36C25522Q0152 Signed 6-2-2022.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

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

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

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

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

6/2/2022 36C25522Q0152 06-02-2022

Mike Crader michael.crader@va.gov 913-230-7042 07-01-2022 2:00 PM Central

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

X 100

X

339113

750 Employees

N/A

X

Veterans in the VISN 15 Region.

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15

36C255

Financial Services Center http://www.fsc.va.gov/einvoice.asp

Austin TX

877-353-9791 512-460-5429

See CONTINUATION Page

Vendor shall provide all labor, materials and equipment for the fabrication of artificial limbs in strict conformance to the prosthetic prescription.

See attached Statement of Work, Price Schedule and Quality Assurance Surveillance Plan (QASP).

There will be multiple awards for this requirement.

Quotes will be evaluated using Lowest Price Technically Acceptable (LPTA) criteria using Tiered Evaluations including Large Business Concerns.

TIERED EVALUATIONS INCLUDING LARGE BUSINESS CONCERNS:

This solicitation is being issued as tiered evaluation with the following tiers: (1) SDVOSB concerns, (2) VOSB concerns,

(3) small business concerns with HUBZone small business Concerns and 8(a) participants having priority; and (4) large business concerns. If award cannot be made, the solicitation will be cancelled and the requirement resolicited.

$0.00 See CONTINUATION Page

X X

Mike Crader Contracting Officer

VISN 15 Artificial Limbs 36C25522Q0152

Table of Contents Table of Contents

B.1 CONTRACT ADMINISTRATION DATA

B.2. PRICE SCHEDULE

B.3 BPA ON-RAMP

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

C.2 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.3 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.5 VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020)

C.6 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

C.7 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.8 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE

(JUL 2018)

C.9 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.11 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.12 VAAR 852.242-71…ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) .35

C.13 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE, 6500.6

APPENDIX C

C.14 VHA Supplemental Contract Requirements for Combatting COVID-19

C.15 FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (JAN 2022)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

See attached document: SOW Supplement - Counties

SECTION E - SOLICITATION PROVISIONS

E.1 FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2021)

E.2 ADDENDUM TO FAR 52.212-1

E.3 52.212-1 ADDENDUM – TIERED EVALUATION GUIDANCE

E.4 52.212-1 ADDENDUM – QUOTATION INSTRUCTIONS

E.5 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.6 FAR 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT

(NOV 2021)

E.7 FAR 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)

E.9 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (NOV 2021)

E.10 FAR 52.212-2 ADDENDUM – EVALUATION – COMMERCIAL PRODUCTS

E.11 FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

END OF DOCUMENT

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 36C255 Mike Crader

Network Contracting Office (NCO) 15

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon receipt of artificial limb and/or repair

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 Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX

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

AMENDMENT NO DATE

B.2. PRICE SCHEDULE

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 ten (10) 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 order for supplies or services that will be acquired under all BPAs is $88,000,000.00. 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) 15. Any participating VA facilities may issue a delivery order from the BPAs awarded under this solicitation.

Kansas City; 4801 Linwood Blvd., Kansas City, MO 64128

Leavenworth; 4101 South 4th St., Leavenworth, KS 66048

Topeka; 2200 Gage Blvd., Topeka, KS 66622

Columbia; 800 Hospital Dr., Columbia, MO 65201

Wichita; 5500 East Kellogg, Wichita, KS 67218

St. Louis; # 1 Jefferson Barracks Dr., St. Louis, MO 63125

St. Louis; 915 N. Grand Blvd., St. Louis, MO 63106

Marion; 2401 west Main St., Marion, IL 62959

Poplar Bluff; 1500 N. Westwood Blvd., Poplar Bluff, MO 63901

The Government intends to provide prosthetic limb coverage to Veterans for the following counties through this solicitation (see attached).

For the purposes of this solicitation, a county is considered to have coverage by the Contractor if the county is within 40 miles from a contractor’s location.

In fiscal year 2019, the VA Medical Centers (VAMCs) listed in this solicitation, on a combined basis, have requested an average number of 366 new prosthetic legs, and an average number of 41 new prosthetic arms. During the same time period, these VAMCs recorded an estimated average number of 1,936 unique incidences of repair to prosthetic legs and an estimated average number of 313 unique incidences of repair to prosthetic arms.

The following is the breakdown by the participating VA facilities:

Kansas City: 36 New Prosthetic Legs, 17 New Prosthetic Arms, 307 Unique Incidences of Repair to Prosthetic Legs & 104 Unique Incidences of Repair to Prosthetic Arms

Columbia: 42 New Prosthetic Legs, 3 New Prosthetic Arms, 240 Unique Incidences of Repair to Prosthetic Legs & 28 Unique Incidences of Repair to Prosthetic Arms

Topeka: 13 New Prosthetic Legs, 1 New Prosthetic Arms, 82 Unique Incidences of Repair to Prosthetic Legs & 6 Unique Incidences of Repair to Prosthetic Arms

Leavenworth: 15 New Prosthetic Legs, 2 New Prosthetic Arms, 313 Unique Incidences of Repair to Prosthetic Legs & 10 Unique Incidences of Repair to Prosthetic Arms

Wichita: 62 New Prosthetic Legs, 8 New Prosthetic Arms, 249 Unique Incidences of Repair to Prosthetic Legs & 94 Unique Incidences of Repair to Prosthetic Arms

St. Louis: 162 New Prosthetic Legs, 10 New Prosthetic Arms, 579 Unique Incidences of Repair to Prosthetic Legs & 44 Unique Incidences of Repair to Prosthetic Arms

Poplar Bluff: 1 New Prosthetic Legs, 0 New Prosthetic Arms, 2 Unique Incidences of Repair to Prosthetic Legs & 10 Unique

Incidences of Repair to Prosthetic Arms

Marion: 35 New Prosthetic Legs, 0 New Prosthetic Arms, 164 Unique Incidences of Repair to Prosthetic Legs & 17 Unique Incidences of Repair to Prosthetic Arms

Pricing Schedule

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.

Year 1 L-Code Pricing less % Discount.

Period of one (1) year commencing on the date of BPA award

Year 2 L-Code Pricing less __ % Discount.

Period of one (1) year commencing on the day following the last day of the 1st Year

Year 3 L-Code Pricing less __% Discount

Period of one (1) year commencing on the day following the last day of the 2nd Year

Year 4 L-Code Pricing less __ % Discount

Period of one (1) year commencing on the day following the last day of the 3rd Year

Year 5 L-Code Pricing less ______ % Discount

Period of one (1) year commencing on the day following the last day of the 4th Year

Year 6 L-Code Pricing less ______ % Discount

Period of one (1) year commencing on the day following the last day of the 5th Year

Year 7 L-Code Pricing less ______ % Discount

Period of one (1) year commencing on the day following the last day of the 6th Year

Year 8 L-Code Pricing less ______ % Discount

Period of one (1) year commencing on the day following the last day of the 7th Year

Year 9 L-Code Pricing less ______ % Discount

Period of one (1) year commencing on the day following the last day of the 8th Year

Year 10 L-Code Pricing less ______ % Discount

Period of one (1) year commencing on the day following the last day of the 9th Year

* 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.

The L-Code pricing shall be referenced as published by CMS HCPCS which can be found at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/DMEPOSFeeSched/index.html.

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

Not Otherwise Classified or Specified L-Codes

Not Otherwise Classified (NOC) orthotic and prosthetic limb components: Orthotic and prosthetic components that do not have or have not been assigned an L Code are defined as Not Otherwise Classified (NOC) devices. If a NOC code has been determined appropriate by the Coding Guidance Counsel (CGC), only a single NOC code is to be utilized for the component. No other L Code will be accepted in conjunction with the NOC code.

The CMS HCPCS contains two (2) NOC L-Codes for prosthetic limbs, L5999 and L7499. VA recognizes only these NOC L-Codes for use with lower and upper extremity prosthetic limbs and modification of the NOC L-Code language is not permissible:

• L5999 – Lower extremity prosthesis, not otherwise specified

• L7499 – Upper extremity prosthesis, not otherwise specified

The NOC L-Code is all-inclusive and therefore, only one NOC L-Code is authorized per device. Multiple NOC L-Codes may be utilized per prosthetic limb. For example, if a lower extremity prosthetic limb is being ordered with a NOC L-Code prosthetic knee and a NOC L-Code prosthetic foot, it is permissible to use a NOC L-Code for each device, prosthetic knee and foot and be authorized. However, no other L- Codes will be authorized with these NOC L-Codes. The Contractor understands that VA retains sole discretion to determine whether a device would classify for a NOC L-Code designation.

For NOC L-Codes that do not have L-Code fee schedule published by CMS HCPCS, the Contractor shall be paid subject to the following guidelines:

For an item or service that is classified in the CMS HCPCS, the Contractor shall be paid the lesser of the L-Code amount or the Contractor’s billed amount.

For an item or service that is not otherwise classified in the CMS HCPCS, VA may assign L5999 or L7499 until CMS assigns a HCPCS with fee schedule. The Contractor understands that VA retains sole discretion to determine coding, including whether a device would classify for a NOC L-Code designation. The Contractor shall be paid the lesser of the amount for the L-Code temporarily assigned by VA or the Contractor’s billed amount.

For an item or service that is not otherwise classified in the CMS HCPCS, and for which VA assigns any miscellaneous or Not Otherwise Classified (NOC) code, the contractor shall submit a quote. Quotes must be received no later than two (2) business days after receipt of VA’s request for quote. The Contracting Officer or Prosthetics and Sensory Aids Service (PSAS) Official will issue a fixed price order based on the quote, negotiated if necessary, or based on the government estimate if a quote is not received. The Contracting Officer or PSAS Official may request additional supporting documentation as needed.

Expedited Delivery

Expedited delivery terms and conditions, when required, shall be determined by the Contracting Officer or VAMC Authorized Ordering Official/Officer 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 prior to the VA authorization for expedited delivery. The total cost for the expedited delivery shall not exceed 1.5 times the cost of normal delivery for the same or similar item with any applicable discounts.

Payment and Invoicing

General 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 the VA acceptance of the item or service. 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.

The invoice shall contain:

The veteran’s signature certifying acceptance, or separate certifying statement, of the prosthetic limb or service and the date of initial delivery.

The date of final delivery verified by the VA Amputee Clinic Team, if applicable.

Contract number.

All HCPCS codes reflected in the billing.

Discount pricing reflected per HCPCS (discount incorporated into pricing and reflected as charged per HCPCS); and

Serial and lot numbers recorded for major components such as prosthetic feet, prosthetic knee units and outcome monitoring device.

Veteran Outcome Utilization Device

VA may prescribe and authorize an automated prosthetic utilization and function monitoring device for data collection and analysis for new lower extremity prosthetic limb. For any utilization and function monitoring device authorized, VA may request “Veteran Outcome Reports” as described in the Statement of Work for this solicitation.

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.

Semi-Annual Service

The Contractor shall be reimbursed for the semi-annual service as required by this solicitation utilizing the following L-Code:

L7520 – Repair prosthetic device, labor component, per 15 minutes (not to exceed 4 units or 60 minutes).

Repair and Replacement of Minor Parts of Prosthetic Device and Labor

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

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)

Other than Repair or Replacement of Minor Parts of Prosthetic Device and Labor

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.

Salvage

In the event that a veteran dies prior to delivery and acceptance of a prosthetic limb, VA shall pay the Contractor for the work performed up to the point that 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.

Loaner Unit

The Contractor shall not be reimbursed for loaner units.

Recall

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.

4.0. Price Quote Reviews

The Contractor understands that all price quotations for items and services will be reviewed by the CO. It is understood that in instances of double coding and unnecessary uses of HCPCS L-Codes, the Contractor will be asked to resubmit price quotation with appropriate HCPCS L-Codes or provide justification for the need for additional L-Codes.

VA retains sole discretion to determine appropriate HCPCS L-Codes for prosthetic limb and prosthetic limb devices/components.

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 initial BPA award.

B.4 STATEMENT OF WORK

1.0. Background

The Department of Veterans Affairs (VA) provides prosthetic limbs and related services to veterans who are eligible for VA health care services and have medical needs for such items and services. This acquisition will supplement VA in providing comprehensive prosthetic care and support to the veterans in need. It is VA’s intent to solicit quotes and award multiple Blanket Purchase Agreements (BPAs).

2.0. 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. 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 Contracting Officer’s Representative (COR) or VAMC Point of Contact (POC) as appropriate. 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.

3.0. 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 BPA period of performance. “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 BPA.

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 BPA termination in accordance with the contract clauses in the BPA.

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.

4.0. 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 or POC.

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 or POC.

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 BPA shall be listed in the quote. All work required under this BPA shall be conducted at the facility locations included in the BPA. 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 quote 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 BPA, 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 BPA.

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 BPA: 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 BPA award, annually on the date of the BPA 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 BPA.

The Contractor shall be responsible for ensuring that contractor employees providing work on this BPA 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 BPA 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 BPA 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 BPA, 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 BPA. The Contractor shall notify the COR or POC for the required semi-annual service and receive written authorization prior to providing the semi-annual service to the veteran.

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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 COR or POC. 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 BPA. 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 BPA.

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 or POC, 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. 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 POC. 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:

(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.

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 COR or POC.

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 BPA number, order numbers and order date.

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

• Instructions for appropriate corrective action.

5.0. Special Contract Requirements

5.1. Key Personnel and Temporary Emergency Substitutions

The Contractor shall assign the following key personnel to this BPA: 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 BPA 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 BPA may be terminated.

For temporary substitutions where the key person will not be reporting to work for three (3) consecutive workdays 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

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 may be required to enter into a Business Associate Agreement. The VA 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 Department health care activity. 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 provisions of the BPA, 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 BPA 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 BPA or termination of the BPA, 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.

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 HIPAA Privacy rule, 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.

6.0. Performance, Delivery, Inspection and Acceptance

6.1. Performance and Delivery

The Contractor shall complete initial delivery of items ordered under this BPA 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 or POC 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 or POC 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, COR or POC 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 BPA or otherwise in accordance with applicable statutes and regulations.

6.2. Inspection and Acceptance

Contractor performance shall be monitored by the Quality Assurance Surveillance Plan (QASP). 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. COR or POC 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.

7.0. 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…