GL_CMOP_UUA_SOR_v4-DRAFT w Attachments.docx

B.3. STATEMENT OF REQUIREMENTS (SOR)

Great Lakes CMOP Unit of Use Automation (UUA)

PART I: BACKGROUND

A. INTRODUCTION

1. The Great Lakes Consolidated Mail Outpatient Pharmacy (CMOP), located in Hines, Illinois, requires a Unit of Use Automation (UUA) that fully supports industry dispensing trends, provides improvements in processing accuracy and throughput, contains all commercial-off-the-shelf (COTS) as well as commercially available replacement components for sustainment maintenance, and is expandable and configurable to meet an increase with future prescription fulfillment needs.

2. The Great Lakes CMOP is one of seven CMOP facilities located across the United States. This Department of Veterans Affairs (VA) program provides prescription fulfillment and mailing for veteran patients and beneficiaries. Advanced industry standard automation and equipment systems are used in this highly automated environment to fulfill prescription orders generated by the Department of Veterans Affairs Medical Centers (VAMCs) and Community Based Outpatient Clinics (CBOCs). Great Lakes CMOP also provides prescription fulfillment and mailing for Indian Health Service Pharmacies (IHS) with the potential for future growth based upon agreements with other Federal agencies.

B. STATEMENT OF NEED

The purpose of this procurement is to design, build, interconnect, and integrate a proven Unit of Use Automation (UUA) system that is fully integrated with a new Tablet and Capsule (counting) Automation (TCA) and Packing system, which is under contract with Innovations Associates, Inc. (Public Award Notice Number 36C77024C0005). The systems integrator is required to fully interface the VA’s Central Database (CDB), OneCMOP, VA Technical Reference Model (VA TRM) approved Microsoft operating systems, VA’s Warehouse Management System (WMS) and NEXiA® throughout all systems. The UUA must have no single point of failure and must meet the accuracy, timeliness, and throughput requirements to include the dynamic flow of workload from the TCA to the UUA system and includes Cold Chain dispensing and packing. It must support integration (but is not limited to) of all components (equipment, computers, conveyance, scanning, labeling, sorting, electrical, E-stop) and life safety features meeting all OSHA standards. Additional inclusive hardware is as follows (but is not limited to): ancillary support systems, automatic labelling, collation, automatic verification, computer servers, computer workstations, and packing components. Software must be VA TRM approved and integrate with existing Warehouse Management System (WMS), VA’s CMOP National data infrastructure, VA’s OneCMOP, exchange data with the VA’s MS SQL server data backbone, NEXiA®, and include comprehensive data logging, collection, bidirectional data update, and reporting systems that are required to support the UUA and its full integration with the TCA. The UUA system must be capable of dispensing unit of use products of various sizes, shapes, and weights. All software and hardware solutions must conform to the Statement of Requirements (SOR). The UUA system shall be capable of a minimum of 50,000 ambient items per 7.5 hours of operation (within an 8-hour work shift) and a minimum 18,000 refrigerated items per 7.5 hours of operation (within an 8-hour work shift).

A successful UUA system implementation will have the following characteristics:

· The UUA must be a turn-key system with all components, operating systems and other dependent software in compliance with approved VA TRM standards, VA Directive 6500 and Handbook, VA Cybersecurity Program, Risk Management Framework for VA Information Systems, VA Information Security Program, and NIST SP 800-53 rev. 5, Security and Privacy Controls for Information Systems and Organizations CM-6: Configuration Settings Checklists and all other VA standardized processes.

· The UUA system must have a seamless integration with existing control systems, WMS, VA Production CMOP software, VA Central Database, VA OneCMOP, VA’s MS SQL server data backbone, NEXiA® software, and with the TCA system for any collated combination orders (defined as patient orders that require both TCA items and UUA items to be shipped).

· The UUA system automatically dispenses AND labels ambient and refrigerated Unit of Use prescriptions utilizing automatic verification while using a minimum number of Full Time Employees (FTEs). The system must also complete all necessary Pharmacist Verification (PV) collation and packing of UUA and combination orders (with matching destination shipments from the TCA).

· The UUA system installation needs to minimally disrupt existing CMOP operations as little as possible in the integration and implementation plan.

· The UUA system should fit within the provided footprint while also being able to meet its throughput requirements.

· The UUA system will be fully integrated, accepted, operational, and processing prescriptions within two years from contract award.

C. DEFINITIONS

ACK – Acknowledge.

API - Application Programming Interfaces.

Automated Production System Database Structure (APSDS) – Database tables and electronic data format in a Microsoft SQL Server database structure that provides for two-way data exchange between VA patient orders, the UUA, and the Central Database (CDB).

AVS – Auto Verify Signature.

Backordered Prescription – A prescription for an out-of-stock item that is unavailable for fulfillment through the production system.

Central Database (CDB) – A MS-SQL database consisting of all VA CMOP prescription data details required for prescription fulfillment. The CDB resides in Tucson, AZ.

Collate - Combine items and potentially vials into a group for parcel package shipment.

Combination Orders – (Combo Orders) Orders that are comprised of labeled dispensed product vials from the TCA system AND ambient items (could potentially include refrigerated items) UUA system that are capable of being packed into one shipping parcel.

COR – Contracting Officer’s Representative.

Commercial Of The Shelf (COTS) – per the Federal Acquisition Regulation, a commercial product that is sold in substantial quantities in the commercial marketplace, and when offered to the Government under a contract or subcontract at any tier without modification and in the same form, which it is sold in the commercial marketplace.

Dispense - An automated process designed to accurately deliver the product. For the UUA it will dispense pre-packaged unit-of-issue product items.

Document Set – Patient specific printed documents that may (but not necessarily) consist of a refill request form, address correction form, medication instructions, and information.

Dynamic flow – A manufacturing process where the flow of workload constantly adjusts to changing conditions, allowing for flexibility and responsiveness to real-time demands.

EASY OPEN - Refers to caps on filled prescription bottles, which are capable of being opened with either the safety ring removed or disabled on the bottle’s cap.

Ergonomic Design Principles – Industry standard principles to prevent musculoskeletal disorders and injuries by adherence to ergonomic design principles (e.g. allow for shortest and tallest workers, avoiding forced forward posture of the head, avoiding narrow viewing angles, avoiding visual obstructions, avoiding reaches above the shoulder, avoid greater than 45 degree shoulder flexion and abduction, avoid excessive reaching and repetitive movements, enable placement of items and parts between shoulders and waist height, capable of work surfaces designed just below elbow height (heavy work surfaces would be 6-8” below elbow height), maintain neutral posture, avoid repeated or sustained flexion and ulnar deviation with hands, avoid repeated or sustained pinching and allow for small hands when designing gripping tasks, allow plenty of access space for large hands, avoid repeated lifting and excessive and sustained forward bending, if possible avoid foot actuation, avoid mechanical stress on the legs, allow for long legs, provide adjustments or foot rests for shorter legs for prolonged sitting or standing, and provide anti-fatigue mats for prolonged standing) with user adjustable controls. An example of the application of these principles is found at eTool : Hospitals - Pharmacy | Occupational Safety and Health Administration on (osha.gov).

Final Acceptance Testing (FAT) – Final UUA system (includes all components and subcomponents) testing with satisfactory result standards met (or better) according to the Quality Assurance Surveillance Plan (QASP) with Large Scale Stress Testing.

FMEA - Failure Mode and Effects Analysis is a process used by the VA to identify weaknesses that can cause error or harm in order to identify and reduce unanticipated adverse events and safety risks by identifying where a process can fail. The goal is a quality level of 6-Sigma for the entire system (3.4 errors per 1 million opportunities). The FMEA team at the CMOP develops internal test documents, data validation checklists, and Standard Operating Procedures (SOPs), which include vendor subject matter experts (SME) for assistance. Additionally, the team includes training processes and supporting documents. The team will also determine validation processes for final acceptance for each step of the FMEA process.

Food and Drug Administration (FDA) – The federal agency under the Department of Health and Human Services, responsible for protecting and promoting public health.

FTP – File Transfer Protocol.

Fulfillment – The complete process from receipt of patient prescription order through processing and packaging.

Item – A Legend or Non-Legend drug or other product for pharmaceutical fulfillment. Individual prescriptions may requires multiple items. A UUA prescription may consist of one-to-many boxes, bottles, vials, or items.

Large Scale Stress Testing – Includes

Long Sig – A larger label that accommodates longer directions to the patient.

Medication Guides – Printed information that may be associated with a specific product or drug class and required to accompany all patient prescriptions for that product.

NAK - Non-Acknowledge.

National Institute for Occupational Safety and Health (NIOSH) – US Department of Health and Human Services non-regulatory agency, part of the Centers for Disease Control and Prevention, whose mission is to develop new knowledge in the field of occupational safety and health and to transfer that knowledge into practice.

National Fire Protection Association (NFPA) - A nonprofit organization that delivers expert knowledge through codes and standards, innovative research, professional training, public education, and outreach for public safety.

National Drug Code (NDC) – A unique 11-digit, 3-segment number used by the FDA to identify human drugs in the United States. Note that for CMOP implementation NDC is a 11-digit number to confirm to the new standard 5-4-2 format. This requires adding “0” strategically based on the number of characters in the baseline NDC code. For example, if the baseline NDC is only 9 digits then CMOP implementation requires adding “00” to bring it to an 11-digit standard. If the NDC is only 10 digits, then CMOP requires placing a “0” in the middle segment to create a CMOP standard NDC representation.

NEW RX - First fill of a patient’s prescription.

Non-Legend– A term used to describe a drug or other product that does not require the express written prescription of a health care provider.

Order- Single mailing unit to a patient with all requested items/prescriptions in a parcel package. Also see Patient Order.

Order Profile - See patient order

Occupational Safety and Health Administration (OSHA) – A federal agency charged with the enforcement of safety and health legislation.

OneCMOP – This is the only database at the CMOP with which vendors or contractors are able to interface and to interact regarding pharmaceutical orders, fulfillment, and shipping. The OneCMOP Vendor database is the conduit from National CDB and CCDB databases to a CMOP which has a third-party vendor acting in place of a traditional CMOP or partially in place of a traditional CMOP. The vendor will be required to read and write data to the OneCMOP database through stored procedures and views set up by the government for this purpose.

Operational Costs – The combined expense of personnel and consumable supplies required to achieve UUA throughput at the specified rate. These are typically reported as separate entries. When personnel costs are needed VA will apply actual labor rates to the recommended staffing profile to establish cost estimates.

Parcel – A completed patient order containing all prescriptions and documentation sealed in an appropriately sized mylar bag or box that is ready for shipment.

Patient Centric Label – A VA CMOP developed specific patient labeling requirement for all items dispensed by CMOP on patient order.

Patient Order - Identifies a single order to a specific patient and all the associated Rx prescriptions contained in that order. Patient orders are unique to a package and may contain multiple prescriptions and multiple items. For the purposes of this definition, it can be assumed that there will be ONLY ONE DELIVERY PACKAGE (PARCEL) PER ORDER.

Pharmaceutical Prime Vendor (PPV) – The pharmaceutical drug distribution contractor used by VA.

Pharmacist Verification (PV) – A quality control process where prescriptions are presented to a licensed pharmacist for inspection and approval prior to forwarding for packaging and shipment.

PIL – Patient Information Literature.

Prescription – A unique drug product or supply item ordered by a health care provider for a specific patient.

Primary Location – Will house stock that is being dispensed. Area will be able to house a one-week supply of all products assigned to that area.

Product Code – Identifies the specific strength, dosage form, and formulation of a drug.

Product – Pack Size – A combination of multiple drug identifiers (product code and pack size). This identifier will most closely align to the unique number of facings required for dispensing in the mail order pharmacy.

Proven Industry Standard System - Refers to existing equipment that is on the market or common off the shelf (COTS) in the pharmaceutical industry (currently in use through the industry for production and pharmaceutical UUA dispensing (with all-inclusive components). A proven COTS system is one that is fully functioning, tested, with industry proven reliability, performance, and in the commercial market, and uses existing pharmaceutical UUA dispensing technologies and equipment (includes, but not limited to) conveyance, quality check system, visual inspection systems, Pharmacist verification stations, and prescription labelling components.

PPS – Ports, Protocols, and Service refers to a system used by the VA to manage and control the use of network protocols, data services, and their associated ports on VA networks. This management is crucial for maintaining operational security and preventing disruptions to VA operations.

PPSM- Ports, Protocols, and Services Management program within the VA aims to standardize procedures for cataloging, regulating, and controlling the use of these elements on VA information networks according to DISA.

PV- Pharmacist Verification: A quality control process where prescriptions with medications are presented to a licensed pharmacist for inspection and approval prior to forwarding for packaging and shipment.

Quality Assurance Surveillance Plan- Quality Assurance Surveillance Plan contains the mandatory QA thresholds the UUA needs to meet.

Random Inventory Storage – Storage of product (that fits) in any empty storage location that maximizes the use of empty locations and results in higher space utilization and improved labor productivity during stock put-away.

REFILL RX - Refill of an existing patient’s prescription.

Replenishment – The process of refilling UUA equipment with product.

Rx - Prescription from physician to patient.

Secure Client Software – Software that provides a wireless security solution that meets VA Office of Information & Technology PPS & PPSM requirements (such as Air Fortress) that covers a broad range of devices.

SDLC – System Development Life Cycle

SFTP – Secure File Transfer Protocol that is required withing the CMOP’s, CDB, and OneCMOP.

Split Orders (Split) - A term used to describe breaking a single patient order for multiple items into smaller divisions for processing in different production areas.

Stock Keeping-Units (SKU) – A unique item that is associated with a single bar code for identification.

Super tote – A term used to describe a many-to-one type - relationship of a single prescription (containing only one item) for multiple patients batched into a single transport container (tote) capable of supporting a capacity of at least 5 Liters of prescribed items, which can be packed in an automatic packer.

Tablet/Capsule Vial - Countable and dispensed pills in a bottle or vial.

Tablet and Capsule Automation (TCA) – Automated tablet counting and dispensing system that directs the filling of prescriptions from induction through sortation and handoff to other automated systems (e.g. controls the vials or totes receiving the dispensed product, applies patient labels [simultaneously handles 120 cc and 250 cc bottles or vials and long sig labels], caps vials to specified torque and uses cap inspection components, accurately counts product during dispense, allows pharmacist verification, includes built in quality check system components, collates, and sorts vials matching patient specific prescriptions).

Tote – A container that is normally a plastic five-sided container open on top for access. The tote contains an RFI tag in the center of the bottom side for tracking and routing tied to a patient order. Each tote container has a unique system ID number and a tote typically contains a single patient order transported on conveyors through a UUA (sometimes from a TCA). In some instances, totes can contain multiple, or single container customer orders and are referred to as “super totes”.

Tote Marriage – This is the process of grouping vials with UUA items creating combination orders for a single patient. This also includes multiple items in a UUA tote. The Tote Marriage area is the first decision point for an empty order tote and totes that may by-pass the tote marriage if no TCA Rxs are required to be combined with UUA items in a patient’s order.

Tote Return - Tote Return is the conveyor used to return empty totes to the start of the tote portion of The UUA.

Turnkey System - A complete, designed, or constructed system that is completely ready for operation;

fully equipped and ready to independently and interdependently operate.

Uninterruptible Power Supply (UPS) – A device that provides continuous power to critical loads, primarily during a utility power outage.

United States Pharmacopeia and The National Formulary (USP-NF) - A book of public pharmacopeia standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements.

U.S. Pharmacopeial Convention (USP) - a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration

Unit-of-Use Automation (UUA) – A mechanical device that stores and dispenses unit-of-issue medications and supplies of various sizes, weights, and shapes.

VA CMOP Production Software– Integrated applications utilizing a Microsoft SQL Server database and associated applications that provide for two-way data exchange between VA patient orders and the UUA.

Warehouse Management System (WMS) – An integrated software system that controls the movement and storage of materials within the warehouse and processes the associated transactions, including shipping, receiving, put-away, picking, locations and inventory control. The system also directs and optimizes stock put-away based on real-time information about the status of product utilization.

D. SYSTEM RELATIONSHIPS

1. Patient Order Relationships - A one-to-one or one-to-many relationship exists (when collated) between a patient order and the final bottle-unit or dispense-unit processed by the UUA. These terms are often used interchangeably, but depending on the context of use, they may represent significantly different concepts. The following chart demonstrates and defines terms and relationships:

The average current Patient Order to the Great Lakes CMOP from VA’s CDB allocates 1.72 prescriptions.

Dispense-Unit (item) A discrete item or item dispensed through the production system. Individual prescriptions may be of a quantity that requires multiple items to be contained in the overall required item count. A dispensed prescription may consist of multiple items. Each dispensed prescription may contain one to many tablets or capsules. Comparatively, a UUA prescription may consist of one-to-many boxes or items.

The product master table refers to items, or Unit of Use from the drug database. It checks into the formulary master table in OneCMOP.

If Drug A is filled from a TCA and the individual tablet or capsule count exceeds one vial requiring two vials in a single prescription, then this single prescription requires the two vials to be tracked, collated, and married together with the UUA when dispensed items are identified for the same patient.

If Drug B is filled from UUA and the prescription order calls for five boxes (items) to complete the requested count, then this single prescription requires five items to be processed and collated by the UUA and tracked throughout the system for packing.

The projected UUA prescription combination quantity is 1.5 Unit of Use items to be processed, collated, and packed counted through UUA system.

2. Product Code, NDC, and SKU Relationship – Each product code has a unique SKU and each product code could have multiple NDCs. The following chart demonstrates and defines terms and relationships:

Drug A from manufacturer Y might be assigned the NDC number 98765-1234-01.

Each NDC has a unique SKU associated with it.

Drug A from manufacturer Y may be repackaged and dispensed in pack sizes of 30 count, 60 count, 90 count, etc. for as many pack sizes as are required for fulfillment of Drug A.

There may be multiple pack sizes or SKUs associated with an NDC number.

PART II: SYSTEM

A. SYSTEM PERFORMANCE AND DESIGN

1. Data Transfer and Acceptance

(a) The UUA must integrate with the TCA software platform NEXiA®, (a proprietary software system owned and operated by Innovation Associates [iA]).

(b) The UUA must integrate with and support the current logistics and Warehouse Management Systems (WMS) along with existing VA CMOP Production Software.

(c) The UUA must integrate with the current VA OneCMOP database structure (format), which currently operates using the most up to date MS Server product and must meet current VA OIT baselines and standards with licenses provided by the VA. The most up to date MS SQL version must also meet current VA OIT standards with licenses provided by the VA. Any system, component, or product must be fully functional in this environment.

(d) All data file transfer protocols must use SFTP. The CMOP is able to provide the existing OneCMOP database structure (format) upon award.

(e) The UUA must be capable of continual 24-hour operational data transmission and receipt of data to include (but not limited to) with NEXiA®, accepting electronic patient order information from OneCMOP (the National CMOP CDB system database), acknowledging receipt of orders, accurately processing orders in all aspects of automated and manual dispensing, and returning the appropriate data to the CMOP CDB transmitting site, local database, and CDB without disruption of operations. The UUA must accept and return patient order data consistent with the electronic data structure as outlined in the current versions of the OneCMOP Vendor Interfacing Database document (V. 1.5, March 2024), and the CMOP Electronic Data Interface (EDI) Guidelines (V. 2, March 2009).

(f) Electronic transmissions are batched and transmitted periodically throughout the day and consist of orders for multiple patients from OneCMOP. Patient orders may consist of single or multiple prescriptions. A prescription may consist of a prescribed quantity of tablets or capsules, unit-of-issue items contained in boxes or bottles, or bulk items that may be boxed. A single prescription may require more than one dispensing unit (bottle, or item).

(g) The UUA will efficiently utilize automation and workflow algorithms and logic for order fulfillment and provide mechanisms to take independent action(s) (cancel, backorder, collate, reallocate, repick, etc.) on individual prescriptions (includes super totes) without impacting the remainder of a patient order for automatic packing, which may also have vials for the same patient from the TCA that must be collated together for packing.

(h) The UUA shall be designed to receive and process data from barcode scans (linear and 2D) and RFID input. Inability to meet this requirement is a disqualifying factor.

2. Software Development and Source Code

(a) Software development must follow established industry standard methods such as Software Development Life Cycle (SDLC) or Agile for covering the following – PLC Programming, HMI Programming, WMS, VA CMOP Production Software interface development, Workstation Control Logic, Communication Protocols, and Code Reviews with the VA.

(b) The system must be developed as a distributed architecture. Systems must be standardized to work on a Microsoft platform, which will be imaged by the VA using current approved VA baseline for MS Windows Server. (VA Technical Reference Model [TRM)] approved version). It must be capable of running the VA’s most up to date VA approved baselined Microsoft SQL version (a VA TRM approved version), which the VA will load with existing licensing. All systems must be compliant with VA Directive 6500, VA Cybersecurity Program and VA Handbook 6500, Risk Management Framework for VA Information Systems, VA Information Security Program, PPS, PPSM, and NIST SP 800-53, Security and Privacy Controls for Information Systems and Organizations CM-6:Configuration Settings, and comply with VA authenticate user methods using PIV-2. IT products will be configured using a Secure Configuration checklist provided by the VA. VA must acquire rights with data (from the Contractor), firmware update rights, access for patches, and ability to update automation with the most current VA baseline and OS provided by the Contractor according to the Federal Acquisition Regulation (FAR) clause 52.227-14.

(1) Software development must be web enabled/based software produced using the current VA TRM approved Microsoft.Net technology at the time of system go-live. Other software development must use the current VA TRM approved Microsoft Visual Studio Suite at the time of system go-live.

(2) A combination of .Net programming language (such as C# and WPF [Windows Presentation Foundation] or Windows User Interface [WINUI]) for user interface layer is preferred, in order to conform to VA standards.

(3) Software programming must use standard Windows programming techniques and standard Windows Application Programming Interfaces (APIs). Programs must be designed and implemented to run on any machine in the facility that has the necessary hardware components and running the latest version of the VA approved Windows operating system running (for example a labeling application must be able to run on any computer that is connected to the network and has the necessary label and tote identification/scanning equipment). VA will provide Windows licensure(s).

(4) All workstations must conform to VA baseline and standard desktop environment, which is a Microsoft Windows VA approved system and can be included in the VA refresh life cycles. The VA will image all servers and workstations with the VA’s licensing.

(c) The contractor must deliver a configured development environment. At a minimum this environment must have the following:

(1) The completed source code to the CMOP such that VA has unlimited rights per FAR 52.227-14 and can change the source code as needed to improve the throughput of the automated system. This includes all programs, Patient Centric Label definition files for barcode printer, PLC software, Package Sealing, etc. developed specifically for the CMOP, as well as with any of the contractor’s standard software libraries that are required for this system.

(2) The completed source code must be clearly documented and available according to FAR 52.227-14. PLC/control code must include tag names and descriptions on all I/O and internal memory points, as well as descriptions of the purpose and function of each major section of source code.

(3) The compiler/development software, PLC programming software, debugger, DLLs, need to be provided, which are necessary to modify, compile and link the control system software.

(4) The contractor’s applications must link to all third-party software libraries.

(5) Installation batch procedures for all control and workstation computers to load the necessary executables, DLLs, configuration files, etc., that are part of the contractor’s deliverables needed to operate stations. It is not required that this procedure load third party software (such as drivers for add-on hardware, database drivers, etc).

(6) Include programming software for PLCs, smart motors, robots, scanners, and all other programmable control or IO devices.

(7) The contractor must provide two (2) complete sets of software, communication cables, cards, and/or converter devices, etc. required for programming the PLCs, smart motors, robots, scanners, and all other programmable control or IO devices. All software and associated programmable devices must be compatible with current VA Office of Information and Technology (OIT) security and group policies.

(8) All systems must have a restore point (snapshot) to restore to the previous software version, OS, software code, database, and etc. It must have a corresponding version control function that can be automatically deployed through automated means (or pushed) is required for all software. Each modification of the software module requires a new version number to allow tracking of changes to the software. Version control and restore points must be used to ensure the correct version of software is running on all systems.

i. The VA will furnish a source code repository such as application versioning or version control to track all versions of all code developed by the Contractor.

ii. All VA information, data, and source code will be stored and processed exclusively through the virtual desktop environment whether a Contractor is accessing the VA through VPN or through access from within a VA facility.

(9) All application, OS, and firmware changes/modification must follow the VA Base Change Control Requirements. This includes requesting SNAPSHOT of the Virtual Machine with backup of data and restore points (wherever possible) in case of any issues that require a restore of the system and/or data to its previous version and status.

(d) Audit Trails:

(1) The system and applications must be able to create, maintain, and protect from modification or unauthorized access or destruction of an audit trail of accesses to the objects it protects. The audit data must be protected so that read access to it is limited to those who are authorized. Audit logs containing prescription specific data will be available from date received for the prescription fill plus 90 days. A system for archiving the audit logs will be included and must allow for storing the logs on a removable storage medium.

(2) The system and applications must be able to record these types of events with the ability to immediately access the recorded data with real time and archived reports as follows:

· File changes, journal entries, exceptions, validation changes, error reports.

· Identify access via the remote diagnostic capabilities.

· Identify use of debugging tools, which may modify date, operating system, and application programs.

· Identify all commands to enable or disable logging activities.

· Identify all detected attempts of unauthorized access including user identification code and invalid password with date, time, and location.

· Identify all modifications to security settings and parameters.

· Identify all changes to access authorities including creating, disabling, and deleting user identification codes.

· Identify all areas accessed through a communication link.

· Identify all users who have signed on the system with date, time and system name or mode of sign on (port, terminal, dial-up or LAN [Local Area Network]).

· Identify users signed off the system with date, time, and system name of sign off.

· Identify all users who have a selected function.

· Identify all activity for a given user.

(3) For each recorded event, the audit record must be able to identify the date and time of the event, user, type of event, and success or failure of the event. The origin of request (e.g. terminal id, port, etc.) must be included in the audit record for identification and authentication events. The audit record must include the name of the object and the object’s label for events that introduce an object into the user’s address space and for object deletion events. The system administrator must be able to selectively audit the actions of any single or multiple users based on individual identity and/or object label. The audit system must raise alarms whenever a threshold is reached with respect to an auditing system resource (disk space in audit log volume) or when auditing has been turned off (either inadvertently or deliberately). It must also support alarm features, which provide immediate notification of predefined events (including events recorded on the audit log).

(e) Deliverable documentation will be provided to the COR immediately after installation and prior to system acceptance. Additional documentation requirements are in PART II, subsection D of this document. Minimum documents to include are as follows:

Responsible, Accountable, Consulted, and Informed (RACI) Topics

(1) Security Feature User Guide

(2) System Administrator Manual

(3) User Manuals

(4) Preventative maintenance tasks, schedules, and recommended parts stock levels

(5) Software and Hardware Testing Procedures and Results

(6) Network Diagram

(7) Site Plan (Floor Plan) Drawings

(8) “As Built” drawings

(9) Process and Instrumentation Piping (P&ID) Drawings

(10) Wiring Diagrams

(11) Control Logic Diagrams

(12) Hardware, Parts, and Software Inventory

(13) Firmware update user guides

(14) Patch update user guides

(15) Technical Documentation (e.g. all input/output points, ports, etc. used on the system; software programs for programmable devices including but not limited to PLCs, port expanders, etc.) This documentation must be as implemented (not as designed) and include (but not limited to) the following:

· A Detailed Network Diagram

· Software Technical Documentation. This documentation includes software and process flow charts. All source code must be documented within the code itself. Software must have version control and be provided to the CMOP in digital format.

(16) Provide 4 soft copies of documentation via SharePoint transfer. Soft copy drawings shall be in AutoCad (.dwg) and Adobe Acrobat formats. Documents must be provided in Microsoft Word and Adobe Acrobat format in the English language, allowing for future edits and updates and providing a table of contents to include jump links.

(17) Provide 4 hard copies of all documents, bound in 3-ring binders.

(18) Provide 4 full size (22” x 34”) copies of the Site Plan and P&ID Drawings.

(19) Provide 4 half size (11” x 17”) copies of all other drawings

3. System Throughput Requirements

(a) The UUA system must be capable of a minimum of 50,000 ambient items per 7.5 hours of operation (within an 8-hour work shift) and 18,000 refrigerated items per 7.5 hours of operation (within an 8-hour work shift). Complete is defined as the prescription is filled, verified, packaged, and ready for induction to the delivery or shipping stream. Weekend and Holiday overtime may be required to support additional workload. Any routine system maintenance and back-up protocol must not impact production, and it must be able to be scheduled with VA approval during non-production hours. Any preventative maintenance or routine software/database maintenance that requires off-production hours must be identified in hours and periodicity. Refer to Attachment A regarding an analysis on the UUA throughput workload.

(b) The UUA must be capable of accommodating any system stoppages or other interruptions in operations without any single point of failure in the system or without failure interfacing with all other connected systems, and without requiring any extended cycle-down or cycle-up time (time required to go between system-idle and system-full operation) within a total work shift of 8 hours (two shifts a day). Extended is defined as more than 60 seconds. Each component of the system must also be capable of independent operation with no single point of failure from the moment an order is received through automatic packing and package manifesting. The UUA shall maintain sufficient UPS capacity for critical equipment throughout the system ensuring no single point of failure. Replenishment at any point in the UUA shall not degrade system performance.

(c) The UUA must be capable of batching single prescription items for multiple patients dispensed into a single tote (super tote) and queued for automatic packing. Additionally, the UUA must be capable of taking a single patient’s order that has multiple vials (from the TCA), and items and be able to collate them for automatic packing, otherwise it may go to manual packing.

(d) The contractor must deliver a fully integrated turnkey UUA system (not isolated) that minimizes the costs associated with prescription fulfillment and consolidates shipping to the greatest possible extent following all standard VA processes. The contractor must provide the cost point of diminishing return for its components and provide the most cost-effective balance between automated and manual processes. The UUA must be designed to ensure throughput is not impacted by rework. Reject rates must not exceed 0.05%.

(e) The UUA system must include a mechanism with site-controlled settings to release and report backordered items without system impact.

(f) Rejects are system generated dead end events that result in restart of a prescription, process, or package and generates wasted product or supplies.

a. Rejects in this sense includes:

i. Label, product waste.

ii. RTS that cannot be reused through an automated process.

iii. Product/supplies damaged by automation.

iv. Spills in conveyance.

v. Items missing in a tote.

b. Does not include:

i. Self-correcting operational failures that do not generate waste or restart.

ii. Routing recirculation and/or repacks.

iii. Operator induced error or failure.

iv. Failures related to inventory errors, shortages, patient level recalls, or Rx cancellations.

4. Footprint for Automation / Workflow Design

(a) The UUA with integrated storage locations for pharmaceutical stock and consumable supplies must fit within the identified facility space as determined at the initial proposal site visit or preliminary/conceptual drawing (VA is in the process of installing a new TCA however, “as-built” drawings are not yet available. See Attachment B for the floorplan and TCA Final Proof of Concept drawings).

(b) The VA will provide preliminary/conceptual drawing of the available space for the UUA. The VA requires a logical and efficient workflow that terminates at shipping. The contractor must utilize the basic workflow concepts detailed in the nominal space plan. The below image shows the building where the UUA system will be installed. The TCA area is called out (26,575 square feet). The UUA design must not overlap with the TCA area. The preferred zone for installation is in Zone 1. Designs that feasibly and operationally fit in Zone 1 will be considered to exceed acceptable standards. If extra space is needed for the design, Zone 2 may be used. Zone 3 is the current production area for the UUA and cannot be utilized without negatively impacting CMOP operations. Please see Attachment C for detailed floor layouts. The DWG files will be made available post award.

The available space in zone 1 has a clear height that is generally 13’4”. Under the sprinkler main it is 11’9” and 9’9” under the remaining area.

TCA Area is approximately 26,575 SQ FT. Zone 1 is approximately 13,824 SQ FT.

(c) The Great Lakes CMOP is federally owned property; therefore, is required by Public Law 100-678 (40 US Code 3312) to follow the latest editions of national recognized codes (e.g. OSHA, NFPA, etc.) and must comply with all federal building codes relevant to the building’s location. The contractor shall supply life safety drawings/plans delineating compliance with all requirements (e.g. egress paths, travel distances, etc.) in accordance with the latest edition of NFPA 101, Industrial Occupancy classification and include an assessment and design, as required, for high bay storage sprinkler protection in accordance with the latest edition of NFPA 72. In addition, if high-pile/bay storage is planned, then the contractor shall include an assessment and design in compliance with NFPA. The drawings/plans and designs shall be signed and stamped/sealed by a Professional Engineer, Fire Protection, licensed in the state of Illinois.

(d) The contractor must design the UUA with appropriate engineering principles that consider product storage, OHSA ergonomic design principle requirements, housekeeping, and maintenance access needs and other operational requirements, which promote an effective and efficient workflow. Additionally, any potential building modifications required (such as hanging conveyor) must be engineered by the contractor.

(e) The UUA footprint shall include storage for stock dispensing areas. Stock dispensing areas are designated for stock that has been assigned to a specific dispensing location(s). The contractor shall provide all appropriate shelves, racks, (gravity feed), or other storage systems for each stock storage area for primary (typically a 1-week supply).

(f) The UUA footprint must also include stock storage locations designated for unopened bulk product picking storage prior to assignment to a stock dispensing area. Stock resupply is from the CMOP’s current WMS and existing warehouse storage areas.

(g) UUA Operation and Staffing Plan must be submitted with the proposal and will be incorporated in final contract. The plan shall include, at a minimum:

(1) Anticipated staffing for UUA operation at full capacity, as well as the number and mix of pharmacists, pharmacy technicians, shipper/packers, and any other personnel or disciplines recommended by the contractor for each production and support area.

(2) Anticipated staffing for UUA routine, preventative, and unscheduled maintenance of the UUA including the number and recommended background specialty of required staff, such as automation technicians, housekeeping personnel, and engineering.

(3) Estimated annual maintenance cost which includes quarterly preventive maintenance visits for five years.

(4) Software license costs for five years.

5. Proof of Concept

(a) Proof of Concept must contain sufficient detail to demonstrate understanding and capability. The contractor must provide a written proof of concept and provide a presentation that details the automation layout and demonstrates (through a detailed simulation or mathematical process model) the rationale for their concept. This shall include workload distribution through all system components and all associated operational costs calculated on an individual prescription basis. The contractor shall be able to state and connect the operational costs of processing throughput per item(s) within prescriptions and orders for the production area. The written proof of concept will become a part of the successful offeror’s contract.

(b) Contractor must include a narrative and equipment layout in accordance with the parameters described in the previous (Section 4). The contractor must include one dimensional and three-dimensional renderings of each type of task, and station throughout the system and demonstrate how each type of task, and station ergonomically integrates into the UUA system that is integrated with the existing TCA, collation, packing, and with the VA’s OneCMOP.

(c) If the proposed UUA exceeds the space in Zone 1, and the UUA with cold chain exceeds the space in Zones 1 and 2, then acknowledgement, considerations, and justification must be provided.

(d) Provide a flow diagram that demonstrates how the different types of orders will be processed (includes Cold Chain).

(e) Provide evidence (such as past performance) that the proposed UUA software can integrate with the TCA software platform NEXiA® (a proprietary software system owned and operated by Innovation Associates [iA]), for combination orders.

(f) Demonstrate, in a layout and a narrative, how the proposed hardware will integrate with the TCA and VA’s OneCMOP processing combination orders through packaging for shipment.

(g) Contractor is able to provide evidence (such as past performance and uncut video) of the proposed UUA solution’s auto labeling product. If the system is in use at a pharmacy fulfillment location, then also provide the contact information for the VA to potentially make a site visit.

6. Project Management Plan (Shall be submitted with the proposal and if accepted will be incorporated in final contract)

(a) The contractor shall dedicate a Project Manager from contract award through completion of warranty period and detail his/her qualifications. The Project Manager shall be on-site for milestones, including, but not limited to, design approval, site acceptance, and component delivery through system acceptance. During the installation and pre-acceptance period, on-site technical support and remote assistance shall be available as stipulated in the Warranty (Part II, Subsection D) whenever equipment will be energized/pressurized.

(b) The contractor shall provide a detailed Project Management Plan in MS Project format which shall include:

(1) A comprehensive risk assessment and mitigation plan including:

i. Identification of contract vulnerabilities and risks, including, but not limited to, considerations of project scope, personnel required, data interfaces, sub-contractor product deliverables.

ii. Prediction of potential consequences

iii. Proposed mitigation and assignment of responsibility

(2) An Emergency Recovery Plan to address potential interruptions to milestone completion that are outside the contractor’s direct control.

(3)…