PWS TCA System Installation.docx

DALLAS (Lancaster) CMOP TCA/LOOP SORTER AREA INSTALLATION

PERFORMANCE WORK STATEMENT (PWS)

PART I: BACKGROUND

A. INTRODUCTION:

1. LOCATION:

The Department of Veterans Affairs (VA) Dallas Consolidated Mail Outpatient Pharmacy (CMOP) located at 2962 South Longhorn Drive, Lancaster, TX 75134-2118.

2. BACKGROUND:

The Dallas (Lancaster) CMOP operates a high-volume, automated prescription fulfillment environment that supports more than 112 million prescriptions annually. The Dallas CMOP is one of seven CMOP facilities located across the United States. This 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 (VAMCs) and Community Based Outpatient Clinics (CBOCs) throughout the country, with the potential for future growth based upon agreements with other Federal agencies. The total production goals currently are 90,000 prescriptions per day consistently with additional growth anticipated.

· In the current CMOP automated production system, the Pharmacy Operating System (POS) searches for oldest orders first in a shared directory and sends that data to the Unit of Use Automation (UUA) for dispensing. The POS will track using Radio Frequency Identification (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 (TCA), a 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. DEFINITIONS:

Ancillary Support Systems – Supporting subsystems, equipment, or infrastructure required to enable, sustain, or enhance the operation of the primary TCA system. These systems do not perform the main dispensing or automation functions but are necessary for safe, efficient, and reliable system performance.

API - Application Programming Interfaces.

ATD - Automated Tablet Dispensers. This refers to high-speed TCA.

Automated TCA Database Structure – Database tables and electronic data format in a Microsoft Structured Query Language (SQL). Server database structure that provides for a 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 United States Pharmacopeia-National Formulary (USP-NF) 621 standards for storage of pharmaceuticals, and protected with a fail-safe and tamper evident interlock system.

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

CO - Contracting Officer

Consumable – Parts or materials that are expected to be used up, depleted, or worn out during normal operation of the equipment and require routine replacement. Consumables typically have a short service life, are not repairable, and are intended to be replenished regularly to maintain system performance.

COR – Contracting Officer Representative

Costs – The expenses associated with providing the supplies, services, materials, labor, equipment, or resources required to fulfill the contract. Costs may include direct expenses (such as labor, parts, and materials) and indirect expenses (such as overhead or administrative effort) when applicable to contract performance. All costs must comply with the pricing structure, terms, and limitations defined in the contract.

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.

Go-live - Final Acceptance

Item – A Legend or Non-Legend drug or other product for fulfillment.

IPD – Independent Pill Dispensers.

Lock-out/tag-out (LOTO) - Safety procedure used in industrial and maintenance environments to ensure that machines and equipment are properly shut off, isolated from energy sources, and cannot be started up again until maintenance or repair work is completed.

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-Consumable - Item that is not used up, depleted, or consumed during normal use. These items are typically durable, reusable, and expected to last overtime.

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.

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. A C++ software application that is the heart of the CMOP pharmacy inventory, dispensing and tracking all prescriptions that are processed in the facility.

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.

C. GENERAL INFORMATION:

1. FEDERAL HOLIDAYS:

The following Federal holidays are observed at the Dallas CMOP. The contractor will not perform services on Federal holidays.

Independence Day

2. WORK HOURS:

To limit any impacts to production, the contractor will have access to Dallas CMOP, from 7:00 a.m. – 7:30 p.m. Saturday through Sunday for removal and installation of equipment, excluding Federal Holidays. Monday through Friday operating hours are 6:00am through 12:00am. If the contractor wants to work outside of these days/hours; the contractor shall submit the request in writing to Contracting Officer Representative (COR) and the Dallas CMOP Engineering office at least one week (7 days) in advance. The contractor is advised that requests are subject to disapproval.

Work must not impact production.

If production has a chance of interruption, contractor must schedule this work on off shifts or weekends. If work does not impact operations, they will be allowed to work during operational shifts. COR must be advised of work schedules a week prior.

D. STATEMENT OF NEED:

The Dallas CMOP requires a contractor to design, furnish, install, integrate, and commission a new pharmacy Tablet Capsule Automation (TCA) system and loop sortation area that are faster, safer, more reliable, and more flexible than existing equipment.

The new solution shall:

· Expand automated capacity for low‑ and medium‑volume prescriptions.

· Optimize use of existing high‑volume TCA equipment.

· Replace aging conveyors, robots, and sortation hardware to increase throughput and support future workload growth.

The updated system shall include new conveyors and sorter tables that:

· De-puck vials from low, medium, and high volume TCA equipment into totes.

· Route pucks to puck packing stations.

· Return empty pucks to all TCA equipment via controlled, balanced distribution.

The loop sortation system shall be be redesigned to receive, sort, and divert pucks from both the new low/medium‑volume TCA and existing high‑volume TCA without negatively impacting production throughput.

The new low/medium TCA area shall include:

· A minimum of 350dispensers supporting at least 350 unique National Drug Codes (NDCs).

· Integrated replenishment stations and ancillary support systems.

· Sufficient capacity to meet or exceed the performance requirements in this PWS.

New equipment shall include, but not be limited to:

· Puck ponds, puck conveyance, sorting equipment, de‑puckers, labelers, cross‑check stations, weight scales and post‑weight scales, automatic dispensers and canisters, high‑resolution cameras, exception stations, workstations, pharmacy verification stations, cappers, sealers, diagnostics/analytics Human‑Machine Interfaces (HMI), and associated conveyors, controls, and ancillary support systems.

The new TCA and loop sortation system must be fully integrated with:

· Existing Pharmacy Operating System (POS)

· CMOP production systems

· National CMOP data infrastructure While avoiding single points of failure and meeting Dallas CMOP’s accuracy, timeliness, and availability requirements.

E. OVERVIEW:

This project will expand and modernize Dallas CMOP’s automated dispensing and sortation capabilities to increase throughput, improve operational flexibility, and better separate high‑volume from low‑ and medium‑volume prescription processing. It will establish a new, fully automatic low/medium‑volume TCA area that operates in coordination with existing high‑volume KNAPP TCA equipment, while replacing aging loop sorting hardware and software to improve reliability and performance.

The new low/medium‑volume TCA area will provide at least 350 dispensers supporting at least 350 unique NDCs and will be fully integrated with existing CMOP POS and data servers, conveyors, replenishment processes, and puck handling systems. All TCA equipment (existing and new) will connect to redesigned conveyors and loop sortation that route pucks and vials efficiently to totes, puck packing stations, auto‑packers, and return “puck ponds” without impacting ongoing production.

This is a software‑intensive project that will require close coordination with CMOP programmers to ensure seamless data exchange, comprehensive audit trails, and operational messaging. The solution will introduce improved diagnostics, analytics, and HMI controls that allow maintenance and operations staff to monitor performance, manage exceptions, and start/stop equipment from centralized interfaces while maintaining safe and maintainable conveyance layouts.

Key outcomes include increased prescription and vial throughput, better utilization of existing high‑volume equipment, enhanced support for future growth, and reduced risk of bottlenecks or failures in sorting and de‑pucking operations. Work shall be staged so that production remains uninterrupted: the new loop sortation will be completed and accepted first, followed by installation and acceptance of the new low/medium‑volume TCA area.

1. Installation of low/medium TCA Hardware and Software:

1. This phase is clearly defined in this PWS, Part II.

2. ALL TCA equipment must be connected to new conveyors going into the loops for sortation, de pucking into Totes, and diverting to puck packing stations.

3. Return pucks must be returned to the new puck pond in a balanced number from existing conveyors coming from Puck packing stations, TCA single de pucker Auto packer stations, as well as sorting tables.

4. Single order vials must be able to divert to the existing TCA conveyor going to the new Auto Packers or de pucker into totes.

5. New replenishment stations must be in the area to fill canisters to the new TCA. Number of stations needed will be determined by contractor to meet the 350 dispensers minimum and must support the throughput required in the PWS.

6. Vertical lift modules (VLM) (storage cells) to store pharmaceuticals needed to supply both replenishment areas for the high and low/medium volume TCAs. Awarded contractors must determine the size and capacity of needed equipment, which may be done during the site visit. VLM’s are required to be proposed; however, VLM design details will not be comparatively evaluated. The Government will not assign strengths for larger capacity, additional features, or brand distinctions. Following award, the Government reserves the right, at its sole discretion, to adjust VLM size, capacity, and configuration within the overall system design, provided such changes are within the general scope of the contract. The Contractor shall support these adjustments without redesigning the core TCA or loop sortation architecture.

7. CMOP needs an Additional Standard Operating Procedures (SOP) for canister refill, dispenser refill, Audit trail examples, and CMOP messages are in Attachment 1.

8. TCA must integrate with CMOP POS and data servers for audit trails and data messages, Attachment 1 for example. This project will be software intensive and will work closely with CMOP programmers for integration.

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

10. Exception stations shall be engineered to accommodate all exceptions without slowing throughput. Length of buffering conveyors must be large enough to hold all rejects without impeding verified pucks. All research and engineering will be the responsibility of the awarded contractor.

11. Diagnostics and analytics will be displayed on a Human Machine Interface (HMI) tablet/computer for maintenance/operational needs in the area.

12. Equipment start/stop shall be located on the tablet/computer as well as manual controls in the area.

13. Contractor is responsible for connecting all air, power, controls, and Cat 6a communications.

14. Contractor will be responsible for additional pucks as needed. These pucks shall be the same dimensions, type of material, and RFID chips, as current pucks. Pucks shall be numbered with same Font for numbers. CMOP will dictate numbering sequence.

15. All local permits must be submitted to COR before work is started.

16. Installation and acceptance of low/medium TCA hardware and software must be completed no later than June 30, 2028.

2. NEW LOOP SORTATION AREA REQUIREMENTS:

The purpose of this area will be to receive pucks with vials and sort them for a particular patient, drop single or multiple vials into totes or divert multiple pucks with vials to puck packing stations. Pucks will arrive from the new low/medium volume TCA as well as the current high-volume TCA, Single pucks from the new low/medium volume TCA (single vial per patient) will be diverted to the current TCA single de pucker conveyor where it will travel to the auto Packers. Empty pucks will be returned to all TCA equipment in a controlled even distribution as demand dictates.

1. ALL TCA equipment must be connected to new conveyors going into the loops for sortation, de pucking into Totes, and diverting to puck packing stations. This will include all current low/medium/high volume TCAs.

i. NOTE: Successful contractors will have the liberty of designing this area if it meets all requirements in this PWS. Current layout is an example only.

2. Return pucks must be returned to the new puck pond as well as the high-volume TCA in a balanced number from existing conveyors coming from Puck Packing Stations, TCA single de pucker Auto packer stations, as well as sorting tables.

3. Number of sorting lanes will accommodate stated PWS throughput for new TCA with the additional throughput from current high volume TCA plus consideration for increased throughput for future needs.

4. Current conveyors including the Puck Packing Loop conveyors on Puck Packing stations, robot de puckers, and associated conveyance (return puck and infeed conveyors), electrical, pneumatic, and controls (motor control cabinet) for entire sorting area will be removed and replaced with new hardware per approved design.

5. All utilities, equipment, software, and controls will be the responsibility of the contractor to design and install.

6. New system must work and communicate with existing equipment (Puck Packing Stations) and current POS software.

7. Conveyors and e-stop circuits will be controlled by the new TCA equipment and stop all conveyors associated with the new area.

8. Conveyance shall be designed with appropriate space for maintenance in mind.

9. Contractors shall demolish existing conveyors, steps, robots, motor control cabinets, and controls not needed for the new area and store them on pallets outside for removal.

10. Removal and installation of new equipment must not impact production.

11. Diagnostics and analytics will be displayed on an HMI tablet/computer for maintenance/operational needs in the area.

12. Equipment start and stop shall be on tablet/computer as well as manual controls in the area.

13. Installation and acceptance of loop sortation must be completed no later than June 30, 2027; and shall be able to support new equipment testing when scheduled. This equipment shall be completed before the low/medium volume TCA is completed to support CMOP production needs to the Semi Auto-Packers (SAP) puck packing stations from current TCA equipment.

3. PERFORMANCE REQUIREMENTS:

1. New loop sortation, de pucking into Totes, and diverting to puck packing stations must be designed to handle workload from current Low/Medium/High volume TCA Equipment without impact to throughput. Consideration for increased throughput for future needs must be factored into the design for future growth.

2. Low/medium TCA dispensers shall meet all minimum 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% per shift.

1. Weight errors

2. Pill under count

3. Pill over count

4. Cross check error

5. Pharmacist rejects

3. Replenishment Area

i. Must have sufficient capacity to fully meet equipment capacity or minimum throughput goals; whichever is larger.

F. 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 equipment. 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

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 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, 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. This will include all audit trail messages. A list of projected faults is in Attachment 1. If additional audit trail documentation is required it will be provided to contractor.

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 including linear, 2D, GS1-128, and any current format at time of acceptance. The equipment shall also be designed to receive and process data from RFID input.

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 the newest VA approved version at time of acceptance, and Microsoft SQL Server 2019/2022, or the newest VA approved version at time of acceptance.

i. 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 developments shall use the current VA approved Microsoft Visual Studio Suite at the time of system go-live.

ii. 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).

iii. 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:

i. 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 final acceptance. 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.

ii. 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. All efforts shall be made to keep any HIPPA information off of PLC systems and PLC’s should be controlled with information of what actions to perform on a Puck, bottle/vial or tote, but all HIPPA or PII information shall be retained on computerized systems and not on the PLC.

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

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

v. 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. All Drivers, and their versions including software libraries shall be provided and be under version control for the system operations. No Changes or updates to the system are to happen without VA Approval once under version control.

vi. Programming software for PLCs, smart motors, robots, scanners, and all other programmable control or IO devices. Including Parameter settings and home position documentation for anything programmed including sensor photos showing target point of sensors shall be documented in the As build documentation.

vii. 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 the current at time of acceptance; following VA OI&T security and group policies.

viii. 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.

1. 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.

2. 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.

ix. New versions of software shall be capable of being “pushed” out of the appropriated systems using automated tools such as MS SCCM.

c. Audit Trails:

i. Audit trails are Quality control (QC) driven messages to and from the equipment that will track all vials through the process of labeling, cross check, weigh scale, dispensing, verifying, and any exceptions before completed order is delivered to the sorting loops.

ii. Audit trails are also part of replenishment both on the machine and filling replenishment canisters. See example of SOP on canister fill and dispenser fill in attachment 1.

iii. These audit trails must be communicated to the POS software for report generations. Any events that will be part of the process may be asked to be communicated to the POS system. The sample list in attachment 1 may be incomplete due to differences in equipment. These messages must be accurate and accessible for patient safety concerns.

iv. The system shall be able to create, maintain, and protect from modification or unauthorized access or destruction of an audit trail of access 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.

v. 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:

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

2. Identify access via the remote diagnostic capabilities.

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

4. Identify all commands to enable or disable logging activities.

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

6. Identify all modifications to security settings and parameters.

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

8. Identify all areas accessed via a communication link.

9. 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).

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

11. Identify all users who have a selected function.

12. Identify all activity for a given user.

13. Example Audit Trail messages is in Attachment 1.

vi. 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:

i. Security Feature User Guide.

ii. System Administrator Manual.

iii. User Manuals.

iv. Preventative maintenance tasks, schedules, and recommended parts stock levels.

v. Software and Hardware Testing Procedures and Results.

vi. All safety Devices Lock out tag out and utility connection isolation devices and locations. In a drawing.

vii. Network Diagram.

viii. Site Plan (Floor Plan) Drawings.

ix. “As Built” drawings.

x. Process and Instrumentation Piping (P&ID) Drawings.

xi. Wiring Diagrams including tags that are associated in the control logic.

xii. Control Logic Diagrams.

xiii. Hardware and Software Inventory.

xiv. Technical Documentation (i.e. all input/output points, ports, etc. used on the system; software programs for programmable devices including PLCs, port expanders, etc.) This documentation shall be as implemented, not as designed, and include:

1. Detailed Network Diagram.

2. 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.

xv. Provide four (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.

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

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

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

3. STYSTEM 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. The TCA 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 computers and servers shall provide UPS capacity throughout the system. Replenishment at any point in the TCA equipment shall not degrade system performance.

c. The contractor shall deliver a fully integrated TCA system that minimizes the costs associated with prescription fulfillment; which is measured through exception rates. The TCA system shall be designed to ensure throughput is not impacted by rework.

d. Reject rates shall not exceed 2.1% on any subsystem.

e. Rejects are system generated dead end events that result in restart/re-dispense of a prescription, process, or package and generates wasted product or supplies. All bottles that are rejected shall be captured for Quality Control (QC) disposition and documentation, a method of tracking the rejected bottle/order shall make a clear human readable identification on the repick attempt on the processing label of the repicked bottle.

i. Rejects in this sense includes:

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

2. Return to Stock (RTS) that cannot be reused through an automated process.

3. Product/supplies damaged by automation.

4. Spills in conveyance.

5. Vials labeled and then rejected for label print quality or process errors.

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 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 has provided preliminary conceptual drawing of the available space for the TCA area in Attachment 1. The Government required 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 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 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 design shall not have any material attachments to the floor other than the equipment legs below 150 mm to provide cleaning and visual inspection of floor.

f. 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).

g. 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.

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

i. 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.

ii. Anticipated staffing for TCA area, routine and preventative maintenance of the TCA equipment including the number and recommended background specialty of required staff.

5. PROOF OF CONCEPT TCA EQUIPMENT (SHALL BE SUBMITTED WITH PROPOSAL AND IF ACCEPTED MAY 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 provided under this contract and all associated 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 may 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 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 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 and Copies in PDF and or Excel which shall include:

i. A comprehensive risk assessment and mitigation plan including:

1. Identification of contract vulnerabilities and risks, including considerations of project scope, personnel required, data interfaces, sub-contractor product deliverables.

2. Prediction of potential consequences

3. Proposed mitigation and assignment of responsibility

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

iii. Quality Management Plan to ensure integrity and function of components and systems from delivery through acceptance and includes government inspection and concurrence.

iv. 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:

1. Milestone major event electrical interface

2. Component contractor delivery dates

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

4. Component installation

5. Component equipment testing to include capacity and documentation of published specifications

6. Communication interface of subsystems

7. Contractor software installation and testing

8. Validation of reporting functions and training of government supervisors and quality support staff

9. Integration with current VA CMOP National data infrastructure

10. Contractor training of government operations personnel

11. Live switch over

12. Contractor training of government maintenance staff

13. Contractor provided user and maintenance manuals (including periodic…