Solicitation 36C25623Q0128.pdf

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Attached to: 6515--BLOOD AND BLOOD PRODUCTS
Solicitation number: 36C25623Q0128
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 16

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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. UEI: EFT:

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. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25623Q0128

11-11-2022

15:00 CST

00586 Department of Veterans Affairs G.V. (Sonny) Montgomery VAMC

1500 E. Woodrow Wilson Dr.

Jackson MS 39216

325414

1250 Employees

N/A

00586

Department of Veterans Affairs Central Arkansas Veterans Healthcare Sys A&MM Service (90C) 4300 West 7th Street Little Rock AR 72205

10N16

Department of Veterans Affairs G.V. (Sonny) Montgomery VAMC A&MM Service (90C) 715 South Pear Orchard Road Ridgeland MS 39157

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 invoice must be submitted electronically

1-877-489-6135

See CONTINUATION Page

Blood & Blood Products See Statement of Work

See Addendum to 52.212-1 Instruction to Offerors for Instructions on proposal submission.

See CONTINUATION Page

X X

Table of Contents

SECTION A ...................................................................................... Error! Bookmark not defined.

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

AND COMMERCIAL SERVICES ...................................... Error! Bookmark not defined.

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

I. STATEMENT OF WORK

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2021)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 72

C.7 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.8 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 75

C.10 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020)

(DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C256

Department of Veterans Affairs

715 S. Pear Orchard

Plaza 1

Ridgeland, MS 39157

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

[X] 52.232-33, Payment by Electronic Funds Transfer—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.

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

AMENDMENT NO DATE

VA256-17-R-0098

Central Arkansas Veterans Healthcare System

4300 West 7th Street

Little Rock, AR 72205

STATEMENT OF WORK

Pathology & Laboratory Medicine Service (P&LMS) Blood, Blood Products and Testing Services

I. STATEMENT OF WORK

A. Quality of the Product

1. All whole blood and blood components provided to patients in the VA medical center must meet the requirements of the American Association of Blood Banks (AABB) and/or the Food and Drug Administration (FDA), Department of Health and Human Services. The period of performance will be from 1 December 2022 to November 30 2027 for a base plus 4 year contract.

2. Allogeneic blood/blood components must be typed for ABO and Rho (D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB.

a. All blood must be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label must also bear the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn.

b. All blood supplied must be free of hemolysis, clots, and excessive chyle.

3. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by the FDA.

4. The Contractor shall supply 100% “volunteer donor” blood as defined in 21CFR606.121(c)(5)(ii) . All blood/blood components must be collected from donors in accordance with the requirements of the AABB and the FDA.

5. In the event of a recall, Contractor shall promptly send copies of the recall request to the Blood Bank Medical Director at the VA medical center where the blood product was issued.

6. Contractor shall make reference transfusion services available to the VA medical center. The offeror must be capable of providing the blood components and specialized testing detailed in the Schedule of Supplies/Services and Prices/Costs (the Schedule) on a 24-hour per day, seven days per week basis.

7. The VA medical center reserves the right to inspect the contractor’s facilities at a mutually agreed upon date and time and has the authority to inspect quality, quantity and verify adherence by the contractor to the technical requirements of the contract.

B. Changes in Testing Requirements for Transfusion Transmitted Diseases

In the event that additional testing for transfusion transmitted diseases is nationally mandated by the FDA during the contract period, specific price adjustments may be requested by the supplier to address the cost for the additional testing. In the event that this should occur, a letter detailing the rationale for the price increase must be submitted to the Contracting Officer at least 30 days before the intended implementation date.

C. Donor Requirements

1. The contractor shall maintain readily available blood donor lists, including names, addresses, and social security numbers. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to the VA under this contract.

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

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

3. Each unit of blood collected through voluntary donation must minimally be tested and found negative for the following:

• hepatitis B surface antigen (HBsAg)

• antibodies to hepatitis B core (anti-HBc)

• antibodies to hepatitis C (anti-HCV)

• antibodies to human immunodeficiency virus, type 1 and type 2 (anti-HIV1 and anti-

HIV2)

• antibodies to human T lymphotropic virus, type 1 and type 2 (anti-HTLV-I and anti-

HTLV-II)

• genetic viral material to detect HIV type 1 and HCV by nucleic acid amplification

• West Nile virus

• syphilis

4. Each platelet component must be tested for bacterial contamination in accordance with AABB standard 5.1.5.1 effective March 1, 2004.

D. Contractor Requirements

1. The contractor shall have the following licenses and or registrations and shall make them available for review by the VA medical center with the proposal:

a The Contractor shall maintain 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.

b. If the Contractor is involved in interstate shipment of blood or blood component is involved, the Contractor must maintain approval authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262.

c. The Contractor's blood bank must maintain registration and/or licensing 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 at all times during the contract period.

e. Certificate of Accreditation under the Clinical Laboratory Improvement Act of 1988 or current certification by the College of American Pathologists.

2. Contractor will protect any Veterans’ personal and medical information required by the contractor to provide blood products which compromise the Veteran’s information’s security or privacy, exposing the Veteran to identity theft, credit fraud, and other financial woes.

Certification and Accreditation requirements do not apply, and a Security Accreditation Package is not required.

E. Orders/Deliveries

1. Orders will be categorized into three types: routine, as soon as possible and STAT. These categories are defined as follows:

a. Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.

b. As Soon As Possible (ASAP) – Shipments of blood products to fill a request for a waiting outpatient, or a non-life threatening need, or to replenish a depleted inventory of a particular blood product which has been used since the previous routine delivery. ASAP orders must be delivered within four (4) hours.

c. STAT – A need for blood products so acute that a patient’s life could be jeopardized if the request for blood products is unfulfilled. STAT orders must be delivered within one (1) hour.

2. Contractor shall make delivery services for blood and blood components available to VA site 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).

3. The specific volumes distributed in a routine order will be established by the VA Medical Center Transfusion Service. Within ten days after contract award, the contractor shall submit a proposed delivery and route schedule, identifying specific times and room number(s) for approval. Schedule may be adjusted periodically.

4. Products will be leukoreduced unless ordered on a site-specific basis.

5. Once units are received by the VA medical center, those units become the property of the VA medical center, and payment will be made appropriately, based on contract terms and proper invoicing. They are not to be treated as though they are on consignment. However, for inventory control purposes, efforts will be made by the VA medical center to assist the contractor and other facilities in meeting patient transfusion needs.

6. The VA will comply with all requirements and regulations associated with the recall and withdrawal of blood or blood components from its inventory due to health and safety risks.

7. Efforts will be made to assist the supplier in hosting blood donor drives at the VA medical center(s) in those cases where it can be reasonably accommodated by the hosting VA site, and where there are no previous commitments to other blood centers, including the Department of Defense. The annual number of blood donor drives will be negotiated between the contractor and the VA medical center.

F. Shelf Life

1. All blood/blood components must be labeled, stored, and shipped in accordance with the current regulations of both the FDA and the AABB. In the event that these regulations change during the course of the contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies.

2. For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below.

Allogeneic blood/blood components Appropriate Remaining Shelf Life

Whole Blood Shelf life more than 21 days, regardless of anti-coagulant

Red Blood Cells Shelf life more than 21 days, regardless of anti-coagulant

Fresh Frozen Plasma Shelf life more than 60 days

Platelets (random) Shelf life more than 48 hours

Plateletpheresis Shelf life more than 48 hours, if not ordered/collected for a specific patient

Cryoprecipitate Shelf life more than 60 days

3. For ASAP and STAT orders, the contractor shall provide units with the appropriate remaining shelf life whenever possible, however, the VA understands that the urgency of the situation and the availability of the blood product may preclude this possibility.

4. 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.

G. Value Added Services

1. Contractor shall provide physician consultative services to the VISN 16 VA medical center that are consistent with the services offered to other non-VA contracted customers. A description of the services must be included with the offeror’s proposal.

2. Contractor shall provide educational programs to the VISN 16 VA medical center that are consistent with the programs offered to other non-VA contracted customers. A description of the educational programs must be included with the offeror’s proposal.

H. Security

Information Systems Officer, Information Protection:

The contractor will not have access to VA Desktop computers and nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer:

The contractor will have access to protected Patient Health Information (PHI) and they will not have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $_37.50_____ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete

Records Manager:

1. Records Manager:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their

[Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a).

These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C.

2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity.

When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

8. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The [Agency] owns the rights to all data and records produced as part of this contract.

All deliverables under the contract are the property of the U.S. Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

I. Definitions

ALLOGENEIC: Blood or blood components drawn from a non-related donor for subsequent transfusion to a patient (synonymous with homologous).

ANTIBODY WORK-UP: Serological work-up performed on potential transfusion recipients, per patient per episode (set of examples); may be defined as simple or complex.

AUTOLOGOUS: Blood drawn from a donor-patient for subsequent transfusion; in this case, restricted to pre-deposit units of blood, i.e., not including intra-operative or post-operative blood salvage.

BLOOD GROUP: ABO Blood group plus the Rho(D) type of the unit, specifically O+, O-, A+, A-, B+, B-, AB+, AB-.

CMV NEGATIVE: Unit from a donor who has been screened for antibody to Cytomegalovirus and deemed to be negative. Use of CMV negative blood components are indicated in those patients who are undergoing transplantation or are otherwise severely immunocompromised.

COMPONENT (BLOOD COMPONENT): Portion of a unit of whole blood which has been physically separated by some mechanical means, e.g., centrifugation.

CRYOPRECIPITATE: Plasma component which has been prepared to contain high concentrations of Factor VIII and fibrinogen. It is stored in the frozen state and thawed immediately prior to transfusion. Product is used for the treatment of specific coagulation factor deficiencies, such as von-Willebrand’s Disease, hypofibrinogenemia and uremic thrombocytopenia which have been shown to be irresponsive to DDAVP treatment.

DERIVATIVE: Portion of a unit of whole blood or blood component which has been chemically separated by some type of fractionation process. Examples include albumin, plasma protein fraction, intravenous gamma globulin, and various coagulation products.

FRESH FROZEN PLASMA (FFP): Plasma component that is stored in the frozen state and is thawed immediately prior to transfusion. Used for the treatment of significant multiple coagulation factor deficiencies or congenital factor deficiencies not treatable by cryoprecipitate.

These may be associated with massive transfusion, severe liver disease, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenia purpura, but not as a volume expander. Fresh frozen plasma 24 (FP24) is plasma frozen within 24 hours of collection and contains reduced levels of Factor VII and normal levels of Factor V. FP24 may be used interchangeably with FFP unless used to treat Factor VII deficiency.

HOMOLOGOUS: Blood or blood component drawn from a non-related donor for subsequent transfusion to a patient (synonymous with allogeneic).

IRRADIATED COMPONENT: Blood component that has been subject to a minimum central dose of 2500 cGy of irradiation.

LEUKOCYTE-REDUCED BLOOD COMPONENTS: Cellular products prepared by an approved filtration method.

PLATELETPHERESIS: Platelet component which is drawn from a donor using apheresis equipment, is stored in the liquid state, and is roughly equivalent to six to eight units of random platelets. Used for the treatment of significant thrombocytopenia as indicated for random platelets; however, it offers the advantage of minimizing donor exposures to prevent the patient from becoming refractory and/or contracting a transfusion transmitted disease.

PLATELETS (RANDOM): Platelet component that is prepared from a single unit of whole blood and is stored in the liquid state. Used for the treatment of significant thrombocytopenia associated with a variety of other clinical conditions, including active bleeding, massive transfusion, disseminated intravascular coagulation, and scheduled invasive procedures.

RECALL: A request from the supplier of blood component to return a specific unit(s) which was inadvertently issued to the VA medical center, regardless of the reason, or was issued to the VA medical center prior to the receipt of information about a donor which would have prevented such release.

RED BLOOD CELLS (RBC): Red cell components that remain in the liquid state, i.e., not frozen, regardless of anticoagulant. Used for the treatment of anemia which is not treated pharmacologically either due to etiology or time constraints.

ROUTINE ORDERS: Orders that are generally placed on a regular basis at a pre-established time to provide adequate inventory of specific blood components of specific blood groups.

SHELF LIFE: Number of days remaining prior to the expiration date from the date received in the facility.

SPECIAL TYPINGS: Typings for RBC antigens other than ABO and Rho(D); performed in order to find red blood cell units appropriate for patients who have developed unexpected antibodies.

STANDING ORDER: A type of routine order which allows for shipment of a specific volume of specific blood components according to an established delivery schedule; assists the supplier in projecting volumes of components required in order to improve recruitment and minimize waste.

VOLUNTEER DONOR: 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.

B.2 PRICE/COST SCHEDULE

Estimated quantities listed for each Contract Line Item (CLIN) are estimates of the total requirement for the described product. The Government may place orders at quantities less than the estimated total quantity as stated in the schedule of items. There is no express or implied guarantee that the quantities will be ordered regularly.

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2,000.00 EA __________________ __________________

16B Leukoreduced Red Blood Cells (Prestorage) Contract Period: Base POP Begin:

POP End:

255.00 EA __________________ __________________

16I Irradiated Leukoreduced Red Blood Cells (Prestorage) Contract Period: Base

43.00 EA __________________ __________________

16CP Leukoreduced Red Blood Cells CPD Unit Contract Period: Base

6.00 EA __________________ __________________

16CPI Irradiated Leukoreduced Red Blood Cells CPD Unit Contract Period: Base

2.00 EA __________________ __________________

20 Autologous Red Blood Cells (Prestorage Leukoreduced) Contract Period: Base

24C Autologous Red Blood Cells - Collected by Apheresis Contract Period: Base

12.00 EA __________________ __________________

44 Cryoprecipitate - Whole Blood Derived (from 200 ml plasma) Contract Period: Base

50.00 EA __________________ __________________

44PD5 Pooled Cryoprecipitate - (5) Whole Blood Derived Contract Period: Base

216.00 EA __________________ __________________

61 Leukoreduced Platelets - Collected by Apheresis (Full Dose> or = 3.0X10(11)) Contract Period: Base

112.00 EA __________________ __________________

61I Irradiated Leukoreduced Platelets - Collected by Apheresis (Full Dose> or = 3.0X10(11)) Contract Period: Base

10.00 EA __________________ __________________

62 Leukoreduced Platelets - Collected by Apheresis (HLA Matched) (Full Dose) Contract Period: Base

63 Leukoreduced Platelets - Collected by Apheresis (Partial Dose) Contract Period: Base

40 AFFP (250 +/- 25ml) x2 Apheresis Derived Contract Period: Base

40PED AFFP (100 +/- 10ml) x1 Apheresis Derived Contract Period: Base

42PED FP-24 (Frozen < 24 hours) 1 x 100ml (100 +/- 10ml) Contract Period: Base

100.00 EA __________________ __________________

40-2 AFP-24 ( 250 + 25ml) x 1 Apheresis Derived Contract Period: Base

42 FFP-WBD 1 x 250ml (250 + 25 ml) Whole Blood Derived Contract Period: Base

200.00 EA __________________ __________________

42HR FP-24 (Frozen < 24 hours) 1 x 250ml (250 + 25ml) Contract Period: Base

1.00 EA __________________ __________________

40CCP COVID-19 Convalescent Plasma (CCP) ~200 ml dose, High Titer Contract Period: Base

11 Red Blood Cells - Washing Fee Contract Period: Base

12 Red Blood Cells - Freezing and Deglycerolization Fee Contract Period: Base

5.00 EA __________________ __________________

14 CMV Negative Blood Product (Available Inventory) Contract Period: Base

34 Platelet Washing Fee (plus plasma) Contract Period: Base

168.00 EA __________________ __________________

LVDS Platelet Large Volume Delayed Sampling Fee Non-refundable on returned units Contract Period: Base

4.00 EA __________________ __________________

L16 STAT Component Modification Fee Contract Period: Base

7.00 EA __________________ __________________

98 Irradiation Procedure Fee Contract Period: Base

CPD CPD Manufacturing Fee Contract Period: Base

97 Directed Donor Handling Fee Contract Period: Base

96 Autologous Donor Handling Fee Contract Period: Base

14.00 EA __________________ __________________

01A ABO-Rh Contract Period: Base

02A Direct Antiglobulin Test (Coombs Test) - single Contract Period: Base

L03 Antibody Screen Contract Period: Base

L04 Antibody Identification Contract Period: Base

04A Cold Agglutinin Low Temperature Screen Contract Period: Base

8.00 EA __________________ __________________

04B Antibody Elution and Red Cell Panel Contract Period: Base

04E Antibody Absorption and Red Cell Panel Contract Period: Base

36.00 EA __________________ __________________

04F Additional Red Cell Antibody Panel Contract Period: Base

13.00 EA __________________ __________________

L08 After-Hours Tech Call Fee: Surcharge per patient request Contract Period: Base

40.00 EA __________________ __________________

RH2 C Antigen Type Contract Period: Base

76.00 EA __________________ __________________

RH3 E Antigen Type Contract Period: Base

22.00 EA __________________ __________________

RH4 c Antigen Type Contract Period: Base

RH5 e Antigen Type Contract Period: Base

RH8 Cw Antigen Type Contract Period: Base

MS1 M Antigen Type Contract Period: Base

MS2 N Antigen Type Contract Period: Base

29.00 EA __________________ __________________

MS3 S Antigen Type Contract Period: Base

MS4 s Antigen Type Contract Period: Base

85.00 EA __________________ __________________

K1 K Antigen Type Contract Period: Base

K2 k Antigen Type Contract Period: Base

K3 Kpa Antigen Type Contract Period: Base

47.00 EA __________________ __________________

FY1 Fya Antigen Type Contract Period: Base

FY2 Fyb Antigen Type Contract Period: Base

18.00 EA __________________ __________________

JK1 Jka Antigen Type Contract Period: Base

37.00 EA __________________ __________________

JK2 Jkb Antigen Type Contract Period: Base

LE1 Lea Antigen Type Contract Period: Base

LE2 Leb Antigen Type Contract Period: Base

P1 P1 Antigen Type Contract Period: Base

DI3 Wra Antigen Type Contract Period: Base

AB4 A1 Type - Lectin A1 Type Contract Period: Base

WDV Partial D Weak D Testing Contract Period: Base

OTH Rare Antigen Type - Ag types requring rare antisera or genotyping Contract Period: Base

12B Compatibility Test (Allogeneic) per Unit - Full Crossmatch (AHG) Contract Period: Base

L13 Pretreatment of Serum Contract Period: Base

L14 Pretreatment of RBCs Contract Period: Base

L17 Complete Red Blood Cells Phenotype Contract Period: Base

RHD Partial D typing by molecular method Contract Period: Base

RHC RHCE variant typing by molecular testing Contract Period: Base

RMT RBC Phenotype by Molecular Testing Contract Period: Base

EXT Extraction of DNA for Red Cell Phenotype by Molecular Testing Contract Period: Base

L85 Platelet Antibody Screen - Indirect Contract Period: Base

L88 Platelet Antibodies - Crossmatch (per strip) Contract Period: Base

L89 Hemoglobin S Screen (sickle cell) Contract Period: Base

F100 Freight Contract Period: Base

HLA Platelets-HLA macthing fee Contract Period: Base

Contract Period: Option 1

3.0X10(11)) Contract Period: Option 1

Dose> or = 3.0X10(11)) Contract Period: Option 1

(Full Dose) Contract Period: Option 1

Contract Period: Option 1

40PED AFFP (100 +/- 10ml) x1 Apheresis Derived Contract Period: Option 1

Contract Period: Option 1

Titer Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1 on returned units Contract Period: Option 1

Contract Period: Option 1

96 Autologous Donor Handling Fee Contract Period: Option 1

Contract Period: Option 1

MS1 M Antigen Type Contract Period: Option 1

MS2 N Antigen Type Contract Period: Option 1

Contract Period: Option 1

AB4 A1 Type - Lectin A1 Type Contract Period: Option 1

WDV Partial D Weak D Testing Contract Period: Option 1 genotyping Contract Period: Option 1

Contract Period: Option 1

HLA Platelets-HLA macthing fee Contract Period: Option 1

16B Leukoreduced Red Blood Cells (Prestorage) Contract Period: Option 2

Contract Period: Option 2

3.0X10(11)) Contract Period: Option 2

Dose> or = 3.0X10(11)) Contract Period: Option 2

(Full Dose) Contract Period: Option 2

Contract Period: Option 2

Titer Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2 on returned units Contract Period: Option 2

Contract Period: Option 2

MS3 S Antigen Type Contract Period: Option 2

Contract Period: Option 2

OTH Rare Antigen Type - Ag types requring rare antisera or genotyping Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 3

16I Irradiated Leukoreduced Red Blood Cells (Prestorage) Contract Period: Option 3

Contract Period: Option 3

3.0X10(11)) Contract Period: Option 3

Dose> or = 3.0X10(11)) Contract Period: Option 3

(Full Dose) Contract Period: Option 3

Contract Period: Option 3

Titer Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3 on returned units

Contract Period: Option 3

MS4 s Antigen Type Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3 genotyping Contract Period: Option 3

12B Compatibility Test (Allogeneic) per Unit - Full Crossmatch (AHG) Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 4

16CP Leukoreduced Red Blood Cells CPD Unit Contract Period: Option 4

Contract Period: Option 4

3.0X10(11)) Contract Period: Option 4

Dose> or = 3.0X10(11)) Contract Period: Option 4

(Full Dose) Contract Period: Option 4

Contract Period: Option 4

Titer Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4 on returned units Contract Period: Option 4

L16 STAT Component Modification Fee Contract Period: Option 4

Contract Period: Option 4

RH3 E Antigen Type Contract Period: Option 4

Contract Period: Option 4

LE1 Lea Antigen Type Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4 genotyping Contract Period: Option 4

Contract Period: Option 4

L13 Pretreatment of Serum Contract Period: Option 4

Contract Period: Option 4

GRAND TOTAL __________________

Guaranteed Minimum for the contract is $300,000.00.

Maximum Amount for the life of the contract is $7,000,000.00.

B.3 DELIVERY SCHEDULE

ITEM NUMBER DELIVERY DATE

0001-

Base

1001-

Option 1

2001-

Option 2

3001-

Option 3

4001-

Option 4

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of…

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