S02_SOR TCA System Installation and Tote Line Upgrade.docx

DALLAS CMOP TCA Installation / Tote Line Upgrade Statement of Requirements

PART I: BACKGROUND

A. INTRODUCTION

1. The Dallas CMOP located in Lancaster Texas, is one of seven Consolidated Mail Outpatient Pharmacy (CMOP) facilities located across the United States. This Department of Veterans Affairs (VA) program provides prescription fulfillment and mailing for Veteran patients. Advanced automation and equipment schemes are used in this highly automated environment to fulfill prescription orders from Department of Veterans Affairs Medical Centers (VAMC) and Community Based Outpatient Clinics (CBOC) throughout the country, with the potential for future growth based upon agreements with other Federal agencies. The total production goals currently are 80,000 prescription a day consistently with future growth anticipated.

· In the current CMOP automated production system, the POS searches for oldest orders first in a shared directory and sends that data to the UUA for dispensing. The POS will track using RFID readers and directs the tote to the Labeling area and then Pharmacy verification which then will travel to the packing stations to be packaged and mailed to the patients.

· The Tablet and Capsule Automation (NEW TCA AREA uses Ethernet connectivity for communications with the POS system software to download patient orders oldest work first, to dispense pharmaceuticals. New TCA area will send an order verified message back to the POS after order has been completed for further routing.

· Conveyance start-up, routing and tracking are managed through the current production POS software.

· Background procedures continuously run on a server pulling data from the VA Central Database (CDB) and creating a data file. Induction software utilizes that data file to process orders. The VA CDB and local servers populate the non-automated work areas of the Dallas CMOP with orders to be filled.

B. STATEMENT OF NEED

The purpose of this procurement is to replace the existing Tablet and Capsule Automation (IPD area) and ancillary support systems at the Dallas CMOP with new, proven pharmacy automation (TCA) that is faster, safer, and more reliable. Hardware shall include, but is not limited to, pucks, puck conveyance, labelers, weight scale, automatic dispensers, canisters, post weight scales, high resolution camera, exception station, workstations, pharmacy verification stations, cappers, sealers, and associated tote conveyors. Tote line upgrades are needed to increase tote capacity and reduce choke points which will increase throughput throughout the system. The new Tablet Capsule Automation aka TCA, plus Tote line upgrade equipment must be fully integrated with the existing Pharmacy Operating System (POS) and Tote Conveyor and production system, with no single point of failure that meets the accuracy, timeliness, and throughput requirements of the dynamic workload of the Dallas CMOP. The Dallas CMOP requires a contractor to serve as a systems integrator who will design, build, and integrate a working TCA area, and upgrade tote line equipment, with the current VA CMOP National data infrastructure and POS. Any system, subsystem, or component shall be fully functional and fully integrated with the CMOP electronic data structure and the Pharmacy Operating System (POS). The TCA equipment shall be capable of dispensing individual solid dosage forms. Ancillary support systems, comprehensive data logging, collection and reporting system are required. Responses shall demonstrate a complete understanding of the need and how the contractor plans to meet the SOR requirements.

C. OVERVIEW

This project will utilize a three-stage approach to ensure key tasks are performed in an organized manner. The below is an overview of each phase.

1. Phase I - Removal of Production Hardware

a. Demolition of all existing Independent Pill Dispenser aka IPD Dispenser Banks and associated Mezzanines, conveyors, electrical components, pneumatic and supporting equipment not needed for the remaining equipment to free up floor space for the new TCA area equipment.

b. Demolition and removal of Pharmacy verification stations.

c. Demolition and removal of cappers and cap feed equipment.

d. Demolition and removal of sealer and upper conveyor that traverse through the pharmacy verification area.

e. Demolition and removal of conveyance up to three feet West of the vertical puck return on the North side. Remove and re use motor and associated equipment from removed conveyance to drive puck return belt.

f. Removal of all air drops not needed for new TCA area. Install branch isolation valve at removal locations.

g. The furthest West air drop will remain for the Replenishment area needs. Install branch isolation valve for future use.

h. CAT 6E shall be ran from CMOP switches to Replenishment stations when moved to open area.

i. 120Volt plugs shall be installed at replenishment stations moved into the new area. This will include current ATD replenishment stations.

j. All existing Cat 5 communication cables needed for production must be rerouted to open floor space to foot traffic.

k. All existing power shall be rerouted if needed for remaining equipment on the CMOP production floor.

l. All electrical wires not in use shall be demoed with no exposed wires. Electrical work shall conform to NFPA-70 and 70E standards.

m. Return puck conveyance must not be removed that serves the loops and de pucker robot and must be fully functional.

n. All removed equipment shall be wrapped and palletized to ensure safe transport to a designated storage area outside the CMOP for VA disposal.

o. Full production operations shall include the existing loops, two robot de puckers, associated conveyance, and sorting table must be operational, after removal of old equipment. The equipment is physically located outside of the demolition space, but all supporting infrastructure for the equipment must remain operational.

p. Starting of conveyors must be integrated into the CMOP POS

q. E-stops must function as intended on the remaining equipment.

r. Additional information and example layouts are in supporting material.

s. Phase I must be completed no later than September 1, 2025.

2. Phase II - Installation of TCA Hardware and Software

a. This phase is clearly defined in the Statement of Requirements (SOR)Part II

b. New equipment must be connected to existing conveyors going into the loops for sortation.

c. Additional SOP for canister refill, dispenser refill, Audit trail examples, and CMOP messages are in Attachment 1

d. TCA must integrate with CMOP POS and data servers for audit trails and data messages, Attachment 1 for example.

e. Area must have at a minimum, of 350 Dispensers which would include 350 Unique NDCs.

f. Contractor is responsible for connecting all air, power, and Cat 6 communications.

g. Phase II must be completed no later than October 31, 2026

3. Phase III – Additional Tasks and Tote Line Upgrades

a. Phase III is unrelated to Phases I & II and can be accomplished at any time during the project. Since the tasks will have impact to active production lines, the work must be coordinated 30 days in advance.

b. Demolition of two labeling loop conveyors, electrical, and pneumatic lines to packing conveyor areas and ancillary tasks.

c. Installation of two new larger labeling area conveyor loops with 90-degree transfers (non-pusher) needed for diverting to stations and recirculating loops. Example Layout in attachment 1.

d. Installation of two new conveyors leaving both labeling loops and connecting inside and outside packing stations. The removal and addition of a transfer station (Non-Pusher Transfer) controlled by the QMSI controller will balance out workload between the packing areas.

e. Installation of new PLC and remote I/O to control the entire tote system as well as remaining puck conveyor and depucking robots from the current CMOP C++ POS system software. Communication for remote I/O shall be ethernet based. Integration shall be seamless. Allen Bradly 5000 is currently in use on the production floor. this equipment shall replace existing Think and Do control software and hardware.

f. RFID readers are used to track RFID Chipped totes through the system as well as marry prescriptions to the tote.

g. There shall be integration between CMOP equipment already installed for the new packing transfer station. Semi Auto Packers currently controls diverter into Outside and Inside Conveyors and will remain in control.

h. All existing one thousand (1000) Totes shall be replaced with new Totes that are RFID chipped and numbered on two sides. They must be substantial in construction, chipped for compatibility of existing RFID readers and the same dimensions as existing Totes.

i. Install two additional 90-degree transfer stations (non-pushers) not listed above shall be installed at locations in supporting documentation. Attachment 1 starting on page 48.

j. Example lay out, current description, future design needs, and ancillary documentation is attached in supporting document. Attachment 1.

k. Installation of two (2) three phase electrical circuits that will supply power to two(2) new Auto packers in the Southeast corner of the facility after initial installation is complete.

l. Install air lines with lockout tagout valves air filter, regulator, and water separator at each Auto Packer location.

m. Install CAT 6E from CMOP switches to New Auto packer Locations.

n. Lines K, L, and M must be completed within 5 days after equipment is installed.

o. Auto packers will be installed in late October early November. Date will be supplied 30 days prior to installation.

p. Contractor is responsible for connecting all air, power, and Cat 6 communications for new Tote line equipment.

q. Tote line equipment must balance work to all labeling and Pharmacy verification stations equally without sacrificing throughput.

r. Phase III Tote line upgrades must be completed no later than October 31, 2026

s. Vendor will be responsible for tote line as well as puck conveyor and depucking robots and conveyor upgrades electrical pneumatics and control wiring including communications.

4. PERFORMANCE REQUIRMENTS

a. TCA dispensers Shall meet all Goals.

i. Throughput per hour Prescriptions = 449

ii. Throughput per hour Vials = 449 X 1.7 = 763.3

iii. Throughput per Shift Vials = 5,725

iv. Weight variances = 300% of tablet weight. plus, or minus three tablets.

v. Reject Rates % cumulative overall = 2.1%

1. Weight errors

2. Pill under count.

3. Pill over count.

4. Cross check error

5. Pharmacist rejects

b. Tote Line Upgrade Shall Meet all Total Volume Goals

i. Totes per Hour = 3,165 Totes

ii. Totes per Day (two shifts) = 47,471 Totes

iii. Recirculation Totes per Hour = 949 Totes

D. DEFINITIONS

API - Application Programming Interfaces.

ATD - Automated Tablet Dispensers. This references the high-speed KNAPP TCA

Automated TCA Database Structure – 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 TCA equipment, and the Central Database (CDB).

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

Bottle – Refers to the physical container into which solid dosage forms are dispensed.

Bulk location – area in which all items that are contained on pallets will be stored. This will be 15 – 20 days of inventory.

Canister – A sealable container for tablet or capsule storage and delivery of product to a dispenser, conforming to USP-NF 621 standards for storage of pharmaceuticals, and protected with a fail-safe and tamper evident interlock system

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

CO -Contracting Officer

COR – Contracting Officer Representative

De-pucker – An automated process used to remove a vial from a transport puck when the system uses a puck-based transport.

Dispense - An automated process designed to accurately deliver the product. For the TCA Equipment, the dispenser will accurately count tablets or capsules prior to dispensing. For the Unit of Use Automation (UUA) it will dispense pre-packaged unit-of-issue product.

Ergonomic Design – Consideration of the interactions between humans and the TCA equipment plus Tote conveyor that are designed to maximize user interaction with assigned task and system performance while minimizing potential of repetitive strain injuries and inefficient motion.

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

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 fulfillment.

IPD – Independent Pill Dispensers. Old KNAPP High Speed TCA area.

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.

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 devoted to eliminating death, injury, property and economic loss due to fire, electrical and related hazards by developing and publishing Codes and Standards designed to minimize the risk and effects of fire by establishing criteria for building, processing, design, service, and installation.

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- See patient order

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

Operational Costs – The combined expense of personnel and consumable supplies required to achieve TCA MEDIUM MOVER 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 Order - A combination of prescriptions, prescribed by a healthcare provider, from a remote site, batched together and electronically transmitted for CMOP fulfillment.

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.

Piece – A term used within the TCA and UUA order management software that refers to a discrete item of throughput. Individual prescriptions may be of a quantity that requires multiple pieces to contain the required item count. A TCA or UUA prescription may consist of one to many items (pieces).

POS – Pharmacy Operating System

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.

Puck – A weighted and sturdy device, made of plastic or similar material, used to transport upright vials on a conveyor to TCA dispensing units and other applicable routing locations.

Replenishment – The process of refilling TCA canisters with pharmaceuticals.

Secondary Location – will house stock that will be used to replenish Primary Location. Area will house up to 10 – 12 days of inventory.

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

Split Orders – 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.

Tablet and Capsule Automation (TCA) – Automated dispensing system that directs the filling of prescription orders from induction through sortation and handoff to other automated systems, i.e., controls the vials receiving the dispensed product, applies patient labels, accurately counts product during dispensing, captures and records vial weight, allows pharmacist verification, applies, seals and secures caps on the vials, and sorts patient specific prescriptions utilizing bulk tablet and capsule stock of various sizes, weights, textures, and shapes.

Think and Do Software – Software that was designed specifically for the CMOP to control conveyor systems.

Tote – A container tied to a patient order used to transport one-to-many products on conveyors through the TCA System.

UOU – Unit of Use Container (ex: retail pack format) Found on the UUA aka A-Frame

UPS – Un-interrupted Power Supply 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. Pharmacopeia 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). Dallas CMOP refers to this equipment as the A-Frame. This equipment drops prepackaged pharmaceuticals into a Tote as it travels through the High Speed Induction Unit.

Vial – A term used within the order management software that refers to a discrete item of throughput. An individual prescription may require multiple items of throughput to contain the required quantity. Each of those items of throughput is tracked separately.

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 and picking. The system also directs and optimizes stock put-away based on real-time information about the status of product utilization.

E. SYSTEM RELATIONSHIPS

1. Patient Order Relationships - A one-to-one or one-to-many relationship exists between a patient order and the final bottle-unit or dispense-unit processed by TCA MEDIUM MOVER AND TOTE CONVEYOR. 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 current (3/2025) average Patient Order for Dallas CMOP contains 1.72 prescriptions

Dispense Unit (Vial or piece)

If Drug B is filled from UUA and the prescription order calls for five boxes to complete the requested item count, then this single prescription requires five pieces to be processed by UUA and tracked through the system.

The current average Dallas TCA prescription consists of 1.7 vials for processing.

The current average Dallas CMOP UUA prescription consists of 1.5pieces to be counted through UUA system.

2. Product Code – National Drug Code (NDC) Number - Stock Keeping Unit (SKU) Relationship - A one-to-many relationship exists between a product code and a unique SKU in the TCA. The following chart demonstrates and defines terms and relationships:

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

A Product Code potentially may have multiple NDC numbers 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 may be required for fulfillment of Drug A There may be hundreds of pack sizes or SKU associated with each 9-digit NDC number

PART II: SYSTEM

A SYSTEM PERFORMANCE AND DESIGN

1. Data Transfer and Acceptance

(a) The TCA equipment and Tote line controls shall integrate with the current VA CMOP National data infrastructure which currently operates in an MSSQL 2019/2022 or current environment in a format and structure specified by the CMOP. The CMOP will provide existing table structure (format) upon award. Any product, subsystem, or system shall be fully functional in this environment.

(b) The TCA equipment shall be capable of 24/7 operational transmitting and receiving of data, to include, but not limited to, accepting electronic patient order information from the National CMOP system database, acknowledging receipt of orders, accurately processing orders in all aspects of automated and manual dispensing, and returning the appropriate data to transmitting site, local database, and CDB without disruption of operations. The TCA equipment shall accept and return patient order data consistent with the CMOP POS system.

(c) Electronic transmissions are batched and transmitted periodically throughout the day and consist of orders for multiple patients. 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 (vial or piece).

(d) The TCA equipment shall efficiently utilize automation and workflow algorithms for order fulfillment and provide mechanisms to take independent action (cancel, reallocate, etc.) on individual prescriptions without impacting the remainder of a patient order.

(e) The TCA equipment shall efficiently utilize automation and workflow algorithms for order fulfillment and provide mechanisms to take independent action to ensure old work is done first.

(f) The TCA equipment shall be designed to receive and process data from barcode scans (linear, 2D and any current format at time of acceptance) and RFID input.

(g) Tote Line PLC must integrate with the POS system at the CMOP for Tote control. PLC replaces current Think and Do software.

2. Software Development and Source Code

(a) The system shall be developed as a distributed architecture. Systems shall be standardized to a Microsoft platform using MS Windows 2019/2022 Server R2 (or newer VA approved version) and Microsoft SQL Server 2019/2022 (or newer VA approved version).

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

(2) Software programming shall use standard Windows programming techniques and standard Windows APIs. Programs shall be designed and implemented to run on any machine in the facility that has the necessary hardware components to run that software. (For example, a labeling application shall be able to run on any computer that is connected to the network and has the necessary label and tote identification/scanning equipment).

(3) All workstations shall conform to VA secured standard desktop environment, which is a Microsoft Windows VA approved system.

(b) The contractor shall deliver a configured development environment. This environment shall have at a minimum:

(1) To the extent that restricted computer software is a part of the offeror’s solution, the source code shall be provided to the CMOP in escrow at time of delivery of the system. The terms of such escrow shall require the release of the source code to the Government upon the existence of (a) Breach of Contract, (b) Failure to act in good faith as it pertains to the contract (c) Voluntary or involuntary bankruptcy. The only exemption is this: if the contractor delivers restricted computer software to the government as part of this solution, and if that software is listed specifically in an Approved or Approved With Constraints decision on the One-VA Technical Reference Model (VA TRM) v19.1 (not any later version, v19.1 specifically) then the contractor is not required to deliver the source code for that application.

(2) The completed source code shall be clearly documented. PLC/Control code shall 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 code.

(3) The compiler/development software, PLC programming software, debugger, DLLs, as necessary to modify, compile and link the control system software.

(4) All libraries for third party software to which the contractor’s applications shall link.

(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, that are required to operate that station. It is not required that this procedure load third party software, such as drivers for add-on hardware, database drivers, etc.

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

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

(8) Version control for all software. Each modification of the software module requires a new version number to allow for tracking changes to the software. Version control shall be used to ensure the correct version of the software is running on all systems.

i. The Government will furnish a source code repository such as Microsoft Team Foundation Server in order to track all versions of all code developed by the Contractor.

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

(9) New versions of software shall be capable of being ‘pushed’ out to the appropriated systems using automated tools such as MS SCCM.

(c) Audit Trails:

(1) The system shall 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 shall be protected so that read access to it is limited to those who are authorized. Audit logs containing prescription specific data will be available for the life of the prescription fill plus 30 days. A system for archiving the audit logs will be included and shall allow for storing the logs on a removable storage medium. Example audit trail report is in supporting documentation, Attachment 1.

(2) The system shall be able to record the following types of events with the ability to immediately access the recorded data with real time and archived reports:

· 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, the 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 via 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)

· Identify users signed off of 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.

· Example Audit Trail is in Attachment 1 section 2 B

· Tote Line upgrade must pass data to the POS system to correctly track RFID Chipped totes through the system.

(3) For each recorded event, the audit record shall be able to identify the date and time of the event, user, type of event, and success or failure of the event. For identification and authentication events, the origin of request (e.g. terminal id, port, etc.) shall be included in the audit record. For events that introduce an object into the user’s address space and for object deletion events, the audit record shall include the name of the object and the object’s label. The system administrator shall be able to selectively audit the actions of any one or more users based on individual identity and/or object label. The audit system shall 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 shall also support alarm features, which provide immediate notification of predefined events, including events recorded on the audit log. Sample audit log for one order in Attachment 1.

(d) Deliverable documentation will be provided to the COR immediately after installation and prior to system acceptance. Additional documentation requirements are located in PART II, subsection D.5 of this document. Minimum documents include:

(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 and Software Inventory

(13) Technical Documentation (i.e. 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 shall be as implemented, not as designed, and include but not limited to:

· Detailed Network Diagram

· Software Technical Documentation. This documentation includes software and process flow charts. All source code shall be documented within the code itself. Software shall have version control and be provided to the government in Microsoft Team Foundation Server.

(14) Provide 4 soft copies of documentation on DVD. Soft copy drawings shall be in AutoCAD (.dwg) and Adobe Acrobat formats. Documents shall 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.

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

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

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

3. System Throughput Requirements

(a) The new TCA equipment shall accurately process and complete a minimum of 5,725 vials during each 7.5 hours of operation within an 8.5-hour work shift. Complete is defined as the prescription is filled, verified, packaged, and ready for induction to the delivery stream. Throughput is based on 449 prescriptions multiplied by 1.7 vials which totals 763.3 vial an hour, multiplied by 7.5 equals 5724.75 vials a shift. With a minimum of 350 different NDCs.

(b) Tote Line shall accurately process a minimum of

i. Totes per Hour = 3,165 Totes

ii. Totes per Day (two shifts) = 47,471 Totes

iii. Recirculation Totes per Hour = 949 Totes

(c) The TCA and Tote equipment shall accommodate any system stoppages or other interruptions 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 8.5 hours. Extended is defined as more than 60 seconds. Each sub-system shall be capable of independent operation with no single point of failure. The TCA and Tote computers and servers shall provide UPS capacity throughout the system. Replenishment at any point in the TCA equipment shall not degrade system performance.

(d) The contractor shall deliver a fully integrated TCA system that minimizes the costs associated with prescription fulfillment. The TCA system shall be designed to ensure throughput is not impacted by rework.

(e) Reject rates shall not exceed 2.1% on any subsystem.

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

i. Rejects in this sense includes:

1. Vials falling out of pucks, label print quality, product waste (to many tablets in vials) (spills)

2. RTS that cannot be reused through an automated process

3. Product/supplies damaged by automation

4. Spills in conveyance

ii. Does not include:

1. Self-correcting operational failures that do not generate waste or re-start Routing recirculation and/or re-packs. Operator induced error or failure

2. Failures related to bad vials, caps, broken pills, or bad labels (format)

4. Footprint for Automation / Workflow Design

(a) The TCA/Tote line system shall integrate storage locations for pharmaceutical stock and consumable supplies and shall fit within the identified facility space as determined at the initial pre-proposal site visit or preliminary/conceptual drawing. Layout is in supporting documentation and is not to scale.

(b) The Government will provide preliminary/conceptual drawing of the available space for the TCA/Tote line area. The Government requires a logical and efficient workflow that begins in receiving and terminates at shipping. The contractor shall utilize the basic workflow concepts detailed in the nominal space plan.

(c) The TCA/Tote equipment shall be compliant with National Fire Protection Association (NFPA) codes and all local, state, and federal building codes relevant to the building’s location.

(d) The contractor shall design the TCA/Tote equipment with appropriate engineering principles that consider product storage, ergonomic requirements, housekeeping and maintenance access needs and other operational requirements which promote an effective and efficient workflow.

(e) The TCA equipment 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, or other storage systems for each stock storage area for primary (typically a 1-week supply.

(f) The TCA equipment footprint shall also include stock storage locations designated for unopened bulk product storage prior to assignment to a stock dispensing area. The stock storage location shall be physically separate and securable from stock dispensing areas with consideration given to safe and efficient movement from the receiving areas as well as to the stock dispensing areas.

(g) TCA/Tote system Operation and Staffing Plan shall be submitted with proposal and will be incorporated in final contract. The plan shall include, at a minimum:

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

(2) Anticipated staffing for TCA area, routine and preventative maintenance of the TCA equipment and Tote line equipment including the number and recommended background specialty of required staff.

5. Proof of Concept TCA and Tote Line Redesign (Shall be submitted with proposal and if accepted will be incorporated in final contract)

(a) Responses shall contain sufficient detail to demonstrate understanding and capability. The contractor shall 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 sub-systems and all associated operational costs calculated on an individual prescription basis. The contractor shall be able to state the operational costs of processing throughput per prescription for each production area. The written proof of concept shall become a part of the successful offeror’s contract.

(b) The contractor shall include one dimensional and three-dimensional renderings of each type of task station throughout the system and demonstrate how each type of task station ergonomically integrates into the TCA/Tote system.

6. Project Management Plan (Shall be submitted with 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. 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.9) 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) Quality Management Plan to ensure integrity and function of components and systems from delivery through acceptance and includes government inspection and concurrence.

(4) A detailed project timeline with measurable milestones, including activity duration and relationship to other activities with estimated start and completion dates. At a minimum, the contractor shall include the following milestones for government acceptance in the project schedule:

· Milestone major event electrical interface

· Component contractor delivery dates

· Consumable requirements specifications, projected usage (for both testing purposes and once fully operational) and required delivery date(s)

· Component installation

· Component equipment testing to include capacity and documentation of published specifications

· Communication interface of subsystems

· Contractor software installation and testing

· Validation of reporting functions and training of government supervisors and quality support staff

· Integration with current VA CMOP National data infrastructure

· Contractor training of government operations personnel

· Live switch over

· Contractor training of government maintenance staff

· Contractor provided user and maintenance manuals (including periodic maintenance schedule)

· Contractor provided bench stock of repair parts

7. Progress Meetings and Progress Reports

(a) The contractor shall attend progress meetings, frequency depending on milestone(s), but at least twice monthly, to brief Government personnel on the progress of design, installation, and integration of the TCA/Tote systems. The contractor shall provide briefing notes after each meeting. Meeting location will be determined by the Government.

(b) The contractor shall attend technical meetings to discuss the technical requirements and development with government personnel. Frequency of meetings will be determined by the government upon award.

(c) The contractor shall submit written, bi-weekly progress reports to the VA Contracting Officer. Each report shall include:

(1) Percentage of the work completed by phase and trade

(2) A statement regarding expected TCA/Tote equipment completion and system go-live (operational) date(s)

(3) Any approved changes introduced into the work

(4) General remarks on items such as material shortages, strikes, weather, etc.

B. TECHNICAL QUALITY

1. Patient Safety

(a) The TCA/Tote system design shall fully utilize available technology and accepted standards of practice to ensure all products are accurately filled, labeled, sorted, and packaged for the correct patient and that the product dispensed is without defect, extraneous debris, or other contamination. The TCA systems shall accept and accurately process 100 percent of all data communicated to it and product selection accuracy shall be 100 percent. Process exceptions that impact patient safety shall cause system rejections with status displays and alerts and occur in real time. System rejections shall be rerouted for automated correction or routed to Quality Assurance as determined by the Government.

(b) The TCA system shall incorporate an exceptions station that will fix any rejected vials for issues due to the following.

i. Incorrect number of pills

ii. weight errors.

iii. empty vials.

iv. Failed cross check.

v. Pharmacy Verification rejects.

vi. complete rejection messages and sample computer screen is in Attachment 1

(c) TCA system exception station will have the ability to do the following.

i. Eycon must be installed to correctly count tablets.

ii. Printer must be installed to re label vials and print long sigs.

iii. computer terminal with scanner to scan vials and correct reject issues.

iv. Eycon example screen is in Attachment 1.

(d) The TCA system shall prohibit the dispensing of expired product or product that will expire before the duration of the days’ supply of medication by sequestering or diverting the item as an identified processing error. The parameter that controls this feature shall be site configurable.

(e) TCA equipment devices designed for holding or storing oral solid pharmaceuticals shall meet or exceed the USP-NF 621 standards for protection from environmental and light induced product degradation.

(f) All TCA dispensing devices shall electronically log all replenishment activities by utilizing a bar code scanner, RFID, or some other reliable electronic means to verify that the correct product is loaded into the proper replenishment device or dispensing location. When an incorrect product is selected for a replenishment action, the system shall alert the operator in real-time and prevent the TCA system from accepting the incorrect replenishment action.

(g) All computer-controlled operator interactions with the TCA/Tote systems shall require a personal login and verify code and shall be capable of integrating with Active Directory and accepting smart card tokens (PIV Cards) (approved by VA Office of Information and Technology) for personal identification. The TCA/Tote systems shall include a system of permission keys to assign system access and functionality to operators, supervisors, and system administrators at a level appropriate for the duties of the individual and provide a retrievable log of all transactions. The system shall allow immediate access to the recorded data with real time and archived reports.

(h) The TCA system design shall not permit cross-contamination of product during the filling process. Under no circumstances shall canisters and counting devices for oral solid dosage forms utilize common chutes or funnel devices where particulate or solid matter from one product could be mixed with another product. In addition, under no circumstances shall an open bottle pass under other than the designated output location for the item being dispensed into the bottle. All dispensing devices for solid oral dosage forms shall provide spill-free dispensing of product into the bottle and ensure positive dispenser/vial contact during dispensing and spill free conveyance of the filled bottle.

(i) The TCA/Tote system shall eliminate any source of “out of sequence” processing and incorporate safeguards to prevent or detect and reject mismatched bottles, Totes and pucks or other transport devices.

(j) Canisters and dispensing devices for oral solid dosage forms shall possess a safety locking mechanism that prevents unauthorized access to contents during normal operation.

(k) All TCA system functions that require an operator to handle, manipulate, or otherwise interact with a product shall provide a mechanism that forces correct product selection, labeling, sorting, or other action to prevent or detect and reject incorrect product handling. Such systems shall be electronically driven or shall utilize such technology that ensures all user interactions are tracked and improper user interactions are stopped and logged.

(l) All TCA system filled products shall require pharmacist verification, or a certified technological equivalent that is an accepted standard of practice and approved for VA use. For oral solid dosage forms where a bottle is filled within the TCA system, an as-dispensed image shall be captured immediately following counting and the bottle shall be capped to include placement of an inner tamper-evident seal, post imaging. The bottle and image shall be presented to the pharmacist for comparison to a government supplied reference image (Medication Image Library (MIL). The tamper-evident seal shall be secured post verification to remain in place if the cap is removed from the bottle.

(m) The system shall detect any foreign matter in bottles exceeding 0.5 grams and reject the fill prior to verification.

(n) The TCA system shall prohibit the packing of prescriptions to the wrong patient.

b. System Accuracy

(a) Product selection accuracy for all systems and sub-systems of the TCA system shall be 100 percent with immediate detection and rejection of system failures.

(b) The TCA system shall offer a user adjustable, product specific parameter that will allow the system to accept over count.

(c) The TCA system shall offer a user adjustable parameter that will allow the system to accept or reject the dispensing per bottle by item dispensed exceeding 0.5 grams. System status reports shall notify operators when count errors occur for troubleshooting and maintenance purposes.

(d) The TCA/Tote systems shall integrate queue balancing logic to…