Attachment B

DRAFT PERFORMANCE WORK STATEMENT

Inpatient Pharmacy Automation Dispensing 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 Inpatient Pharmacy Automation System (IPAS) suites across the country.

The suite of equipment includes automation dispensing cabinets, IV prep systems, carousels, refrigerators, auxiliary equipment and accessories. 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 provide all equipment, supplies, transportation, tools, materials, supervision, and other items and non-personal services necessary to install and support the inpatient pharmacy automation system as defined in this Performance Work Statement (PWS), except for those items specified as government furnished property and services. The Contractor shall perform to the standards in this performance work statement.

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

1. The system shall store and dispense controlled and non-controlled medications and products in various packaging forms, sizes, and types, including but not limited to:

• Ampules

• Bags (e.g., Ready-To-Use IV bags, premixed IV bags)

• Bottled medications (e.g., oral liquids, spray, canister, droppers)

• Boxes (e.g., dose packs, inhalers, cream, ointment)

• Refrigerated medications

• Syringes up to 60ml (e.g., oral syringes, intravenous (IV) syringe)

• Unit dose packaged medications (e.g., blister packs, liquid cups)

• Re-packaged medications

• Vials (e.g., single-dose, multi-dose)

• Patient-specific medications

2. The system shall support equipment appropriate for specific clinical settings, including but not limited to clinics, inpatient wards, pharmacies, sterile environments (e.g., operating rooms), community-based facilities, or other ambulatory service areas.

3. The system shall accurately increment and decrement the medication inventory during user transactions (e.g., dispensing, returning, wasting, refilling).

4. The purchase of the IPAS shall include all installed equipment at the facility. This includes:

• 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.

• Drug Storage Carousel (medication store and retrieval shelves which spin to a selected drug location along with workstations)

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

• Controlled Substance Safe with at least 3 locking storage doors with adjustable shelves inside each compartment.

• Controlled Substance Safe with at least 11 locking storage doors with adjustable shelves inside each compartment.

• Refrigerators allowing secure storage of refrigerated medications with inventory tracking and integration into the main system. Refrigerator offerings shall include at least two sizes, one between 5-10 cu feet and the other 12-15 cu feet. If available, the vendor shall offer locking mechanisms or medication storage drawers that do not require a specific refrigerator to be purchased.

• IV prep system, software, and all accessories

• Dose Retrieval automation

• Auxiliary Equipment (waste bins, smart shelves, etc.)

• Accessories (label printers, barcode scanners, All in one workstations, Anesthesia point of care labeling solutions, etc.)

• All licenses and software to provide a comprehensive system of medication accountability for a specified number of users.

• All interfaces required to connect devices to server, including third party interfaces.

• At least a 12 mo. warranty that includes hardware repairs and software support or if the warranty does not cover all these items, then the contractor shall include the appropriate support program for coverage to total at least 12 months following individual award.

• User Training

• Annual support agreement/hardware & software maintenance throughout the life of the contract. The support agreement shall include software updates to ensure the product is not obsolete during the life of the contract.

5. The system shall display and utilize a clinical setting-specific patient list and a global patient list for medication administration.

6. The system shall alert the clinical setting user whenever a product is not available (e.g., temporarily out of stock) and direct the user to nearby equipment in clinical settings with available stock.

7. The system shall use barcode scanning. The barcode scanners shall be able to read 1D and 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 and controlled substance storage. The scanners shall be wireless for carousels. The barcode scanning system shall be able to assist in the receipt, distribution, and return of medications.

8. The system shall provide inventory management and an automated audit trail.

9. The system shall allow physical access to the medications, via manual lock and key, during power failure and device outages.

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

11. 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.

12. 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.

13. 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.

14. System will integrate with the current VISTA, EHR Cerner/Oracle Health, and Prime Vendor Systems (McKesson but is subject to change).

Everhardt, Danielle M.

Does everyone use Mckesson?

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

16. The proposal shall include all software and licenses to fully operate the system using virtual servers provided by the local facility. User licenses shall be included in the quantity specified in each task order.

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

18. All axillary items, components, and accessories will be listed as separate line items within the price book to allow for additional ordering should one be needed (waste bin, barcode scanner, labeling printer, workstation etc).

19. Remediation, vulnerability fixes, and upgrade services pertaining to recalls and medical device correction notices shall be available at no-cost to VA.

20. The system shall allow authorized users to perform system activity functions remotely and locally (e.g., reset drawers on equipment, restart a server).

21. The system shall support the importing of external configuration data (e.g., drug files, user database, formulary data, equipment in clinical settings) from an external source file (e.g., database, spreadsheet, text file).

22. The system shall support the initial and ongoing import and utilization of external source files.

23. The system shall be configurable by local sites to log users out of the system automatically (e.g., the session times out after three minutes of inactivity).

24. The system shall provide roles-based access to administer the ability:

• For local users to manage temporary accounts (e.g., username/password)

• Suspension of user credentials due to system access inactivity (e.g., user has not logged-in within the 30 days)

• Administer, per medication, the requirement of verification via second authorized user during transactions, to administer, per user role, the requirement of verification via a second authorized user during transactions (e.g., system administrator assigning to nurse access to controlled medications)

• Review of all medication orders by a pharmacist prior to dispensing (e.g., medication profiling from pharmacy information system).

• To assign program office managed medication label templates on a per medication basis (e.g., IVs, cream/ointment, eye drops, syringes, unit dose, outpatient prescriptions).

• access to design and distribute medication label templates.

• The system shall provide unique qualifiers (e.g., high alert, locally controlled, sound-a- like/ look-a-like, override medications) within drug properties configurable by roles bases access

• To administer the ability to prompt users, per medication, verification of the inventory during transactions (e.g., loading, refilling, dispensing).

• to administer the guardrails for the dispensing of medications due to predetermined conditions (e.g., expired medication, incorrectly stocked, user access level).

• To administer the ability to withhold medications that are not due for administration based on site-defined time frame.

• to administer the setting defining the configurable minimum number of characters necessary to activate the search functionality.

• to administer the ability to allow the return of unused and sealed controlled medication(s) to a secured integrated return bin.

• to administer the definition and assignment of local user roles and access to the equipment in clinical settings.

• to define the unique patient identifier (e.g., VHA identification number) displayed on the equipment.

• to administer the connection to a network printer (e.g., inkjet, laser, thermal) for printing reports (e.g., user report, inventory, system reports).

• the ability to schedule the generation of pre-determined and ADHOC reports.

• to administer the parameters for incremental database back-up.

25. The system shall automatically document transactions including details [(e.g., date, time, drug, patient, dose, quantity, username, witness information (when applicable), user identifications (IDs)].

26. The system shall allow for the electronic issuance and receipt of controlled medications between different equipment located in separate equipment in clinical settings (e.g., equipment located on Ward 3A can issue and receive controlled substances to and from any equipment located at the local site)

27. The system shall be capable of transaction continuity by allowing users to start transactions on equipment in one clinical setting and allow completion of that transaction on equipment in a different clinical setting (e.g., start transaction on equipment located in Ward 3A and complete transaction on equipment located in Ward 3B).

28. The system shall allow authorized users to monitor and perform administrative functionalities. For example:

• Managing of medications within clinical settings (e.g., assign medication, modify par level, modify inventory)

• Resetting/restarting of equipment in clinical settings

• Managing database (e.g., users, formulary, drug files)

29. The system shall aggregate and display the operational status of locally deployed network connected equipment in clinical settings equipment for local site administrators via dashboard.

30. The system shall present a list of medications due for administration for a selected patient.

31. The system shall serially dispense medications when multiple medications are selected for removal (e.g., allow users to withdraw one medication at a time).

32. The system shall allow authorized users to filter the medication pick list.

33. The system shall cross-reference when performing medication searches within the system (i.e., user search using brand name, while the system displays the generic name for reference).

34. The system shall allow users to suspend inventory transactions or cancel all other in- progress transactions.

35. The system shall display two patient identifiers, one of which is the patient name.

36. The system shall archive and unarchive data. The system shall ingest and utilize archived data.

37. The system shall have a minimum underlying Operating System (OS) of Microsoft® Windows™ 11 and Windows™ Server 2019 or as approved by the VHA Cybersecurity Division

38. The system shall provide an Enterprise Management Server (EMS) supporting sites with capabilities (e.g., patch management, security monitoring, and reporting functions).

39. The Government will be responsible for the scheduling and installation of Contractor deployed patches to the devices.

40. 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.

41. The Government shall provide station and server environment, data center and network availability, conformance with minimum server environment requirements for the system provided by the Contractor during project scoping, and a virtual platform mutually agreed upon by the Government and Contractor for all Contractor-provided Virtual Machine deployments.

42. For software deployed using VM technology, the Government will provide all services for database backup and recovery, operating system patches, updates and security, and the performance of the applicable relational database server (e.g., Microsoft® Structured Query Language) instance for the system components as set forth in the mutually agreed upon Equipment Requirements Schedule.

43. Customer Portal: The system shall provide authorized users role-based access to an interactive web-based customer portal with graphical representation and drill-down charts

44. The system shall generate and print reports. The system shall export reports into multiple file formats

(e.g., spreadsheet, database, text file). The system shall provide descriptive statistical analysis reports (e.g., average usage, frequency distribution, and standard deviations). The system shall centrally collate data into a single enterprise database, and create visual representation of descriptive statistical analysis reports (e.g., histograms, bar charts, and frequency tables). The system shall generate reports in real-time without negatively affecting system performance.

45. The system shall maintain logs (e.g., activity logs, issue logs, technical logs).The system shall utilize log data to generate reports. The pre-determined reports shall include:

• User activity reports (e.g., load, refill, unload, remove, return, waste, override, log-in attempts)

• Inventory reports (e.g., load list, refill list, expired list, inventory list)

• System reports (e.g., user database, formulary, data dictionary, data schema, maintenance report, failed drawer/pocket, system status)

46. The system shall maintain transaction data upon loss of network connectivity. The system shall automatically reconcile transaction data upon re-establishment of network connectivity. The system shall utilize the Commvault to back-up and restore transaction data based on Government defined timeframe (e.g., 30 days, 45 days, or 60 days). The system shall rebuild damaged/lost files during data recovery processes using database back-up data.

C. DEVICE SPECIFIC REQUIREMENTS

o Line Item 0001: Automated Dispensing Cabinets (ADC)

Each ADC shall:

Include a fingerprint scanner, touch screen, keyboard, touchpad, barcode scanner, and label printer for each cabinet. Each of these accessories will be listed as separate line items within the price book to allow for additional ordering should one be needed.

Include pockets or cubies which have locking lids. They shall be able to store patient specific medications in a location with a locking mechanism 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.

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

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. 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 of 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.

Shall integrate with the Oracle Health and/or Cerner electronic health record within the VHA.

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.

The system shall provide adjustable configurations to support local sites’ dynamic capacity needs (i.e., minimum storage capacity per equipment in clinical settings of 120 medications and configurable up to 300+ medications).

The system shall provide adjustable configurations allowing local sites to share common stocks on separate devices (e.g., floor stock from Ward 3A can be used (dispensed) by users from Ward 3B).

o Line Item 0002: 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.

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.

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, touchscreen workstation, and printer for each carousel. Each of these accessories will be listed as separate line items within the price book to allow for additional ordering should one be needed.

o Line Item 0003: 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.

For sites without an anesthesia station but require anesthesia medication labeling (moderate sedation), a point of care labeling printer shall be included.

Must include a bar code scanner and printer.

Each anesthesia ADC shall include an external storage bin.

o Line Item 0004: Controlled Substance Safe (at least 3 storage compartments) 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.

Have 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, discrepancies, quality assurance reports, Controlled Substance Safe inventory, ADC inventory and dispensing record, ADC suggested order or pick list, Drug diversion automated trending events that fall outside the parameters.

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

Have the ability to store waste in a secure location away from other pharmacy inventory.

Contents of waste report shall be included.

Be capable to run reports to show Override removal vs documentation time, Removal time vs documentation time, Waste vs documentation vs removal vs removals amounts/times, Anomalous usage report of Individuals with High usage. Ideally with a filter feature.

Include a barcode scanner and printer per cabinet.

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

Vendors shall specify the clearance required to safely open the drawers and operate the system within their proposal.

Clear doors and solid doors shall be offered.

o Line Item 0005: Controlled Substance Safe (at least 11 storage compartments) 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 include facilitation of drug tracers, medication reconciliation, discrepancy resystem, 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.

Contractors/offerors shall specify the clearance required to safely open the drawers and operate the system within their proposal.

Clear doors and solid doors shall be included in the IDIQ o Line Item 0006: Medication Storage Refrigerators Shall be between 5-10 cu feet Shall be secure by using a locking mechanism to prevent diversion.

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

A catalog of available options (hinge configurations etc) shall be provided at the time of a sites individual award.

o Line Item 0007 Medication Storage Refrigerators Shall be between 12-15 cu feet Shall be secure by using a locking mechanism to prevent diversion.

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

A catalog of available options (hinge configurations etc) shall be provided at the time of a sites individual award.

o Optional Item 0008: Medication Refrigerator Locks and/or Drawers

Be able to securely dispense refrigerated or non-refrigerated medications while keeping track of inventory of items in refrigeration.

o Line Item 0009: IV Prep Shall be able to interface with existing pharmacy information systems. (VISTA/Oracle

Health). All integration fees shall be included as a sperate line item.

The system shall support electronic orders from the EHR.

Shall support bulk compounding for non-patient specific IVs Shall support reassigning previously compounded unused preparations for alternate patient use.

Shall support dynamic Beyond Used dating based on compounding characteristics.

The system shall capture all compounding activities performed.

Support photographing the compound in various stages of preparation.

Support for both volumetric and gravimetric dose analysis.

• Provide drug formulary containing density information to support gravimetric analysis.

Support remote pharmacist verification.

Meet USP 797 and 800 standards for compounding sterile and hazardous medications.

Include all component hardware such as scales, cameras, client workstations, etc.

o Line Item 0010: Licenses and Software

Software to support analytics, nursing, or other licenses shall be included as options in the IDIQ.

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

The Contractor shall provide upgradeable perpetual licenses as Contractor Acquired Property (CAP). All licenses required for the operations and sustainment of IPAS are CAP. Perpetual licenses shall be upgraded at no additional cost to the government. When subscription-based licensing is required, the Contractor shall acquire the licensing as CAP. Hardware shall be upgraded to accommodate licensing requirements at no additional cost to the government. The Contractor shall upgrade licenses when commercial offerings are available. The Contractor shall acquire licenses to maintain the cybersecurity posture of the system.

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.

All VA sensitive information shall be protected at all times, in accordance with VA Handbook 6500.6 Appendix A and the VA directive 6550. 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.

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 Contractor’s policies.

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

If the system/software will be installed on VHA-Owned IT computers, the vendor must ensure all deliverables comply with the VA Technical Reference Model (TRM) v26.1 Standards Profile and Product List. All software components must be listed in the approved Product List, and all technical specifications must reference applicable TRM standards. Compliance shall be documented in the RTM and reviewed by the VA Office of Information and Technology before project installation.

All medical devices/systems that connect to the Veterans Health Administration network or store sensitive patient information must undergo an Enterprise Risk Assessment (ERA) prior to deployment of the system.

The system shall have an OS with current commercial support. All major component software applications (SQL, IIS, .Net, etc.) have current commercial support.

The contractor shall provide the MDS2.

Software Update/Patching: Software update and/or application patching shall be included. Contractor/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 contractor approves the patch.

HTM shall be able to login, restart, shutdown and perform basic maintenance on servers with any contractor software loaded.

For Windows-based devices, the contractor shall agree to provide a complete software and application inventory for all system components.

Each station/VISN shall build and host the virtual server. Specifications for the virtual server shall be provided with the contractor’s proposal.

o Line Item 0011: Auxiliary Equipment

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.

o Line Item 0012: Training

• 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.

• 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.

o 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.

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

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

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

o Line Item 0013-14: Warranty, Maintenance Support Resources, Support Agreement and Hardware & Software Maintenance General:

• The Contractor shall furnish maintenance service support that includes, as a minimum, scheduled and corrective maintenance services for the ADC 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.

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

• 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).

• 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.

• 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 ADCs. This shall be independent from any post warranty service support purchased by the Government for a specific site.

• 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.

• 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.

• 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.

• 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.

• 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.

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

• 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.

• 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.

• 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.

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

• 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.

• 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.

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

• 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).

• 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.

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

• 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).

• 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

• 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.

• 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.

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

• 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.

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

• 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:

o Name of contractor and contract number o Name of FSE who performed services o Contractor service ESR number/log number o Date, time (starting and ending), equipment downtime and hours on-site for service call.

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

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

o Identification of equipment to be serviced:

o Inventory ID number, o Manufacturer's name, device name, model number & serial number, o Any other manufacturer's identification numbers.

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

o Labor and Travel, o Parts (with part numbers), o Materials and Circuit Location of problem/corrective action.

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

o Signatures:

o FSE performing services described.

o Authorized VA Employee who witnessed service described.

o NOTE: - Any additional charges claimed must be approved by the COR or CO before service is completed

• 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).

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

• 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.

Warranty:

• Meet all the general requirements above.

• 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.

• 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 ADC 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.

Commercial Post Warranty Maintenance Plan Support shall:

• Meet all the general requirements above.

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

• Contractors are encouraged to offer their normal, commercial maintenance service plans (based on their standard commercial maintenance service terms and conditions.

If such commercial plans are offered, the following shall be provided:

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

• 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.)

• 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.

• The Contractor shall provide diagnostic and repair services, as well as preventative maintenance via on-site or remote support o Line Item 0015: Delivery and Installation

• The vendor shall deliver the equipment to the designated location(s) and perform all installation tasks required.

o Line Item 0016-0017: Deinstallation and Relocation of equipment

• 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)

• 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.

• 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.

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

o Line Item 0018: EHR Integration

• VHA Oracle Health /IPAS 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.

• The IPAS Contractor shall implement, maintain, and update an interface between the IPAS and VHA Oracle Health systems.

• The Contractor shall implement and upgrade the IPAS/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.

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

• 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.

• 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.

• 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.

• 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.

o Line Item 0019: Interface Requirements

• The IPAS shall support interface connections to external…