36C24720Q0164-001.pdf

STATEMENT OF WORK:

WASP AND SLIDE PREP SYSTEM PREVENTIVE MAINTENANCE & REPAIRS

Dated 09/17/2019

A. GENERAL GUIDANCE

1. Scope of Work: Vendor shall provide full annual preventive maintenance and repairs service on:

WASP and Slide Prep System:

WASP#: 086-080-0617

WASP Slide Prep #: MX 1927530 located at the Ralph H. Johnson Veteran Affairs Medical Center (109 Bee St, Charleston, South Carolina). Preventive maintenance is defined as such services which involves checking the correct functioning of these devices and the replacement of expendable parts to ensure the fault-free operation.

2. Performance Period: The Vendor shall complete the work required under the SOW during:

Base Year: February 21, 2020 – February 20, 2021 Option Year 1: February 21, 2021 – February 20, 2022 Option Year 2: February 21, 2022 – February 20, 2023 Option Year 3 February 21, 2023 – February 20, 2024 Option Year 4: February 21, 2024 – February 20, 2025

Unless otherwise directed by the Contracting Officer (CO).

SCOPE: The Vendor shall be fully responsible and accountable for the maintenance of all listed equipment beginning on the date specified in the Notice to Proceed. These specifications are a statement of the minimum level of work and services that are to be provided. They are not intended to be, nor shall they be construed as, limiting specifications or requirements. The vendor will perform two preventive maintenance visits for a complete checkup of the instrument. The vendor will take all measures which would be to maximize the life expectancy, maximize downtime of related systems, and ensure safe and reliable operation. A detailed report will be filled out indicating the controls performed and components replaced. The report with the checklist of activities performed will be given to and countersigned by the Laboratory Director and copy shall be kept by COPAN.

All equipment shall be maintained in accordance with the manufacturers’ recommendations, the best practices of the industry, and applicable codes, standards, and regulations. If a conflict arises between these standards, the most stringent will prevail.

The Contractor shall provide a reliable and well-trained certified service technician on-site to provide non-emergent as needed repair during normal working hours, Monday- Friday, 8:00 am to 4:30 pm except for National Holiday as well as Day after Thanksgiving, Christmas Eve, and New Year’s Eve.

Intervention within 24 hours in case of machine breakdown. If the service call is received after 3pm on Friday, an engineer will be dispatched for service the following Monday morning. Unlimited technical assistance by vendor by telephone, web video/audio remote connection, and software upgrades. All replacements parts needed are covered by this maintenance contract.

The Contractor shall provide qualified personnel with an approved vendor clearance to repair and do preventive maintenance at the medical center. If the unit needs more extensive repair and has to be shipped out, the vendor will provide pertinent shipping materials and prepaid shipping labels. Vendor will take full responsibility during this process.

All scheduled work that requires the unit to be taken out of service shall be coordinated with the COR or designee and the contractor shall report to the COTS or designee the status of equipment of systems not operating by close of each work day. Any equipment or system not operational by the official start time of the occupants shall be reported to the COR or designee by 8:00 am that day. The contractor shall be responsible for the installation of signs as related to equipment and/or systems as deemed necessary by the COR or designee.

The Contractor shall maintain the machinery spaces, shops, and storage areas in a clean and orderly manner. When work is performed in these areas, the Contractor’s personnel shall clean up all debris and leave the area in a presentable condition. The Contractor must obtain the approval of the COR or designee before storing anything in equipment areas. Operating supplies such as lubricants, rags, cleaners, etc. shall be properly secured in containers approved by the COR or designee. Storage shall not negatively impact the means of egress, fire protection systems, and emergency lighting, nor shall it significantly increase the amount of combustible material in the equipment space. Safety requirements shall be maintained as required by NFPA, the National Electrical Code and the manufacturer recommendations.

B. Performance Requirements

1. Materials to be Furnished:

The contractor shall furnish all lubricants, test equipment, cleaning supplies, parts and tools necessary to perform the work above. Only accessories, disposable items and spare parts that do not pose a technical safety risk and demonstrably comply with Medical Devices Directive 93/42/EEC (MDD) may be used. To ensure the full functionality of the WASP and Slide Prep System, we recommend using products/parts made by Copan. VA shall supply standard consumables for testing purposes.

2. Service Manuals/Tools/Equipment: The Medical Centers 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 stall, all operational and technical documentation (such as: operational and service manuals, schematics, and parts lists) 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 or COR upon request.

3. Report of Services/Documentation: Upon completion of any maintenance and/or repair services, the contractor shall report to the COR or designee and provide an electronic report detailing services performed and obtain an acceptable signature. Contract shall prepare and submit an electronic report on or before the third (3rd) day after service detailing all services performed. This report shall be required prior to billing. If this service report is not received, invoices shall not be paid until report is received and verified. Contractor shall maintain a complete orderly chronological file, including, but not limited to, parts list, copies of repairs required by contract, etc. This file shall be made available for inspection upon request if the Contracting Officer or COR.

4. Equipment to Be Serviced: Copan WASP and Slide Prep System

Information Security:

1. The Contractor and their personnel shall be subject to the same Federal laws, regulations, standards, and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards available from the Department of Commerce’s National Institute of Standards and Technology (NIST). This also includes the use od common security configurations available from NIST’s Web site at:

http://checklists.nist.gov

2. To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in “VA Information and Information System Security/Privacy Requirements for IT Contracts” located at the following website:

http://www.iprm.oit.va.gov/Security_and_Privacy_Requirements_for_Contractors.asp

For Information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of any contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

1. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500, l. Electronic Media Sanitization upon : (i) completion or termination of http://checklists.nist.gov/ http://checklists.nist.gov/ the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier.

Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

2. 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:

a. Vendor must accept the system without the drive;

b. 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

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

C. GENERAL REQUIREMENTS:

1. The contractor shall provide the COR with a list of contractor employees expected to enter building.

While on VA premises, all contractor personnel shall comply with the rules, regulations, and procedures governing the conduct of personnel and the operation of the facility.

2. An access badge will be given to the contractor’s employee upon entrance into VA buildings. The contractor employee must safeguard the access badge and immediately report any lost, stolen, or destroyed badges to the COR. All contract personnel must properly display their access badges. Access badges must be worn at or above the waist (facing forward) at all times in the facility. The contractor’s employees must return the access badge(s) to the COR or designee when the work is complete.

3. It is the responsibility of the contractor’s personnel to park in the appropriate designated parking areas.

Parking information shall be coordinated with each facility COR.

4. RHJVAMC does not validate or make reimbursement for parking violations of the contractor’s personnel under any circumstance.

D. GOVERNMENT RESPONSIBILITIES:

The Government shall be responsible for making the equipment available to the Contractor during normal business hours 8:00 am - 5:00 pm. If there is a need for work to be done after hours, the Government will make arrangements for the Contractor to have access to the equipment.

E. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

The contractor shall be required to comply with all security policies/requirements. All security policies/requirements must be met and employees cleared prior to the contractor performing work under this contract. Employees that cannot meet the security and clearance requirements shall not be allowed to perform work under this contract.

F. INTERFERENCE TO NORMAL FUNCTION:

Contractor may be required to interrupt their work at any time so as not to interfere with the normal functioning of the facility, including utility services, fire protection systems, and passage of facility patients, personnel, equipment and carts.

1. In the event of an emergency, contractor services may be stopped and rescheduled at no additional cost to the government.

2. Contractor personnel shall inform the COR or the designee of the need to gain access to secured areas.

If access is required to secure areas, prearranged scheduling will be made with COR or designee.

G. CONTRACTING REQUIREMENTS

REPORTING:

For repairs or services that will be performed during normal working hours, the Contractor’s repairman must report to the Biomedical Engineering Section, G200 or by telephone at 843-789-7396, and while on station an identification badge shall be worn at all times. During the repair process, once the problem is identified, the vendor shall notify VA Biomedical Engineering before replacement parts are installed. After all work is completed, the Contractor’s repairman must again report to the Biomedical Engineering Section and provide a complete report of services or repairs performed for each item of equipment and must also include a listing of replacement parts, when applicable.

NOTE: Payment of invoices may be delayed if the appropriate reports are not properly completed and submitted to the Biomedical Engineering Section as required above.

PERIOD OF PERFORMANCE:

The Preventative Maintenance contract shall have a base year from 2/21/2020 through 02/20/2021, with 4 option years through 2025. Option years will be exercised at RHJVAMC’s discretion.

HOURS OF WORK:

The contractor shall be available during normal business hours of 8:00am – 4:30pm Monday – Friday excluding Federal Holidays and weekends. If it is deemed necessary that work be done outside of normal business hours due to clinic schedule, the contract will be flexible and decide – with HTM staff – on a time that does not impact patient care.

TRAVEL:

All work is to be conducted at the Ralph H. Johnson VAMC located at 109 Bee Street, Charleston, South Carolina. The contractor is responsible for any anticipated travel and per diem.

ADDITIONAL SERVICES:

The Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date, provided the Contractor is notified of deficiencies at least one

(1) day before the contract expiration date. All changes, updates or retrofits made on any component or system shall be annotated on station equipment manuals and records. Services also include recording all routine work; corrections and repair work in the equipment log.

AUTHORIZED SERVICES:

Only those services specified within the contract are authorized. Before performing any service or repair of a non-contract nature, the Contracting Officer or his/her designee must be advised of the reason for this additional work. If appropriate, the Contracting Officer or his/her designee may authorize the additional services or repairs under a separate purchase authorization. Contractor is cautioned that only the Contracting Officer or his/her designee may authorize additional services or repairs and reimbursement will not be made unless this prior authorization is obtained.

DISCONTINUANCE OF SERVICE:

The Government reserves the right to terminate service on a particular machine meeting replacement criterion upon thirty (30) days written notice to the Contractor with payment to be prorated.

TEST EQUIPMENT:

RHJVAMC will not furnish parts and/or test equipment for the performance of this contract. It is the responsibility of the Contractor to bring the appropriate equipment and/or supplies necessary to complete the work as required within.

PERFORMANCE CONFERENCE:

If appropriate, the Contracting Officer will schedule a performance conference for contract orientation purposes with the Contractor receiving award.

SPECIAL CONTRACT REQUIREMENTS:

Vendor must follow all Department of Veterans Affairs, Joint Commission, OSHA, and NFPA regulations when working on VA equipment.

CONTRACTOR SUBMITTALS:

Within fifteen calendar days after award date, but not later than performance of the first servicing of equipment, the Contractor will furnish two (2) copies of its preventive maintenance procedures manual which will be used during the preventive maintenance services of this contract to the Contracting Officer. These manuals are required by the Government as a condition of the facility’s

JCAHO accreditation and must be received before any invoice can be certified for payment.

SERVICE CONTRACTS:

Bidder shall provide in the space provided below, the name, location, and telephone number of the office where service calls are to be placed:

OBSOLETE MACHINES:

Services under a resulting contract will not cover obsolete machines where parts for such obsolete machines are not available under the original manufacturer’s commercial price list, unless mutually agreed to by the Contracting Officer and the Contractor.

ORDERS:

The Contractor’s repairman will report to the office of the Contracting Officer’s Representative (COR) prior to start of work and after completing the services required during that call. Services to be rendered will be directed by the COR and any changes must receive concurrence of the Contracting Officer and/or the COR.

CHANGES TO STATEMENT OF WORK:

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project.

Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

TYPE OF CONTRACT

The RHJVAMC anticipates award of a FIRM FIXED PRICE contract based on the contents of this solicitation.