RFI to determine potential SDVOSB and VOSB offerors for Cost Per Reportable Requirement for Hematology Coagulation Testing for the Birmingham VA Medical Center
Page 19 of 22
VA Medical Center Birmingham, AL
Pathology & Laboratory Medicine Service
STATEMENT OF WORK
Hematology Coagulation Equipment/System to Perform Diagnostic Patient Testing Described Herein Through a Cost-Per Reportable Contract
Cost-per-Reportable (CPR) is an all-inclusive price. The price shall include costs covering: (1) equipment use, (2) all reagents, standards, quality controls, supplies, and any other item required for the proper operation of the Contractor s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI), (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs), and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.
1. BACKGROUND: VA Medical Center Birmingham, AL (BVAMC) currently uses two (2) fully automated analyzers (one primary and one secondary/backup) to perform coagulation testing through a CPR task order which will expire August 31, 2018. Therefore, we must obtain a new CPR task order for appropriate equipment/system to continue uninterrupted patient testing. This new requirement is expected to begin May 1, 2018 through April 30, 2019 with four (4) one-year option periods.
2. SCOPE: BVAMC needs this fully automated equipment to perform the specified patient testing through a CPR task order in Pathology & Laboratory Medicine Service (P&LMS) at BVAMC, 700 South 19th Street, Birmingham, AL. Offers will be accepted, and awarded to a vendor who provides such on a CPR basis.
2.1 The cost-per-reportable price shall include the use of all equipment (2 of the same analyzers primary and secondary/backup analyzers) and necessary peripherals (carts, printers, UPS system, barcode readers, etc.), to perform and report clinical coagulation testing (specified below). The price shall also include calibration/controls/repeats; inside lab delivery and installation; reagents, controls, and consumable products; shipping and handling; initial off-site training for one key operator per analyzer (includes airfare, room, board, and training materials); additional annual off-site training for one key operator per analyzer (includes airfare, room, board, and training materials) for each completed year of cost-per-reportable agreement; and maintenance/service coverage.
2.2 All work is to be performed in accordance with the Contract. The vendor selected is responsible for equipment and service components.
2.3 The equipment/system shall be able to simultaneously perform the required testing and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).
2.4 The equipment shall maintain, or reduce the number of work stations or overall labor required to accomplish the required testing.
2.5 The equipment shall provide the following required test menu. All of the required tests shall run on the vendor s system with NO manual pre-analytical preparation/pre-treatment of the sample.
REQUIRED TEST MENU
PROJECTED WORKLOAD
PT
25659
APTT
18255
FIBRINOGEN
480
D-DIMER
2340
HEPARIN (anti Xa)
140
THROMBIN TIME
11
NOTE: Test volumes/workload are estimates and do not include calibrators, controls, and repeats. The estimates are based upon prior history and are not a guaranteed minimum.
3. GENERAL REQUIREMENTS:
3.1 The vendor shall provide all supplies and services as described herein in accordance with the applicable contract. The Schedule of Pricing below shall be utilized by interested offerors to submit their cost proposal. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees shall be clearly indicated in the price quote.
3.2 The purpose of this SOW is for the VA to obtain the greatest benefit in response to the requirements.
3.3 Offered models of equipment shall be capable of producing accurate and reproducible assays on patient samples. Model shall provide accurate test assay results for sample up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.
3.4 Offered equipment shall be new state-of-the-art equipment. All offerors shall submit an offer for new equipment, not previously used. Remanufactured and discontinued models will not be accepted.
3.5 The awarded contractor shall provide all necessary upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance to the commercial market.
3.6 The models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the analyzer model being offered is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.
3.7 Contractor shall provide printer(s) for analyzer(s) and provide replacement printer(s), as needed, if applicable, at no extra charge.
3.8 Contractor shall provide all manuals, documents, and initial supplies. Includes the right to reproduce any printed materials supplies with the product for the purpose of using the product.
4. SYSTEM REQUIREMENTS:
4.1. Vendor shall provide FDA-approved, fully-integrated and automated analysis instruments that use Windows based program(s) with touch-screen user interface that is easy to read and to navigate. All hardware shall run on Windows 7 or newer version of Windows.
4.2 The system shall allow the medical technologists to multitask (QC review, troubleshooting, etc.) during system operation without interrupting patient testing and reducing technologist manual interventions.
4.3 The system shall include the necessary software/hardware (drivers) for bi-directional interface with Data Innovations, or other LIS vendor, LIS, where applicable. Software shall be compatible with all barcode styles. Proposals shall include an interface allowance, if necessary.
4.4 The system shall allow walk-away capability for the maximum number of patients and/or tests. Proposals shall include the number of patients and tests the proposed instrumentation will allow in reference to this requirement.
4.5 System shall come standard with closed-tube (cap-piercing) sampling validated for multiple tube types.
4.6 The system shall automatically monitor levels of reagents, controls, etc. It shall automatically alert (audible and/or visual) the technologist when levels are reaching required action.
4.7 The system shall include comprehensive bar-code reader(s) integrated sample and reagent barcode reader(s). Automated barcoded reagent tracking includes material name, lot#, expiration dates, vial size and on-board volume.
4.8 The system shall allow the technologist to load and unload samples, reagents, cuvettes, etc. without interrupting patient testing.
4.9 The system shall offer optimal extended on-board reagent and controls stabilities.
4.10 Heparin assay reagents shall be ready to use (no pipetting).
4.11 Calibration curve for both LMWH and UFH.
4.12 The system shall be able to automatically track lot-specific and on-board stabilities to ensure expired lots and reagents are not used, eliminating the potential for erroneous patient result reporting.
4.13 The system shall include an on-board Quality Control (QC) program that is fully compliant with College of American Pathologist (CAP). The program shall include configurable multi-rules, QC shift/trend detection, and achievable results and charts, and a comprehensive events log system. QC program shall perform all calculations and report intra-lab comparison within 24 hours.
4.14 The system shall ensure quality control for all tests are performed at technologist-specified time intervals, in accordance with CAP requirements, and at new vial change.
4.15 The system shall include user-definable result auto-validation.
4.16 The system shall significantly reduce/eliminate patient results that are reported incorrectly due to poor sample integrity or coagulation abnormalities.
4.17 The system shall automatically track, alert technologist, and document daily, weekly, and monthly maintenance, with print/save capability.
4.18 Sequential Testing Capability: System shall be able to run individual samples without the need for batching.
4.19 The system shall include automated rerun and automated dilutions for abnormal results.
4.20 The system shall be able to conduct the test and give results rapidly - measured in minutes. Throughput shall allow at least 240 PT/hour, 180 PTT/hour, and 180 PT & PTT/hour.
5. REAGENTS AND SUPPLIES REQUIREMENTS:
5.1 Inventory Management - The Contractor is required to provide a continuously stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Unexpected changes in methodology/technology shall be at the expense of the vendor. Alert/Notification of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to Chief, P&LMS or designee.
5.2 Any items excluded by the vendor but required for operation of the system at any time, shall be delineated in their technical proposal. The cost of any excluded items shall be disclosed in the cost proposal.
5.3 Quality of Reagents, Supplies and Disposables - The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO). In the event that the supplies 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, if verbal order is received by 1 pm CST time, for priority delivery from the government activity. This shall be done at no cost to the government, in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).
5.4 Hazardous Constituents - For reagents with hazardous constituents, the Contractor shall provide a mechanism for the Laboratory to meet local discharge requirements.
5.5 Shipping Charges - No delivery charges for shipping or fee handling.
5.6 Shipping Schedule - Offerors should provide initial inventory based on projected volume, then establish a standing weekly/monthly/quarterly shipment (to be determined in conjunction with Hematology Supervisor or designee) based on current use, with the capacity to fill emergency requests on-demand. Contractor shall work with BVAMC to adjust reagent supply to match workload changes, when necessary.
5.7 Special Handling for Emergency Orders of Supplies - If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival at the government site of the monthly standing order or routine supply delivery.
6. MAINTENANCE AND SERVICE SUPPORT REQUIREMENTS:
6.1 Contractor shall provide telephone assistance 24-hours/day, 7 days/week, 365 days per year. Following determination that service is required, technical on-site support shall be provided according to Repairs/Service below.
6.2 The Contractor shall provide maintenance to keep the equipment in good operating condition and subject to security regulations. The government will provide the contractor access to the equipment to perform maintenance service according to the maintenance and service terms herein.
6.3 Preventative Maintenance - Contractor shall provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment.
6.4 Repairs/Service Contractor shall provide for repairs/service sufficient to meet the needs of BVAMC Monday through Friday, 8:00 a.m. 4:30 p.m. Requests for repairs/service shall be through one vendor. Repairs/service shall be performed after notification that the equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification.
6.5 Service shall also include replacement or repair of all ancillary equipment, as needed.
6.6 The contractor shall provide all tools, parts, and labor needed for preventive maintenance and repairs. Travel, per diem, and other expenses associated with the preventive maintenance and repairs shall be borne by the contractor.
6.7 Malfunction Incident Report - The contractor shall furnish a malfunction incident report to the department upon completion of each maintenance call. The report shall include, as a minimum, the following:
6.6.1 Date and time of arrival;
6.6.2 Serial number type and model numbers(s) of equipment;
6.6.3 Time spent for repair;
6.6.4 Description of malfunction and;
6.6.5 Proof of repair.
6.8 Replacement of Laboratory Equipment - During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination may be made to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the contractor.
6.9 Patient Data Handling Due to the nature of this requirement (clinical laboratory diagnostic testing system), the contractor s maintenance/service repair/installation person(s) may have incidental access to patient information during installation or servicing the contractor s equipment. Any access to this information is incidental; it is not required by the contractor to perform the work outlined herein. A Business Associate Agreement (BAA) is not required. No hardware is to be removed from any location, without written approval and removal of data by the VA Office of Information and Technology (OI&T) department. Failure to comply with this VA requirement may result in prosecution. See Equipment Removal Requirement.
6.10 Daily/Routine Maintenance The system shall require minimal system maintenance, including limited reagent preparation prior to use. BVAMC technical staff (user) will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The BVAMC user will maintain appropriate daily records to satisfy the requirements of this paragraph.
7. EQUIPMENT AND SERVICE PROPOSED: The contractor shall complete the following table with the equipment and service plans proposed to meet the requirements specified in the Statement of Work herein.
Proposed Equipment
Contractor's Proposed Service Plan
8. TRAINING AND TECHNICAL SERVICE TRAINING REQUIREMENTS:
8.1 The contractor shall provide a comprehensive off-site (manufacturer facility) instrument training program that is coordinated with and timely to the equipment installation at no additional charge. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair. This shall be available for the maximum number of operating personnel for each instrument installed and all automation system components at the time of installation. User training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc.
8.2 The contractor shall provide one (1) additional training slot per analyzer for each completed year of this agreement, upon request, at no additional charge (includes airfare, room, board, and training materials).
8.3 On-site education and training by contractor shall also be supplied to all laboratory staff regarding basic operation and maintenance.
8.4 In addition, the contractor shall provide supplemental operating training to above government personnel, without additional charge to the government, upon installation of any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.
8.5 The contractor, at his/her discretion, may make additional training available at his/her facility on terms and conditions mutually agreed upon by the agency and the contractor.
8.6 Operator Procedure Manuals Operator, service, and troubleshooting manuals along with CLSI compliant procedures shall be furnished for each instrument/system. All technical procedures shall be provided electronically CLSI format, using software compatible with Laboratory's computer system, for local modification to meet CAP requirements.
9. INSTALLATION, INITIAL SET UP, CORRELATION/VALIDATION:
9.1 Site Preparation - Site preparation specifications shall be furnished in writing by the contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications.
9.2 Space Requirements, Systems, Specifications - Configuration of the proposed equipment shall conform to the BVAMC space currently allotted for this function. System specifications must all be disclosed in the proposed space. A site visit/walk-through is available upon request and will be scheduled at the convenience of the BVAMC Clinical Laboratory. Arrangements shall be made through the COR, or designee, to establish an acceptable time to ensure minimum interruption of patient care. The site visit/walk-through must be requested in sufficient time to be completed at least 5 days before the close of the subject solicitation.
9.3 Installation The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment in coordination with the facility Biomedical Engineer, PLMS Hematology Supervisor or designee, and P&LMS Laboratory Information Manager. 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, the continuous installation referenced herein 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.
9.4 Crossover from current to new instrumentation shall be performed timely with no interruption in patient care laboratory service.
9.5 Technical support specialist shall assist in set-up, correlation studies (evaluation/comparison data sufficient to satisfy College of American Pathologist standards), staff training and resolve/answer methodology problems and questions. Technical support for reagent and control lot changes is also included.
9.6 Upon completion of installation, correlations, validations, the equipment shall be turned over to the BVAMC P&LMS for use.
9.7 Contractor shall provide equipment installation/reinstallation at minimal costs if the equipment is required to be moved due to construction or laboratory redesign.
10. UPGRADES:
10.1 Upgrades or Replacement - Request for instrumentation upgrades or replacement, due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the vendor for modification of the contract. 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 facility to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. See Equipment Removal Requirement.
10.2 Upgraded Software/ Equipment - The Contractor shall provide all upgrades to the equipment hardware and operating system software in order to maintain the integrity of the system and the state-of-the-art technology, at no additional charge to the Government. These enhancements shall be provided as they become available and at the same time as they are being provided to commercial customers. This only applies to system upgrades that enhance the model of the equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, etc. This does not refer to replacing the original piece of equipment under the contract/order; however, it does refer to significant changes in the hardware operational capability.
11. OWNERSHIP OF EQUIPMENT: Ownership of the equipment shall remain with the contractor. All accessories furnished by the contractor shall accompany the equipment when returned to the contractor.
12. EQUIPMENT REMOVAL REQUIREMENT:
12.1 The contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the analyzer (gas, water, air, etc., as applicable) and shall be responsible for decontamination of the system, packing and shipping required to remove the analyzer.
12.2 The contractor shall remove all equipment within 60 days after notification of the expiration of the terms of this contract but not until the completion of new contractor s equipment installation inclusive of completed cross over studies.
12.3 Contractor shall not remove hard drive(s) from premises. All drives remain the property of VA. All service personnel shall be instructed regarding this requirement. NOTE: Prior to instrument removal, the hard-drive(s) shall be removed in the presence of the BVAMC Information Security Officer (ISO), or VA designee, and retained by BVAMC OI&T, or VA designee, for destruction according to current BVAMC policy/procedure at the time.
13. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS:
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.B
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.B
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.B
[Agency] 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 [Agency] 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 B any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.
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 vehicle]. 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 [Agency] 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 vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).
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 [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.
The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.B
The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.B
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.B
The [Agency] 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 [Agency] 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.
Training. B 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.B
14. VA Directive 6550 Appendix A: All offerors must complete and submit with their respective proposal(s) the following forms:
Medical Equipment Pre-Procurement Assessment (see hyperlink below)
Manufacturer Disclosure Statement for Medical Device Security MDS2 (see hyperlink below)
A&MM & Contract Forms\Directive 6550 - February 2015 fillable.pdf
A&MM & Contract Forms\MDS2 Form for VA Medical Centers.pdf
15. VA Handbook 6500.6 Appendix Clause:
VA Acquisition Regulation Solicitation Provision and Contract Clause
(October 2008)
SUBPART 839.2 Information and Information Technology Security Requirements
839.201 Contract clause for Information and Information Technology Security
Due to the threat of data breach 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 information is 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).
In solicitations and contracts where VA Information and/or Information Technology will be accessed or utilized, the contracting officer shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources
852.273-75B - Security Requirements for Unclassified Information
Technology Resources (interim- October 2008)
As prescribed in 839.201, insert the following clause:
The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web site at:
http://checklists.nist.gov
To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site :
http://www.iprm.oit.va.gov/Security_and_Privacy_Requirements_for_Contractors.asp
16. VA INFORMATION AND INFORMATION SYSTEMS SECURITY/PRIVACY LANGUAGE
MARCH 12, 2010 VA HANDBOOK 6500.6
APPENDIX C
VA INFORMATION AND INFORMATION SYSTEMS SECURITY/PRIVACY LANGUAGE
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.
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 on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.
c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.
d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.
e. The contractor/subcontractor shall not make copies of VA information except as
authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.
f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.
h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.
i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request.
j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.
k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.
l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.
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 COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.
b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.
c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall.
d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.
e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.
f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.
g. The contractor/subcontractor agrees to:
(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 particular assigned to the individual.
i. The vendor shall ensure the security of all procured or developed systems and
technologies, including their subcomponents (hereinafter referred to as Systems ), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hot-fixes, 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 twenty (20) days.
k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within than twenty (20) 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 COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation.
b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.
c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.
d. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.
e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.
f. VA prohibits the installation and use of personally-owned or contractor/subcontractor-owned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.
g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.
h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:
(1) Vendor must accept the system without the drive;
(2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or
(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.
(4) 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;
(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and
(b) 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 preapproved and described in the purchase order or contract.
(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
6. SECURITY INCIDENT INVESTIGATION
a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.
b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.
c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.
d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.
7. LIQUIDATED DAMAGES FOR DATA BREACH
a. Consistent with the requirements of 38 U.S.C. B'5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.
b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
c. Each risk analysis shall address all relevant information concerning the data breach, including the following:
(1) Nature of the event (loss, theft, unauthorized access);
(2) Description of the event, including:
(a) Date of occurrence;
(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
(3) Number of individuals affected or potentially affected;
(4) Names of individuals or groups affected or potentially affected;
(5) 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;
(6) Amount of time the data has been out of VA control;
(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
(8) Known misuses of data containing sensitive personal information, if any;
(9) Assessment of the potential harm to the affected individuals;
(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
d. 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 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
(1) Notification;
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
(3) Data breach analysis;
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
8. 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-day s 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.
9. TRAINING
a. All contractor employees and subcontractor employees requiring access to VA
information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix D relating to access to VA information and information systems;
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and
(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
PRICE/COST SCHEDULE:
ITEM UNIT
NO. DESCRIPTION OF SUPPLIES/SVCS QTY UNIT PRICE TOTAL
0001 Base Year (May 1, 2018 April 12 MO _______ _________
30, 2019 Cost-Per-Reportable (CPR)
Requirement for lab equipment to
Perform coagulation testing at BVAMC
Hematology Dept. See SOW for
Detailed description of requirement.
1001 Option Yr I (May 1, 2019 April 12 MO _______ _________
30, 2020 Cost-Per-Reportable (CPR)
Requirement for lab equipment to
Perform coagulation testing at BVAMC
Hematology Dept. See SOW for
Detailed description of requirement.
2001 Option Yr II (May 1, 2020 April 12 MO _______ _________
30, 2021 Cost-Per-Reportable (CPR)
Requirement for lab equipment to
Perform coagulation testing at BVAMC
Hematology Dept. See SOW for
Detailed description of requirement.
3001 Option Yr III (May 1, 2021 April 12 MO _______ _________
30, 2022 Cost-Per-Reportable (CPR)
Requirement for lab equipment to
Perform coagulation testing at BVAMC
Hematology Dept. See SOW for
Detailed description of requirement.
4001 Option Yr IV (May 1, 2022 April 12 MO _______ _________
30, 2023 Cost-Per-Reportable (CPR)
Requirement for lab equipment to
Perform coagulation testing at BVAMC
Hematology Dept. See SOW for
Detailed description of requirement.
GRAND TOTAL: _________________
Connie Ganier
Contract Specialist
205-933-8101 x6018
Contract Specialist E-mail Address
