P09 SOW V23 BD Pyxis Service Agreement NC.docx

?.## STATEMENT OF WORK

VISN 23 BD Pyxis Medication System Service Contract

1. Background VA Midwest Healthcare Network (VISN 23) has existing BD Pyxis medication equipment and software that requires a support maintenance contract.

BD Pyxis medication system is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment. The system helps clinicians dispense medications in a safe, efficient way and provides enterprise-ready integration capabilities. The software records the medication being dispensed and ensures it is the right patient, medication, dosage, and time. This technology also provides access to allergy warnings, safety alerts, and order verification. The system supports nursing workflows by decreasing the number of steps in the medication management process and supports diversion efforts by providing discrepancy reports.

2. Place of Performance Unless otherwise noted, work shall be performed during normal business days and hours at each VA facility listed below, which is typically comprised of Monday through Friday each week (except federal holidays) between 8:00 a.m. and 4:30 p.m. local standard time. Contractor shall confirm each facility normal business days and hours with onsite POC (s).

Holdrege CBOC, 1118 Burlington Street Holdrege, NE 68949-1705

Sarpy CBOC, 1330 Jersey St Papillion, NE 68046

Shenandoah CBOC VA Clinic, 2043 A Ave, Shenandoah, IA 51601-4505

Grand Island VA Clinic, 2201 N Broadwell Ave, Grand Island, NE 68803-2153

Lincoln VA Clinic, 420 Victory Park Dr Lincoln, NE 68510

Norfolk, 3204 Raasch Drive Norfolk, NE 68701

Papillion CLC at Midlands Hospital 11111 S 84th St, Papillion, NE 68046

Northwest Metro Clinic 7545 Veterans Drive, Ramsey, MN 55303

Twin Ports Clinic 3520 Tower Ave, Superior, WI 54880

2805 Dodd Rd. Ste 250 Eagan, MN 55121

3. Equipment Inventory Upon request, the contractor shall confirm and provide equipment quantities and serial numbers covered under the service contract at each site in an excel document.

4. Equipment Changes Equipment may be deleted from the Service Contract if replaced or "in excess" during the period of this contract at the discretion of the CO/COR. New equipment may be added as needed at the discretion of the CO/COR. Deleted equipment will be credited in the full amount if deleted before any scheduled maintenance has been performed on it. The Government reserves the right to purchase additional medical equipment not contained within the Service Contract as well as delete existing items upon the approval of the AO. The Service Contract shall be updated with the addition of new equipment and existing items that are taken out of service shall be deleted upon contract renewal and upon request.

5. Work Performance Contractor shall perform the following work at the VISN 23 sites:

a. Furnish all labor, transportation, tools, parts, materials, test equipment, and expertise necessary to provide repair service and annual preventive maintenance and support of the BD Pyxis equipment hardware, software and databases.

b. Provide repair service, which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and installing parts.

c. Provide remote support services (“RSS”) on a 24/7/365 basis through CareFusion’s Technical Support Center (“TSC”). BD utilizes RSS feature to connect into any Pyxis Server or console to help resolve issues. RSS allows BD to provide software updates remotely.

d. Adjust and replace non-consumable parts in Pyxis equipment, including Pyxis CUBIE® Pockets, which are not properly performing for any reason other than an external cause.

e. Perform onsite repair and preventive maintenance of Pyxis equipment inspections in accordance with current manufacturer/factory specifications and maintenance schedule.

a. Contract service shall ensure that the equipment/system functions in conformance with the latest published edition of NFPA-99, OSHA, manufacturer’s Network Equipment/System upgrades/updates shall be installed in strict accordance with manufacturer’s specifications and must operate within manufacturer’s specifications and must operate within manufacturer’s specified parameters.

b. Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) provided to the onsite POC (s) at the completion of the PM.

f. PM services shall include, but need not be limited to, the following:

a. Cleaning of equipment to include filters, gearing, and other parts.

b. Reviewing operating system software diagnostics to ensure that the system is operating as specified by the manufacturer’s specifications.

c. Calibrating and lubricating the equipment.

d. Performing remedial maintenance of non-emergent nature.

e. Performing electrical safety inspection IAW NFPA 99.

g. Provide 24/7/365 access to BD’s technical support phone and web portal to receive technical support for repairs and maintenance, and answer any questions about the BD Pyxis medication equipment:

a. 1-866-488-1408

b. https://bd.com/self-service

h. Address VA support issues/requests within the following timeline, when contractor receives a VA support request via email, phone call or web inquiry:

a. 24 hours for NWI onsite response time from time of dispatch.

b. 8 hours for MIN onsite response time from time of dispatch.

i. If the problem cannot be corrected by phone or by remote diagnostics the contractor will dispatch a technician to arrive not later than the next business day after the call is placed.

j. Supply and bear the cost of all parts, and software updates required for service repair and maintenance and, as a result of normal wear and tear, restore equipment to full performance system in operating condition as originally designed by the manufacturer.

a. All parts shall meet the original manufacturer’s design specifications.

b. Parts may be repaired or replaced, as the contractor deems appropriate. No used parts will be used to repair this equipment.

k. Provide VA access to new software/firmware versions, updates, enhancements, bug fixes and patches as they are released. Provide all third-party licensing. Provide all third-party licensing for embedded software.

l. Promptly notify the CO/COR and the VA POC (s) listed in this Statement of Work (SOW) of any recalls and end of life/service cycles.

m. Test equipment calibration shall be traceable to National Institutes of Standard Technology standards. Each service report shall list test equipment used and date calibration to NIST is due. Test equipment out of calibration shall not be used.

6. Facility Check In Requirements Upon arrival at the VA facilities the contractor is required to check in with Biomed in the following locations:

This check in is mandatory as well as wearing the contractor badge issued upon checking in. Contractor’s FSE(s) shall wear visible identification at all times while on the premises of the VA. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name. In addition, if required the contractor shall submit fingerprints through the VA police for issuance of a VA identification badge that shall be worn at all time while working at a VA facility.

Before leaving the VA facility, the contractor shall checkout with Biomed. In those cases when the Biomed office is closed, contractor personnel will log in and/or out directly with Pharmacy and after hours service shall be prearranged with the VA onsite POC (s).

7. Service Reports When service is completed, the FSE shall document services rendered on a legible ESR(s) and submit to the onsite POC (s) who set-up the service. The service report can be submitted when logging out with Biomed, via an internet web site or e-mail. Contractor shall provide all service reports within 72 hours of completed service.

1. NWI: **

2. MPLS: **

Documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices required to maintain the equipment in accordance with manufacturer specifications.

For each service visit, a detailed Equipment Service Report will be required. Each service report shall include:

1. Name of the contractor and contracting number.

2. Name of the Field Service Engineer (FSE) performing the services.

3. Contractor Service Number/Log Number.

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

5. Identification of equipment to be serviced, invoice or ID number, manufacturer’s name, device name, model number, serial number and any other manufacturer’s identification numbers.

6. Description of problem reported by COR/User.

7. Signature from the FSE performing services described.

8. Signature from an authorized employee who witnessed services described.

8. Out of Scope Services Contractor shall immediately, but not later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence of 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.

Contactor shall furnish the COR with a written estimate of the cost to make necessary repairs.

Any additional charges claimed will be approved by the CO via the COR before service is completed.

9. Service and Operator Manuals VA will not provide service manuals of service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSEs all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary the 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 Contracting Officer upon request.

Upon request, the contractor shall provide the following documentation for the equipment being serviced:

1. Unlimited ongoing electronic and web-based access to Contractor Clinical End User Operators Manuals and Guides.

2. Unlimited ongoing access to web-based training via Contractor online learning management system including scheduled trainings and webinars. VA may participate in Contractor hosted webinars with clinicians to discuss best practices in using the Software. Webinars may be accessed at MyBDLearning.litmos.com

3. Unlimited and ongoing access to the equipment/software Preventive Maintenance schedule and current PM compliance reports.

4. Any upgrades to these documents shall be provided by the contractor free of charge.

10. Training The Contractor shall provide Clinical End User training remotely for any upgrades where the end user steps have changed.

Education curriculum must include the following:

a. Operations and set-up

b. Safety

c. User troubleshooting tips

d. Service Passwords for using the software, if applicable.

Upon request, the contractor shall provide cost information for additional training opportunities not included in this SOW.

Training materials provided (instructional texts, audio-visual materials) will become the property of the government and will be reproduced as needed.

11. Security Requirements The contractor shall comply with all VHA security protocols, procedures and requirements of the VA’s Office of Information Technology including filling out and providing all necessary forms upon request within 10 days from receipt from the VA:

a. Any connections to the VA OI&T network shall be compliant with VA Directive 6500 and 6550.

1) The contractor shall complete and return separate 6550 forms with accurate information for the equipment and software.

2) Additionally, the contractor shall provide each product’s MDS2 and a diagram of data flow for each product.

b. Any offsite server or network maintenance or support provided by the contractor can only be done via VPN access after the contractor has obtained the Site-to-Site (S2S) VPN access from the VA. A Business Associates Agreement (BAA) and Memorandum of Site Site-to-Site Understanding/Interconnection Security Agreement (MOU/ISA) may be required.

1) The contractor shall complete and return BAA forms for the equipment upon request within 10 days from receipt from the VA.

2) Contractor shall have an active MOU-ISA in place, or the contractor shall work with VA to get an MOU-ISA in place within 6 months of award if determined beneficial. The contractor shall return completed forms within 10 days of receipt/request from the VA.

c. If applicable, the equipment software shall be approved in the Office of Information Technology’s Technical Resource Manual (TRM) or the contractor shall be willing to gain approval in TRM.

d. The equipment shall be FIPS 140-2 compliant. The contractor will identify the certificate number for FIPS compliance.

e. The medical equipment covered by this contract may contain electronic patient health information (EPHI). The vendor shall not remove/copy/delete any of the EPHI. If a computer hard drive needs to be replaced, the old hard drive must be turned-in to biomedical engineering for destruction. The vendor will not receive compensation for the hard drive.

f. If a cloud service Platform as a Service (PaaS), Cloud Instance or Software as a Service (SaaS) is selected as part of the project to include providing software patches, please review and reference VA Directive 6517 Cloud Computing Services and follow VA Enterprise Cloud Solution Intake processes.

g. Contractors shall allow for SMAK installation on all endpoint and server-based equipment. SMAK-AM = System Monitoring and Accountability Knowledge AntiMalware (SMAK-AM) toolset.

h. Contractor must supply all MAC addresses for networked devices at least one week prior to delivery of equipment.

12. Hardware Requirements

a. Hardware servers must be from a major brand manufacturer (Cisco, Dell, HP, Intel, etc.) and must include the following:

1) 19” rackmount chassis, prefer 2U or less per hardware server

2) Redundant components for networking at least 1Gbps per interface

3) Redundant components for power supply, capable of 208V operation

4) Out of Band management (iDRAC, iLO, etc.)

5) Current generation CPUs (dual or more per server)

6) Vendor’s recommended quantity of RAM per software application specifications.

7) Contractor shall allow for additional data storage quantity if desired by the site.

8) Redundant solid-state drives (SSD) for Operating System/Boot (RAID 1 or better)

9) Applications and data may reside on standard hard drives in a RAID configuration for redundancy.

10) Currently supported operating system (OS), preferably Windows Server 2019 or Windows Server 2022 Long-Term Support Channel build or most recent release. If a Long-Term Support Channel build cannot be supplied, Vendor must supply OS upgrades at no additional charge prior to currently installed OS reaching End of Support for the full term of the warranty or contract support coverage.

11) Sufficient capacity for future expansion of memory and disk space

12) ALL hardware or software login credentials must be documented and supplied.

b. Virtual servers are presented with a standard virtual hardware environment running on our Nutanix HCI system running the Acropolis hypervisor. At this time, VMWare OVA/VMDK packages are supported, Hyper-V packages are not supported. This environment provides a standard intel-compatible virtual server environment meeting the virtual hardware specifications required by the software being installed. All virtual servers are archived on a nightly basis by the Nutanix system.

c. Workstations must be from a major brand manufacturer (Dell, HP, etc.) and must include the following:

a. Current Trusted Platform Module (TPM) chip

b. Solid state drive for the Operating System. Applications and Data may be stored on additional standard or solid-state drives as needed; solid state drives are preferred.

c. Ability to encrypt drives for security.

d. Vendor’s recommended quantity of RAM per software application specifications.

e. Contractor shall allow for additional data storage quantity if desired by the site.

f. Currently supported operating system, preferably Windows 10 Enterprise Long-Term Support Channel build 1809, 21H2 or most recent release. If a Long-Term Support Channel build cannot be supplied, Vendor must supply OS upgrades at no additional charge prior to currently installed OS reaching End of Support for the full term of the warranty or contract support coverage.

g. Current generation CPU, Intel preferred. Processor shall be I5 equivalent or greater.

h. Display should be 24” class non-glare, and support at least FHD resolution (1920x1080) unless otherwise stated.

i. Laptops: Screen should be 15” class or larger, non-glare, and support at least FHD resolution (1920x1080) unless otherwise stated.

j. ALL hardware or software login credentials must be documented and supplied.

13. Implementation/Project Management Services The Contractor shall provide project management services as part of the service purchase for software upgrades. Updates are remotely provided directly to the VA’s applicable devices by Contractor and the VA will schedule when those Updates will be deployed.

Project Management Services shall include, but are not limited to a project manager, a detailed project timeline including a Gantt Chart with defined roles and responsibilities (including contractor provided and VA resources), a detailed schedule for software upgrades.

The Contractor shall work with the COR and onsite POC (s) to coordinate and implement the upgrades. The Contractor shall collaborate with onsite POC (s) to minimize down time and impact to patient care related to the upgrade, including accommodating site requests for after-hours work. The dates resulting from this collaboration will be recorded in the project plan for each facility.

The Contractor shall provide at least 60-day notice to onsite POC (s) when downtime is required for routine maintenance and software upgrades. Emergency maintenance to be planned with the onsite POC (s).

The Contractor shall hold a kickoff meeting with the designated technical and clinical points of contact for each facility and COR to discuss any software upgrades. The project management plan and communications plan shall be reviewed at the kickoff meeting. Discussion about site order and schedule for the upgrades will begin at the kick-off meeting.

14. Invoicing and Pricing Detailed invoices will be submitted by the contractor in arrears after VA receipt and acceptance of equipment services. Invoices must include purchase order (PO) number, contract number, PO line items and description, period of service covered/dates, and cost at a minimum. The contractor shall reduce the number of invoices by including all relevant line items onto one invoice. Each line item on the invoice shall include the facility, POP and CLINS each line item pertains to. Invoices may be rejected that do not conform to this requirement. Pricing shall be competitive market value and reasonable.

Contractor shall submit invoices electronically through the VA’s Financial Service Center (FSC) for payment. Paper, emailed and faxed invoices are not accepted by the government. Electronic invoicing process can be found at http://www.fsc.va.gov/einvoice.asp Contact vafsccshd@va.gov or call 877-353-9791 for questions on invoicing.

Number for technical support: 866-340-4980 Technical Support site: https://www.tungsten-network.com/us/contact-us/#email-us https://www.tungsten-network.com/customer-campaigns/veterans-affairs/

15. Inspection and Acceptance Contractor shall inspect, adjust, repair and test to ensure safe reliable service within all tolerances as required by manufacturer’s specifications. The contractor shall conduct a joint inspection of services with the on-site POCs upon completion of the project. In the event deficiencies are identified, the contractor shall provide the date when the identified deficiencies will be addressed if not addressed on the date of installation. The contractor shall conduct a joint inspection of services with the on-site POCs after addressing all deficiencies. All deficiencies identified in the joint inspections shall be fixed by the contractor prior to government acceptance of the item. Any disputes shall be resolved mutually by the Contracting Officer and the Contractor.

16. Disposal of Waste and Job Site Cleanup The contractor shall provide, maintain, and dispose of all material waste and packaging associated with the delivery of the specified services and/or waste generated during the services provided. Contractor will be responsible for moving waste materials daily from job site(s) to a contractor-provided waste container, and then off site.

17. Delivery and Materials Requirements The contractor shall coordinate delivery of all services and parts with the on-site POC (s) and COR prior to shipment/arrival. Parts shall not be delivered more than one week prior to installation. Parts shall be stored no longer than one week in the warehouse. The contractor shall provide parts delivery, shipping and tracking information to the on-site POC (s) and COR in advance before equipment arrival at the facility. Materials provided shall be new equipment, parts, and accessories. The contractor shall deliver materials to the job site in OEM's (Original Equipment Manufacturer) original unopened containers, clearly labeled with the OEM's name, equipment model and serial identification numbers, Purchase Order (PO) number and site Technical POC. The contractor is responsible for inventorying materials prior to delivery to VA sites to check for accuracy in quantity and part number. The contractor shall tag the bill of materials by area/room for ease of installation. Site POC (s) may reject items that do not conform to this requirement.

The contractor shall coordinate in advance with on-site designated facility POC (s) the delivery of equipment to final destination and obtain the appropriate Supply Chain Management POC. All equipment must be processed through Supply Chain Management prior to going to final destination.

18. Order of Precedence All work described and provided by the contractor, shall be performed in accordance with this SOW and Addendum applicable. The VA provided SOW shall become effective on the date the contractor receives a signed Purchase Order. Contractor shall be bound by any conflicting terms that may appear in any contractor provided documentation presented as part of the bid solicitation. Any services that are not in this SOW are considered Out-of-Scope.

END OF STATEMENT OF WORK