Q515--Blood Products

SOURCES SOUGHT

This is a Sources Sought Synopsis (SSS) ONLY. The U.S. Government is conducting market research only to determine the availability of certified/qualified sources capable of providing blood products and testing services. Potential Contractors are invited to provide a response via e-mail to Contract Specialist at ross.byrne@va.gov by Dec 16, 2021 12:00 pm (PT). Responses will be used to determine the appropriate strategy for a potential acquisition. Please clearly identify any information your company considers sensitive or proprietary. This notice is issued solely for information and planning purposes - it does not constitute a Request for Quotation (RFQ), or a promise to issue an RFQ in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, or proposals at this time and will not accept unsolicited quotes in response to this sources sought synopsis. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Not responding to this notice does not preclude participation in any future RFQ, if any is issued.

BACKGROUND: The VA Portland Sound Healthcare System, Portland, Oregon, has a requirement for a Contractor to provide blood products and testing services. Please see draft Statement of Work for requirements.

NAICS: 621991 (Blood and Organ Banks)

Interested potential Contractors please provide the following.

1) Company Name, address, point of contact, phone number, email address, and DUNS

Please indicate business size:

Small Disadvantage Business (SDB)____

8(a)____

Historically Underutilized Business Zone (HUBZone)____

Service-Disabled Veteran-Owned Small Business (SDVOSB)____

Veteran-Owned Small Business (VOSB)_____

Economically Disadvantaged Women-Owned Small Business (EDWOSB)_____

Women-Owned Small Business concerns (WOSB)_____

Small Business_____

Large Business_____

Federal Supply Schedule______

2) Please submit a brief capability statement (maximum three (3) pages) with enough information to demonstrate to the Veterans Affairs that you have the resources, personnel, and qualifications as required in the Draft Statement of Work to provide the required blood products and testing services.

**Draft Statement of Work

Background:

This contract is needed so that the Portland VA Healthcare System (VAPORHCS) laboratory transfusion service (Blood Bank) can supply blood and blood products as required throughout the hospital.

Scope:

Supply blood and blood products to VAPORHCS on a Routine, ASAP and STAT basis. Approximately 2400 unit s leukocytes reduced RBCs 700 units Frozen Plasma, and other blood products.

Specific Tasks:

Contractor shall provide healthcare resources as stated herein and in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide the following blood and blood components in support of the Portland VA Healthcare System in Portland Oregon.

1. Blood shall be typed for ABO and Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and Technical Manual of the American Association of Blood Banks (AABB).

A sample of blood from each donation shall be tested for Syphilis. Whole blood and/or components shall not be used for transfusion unless the test is nonreactive. In addition, only blood testing negative for antibody to human to human immunodeficiency virus (HIV), for hepatitis B surface antigen (HBsAg) and for anti-hepatitis B core antigen (Anti-HBc) shall be used for transfusion. Blood and components shall not be used for transfusion if the results are outside established limits.

All blood shall be collected by the closed system under aseptic conditions and shall be processed in appropriate solutions and the container so labeled. The label shall also bear the expiration date of the contents, which shall not exceed 21 days from date of collection of source blood or 35 days from date of collection of source blood, when collected and stored with anti-coagulant citrate phosphate, dextrose adenine solution (CPDA-1). AS-1 Red Cells (Adsol anti-coagulant) has 42 days from date of collection.

All blood supplied will be grossly free of hemolysis, excessive chyle and clots.

2. Contractor shall be currently registered and licensed with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260 and certified by the American Association of Blood Banks.

3. Contractor shall submit proof that they hold an unrevoked U.S. License which is issued by the Director, Bureau of Biologics, FDA under section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood.

4. All products, if interstate shipment of blood or blood component is involved, Contractor must submit a statement that such approval has been authorized under section 251 of the Public Health Service Act, as amended, 42 USC Section 262. All products delivered shall be FDA licensed.

5. The Contractor certifies that they shall comply with the requirements outlined below with respect to donors, containers, delivery, etc.

6. Contractor shall submit copies of their annual license and certifications each year, or upon request from the government.

7. Contractor shall submit proof of AABB accreditation and CLIA certification upon request of the government.

Donor Requirements:

Donor selection must be in accordance with criteria established by the FDA and the AABB.

The Contractor shall maintain blood donor lists including names, previous name, date of birth, addresses and phone numbers.

Contractor s donor identification numbers must be unique to the donor unit and must have a FDA approved numbering schematic.

The Contractor shall only provide the VA with 100% "volunteer donor" blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off work, membership in blood assurance programs and cancellation on non-repayment fees that are not readily convertible to cash, do not constitute monetary payment.

Blood Products:

1. Whole blood, red blood cells and components shall be supplied in standard FDA licensed collection containers or brand name or equal, with appropriate samples for laboratory work.

2. Contractor, prior to delivery, shall complete the following tests:

ABO Grouping

RHo(D) Testing

Serology (S.T.S.)

Irregular Red Blood Cell Antibody Detection

Hepatitis B Surface Antigen (HBV-sAg)

HIV I/II Antibody Screening

Hepatitis C Virus (HCV) Antibody, and Antigen.

Hepatitis B Core Antibody (HbcAb) Screening

HTLV 1/1I Antibody Screening

HIV-1 RNA by nucleic acid amplification

HCV RNA by nucleic acid amplification

HBV DNA by nucleic acid amplification

West Nile Virus RNA by nucleic acid amplification

HBV DNA by nucleic acid amplification

Trypanosoma cruzi antibodies

NAT Test for the Zika Virus.

New tests may be mandated during the period of performance of this contract by the Office of Biologics, a division of the Food and Drug Administration. A modification to the contract will be completed before the Contractor performs any new blood testing that is mandated.

3. Blood Shall be furnished labeled as ABO Group and Rh type.

4. Other than in the case of an emergency, the above work shall be completed on all blood and its components prior to shipment. In emergent situations, some blood may be sent before testing is complete. In the event of an emergent situation, products may be released with a statement of justifications for request of incompletely tested blood components.

5. Immediately after bleeding, the blood shall be stored refrigerated between 1 and 6 degrees with fluctuation of no more than 2 degrees Celsius within this range. Freezing shall be always avoided. If public transportation of the blood is necessary, it shall be transported in clean shipping containers provided with refrigeration sufficient to hold the blood at 1-10 degrees Celsius if it has been precooled. If the blood has not been cooled, the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10 degrees Celsius, preferably 1-6 degrees while in transit.

6. All blood and blood components shall be prepared, stored and transported in compliance with the current American Association of Blood Bank standards, and Federal Drug Administration regulations, including appropriate labeling for directed and autologous donations and irradiated products.

7. Routine blood orders shall be delivered as specified within twenty-four (24) hours following request. Requests may be made seven (7) days a week, 365 days a year.

As Soon As Possible (ASAP) blood orders shall be delivered within four (4) hours following request.

(STAT) and Emergency orders are to be delivered to VAPORHCS within one hour from request and the Contractor shall be responsible for the cost of delivery to include use of cabs for delivery. For Emergency orders requiring delivery of incompletely tested blood components, a copy of the "Statement of justification for request of incompletely tested blood components" completed and signed by an authorized physician, shall be returned to the contractor.

Contractor needs to be located within the Metropolitan Area of Portland, empty shipping containers, being returned for credit shall be returned at contractor's expense. Contractor shall make delivery services for blood and blood components available to VAPORHCS 24 hours per day, seven days a week, 365 days a year, subject to blood product availability and a lack of force majeure events as set forth in 48CFR52.212-4(f).

8. Contract shall in the event there is an issue with antibodies and/or compatibility of the blood type requested, or if the product requires washing, volume reduction, additive removal, splitting or other manufacturing processes, the delivery time may be longer than 1 hour. The Contractor shall notify VA immediately in the event the requirement will not be delivered within 1 hour. It is the responsibility of the contractor to arrange for pickup of specimens and delivery of blood products in an emergency. Contractor is responsible for transportation; VA is responsible for transportation costs (see fee schedule).

Autologous blood shall be fully tested before being sent out by contractor. Autologous Blood shall be delivered to the hospital blood bank designated by the patient s physician within five (5) working days of collection.

All ordering on an as needed basis and be compatibility tested as necessary prior to delivery. Orders may be verbal or written; however, a written record of verbal orders shall be made as soon as practical. Ordering should be based on maintaining inventory targets created and maintained by the VA. Routine orders should be placed using vendor s online ordering system only, prior to the order cut-off time for daily routine delivery. STAT/Emergency needs should be placed in a manner directed by the vendor (phone call or on-line). Two routine deliveries per day is provided at no cost. In most cases, VA Portland HCS inventory targets should ensure they have adequate blood on the shelf with normal usage for a 24 hour period. STAT needs should not be a routine occurrence; however, if it becomes regular, vendor and VA will meet to discuss inventory management and delivery times.

Blood shall be furnished for liver transplant surgeries with at least three (3) weeks shelf life remaining before expiration date. This time limit may be slightly adjusted with concurrence of the VAPORHCS to accommodate blood shortages. The supplier must be able to support an order of 20 LRPC, 30 FP, 2 PPH and 2 Cryo on a stat order basis. Able to handle ASAP orders of Antigen negative LRPC totaling 20 units for liver transplants with antibodies.

The Contractor shall modify products as requested and as necessary for the protection of the patient, to include, but not limited to leukocyte reduction, washed, and irradiation.

The Contactor shall maintain a quantity and/or type specific or type compatible products to include but not limited to the following products in-order to meet the needs of the VA Medical Center:

Red Blood Cells all 8 groups

Fresh Frozen Plasma (FFP) to include all groups, but not limited to group AB

Cryoprecipitate to include all groups, but not limited to group AB

Apheresis platelets all 4 ABO groups

Credits accrued and used each month will be forwarded on a monthly statement to the Laboratory .

If the Contractor is unable to recruit enough donors to meet the community needs and the needs of this Medical Center, it shall be the Contractor's responsibility to import blood products in order to meet the Medical Center's requirements at no additional costs.

The VA Medical Center will not be required to provide confidential patient information unrelated to patient care unless it relates to the transfusion. All confidential patient information must be requested through the "Release of Information" office.

The VA recognizes there are a limited amount of resources of blood components in the region and will attempt to reduce outdating. The oldest blood components are to be used first when clinically feasible.

Units of blood and platelet pheresis products will be received by the VA on a non-consignment basis. However, for inventory control purposes, efforts will be made by the VA to assist the contractor and other facilities in meeting patient transfusion needs.

VA will return Red Blood Cells that were crossed matched by Contractor as soon as possible after the blood is no longer needed by the intended recipient.

When the VA returns units prior to expiration in accordance with the Contractors return policy, the Contractor shall credit the VA for units which are returned as detailed in the Price Schedule.

The estimated quantities are not a guarantee of actual quantities, as the Government does not guarantee any particular volume of traffic described in this contract and in accordance with the terms of this contract, orders for these services will be place with the contractor.

VA will, upon request, provide vendor an inventory of blood on hand.

The VA understands that no credit will be given for the following, unless transfer or return is preauthorized or requested by vendor.

Deglycerolized Red Cells

Washed Red Cells

Autologous Blood Products

Pediatric Units

Additive removed Red Cells

Leukocytes

Fresh Frozen plasma/cryoprecipitate has a shelf life of 1 year and is not returnable due to its tendency to break during transport. VA is responsible for managing frozen product inventory to avoid product outdating.

Special processing fees such as for irradiation of blood products.

Apheresis Platelets returned with less than 24 hours remaining to outdate.

Pathogen Reduced Platelets.

Leukoreduced Red Blood Cell units returned with less than 7 days to outdate.

Group O red cells regardless of dating.

Ability to support/facilitate Plasma Exchanges by contractor if needed

Courier System in Place for all blood deliveries.

Ability to share inventory for STAT requests with facilities located near us.

Continuing Education online program.

Frequent meetings with other customers such as a re-occurring committee.

Reference Lab with the ability to do complex antibody workups, HLA testing and molecular genotyping.

Ability to provide antigen negative units for STAT order (delivered within 1 hour).

Physician consults available.

Ability to support critical services that require platelet products in a quicker turn-around-time than STAT delivery can provide by committing to have a platelet product on our shelf at all times (24/7)

Quality Control:

Contractor is required to implement and report on quality control monitors, which will review and monitor the quality and timeliness of the services provided under this contract as agreed upon by both parties. The Contractor shall submit a report quarterly to the Contracting Officer s Point of Contact (POC) for review regarding the control monitors. These reports are due: April 1 (for Jan/Feb/Mar), July 1 (Apr/May/Jun), October 1 (Jul/Aug/Sep), and January 1 (Oct/Nov/Dec).

The Contractor, throughout the life of this contract, shall meet or exceed the standards of FDA and AABB concerning the recall of blood products and shall participate in look back procedures initiated by the VA Medical Center, so as not to impede the ability of the Medical Center to identify if a patient has contracted a transfusion associated disease as a result of a transfusion. If at any time the contractor fails to maintain FDA licensure and/or AABB or CAP accreditation, the government reserves the right to terminate this contract for cause.

The Contractor's records pertaining to potency, safety, compatibility testing and quality of units transfused to VA patient's will be available to the VA Medical Center upon request, with the exception of the identity of the donor.

The Contractor shall perform pre-transfusion testing for the VAMC, antibody identification, adverse effects of transfusion investigations, and immunity problem investigations.

If the Contractor fails to meet FDA requirements, the Contractor shall continue to supply the VA Medical Center and perform compatibility testing and other testing as stated herein as the agreed upon pricing. No additional charges shall be imposed on the VA if the Contractor must import products.

The Government will promptly inspect the blood upon receipt, and report any actual or suspected damage, irregularity, testing or labeling error. The Government will also promptly report blood lost due to shipping error. The Government will keep complete and accurate records, as required by the law, of patients supplied with blood (product names, lot identifications and quantities), any therapeutic adverse effects and complaints and other blood-related information.

Upon discovery, the Government will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from blood ( Adverse Event ). The Government will cooperate with the contractor s investigation of any Adverse Event and supply information concerning the recipient of the blood to the Contractor, upon forms provided by the Contractor.

VA will conform to FDA and The Joint Commission requirements regarding reporting, handling, storage and shipping of blood components. VA is TJC and AABB accredited. Contractor shall perform blood storage audits as necessary.

VA will appoint a committee, which has the following responsibilities:

Review the transfusion of blood, blood components and derivatives in the Medical Center as required by the Joint Commission of Accreditation of Hospitals.

Make recommendations to the medical staff concerning the proper usage of blood products.

Insure that adequate records of transfusions and transfusion associated reactions are kept.

There are risks, side effects and hazards associated with human blood products that cannot be prevented, even through careful blood donor screening and testing. These risks, side effects and hazards are set forth in the circular of information for the use of human blood and blood components as prepared by the American Association of Blood Banks and America's Blood Centers and recognized as acceptable by the US Food and Drug Administration. It therefore follows that the Contractor cannot guarantee or warrant the blood in any way. The Contractor is not responsible for any loss or damage arising out of the blood unless and to the extent caused by negligence or misconduct or the contractor. This language supersedes and replaces 52.212-4 (o) per the FAR regulation 12.302.

GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law.

MARKETING: Contractor shall not advertise or use any marketing material, logos, trade

names, service marks, or other material belonging to the VA without the VA's consent.

ORDER OF PRECEDENCE: The terms, conditions, and attachments referenced herein, including any formal written modifications thereto, constitute the complete agreement between the parties and take precedence over any other language, oral or written.

ORDER PLACEMENT: Task orders will be issued by the Network Contracting Office 20 to fulfill requirements on an as needed basis. Unit quantities are currently unknown. Each individual task/delivery order will state the unit quantities of supplies and/or services required at time of issuance. Orders will be placed orally, facsimile, or by email.

SECURITY REQUIREMENTS: The Contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The Contractor employees shall have intermittent access only and will be escorted by VA employees while at VA Facilities. No background investigation is required.

FEE SCHEDULE & INVOICING: Task and delivery orders will be issued to order various supplies and services stated in the attached fee schedule. The Contractor may give discounts from the stated prices; however, the Contractor shall never quote or invoice for more than the stated prices in the given fiscal year.

Invoice: The Contractor shall invoice the VA Medical Center Monthly in arrears through the Tungsten Network. Review the information at http://www.tungsten-network.com/us/en/ for invoicing procedures. Vendor bills roughly 4 times per month.

Payment: Credits for returned blood may be reflected on the next or current invoice. Depending on when the credit is submitted, it may skip an invoice cycle. However, the invoice cycles are roughly weekly so there isn't much/if any delay.

CREDIT FOR RETURNED BLOOD AND COMPONENTS: Credit prices are the same prices as charged in the contract. Full credit shall be given when blood products are sent to the VA with less than 10 days dating and outdate at the VA. Leukoreduced Red Blood Cell units received with less than 10 days (Apheresis platelets with