ATTACHMENT A PWS Pill Packaging System.pdf

ATTACHMENT A

DRAFT PERFORMANCE WORK STATEMENT

Automated unit dose repacking systems (Pill packaging system)

1. BACKGROUND

VHA Office of Healthcare Technology Management (HTM), in conjunction with Pharmacy Benefits Administration (PBM), develops and guides the comprehensive management of pharmacy technologies to assure safe, available, and innovative medical technology used to deliver exceptional health care for Veterans. HTM/Biomedical Engineering at the medical facilities direct the medical equipment management program and support clinical care through providing preventive and corrective maintenance, healthcare consulting, and professional services for the technology assessment, implementation and sustainment of medical equipment and clinical systems.

2. SCOPE OF WORK

The Veterans Healthcare Administration (VHA) is seeking an Indefinite Delivery-Indefinite contract for an enterprise procurement of Automated unit dose repacking systems (Pill packaging system) for inpatient pharmacies across the country. The procurement shall include the unit dose packager, supplemental lower packaging unit, tray system, cannisters, canister calibration system, all software and interfaces required to integrated into the existing pharmacy information system. The contract shall include all software and professional services required to install and operate the inpatient medication dispensing workflow to include interfaces, licenses, equipment relocations, enterprise reporting, and Electronic Health Record integration, as well as maintenance and support agreements. It shall include VHA personnel training, technology refreshes, upgrades, additional components, architecture enhancements and licensing support as needed.

The Contractor shall comply with and meet the specific requirements defined below.

1. The requirement is for the entire pill packaging system and all components. The system shall include the unit dose packager, supplemental lower packaging unit, tray system, canisters, canister calibration system, all software and interfaces required to integrate into the existing pharmacy information system.

2. The IDIQ should include a variety of unit dose packaging units with varying cannister quantities (i.e. 200, 320, 400, etc).

3. Parts, consumables, and product support shall be available for the useful life of the device.

4. Remediation, vulnerability fixes, and upgrade services pertaining to recalls and medical device correction notices shall be available at no cost to VA for the useful life of the device.

5. Vendor/offeror shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

6. All equipment, hardware and software will be new and the latest technology available by the contractor at the time of delivery.

7. The packaging system should have functionality to allow for single- and multi-dose pouch packaging.

8. It shall support medication strip sorting by facility specifications such as by Location/Patient/Administration time, Location/Patient/Medication Name, etc.

9. The packaging system should contain at least the number of canisters specified in the facility specific section, with the option to increase this throughput by site specifications.

10. The packaging system should accurately package a minimum of 50 unit-dose and 40 multi-dose pouches per minute.

11. The packaging system should include at least one pre-fill tray to allow for continuous dispensing of non-canister medications. It shall also be able to pause a batch during a production run to work on another batch allowing users to come back to the paused batch and pick up where it left off. It shall also skip medication if unavailable then removing it from the order staging it as separate order when inventory is available.

12. It shall allow users to separate an order with multiple patients into separate orders at the packager level.

13. The packaging system should include a tray docking system with clients, scanners, UPS, and trays.

14. The packaging system shall include a calibration canister kit, allowing users to modify canisters in-house.

15. The packaging system should include an optional inventory counting and canister QC device.

16. The packaging system shall include a set of universal, manually adjustable canisters allowing staff to calibrate canisters for new NDCs without needing to swap out canister parts or sending the cannister back to the manufacturer.

17. Each system must have an automatic canister recognition chip system available, which will enable any canister to be seated in any location in the packager.

18. The packaging system will have a touch screen for navigation as an all-in-one, with biometric scanning for user login.

19. The packaging system shall include a package auto verification unit to perform QC analysis.

20. The packaging system shall include canisters that are pin, autosensing, and/or RFID identifiable.

21. The system shall support electronic orders from the EHR.

22. Packages produced from system must be individually packaged and at a minimum contain:

drug name, dose, dosage form, lot number, expiration date, and Bar Code medication Administration (BCMA) compatible barcode/ 2-D printing options.

23. The packaging system shall print pouches with pre-folded paper and a serrated edge for easy access to medications. System must have the ability to change pouch sizes to fit different sized medications. System must be able to print custom labels (color included).

24. Each system shall include a thermal printer capable of continuously printing package labels with a barcode label.

25. The packaging system shall include a reporting tool that allows users to view metrics and run auditing.

26. The packaging system shall be able to interface with existing pharmacy information systems (VISTA and Oracle Health EHR)

27. The pill packaging system must have a pouch verification system that can verify label and contents of each packet to improve accuracy and efficiency.

28. The pouch verification system must be able to produce a cut and rolled group of medications by patient, facility, or hour of administration.

29. Licenses and Software:

a. Software licensing for at least the first year of the packaging system will be included within the initial procurement.

b. Shall include 2 licenses for the pouch verification system.

c. All Licenses will grant permission for the use of the product while protecting personal information of patients and staff.

d. Contractor Software must protect VA systems from malware, spyware or any breach of VA information by any Non VA entity.

e. The licenses must allow for the interconnection between all locations on a single platform.

f. The system shall have an OS with current commercial support. All major component software applications (SQL, IIS, .Net, etc.) shall have current commercial support. A strength rating shall be applied if the OS or the component software applications have 60 months of commercial support.

g. Vendor shall be in compliance with VA network security regulation according to VA Directive 6500 and 6550.

h. Software Update/Patching: Software update and/or application patching shall be included. Vendor/offeror is responsible to coordinate with Facility Biomedical POC and work through facility change contract board prior to any update and/patching.

i. The VA Biomedical POC is responsible for Window security patch after vendor approves the patch.

j. HTM shall be able to login, restart, shutdown and perform basic maintenance on servers with any vendor software loaded. The system shall allow for management of users and enable termination or initiation of users from a web-based server interface or similar. A trained biomed technician shall have a standard user account and Windows administrator rights, either locally or through the domain, on the server with restart/shutdown rights, should the action be needed for maintenance/repair.

k. In coordination with a trained VA biomed technician, the vendor shall allow for access by the biomed to SMAK the system.

30. The vendor shall provide Two (2) electronic copies of operator instruction manuals, Two

(2) electronic copies of Indications for Use (IFU) and Two (2) electronic copies of service manuals shall be provided upon delivery of the equipment to each site. The manuals shall be permitted to be uploaded to VA’s OneSource application and have unlimited access online through a user portal regardless of the type of maintenance support purchased.

31. Networking Requirements.

a. The system requires connection to the VA network. The Contractor shall complete the VA s required documentation. Should the manufacturer of the equipment not have an approved Enterprise Risk Analysis completed, this will be required to fully install the system on the network.

b. Following purchase, the VA will provide specific network information for the configuration of the system. If remote support is required, the Contractor must have a completed MOU/ISA.

c. The system shall be compatible with the incoming Cerner patient health record.

d. The system shall have all VISTA/CPRS HL7 integrations built prior to going live with the equipment.

32. Cleaning/Sterilization Requirements.

a. The Contractor shall provide cleaning/sterilization instructions (Instructions for Use

IFU) for the Government to determine the ability of the facility to properly process the equipment.

b. The packaging system should have a means to clean the inside of the unit by a pharmacy technician.

33. Delivery Requirements:

a. Prior to device delivery, the contractor shall provide the following:

i. Serial numbers.

ii. MAC addresses of any wireless devices.

b. Large deliveries are to be coordinated in advance with the Site Point of Contact (POC)/Biomedical Engineering Designee to ensure necessary planning takes place.

c. Contractor is to provide the POC/Biomedical Engineering Designee with shipment tracking information.

34. Installation Requirements

a. Full installation of the system shall be included as a part of this contract. All parts, materials, tools, labor, and travel to complete the installation shall be included as a part of this contract.

b. Contractor is required to complete all configurations for the system to be usable.

Contractor shall provide validation that the system is fully functional upon completion of the installation/implementation.

c. The contractor shall provide on-site installation services, to include the following (if applicable):

i. Unboxing.

ii. Staging of equipment.

iii. Incoming inspection

iv. Download of medication libraries

v. Asset sticker tagging.

vi. Maintenance sticker tagging.

vii. Disinfection of equipment.

viii. Removal of trash.

ix. Installation at all sites listed

d. The contractor shall connect all applicable devices to the wireless network and server.

Performance shall be validated and documented.

e. The contractor shall provide project management services, including, but not limited to, the following:

x. Determining project tasks.

xi. Scheduling meetings with stakeholders.

xii. Developing timelines.

xiii. Closing out project with sustainment plan.

xiv. Ensure the system is completely operational and performs all required functions prior to close out.

f. The contractor shall provide a formal report at the conclusion of deployment to include the following for each item:

i. Model.

ii. Serial number.

iii. Asset number.

iv. Original deployment location.

v. Incoming inspection results.

vi. Manufacturer inspection results (if applicable).

35. Deinstallation and Relocation of equipment

a. The contractor shall support the de-installation of their existing equipment.

The Contractor shall support the relocation of contractor owned equipment within the local site in the same building (ie clinic renovation, new install)

b. When the Government provides 30-days advance notice, the Contractor shall relocate and reconfigure clinical equipment from one facility to another facility within 100-miles.

c. When the Government provides 45-days advanced notice, the Contractor shall relocate and reconfigure clinical equipment from one facility to another facility outside 100-miles.

d. The Government shall request a proposal describing the Rough Order of Magnitude (ROM) and associated costs commiserate of the anticipated Level of Effort (LOE).

36. EHR Integration

a. VHA Oracle Health /Pill packaging Interface: The VHA Oracle Health Electronic Health Record (EHR) is a commercial off-the-shelf system that consists of an inpatient, outpatient, and dental system currently being designed to be deployed across the VHA enterprise. The VHA Oracle Health EHR will replace functionality of core legacy systems (i.e., VISTA, among others), and will be deployed to all facilities. The VHA Oracle Health will communicate via existing VA IT Networks as well as VHA infrastructure to support the system. In addition to network infrastructure, the VHA Oracle Health EHR system will have a hosting infrastructure in which to deploy the system, store data generated by the system, and provide any server-side application processing.

b. The Contractor shall implement, maintain, and update an interface between the pill packager system and VHA Oracle Health systems.

c. The Contractor shall implement and upgrade the pill packaging/VHA Oracle Health interface to add bi-directional communications, display additional data elements within the system, as well as support for the associated testing events.

d. The vendor may interface with other pharmacy and supply systems. When required, the Contractor may separately price new interface requirements.

e. In accordance with the ERA, the Government shall permit the Contractor to install and maintain at the Government’s site the applications necessary to allow the deployment of system updates and upgrades.

f. When development is required to install an Upgrade or Update using a process that is not validated and approved by the OEM, then the request will be scoped and chargeable at then current per diem rates.

g. The Contractor shall be specifically excluded from support coverage related to external causes (e.g., abuse, misuse, vandalism, and unauthorized repairs including modification, alteration, and adjustment), environmental hazards such as fires, floods, acts of nature (e.g., earthquakes, hurricanes, tornados), unregulated power, gas/atmosphere contamination, physical damage that is not in the normal course of instrument operation, failure of equipment not supplied by the Contractor, a computer virus or other disabling code introduced by a source other than the Contractor, government installation of a third party software or application not approved in the ERA, and Contractor resource vetting delays due to no fault of the Contractor.

h. The Government reserves the right to correction of issues caused by any of the referenced external causes above and would negotiate with the Contractor for any required repairs.

37. Interface Requirements

a. The system shall support interface connections to external systems for existing systems (Omnicell ADCs, BD ADCs, etc)

b. All interfaces shall be available as separate line items within the IDIQ.

38. Professional Services

a. The vendor shall include an onsite optimization reviews/re-configuration line item their price book.

b. For new installs or upgrades: The contractor shall provide professional services to install and configure the system at each site. This may include, but is not limited to, workflow re-evaluation, recommendation and testing, integration testing with Vista/CPRS and/or associate medical equipment, report building/report configuration, post deployment assessment 6 months after the Go Live, etc. The Contractor shall coordinate with other Contractors when necessary to accomplish this task.

c. The contractor shall identify a project manager for each site specific delivery order after award. The contractor shall provide a schedule with deliverables, milestones, site prep work, training plan, risk management plan, and operations and maintenance plan. The contractor shall meet weekly or as-needed with the VA.

39. Auxiliary Equipment and Accessories

a. To apply to equipment the contractor/offeror determines to be necessary for the proper functions of system but is not included with other line items.

40. Training

a. The Contractor shall provide clinical training onsite at each location, assuming users have no experience with medication dispensing systems. Training shall be provided in various forms of media such as, but not limited to, tutorials, manuals, computer-based training, distance learning, and on-site training, as appropriate. The Contractor shall provide web-based, self-paced training, including modular training for clinical staff, shared across VHA at no additional cost to VHA.

b. Training shall include, but not be limited to, initial training of new personnel in the operation and care of the system and reporting tools, as well as an actual demonstration of the system and its interaction with existing systems, e.g., VistA, medical device integration, Reporting Tool(s), and VA and/or commercial analytics systems.

i. Follow-on training shall be quoted for an additional users per site per each task order, to be taken within one year post go-live.

ii. The Contractor shall provide guidance on adjustments or other actions that may be undertaken by operating personnel in the event of malfunction or failure.

iii. The Contractor shall plan, schedule, and conduct formal training for all levels of users (e.g., system administrators, pharmacy, and nursing).

iv. The Contractor shall plan, schedule, and conduct mutually agreed upon ongoing remote training via VHA communication tools (e.g., Microsoft® Teams).

41. Warranty, Maintenance Support Resources, Support Agreement and Hardware & Software Maintenance

a. General:

i. The Contractor shall furnish maintenance service support that includes, as a minimum, scheduled and corrective maintenance services for the pill packaging system and all associated hardware, firmware and software parts, labor, travel and expenses necessary to perform such services at no additional cost to the Government, except in those circumstances where maintenance or repair service is required as a direct result of abuse, misuse, misconduct or other gross or willful damage done by the Government.

ii. The Contractor shall provide diagnostic and repair services, as well as preventative maintenance via on-site or remote support.

iii. Preventive Maintenance is defined as those periodic and “as required” services necessary to maintain equipment in an operating condition which minimizes corrective maintenance, including but not limited to calibration, adjustment, lubrication, updating and upgrading software for security, safety, compliance, and compatibility issues, as well as that testing required to maintain a safe environment of care, output testing (non-electrical), replacement of worn components and other components excluding consumables per Original Equipment Manufacturer (OEM) Preventive Maintenance (PM) Schedule basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

iv. The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment. All required parts shall be furnished by the contractor to the VA at no cost. The contractor shall repair the equipment to functional level equivalent to the original manufacturer’s specifications.

v. The contractor shall provide tools, test equipment, service manuals or service diagnostic software. 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) necessary to meet the performance requirements and repair of the medical equipment. A reference list of applicable service manuals and their respective locations shall be provided to the Biomedical Engineer upon request. The Contractor shall make available for purchase by the Government all components or spare parts required to maintain the pill packing units. This shall be independent from any post warranty service support purchased by the Government for a specific site.

vi. The contractor shall ensure all contractor supplied test equipment is properly calibrated, and certified. If requested by the COR or POC, the contract shall be able to supply any certificates tied to the quality of the test equipment. Test equipment calibration shall be traceable to a national standard.

vii. When a consumable is not provided during a preventative maintenance visit, the Government shall be solely responsible for the cost of the replacement or installation of consumables, including but not limited to batteries, paper and toner.

viii. The contractor shall furnish all spare and replacement parts needed to service the equipment. The price of all parts used to perform all scheduled preventive and unscheduled maintenance shall be included in the coverage. The Government will not pay for any parts provided (during either scheduled or unscheduled maintenance), by the contractor during the period of the medical equipment being covered. Only new standard parts (manufactured by the maker of the equipment, or equal) shall be furnished to maintain the equipment.

ix. The contractor shall provide as necessary on-site support coverage 24 hours per day, 7 days per week. For disabled systems, the Contractor shall have a 6-hour response time, for non-critical failures, the Contractor shall have a 24-hour response time.

x. The Contractor shall provide any necessary replacement parts to properly repair equipment. Replacement parts should be provided on-site within a 24-hour period from when the Contractor technician has determined the need.

xi. The Contractor shall provide a 96% uptime commitment of all equipment listed.

xii. All service/repairs shall be performed during normal hours of coverage unless requested or approved by the Biomedical Engineer. Work performed outside the normal hours of coverage, at the request of FSE, shall be considered service during normal hours of coverage and shall be exempt from an extra labor hour charge.

xiii. Only the onsite HTM POC, or Contracting Office Representative designated by the CO has the authority to approve/request a maintenance service call to the contractor.

xiv. There shall be no hourly charge to the Government for unscheduled service performed within the normal hours of coverage. Work performed outside the normal hours of coverage, at the request of the Biomedical Engineer, Point of Contact, or Contracting Office Representative, shall be invoiced separately and shall not have service rendered until Purchase

Order is obtained. In the event of a Government caused delay, the VA will pay hourly labor charges for unscheduled service the inadvertently extends beyond the specified normal hours of coverage.

xv. The Contractor shall physically check-in and check-out with the authorized local site personnel prior to performing services on the system.

xvi. Contractor personnel shall not handle any medications stored in the system. Local site personnel shall be present and capable of monitoring Contract personnel during any activity in which medications are present.

xvii. The Contractor shall allow authorized local site personnel to create and manage service events by customer service requests via a web-based customer portal or telephone.

xviii. The contractor shall include an optional line item for weekend or after hours support services.

xix. The contractor shall provide 24 hours per day, 7 days per week, telephone support coverage. The Contractor shall have a response time of 30 minutes during normal hours of coverage (Monday – Friday 6AM – 6PM CST), and 2 hours outside of normal hours of coverage (Monday – Friday 6PM – 6AM CST, Saturdays and Sundays, and Holidays).

xx. The Contractor shall provide remote software and interface diagnostics as necessary given the VA provides the proper access via a proactive remote through a secure server.

xxi. The Contractor shall perform and provide any software updates and upgrades as necessary at no charge.

xxii. Software updates/upgrades shall be scheduled and performed during normal hours of coverage if there is no impact or downtime to the system and patient care. If system downtime is expected or patient care will be impacted, the software update/upgrade shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government (to be determined by the Biomedical Engineer).

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

xxiv. The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the COR or POC, in writing, of the existence or development of any defects in, or repairs required, to the scheduled equipment which, the contractor does not consider his/her responsibility due to “abuse” or “damage” to the equipment. The contractor shall furnish the Government with a written estimate of the cost to make the necessary repairs.

xxv. The contractor accepts responsibility for the equipment covered under this equipment in an “as is” condition. Inspection of the equipment by the contractor shall be done prior to coverage, if required by the contractor.

xxvi. The contractor shall provide a point of contact for each site for both hardware and software maintenance.

xxvii. The Contractor shall perform root cause analysis for issues and repairs involving hardware, software, or procedural problems that result in substantial operational difficulty, and prevents a system from dispensing medications and system downtime to include remote connectivity.

xxviii. The Contractor shall provide Engineer Service Report (ESR) to authorized local site personnel upon completion of each service event.

xxix. The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with the specifications. Each Engineer Service Report (ESR) must, at a minimum, document the following data legibly and in complete detail:

1. Name of contractor and contract number

2. Name of FSE who performed services

3. Contractor service ESR number/log number

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

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

6. Description of problems reported by the POC/user (if applicable).

7. Identification of equipment to be serviced:

8. Inventory ID number,

9. Manufacturer's name, device name, model number & serial number,

10. Any other manufacturer's identification numbers.

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

12. Labor and Travel,

13. Parts (with part numbers),

14. Materials and Circuit Location of problem/corrective action.

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

16. Signatures:

17. FSE performing services described.

18. Authorized VA Employee who witnessed service described.

19. NOTE: - Any additional charges claimed must be approved by the

COR or CO before service is completed

xxx. The Contractor shall log in with Biomedical Engineering prior to performing any services. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall log out with Biomedical Engineering and submit the ESR(s) to the Biomedical Engineer, or Point of Contact. All ESRs shall be submitted to the equipment user for an “acceptance signature” and then to the POC for an “authorization signature”. If the POC is unavailable, a signed, authorized copy of the ESR shall be sent to the contractor after the work can be reviewed (if requested or noted on the ESR).

xxxi. All service shall be provided by factory trained, English speaking, technically qualified and authorized service personnel.

xxxii. The Government shall provide high-speed internet access and firewall modifications to enable connectivity to the system or other mutually agreed upon remote connection system, and the Contractor shall provide remote support as appropriate to verify, diagnose, and resolve any issue.

b. Warranty:

i. Meet all the general requirements above.

ii. All systems, including hardware, licenses, and software shall be given at least a 12-month warranty. If the warranty does not include coverage for these items, then the contractor shall quote the required support agreement to have coverage throughout the 12 months post go-live.

iii. During the 12 month warranty period, the contractor shall furnish maintenance service support that includes, at a minimum, preventative and corrective maintenance services for the pill packager system and all associated hardware, firmware and software, parts labor, travel and expenses, necessary to perform such services at no additional cost the government, except in those circumstances where maintenance or repair service is required as a direct result of abuse, misuse, misconduct, or other gross or willful damage done by the Government.

c. Commercial Post Warranty Maintenance Plan Support shall:

i. Meet all the general requirements above.

ii. All definitions and requirements as defined above for the warranty period shall apply during the post-warranty period unless exceptions are defined.

iii. Contractors are encouraged to offer their normal, commercial maintenance service plans (based on their standard commercial maintenance service

Leonard, Robert (National Program Manager, PBM) Reference to ADC changed to pill packager for this RFI.

terms and conditions. If such commercial plans are offered, the following shall be provided:

iv. Contractor shall provide a maintenance program for each system installed for at least 5 option years following conclusion of the one year warranty.

v. The methodology, or process used by the Contractor to calculate the maintenance service price for a specific medical treatment facility (e.g. the price is calculated as a fixed percentage of the equipment cost.)

vi. Prior to award of each site specific delivery order, vendors will be required to submit firm, fixed price post-warranty maintenance proposals for 5 option years.

vii. The Contractor shall provide diagnostic and repair services, as well as preventative maintenance via on-site or remote support

PERFORMANCE WORK STATEMENT