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This is a Sources Sought Only As needed Preventive Maintenance and Repairs of Siemens Medical Equipment


Pennsylvania, United States
Government : Federal
RFP
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This is not a request for quote, the government is currently conducting market research with the intent to sole source to the manufacture due to the highly technical requirements for maintenance and repairs on a as needed basis. If interested please send a one page capability statement to andrew.taylor3@va.gov by May 25, 2018 by 4:00 pm. est.

Example Statement of Work

STATEMENT OF WORK: Preventive maintenance services and unscheduled maintenance as needed for Government Owned Equipment listed under the schedule(s) of equipment in accordance with all terms, conditions, provisions, schedules and specifications of this solicitation.

EQUIPMENT IDENTIFICATION: Contractor shall furnish all necessary travel, labor, test equipment, tools, parts, accessories required for the inspection, support, updates to embedded software, and repair of the equipment, listed in the Schedule of Equipment, located at the VA Pittsburgh Healthcare System (VAPHS). The Schedule of Equipment is subject to change. Any changes or additions to this equipment will be agreed to by a bilateral modification to the contract from the Contracting Officer. This contract shall cover 5 years in accordance with all terms, conditions, provisions, schedules, and specifications of this solicitation.

1.2 CONFORMANCE STANDARDS: Contract service shall ensure that the equipment functions in conformance with the specifications used when the equipment was procured by VAPHS and any upgrades and/or updates, as well as following most current published standards, specifications, and regulations:

Manufacturer s specifications, Association for the Advancement of Medical Instrumentation (AAMI), Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), National Fire Protection Agency 99 (NFPA-99), Center for Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic Engineers (IEEE), Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), VAPHS standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract.

Association for the Advancement of Medical Instrumentation (AAMI) www.aami.org
The Joint Commission http://www.jointcommission.org
National Fire Protection Agency 99 (NFPA 99) http://www.nfpa.org
Center for Device and Radiological Health (CDRH) http://www.fda.gov








1.2.1 Hours of Coverage: Normal VAPHS Hours of Utilization or operations of this equipment are Monday through Friday, 8 a.m. to 5 p.m., excluding federal holidays.

Federal Holidays observed by the government are:

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

Or any other period as declared by Executive Order of the President of the United States.
The Contractor shall provide telephone and repair/service coverage for this contract during the time period described as normal VAPHS Hours of Utilization for normal service rates. If vendor is called outside of these hours, the rates for service will be the after-hours rate.

Contractor must provide the means to request and receive prompt emergency telephone support from a Field Service Engineer (FSE), within 1 hour of the Contracting Officer Representatives (COR) s request. Also see paragraph 1.4, Unscheduled Maintenance and Repair Services.

Emergency call services shall be provided twenty-four hours a day, seven days a week by calling Siemens customer care center

1-888-7436 (SIEM) at no extra charge to the Government.

1.3 PREVENTIVE MAINTENANCE: When the Vendor is called in for Preventive Maintenance (PM) service the following shall occur: The Contractor shall perform PM Service to ensure that equipment listed in the schedules performs in accordance with Conformance Standards.

The date of Preventive Maintenance must be scheduled by COR and a fully executed modification to fund the maintenance must be issued by the Contracting Officer before the services are performed. All exceptions to the preventive maintenance schedule and procedure shall be addressed and approved in advance with the COR.

PM services shall be performed according to the manufacturer s recommendations and the PM schedule set forth by COR and CO. The Contractor shall provide written notice to the COR advising of any changes in the PM requirements or changes in the PM service schedule.

The Contractor shall conduct the preventive maintenance according to the manufacturer specifications and any additional procedures followed by the Contractor.
The Contractor shall provide complete and original documentation indicating PM work performed, referencing the procedures followed, actual tests and/or evaluation results obtained to the COR at the completion of the PM service.

Any charges for materials such as lubricants, fluids, cleaning supplies, services, manuals, or tools
required for the Contractor to successfully complete scheduled PM shall be provided by the Contractor and are included within this contract, and its agreed upon price.

1.4 UNSCHEDULED MAINTENANCE AND REPAIR SERVICES: Contractor must provide prompt emergency telephone support to request service. Service calls to the Contractor requesting service are only authorized when they are received from the COR, CO, or designated alternates. Outside of the Contract s hours of coverage, emergency on-site services require authorization by the COR. Usually the COR or a Bioengineer Staff Member shall initiate these calls. If VA staff other than the COR or a Biomedical Engineering Staff Member place calls requesting services, the Contractor shall contact Biomedical Engineering Services and verify the request. Service responses on calls from unauthorized personnel can result in nonpayment. The VA Administrative Officer of the Day is an authorized caller and can also be contacted for verification. Response Time: Contractor's FSE must respond with a phone call to the COR 1 hour after receipt of telephoned notification. If the problem cannot be corrected by phone, e-mail or modem, the FSE shall commence work (on-site physical response) within 4 hours after receipt of initial notification unless otherwise agreed upon, in writing, by the COR or biomedical engineering personnel. Response time is based on the normal hours of coverage as detailed in the Hours of Coverage. (For example, if hours of coverage are 8:00 a.m. to 5:00 p.m., Mon. through Fri., a four hour response means, if a call is placed at 3:15 p.m., Monday August 10th, the FSE must start on-site service before 10:15 a.m., Tuesday, August 11th, except when appropriate personnel authorize service outside hours of coverage.)

The Contractor shall provide timely and quality maintenance service and materials to insure all
equipment is operable and available for use. Uncorrected deficiencies or unfavorable histories of
downtime can result in the termination of this contract under the Termination for Default clauses of the Federal Acquisition Regulations.

1.5 MAINTENANCE MATERIALS: The Contractor shall have ready access to all materials needed to maintain equipment to meet the Conformance Standards, and shall make them available to its FSE s at no extra cost to the Government.

This includes all manufacturer operator and technical documentation (service manuals, operator
manuals, parts list, schematics, etc.), test equipment, tools, equipment software versions, and all other materials needed to perform the necessary unscheduled and scheduled maintenance to the equipment.

1.5.1 PARTS: The Contractor shall furnish and replace all equipment replacement parts necessary for repair. The Contractor shall furnish only new standard parts or OEM refirbished parts (manufactured by the OEM or - equal or superior to the OEM parts). All parts supplied by the Contractor shall be of current manufacture and have complete compatibility and functionality with the presently installed equipment. All parts shall perform identically to the original equipment specifications.

1.5.2 SERVICE MANUALS: The VAPHS 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.

1.5.3 TEST EQUIPMENT: The Contractor shall provide the VAPHS with a copy of the current calibration certification of all test equipment which are to be used by the Contractor on VAPHS's equipment. This certification shall also be provided on a periodic basis when requested by the VAPHS.

Test equipment calibration shall be traceable to the criteria of Conformance Standards specifications or of the equipment s OEM.


1.6 REPORTING REQUIREMENTS: The Contractor shall be required to report to the Police office when first arriving on-site to obtain a Vendor s badge. The Contractor shall then be required to report to the COR in Biomedical Engineering, Room AN305C, during normal working hours, prior to and after any work being performed, on each day that is required to complete the service. This check-in is mandatory. At this time FSE will be required to enter the following information into a log VAPHS book: current date, name of FSE, name of Contractor, equipment being serviced, Electronic Service Report (ESR) number, and time in and out.
When service is completed, the FSE shall document services rendered on a properly completed ESR, as required in Section C.11. The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature". If the COR is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested on the ESR).

When the job cannot be completed by 8:00 p.m. during normal working hours, a status of progress, in the form of an ESR or verbal description, must be provided to the COR before 7:30 p.m. If work is authorized to be completed outside normal working hours and Biomedical Engineering is not staffed, FSE s shall be required to log in and out with Security/Police Service at the VAPHS entrance and receive proper identification badges. ESR s for these services, both completed and left in progress, will need an acceptance signature and be provided to Biomedical Engineering Services.

1.7 DOCUMENTATION/REPORTS: Documentation in the form of ESR s must be furnished to the COR for all scheduled and unscheduled maintenance performed by the Contractor. Payment will not be certified by Biomedical Engineering if proper documentation is not provided.

The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance, including replaced parts and prices (for service outside normal working hours) procedures performed required to maintain the equipment in accordance with Section C.3, Conformance Standards. Each ESR must, at a minimum, document the following data legibly and in complete detail:


Name of Contractor

Name of FSE who performed services.

Contractor service ESR number/log number.

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

The number of this Contract and/or VA purchase order number(s) covering the call

Description of problem reported by COR/user (if applicable).


Identification of all equipment serviced:

(a) device name/description, device location (if applicable),
(b) manufacturer's name,
(c) model number,
(d) serial number,
(e) VA inventory/barcode number, and/or other identification numbers.

8. Itemized description of service performed and parts replaced.

9. Results of calibration and/or performance testing.

10. Signatures:

(a) FSE performing services described.
(b) Acceptance signature as defined in Section C.2.
(c) Authorization signature by COR. (If the COR is unavailable a signed, authorized,
copy of the ESR will be sent to the Contractor after the work can be reviewed, if so requested by the FSE and noted on the ESR.)

Any additional charges claimed by the FSE/Contractor must be approved by the COR prior to the performance of the service. A purchase order number must then be provided to the FSE/Contractor by the COR.

1.8 PAYMENTS AND ADDITIONAL CHARGES:

1.8.1 PAYMENTS: Invoices will be paid IN ARREARS on a monthly basis.

1.8.2 REPORTING REQUIRED FOR SERVICES BEYOND THE CONTRACT:
The Contractor shall immediately, but not later than twenty-four (24) hours after discovery, notify the CO and the COR, IN WRITING of the existence or the development of any defects in, or repairs required to the schedule of equipment which the Contractor considers not to be 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.

1.8.3. ADDITIONAL CHARGES: There shall 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.

1.9 CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in the equipment schedule 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.

2.0 COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: Each respondent must have an established business, with an office and full time staff. Generally, the Contractor shall have two years of successful experience in fully maintaining the full schedule of equipment for this contract. This staff includes two "fully qualified" FSEs who shall serve as the primary technician and backup for the servicing of the items listed on the schedule of equipment at this VAPHS. "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 schedule of equipment. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) performing preventive maintenance and equipment repairs on the equipment. 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 VAPHS , as detailed in Section C.14. 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 VAPHS equipment. The CO and COR specifically reserves the right to reject any of the Contractor's personnel and refuse them permission to work on the VAPHS equipment.
If subcontractor(s) are used, they must be approved by the CO and COR; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval or disapproval.

2.1 SPECIAL CONDITIONS: The Contractor shall support all system and third party existing equipment embedded software of the equipment, providing on-site support and repairs during normal hours of coverage. The Contractor will provide telephone support during normal hours of coverage. The Contractor will provide provision revisions and updates of all software that corrects functional flaws. All system software updates will be provided and installed on equipment at no additional cost to the government, within six (6) months after each software version is released. Installation shall be done outside normal working hours, unless requested by the COR, at no additional cost to the government. Parts shall be available for shipment within 24 consecutive hours of request. Contract labor/parts coverage to include all system options, third party pass thru devices, such as injectors, printers, compact disk devices, remote workstations, etc. and will include all Siemens embedded software updates including that used by third party devices.

2.2 CONTRACT SECURITY REQUIREMENTS: Contractor will be required to comply with physical security guidelines by either checking in with the VA Police each time they come on-site to perform contracted services or by obtaining a VA Contractor ID badge from the VA Police. VA ID badge must be worn at all times while on VA premises. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network.
The following language from VA Handbook 6500.6 applies to this contract:

2.3 VA INFORMATION CUSTODIAL LANGUAGE: 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).
2.4 INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE: 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:

2.4.1 Vendor must accept the system without the drive;

2.4.2 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

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

2.4.4 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;

2.4.4.1 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

2.4.4.2 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.

2.4.4.3 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 Information Security Officer (ISO) needs to maintain the documentation.

2.5 SECURITY INCIDENT INVESTIGATION: 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.

2.6 LIQUIDATED DAMAGES FOR DATA BREACH: 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.
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:

2.6.1 Notification;

2.6.2 One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

2.6.3 Data breach analysis;

2.6.4 Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

2.6.6 One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

2.6.7 Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

2.7 TRAINING: 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:

2.7.1 Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

2.7.2 Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

2.7.3 Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

2.7.4 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.]

2.7.5 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. 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.

OTHER: Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access must sign the VA s Contractor Rules of Behavior. Contractor must complete VA Privacy and Information Security Awareness and Rules of Behavior training prior to the performance of the contract and annually thereafter. Training must be completed in VA s TMS system (https://www.tms.va.gov/). Contractors must use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain. Proof of training completion must be verified and tracked by the COR.

Example Schedule
Item No.
Description
Functional Location #
Estimated Quantity
Unit
Unit Price
Total
1001
Preventative Maintenance (PM)





1001AA
Symbia T2
400-406951
1
EA


1001AB
Magnetom Espree
400-181901
1
EA


1001AC
Espree MR Chiller SC218
400-214235
1
EA


1001AD
Magnetom Verio
400-296930
1
EA


1001AE
Verio MR Chiller SC218
400-296931
1
EA


1001AF
Luminos TF
400-285584
1
EA


1001AG
Luminos TF
400-208109
1
EA


1001AH
Axiom Artis Zee
400-392025
1
EA


1001AI
Axiom Artis Zee
400-396427
1
EA


1001AJ
Axiom Artis Zee
400-469203
1
EA


1001AK
SC2000
400-469506
1
EA


1001AL
Luminos Agile Max
400-453466
1
EA


1001AM
Leonardo/Syngo Workstation
400-469204
1
EA


1001AN
Leonardo/Syngo Workstation
400-396428
1
EA


1001AO
Syngo Dynamics Virtual Server
400-352101
1
EA



Item No.
Description
Estimated
Quantity
Unit
Unit Price
Total
1002
Technician Labor repairs




1002AA
Labor normal hours
1
Hour


1002AB
Labor after hours
1
Hour



Subtotal repairs




1003
Replacement Parts*
%
EA



Total Option Year





Grand Total





Percentage less than parts catalog

Andrew Taylor
andrew.taylor3@va.gov
878-271-6640

Contract Specialist

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