Draft Statement of Work.docx

B.3 STATEMENT OF WORK (SOW)

1.0. Abbreviations

2.0. Authority

The authority for this BPA is Veterans Benefits Title 38 USC § 8123 Procurement of Prosthetics Appliances, and FAR Part 12 in combination with FAR Part 13.

3.0. Background

The VA has an ongoing program to furnish prosthetic limbs, orthotic devices, and related services to those Veterans who require artificial limbs and are eligible for assistance. The VAMC facilities are located in Nashville, TN; Murfreesboro, TN; Memphis, TN; Mountain Home, TN; Lexington, KY; and Louisville, KY. An agreement between the VA and respective providers shall be established as Firm Fixed-Priced Blanket Purchase Agreements (BPAs). It is the VA’s intent to solicit quotes and establish multiple BPAs on a competitive basis to preferred providers within the VISN 9 service area.

4.0. Scope

The Contractor shall fabricate all prosthetic/orthotic devices in strict conformance to the prescription that has been provided by the VA clinician and/or VA Amputee Clinic Team. The VA will provide a list of approved HCPCS 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 prescription, in any way without prior approval and written authorization from either the CO or VA Prosthetic POC. The solicitation only includes commercial items. Products that are not commercial items, as defined by FAR Subpart 2.101, are considered experimental and purchase of experimental products shall not be authorized under this agreement.

5.0. Education and Training Requirements

5.1. General Education

The Contractor shall have a full-time ABC certified, or BOC certified prosthetist(s)on staff in “good standing” at each of the proposed service locations throughout the agreement period. “Good standing” is defined as participating and achieving appropriate continuing education credits and pays dues as determined by Certifying Agency such as ABC and BOC. A waiver for this requirement may be granted on a case-by-case basis for branch offices only if the VA determines this requirement would place an undue burden on the Veteran.

VA reserves the right to verify credentials anytime during the term of this agreement. 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 agreement termination in accordance with the pertinent clauses in the BPA.

5.1.1. Special Education Requirements for Certain Prosthetic Limb Devices/Components

The fitting and alignment of prosthetic and orthotic devices and associated services shall be performed under the supervision of a Prosthetist/Orthotist 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/Orthotists specifically trained or completing training for purposes of providing an item by the time of delivery 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 or future technologies require specialized training from the manufacturer in order to provide to Veterans.

5.2. Patient Education and Acceptance

The Contractor shall ensure that Veteran patient has received training in use and care of Contractor’s device and is able to use device. Patient shall be able to demonstrate proper donning and doffing of, and wear and care of, the device. Device shall be acceptable to Veteran patient in all aspects (cosmetically and functionally).

6.0. Specific Requirements

6.1. Compliance with VA Prescription and Coding of Prosthetic Orthotic Devices/Components

The Contractor shall not add or substitute components or alter the Veteran’s prescription in any way without prior approval and written authorization from either the Contracting Officer or VA Prosthetic Point of Contact. Agreed upon changes to the Veteran’s prescription must be communicated on the Call Order.

6.1.1. NOC Pricing

The agreement shall include a contract line item for a service hourly rate to be used for Veteran service when a CMS HCPCS is not available. For an item that is not otherwise classified in the CMS HCPCS, and for which VA assigns any miscellaneous or NOC code, the contractor shall submit a quote for the invoice price of the item plus the number of service hours proposed. The quote shall be received no later than two (2) business days after receipt of the request for quote. The Contracting Officer will issue a fixed price Call Order based on the quote, negotiated if necessary.

NOC L-Codes

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 NOC devices. If a NOC code has been determined appropriate by the 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 NOC L-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 VA Prosthetic POC will issue a fixed price order based on the quote, negotiated if necessary. The Contracting Officer or VA Prosthetic POC may request additional supporting documentation as needed.

6.1.2. 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 6.1.1. 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.

6.2. Contractor Facility Locations

All Contractor facilities as well as other fabrication facilities such as commercial central fabrication facilities that will be utilized for this agreement shall be included in the quote. All work required under this agreement 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 agreement, the Contractor shall provide notification, in writing, of any facilities that are added, changed, or closed to the CO and the COR within fifteen (15) calendar days of any change. Approval by the CO for added or changed facilities must be obtained before those facilities may be used for this agreement.

6.3. The Joint Commission and Other Special Requirements

The Contractor shall perform the required work in accordance with the Accreditation standards applicable for services provided. Examples include but are not limited to: Joint Commission and ABC and/or BOC standards. All Contractor employees shall continuously meet or exceed applicable Accreditation standards, i.e., TJC and ABC and/or BOC standards. The Contractor shall be responsible for ensuring that Contractor employees providing work on this agreement are fully trained and completely competent to perform the required work.

While the agreement 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/.

Contractor shall have an established Quality Control Plan detailing steps and or measures to be taken by the offeror to ensure that the products and services rendered to the Veterans are maintain at a high level of quality.

6.4. 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:

6.4.1. Stance and swing time for gait symmetry, dynamic function including alignment, forces, and moments;

6.4.2. Cadence and cadence variability;

6.4.3. Step count – continuous recording of total step count;

6.4.4. Number of steps per selected time interval;

6.4.5. Longitudinal, historical and objective analysis;

6.4.6. Peak performance index, quantifiable into baseline and faster than baseline rate of walking, distance and variable cadence;

6.4.7. Functional level assessment capability; and

6.4.8. Measurement of socket load during gait.

VA may request “Veteran Outcome Reports” based on the data collected and shall be provided by the Contractor to the VA upon request.

6.5. Semi-Annual Service

The Contractor will provide semi-annual service to each Veteran for whom the Contractor is managing prosthetic limb care. For the purposes of this agreement, 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 agreement. The Contractor shall notify the VA Prosthetic POC or COR for the required semi-annual service and receive written authorization prior to providing the semi-annual service to the Veteran. At no time will the Contractor suggest or promote upgrades to the veteran, unless medically justified and discussed with the COR or VA Prosthetic POC.

The Contractor will also provide semi-annual service for Custom Orthotic devices (i.e., custom KAFO, DUAFO, AFO, etc.)

The following L-Code shall be used for semi-annual service:

6.5.1. L7520 – Repair prosthetic device, labor component, per 15 minutes (not to exceed 6 units or 90 minutes)

6.5.2. L4205 – Repair orthotic device, labor component, per 15 minutes (not to exceed 6 units or 90 minutes)

6.6. Warranty

The Contractor shall warrant the device(s) provided against defective material and/or workmanship for a minimum of ninety (90) calendar days from the date of acceptance by VA. The minimum warranty period shall commence after the final check out, and deliverable acceptance, by the VAMC Amputee Clinic Team Manufacturer’s warranties of prosthetic & orthotic devices/components that extend beyond the minimum ninety (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 or orthotic device(s), 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 section 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 a new prosthetic limb (minimum 90 calendar day period) and shall be effective from the date of the acceptance of the repaired or “loaner” prosthetic limb by VA Prosthetic POC.

The Contractor shall warrant and imply that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this agreement. The rights and remedies of the Government provided in this section are in addition to, and do not limit any, rights afforded to the Government by any other clause of the agreement.

6.7. Repair and Replacement

6.7.1. 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/orthotic device required by wear or a change in the Veteran’s condition. A minor repair or replacement means a 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:

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

5.7.1.2. L7520 – Repair prosthetic device, labor component, per 15 minutes (not to exceed 8 units or 120 minutes)

5.7.1.3. L4210 – Repair orthotic device, repair or replace minor parts (not to exceed $250.00)

5.7.1.4. L4205 – Repair orthotic 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 VA Prosthetic POC.

6.7.2. Removed

6.7.3. Other than Repair or Replacement of Minor Parts of Prosthetic & Orthotic Device and Labor

Repairs to a prosthesis or orthosis are covered when necessary to make the device 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 and covered as a repair to make the device functional.

Replacement of a prosthetic or orthotic device or replacement of a device/component requires prior approval and written authorization from the VA Amputee Clinic Team. Replacement of a 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 care, prescribes a prosthetic limb or device for the following reasons:

6.7.3.1. 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.

6.7.3.2. 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.

6.7.4. Delivery and Compliance

Replacement of a part or repair shall be completed, and item shall be delivered within 30 calendar days to Veteran patient. Limb or socket replacement shall match the prescription from VA Provider and be acceptable by the Veteran patient in all aspects (cosmetically and functionally).

6.8. Government Supplied Items

VA may provide certain supplies such as shrinkers, liners, sleeves, and socks, etc. 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 Amputee Clinic Team or VA provider or VA Prosthetic POC. At the time of the request for Government Supplied Items, the Contractor will provide the appropriate item description, HCPCS Coding, and related discounts.

6.9. 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 5.1.1. 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.

6.10. Salvage

If a Veteran beneficiary dies prior to delivery and acceptance of an artificial limb, 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 in writing and shall not exceed the Call Order price of the limb, less the salvage value of the unused limb.

6.11. 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:

6.11.1. A complete item description and identification;

6.11.2. Administrative identification data including BPA number, order numbers and order date;

6.11.3. Reasons for recall, removal, adjustment, or modification;

6.11.4. Instructions for appropriate corrective action; and

6.11.5. If the Veteran uses a prosthetic device, the date of issuance of a loaner device.

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.

7. Special Contract Requirements

7.1. HHS/OIG

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

7.2. HIPAA Compliance

HIPAA compliance is required. Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the VA.

7.3. 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 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 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. 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 claimant’s 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 agreement 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, or termination, of this agreement, 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.

7.4. 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.

7.5. On-Ramp Procedures

The CO will periodically review the total number of Contractors to ensure adequate small business competition is maintained for work orders throughout the period of performance. Over time, the total number of Contractors may fluctuate due to various reasons including novation, acquisition, and merger. If the CO determines that it is in the best interest of the Government to replenish the Contractor pool with new Contractors, the CO has the discretion to determine the optimum way to solicit additional quotes from industry at any time during the effective period of the BPA. Solicitation procedures will be subject to applicable federal procurement laws. Any offeror meeting the size eligibility requirements identified in the new “On Ramp” solicitation may submit a quote in response to the solicitation. However, the CO has the discretion to establish more or fewer BPAs than the number anticipated in the solicitation depending upon the quality of the offers received.

7.6. Off-Ramp Procedures

The Government reserves the right to implement off-ramp procedures, which would result in the removal of Contractors with established BPAs. The criteria for off-ramping may include, but not limited to, Contractors not proposing on order request(s), not having at least one order award, and/or unsatisfactorily meeting the SOW requirements. If implemented, off-ramp procedures will remove Contractors by terminating the BPA. If a “ramped off” Contractor is currently providing goods and services under an awarded Call Order, the Contractor will be required to continue to perform under the terms of the specific Call Order. Contractors that are “ramped off” will no longer be eligible to compete for Call Orders that are issued under BPA.

8. Performance, Delivery, Inspection, and Acceptance

8.1. Performance and Delivery

8.1.1. Prosthesis

The Contractor shall complete initial delivery of items ordered under this agreement no later than 30 calendars days after receipt of a Call 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 and VA Prosthetic POC within 7 calendar days of the receipt of a Call 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.

The Contractor shall obtain a signature and date from the Veteran at time of delivery of the completed prosthesis. This record shall be kept in the patient file with no charges processed until delivery is made. At the time of delivery, a copy of this signed and dated form accompanying a copy of the charge that is made for the prosthesis shall be emailed (encrypted) to the VA Prosthetic POC at the Healthcare System.

In the event the Government desires expedited delivery, either the Contracting Officer, Contracting Officer Representative, or VA Prosthetic 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, in writing. Expedited delivery terms and conditions, when required, shall be determined by the CO or Contracting Officer Representative, VA Prosthetic POC, and the Contractor on a case-by-case basis and stated in the individual Call 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 establishment of the agreement, or otherwise in accordance with applicable statutes and regulations.

Typically, eligible Veteran who are experienced prosthetic wearers will normally be measured, fitted, and accept delivery of their prosthesis at the Contractor’s facility. Eligible Veteran who are not experienced prosthetic wearers (first time prosthetic user) will normally be measured, fitted, and accept delivery at the ordering VA facility. The conditions of and point of measurement, fitting, delivery, inspection, and acceptance of prosthetic appliances shall be at the discretion of the appropriate VA Prosthetic POC handled on a case-by-case-basis.

8.1.2. Orthoses/Therapeutic Shoes

The Contractor shall contact the patient within 48 hours of receipt of a Call Order. The Contractor shall complete initial delivery of items ordered under this agreement within 14 days after receipt of a Call Order unless the patient requests a later date. The VA Prosthetic POC shall be notified 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 means an ordered item or service is complete and the item is provided to and accepted by the patient. 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 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 table of payments. 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. 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 establishment of the agreement, or otherwise in accordance with applicable statutes and regulations.

8.1.3. After-Hours Emergency

An after-hours emergency telephone number will be provided at the time of the establishing the agreement. The Contractor shall contact the COR and/or the VA Prosthetic POC, within 24 hours or the next business day, to inform them of the after-hours emergency and the CO who approved the care. Reimbursement for emergency visits to the VA for fittings are pre-priced in Section B.2.1.

8.2. 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:

8.2.1. Delivery time requirement

8.2.2. Device compliant with VA physician prescription

8.2.3. Workmanship free of defect (socket fits appropriately, limb correctly aligned)

8.2.4. Patient education

8.2.5. Patient acceptance of the device in all aspects (cosmetically and functionally)

Payment shall be rendered for a prosthetic limb/orthotic device or service that satisfactorily meets all of the indicators. Payment shall be delayed for any prosthetic limb/orthotic device or service that does not meet one or more of the indicators. The Contractor shall correct all deficiency of non-compliant prosthetic limb/orthotic device or service within fifteen (15) calendar days of written rejection notification from the COR and/or the VA Prosthetic POC. The corrected prosthetic limb/orthotic device 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 Call 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 within 45 days of delivery of VA prescription. 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. VA Prosthetic 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 Call Order. VA retains sole discretion to determine whether a final check-out is necessary for the Call Order.

9. Prohibition of Soliciting Veterans

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.

Eligible Veterans, as identified in VHA Handbook 1173.1, who have previously received artificial limbs from commercial sources, will continue to have their choice of Contractors possessing BPAs with the VA or their non-agreement-based prosthetist, providing the prosthetist accepts the VA preferred provider rate for the geographic area. In some instances, a VA clinician determines that it is medically necessary to select a certain Contractor as documented in clinical notes.

Each list of contracted providers shall contain the following header statement in boldface type:

YOU HAVE THE RIGHT TO SELECT THE PROSTHETIST (ARTIFICIAL LIMB) 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 HEALTHCARE FACILITY DIRECTOR OF THIS FACILITY.

It will continue to be VA’s policy to permit all service-connected and nonservice-connected prosthetic-needs eligible Veterans, who have continuing eligibility and who have established ties with an existing Prosthetist, to continue to use that Prosthetist if Prosthetist is willing to accept the current preferred provider terms for the geographical area covered by the agreement and follows the same directions as in this agreement by all Contractors.

10. Invoices

Invoices submitted for payment shall include the BPA number, Call Order number, beneficiary’s name, and detail of work accomplished. The mandatory and only method of payment will be the Government Purchase Card as prescribed by national directive and the Contractor must be capable of accepting it for payment. The Contractor must be able to process at Level II using the appropriate field for the Call Order number. 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 prosthesis or device is delivered to the Veteran and he/she has signed and dated a delivery acceptance form provided by the Contractor. Each invoice package must be submitted to the Healthcare System PSAS within ten (10) days of prosthesis delivery to the veteran beneficiary. Payment of invoices may be delayed if the appropriate invoices as specified in the agreement are not completed and submitted as required.

10.1. Purchase Card Level II

Enhanced data is the additional information that accompanies charge card transactions. Enhanced data is 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.

10.2. Invoice Submission

The Contractor shall send via encrypted email, the complete invoice package, which includes a copy of the Veteran signed and dated form of delivery acceptance, a credit card receipt and invoice to the VA Government Purchase Card holder.

11. Insurance Requirements

The Contractor agrees to procure and maintain, while the agreement is in effect, Workers Compensation and Employee’s Public Liability Insurance. Contractors are required to comply with applicable Federal and State workers compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer’s liability section of the insurance policy, except when contract operations are so commingled with a Contractor’s commercial operations that it would not be practical to require this coverage. Employer’s liability coverage of at least $100,000 shall be required, except in States with exclusive or monopolistic funds that do not permit workers’ compensation to be written by private carriers. Before commencing work under this agreement, the Contracting Officer shall require the Contractor to furnish certification from his/her insurance company indicating that the coverage specified herein has been obtained and that it may not be changed or canceled without guaranteed thirty (30) days’ notice to the Contracting Officer in writing.

11.1. General Liability

The Contracting Officer shall require bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

12. Hours of Operation

12.1. Normal Work Hours

This agreement is a full-service agreement. Minimally, the Contractor shall provide service forty (40) hours per week, excluding National Holidays. The Contractor may set the hours for operation utilizing evening, weekend, and holiday hours if desired; the Contractor shall not be compensated any additional fees for utilizing these type of hours. Any delivery service performed during other than normal work hours must be approved in advance by the CO and be performed at no additional charge to the Government. Each facility will specify its delivery hours and complete address.

12.2. Holidays

The Contractor is not required to provide delivery services on the following Federal Holidays, nor shall the Contractor be paid for these holidays:

Independence Day

Note: When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed by U.S. Government agencies. Any day specifically declared by the President of the United States to be a national holiday will be included as an observed federal holiday.