36C25623Q0569.pdf

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Attached to: 6515--Blood Products and Services
Solicitation number: 36C25623Q0569
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

36C25623Q0569 03-14-2023

Lakeisha White 601-362-4771 X56378 03-21-2023

15:00 CDT

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

1500 E. Woodrow Wilson Dr.

Jackson MS 39216

325414

$41.5 Million

N/A

00586

Department of Veterans Affairs G.V. Sonny Montgomery VAMC Pathology & Laboratory Medicine 1500 E. Woodrow Wilson Jackson MS 39216

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

X 1

36C25623Q0569

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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 (DEC 2022)

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) ... 34

C.7 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.8 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 37

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 (DEC 2022)

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 (DEC 2022)

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

G.V. (Sonny) Montgomery VAMC

1500 E. Woodrow Wilson Dr.

Jackson MS 39216

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 [X] Monthly

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

Scope of Work for Blood Contract:

The contractor shall furnish blood and blood components, in suitable containers, to be delivered FOB Destination within consignee’s premises, to the G.V. (Sonny) Montgomery VA Medical Center, 1500 Woodrow Drive, Jackson, MS 39216.

The blood shall be delivered as specified within twenty-four (24) hours following receipt of request. Emergency deliveries shall be delivered within one (1) hour after receipt of request. It is estimated that two to three emergency deliveries will be required each week. Empty containers, blood, and equipment being returned for credit shall be returned at contractor’s expense.

All blood received by the G.V. (Sonny) Montgomery VA Medical Center under this contract shall be properly packed and insulated in such a way as to ensure that 8 degrees Celsius is maintained during a normal automobile trip between contractor’s place of business and the G.V.

(Sonny) Montgomery VA Medical Center.

A. TYPING BLOOD

Blood shall be typed for ABO and Rh antigens in accordance with methods recommended in the current edition of “Standards for Transfusion Services” and the “Technical Manual of the American Association of Blood Banks (AABB)”. A sample of blood from each donation shall be tested for syphilis. Whole blood and/or components shall not be used for transfusion unless the test is nonreactive. In addition, only blood testing negative for antibody to human immunodeficiency virus (HIV), for human T-cell lymphotropic virus (HTLV), for hepatitis B surface antigen (HBsAg), for antihepatitis B core antigen (Anti-HBc), and for hepatitis C shall be used for transfusion.

(1) All blood is to be collected by the closed system under aseptic conditions and shall be processed in appropriate solutions and the container so labeled. The label shall also bear the expiration date of the contents in accordance with regulations.

(2) All blood supplied shall be grossly free of hemolysis, excessive chyle and clots.

(3) Reference Testing: Patient blood may be sent for reference testing to include antigen testing, antibody identification, etc. PLMS will provide the vendor with necessary treatment information such as transfusion history, medication, etc. to aid in testing resolution.

B. FDA REGISTRATION/LICENSE:

Offers shall be considered from those whose blood bank is currently 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.

C. U.S. LICENSE:

Prior to award the offeror must submit proof that the company holds an unrevoked U.S. license which is issued by the Director, Bureau of Biologic, FDA under Section 351 of the Public Health

Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood. Offers shall be accepted from offerors who are licensed and/or registered and in compliance with all Federal, State, County and City regulations

D. INTERSTATE SHIPMENTS:

If interstate shipment of blood components is involved, the offeror shall submit with the bid statement that such approval has been authorized under Public Health Service Act 351, as amended, 42 USC section 262.

E. DONORS, CONTAINERS, DELIVERY, ETC:

The offeror shall certify that he shall comply with the requirements outlined below with respect to donors, containers, delivery, etc.

(1) Offers will be considered only from blood banks that are able to provide the VA with 100% “volunteer donor” blood in accordance with the most current FDA rules and regulations. The definition of 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 cancellation of non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.

(2) Donor Requirement: The offeror shall maintain readily available blood donor lists including names, addresses, and social security numbers. Such lists shall indicate if, when and on what date blood of a particular donor was furnished to the G.V. (Sonny) Montgomery VA Medical Center. Donor selection shall be in accordance with criteria established by the FDA and/or the AABB.

F. REPORT OF SUSPECTED TRANSFUION TRANSMITTED INFECTION:

The VA shall report to contractor each case of suspected/ established transfusion transmitted infection. The contractor shall immediately review donor records for all units involved to verify that all tests were correctly interpreted and assure that the donor answered questions appropriately. A WRITTEN report shall be submitted by the contractor to the G.V. (Sonny) Montgomery VA Medical Center documenting the results of their investigation. Reports shall be submitted within two (2) weeks after notification of suspected transfusion infection. If report of investigation cannot be completed within the mandated two weeks after notification, the contractor shall provide a written acknowledgement advising of receipt of notification and give expected date of completion of report.

G. UNAVAILABLE SPECIFIC BLOOD REQUIREMENTS:

It the event of the unavailability of a specific blood requirement, the VA may go to another source to attain the required blood component. Documentation shall be maintained as to the date/time/person that was contacted from the contract source indicating they did not have the required item(s).

H. PAYMENTS:

The Contractor will be paid twice monthly in arrears upon receipt of an invoice for products delivered. All invoices shall include in each instance the invoice number and date. Each invoice shall represent charges covering the first day of the month to the 15th day of the month and the 16th day of the month to the last day of the month. Invoices are to be submitted by the 10th workday following the end of the weeks that are billed.

I. LICENSE INDEPENDENT PRACTIONERS:

The contracting entity shall ensure that all services provided by contracted individuals who are LIPs (Licensed Independent Practitioner) shall be within the scope of his or her privileges.

J. FURNISHING BLOOD

1. Blood shall be furnished labeled A,B,O and Rh type. Type A Rh negative and O Rh negative must have been drawn from donor not more than five (5) days before date on which purchase 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 time limits may be adjusted if a system for exchange on credit is provided which minimizes or precludes losses due to outdating.

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

K. SPECIAL CONTRACT REQUIREMENTS

1. HHS/OIG: To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services-Office of Inspector General (HHS/OIG), List of Excluded Individuals/ Entities on the OIG website (www.hhs.gov/oig) for each person providing services under this contract. Further the Contractor is required to certify in its proposal that all persons listed in the contractor’s proposal 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.

2. The contractor agrees to provide commercial services in accordance with the terms and conditions stated herein, to the Department of Veterans Affairs Medical Center, 1500 E.

Woodrow Wilson Drive, Jackson, Mississippi, at the prices in the Sections entitled Schedule of Cost and Schedule of Service of this contract.

3. Period of Performance: Five (5) Year Ordering Period. The contractor shall perform no services after the end of one performance period until the Contracting Officer authorizes such services in writing.

http://www.hhs.gov/oig

*Credit for Returned Blood: (Base Year)

Credit at the rate of $__Full___ shall be allowed for blood returned prior to the expiration date.

L. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. 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).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate

Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140- 2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR

LIQUIDATED DAMAGES FOR DATA BREACH

a. 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.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access).

(2) Description of the event, including:

(a) date of occurrence.

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code.

(3) Number of individuals affected or potentially affected.

(4) Names of individuals or groups affected or potentially affected.

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text.

(6) Amount of time the data has been out of VA control.

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons).

(9) Assessment of the potential harm to the affected individuals.

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate: and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. 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

NARA Records Management Language Clause:

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 while 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. G.V. Sonny Montgomery VAMC (GVSMVAMC) 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.

Contractor personnel shall sign VA Form 10-0708 “Employee Clearance from Indebtedness” before resigning or termination from Contractor working for GVSMVAMC and Facility Records Officer must sign form. A copy of completed signed VA Form 10-0708 (Contractor personnel and Facility Records Officer signatures) shall be place in each competency folder. 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 GVSMVAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public

GVSMVAMC 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 GVSMVAMC 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 GVSMVAC 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. TMS (Talent Management System) course VA 4192704: “Records Management for Everyone” [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

12. Flow-down of requirements to subcontractors:

a. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

b. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

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

1,000.00 EA __________________ __________________

Leukodepleted Red Blood Cells (RBC) Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

100.00 EA __________________ __________________

Fresh Frozen Plasma (FFP) Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Cryoprecipitate Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Apheresis Platelets Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

10.00 EA __________________ __________________

Washed Red Blood Cells (RBC) Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

50.00 EA __________________ __________________

Autologous Units Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Antigen Screens, Per Negative Unit Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Apheresis Platelets Irradiated Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

200.00 EA __________________ __________________

Irradiated Leukocyte Reduced Red Blood Cells (LABC) Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

8.00 EA __________________ __________________

Transfusion Medicine Technical Publications and CFR Updates Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Antigen Typing Class I: C, E, K, S, Lea, Leb (per unit) Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Antigen Typing Class II: Fya, Fyb, Jka, Jkb, M, N (Per Unit) Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Antigen Typing Class III: e, s, high frequency (per unit) Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Contract Period: Ordering Period 1 POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Contract Period: Ordering Period 2 POP Begin: 04-01-2025 POP End: 03-31-2026 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Contract Period: Ordering Period 3 POP Begin: 04-01-2026 POP End: 03-31-2027 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

Contract Period: Ordering Period 4 POP Begin: 04-01-2027 POP End: 03-31-2028 PRINCIPAL NAICS CODE: 325414 - Biological Product (except Diagnostic) Manufacturing

GRAND TOTAL __________________

Guaranteed Minimum for the contract is $500,000.00.

Maximum Amount for the life of the contract is $4,000,000.00.

B.3 DELIVERY SCHEDULE

ITEM NUMBER DELIVERY DATE

0001-0013

04/01/23-03/31/24

1001-1013 04/01/24-03/31/25

2001-2013

04/01/25-03/31/26

3001-3013

04/01/26-03/31/27

4001-4013

04/01/27-04/01/28

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(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 the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

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File details come from the government source that posted it. Updated Mar 14, 2023.