P03 SOW.pdf

TITLE Boston Scientific EP MicroPace and Farastar

CATEGORY SERVICE CONTRACTING

LOCATION SFVAMC BUILDING 203

SOLICITATION FORMAT OF STATEMENT OF WORK

SECTION – CARESTREAM HEALTH INC

DESCRIPTION/SPECIFICATIONS

FOR PREVENTIVE MAINTENANCE/EMERGENCY SERVICE

FOR MEDICAL EQUIPMENT

1. EQUIPMENT IDENTIFICATION:

A. NAME/DESCRIPTION OF EQUIPMENT:

i. MANUFACTURER - MicroPace PTY LTD

ii. MODEL - STIMCOR

iii. SERIAL NUMBER - SC865

iv. EE NUMBER - 375835

v. LOCATION – SFVA BUILDING 203, CATH LAB

B. NAME/DESCRIPTION OF EQUIPMENT

i. MANUFACTURER – MicroPace PTY LTD

ii. MODEL - STIMCOR

iii. SERIAL NUMBER - SC866

iv. EE NUMBER - 375952

v. LOCATION – SFVA BUILDING 203, CATH LAB

C. NAME/DESCRIPTION OF EQUIPMENT:

i. MANUFACTURER – BOSTON SCIENTIFIC CORP

ii. MODEL – FARASTAR

iii. SERIAL NUMBER – 107588457

iv. EE NUMBER – 373567

v. LOCATION – LOCATION – SFVA BUILDING 203, CATH LAB

2. DEFINITIONS/ACRONYMS:

A. Biomedical Engineer(ing) - Supervisor or designee.

B. CO - Contracting Officer

C. COTR - Contracting Officer's Technical Representative

D. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

E. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

F. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

G. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

H. Authorization Signature - COTR signature; indicates COTR accepts work status as stated in ESR.

I. NFPA - National Fire Protection Association.

J. CDRH - Center for Devices and Radiological Health.

K. VAMC - Department of Veterans Affairs Medical Center

L. VAH - Department of Veterans Affairs Hospital

3. CONFORMANCE STANDARDS: - Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, UL, VA, and CDRH.

4. CONTRACT COVERAGE

A. The contract will cover at a minimum the following

i. New Equipment or Software Upgrades

ii. STIMCOR and FARASTAR System Premium Service for Existing System

iii. Service features include:

1. Parts, Labor and associated Travel to service Equipment by local Service Engineer. (Emergency/immediate support if required may be performed by a non-local Field Service Engineer.)

2. Call Center Telephone Support • Priority Response Time and On-Site Support (for system failures that cannot be resolved through telephone support)

3. Annual Preventative Maintenance

4. Unlimited relocations*** per Agreement Term (subject to Company approval)

5. Standard Wear and Tear (subject to the terms and conditions)

6. Loaner Generators, Irrigation Pumps, and Remote Controls (based on availability)

5. OPERATIONAL UPTIME - REQUIREMENTS: - The EP MicroPace and Farastar devices shall be operable and available for use 94% of the normal operating hours of the equipment as detailed in paragraph V., HOURS OF COVERAGE. Downtime will be computed from notification of problems during normal work hours. Scheduled maintenance will be excluded from downtime. Operational Uptime will be computed during a month-long time period.

Repeated failure to meet this requirement can subject the contractor to DEFAULT action.

6. HOURS OF COVERAGE:

Normal hours of coverage are Monday through Friday from 8:00 AM to 5:00 PM, excluding federal holidays. 24-hour expert phone support is also included. All service/repairs will be performed during normal hours of coverage unless requested or approved by Contracting Officer Representative or Designee.

A. Preventive maintenance will be performed in accordance with manufacturer’s recommendations. Preventive maintenance will be performed at the OEM and a loaner will be provided prior to service. Loaner will be free of charge including freight.

B. Work performed outside the normal hours of coverage at the request of Contracting Officer Representative or Designee will be billed at the price listed in the Service Contract. Billing will include service time plus one (1) hour for travel time and exclude parts. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.

i. NOTE: - Hardware/software update/upgrade installations will be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by Contracting Officer Representative or Designee). Government provides software/hardware upgrade/update.

C. Federal Holidays observed by the VAMC are:

1. New Years' Day

2. Martin Luther King Day

3. Presidents' Day

4. Memorial Day

5. Independence Day

6. Labor Day

7. Columbus Day

8. Veterans' Day

9. Thanksgiving Day

10. Christmas Day

7. UNSCHEDULED MAINTENANCE (Emergency Repair Service):

A. Contractor shall maintain the equipment in accordance with the original equipment manufacturer's specifications. The Contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.

All required parts shall be furnished with OEM parts.

B. The CO, Contracting Officer Representative or designated alternate has the authority to approve/request a service call from the Contractor.

C. Response Time: - Contractor's FSE must respond with a phone call to Contracting Officer Representative or Designee within 4 hours after receipt of telephoned notification during normal hours of coverage. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within 2 business days, or as agreed upon per event, after receipt of this second notification and will proceed progressively to completion without undue delay. For example, if hours of coverage are 08:00 AM to 05:00 PM, Mon. thru Fri., a 4-hour response means, if a call is placed at 8:45 AM., Monday August 10th; the FSE must start on-site service before 8:45 AM, Wednesday, August 12th. Emergency Repairs performed outside the normal hours of coverage, at the request of Contracting Officer Representative or Designee will be billed at the price listed in Section B.

8. SCHEDULED MAINTENANCE:

A. The Contractor shall perform PM Service to ensure that equipment listed in the schedule performs in accordance with Section 3, Conformance Standards. (An outline of the PM procedures and schedule shall be provided to Contracting Officer Representative or Designee). The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to Designee at the completion of the PM (preferably in electronic format). The contractor shall provide written description of Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

i. Cleaning of equipment.

ii. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards or the manufacturer's specifications.

iii. Calibrating and lubricating the equipment.

iv. Performing remedial maintenance of non-emergent nature.

v. Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.

vi. Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

vii. Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance.

viii. Returning the equipment to the operating condition [defined in Section 3, Conformance Standards].

ix. Providing documentation of services performed.

x. Inspecting and calibrating the hard copy image device.

1. PM Services shall be performed in accordance with, and during the hours defined in, the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with Contracting Officer Representative or Designee.

2. Any charges for parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise.

9. PARTS: - The Contractor shall furnish and replace parts to meet uptime requirements. The Contractor has ready access to all Original Equipment Manufacture parts, including unique and/or high mortality replacement parts. All parts supplied shall be from the Original Equipment Manufacturer. The contract shall include all parts; all parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. The contract allows for one free rental up to 5 days per contract year per device.

10. SERVICE MANUALS/TOOLS/EQUIPMENT: - The VAMC shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the CO upon request.

11. DOCUMENTATION/REPORTS: - The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with {Section 3, Conformance Standards or the manufacturer's specifications}. Such documentation shall meet the guidelines as set forth in the {Conformance Standards section}. The ESR will consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number.

B. Name of FSE who performed services.

C. Contractor service ESR number/log number.

D. Date, time (starting and ending), equipment downtime and hours on-site for service call.

E. VA purchase order number(s) covering the call if outside normal working hours.

F. Description of problem reported by Contracting Officer Representative, Designee, or user (if applicable).

G. Identification of equipment to be serviced:

1) Inventory ID number,

2) Manufacturer's name,

3) Device name,

4) Model number,

5) Serial number,

6) Any other manufacturer's identification numbers.

H. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

1) Labor and Travel,

2) Parts (with part numbers),

3) Materials and Circuit Location of problem/corrective action.

I. Total Cost to be billed (if applicable - i.e., part(s) not covered, or service rendered after normal hours of coverage).

J. Signatures:

1) FSE performing services described.

2) Authorized VA Employee who witnessed service described.

ii. NOTE: - Any additional charges claimed must be approved by Contracting Officer Representative or Designee before service is completed!

12. REPORTING REQUIREMENTS: - The Contractor shall be required to report to Biomedical Engineering to log in. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to Contracting Officer Representative or Designee. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to Contracting Officer Representative or Designee for an "authorization signature". If Designee is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).

VA Biomedical Contact Person(s): Miles Uribe _____

Telephone Number & Extension(s): 628-297-1121 __________

Location: Building 203, Room 1B-79, Biomedical Engineering Office

13. PAYMENT: - Invoices will be paid in arrears on a quarterly basis. Invoices, MUST

A. INCLUDE, at a minimum, the following information: Contract No., Purchase

B. Order No., Item(s) covered (to include serial #'s) by the PMI and covered period

C. of service.

14. ADDITIONAL CHARGES: - There will be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.

15. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: - The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and Contracting Officer Representative (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and Contracting Officer Representative or Designee with a written estimate of the cost to make necessary repairs.

16. CONDITION OF EQUIPMENT: - The Contractor accepts responsibility for the equipment described in Section C, paragraph I., in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

17. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

B. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment identified in the Section B schedule. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance.

C. The FSEs shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC. The CO may authenticate the training requirements, request training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any VAMC equipment.

The CO and/or Contracting Officer Representative specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment.

D. If subcontractor(s) are used, they must be approved by the CO; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

18. TEST EQUIPMENT: - Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.

19. MOBILE MEDIA SCANNING: - The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Contracting Officer Representative or Designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system. The computer system for scanning removable media is in the Biomedical Engineering Shop, Building 6, Room 11.

20. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: - The Contractor's FSEs shall always wear visible identification while on the premises of the VAMC. It is the responsibility of the Contractor to park in the appropriate designated parking areas.

Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

21. INSURANCE:

A. Worker compensation and employer's liability: - Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.

B. General Liability: - Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

C. Property Damage Liability: - Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.

21. VA Information and Information System Security/Privacy Language

Device will be sent to vendor or Contractor will be on site to perform maintenance/repair/upgrades.

The contractor shall not be authorized to access any VA systems. Contractor shall not access protected health information (PHI) or personally identifiable information (PII). Accordingly, Certification and Accreditation (C&A) requirements are not applicable, and a Security Accreditation Package is not required.

PO- Based upon a review of the PWS/SOW as presented, the contractor will not have access to VA sensitive information or PII/PHI to fulfill the terms of the contract. A BAA will not be required.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

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

B. Definitions

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

The term Federal record:

1. includes VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

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

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

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

4. VHA 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 VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract 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 VHA 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).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VHA 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 VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training.

The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flow down of requirements to subcontractors

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

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

1. EQUIPMENT IDENTIFICATION: