Description of Services.pdf

SCOPE OF WORK

SUPPLIES OR SERVICES

Contractor shall provide Full-Service including Preventative and Corrective Maintenance Service Agreement for two (2) R/F Systems: General-Purpose shall be provided for the Department of Veterans Affairs Northern California Health Care System. All services shall be provided in accordance with the specifications, terms and conditions contained herein.

Period of Performance: The Period of Performance is for one base year with (4) one-year options:

Base Year Period: FY23 Option Year 1: FY24 Option Year 2: FY25 Option Year 3: FY26 Option Year 4: FY27

The following equipment located at NCHCS, Martinez, CA and Redding, CA

Shimadzu SonialVision G4 R/F: MX# 2565689 / Serial# 41C3517B1001 / Location: 19-

MTZ-C134

Shimadzu SonialVision G4 R/F: MX# 2641485 / Serial# 41C3518B4002 / Location: 345-

RED-RD19

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

1. SERVICES: The C&A requirements do not apply, and that a Security Accreditation

Package is not required.

Contractor shall furnish the following:

Preventative Maintenance including PM required parts, system verification, alignment, and adjustments are provided by the Contractor at no additional customer cost

Parts, Labor, and Travel necessary for PM are provided by the Contractor at no additional customer cost or at discounted cost.

Unscheduled Service and maintenance parts, labor, and travel are provided at no additional or at discounted cost

Modifications for Safety or Reliability modifications including equipment, parts, hardware, and safety is provided by the Contractor at no additional customer cost or at discounted cost

Equipment Verification will be provided by the Contractor at no additional customer cost.

Quantity one (1) Accredited Self Study Program and quantity one (1) Enhanced Virtual

Learning Sub are included if available

2. DEFINITIONS/ACRONYMS:

A. Biomedical Engineering - Supervisor or COR designee

B. CO - Contracting Officer.

C. COR - Contracting Officer's Technical Representative.

D. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.

E. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Outpatient Clinic premises.

F. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

G. Acceptance Signature - VAOPC employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

H. Authorization Signature - COR's signature; indicates COR accepts work status as stated in

ESR.

I. NFPA - National Fire Protection Association.

J. CDRH - Center for Devices and Radiological Health.

K. VAOPC - Department of Veterans Affairs Outpatient Clinic.

L. OEM - Original Equipment Manufacturer

M. TJC – The Joint Commission

3. CONFORMANCE STANDARDS:

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

4. PREVENTIVE MAINTENANCE (PM):

A. Contractor shall perform Preventive Maintenance inspections on the two (2) R/F Systems:

General-Purpose as per contract and manufacturer recommendations.

B. The contractor shall furnish documentation, including all measurement and calibration data to certify that the system is performing in accordance with the performance specifications.

C. All required parts shall be furnished, with the exception of expendable, consumable parts.

Consumable and expendable parts are defined as items that require replacement on a greater than one-month frequency. Any exceptions shall be noted by the contractor in writing prior to the initiation of the contract. Please see Section 7, PARTS for more information about parts.

D. Contractor shall be OEM trained and provide proof of OEM training upon award.

5. EMERGENCY MAINTENANCE:

A. All required parts shall be furnished, with the exception of expendable, consumable parts.

Consumable and expendable parts are defined as items that require replacement on a greater than one-month frequency. Any exceptions shall be noted by the contractor in writing prior to the initiation of the contract. Please see Section 7, PARTS for more information about parts.

B. All subsequent decisions on classification of parts are at the discretion of the Biomedical Engineer. The CO, COR or designated alternate has the authority to approve/request a service call from the contractor.

C. On-site response within 24 hours.

D. Labor and travel are covered.

E. Uptime guarantee is 95%.

F. Phone, remote, and on-site support are covered.

G. Updates that increase safety, performance level, or reliability are included. Does not include enhancements to the operating systems or additional functionality.

H. Contractor shall be OEM trained and provide proof of OEM training upon award.

6. HOURS OF COVERAGE:

Normal hours of coverage for the SCANNING SYSTEMS: CT are (Monday through Friday) from 8:00am to 6:00pm, excluding federal holidays. Work performed outside the normal hours of coverage at the request of COR will be billed at the government rate. A separate purchase order will be issued to cover the cost(s) associated with any call back service as described herein.

7. PARTS:

The contractor shall furnish and replace all parts except exclusions identified at the end of this section at no cost or at discounted cost.

general spare parts are covered.

The contractor will deliver parts for the R/F Systems: General-Purpose located at the VA

Martinez OPC and Redding OPC to the following address with attention to Biomedical Engineering: 150 Muir Rd, Martinez, CA 94553 and 3455 Knighton Road, Redding CA, 96002.

The contractor shall have ready access to unique and/or high mortality replacement parts.

All parts supplied shall be OEM parts.

The contractor shall use new or rebuilt parts. Used parts, those removed from another system, shall not be installed without approval by the COR. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible. The determination of compatibility is at the discretion of the COR.

Parts replacement excludes: Parts defective due to "acts of God", abuse, misuse, neglect, thermal and shock.

8. SERVICE MANUALS:

The VAOPC shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), 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.

9. DOCUMENTATION/REPORTS:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

A. Name of Contractor B. Name of FSE who performed services.

C. Contractor Service ESR Number/Log Number.

D. Date, Time (starting and ending), Hours-On-Site for service call.

E. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

F. Description of Problem Reported by COR/User.

G. Identification of Equipment to be serviced to include the following: Equipment ID # or

MX/EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

H. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

I. Total Cost to be billed.

J. Signatures from the following:

1. FSE performing services described.

2. VA Employee who witnessed service described.

K. Equipment downtime calculated in accordance with Conformance Standards.

NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY

THE COR BEFORE SERVICE IS COMPLETED!

10. REPORTING REQUIREMENTS:

The contractor shall report to Biomedical Engineering to "check-in" upon arrival and prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person or by phone contact. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s). The FSE shall be required to check out with the Biomedical Engineering Department (location to be specified at time of contract award) and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COR within 5 business days of work completion.

FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE

NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-

COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR

TERMINATION OF THE CONTRACT.

11. ADDITIONAL CHARGES:

There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts.

12. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

13. CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in Section B, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

14. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified," OEM-trained FSE and a "fully qualified," OEM-trained FSE who will serve as the backup.

B. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment identified in Section B. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment identified in Section B.

C. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the VAOPC. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAOPC equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAOPC equipment.

15. TEST EQUIPMENT:

Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by the VAOPC. Test equipment calibration shall be traceable to a national standard.

16. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA

REGULATIONS:

The contractor's FSE shall always wear visible identification while on the premises of the VAOPC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VAOPC will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VAOPC. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search.

Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

17. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall:

A. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

B. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

C. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

Records Management Language for Contracts Required

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.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

1. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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.

2. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1).

b. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

c. 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.

3. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. VA prohibits the installation and use of personally-owned or contractor/subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned

OE.

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:

(1) Vendor must accept the system without the drive;

(2) 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

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

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed.

The ISSO needs to maintain the documentation.

4. 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 COTR and simultaneously, the designated ISSO 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.

4. 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 SP/ 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.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

5. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following 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 Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

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