SON - ESR Testing CPT 02.docx

STATEMENT OF WORK

TITLE: Automated Erythrocyte Sedimentation Rate (ESR) Testing CPT

1. SCOPE: The Contractor shall provide a Cost-Per-Test (CPT) fully automated Erythrocyte Sedimentation Rate (ESR) Testing within VISN 8, Department of Pathology and Laboratory Medicine Service (P&LMS). P&LMS requires equipment in at least two (2) healthcare systems, for the Tampa VA Healthcare Network (TVAHCN) and Bay Pines VA Healthcare System (BPVAHCS). Testing is currently performed in five (5) separate locations, including but not limited to, the following locations, with the flexibility and ability to expand testing / add instrumentation to future locations throughout the VISN as needed to meet the healthcare system’s demand and growth:

1) Tampa VA Healthcare Network, James A. Haley Veterans Hospital (JAHVH) 13000 Bruce B. Downs Blvd., Tampa, Florida 33612

2) Tampa VA Healthcare Network, New Port Richey VA Outpatient Clinic (NPROPC) 7900 Little Road, New Port Richey, Florida 34654

3) Tampa VA Healthcare Network, Lakeland Community-Based Outpatient Clinic (LCBOC) 2080 Meadowland Park Blvd, Lakeland, Florida 33803

4) Bay Pines VA Healthcare System, C.W. Bill Young VA Medical Center (CWBY VAMC) 10,000 Bay Pines Blvd, Bay Pines, Florida 33744

5) Bay Pines VA Healthcare System, Lee County VA Healthcare Center (LCHCC), 2489 Diplomat Parkway East, Cape Coral, Florida 33909

All work is to be performed in accordance with the guidelines established by the Federal, State, and local ordinances. FDA and manufacturer's guidelines, with all terms, conditions, provisions, schedules, and specifications provided herein. The Contractor selected is responsible for system installation, maintenance coordination and supply procurement for all equipment.

2. GENERAL:

A. The Contractor is required to provide, as part of the CPT contract, BRAND NAME or EQUIVALENT, Alcor iSED® Pro instrumentation, all reagents, consumables (including, but not limited to, all reagents, controls and calibrators) necessary to operate the equipment, delivery, installation, validation, hardware and software upgrades, and equipment service/maintenance for the life of the contract necessary to fulfill the test requirements. CPT shall be based on a tiered volume with additional savings as testing volume increases. Failure to adequately charge for estimated cost on volume as disclosed will not incur additional charges. Inflated reagent estimates if not consumed will not be charged.

B. Annual test volumes provided are based upon historical reported result data and are not guaranteed a minimum.

Bay Pines VA Healthcare System

Tampa VA Healthcare Network

C. All reagents for instrumentation and test validation shall be supplied at no additional cost.

D. If at any time during the contract period, tests are not available on this list, the Contractor shall replace the existing equipment at no charge or provide alternative testing and reimburse the Government for any additional costs associated with the procurement of another source of test performance.

E. Required Test Equipment, Reagents and Supplies based on the above estimated test volumes:

F. Instrument Specifications:

1) Must utilize rack-based specimen loading

2) Must utilize Photometric rheology principle of measure with high correlation to the Westergen method (gold standard)

3) Must have at least a 25-hour room and refrigerated temperature specimen stability

4) Must have a reportable range of 1-130 mm/hour

5) Must have an onboard sample capacity of at least 100 specimens

6) Must have a specimen throughput of at least 175 samples per hour

7) Must be compatible with Sysmex® Hematology specimen racks

8) Must have a STAT testing function to prioritize specimen testing on critical patients

9) Must have an automatic washing cycle

10) Must have programmable preventative maintenance

11) Must have onboard storage of controls with automatic scheduling for periodic quality control testing

12) Must allow for the continuous feed of specimens (random access operation)

13) Must be a fully automated instrument with true “walk-away” capability, including sample mixing, aspiration, and reading of results

14) Must have turn-around time to result in <30 seconds

15) Must utilize EDTA whole blood in a 13 x 75 mm collection tube

16) Must be a cap-piercing test system

17) Must fit within the allocated space (H x W x D): 24” x 24” x 30” (inches) G. Operating System Software:

1) Must have a bidirectional interface to Data Innovations Instrument Manager software.

2) Must be capable of printing/displaying calibration verification, results, and all QC.

3) Must include a printer with printer driver

4) Must be compatible with all barcode style formats.

5) General instrument characteristics include a simple, touch-screen user interface, with easy-to-use software

6) Instruments / Operating Systems are is connected to the VA Network.

3. TECHNICAL SERVICE, SUPPORT and PREVENTATIVE MAINTENANCE:

A. Contractor shall provide full service on-site technical support and telephone support for all instrumentation which shall be available, at a minimum of 8 hours per day, Monday – Friday, excluding federal holidays. Technical Support and repairs shall be included for the life of the contract.

B. Following determination that service is required, technical on-site support must be provided within 24 business hours. The contractor shall provide maintenance (labor and parts). The government shall provide the Contractor with access to the equipment to perform maintenance service according to the maintenance and service terms below.

C. The government shall provide the Contractor with access to the equipment to perform the repair.

D. The Contractor will provide all parts and labor needed to repair the malfunction.

E. Travel, per diem and other expenses associated with the repair will be borne by the Contractor.

F. The contractor shall furnish a malfunction incident report to the institution upon completion of each maintenance call. The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

G. Preventative Maintenance is provided by the Contractor per the published manufacturer's recommended guidelines to keep the instrument in good operating condition.

4. UPGRADES / REPLACEMENT OF EQUIPMENT:

A. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the Government to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily.

B. Enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

C. The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government, including unpredictable changes to VHA IT requirements.

5. PLACE OF DELIVERY:

A. Tampa VA Healthcare Network, James A. Haley Veterans Hospital (JAHVH) 13000 Bruce B. Downs Blvd., Tampa, Florida 33612 B. Tampa VA Healthcare Network, New Port Richey VA Outpatient Clinic (NPROPC) 7900 Little Road, New Port Richey, Florida 34654 C. Tampa VA Healthcare Network, Lakeland Community-Based Outpatient Clinic (LCBOC) 2080 Meadowland Park Blvd, Lakeland, Florida 33803 D. Bay Pines VA Healthcare System, C.W. Bill Young VA Medical Center (CWBY VAMC) 10,000 Bay Pines Blvd, Bay Pines, Florida 33744 E. Bay Pines VA Healthcare System, Lee County VA Healthcare Center (LCHCC), 2489 Diplomat Parkway East, Cape Coral, Florida 33909

6. DELIVERY, PERFORMANCE, INSPECTION AND ACCEPTANCE:

A. General:

1) The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies and services furnished under the contract conform to contract requirements. The VA has the right to test all services ordered under the contract at all times and places throughout the term of the contract Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract.

2) The VA reserves the right to thoroughly inspect and investigate the contractor and manufacturer’s business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined, lacking in any of the essentials necessary to ensure acceptable standards of performance.

3) Returned goods: The VA is responsible for inspecting all products shipped here under and will give the contractor a written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor.

4) Standard and Acceptance of performance shall begin on the installation date. It shall end on the earlier date when a certificate of acceptance has been signed, or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor's technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order upon mutual agreement.

5) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fine attempt to contact the contractor's designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

6) During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

7) Government's Responsibility: The user will perform routine operation maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user shall maintain appropriate daily records to satisfy the requirements of this paragraph.

B. Equipment:

1) The contractor is required to deliver the equipment ordered under this contract no later than THIRTY (30) calendar days after receipt of notice of award. The contractor is required to provide new state-of the art equipment. Previously used or discontinued models are not acceptable.

2) Any required initial equipment placement/staging, setup, and/or installation shall be completed by the contractor within fifteen (15) calendar days following delivery to the VA facility.

3) All supplies, reagents, to be delivered within fifteen (15) calendar days ARO processing and placement.

4) The contractor shall be responsible for installation, which consists of in-house delivery (white-glove service), positioning and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor or government, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

5) All validation and/or correlations shall be completed within ninety (90) calendar days after placement. Acceptance of equipment will normally be consummated upon delivery and, when applicable, installation and completion of personnel training. The VA reserves the right to request a ninety (90) day test and evaluation of all pieces of equipment prior to placing a delivery order under the contract. If the test and evaluation is not successful as determined by the CO and COR, the VA will not be required to continue with placing a delivery order under this contract, and no default or penalty will accrue.

6) The contractor will provide all operational upgrades to the equipment’s hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability.

C. Reagents/Supplies/Consumables:

1) The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included, as needed (including emergency orders) from CALL orders within 24 hours.

2) The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission (TJC). In the event that the supplies to include consumables are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order for priority delivery from the government activity. This will be done at no cost to the government and in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).

7. TRAINING:

A. The contractor, without additional charge to the government, shall provide training on- or off-site training for at least two (2) key operating personnel per instrument module installed and all automation system components at the time of installation of the contractor's equipment. In addition, the contractor shall provide supplemental operating training to (2) two government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. The contractor will also supply two (2) additional training slots per year throughout the life of the contract.

B. Training of Operating Personnel: The contractor shall provide the services of a qualified technical person, at the time of equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Representative (COR) to on-site orientation and training to designated personnel in: operation and care of equipment; techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause. This training shall include at least (2) two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training.

8. REGULATORY REQUIREMENTS: If the product(s) included in this solicitation are considered medical devices by the US Food and Drug Administration, the manufacturer shall be in compliance with the Food, Drug and Cosmetic Act, as amended, and regulations promulgated there under. The contractor will assure that all supplies provided/ordered for use on their equipment will be FDA-approved and of high-quality necessary to produce accurate and reliable patient results. The FDA-approved supply quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC).

9. TECHNICAL INDUSTRY STANDARDS: The contractor certifies that all applicable equipment offered under this contract shall conform to all common industry standards.

10. MANUFACTURED PRODUCTS: Materials furnished shall be of the current productions of manufacturers regularly engaged in manufacture of such items. Approval by Contracting Officer is required of deviation from products and manufacturers as shown in the schedule of items. The shelf-life of all consumables shall be at least ONE YEAR from shipping date unless FDA requires different expiration date.

11. REFERENCE SPECIFICATIONS AND PUBLICATIONS: Where an item is required to conform to certain requirements, conformance shall be evidenced by seal, label, stamp, or approval listing from such agency, or by a certified test report from an independent testing laboratory acceptable to the Government, that the item has been tested and conforms to requirements of referenced agency.

12. RECALLS: If at any time during the term of the contract, the FDA or the Contractor, or subcontractor initiates an item recall or FDA withdraws its approval to manufacture an item, the contractor will issue a notice to indicate the complete item description and identification of the recall with necessary instructions for return for credit or replacement.

13. CONTRACT ADMINISTRATION DATA: The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority and no adjustment will be made in contract price to cover any increase in costs incurred as a result thereof.

14. RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes James A. Haley Veterans’ Hospital System records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their James A. Haley Veterans’ Hospital contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. The Healthcare System and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of James A. Haley Veterans’ Hospital or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to James A. Haley Veterans’ Hospital. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to James A. Haley Veterans’ Hospital control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA Healthcare System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with James A. Haley Veterans’ Hospital policy.

8. The Contractor shall not create or maintain any records containing any non-public James A. Haley Veterans’ Hospital information that are not specifically tied to or authorized by the contract.

9. The 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 from public disclosure by an exemption to the Freedom of Information Act.

10. The James A. Haley Veterans’ Hospital owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which James A. Haley Veterans’ Hospital shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flow-down of requirements to subcontractors:

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

15. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

A. Access To Va Information and VA Information Systems:

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. 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.

3. 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.

4. 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.

5. Contractor Personnel Security Requirements:

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

Position Sensitivity – The position sensitivity has been designated as ( low ) risk.

Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries.

Contractor Responsibilities:

a) The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days.The web site which provides information on the cost of the security investigation is: www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01) The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak, and understand the English language.

b) The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address. The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation.

c) The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

· Standard From 85P, Questionnaire for Public Trust Positions

· Standard Form 85P-S, Supplemental Questionnaire for Selected Positions

· FD 258, U.S. Department of Justice Fingerprint Applicant Chart

· VA Form 0710, Authority for Release of Information Form

· Optional Form 306, Declaration for Federal Employment

· Optional Form 612, Optional Application for Federal Employment

d) The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

e) Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

B. VA Information Custodial Language:

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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.1, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

C. 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. 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.

2. 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.

3. 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.

4. 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.

D. Liquidated Damages for Data Breach:

1. 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. However, it is the policy of the VA to forego collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

2. 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.

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

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

b) Description of the event, including:

1) date of occurrence;

2) (b)data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

c) Number of individuals affected or potentially affected;

d) Names of individuals or groups affected or potentially affected;

e) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

f) Amount of time the data has been out of VA control;

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

h) Known misuses of data containing sensitive personal information, if any;

i) Assessment of the potential harm to the affected individuals;

j) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

k) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

4. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 for affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

a) Notification;

b) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

c) Data breach analysis;

d) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

e) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

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

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

F. Training:

1. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training and Privacy and HIPAA Training and HIPAA Training before being granted access to VA information and its systems.

a) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems.

2. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

3. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this SOW.

*** IF APPLICABLE***

G. 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.

2. 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.

3. 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.

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

5. 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.

6. 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.

7. The contractor/subcontractor agrees to:

a) 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:

1) The Systems of Records (SOR); and

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

b) 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

c) 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.

8. 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.

a) “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.

b) “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

c) history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the…