36C26021R0039.docx

36C26021R0039

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C26021R0039 07-02-2021 Ross Byrne 253-888-4922 07-13-2021

11:00 AM

PDT

Department of Veterans Affairs Network Contracting Office 20 5115 NE 82nd Ave, Suite 102 Vancouver WA 98662 X 621991 $35 Million Net 30 N/A X Department of Veterans Affairs Seattle VA Medical Center Lab 1660 S. Columbian Way Seattle WA 98108 Department of Veterans Affairs Network Contracting Office 20 5115 NE 82nd Ave, Suite 102 Vancouver WA 98662

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Contractor shall provide Blood Products and Testing services in accordance with the Statement of Work at the Seattle VA Medical Center.

The Government intends to award a single award Indefinite Delivery Indefinite Quantity (IDIQ) five-year contract.

Individual bulk funded task orders with be issued by the NCO 20 Contracting Office.

Period of Performance (POP): 08/01/2021 - 07/31/2026.

Offerors must comply with Offerors Submission Checklist in Section E.4, to be eligible for award.

See CONTINUATION Page X X X One Ross Byrne 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: To Be Determined

b. GOVERNMENT: Contracting Officer 36C260 Department of Veterans Affairs Network Contracting Office 20 5115 NE 82nd Ave, Suite 102 Vancouver WA 98662

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.

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

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

B.2 ORDERING PROCEDURES

An initial Task Order for Services will be issued by the VA Contracting Officer at the beginning of the contract’s period of performance. The Task Order will be emailed to the Contractor. The VA anticipates funding one Task Order per 12-months. If the value of a particular Task Order needs to be increased or decreased, a Modification will be done to the Task Order by a VA Contracting Officer. Task Orders will be bulk funded so that funds are already available when the VA requires product/services. Contractor shall not exceed the amount bulk funded without first receiving a Modification. VA’s requests for services will be in accordance with the Statement of Work. The Contractor shall invoice only for the quantities scheduled for delivery and actually delivered and accepted. The Government will place orders orally, facsimile, or by email to the Contractor.

B.3 CONTRACT MINIMUM

In accordance with FAR 16.504(a)(4)(ii): The guaranteed minimum contract amount is $5,000.00. The guaranteed minimum amount will be paid during the base ordering period. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

B.4 PRICE/COST SCHEDULE

B.5 STATEMENT OF WORK

1. Contract Title. Blood Products and Testing Services

2. Background.

The purpose of this contract is to obtain blood products and services for the Seattle Division of the VA Puget Sound Health Care System (VAPSHCS). Actual blood products are dispensed to the laboratory for all Veteran patients in the hospital.

3. Scope.

a. Contractor shall provide blood bank products and services for veteran patients located at the Seattle location of the VA Medical Center. Blood must be donated blood product and not purchased blood product.

b. Contractor shall be currently registered and 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 USC Section 260.

c. Contractor shall provide blood products and services 24/7, and STATs (within 1-hour turn-around-time when no testing is needed and within 2-hour turn-around time when testing is needed from time of order to delivery at VAPSHCS). As Soon As Possible (ASAP) blood orders shall be delivered within four (4) hours of order. Requests may be made seven (7) days a week, 365 days a year.

d. Contractor shall provide consultative services 24/7; to include, but not limited to a pathologist trained or training in transfusion medicine, technical transfusion medicine on equipment, testing, interpretation, and emergency management.

e. Any downtimes will be communicated with VAPSHCS as soon as possible with the contingency plan for that downtime.

f. Contractor shall provide monthly turn-around-time reports with explanations to any outliers.

g. Contractor shall provide a quarterly utilization report.

h. Contractor shall provide quarterly comparison reports to other hospitals of similar size and volume.

i. Contractor shall provide monthly STAT vs. Routine reports.

j. Contractor shall provide monthly suspected transfusion reaction reports.

k. Contractor shall provide monthly unacceptable specimen reports with details as to why the specimens were not acceptable.

l. The C&A requirements do not apply, and that a Security Accreditation Package is not required.

4. Specific Tasks.

a. Specific Products - the Contract shall provide all blood, blood products, and all laboratory testing.

b. Contractor shall provide a Haemobank (trademark or copyright) to VAPSHCS. This shall be stocked with Red Blood Cell products and Fresh Frozen Plasma, which when unused shall be rotated out by the Contractor with credits given for the unused products.

c. Contractor shall also provide platelets (either pooled or apheresis) with a 5-day expiration that will be rotated through the VAPSHCS platelet incubator agitator to ensure any unused products are not destroyed, but instead credited.

d. Contractor shall provide all transportation services, including the need for STAT courier services. Transportation time shall be minimized and be included in the determination of turn-around-times. Contractor shall provide a validated method of transportation as defined by regulatory agencies.

e. Contractor shall provide massive transfusion protocols to include customized protocols for VAPSHCS.

f. Contractor shall provide all patient history electronically to VAPSHCS, this can be via a secure internet website.

g. Contractor shall help in the validation and implementation of equipment necessary for the transfusion medicine services.

h. Contractor shall provide lookback and Federal Drug Administration (FDA) reporting services as specified in 21 CFR 606.170(b), 21 CFR 606.171, and 21 CFR 610.48.

i. Contractor shall provide all blood products and services in compliance with all regulatory agencies’ requirements; to include, but not limited to the use of electronic crossmatching, antibody identification, confirmation blood typing on patients without a historical blood type on record.

j. Contractor shall provide group O pRBCs for emergency transfusions to be stocked in VAPSHCS, unused products will be rotated by the contractor to ensure the products do not expire and will provide full credit for the unused products.

k. Contractor shall provide special procedures for specific populations of patients, such as, bone marrow transplant patients and pre-admission crossmatch for patients with scheduled (operating) procedures.

l. Contractor shall manage blood supply to ensure blood products are available 24/7 as needed. Contractor shall manage blood supply within VAPSHCS via the use of the Haemobank.

m. All products, if interstate shipment of blood or blood component is involved, must submit a statement that such approval has been authorized under section 251 of the Public Health Service Act, as amended, 42 USC Section 262. All products delivered shall be FDA licensed.

Item Description List

Cryoprecipitated Ahf, Preparation

Pooled Cryo (Flat Fee)

Plasma Cryo Depleted, Preparation

Fresh Frozen Plasma(250ml)

Fresh Frozen Plasma(250ml), type AB

FFP Frozen w/i 24 Hours

FFP Frozen w/i 24 Hours type AB

Fresh Frozen Plasma(50ml), Prep

Liquid Plasma

Deglycerolized-Autologous RBC

Autologous RBC, Frozen

Red Blood Cells(Auto) Processing

Resuspended Cells, Processing

RBC, Leukoreduced

RBC, Leukoreduced, returned AB

RBC, Leukoreduced, Frozen

RBC, Leukoreduced, CMV NEG

RBC, Leukoreduced, Irradiate

RBC, Leukoreduced, Irradiate, CMV

RBC, Leukoreduced, Washed

RBC, LR, IRR, Washed

RBC, LR, Frozen, Washed, Deglycerolized

RBC, LR, IRR, Frozen, Washed, Deglycerolized

Assigned Pediatric 8-Pack Billing

PLATELETS BY APHERESIS DIRECTED

Platelets by Apheresis LR

Platelets by Apheresis LR IRRD

Platelets by Apheresis LR, CMV, IRRD

GRANULOCYTES BY APHERESIS

Platelets, Leukocytes Reduced (PSPP)

Platelets, LR, Irradiated (PSPP)

Plateletpheresis, LVDS, Irradiated

Plateletpheresis, PRT

Hepatitis Test (HBSAG)

HEP B Surface(HBS) Neutralization

Hepatitis Test (Anti-HCV)

HEPATITIS C (HCV) RIBA TEST

Hepatitis Test (Anti-HBC)

Serologic Test For Syphilis

FLOURESCENT TREPONEMAL ANTIBODY TEST FTA

Anti Cytomegalovirus(CMV) Test

Chagas Test-Patient

Chagas Confirmatory Testing

Anti-HIV 1/2 Antibody Test

HIV 1/2 Confirmation

Anti HTLV-1/-2 Test

HTLV Confirmation

Donor HCV NAT Test

Donor HIV NAT Test

DONOR HBV NAT

Donor WNV Nat

EBV-VCA-IgG

Epstein Barr Virus NA-IgG

Toxoplasma-IgG

Zika Virus by Nucleic Acid Testing

THERAPEUTIC PLASMA EXCH

THERAPEUTIC PLATELETPHERESIS

THERAPEUTIC RED CELL EXCH

THERAPEUTIC LEUKAPHERESIS

CUSTOM PRIME

Travel

EMERGENCY REQUEST

SETUP FEE

Red Cell Genotyping for Single Antigen

Rh Genotyping - Multiplex (D,C)

Red Cell Genotyping for MNS

Red Cell Genotyping Multiple Groups

Rhd Zygosity inc CDE Systems

RhD Evaluation

ABO Blood Groups by PCR

RhD variant - weak D type 1, 2, and 3

Thrombin Time

Prothrombin Time aPTT

Factor XIII (By Urea Solubility)

Factor XIII Quantitative

Fibrinogen Activity

CBC with Diff aPTT 1:1 Mix

Reptilase Time

VWF Activity by Ristocetin Cofactor

FDP in plasma (semi quantitative)

Factor V Activity

Factor VII Activity

Factor VIII Activity (one stage)

Factor IX Activity

Factor X Activity

Factor XII Activity

Factor VIII Activity (Chromogenic)

VWF Antigen

Von Willebrand Factor Multimers

Von Willebrand Collagen Binding

Factor VIII INHIBITOR TITER-PORCINE

Staclot-La (Hexagonal Pl) dRVVT Screen dRVVT Confirmation

Factor IX Inhib Bethesda Human

Factor II Inhib Bethesda Human

Factor V Inhib Bethesda Human

Factor VII Inhib Bethesda Human

Factor X Inhib Bethesda Human

Factor XI Inhib Bethesda Human

Factor VIII Inhibitor Bethesda Titer - Chromogenic

Antiplasmin

Platelet Aggregation (9 Agonists)

Red Cell Separate for Phenotyping

RIPA

Platelet Function Assay (PFA) Epine

Platelet Function Assay (PFA) Adp

HEMOPHILIA A Mutation Evaluation

Factor VIII Inversion

DNA Von Willebrand Disease Type 2A/2B/2M

DNA Von Willebrand Disease Type 2N

Hemophilia B Mutation Evaluation

Genotype for known Hemophilia/VWD mutations

DECEASED DONOR WORKUP

DECEASED DONOR WORKUP-IMPORT

HLA B27 TYPING

HLA A 29 Typing

HLA B51 Typing

HLA B57:01 Typing

HLA B58:01 Typing

HLA B15 Typing

HLA-DQ2/DQ8/DQA1*05 (Celiac association)

HLA ANTIBODY DETECTION

HLA Antibody Specificity

HLA Antibody Specificity Monitoring DSA

HLA Antibody Specificity Monitoring DSA - STAT

MIC Antibody Specificity

C1q fixing HLA Antibody Specificity

C1q fixing HLA Antibody Monitoring DSA

Anti-AT1R Antibody

HLA CLASS I (A,B, C) TYPING

HLA CLASS II (DR,DQ) TYPING

MICA Typing

HLA CLASS I & CLASS II (A,B,C,DR,DQ) Typing

SPECIMEN PROCESSING (SERUM)

SPECIMEN PROCESSING (CELLS)

LYMPHOCYTE CROSSMATCH

LYMPHOCYTE CROSSMATCH - STAT

LYMPHOCYTE CROSSMATCH -Cytotoxicity

Platelet Alloantibody Workup (Basic)

HLA -A2 or A*0201 Typing

HIGH-RESOLUTION TYPING, HLA-A

HIGH-RESOLUTION TYPING, HLA-B

HIGH-RESOLUTION TYPING, HLA-C

HIGH-RESOLUTION TYPING, HLA-DPA1

HIGH-RESOLUTION TYPING, HLA-DPB1

HIGH-RESOLUTION TYPING, HLA-DQA1

HIGH-RESOLUTION TYPING, HLA-DQB1

HIGH-RESOLUTION TYPING, HLA-DRB1

High Resolution HLA DRB3/DRB4/DRB5

CROSSMATCH ANTIGLOBULIN IRL

CROSSMATCH ELECTRONIC IRL

STAT FEE - IRL

ANTIBODY SCREEN IRL

RED CELL ANTIBODY TITRATION

RH PHENOTYPE (D,C,E,C Antigentype)

Patient PHENOTYPE Single Antigen

Screening of compatible RBC units

Direct Antiglobulin Test Monospecific IRL

Direct Antiglobulin Test Polyspecific IRL

Red Cell ANTIBODY PANEL (per panel)

Red Cell ANTIBODY PANEL (per panel) TSL

Autoabsorption

ALLOABSORPTION

ELUTION

NEUTRALIZATION

Chemical Treatment Red Cells

Enzyme Treatment Red Cells

CHEMICAL TREATMENT SERUM

PATIENT PHENOTYPE EXTENDED

Lectin Panel

DONATH-LANDSTEINER

THERMAL AMPLITUDE

AFTER HOURS SURCHARGE

UNIT PHENOTYPE/ANTIGEN/UNIT

HEMOGLOBIN S SCREEN

SCREEN FOR FETAL-MATRN HEMORRHAGE

KLEIHAUER-BETKE STAIN

Rare/Uncommon Unit Search Fee

Imported Unit Fees - per unit

RARE UNIT FEE

ADAMTS 13 ACTIVITY

ADAMTS 13 INHIBITOR

ADAMTS-13 Antibody

Platelet Alloantibody Workup (Advanced)

Platelet Autoantibody Test

Platelet Drug Antibody Test

Hep/PF4 IgG ELISA (HIT)

Hep/PF4 IgG ELISA Confirmation

Post-Transfusion Purpura (PTP) Workup

Neonatal Alloimmune Thrombocytopenia Eval

Platelet Typing/Single Platelet Antigen

TYPE CONFIRM UNIT

CROSSMATCH ANTIGLOBULIN

RETROSPECTIVE XMATCH ANTIGLOBULIN

Xmatch Immediate Spin

ABO COMPATIBLE TEST

XMatch Potential Donor ABO Compatible

XMatch Potential Donor ABO Incompatible

CROSSMATCH ELECTRONIC

RETROSPECTIVE CROSSMATCH ELECTRONIC

Uncrossmatched Unit Handling fee

EMERGENCY TESTING OR RELEASE

ABO, RH

Confirmatory 2nd Sample

ABO/RH IRL

INDIRECT ANTIGLOBULIN TEST

% ABO

Patient antigen type - TSL

HOLD Specimen Charge

DIRECT ANTIGLOBULIN TEST

INVESTIGATION OF TRANSFUSION REAC

Limited Transfusion Reaction Invest

Irradiated Unit, Preparation

Reduced Volume, Preparation

Prep of RBCs, Plasma Reduced

Preparation of Red Cells, Washed

Preparation of Platelets, Washed

CMV Negative

Pooling

Pooling, Resuspended RBC

Thawing Of Plasma

Verax Fee

Hemosafe/HaemoBank - Site VPN monitoring

Hemosafe/HaemoBank - Support/Maintenance

Hemosafe/HaemoBank Software Licensing

HaemoBank 80 Rental Fee

n. Contractor shall provide all HLA, hemostasis, donor, immunogenetics, molecular, and reference testing. Any future required blood products and testing procedures once validated, may be added to the contract upon completion of a contract modification.

4.1 Task 1 - Enterprise Management Controls.

4.1.1 Subtask 1 - Integration Management Control Planning. Provide the technical and functional activities at the required level for integration of all tasks specified within this contract. Include productivity and management methods such as quality assurance, progress/status reporting and program reviews. Provide the centralized administrative, clerical, documentation and related functions.

Deliverables: Technical & Functional Activities

4.1.2 Subtask 2 - Contract Management. Prepare a Contract Management Plan describing the technical approach, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout Contract execution. Provide a monthly status report monitoring the quality assurance, progress/status reporting and program reviews applied to this contract.

Deliverables: Contract Management Plan Monthly Status Report

5. Performance Monitoring The following terms and conditions are applicable:

a. All services shall be initiated within one calendar day following receipt of a valid order, unless otherwise specified in the order.

b. The Contractor shall be familiar with Federal Government and Department of Veterans Affairs acquisition regulations, directives and instructions. If a particular document is required in a specific order, it will be cited within the Statement of Work.

c. The Contractor shall not provide technical direction to government personnel at any time. Neither shall the Government directly supervise the Contractor employees. The Contractor Task Leader shall conduct day to day supervision of to all Contractor employees wherever they are located. All direction of the Contractor shall be through the Contracting Officer Representative (COR) of the ordering organization specified in each individual order. Technical "tasking" assignments for the Contractor will be transmitted by the program office's COR (or program manager) to the Contractor Task Leader.

d. Capitalization Requirements: The Contractor shall provide their employees sufficient computer equipment to support orders. The Contractor shall be able to support the automatic transmission of unclassified data only to the requiring Program Office by modem if so requested. Any computers connected to, or transmits to (connected or via magnetic media) the government shall be properly protected from computer viruses. The Contractor shall be capable of supporting the software packages utilized by Department of Veterans Affairs for the indicated processors. Specific software packages utilized within a program office shall be stated in the order Statement of Work if it is other than Microsoft Office Professional or Microsoft Project.

6. Security Requirements 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.

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 US 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 Veteran Affairs does not have a Memorandum of Agreement with Defense Security Services (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 US 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-US services are provided and detail a security plan, deemed to be acceptable to VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the US 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.

7. Custody of VA Information

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

b. VA information should not be co-mingled, if possible, with any other data on the contractor/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 the 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 VA Directive 6300, Records and Information Management and its Handbook 6300.1, Electronic Media Sanitization. Self0-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 to 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 date used by the contractor/subcontractor needs to be restored in 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 FAR Part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated an appropriate action 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 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, the 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.

8.0 Security Incident Investigation

a. 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 Contracting Officer and the COR 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.

b. To the extent known by the contractor/subcontractor, the notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a date breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft, break-in, or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The Contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

9. Liquidated Damages for Data Breach

a. Consistent with the requirements of 38U.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 the 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 of the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the date 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 event (loss, theft, unauthorized access);

2. Description of the event, including:

a. Date of occurrence

b. Date 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 date 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);

8. Known misuses of date containing sensitive personal information, if any;

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 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 report 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 coverage at $0 deductible; and

6. Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

10. Security Controls Compliance Testing On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. Within 10 working days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

11. Training

a. 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 compete the 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.

b. The contractor shall provide to the Contracting Officer and/or the COR a copy of 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.

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

a. One (1) computer workstation

13. Other Pertinent Information or Special Considerations.

Not Applicable (N/A)

N/A

c. Identification of Non-Disclosure Requirements.

N/A

d. Packaging, Packing and Shipping Instructions.

All packaging, packing and shipping will be completed in compliance with all regulatory and accrediting bodies.

e. Inspection and Acceptance Criteria.

Inspection and acceptance of blood and blood products will be determined at the time of receipt by laboratory staff following the below standard. Any products not deemed acceptable will be returned with the next return shipment for credit.

Integrity of Unit: Inspect for leaks, especially in port areas, by inverting and applying light pressure to the unit. Observe for missing port covers. Red Blood cells should have at least one firmly attached segment.

Appearance of the blood product: Observe for color abnormalities. The color of a RBC bag should not be significantly darker than the segments. Plasma in the RBC unit should not be murky, purple, brown or red. Platelets will be clear to yellow/straw to light strawberry color. Platelets should not contain grossly visible aggregates. Thawed FFP will be clear with the color varying from yellow straw to light green to orange. Cryoprecipitate will usually be cloudy.

Known abnormalities and their probable causes:

If any abnormalities are noted, the component should NOT be transfused. Return the units to the Blood Supplier. Follow Outgoing Shipment procedure. Request the Blood Center to replace blood product.

Verify that the irradiation indicator (if present) indicates that any component labeled as irradiated has in fact been irradiated-see examples below.

NOT IRRADIATED IRRADIATED

14. Risk Control N/A

15. Place of Performance.

All work shall be performed at the Contractor’s facilities, unless specifically requested by the VAPSHCS, such as, for transfusion services in the OR.

16. Delivery Schedule.

Final - 30

* Standard Distribution: 1 copy of the transmittal letter without the deliverable to the Contracting Officer shall be Emailed.

17. Privacy Office Language for SOW

1. 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).

1. 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.

1. 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.

1. 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.

1. 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.

18. Records Management Language The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. 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.

1. 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.

1. 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.

1. 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.

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

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

1. 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.

1. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

1. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

1. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

19. Government Invoicing Instructions: The Contractor shall invoice in accordance with the requirements of The Department of Veterans Affairs (VA) Financial Services Center (VAFSC). The latest information shall be used for invoicing and payments may change during the Period of Performance of this acquisition. Invoice requirements are currently as follows: Invoice Number, Invoice Date, Purchase Order Number, Unit Price, Quantity and Unit of Measure, Total Invoice Price, Ship-To Location Name and/or code, Receipt of Goods/ Services, Invoice Payment Terms.

Current Invoicing information is located at http://www.fsc.va.gov/einvoice.asp. It states:

a. FSC Mandatory Electronic Invoice Submission: The Department of Veterans Affairs published a final rule in the Federal Register on November 27, 2012 to require contractors to submit payment requests in electronic form in order to enhance customer service, departmental productivity, and adoption of innovative information technology, including the appropriate use of commercial best practices. The rule is effective December 27, 2012.

b. Vendor Electronic Invoice Submission Methods Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

c.VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

d.A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National…