Final-SOWPrismax.docx

STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: Prismax Hemofiltration Units (Dialysis Machine) Maintenance

2. Scope of Work: The contractor shall furnish all labor, transportation, tools, and parts necessary to provide preventive maintenance and repair of the hemodialysis machines (Prismax) and associated heating units (Thermax) listed below for a one-year period of performance plus four (4) option years.

3. Background: Medical equipment must be properly maintained in order to assure proper function and reduce equipment down-time. The listed equipment is used for life-sustaining hemodialysis treatments daily at the hospital.

4. Type of Contract: The contract will be firm-fixed-price.

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the Contracting Officer (CO) has conducted a kick-off meeting, or has advised the contractor that a kick-off meeting is waived.

C. GENERAL REQUIREMENTS

1. Services to be Provided:

A. Repair –

1. All repairs will be performed during normal VA business hours, 8:00 AM - 5:00 PM, Monday-Friday, except Federal Holidays, unless otherwise specified. Contractor may work outside normal business hours by arrangement with Contracting Officer’s Representative (COR) if such services are provided without additional charge to the government. Any overtime charges must be approved by the COR or designee prior to the initiation of overtime work.

2. A technical maintenance representative will respond by telephone to the VA within one (1) hour of the original service call. The contractor will arrive on-site for repair within two (2) business days of the original service call. Equipment will be returned to full operation within twenty-four (24) business hours (three days) of the original call. On-site visits will be authorized by COR only.

3. The VA shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its Field Service Engineers (FSEs) all operational and technical documentation (e.g., 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 upon request. Any charges for parts, manuals, tools, or software required to successfully complete scheduled Preventive Maintenance (PM) are included within this contract and its agreed upon price unless specifically stated in writing otherwise.

4. All removable media materials (laptop, DVD/CD, USB drive, etc.) will need to be scanned on site with approved anti-virus by OI&T or Biomedical staff and approved for use prior to the start of any work.

B. Parts – All replacement parts, except exclusions listed below, required to keep equipment performing within the manufacturer's specifications will be provided by the contractor. All parts must meet or exceed factory specifications to maintain compatibility with systems presently in place and with future performance/reliability upgrades. Parts removed (replaced) by the contractor become the property of the contractor.

C. Scheduled Maintenance –

1. The contract will include not less than one (1) comprehensive scheduled maintenance inspection (preventive maintenance, PM) per machine to be performed after three thousand (3000) hours of use or one (1) year after the last preventative maintenance inspection. A mutually agreeable time for the inspections will be scheduled through the COR.

2. The contractor will perform PM service to ensure that equipment listed below functions in conformance with the latest published editions of NFPA-99, OSHA, CDRH, CAP. The contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) provided to the COR at the completion of the PM. Preventive maintenance procedures will be submitted to COR for approval prior to initiation of this service contract. PM services shall include but need not be limited to the following: Cleaning of equipment; Reviewing operating system diagnostics to ensure that the system is operating to the manufacturer's specifications; Calibrating and lubricating the equipment; Performing remedial maintenance of non-emergent nature; Testing and replacing faulty or worn parts and/or parts which are likely to become faulty, fail, or become worn; Inspecting all cables and bushings and replacement as necessary; Measuring, adjusting, aligning, and calibrating as necessary for optimal performance; Inspecting and replacing where indicated electrical wiring and cables for wear and fraying; Inspecting and replacing where indicated all mechanical components including but not limited to devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, and keyboards for mechanical integrity, safety, and performance; Returning the equipment to full and proper operating condition; Providing documentation of service performed. Parts and assemblies will be repaired or replaced as necessary. An electrical safety inspection will be done at the time of the preventive maintenance and results will be documented.

2. Special Instructions:

A. Contractor Check-in - The contractor's representative will report to Biomedical Engineering, D022-01, prior to performance of service. On approved overtime, contractor will report to Hospital Police, E.R. Lobby.

B. Documentation - At the conclusion of each repair or scheduled maintenance visit, the contractor will provide a written service report indicating the date of service, the Bar Code Number (EE#), the model, serial number, and location of the equipment serviced, the name of the service representative, the hours worked, and the services performed and parts replaced. The reports will be delivered to Biomedical Engineering for signature when work is complete. During non-standard hours, report will be taken to Hospital Police for signature.

3. Terms and Conditions:

A. Exclusions - Consumable parts and supplies are not covered under this contract.

B. Inspection of Equipment - Any site visits will be coordinated in advance with COR, Biomedical Engineering, (813) 972-7632.

D. 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.

E. GOVERNMENT RESPONSIBILITIES

The government will make the equipment available in accordance with the established schedule for the work.

F. CONTRACTOR EXPERIENCE REQUIREMENTS

Each respondent must have an established business, with an office and full time staff to include a "fully qualified" field service engineer (FSE) and a "fully qualified" FSE who will serve as backup. "Fully qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program of the equipment identified below. For field experience, the FSE(s) has a minimum of two years experience with respect to scheduled and unscheduled preventive and remedial maintenance of hemodialysis equipment. 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 to the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the VA. The Contracting Officer (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 VA equipment. The CO and/or Contracting Officer's Representative (COR) specifically reserves the right to reject any of the contractor's personnel and refuse them permission to work on the VA equipment. If subcontractors are used, they must be approved in advance by the CO; the contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

G. EQUIPMENT COVERED

H. 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.

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.

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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

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.

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.

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.

The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this SOW.

H. Records Management Language

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. All Contractor, Pharmaceutical Company Representative (PCR), and Healthcare Industry Representatives (HIR) will coordinate with Contracting Officer Representative for instructions so they are in compliance with James A. Haley Veterans’ Hospital policies:

HPM NO. 90-25; JANUARY 2014; HEALTHCARE VENDOR ACCESS AND COMPETENCY

HPM NO. 132-04; DECEMBER 2012; SECURITY MANAGEMENT PROGRAM

HPM NO. 13205; DECEMBER 2012; HOSPITAL IDENTIFICATION PROGRAM

HPM NO. 11-91; MAY 2013; PHARMACEUTICAL COMPANY REPRESENTATIVES

HIR are required to report to MSDU (Room GC-003), immediately after entering the facility. HIR will be required to sign into the monitoring system and print a badge for proper identification. . The Healthcare Industry Representatives for Nutrition and Food Services, Office of Information and Technology, and Social Work Services are in included in this policy; vendors (HIR) for Pharmacy Services are to follow (HPM 11-91) policy. HIR must be sponsored by a physician, a Service Chief, or their designee, for a specified date and a specified case. HIR are not permitted in patient care areas or clinics unless a prior appointment has been made.

Pharmaceutical Company Representative (PCR) refers to anyone acting on behalf of a pharmaceutical company or its business partners for the purpose of promoting the use of items managed under the VA formulary process. These items primarily include drugs, but to a lesser extent also include any medical supplies, nutritional supplements, and similar commodities managed under the VA formulary process.

a. Sign-In: PCRs may visit VA Medical care facilities no earlier than 8:00 a.m. and stay no later than 3:30 p.m., Monday through Friday, unless they receive prior approval from both the Chief of the Service that they will be visiting and the Chief of Pharmacy. Representatives visiting the JAHVH must sign in at the Pharmacy Administrative Office (Located in Trailer 78) and wear a visitor’s badge as well as their company’s personal name badge while in the hospital.

Vendors: Reference Hospital Memorandum Policy Number 90-25 Healthcare Vendor Access and Competency.

Contractors and/or project managers: Will be issued a PIV/ID badge in accordance with the facility PIV Policy. Contactors will contact their assigned VA Contracting Officer Representative (COR) for coordination.

Contract Personnel/Sub-Contractors: Contractors are responsible for the daily accountability and identification of all personnel assigned to their respective contract including sub-contractors. Contractors will identify personnel using the following procedures as appropriate.

Construction Project contract personnel will report to the contractor for issuance of a temporary self-adhesive identification badge. This badge will be issued on a daily basis and must include the following information: Company name, project number, date and name of individual. Contractor will maintain a daily log of all personnel.

Contract personnel not involved in an actual construction project will report to police dispatch for issuance of a numbered badge. A driver’s license or photo ID will be required each day upon entering the facility, in exchange for the badge, and will be given back once the badge is returned to police dispatch. The contractor will provide Police Service with a list of names for all sub-contract personnel requiring access to the facility. It is the responsibility of the contractor to update the list as necessary.

NPR OPC; CBOCs and Off-site Lease facilities with VA Police staffing: As above with check-in with VA Police.

Off-site Lease facilities w/o VA Police staffing: Coordinate with COR, Administrative Officer, or Service Point of Contact.