DRAFT Statement of Work shoes and inserts.docx

B.2 STATEMENT OF WORK

1.0. Background

The Department of Veterans Affairs (VA) provides orthopedic shoes, inserts, 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 orthopedic care and support to the veterans in need. It is VA’s intent to solicit proposals and award multiple Blanket Purchase Agreements (BPAs).

2.0. Scope

The Contractor shall provide all orthopedic shoes and inserts in strict conformance to the prosthetic prescription that has been provided by the prescribing practitioner. The VA will provide a list of approved Healthcare Common Procedures Coding System (HCPC) Codes for work to be provided by the Contractor for the specific prescription. The VA also prescribes boots and high-top shoes (such as hiking shoes) for diabetic patients that do not have HCPC’s codes assigned to them. All boots and shoes, to include high-top shoes, provided by the contractor must be Pricing, Data Analysis, and Coding (PDAC) approved when provided to diabetic patients. The Contractor shall not add or substitute components or alter the veteran’s prescription in any way without prior approval and written authorization from the Contracting Officer’s Representative (COR) or VAMC Point of Contact (POC) as appropriate. The 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.

3.0. Education and Training Requirements

3.1. General Education

The Contractor shall have a Podiatrist, Pedorthist, Certified Orthotist, Prosthetist on staff in “good standing” at each of the proposed service locations throughout the BPA period of performance. “Good standing” is defined being within compliance of VHA Directive 1173.9, VHA directive 1410, Medicare guidelines for Orthopedic/Therapeutic Footwear Articles A52481 and A52501, participating and achieving appropriate continuing education credits and paying dues as determined by Certifying Agency.

VA reserves the right to verify contractors and staff credentials anytime during the term of this BPA. 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 BPA termination in accordance with the contract clauses in the BPA.

4.0. Specific Requirements

4.1. Compliance with VA Prescription and Coding of Prosthetic Limb 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 the COR or VAMC POC. Any changes to the veteran’s prescription, components or codes require review and approval by the VA prescribing practitioner and shall be authorized in writing by the COR or VAMC POC.

5.0. Special Contract Requirements

5.1. 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 VA 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, 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, 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 BPA, 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 BPA 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 of this BPA or termination of the BPA, 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.

5.2. 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.

6.0. Performance, Delivery, Inspection and Acceptance

Contractors supplying orthopedic items must be Podiatrist, Pedorthist, Certified Orthotist, Prosthetist, orthotic fitters may fit the final product. Orthopedic prescription may be fulfilled by the prescribing practitioner. The certifying physician may only fulfill the prescription if the certifying physician is practicing in a defined rural area or a defined healthcare professional shortage area.

6.1. Performance and Delivery

6.1.1 Consultation

Contractor shall contact patient for scheduling attempts within seven (7) business days of receiving a Purchase Order. Patients will be scheduled for a consultation within twenty-eight (28) calendar days of receiving a Purchase Order (PO). In instances when the patient requests an appointment outside of twenty-eight (28) calendar days, the contractor must notify the PO point of contact within three (3) business days.

All measuring and fitting occur at the contractor’s facility; no work or issuance of prescribed products shall commence until contractor receives the purchase order defining the prescription. All measurements and impressions for the prescription required on the purchase order must be completed during initial consultation date and time. In instances that items need to be ordered to fulfill prescription requirements, the contractor must schedule an additional appointment for final fitting and patient acceptance of product.

The Contractor shall complete initial delivery of items ordered under this BPA no later than 45 calendar days after receipt of a purchase 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 confirm with written notification to the PO issuer within seven (7) calendar days of the receipt of a purchase 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.

6.1.2 Fittings

Contractor must schedule an additional appointment for final fitting and patient acceptance of product within five (5) business days of receiving ordered items. Product defects and other patient concerns must be addressed and rectified at the time of fitting.

Contractor must provide PO issuer with written proof of delivery with date and patient signature that items have been delivered and are accepted within seven (7) business days of finial delivery.

7.0. Ordering Procedures

Orders to fulfill orthopedic prescription, repairs and services will be placed through the use of purchase orders as described above and paid through the use of a Government Purchase Card (GPC). The contractor is responsible for any work performed, items delivered, or services rendered without the issuance of a purchase order or other written or verbal approval from a VA purchasing agents.

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. Veterans are allowed to select a non-VA provider from a list of VA approved contractors and this satisfies the requirement for fair opportunity. In some instances, a VA clinician determines that it is medically necessary to select a certain contractor as documented in clinical notes, which would also satisfy the fair opportunity requirement of FAR 16.505(b)(1). Exceptions to the fair opportunity process are:

· The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

· Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

· The order must be issued on a sole-source basis in the interest of economy and efficiency because it is logical follow-on to an order already issued under the BPA, provided that all awardees were given a fair opportunity to be considered for the original order.

· For orders exceeding the simplified acquisition threshold, a statue expressly authorizes or required that the purchase be made from a specified source.

· In accordance with section 1331 of Public Law 111-240 (15 USC 644(4)), contracting offers may, at their discretion, set aside orders for any of the small business concerns identified in 19.000(a)(3). When setting aside orders for small business concerns, the specific small business program eligibility requirements identified in part 19 apply.

8.0 Invoicing

The invoice shall contain:

· The veteran’s printed name and signature certifying acceptance, or separate certifying statement, of the Orthopedic product or service and the date of delivery.

· All HCPCS codes reflected in the billing.

· VA purchase order associated with the order.

· Discount pricing reflected per HCPCS (discount incorporated into pricing and reflected as charged per HCPCS).

· VA issued contract number.