6515-- VISN-07 Artificial Limb Contract VISN-WIDE (VA-22-00005817)
Pre-solicitation Notice The Department of Veterans Affairs (VA) provides prosthetic limbs and related services to veterans who are eligible for VA health care services and have medical needs for such ... Pre-solicitation Notice The Department of Veterans Affairs (VA) provides prosthetic limbs and related services to veterans who are eligible for VA health care services and have medical needs for such items and services. This acquisition will supplement VISN 7 Southeast Network located in Alabama, Georgia and South Carolina in providing comprehensive prosthetic care and support to the veterans in need. It is the VA s intent to solicit proposals and award multiple Blanket Purchase Agreement(s) (BPAs) within the VA Medical Center s (VAMC) Veterans Integrated Service Network (VISN) 7 jurisdiction under the authority of Title 38 U.S.C. Section 8123.. The requirement will be a MULTIPLE AWARD BPA. The government anticipates awarding a contract for a period of 5 years. Est. POP 12-1-2021 thru 11-30-2026 Statement of Work (SOW) information is attached for additional information. The applicable North American Industry Classification System Code (NAICS) for this procurement is 339113: Other Electronic and Precision Equipment Repair and Maintenance. The Small Business Size Standards is 750 employees. THIS PRESOLICITATION NOTICE IS NOT A REQUEST FOR QUOTE (RFQ). VENDORS SHOULD NOT SUBMIT FORMAL QUOTES UNTIL THE RFQ IS POSTED TO THE GENERAL PUBLIC. This notice is not to be construed as a commitment by the Government nor will the Government pay for the information resulting from this posting. All interested parties shall have a current registration and current annual On-line Representation and Certifications Application (ORCA) in the System Award Management (SAM) database https://www.sam.gov at time of submission and award. Points of Contact: Joseph Horn Joseph.Horn@va.gov B.3 STATEMENT OF WORK FABRICATED ARTIFICIAL PROSTHETIC LIMBS VISN 07 ABBREVIATIONS: ABC American Board for Certification in Orthotics, Prosthetics & Pedorthics BOC Board of Certification/Accreditation International CMS Centers for Medicare and Medicaid Services CO Contracting Officer COR Contracting Officer s Representative DMEPOS Durable Medical Equipment Prosthetics, Orthotics, and Supplies FAR Federal Acquisition Regulation HCPCS Healthcare Common Procedure Coding System HIPAA Health Insurance Portability and Accountability Act NOC Not Otherwise Classified or Specified PSC Prosthetic Service Card QASP Quality Assurance Surveillance Plan RPO Regional Procurement Office TJC The Joint Commission VA Department of Veterans Affairs VAMC VA Medical Center USC United States Code BACKGROUND The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Regional Procurement Office (RPO) Central Region provides prosthetic limbs and related services to veterans who are eligible for VA health care services and have medical needs for such items and services. This acquisition will supplement VA in providing comprehensive prosthetic care and support to veterans in need. It is the VA s intent to solicit proposals and award multiple Blanket Purchase Agreement(s) (BPAs) within the VA Medical Center s (VAMC) Veterans Integrated Service Network (VISN) 07 jurisdiction under the authority of Title 38 U.S.C. Section 8123. SCOPE The Contractor shall fabricate all prosthetic limbs in strict conformance to the prosthetic prescription that has been provided by the VA Amputee Clinic Team. The VA will provide a list of approved L Codes for work to be provided by the Contractor for the specific prescription. The Contractor shall not add or substitute components or alter the patient s limb prescription in any way without prior approval and written authorization from the Contracting Officer Representative (COR) or local area VAMC Point of Contact (POC). This solicitation only includes commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized under this solicitation. REQUIREMENTS General Education Requirements The Contractor shall have a full-time American Board for Certification (ABC) in Orthotics, Prosthetics & Pedorthics or Board of Certification/Accreditation International (BOC) certified prosthetist(s) on staff in Good Standing at each of the proposed service locations throughout the contract period. Good Standing is defined as participating and achieving appropriate continuing education credits and paying dues as determined by Certifying Agencies such as ABC and BOC. VA reserves the right to verify prosthetists credentials anytime during the term of this Contract. The Contractor shall provide current copies of certifications upon request of the COR. Failure to comply with this requirement may lead to adverse actions by the Government up to and including contract termination in accordance with the contract clauses in the Contract. Special Education Requirements for Certain Prosthetic Limb Devices/Components The fitting and alignment of prosthetic limbs and associated services shall be performed under the supervision of a prosthetist who has met the applicable educational and training requirements covered under the manufacturing training program for that device. Certain new or innovative technologies may require proof of training and only those prosthetists specifically trained or are actively completing training for purposes of providing an item by the time of delivery of the item, may deliver the item and perform follow up services to a patient. VA reserves the right to determine which technologies require specific training. VA will notify the Contractor when current technologies require specialized training from the manufacturer in order to provide service to patients. General Requirements for All Prosthetic Limbs/Components Artificial limbs, parts and repairs must be procured, fabricated and issued to eligible beneficiaries by prescription from a designated physician assigned to the Amputee Clinic Team or from the Prosthetic Representative in accordance with the policies and procedures outlined in VHA Handbook 1173.1, VHA Handbook 1173.2, and VHA Handbook 1173.3. Compliance with VA Prescription and Coding of Prosthetic Limbs/Components The Contractor shall not add or substitute components or alter the patient s prosthetic limb prescription in any way without prior approval and written authorization from the COR or local area VAMC POC. Any changes to a patient s prescription, components or codes require review and approval by the VA Amputee Clinic Team and shall be authorized in writing, via fax and or email, by the COR or local area VAMC POC. Contractor Facility Locations All Contractor facilities as well as other fabrication facilities such as commercial central fabrication facilities that will be utilized for this Contract shall be listed in the proposal. All work required under this Contract shall be conducted at the facility locations included in the contract. The Contractor s facilities shall be accredited either by the Facility Accreditation Program of the ABC or the Accredited Facilities Program of the BOC at the time of proposal submission. 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 Contract, the Contractor shall notify VA of any facilities that are added, changed, or closed to the Contracting Officer (CO) and the COR within fifteen (15) calendar days of any change. Approval for added or changed facilities must be obtained before those facilities may be used for this contract. Accreditation and certification documents shall be submitted to the CO and COR at the time the Contractor seeks approval for added or changed facilities. The Joint Commission and Other Special Requirements The Contractor shall perform the required work in accordance with The Joint Commission (TJC) and ABC and/or BOC standards. All Contractor employees shall continuously meet or exceed TJC and ABC and/or BOC standards. The Contractor shall develop and maintain the following documents for each contractor employee working on this Contract: credentials and qualifications for the job; a current competence assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully, and including knowledge and skills required to provide care for certain patient populations, as appropriate); a current performance evaluation supporting ability of the contractor employee to successfully perform the work required under this solicitation; and, listing of relevant continuing education for the last two years. The Contractor shall provide current copies of these records for each contractor employee performing work under this contract at the time of contract award, annually on the date of the contract award thereafter, and at any other time requested by the CO or COR. The Contractor shall be responsible for ensuring that contractor employees providing work on this Contract are fully trained and completely competent to perform the required work. When changes in contractor personnel are approved in accordance with the Key Personnel clause of the Contract in section 5.1 (Key Personnel and Temporary Emergency Substitutions), the Contractor shall provide evidence of orientation, the current competence assessment, and current performance evaluation that supports the above. Where the Contract 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/. Outcome Monitoring and Utilization for High Technology Components The VA may require Contractors to create an automated prosthetic utilization and function monitoring device for data collection and analysis for a new lower extremity prosthetic limb (transtibial, knee disarticulation, transfemoral and hip disarticulation level; does not include socket replacements). The utilization and function monitoring device will have the ability to record intensity, endurance, gait symmetry, dynamic function, including alignment, forces and moments with proven accuracy. The device will monitor and continuously record the following: Stance and swing time for gait symmetry, dynamic function including alignment, forces, and moments; Cadence and cadence variability; Step count continuous recording of total step count; Number of steps per selected time interval; Longitudinal, historical and objective analysis; Peak performance index, quantifiable into baseline and faster than baseline rate of walking, distance and variable cadence; Functional level assessment capability; and Measurement of socket load during gait. The Contractor shall produce Veteran Outcome Reports based on the data collected, if requested by VA. The report shall contain narrative and graphical representation of the above variables. Semi-Annual Service The Contractor shall provide semi-annual service to each patient for whom the Contractor is managing prosthetic limb care. For the purposes of this Contract, semi-annual service is defined as a follow up visit for inspection of the prosthetic limb(s) and evaluation for fit and function for all VA-approved prosthetic limb(s) the patient owns and is actively using. Typically, semi-annual service includes inspection, testing, cleaning, and checking of the prosthetic limb(s) and/or residual limb(s) to include maintenance specific to the warranty of devices. Semi-annual service shall not be incumbent upon the number of prosthetic limbs a patient owns. Two follow up visits per patient are required annually for a patient to whom the Contractor delivered a prosthetic limb(s) under this Contract. The Contractor shall notify the COR for the required semi-annual service and receive written authorization prior to providing the semi-annual service to the patient. The following L-Code shall be used for semi-annual service: L7520 Repair prosthetic device, labor component, per 15 minutes (not to exceed 4 units or 60 minutes) Warranty The Contractor shall warrant all prosthetic limb products 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 at the VAMC by the Amputee Clinic Team and deliverable acceptance by the COR or local area VAMC POC. Manufacturer s warranties of prosthetic limb and limb 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 limb, adjustments required by physical change of the wearer, or where there is evidence of deliberate misuse or alteration by anyone other than the Contractor. Any prosthetic limb repaired or furnished as a loaner shall be subject to this clause to the same extent as a new prosthetic limb delivered. As discussed in section 4.12 (Loaner Prosthetic Limb Requirements), A loaner is defined as a suitable prosthetic device or component, fit for patient use during the time their original device is being repaired. The warranty for a repaired limb or loaner limb shall be equal in duration to the term the Contractor is required to offer to a new prosthetic limb and shall run from the date of the acceptance of the repaired or loaner prosthetic limb by VA. The Contractor shall warrant and imply that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this Contract. The rights and remedies of the Government provided in this clause are in addition to, and do not limit any, rights afforded to the Government by any other clause of the Contract. Repair and Replacement Minor Parts of Prosthetic Device and Labor All parts procured or fabricated to replace existing parts or to modify a previously issued or fabricated device is considered a repair, regardless of who fabricated or supplied the original part. Repair and replacement of minor parts may require adjustments to a prosthetic limb required by wear or a change in the patient s condition. A minor repair or replacement can be defined as 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. The following factors shall be considered in determining whether a repair or replacement is minor: the value and size of the repair or replacement and the comparative value and size of the final product. Dollar values and percentages may be used as guideposts but are not conclusive evidence that a repair or replacement is minor. The following L-Codes shall be used for repair and replacement of minor parts and for labor: L7510 Repair prosthetic device, repair or replace minor parts (not to exceed $500.00) L7520 Repair prosthetic device, labor component, per 15 minutes (not to exceed 8 units or 120 minutes) Repair and replacement of minor parts and labor requires prior approval and written authorization from the COR or local area VAMC point of contact, except for repairs provided to patients with VA Prosthetic Service Card (PSC) VA Form (10-2501) as described in Emergency Appointments/Repairs. The Contractor shall provide an after-hours number or an on-call service. The Contractor shall provide emergency services to patients within 24- 48 hours after initial call. In an emergency situation, the patient may call the Contractor for assistance. The Contractor shall take corrective action, whether during or outside of business hours. Under no circumstances shall the Contractor refuse service if the patient or caregiver states that there is a risk to the patient s health or personal well-being. If the COR or designee emergency contact number is provided, the Contractor shall attempt to make contact for verbal authorization. If unable to contact COR or designee, the Contractor shall notify the COR on the next regular workday not later than 10:00 a.m. local time.   Use of Prosthetic Service Card (VA Form 10-2501) Patients may obtain repair services using a VA PSC (VA Form 10-2501). A PSC is a pre-authorized card that can be used to receive needed repairs to a patient s qualified prosthetic device up to the amount indicated on the PSC. For prosthetic limbs, patients may obtain repairs up to $500.00 with the PSC. For repairs or replacement of parts other than using a PSC or over $500.00 shall be completed with prior approval and written authorization from VA and in accordance with section 4.10.1 (Minor Parts of Prosthetic Device and Labor). The Contractor shall submit VA Form 10-2520 PSC Invoice (Attachment B) to the Prosthetic and Sensory Aids Service at the VAMC with the primary service area responsibility where the patient resides for reimbursement. The Contractor shall obtain the patient s signature acknowledging receipt of appropriate repair for invoices for such repairs under the authority of a PSC. Other than Repair or Replacement of Minor Parts of Prosthetic Device and Labor Repairs to a prosthetic limb are covered when it is necessary to make the prosthetic limb functional. If the expense for repairs exceeds the estimated expense of purchasing a new prosthetic limb or device, no payment can be made for the excess amount spent. Maintenance that may be necessitated by a manufacturer s recommendations or construction of the prosthetic limb shall be performed by the Contractor, covered as a repair. The replacement of a prosthetic limb or prosthetic limb device/component requires prior approval and written authorization from the COR or local area VAMC point of contact. The replacement of a prosthetic limb or related 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 the patient s amputation care, prescribes a prosthetic limb or device for the following reasons: 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 repairs would be more than 60% of the cost of a replacement device, or of the part being replaced. 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. Government Supplied Items VA may provide certain supplies such as shrinkers, liners, sleeves, and socks to the patient at the discretion of the VA. Any items or supplies provided to the patient by the Contractor shall be pre-authorized by the COR or local area VAMC Point of Contact. The Contractor will provide the following information: name of company, style of shrinker, liners, sleeves and socks, size of the item(s) and thickness (if applicable). 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 4.2 (Special Education Requirements for Certain Prosthetic Limb Devices/Components) 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 patient s prosthetic limb requires repair by the manufacturer. VA will not reimburse for loaner units. Recalls The Contractor shall immediately notify all affected VAMC(s) and COR(s) in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Contractor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification: A complete item description and identification; Administrative identification data including contract number, order numbers and order date; Number of devices furnished to the Government Removal, adjustment, or modification reasons for recall; and Instructions for appropriate corrective action. SPECIAL REQUIREMENTS Key Personnel and Temporary Emergency Substitutions The Contractor shall assign the following key personnel to this Contract: all individuals providing items and related services to VA patients and for whom information about education and training is required to be submitted as a part of the response to this solicitation including, but not limited to, those individuals who must meet the training requirements set forth in the Education and Training Requirements in sections 4.1 (General Education Requirements) & 4.2 (Special Education Requirements for Certain Prosthetic Limb Devices/Components). During the first ninety (90) calendar days of performance, the Contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the CO, in writing, within fifteen (15) calendar days after the occurrence of any of these events and provide the following information: Changes to Phone/Fax number Detailed explanation of the circumstances necessitating the proposed substitution; Complete resume for the proposed substitute; and Any additional information requested by the CO Proposed substitutes shall have comparable qualification to those of the individuals being replaced. The CO will notify the Contractor within fifteen (15) calendar days after the receipt of all required information of the decision on the proposed substitutes. The Contract will be modified to reflect any approved changes of key personnel. In the case where VA does not agree with the proposed substitutes and their qualifications, the Contract may be terminated, and the Contractor may not receive the minimum dollar amount specified in this Contract. For temporary substitutions, where the key person will not be reporting to work for three (3) or more consecutive workdays, the Contractor shall provide a qualified replacement. This substitute shall have comparable qualifications to the key person being replaced temporarily. Any substitution exceeding a period of two weeks consecutively shall follow the key personnel replacement procedure described in paragraph above. Confidentiality of Patient Records The Contractor shall assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the 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 considered to be 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 Contractor, may have access to VA s records, at any participating VA place of business, on request during normal business hours to inspect and review and make copies of such records. VA Sensitive Information Security Accreditation Package C&A requirements do not apply and a Security Accreditation Package is not required for this BPA. The Contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this BPA. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE Performance and Delivery Any items ordered, or services performed under this BPA shall be completed by the Contractor no later than thirty (30) calendar days after receipt of a delivery order. Any product ordered or service performed under this BPA is considered complete when an ordered product is successfully delivered and verified as satisfactory or service have been successfully performed and verified as satisfactory by the patient. The Contractor shall provide a written notification to the COR or local area VAMC POC within seven (7) calendar days of the receipt of a delivery/purchase order to show cause in the event the Contractor is unable to deliver the required item(s) and/or service(s) in accordance with the Government s required delivery date. Initial delivery shall not be construed as final delivery or acceptance of an item or service by the Government. In the event the Government desires expedited delivery, the COR or local area VAMC POC must contact the Contractor and inquire into the feasibility of obtaining the device under this condition. The Contractor shall respond within twenty-four (24) hours to such request and expedited delivery shall be mutually agreed upon. Expedited delivery terms and conditions, when required, shall be determined by the CO, COR, local area VAMC POC and the Contractor on a case by case basis and stated in the individual task or delivery order. Any additional costs incurred by the Contractor for meeting this requirement shall be negotiated in accordance with 48 U.S.C. 52.212-4, Contract Terms and Conditions Commercial Items. The total cost for the expedited delivery shall not exceed 1.5 times the cost of the normal delivery for the same or similar item with any applicable discounts. Failure by the Contractor to deliver the ordered items on an expedited basis, or otherwise fulfill the agreed upon requirements shall constitute an event of default, and the CO shall undertake any action authorized pursuant to the awarded BPA, or otherwise in accordance with applicable statutes and regulations. Inspection and Acceptance Contractor performance shall be monitored by the indicators below: Delivery time requirement Limb compliant with VA physician prescription Workmanship free of defect (socket fits appropriately, limb correctly aligned) Patient education Patient acceptance of the device in all aspects (cosmetically and functionally) Payment shall be rendered for a prosthetic limb product or service that satisfactorily meets all of the indicators. Payment shall be delayed for any order that does not meet one or more of the indicators. The Contractor shall correct all deficiency of non-compliant orders within fifteen (15) calendar days of written rejection notification from the COR. The corrected prosthetic limb or service will be re-inspected for acceptance. No invoice shall be submitted until the Government accepts the item or service. For new prosthetic limbs or socket replacement for existing prosthetic limbs, a final check-out by the VA Amputee Clinic Team at the VAMC from which the task order was generated is required. Final delivery and check out shall be conducted at the VAMC, either by in person inspection or via Tele-health capabilities at an outlying VA facility. Final acceptance or rejection and authorization for payment shall occur with the final delivery and checkout of the prosthetic limb to ensure accuracy of prescription and acceptance by the patient. The COR or local area VAMC POC will provide a written acceptance notification for any items accepted by the Government. VA patients, who require prosthetic limbs, 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. The repair or replacement of prosthetic limb components other than socket replacement does not generally require final check-out by the VA Amputee Clinic Team unless VA determines and notifies the Contractor that the final check-out is required with the issuance of the task or delivery order. VA retains sole discretion to determine whether a final check-out is necessary for the task order. ORDERING PROCEDURES All prosthetic supplies or services to be furnished under this Contract shall be ordered by issuance of delivery orders or task orders by the individual ordering facilities. Each patient is initially required to visit a VA amputee clinic at their local VA facility. Each patient shall be properly evaluated, and the VA doctor will determine each patient s needs. Each patient shall receive a list of participating vendors during their initial visit at the amputee clinic and each patient shall choose their preferred Vendor. The VA doctor shall use the patient s evaluation to prepare orders using appropriate L-Codes and submit orders to the Contractor selected by the patient. After receiving the patient s order, submitted by the VA doctor, Contractors must determine pricing based on the L-Codes provided and return this information to the requesting facility. Contractors can provide discounts to VA patients, solely at the Contractor s discretion. The requesting facility shall prepare a delivery or task order and include a description of the supplies or service, proposed pricing (including any discounts), and any deliverables. The requesting facility shall submit orders to Contractor. Ordering officers (OOs) will be authorized to place orders against this contract. The Contracting Officer (CO) will furnish the Contractor with the names of individuals authorized as OOs, by separate memorandum upon issuance of the contract. When OOs are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs, by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders. All delivery or task orders are subject to the terms and conditions of this Contract. Orders shall be placed against this Contract via e-mail, Electronic Data Interchange (EDI), or FAX. Contractors shall deliver the produc...
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