Umano Beds PWS.pdf

B.3 PERFORMANCE WORK STATEMENT

1. EQUIPMENT IDENTIFICATION:

MANUFACTURER – Umano

EQUIPMENT:

Model Quantity Type

Ook Snow 62 Patient Bed Ook ALL 11 Patient Bed

LOCATION – 4150 Clement Street, San Francisco, CA 94121

2. DEFINITIONS/ACRONYMS:

A. Authorization Signature – COR signature; indicates COR accepts work status as stated in ESR.

B. BAA – Business Associate Agreement C. Biomedical Engineer(ing) – Supervisor or designee.

D. CDRH – Center for Devices and Radiological Health.

E. CO – Contracting Officer F. COR – Contracting Officer Representative G. ESR – Vendor Engineering Service Report. Documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

H. FSE – Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

I. ISO – Information System Owner J. IT – Information Technology K. MOU-ISA – Memorandum of Understanding and Interconnection Security Agreement L. NFPA – National Fire Protection Association.

M. OIG – Office of Inspector General N. PMI – Project Management Institute O. UL – Underwriters Laboratories P. VA – Veterans Affairs Q. VAH – Department of Veterans Affairs Hospital R. VAMC – Department of Veterans Affairs Medical Center

3. CONFORMANCE STANDARDS: Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, UL, VA, and CDRH.

4. OPERATIONAL UPTIME - REQUIREMENTS: - The Umano Patient Beds shall be operable and available for use 96% of the normal operating hours of the equipment as detailed in paragraph 5, HOURS OF COVERAGE. Downtime will be computed from notification of problems during normal work hours. Scheduled maintenance will be excluded from downtime. Operational Uptime will be computed during a month-long time period. Repeated failure to meet this requirement can subject the contractor to DEFAULT action.

5. HOURS OF COVERAGE:

A. Normal hours of coverage are Monday through Friday from 8:00 AM to 5:00 PM with 24-hour-seven-day-a-week phone support, excluding federal holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or Designee.

B. Preventive maintenance will be performed twice a year and coordinated with Pharmacy and Engineering.

NOTE: Hardware/software update/upgrade installations will be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by COR or Designee). Government provides software/hardware upgrade/update.

C. Federal Holidays observed by the VAMC are:

• New Years’ Day

• Martin Luther King Day

• Presidents’ Day

• Memorial Day

• Juneteenth Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans’ Day

• Thanksgiving Day

• Christmas Day

6. UNSCHEDULED MAINTENANCE (Emergency Repair Service):

A. The Contractor shall maintain the equipment in accordance with the Conformance Standards Section OR the manufacturer’s specifications. The Contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations.

All required parts shall be furnished

B. The CO, or the authorized VA Biomedical Point of Contact/COR has the authority to approve/request a service call from the Contractor that is within the scope of this contract. Any requests outside the scope of this contract can only be approved in writing by the Contracting Officer.

C. Response Time: The Contractor’s FSE must respond with a phone call to COR or Designee within two (2) hours after receipt of telephoned notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within six (6) hours after receipt of this second notification and will proceed progressively to completion without undue delay.

7. PARTS: The Contractor shall furnish and replace parts to meet uptime requirements. The Contractor has ready access to all Original Equipment Manufacture parts, including unique and/or high mortality replacement parts. All parts supplied shall be from the Original Equipment Manufacturer. The contract shall include all parts. All parts shall perform identically to the original equipment specifications.

8. SERVICE MANUALS/TOOLS/EQUIPMENT: The VAMC shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. 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 shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with {Section 3, Conformance Standards or the manufacturer’s specifications} Such documentation shall meet the guidelines as set forth in the {Conformance Standards section}. Grouping different equipment from different contracts on “one” ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number.

B. Name of FSE who performed services.

C. Contractor service ESR number/log number.

D. Date, time (starting and ending), equipment downtime and hours on-site for service call.

E. VA purchase order number(s) covering the call if outside normal working hours.

F. Description of problem reported by COR or Designee /user (if applicable).

G. Identification of equipment to be serviced:

1) Inventory ID number,

2) Manufacturer's name,

3) Device name,

4) Model number,

5) Serial number,

6) Any other manufacturer’s identification numbers.

H. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

1) Labor and Travel,

2) Parts (with part numbers),

3) Materials and Circuit Location of problem/corrective action.

I. Total Cost to be billed (if applicable - i.e., part(s) not covered, or service rendered after normal hours of coverage).

S. Signatures:

1) FSE performing services described.

2) Authorized VA Employee who witnessed service described.

NOTE: Any additional charges claimed must be approved by COR before service is completed!

10. REPORTING REQUIREMENTS: - The Contractor shall be required to report to Biomedical Engineering to log in. This check-in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to COR or Designee. ALL ESRs shall be submitted to the equipment user for an “acceptance signature” and to COR or Designee for an “authorization signature”. If COR or Designee is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).

VA Biomedical Contact Person(s): TBD Location (Building/Room Number): Building 6, Room 11, Engineering Services 4150 Clement Street, San Francisco, CA 94121 Telephone Number & Extension(s): TBD

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

12. PAYMENT: Invoices will be paid in arrears on a monthly basis. Invoices MUST INCLUDE, at a minimum, the following information: Contract No., Purchase Order No., Item(s) covered (to include serial #’s) by the PMI and covered period of service. Each invoice must be provided in triplicate.

13. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: The Contractor shall immediately, but no later than twenty-four (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 or designee with a written estimate of the cost to make necessary repairs.

14. CONDITION OF EQUIPMENT: The Contractor accepts responsibility for the equipment described in Section C, paragraph I, 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.

15. 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” FSE and a “fully qualified” 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) has successfully completed a formalized training program, for the equipment identified in the Section B schedule. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on [enter the name/type of equipment under coverage].

C. The FSEs shall be authorized by the Contractor to perform the maintenance services. 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 VAMC. The 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 VAMC equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment.

D. If subcontractor(s) are used, they must be approved by the CO; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

16. TEST EQUIPMENT: Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC’s equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.

17. REMOTE SUPPORT: The contractor shall have proper access and control to remotely monitor all equipment as required in Section 5. This includes background checks and Information Security Officer approval as required by Directive 6500. The contractor must demonstrate active security clearance before award

18. MOBILE MEDIA SCANNING: The Contractor will identify if removable media (i.e. USB or

DVD/CD Device) is required to perform his/her duties. COR or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system. The computer system for scanning removable media is located in the biomedical engineering shop, Building 6, Room 11.

19. INFORMATION AND INFORMATION SYSTEM SECURITY\

A. GENERAL

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. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1) 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) 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.

3) Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the Contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

4) The Contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the Contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

C. VA INFORMATION CUSTODIAL LANGUAGE

1) 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).

2) VA information should not be co-mingled, if possible, with any other data on the Contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the Contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

3) Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within thirty (30) days of termination of the contract.

4) The Contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

5) 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.

6) 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.

7) If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

8) The Contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

9) The Contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

10) Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the Contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The Contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA Contracting Officer for response.

11) Notwithstanding the provision above, the contractor/subcontractor 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 health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the Contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that Contractor/subcontractor shall immediately refer such court orders or other requests to the VA Contracting Officer for response.

12) For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the Contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

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

1) 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, PWS 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.

2) 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 thirty (30) days of termination of the contract.

3) 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.

d. 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;

1. 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

2. 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 pre-approved and described in the purchase order or contract.

3. A statement that needs to be signed by the Director (System Owner) states that the drive cannot be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

E. SECURITY INCIDENT INVESTIGATION

1) 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.

2) 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.

3) 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.

4) 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.

F. LIQUIDATED DAMAGES FOR DATA BREACH

1) 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.

2) 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 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.

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

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

b. Description of the event, including:

1. date of occurrence;

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

c. Number of individuals affected or potentially affected;

d. Names of individuals or groups affected or potentially affected;

e. 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;

f. Amount of time the data has been out of VA control;

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

h. Known misuses of data containing sensitive personal information, if any;

i. Assessment of the potential harm to the affected individuals;

j. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

k. 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.

4) Based on the determinations of the independent risk analysis, the Contractor shall be responsible for paying to the VA liquidated damages in the amount to cover the cost of providing credit protection services to affected individuals consisting of the following:

a. Notification;

b. One (1) year of credit monitoring services consisting of automatic daily monitoring of at least three (3) relevant credit bureau reports;

c. Data breach analysis;

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

e. One (1) year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

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

20. 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 the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within one (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.

21. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The Contractor’s FSE’s shall wear visible identification at all times while on the premises of the VAMC. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any building at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

(END OF PERFORMANCE WORK STATEMENT)