Tissue Transplant Final.pdf

STATEMENT OF WORK (SOW)

1. Contracting Officer’s Representative (COR).

Name: Carole Amos Section: SIPS/NURSING SERVICES (118) Address: 3801 Miranda Ave., Palo Alto, CA 94304-1290 Phone Number: (650)493-5000 x 69924 Fax Number: (650) 858-3988 E-Mail Address: Carole.amos@va.gov

2. Contract Title.

Autologous Bone Tissue Storage and Interfacility Transfer Contract

3. Background.

The VA Palo Alto Health Care System (VAPAHCS) requires a safe and efficient process for the storing and transferring of autologous bone tissue. The contractor, an American Association of Tissue Banks (AATB) accredited tissue bank, will assist the facility in meeting, AATB. FDA, and VHA requirements related to autologous tissue.

Duties include, but are not limited to, the transport, and storage of autologous bone tissue.

The contractor will provide interfacility bone flap transfers, autologous tissue storage, and will deliver the tissue back to the facility upon request.

Objectives

Maintain safe and compliant storage and transfer of autologous tissue The providing of autologous tissue storage kits, transport, and storage of autologous bone tissue.

Provide interfacility bone flap transfers, autologous tissue storage, and will deliver the tissue back to the facility upon request.

The contractor maintains AATB certification and keeps current with regulatory compliance requirements related to autologous tissue.

4. Specific Tasks.

Contractor’s Terms and Scope of Services

4.1. TISSUE RECOVERY PROCEDURE

The contractor shall provide VAPAHCS with autologous tissue storage kits to use in the surgical recovery of autologous tissue by VAPAHCS. VAPAHCS shall be responsible for any contactor provided packaging and storage material and shall maintain said packaging and storage materials in accordance with contractor specifications.

VAPAHCS assumes liability for the adequacy of all other supplies and instruments used in its tissue recovery process.

Any contractor provided packing and storage materials that are lost, damaged, misused, or that are unable to be located by VAPAHCS will be replaced by the contractor as necessary, and the contractor shall be entitled to charge VAPAHCS for such replacement in accordance with the fee schedule.

VAPAHCS shall immediately notify the contractor by telephone of the readiness and availability of human autologous bone or skull flaps for shipment to the contractor.

VAPAHCS shall provide to the contractor all aseptically procured autologous tissue, bone or skull flaps in packaging and storage materials provided by the contractor to VAPAHCS, or other suitable packaging which complies with applicable federal, state, and local requirements for transportation of human autologous bone or skull flaps and/or blood specimens. Any packaging other than that supplied by the contractor must be approved by the contractor prior to its use by VAPAHCS.

VAPAHCS shall assure that its surgical staff reads, becomes familiar with, and will follow the instructions provided by the contractor. The instructions may be modified from time to time to comply with American Association of Tissue Banks standards, regulatory requirements, or to improve clarity of the instructions and the process of tissue recovery and packaging.

VAPAHCS shall include with each shipment of autologous bone or skull flap to the contractor, all requested documents, fully completed and signed. If only trauma names (aliases) are available at the time of recovery and packaging of the autograft, patient identification such as the true name and medical record number shall be provided to the contractor when the true identity of the patient becomes known by VAPAHCS.

Upon request by the contractor, VAPAHCS shall provide to the contractor complete copies of the results of bacteriological cultures and/or serological testing results performed by VAPAHCS on the autologous bone or skull flaps corresponding to each shipment of autologous bone or skull flap to the contractor. Such requests shall be limited to purposes of audit, quality assurance, or regulatory requirement.

VAPAHCS shall be solely responsible for obtaining an informed consent from the patient prior to the recovery of autologous tissue, or skull flap bone that is shipped to the contractor. It is agreed that the recovery of tissue from the patient by VAPAHCS shall be covered by VAPAHCS’s informed consent obtained and is applicable to the surgical procedure confirming there is no warranty as to the viability, suitability, or any other aspect of the patient’s tissue or skull flap bone if, and when re-implanted back in the patient. The tissue recovered by VAPAHCS shall be subject to the cautions and provisions included in, implied, and contemplated by VAPAHCS’s informed consent that is obtained and applicable to the surgical procedure.

4.2. SHIPPING

The contractor shall arrange for and pay for the cost of couriers, shipment, and carriage for donor autologous bone and skull flaps picked up by contractor or courier or otherwise transported from VAPAHCS to the contractor’s facility. The contractor shall facilitate the return shipping on all shipments which the contractor returns to VAPAHCS and charge VAPAHCS for said, shipping, and handling of the autologous bone and skull flaps in accordance with the fees set forth in the fee schedule.

The contractor shall inspect the outer packaging that autologous bone or skull flaps are received in from VAPAHCS and shall promptly notify VAPAHCS if it determines the outer packaging of any autologous bone or skull flap, or other tissue it receives from VAPAHCS has been breached or is in a condition that renders the autologous bone or skull flap, or other tissue compromised or not suitable for re-implantation. Any inspection of autologous bone or skull flaps or other tissue by the contractor shall be of the outer visible packaging only, and not of the bone or other tissue contained within. Therefore, nothing in the contractor’s inspection of the outer packaging that autologous bone or skull flaps and other tissue is received in from VAPAHCS shall be construed in any way to be a determination by the contractor of the usability, safety, suitability, determination of the presence or absence of any communicable disease, or a determination of the presence or absence of any serological or bacteriological testing of the tissue received.

4.3. RIGHT TO REFUSE

The contractor reserves the exclusive right to refuse acceptance of autologous bone, skull flaps, or other tissue it is sent by VAPAHCS, its physicians or staff without obligation or liability. The contractor may exercise this right to refuse acceptance for several reasons, including but not limited to:

a. Failure by VAPAHCS, its physicians and staff to timely and adequately notify the contractor that an autologous bone or skull flap or other autograft tissue has been recovered and is ready for pick-up by the contractor.

b. Failure by VAPAHCS, its physicians and staff to timely make the autograft tissue accessible and available to the contractor’s staff or authorized representatives at the VAPAHCS for pick-up and retrieval for shipment to the contractor.

c. Failure by VAPAHCS, its physicians and staff to utilize contractor provided packaging and storage materials. Deviation from using these materials must be done in a manner that is safe and suitable and will not cause the possibility of personnel exposure to any communicable disease. Deviations from normal packaging materials and/or procedures must be done in conjunction with timely notice to the contractor of a deviation and the nature of the deviation.

d. Failure by VAPAHCS to fully complete the contactor requested preservation forms or to obtain the surgeon’s or other authorized signature at the bottom of the form.

e. Failure by VAPAHCS, its physicians and staff to follow the contractor’s instructions as provided and/or updated as to the correct packaging and shipment of autologous bone or skull flaps or other autograft tissue.

f. Improper and/or unsafe packaging of autologous bone or skull flaps or other autograft tissue by VAPAHCS, its physicians and staff. Improper or unauthorized use of solutions, media, or other materials in the preparation or packaging of the autograft tissue. Infection of the tissue with a known biological agent that would render it unsafe or dangerous despite using normally accepted procedures for handling donor tissue and Universal Precautions as published by the CDC.

g. Failure by VAPAHCS to include the prescribed quantity of solidly frozen ice, or other suitable cold packs to the box containing the tissue for shipment to the contractor, or in an adequate quantity, prior to making packaging or storage materials available for pick-up by the contractor or its authorized representative.

4.4. LICENSURE/FEDERAL REGISTRATION

The contractor hereby represents and warrants that it will comply with all standards of procedure and operation required by the American Association of Tissue Banks and all applicable Federal (21 CFR 1271) and State of California laws and regulations throughout the term of this Agreement. These warranties are the contractor's only warranties and they are exclusive an in lieu of all other warranties whether oral or written. The contractor will maintain licensure by the California Department of Public Health Laboratory Field Services as a Tissue Bank and registered with the United States Food and Drug Administration (FDA) for the storage and distribution of human tissue.

4.5. COMPLIANCE WITH STANDARDS

VAPAHCS hereby represents and warrants to the contractor that VAPAHCS will comply with all standards for procedure and operation required of it by The Joint Commission, whether or not VAPAHCS is accredited by The Joint Commission. VAPAHCS will also comply will all applicable Federal (21 CFR 1271), State, and local laws and regulations throughout the term of this Agreement.

4.6. INSTRUCTION MODIFICATION

If VAPAHCS modifies any documents that the contractor has previously approved for VAPAHCS's use in the autologous bone or skull flap recovery process, VAPAHCS shall provide copies of such documents to the contractor for review, and the contractor must first approve all such modifications prior to their use by VAPAHCS. The contractor shall also have the right to require VAPAHCS to use updated the contractor forms and placards whenever they are provided to VAPAHCS or otherwise made available by the contractor.

4.7. STATUS OF PATIENT

VAPAHCS, its physicians, and agents shall timely notify the contractor of the death of patients VAPAHCS is aware they have provided autologous bone or skull flap to the contractor, and are still banked with the contractor’s autograft storage program. VAPAHCS shall notify the contractor of any change of contact information it knows of for the treating physician for patients that have autologous bone or skull flap on deposit with the contractor.

The contractor shall periodically send a form to VAPAHCS regarding the disposal or continued storage of autologous bone or skull flap. VAPAHCS shall complete the form and return them to the contractor thereby instructing the contractor on the continued storage or destruction of the autologous bone or skull flap stored. Failure to return these patient status forms with best known information within sixty (60) days of receipt of the forms shall result in charges for continued storage as set forth in the terms of the agreement.

4.8. DESTRUCTION

If, after two (2) years from the date of autologous bone or skull flap recovery and shipment of the autologous bone or skull flap to the contractor for storage, the contractor can no longer contact the patient, identify the patient’s legal guardian, and cannot reasonably ascertain the patient’s treating physician or a medical professional legally authorized to advocate on behalf of the patient, the contractor shall send a certified letter with return receipt to the address where the patient was last known to reside stating this fact and the intention of the contractor to dispose of the autologous bone or skull flap being stored. The contractor shall dispose of the autologous bone or skull flap as biomedical waste under one of more of the following conditions:

1) In the event the patient is deceased and/or the contractor has reliably confirmed from public records, or from VAPAHCS, the death of a patient for whom skull flap(s) or autologous tissue has been stored at the contractor’s facility; or

2) Thirty (30) days has passed after the receipt of the notice to the patient/the patient’s legal guardian to contact the contractor regarding continuing autologous bone or skull flap storage arrangements; or

3) Thirty (30) days has passed after return of the letter as undeliverable by the US Postal Service and the contractor has made reasonable attempts to locate the patient; or

4) Passage of time beyond the five (5) year expiration date assigned to the autograft tissue by the contractor, in the absence of written overriding instruction from VAPAHCS or patient’s treating physician; or

5) Nonpayment to the contractor after invoicing for additional storage periods after the initial two-year period for storage of autologous tissue or bone has elapsed by VAPAHCS or Patient, the patient’s legal guardian, or patient’s current healthcare provider to, or in the alternative the absence of instruction to the contractor to arrange to forward the tissue or bone onward to another suitable licensed tissue bank for continued storage; or

6) The contractor has first obtained from VAPAHCS or the patient’s treating physician, the patient, or the patient’s legally authorized representative a signed request for destruction and disposal, a signed authorization for the destruction and disposal of the tissue, or in the event the contractor obtains verifiable proof of the death of the patient or upon expiration of the tissue.

The contractor shall only destroy or dispose of any tissue sent to it by VAPAHCS and that has been accepted by the contractor for storage, by safe and legal means, and such destruction and disposal shall be performed in compliance with all applicable regulatory requirements. VAPAHCS, its physicians and agents shall not unreasonably withhold authorization for the destruction and disposal of any autologous bone or skull flap or autograft tissue stored by the contractor.

If the contractor is unable to obtain a signed authorization for the destruction and disposal of any tissue sent to it by VAPAHCS, its physicians or staff, and the contractor is unable to independently and reliably ascertain the death of the patient it belongs to, the contractor shall have the right to charge and invoice VAPAHCS for the continued storage of such tissue on an annual basis prepaid until such time that the contractor has reasonably determined that it can legally destroy and dispose of the tissue.

4.9. SERVICES PROVIDED BY CONTRACTOR

It is agreed by and between the parties that the contractor is providing autograft storage services to VAPAHCS as outlined in this Agreement. The services under this agreement are being rendered by the contractor as an IRS qualified 501(c)3 public charity. It is agreed between the parties that the contractor is not, and it shall not be construed in any way that the contractor is in control, supervision, or direction of patient care. The decision to recover any autograft tissue, or to re-implant it in a patient, rests with VAPAHCS and the surgical surroundings, surgical procedures, general medical arts and care provided by VAPAHCS to its patients is outside the services provided by contractor. The contractor is not in control of or responsible for the outcome of any surgical procedure performed by VAPAHCS related to this Agreement. The VAPAHCS understands and agrees that the VAPAHCS controls, and is solely responsible for, the autograft tissue while in the VAPAHCS’s possession. VAPAHCS is responsible for the tissue recovery from the patient, processing, storage, labeling and packaging for shipment and of the tissue to the contractor. VAPAHCS is also responsible for the receipt of the tissue that is returned to it from the contractor’s facility including pre-implant storage, processing, and the implant of the tissue into the patient. The contractor does not warrant the success or failure of any medical procedure.

The VAPAHCS and the contractor agree that the contractor controls and is responsible for the handling of the autograft tissue as provided by the VAPAHCS once received and accepted by the contractor at the contractor facility. The contractor shall only be in control of labeling and processing, if any, that is performed by it, and for storage, distribution, or destruction of the autograft tissue only while the tissue is in the contractor’s custody at its facility.

Furthermore, it is agreed by VAPAHCS and the contractor that at no time shall it be construed by and between the parties that the contractor is providing anything but a service, and that nothing under this Agreement shall be deemed the sale or dispensing of a product, or any act or activity that is subject to the Uniform Commercial Code.

4.10. TRANSPORTATION DELAY AND LOSS OF TISSUE DURING TRANSPORT

The VAPAHCS and the contractor agree that the contractor is responsible for paying for and arranging transportation and shipping of the autograft tissue between VAPAHCS and the contractor’s facility. Because the contractor makes use of couriers, common carrier airlines, and possibly other types of transportation that the contractor is not in direct control of, it is agreed between the parties that the contractor is not responsible for delays, rerouting, or any potential damage to or loss of tissue during transportation between VAPAHCS and the contractor’s facility that is caused by couriers or common carriers. For clarity, the contractor is not responsible for damages, economic loss, bodily harm, or even loss of life that is the result of damage caused to the tissue during transport, or for its loss caused by circumstance or event that may render the tissue unusable or unsuitable for acceptance by the contractor when received at its facility, or after return shipment to VAPAHCS for surgical re-implantation caused during transportation.

The contractor shall use its commercially reasonable efforts to track and mitigate any and delay to help ensure the safe and timely shipment of tissue between VAPAHCS and the contractor’s facility.

4.11. FORCE MAJEURE

Performance under this Agreement, or any part thereof, may be excused or delayed, and neither party shall be held in breach of any of its obligations under this Agreement or be liable for damages or offset resulting from such delay if such delay is due to causes beyond the reasonable control of either party such as, but not limited to, acts of God, acts of civil or military authority, terrorism, fires, floods, failure of electrical services or other public utilities, labor troubles, cancellation, delay, weather, or unavailability of essential components, dry ice, equipment, materials, transportation, epidemics, war, or riot.

4.12. COMMENT OR COMPLAINT NOTIFICATION

The contractor and VAPAHCS shall immediately notify the other party upon receipt of any adverse serological or bacteriological test results and/or any adverse reactions, or deviations from procedure either during the autograft tissue recovery or resulting from any use of human autologous bone or skull flap under this Agreement that becomes known to either party. In the event of an adverse reaction, VAPAHCS will immediately notify the contractor for determination of suitability of FDA adverse reaction notification that may be required by 21 CFR 1271.

4.13. RETURN OF TISSUE

The contractor shall promptly return autologous bone and skull flaps, or other autograft tissue after it has received verbal telephonic instructions from an authorized representative of VAPAHCS and is in receipt of a valid purchase order number issued by VAPAHCS for the return handling and shipping fees relating to the tissue stored. The contractor shall have the right to have any order for the return of autograft tissue to VAPAHCS concurrently followed-up with the order in writing via email or fax to the contractor’s offices. All orders for return of autograft tissue shall be made with reasonable advance notice sufficient to allow the contractor to safely transport the tissue to VAPAHCS, or other designated location without extraordinary means or jeopardizing the safety of personnel or the autograft. Notice for the return of tissue shall be given to the contractor by VAPAHCS as soon as possible, but not later than 24 hours in advance prior to the time the tissue must arrive at the receiving location prior to the scheduled surgery. It is agreed by VAPAHCS that tissue requested for return shall be sent for specific scheduled surgery dates and shall not be ordered for continued day to day storage at VAPAHCS or returned for arrival at VAPAHCS greater than 24 hours prior to the scheduled dates of re-implant of the tissue unless special arrangements have been made in advance with the contractor specific to a particular order.

If return of an autograft tissue cannot be accomplished by the contractor to meet a day and time as specified by VAPAHCS because of the unavailability of flights or couriers, the contractor shall have the right to notify VAPAHCS of the situation, and VAPAHCS shall schedule or reschedule surgery times according to its requirements and available transportation schedules. However, the contractor shall use its best commercially reasonable efforts to meet the scheduling requirements of the VAPAHCS.

The contractor shall return autograft tissue pursuant to receiving proper legal demand from authorized parties (patient or legal next of kin), government agencies (Office of the Chief Medical Examiner), or funeral director to appropriate and suitable locations. The VAPAHCS agrees to reimburse the contractor in accordance with the fee schedule.

4.14. TRAINING

It is the objective of the contractor for the autologous tissue storage service to run smoothly, without incident or error, and for the benefit of VAPAHCS and the patient. Toward achieving this goal, the contractor makes available periodic in-service training for VAPAHCS’s surgical staff. VAPAHCS shall make available appropriate operating room staff for reasonable periodic in-service training at times convenient to both VAPAHCS and the contractor. There shall be no additional charge to VAPAHCS or staff for periodic in-service training.

4.15. OWNERSHIP OF SUPPLIES

Any autologous tissue storage kits and written materials provided to VAPAHCS by the contractor, always remain the property of contractor and if lost VAPAHCS shall be charged for replacement cost.

4.16. TERMINATION OF AGREEMENT BY VAPAHCS

If for any reason this agreement is cancelled or terminated by VAPAHCS, any charges incurred for the return or disposal of actively stored autologous tissue any contractor will be in accordance with fees set forth in this agreement and contractor services shall no longer remain in effect.

4.17. MISCELLANEOUS

a. The services provided herein are exempt from HIPPA authorization requirements under HHS Regulations: Uses and Disclosures for Organ, Eye or Tissue Donation Purposes - § 164.512(h).

b. In the event this agreement expires and VAPAHCS continues to send or receive new autologous tissue for storage to the contractor that storage falls under the same terms of the most recent agreement in that was force.

5.1 Task 1 - Enterprise Management Controls.

Tissue Delivery Deliverables:

The contractor is responsible for performance of ALL terms and conditions of the contract.

The Government performs surveillance to determine the level of Contractor performance to these standards.

The Performance Requirements are listed in Section 6 of the Quality Assurance Surveillance Plan (QASP).

6. Performance Monitoring

If there are performance problems with the service, it will be reported to Facility Tissue Management Coordinator and the Contracting Officer’s Representative (COR) to assist. The COR will monitor the execution and contract performance to meet contractual agreement and approve invoices for payment of this contract.

7. Security Requirements

The autologous tissue storage kits will be located in assigned units/wards and will be included in the packaging supplies EIL reviews as assigned by Logistics.

7.1 Security Considerations

Vendor contractors requiring access to VAPAHCS facilities will obtain an active VA identification in accordance with VAPAHCS policies.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

N/A

9. Other Pertinent Information or Special Considerations.

The contractor will enter a contract with VAPAHCS and is the storer of the Autologous tissue. I believe this is the best price for the service and they are equipped to honor the warranty to the satisfaction of the government needs.

a. Identification of Possible Follow-on Work.

Warranty. NOT WITHSTANDING ANY PROVISION IN THIS AGREEMENT, contractor MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A

PARTICULAR USE OF ANY PRODUCT OR SERVICE IT PROVIDES, EXPRESSED

OR IMPLIED, IN THIS DOCUMENT. THERE ARE NO WARRANTIES PROVIDED.

b. Identification of Potential Conflicts of Interest (COI).

There are no anticipated conflicts of interest.

c. Identification of Non-Disclosure Requirements.

N/A

d. Packaging, Packing and Shipping Instructions.

Autologous tissue storage kits shall be provided by contractor and shipping will be done by contractor. Goods will be shipped to: VA Palo Alto Health Care Systems (VAPAHCS); 3801 Miranda Avenue, Palo Alto, CA 94304.

e. Inspection and Acceptance Criteria.

The COR will provide inspection to product to issue to units. The COR will verify package integrity was met by communicating with Facility Tissue Management Coordinator directly or by email. (Kits will be direct delivered to the OR. They will be stored in the P&P room. Inspection of kits will be done by trained OR staff or Tissue Management Coordinator.

10. Risk Control.

N/A

11. Place of Performance. VA Palo Alto Health Care Systems (VAPAHCS)

12. Period of Performance.

Performance period is one year from the day of award. The contractor shall provide deliveries and maintenance under this contract during normal VA working hours (8:00 a.m. – 4:30 p.m.), Monday through Friday unless otherwise approved by the Contracting Officer.

Base Year (The contractor, Inc. first Year) – One year from Award date

Option Year 1 (2nd year fees) – (2nd year fees) – One year from award date

Option Year 2 (3rd year fees) ‐ One year from award date

Option Year 3 (4th year fees) ‐ One year from award date

Option Year 4 (5th year fees) ‐ One year from award date

.13. Performance Deliverables Status Report.

SOW

Task# Deliverable Title Format Number

Calendar Days after contract award date

1 Monthly Status Report Contractor-Determined Format Email to Contracting

Officer Representative

(COR)

Monthly, on 5th Workday

14. Invoice / Payment: The contractor shall submit the invoice after each autologous tissue is submitted to contractor for storage to the POC/COR prior to submitting it to OB10 for verification. OB10 shall forward contractor’s invoice directly to DFAS Austin (also known as the Finance Service Center) for payment. All invoices shall include the Contract number, Purchase Order number, Order Date, date of service, and Description of Services. The invoices shall provide significant detail to enable reconciliation.

15. OB10 electronic registration. VA entered a relationship with OB10, a global provider of electronic invoicing. With OB10, all Contractors will be able to securely submit invoices directly from their existing billing systems. Contractors can easily submit invoices electronically through OB10.

By submitting invoices electronically through OB10, the contractor will experience prompt payment with reduced exceptions. Your participation is required to continue providing product or services to the VA in compliance with the Improper Payments Elimination and Recovery Act of 2010 (IPERA) and Mandate AN97. The rule mandating electronic invoice submission was published on Nov. 27, 2012, and has an effective date of Dec 27, 2012. “Mandate” AN97 can be located on the Federal Registry at the link provided: https://federalregister.gov/a/2012-28612 .

16.1 “How-to register with OB10” instructions will be provided to the vendor if needed.

16.2 Vendor e-Invoice Set-Up Information: Contact OB10 at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or OB10, contact the FSC at the phone number or email address listed below:

OB10 e-Invoice Setup Information: 1-877-489-6135 OB10 e-Invoice email: VA.Registration@ob10.com FSC e-Invoice Contact Information: 1-877-353-9791 FSC e-invoice email: vafsccshd@va.gov