36C25620Q0852.pdf

PDF 1 MB Posted Jul 21, 2020

Attached to: 6550--667-20-3-058-0090 Blood & Blood Related Products (SHR & ALX) 36C25620Q0852
Solicitation number: 36C25620Q0852
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 16

View the file

Other files

File	Type	Posted
36C25620Q0852_1.docx	DOCX document	Jul 21, 2020

On GovTribe

Work with this file

Download the original file
Contacts named in this file
Similar government files
Ask GovTribe AI about this file

Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 83

See Individual Task Order

36C25620Q0852 07-21-2020

Lonest Bonton 318-466-2234 08-06-2020

2:00pm

36C502

ALEXANDRIA VA HEALTH CARE SYSTEM

NETWORK CONTRACTING OFFICE 16

ALEXANDRIA VA HEALTH CARE SYSTEM

PO BOX 69004

ALEXANDRIA LA 71306-9004

621991

$32.5 Million

N/A

36C520

SEE DELIVERY SCHEDULE

00502

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 16

ALEXANDRIA VA HEALTH CARE SYSTEM

2495 SHREVEPORT HIGHWAY

PINEVILLE LA 71360-4004

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714

877-353-9791 512-460-5429

See CONTINUATION Page

Contractor shall provide non-personal services to include management, tools, supplies, equipment, labor, transporation and applicable licenses and permits necessary to provided blood and blood products/services to the Overton Brook VAMC, Shreveport, LA and the Alexandria VAHCS, Pineville, LA.

See Price/Cost Schedule & Statement of Work (SOW)

Period of Performance:

Base Year - Oct 1, 2020 - Sep 30, 2021

Option Year 1 - Oct 1, 2021 - Sep 30, 2022

Option Year 2 - Oct 1, 2022 - Sep 30, 2023

Option Year 3 - Oct 1, 2023 - Sep 30, 2024

Option Year 4 - Oct 1, 2024 - Sep 30, 2025

For Contract Administrative questions or concerns please contact Lonest Bonton @ 318-466-2234.

See CONTINUATION Page

See Individual Task Orders

X X

Lonest Bonton

VA256-17-Q-1516

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN

2011)

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.216-18 ORDERING (OCT 1995)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.3 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...41

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

C.7 52.203-98 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE

CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS—REPRESENTATION

(DEVIATION) (FEB 2015)

C.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2012)

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.11 52.224-1 PRIVACY ACT NOTIFICATION (APR 1984)

C.12 52.224-2 PRIVACY ACT (APR 1984)

C.13 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES

INCORPORATED BY REFERENCE (JAN 2008)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2017)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

ITEMS

E.1 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013)59

E.2 52.216-1 TYPE OF CONTRACT (APR 1984)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (JAN 2017)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C256

ALEXANDRIA VA HEALTH CARE SYSTEM

NETWORK CONTRACTING OFFICE 16

ALEXANDRIA VA HEALTH CARE SYSTEM

PO BOX 69004

ALEXANDRIA LA 71306-9004

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-34, Payment by Electronic Funds Transfer—Other Than System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other []

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment

Requests.

Department of Veterans Affairs

Financial Services Center

PO Box 149971

Austin TX 78714

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND

COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for HubZone

Small Business Concerns. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of

Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

Statement of Work

Blood and Related Products and Services

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 American

Association of Blood Banks (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 the Alexandria VA Health Care System (AVHCS), Pathology and

Laboratory Medicine Service (113), Bldg 7 Rm. 352, 2495 Hwy 71 North, Pineville, LA, AND the Overton Brooks VAMC Shreveport, Laboratory Service, 510 East Stoner

Avenue, Shreveport, LA – for the period October 1, 2020 through Sep 30, 2021 subject to availability of funds, with 4 (four) option years - 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). This is a requirement contract EXCEPT for Fresh Frozen Plasma (FFP), which is included for emergency backup supply only.

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. 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:

o Routine: Monday through Friday, 8:00 AM through 4:30 PM o 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 10 holidays observed by the Federal Government are:

o New Years Day o Martin Luther King’s Birthday o Presidents Day o Memorial Day o Independence Day o Labor Day o Columbus Day o Veterans Day o Thanksgiving o Christmas AND, o any other day specifically declared by the President of the United States to be a national holiday.

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

2.2.1. 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.

2.3. Place of Performance. Most services under this contract shall be performed at the

Contractor’s place of business.

2.3.1. 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 Laboratory Service 510 East Stoner Avenue Shreveport, LA

2.4. 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.

2.4.1. Routine Orders for Blood. Contractor shall deliver blood as specified within twelve

(12) hours following routine request(s).

2.4.2. 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 Blood Center staff and in route to the Contractor’s Lab for testing within that 1-hour time frame.

2.4.2.1. The contractor shall delivery 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.

2.4.2.2. 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.

2.4.3. Specific Requirements for Delivery.

2.3.3.1. 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 insure that 1-10 degree Celsius is maintained during shipment between the Contractor's place of business and the designated Medical Center as specified.

2.4.3.2. 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.

2.4.4. Transportation.

2.4.4.1. 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), Laboratory

Service, VA Medical Centers, Alexandria and Shreveport, LA.

2.4.4.2. 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.

2.4.4.3. 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/GuidanceComplianceRegulator yInformation/Guidances/Blood/UCM080974.pdf). To include the anticoagulant used and the appropriate expiration date. The Contractor shall prepare the venipuncture site so as to minimize risk of bacterial contamination. Green soap shall not be used. At the time of collection or component preparation, the Contractor shall fill the integral donor tubing with anticoagulated blood and sealed in such a manner that it will be available for subsequent compatibility testing. The integral donor tubing segments shall be separable from the container without breaking the sterility of the container. At the time of collection, if additional blood is collected for laboratory tests, Contractor shall properly label the containers before or at the time of collection, shall accompany the blood container, and shall be re-identified with the blood container immediately after filling.

Storage of samples before testing shall meet the requirements stated in the manufacturer’s written instructions for the test being performed. The volume of blood to be collected shall be proportional to the amount of anticoagulant/preservative solution in the collection container.

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

Brook 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.

http://www.fda.gov/ http://www.aabb.org/ http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM080974.pdf http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM080974.pdf

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 American Association of Blood Banks

(http://marketplace.aabb.org/ebuspprod/Marketplace/AllProducts/ProductDetail.aspx?prod uctId=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 http://marketplace.aabb.org/ebuspprod/Marketplace/AllProducts/ProductDetail.aspx?productId=1963050 http://marketplace.aabb.org/ebuspprod/Marketplace/AllProducts/ProductDetail.aspx?productId=1963050 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 polled 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 pr 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. Cryoprecipitated AHF (Cryoprecipitated Antihemophilic Factor). The contractor shall cyroprecipitated 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 Leuocytes 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 Leuocytes 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. Plasma is maintained at -18 degrees Celsius or below in a monitored (alarm and recording chart) freezer. 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 American

Association of Blood Banks; 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 that he holds 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 American Association of Blood Banks 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 American Association of Blood Banks (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. The current CO at Overton Brooks

VAMC Shreveport authorized to issue orders against this contract is Sheronda Stewart, TEL: 318-990-4089.

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

Alexandria VA Health Care System Points of Contact:

Name Position Telephone

Annjanette Savant Medical Technologist 318 466 2317

Amanda Perrotti Chief Med Tech 318-466-2349

VAMC Shreveport Points of Contact:

Name Position Telephone

Michael Salinas Chief Medical

Technologist

318 990 5482

Shelly Price Hematology Supervisor 318 990 4953

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).

Task ID Indicator Standard Acceptable

Quality

Level

Method of

Surveillance

Testing 2.2.1 STAT Testing Testing started within 30 mins of rcpt of specimen

100% Periodic

Inspection

Testing 2.2.1 Testing

Availability

24/7 100% Periodic

Inspection

Transportation of Specimen

2.4.2 STAT

Transportation

W/I 1 hr of notification

100% Periodic

Inspection

Blood Delivery 2.4.1 Routine Delivery W/I 12 hours of request

100% Periodic

Inspection

2.4.2.1 Emergency W/I 4 hours of test

completion and location of suitable product

100% Periodic

Inspection

2.4.2.2 STAT 2 hr response –

SHR

4 hr response –

ALX

100% Periodic

Inspection

Quality of

Blood/Blood

Component

Quality of

Blood/Blood

Component

100% Periodic

Inspection

2.3.3.1 Temperature of

Blood maintained during shipment

1 -10 dg Celsuis maintained

100% Periodic

Inspection

2.4.3.2 On-site Stock of

Products at

VAMCs

Maintain Stock levels

100% Periodic

Inspection

Testing/Typing 3.4 Testing and

Typing donor blood and components

IAW Standards defined

100% Periodic

Inspection

Labeling 3.5 Accurate blood labelling

IAW Standards defined

100% Periodic

Inspection

Components 3.7 Preparation and

Process

Procedures

IAW Standards defines

100% Periodic

Inspection

Storage 3.9 Storage of

Blood

Blood is stored between 1 – 6 dg

Celsuis

100% Periodic

Administrative

3.1 Insurance Maintain required

Insurance

100% Periodic

Inspection

3.1.2 Provide policies to

Govt on time

100% Periodic

Inspection

3.3.2.1 Donor Records Records are

maintained to identify blood history

100% Periodic

Inspection

3.11 Qualifications Contractor and

staff are in compliance with licensing and accreditation

100% Periodic

The Contractor shall follow the current edition of “Standards for Blood Banks and

Transfusion Services” and the “Technical Manual” of the American Association of Blood

Banks. 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

American Association of Blood Banks (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.

http://www.hhs.gov/oig

B.3 PRICE/COST SCHEDULE

ITEM

NO. DESCRIPTION OF SUPPLY/SERVICE

ESTIMATED

QUANTITY

UNIT OF

ISSUE UNIT PRICE

TOTAL

PRICE

BASE PERIOD: 1 OCT 2020 to 30 SEP

ALEXANDRIA REQUIREMENT

Estimated Blood/Blood Components/Other Service Needs in accordance with the Scope of Work/Special Requirements

Packed Human Red Blood Cells Leuko reduced 525 EA

002 Cryoprecipitated, Human 0 EA

Fresh Frozen Plasma (Approx 190 ML Vol) Leuko reduced 6 EA

Platelet Concentrate, Human (pooled) 4 EA

005 Antibody ID - Multiple 4 EA 006 Crossmatch (test) 34 EA 007 Antibody ID - Single 15 EA 008 Antibody ID - Auto 1 EA 009 Elution & ID 4 EA

Directed Donations (Blood donated by relatives, friends, members of service organizations, etc.,) for the specific use of a specific VA patient:

Red Blood Cells 2 EA

Autologous Donation by a Veteran Patient at one of the Blood Processing Centers Donor Station (Whole Blood or RBC) 2 EA

Platelets Pheresis single donor, Leuko reduced 25 EA

Therapeutic Philebotomy at Donor Center 2 EA

014 Blood/Component Irradiation Fee 50 EA

Billing for Non-Routine Fee (includes work after 5 PM, Weekends and Holidays) 10 EA

Fee for Emergency transportation of patient samples to reference laboratory for blood bank reference testing, and return trip of suitable units for transfusion 9 EA

017 Courier Service 9 EA 018 GP 1 : Antigen Typing (# units) 9 EA 019 GP 2 : Antigen Typing (# units) 5 EA 020 GP 3: Antigen Typing (# units) 5 EA 021 GP 4: Antigen Typing (#units) 0 EA

Crossmatch (Test) Not specified on contract - Part of LifeShare Price List 60 EA

ABO/RH Type Not specified on contract - Part of LifeShare Price List 22 EA

DAT - Reagent Tested Not specified on contract - Part of LifeShare Price List 21 EA

Select Cell Panel Not specified on contract - Part of LifeShare Price List 18 EA

Stat Fee Not specified on contract - Part of LifeShare Price List 4 EA

Blood Bag Triple Not specified on contract - Part of LifeShare Price List 45 EA

Courier Service > 60 Miles Not specified on contract - Part of LifeShare Price List 3 EA

AD ID Standard Com Panel Not specified on contract - Part of LifeShare Price List 4 EA

Cold Screen Not specified on contract

- Part of LifeShare Price List 2 EA

Sickle Test Per Unit Shipped Not specified on contract - Part of LifeShare Price List 3 EA

SUBTOTAL

SHREVEPORT REQUIREMENT

Packed Human Red Blood Cells Leuko reduced 2220 EA

033 Cryoprecipitated, Human 32 EA

Fresh Frozen Plasma (Approx 190 ML Vol) Leuko reduced 40 EA

Platelet Concentrate, Human (pooled) 0 EA

036 Antibody ID - Multiple 28 EA 037 Crossmatch (test) 30 EA 038 Antibody ID - Single 20 EA 039 Antibody ID - Auto 10 EA 040 Elution & ID 9 EA

Directed Donations (Blood donated by relatives, friends, members of service organizations, etc.,) for the specific use of a specific VA patient:

Red Blood Cells 0 EA

Autologous Donation by a Veteran Patient at one of the Blood Processing Centers Donor Station (Whole Blood or RBC) 2 EA

Platelets Pheresis single donor, Leuko reduced 340 EA

Therapeutic Philebotomy at Donor Center 0 EA

045 Blood/Component Irradiation Fee 530 EA

Billing for Non-Routine Fee (includes work after 5 PM, Weekends and Holidays) 25 EA

Fee for Emergency transportation of patient samples to reference laboratory for blood bank reference testing, and return trip of suitable units for transfusion 15 EA

048 Courier Service 25 EA

049 GP 1 : Antigen Typing (# units) 25 EA 050 GP 2 : Antigen Typing (# units) 15 EA 051 GP 3: Antigen Typing (# units) 15 EA 052 GP 4: Antigen Typing (#units) 15 EA

Crossmatch (Test) Not specified on contract - Part of LifeShare Price List 0 EA

ABO/RH Type Not specified on contract - Part of LifeShare Price List 0 EA

DAT - Reagent Tested Not specified on contract - Part of LifeShare Price List 0 EA

Select Cell Panel Not specified on contract - Part of LifeShare Price List 0 EA

Stat Fee Not specified on contract - Part of LifeShare Price List 0 EA

Blood Bag Triple Not specified on contract - Part of LifeShare Price List 0 EA

Courier Service > 60 Miles Not specified on contract - Part of LifeShare Price List 0 EA

AD ID Standard Com Panel Not specified on contract - Part of LifeShare Price List 0 EA

Cold Screen Not specified on contract

- Part of LifeShare Price List 0 EA

Sickle Test Per Unit Shipped Not specified on contract - Part of LifeShare Price List 0 EA

BASE PERIOD TOTAL

OPTION YEAR 1: 1 OCT 2021 TO 30

SEP 2022

ALEXANDRIA REQUIREMENT

Estimated Blood/Blood Components/Other Service Needs in accordance with the Scope of Work/Special Requirements reduced 525 EA

2002 Cryoprecipitated, Human 0 EA

Fresh Frozen Plasma (Approx 190 ML Vol) Leuko reduced 6 EA

Platelet Concentrate, Human (pooled) 4 EA

2005 Antibody ID - Multiple 4 EA 2006 Crossmatch (test) 34 EA 2007 Antibody ID - Single 15 EA 2008 Antibody ID - Auto 1 EA 2009 Elution & ID 4 EA

Directed Donations (Blood donated by relatives, friends, members of service organizations, etc.,) for the specific use of a specific VA patient:

Red Blood Cells 2 EA

Autologous Donation by a Veteran Patient at one of the Blood Processing Centers Donor Station (Whole Blood or RBC) 2 EA

Platelets Pheresis single donor, Leuko reduced 25 EA

Therapeutic Philebotomy at Donor Center 2 EA

2014 Blood/Component Irradiation Fee 50 EA

Billing for Non-Routine Fee (includes work after 5 PM, Weekends and Holidays) 10 EA

Fee for Emergency transportation of patient samples to reference laboratory for blood bank reference testing, and return trip of suitable units for transfusion 9 EA

2017 Courier Service 9 EA 2018 GP 1 : Antigen Typing (# units) 9 EA 2019 GP 2 : Antigen Typing (# units) 5 EA 2020 GP 3: Antigen Typing (# units) 5 EA 2021 GP 4: Antigen Typing (#units) 0 EA