P09 - Draft Alaris Contract SOW v1 (1).pdf

Statement of Work

For Alaris Guardrails Software Management Services

VISN Wide

February 2, 2022

1. GENERAL

The Contractor shall provide Software Management Services for the VISN 21 Alaris System Infusion Pumps to include all applicable pump and server software enhancements covering the whole Guardrails Suite MX and the

Alaris Systems Manager. Services shall also include internet, webinar and on‐site training and clinical education as well as support ranging from remote monitoring of the Alaris Systems Manager to technical support for the

Alaris System. Software Management also includes data and analytics tools and services. All services shall be provided in accordance with the specifications, terms and conditions contained herein to the VA sites listed below:

Fresno Palo Alto

Sacramento Livermore

Martinez San Francisco

Reno Las Vegas

2. SERVICES

Contractor shall provide the VISN 21 VA facilities maintenance and support to include: licensing agreements, software and server hardware support (including all applicable software upgrades and updates), technical support via telephone, remote support and optimization support per description below. Contractor shall keep the V21 Alaris System Infusion Pumps/Controllers on the most current version of software. Software coverage includes the PC Unit and Guardrails Editor; LVP, Syringe, PCA, ET/CO2 and SPO2 modules; CQI Reporter, and

Alaris Systems Maintenance (ASM). The Contractor shall provide all applicable Enhancements to the Alaris

Systems Manager and test server and keep the Alaris Systems Manager on the most current version of server software.

Services provided are under (SMS‐3) Software Management Services (SMS) ‐ Level 3 (per bed), the estimated bed count for services are as follows:

Facility Estimated PC + Modules Count

Estimated Bed Count

VA Central California ‐ Fresno 534 137

VA San Francisco 755 259

VA Northern California ‐ Sacramento 578 65

VA Martinez 147 120

VA Sierra Nevada ‐ Reno 530 135

VA Palo Alto 1033 415

VA Livermore 110 120

VA Southern Nevada ‐ Las Vegas 734 90

a. Enhancements: If the Contractor releases an update to the Software to enhance the security or operation of the Software (each, an “Enhancement”), then the Contractor shall deliver the Enhancement to the Government in a machine‐readable form along with instructions to assist the Government to install the Enhancement.

Enhancements shall be Software pursuant to the License Agreement. The Government shall install each

Enhancement on each Licensed Unit within a reasonable period after the contractor delivers the Enhancement.

If there are no Enhancements during the current Optimization Service Term, then the Contractor will not be required to perform any technical service visits.

b. Telephone Support: Monday through Friday between 5:00 a.m. and 5:00 p.m. Pacific Time

c. Technical Support: If an Enhancement requires a change to the device’s embedded software, then the contractor shall perform one (1) on‐site technical service visit for up to eight (8) business hours for each eighty

(80) PC Units to: (i) install the latest version of the Software; (ii) download CQI data; and (iii) upload

Government’s Customized Data Set onto the Licensed Units at each location specified in Section 2.

e. Pharmacy and CQI support: The Contractor will provide pharmacy support and CQI Account Manager Support, by telephone or email Monday through Friday, between 5:00am and 5:00 pm Pacific Time for questions related to the use and operation of the software. Access to an on‐demand, web‐based software tool that will provide retrospective data analysis on pump utilization, dose overrides, etc.

f. Clinical Training. The Contractor will provide one (1) eight‐hour day of on‐site clinical consulting (one consultant) for each 500 PC Units (minimum of one day) per Optimization Service Term. Training days may be split amongst VISN 21 sites. Contractor shall provide continued access to the contractor’s internet site for technical support. Webcast training on Guardrails Editor will be made available on a monthly basis.

g. Drug Information Resource Website. The Contractor shall grant each VA Site (Account) a limited, non‐ exclusive, non‐transferable license to use the Drug Information Resource Website during the Term. “Drug

Information Resource Website” means the Contractor’s web‐based drug information resource. Each designated facility listed in Section 2 may access the Drug Information Resource Website using the three (3) user IDs and passwords provided to Government by the Contractor.

h. Guardrails: One (1) time during each annual period during the Optimization Service Term, the Contractor shall pay the tuition for up to (2) Government representatives to attend a CareFusion Guardrails CQI Workshop.

i. Third Party Patching: The Contractor shall validate and deploy patches to third party software application when available.

j. Data Reporting and Informatics Support: The Contractor shall provide access to a web‐based data dashboard of retrospective infusion data and quarterly infusion analytics reports. Additionally, the Contactor shall provide access to data consultants by phone or email to assist with reporting and analytics.

3. DEFINITIONS/ACRONYMS

CO – Contracting Officer

COR – Contracting Officer's Representative

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

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

Acceptance Signature – VA Biomedical Engineering employee or designee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR

Authorization Signature – COR's signature; indicates COR accepts work status as stated in ESR

NFPA – National Fire Protection Association

OEM – Original Equipment Manufacturer

TJC – The Joint Commission

HIPAA – The Health Insurance Portability and Accountability Act

OSHA – Occupational Safety and Health Administration

NEC – National Electric Code

ACR – American College of Radiology

4. CONFORMANCE STANDARDS

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA‐99, The Joint Commission (TJC), HIPAA, NEC, OSHA, ACR, Federal and VA specifications and requirements as applicable. The equipment and software versions 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’s specifications shall be specified in writing by the

VA.

5. PREVENTIVE MAINTENANCE (PM)

Post installation of any System Manager software updates, the contractor shall furnish documentation to certify that the system is performing in accordance with the performance specifications.

6. EMERGENCY MAINTENANCE

Provided via telephone support during the hours of coverage. If parts are required for a repair of the pumps, modules PC units or server, VA will issue a separate purchase order.

7. HOURS OF COVERAGE

Support provided 5:00 am to 5:00 pm Pacific

During business hours, contractor shall provide immediate response to technical questions and unlimited telephone support via a toll‐free support hotline.

8. PARTS

Not included in this contract.

9. DOCUMENTATION/REPORTS

Contractor shall document/report equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts 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:

Name of Contractor

Name of FSE who performed services

Contractor Service ESR Number/Log Number

Date, Time (starting and ending), Hours worked for service call

Description of Problem Reported by COR/User

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

Equipment downtime, calculated in accordance with Conformance Standards

NOTE: Any additional charges claimed/incurred must be approved by the contracting officer prior to the commencement of services performed.

10. REPORTING REQUIREMENTS

The contractor shall provide VISN 21 Biomedical Engineering with electronic service reports and cumulative work order history. Status updates will be provided at significant milestones for repair work and at work order closeout for routine work.

11. ADDITIONAL CHARGES

Contractor shall not 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 they are 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 2, in "as is" condition. Failure to inspect the equipment prior to contract award shall not relieve the contractor from performance of the requirements of this contract.

14. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT

The Contractor must have an established business, with an office and full‐time staff. The staff includes a "fully qualified" FSE and remote TSS. Staff shall provide proof of qualification from the equipment OEM.

"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 provided by the equipment OEM for the equipment identified in Section 2. 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

2.

The FSE(s)/Technical Support Specialists shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs/TSSs. The COR 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 VA equipment and notify the CO of any concerns regarding the technical competence of contractor personnel. The VA specifically reserves the right to reject any of the contractor's personnel and refuse them permission to work on the VA equipment.

15. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS

The contractor's representatives shall wear visible identification at all times while on the premises of a VA site.

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 VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited on all VA campuses. 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.

16. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD

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

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

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

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

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

17. DATA

The contractor shall comply with applicable VA Information Security requirements, shall maintain an approved

VA VPN account (or corporate site to site VPN) and shall abide by all applicable security/confidentiality requirements as set forth by HIPAA.

The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform their duties.

Personally owned USB thumb drive utilization is prohibited. Non‐VA support personnel must furnish their own

FIPS140‐2 certified USB thumb drives and only with the permission of a designated VA supervisor. All USB drives must be scanned with an antivirus program running current virus definitions by the local VA staff, prior to connection to any VA device. 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 Contractor shall coordinate with local Biomedical Engineering staff for removable media scanning at each medical facility.

Any failed hard drives shall be retained by VA VISN 21 Biomedical Engineering and will be sanitized/destroyed per requirements of Directive 6500.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

18. RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the

United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non‐public information is limited to authorized personnel with a need‐to‐know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand‐carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The 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, contracts. The Contractor (and any sub‐contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy.

8. The Contractor shall not create or maintain any records containing any non‐public VHA information that is not specifically tied to or authorized by the contract.

9. The 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 from public disclosure by an exemption to the Freedom of Information Act.

10. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any

Contractor rights in the data or deliverables must be identified as required by FAR 52.227‐11 through

FAR 52.227‐20.

11. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA‐provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.