RFP 36C24524R0063 - Beckley Orthotics V2.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. 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

36C24524R0063 09-03-2024

Darcy Gray; darcy.gray2@va.gov 09-13-2024

12:00 EDT

Department of Veterans Affairs

VAMC(688)

50 Irving Street NW Washington DC 20422

X

339113

800 Employees

N/A

VAMC(517)

Brenda Shelton 200 Veterans Avenue Beckley WV 25801

VAMC(688)

Darcy Gray 50 Irving Street NW Washington DC 20422

PAYMENT WILL BE MADE BY

Purchase Card Only Instructions for Submitting Invoices: See Page 16

See CONTINUATION Page

Contractor shall provide Orthotic Appliances and Services as described in the Performance Work Statement (PWS).

Period of Performance shall be from October 01, 2024 through September 30, 2029.

See Section E.1 for Instructions for Submission of Proposals.

All questions shall be submitted in writing by close of business on September 6, 2024.

See CONTINUATION Page

X X

Paschal L. Dawson Contracting Officer

36C24524R0063

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

B.3 DELIVERY SCHEDULE

B.4 PERFORMANCE WORK STATEMENT (PWS)

B.5 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

SECTION C - CONTRACT CLAUSES

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

COMMERCIAL SERVICES (NOV 2023)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-2 CANCELLATION UNDER MULTI-YEAR CONTRACTS (OCT 1997)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984) ... 32

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

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

2018)

C.11 MANDATORY WRITTEN DISCLOSURES

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

D.2 WAGE DETERMINATION SCHEDULE

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

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

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

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:

Business Name Address City/State/Zip Code Unique Entity ID (SAM UEI#) Point of Contact Email Address Telephone Number

b. GOVERNMENT:

Paschal L. Dawson, Contracting Officer 36C245 Darcy Gray, Contract Specialist 36C245 Department of Veterans Affairs Department of Veterans Affairs NCO 5 Contracting Office (90C) NCO 5 Contracting Office (90C) 1 Boiler House Road, Bldg. 101C, Rm 4 50 Irving Street NW Perry Point, MD 20922 Washington, DC 20422

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Paid by Purchase Card

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.

Payment will be made by Government Purchase Card.

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0.00

Beckley VAMC Orthotics Period of Performance: 10/01/2024 – 9/30/2029 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: Q201 - Medical - General Health Care

0001A

0.00 EA

Year 1:

L-Code Pricing Less % Discount/ A-Code Pricing Less % Discount Period of Performance: 10/01/2024 – 9/30/2025

0001B

0.00 EA _________ ________________

Year 2:

L-Code Pricing Less % Discount/

Period of Performance: 10/01/2025 – 9/30/2026

0001C

0.00 EA _________ _______________

Year 3:

L-Code Pricing Less % Discount/

Period of Performance: 10/01/2026 – 9/30/2027

0001D

0.00 EA _________ _______________

Year 4:

L-Code Pricing Less % Discount/

Period of Performance: 10/01/2027 – 9/30/2028

0001E

0.00 EA _________ ______________

Year 5:

L-Code Pricing Less % Discount/

Period of Performance: 10/01/2028 – 9/30/2029

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001A

0.00 September 30, 2025

0001B

0.00 September 30, 2026

0001C

0.00 September 30, 2027

0001D

0.00 September 30, 2028

0001E

0.00 September 30, 2029

B.4 PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER

Orthotics Appliances and Related Services

1. BACKGROUND:

The Beckley VA Medical Center (VAMC) has an ongoing requirement to furnish orthotic appliances and related services (including custom orthotics, braces, diabetic shoes, inserts, elastic supports for joints, stockings, compression garments, and other new devices and repairs) to those Veterans that require them and are eligible for assistance.

2. SCOPE:

Beckley VAMC has an ongoing program to furnish Orthotic Appliances and Related Services to those Veterans that require them and are eligible for assistance. Beckley VAMC is seeking to acquire Orthotic Appliances and Related Services to support the Veterans in need. It is the VA’s intent to issue a Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ). Anticipated period of performance is October 1, 2024 through September 30, 2029.

A. General Requirements:

(1) Standards of Performance. The Contractor shall fabricate all orthotic appliances in strict conformance to the orthotic prescription that has been submitted by the designated VA requesting provider. Contractors shall not add or substitute components or alter the beneficiary’s orthotic prescription in any way without prior approval and written authority from the appropriate VA Clinic Team Orthotic Representative or Contacting Officer. Contractor shall provide delivery certification to Prosthetics and Sensory Aids Service (PSAS) the same day the service is provided.

(2) Educational and Training Requirements. All contractors shall have a full-time Orthotist on staff at each of their locations with current and valid credentials provided by the American Board Certification (ABC), or Board for Orthotist-Prosthetist Certification (BOC). A waiver for this requirement may be granted on a case-by-case basis for branch offices only in the event that VA determines this requirement would place an undue burden on the veteran. VA reserves the right to verify Orthotist(s) credentials any time during the term of this contact. In the event that VA determines that the contractor is not meeting the above requirements, VA may terminate the contract for cause in accordance with FAR Clause 52.212-4 paragraph (m).

(3) Approved Facilities. The contractor’s facilities shall be approved by the Facility Accreditation Program of the American Board for Certification in Orthotics and Prosthetics, Inc. (ABC), the Accredited Facilities Program of the Board of Certification (BOC) or have successfully passed inspection by local VA Orthotic Service.

B. Specific Requirements:

(a) Solicitation of Beneficiaries. The Contractor agrees not to directly or indirectly through agents solicit eligible veteran beneficiaries. VA personnel shall not direct, guide, or prompt a veteran beneficiary to a specific contractor except when a physician determines that it is a medical necessity. To assist in the selection of their Orthotist, all eligible veteran beneficiaries shall be given a current list of the preferred providers that are located in the Medical Center jurisdiction. Each list of preferred providers shall contain the following header statement in boldface type:

“YOU HAVE THE RIGHT TO SELECT THE ORTHOTIC APPLIANCE CONTRACTOR OF

YOUR CHOICE FROM ANY OF THE VA APPROVED CONTRACTORS. ANY ATTEMPT TO

INFLUENCE YOUR DECISION OR TO DIRECT YOU TO ANY PARTICULAR

CONTRACTOR SHOULD BE REPORTED TO THE MEDICAL CENTER DIRECTOR OF

THIS FACILITY.”

It will continue to be VA’s policy to permit all service-connected and non-service-connected Orthotic need veteran beneficiaries who have continuing eligibility and who have established ties with an existing Orthotist to continue to use that Orthotist provided that Orthotist is willing to accept the current preferred provider terms for the geographic area covered by the contract, follows the same directions as in the VA contract by all contractors and accepts the average Centers for Medicare and Medicaid Services discount of the contractors for the geographic covered area. The non-contracted contractor is subject to providing these current documents to the Chief of Prosthetics and/or COR prior to giving service to the Veteran.

(b) Salvage. In the event that a veteran beneficiary dies prior to delivery and acceptance of an orthosis, VA shall pay the contractor for the work performed up to the point that they are notified to stop work. The pricing paid shall be mutually agreed upon and shall not exceed the contract price of the orthotic appliance less the salvage value of the unused orthosis.

(c) Same Day Service. Contractor shall keep the following items in contractor’s facility inventory for same day issuance to Veterans:

A5512 - Multi Den Insert Form A5500 - Diabetic Shoe for Density Insert L0628 - LSO NO RI Stays Pre OTS (Lumbosacral Orthosis) L3221 - Orthopedic Mens Shoes DPTH L3040 - FT Arch Support Premold Longit

a. National Prosthetic Patient Database (NPPD) Categories/lines – new and repairs:

I. ORTHOSIS/ORTHOTICS

400 A ORTHOSIS ANKLE

400 B ORTHOSIS LEG A/K

400 C ORTHOSIS SPINAL

400 D ORTHOSIS AL/OTH

400 E ELAS HOSE

400 F ORTHOSIS KNEE

400 G CORSET/BELT

400 H ORTHOSIS WHO

400 X ORTHOTICS UNKNOWN

II. SHOES/ORTHOTICS

500 A ARCH SUPT

500 B SHOE INLAY

500 C SHOE MOLDED

500 D SHOE ORTH OTH

500 E INSERTS, SHOE

500 F SHOES A/O

III. ORTHOSIS

R40 ORTHOSIS TOTAL

IV. SHOES/ORTHOTICS

R50 A ORTH SHOE ALL

R50 B SHOE MOD

R50 C A/O ITEM SERV

C. Pricing

For fabrication and repair of orthotic appliances, the prices proposed shall not exceed the established L- Code prices 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 schedule.

Considering this, please apply the best percentage discount that you offer against the L-Code pricing baseline.

Offerors are encouraged to give a discount on all L-Codes and A-Codes (Orthotic appliances, labor rates for repairs and components*).

Line Item 1: BASE YEAR

L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________%

DISCOUNT

Line Item 1a: OPTION YEAR 1

L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________%

DISCOUNT

Line Item 1b: OPTION YEAR 2

L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________%

DISCOUNT

Line Item 1c: OPTION YEAR 3

L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________%

DISCOUNT

Line Item 1d: OPTION YEAR 4:

L-CODE PRICING LESS _________% DISCOUNT / A-CODE PRICING LESS _________%

DISCOUNT

Note: *It should be noted that L-Code and A-Code pricing are published by the Centers for Medicare and Medicaid Services (CMS) – Healthcare Common Procedure Coding System (HCPCS). The website for the L-Code & A-Code Pricing: List of CPT/HCPCS Codes | CMS (DME, Orthotics and Prosthetics). The Codes are updated every year and are released in December, for the following year. The discounts shown in the Schedule above are for the categories as stated in the Description of Services above, with the CMS representing the L-Codes for Orthotics (new and repair) and the A-Codes for shoes, inserts and related items.

a. Reimbursement for Items Not Having a Dedicated Code:

Reimbursement for New Technology Components Not Having Dedicated HCPCS codes for new technology components not yet reviewed by the Medicare Pricing, Data Analysis and Coding contractor (PDAC) for the Centers for Medicare and Medicaid Services, the maximum allowable reimbursement will be 150% of the contracted vendors invoice for the item. The reimbursement shall include the technical labor and the clinical time to attach, adjust, modify and/or program the component through the initial fittings. The contractor’s invoices shall be submitted with the quote for review with the FL10-90 Form.

Offerors are encouraged to submit their best discounts off of the CMS pricing schedule to be considered for a contract award (a discount must be provided to be considered for a contract award). The Contracting Officer reserves the right to make a contract award without discussions, thus making it in the offeror’s best interest to submit the absolute best discount when submitting the proposal.

https://www.cms.gov/medicare/regulations-guidance/physician-self-referral/list-cpt-hcpcs-codes

D. Warranty

The Contractor shall warrant the Orthotic Appliances and Related Services 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 Clinic Team and deliverable acceptance by the VA Clinical Team Prosthetic Representative or COR. Manufacturer’s warranties of Orthotic Appliances and Related Services 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.

E. Recalls

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

• A complete item description and identification;

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

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

• Instructions for appropriate corrective action.

F. Educational and Training Requirements:

All Contractors shall have a full-time American Board Certified (ABC), or Board for Orthotist-Prosthetist Certification (BOC) Orthotist on staff at each of their locations – with current and valid credentials for the State in which he/she practices in good standing. A waiver for these requirements may be granted on a case-by-case basis for branch offices, only in the event that VA determines this requirement would place an undue burden on the veteran. The VA reserves the right to verify Orthotist(s) credentials anytime during the term of this contract. A copy of the ABC/BOC Orthotist Certification with which location he/she is on full-time staff must be included in the Technical Proposal submission of this solicitation. In the event the VA determines that the Contractor is not meeting the above requirements, VA may terminate the contract for cause in accordance with the applicable clauses listed in the contract. See FAR Clause 52.212-4 paragraph (m). For all new personnel that are brought on board after the final contract award, submission of all required training must be provided within 60 days of hire.

a. Special Education Requirements for Certain Orthoses:

The fitting and alignment of the following orthoses/services must be performed under the supervision of an Orthotist who has met the applicable educational and training requirements, such as completion of a National Commission on Orthotic and Prosthetic Education (NCOPE) accredited educational program for Orthotics. For all new personnel that are brought on board after the final contract award, submission of all required training must be provided within 60 days of hire.

At a minimum, this training shall include Computer Aided Design/Computer Aided Manufacturing (CAD/CAM), Longs Technique, NSNA, and/or educational seminars specific to the fabrication and servicing of these components that were presented by organizations such as National Association for the Advancement of Orthotics and Prosthetics (NAAOP), American Academy of Orthotics and Prosthetics (AAOP), American Orthotic and Prosthetic Association (AOPA), International Association of Orthotics and Prosthetics (IAOP), or a formal program which is specifically designed to train Orthotists in the fabrication of these items. Examples of advanced Orthotic componentry would include, but not limited to:

(1) Spiral Ankle Foot Orthosis (AFO)/Knee Ankle Foot Orthosis (KAFO) designs

(2) Stance control knee joints

(3) Reciprocating Gait Orthosis (RGO’s)

(4) Tenodesis orthoses

(5) AFO or other devices that involve electrical stimulation of muscles

(6) Dynamic contracture orthoses

(7) Any device that contains a microprocessor on-board unit

Additionally, due to the nature of personal information involved in the Contractor carrying out required duties, all Contractor personnel will be required to complete Privacy Policy training annually. This can be their own internal education or VA-approved, but documentation of completion should be provided to the COR annually.

G. Approved Facilities:

The Contractor’s facilities shall be approved by the Facility Accreditation Program of the American Board for Certification in Orthotics and Prosthetics, Inc. (ABC), the Accredited Facilities Program of the Board of Certification (BOC), and follow applicable CMS standards. A copy of the ABC/BOC Facility Certification for each Contractor facility location must be included in the Contractor’s Technical Proposal submission of this solicitation. All contractor facility locations used in this contract are subject to VA inspection at any time during the contract period by the Chief of Prosthetics or designee whose location is closest to the contractor’s facility.

Throughout the duration of this contract, notification of any facilities which are added, changed, or closed must be immediately conveyed to both the Contracting Officer (CO) and the Contracting Officer Representative (COR) to obtain approval before it may be used for this contract. Added new facilities must be ABC or BOC certified prior to any veteran being seen or treated in the facility.

The Contractor(s) must have a facility located within 40 miles of the Beckley VAMC to include Princeton and/or Greenbrier Community-Based Outpatient Clinics (CBOC). The Offeror must provide address(es) of all facilities that will be used in the service of this contract.

Beckley VAMC Greenbrier CBOC Princeton CBOC 200 Veterans Avenue 1500 Courthouse Road 228 Shamrock Lane Beckley, WV 25801 Princeton, WV 24740 Ronceverte, WV 24970

H. Days/Hours of Operations

The VA VAMC /VISN 5 Medical Centers operate during normal business hours - Monday through Friday, 8:00am – 4:00pm. Clinic sessions will be established at each VA Facility by the Prosthetics Representative/Lab Manager/VA Orthotist/COR/designee, in association with the Physician/Clinician. A clinic contractor rotation schedule may be implemented depending upon the number of vendors selected for contracts.

a. Federal Holidays:

The eleven holidays observed by the Federal Government are:

New Year’s Day – January 1st Martin Luther King’s Birthday – Third Monday of January Presidents’ Day – Third Monday of February Memorial Day – Last Monday of May Juneteenth – June 19th Independence Day – July 4th

Labor Day – First Monday of September Columbus Day – Second Monday of October Veterans Day – November 11th Thanksgiving Day – Fourth Thursday of November Christmas Day – December 25th

When a Federal Holiday falls on a Sunday, the following Monday shall be observed as a Federal Holiday.

When a Federal Holiday falls on a Saturday, the preceding Friday is observed as a Federal Holiday. Also included – any other day specifically declared by the President of the United States of America to be a Federal Holiday.

I. CONFIDENTIALITY OF PATIENT RECORDS

The Contractor is a VA contractor and will 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, the Contractor is a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, the 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 sharing agreement, 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 the 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.

J. 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.

K. INVOICES:

Invoices shall be submitted monthly, in arrears and mailed to:

Beckley VAMC 200 Veterans Avenue Beckley, WV 25801

Invoices submitted for payment shall include the contract number, purchase/delivery order number, beneficiary’s name; detail of work accomplished, HCPCS Codes for each item, and the VA contract discount. All invoices will be submitted in accordance with the addresses provided in above. The preferred method of payment will be the Government Purchase/Visa Credit Card or Pay only card – using the appropriate field for the obligation number - and the Contractor must be capable of accepting it for payment. The contractor will also need to be able to process at Level II. If this involves additional machinery or computers, this will be at the contractor’s expense. No advance payments shall be authorized. No charge shall be made until the orthosis is delivered to the veteran and he/she has signed and dated an acceptance form provided by the contractor. Each invoice must be submitted to the VA Facility within three (3) business or calendar days of orthosis delivery to the veteran. Payment of invoices may be delayed if the appropriate invoices as specified in the contract are not completed and submitted as required.

Contractor invoices will be reviewed by a VA practitioner to ensure they meet the requirements of the VA prescription and have the proper assignment of HCPCS Codes. Contractors can anticipate contact from a VA practitioner seeking clarification and/or justification for specific items on invoices/quotes.

A credit card receipt with the invoice and signed acceptance receipt must be forwarded to Beckley VAMC as soon as the transaction has been completed in accordance with the guidelines and time frames in utilizing the Government Purchase/Visa Credit Card/Pay only card. The Government Purchase Card/Pay only card should not be charged until the orthosis(es) is delivered and accepted.

1. DEFINITIONS:

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

PURCHASE CARD/VISA LEVEL II: Enhanced data is the additional information that accompanies charge card transactions. However, enhanced data is not required for processing financial transactions or for settlement of that transaction. Level II provides additional summary data that accompanies Level I (minimum amount of data required to clear and settle a financial transaction) through the clearing and settlement process.

2. ABBREVIATIONS:

A-CODE Medicare Code for Orthotic Shoes, Inserts & Orthotic Supplements L-CODE Medicare Code for Artificial Limbs & Orthotic Appliances/Services AAOP American Academy of Orthotics and Prosthetics ABC American Board Certified AOPA American Orthotic and Prosthetic Association BOC Board for Orthotist Prosthetist Certification IAOP International Association of Orthotics and Prosthetics CMS Centers for Medicare and Medicaid Services CO Contracting Officer COR Contracting Officer Representative HCPCS Healthcare Common Procedure Coding System

NAAOP National Association for the Advancement of Orthotics and Prosthetics NCOPE National Commission on Orthotic and Prosthetic Education NPPD National Prosthetic Patient Database PSAS Prosthetic and Sensory Aids Service

L. PERFORMANCE, DELIVERY, INSPECTION, AND ACCEPTANCE:

Contractor shall deliver items ordered under this contract no later than 21 calendar days after acceptance of a purchase/delivery order. The Contractor shall notify the VA Orthotic Representative and show cause in the event they are unable to deliver the required items in accordance with the Government’s required delivery date. Such notice shall be given in writing within 5 calendar days after receipt of order. Failure by the Contractor to provide such notice within the time specified shall constitute acceptance of the order.

Delivery includes patient education on all issued items, to include, but not limited to, demonstration of proper donning and doffing of and wear and care of the issued device and question/answer session. All issued orthosis/devices must be acceptable to patient in all aspects (cosmetically and functionally).

In the event the Government desires expedited delivery, the ordering activity shall telephonically contact the contractor and inquire into the feasibility of obtaining this condition. The contractor shall respond within 24 hours to such request and expedited delivery shall be mutually agreed upon. Any additional costs incurred by the contractor for meeting this requirement shall be negotiated in accordance with clause 52.212-4, Contract Terms and Conditions--Commercial Products and Commercial Services.

Failure by the contractor to deliver the ordered orthotic appliances on an expedited basis, or otherwise fulfill the agreed upon requirements shall constitute an event of default, and the Contracting Officer shall undertake any action authorized pursuant to this solicitation, or otherwise in accordance with applicable statutes and regulations.

Veteran beneficiaries will be measured, fitted, and accept delivery of their orthosis at the contractor’s facility. The conditions of and point of measurement, fitting, delivery, inspection, and acceptance of orthotic appliances shall be at the discretion of the appropriate VA Clinical Team, Orthotic Representative, Chief of Orthotics, or prescribing physician and handled on a case-by-case basis.

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

The Contractor shall immediately notify all effected VAMC(s) and contracting activities in the event of a product recall, removal, required adjustment, or required modification that is suggested or mandated by the contractor, distributor, manufacturer, or any regulatory or official agency. The information that shall be included in this notification includes:

(1) A complete item description, identification.

(2) Administrative identification data including contract number, order numbers, and order date.

(3) Reasons for recall, removal, adjustment, or modification.

(4) Instructions for appropriate corrective action.

VA CONTACT INFORMATION:

David Nunley, RMA Chief, Prosthetics Service Line

(304) 255-2121 ext. 4252 David.Nunley@va.gov mailto:David.Nunley@va.gov

B.5 VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

may be an evaluation factor.

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

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

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

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

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

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements.

Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations:

(i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38

U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program).

During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than N/A days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within N/A days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks.

This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system.

The contractor's security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing,…