Attachment C - V20 FIT Statement of Work.docx

REQUIREMENT SPECIFICATIONS / STATEMENT OF WORK

1. SCOPE:

The Vendor shall provide automated Fecal Immunoassay Testing (FIT) analyzers to produce Cost Per Reportable Results (CPRR) for VA Medical Centers throughout VISN20 (see below participation VISN20 medical centers) and Custom Mailing Kits. Installation and operational training will be provided by Vendor at Government’s facility. Vendor will provide Field Service Support for the lifetime of the analyzer. Vendor will also supply the Government with sufficient supplies, reagents, consumables, and training to perform testing on the Fecal Immunoassay Testing (FIT) analyzer systems for each facility based on estimated patient results per month. Equipment will be defined by the facility.

Participating Locations:

· Alaska VA Healthcare System: 1201 North Muldoon Road, Anchorage, AK 99504

· Boise VA Medical Center: 500 West Fort Street. Boise, ID 83702

· Eugene Health Care Center: 3355 Chad Dr., Eugene, OR 97408

· VA Portland Health Care System: 3710 SW U.S. Veterans Hospital Road, Portland, OR 97239

· Roseburg VA Health Care System: 913 NW Garden Valley Blvd., Roseburg, OR 97471

· VA Southern Oregon Rehabilitation Center: 8495 Crater Lake Hwy., White City, OR 97503

· VA Puget Sound Health Care System - American Lake Division: 9600 Veterans Dr Southwest, Tacoma, WA 98493

· VA Puget Sound Health Care System: 1660 S. Columbian Way, Seattle, WA 98108

· Mann-Grandstaff VA Medical Center: 4815 N. Assembly Street, Spokane, WA 99205

· Jonathan M. Wainwright Memorial VA Medical Center: 77 Wainwright Drive, Walla Walla, WA 99362

· Map and locations for Medical Centers and Clinics within the V20 Northwest Network can be found at the following link: https://www.va.gov/directory/guide/region.asp?ID=1020.

2. GENERAL REQUIREMENTS:

A. Leased (Cost per Reportable Result) equipment to include installation.

B. All supplies, reagents, and consumables for testing and collection include expedited shipping, if requested.

C. Collection kits.

D. Field Service support and customer troubleshooting helpline to keep equipment in manufacturer's operating conditions, both preventive maintenance and emergency repairs.

E. Training for personnel operating equipment.

F. All items above provided at no charge for CPRR.

G. Custom Mailing Kits.

3. COST PER REPORTABLE RESULT CPRR:

Cost per Patient Reportable Result (CPRR): Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5-year equipment use, (2) all reagents, standards, Vendor provided quality Controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution: repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI), (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. Contractors shall provide delivery, installation and removal of equipment at no additional charge.

A. Parameters: The calculation for price and quantity of reagents are based on an estimated annual number of reportable results provided by the Government. The quantities of the annual supply needs shall be sufficient for testing performed within the following parameters:

a) Numbers of reportable results performed by the Government are within ten percent of the annual estimated reportable results as indicated by the annual supply list.

b) Use of the instrument(s) are in accordance with instrument usage information provided by Government (Primary, Back-up or Alternate).

c) Test volumes are determined by the Government.

d) Two levels of quality control to be run as required by the manufacturer every test day.

e) Calibrators for periodic calibration checks and as necessary to validate systems following major repair or resolution of negative quality control trends.

B. Adjustments:

a) The Government and vendor will conduct reviews annually to monitor contract performance against agreed upon efficiencies, operational assumptions and product utilization (CPPR parameters).

b) The vendor will notify the Government when such reviews indicate an adjustment to the quarterly standing order shipments may be required. The Government will cooperate with the vendor in the conduct of the reviews.

c) The vendor, their personnel, and their sub-vendors 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.839.201 Contract Clause for Information and Technology Security.

4. EQUIPMENT:

Vendor will provide leased equipment to meet VISN20 facilities usage needs.

A. Equipment Requirements: Offered models of Automated Fecal Immunoassay Testing (FIT) Analyzers shall be capable of producing accurate and reproducible assays on fecal specimens by established in-vitro diagnostic methods. Models shall provide accurate test assay result for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

a) The awarded vendor shall provide all upgrades to the equipment operating system software, and hardware at no additional cost to the Government. These enhancements shall be delivered and installed at VISN20 Hospitals within 60 days of issuance to the commercial market.

b) The models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, "current production" shall mean that the clinical laboratory analyzer model is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

c) Vendor offered equipment shall perform satisfactorily at ambient laboratory temperatures between 50- and 90-degrees Fahrenheit (10 and 32 Celsius) and at relative humidity between 15 and 85 percent.

d) An operator’s manual shall be furnished with each model supplied.

B. Installation: The vendor shall deliver and install all leased equipment under this CONTRACT to the requesting facility after an order is placed. Equipment shall be installed within 60 business days after receipt of order unless other arrangements are approved by individual medical center laboratory managers. Equipment shall not be considered installed until a VA employee certifies that the equipment is properly functioning and has the necessary supplies to perform its required function.

a) The vendor shall maintain a record of installation to include location, model number, serial number, and date of installation.

C. Removal: The vendor shall un-install and remove all leased equipment (less any hard drive with Personal Protective Information PPI) under this CONTRACT from the requesting facility upon request. The Vendor will turn over the hard drive to OIT staff. OIT will produce form VA0751 for the destruction of the Hard Drive. Equipment shall be removed within 30 days of request. Equipment shall be considered removed upon a VA employee certification that the equipment and all accessories have been taken by an employee of the vendor and there is no disruption and /or damage to the surrounding area.

a) The vendor shall maintain a record of removal to include location, model number, serial number, decontamination certification, and date of removal.

5. SPECIAL REQUIREMENTS:

A. In addition to the general requirements for the Automated Fecal Immunoassay Testing (FIT) Analyzers CPRR requirements stated above, the vendor shall meet the following special requirements:

a. Uninterruptible Power Supply (UPS) and line conditioner for each analyzer. Systems shall be installed and maintained by the vendor. Preventive maintenance shall be performed in accordance with manufacturer’s recommended guidelines.

b. Interfaces with the EHR or VISTA proceed through the Data Innovations System.

B. Custom Mailing Kits will be provided to participating V20 locations for their mailout program for yearly maintenance.

a. Vendor to provide mailing system for specimen transport that meets the US Postal Service mailing requirements. Mailing system must be easy to use and include, but not limited to, specimen collection and labeling instructions, specimen transport tube/vial/card, and mailing envelope. Vendor shall work with each facility to develop an acceptable system to meet the needs for postage and addressing mailing envelopes of that facility.

6. METHOD VALIDATIONS:

A. Once the instrument has been installed according to the Vendor specifications at the Government location, the vendor shall ensure that installation of equipment, instrument correlations, validation studies, carry-over studies, operator training, and all other tasks that are necessary for implementation of this agreement are completed prior to going live.

B. The Method validations will be completed to include the necessary studies required for Clinical Laboratory Information Act (CLIA), College of American Pathologist (CAP), Clinical Laboratory Standards Institute (CLSI), and Department of Veterans Affairs (VA) regulatory agencies. Validations shall include precision, linearity and current system to new system correlations as well as establishment of normal and therapeutic ranges not to deviate significantly from current facility ranges.

a) Method Performance/Comparison will be at the expense of the Vendor, will include reagents, and be consistent with current CLSI and related documents, CAP Standards and Federal Regulations, for the following:

i. Accuracy studies for each analyte: A minimum of 30 samples, consisting of an adequate number of both positive and negative samples will be run by the present and the proposed method. Vendor will analyze results and provide data to support acceptance of the new method. The evaluation will include validation of accuracy, in concordance to current method and meet current standards defined by CLSI.

ii. Precision study using negative and positive control material: This will consist of a within run precision study of 10 negative and 10 positive controls.

iii. Specificity Studies: Manufacturer’s package inserts including any limitations and interferences will be provided by the vendor.

iv. Sensitivity Studies: Manufacturer’s package insert will be provided by the vendor.

v. Carryover Studies: Presence of assay carryover is ruled out during the vendor’s instrument validation process. Documentation of carryover studies performed during the validation process will be provided by the vendor.

C. The vendor shall provide on-site support to assist with performance of validation studies: precision, method comparison with current analyzer, accuracy (recovery), carry over (reagent & particulate/cell carry-over) studies. These services shall also apply to the validation and troubleshooting of all required, third party reagents. Vendor shall perform all required statistical analyses and report data in an organized, clearly comprehensible format.

D. Vendors should provide a list or otherwise specify all maintenance requirements/tasks to be performed by the analyzer operator(s) as well as the service engineers.

E. Vendors should provide commercial literature, other information describing compliance with technical specifications, and all customer references from successful installations over the past year. Vendors should also provide certification of the capability of proposed analyzers to interface with new upcoming Electronic Heath Record (Oracle Cerner) or VA’s laboratory information system VISTA.

F. Vendors should provide alternate proposals which provide differing levels of automation/instrumentation, at larger and smaller sites Proposals should be based on workload figures provided in the attached document.

G. A current editable, electronic (Microsoft Word) copy of the instrument operating guide(s) and procedures shall be provided to each site. The document(s) shall be formatted in accordance with current, approved CLSI guidelines. Electronic (CD Format) and hard copy Safety Data Sheets (SDS) shall also be provided. Updates to all procedure manuals in Microsoft Word format and MSDS sheets in electronic format shall be provided when package inserts are modified.

H. The VA will not accept equipment until it passes initial validation testing.

7. UPTIME GUARANTEE/ PERFORMANCE PENALTY:

Each instrument provided by the vendor shall maintain an uptime of 95% in each month of the term of the agreement. During the term of this CONTRACT, should the repair record of any individual piece of laboratory equipment reflects a downtime of 5% or greater of the normal working days in one calendar month, it is the responsibility of the vendor to immediately replace the broken laboratory equipment with new equipment at no additional cost to the Government. The responsibility for maintaining the equipment furnished in operating conditions in accordance with manufacturer's instruction shall solely be the responsibility of the vendor.

A. Operational time is 24 hours per day, 7 days a week.

B. Downtime is defined as when the instrument is not able to produce clinically acceptable results: and will be computed from the time the Government notified the hotline, and the instrument can produce acceptable results. Scheduled maintenance is excluded from downtime.

C. Preventive maintenance, emergency repair, maintenance credit for equipment malfunction, and replacement laboratory equipment.

8. MAINTENANCE AND REPAIRS:

A. Vendor shall provide preventative and corrective maintenance per manufacturer's recommendation. This shall include software upgrades and parts and labor, to maintain all Automated Fecal Immunoassay Testing (FIT) Analyzers equipment and accessories. At a minimum, preventative maintenance annually, beginning twelve (12) months after installation.

B. Vendor shall furnish all transportation, equipment, parts, tools and labor to accomplish the required maintenance and/or repair.

C. Technical support services shall be provided at no additional charge. Technical support by telephone shall be available 5 days a week, Monday through Friday between the hours of 8:00 a.m. and 5:00 p.m. PST at least. Technical support shall return all downtime calls within one hour.

D. Should on-site service be required, the vendor shall provide on-site service response within 24 hours after being contacted. The vendor shall also, prior to departure, provide the visited site with written documentation of services performed.

E. Efforts shall be made by the vendor to minimize disruption to the Government and employees (i.e. reschedule if work interferes with normal operation, access equipment when convenient to the needs of the VA, etc.) Repair service is expected to be provided between 8:00 a.m. – 5:00 p.m. Monday through Friday.

F. Vendor shall maintain cleanliness of work area and minimize dust and contaminants to areas adjacent to the job site.

G. Vendor shall furnish a malfunction incident report to the facility upon completion of repair call within 2 business days after the completion of work. The report shall include as a minimum the following:

a) Date and time notified.

b) Date and time of arrival.

c) Serial number, type and model number(s) of equipment.

d) Time spent for repairs.

e) Description of malfunction and repair.

f) Proof of repair included documentation of a sample run of quality control verifying acceptable performance.

H. Emergency repairs shall be performed after notification that the equipment is inoperative. The vendor shall provide the Government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification.

I. For each instrument provided, the vendor shall treat each notification for an emergency/repair service call form the Government as a separate and new service call.

J. The following are guaranteed throughout the life of this Contract:

a) Priority scheduling of requests for service.

b) Unlimited Emergency Service. No charges for labor, travel or any other related expenses.

c) Unlimited Parts. No charge for replacement parts, or accessories, which become marginal or defective due to normal use during the agreement period.

d) Factory Authorized Product Updates and Modifications. Installed at no additional charge for improved product performance and reliability.

e) Factory trained and Authorized Service Engineers. Continual upgrading and certification of engineers in latest instrument technology.

9. TRAINING:

With the exception of specific training requirements stated herein, which shall have precedence; vendor shall provide "operator" training in accordance with the terms, conditions, and provisions of the vendor's existing Federal Supply Service Contract. Listed below are the training requirements:

A. The vendor shall provide, at no cost to the Government, on-site vendor operator training at the time of installation for all personnel who will run instrument with training on all applicable shifts per site.

B. Provide initial in-depth training for two key operators at the facility and for each individual instrument provided. Provide annual training for one VA equipment operator, per each instrument, for the participating medical center.

C. The Vendor shall have an on-going training program for Employees by the Technical Service Representatives on any new products or updates on the product lines. All materials for training will be provided at no additional cost to the Government.

10. REAGENTS, CONTROLS, AND SUPPLIES:

Routine Reagents, controls and Disposables (supplies) for Automated Fecal Immunoassay Testing (FIT), shall be provided by the vendor and shall adhere to the following requirements.

A. All consumable supplies (reagents, standards, control, disposables, etc.) required for the proper operation of the vendor's equipment and necessary to perform tests on the equipment provided shall be included and shall be furnished by the vendor for each clinical laboratory analyzer model.

B. In the event that the consumables are found to be defective and unsuitable for use with the vendor's equipment, or the vendor has failed to comply with the requirements for routine supply delivery, the vendor shall deliver the consumable supplies within a period of twenty- four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the vendor shall deliver to VISN20 Hospitals, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the vendor's equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they will be honored by the vendor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory will result in default.

C. Inventory Control Reagents, Supplies and Disposable: The vendor shall maintain on Government provided space a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other material required to properly perform tests on the offered equipment. 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 (JC).

D. Vendor Provided: Supplier shall provide kits (200 tests per kit) as needed.

11. THE VENDOR WILL BE RESPONSIBLE FOR THE FOLLOWING: COST PER REPORTABLE RESULT PROGRAM, REAGENTS, CONTROLS AND SUPPLIES AND CUSTOM MAILING KITS:

A. Routine Reagents and Disposables.

B. Reagents including controls and Disposables to be listed in separate Table. Includes Annual kits included in the contract including shipping charges for monthly shipping of standing orders.

C. Vendor shall supply a list of reagents, controls and disposables that will be shipped as part of the agreement.

D. Supplies for testing material will be shipped on a standing order schedule, agreed upon by the Government and Vendor.

E. All or part of a future monthly standing order may be advanced up to 10 days ahead of the scheduled ship date of the standing order.

F. Vendor will contact the Customer to determine the quantity of Test Materials required by the Customer, and Supplier will use commercially reasonable efforts to ship Monthly Stocking Orders to the Customer within ten (10) ARO following receipt of the Customer’s requirements for Test Materials. Supplier will designate the method of shipment of the Test Materials in the Monthly Stocking Order.

G. Vendor shall provide sufficient reagents and supplies for performance of patient results for all VISN 20 sites.

H. 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 (TJC).

I. Changes in maintenance schedules that affect reagent or cleaning reagent volumes will be approved by the Vendor in accordance with manufacturer's recommendations.

J. Additional reagents, if required, will be provided by the vendor at no additional charge.

K. The vendor will invoice the Government monthly based on actual Cost Per Reportable Result performed during the preceding month of the CPRR Term, as reflected in the Customer’s Monthly Usage Report, generated from the Customer’s LIS System or Customer’s other reporting system.

L. Provide Custom Mailing Kits to participating V20 facilities to their specifications.

M. The vendor shall provide at minimum yearly cost saving reports, showing the price and the discounted price to determine savings. Reports shall be sent to the Contract Officer and Contract Officer Representative for the contract.

a) Cost savings reports are a significant condition of this agreement. If the Vendor fails to provide a complete cost savings report this CONTRACT may be terminated by the Government without cost or penalty.

12. THE GOVERNMENT WILL BE RESPONSIBLE FOR THE FOLLOWING: COST PER REPORTABLE RESULT PROGRAM:

A. During the agreement the Government will report no later the ten (10) business days from the end of the preceding month and must include the number of tests used for calibration, numbers of tests used for controls (QC data), patient results (positive and negative) indicating the total number of tests used to produce the patient results reported. Supplier will charge each CPRR to the Customer at the corresponding price per CPRR set forth in the agreement.

B. VISN designated Pathology and Laboratory Manager or designee will act as Contracting Officer Representative (COR) for this contract.

13. INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

A. 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.

B. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

C. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

g) If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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

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

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

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

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

D. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

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

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

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

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

g) The contractor/subcontractor agrees to:

i. 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:

ii. The Systems of Records (SOR); and

iii. The design, development, or operation work that the contractor/ subcontractor is to perform I. 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 II. Include this Privacy Act clause, including this suContractragraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

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

i. "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.

ii. "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.

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

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

j) The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 days.

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

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

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

a) For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine 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 COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

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

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

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

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

f) 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 of 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.

g) 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.

h) 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:

i. Vendor must accept the system without the drive;

ii. 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

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

iv. 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;

I. 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 II. 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.

III. 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.

F. 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 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 contractor/ subcontractor's 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 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 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.

G. LIQUIDATED DAMAGES FOR DATA BREACH

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

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

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

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

ii. Description of the event, including:

I. date of occurrence;

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

III. Number of individuals affected or potentially affected;

IV. Names of individuals or groups affected or…