VA approved contractors from which the Veteran may select the provider.

Once selected, the contractor will provide the requested services pursuant to the contract and resulting task order.

$0.00 See CONTINUATION Page X 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 36C241

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.

Department of Veterans Affairs VISN 01 Prosthetics Government Purchase Card ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 SCHEDULE OF SERVICES AND PRICE

Multiple Awards The Government intends to award one or more Blanket Purchase Agreements (BPAs) pursuant to this solicitation for commercial items. The BPAs shall be for a five (5) year period. The Contracting Officer shall determine the individual quotes evaluated to be most advantageous to the Government based on an integrated assessment of each offeror’s quote. The total maximum orders for supplies or services that will be acquired for each BPA is $7,500,000.00.

Participating VA Facilities and Contract Service Areas Items and services are to be provided to the following participating VA facilities located in Veterans Integrated Service Network (VISN) 1. Any participating VA facilities may issue a delivery order from the BPAs awarded under this solicitation.

Togus VA Medical Center 1 VA Center Augusta, ME 04330‐6796

VA Maine HCS, Portland CBOC 141 West Commercial Street Portland, ME 04102-3905

Manchester VA Medical Center 718 Smyth Road Manchester, NH 03104‐7007

White River Junction VA Medical Center 163 Veterans Drive White River Junction, VT 05001‐0001

Northampton VA Medical Center 421 N. Main Street Leeds, MA 01053‐9764

Bedford VA Medical Center 200 Springs Road Bedford, MA 01730‐1114

Brockton VA Medical Center 940 Belmont Street Brockton, MA 02301‐5596

Jamaica Plain VA Medical Center 150 S. Huntington Avenue Jamaica Plain, MA 02130‐4817

West Roxbury VA Medical Center 1400 VFW Parkway West Roxbury, MA 02132‐4927

West Haven VA Medical Center 950 Campbell Avenue West Haven, CT 06516‐2770

VA Connecticut HCS, Newington Campus 555 Willard Avenue Newington, CT 06111

Providence VA Medical Center 830 Chalkstone Avenue Providence, RI 02908‐4734

VAMC Providence Eagle Square Annex 75 Eagle Street Providence, RI 02909-1012

1. The purpose of this schedule is to provide services in accordance with the requirements of the agreement at the discounts listed below.

2. The anticipated period of performance shall be for one Base Year and four one-year periods.

Anticipated Period of Performance:

BASE YEAR (1 Year): 1 January 2024 – 31 December 2024 YEAR I (1 Year): 1 January 2025 – 31 December 2025 YEAR II (1 Year): 1 January 2026 – 31 December 2026 YEAR III (1 Year): 1 January 2027 – 31 December 2027 YEAR IV (1 Year): 1 January 2028 – 31 December 2028

3. For fabrication and repair of artificial limbs, the prices quoted shall not exceed the established L-Code prices applicable to the geographic area subject to the vendor’s location at the time of performance. It should be noted that repair rates for 15 minute increments are now part of the L-Code pricing schedule. Considering this, apply your offered percentage discount to the following L-Code base pricing.

Base year L-Code Pricing less ________ % discount Year 1 L-Code Pricing less ________ % discount Year 2 L-Code Pricing less ________ % discount Year 3 L-Code Pricing less ________% discount Year 4 L-Code Pricing less ________% discount

4. L-Code pricing shall be referenced as published by Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS). L-Code pricing is generally modified by CMS at a minimum basis of annually. L-Code pricing is subject to the published rates in effect at the time services are rendered, using geographical locality of the vendor’s facility providing the limb, less the discount percentage identified above. Revisions to the L-Code base pricing shall be priced utilizing the same discount methodology accepted at contract award. L-Code discounts shall not be re-negotiated once contract award has been made.

The VA Prosthetist shall review all quotes for appropriateness and has the authority to propose changes to quotes. The VA Prosthetist must be able to determine price reasonableness based on the market for all quotes.

5. All pricing shall be limited to the states listed below.

Rhode Island Connecticut Massachusetts New Hampshire Vermont Maine

6. The website to be utilized for establishing the L-code base pricing is:

http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/DMEPOSFeeSched/index.html

8. L7510 - Repair prosthetic device, repair or replace minor parts (not to exceed $500.00)

B.3 BPA ON-RAMP

AGREEMENT ON-RAMP

This solicitation is considered open for two (2) years from the date issued; however, it will have set dates when quotes are due which will be communicated via Contract Opportunities https:// sam.gov/. Quotes are only being accepted prior to or on those dates following closure of the initial round of submissions. The Government will evaluate the market to determine if it is in the Government’s interest to award Artificial Limb Blanket Purchase Agreement(s) (BPAs) to additional qualified firms by employing “on-ramp” procedures following initial selections and awards. The Government reserves the right, based upon the evaluation of the market, to accept new quotes with the intention of adding awarded agreements to provide the Government with better buying power. Quotes will be subject to the same quote instructions and evaluation procedures as contained in the original solicitation. Previously awarded BPAs will be unaffected by on-ramp actions taken to refresh the BPA pool. On-ramping will be accomplished by either issuing an amendment to the solicitation or via a notice to Contract Opportunities https://sam.gov/. Any quoter awarded a BPA during an on-ramp will be subject to the established ordering period at initial award and as identified within this document at the time of 36C24123Q0883 initial BPA award.

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B.4 STATEMENT OF WORK

1.0. Background

The Department of Veterans Affairs (VA) provides prosthetic limbs and related services to Veterans (also referred to as “VA patients”) who are eligible for these VA health care services. This acquisition will allow the VA medical centers (VAMC) with the Veterans Integrated Services Network (VISN) 1 of New England to provide comprehensive prosthetic care and support to the VA customers in need.

2.0. Scope

The Contractor (also referred to as “Vendor”) shall fabricate prosthetic limbs and components per the VAMC Amputation Clinic Team prosthetic prescription provided in each order, and shall provide all required patient services (initial and follow-up visits, fittings, new and repair) at its facilities. A VA employed and certified prosthetist will participate in the VAMC Amputation Care Clinic to provide oversight and guidance when writing prescriptions and will ensure that all vendor quotes meet the VA prescription and coding standards. The VAMC Amputation Care Clinic prescription will outline and specify the patient’s prescription by Healthcare Common Procedure Coding System (HCPCS) Code. The VA will also provide a list of approved L Codes for each prescription, per Veterans Health Administration (VHA) Directive 1045(1), which establishes national coding and pricing guidance to be used in all cases, without deviation. The Contractor shall not alter VA prescriptions in any way without prior written approval from the VAMC Amputation Care Clinic Team. Additionally, products that are not considered commercial items are considered experimental and shall not be authorized for patient use under this solicitation and contract.

As part of a Vendor’s proposal, the Vendor shall indicate and specify which VISN 1 facilities they are proposing to provide artificial limbs to eligible veterans. As part of the scope of work, the Vendor facilities must be within 50 miles of the indicated VA facility to support the needs of the veterans.

The following locations are part of the proposal for this requirement:

1. Dept. of Veterans Affairs Togus VA Medical Center 1 VA Center Augusta, ME 04330‐6796

2. Dept. of Veterans Affairs VA Maine HCS, Portland CBOC 141 West Commercial Street Portland, ME 04102-3905

3. Dept. of Veterans Affairs Manchester VA Medical Center 718 Smyth Road Manchester, NH 03104‐7007

4. Dept. of Veterans Affairs White River Junction VA Medical Center 163 Veterans Drive White River Junction, VT 05001‐0001

5. Dept. of Veterans Affairs Northampton VA Medical Center 421 N. Main Street Leeds, MA 01053‐9764

6. Dept. of Veterans Affairs Bedford VA Medical Center 200 Springs Road Bedford, MA 01730‐1114

7. Dept. of Veterans Affairs Brockton VA Medical Center 940 Belmont Street Brockton, MA 02301‐5596

8. Dept. of Veterans Affairs Jamaica Plain VA Medical Center 150 S. Huntington Avenue Jamaica Plain, MA 02130‐4817

9. Dept. of Veterans Affairs West Roxbury VA Medical Center 1400 VFW Parkway West Roxbury, MA 02132‐4927

10. Dept. of Veterans Affairs West Haven VA Medical Center 950 Campbell Avenue West Haven, CT 06516‐2770

11. Dept. of Veterans Affairs VA Connecticut HCS, Newington Campus 555 Willard Avenue Newington, CT 06111

12. Dept. of Veterans Affairs Providence VA Medical Center 830 Chalkstone Avenue Providence, RI 02908‐4734

13. Dept. of Veterans Affairs VAMC Providence Eagle Square Annex 75 Eagle Street Providence, RI 02909-1012

3.0. Education and Training Requirements

3.1. General Education

The Contractor shall employ at least one (1) full-time prosthetist that is certified by either the American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC), or accredited by the Board of Certification/Accreditation International (BOC).

Failure to remain certified or accredited shall be at the fault of the Contractor, and another designee must be vetted for this position for immediate use and coverage. 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 Contracting Officer’s Representative (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 devices and associated services shall be performed under the supervision of a certified prosthetist who has met the applicable educational and training requirements under the manufacturing training program for that device.

The use of certain technologies may require the contractor employee to be specially trained in that item prior to interfacing with a VA patient. VA reserves the right to determine which technologies require specific training, and will notify the Contractor if and when specialized training from the manufacturer is required in order to provide services to VA patients. Such technologies may include, but are not limited to: C-Leg; Genium Knee; Biom Foot and System; Microprocessor Componentry; Ischial Containment Prosthetic Designs; Silicon Suction Sockets (3S); and Tec Harmony System.

4.0. Specific Requirements

4.1. Compliance with VA Prescription and Coding of Prosthetic Limb Devices/Components The Contractor shall not alter VA prescriptions in any way without prior written approval from the prescribing VAMC Amputation Care Clinic Team. If necessary, a written request for changes must be submitted to the VAMC Amputation Care Team for review and approval. All patient prescriptions and orders must match deliverables for patient use in order to be in compliance with this contract and VA standards.

Additionally, products that are not considered commercial items will be considered “experimental” and shall not be authorized for VA patient use under this contract. Contractors shall not trial any componentry on a VA patient without the prior written authorization of the VAMC Amputation Care Clinic provider. If this occurs, the device is to be removed immediately and the vendor shall not be paid for the use of the device for the period in question. Furthermore, VA patients and their family members shall not be solicited to participate in a manufacturer’s trial, vendor study, or the like.

4.2. Contractor Facility Locations

All Contractor facilities, in addition to any 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, and remain accredited throughout the duration of the contract. The Contractor shall provide all applicable accreditation documents at the time of proposal, and as additionally requested by the Government.

Home (abcop.org) Home - Board of Certification/Accreditation (bocusa.org)

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 Contracting Officer Representative (COR) and will work with their accrediting body (ABC or BOC) to ensure its information is current and accurate on its websites. VA may conduct site visits as needed by the COR and other VA subject matter experts as determined by the COR to ensure compliance with Business Practices (BP) and Quality and Performance requirements.

Information regarding the location, including space and equipment present, safety requirements, access/egress, hours of service and other items as needed (Attachment 2793) and the actual inspection visit results (Attachment 2130). The Contractor shall complete and submit these attachments at the time of proposal.

Throughout the duration of this contract, the Contractor shall notify the Contracting Officer (CO), the COR, and the designated VAMC Amputation Care Clinic Team of any company ownership changes and/or facilities that are added, changed/relocated, or closed within 15 calendar days of any change. Written approval from the CO and COR must be obtained prior to VA patients receiving services at additional facilities in accordance with FAR 42.1203 Processing Agreements.

4.3. ABC and/or BOC and Other Special Requirements

The Contractor shall perform the required work in accordance with the ABC and/or BOC standards (reference section 3.1). The Contractor shall develop and maintain the following documents for each contractor employee working on this contract: (1) Credentials and qualifications for the job; (2) Current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully, including knowledge and skills required to provide care for certain patient populations, as appropriate); (3) Current performance evaluation supporting ability of the contractor employee to successfully perform the work required under this solicitation; and (4) List of relevant continuing education completed within 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 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 Statement of Work paragraph 5.1 , the Contractor shall provide evidence of orientation, the current competence assessment, and current performance evaluation that supports the above, to the COR.

Although this contract does not require The Joint Commission (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 online at https://www.jointcommission.org/standards.

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 may be used at the Contractor’s location or by the VAMC Amputation Care Clinic Team to check on patient usage of the limb and positive/negative results from the limb. Any such device will not be considered government furnished equipment or property (GFE/GFP) as it will remain in the possession of the patient or VA. The troubleshooting and maintenance of any such device will be the responsibility of the VA.

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

· Measurement of socket load during gait

If such an item is prescribed by the VA, and the VA orders “Veteran Outcome Reports” based on the data collected, it may be provided through encrypted e-mail, United States Postal Service mail, or other secure means of delivery to the VAMC Amputation Care Clinic Team and/or VA Certified Prosthetist. The report shall contain narrative and graphical representation of the above variables.

The Contractor shall be paid subject to the following guideline for a utilization and function monitoring device and associated report(s):

· CMS HCPCS L5999 (lower extremity prosthesis, not otherwise specified – outcome device(s)) code shall be used to reimburse the Contractor for the utilization and function monitoring device.

· Total reimbursement for the device and outcome report(s) will be reimbursed in accordance with the NOC L-Code item reimbursement guidelines referenced in Section 2.2. The total reimbursement includes the device and outcome report(s). Outcome report(s) requested by VA shall not be reimbursed separately.

· This is a one-time billable charge for the utilization and function monitoring device and associated outcome report(s) for new prosthetic limbs only.

4.5. Semi-Annual Service

The Contractor shall provide semi-annual service to each VA patient 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 (2) 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 and/or VAMC Amputation Care Clinic Team for the required semi-annual service and receive written authorization prior to providing the semi-annual service to the VA patient.

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)

If the Contractor does not perform proper maintenance on the limb component(s) according to the manufacturer’s recommendations, then the Contractor is responsible for all costs incurred to restore and rectify the limb component(s) to the proper functioning level, in accordance with manufacturer recommendations.

4.6. Warranty

The Contractor shall provide a warranty on the prosthetic limb and all other limb related components provided against defective material and/or workmanship for a minimum of 90 calendar days, which shall commence after the final check out at the VAMC by the VAMC Amputation Clinic Team and deliverable acceptance by the COR and/or by the VAMC Amputation Clinic Team. 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 any defects 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.

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 patient’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 written authorization from the COR and by the VAMC Amputation Clinic Team, except for repairs provided to patients 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)

A VA patient 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 patient’s qualified prosthetic device up to the amount indicated on the PSC. For prosthetic limbs, a VA patient 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 4.7.1.

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 VA patient’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 paid by the VA when necessary to make the prosthetic limb functional. If the Contractor’s expense for repairs exceeds the estimated expense of purchasing a new prosthetic limb or device, no payment can be made for the excess cost without written justification and approval by the VAMC Amputation Care Clinic Team. Maintenance that may be required by manufacturer’s recommendations or construction of the prosthetic limb shall be performed by the Contractor billed as a repair. If the Contractor does not perform proper maintenance on the limb component(s) according to the manufacturer’s recommendations, the vendor is then responsible for all costs incurred to correct the problem and bring the limb component(s) to the proper functioning level.

Replacement of a prosthetic limb or prosthetic limb device/component will be initiated if the VAMC Amputation Care Clinic Team with granted prescription authority, and who is involved in Veteran’s amputation care, prescribes a prosthetic limb or device for the following reasons:

(1) 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.

(2) 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.

The Contractor shall be reimbursed for repair and replacement of other than minor parts of prosthetic device and labor as required by this solicitation utilizing the following L-Codes:

· L7510 – Repair prosthetic device, repair or replace minor parts

· L7520 – Repair prosthetic device, labor component, per 15 minutes

The Contractor shall submit a copy of the invoice from the manufacturer to support the cost of repairing a malfunctioning unit. Any salvage value granted by the manufacturer for a non-repairable unit shall be credited to VA against the cost of a replacement unit.

4.7.4 Salvage

In the event that a VA patient passes away prior to delivery and acceptance of a prosthetic limb or repair, VA shall pay the Contractor for the work performed up to the point when the Contractor is notified to stop work. The pricing paid shall be mutually agreed upon and shall not exceed the contract price of the prosthetic limb less the salvage value of the unused prosthetic devices. The VA and Contractor may discuss and mutually agree if any unused prosthetics devices can be used for another Veteran who has a similar prescription.

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, outside of the prosthetic prescription, shall be pre-authorized by the CO or VAMC Amputation Care Clinic Lead.

4.9. Loaner Prosthetic Limb Requirements

A “loaner” is defined as a suitable prosthetic device, fit for patient use during the repair period. The Contractor shall be permitted 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 if a VA patient’s prosthetic limb requires repair by the manufacturer; and the plan must be preapproved by the VA Amputation Care Clinic Team in each case. 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. 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

· Explanation for the removal, adjustment, or modification for item recall

· Instructions for appropriate corrective action.

The Contractor shall not be reimbursed for any fees associated with a device recall, removal, required adjustment, or required modification mandated by the manufacturer, distributor, or any regulatory or government agency.

5.0. Special Contract Requirements

5.1. Points of Contact, Temporary Emergency Substitutions and HHS/OIG The Contractor shall assign the following points of contact 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 not make substitutions of points of contact 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 may need to be modified to reflect any approved changes of points of contact. 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.

This substitute shall have comparable qualifications to the point of contact being replaced temporarily, namely an ABC or BOC certified prosthetist.

To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website: Exclusions | Office of Inspector General | U.S. Department of Health and Human Services (hhs.gov) for each person providing services under this contract. Further the Contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG list and are NOT listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

5.2. 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 shall be required to enter into a Business Associate Agreement.

The Contractor shall assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the VA’s health care activity. The contractor shall be known as a “VA contractor” for purposes of the Privacy Act, Title 5 U.S.C. 552a., and the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. As such, a VA Contractor may have access 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 provisions 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 and remain the property of 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, 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 VA, the contractor shall encrypt the data and provide it in an encrypted/secured manner.

The contractor will possess and maintain access to digital certificates for all contractor personnel for the safe electronic transmission of patient information via patient encryption (e.g. RMS/AZURE or PKI). The VA can assist the contractor in obtaining RMS/AZURE or PKI access. Any initial or recurring costs that may be incurred are the responsibility of the contractor.

5.3. 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 Health Insurance Portability and Accountability Act (HIPAA), and information that can be withheld under the Freedom of Information Act. Examples of VA sensitive information include the following: individually-identifiable medical, benefits, and personnel information; financial, budgetary, research, quality assurance; confidential commercial, critical infrastructure, investigatory, and law enforcement information; information that is confidential and privileged in litigation such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney client privilege; and other information which, if released, could result in violation of law or harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of federal programs.

5.4 Infection Control and Emergency Procedures

In the event of a declared National, State, or other Emergency which affects the Contractor’s ability to perform in accordance with the specifications in the Statement of Work (SOW), the contractor shall have an action plan and protocols in place which comply with local, state, federal and Department of Veterans Affairs requirements. The contractor shall submit a written action plan and protocols and provide notification of implementation of them within 48 hours of declared National or State Emergency to the Contracting Officer, COR and the Facility Chiefs of Prosthetics and Physical Medicine and Rehabilitation.

· The contractor shall follow VHA and applicable local/state/national public health and infection control guidance and personal protective equipment (PPE) requirements at the VAMC. Contractor shall be responsible for the provision of all required PPE and materials/supplies.

· Devices and spaces used for prosthetic fittings should be appropriately cleaned after each patient use in accordance with manufacturer’s recommendations. The Centers for Disease Control and Prevention (CDC) and Professional Prosthetics societies may have other guidelines that should be followed pertaining to prosthetic fitting, manufacturing, mailing, dispensing, adjustments, and repairs.

· The contractor will provide to the Contracting Officer and COR an electronic copy of all infection control, cleaning and safety procedures that the contract staff will practice on-site.

· Contractor shall abide by all CDC guidelines regarding social distancing, cleaning of equipment and materials, and personal protection equipment. Updated guidelines can be found on the CDC website:

Community, Work, and School | COVID-19 | CDC

5.5 Professional Responsibilities

All contractor and subcontractor employees performing work under this contract will follow The Code of Professional Responsibility and Rules and Procedures (January 2020) from the American Board for Certification in Orthotics, Prosthetics and Pedorthics, Inc. (ABC). The website link for the ABC Code: The Code of Professional Responsibility and Rules & Procedures (abcop.org)

5.6 Required Reports/Documentation

The Contractor shall provide the Government Contracting Officer and COR the following reports below - these reports shall be received by the Government Contracting Officer and COR no later than the 15th day of each month following the end of each quarter of the Government Fiscal Year (October 15th, January 15th, April 15th, and July 15th). It is the Contractor’s responsibility to ensure these reports are received on a timely basis. Reports are to be submitted per the established timeframe whether the Contractor has had business or not during that time period. Contractors not submitting the report by the required date are subject to contract termination.

· Cost Savings Report for each VA Facility participating in this contract (use of discount off the Medicare price). Items provided by HCPCS code and date, and savings off the current Medicare price based on the vendor’s discount.

· Service Quality - The vendor shall report on a quarterly basis the type and total number of service errors by office location – and any patient complaints and their resolution during the quarter.

· Turnaround Time - The vendor shall report on a quarterly basis report the turnaround time by office location.

· Volume - The vendor locations will provide quarterly reports to the COR on all items provided for each facility, including the number of patients served.

· NOTE: Weekly updates on progress with completion of each Prosthetics request shall be provided to each VA facility, with a copy to the VISN COR. The correspondence shall be delivered via RMS/AZURE or PKI-encrypted e-mail, fax or mail – or by PO number via regular e-mail. The summary will include the patient’s name & SSN, PO/purchase order number, date of original request, type of Prosthetics item requested, date (if applicable) of patient’s scheduled visit, any issues/problems encountered, date the item will be delivered and/or fit with the Veteran, and any other comments.

Date of VA order

VA Pt. name

SSN

Pt. Phone number

VA PO number

Dollar amount Called Pt./ Date Sched. Pt./Left Voicemail

Date of Eval.

Delivery Date

· Patient Satisfaction – Survey of a minimum of 5 patients (or the total served if less than 5) to receive feedback on the services performed (new or repair of a shoe or orthotics item)

· Every 6 months: ABC/BOC Site Accreditation for all locations part of the contract; this includes any changes to the locations (openings/closings of office locations – within 15 days of changes)

· Log of Issues/Complaint Log - The vendor shall maintain a log that tracks all patient and VA staff issues or concerns and provide a timely, appropriate response within three (3) business days of receipt of the complaint. The log will be sent back to the COR preferably via PKI encryption and include the patient’s name and SSN, date of complaint, statement of the actual complaint, the action/resolution taken, statement of whether the complaint was valid or not, and what is being done to prevent a reoccurrence in the future.

· Emergent Patient Safety Reports. The Contractor shall provide the following emergent patient safety reports in writing, within the contract period:

· Sentinel Events - The Contractor is required to inform the Facility Prosthetics Chief and VISN COR(s) within one business day of a sentinel event (as defined by The Joint Commission) that occurs during the performance of this contract that involves VAMC beneficiaries.

· The Contractor shall report suspected incidents of abuse or neglect to the patient by family members or caregivers. Suspected incidents shall be reported immediately (within 24 hours during business hours) to the COR or designee, as well as to the local adult protective agency. The Contractor will follow all state and local laws in reporting suspected incidents of abuse or neglect.

6.0. Performance, Delivery, Inspection and Acceptance

6.1.…