Draft SOW - Pill Packaging System.docx

Department of Veterans Affairs VISN 19 Contracting – NCO19 VISN 19 Rocky Mountain Network Pill Packaging Procurement

STATEMENT OF WORK

1. Background:

VISN19 is seeking the procurement of one (1) computerized automated unit dose repacking machine systems (pill packaging system) at the Eastern Colorado Healthcare System. 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 procurement shall include all parts, materials, labor, software/licenses, and travel to complete the full installation of the unit dose packaging machines. It shall include de-installation of the current system. In addition, the contractor shall provide clinical and technical user training, as needed, to ensure safe operation of the new pill packaging 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.

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).

Table 1 – Location

554 - VA Eastern Colorado Health Care System (ECH)

VA Rocky Mountain Regional Medical Center

1700 N Wheeling St, Aurora CO 80045

2. Functional and technical specifications:

2.1. The requirement is for the replacement of the pill packaging systems utilized at the location listed above. 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.

2.2. The pill packaging system shall consist of the following facility specific specifications:

2.2.1. Eastern Colorado-Main Hospital Requirement: One (1) unit dose packaging unit with a cannister quantity of at least 400.

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

2.4. 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.

2.5. 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.

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

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

2.8. 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.

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

2.10. 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.

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

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

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

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

2.15. 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.

2.16. 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.

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

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

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

2.20. 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.

2.21. 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).

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

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

2.24. The packaging system shall be able to interface with existing pharmacy information systems. (VISTA)

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

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

2.27. Licenses and Software:

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

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

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

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

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

2.27.6. 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.

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

2.27.8. 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.

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

2.27.10. 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.

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

2.28. 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.

2.29. Networking Requirements.

2.29.1. 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.

2.29.2. 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.

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

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

2.30. Cleaning/Sterilization Requirements.

2.30.1. 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.

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

2.31. Delivery Requirements:

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

2.31.1.1. Serial numbers.

2.31.1.2. MAC addresses of any wireless devices.

2.31.2. Delivery is required 180 days from award of the contract.

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

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

2.32. Installation Requirements

2.32.1. 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.

2.32.2. 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.

2.33. De-Installation Requirements

2.33.1. De-installation of the existing packaging system is required. A strength rating shall be applied if a trade-in is offered.

2.33.2. Contractor shall remove any hard-drives or storage systems containing sensitive or patient health information and consign to Biomedical Engineering staff for proper sanitization.

2.33.3. No equipment will be left on site once install is complete.

2.33.4. Vendor must ensure that staff installation or removal of equipment has no criminal history that would pose a risk to the pharmacy and inventory.

2.33.5. The existing equipment consists of:

2.34. Training Requirements

2.34.1. Contract shall include training for the end-users in the operation of the system. Training shall be on the function and use of the device, in addition to any software/applications. Training shall be on-site for at least one day.

2.34.2. Contract shall include optional training for the technical professionals (Biomedical Equipment Support Specialists) Training shall cover the maintenance, troubleshooting, and repair of the system.

2.35. Contractor Requirements

2.35.1. All Contractor personnel performing installation services of the equipment shall have factory training and experience in the implementation of the equipment. Contractor shall provide copies of training certificates for the Contractor personnel performing work on-site upon the request of the Government.

2.36. Warranty Information

2.36.1. The equipment and software shall have a warranty and/or a support agreement of at least 12-months from the full installation/acceptance of the equipment included.

2.36.2. Warranty/support agreement shall include repair of the system, including hardware and software maintenance.

2.36.3. The warranty/support agreement shall include preventative maintenance of the system.

2.36.4. The warranty/support agreement shall include all software maintenance, bug fixes, software updates, and troubleshooting needed to keep the software operational.

2.36.5. The Warranty/support agreement shall include all parts, materials, labor, and travel to complete the repair or maintenance. Requests for warranty support shall be made to the telephone support number provided by the Contractor.

2.36.6. The warranty/support agreement shall include remote support. The Contractor must have a completed MOU/ISA.

2.36.7. Warranty/support agreement requests shall be responded to within 24 hours. Contractor shall perform any available system updates during the warranty period at the discretion of Biomedical Engineering.

2.36.8. Contractor shall provide a copy of the service report, complete with test data, to the contract COR/Biomedical Engineering Designee within five working days after completion of any services.

2.36.9. Service reports shall include identifying information about the equipment, all services provided during the service visit, any issues found during the visit, the technician/engineer’s names of the personnel performing work, and the date service was provided.

2.37. On-Site Procedures

2.37.1. Contractor personnel arriving on-site to perform work shall report to the Biomedical Engineering Department.

2.37.2. Contractor personnel shall sign in using the department vendor sign-in sheet, filling out all required information.

2.37.3. Contractor personnel’s tool bags are subject to inspection by the Biomedical Engineering department upon arrival and upon departure.

2.37.4. Contractor personnel shall sign upon completion of visit. Prior to departure, Contractor personnel are required to, at a minimum, verbally report any issues with the equipment to the Biomedical Engineering department, especially noting if the system is still down or not fully repaired.

2.37.5. The VA campus is non-smoking. Contractor personnel are required to comply with this policy.

2.37.6. Parking. It is the responsibility of the Contractor to park in the appropriate designated parking areas.

2.38. 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.

2.39. 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.

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

2.40.1. Unboxing.

2.40.2. Staging of equipment.

2.40.3. Incoming inspection

2.40.4. Download of infusion library/dataset.

2.40.5. Asset sticker tagging.

2.40.6. Maintenance sticker tagging.

2.40.7. Disinfection of equipment.

2.40.8. Removal of trash.

2.40.9. Installation at all sites listed

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

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

2.42.1. Determining project tasks.

2.42.2. Scheduling meetings with stakeholders.

2.42.3. Developing timelines.

2.42.4. Closing out project with sustainment plan.

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

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

2.43.1. Model.

2.43.2. Serial number.

2.43.3. Asset number.

2.43.4. Original deployment location.

2.43.5. Incoming inspection results.

2.43.6. Manufacturer inspection results (if applicable).

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

2.45. Safety and Security Contractor shall follow all Occupational Safety and Health Administration (OSHA) laws and regulations. The Contractor is responsible for reporting any hazards they come across to their point of contact. Contractor shall follow all local procedures concerning infection control. Should the Contractor be unsure of the requirements, the COR can provide the specific information and procedures. Contractor personnel shall wear visible identification at all times while on VA property. Contract personnel are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials.

2.46. Property Damage The contractor shall take all necessary precautions to prevent damage to any Government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (i.e., trees, shrubs, lawn/turf, curbs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the Government, upon approval of the Contracting Officer.

2.47. QUALITY ASSURANCE End-users, Biomedical Engineering, site POC and/or the contract COR shall perform system verification tests to ensure the system is fully functional. Issues with the quality of the Contractor s work will be communicated through the Contracting Officer to the Contractor point of contact for resolution. Documentation with be completed in the Government systems.

IV. Information Security:

NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy.

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(END OF CLAUSE)

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY language FOR Inclusion into CONTRACTS, as appropriate

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

ACCESS to VA INFORMATION AND VA INFORMATION SYSTEMS

1. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

1. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

INFORMATION SECURITY/PRIVACY REQUIREMENTS

VA Maintenance/Installation Contracts

1. VA INFORMATION CUSTODIAL LANGUAGE

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

2. SECURITY INCIDENT INVESTIGATION

The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

3. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $42.00 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,00.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

4. TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Department of Veterans Affairs (VA) Information Security Rules of Behavior (ROB) for Organizational Users, Appendix A relating to access to VA information and information systems;

(2) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior training and annually complete required privacy and security training; and

(3) Successfully complete any additional information security or privacy training, as required for VA personnel with equivalent information system access.

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.