36C24720Q0251-000.docx

Contract Opportunity Special Notice

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GENERAL INFORMATION

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* = Required Field Contract Opportunity Special Notice J065 Heart Lung Machines Annual Maintenance 29209-1639 36C24720Q0251 N 811219 VHA Regional Procurement Office-East Department of Veterans Affairs W.J.B. Dorn VA Medical Center 6439 Garners Ferry Road Columbia SC 29209-1639 Wileen Stokes wileen.stokes@va.gov THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A QUOTE/ PROPOSAL. A SOLICITATION DOCUMENT HAS NOT BEEN ISSUED AND PROPOSALS HAVE NOT BEEN REQUESTED.

The Department of Veterans Affairs, VHA Regional Procurement Office -East, intends to enter into on a sole source basis, under the authority of 41 U.S.C. 253 (c) (1) and FAR 6.302-1(a) (2) (ii), a contract, entitled " “Preventative and Repair Maintenance for Heart/ Lung Machines” This contract is necessary to perform Annual Maintenance and Repairs of 2 LivaNova Heart Lung Machines and all ancillary systems. However, LivaNova, USA, Inc. of Arvada, CO is the only Company that can successfully provide only their certified field service representatives located throughout the country and are employees of LivaNova for servicing this LivaNova equipment.

This notice of intent is not a request for competitive quotes/ proposals. However, if there are sources other than LivaNova USA, Inc., able to provide these services for this requirement, they must respond by submitting a capability statement within 5 business days of publication of this synopsis. Quotes/Proposals received within 5 business days of publication of this synopsis will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Deliveries should be by made by electronic mail (e-mail), hand carried or sent via other mail or package delivery services. NO COLLECT CALLS OR FACSIMILE TRANSMISSIONS WILL BE ACCEPTED.

This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(2) and 13.501-(a)(1) to use simplified procedures for commercial acquisitions. The North American Industry Classification System Code is 811219-Other Electronic and Precision Equipment Repair and Maintenance- business size standard is $20.5 M.

Only one award will be made as a result of this solicitation. This will be a firm fixed price type contract for Base year and (4) one -year Options of the requested services.

Any interested party that believes it can meet the above requirement may submit a capability statement. All information furnished must be in writing and must contain sufficient detail to allow determining if the interested party can meet the above criteria, meaning experience and expertise. The capability statement must be received in the Contracting Office mentioned below on or before 10:00 AM EST on February 14, 2020. All questions must be submitted in writing and can be emailed to Wileen Stokes, Contract Specialist, at wileen.stokes@va.gov. In the event this procurement is solicited in the future on a competitive basis, in order to receive an award, contractors must have valid registration and certification in the System for Acquisition Management (SAM) www.sam.gov. Please reference solicitation No. 36C24720Q0251 on all correspondence.

Contracting Office Address:

VHA Regional Procurement Office-East W.J.B Dorn VA Medical Center, Bldg.#100 6439 Garners Ferry Road Columbia, SC 29209

Place of Performance:

Ralph H. Johnson VA Medical Center 109 Bee Street Charleston, SC 29401 Primary Point of Contact:

Wileen Stokes, Contract Specialist wileen.stokes@va.gov

STATEMENT OF WORK

The Ralph H Johnson VAMC requires Annual Maintenance and Repairs of 2 LivaNova USA Inc. Heart Lung Machines, and all ancillary systems. The following are included in this request for service: EE: 180845, Model 48-50-00, SN# 48E02799, EE:180848, Model 48-50-00, SN# 48E2801, Model 24-90-30-Connect, S5 Complete, SN# 24S04051 and SN#24S04052.

MAINTENANCE SERVICE AGREEMENT COVERAGE:

A. Vendor shall provide the following:

a. Preventative Maintenance:

i. Preventative maintenance will be carried out according to the manufacturer's recommended schedule. Preventative maintenance generally includes checking mechanical and electrical safety, lubrication, functional testing and adjusting for optimum performance as specified in the detailed preventative maintenance work plan. PMs are scheduled for October of each year for the devices listed in the opening comments above. The PM can be performed any time during the scheduled month but, must be completed no later than 10 days after the end of the month in which it is scheduled.

b. Remedial Maintenance:

i. Vendor shall provide unlimited technical support and remedial maintenance service on the equipment when requested by the Customer, as well as planned maintenance inspections, when scheduled in order to keep the Equipment operating in accordance with the manufacturer’s specifications.

c. Replacement Parts:

i. Vendor shall supply at its own expense, necessary parts, provided replacement of the parts are required because of normal wear and tear or otherwise deemed necessary by vendor and VA. All Parts will be new, standard parts.

d. Software Maintenance:

i. Vendor shall provide all maintenance and updates for the LivaNova USA, Inc. is the only Service Provider in the US authorized and certified by LivaNova to service LivaNova equipment. LivaNova does not subcontract to 3rd party service suppliers. They do not train or certify 3rd party biomed service providers on our equipment Console, S5 Pumps and all ancillary equipment associated with the operation of the Heart Lung System operating system software. Such updates will solely enhance previously purchased capacities of the Equipment. Operating system software upgrades that provide new features or capabilities or that require hardware changes will be offered to VA at under the existing contract established by LivaNova USA, Inc. is the only Service Provider in the US authorized and certified by LivaNova to service LivaNova equipment. LivaNova does not subcontract to 3rd party service suppliers. They do not train or certify 3rd party biomed service providers on our equipment. In addition, some upgrades may require Applications Training performed by LivaNova USA, Inc. is the only Service Provider in the US authorized and certified by LivaNova to service LivaNova equipment. LivaNova does not subcontract to 3rd party service suppliers. They do not train or certify 3rd party biomed service providers on our equipment. personnel that will be offered at no cost to the VA.

e. Technician Training Requirements:

i. All maintenance and service preformed on “Heart Lung System” shall be facilitated by LivaNova USA, Inc. is the only Service Provider in the US authorized and certified by LivaNova to service LivaNova equipment. LivaNova does not subcontract to 3rd party service suppliers. They do not train or certify 3rd party biomed service providers on our equipment. trained technicians and Certificates of Training shall be presented upon request by the VA.

INFORMATION SECURITY:

a. 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 of common security configurations available from NIST’s Web site at:

http://checklists.nist.gov

b. 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 Web site:

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

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE:

a. 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 an acceptable 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 COTR 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.

b. 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 6500.1, Electronic Media Sanitization upon: (i) completion or termination of 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 contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or 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.

c. 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.

REPORTING: All repairs and services that will be performed during normal working hours, should be done in coordination with the Biomedical Engineering Section, as described above, to report/sign-in and to obtain an identification badge which shall be worn at all times while repairman is on station. After all work is completed, the Vendor must again report in person to the Biomedical Engineering Section, to submit in writing, 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.

PERFORMANCE: The Contractor must respond to service calls within two (2) hours of notification and be on-station within Forty-eight (48) hours. Competent personnel who are experienced and qualified to work on the specific equipment must perform all work. All work performed shall be accomplished in accordance with the manufacturer’s instructions including, but not limited to, adjustments, calibrations, cleaning, lubrication, testing, disassembly, check-out, replacement of worn or defective parts, etc., required to keep the equipment in operating condition. Contractor’s maintenance of the equipment must satisfy all requirements as set forth by NFPA and JCAHO. One (1) Preventive Maintenance service will be provided each year. All corrective maintenance services, travel and related expenses, Telephone Technical Support, Spare parts support and automatic call escalation are included in this full-service maintenance plan.

HOURS OF WORK: This contract is a full-service contract to include all necessary service calls, five

(5) days per week, between the hours of 8:00 AM and 8:00 PM, Monday through Friday, excluding Federal Holidays.

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 criteria upon thirty (30) days written notice to the Contractor with payment to be prorated.

SUBCONTRACTING: Due to the complexity of the services required herein, subcontracting will not be permitted.

TEST EQUIPMENT: The VA Medical Center 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:

OBSELETE 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.

TYPE OF CONTRACT

FIRM FIXED PRICE

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