STATEMENT OF WORK v2.doc

STATEMENT OF WORK

Histology Equipment Service and Support 1.

EQUIPMENT IDENTIFICATION AND COVERAGE:

· Microtomes

· Slide Printers

· Slide Stainers

· Tissue Embedding Equipment

· Tissue Processors

. Support provided in the form of, but not limited to:

• Preventive maintenance (PM) services according to the OEM service manual

• Unlimited corrective maintenance services

• Technical Phone Support 24/7

Refer to Appendix A for full listing of equipment

2.

GENERAL REQUIREMENT: Michael E. DeBakey Medical Center is requesting for a contractor to provide preventative maintenance and service on the Histology lab equipment at the Michael E. Debakey Medical Center located at 2002 Holcombe Blvd, Houston, TX 77030. The Contractor shall furnish all labor, travel, materials, parts, equipment, tools to service and perform yearly preventative maintenance on the equipment. The Contractor must provide 24/7 technical support via phone, email and web. In the event the Contractor must replace any part, the part must be replaced with certified OEM replacement parts. The full listing of the equipment can be found in Appendix A.

3.

DEFINITIONS/ACRONYMS:

A.

Biomedical Engineer(ing) - Supervisor or designee.

B.

CO - Contracting Officer

C.

COR - 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 - COR's signature; indicates COR 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

4.

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

5.

HOURS OF COVERAGE:

A.

Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or his designee.

B.

Preventive maintenance will be performed at least yearly or to the OEM’s standards, whichever is more frequent.

C.

Hardware/software update installations will be scheduled and performed outside normal hours of coverage at no additional charge to the Government. Updates can be performed during normal hours of coverage upon approval from the COR or designee. Contractor provides software/hardware update.

D.

Federal Holidays observed by the VAMC are:

New Years' Day

Martin Luther King Day

Presidents' Day

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans' Day

Thanksgiving Day

Christmas Day

6.

UNSCHEDULED MAINTENANCE (Emergency Repair Service):

A.

Contractor shall maintain the equipment in accordance with the 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.

B.

The CO or COR 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 the COR or his/her designee within two (2) hours after receipt of telephoned notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within forty-eight (48) hours after receipt of this second notification and will proceed progressively to completion without undue delay.

7.

SCHEDULED MAINTENANCE:

A.

The Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with Section 4, Conformance Standards. (An outline of the PM procedures and schedule shall be provided to the COR). The PM shall be performed in accordance against the latest OEM standards. 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 the COR at the completion of the PM. 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:

1) Cleaning of equipment.

2) Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 4, Conformance Standards or the manufacturer's specifications.

3) Calibrating and lubricating the equipment.

4) Performing remedial maintenance of non-emergent nature.

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

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

7) 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.

8) Returning the equipment to the operating condition defined in Section 4, Conformance Standards.

9) Providing documentation of services performed.

10) Inspecting and calibrating the hard copy image device.

B.

PM services shall be performed in accordance with, and during the hours defined in, Section 5, the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.

C.

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.

8.

PARTS & TRAVEL: - The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. The contractor shall use new original equipment manufacturer (OEM) 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. Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the COR. (The Contractor shall also list any excluded parts under the service contract).

Travel for any and all service and preventative maintenance covered within this contract shall be covered by the contractor and shall not be reimbursed by the CO, VAMC, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances.

9.

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.

10.

DOCUMENTATION/REPORTS: - The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, required to maintain the equipment in accordance with Section 4, Conformance Standards or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. 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.

F.

Description of problem reported by COR.

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.

NOTE: - Any additional charges claimed must be approved by the COR before service is completed!

11.

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 the COR.

VA Biomedical Contact Persons:

VHAHOUBIOMED@va.gov; jason.graham2@va.gov

Location (Building/Room Number):

BA-200

12.

LIQUIDATED DAMAGES:

A.

Contractor shall be liable to the Government for losses of production due to significant equipment downtime. Significant equipment downtime is that which exceeds twenty-four (24) hours/month. Records regarding downtime will be kept by the COR and the maintenance contractor.

B.

Equipment downtime is calculated only from those normal hours of coverage (see Hours of Coverage Section) that the scheduled equipment is not fully operational. Downtime will begin when the Contractor is required to be on site (see Unscheduled Maintenance Section response time definition) after notification by the CO, COR or designated alternate. Downtime will accumulate until the scheduled equipment is returned to full and usual operation and accepted as such by the CO, COR or designated alternate. This does not include scheduled maintenance for PM purposes. Refusal of access to the equipment indicates that the unit is up and running and this time will not be considered when determining downtime. Refusal of access to the equipment voids the service call.

C.

If downtime exceeds thirty-three (33) consecutive hours, the CO may exercise the option to hire an alternate source to resolve the problem. The decision to exercise this alternative will reside exclusively with the CO. All fees generated by the alternate Contractor(s) will be handled in accordance with Default clause.

13. PAYMENT: - Invoices will be paid in arrears on a quarterly basis. Invoices, MUST INCLUDE, at a minimum, the following information: Contract No., Purchase Order No., Item(s) covered (to include serial #'s) by the PMI and covered period 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 COR (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 COR with a written estimate of the cost to make necessary repairs.

16.

CONDITION OF EQUIPMENT: - The Contractor accepts responsibility for the equipment 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.

Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records. For any service call made during normal working hours, the Contractor‘s repairman shall report their arrival and departure to the COR.

Contractor shall include, at no extra charge, any engineering and software update necessary for continued optimum operation of the equipment listed in this contract.

17.

REMOVAL OF EQUIPMENT: - Should a piece of equipment require repair at the Contractor ‘s plant, the Contractor shall coordinate with the COR the removal of equipment. Government property cannot be removed from the station without a signed Property Pass. This Property Pass may be obtained from Acquisition & Material Management Service, Personal Property Section, 4A-320 after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor ‘s charge.

18.

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. 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, on the equipment.

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 COR 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.

19.

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.

20.

IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: - The Contractor's FSEs shall wear visible identification at all times 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 and is only permitted in specified smoking areas on the VA medical center campus. 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.

NOTE: - Enter unique or unusual conditions [modify to suit your specific situation(s)] if the above clause is not entirely applicable.

21.

SAFETY REQUIREMENTS: - In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee, may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall have one supervisory employee, who will disseminate requirements to those who work at our facility, report to the Safety Manager’s office for a one- (1) time training class before working on-site. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly with such notice, the contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.

22.

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.

The Vendor will need to access VA systems in order to perform software updates, preventative maintenance and maintenance repairs.

23.

GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT: - After the contract has been in force for a period of time, it may be necessary to change and/or modify the operations to provide better service. Pursuant to FAR 43.102, no government personnel other than the Contracting Officer can execute contract modifications on behalf of the government.

24. END OF SERVICE PERIOD: - No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting

Officer.

25.

MOBILE MEDIA SCANNING:

The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Personally-owned USB thumb drive utilization is prohibited. Non-VA support personnel must furnish their own FIPS140-2 certified USB thumb drives, and only with the permission of a designated VA supervisor. All USB drives must be scanned with an antivirus program running current virus definitions by the local VA staff, prior to connection to any VA device. COR 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 located in the biomedical engineering shop, Building 100, Room BA200.

26.

PRIVACY/SECURITY:

The contractor will not have electronic connectivity to the devices. The contractor will not have access to PHI.

Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO. Electronic or magnetic data storage devices are not to be removed from VA property.

Appendix A

Microtomes

Microtomes: Cryostat

Printers: Cytology/Histology Slide

Slide Stainers

Tissue Embedding Equipment

Tissue Processors