S02 Blood Bank Products St. Cloud VAMC 36C26324R0134.docx

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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

656-25-1-044-0015

36C26324R0134 08-09-2024 Jeffrey Brown 651-293-3009 08-30-2024 17:00

CDT

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

X

325414 1250 Employees

N/A

Department of Veterans Affairs St. Cloud VAMC

4801 Veterans Drive St. Cloud MN 56303

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

Y

Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page Provide blood bank products and services to the St. Cloud VAMC in accordance with the Performance Work Statement and Price Schedule below.

Prior to submitting a quote, review all documentation within.

Review and follow INSTRUCTIONS TO OFFERORS In Clause 52.212-1 Addendum.

Contract Ordering Period with estimated pricing periods of:

Base Portion of the Ordering Period: 10/01/2024-09/30/2025 Year One of the Ordering Period: 10/01/2025-09/30/2026 Year Two of the Ordering Period: 10/01/2026-09/30/2027 Year Three of the Ordering Period: 10/01/2027-09/30/2028 Year Four of the Ordering Period: 10/01/2028-09/30/2029

See CONTINUATION Page 656-3650160-044-822300 Laboratory-2560 Medical Care Contract an-010022300

Jeffrey Brown

VA-VHA-RPOC-2024-0033

Table of Contents

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 36C263 Jeffrey Brown

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

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

3. INVOICES: Invoices shall be submitted in arrears:

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:

B.2 PRICE/COST SCHEDULE

This Indefinite Quantity contract minimum guarantee is $2,000.00; the maximum spend (ceiling price) shall not exceed $1,200,000.00.

See attached S02 Item Schedule.

B.3 Performance Work Statement Blood Product Supply and Transfusion Related Referral Lab Testing

1. General Requirements:

Contractor will provide the St. Cloud VA Healthcare System, 4801 Veterans Dr, St. Cloud, MN 56303, herein after referred to as SCVAHCS, with blood products and transfusion related referral lab testing as specified in the schedule of items.

1.A. Schedule of items:

Listed below are products and services required by SCVAHCS from Contractor. The quantities as listed in this Schedule of Items are estimated yearly requirements. The SCVAHCS attempt to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from quantities as listed below. All products and services will be requested on an “on demand, as needed” basis.

The SCVAHCS may require an unexpected blood product or reference laboratory test that is not listed in the Schedule of Items but available from the Contractor. In this event, SCVAHCS will pay for it at the open market list price and apply it towards the Misc. Emergency Blood Products or Testing Services category. SCVAHCS will track usage and submit requests to VA contracting to update the Schedule of Items via a contract modification, if necessary. These items will be considered part of the overall contract value and together with the other tests cannot exceed the total estimated contract value.

If additional fees are anticipated, contractor must submit pricing with their response to the solicitation.

Schedule of Items:

2. Specifications of Contractor:

A. All blood products offered must be provided from a blood bank that is currently registered and/or licensed with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 260.

B. The Contractor must make paper copies available of the “Circular of Information for the Use of Human Blood and Blood Components”, which, by FDA regulation, must be available to all prescribing physicians.

C. The Contractor shall submit upon request that it holds 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 U.S.C. Section 262, as a source of supply for biological products.

D. Contractor must provide products from blood banks that are able to provide SCVAHCS with 100% volunteer donor blood in accordance with FDA rules and regulations.

i. Definition of a “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.”

E. The Contractor and its health-care providers will be liable for their liability-producing acts or omissions. The Contractor will 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 subdivision of a State that either provides for self-insurance or limits the liability of the amount of insurance purchased by State entities, then the insurance requirement of this contract will be fulfilled by incorporating the provisions the applicable State law. The Contractor, upon request of the contracting officer, prior to contract award, will furnish evidence of the insurability of the Contractor and/or of all health-care providers who will perform under this contract. The submission will provide evidence of insurability concerning the medical liability insurance required as described above or the provisions of State law as to self-insurance, or limitations on liability or insurance.

F. The Contractor must provide 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 will not be effective until 30 days after the insurer or the Contractor gives written notice to the contracting officer. Certificates or polices will be provided for the Contractor and/or each health-care provider who will perform under this contract.

G. The Contractor must notify the contracting officer, or any of the health-care providers performing under this contract, of any change in insurance providers during the performance period of this contract. The notification will provide evidence that the Contractor and/or health-care providers 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 polices, if applicable.

H. The Contractor must obtain all necessary licenses and/or permits required to performed work described in this contract. Contractor will take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. The Contractor will 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 or negligence, and will maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of Minnesota. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, will not be the responsibility of the Contractor here under with the regard to any claims, loss, damage, injury, and liability resulting there from.

I. TheContractor on request shall present evidence of their current technical capability to provide blood products which pass acceptable standards for blood banks per the Association for the Advancement of Blood and Biotherapies (AABB).

J. The Contractor on request shall provide a current accreditation document from Clinical Laboratory Improvement Amendments (CLIA) showing that their laboratory has successfully passed inspection.

K. Upon request, the Contractor must provide evidence of their quality process, proficiency testing, and surveillance by accreditation agencies.

3. Collection Requirements:

A. Minimum collection requirements contractor must follow:

i. All blood products are to be collected by the closed system under aseptic conditions and will be processed in appropriate solutions and the container so labeled.

ii. A sample of blood from each donation will be tested for infectious diseases and all testing shall comply with current AABB Standards and the Code of Federal Regulations, 21 CFR Parts 606, 607, 610, 630, 640, 660, governing blood products.

iii. Products must be non-reactive for infectious disease marker prior to shipment, except with the express written authorization of the VA Blood Bank Medical Director or his/her designee.

iv. The contractor will utilize methods to limit introduction of bacteria during collection and processing of blood products, in accordance with current AABB Standards.

v. Each platelet component must be tested for bacterial contamination using a FDA approved commercial detection system, or use pathogen reduction technology, in accordance with current AABB Standard.

vi. The contractor will immediately notify SCVAHCS if subsequent testing indicates the supplied platelets may be contaminated with bacteria.

B. Donor Requirements

i. The contractor will ensure that all donor and blood component records are identified and traceable.

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

iii. The contractor will maintain 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 SCVAHCS under this contract.

a. Under no circumstances will the contractor ever reveal the identity of the blood donor.

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

v. Each voluntary donation must be minimally tested for the following infectious diseases:

a. Hepatitis B Surface antigen (HBsAg)

b. Antibodies to hepatitis B core (anti-HBc)

c. Antibodies to hepatitis C (anti-HCV)

d. Antibodies to human immunodeficiency virus, type 1 and type 2 (anti-HIV1 and anti-HIV2)

e. Antibodies to human T lymphotropic virus type 1 and type 2 (anti-HTLV-1 and anti-HTLV-II)

f. Genetic viral material to detect HIV type 1 and HCV by nucleic acid amplification

g. Syphilis

h. Zika

i. Babesia

4. Minimum Labeling Blood Product Requirements:

A. All blood products will be typed and labeled for ABO and Rh antigens in accordance with methods recommended in the current AABB Standards and Technical Manual.

B. All labels on blood products must be compatible with SCVAHCS VBECS computer system.

C. The label will also indicate 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.

D. ISBT-128 labeling must be used on all blood products offered to SCVAHCS.

5. Ordering methods and procedures:

A. Contractor shall define the preferred method of ordering. If preferred method is a web-based portal or computer-based ordering system of any type, implementation is dependent on being found acceptable for use by the ISO (Informational Security Officers) in the VA Healthcare System. If deemed unacceptable for use, there will be no extra charges that incur to the Government for an alternative process of ordering.

(For Contractor to fill out):

Contractor’s preferred method of ordering: __________________________________________

B. A back up method of placing the order via telephone must be readily available in the instance the preferred method will not work.

(For Contractor to fill out) Contractor’s point of contact: ___________________ Contractor’s Telephone Number for ordering:

Contractor’s Telephone Number for issues with Ordering: ___________________________ C. Standing Orders: SCVAHCS will establish standing orders with the contractor for various blood products. Multiple standing orders can be established at no additional cost to the Government, if necessary. Contractor must be flexible with making adjustments to the standing order(s) if requested.

D. Routine, ASAP, or STAT orders: SCVAHCS will place additional orders stating the products and quantities on an on-demand, as needed basis via the contractors preferred or backup ordering method. Urgency of order will be determined by the SCVAHCS. SCVAHCS laboratory personnel may need to place orders Monday through Friday, excluding Federal Holidays, between the hours of 0600 and 1800 CST. Names of lab personnel authorized to place, accept, or reject orders will be provided to the contractor upon request.

6. Packaging, Shipping, and Delivery Time Requirements:

A. Packaging for delivery:

i. All blood products delivered under this contract will be properly packaged and insulated in such a way as to ensure that a proper temperature appropriate for the product is maintained during transport between the contractor’s place of business and the SCVAHCS.

a. Red blood cells: Proper in-transit temp is +1C to +10C, packaged with wet ice.

b. Platelet Products: Proper in-transit temp is +20C to +24C.

c. Frozen Products: Must maintain frozen state.

ii. Blood products must be collected, stored, prepared, tested, and shipped in accordance with FDA regulations, AABB Standards, and U. S. Department of Transportation (DOT) requirements.

B. Shipping:

i. Contractor will be responsible for providing courier service to transport blood products to the SCVAHC and pick-up blood product returns, extra boxes, and specimens for reference laboratory testing. Courier service must be available Monday through Friday, excluding Federal Holidays, between the hours of 0600 and 1800 CST.

ii. Contractor will make a minimum of one scheduled delivery per week to SCVAHCS Mon through Friday, excluding Federal holidays, between the hours of 0600 and 1800 CST. Additional scheduled deliveries may be added at no additional cost to the Government, if necessary, through mutual agreement between contractor and the SCVAHCS. The contractor must be able to provide additional deliveries for orders that cannot wait until the next scheduled delivery.

iii. Contractor will define expected delivery times based on order type.

iv. St. Cloud Address/Hours:

St. Cloud Laboratory Building 1 Basement 4801 Veterans Drive St. Cloud, MN 56303 Hours: Mon-Fri, 0600-1800 CST C. Delivery time requirements:

i. Standing orders: planned and recuring deliveries will be made at mutually agreed upon day(s) between contractor and the SCVAHCS.

ii. Routine orders: deliveries will be made on the next scheduled delivery day. SCVAHCS will be flexible with routine orders to accommodate local transfusion needs.

iii. ASAP orders: products will be out the door within 4 hours of order.

iv. STAT orders: products will be out the door within 1 hour of order. Delivery time is variable but shall not exceed 1.5 hours for the SCVAHCS. Blood must be available Monday through Friday, excluding Federal Holidays, between the hours of 0600 and 1800 CST.

D. Once units are received at SCVAHCS, those units become their property, and payment will be made appropriately, based on contract terms and proper invoicing. For inventory control purposes, efforts will be made by SCVAHCS to assist the contractor and other facilities in meeting patient transfusion needs. Products may be transferred to and from other local hospitals as long as both sites are serviced by the same contractor and contractor is in agreement with the transfer arrangements. In the event contractor does not service any local hospitals for SCVAHCS, contractor must supply STAT blood products at no additional cost to the Government, allow rotation of blood product inventory (to include at minimum red blood cells and platelets), and meet the delivery time requirements.

7. Acceptance and Rejection Criteria for Blood Products:

A. All blood components will be labeled, stored, and shipped in accordance with the current regulations of the FDA, AABB and DOT. In the event these regulations change during the contract, the contractor will implement the necessary changes as directed/recommended by the regulatory and accrediting agencies. The contractor must notify both sites of any changes. All blood products supplied will be grossly free of hemolysis, excessive chyle, and clots.

i. Additional criteria for red blood cells:

a. The individual units must be visually inspected for any abnormality in color or physical appearance and for any indication of microbial contamination. If evidence exists, the units will not be accepted into inventory.

b. Units must have at least four segments remaining.

ii. Additional criteria for platelet products:

a. The individual units must be visually inspected for any abnormality in color or physical appearance and for any indication of microbial contamination. If evidence exists the units will not be accepted into inventory.

B. Shelf life of blood products that will be found acceptable:

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

a. Whole Blood: Shelf life more than 21 calendar days, regardless of anti-coagulant

b. Red Blood Cells: Shelf life more than 21 calendar days, regardless of anti-coagulant

c. Fresh Frozen Plasma: Shelf Life more than 60 calendar days

d. Platelets (random): Shelf life more than 48 hours

e. Cryoprecipitate: Shelf life more than 60 days

8. Credit for Returned or Rejected Blood Products:

A. Credit will be given when blood is delivered with a shelf life of 10 days or fewer. The contractor may contact SCVAHCS if the only product available has a short shelf life, and it is the only blood available to meet the patient’s needs. The SCVAHCS can determine whether to accept or reject the blood available to meet the patient’s needs.

B. The contractor will provide credit for products that are put into quarantine at their direction, which either expire while in quarantine, or if SCVAHCS is unable to use due to the extended time the products were out of circulation.

C. When blood products do not meet the acceptance criteria. Acceptance criteria may be based on abnormalities in physical appearance, indications of contamination, product temperature on receipt, and other criteria regarding the quality or acceptability of blood products.

D. Full credit will be given for frozen plasma that ruptures during thaw.

E. Contractor will make an effort to work with SCVAHCS to return red blood cells to rotate stock and avoid components from expiring on the shelf. Credit shall be given. Vendor shall provide minimum return requirements such as minimum days until expiration and minimum remaining segments.

9. Recalled and Defective Products: The contractor will immediately notify SCVAHCS when information is discovered indicating that a blood product may not be considered safe.

A. As appropriate, the contractor will replace and/or reimburse recalled/defective products at no cost to the government.

B. With respect to blood manufactured by the contractor, contractor will provide the following notifications to SCVAHCS.

i. Within 3 calendar days if blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection.

ii. Within forty-five (45) calendar days of the test, the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA

iii. As set forth in 21 C.F.R 610.46-610.48.

10. TRALI Risk Reduction Strategies: Transfusion-related acute lung injury (TRALI) is a major cause of transfusion-related morbidity and mortality. The contractor will implement all published AABB recommendations and Standards regarding donor management strategies to reduce the risk of TRALI, and must inform SCVAHCS in writing of any changes to their TRALI risk reduction plan. An updated risk reduction plan will be sent to each site annually.

11. Reporting of Adverse Transfusion Events: SCVAHCS will keep complete and accurate records, as required by law, of patients transfused with any blood products. SCVAHCS will report any possible transfusion-transmitted infections or other serious complications associated with transfusion to the contractor. SCVAHCS will co-operate with the contractors’ investigation of any adverse event and supply information concerning the recipient of the blood product to the contractor on forms provided by the contractor. Patient information will only be shared if deemed necessary by the AABB, FDA, or Department of Health regulations. In this event, the SCVAHCS privacy officers may need to provide written approval.

12. Immunohematology Reference Laboratory Services:

A. Availability and turn-around times: Immunohematology Reference Laboratory (IRL) Services for red cell antibody identification must be available twenty-four hours per day, seven days per week, and must provide test results and antigen negative blood products within twenty-four hours for urgent clinical situations, and within forty-eight hours in non-urgent situations.

i. The reference laboratory must keep SCVAHCS informed if the required testing is going to exceed the listed timeframe.

ii. Tests that will be performed are specified in the “1.A Schedule of Items” section.

13. Government Roles and Responsibilities:

A. The SCVAHCS shall designate a Technical Representative to coordinate and monitor the work to be completed under this contract. Contact information is listed below.

Technical Representative:

TBD

14. Performance Measures:

A. The following performance measures will be regularly tracked and monitored throughout the effective period of this contract by the SCVAHCS Technical Representative and reported to the Contracting Officer. Acceptable performance on these measures, along with other factors, will be primary indices of contractor performance and a key consideration in contract renewal decisions.

Performance will be monitored using the following criteria:

15. Security Requirements The Contractor shall adhere to the following sections of the IT Contract Security Clause below:

1. General Security/Privacy Clause

2. Access to VA Information and VA Information Systems Clause

3. VA information Custodial Language Clause

6. Security Incident Investigation Clause

7. Liquidated Damages for Data Breach Clause

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

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/subcontractor 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 COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 5 days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 5 days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor.