Draft SOW - Automated Medication Dispensing System.docx

STATEMENT OF WORK (SOW)

Eastern Colorado VA Health Care System Replacement of an Automatic Medication Dispensing System

BACKGROUND:

The Eastern Colorado (ECH) VA Health Care System is seeking:

A. A Carousel replacement at the Rocky Mountain Regional VA medical center (RMR VAMC)

B. Replacement of its existing automatic medication dispensing system at the RMR VAMC and VA Community Based Outpatient Clinics (CBOCs).

C. Additional Automated Dispensing Cabinets (ADCs) and other equipment for patient care areas as outlined below at the RMR VAMC and CBOCs

The contractor shall provide the equipment and perform services to the Department of Veterans Affairs (VA) in accordance with the tasks and deliverables as described in this Statement of Work (SOW). Contractor must provide the hardware, licenses, and software to set up virtual servers and to operate a fully automated dispensing cabinet system. The contractor shall provide technical support for the installation of each device as well as clinical support for the quality improvement, medication management, reporting infrastructure and Electronic Health Record (EHR) system integration. It shall include de-installation of the current system with an optional trade-in. The vendor shall provide a list of specific facility modifications needed to add their technology to the facility—such as power outlets, data drops, ceiling modifications needed for carousel placement, floor, etc with their proposal. In addition, the contractor shall provide clinical and technical user training, as needed, to ensure safe operation of the new ADC system. Final acceptance is completed once all equipment has been delivered, training, implementation, and any integration has been accomplished, and turnover/go-live has been completed.

FUNCTIONAL AND TECHNICAL SPECIFICATIONS

1. The requirement is for the addition and replacement of automatic medication dispensing cabinets and carousel utilized amongst the main Rocky Mountain Regional medical center and the ten (10) offsite VA clinic locations. The medication dispensing system shall be able to store, manage, and dispense controlled substances. The system shall include cabinets, workstations, refrigerators, and utilize barcode scanning. The system shall provide inventory management and an automated audit trail. The barcode scanning system shall be able to assist in the receipt, distribution, and return of medications. The proposal shall include all software and licenses to fully operate the system using virtual servers provided by ECH.

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

3. 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.

4. Vendor/offeror shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/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.

5. The purchase of the Automated Medication Distribution System will cover all installed equipment at the facility. This includes:

· Qty 61: Automated Dispensing Cabinets configuration (ADCs - that act like vending machines at point of care locations like wards, CBOC’s or clinics) with the ability to add additional storage cabinets or auxiliary units if needed.

· ADCs will be distributed at the Aurora main VA medical center, VA CBOC and other clinic locations and shall be a combination of both full size and half size as proposed by the vendor/offeror. Vendor’s proposed cabinets shall be able to hold all medications as specified in attachment A document and include a 25% growth annually in both the number of medications and count of each medication over the next 5 years.

-Research -Cardiology -Pharmacy IV room -Dialysis -Bronchoscopy -PACT #1 -EP Cath Lab #1 -PACT #2 -EP Cath Lab #2 -PACT #3 -Dental Corridor -PFT Lab -Derm/Podiatry -PTSD -Emergency Room -Radiology -Anesthesia Workroom -Eye Clinic Procedure Room -GI/Colonoscopy Med Room -ICU Med Room #1 -ICU Med Room #2 -Infusion Clinic Med Room -Inpatient Medicine A -Inpatient Medicine B -Mental Health #1 -Mental Health #2 -CT Control Room -Ortho/ENT/AMB Blood Draw -OP Mental Health A1 -OP Mental Health A4 -PACU Med Room #3 -PACU/Preop Med Room #2 -PACU/Preop Med Room #1 -Physical Medicine and Rehab -IR Procedure Room -SCI Inpatient Med Room A -SCI Inpatient Med Room B -SCI Outpatient -Cysto/Specialty/Eye -Surgery/Rehab Med Room A -Surgery/Rehab Med Room B -Surgery Clean Core

At least 6 ADCs. At least 1 for each department: Mental Health, Dental, Primary Care, Specialty, Radiology, and Infusion clinics

· One (1) Drug Storage Carousel (medication store and retrieval shelves which spin to a selected drug location) at the RMR VAMC

· Fourteen (1) Anesthesia Stations (provide medication security and safe dispensing for the anesthesia providers during the intraoperative period)

· Thirty-Six (36) refrigerators allowing secure storage of refrigerated medications with inventory tracking and integration into the main system.

· If existing AIOs cannot be used, will need eleven (11) All in One Workstations/Pharmacy Consoles

· One (1) Controlled Substance Safe with at least 11 locking storage doors with adjustable - shelfs inside each compartment).

· Auxiliary Equipment

· All licenses and software to provide a comprehensive system of medication accountability.

· At least a 12 mo. Warranty that includes hardware repairs and software support or if the warranty does not cover all of these items, then the vendor shall include the appropriate support program for coverage to total at least 12 months.

· User Training

*Reference attached ‘Attachment A – ADC Capacity per Location’ document to determine appropriate design, size, and quantity to ensure vendor can meet each location’s specific storage capacity needs.*

6. System will work with the current VISTA and Prime Vendor systems.

7. All equipment shall be FDA cleared.

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

9. System will include inventory management and suggested orders for ADCs.

10. System will have a drug formulary that can link drug names (brand, and generic names) and dose forms (liquids). The formulary must require at least a 5-letter medication name search.

11. The system shall be configured to print reports and can access reports from a computer. System reports must include the ability to show null or cancelled cabinet activity report. A strength rating shall be applied if they can be configured to print reports automatically. **

12. The system shall print patient specific label with drug and dose information when withdrawing from a multi-dose container. Label printers shall be included within the quote.

13. A strength rating shall be applied if the system can access the data server from multiple computers at multiple locations. **

14. A strength rating shall be applied if the system provides Web-access/dashboard for tracking out of stock items, discrepancies, etc. at all locations **

15. Shall be able to assist in the receipt, distribution, and return of medications

16. The barcode scanners shall be able to read 2D barcodes, shall be heavy duty and able to handle constant use. They shall be able to interface with ADCs, controlled substance cabinets, and inventory systems. They shall be hard wired or integrated into the cabinet for ADCs, controlled substance storage, and wireless for carousels.

17. All auxiliary equipment will interface with the ADCs, controlled substance cabinets and the main systems controlling the distribution and security of medications. They will ensure that medications will be accounted for and secured. All auxiliary equipment, such as waste or return to Pharmacy bins, must be a part of the system that will restrict access and be secured to the system as not allow the removal of the auxiliary equipment.

18. The proposal must include a site preparation list of specific facility modifications required to install and operate the system. This includes, but is not limited to, power outlets, data ports, wall mounts, ceiling modifications etc. A general site prep or installation guide does not meet this requirement. The list must be specific to ECH and the clinics.

19. Information Security. All VA sensitive information shall be protected at all times, in accordance with VA Handbook 6500.6 Appendix A. The contractor shall follow all VA rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy & Security, the Privacy Act, and Health Insurance Portability and Accountability Act (HIPPA) requirements when obtaining and reviewing information.

a. The contractor shall report any known or expected security/privacy incidents, or any unauthorized disclosure of sensitive information, to the Contractor Officer’s Representative (COR) within 24 hours of discovery or as soon as possible per the Vendor’s policies.

b. The vendor shall obtain and maintain an Active MOU/ISA for the life of the equipment.

c. The vendor shall agree to work their system through the TRM approval process. A strength rating shall be applied if the system is already TRM approved.

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

e. The vendor shall provide the MDS2.

20. Manuals. 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 the Aurora Main Facility. 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.

21. Integration and Project Management

a. The vendor shall identify a project manager. The vendor shall provide a schedule with deliverables, milestones, site prep work, training plan, risk management plan, and operations and maintenance plan. The vendor shall meet weekly or as-needed with the VA.

b. The vendor 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 Vendors and/or Contractors when necessary to accomplish this task.

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

i. Finalized Server and workstation specifications.

ii. Serial numbers.

iii. MAC addresses of any wireless devices.

d. 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

e. The contractor shall connect all applicable devices to the wireless network and server. Performance shall be validated and documented.

f. 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.

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

xv. Model.

xvi. Serial number.

xvii. Asset number.

xviii. Original deployment location.

xix. Incoming inspection results.

xx. Manufacturer inspection results (if applicable).

h. The cost of travel for onsite installation, training, implementation, and integration services must not exceed the federal Joint Travel Regulations (JTR) rates.

SALIENT CHARACTERISTICS:

· Line Item 0001: Automated Dispensing Cabinets (ADC) **QTY: Minimum of 61 – Final quantity to be determined by the vendor/offeror** At least 43 at the RMR VAMC, 6 at the Colorado Springs Lindstrom CBOC, 2 at the Golden, Aurora, Union CBOCs and 1 at each of the other 6 Clinics as specified in the above table.

Each ADC shall:

· Include a fingerprint scanner, touch screen, keyboard, touchpad, barcode scanner, and label printer for each cabinet.

· Include pockets or cubies which have locking lids. They shall be able to store patient specific medications in a location with a locking mechanism. A strength rating shall be applied if the multiple single-patients’ medications can be found in a single drawer with individual bins that have locking lids. Also, the storage pockets or cubies shall be configurable, and provide flexibility to reconfigure secure storage drawers or areas within drawers to accommodate changing medications requirements at no additional cost. After the award, the VA will configure the cabinet to meet that area’s requirements. Drawers and pockets or cubies shall have mechanisms to prevent tampering using physical methods. Secure cabinets must be a unit in which inventory may only be accessed with bio id, fingerprinting, or unique codes per individual.

· Store large bulky items such as IV fluids. Identification of which cabinets will store bulky items will be identified prior to delivery depending on cabinet location.

· Be able to securely dispense refrigerated or non-refrigerated medications while keeping track of inventory of items in refrigeration. Provide secure dispensing of controlled substances with single unit dispensing restricting access to more than required dose.

· Have inventory reports to optimize station inventory and diversion reports. A strength rating shall be applied if the system can track inventory of patient specific medications (e.g. patient name and drug name). Must be able to report inventory, stock levels, access reports, refill reports, medication tracking, and work with all current VA systems at the facility to maintain inventory and security.

· Alert users for quantities removed greater or less than ordered and require witness verification of inventory, waste, or discrepancies using unique individual access steps. The system shall allow an end user (Nurse) or Pharmacy staff member to select multiple medications for a single patient using a single scan of the badge, without access to other patient’s medications.

· User access: ADCs will have security and various levels of access for individual users. Shall allow for management of users and enable termination or initiation of users from a web-based server interface or similar. The ADC will have a mechanism in place to prevent the addition of temporary users and to allow access to a float user. System shall allow some users to have multiple levels of access. The system shall have the option for increasing security when dispensing controlled substances or other high alert medications (e.g. only access to the needed doses to dispense). The system will leverage bio-ID technology for fingerprint scanning for security. The system shall have to capability to “lock” a user after no more than 5 failed attempts. Pharmacy and other authorized users must be able to manage drug formulary, inventory, users, device settings, run reports, and server setting from the server interface.

· Communicate with pharmacy systems using the same server to transfer admissions, transfers, discharges, and orders in real time.

· Be compatible with VISTA PADE HL7 interface, be HL7 messaging compatible with VISTA, and interface, via HL7 or other means, with other ADCs, carousels, safes, refrigerators, and all medication management systems.

· If communication between the server and ADC fails, the system shall be able to dispense medications (critical override).

· Must have the ability to configure the cabinet’s database to require at least a 5-letter medication name entry.

· Vendor/offeror shall specify the type of configuration and quantity of ADCs, for each of the following CBOCs, using the attached department medication storage list (Attachment A). Vendor shall specify which configuration and quantity of each will go in each ward in their proposal (i.e. two full size cabinet for 2-East or three 6 drawer cabinets for 2-East). Vendor shall identify any medicine incapable of being stored into the ADC and a short description of any limitations the cabinets would pose to existing operations.

· The ADCs shall be able to hold all mediations provided in Attachment A and account for a 25% growth annually in both the number of medications and count of each mediation over the next 5 years.

· Line Item 0002: One (1) Drug Storage Carousel

The Carousel shall:

· Integrate with ADCs for replenishment of ADCs.

· Be HL7 messaging compatible with VISTA.

· Be able, upon receiving a new order from HL7 interface or VISTA, correctly spin to the correct drug, have a mechanism (e.g., display pointing to correct location of drug) to identify where drug is stored, print a patient specific label, group multiple order for one patient. The printers shall be included within the quote. A strength rating shall be applied if a BCMA barcode can be incorporated.

· Have user interfaces that will include biometrics, display, keyboard, mouse, touch screen, wireless hand scanners.

· Have the following systems capability: Suggested order, inventory management, usage reports, ability to add/move/remove drugs from active inventory, remote location inventory (e.g., drug inventory not stocked in carousel) and the ability to easily manage the remote inventory.

· Be able to report current inventory, stocking activity, system changes, user access, and user actions. User shall be able to access it from the server interface.

· Be able to receive cart fill list via HL7 interface and will have the ability to either skip or pick items currently stocked in ADC depending on administration system settings.

· Have the ability of a user to manually access all stored medications in the event of a total power loss, malfunction, or damage to electric motor.

· Must be compatible with 2D barcodes to capture lots and expiration dates from compatible drug bottles barcodes and be able to store that information on the server.

· Be able to interface with site’s prime vendor (McKesson Drug).

· Be able to store the same drug in multiple storage bins.

· Allow for the storage of more than one drug per storage bin.

· Be able to discern between bulk bottles and unit dose medications for the same drug.

· A strength rating shall be applied if the device is energy star rated. **

· A strength rating shall be applied if the system provides storage locations outside of carousels and tracking (e.g. keep track of refrigerator stock).**

· Have the ability to connect to all other components within the Pharmacy dispensing system. ie. ADM’s Carousel, Safes, cabinets, packager, auxiliary equipment.

· Must include a wireless barcode scanner and printer for each carousel.

· Each carousel shall be no larger than 155 W x 95” D x 120”H with the work counter.

· Line Item 0003: One (1) Controlled Substance Safe (at least 11 storage compartments) at the main facility.

The safe shall:

· Report inventory reconciliation between ADCs and product dispensed from Pharmacy Vault.

· Be able to run reports to trace medications, individuals, or access.

· Include drug accountability from receipt to waste.

· Store medication under security and have levels of access for individual users.

· Be able to store multiple drugs per storage area (e.g. one storage bin with 4 drugs stored)

· Have the ability to print reports that includes facilitation of drug tracers, medication reconciliation, discrepancy resolution, quality assurance reports, Controlled Substance Safe inventory, ADC inventory and dispensing record, ADC suggested order or pick list.

· Dispense patient specific medications (e.g. outpatient prescriptions) or to ADCs while tracking inventory in real time.

· Have ability to store waste in a secure location away from other pharmacy inventory. Contents of waste report shall be included.

· Include a barcode scanner and printer per safe.

· Be able to hold syringes, 1L IV bags, and at least room for 200-1000 count standard medication bottles.

· The safe shall be no larger than 125” W x 30” D x 85” H. Vendors/offerors shall specify the clearance required to safely open the drawers and operate the system within their proposal.

· Clear doors are preferred but not mandatory

· Line Item 0004: (14) Anesthesia Stations

Each Anesthesia station shall:

· Will provide a secure environment for controlled substances and non-controlled medications.

· Will come with or be compatible with an anesthesia barcode medication labeling system.

· Must include a bar code scanner and printer.

· Each anesthesia ADC shall include an external storage bin.

· Each anesthesia ADC shall be no larger than 52”W x 32”D x 65”H.

· Line Item 0005: (14) Medication Storage Refrigerators

· Shall be between 5-10 cu feet

· Shall be secure by using a locking mechanism to prevent diversion.

· A strength rating shall be applied if the system has locking refrigerator bins or drawers.

· Allow secure storage of refrigerated controlled substances in individual locking bins or drawers that open and lock based on communication from the ADC equipment.

· All will be delivered to main, Aurora facility.

· Line Item 0006 (22) Medication Storage Refrigerators

· Shall be between 12-15 cu feet

· Shall be secure by using a locking mechanism to prevent diversion.

· A strength rating shall be applied if the system has locking refrigerator bins or drawers.

· Allow secure storage of refrigerated controlled substances in individual locking bins that open and lock based on communication from the ADC equipment.

· Line Item 0007: Licenses and Software

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

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

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

· 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.

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

· 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.

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

· HTM shall be able to login, restart, shutdown and preform basic maintenance on servers with any vendor software loaded.

· For Windows-based devices, the vendor shall agree to provide a complete software and application inventory for all system components. A strength rating shall be applied if the SMAK toolkit can be installed without voiding the support agreement or warranty. Shall allow for management of users and enable termination or initiation of users from a web-based server interface or similar.

· ECH will build and host the virtual server. Specifications for the virtual server shall be provided with the vendor’s proposal.

· Line Item 0008: Auxiliary Equipment

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

· Line Item 0009: TRAINING

USER TRAINING

· The vendor shall provide clinical training onsite at each location. Assume 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, and on-site training, as appropriate. The Contractor must provide web-based training, self-paced to include modular training for clinical, that must be shared across VISNs at no additional cost to VA. Number of users expecting training: 6 pharmacy super-users, 7 pharmacy train-the-trainer users, 2 CBOCs train-the-trainer users (at each CBOC), 40 nursing train-the-trainer users at main facility:

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

· Follow-on training shall be quoted for an additional 3 users per site to be taken within one year of post go-live. The Contractor shall provide guidance on completing any adjustments or other actions that may be undertaken by operating personnel in the event of malfunction or failure.

· The Contractor shall provide training manuals and instruction materials with implementation with each update to each attendee.

· Line Item 0010: Warranty and Support Agreement

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

· Line Item 0011: Relocation of Existing Equipment from the RMRVAMC and CBOCs

· The vendor shall relocate all existing equipment to a designated site within the RMR VAMC and the ECH CBOCs to a designated space for disposal by ECH personnel. A strength rating shall be applied if a trade-in is offered and disposal by the vendor is included.