36C24820Q0776-001.pdf

STATEMENT OF WORK (SOW)

1. Statement of work:

1.1 Provide all labor, equipment and materials for the preventive and corrective maintenance of the systems hardware and software included under schedule A (item 1.2) herein located in the Surgical Service of the VA Caribbean Healthcare System for the period of June 1, 2020 thru May 31, 2021 and four years option period, in accordance with the following conditions:

1.1.1 Perform all inspections and maintenance services in accordance to manufacturer’s service manual instructions and procedures.

1.1.2 Thorough inspection of equipment to detect defective components capable of adversely affecting system performance.

1.1.3 Replacement of parts found defective during inspections. Contractor will repair or replace the system component with equal or superior functioning equipment or software with respect to any part of the system that is not properly functioning.

1.1.4 Cleaning, calibration and adjustment of components to maintain equipment within manufacturer’s specifications, level of performance and accuracy.

1.1.5 Operational tests after each corrective and preventive maintenance service to assure level of performance is within specifications.

1.1.6 Contractor shall perform one (1) preventive maintenance service to the system per year in the month of June in accordance with manufacturer’s recommendations and procedures. If updates to manufacturer’s requirements and/or recommendations occur, contractor must assure compliance with these requirements. A Loaner will be provided while the machine is under preventive or corrective maintenance.

1.1.7 Contractor will provide and install any software update, patches and enhancement intended to update system software version or correct software errors and deficiencies.

1.1.8 Contractor shall supply all labor, parts, test instruments, tools, hardware and software required to perform all maintenance and repair work.

1.1.9 Unlimited service and technical support calls can be performed during regular hours, 8:30AM to 5:30PM.

1.1.10 The response time to emergency calls for service will be no more than two (2) hour after notification.

1.1.11 Contractor will respond with onsite visits to service calls within 24 hours in the event that phone or technical support cannot resolve the problem.

1.1.12 On-site service will be offered between 8:30am and end by 5:30pm, except when a change in hours is requested by the VACHS. If service is to be continued after 3:30PM, prior notification needs to be provided to Contracting Officer Representative (COR) or his/her designee.

1.1.13 Unlimited technical support will be available Monday through Friday except holidays.

1.1.14 Contractor’s service personnel shall report to the Biomedical Supervisor or his designee when called.

1.1.15 Contractor’s service personnel shall possess training certification by Medtronic.

1.1.16 A copy of each service report with a checklist of all tasks performed will be provided to the

Biomedical Supervisor or his designee at the conclusion of each service call.

1.1.17 Major repairs due to acts of God, renovation of equipment, negligence or misuse, power line fluctuations and computer virus unattributable to contractor, are not covered by this contract.

1.2 Schedule A:

Manufacturer Model VA property number Serial number Location

Medtronic Model: NIM-

NEURO 3.0

65205532 2NN3-0103 O/R

1.3 Safety Requirements

1.3.1. The contractor shall take all safety precautions and safety measurement necessary to protect the lives and health of occupants of the building.

2 Delivery/Performance Information

2.1 Preventive and corrective maintenance services will be provided from June 1, 2020 thru May

31, 2021 and four option years. Preventive maintenance service will be given as specified in this SOW.

2.2 Unlimited service and technical support calls can be performed during regular hours, 8:30AM to 5:30PM.

2.3 The response time to emergency calls for service will be no more than two (2) hour after notification.

2.4 Contractor will respond with onsite visits to service calls within 24 hours in the event that phone or technical support cannot resolve the problem.

2.4.1 Unlimited technical support will be available Monday through Friday except holidays.

2.5 Contractor’s service personnel shall report to the COR prior to starting any component of the system detailed in item 1.2.

2.6 A copy of each service report will be furnished to the COR at the conclusion of each day until the service has been completed.

3 Information and Information Technology Security

3.1 Equipment is not connected to the network and it do not involve patient information.

4 Quality Assurance Service Plan

4.1 The contractor shall establish complete quality control programs to ensure the requirement of the contract are provided as specified.

4.2 Within five workdays prior to the starting date of the contract the contractor shall submit a copy of his Preventive and Corrective Maintenance program to the Contracting Officer and/or COR. The program shall include, but not be limited to the following:

4.2.1 The name(s) of the individual(s) who will perform the services described in contract.

4.2.2 A checklist used in the inspection and performance verification during preventive maintenance and corrective maintenance services. The checklist shall include every requirement included in the manufacturer’s manual(s), updates, notices and any other requirement from accrediting organizations or agencies, as well as every task required to be performed.

4.2.3 A schedule of the dates scheduled for the preventive maintenance service requested.

4.2.4 A system for identifying and correcting deficiencies in the quality of services before the level of performance becomes unacceptable and/or the COR identifies the deficiencies.

4.2.5 An audit system covering all the services required.

4.3 In addition to providing the documentation at the end of each service, the contractor is responsible for maintaining the required documents of all the services conducted by the Contractor and the corrective actions taken. All documentation shall be made available to the Government during the term of the contract.

5 Performance Requirement Summary (PRS)

Performance Objective Surveillance Methods

Performance Threshold SOW

Emergency calls are answered within established requirement in SOW

Random Sampling

No deficiencies accepted.

As per SOW

Regular service calls are answered within established requirement in SOW

Random Sampling

No more than 1 deficiency complaints per month

As per SOW

Service personnel are on site within established requirement in SOW

Random Sampling

No more than 2 deficiencies per year.

As per SOW

Preventive maintenance service is performed within the due month

Random Sampling

No deficiencies accepted.

As per SOW

Service personnel reports to COR or his/her designee prior to

Random Sampling

No more than 3 deficiencies per year

As per SOW performing service on equipment Service is accepted by COR or his/her designee

Random Sampling

No deficiencies accepted.

As per SOW

Service documentation is provided to COR or his/her designee at the end of each service

Random Sampling

No deficiencies accepted.

As per SOW

Service documentation includes a completed performance verification checklist

Random Sampling

No deficiencies accepted.

As per SOW

6 Competency Requirements

6.1 The contractor shall comply with requirements of The Joint Commission Accreditation of

Health Care Organizations (TJC). To comply with TJC requirements the contractor shall provide written confirmation that employees are competent to perform the task as described in the SOW assigned on this contract. This written confirmation shall specify in which areas each contract employees are competent.

Certification of Competency

(SAMPLE)

This is to certify that meets all qualification requirements for the services requested, is properly trained, has all applicable credentials and is competent to perform the tasks as described in the statement of work contract.

Signature Date:

Name:

Position Title: Contractor:

6.2 Training Certifications: The contractor shall submit evidence of manufacturer (Medtronic) training certification at the time of quote submission.

7 COR Designation

7.1 COR: Felix Concepcion, Biomedical Equipment Support Specialist, VACHS 001FM

8 Access to VA Information and VA Information Systems

8.1 VA INFORMATION CUSTODIAL LANGUAGE:

a. 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.

b. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

c. 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.

d. 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.

8.2 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 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.

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.

8.3 LIQUIDATED DAMAGES FOR DATA BREACH:

a. Consistent with the requirements of 38 U.S.C. §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.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

8.4 SECURITY CONTROLS COMPLIANCE TESTING:

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

8.5 TRAINING:

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training 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 Rules of Behavior before being granted access to VA information and its systems.

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the 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.

STATEMENT OF WORK (SOW)