6515--Supplies - Orthotics - VISN 10 Sites

Amendment / Modification

This amendment updates the Statement of Work (SOW) sections 4.3 Contractor Facility Locations and 5.1 Key Personnel and Temporary Emergency Substitutions. Specific changes are highlighted in red within the attached document.

• Section 4.3: Contractor Facility Locations
• Section 5.1: Key Personnel and Temporary Emergency Substitutions

The Request for Quotation (RFQ) due date and time remains unchanged. Offers are due Friday, July 18, 2025, at 4:30 PM EST. No extension to the RFQ period is being granted.

Statement of Work (SOW) / Performance Work Statement (PWS)

To supplement the Department of Veterans Affairs (VA) in providing comprehensive orthotic appliances and related services to eligible veterans.

• Fabrication of orthotic appliances strictly according to VA prescriptions.

• Provision of custom orthotics, braces, diabetic shoes, inserts, elastic supports, stockings, compression garments, and repairs.

• Use of VA-provided lists of approved A-Codes and L-Codes.

• Prohibition of altering veteran prescriptions without written authorization.

• Acquisition limited to commercial items only.

• Appliances must conform to VA prescriptions and meet quality standards.

• Workmanship must be free of defects.

• Patient education and acceptance are key indicators.

• Appliances must be compliant with Joint Commission (TJC) and ABC/BOC standards.

• Warranty for 90 calendar days against defective material and workmanship.

• Multiple Blanket Purchase Agreements (BPAs) intended for multiple geographic locations within Veterans Integrated Service Network 10 (VISN 10), covering four states.

• Anticipated 5-year ordering period.

• Performance at contractor facilities and potentially VA clinics.

• Vendor must have full-time ABC or BOC certified Orthotist(s) on staff.

• Specific training may be required for new technologies.

• Contractor facilities must be accredited by ABC or BOC.

• Compliance with VA prescription and coding is mandatory.

• Strict adherence to confidentiality of patient records (Privacy Act, HIPAA).

• Employees must meet credentialing, competence assessment, and performance evaluation requirements.

• BPA Holder shall not solicit veteran beneficiaries.

• Delivery within 30 calendar days of order receipt, with provisions for expedited delivery.

• Invoices must include specific details and a signed patient delivery and acceptance form.

• BPA Holder must accept Government Purchase/Visa Credit Card for payment.

Statement of Work (SOW) / Performance Work Statement (PWS)

To supplement the Department of Veterans Affairs (VA) in providing comprehensive orthotic appliances and related services to eligible veterans.

• Fabrication of orthotic appliances strictly according to VA prescriptions.

• Use of VA-provided approved A-Codes and/or L-Codes.

• Prohibition of unauthorized component additions, substitutions, or prescription alterations.

• Acquisition is limited to commercial items; experimental products are not authorized.

• Appliances must be compliant with VA physician prescriptions.

• Workmanship must be free of defects.

• Patient education and acceptance (cosmetic and functional) are required.

• Appliances must meet Joint Commission (TJC) and ABC/BOC standards.

• BPA Holder employees must maintain appropriate certifications and credentials.

• Multiple Blanket Purchase Agreements (BPAs) are intended to be established in multiple geographic locations throughout Veterans Integrated Service Network 10 (VISN 10), covering all VISN 10 facilities and associated Community Based Outpatient Centers (CBOCs) in four states.

• Anticipated period of performance includes a 5-year ordering period.

• Performance will occur at contractor facility locations listed in the quote, which must be accredited by ABC or BOC.

• Staffing: A full-time American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC) or Board of Certification/Accreditation International (BOC) certified Orthotist must be on staff at each service location.

• Training: Specific training may be required for new technologies, verified by the VA.

• Compliance: Adherence to VA prescription, Joint Commission, ABC/BOC standards, and federal laws regarding patient confidentiality (Privacy Act, HIPAA) is mandatory.

• Warranty: A minimum 90-calendar day warranty against defective material and/or workmanship is required for all provided orthotic appliances.

• Recalls: Immediate notification to the CO and COR is required in the event of an appliance recall.

• Key Personnel: Specific individuals providing services must meet education and training requirements. Substitutions require justification and approval.

• Facility Accreditation: Contractor facilities must be accredited by ABC or BOC.

• Payment: Invoices require specific documentation, including a signed patient delivery and acceptance form. Payment is contingent upon final acceptance by the veteran. Government Purchase/Visa Credit Card acceptance is preferred.

Amendment / Modification

This amendment extends the deadline for the receipt of offers and provides answers to vendor questions. It also includes an updated Statement of Work (SOW).

• Receipt of Offers Deadline: Extended to July 18, 2025, at 4:30 PM EST.
• Section 2.2.1 Not Otherwise Classified Codes Reimbursement: Clarified that manufacturer invoices are required for NOC items, especially if they exceed national cost estimates or if no national estimate exists. The government will negotiate prices down to within the national estimate if necessary. A second discount on labor is not expected if the invoice already reflects discounts.
• Section 4.3 Contractor Facilities Locations: The SOW is updated to allow 30 days from the date of an update to provide required information regarding office or staffing changes.
• Section 8.3 Orthotic Clinic Process and Conduct: Clarified that the section pertains to the clinical evaluation process at the VA facility before a vendor is selected. Post-delivery care and follow-up are permitted after the veteran selects their provider.
• Section B.4 Information and Information System Security and Privacy Language: Clarified that VA information is protected under multiple statutes beyond HIPAA, including the Privacy Act, 38 USC 5701, and 38 USC 7332.
• Section B.5 Records Management Language: Records pertaining to VA procurements must adhere to this section, potentially with different retention standards than state law.
• Section C.11 VAAR 852.211-72 Technical Industry Standards: "Proof of conformance to the standard" is interpreted as affixing manufacturers' serial numbers or stickers from items used in construction for tracking recalls or warranty issues, confirming products meet industry standards (e.g., ISO testing).
• Section C.12 VAAR 852.211-76 Liquidated Damages: If a data breach is caused by the vendor, the vendor is responsible for breach-related costs. The VA would pay if the VA caused the breach.
• Section E.9 52.209-7 Information Regarding Responsibility Matters: Vendors are advised to consult their legal department for guidance on completing this clause, especially regarding contract values.
• Section E.11 52.225-18 Place of Manufacture: If assembly and substantial transformation of the final product occur in the USA, paragraph (b)(1) should be checked, even if the vendor is not a manufacturer.
• BPA Holder Clinic Staff Presence: BPA holders are not expected to be physically present at Community Outpatient Clinic sites for evaluations or delivery; services will be conducted at the BPA holder's clinic locations.
• Updated SOW: An updated SOW is attached, with changes noted in red.

The deadline for offer receipt has been extended. Vendors should review the Q&A and the updated SOW for changes to requirements and clarifications.

Solicitation / RFP / RFQ

This solicitation is for the establishment of multiple Blanket Purchase Agreements (BPAs) for Orthotics Appliances and Related Services. The Department of Veterans Affairs (VA) intends to procure custom orthotics, braces, diabetic shoes, inserts, elastic supports, compression garments, and related repair services for eligible veterans within Veterans Integrated Service Network 10 (VISN 10) facilities and associated Community Based Outpatient Centers (CBOCs) across four states. The goal is to supplement VA's provision of these services.

• Fabrication of orthotic appliances strictly conforming to VA prescriptions.

• Use of VA-provided A-Codes and/or L-Codes.

• No unauthorized component additions or prescription alterations without written VA authorization.

• All products must be commercial items.

• Vendors must employ full-time, certified Orthotists (ABC or BOC certified) in good standing at each service location.

• Facilities must be accredited by ABC or BOC.

• A minimum 90-day warranty against defective material and workmanship is required for all orthotic appliances.

• Immediate notification to the Contracting Officer (CO) and Contracting Officer’s Representative (COR) in case of an appliance recall.

• Multiple Blanket Purchase Agreements (BPAs) are anticipated.

• The anticipated period of performance includes a 5-year ordering period.

• The authorized Ceiling Limit for the Agreement is set at $7,000,000.00 over the period covered by the Agreement.

• Individual BPA Orders may reach an estimated $10,000.00 per Order.

• Offers are due by July 15, 2025, at 4:30 pm EDT.

• Questions are due by July 1, 2025, at 4:30 pm EDT.

• Offers must be emailed to Kellie.Konopinski@va.gov.

• Pricing will be based on Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) A-Code and L-Code fee schedules, minus any discounts offered by the BPA Holder.

• Evaluation factors include: pricing, acceptance of SOW requirements, orthotist credentials, facility locations, completion of required forms, SAM registration, and warranty information.

• This acquisition is unrestricted.

• NAICS Code: 339113 (Surgical Appliance and Supplies Manufacturing), Size Standard: 500 employees.

• Evaluation will consider Service-Disabled Veteran-Owned Small Business (SDVOSB) and Veteran-Owned Small Business (VOSB) status.

• Placement of delivery orders is not guaranteed.

• The solicitation incorporates FAR clauses 52.212-1, 52.212-4, and 52.212-5.

• VAAR clauses are also incorporated.

Form / Attachment / Pricing Sheet

This document provides a list of facility locations associated with VISN 10 (Veterans Integrated Service Network 10). It details the main medical centers and their associated Community Based Outpatient Clinics (CBOCs), Vet Centers, and Research facilities.

• Facility Name: The name of the primary VA Medical Center or Health Care System.
• Identify Main/CBOC/Vet Center/Research: Categorization of the facility.
• CBOC: Indicates if the facility is a Community Based Outpatient Clinic.
• Facility Address: The street address of the facility.
• City: The city where the facility is located.
• State: The state where the facility is located.
• Zip Code: The zip code of the facility.

This attachment is crucial for bidders to understand the geographic scope of services required for the opportunity. It lists all the specific locations where services may need to be provided, including main medical centers and various outpatient clinics across Indiana, Ohio, and Michigan. Bidders should review this list to assess their capability to serve these diverse locations and to factor in logistical considerations for any potential contract.

Amendment / Modification

This document is a Class Deviation to the VA Acquisition Regulation (VAAR) that requires the inclusion of a new clause, VAAR 852.222-71, "Compliance with Executive Order 13899," in VA solicitations and contracts exceeding the Simplified Acquisition Threshold (SAT).

• VAAR Parts 822 and 852 are impacted.

• Specifically, VAAR 822.810(h) is added to mandate the inclusion of the new clause.

• The new clause, 852.222-71, is provided in full.

• Contracting officers are required to immediately incorporate this deviation.

• The clause must be included in all solicitations and contracts that use appropriated funds and exceed the SAT.

• It must also be incorporated into existing contracts exceeding the SAT if they are not otherwise physically complete or have more than six months remaining until expiration.

• The deviation expires when incorporated into the VAAR or rescinded.