36C24719Q0670-0001001.docx

534-20-1-2715-0001

Statement of Work Ralph H. Johnson VA Medical Center

1.0 SCOPE

The purpose of this effort is to provide technical maintenance and clinical applications support services to sustain and enhance the increasing complexity and sophistication of the Ralph H. Johnson diagnostic radiological program. Under the direction of the Ralph H. Johnson Biomedical Technology Management Department the contractor shall provide full maintenance and clinical applications support with a 97% uptime guarantee on the following diagnostic radiological systems:

2.0 APPLICABLE DOCUMENTS/DIRECTIVES

2.1 All work performed by the contractor shall be accomplished in accordance with applicable publications, technical directives, instructions, standards, and procedures contained in original equipment manufacturing (OEM) manuals. Within fifteen calendar days after award date, but not later than performance of the first servicing of equipment, the Contractor will provide documentation verification of its maintenance procedures manual which will be used during the services of this contract to the Contracting Officer Representative. These manuals are required by the Government as a condition of the facility operational standards and JCAHO accreditation. Contractor must follow all Department of Veterans Affairs, Joint Commission, NRC, OSHA, and NFPA regulations when working on VA equipment/systems. The Contractor must be prepared to provide all necessary equipment to include Personal Computers, internet access, and any other material necessary to conduct the services required under this awarded contract. The VA Medical Center will not furnish parts and/or test equipment for the performance of this contract. It is the responsibility and to the expense of the Contractor to bring the appropriate equipment, repair parts and/or supplies necessary to complete the work within as required.

3.0 CONTRACTOR REQUIREMENTS

The contract will have a 12 month base year of performance along with four (4) Option Years. The contractor shall provide the necessary resources to plan, implement, and manage work necessary to meet the objectives set forth below to the extent provided by the obligated contract funding.

The contractor shall perform tasks which include but will not be limited to: preventive maintenance, troubleshooting, repair, test, calibration, system software updates, unlimited phone support technical and applications, and ability to diagnose error codes in system logs. The tasks range from monitoring environment, preventive actions, minor repair, and major system replacement to include Xray Tubes, MRI coils, and PET pin sources.

Preventive maintenance tasks shall be followed and performed at the intervals indicated per the OEM service literature.

The contractor shall supply at its own expense necessary parts, provided replacement of the parts is required because of normal wear and tear or otherwise deemed necessary by vendor and VA. All Parts will be new and/or standard parts. If used, reworked or refurbished parts are supplied they must be noted and approved by the VA. The parts must comply with applicable performance and reliability specifications.

The contractor must provide proof of personnel competencies that they or their representatives possess to maintain and repair such systems as described in this scope. Documentation must be provided such as service school certificate training or OEM authorized service provider. Each individual designee who will be rendering maintenance services are required to provide such documentation. Also upon request contractor will provide NIST calibration records of test equipment used in the servicing of the systems.

4.0 Specific System Contract Requirements

4.1 General Electric Lightspeed VCT XT 64 Slice 843789VCT

The contractor shall provide full system coverage to include but not limited to:

A) Tube Coverage: replacement of the CT Xray Tube and detectors. Must meet manufacturer standards and be certified via the software or OEM at the cost of the contractor.

B) Preventive Maintenance, Repair, and Battery Replacement of system Eaton Power UPS. Model 9355-15-14GE, S/N FB394JBA15 C) Preventive Maintenance, Repair, and Software Updates of Advantage Workstation. Model 2216155, S/N FW84930240 EE# 152463 D) Preventive Maintenance, Repair, and Software Updates of Medrad Stellant injector. Model 3007301, S/N 31110.

E) Software updates to system and peripherals as needed for optimum performance.

*Note: The preventive maintenance schedule (PM procedures and cycles) must be adhered to by the direction of the OEM service literature. The scheduled month(s) of each specific device PM cycle will be confirmed with the Biomedical Technology Management Department within fifteen calendar days after award date so proper departmental planning, documentation, and work order scheduling can be generated.

4.2 General Electric Echospeed MR Mobile 1.5T HDx 843789HDMR

The contractor shall provide full system coverage to include but not limited to:

A) MR Magnet Maintenance, cold head, and cryogen coverage. System ID 843789HDRMC B) Repair, maintenance, and replacement of MRI coils.

C) Remote environmental monitoring 24 hours/7 days a week of MRI.

D) Preventive Maintenance, Repair, and Software Updates Medrad Solaris injector. Model 3015724, S/N 10081 E) Software updates to system and peripherals as needed for optimum performance.

*Note: The preventive maintenance schedule (PM procedures and cycles) must be adhered to by the direction of the OEM service literature. The scheduled month(s) of each specific device PM cycle will be confirmed with the Biomedical Technology Management Department within fifteen calendar days after award date so proper departmental planning, documentation, and work order scheduling can be generated.

4.3 General Electric PET Discovery VCT 843789PET1

The contractor shall provide full system coverage to include but not limited to:

A) Tube Coverage: replacement of the CT Xray Tube, detectors & PMT tubes. Must meet manufacturer standards and be certified via the software or OEM at the cost of the contractor.

B) Preventive Maintenance, Repair, and Battery Replacement of system Eaton Power UPS. Model 9355-15-14GE, S/N BD083JBA17 C) Preventive Maintenance, Repair, and Software Updates of Advantage Workstation. Model XR8600AW45, S/N 843789PETAW, EE# 178120 D) System PIN source coverage and replacement.

F) Preventive Maintenance, Repair, and Software Updates Medrad Stellant injector. Model 3007301, S/N 33563 G) Software updates to system and peripherals as needed for optimum performance.

*Note: The preventive maintenance schedule (PM procedures and cycles) must be adhered to by the direction of the OEM service literature. The scheduled month(s) of each specific device PM cycle will be confirmed with the Biomedical Technology Management Department within fifteen calendar days after award date so proper departmental planning, documentation, and work order scheduling can be generated.

4.4 Bayer Injectors

The contractor shall provide Preventive Maintenance Only to include:

A) Preventive Maintenance of system Mark 7 Arterion, S/N 201469 B) Preventive Maintenance of system Mark V ProVis, S/N 105065 C) Preventive Maintenance of system Mark V ProVis, S/N 200401 D) Preventive Maintenance of system Stellant D, S/N 37511 E) Preventive Maintenance of system Stellant D, S/N 201034 F) Preventive Maintenance of system Spectris Solaris, S/N 100319 G) Preventive Maintenance of system Spectris Solaris, S/N 47115 H) Preventive Maintenance of system Stellant D Dual Flow Injector, S/N 203666 *Note: The preventive maintenance schedule (PM procedures and cycles) must be adhered to by the direction of the OEM service literature. The scheduled month(s) of each specific device PM cycle will be confirmed with the Biomedical Technology Management Department within fifteen calendar days after award date so proper departmental planning, documentation, and work order scheduling can be generated.

5.0 REPORTING REQUIREMENTS

5.1 Locations of systems are as follows:

1) GE Lightspeed VCT XT 64 Slice located at Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Radiology Department.

2) GE Echospeed MR Mobile 1.5T HDx located at Navy Weapons Station 2418 NNPTC Circle Goose Creek, SC 29445

3) GE PET Discovery VCT located at Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Radiology Department.

4) Bayer Mark 7 Arterion, S/N 201469 located Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Operating Room.

5) Bayer Mark V ProVis, S/N 105065 located Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Angio Room.

6) Bayer Mark V ProVis, S/N 200401 located Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Cath Lab.

7) Bayer Stellant D, S/N 37511 located Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Radiology Department.

8) Bayer Stellant D, S/N 201034 located Savannah VA Outpatient Clinic, 1170 Shawnee St, Savannah GA 31419. Radiology Department.

9) Bayer Spectris Solaris, S/N 100319 located Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Radiology Department.

10) Bayer Spectris Solaris, S/N 47115 located Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Radiology Department.

11) Bayer Stellant D Dual Flow Injector, S/N 203666 located Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston SC 29401. Radiology Department.

Contractor is responsible for their own parking and ability to gain access to the VA medical Center and Navy Weapons Station. The Biomedical Technology Management Department will assist in these matters however it is the sole responsibility of the contractor to gain and maintain any clearance needed to access sites.

5.2 Contractor coverage will be weekdays Monday to Friday 8am-9pm.

Contractor must first report to the Biomedical Technology Management Department before any repairs or services are performed. Reporting can be done in person in room G200 of the Ralph H. Johnson VA Medical Center or by calling 843-789-7396. Identification badges must be worn at all times. After work is completed contractor must follow-up and report in person or by phone the status of the system.

In the event of an emergency service request outside the contractual coverage time, the contractor will be provided a purchase order to cover overtime labor. The contractor is not authorized to perform overtime labor unless a purchase order has been supplied by the VA to cover time.

5.2.1 The contractor shall provide appropriate electronic service reports to the Biomedical Technology Management Department with-in three days of performing service. Report to include but not limited to: type of service performed, system ID, inspection time/ date/ length of work/parts replaced/ and record of certification that work has been accomplished. Also to provide other necessary data/paperwork as required to ensure compliance of federal, state, VA and Nuclear Regulation Commission Guidelines.

5.3 The Contractor shall notify the VA of any condition that may delay performance of contactor requirements.

5.4 When the following conditions occur, the Contractor shall advise the Biomedical Technology Management Department of following conditions or deficiencies.

5.4.1 A condition or material fault that is a hazard to personnel, equipment and missions.

5.4.2 When a prescribed installation or maintenance action cannot be accomplished or when operational characteristics or durability cannot be obtained because of faulty design or materials.

5.5 The Contractor must respond to service calls within one (1) hour of notification and be on-station within four (4) hours. Competent personnel who are experienced and qualified to work on the specific equipment must perform all work. All work performed shall be accomplished in accordance with the manufacturer’s instructions including, but not limited to, adjustments, calibrations, cleaning, lubrication, testing, disassembly, check-out, replacement of worn or defective parts, safety, lock out tag out procedures etc., required to keep the equipment in operating condition. Contractor’s maintenance of the equipment must satisfy all requirements as set forth by NFPA and JCAHO.

5.5.1 As deemed necessary by the VA in order to maintain uptime commitment of 97% the contractor may be required to escalate service request and repair to additional experts in the field. These experts maybe of OEM service or highly trained individuals with-in or outside the vendor organization. In any case all costs associated with the escalated service call to include but not limited to: travel, per diem, overtime costs, parts and shipments will be at the expense of the contractor.

6.0 SPECIAL REQUIREMENTS/INSTRUCTIONS

6.1 Information Security:

a. 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

b. 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

6.2 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. Business Associate Agreement is required due to the accessibility of protected health information. For information on BAA’s see HHS.gov site: http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/businessassociates.html.

The current version of the BAA between the Department of Veterans Affairs, Veterans Health Administration (VHA) and General Electric Company through its division GE Healthcare was revised in October 2013.

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 of the contract.

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

i. Vendor must accept the system without the drive;

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

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

6.2.1 Liquidated Damages for Data Breach

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

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data reach' 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

(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 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.

6.3 REMOTE ACCESS: Vendor must comply with all VA Office of Information and Technology security requirements.

6.3.1 The contractor has the responsibility to conserve and protect Government resources. The use of these resources for non-Governmental use is prohibited. The contractor shall repair any Government-owned equipment, which is damaged through or by the fault of the contractor, with equipment of equal or better quality, at no cost to the Government.

6.3.2 The Contractor shall ensure quality service is maintained throughout the life of the contract. The Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date, provided the Contractor is notified of deficiencies at least one (1) day before the contract expiration date. All changes, updates or retrofits made on any component or system shall be annotated on station equipment manuals and records. Services also include recording all routine work; corrections and repair work in the equipment log.

6.3.3 The contractor shall need to be able to access other companies’ proprietary information in order to perform analyst, maintenance, and repair. As such the contractor shall enter into appropriate Non-Disclosure Agreements.

6.4 DISCONTINUANCE OF SERVICE: The Government reserves the right to terminate service on a particular system meeting replacement criteria upon thirty (30) days written notice to the Contractor with payment to be prorated.