Pre-solicitation Notice The Department of Veterans Affairs (VA) provides prosthetic limbs and related services, orthotic appliances and related services, including custom orthotics, braces, diabetic shoes, inserts, elastic supports for joints, stocking, compression garments, neuromuscular electoral stimulators, stance control joints and repairs to veterans that require them and are eligible for VA health care services and have medical needs for such items and services. This acquisition will supplement the VISN 23 Network in providing comprehensive prosthetic care and support to the veterans in need. It is the VA s intent to solicit quotes and award multiple Blanket Purchase Agreement(s) (BPAs) within the VA Medical Center s (VAMC) Veterans Integrated Service Network (VISN) 23 jurisdiction under the authority of Title 38 U.S.C. Section 8123.. The government anticipates awarding multiple BPAs. The government anticipates awarding for a period of 5 years. Est. POP 1-1-2024 thru 12-31-2029 Statement of Work (SOW) information is attached for additional information. The applicable North American Industry Classification System Code (NAICS) for this procurement is 339113. The Small Business Size Standards is 800 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: Chris Skaggs - Chris.Skaggs@va.gov STATEMENT OF WORK B.3.0 Abbreviations L-CODE: MEDICARE CODE FOR ARTIFICIAL LIMBS & ORTHOTIC APPLIANCES/SERVICES A-CODE: MEDICARE CODE FOR DIABETIC SHOES, INSERTS & ORTHOTIC DEVICES AAOP: AMERICAN ACADEMY OF ORTHOTICS AND PROSTHETICS ABC: AMERICAN BOARD FOR CERTIFICATION IN ORTHOTICS AND PROSTHETICS & PEDORTHICS AOPA: AMERICAN ORTHOTIC AND PROSTHETIC ASSOCIATION BOC: BOARD FOR ORTHOTIST-PROSTHETIST CERTIFICATION (ACCREDITED FACILITIES PROGRAM) CAD/CAM: COMPUTER AIDED DESIGN/COMPUTER AIDED MANUFACTURER CMS: CENTERS FOR MEDICARE AND MEDICAID SERVICES CO: CONTRACTING OFFICER HCPCS: HEALTHCARE COMMON PROCEDURE CODING SYSTEM IAOP: INTERNATIONAL ASSOCIATION OF ORTHOTICS AND PROSTHETICS NAAOP: NATIONAL ASSOCIATION FOR THE ADVANCEMENT OF ORTHOTICS AND PROSTHETICS NOC 99: NOT OTHERWISE CODED CODES PSAS: PROSTHETIC AND SENSORY AID SERVICE QASP: QUALITY ASSURANCE SURVEILLANCE PLAN USC: UNITED STATES CODE B.3.1 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. B.3.2 Definitions Good Standing: Participates and achieves appropriate continuing education credits and pays dues as determined by Certifying Agency such as ABC or BOC or applicable accreditation. 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. 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. B.3.3 Description The Veterans Integrated Service Network (VISN 23), Department of Veterans Affairs (VA) has an ongoing program to furnish artificial limbs and related services, orthotic appliances and related services, including custom orthotics, braces, diabetic shoes, inserts, elastic supports for joints, stockings, compression garments, neuromuscular electrical stimulators, stance control joints and repairs to those veterans that require them and are eligible for assistance. Any items that do not have an established Healthcare Common Procedure Coding System (HCPCS) Code but are considered commercial orthotic item(s) intended for this HCPCS series, will be classified as Not Otherwise Covered (NOC), or 99 codes and will be incorporated into the resulting contract(s) and rates for these items negotiated by way of a bilateral modification. It is VA s intention to solicit quotes and establish multiple Blanket Purchase Agreements (BPAs) on a competitive basis to providers within the VISN 23 service area. The anticipated ordering period is from date of award through a five-year period. The orthotic appliances and related services shall be provided to the following facilities in VISN 23: Fargo VA Health Care System Black Hills (Fort Meade VAMC/Hot Springs VAMC) VA Health Care System Sioux Falls VA Health Care System St. Cloud VA Health Care System Minneapolis VA Health Care System Iowa City VA Health Care System Central Iowa VA Health Care System Des Moines and Knoxville Nebraska-Western Iowa Health Care System Omaha VA Medical Center and Lincoln & Grand Island Outpatient Clinics B.3.4 Extent of Obligation This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer. B.3.5 Purchase Limitations The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $250,000.00/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at $7,500,000.00 over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. Should a contractor perform unauthorized work, regardless of amount, they assume the risk of nonpayment. B.3.6 Individuals Authorized to Purchase. Prosthetics Purchasing Agents are authorized to complete purchases at or below the Micro- Purchase threshold of $10,000.00. For orders above $10,000.00, orders will be referred to Contracting for a Contracting Officer to complete the purchase. B.3.7 Invoicing Itemized invoices submitted for payment shall include the following: Agreement number Purchase order number Beneficiary s name Detail of work accomplished HCPCS Codes for each item Date of device delivery VA agreement discount. All invoices shall be submitted in accordance with VAAR Clause 852.232-72. The preferred method of payment shall be the Government Purchase Card using the appropriate field for the obligation number - and the Contractor shall be capable of accepting it for payment. The VA reserves the right to change preferred payment methods at any time in the agreement and may institute weekly or monthly billing through the VA invoice processing system at any time. The contractor shall be able to process the Government Purchase Card at Level II (see definitions section). If this involves additional machinery or computers, supplying such equipment/resources shall 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 shall be submitted to the VA Facility within three (3) days of item delivery to the veteran. Payment of invoices may be delayed if the appropriate invoices as specified in the agreement are not completed and submitted as required. For VAs using Government Purchase Card, a credit card receipt with the invoice and signed acceptance receipt shall still be forwarded to the appropriate VA facility as soon as the transaction has been completed in accordance with the guidelines and time frames in utilizing the Government Purchase Card. The Government Purchase Card shall not be charged until the item(s) covered by this agreement is/are delivered and accepted. B.3.8 Annual BPA Review Each BPA shall be reviewed annually before the anniversary of its effective date and revised as necessary to conform to the requirements of the FAR. BPAs may need to be revised before the annual review due to statutory requirements. A BPA shall be changed only by modifying the agreement itself and not by individual orders issued under it. Modifying a blanket purchase agreement shall not retroactively affect orders previously issued under it. B.3.9 Area of Responsibility/Jurisdiction Contractor MUST have a physical presence in AT LEAST one of the counties listed in the coverage area of that particular VA Health Care System to be eligible for that VA s respective contract. Coverage areas are as follows: FARGO VA Medical Center: Entire State of North Dakota, with the exception of Adams, Bowman, and Slope counties. The following counties in Minnesota: Becker, Beltrami, Clay, Clearwater, Hubbard, Kittson, Lake of the Woods, Mahnomen, Marshall, Norman, Ottertail, Pennington, Polk, Red Lake, Roseau, Traverse, and Wilkin. The following county in South Dakota: Roberts. BLACK HILLS HEALTHCARE SYSTEM Fort Meade VAMC/Hot Springs VAMC: The following counties in South Dakota: Bennett, Butte, Campbell, Corson, Custer, Dewey, Fall River, Gregory, Haakon, Harding, Hughes, Hyde, Jackson, Jones, Lawrence, Lyman, Meade, Mellette, Pennington, Perkins, Potter, Shannon, Stanley, Sully, Todd, Tripp, Walworth and Ziebach. The following counties in Wyoming: Crook, Niobrara, and Weston. The following counties in Nebraska: Box Butte, Brown, Cherry, Dawes, Grant, Morrill, Scott s Bluff, Sheridan, and Sioux. The following counties in North Dakota: Adams, Bowman, and Slope. SIOUX FALLS VA Medical Center: The following counties in South Dakota: Aurora, Beadle, Bon Homme, Brookings, Brown, Brule, Buffalo, Charles Mix, Clark, Clay, Codington, Day, Davison, Deuel, Douglas, Edmunds, Faulk, Grant, Hamlin, Hand, Hanson, Hutchinson, Jerauld, Kingsbury, Lake, Lincoln, Marshall, McCook, McPherson, Minnehaha, Miner, Moody, Sanborn, Spink, Turner, Union, and Yankton. The following counties in Iowa: Cherokee, Clay, Dickinson, Emmet, Ida, Lyon, O Brien, Osceola, Palo Alto, Plymouth, Sioux, and Woodbury. The following counties in Minnesota: Cottonwood, Jackson, Lac Qui Parle, Lincoln, Lyon, Martin, Murray, Nobles, Pipestone, and Rock. The following counties in Nebraska: Dakota and Dixon. ST. CLOUD VA Medical Center: The following counties in Minnesota: Aitkin, Benton, Big Stone, Cass, Chippewa, Crow Wing, Douglas, Grant, Isanti, Lac Qui Parle, Kanabec, Kandiyohi, McLeod, Meeker, Mille Lacs, Morrison, Pope, Redwood, Renville, Sherburne, Stearns, Stevens, Swift, Todd, Wadena, Wright, and Yellow Medicine. MINNEAPOLIS VA Medical Center: The following counties in Minnesota: Anoka, Blue Earth, Brown, Carlton, Carver, Chisago, Cook, Dodge, Dakota, Faribault, Fillmore, Freeborn, Goodhue, Hennepin, Itasca, Koochiching, Lake, Le Sueur, Mower, Nicollet, Olmsted, Pine, Pipe, Rice, Ramsey, Scott, Sibley, St. Louis, Steele, Wabasha, Waseca, Washington, and Watonwan. The following counties in Wisconsin: Ashland, Barron, Bayfield, Burnett, Chippewa, Douglas, Dunn, Eau Claire, Pepin, Pierce, Polk, Rusk, Sawyer, St. Croix, and Washburn. IOWA CITY VA Medical Center: The following counties in Iowa: Allamakee, Benton, Blackhawk, Bremer, Buchanan, Butler, Cedar, Chickasaw, Clayton, Clinton, Davis, Delaware, Des Moines, Dubuque, Fayette, Grundy, Henry, Howard, Iowa, Jackson, Jefferson, Johnson, Jones, Keokuk, Lee, Linn, Louisa, Muscatine, Poweshiek, Scott, Van Buren, Washington, Wapello, Winnieshiek. The following counties in Illinois: Adams, Brown, Carroll, Knox, Fulton, Hancock, Henderson, Henry, Jo Daviess, McDonough, Mercer, Rock Island, Schuyler, Stark, Warren, and Whiteside. The following county in Missouri: Clark. CENTRAL IOWA HEALTHCARE SYSTEM Des Moines and Knoxville: The following counties in Iowa: Adair, Appanoose, Boone, Buena Vista, Calhoun, Carroll, Cerro Gordo, Clarke, Dallas, Decatur, Floyd, Franklin, Greene, Guthrie, Hamilton, Hancock, Hardin, Humboldt, Jasper, Kossuth, Lucas, Madison, Marshall, Marion, Mahaska, Mitchell, Monroe, Pocahontas, Polk, Ringgold, Sac, Story, Tama, Union, Wapello, Warren, Wayne, Webster, Winnebago, Worth and Wright. The following counties in Missouri: Harrison and Mercer. NEBRASKA-WESTERN IOWA HEALTHCARE SYSTEM Omaha VA Medical Center, Lincoln & Grand Island Outpatient Clinic: The following counties in Nebraska: Adams, Antelope, Arthur, Blaine, Boone, Boyd, Buffalo, Burt, Butler, Cass, Cedar, Chase, Clay, Cuming, Custer, Dawson, Dodge, Douglas, Dundy, Fillmore, Franklin, Frontier, Furnas, Garfield, Grant Gage, Gosper, Greeley, Hall, Harlan, Hamilton, Hayes, Hitchcock, Holt, Hooker, Howard, Jefferson, Johnson, Keith, Keya Paha, Kearney, Knox, Lancaster, Lincoln, Logan, Loup , Madison, McPherson, Merrick, Nance, Nemaha, Nuckolls, Otoe, Pawnee, Perkins, Pierce, Phelps, Platte, Polk, Red Willow , Richardson, Rock, Saline, Sarpy, Saunders, Seward, Sherman, Sioux, Stanton, Thayer, Thomas, Thurston, Washington, Wayne, Webster, Wheeler, Valley, and York The following counties in Kansas: Jewell, Norton, Phillips, Osborne, Smith, and Washington. The following counties in Iowa: Adams, Audubon, Cass, Crawford, Fremont, Harrison, Ida, Mills, Monona, Montgomery, Page, Pottawattamie, Shelby, and Taylor. The following county in Missouri: Atchison. The VISN 23 service area includes portions of North Dakota, South Dakota, Minnesota, Wisconsin, Nebraska, Iowa, Illinois, Wyoming, Montana, and Kansas. All facilities under VISN 23 service area can be found at https://www.va.gov/directory/guide/region.asp?ID=23. B.3.10 Eligibility for Assistance An enrolled Veteran (i.e., Veteran who is in one of the priority groups 1-8 registered in the VA system) with a diagnosis that would meet the need for requested orthotic or prosthetic device. B.3.11 Special Education Requirements for Certain Orthotic/Prosthetic Devices The furnishing of the advanced devices or componentry shall be performed by the contractor under the supervision of an orthotist/prosthetist 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 and prosthetics. A grandfathering provision to the NCOPE requirement will be allowed if the prosthetist, orthotist, or pedorthist has met all educational requirements for ABC or BOC and remains in good standing. At a minimum, educational seminars specific to the fabrication and servicing of orthotic and/or pedorthic devices 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 Society for Prosthetists and Orthotists (ISPO), or a formal program which is specifically designed to train Orthotists or Prosthetists in the fabrication of these items is required. Examples of advanced Orthotic and Prosthetic componentry would include but are not limited to: (1) Spiral Ankle-Foot Orthosis/ Knee-Ankle-Foot Orthosis (AFO/KAFO) designs (2) Stance control knee joints (3) Reciprocating gait orthoses (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 (8) Functional electrical stimulators (FES) (9) Microprocessor knees (10) Microprocessor terminal devices (11) Osseointegration (12) Microprocessor feet B.3.12 Specific Requirements AGREEMENT SPECIFIC LANGUAGE Ordering Procedures for Blanket Purchase Agreements: Multiple fixed price awards will be awarded among the facilities listed in this Statement of Work. The Department of Veterans Affairs medical professional will create an order with a list of HCPCS codes that will be referred to PSAS for processing. During the period of this contract, ordering may be accomplished electronically through a batch delivery order process. If the order is less than $10,000.00, which is the Micro-purchase limit, a Prosthetics Purchasing Agent will place the order. If the order is greater than the Micro-purchase limit, the order will be referred to Contracting for processing. VA reserves the right to determine if services will be provided by the local VA O&P service vs. with a vendor based on each Veterans specific medical needs and other factors, included but not limited to wait times, quality, travel times, Veterans preference, specialization. Performance, Delivery, Inspection and Acceptance: The Contractor shall fabricate all devices in strict conformance to the VA prescription that has been provided by the VA. The VA will provide a list of approved L-codes for work to be provided by the contract vendor for the specific prescription. L-codes will be determined at time of clinic whenever possible, adjustments or repairs will be submitted for VA review prior to work being done. Only the VA determined and approved L-codes will be allowed for submission to Contracting officials or VA HCS Authorized Ordering Officer/Official for authorization of work to be performed. Contractors shall not add or substitute components or alter the beneficiary s device prescription in any way without prior approval and written authority from the VA Prosthetics Department. Modification of HCPCs or quantities will require additional review of the L-codes and approval by the contracting officials or VA HCS Authorized Ordering Officer/Official, and may require a new prescription. This agreement only includes commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized under this agreement. The Contractor upon receipt of the purchase order that authorizes work shall have two business days to contact the Veteran to arrange and schedule an appointment. Also, upon receipt of the purchase order, the contractor has 14 days to evaluate the Veteran and 60 days to deliver the items. This should be completed 95% of the time. If timelines are not going to be met, the local VA Prosthetics Chief requires notification. When trying to initially reach the Veteran, the Contractor shall document three attempts to contact the veteran. If the Veteran does not respond, the vendor will notify the Veteran by mail. If the Veteran does not respond to this initial contact by the Contractor, a copy of this letter will be provided to the VA, and the request will be cancelled and documented on the consult. If the Veteran has already been evaluated but is not responding to Contractors attempts (three documented phone calls, followed up with a letter) to deliver items to the Veteran, the items will be forwarded to the VA and the vendor will be paid for any custom fabricated items that cannot be returned, reused, or refunded. When contact is not made, the Contractor shall inform the appropriate VA PSAS department via telephone or encrypted email. If any custom items are paid by VA, the agreement vendor is required to provide proof of contact attempts prior to payment for custom fabricated items. The VA shall require the contractor to deliver items ordered under this agreement no later than 60 days after receipt of a purchase order. The contractor shall notify the local Prosthetics Chief representing the region where the prosthetists office is located and show cause in the event they are unable to deliver the required items in accordance with the Governments required delivery date. The contractor shall obtain a signature and date from the veteran at the time of delivery of the completed device on the contractor s company letter head. The delivery document shall be submitted by the contractor within 7 days after acceptance of the device. 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 the copy of the charge that is made for the orthoses/prosthetic device shall be mailed or emailed (via proper encryption) to the Prosthetics (purchasing agent) Representative. In the event the Government desires expedited delivery, the ordering VA Prosthetics Chief, or representative with delegated authority, 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 52.212-4(c). Contract Terms and Conditions--Commercial Items, and a bilateral modification executed that includes these negotiated costs. Failure by the contractor to deliver the ordered orthosis on an expedited basis as agreed upon in a bilateral modification, or otherwise fulfill the agreed upon requirements shall constitute an event of default, and the CO shall undertake any action authorized pursuant to the agreement, or otherwise in accordance with applicable statutes and regulations. Required Registrations: Contractor Performance Assessment Reporting System (CPARS): As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the simplified acquisition threshold (currently $250,000.00) and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor is provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is shared with the Past Performance Information Retrieval System (PPIRS) database and the federal Awardee Performance & Integrity Information System (FAPIIS) database, which is available to all Federal agencies. The contractor is required to register with the CPARS database at the following web address: http://www.cpars.gov. Past performance will be considered as part of a responsibility determination. An offeror s existing negative CPARS rating may affect their consideration for receiving an award. In addition, your registered representative data, as well as any other information in your registration data, shall be kept current. Performance evaluations entered into CPARS by the CO shall be assigned to contractor s registered representative for comment. Failure to comment and reassign the report back to the CO, or to maintain current registration, shall result in the Government s evaluation being entered in the database with a statement that contractor has failed to respond. The contractor shall be registered in the U.S. Federal Government s System for Award Management (SAM). The registration website can be found at http://www.sam.gov. After initial registration, the contractor shall update registration data as changes occur and shall reregister annually to ensure all data remains current. Noncompliance with this requirement shall preclude the exercising of any option periods that shall be included herein and shall be cause for termination of the agreement at such time noncompliance is discovered. Refer to cited clause for more details at FAR 52.201-13. FACILITY/STAFFING: Approved Facilities: All Contractor facilities as well as other fabrication facilities such as commercial central fabrication facilities that will be utilized for this Agreement shall be listed in the proposal. All work required under this agreement shall be conducted at the facility locations included in the agreement. The Contractor s facilities shall be accredited either by the Facility Accreditation Program of the ABC, BOC, or an agency that meets or exceeds these standards, 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 Agreement, the Contractor shall notify VA of any facilities that are added, changed, or closed to the CO and the COR within 30 calendar days of any change. Approval for added or changed facilities must be obtained before those facilities may be used for this Agreement. Accreditation/Certification Special Requirements In addition to having physical presence in at least one county of the serviceable area, the contractor shall provide proof of ABC, or BOC practitioner certification. Proof of current certification shall be made available to VA Contracting Officers on an as needed basis. The contractor shall develop and maintain records documenting competence/performance level of the Contractor employees who participate in this agreement are in accordance with ABC or BOC, for all clinical employees participating in the contract. This includes the following: 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; includes 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 in this agreement. The contractor shall assure that the clinician works within the scope of practice identified by ABC or BOC. The records shall be made available during VA site visits. Site visits shall include but not limited to Prosthetic Chiefs, Prosthetics Representatives, Certified VA clinical Staff and Contracting Officers. At the time of the agreement award, annually on the anniversary date of the agreement award, and within 30 days of any certified clinical staffing changes, the contractor shall provide to the Contracting Officer current copies of these records (ABC, BOC certification) for each Contractor employee working on the contract. The VA shall, if at any time discover non-certified, non-supervised, clinical staff providing O&P care to Veterans, request up to date certification. The Contractor shall be responsible to ensure that Contractor employees providing work on this agreement 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, the Contractor shall provide evidence of orientation, the current competence assessment, and current performance evaluation that supports the above within 30 calendar days. Professional Responsibility All contractor and subcontractor employees performing work under this agreement shall follow their respective accrediting bodies conduct codes; The Code of Professional Responsibility and Rules and Procedures from the American Board for Certification in Orthotics, Prosthetics and Pedorthics, Inc. (ABC) or the Board of Certification in Orthotics and Prosthetics (BOC) Code of Ethics. Days/Hours of Operation The Veterans Integrated Service Network 23/VISN 23 Medical Centers operate during normal business hours - Monday through Friday, 8:00am 4:30pm in their respective time zone. Contractors providing services under this BPA shall be required to be open a minimum of 8 hours per day and 40 hours per week between the hours of 7 AM and 6 PM Monday through Friday in the time zone they provide services, with the exception of VA observed federal Holidays. Holidays: New Year s Day 1 January Martin Luther King Jr. Day Third Monday January President s Day Third Monday February Memorial Day Last Monday May Juneteenth Day 19 June Independence Day 4 July Labor Day First Monday September Columbus Day Second Monday October Veteran s Day Day 11 November Thanksgiving Day Fourth Thursday November Christmas Day 25 December e. Infection Control Contractor shall provide its published policies and procedures for the use of universal precautions to minimize the risk of transmission of infection when caring for patients. f. HHS/OIG To ensure that the individuals providing services under the 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 shall check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website: http://oig.hhs.gov/ for each person providing services under this contract. During the performance of this agreement the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. These requirements are to ensure that individuals providing services under the contract have not engaged in fraud or abuse with regard to Sections 1128 and 1128A of the Social Security Act regarding federal health care programs. VA does not have the burden of defending the merits of the HHS/OIG decision established under §42 U.S.C. 1320a-7. g. Key Personnel and Temporary Emergency Substitutions Depending on the scope of the work being awarded by this contract, The Contractor shall assign to this agreement a certified Orthotist, Prosthetist, or Pedorthist as key personnel for this contract. All Orthotic, Prosthetic and Pedorthic facilities shall have an American Board Certified (ABC), or Board for Orthotist/Prosthetist Certification (BOC) Orthotist, ABC/BOC Certified Prosthetist, and/or ABC/BOC Certified Pedorthist on staff at each of their locations - with current and valid credentials that are in good standing, for the State in which he/she practices. During the first 90 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 15 days after the occurrence of any of these events and provide the information required by the next paragraph. After the initial 90-day period of the contract, the Contractor shall submit the information required by the next paragraph to the CO at least 15 days prior to making any permanent substitutions. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO shall notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. For temporary substitutions where the key person shall not be reporting to work for 3 consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks shall require the procedure stated above. h. Contract Personnel Should a Contract Personnel need to present to their local VA to see a Veteran or co-attend an appointment with the Veteran at their local VA, all contractor personnel are required to wear ID Badges during the entire time they are on the VA grounds. ID Badges shall have an identification picture and shall state in English the name of the individual and the company represented. All contractor personnel are required to check into the facility Police and Security Office at each visit to pick up a Contractor or Visitor badge prior to contacting the Prosthetics Representative/COR/designee. The contractor shall not employ persons to work on this agreement if such employee is identified to the contractor as a potential threat to the health, safety, security, general wellbeing or operational mission of the installation and its population. All contractor personnel shall observe the rules and regulations of the VA facility: Parking is permitted in areas designated as Visitor Parking Lots by the facility, or otherwise designated by the Police and Security Office staff. Quality Warranty The contractor warrants the provided device against defective material and/or workmanship for a minimum of 120 calendar days for orthotic devices and 90 days for prosthetic devices. Prosthetic device minimum warranty period shall commence after the final check out at the VA HCS by the VA Amputation Clinic Team and deliverable acceptance by the CO. Manufacturer s warranties of orthotic or artificial limb and limb device/components that extend beyond the minimum warranty 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 wearing of the artificial 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. The Contractor shall warrant and imply that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this BPA. The rights and remedies of the Government provided in this clause are in addition to, and do not limit any, rights afforded to the Government by any other clause of the BPA. Quality Assurance Surveillance Plan Contractor performance shall be monitored by the Quality Assurance Surveillance Plan (QASP). The QASP provides a systematic method to evaluate performance for the stated agreement. The QASP matrix details purpose, government roles and responsibilities, performance requirements standards, the acceptable quality level, the method of surveillance, ratings, documenting performance and frequency of measurement. The indicators are: Delivery time requirement Device compliant with VA physician prescription Workmanship free of defect (device fits/functions appropriately, limb correctly aligned) Patient education Patient acceptance of the device in all aspects (cosmetically and functionally) Inspection and Acceptance Payment shall be rendered for orthotic or prosthetic devices that satisfactorily meet all of the indicators: Delivery time requirement Devices compliant with VA physician prescription Workmanship free of defect (device fits appropriately, limb correctly aligned) Patient education Patient acceptance of the device in all aspects (cosmetically and functionally) Payment shall be delayed if one or more of the above indicators are not met. The Contractor shall correct all deficiencies of non-compliant prosthetic limb or service within fifteen (15) calendar days of written rejection notification from the COR. The corrected/adjusted device will be re-inspected for acceptance. No invoice shall be submitted until the Government accepts the item or service as requested. In addition to the above indicators, prosthetic limbs, sockets, or other specialized componentry, would require a formal checkout in VA amputee clinic. This can be either in-person or via tele-health, when appropriate. Final authorization for payment will be within the agreement and will coincide with final delivery and check out of the prosthetic limb to ensure accuracy of prescription and acceptance by Veteran. If a Veteran fails to attend amputee clinic for checkout, acceptance of the device by the VA will happen on a case-by-case basis. Repair or replacement of prosthetic limb components other than socket replacement does not generally require final check-out by the VA Amputation 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 delivery/task order. Veterans requesting adjustments to previously approved devices may be evaluated without VA orders, however no repair work can be completed without written authorization by appropriate VA approving officials. Fabrication Standards For Definitive Sockets (1) The establishment of consistent, repeatable manufacturing processes that provide a standardized framework for the design and fabrication of prosthetic sockets in accordance with International Standards Organization (ISO) 10328. (2) The identification of standards to quantify prosthetic socket performance requirements based on the individual Veteran s mobility level, size, and weight. (3) The demonstration and validation of prosthetic socket manufacturing techniques that reduce weight, reduce cost, and strengthen key load-bearing areas of the socket to reduce risk of socket failure and enhance the Veteran s mobility. (4) The creation of a personalized digital record of each socket, alignment, and associated fabrication settings. Microprocessor On-Board Unit Contractors who are qualified to furnish microprocessor on-board units and orthoses that require battery charging units are required to provide a "loaner" unit in the event that a veteran beneficiarys unit needs repair by the manufacturer. The VA does not reimburse for loaner units but will reimburse for reasonable amounts of labor associated to swapping and programming of units. The contractor shall submit a copy of the invoice from the manufacturer to support the cost of repairing the malfunctioning unit. Any salvage value granted by the manufacturer for a non-repairable unit shall be credited to VA against the cost of a replacement unit. In the event any manufacturer customarily provides a warranty period greater than one (1) year, the Contractors warranty shall be for the same duration Recalls Upon notification by a manufacturer of a recalled product, the Contractor shall, within 24 hours of when the Contractor became aware of the recalled components, notify all affected 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: A complete item description, identification, and model/serial number. Administrative identification data including agreement number, order numbers, and order date. Reasons for recall, removal, adjustment, or modification. Instructions for appropriate corrective action. If Contractor has exhausted all options via the manufacturer in order to have the recalled item replaced, and manufacturer is unwilling/unable to replace the device, VA may authorize replacement. Reimbursement may be negotiated by the VA and Contractor to either include reimbursement of the Contractors cost of the device, and labor to swap it out with the recalled item, or, in instances where replacement of the entire device is warranted and in the best interest of the Veteran (i.e., prior to recall, the device was beyond its useful life), complete reimbursement may occur. Salvage In the event that a veteran beneficiary passes away prior to delivery and acceptance of a device, VA shall pay the contractor for the work performed up to the point that they are notified to stop work. The amount paid shall be mutually agreed upon in writing and shall not exceed the agreement price of the device less the salvage value of the unused device/component(s) as determined by market practices. PROSTHETIC/ORTHOTIC REPAIRS, MAINTENANCE, AND CODING Repair and Replacement of Prosthetic/Orthotic Device; Minor Parts 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/orthosis required by wear or a change in the veteran s condition. If work is no longer under warranty, a new authorization from the VA is required for payment. A minor repair or replacement means repair or replacement that does not significantly alter the function or essential physical characteristics of an item or component, or change the purpose of an item or component. Factors that will be considered in determining whether a repair or replacement is minor include the value and size of the repair or replacement, and the comparative value and size of the final product. Dollar values and percentages may be used as guideposts, but are not conclusive evidence that a repair or replacement is minor. The following L-codes shall be used for repair and replacement of minor parts and for labor: L7510 Repair Prosthetic device, repair or replace minor parts prior approval is required L7520 Repair Prosthetic device, labor component, per 15 minutes (not to exceed 8 units or 120 minutes) prior approval is required. L4205 Repair of Orthotic device, labor component, per 15 minutes (not to exceed 8 units or 120 minutes) prior approval is required. L4210 Repair Orthotic device, repair or replace minor parts prior approval is required Other Than Minor Repair or Replacement of Minor Parts to Artificial Limb/Orthosis Repairs to an artificial limb or orthosis are covered when necessary to make the device functional. If the expense for repairs exceeds the estimated expense of purchasing another entire prosthetic limb, orthotic device or component, no payment can be made for the amount of the excess. Maintenance that may be necessitated by manufacturer s recommendations or construction of the artificial limb and must be performed by the Prosthetist is a covered as a repair. Replacement of an artificial limb, artificial limb component, or orthotic device requires prior approval and written authorization from the Contracting Officer or Prosthetics Representative within their purchasing authority. Replacement of an artificial limb, artificial limb device/component, or orthosis will be initiated by the VA provider (i.e., Amputation Clinic Team or VA physician) who is involved in Veteran s care, prescribes a prosthetics limb or device because of the following: 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. Damage to the artificial limb or device due to malicious damage, culpable neglect, wrongful disposition or use for purposes other than intended. Unlisted or Not Otherwise Classified / Specific (NOC) L Code The CMS HCPCS contains four NOC L codes for artificial limbs,L2999, L3999, L5999, and L7499. L2999 Lower Extremity orthosis, not otherwise specified. L3999 Upper Extremity orthosis, not otherwise specified. L5999 - Lower Extremity prosthesis, not otherwise specified. L7499 - Upper extremity prosthesis, not otherwise specified. The VA recognizes only these NOC codes for use with artificial limbs. Modification of NOC code language is not permissible. The NOC code is all inclusive and only one NOC L Code is authorized per product. The reimbursement for NOC items is not published in the annual HCPCS Fee Schedule. Reimbursement for NOC Items For an item or service that is not otherwise classified in the CMS HCPCS, and for which VA assigns any miscellaneous or Not Otherwise Classified (NOC) code, the contractor shall submit a quote.  Quotes must be received no later than two (2) business days after receipt of VA s request for quote. The Contracting Officer or Prosthetics and Sensory Aids Service (PSAS) Official will issue a fixed price order based on the quote, negotiated if necessary, or based on the government estimate if a quote is not received. The Contracting Officer or PSAS Official may request additional supporting documentation as needed. Routine Semi-Annual Service The Contractor shall provide semi-annual service to each veteran for whom the Contractor is managing prosthetic limb care. For the purposes of this 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 Contracting Officer for the required semi-annual service and receive written authorization prior to providing the semi-annual service to the veteran. The following L codes are applicable for Semi-Annual Service. L 7520 Repair prosthetic device, labor component, per 15 minutes (not to exceed 4 units or 60 minutes) prior approval is required. Routine Semi-Annual Service is covered under the initial physician s prescription for three years from the date of delivery of the artificial limb. All routine semi-annual service will require a new authorization from the VA for payment. Government Supplied Items VA may provide certain supplies such as shrinkers, liners, sleeves, and socks to the veteran at the discretion of the VA. Any items or supplies provided to the veteran by the Contractor shall be pre-authorized by the CO or VA PSAS staff if micro-purchase.

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