PWS Alaris SMS .docx

PERFORMANCE WORK STATEMENT

The purpose of this procurement is to acquire infusion pump software management services (SMS) for use in Dallas VA Medical Center, VA North Texas Healthcare system (VANTHCS). The Contractor shall provide all software maintenance service on Alaris System from BD (formerly CareFusion) equipment currently in use.

BACKGROUND

Software Management Services for the Alaris System enhances the value of the existing Alaris System and the Alaris Systems Manager. Inclusive to the Alaris System are software enhancements covering the whole Guardrails Suite MX and the Alaris Systems Manager, services that include internet, webinar and on-site training and clinical education; support ranging from remote monitoring of the Alaris Systems Manager to technical support for the Alaris System. Software Management also boasts a powerful collection of data and analytics tools and services. This package allows facilities to leverage and optimize their investment to help the hospital staff enhance patient care and safety, as well as to support the integration and implementation of future products.

The following components comprise the Alaris Infusion System for this requirement.

INFUSION PUMPS: MULTITHERAPY: SYRINGE

INFUSION PUMPS: MULTITHERAPY

INFUSION CONTROLLERS

INFUSION PUMPS: ANALGESIC: PATIENT-CONTROLLED

Infusion system modules will connect to an infusion controller (PCU). The PCU will connect wirelessly to the VA enterprise network to transmit and receive data to and from the Alaris Systems Manager server. The Alaris Systems Manager server will reside on a server (virtual or physical) in a VA data center. Users will access the Alaris Systems Manager server to manage system configuration, retrieve pump connectivity data, capture data analytics, and upload infusion drug libraries. Users will also access software applications such as Guardrails Editor and CQI reporter to manage drug library configuration and analyze reports collected from infusion data. Care Coordination Engines are another server (virtual or physical) residing in a VA data center that allow for the infusion devices to wirelessly communicate interoperability parameters to the EHR.SCOPE OF WORK The Contractor shall provide all software maintenance service on all Alaris system equipment currently at VA North Texas Healthcare system (VANTHCS). The services shall be in accordance with the tasks and deliverables as described in this Performance Work Statement (PWS). The Contractor shall provide software service and support for all devices listed in the Background section. The Contractor shall complete all system enhancements and patching with clear communication and preparation. The Contractor shall communicate all enhancements and support activations required to keep the system running effectively to the primary point of contact (POC) or the contracting officer representative (COR). All maintenance and updates shall be scheduled at least three (3) days in advance with the COR. All activities related to this contract shall be in the best interest of the veterans served and coordination of all activities shall be planned accordingly.

Information Security Considerations All VA sensitive information shall be protected at all times, in accordance with VA Local site guidelines. The Contractor shall report any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information to the COR.

a. Any wireless connectivity to the VA network must be compatible with 802.11b/g/n and FIPS 140-2 compliant.

b. Any remote service support requires a memorandum of understanding/interconnection security agreement (MOU/ISA) with the VA.

Biomedical Engineering shall perform virus scans on all removable media prior to use on VA medical equipment. This includes all types of removable media, including media (e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by VA, and media brought in by vendors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program, September 2007.

The Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information.

During onsite service, the Vendor shall be chaperoned by VA Personnel. However, the vendor shall not be issued a User ID/Password.

Non-volatile memory devices, working or non-working, shall NOT be removed from the VA Medical Center Dallas until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media.

The vendor will not have remote access to complete the repair(s) and preventive maintenance.

DELIVERABLES

The Contractor shall perform/provide the following services:

Training

a. The service shall include on-site nursing clinical support for practice reinforcement that can be used for compliance rounds and hospital best practices.

i. One time during the base year of the contract period and any subsequent option year, the service must provide one eight (8) hour day of on-site clinical consulting at each facility per 500 units. Practice reinforcement should include nursing staff interactions with the devices and recommending improved practices for medication safety.

ii. Written report shall be provided to each facility for each practice reinforcement visit.

b. The service shall include a workshop with clinical peers to support customer adoption of CQI Reporter software and enhance interpretation skills of CQI data.

i. Workshop shall be for a period of 2 days and hosted by the Contractor at Location (can be within VISN or general region) once during the base year of the contract and each subsequent option year (annually).

ii. Workshop shall cover defining and creating a systematic approach to analyzing Guardrails Reporter software alerts and refine drug libraries, dose limits, and clinical advisories to achieve maximum impact for the organization.

c. The service shall include access to online education. Video content must be made available, upon request, to VA education staff and allowed to be uploaded by the VA to internal learning management systems.

d. The service shall include Suite training sessions with clinical peers to refresh skills on the use of CQI Reporter and Editor training. The training sessions shall be available monthly and can be used as needed.

e. The service shall provide tuition annually for up to two (2) representatives to attend the System Data Workshop.

Support

a. The service shall include phone or email access to highly qualified Pharmacy Consultants and Clinical Infusion Data Consultants to address customer data set questions and concerns and assist with the interpretation of CQI data. The Contractor shall provide a turnaround time of 48 hours from the initial phone call or email communicating a customer issue.

iii. Qualified Pharmacy Consultants must be a RPh and have at least 3 years’ experience working with BD (formerly CareFusion) Continuous Quality Improvement (CQI) information to make recommendations for improved safety limits on specific pharmaceutical products.

iv. Clinical Infusion Data Consultants (formerly CQI Managers) must have at least 3 years’ experience working with BD CareFusion CQI information to make recommendations for improved safety limits on specific pharmaceutical products and other data set parameters.

b. The service shall provide live technical telephone support with BD authorized support professionals based in the United States. The team must be ready to assist and provide support for equipment covered in this contract from 7:00am to 7:00pm Central time, Monday through Friday.

c. The service shall provide Clinical Infusion Data Consultant data support via phone or email from 7:00am to 7:00pm Central time, Monday through Friday, for questions related to the use of the software and interpretation, review, and consulting of data.

Data & Analytics

a. The service shall provide real-time monitoring of the Systems Manager to ensure system uptime, functionality, optimization, and health in accordance with the national MOU/ISA.

b. The service shall provide concise, actionable information on the hospital’s infusion management practices, without requiring analytical or reporting software installation or in-house technical resources. This includes unlimited access to a web-based portal defined by hospital with benchmarking tools and the ability to view all infusions. The Government can request a quarterly phone call or report with the data analyst to review the findings in this report.

c. The service shall provide benchmarking tools and the ability to view all infusions (not just those outside of prescribed ranges). This information must be web-based and be accessible to an unlimited number of users per hospital. These services would require hosting on a vendor platform but must not contain any sensitive information, in accordance with the national MOU/ISA.

Software Updates & Maintenance If the Contractor releases updates to the software to enhance the security or operation of the software, the Contractor shall deliver the enhancement to the Government in machine-readable form with instructions to assist the Government with installing the enhancement. These enhancements will be provided to the Government within 60 days of their issuance or data of first commercial availability, with no additional charge to the Government, for all equipment currently in use. As applicable, the Contractor will install each enhancement remotely through the Contractor’s remote access solution. The Contractor shall use commercially reasonable efforts to correct errors in the software that materially affect the functionality of the software.

All labor, time, materials, equipment, travel, service manuals, and supplies necessary to keep the equipment operational during the contract period shall be included. If an enhancement requires a change to the Alaris system embedded software, then one time during each annual period, the Contractor will perform one (1) on-site technical service visit for up to eight (8) hours for each 80 units to install the latest version of the software, download CQI data and upload the Government’s data set onto the licensed units. The contractor shall provide telephone support to the Government regarding the operation of and potential errors in the software.

The Contractor shall deliver the product. After contacting the COR (or COR designee) at the VA, a specific time will be scheduled for delivery of the product.

a. The service shall provide enhancements to the Suite MX software when commercially available enabling the same functionality of infusion pumps as a new Alaris system installation. This includes updates to the Alaris System to install the newest version of Suite MX software.

b. The service shall provide System Manager service patch management of the operating system, systems manager application, and other software components, including rigorous testing before deployment and customized patch cycles and notifications options. All software patches and updates shall be provided at no additional cost to the Government. Remote management of the server shall be delivered in accordance with the most current version of the national MOU/ISA between VA and BD CareFusion.

c. The service shall provide remote installation of server system patches, including the Operating System, Alaris Systems Manager, and other system components which will be patched regularly.

d. Software update/enhancement installations shall be scheduled and performed outside normal business hours, 7:00am to 5:00pm Central time, Monday through Friday, of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time, as determined by the COR).

Unscheduled Maintenance (Emergency Repair Service)

e. The Contractor’s Field Service Engineer (FSE) shall respond via phone call to the COR or his/her designee immediately 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 or remote desktop response) within two (2) hours after receipt of this second notification and will proceed progressively to completion without undue delay. This requirement for response time shall be the same for both service calls during the VA normal business hours and after-hour service calls. The COR will provide the Contractor with (a) an accurate description of the software error; (b) the steps necessary to reproduce the software error, if available; (c) if required, the data being processed at the time of the software error and associated log files; and (d) the severity of the software error, including the circumstances that lead to the software error. The COR and the Contractor will communicate and mutually agree on the severity level of the software error in writing. The severity will be determined based on potential impact to patient care delivery as well as potential patient adverse outcome as follows:

i. High = significant risk of injury to a patient or full system downtime more than four hours

ii. Medium = moderate risk of injury to a patient or partial system downtime more than four hours (or full system more than one hour but less than two)

iii. Low = no risk of injury to a patient or partial system downtime less than four hours Scheduled Maintenance

f. The Contractor shall perform patches, updates, and enhancements to ensure equipment and software perform in accordance with the latest OEM maintenance procedures and protocols. Patching shall be provided for all environments: pre-production, production, and training environments. Scheduled software maintenance shall be scheduled at least three (3) days in advance with the COR. An outline of the scheduled software maintenance procedures and schedule shall be provided to the COR. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained, as applicable. This documentation shall be provided to the COR at the completion of the scheduled software maintenance. The Contractor shall provide written description of scheduled software maintenance. This description shall include an itemized list of the procedures performed.

g. Scheduled software maintenance services shall include, but need not be limited to, the following:

i. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the manufacturer’s specifications

ii. Performing remedial software maintenance of non-emergent nature

iii. Returning the equipment to the operating condition, per OEM standards

iv. Providing documentation of services performed

h. Services shall be performed from 7:00am to 7:00pm Central time, Monday through Friday. All exceptions to the scheduled software maintenance schedule shall be arranged and approved in advance with the COR.

Documentation & Reports The documentation shall include detailed descriptions of the scheduled and unscheduled software maintenance (i.e., emergency software repairs (ESR)) procedures performed, including updates and services required to maintain the software. The ESR shall consist of a separate report for the item(s) covered under the “specific” contract. Grouping different software from different contracts on “one” ESR is prohibited. In addition, each ESR shall, at a minimum, document the following data legibly and in complete detail:

a. Contractor information:

i. Name of Contractor

ii. Contract Number

iii. Name of FSE who performed the services

iv. Contractor service ESR number/log number

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

c. VA purchase order numbers covering the call

d. Description of problem reported by COR

e. Identification of software to be serviced:

i. Software license and version number

ii. Inventory ID number

iii. Manufacturer name

iv. Device name, model number, and serial number

v. Any other manufacturer identification numbers

f. Itemized description of service performed:

i. Labor and travel

ii. Software patches

iii. Parts (with part numbers)

iv. Materials and location of problem/corrective action

g. Total cost to be billed, if applicable (i.e., service rendered after normal hours of coverage) *

h. Signatures:

i. FSE performing services described

ii. Authorized VA employee who witnessed service described *Any additional charges for work performed outside the scope of this contract shall be coordinated with the CO (Contracting Officer) and COR before service is initiated.

Payments All invoices shall be submitted monthly in arrears. Invoices shall be properly prepared in accordance with FAR 52.212-4, shall contain sufficient detail, shall match with the service tickets for the work rendered, and shall match the contracting line-item numbers (CLINs). Invoices shall be sent electronically to the VA Financial Services Center for payment processing via their electronic e-Invoice system. At a minimum, invoices shall include the following details:

a. Contract number

b. Purchase order number (Correct purchase order number which will be issued by the Contracting Officer after the contract is awarded. Invoices without correct purchase order number shall be rejected and returned to the Contractor.)

c. Item(s) covered (to include License numbers)

d. Description of the services rendered

e. Billing period in which the services were rendered

f. Invoice number and date Competency and Certification of Personnel Servicing Equipment

a. Each respondent must have an established business, with an office and full-time staff. The staff shall include a fully qualified FSE and fully qualified alternate FSE.

b. “Fully qualified” is defined as having successfully completed OEM training required for the equipment identified on the schedule.

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 copies of all OEM training certificates for FSEs showing types of equipment and dates of training for all equipment identified to be covered. When deemed appropriate, the COR reserves the right to prohibit Contractor personnel from working on VAMC equipment. All deliverables and tasks described in this PWS are to be provided as part of the agreement and are not limited to the list provided.

PERFORMANCE STANDARDS

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PERFORMANCE PERIOD

The period of performance (POP) shall be for a base year and four (4) one (1) year options:

Base : 08/17/2022 – 08/16/2023

OY 1: 08/17/2023 – 08/16/2024

OY 2: 08/17/2024 – 08/16/2025

OY 3: 08/17/2025 – 08/16/2026

OY 4: 08/17/2026 – 08/16/2027

Normal hours of work are defined as Monday through Friday from 7:00am to 7:00pm Central time, excluding Federal holidays or as otherwise arranged with the COR.

There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, five (5) are set by date:

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six (6) are set by a day of the week and month:

PLACE OF PERFORMANCE

Tasks under this PWS shall be performed remotely, when possible. On-site work may be provided. Work may be performed at remote locations other than the Contractor’s facilities. If the problem cannot be resolved over the phone or remotely, then an authorized Contractor’s representative shall commence work within the designated time identified and will proceed progressively to rectify the problem without undue delay without any additional cost to the Government with prior approval by the COR.

Department of Veterans Affairs Dallas VA Medical Center 4500 S. Lancaster Road Dallas, Texas 75216