36C25625Q1401.docx

Statement of Work Blood and Related Products and Services Overton Brooks VAMC and Alexandria VAHCS

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT*

Contracting Officer Le Kisha Douglas, MPA LeKisha.Douglas@va.gov

PLACE OF PERFORMANCE

Pineville, LA

AND

Overton Brooks VAMC Shreveport

Shreveport, LA

POSTAL CODE

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Sources Sought Notice Sources Sought Notice

DESCRIPTION

Sources Sought Notice

1. Title: Blood Products and Support Services, Base+4OY Shrv and Alex, LA VAMC

2. Purpose: The Network Contracting Office (NCO) 16 located at 5075 Westheimer Road, Galleria Financial Center, Suite 750, Houston, Texas, hereby issues the following Sources Sought to Request Information (RFI) with the intent of determining the contractor interest, capabilities, qualifications of potential businesses, nonmanufacturer rule compliance, Buy American Act compliance, Trade Agreement compliance and estimated industry pricing information for market research and estimated budgetary purpose for Blood and Related Products and Services for the Department of Veterans Affairs Medical Centers (VAMC) in Alexandria and Shreveport, LA. (Pathology & Laboratory Medicine).

This contractor shall ensure an adequate, readily available supply of blood and/or blood components and related services that are in accordance with standards established by recognized accrediting agencies such as the Association for the Advancement of Blood and Biotherapies (AABB), the Food and Drug Administration (FDA), and the College of American Pathologists (CAP). Blood and/or blood components must be available 24 hours per day, seven days per week regardless of holidays to ensure an adequate blood supply at all times.

Government request that interested offerors complete all questions below, provide required documentation, descriptive literature and authorization letter as described below. The Government is in no way obligated to do business with or to enter into any form of contract with any person, firm or other entity that receives or responds to this announcement.

3. Objective: To find qualified and certified contractors with the capability to with the capability to provide the following:

a. Adequate, readily available supply of blood and/or blood components and related services that are in accordance with standards established by recognized accrediting agencies such as the Association for the Advancement of Blood and Biotherapies (AABB), the Food and Drug Administration (FDA), and the College of American Pathologists (CAP). Blood and/or blood components must be available 24 hours per day, seven days per week regardless of holidays to ensure an adequate blood supply at all times. (as prescribed in the included draft of the Statement of Work).

4. Place of Performance:

Alexandria VA Health Care System (AVHCS), Pathology and Laboratory Medicine Service (113), Bldg. 7 Rm. 352, 2495 Hwy 71 North, Pineville, LA, AND

Overton Brooks VAMC Shreveport, Pathology and Laboratory Medicine Service, 510 East Stoner Avenue, Shreveport, LA

5. Responses Requested: The MEDVAMC requires all the following information and questions answered in this RFI/SS: Questions and information that is not provided shall be considered nonresponsive to the Request for Information and contractor shall not be considered as part of the market research.

a. Contractors shall provide their point(s) of contact name, address, telephone number, and email address; and the company's business size, and SAM Unique Entity Identification Number.

b. Is your company a small business, SDBs, HUBZone, or 8A concern? Please provide proof of qualifications.

c. Does your company meet all required four prong factors for the Nonmanufacturer Rule (NMR) per guidance of SBA and 13 C.F.R. § 121.406 Offer must answer all questions below.

1. Does your company exceed size standard for $40M?

2. Is your company primarily engaged in the retail or wholesale trade and normally sells the type of products being supplied? __________

3. Does your company must take ownership or possession of the item(s) with its personnel, equipment, or facilities in a manner consistent with industry practice? __________

4. Does your company supply the end products of a small business manufacturer or processor made in the United States? _____________

d. Is your company considered small under the NAICS code 621991.

e. Do you (offer) manufacture the product yourself or a distributor of the items being researched above?

f. Are you an authorized distributor/reseller? Provide evidence from original equipment manufacturer (OEM).

g. Do you (offer) supply a product manufactured by another domestic small business, if it is a nonmanufacturer?

h. Do you (offer) supply the product of any sized manufacturer if SBA has granted a waiver to the nonmanufacturer rule?

i. Is your (offer) Buy American Certificate completed in SAM? Please provide evidence with response.

j. Is your (offer) Trade Agreement Certificate completed in SAM? Please provide evidence with response.

k. Information for the name brand or equal product being requested, is it manufactured outside the US-Domestic non-available?

l. Information for the name brand or equal product being requested, is it a foreign manufactured end product under the trade agreement?

m. What is your schedule of delivery after receipt of order for the name brand or equal product?

n. For the name brand or equal product required, Is your company available under any;

Government Wide Agency Contract (GWAC) General Services Administration Schedules (GSA) Indefinite Delivery Indefinite Quantity (IDIQ) Blanket Purchase Agreement (BPA) If so, please list the contract number for name brand or equal product.

o. Provide descriptive literature demonstrating ability to meet all of the requirement/salient characteristics listed if other than brand name product is being offered. Please provide list of contracts for commercial, federal, state, and local governments. Listed contracts shall provide communication on the government requirement illustrating the capability for comparison. to the name brand or equal product meeting the specific requirements per the draft Statement of Work.

p. Contractors shall provide an estimated industry pricing for name brand or equal product for market research and budgetary purpose.

6. Opportunity: NCO 16, is seeking information from potential contractors on their ability to provide this service. THIS IS A SOURCES SOUGHT FOR REQUEST INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this Sources Sought in order to assist the MEDVAMC in determining potential levels of competition available in the industry. Contractor shall possess the capability to provide all requirements and objectives.

7. Instructions and Response Guidelines: Sources Sought responses are due by August 26, 2025 at 1630 (CST) via email to LeKisha.Douglas@va.gov .

All Questions shall be submitted by August 25, 2025 at 1200 (CST) via email to LeKisha.Douglas@va.gov.

Telephone requests or inquires will not be accepted.

Public Information will not be provided and shall be utilized to the full extent possible.

This a New Requirement.

The subject line shall read: 36C25625Q1401 -RFI-Sources Sought- The Contractor shall provide Blood and Related Products and Services for the Department of Veterans Affairs Medical Centers (VAMC) in Alexandria and Shreveport, LA. NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 5(a) - 5(o).

Please provide the information you deem relevant in order to respond to the specific inquiries of the Sources Sought. Information provided will be used solely by MEDVAMC as "market research" and will not be released outside of the MEDVAMC Purchasing and Contract Team. This Sources Sought notice does not constitute a Request for Proposal (RFP), Invitation for Bid (IFB), or Request for Quotation (RFQ), and it is not to be construed as a commitment by the Government to enter into a contract, nor will the Government pay for the information submitted in response to this request. All information contained in this Sources Sought is preliminary as well as subject to modification and is in no way binding on the Government.

In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. If a solicitation is released, it will be synopsized on Contracting Opportunities (https://beta.sam.gov/) website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this Sources Sought, or future RFP/RFQ.

8. Contact Information:

Contracting Officer, Le Kisha Douglas, MPA Email address: LeKisha.Douglas@va.gov

Your responses to this notice are appreciated.

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES/PROPOSALS; however, any firm that believes it can meet the requirements may provide answers, responses and give written notification prior to the response due date and time. Supporting evidence and responses will be utilized for market research purposes only.

Sources Sought 36C25625Q1401- Blood Products and Support Services, Base+4OY Shrv and Alex, LA VAMC

Page 1 of

1. General.

The Contractor shall provide Blood and Related Products and Services for the Department of Veterans Affairs Medical Centers (VAMC) in Alexandria and Shreveport, LA.

This contractor shall ensure an adequate, readily available supply of blood and/or blood components and related services that are in accordance with standards established by recognized accrediting agencies such as the Association for the Advancement of Blood and Biotherapies (AABB), the Food and Drug Administration (FDA), and the College of American Pathologists (CAP). Blood and/or blood components must be available 24 hours per day, seven days per week regardless of holidays to ensure an adequate blood supply at all times.

2. Scope of Work.

Under the authority of Public Law 104-262 and 38 USC 8153, the Contractor shall provide Health Care Resources in accordance with the terms and conditions stated herein.

This procurement provides Blood and Related Products & Services for the Department of Veterans Affairs Medical Centers (VAMC) in Alexandria and Shreveport, Louisiana. The contractor shall ensure readily available supply of blood and/or blood components and related services that are in accordance with standards established by recognized accrediting agencies such as the American Association of Blood Banks (AABB), the Food and Drug Administration (FDA), and the College of American Pathologists (CAP).

The contractor shall ensure Blood/blood components and testing are available 24 hours per day, seven days per week regardless of holidays to ensure an adequate blood supply at all times.

The item information referenced in the Solicitation B.2 Price/Cost Schedule shall be drawn, processed, tested, typed and packed as specified in the following sections in suitable containers, and delivered FOB destination to:

Alexandria VA Health Care System (AVHCS), Pathology and Laboratory Medicine Service (113), Bldg. 7 Rm. 352, 2495 Hwy 71 North, Pineville, LA, AND

Overton Brooks VAMC Shreveport, Pathology and Laboratory Medicine Service, 510 East Stoner Avenue, Shreveport, LA in such quantities and at such times as required in accordance with all terms, conditions, provisions and schedules herein – as requested by authorized VA personnel.

It is critical that blood products and those tests needed to ensure compatibility or blood products be available ON A STAT BASIS (immediately).

Only 100% volunteer donor blood shall be provided, under this contract to the VAMC, by the blood bank in accordance with FDA rules and regulations effective May 15, 1978 or latest revision.

2.1. Period of Performance.

The estimated Period of Performance is requested as a 5-year agreement to begin October 1, 2025. The agreement will be reviewed annually by AVAHCS and OBVAMC contracting offices as a minimum of ninety (90) days prior to the anniversary date.

Base Year: Date of Award through September 30, 2026 Option Year 1: October 1, 2026 through September 31, 2027* Option Year 2: October 1, 2027 through September 31, 2028* Option Year 3: October 1, 2028 through September 31, 2029* Option Year 4: October 1, 2029 through September 31, 2030* *Denotes: Exercisable at the discretion of the Government and availability of funds.

2.2. Definitions.

· STAT – Immediately

· Volunteer Donor - "A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.”

· Department of Veterans Affairs work hours are defined as follows:

· Routine: Monday through Friday, 8:00 AM through 4:30 PM

· Off Duty Hours: Friday through Monday, 4:30 PM through 8:00 AM, Weekdays 4:30 through 8:00 AM and holidays, midnight to midnight.

· National Holidays: The 11 holidays observed by the Federal Government are:

· New Years Day

· Martin Luther King’s Birthday

· Presidents Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· AND, any other day specifically declared by the President of the United States to be a national holiday.

2.3. Work Hours. The contractor shall provide services 24 hours per day, seven days per week, regardless of holidays.

2.3.1. Testing. Reference testing such as antibody identification, blood product antigen testing, and compatibility testing shall be available 24 hrs/day, 7 days/week regardless of holidays. In a STAT situation, this testing must be started within 30 minutes of receipt of the specimen to ensure rapid blood product availability. In the event that multiple STAT orders are received at one time, testing shall start as soon as feasible.

2.4. Place of Performance. Most services under this contract shall be performed at the Contractor’s place of business.

2.4.1. Items listed in this contract shall be drawn, processed, tested, typed and packed in accordance with Section 3 Requirements/Performance Standards. The contractor shall place the items in suitable containers and delivery FOB destination to the ordering VAMC at the following addresses:

Alexandria VA Health Care System Pathology and Laboratory Medicine Service (113) Bldg 7, Room 352 2495 Shreveport Highway 71 Pineville, LA Overton Brooks VAMC Shreveport Pathology and Laboratory Medicine Service, Bldg. 1, Room 2N21 510 East Stoner Avenue Shreveport, LA

2.5. CO or Designated Representative. Estimated Delivery Orders will be issued by a VAMC Contracting Officer. The scheduling of delivery of the as-needed supplies will be placed by telephone or fax, on as needed basis, twenty-four (24) hours a day, seven (7) days per week. The names of the lab personnel designated as authorized to place, accept or reject deliveries is provided (See paragraph 4.3). Orders may be placed on a monthly basis. Modifications will be issued, by the Contracting Officer, to increase or decrease orders.

2.5.1. Routine Orders for Blood. Contractor shall deliver blood as specified within twelve (12) hours following routine request(s).

2.5.2. Emergency Requirements. Transportation of specimens to lab for testing. Emergency (STAT) requests for transportation of patient sample to the Contractor laboratory for reference blood bank testing shall be available with a 1-hour response time from notification, and shall be picked up from the VAMC’s by the Contractor’s staff and in route to the Contractor’s Lab for testing within that 1-hour time frame.

2.5.2.1. The contractor shall deliver blood products for transfusion to Alexandria VA Health Care System within four (4) hours of completion of testing and location of a suitable product.

The contractor shall delivery blood products for transfusion to Overton Brooks VAMC Shreveport within two (2) hours of completion of testing and location of a suitable product.

2.5.2.2. Delivery of blood products in STAT situations.

In the event the Contractor cannot provide compatible blood to the patient, the Contractor shall expedite urgent requests for blood and blood products and agrees to exhaust every possibility to respond to medical emergencies on a prompt and timely basis. A prompt and timely manner is considered to be maximum one (1) hour for pickup of a patient’s sample for testing to find compatible units, if necessary, and two (2) hours delivery time for compatible blood for transfusion for Overton Brooks VAMC Shreveport and four (4) hours maximum response time for Alexandria VA Health Care System unless delays are encountered due to complexity of testing and, or locating compatible products.

2.5.3. Specific Requirements for Delivery.

2.5.3.1. Temperature. All blood delivered to the Department of Veterans Affairs Medical Centers, Alexandria and Shreveport, under this contract shall be properly packed and insulated in such a way as to ensure that 1-10 degree Celsius is maintained during shipment between the Contractor's place of business and the designated Medical Center as specified.

2.5.3.2. Stock. The Contractor shall maintain an adequate stock of blood and blood products on site at each Medical Center (Alexandria & Shreveport) and to regularly maintain stock levels.

2.5.4. Transportation.

2.5.4.1. The Contractor shall furnish all transportation for its products, including delivery and pick up. All deliveries shall be made to the laboratory’s blood bank (s), Pathology and Laboratory Medicine, VA Medical Centers, Alexandria and Shreveport, LA.

2.5.4.2. Transportation of blood samples to a non-local center for required testing/cross matching and the return transportation of cross matched/compatible units to the appropriate VA Medical Center shall be the responsibility of the Contractor.

2.5.4.3. EMERGENCY REQUIREMENTS shall be available with a 1-hour response time to request for transportation of patient sample to reference laboratory for blood bank reference testing. Return trip of suitable blood for transfusion shall be completed within four (4) hours for Alexandria VA Health Care System. Delivery of suitable blood for transfusion for Overton Brooks VAMC, Shreveport, shall be completed within two (2) hours of request or at a mutually agreeable time for contractor and VA facility. Empty containers, blood, and equipment returned for credit shall be returned at contractor's expense.

3. Requirements/Performance Standards.

3.1. Insurance.

3.1.1. The Contractor and its health care providers shall be liable for their liability-producing acts or omissions. The Contractor shall maintain or require all health care providers performing under this contract to maintain, during the term of this contract, professional liability insurance issued by a responsible insurance carrier of not less than the following amounts, per specialty, per occurrence: One million dollars, unless the Contractor is an entity or a subdivision of a State that either provides for self-insurance or limits the liability or the amount of insurance purchased by State entities, then the insurance requirement of this contract shall be fulfilled by incorporating the provisions of the applicable State law.

3.1.2. The Contractor shall, prior to commencement of services under the contract, provide to the Contracting Officer, Certificates of Insurance or insurance policies evidencing the required insurance coverage and an endorsement stating that any cancellation or material change adversely affecting the Government’s interest shall not be effective until 30 days after the insurer of the Contractor gives written notice to the Contracting Officer. Certificates or policies shall be provided for the Contractor and/or each health-care provider who will perform under this contract.

3.1.3. The Contractor shall notify the Contracting Officer if it, or any of the health care providers performing under this contract, change insurance providers during the performance period of this contract. The notification shall provide evidence that the Contractor and/or health-care provider will meet all the requirements of this clause, including those concerning liability insurance and endorsements. These requirements may be met either under the new policy, or a combination of old and new policies, if applicable.

3.1.4. The Contractor shall make this requirement known to all subcontracts for health-care services under this contract. The Contractor shall be responsible for compliance by any subcontractor or lower-tier subcontractor with the provisions set forth above.

3.2. Personnel Policy. The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the Contractor shall provide the following for these personnel:

· workers compensation

· professional liability insurance

· health examinations

· income tax withholding, and

· social security payments.

3.2.1. The parties agree that the Contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose.

3.3. Sources of Donor Blood.

3.3.1. Donations. The medical centers shall encourage blood donations.

3.3.2. Donor Records and Selection.

3.3.2.1. Records. The Contractor shall maintain readily available blood donor lists including names, addresses and unique identifying numbers. Such lists shall indicate whether and on what date blood of a particular donor was furnished to the Department of Veterans Affairs under this contract.

3.3.2.2. Selection. The contractor shall ensure donor selection is in accordance with criteria established by the FDA (http://www.fda.gov/) and/or the AABB (http://www.aabb.org/).

3.3.2.3. Collection of Blood/Blood Components. The contractor shall collect all blood by a closed system under aseptic conditions. A closed system means a system in which blood container is not entered or air introduced. The Contractor shall process the blood in appropriate solutions and the container according to “Uniform Labeling Guidelines” (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM080974.pdf). To include the anticoagulant used and the appropriate expiration date.

3.3.2.4. Autologous Donations. The Contractor shall collect autologous blood or components for patients as referred by Alexandria VA Health Care System or Overton Brooks VAMC.

The Contractor shall test the units as stated in paragraph 3.4 Typing/Testing paragraph. These tests shall be performed before shipping on at least the first unit collected during each 30 day period. The Contractor shall inform the patient’s physician and the patient of any medically significant abnormalities discovered.

If an autologous unit is to be shipped to another VAMC or medical facility outside the VA and the unit tests positive for any marker of transfusion-transmitted disease, the Contractor shall be responsible for notifying the VAMC or medical facility outside the VA.

3.4. Typing/Testing of Donor Blood/Blood Components.

3.4.1. The Contractor shall perform typing/testing in accordance with methods recommended in the most current edition of Standards for Blood Banks and Transfusion Services and the Technical Manual of the Association for the Advancement of Blood and Biotherapies (http://marketplace.aabb.org/ebuspprod/Marketplace/AllProducts/ProductDetail.aspx?productId=1963050). The tests required include but are not limited to the following:

3.4.2. The Contractor shall determine the ABO group for each collection by testing the red cells with anti-A and anti-B reagents and by testing the serum or plasma for expected antibodies with A1 and B reagent red cells.

3.4.3. The Contractor shall determine the Rh type for each collection with anti-D reagent. If the initial test with anti-D is negative, the blood hall be tested using a method designed to detect week D. When either test is positive, the label shall read “Rh POSITIVE”. When the test for both D and weak D are negative, the label shall read “Rh NEGATIVE”.

3.4.4. Serum or plasma from donors with a history of transfusion or pregnancy shall be tested for unexpected antibodies to red cell antigens. Methods for testing shall be those that demonstrate clinically significant red cell antibodies. A control system appropriate to the method of testing shall be used.

3.4.5. Testing for HBsAg, anti-HBc, anti-HCV, HCV RNA, anti-HIV-1/2, HIV-1 RNA, anti-HTLV-I/II, and a serologic test for syphilis. Blood components shall not be distributed or issued for transfusion unless the results of these tests are negative, except in the case of a test for syphilis that has been shown to have a biological false-positive result. Units with biological false-positive results shall be labeled in accordance with FDA requirements.

3.4.6. If, due to urgent need, blood or components are distributed or issued before completion of these tests, a notation that testing is not completed shall appear conspicuously on the attached label or tie tag. Required tests shall be completed and results reported to the transfusion service as soon as possible.

3.4.7. Patient/Recipient Testing. Identification of allogenic antibodies in recipient blood specimens, antigen typing of blood/blood components, investigation of blood group discrepancies, and compatibility testing (including investigation of incompatibilities) may be requested for VA patients in order to supply compatible blood/blood products. The contractor shall perform the testing in compliance with AABB and CAP standards.

3.5. Labeling. The Contractor shall furnish and label blood as to A, B, O, and Rh type and type of component. Type A Rh negative and O Rh negative must have been drawn from donor not more than five (5) days before date on which the order is filled. Types such as AB Rh positive, B Rh negative and AB Rh negative shall be supplied as fresh as possible but not over fifteen (15) days old. These limits may be adjusted if a system for exchange on credit is provided which minimizes or precludes losses due to outdating.

3.6. Apheresis Collection Requirements. The Contractor process used in performing a phlebotomy and processing the blood shall be designed to ensure safe reinfusion of the autologous non-retained components.

· Leukapheresis Collection not required.

· Therapeutic Collection not required.

· Therapeutic Phlebotomy and Apheresis shall be performed only when ordered by a Physician. Unit drawn as therapeutic phlebotomies shall not be used for allogeneic transfusion unless the indication for therapeutic phlebotomy is hereditary hemochromatosis and the therapeutic phlebotomy is performed at no expense to individuals with hereditary hemochromatosis. The program must have received a variance from the FDA.

3.7. Preparation/Processing of Components. The Contractor shall employ methods that ensure the quality and safety of components, including aliquots and pooled components, shall be employed. If the seal is broken during processing, components shall be considered to have been prepared in an open system and expiration times specified for such components apply. If a sterile connection device is used to produce sterile welds between two pieces of compatible tubing, the weld shall be inspected for completeness. If the integrity of the weld is complete, the component shall retain original expiration dates or have storage times approved by the FDA.

If the integrity of the weld is incomplete, the container shall be considered an open system and may be sealed and used with a component expiration as indicated for an open system. At the time of preparation of a final red-cell-containing component intended for transfusion, the integrally connected tubing shall be filled with an aliquot of the component and sealed in such a manner that it will be available for subsequent compatibility testing.

3.7.1. Leukocyte Reduction. The Contractor shall prepare Leukocyte-reduced blood and components by a method known to reduce the leukocyte number to <5 X 106 for Apheresis Platelets and Red Blood Cells and to <8.3 X 105 for whole-blood-derived Platelets. Validation and quality control shall demonstrate that at least 95% of the units sampled meet this criterion.

3.7.2. Irradiation. The Contractor shall prepare irradiated blood and components by a method known to ensure that irradiation has occurred. A method shall be used to indicate that irradiation has occurred with each batch. The intended dose of irradiation shall be a minimum 25 Gy (2500cGy) delivered to the central portion of the container. The minimum dose at any point in the components shall be 15 Gy (1500 cGy). Alternate methods shall be demonstrated to be equivalent. Contractor shall verify dose delivery using a fully loaded canister. Records shall be maintained as follows:

· Annually for cesium-137 as a radiation source

· Semi-annually for cobalt-60 as a radiation source.

· Periodically, as recommended by the manufacturer for alternate sources of radiation.

· Upon installation, major repairs, or relocation of the irradiator.

3.7.3. Pooling. For pooled components defined as taking blood or products from multiple donors and pool into one unit, the Contractor shall maintain the records of the identification number and collecting facility for each unit in the pool.

3.7.4. Red Blood Cells Leukocytes Reduced. Red Blood Cells Leukocytes Reduced shall be prepared by a method known to retain at least 85% of the original red cells and contain <5 X 106 residual leukocytes per unit.

3.7.5. Apheresis Red Blood Cells Leukocytes Reduced. Apheresis Red Blood Cells Leukocytes Reduced shall be prepared by a method known to ensure a final component containing a mean hemoglobin of ≥51g (or 153 MI red cell volume) and <5 X 106 residual leukocytes per unit. At least 95% of unit sampled shall have >42.5 g of hemoglobin (or 128 MI red cell volume).

3.7.6. Fresh Frozen Plasma. Fresh Frozen Plasma shall be prepared from a whole blood or apheresis collection and placed at ≤-18 C within the time frame required for the anticoagulant or collection process. If a liquid freezing bath is used, the container shall be protected from chemical alteration.

3.7.7. Cryoprecipitate AHF (Cryoprecipitate Antihemophilic Factor). The contractor shall prepare cryoprecipitate AHF by a method known to separate the cold insoluble portion from Fresh Frozen Plasma and result in a minimum of 150 mg of fibrinogen and a minimum of 80 IU of coagulation Factor VIII. In tests performed on pooled components, the pool shall contain a minimum of 150 mg of fibrinogen and 80 IU of coagulation Factor VIII times the number components in the pool.

3.7.8. Pooled Platelets Leukocytes Reduced. Pooled Platelets Leukocytes Reduced shall be prepared by a method known to result in a residual leukocyte count <5 X 106.

3.7.9. Apheresis Platelets Leukocytes Reduced. Validation and quality control shall demonstrate that 90% of units sampled contain ≥3.0 X 1011 platelets and that at least 90% of units have a Ph ≥6.2 at the end of allowable storage. FDA criteria apply. At a minimum, 95% of units sampled shall contain a residual leukocyte count <5 X 106.

3.8. Hemolysis/Chyle/Clots. All blood supplied shall be grossly free of hemolysis, excessive chyle and clots.

3.9. Storage. Immediately after collection, the contractor shall store red blood cell in a monitored (alarm system and recording chart) refrigerator between 1 and 6 degrees Celsius. If transportation of the blood is necessary, it shall be transported in clean shipping containers provided with refrigeration sufficient to hold at 1-10 degrees Celsius, preferably 1- 6 degrees while in transit.

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3.9.1. Plasma is maintained at -18 degrees Celsius or below in a monitored (alarm and recording chart) freezer.

3.9.2. Platelets are stored between 20-24 degrees Celsius in a monitored (alarm and recording chart) incubator or other environment that is stable.

3.10. Reactions. The VA Medical Centers will report all hemolytic transfusion reactions immediately after occurrence. Any occurrence of jaundice or other blood-transmitted disease in patients subsequent to blood transfusion shall also be reported.

3.11. Qualifications.

3.11.1. Registration/Licensures/Certifications. The Contractor shall be registered and/or licensed with the Food and Drug Administration (FDA), through the Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260; is inspected and accredited by the Association for the Advancement of Blood and Biotherapies; is a member in good standing in the Louisiana Hospital Associations, and participates in a proficiency testing program.

3.11.2. License. The Contractor shall submit proof of holding an unrevoked U.S. License which is issued by the Center for Biologics, Evaluation and Research, Food and Drug Administration, hereinafter referred to as FDA under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for blood and blood products complying with FDA regulations.

3.11.3. The Contractor shall ensure testing personnel assigned to perform the services covered by this contract are licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall also be subject to review by the VAMC Chief of Staff and approval by the VA Facility Director. Each person assigned to work under this contract shall be licensed by the State of Louisiana and shall meet the testing personnel requirements of the Association for the Advancement of Blood and Biotherapies for the type/complexity testing performed.

3.11.4. The Contractor shall obtain all necessary licenses and/or permits required to perform this work. The Contractor shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. The Contractor shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employee’s fault of negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of Louisiana. Further it is agreed, that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the Contractor hereunder with the regard to any claims, loss, damage, injury and liability resulting therefrom.

3.11.5. Certifications. The Contractor shall certify compliance with the requirements outlined below with respect to donors, containers, delivery, and all pertinent elements. The Contractor shall be Association for the Advancement of Blood and Biotherapies (AABB) and College of American Pathologists (CAP) accredited.

4. VAMC Points of Contact.

4.1. CORs in the Alexandria VA Health Care System (AVAHCS) and Overton Brooks VAMC Shreveport will be appointed by the Contracting Officer for this contract.

4.2. A duly appointed Contracting Officer from the Overton Brooks VAMC Shreveport is authorized to issue orders under this contract in accordance with FAR Clause 52.216-18.

A copy of all Overton Brooks VAMC Shreveport orders and modifications to those orders will be forwarded to the AVAHCS Contracting POC or Contracting Officer responsible for the administration of this contract.

4.3. Lab personnel responsible for placing calls and scheduling deliveries of ordered supplies.

Alexandria VA Health Care System Points of Contact:

VAMC Shreveport Points of Contact:

5. Special Terms and Conditions.

5.1. Quality Assurance/Performance Standards:

Performance standards define desired services. The Government performs surveillance to determine if the Contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary Matrix - includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

4 hr response – ALX

Quality of Blood/Blood Component

Administrative

3.1.2

The Contractor shall follow the current edition of “Standards for Blood Banks and Transfusion Services” and the “Technical Manual” of the Association for the Advancement of Blood and Biotherapies. The Contractor shall be licensed by the Food and Drug Administration (FDA), Department of Health and Human Services. The Contractor shall be accredited by the Association for the Advancement of Blood and Biotherapies (AABB).

5.2. HHS/OIG. To ensure that the individuals providing services under the contract have not engaged in fraud of abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor shall check the Health and Human Service – Office of Inspector General List of excluded individuals/entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further, the Contractor shall certify in its proposal that all persons listed in the Contractor’s offer have been compared against the OIG list and are not listed. During the performance of this contract, the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

5.3. HIPAA Compliance. The Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to protect the Privacy and Security of Protected Health Information (PHI). A business associate agreement is not required in this case.

6. Changes / Modifications If any product awarded under this requirement requires modification, is removed or recalled by the Contractor or manufacturer, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will be taken immediately by the Contractor or manufacturer:

6.1.1. Notify the Contracting Officer, in writing, by the most expeditious manner possible. Provide two copies of the notification which shall include, but not be limited to the following:

· Complete item description and/or identification, order numbers from customers, and the contract number assigned as a result of an award on this Statement of Work.

· Reasons for modifications, removal or recall.

· Necessary instructions for return for credit, replacement or corrective action.

6.1.2. Provide the above information to all agencies and VA Facilities who purchased the product. The Contracting Officer Representative shall be provided a copy of the notification in ii. above, and a list of all agencies and/or VA facilities notified.

6.1.3. Contractor shall be responsible for any costs associated with the above.

Changes in the terms and conditions of this contract may be made only by written agreement of Overton Brooks VA Medical Center Pathology and Laboratory Service. Any and all modifications for changes in the prices, terms or conditions of this contract, shall be prepared for signature by the VA Contracting Officer.

7. Performance Monitoring.

The performance of the vendor will be monitored by the PLMS performing staff based on the following criteria:

· Ability of the vendor to consistently provide the reagents necessary for patient testing.

· Availability of the vendor to keep the instruments operational for patient testing.

· Ability of the vendor's availability for technical support by PLMS staff.

8. Security Requirements.

The contractor shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. A&A requirements do not apply and a Security Accreditation Package is not required.

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

No GFE/GFI shall be provided to the contractor.

10. Risk Control.

All employees, contractors, and visitors are required to abide by local infection control procedures. To aid in the prevention of the spread of COVID and other communicable diseases, everyone may be required to wear a surgical mask upon entry to the facility and maintain wear of mask until exiting the facility.