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Service and PM for DRX Detectors at the Northport VAMC


New York, United States
Government : Federal
RFP
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6

STATEMENT OF WORK
SERVICE/MAINTENANCE OF EQUIPMENT
DESCRIPTION/SPECIFICATIONS


REQUIREMENTS:

The regulatory requirements extend to repairs performed by OEMs and required maintenance to return the equipment/instruments and systems to the manufacturer s original specifications. The repair and refurbishment process is subject to regulatory FDA audits and must comply with Medical Device Reporting (MDR) requirements.


FULL SERVICE CONTRACT:

Furnish all necessary labor, equipment, tools, materials, repair service, software updates, parts, etc., for complete On-Site Maintenance Service as specified below in accordance with the terms, conditions and schedule of this agreement.

BASE PERIOD: Date of Award, FOR A PERIOD OF TWELVE MONTHS

EQUIPMENT: Equipment to be serviced/maintained includes:

DESCRIPTION SITE # /SERIAL#

DRX-EVOLUTION/P-FF-P-2G K#4612-5694 / 4535
DETECTOR WIRELESS BAND 1&2 K#4612-5694 / 152500043924
DETECTOR WIRELESS BAND 1&2 K#4612-5694 / 120100034483

DRX-EVOLUTION/P-PCSH-PX K#58009287 / 6516
DRX GOS SINGLE DETECTOR/EVOLUTION K#58009287 / 173100045874
DRX GOS SINGLE DETECTOR/EVOLUTION K#58009287 / 173400045903

ACCIDENT PROTECTION COVERAGE PER INCIDENT FOR DRX-1C DETECTORS:

$5K DROP and $5K LIQUID DAMAGE, MON-FRI: 8-5

Detectors will be replaced with new unfurnished detectors in cases of drop or water damage under accident protection and care plus coverage.

DEFINITIONS/ACRONYMS:

A. Biomedical Engineering - Chief or designee.

B. CO - Contracting Officer.

C. COR - Contracting Officer Technical Representative (Biomedical Engineering)

D. PMI - 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. ESI Electrical Safety Inspection.

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

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

H. Acceptance Signature - VA employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR.

I. Authorization Signature - COTR's signature; indicates COTR accepts work status as stated in ESR.

J. NFPA - National Fire Protection Association.

K. CDRH - Center for Devices and Radiological Health.

L. VAMC - Department of Veterans Affairs Medical Center

OSHA - Occupational Safety and Health Agency.

OEM - Original Equipment Manufacturer.

AQL Acceptable Quality Level


CONFORMANCE STANDARDS:

The contractor shall ensure that the equipment (hardware and software) functions in conformance with the latest FDA (medical device regulations (including but not limited to Class I, Class II, Class III and MDDS), validation, quality assurance and compliance), latest published edition of NFPA-99, TJC, OSHA, CDRH, ISO 9001, and any other performance standards and specifications used when the equipment was procured by VA and any upgrades/updates.


SECURITY:

All vendors/contractors will sign-in at the Biomedical Engineering Administrative Office building 11 room 1, before reporting to their respective work site. Each vendor/contractor will be issued a temporary identification badge that must be worn at all times above the waist, in front, with the face of the card visible.

If removable media (i.e. USB or DVD/CD Device) is required to service, troubleshoot or install/update software, then it must be scanned with an anti-virus program. The removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device at the scanning workstation located in Biomedical Engineering. Any vendor/contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility.

All items covered by the manufacturer's warranty, contractor service of any devices, systems, or other equipment containing media (hard drives, optical disks, etc.) with VA sensitive information must not be removed / returned to the vendor at the end of life, for trade-in, or other purposes.

Upon completion of the scheduled work, the vendor/contractor will return to the Biomedical Engineering Administrative Office building 11 room 1, to sign-out, return the temporary identification badge, and leave any Field Service Reports if necessary.

All medical device workstations and servers must be in compliance with MDIA (Medical Device Infrastructure Architecture) as well as comply with all FDA regulations.
Remote System Diagnosis: Proactive, remote monitoring and diagnosis shall be provided and covered by contractor, however contractor must meet strict VA guidelines on use of virtual private network (VPN) access.

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


HOURS OF COVERAGE:

A. Normal business hours of coverage are [Monday through Friday] from [8:00 am to 5:00 pm], excluding federal holidays.
All service/repairs will be performed during normal business hours of coverage unless requested and approved by [COR].

B. Preventive Maintenance Inspections will be performed PER MANUFACTURER S PUBLISHED PM STANDARDS.

C. Federal Holidays observed by the VAMC are:

New Years Day Labor Day Martin Luther King Day Columbus Day President's Day Veterans Day Memorial Day Thanksgiving Day Independence Day Christmas Day

And any other day specifically declared by the President of the United States to be a national holiday.


UNSCHEDULED MAINTENANCE:

A. The contractor shall maintain the equipment in accordance with the Conformance Standards Section and the Performance Requirements Section, by furnishing all necessary labor, equipment, tools, materials, repair service, software updates and parts for service (excluding consumables) in accordance with the terms, conditions and schedule of this agreement. 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.

B. Only, the CO, COR 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 the COR and his/her designee within [thirty (30) minutes] after receipt of telephoned notification [24 hours per day]. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within [two (2) hours] after receipt of notification of CT Scanner problem, or within [six (6) hours] for a workstation problem and will proceed progressively to completion without undue delay. For example, if hours of coverage are [8:00 am to 5:00 pm], a [2] hour response for a CT problem means, if a call is placed at [3:45] pm [Monday], [September 9th], the FSE must start on-site service before [08:45 am Tuesday], [September 10th], except when outside hours of coverage is authorized by the COR.


SCHEDULED MAINTENANCE:

A. The contractor shall perform Preventive Maintenance Inspection (PMI) service within coverage hours to ensure that equipment listed in the schedule performs in accordance with Section III, Conformance Standards. The contractor shall make thorough technical inspections of the equipment covered in the Schedule. Within ten (10) days after the award of the contract, the contractor shall submit a schedule of PMIs and a PMI checklist describing in detail the scheduled maintenance procedures for inspecting each piece of equipment listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM.

All equipment listed under Section I, Equipment, will have PM service performed per original equipment manufacturer s published PM frequency requirements.

PMI 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 to 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 which are likely to become faulty, fail or become worn.

6. Measuring and adjusting and calibrating as necessary for optimal performance, output or image quality.

7. Inspecting electrical wiring and cables for wear and fraying.

8. Inspecting all mechanical components including, but not limited to: 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.

Performing any Electrical Safety Inspections required by NFPA-99, 2002 as they may apply to this class of equipment and its application.

10. Returning the equipment to the operating condition defined in Section III, Conformance Standards.

11. Providing documentation of services performed.

B. PMI services shall be performed in accordance with, and during the hours defined in, the Preventive Maintenance Inspection schedule established herein. All exceptions to the PMI schedule shall be arranged and approved in advance with the COR and Radiology Service.

C. All parts, services, manuals, tools, or software required to successfully complete scheduled PMI are included within this contract, and it s agreed upon price, unless specifically stated in writing otherwise.

D. Upon completion of the preventive maintenance and any required electrical safety inspection, the FSE must tag the equipment with an inspection tag, label or sticker which provides the following information: date inspected, date next due, and initials of FSE. VA Biomedical Engineering Labels may be provided to the FSE upon request when reporting (signing-in) to Biomedical Engineering.


PARTS:

All parts (including shipping costs) necessary for Scheduled and Unscheduled Maintenance are included/covered. Parts are to be New, Original Equipment Manufacturer (OEM) or certified refurbished only. Parts shall be most recent version, be readily available and shall be delivered/replaced in an expedited manner to meet/exceed uptime requirements. Parts are only to be replaced by Qualified Contractor Field Service Engineers. Software/Parts necessary to correct a safety risk/hazard (mandatory safety release) or which minimally improve original Equipment performance/etc. will be included/installed at no additional charge. Disposables, accessories, cosmetically damaged parts and optional upgrades are excluded.

The contractor has ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contractor shall use OEM new parts, Parts furnished by the contractor shall be guaranteed against defects and/or failure for a period of 1 year from the date of completed installation of the component. Used parts, those removed from another similar system shall not be installed without approval by the COR. Parts shall be delivered on a Priority Overnight Basis.


MISCELLANEOUS SERVICES AND COVERAGE:

SOFTWARE /HARDWARE UPDATES: Software or hardware updates to correct identified software problems or safety risks shall be installed as needed and covered. Software upgrades which provide additional capabilities as opposed to corrective measures are not covered.

UPTIME GUARANTEE: Uptime is guaranteed to be a minimum of 97 percent based upon covered hours (base time) in accordance with the following formula: UPTIME = BASE TIME DOWNTIME
BASE TIME

Downtime begins when call is placed and logged into the Call Center for a problem which results in the equipment not being available to scan patients and diagnose images on the equipment display console or operator s console. Failure of peripheral equipment beyond this description shall not constitute downtime. Downtime ends once repairs are completed and the imaging system is available for clinical use. Downtime does not include time spent for PMs, repairs necessitated by operator error, or accidents, utility interruptions, fires or floods.

If uptime is less than 97%, penalty will be applied as a percentage reduction of the full contract cost for the following year s contract as follows:

5% below 97% guarantee results in a 5 % cost reduction;
5.1 10% below 97% guarantee results in a 10% cost reduction;
More than 10% below 97% guarantee results in a 15% reduction.


SERVICE MANUALS AND DIAGNOSTIC SOFTWARE:

The VAMC shall not provide 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.

SERVICE DOCUMENTATION/REPORTS:

The documentation will include legible detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards Section. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

A. Name of Contractor.

B. Name of FSE who performed services.

C. Contractor Service ESR Number/Log Number.

D. Date, time (starting and ending), and Hours-On-Site for service call.

E. VA Purchase Order (PO) #(s) covering the call, if outside normal working hours.

F. Description of Problem reported by COTR/User.

G. Identification of Equipment to be serviced:

VA Inventory Entry # (if available), manufacturer, model#, serial#, and any other manufacturer's ID# s.

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

Labor, travel hours, and parts replaced (with part #s), location of problem (equipment assembly, circuit, etc) and Corrective Action.

I. Total Cost to be billed.

J. Signatures:

1. FSE performing services described.

2. VA Employee who is notified and accepts that repair /service has been completed.

K. A Log Book to be left with the supervisor at the equipment site for entering arrival and departure times and maintaining a PM and Repair records.


REPORTING REQUIREMENTS:

The contractor shall be required to report to Biomedical Engineering, Building 11, Basement level, Room 1 to log in during Normal Business Hours.B Outside of Normal Business hours, FSE may report directly to area Supervisor at equipment site.B When the service is completed, the FSE shall document services rendered on a legible ESR(s).B All ESRs require an acceptance signature from the Area Supervisor.B The FSE shall be required to log out either by contacting/meeting the COR to provide him with the ESR(s) or at Biomedical Engineering.B Outside of Normal Business Hours, FSR(s) may be left in the Biomedical lock-box located at the entrance to Biomedical Engineering (Building 11, Basement Level, Room 1).B Detailed FSR(s) must be received within five (5) business days after completion of work electronically e-mailed to COR ASSIGNED IN THE Delegation letter.


PAYMENT:

Purchase Order Payment Procedures:

Payments will be made QUARTERLY in arrears upon receipt of properly prepared, certified invoices at the VA Financial Services Center which must show reference to the contract s purchase order number issued upon the award of this contract.

INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [X]

Quarterly Reports:
Records of all scheduled PM Inspections performed under this contract as per manufacturer specifications.
PM checklist and frequency of calibration for each system model, serial number.
Repairs and parts replaced by model and serial number.

b. Semi-Annually []

c. Other []

GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be mailed to the following address:

http://www.ob10.com/veteransaffairs

The VA s OB10 number is AAA544240062


ADDITIONAL CHARGES:

There will be no additional charge to the Government 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.


REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but not later than 24 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 COTR with a written estimate of the cost to make necessary repairs.


QUALIFICATIONS:

Offers will be considered only from offerors who are established in the business called for and whom in the judgment of the Contracting Officer (CO) are financially responsible and able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service.


CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in Section 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.


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.

"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 comparable to that identified in the SOW. For field experience, the FSE(s) has a minimum of one year of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on covered equipment.

The FSEs shall be authorized by the contractor to perform the maintenance services.B All work shall be performed by "Fully Qualified" competent FSEs who are authorized and certified by the OEM.B The contractor shall be able to furnish upon request written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model of equipment the contractor services at the VAMC.B 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.B The CO and/or the 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.


TEST EQUIPMENT:

Contractor is required to utilize testing equipment for calibration which has been certified to be accurate, with accuracy traceable to a national standard. Certification certificates shall be made available to COR upon demand.


IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

The contractor's FSE's shall wear visible company 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. Smoking is prohibited inside any buildings at the VAMC or near entranceways. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to police search. Violations of VA regulations may result in citations answerable in the United States (Federal) District Court.

Natalie Acevedo

natalie.acevedo@va.gov

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