Sources Sought-36C24727Q0083.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Ralph H. Johnson VA Medical Center 109 Bee Street Charleston SC 29403-5799

POINT OF CONTACT*

PLACE OF PERFORMANCE

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is not a solicitation announcement. This is a sources sought synopsis for market research purposes ONLY. The purpose of this synopsis is to gain knowledge of potential qualified vendors that can provide the following:

This requirement is for the acquisition or replacement of Hematology automated CBCD analyzer. The organization has previously procured automated analyzer systems under competitive procedures. Prior procurements involved large manufacturers offering integrated CBCD with Slidemaker Stainer & Digital morphology viewer platforms; this acquisition is a follow-on to meet current throughput, automation, middleware connectivity, and reagent supply needs.

VA Augusta PL&M currently operates a compact automation configuration built on the Sysmex XN 3100 with integrated SP 50 Slidemaker Stainer and DI 60 digital morphology analyzer for standardized smear review. This platform delivers up to about 200 CBC/hour, supports reflex/rerun rules, and provides NRBC & IG reporting with every CBC; SP 50 produces 30–75 slides/hour depending on license; DI 60 provides automated pre classification and archiving. This requirement is relative to NAICS 334516 (Analytical Laboratory Instrument Manufacturing) (size standard of 1,000 employees). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this source sought synopsis, a solicitation announcement may be published in SAM.gov. Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this source sought announcement. The Department of Veterans Affairs, Network 07 Contract Office, is seeking sources to provide:

Cost Per Reportable Result Service for the Augusta, GA VA Medical Center If you are interested and can provide the required supplies, please provide the requested information as indicated below.

All RFI’s must provide the following information in this format:

1. Company Name:

Address:

Phone Number:

2. Point of Contact:

Email:

Phone Number:

All RFI’s must provide the answers to the following questions:

(1) Is your company considered small under the NAICS code identified under this RFI?

(2) Please provide general pricing for your /solutions for market research purposes.

(3) Please submit your capabilities regarding the Performance Work Statement to establish capabilities for planning purposes.

Responses to this notice shall be submitted via email to: Thomas.Nicholls@va.gov Telephone responses will not be accepted. Responses must be received no later than 11/11/2026 at 08:00 AM EST. If a solicitation is issued, it shall be announced later, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.

HEMATOLOGY AUTOMATED CBCD ANALYZER

(COST PER TEST)

1. GENERAL

1.1. INTENT:

Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VA Augusta Health System, Augusta GA 30901 to establish a Blanket Purchase Agreement (BPA) for Automated Hematology Instrumentation. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/ Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The Government will award a Cost per Test to a single Vendor for Automated Hematology Instrumentation. Vendor agrees to the following terms of the BPA exclusively with the VA AUGUSTA HEALTH SYSTEM facilities listed by Attachment/Herein and awarded in the final BPA.

1.2. BACKGROUND:

The Pathology & Laboratory Medicine Service (PALMS), VA Health Augusta requires modernization of hematology workflow, increased analyzer throughput, integrated slide-making and staining capability, integrated Digital cell morphology analyzer for standardized smear review and reduced downtime.

1.3. PRICES AND TERMS:

VA AUGUSTA HEALTH SYSTEM will provide an estimated volume by test as reflected in Test Menu (section 1.6) for each individual medical center and outpatient clinic laboratory. The Government estimates the volumes per facility as listed in the Test Menu but does not guarantee volumes as listed; they are estimates ONLY

1.4. SERVICES REQUIRED:

This will be a single award, cost per reportable per tests contracts with one base year and four, one year options and shall be effective for the term of the FSS Contract including for continuation of services for two integrated identical Hematology CBCD Analyzer, one Slide Maker Stainer, and one automated cell image analyzer instrument with 5 remote Cellavision reviewer to include an estimated test volume of 300 CBCD per day, 5 Retic per day, 40 Slides per day, seven days per week. The current hematology equipment is Sysmex XN 3100 which includes two Sysmex XN, SP-50 Slide maker and stainer, Sysmex DI-60 Digital Cell morphology system analyzer integrated platform is self-contained, freestanding without requiring the additional purchase of tables, platforms, counter tops, printers, PC’s, and other equipment necessary to maintain the instruments full function and operation in completing the testing and reporting patient data. The CBCD analyzers have the capability to perform/report the clinical parameters as defined in this statement of work. The instruments have random access capability and can simultaneously perform the CBC with automated differential, Reticulocyte Panels, make slides for review and smear review using Cell image. The performance characteristics for accuracy and precision must meet or exceed national regulatory and accreditation standards such as JACHO, Joint Commission or Clinical Laboratory Standards Institute (CLSI). Equipment must function to have a continuous output of test results that does not require more than one technologist to operate, perform maintenance, quality control testing, and result reviews in order to accomplish the highest test volume (such as morning collection) or highest average daily test volume for each shifts turn-around-times of up to 100 samples per hour. The reagents, supplies, quality controls, calibrators, standards, consumable, disposable items, parts, accessories and any other item required for the proper operation of the Vendor’s equipment and necessary for the generation and reporting of a test result for proper operation must be the same for both instruments and can be used interchangeably. The Vendor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that the equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. In the event that the supplies or the reagents performance fails upon testing, the Vendor will replace them at no additional cost and deliver the replacements within 24 hours of receipt of the verbal order for emergency delivery. Expiration date must be clearly marked on the reagent, standards, and control containers. The shipping schedule for all bulk supplies and reagents shall be determined by the controlled climate storage space available at the facility. Unexpected changes in methodology/technology shall be at the expense of the Vendor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individual determined at contract award and the Contracting Officer Representative, COR.

1.5. PLACE OF PERFORMANCE:

Services shall be performed at the VA Augusta Health System, Pathology/Laboratory Medicine Services located at Room# 2D133 950 15TH Street, Augusta, GA

1.6. Period of Performance. This request is for a base year and four option years.

1.7. TEST MENU:

CBC with 6- part WBC differential (including Immature Granulocytes), Reticulocytes Count. Estimated Annual volumes approximately 90000 CBCD, 5 Reticulocytes Count per Day, 40 Slides review per Day

1.8. DEFINITIONS:

CLSI- Clinical Laboratory Standards Institute COR- Contracting Officer Representative CPARS- Vendor Performance Assessment Reporting System FDA- Food and Drug Administration VA-Veteran’s Administration VA AUGUSTA HEALTH SYSTEM- Veterans Administration Medical Center, Augusta GA Cost per Test - Vendors are required to provide a price customers will be billed for each test that is performed on its equipment. The per test price shall include costs covering (1) 5-year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Vendor’s equipment and necessary for the generation and reporting of a test result, (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Vendors are required to provide delivery, installation, and removal of equipment at no additional charge.

Parameter Definitions:

CBC- Complete Blood Count WBC- White Blood Cell Count Diff- Automated Differential RBC- Red Blood Cell Count MCH- Mean Corpuscular Hemoglobin MCV- Mean Corpuscular Volume MCHC-Mean Corpuscular Hemoglobin Concentration RDW- Red Cell Distribution Width MPV-Mean Platelet Volume IG-immature granulocytes nRBC- nucleated red blood cells IPF- immature platelet fractions Retic- Reticulocyte Count Body Fluid- Body fluids include CSF, Pleural, Peritoneal, and Synovial Fluids

2. PERSONNEL:

2.1. QUALIFICATIONS:

2.1.1. Technicians/Technologist performing under this contract shall present active license or certification for installation/service of analyzers.

2.1.2. Contract personnel do NOT have VA Employee status

2.1.3. Technicians/technologists shall be trained on applicable trouble shooting codes relating to the specific analyzers.

2.2. NON-PERSONAL SERVICES:

2.2.1. Contract personnel performing under this contract are not considered to be federal employees. They shall provide services as specified in this statement of work.

2.3. KEY PERSONNEL AND EMERGENCY SUBSTITUTIONS:

2.3.1. Personnel entering the medical center are required to complete annual HIPPA training due to the access of patient information.

3. HOURS OF OPERATION:

3.1.1. Business Hours: 24 hours/ 7 days per week including holidays and weekends.

4. VENDOR RESPONSIBILITIES

4.1. Vendors staff shall comply with annual HIPPA Training and reports of completion shall be submitted to the COR for file documentation.

4.2. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Contract 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.

4.3. Vendor provides all technical direction for the performance of service and technical specialist on site for trouble shooting for the analyzers. Vendor personnel interact with designated VA staff in completing work to provide fully functioning analyzers prior to the completion of service call.

4.4. The Vendor shall provide an instrument training program that is coordinated with and timely to the equipment installation.

4.5. The Vendor, without additional charge to the Government, shall provide initial training for four operation personnel for each instrument at the time of installation of the Vendor’s equipment. Annually, the Government may appoint an additional key operator for each instrument to receive Vendor provided training, without additional charge to the Government.

4.6. The method and scope of training must be consistent with, and no less than, the method of training offered to other commercial customers. This may include travel of Government personnel to the manufacturer’s training facility. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

4.7. The Vendor will be responsible for all preventative maintenance including semi-annual or annual PM based on the manufacturer's suggested timeline.

4.8. Services required: Maintaining the full operation and reagents/controls/calibrators required to perform patient testing for CBC with automated differential, Reticulocyte panel, and prepare a slide for manual differential, Digital Cell morphology analyzer, daily, weekly, monthly, annual quality control, and the maintenance requirements to meet patient testing according to all regulatory guidelines must be provided. Vendor provides the reagents, controls and calibrators per the shipping schedule in attachment D.

4.9. Standards of practice: Vendor shall be responsible for meeting or exceeding VA, CAP, and Joint Commission (or equivalent) standards.

4.10. Maintain a current Business Associate Agreement between the Department of VA, VHA.

4.11. Provides customer service hot line telephone number.

4.12. VENDOR must provide a trained CPARS representative to respond on the Vendor’s behalf. Contract personnel who require access to national security programs must have a valid security clearance to meet the National Industrial Security Program (NISP) that was established by Executive Order 12829 to ensure the 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.

5. GOVERNMENT RESPONSIBILITIES:

5.1. Daily quality control testing and necessary daily/weekly/monthly maintenance will be performed by trained and certified technologist personnel of the Charlie Norwood VAMC in collaboration, oversight, and monitoring by the COR or designee regarding the direct operation of the instruments.

5.2. VA AUGUSTA HEALTH SYSTEM support personnel, services or equipment will be subject to the terms and conditions of the Vendor to not void the Vendor’s warranty.

5.3. Servicing by VA staff will only be performed as instructed by the contactor under technical support’s authorization or standard methods of operation as guided by the onboard help menu.

5.4. All equipment and supplies will be supplied by the Vendor except consumables such as computer paper, ink cartridges, labels, and glass/plastic sodium citrate tubes.

5.5. The Government shall contact the Vendor within (1) one hour of any nonfunctional analyzer.

5.6. The Government shall ensure that the Vendor has access to the location of all analyzers.

5.7. The COR will provide the CPARS evaluation of services received.

6. PERFORMANCE STANDARDS, QUALITY ASSURANCE AND QUALITY IMPROVEMENT:

6.1. Methods of Surveillance: Timeliness of shipments, the physical condition of receipt for integrity, quantity ordered, and quality of performance in passing all levels of QC testing as designated by the manufacturer.

6.2. Performance Standards: The Instrument must be approved by the Food and Drug Administration and Contract personnel shall be subject to the following standards and acceptable quality levels:

6.2.1. CAP, JACHO, FDA guidelines, and Joint Commission or CLSI for accrediting hospitals.

6.2.2. Instrument configuration must include integrated Automated CBCD analyzer with integrated Slide Maker and Stainer and Automated Digital Cell Viewer.

6.2.3. The automation technology must report the test results in the parameters that are currently in place for CBC, Reticulocytes, Immature Granulocytes, nRBC(nucleated red blood cells), and IPF (immature platelet fractions).

6.2.4. An auto sampling system that includes barcode reading, primary closed tube (cap-piercing) aspiration, auto-loader, and auto-mixing.

6.2.5. Testing of Critical patient test results and delta checks that will meet the 1-hour turn-around-timeframe for reporting patient results without requiring any additional equipment such as extra tracks and lanes.

6.2.9. Able to auto verify CBCD at higher rate, with less manual smear reviews.

6.2.10. Must require aspiration volumes of no more than 50 ul to perform full hematology reportable test profile (CBC with fluorescent NRBC count, 6-part fluorescent differential and fluorescent reticulocytes count).

6.2.11. Ability to prioritize STAT testing without compromising existing programmed testing.

6.2.12. Instruments have an automatic drain capability without operator involvement for biohazard exposure.

6.2.13. Current Business Associate Agreement between the Department of Veterans and the Vendor

6.2.14. Calibration on the instrument is stable for a minimum of 12 months without validation and calibration kit is included as a product within the cost per test agreement. Calibration will be performed by VA trained and certified technologist personnel in collaboration, oversight, and monitoring by the Vendor.

6.2.15. The PM is provided by the vendor’s service engineer and is not performed as a procedure by the VA AUGUSTA HEALTH SYSTEM technologist.

6.2.16. Instruments include a printer and a UPS with batteries for each, and both are replaced if nonfunctional by the vendor at no cost to the VA for installation and shipping.

6.2.17. Instruments include a sturdy mobile surface or tabletop for the instrument to reside on while it is within VA AUGUSTA HEALTH SYSTEM facility.

6.2.18. All consumable reagents required for operation, cleaning solutions, controls, calibrators, test and control racks, and rack barcodes are supplied by the vendor at no cost to the VA.

6.2.19. Controls are stable and require testing every 24 hours of testing.

6.2.20. An external monitoring system to show comparison data with other hospital users of the same equipment, and the same commercial controls lot # for quality monitoring and performance of the instrument.

6.2.21. The technology interfaces with VISTA computer system through Data Innovations without an install cost generated by the VA.

6.2.22. The instrument’s computer must read code 128 label.

6.2.23. The system must have the capacity to connect to the current VA LIS system (VISTA/Oracle Health) through Data Innovations and include a bi-directional LIS host query interfacing for both.

6.2.24. Capability of programming CAP specimens to allow interfacing with the CAP website.

6.2.25. Vendor supplies responses to required documents to add systems to the VA network including but not limited to the Enterprise Risk Analysis (ERA) VA Form 6550, Access Control List (ACL) Communication Protocol, and MSD2

6.2.26. If the SQL server is included on the computer, it must be the newest vendor allows.

6.2.27. The instrumentation is 508 compliant.

6.2.28. VA form 6500, 6550, Risk Analysis, and MSD2 must be completed and signed by all parties before the contract can be awarded.

6.2.29. The hardware must meet all VA minimum specifications, and the operating system software version must be currently sold and supported. Windows versions no longer supported (e.g. Windows 10) shall not be proposed.

6.2.30. The instrument has a cap piercing ability and uses Becton Dickinson 5 ml K2EDTA sample tubes.

6.2.31. Continuous operation of testing without interruption while changing reagents during the test operation mode.

6.2.32. Technical support is provided for servicing instrumentation to prevent service interruptions to patient testing. One CBCD instrument must always be fully operational, and service provided to comply with having a minimum of one instrument operational on a 24/7 basis. Certain circumstances including emergency repairs may dictate the need for repair service to be conducted outside defined repair service hours at no cost to the Government. Vendor should ensure adequate repair engineers (field service engineers) to cover the geographical area.

6.2.33. The Vendor must be capable of performing repair service 24 hours per day, 7 days per week. The Vendor will provide all parts and labor needed to repair the malfunction. Travel, per-diem and other expenses associated with the repairs will be borne by the Vendor. A service report (both preventative and emergency repair) shall be furnished to the Laboratory upon completion of each service call.

6.2.34. Emergency repairs shall be performed after notification that the equipment is inoperable.

6.2.35. System failure downtime is that period of time when either the clinical analyzer or component piece in the system is inoperable and not capable of generating reportable results.

6.2.36. If an instrument remains inoperative due to a malfunction through no fault or negligence of the Government for a total of more than twenty-four hours, the Vendor shall be assessed damages which will be applied to the invoice in the form of a credit or deduction, at the rate of 1/30 of the preceding average three month cost-per-test/reportable billings times the total number of days certified as downtime.\

6.2.37. Each instrument provided by the Vendor shall maintain an uptime of 95% in each month of the term of the agreement for equipment

6.2.38. The reportable ranges include extended reportable ranges.

6.2.39. The instruments printer capability must include the ability to print all patient results as required during computer downtime automatically.

6.2.40. The instrument has updated equipment available for offering sensitivities for detecting minimum number of reagents used for testing, bar-coded reagents, change reagents during operation, remote troubleshooting, on-board video troubleshooting, positive patient ID, and digital technology.

6.2.41. The instrument’s interfacing is comparable to the VA Vista test reporting format.

6.2.42. The instrument has a maximum database storage capacity of a minimum of 100,000 retrievable patient results or a minimum of 2 years.

6.2.43. The instrument’s methodology has first pass efficiency. Must have a single aspiration pathway, eliminating the need for mode-to-mode correlation and/or QC, Calibration.

6.2.44. The instrument’s methodology is capable of producing accurate results without interference by lipemia, bilirubin, and hemolysis.

6.2.45. The instrument’s methodology is capable of detecting clots and reducing the amount of technologist exposure to biological samples.

6.2.46. The instrument’s reagents have a lengthy on-board stability, to minimize reagent waste, prep time, and storage requirements.

6.2.47. The instrument’s methodology has low hemolysis interference ratios.

6.2.48. The instrument’s methodology has a low-tech review rate of 10% or less.

6.2.49. The waste contains no increased azides or hazardous chemicals leading to increased hazardous exposure or disposal for the VA. Vendor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements

6.2.50. Compatible with current space limitations

6.2.51. All startup reagents and controls will be provided by the Vendor upon install at no additional cost to the VA facility.

6.2.52. The Vendor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that the equipment operations are not interrupted.

6.2.53. The reagents, supplies, quality controls, calibrators, standards, consumable, disposable items, parts, accessories and any other item required for the proper operation of the Vendor’s equipment and necessary for the generation and reporting of a test result for proper operation must be the same for both instruments and can be used interchangeably.

6.2.54. Vendor personnel are to perform software and equipment upgrades, training, and troubleshooting via phone if necessary.

6.2.55. Vendor will provide a peer review evaluation program of quality control results obtained by the facility.

6.2.56. Vendor will provide method validation studies required by CLIA and CAP regulatory agencies and shall cover precision, linearity, current system to new system correlations, as well as establishment of normal and therapeutic ranges.

6.2.57. The VA will provide the necessary samples for method validation and lot number conversions of the chosen test menu CBC and Reticulocytes.

6.2.58. The VA will perform lot-to-lot comparisons between the current lot of reagents and new lots of reagents that are utilized on the instrument throughout the contract period.

6.3. A QASP should mirror the above standards and be attached to the resultant contract.

6.4. Required registration with Vendor performance assessment reporting system (CPARS).

6.5. QASP table:

On time; 100% within 7 days of requested ship date

7. SPECIAL CONTRACT REQUIREMENTS

7.1. VENDOR SECURITY REQUIREMENTS (HANDBOOK 6500.6)-

7.1.1. GENERAL: VENDORS, VENDOR PERSONNEL, SUBVENDORS,

AND SUBVENDOR 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.

7.1.2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

A. A VENDOR/SUBCONTRATOR SHALL REQUEST LOGICAL (TECHNICAL) OR PHYSICAL ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS FOR THEIR EMPLOYEES, SUBVENDORS, AND AFFILIATES ONLY TO THE EXTENT NECESSARY TO PERFORM THE SERVICES SPECIFIED IN THE CONTRACT, AGREEMENT, OR TASK ORDER.

B. ALL VENDORS, SUBVENDORS, 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 VENDORS 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 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. THE VENDOR OR SUBVENDOR 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 VENDOR OR SUBVENDOR’S EMPLOY. THE CONTRACTING OFFICER MUST ALSO BE NOTIFIED IMMEDIATELY BY THE VENDOR OR SUBVENDOR PRIOR TO AN UNFRIENDLY TERMINATION VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

7.1.3. VA INFORMATION CUSTODIAL LANGUAGE

A. INFORMATION MADE AVAILABLE TO THE VENDOR OR SUBVENDOR BY VA FOR THE PERFORMANCE OR ADMINISTRATION OF THIS CONTRACT OR INFORMATION DEVELOPED BY THE VENDOR/SUBVENDOR 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 VENDOR/SUBVENDOR'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 VENDORS/SUBVENDOR’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 VENDOR 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 VENDOR AND SUBVENDOR 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, VENDOR/SUBVENDOR MUST NOT DESTROY INFORMATION RECEIVED FROM VA, OR GATHERED/CREATED BY THE VENDOR IN THE COURSE OF PERFORMING THIS CONTRACT WITHOUT PRIOR WRITTEN APPROVAL BY THE VA. ANY DATA DESTRUCTION DONE ON BEHALF OF VA BY A VENDOR/SUBVENDOR 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 VENDOR 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 VENDOR/SUBVENDOR 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. E. THE VENDOR/SUBVENDOR 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 VENDOR/SUBVENDOR ELECTRONIC STORAGE MEDIA FOR RESTORATION IN CASE ANY ELECTRONIC EQUIPMENT OR DATA USED BY THE VENDOR/SUBVENDOR 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. F. IF VA DETERMINES THAT THE VENDOR 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 VENDOR OR THIRD PARTY OR TERMINATE THE CONTRACT FOR DEFAULT OR TERMINATE FOR CAUSE UNDER FEDERAL ACQUISITION REGULATION (FAR) PART 12.

G. THE VENDOR/SUBVENDOR 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.

H. THE VENDOR/SUBVENDOR’S FIREWALL AND WEB SERVICES SECURITY CONTROLS, IF APPLICABLE, SHALL MEET OR EXCEED VA’S MINIMUM REQUIREMENTS. VA CONFIGURATION GUIDELINES ARE AVAILABLE UPON REQUEST.

I. EXCEPT FOR USES AND DISCLOSURES OF VA INFORMATION AUTHORIZED BY THIS CONTRACT FOR PERFORMANCE OF THE CONTRACT, THE VENDOR/SUBVENDOR 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 VENDOR/SUBVENDOR MUST REFER ALL REQUESTS FOR DEMANDS FOR PRODUCTION OF, OR INQUIRIES ABOUT, VA INFORMATION AND INFORMATION SYSTEMS TO THE VA CONTRACTING OFFICER FOR RESPONSE.

J. NOTWITHSTANDING THE PROVISION ABOVE, THE VENDOR/SUBVENDOR 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 VENDOR/SUBVENDOR IS IN RECEIPT OF A COURT ORDER OR OTHER REQUESTS FOR THE ABOVE-MENTIONED INFORMATION, THAT VENDOR/SUBVENDOR SHALL IMMEDIATELY REFER SUCH COURT ORDERS OR OTHER REQUESTS TO THE VA CONTRACTING OFFICER FOR RESPONSE.

K. 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 VENDOR/SUBVENDOR MUST COMPLETE A VENDOR SECURITY CONTROL ASSESSMENT (CSCA) ON A YEARLY BASIS AND PROVIDE IT TO THE COTR.

7.1.4. 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 VENDOR/SUBVENDOR SHALL IMMEDIATELY NOTIFY THE COTR AND SIMULTANEOUSLY, THE DESIGNATED ISO AND PRIVACY OFFICER FOR THE CONTRACT OF ANY KNOWN OR SUSPECTED SECURITY/PRIVACY INCIDENTS, OR ANY UNAUTHORIZED DISCLOSURE OF SENSITIVE INFORMATION, INCLUDING THAT CONTAINED IN SYSTEM(S) TO WHICH THE VENDOR/SUBVENDOR HAS ACCESS.

B. TO THE EXTENT KNOWN BY THE VENDOR/SUBVENDOR, THE

VENDOR/SUBVENDOR’S NOTICE TO VA SHALL IDENTIFY THE

INFORMATION INVOLVED, THE CIRCUMSTANCES SURROUNDING THE

INCIDENT (INCLUDING WHOM, HOW, WHEN, AND WHERE THE VA

INFORMATION OR ASSETS WERE PLACED AT RISK OR COMPROMISED), AND

ANY OTHER INFORMATION THAT THE VENDOR/SUBVENDOR

CONSIDERS RELEVANT.

C. WITH RESPECT TO UNSECURED PROTECTED HEALTH INFORMATION, THE BUSINESS ASSOCIATE IS DEEMED TO HAVE DISCOVERED A DATA 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 OR BREAK-IN OR OTHER CRIMINAL ACTIVITY, THE VENDOR/SUBVENDOR 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 VENDOR, ITS EMPLOYEES, AND ITS SUBVENDORS 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 VENDOR/SUBVENDOR 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.

8.1.1 LIQUIDATED DAMAGES FOR DATA BREACH

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

B. The Vendor/subVendor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Vendor 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:

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

(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.

8.1.2 TRAINING:

A. All Vendor employees and subVendor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

b. The Vendor shall provide the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Vendor 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.

NARA RECORDS MANAGEMENT LANGUAGE CLAUSE:

NARA RM Language Clause to be included in contracts, as necessary:

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.

2. 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.

3. 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.

4. 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.

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

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

7. 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.

8. 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.].

9. 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.

10. 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.

Sources Sought Notice