36C24825Q0395 0001.docx

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF

PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED

STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF

CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF

SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 03-18-2025 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) West Palm Beach VA Medical Center 7305 North Military Trail West Palm Beach FL 33410-6400 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) West Palm Beach VA Medical Center 7305 North Military Trail West Palm Beach FL 33410-6400 To all Offerors/Bidders

36C24825Q0395 03-26-2025

X X X

** HOUR & DATE

for Receipt of Offers is EXTENDED to: 03-26-2025 2:00PM EDT See CONTINUATION Page 548-3650160-223-822300-2633 010022300 X

1(ONE)

548 - Micro Molecular Testing Please see section B for Statement of Requirements Must be registered and in good standing in SAM.gov All quotes are to be sent to David.Henry3@va.gov All quotes will list rather they are Open Market or Under Government Contract.

The purpose of this amendment is to provide a revised Statement of Work (SOW), as the Medical Center found the SOW did not adequately address their needs. See attached SOW below. This RFQ is hereby extended from 03/19/2025 to 03/26/2025 NLT

2:00PM EST.

David Henry Contracting Officer

VA-VHA-RPOE-2023-0132

CONTINUATION PAGE

STATEMENT OF WORK

REQUIREMENTS FOR PCR TESTING - MICROBIOLOGY

PATHOLOGY AND LABORATORY MEDICINE SERVICE WPB VAHCS

I. INTRODUCTION:

The microbiology department of the Pathology and Laboratory Service within the WPB VAHCS is in need of a lease/reagent rental (cost per kit/test) agreement to cover equipment, service calls (including routine maintenance beyond manufacturer recommended user maintenance), reagents and consumables. Testing is for real-time PCR nucleic acid analysis to rapidly detect (at the minimum): Clostridium difficile including the Epidemic 027 Strain from stool (CDT), Methicillin Resistant Staphylococcus aureus (MRSA) from nasal swabs, SARS-CoV-2, FLU A&B/RSV virus and Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG) from male and female urine, vaginal or endocervical swabs. The contract shall be for Six (6) month Base and up to four (4) Option Years.

II.SCOPE OF PROCUREMENT:

Vendor shall provide the test menu listed on the FSS. Annual test volumes provided with this contract are based upon prior history and are not a guaranteed minimum. If at any time during the contract period, tests are not available on this list, the vendor shall reimburse the WPB VAMC any additional costs associated with the procurement of another source of test performance.

Testing required in this contract for the WPB VAMC are listed below:

· C. DIFF- Clostridium difficile. A qualitative in vitro diagnostic test for rapid detection of toxin B gene sequences and for presumptive identification of O27/NAP1/BI strains of toxigenic Clostridium difficile from unformed (liquid or soft) stool specimens.

· MRSA- Methicillin Resistant Staphylococcus aureus. A qualitative in vitro diagnostic test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from nasal swabs using automated real-time polymerase chain reaction (PCR) for the amplification of MRSA-specific DNA targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA.

· CT/NG - A qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG).

· SARS-COV-2/FLUA&B/RSV - A rapid, multiplexed real-time PCR test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and/or respiratory syncytial virus (RSV) in either nasopharyngeal swab, anterior nasal swab, nasal swab or nasal wash/aspirate specimens.

The WPB VAMC facility runs approximately 7500 test per year. Estimated annual test kit volumes are listed below:

III. PERIOD OF PERFORMANCE:

IV. TESTING MENU REQUIREMENT:

Vendor shall provide the test menu listed on the FSS. Annual test volumes provided with this contract are based upon prior history and are not a guaranteed minimum.

If at any time during the contract period, tests are not available on this list, the vendor shall reimburse the WPB VAMC any additional costs associated with the procurement of another source of test performance.

A. GENERAL REQUIREMENTS:

1) 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) All instruments, equipment and work shall be performed in accordance with the guidelines established by Federal, State, and local ordinances, FDA manufacturer’s guidelines, and with all terms, conditions, provisions, schedules and specifications provided herein.

3) The Laboratory space available is a critical element for instrument dimension or installation location maximum dimensions (7'W x 2'D x 3'H - in feet). Site preparation specifications shall be furnished in writing by the vendor as a part of the equipment proposal. In addition, the vendor is responsible for assessing the space available in the facility to ensure the right size equipment is provided; thereby not creating a safety hazard.

4) A high incidence of problems with any instrumentation/test supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility to replacement of equipment/test that can produce the required criteria of this contract satisfactorily to the user.

5) The vendor shall provide users with the utility requirements (electrical, guidelines for disposal of waste and hazardous reagents, etc.).

6) An operator’s manual must be furnished with model supplied.

7) Upon installation the contractor shall provide for an onsite Technical Support Specialist to assist in equipment installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), staff training and methodology problems and questions.

a) The contractor shall provide on-site training (basic operating and maintenance) during installation or equipment updates, for test and procedures offered and conduct instructional course(s) to meet operational objectives. In addition, the contractor shall provide handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses, and the contractor shall provide lesson plan, course materials and media (DVD’s, CD’s, videos, etc. if required) for each procedure at no additional cost to the Government.

B. SYSTEM REQUIREMENTS:

1) The vendor shall provide:

Molecular Diagnostic analyzer that uses a random-access platform – the system shall perform all PCR steps (automated extraction, amplification, and detection of the target), shall process the different specimens (sputum, nasopharynx swabs, Nares swabs, Stool and from pure culture) and shall generate a final result that will be transmitted to the LIS system.

2) Part of the system components are printer, computer with a software package.

3) All consumable supplies (reagents, disposables, collection devices, etc.) required for the proper specimen collection and operation of the contractor’s equipment and necessary to perform tests on the equipment provided shall be included in the price and shall be furnished by the contractor. This is an estimated quantities order; order will be based on anticipated inventory needs. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO).

a. Contractor shall deliver test kits and consumables third day air as ordered and shall set up scheduled delivery dates with each facility or deliver as above per email orders.

b. If the consumables are found to be defective and unsuitable for use with the contractor’s equipment, or the contractor has failed to comply with requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of forty-eight (48) hours after receipt of notification for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the Government site the next day without any additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor’s equipment for one (1) week (under normal Government test load volume). If additional request for emergency supply delivery is required by the Government, they shall be honored by the contractor until the arrival of the monthly standing order/routine supplies at the Government facility.

c. The contractor shall immediately notify the COR of any changes in reagents or equipment modifications by electronic means as well as by postal mail with supporting documentation of the change and, detailed guidance on implementation within twenty-four (24) hours of its application or according to FDA guidelines.

4) System must provide random access testing of different assay protocols.

5) Must provide testing in one unit to avoid cross-contamination.

6) Must provide minimal hands-on processing and loading time.

7) User friendly software that provides access to amplification curves within runs.

8) Testing menu: Ability to run multiple assay protocols simultaneously. The protocols or testing needed at a minimum shall be MRSA, SARS-CoV-2/FLU/RSV and CDT.

9) The system must provide a result at least two hours after start to analyze each specimen.

10) Software that integrates with Laboratory Information System (LIS) and Hospital Information System (HIS) networks to provide communication for all incoming and outgoing test orders and results.

11) Requires no user or medical technologist action beyond loading prepared test in instrument to achieve results.

C. FACILITY LOCATION:

V MAINTENANCE AND SERVICE

1. Business hours service provided for length of contract.

2. All service, repair, and maintenance (other than user performed maintenance) will be performed by the contractor with no additional expense to the government (service cost included in CPRR). Vendor service must be available within 2 hours of notification by customer during business hours.

3. Vendor will ensure that maintenance is scheduled with customer in advance of arrival on site.

4. Vendor to provide hazardous waste determination with proposal. The Hazardous Waste Determination is a procedure used to determine whether the by-products of an analytical process are characterized as a hazardous waste. This information to be provided based on the estimated workload as noted above.

5. The vendor shall provide and warrant the necessary technical support (i.e., disinfection, relocation, shipment, installation) in case of equipment relocation during the contract life without additional charges to the government.

6. The vendor shall warrant all provided equipment, printers, keyboards, and computers of the analyzer during the contract life as integral peripheral equipment items without which the laboratory work is affected, causing service delays due to equipment incomplete/or complete operation. These items must be replaced when inoperable at no additional cost to the government.

7. The vendor shall provide and warrant the appropriate UPS (Uninterruptible Power Supply) units according with the equipment model necessary for equipment protection against electrical power failure during the contract life and replace these units when defective at no additional charge.

8. The vendor shall provide all upgrades to equipment hardware and operating system software without additional charge. These enhancements to the vendor equipment shall be delivered to the government site and installed by the vendor within 60 days of their issuance or date of first commercial availability.

9. The vendor shall provide emergency back-up equipment and validation studies assistance in case it is necessary to maintain laboratory testing service continuity.

10. The vendor shall provide onsite Technical Service Specialist assistance during the equipment installation, implementation, and validation studies in San Juan.

11. Except for manufacturer recommended daily, weekly, or monthly user maintenance, the responsibility for maintaining the equipment furnished in complete operating condition shall be solely that of the contractor.

12. The contractor must provide monthly invoices.

13. The vendor quality performance will be measured on an annual basis by evaluating the following elements, rating from 1 to 5, unsatisfactory to outstanding performance:

a. Test/assay performance (accuracy, precision, and sensitivity)

b. Instrument performance (minimal downtime and accuracy)

c. Service-maintenance and repair (contractor has been responsive in resolving any unsatisfactory performance and has taken immediate corrective action)

d. Deliveries of reagents and supplies (timeliness, accuracy, complete orders, reagent lot consistency, acceptable expiration dates.)

e. Invoicing/Account payable (timeliness and accuracy).

VI INSTALLATION AND IMPLEMENTATION:

(a) Configuration of the proposed equipment shall be able to conform to the space previously allotted for this function. System specifications shall all be disclosed in the proposed space.

(b) Installation by the vendor must be complete and in accordance with manufacturer’s Instructions. The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility biomedical engineer. Upon receipt of notice to proceed with installation, it shall be the contractor’s responsibility to inform the Contacting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. Upon completion of installation the equipment shall be turned over to the hospital for use. Installation must include:

1) Shipment of equipment to the West Palm Beach VAMC facility.

2) Unpacking the equipment.

3) Inspection of all parts and accessories to assure that all components are present and undamaged.

4) Assembly of the analyzers (including electrical power connections, drains, etc.) for a normal operation.

5) Performing a complete system operation check (mechanical adjustments, calibrations, etc.).

6) Configuring tests parameters.

7) Verification of system operation and performance by multiple trial sample runs.

8) Before leaving the site, the following must be provided: a certified copy verifying the analyzers operation performance and all required operating manuals.

9) The vendor will provide Technical Support Specialist for validation Studies in San Juan, (including correlation studies, evaluation/comparison data sufficient to satisfy CAP specifications regarding implementation of new tests). Validation binder will be provided 1 week after installation is completed.

10) The contractor during a replacement, expiration/termination of contract shall remove the equipment. The contractor shall disconnect the analyzer and shall be responsible for decontamination of the system, packing and shipping within ten (10) calendar days.

Safety Requirements:

1. The contractor personnel must possess the required Occupational Safety and Health Administration (OSHA) training and certifications to provide the services requested in this SOW. The contractor shall assume full responsibility and liability for compliance with all applicable regulations pertaining to the health and safety of personnel during the execution of work.

2. The Contractor's equipment shall meet comply with the occupational safety and health standards (OSHA) and fire regulations. Equipment shall be in good conditions, the Contractor is responsible to identify, provide and maintain all personal protective equipment (PPE) required to perform the duties outlined in the SOW. In addition, the contractor is responsible for identifying and providing all applicable safety programs (i.e., lockout/tag out, universal precautions, etc.) required to perform the work, training on required safety programs and the proper use of PPE's shall be provided.

3. The Contractor shall immediately notify the Government of any changes in reagent kits composition, procedure modifications, recall notifications, equipment modifications, or any changes that will affect the performance of the test or procedure according to FDA regulations.

4. Notification shall be provided via electronic means as well as by postal mail with supporting documentation of the change and, detailed guidance on implementation within twenty-four (24) hours of its application or according to FDA guidelines.

VII. INFORMATION SECURITY

VA Handbook 6500.6, Appendix B.doc

VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy.

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITYREQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. Due to the threat of data breach, compromise or loss of information that resides o neither VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format(e.g., paper, microfiche, electronic or magnetic portable media).

b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources.

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(END OF CLAUSE)

VA Handbook 6500.6, Appendix c .doc

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY language FOR Inclusion into CONTRACTS, as appropriate

1. GENERAL

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

ACCESS to VA INFORMATION AND VA INFORMATION SYSTEMS

1. 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.

1. 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.

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.

Custom software development and outsourced operations must be 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.

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.

VA INFORMATION CUSTODIAL Language

1. 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.

1. 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.

1. 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.

1. 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.

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).

VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems 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 onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures follow VA directive requirements.

Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor during 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.

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.

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.

If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be enough 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.

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.

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.

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.

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.

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.

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

Records Management Contract 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.

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.

INFORMATION SYSTEM DESIGN AND DEVELOPMENT

1. 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 COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

The contractor/subcontractor shall certify to the COTR 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.

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.

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

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.

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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.

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

1. 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.

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 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.

1. “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.

1. “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 assigned to the individual.

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.

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 2 days.

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.

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.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

1. 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 vulnerability 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 COTR 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.

1. 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.

1. 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.

1. 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 the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

1. 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 COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

1. VA prohibits the installation and use of personally-owned or contractor/subcontractor-owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

1. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

1. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

1. Vendor must accept the system without the drive;

1. VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

1. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

1. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

SECURITY INCIDENT INVESTIGATION

1. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures.