SOW Electrophoresis CPT.pdf

STATEMENT OF WORK

A. GENERAL INFORMATION

Scope of Work:

The South Texas Veterans Health Care System (STVHCS) has a continued need for Serum and Urine Protein Electrophoresis, IFE, and IT instrumentation. The contractor shall provide a fully automated, gel electrophoresis instrument that can perform both serum and urine electrophoresis (SPEP/UPEP), immunofixation (SIFE/UIFE) and Immunotyping (IT) to identify monoclonal and polyclonal gammopathies. The Sebia instruments Capillarys and Hydrasys have been in use in the STVHCS Chemistry Laboratory 2016.

Technical Requirements:

• SEBIA OR EQUAL

Hydrasys 2 or equal system for automated agarose gel electrophoresis.

Capillarys 3 Octa or equal system

• When considering the specified workload pricing is based on cartridge price plus add on. Add on is figured by equipment at the facility divided by the average monthly test volume and includes service.

This also includes calibrators and controls (where applicable) to be included in the cost per test pricing.

The STVHCS shall be responsible for submitting their test counts each month to the awarded Contractor. The Government estimates the volumes as listed on Attachment A but does not guarantee volumes as listed. These monthly testing numbers provided by the STVHCS are best estimates only derived from past patient care numbers.

• The instrumentation must be approved by the Food and Drug Administration (FDA).

• Multi-parameter semi-automated agarose gel electrophoresis instrument for SPEP, UPEP, IFE, IT.

• Walk away after sample inoculation.

• Sequenced sample application, migration, incubation, staining, destaining, and drying.

• High voltage protein separation and direct protein detection of the following five protein zones: Albumin, Alpha-1, Alpha-2, Beta, and Gamma.

• Scanner required for the identification of protein fractions.

• Independent and separate self-contained assay kits.

• Software compatible with instrumentation to provide the software features to complete patient demographic, curve editing, modification of the baseline, fraction identification, and curve overlay.

• Software to provide a comprehensive patient report with electrophoretic curve, immunofixation pattern, and quantitively specific protein results.

• A comprehensive quality control program with two levels of quality control to include Levy-Jennings charts.

• Hardware Features- The instrumentation shall have the following Hardware Features:

• A total equipment footprint that when installed in the Laboratories shall not impact the functionality and or operations Laboratory.

• Contractor shall supply a printer, replacement printers if required, and toner cartridges as part of their cost per test pricing.

• Equipment must be able to support multiple barcode formats with a minimum of ten characters in the specimen identifier.

• Ability to store and retransmit records in case of interface outage.

• The flexibility to set multiple units of measurements.

Method Performance and Validation Requirements:

Method performance and comparison will be at the expense of the Contractor and shall include the following:

all reagents consumables and replacement parts, assayed quality control material, calibration material, and linearity material every six months. Linearity material and reagents, and results shall be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards, and Federal Regulations. The Contractor shall perform method validation to include correlation study, crossover studies, sensitivity, linearity, reproducibility, and any additional test workup required to demonstrate satisfactory instrument performance consistent with CLSI Standards.

Carryover Studies Successful carryover studies, demonstrating absence of any clinically significant carryover, shall be completed by the Contractor on the analyzers during installation. These studies shall be performed using either Contractor developed programs or programs developed by a third party (CAP/CLSI). The programs shall be provided to each Laboratory at no charge.

Support Features:

Commercial marketing. The equipment models being offered shall be in current production as of the date the Contractor’s offer is submitted. For purposes of this Statement of Work, “current production” shall mean that the chemistry laboratory analyzer model being offered is new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. The Contractor shall perform to the satisfaction of the Government, as determined by the Laboratory Medical Director at each site, all validation studies to include: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specify as part of their cost per test pricing. The Contractor shall perform all the statistical analysis as stated in the Method Performance and Validation section above and report data in an organized and clearly comprehensible format to the satisfaction of the Laboratory Medical Director at each site.

Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable and disposable items, parts, accessories, and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform to the satisfaction of the Government, as determined by the STVHCS all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity as part of their cost per test pricing. The Contractor shall perform all the statistical analysis as stated in the Method Performance and Validation section above and report data in an organized and clearly comprehensible format to the satisfaction of the STVHCS.

Training. The Contractor shall provide an instrument training program, as well as onsite training, that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the STVHCS. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair.

Thereafter, the Contractor shall provide training for minimally two operators per Laboratory per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the three Laboratories and the Contractor. A training program that involves off site travel shall include the cost of airfare and room and board for each participant.

Equipment Preventative Maintenance and Repair Service. The Contractor shall provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation according to the following terms:

Service Requirements:

Technical support by telephone available 24 hours a day 7 days a week. Onsite service Monday through Friday from 8:00 AM to 5:00 PM with emergency service provided within 24 hours.

A current contractor Service Agreement Plan will replace equipment and or any incremental networking or support equipment within one business day of complaint being received.

Upgrades:

The Contractor shall provide upgrades to both the equipment hardware and software, excluding analyzers and related accessories, in order to maintain the integrity of the system and the state-of-the-art technology as part of their cost per test price. These upgrades shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrades offered to commercial customers at no additional charge, upgrades to replace a model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the awarded Contract; however, it does refer to significant changes in the hardware operational capability.

Ancillary Support Equipment:

The Contractor shall provide, install, and maintain through the life of the awarded Contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, cabinetry to support and house the analyzers if necessary, water systems (including consumable polishers, filters, etc.), and universal interface equipment. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment they are proposing to include starter kits, tables, stands, etc. If any of the above items are subcontracted. As subcontracting plan is required.

Characterization of Waste:

The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

The determination and description shall address the following:

• Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

• Waste ignitability (Reference 40 CFR §261.21)

• Waste corrosivity (Reference 40 CFR §261.22)

• Waste reactivity (Reference 40 CFR §261.23)

• Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

• Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR

§261.33)

• Solid Waste (Reference 40 CFR §261.2)

• Exclusions (Reference 40 CFR §261.4)

The Contractor will provide written instructions and training material to ensure all required VHA Laboratory Staffs are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and State requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

The Contractor shall provide a description of all wastes their equipment may discharge so that the Laboratory can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State, and Federal discharge requirements. At a minimum, the characteristics of ignitability, corrosiveness, reactivity, and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the Laboratories to meet local discharge requirements (i.e. mercury, thimerosal, and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with the Contractors proposal:

• Barium (Total)

• Cadmium (Total)

• Chromium (Total)

• Copper (Total)

• Cyanide (Total)

• Lead (Total)

• Mercury (Total)

• Nickel (Total)

• Silver (Total)

• Zinc (Total)

• Arsenic (Total)

• Selenium (Total)

• Tin (Total)

• pH

• Flash point (to higher than 200 F)

• BOD; biochemical oxygen demand

The documentation the Contractor provides will be used to work with the VA Medical Centers to determine whether the waste from each device can legally be disposed of via the sewerage system.

The systems shall be totally self-contained excluding waste and shall not require external water, pressure, or vacuum. The Contractor shall provide a waste stream analysis for each proposed instrument and if any waste requires special handling before disposal.

Implementation and Transition Timeframe:

The implementation of the requirements described in this Statement of Work shall be completed no later than ninety days after the Contract award date. This ninety-day timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated ninety-day timeframe. The Contractor shall not be penalized for implementation timelines that extend beyond the ninety day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award of the Contract, the transition period for the awarded Contract to have all equipment and peripherals installed and operational shall be from the date of award through ninety days.

During this ninety-day time all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. Training will include two operators per instrument at the Contractor’s location for all of the Laboratories shifts. Further, training shall include provisions for additional training at the Contractor’s location or at the respective Laboratory Facility as agreed upon by the Contractor and the respective Laboratory facility. During this ninety-day time period all initial validations shall be completed to the satisfaction of the STVHCS.

The Contractor shall provide with their proposal an implementation plan for installation of their new equipment. The Contractor’s submitted plan shall not exceed ninety days for the transition of all requirements under the awarded Contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., and performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate the awarded Contract for cause under the Termination for Cause clause of the awarded Contract.

At the end of ninety days from the award of the Contract, the awarded Contractor shall have full and sole responsibility for all requirements identified in this Statement of Work under the awarded Contract.

Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the awarded Contract is accepted by the Government. This includes replacements, substitute machines, and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of thirty consecutive calendar days by operating in conformance with the Contractor’s technical specifications or as specified in the awarded Contract at an effectiveness level of 90% or greater.

In the event that the equipment does not meet the standard of performance during the initial thirty consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of thirty consecutive calendar days.

If the equipment fails to meet the standards of performance after ninety calendar days from the installation date, the user or users may at their option request a replacement or terminate the awarded Contract in accordance with the provisions of FAR 52.212-4 entitled “Termination for Cause.” The Contractor shall receive payment for tests reported during the ninety-day acceptance period.

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 fide attempt to contact the Contractor’s designated account representative until the system or machine(s) is returned to the Government in proper operating condition.

During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall 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 daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes.

Downtime. During the term of the awarded Contract, should the repair record of any individual piece of Laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the CO to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with the manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of at least 90% in each month of the term of the Contract for the equipment Interface. Equipment shall have a fully bi-directional, ASTM or HL7 Lab Information System (LIS) interfacing.

All downloads/software necessary to transfer orders and data into patient files via LIS interface will be at no additional cost to VA. System must have a bi-directional bar-coded computer interface compatible with Data Innovations. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system for Laboratories simultaneously.

a. Contractor shall provide at least one (1) each automated, auto-sampler instrument and (1) each automated electrophoresis/scanner instrument and peripherals

b. Electrophoresis separation system shall have barcode reading capabilities to assure Positive Patient ID.

c. All consumables, reagents, calibrators, controls, supplies, disposable items, parts, accessories and any other items required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a patient test result shall be included if CPRR

d. Data backup shall be provided.

e. Flexibility in test volumes shall be considered.

f. Extended expiration date of supplies shall be provided.

g. Uninterruptible power supply (surge protection, battery backup) shall be provided by the vendor for all associated electrical instruments and ancillary components excluding printer.

h. Imaging system must provide permanent file retention of non-modified pattern image.

i. Training for all testing personnel, and Key Operator training for a minimum of two operators is required.

j. Systems shall provide ease of use menus, with minimal maintenance required and simple troubleshooting processes.

General Requirements: Electrophoresis instruments shall produce accurate and reproducible assay results on serum or urine specimens for SPEP/UPEP and SIFE/UIFE electrophoresis by established in vitro diagnostic methods. Models shall provide positive sample identification and accurate test assay results for sample specimens up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

1. Offered equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

2. Upgrades to the equipment hardware and operating system software shall be provided at no additional cost to the Government. These enhancements shall be delivered and installed within 60 days of issuance to the commercial market.

3. An operator’s manual shall be furnished with each instrument supplied and updates to manual shall be provided in a timely manner. Editable electronic copy in CLSI format of operating procedures shall be furnished with each instrument supplied to the VA.

4. Electrophoresis instrument(s) shall conform to the existing available space at STVHCS, P&LMS.

Available counter space:

Hydrasis 2 Height 8 ‘ x Length 19’ x Width 30’ Capillarys 3 Height 16 ‘ x Length 25’ x Width 37’

A. Laboratory assays currently performed shall include but may not be limited to the following automated assays.

1. Serum Protein Electrophoresis

2. Serum Immunofixation/Immunotyping.

3. Urine Protein Electrophoresis

4. Urine Immunofixation/Immunotyping.

E. SCHEDULE FOR DELIVERABLES

1. The contractor shall complete the Delivery Date column in Attachment A for each deliverable specified.

2. Unless otherwise specified, the number of draft copies and the number of final copies shall be the same.

3. If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to explain why in writing to the CO, including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response, in accordance with applicable regulations.

4. If the consumables are found to be defective and unsuitable for use with the contractor’s equipment, or the contractor has failed to comply with the requirements for routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority deliver. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the government

F. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

G. GOVERNMENT RESPONSIBILITIES

The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operational use time and downtime shall be measured in hours and whole minutes.

The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

H. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

I. CONTRACTOR 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 subcontractor personnel requiring the same access.

Contractor Personnel Security:

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 not applicable.

Contractor Responsibilities:

A. The Contractor will identify if removable media is required to perform their duties. The Clinical

Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

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

C. 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 or completion of the contract or disposal or return of the IT equipment, whichever is earlier.

a. 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 Contractor at the end of lease, for trade-in, or other purposes. The options are:

b. Contractor must accept the system without the drive.

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

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

e. 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.

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

2. 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.

3. 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 Information Security Officer (ISO) needs to maintain the documentation.

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

Performance Period:

Performance Period for this contract shall be one base year plus four option years as follows:

Base + 4 years

Government Inherent Functions:

Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

General Duties, Requirements, and Expectations:

1. Be professionally competent to handle required duties.

2. Work with staff to ensure safety measures are in place and documented.

3. Services provided under the terms of this contract are required to be in compliance with the American

Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws required by the Veteran’s Healthcare System and VHA Directive 1106.

Appendix B: Information Systems Officer, Information Protection:

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

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

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008):

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

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. 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-2

3. 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 onsite 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 COTR.

4. 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, 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.

b. 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.

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:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/subcontractor is to perform.

(2) 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

(3) 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.

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.

(1) “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) “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.

(3) “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying assigned to the individual.

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 24 hours.

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 2 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.

5. 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 COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

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.