Attachment A - Statement of Work - RFQ No.36C26224Q1817.docx

RFQ: 36C26224Q1817

STATEMENT OF WORK

For

SURGICAL EQUIPMENT LEASE

1. SCOPE OF WORK: The contractor shall provide surgical equipment, preventative maintenance inspections, and intervening service calls with equipment service coverage to the VA Loma Linda Healthcare System (VALL) under a contract for leased surgical equipment. This equipment shall be capable of surgical procedures in the operating rooms to visualize, display, record, and store images and video during minimally invasive scope cases, as well as be used for drilling, reaming, cutting, pinning, or burring during surgeries. The contractor shall provide, install, integrate, and maintain a fully functional connected operating room communication integration system for connected surgical equipment and devices.

· SEE ATTACHED RFQ DESCRIPTION DOCUMENT

· SEE ATTACHMENT B – SALIENT CHARACTERISTICS

· SEE ATTACHMENT C- SCHEDULE OF ITEMS with SPECIFICATIONS

2. PERIOD OF PERFORMANCE: This is a firm-fixed price contract. The performance period is for a base year plus three (3) option years.

Within 45 days of the award, the awardee must begin coordination and implementation efforts with the VA POC for the leased equipment including systems to become fully operational within 120 days of the award's effective date.

The specific dates for the performance periods will be established upon offer acceptance and award announcement.

3. PLACE OF PERFORMANCE: VA Loma Linda Healthcare System Surgical Service 11201 Benton Street Loma Linda, CA 92357

4. DOLLAR BUY-OUT: After the lease term ends (base and option years), the VA Loma Linda Healthcare System shall have the option to purchase the leased equipment of their choosing and obtain full ownership for $1.00. Upon notification, the contractor shall prepare the offering as required to transfer ownership.

5. PREVENTATIVE MAINTENANCE INSPECTIONS AND INTERVENING SERVICE CALLS:

a. The Contractor shall provide all labor, supplies, parts, supervision, and materials required to repair and maintain the leased equipment. The Contractor shall provide a full-time, on-call, on-site, factory-trained, and certified field technician to perform repairs, maintenance, and diagnostics following the original equipment manufacturer (OEM) service manuals, specifications, and recommendations.

b. The full-service contract will cover repair, exchange, and maintenance on each unit, plus needed repairs during the term of the contract, excluding misuse or abuse of the scope; equal or equivalent to the Stryker ProCare Protect manufacturer’s preventive maintenance service coverage. The full-service contract requires repairs, maintenance, and diagnostic assessments to be conducted by no individual other than a Stryker endoscope and communications trained and certified field technician.

c. The full-service contract requires the OEM endoscope and communications trained and certified field technician to be available and on-site 1) Monday through Friday (during normal business hours), 2) Monday through Friday after normal business hours (as required by surgical caseload), 3) on call and readily available Monday through Sunday.

d. The equipment must remain in good working condition as VALL is dependent on patient results within a limited agreed upon time. All services performed shall be provided by an OEM endoscope and communications trained and certified field technician. All preventative maintenance and repair services shall be performed in accordance with the original manufacturer’s specifications and service manual.

e. Replacement parts will be furnished on an exchange basis at the contractor’s expense and will be a new part or reconditioned part equivalent to new. Replaced parts become the property of the contractor.

f. The contractor shall provide an annual consumption (usage) report of all leased equipment.

g. The contractor shall provide a listing to identify all items with service coverage including which type of service they are covered under, such as prevent, protect, or both, etc.

6. PREVENTIVE MAINTENANCE (PM) AND INTERVENING SERVICES: PM and Intervening services shall include, but not limited to the following:

a. All labor, parts, equipment/instruments, and travel are all-inclusive for scheduled and unscheduled services.

b. Setting up any Stryker Products leased/purchased by the VALL identified in the list under section 1, Scope of Work.

c. Annual preventative maintenance in accordance with Original Equipment Manufacturer (OEM) specifications and service manual.

d. Scheduled services to perform OEM’s Periodic Manufacturer’s Certification solely by a Stryker endoscope and communications trained and certified field technician.

e. Use of OEM parts only.

f. Unlimited on-site repair services solely managed by a Stryker endoscope and communications trained and certified field technician.

g. Diagnostics checks.

h. An unlimited number of repairs of Service equipment.

i. Loaner of Equipment.

j. Train the VALL personnel and surgeons on how to use any Stryker products leased/purchased by VALL.

7. PARTS:

a. The contractor shall furnish replacement parts meeting or exceeding the original equipment manufacturer's (OEM) specifications.

b. Replaced parts are to be disposed of by the contractor after obtaining approval from the VA POC, except for hard drives that have the capability of storing sensitive information. They must be disposed of in accordance with the VA Information Security Requirements and with the Information Security Officer (ISO) concurrence.

c. Operating and consumable supplies are not part of this contract. Replaced parts covered by the Preventive Maintenance Inspection or intervening services shall be itemized as a no-charge item on the Contractor’s invoice and shall be identified by the part listed on the manufacturer’s schematics or part list.

d. The contractor shall have sufficient supply in stock or be able to obtain all parts required for work under this contract. The contractor shall have complete service documentation, including necessary manuals and schematics.

e. Unserviceable parts shall be replaced by the contractor on an exchange basis within eight (8) working hours, labor to install replacement part are included.

f. Part numbers as shown on the manufacture schematics/parts list will identify all parts that are replaced. All newly installed replacement parts become the property of the Government. Any worn defective parts will be replaced free of any charges.

g. When parts are required and are not covered by Preventive Maintenance and have intervening services, such needs shall be identified to the VA POC along with an estimate of charges. The VA POC will evaluate these needs and request through the Contracting Officer appropriate action(s). These parts will be installed under a separate purchase order. The contractor may be required to furnish parts when required. Acceptable documentation may be required to show that parts furnished to the Government shall be obtained at the lowest cost reasonably available. Such documentation may include:

(1) Copies of supplier invoices for parts furnished to the Government;

(2) Records of payment to suppliers;

(3) Documentation or written Quotations for parts;

(4) Other documentation that shows that parts were obtained at the lowest cost available.

8. TEST EQUIPMENT: The VALL shall 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.

9. REMOVAL OF EQUIPMENT: Government property shall not be removed from the station without a signed property pass. This property pass may be obtained after the removal is authorized by the Contracting Officer or VA POC. If sensitive data is stored on the device, the VA Information Security Policies must be followed and should the Information Security Officer shall approve the process of removing equipment from the government site. Equipment shall not be removed by the contractor from the government site for minor repairs. The contractor assumes full responsibility for the equipment while it is off-site or in transit.

10. REPORTING:

a. REPORTING (During Normal Working Hours): For any repairs or service that will be performed during the normal working hours of 7:30 a.m. through 4:00 p.m. the Contractor shall check-in with the VALL Security Officer on duty and with the VA POC or Clinical Administrator before proceeding to the job site.

After all work is completed, the Contractor is required to submit, in writing, a complete report of services or repairs rendered, and deliver it to the VALL using service where the equipment is located within 5 days after completion of each monthly service. At a minimum, this report must contain a detailed description of any services or repairs performed for each item of equipment, and must also include a listing of replacement parts, when applicable, total hours of service, safety check, performance data, and the date. The report will also include any Contractor recommendations necessary to maintain the equipment in optimum operating condition. Service Technician shall document and report to the using service and VA POC, any unsafe conditions or signs of misuse or abuse in regards to this medical equipment. Service Technician shall document any problems along with their corrections and all performance verification of the field service report. The service report must be legible and signed by the VA POC.

b. REPORTING (During Other than Normal Working Hours): For repairs or services required other than normal working hours, the Contractor is required to check-in with the VALL Security Officer on duty and with VALL prior to repairs or service. After receiving a separate, pre-authorized obligation number and after the repair has been completed, the Contractor’s service technician is required to complete report of services or repairs rendered and deliver it to the VALL of the using service where the equipment is located. Both the check-in and check-out procedures defined above are mandatory and will be strictly enforced.

11. RECONDITIONING: Reconditioning and/or extensive repair work determined not to be economically feasible is not included in the contract and the Government reserves the right to obtain such service from other than the listed Contractor.

12. TRAVEL: Transportation charges for service technicians will not be billed or paid under the resulting contract.

13. PERFORMANCE: The contractor shall respond to service calls within 24 hours and be on-site for repair within 72 hours after receipt of telephone, written or verbal notification. All work is to be performed by OEM certified, competent personnel, experienced, and qualified to work on the specific equipment. All work performed shall be accomplished following the OEM instructions. Preventative Maintenance Inspections shall be completed within one workday unless approval for a longer completion time is given the by the VA POC.

14. AUTHORIZED SERVICES: Only those services specified herein are authorized under this contract. Before performing any service or repairs of a non-contract nature, the VA POC, or Contracting Officer must be advised of the reasons 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. The contractor is cautioned that only the Contracting Officer may authorize additional services or repairs and that reimbursement will not be made unless this prior authorization is obtained.

15. DELAY IN ACCESS/INTERVENING SERVICE CALL: If patient care necessitates delay in access to equipment, the Contractor’s Personnel shall notify the VA POC. Documentation of the delay on the Field Service Report with a concurring signature from the VA POC is required. The contractor’s Repair Personnel are responsible for proper documentation of delays. The Field Service Report must confirm the actual time that access, for repair of the equipment, is given.

16. BADGES AND PARKING:

a. All Contractor personnel are required to wear I.D. badges during the entire time he/she is on Government property. I.D. badges must have an identification picture and shall state the name of the individual and the company he/she represents.

b. It is the responsibility of the contractor’s personnel to park in the appropriate designated parking areas. Parking information is available from the participating healthcare center’s Security Office. VALL will not validate or make reimbursement for parking violations of the contractor’s personnel under any circumstance.

c. The contractors shall follow up with the VA POC for further guidance regarding access to VALL.

17. SAFETY STANDARDS: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer or VA POC may determine to be reasonably necessary to protect the lives and the health of the occupants of any building. The Contracting Officer, or VA POC, will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. After receipt of such notice, the Contractor shall immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed sufficient for the purposes aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue a stop-work order for all or any part of the work and hold the Contractor in default as provided elsewhere in this contract.

18. INFORMATION SECURITY REQUIREMENTS: The contractor and their personnel shall be subject to the following:

a) Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

b) VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

c) The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

d) The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

e) The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

f) Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality-assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

g) Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

h) A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

i) All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems (if deemed necessary by the VA POC):

I. VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176; https://www.tms.va.gov/SecureAuth35/).

II. Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and III. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role-based information security training].

j) The contractor shall provide to the VA POC a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee upon request.

19. ADDITIONAL REQUIREMENTS: 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. Any changes, updates, or retrofits made on any component or system shall be annotated on station equipment manuals and records. Service will also include recording all routine work, corrections, and repair work in the equipment log.

20. GOVERNMENT HOLIDAYS: The contractor is not required to provide service on the following National holidays, nor shall the Contractor be paid for these holidays.

The following national holidays are observed by the Federal Government:

If a holiday falls on a Sunday, the following Monday shall be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government agencies. Also included would be any day specifically declared by the President of the United States.

21. INSURANCE LIABILITY:

a. Workers Compensation and Employer’s Liability: The Contractor is required to comply with applicable Federal and State worker's compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $1,000,000 shall be required.

b. General Liability:

(1) The Contractor is required to maintain bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

(2) The Contractor will be responsible for all damage to property, which may be caused by him, or any employee engaged in the performance of this contract.

c. Automobile Liability: The Contractor is required to maintain automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing the contract. Policies covering automobiles operated in the U.S. shall provide coverage of at least $200,000 per person and $500,000 per occurrence for bodily injury and $20,000 per occurrence for property damage. The amount of liability coverage on other policies shall be commensurate with any legal requirements of the locality and sufficient to meet normal and customary claims.

d. Before commencing work under this contract, the Contracting Officer may require the Contractor to furnish certification from his insurance company indicating that the coverage outlined in paragraphs (a) and (b) and (c) has been obtained and that it may not be changed or canceled without a guaranteed thirty (30) days notice to the Contracting Officer. The Contracting Officer may waive the requirement if it is determined that insurance certifications now on file are acceptable, however, new certifications shall be furnished prior to the expiration date.

(End of Statement of Work)