36C26121Q0016 – Sources Sought – J065–Full-Service Maintenance and Repairs on Mizuho Surgical Tables.

Sep 1, 2020 | Sources Sought

This is a Sources Sought Announcement Only. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business (e.g. Services Disabled Veteran Owned Small Business, Veteran-owned small business, etc.). Vendor must provide a capability statement that addresses the company s qualifications and ability to perform as a contractor for the work described below.
The San Francisco VA Health Care System (SFVAHCS) is seeking a qualified contractor that can provide full-service maintenance and repairs on Mizuho OSI Surgical Tables. All professionals providing services under the terms of this contract must be appropriately certified and possess the skills and experience to perform the services as required.
The NAICS code for this acquisition is 811219 ($22M). All offerors must be registered in the System for Award Management (SAM) at www.sam.gov. All offerors should submit their information by email to Jocelyn.layson-castillo@va.gov. Submissions should be received no later than Friday, September 4, 2020 by 3:00pm HST.
(See draft Statement of Work).

STATEMENT OF WORK

1. EQUIPMENT IDENTIFICATION:

Model
Quantity

Company

Type
PROAXIS (6988)
1
MIZUHO
TABLE
HANA (6875)
1
MIZUHO
TABLE
ALLEGRO (6800)
1
MIZUHO
TABLE
MTS (5803)
1
MIZUHO
TABLE

TOTAL
4

2. DEFINITIONS/ACRONYMS:

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

B. CO – Contracting Officer

C. COR – Contracting Officer 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 signature; indicates COR accepts work status as stated in ESR.

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

M. OEM Original Equipment Manufacturer

3. CONFORMANCE STANDARDS: – Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, HIPAA, NEC, OSHA, CAP, JCAHO, UL, VA, CDRH, and/or requirements as applicable.

4. OPERATIONAL UPTIME – REQUIREMENTS: –
The MIZUHO SURGICAL TABLES shall be operable and available for use 96% of the normal operating hours of the equipment as detailed in paragraph V., HOURS OF COVERAGE.

Downtime will be computed from notification of problem during normal work hours. Scheduled maintenance will be excluded from downtime. (Normal work hours are 08:00 AM to 05:00 PM, Monday thru Friday, excluding federal holidays). Operational Uptime will be computed during a month long time period. Repeated failure to meet this requirement can subject the contractor to DEFAULT action.

5. HOURS OF COVERAGE:

A. Normal hours of coverage are Monday through Friday from 08:00AM to 05:00PM, excluding federal holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by Contracting Officer Representative or Designee.

B. Preventive maintenance will be performed in accordance with manufacturer s recommendations. Preventive maintenance will be performed during normal hours of coverage or as agreed to by user and Designee.

C. 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 vendor contract. Billing will include service time plus one (1) hour for travel time, and exclude parts, as they are included in the Vendor Contract. Work performed outside the normal hours of coverage at the request of FSE will be considered service during normal hours of coverage.

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.

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 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.

7. 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:

1) Cleaning of equipment.
2) Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, 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: cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, and keypads.
8) Returning the equipment to the operating condition [defined in Section 3, 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, 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.

C. The FSE must schedule an appointment for maintenance with the COR or designee. The FSE should not reschedule the agreed appointment for non-emergent reasons. Any non-emergent rescheduling that prolongs the timeframe that service can be completed will be documented.

D. 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: – 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.

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, 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 or Designee /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.

NOTE: – Any additional charges claimed must be approved by Contracting Officer Representative before service is completed!

11. REPORTING REQUIREMENTS: – The Contractor shall be required to report to Biomedical Engineering to log in when arriving onsite, phone or in-person contact is acceptable. 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 Designee. ALL ESRs shall be submitted to the equipment user for an “acceptance signature” and to 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): David Sperow __________
Telephone Number & Extension(s): 415-221-4810 ext. 26443_ _____
Location: Building 6, Room 11, Biomedical Engineering Shop____________________

12. REMOTE SUPPORT: The contractor shall have proper access and control to remotely monitor all equipment as required in Section 5. This includes background checks and Information Security Officer approval as required by Directive 6500. The contractor must demonstrate active security clearance before award.

PAYMENT: – Invoices will be paid in arrears on a monthly 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 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 FSE’s shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by “Fully Qualified” competent FSE s. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSE s for each make and models 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 located in the biomedical engineering shop, Building 6, Room 11.

20. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: – The Contractor’s FSE s 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. 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.

Appendix B

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

Appendix C

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be
subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA
information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with
VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S.to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when
an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE
a. 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).
b. VA information should not be co-mingled, if possible, with any other data on the
contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request.

6. SECURITY INCIDENT INVESTIGATION

a. 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 COTR 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.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s
notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.
c. With respect to unsecured protected health information, the business associate is
deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor
must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

9. TRAINING

a. 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:
(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) Successfully complete the VA Cyber Security Awareness and Rules of Behavior
training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete
required privacy training; and
(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.]
b. The contractor shall provide to the contracting officer and/or the COTR 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.
c. 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.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

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