Attachment 1 20240806 Final PWS Hines-TCA-V2.docx

Great Lakes VA CMOP – Functional System Description – Hines, IL

Great Lakes VA CMOP Functional System Description & Performance Work Statement (PWS) – Tablet Capsule (Counting) Automation System and Auto Packaging Hines, IL

Updated - DATE: 16 August 2024 Site: Great Lakes VA CMOP, Hines, IL 60141

GLOSSARY OF TERMS

VA – U.S. Department of Veterans Affairs CMOP – Consolidated Mail Outpatient Pharmacy – VA’s high‐volume prescription filling unit.

VISTA/CERNER – VA’s central system for veteran’s her information storage & processing APFS – Automated Prescription Fulfillment System AUOU – Automated Unit of Use, see UUA below BULK – Non‐NDC or high unit count pharmacy items on a prescription.

CDB –Central Database hosting the patient orders at VA’s central location.

Combo Order –Combo Orders are orders that are placed in totes that require both TCA (puck) dispenses and UOU dispenses. These orders will have both vials containing tablet counted RXs and RXs dispensed from A‐Frames or Manual UOU dispensing.

Container – a logistical entity that contains tablet/capsule or a UoU retail pack dispensed on a Rx.

Sometimes referred to as Item being dispensed.

CO - Contracting Officer COR – Contracting Officer’s Representative COTS – Common Off The Shelf for parts and assemblies.

CS – Control Substance Prescription Dummy Order – This is a mock patient order with minimal data used to test the TCA and packing systems with fictitious patient ID information and return data from the system back to the VA (puck tracking data file).

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

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

FTP – File Transfer Protocol I–C - International Electrotechnical Commission IT – Information Technology Item – Drug or ancillary item. Sometimes interchangeably referred to as Container. See Container below.

Island of Automation (IOS) – A stand-alone system that is capable of integration with other systems, etc. regarding pharmaceutical fulfillment and packing.

NDC ‐ National Drug Code, a unique 10‐digit or 11‐digit code and universal product identifier for human drugs dispensed in a pharmacy. NDCs defines a specific manufacture, drug, strength, dosage form, and packaging code/quantity.

GL‐CMOP – Great Lakes Consolidated Mail Outpatient Pharmacy Long Sigs – A larger label that accommodates longer directions to the patient.

NFPA – National Fire Protection Association Package – A collection of one or more patient orders in a shippable form (bag/box/cooler etc.)

Patient Order – Identifies a single order to a specific patient and all the associated RX prescriptions contained in that order. Patient orders are unique to a package and may contain multiple RX prescriptions and multiple containers. For the purposes of this request, it can be assumed that there will be ONLY ONE DELIVERY PACKAGE PER ORDER PIL – Patient Information Literature POS – Pharmacy Operating System. Currently a McKesson system with some customization by QMSI.

There are no plans to change the POS.

Project ‐ Pharmacy Printing and Packing Automation Proven Industry Standard System – Refers to existing equipment that is on the market or common off the shelf (COTS) in the pharmaceutical industry (currently in use through the industry for production and pharmaceutical tablet dispensing and packing with inclusive components). A proven COTS system is one that is fully functioning, tested, industry proven reliability, performance, and in the commercial market, and uses existing pharmaceutical tablet dispensing technologies and equipment (includes conveyance, quality check system, tare and gross weighing systems, visual inspection systems, tablet and capsule counting-fulfillment bottling and prescription labelling systems (simultaneously handling 120 cc and 250 cc bottles and long sig labels), bottle descrambling systems, capping systems, cap inspection systems, pharmacist verification stations, and automated packing stations).

Puck – A puck is a round polyethylene (Ultra High Molecular Weight Polyethylene) carrier that is specifically designed to transport vials through the dispensing process. Each carrier is uniquely identified and contains an RFI chip located in the bottom of the carrier. Puck are used for tracking patient containers through the pharmacy. Each puck measures approximately 3‐3/4" wide at the base and is 3" tall with a 2‐1/4" center hole. Center hole is approximately 2‐1/4" deep. Some pucks (if required) have a plastic insert that stands out an additional 1" tall and makes the center hole approximately 1‐3/4" diameter center hole to accommodate smaller vials.

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

QASP – Quality Assurance Surveillance Plan contains QA thresholds the TCA is to meet.

SCADA – Supervisory Control and Data Acquisition SFTP – Secure File Transfer Protocol TCA ‐ Tablet and Capsule Automation system – Includes components, but is not necessarily limited to these as follows: conveyance, computer servers and workstations with monitors and printers (as needed for fluid TCA operations with all components, which can be monitored and controlled by VA network protocols within its own network), quality check system components, tare and gross weighing components, visual inspection system components connected to remote pharmacist verification stations, tablet and capsule counting-fulfillment bottling and prescription labeling components (simultaneously handling 120 cc and 250 cc bottles and long sig labels), bottle descrambling component systems, capping component systems, cap inspection component systems, and automated packing stations. This TCA includes the integration of four semi-automatic printing and packing systems owned by the VA from a previous contract.

Throughput – The amount of material or items passing through a system or process.

Tote – A tote is a plastic six‐sided container open on top for access. The tote contains an RFI tag in the center of the bottom side for tracking and routing. Each tote container has a unique system ID number and a tote typically contains a single patient order. The tote dimensions are 15 inches long by 11 inches wide by 9 inches high. In some instances, totes can contain multiple, single container customer orders and are referred to as “super totes.”

Tote Marriage – Tote Marriage is the process of removing vials from pucks (if required) and placing the vials into an empty tote for combo orders. The Tote Marriage area is the first decision point for empty order tote and totes may by‐pass the tote marriage if no TCA RXs are required for the patient order.

Tote Return – Tote Return is the conveyor used to return empty totes to the start of the tote portion of the APFS. The empty tote return will be a separate conveyor to the full tote delivery conveyor from the

APFS.

TSP – Tote Semi‐Auto Packer – A type of staffed packing workstation assisted by electro‐mechanical devices commonly used in order fulfillment operation.

Turnkey System – A complete, designed, or constructed system that is completely ready for operation; fully equipped and ready to independently and interdependently operate.

VTD – Vendor To Determine.

UoU – Unit of Use Automation.

UPS - Uninterruptable Power Source with surge suppression protecting all connected automation equipment.

UUA ‐ Unit of Use Automation.

Operational Terms:

ACK ‐ Acknowledge CONTAINER – Labeled item in patient order (some RXs can contain multiple containers). Can be either:

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

NAK – Non‐Acknowledge NEW RX – First fill of the patient prescription ORDER – Single mailing unit to patient with all requested items/prescriptions REFILL RX – Refill of existing patient prescription RX – Prescription from physician to patient Tablet/Capsule Vial (ex: countable pills in a bottle) UOU – Unit of Use Container (ex: retail pack format) Order Type Definitions:

MANUAL – Orders filled entirely in manual work area TOTE – Orders that will reach their pack area in totes; this includes orders with:

UOU: >=1 UOU containers dispensed from the Sam Jared AUOU work area COMBO: >=1 UOU container and >=1 TCA container dispensed from AUOU/ATD, respectively VIAL – Orders that will reach their pack area in vials; this only includes orders with all RX(s) dispensed at counted tablets or pills.

Area Definitions:

ATD – Automated Tablet Dispensing AUOU – Automated Unit of Use Dispensing MTD – Manual Tablet Dispensing MUOU – Manual Dispensing for Unit of Use Items OVERVIEW

CMOP BACKGROUND

The United States Department of Veterans Affairs Consolidated Mail Outpatient Pharmacy (VA CMOP) Great Lakes Hines, IL facility processes over 100,000 prescriptions per day. Prescriptions are entered into the patient’s Electronic Health Record (HER) at VA hospitals and clinics, and then the prescriptions are assigned to the Great Lakes facility and are transmitted to the CMOP for dispensing and mailed to the veteran.

The prescriptions are currently processed via one or more of the nine Islands of Automation – TCA, ADU, CLS, Cold Pack, Unit of Use, LDP, Controls, Hazardous, or Manual. The VA CMOP desires to increase the amount of automation within the Great Lakes location to as much as 160,000 scripts per day in a two-shift operation. Proposals should be designed to support this initiative.

Requirement is to procure a proven turnkey industry standard tablet and capsule automation (TCA) system with a fully automatic printing and packing system and to also integrate four existing semi-automatic printing and packing stations (capable of also managing and packing easy open caps on pharmaceutical bottles).

The specific area to add the TCA system is as follows:

The CMOP’s existing manual labeling and packaging operation is in the floor footprint area of where the new TCA system is to be emplaced (at the conclusion of this requirement). This new TCA system is envisioned to replace the existing manual labeling and packing equipment that is in this floor location. The current TCA is at the end of life and the current packaging process is too labor dependent for future expansion. The new TCA system equipment will still have ability to accommodate completely automated and remote pharmacist verification stations for final quality review before filled prescriptions move to packaging; however, the exceptions station or stations will need to accommodate a pharmacist station.

Facility Location

US Department of Veterans Affairs Great Lakes CMOP Bldg. 37NW, 5000 5th Ave., Hines, IL 60141

Confidentiality

VA CMOP considers all equipment, systems, distribution processes, and documentation relating to such equipment, systems, and processes to be confidential and proprietary information. The Contractor will not distribute, disclose, or disseminate, in any way, such information to anyone except its employees who are involved in responding to this effort.

All information relating to this project is considered confidential information. This includes not only technical and requirements information but also non-technical information such as costs, prices, and sizes of equipment, quantities, material, etc. The Contractor agrees to keep such information in confidence. No information relative to the project shall be released by the Contractor, either before or after completion of the project, for publication or advertising purposes without the prior written consent of the US Department of Veterans Affairs (VA). The contractor is capable and is able to enter into a VA Business Associate Agreement (BAA).

Background Checks As needed, any cost associated with background checks shall be at the expense of the vendor

Drawings Supplied

A general layout of the planned Great Lakes pharmacy is provided to scale in the attached drawing files. AutoCAD drawings of the existing facility can be made available upon request.

An approximate location and quantity for the equipment is identified.

STATEMENT OF NEED

The purpose of this procurement is to obtain a proven industry standard Tablet Capsule Automation (TCA) system with no single point of failure with sufficient automatic printing and packing stations to handle up to 8,948 bottles an hour and integrates four semi-automatic printing and packing stations (1,000 bottles an hour). It must meet the accuracy, timeliness, and throughput requirements of the dynamic workload of the Great Lakes CMOP. The Great Lakes CMOP requires a contractor to serve as a systems integrator who will design a working TCA, procure all system components, and configure the TCA to successfully integrate with the current VA CMOP National data and its applications, databases, tables, and IT infrastructure. The entire system with all components must be fully functional and fully integrated with the CMOP electronic data structure as outlined in the CMOP Electronic Data Interface Guidelines (Encl. 1), and VA Office of IT Design Guide (Encl. 2) with no single point of failure. The TCA must be capable of dispensing individual dosage tablets using ancillary support components, and a comprehensive data logging, collection, and reporting system. Remote pharmacy verification software application capabilities must be integrated into this system. Responses must contain sufficient detail to demonstrate understanding and capability of the TCA system requirements.

Tablet and Capsule Automated (TCA) System Integrator It is envisioned that the system integrator for the facility’s tablet and capsule automation system and automatic printing and packing systems (contractor must provide a solution to handle up to 8,948 bottles per hour) and will be able to fully integrate a comprehensive turnkey and proven industry standard TCA system that contains these components, but is not necessarily limited to these as follows: replenishment station, conveyance, computer servers and workstations with monitors and printers (as needed for fluid TCA operations with all components, which can be monitored and controlled by VA network protocols within its own network), quality check system components, tare and gross weighing components, visual inspection system components connected to remote pharmacist verification software (hardware and software provided by the contractor) for VA computers, tablet and capsule counting-fulfillment bottling and prescription labeling components (simultaneously handling 120 cc and 250 cc bottles and long sig labels), bottle descrambling component systems, capping component systems, cap inspection component systems, and automated packing stations. All these components are envisioned to be interconnected and capable of intercommunication with data interconnected with the VA’s current database infrastructure, and tables throughout the entire TCA system (also includes the automated packing stations and integrates the four semi-automatic packing stations, which are at the CMOP). This system must be capable of communicating, intercommunicating, and connecting to the VA’s current application software, the VA’s database, and tables within the available floorplan structure. This TCA will need to also be integrated with four existing semi-automatic packers (QMSI’s QPak PTL semi-automatic packing system with a Clamco R3200 bagger), which each handle packing no less than 250 bottles per hour. This will require the contractor to provide a solution determining the number of fully automatic packers needed to handle printing and packing up to a rate of 8,948 bottles per hour.

Contractor Past Performance

Contractors should recognize that the VA’s selection team will desire an oral presentation (of the most highly rated proposals) and to visit one or more fully functioning, operational, and established Tablet Counting Automation equipment sites with automatic packing equipment that uses the contractor’s integrated equipment in a pharmaceutical environment that is similar to the Great Lakes CMOP environment and should be prepared to support these requests. Contractors that have experience with the VA and have fully functioning, operational, and established sites in the VA to visit are considered to exceed this requirement.

The Government will review all files and information pertaining to past performance information to include Government obtained reports Past Performance Information Retrieval System (PPIRS) and past performance questionnaires. Contractors are required to furnish (if possible) five (5) references for contracts occurring within five (5) years prior to the solicitation release date with the following information for each contract referenced (experience as a Contractor with fully completed contracts are weighted more favorably than as a subcontractor):

· Company/Division name

· Product

· Contracting Agency/Customer

· Contract Number

· Contract Dollar Value

· Period of Performance

· Verified, up-to-date name, address, FAX and telephone number of the contracting officer.

There are five sub factors to be rated: Quality of Workmanship (providing a Turnkey System), Timeliness/Adherence to Schedules, Management Effectiveness, Customer Satisfaction, and Training/Technical Support. Past Performance is evaluated in a two-step process as follows: (1) Determine the relevancy of recent efforts accomplished by the offeror matched to the requirements from the PWS; and (2) Contractor’s overall performance on the past contracts, which meet relevancy requirements matched to the PWS. The government will evaluate the quality and extent of the contractor’s performance deemed relevant to the requirements of this solicitation and the PWS.

Technical Submissions with the Quotation

The Contractor should also recommend the content and quantity of start-up supplies and spare parts that should be maintained by the VA with prices and estimated delivery times. Spare parts are to be industry standard Common Off The Shelf (COTS) parts to the greatest extent possible. This information shall be submitted with the proposal.

All physical characteristics of the proposed equipment are to be submitted. These include the critical dimension related to length, width, height, capacity, and clearances.

Mechanical and electrical requirements (power, voltage, current, etc.) of the Contractor’s proposed solution must be provided and clearly described in industry standard language.

All control software / systems must be capable of running Microsoft based applications and to intercommunicate and interface with the CMOP’s VA databases and tables to operate the Contractor’s TCA system equipment with all components. The Contractor’s control software/application(s) and IT systems are to be clearly described and must enable interconnecting VA data to be fully integrated (includes to all SQL data) to the CMOP’s automated pharmaceutical dispensing system software, databases, and tables.

Numerous requirements are elicited in the RFP. Contractors are advised to respond in as much technical detail as possible with the quotation.

Submissions shall contain a Contractor-developed plan view and elevations as required to demonstrate the Contractor’s proposed equipment installation details. Submissions shall contain equipment numbers in the layout drawings and should match the Contractor’s proposed solution.

Contractor will provide a system integration strategy to include hardware, software, components, and scalability to add future Islands of Automation to the Tablet Counting Automation system within the floor space provided at the Great Lakes CMOP.

Training, Maintenance, and Warranty Submissions (Warranty Administration & Management)

Contractors are requested to submit information regarding available services for repair and maintenance. Such shall include the names and locations of a local representative, service hours, factory branches, or manufacturer’s representatives capable of supplying spare parts, maintenance, and warranty service to the VA’s facility.

The Contractor is to provide training for the VA in the proper repair and preventive/corrective maintenance of the equipment.

The Contractor must provide a listing of the top three repairs to be expected for each type of electro-mechanical system proposed, necessary corrective actions, and the expected mean time between failures for these occurrences.

The equipment must be warrantied for workmanship, materials, design, installation, and performance for a period of time to be agreed upon from the day of beneficial use at the VA CMOP. Specific warranty and guarantee information is to be submitted with the quotation. For all key subcomponents (defined as those listed on the recommended spare parts inventory list), Contractors should provide information from subcomponent Contractors on the anticipated life cycle of each key subcomponent. Warranty offerings will be considered in the quotation evaluation.

Any warranty should be a minimum of one-year unconditional extended warranty, which will include all parts and labor. Normal fair, wear, and tear items are excluded.

Attachment 5 – References and Qualifications

A list of current and/or recently completed projects of similar scope and nature showing awarded contract value, type of system supplied, and when completed, shall be provided in a quotation. A contact name and phone number for each project shall be included. A minimum of three such existing projects are to be listed within the last 5 years. Contacts provided should be knowledgeable in the history of the installation, operating performance, and maintenance history of the installation. Contacts in the Midwest region are preferred but need not be limited to this geographical area. If applicable, federal government procurements should be included. Contracts successfully completed with the VA are considered to exceed an acceptable rating.

Attachment 8 – Bill of Materials (Delivery and Integration)

A complete Bill of Materials shall be supplied with the quotation reflecting total component quantities, required software, delivery weight, and expected number of truckloads to be shipped with projected delivery dates.

Information Must Include the following:

The base proposal should include the following areas broken out per component or assembly of equipment. All major components must be listed with manufactured location as follows:

**If only providing individual piece of equipment – specifically state exclusions in base quote.

1. Conveyance

2. Unscrambler equipment.

3. Tablet Counting equipment.

4. Fully automatic labeling and packaging that is also capable of segregating filled prescription bottles needing caps either set into an easy open mode-configuration or have the cap’s safety snap ring removed with an integrated inspection system and then packaged. Number of fully automatic labeling and packaging components to process up to 8,948 bottles per hour.

5. Integrate four of the CMOP’s existing Semi-Automatic Packing machines (QMSI’s QPak PTL semi-automatic packing system with a Clamco R3200 bagger) for packing multiple vials in a single bag (owned by the VA from a previous contract).

6. Quality Check System

a. Simultaneously Produces a mix of 4,000 120cc and 250cc Dispensed Bottles Packaged and ready for shipping manifest labels.

b. Includes tare and gross weighing systems that divert discrepancies to exception locations and communicates to operation events and to the exception station for corrective action.

c. Including electronic verification automated technology to complete Pharmacist Verification tasks with Pharmacist Verification software (application) that is capable of electronic fill verification of canisters and installed on VA computers.

d. 100% Visual inspection, Electronic, Electrostatic (capable of accurate counting in a dusty environment), and Weight Verification with tare and gross weight comparison.

7. Simultaneously capping and torquing 120cc and 250cc dispensed bottles with a cap inspection component.

8. Replenishment area (design and build), equipment, and operations.

9. List all components into the TCA system (e.g. replenishment station, conveyance, computer servers and workstations with monitors and printers) as needed for fluid TCA operations with all components, which can be monitored and controlled by VA network protocols within its own network), quality check system components, tare and gross weighing components, visual inspection system components connected to remote pharmacist verification software for VA computers, tablet and capsule counting-fulfillment bottling and prescription labeling components (simultaneously handling 120 cc and 250 cc bottles and long sig labels), bottle descrambling component systems, capping component systems, cap inspection component systems, and automated packing stations (handling up to 8,948 bottles per hour).

PROJECT SCHEDULE

Project Schedule Requirements (Delivery, Integration, Test & Evaluation, and Warranty)

As part of the quotation, Contractors provide a proposed schedule for the entire scope of work (in English). The VA envisions the schedule, at a minimum, to encompass the events identified in the table below. The Contractor must perform the work in phases or schedule meeting deliverable requirements. With the quotation, the Contractor must submit a firm schedule for the system procurement, delivery, installation, and testing. As a minimum this schedule shall detail the elements and duration relating to these listed milestones. It is expected that fabrication, shipment, and installation will result with overlapping and concurrent activities.

** Any Dates shown are preliminary estimate and subject to change. **

QASP (Quality Assurance Surveillance Plan)

Review of operational logs, databases, or metrics

Review of operational logs, databases, or metrics

Review of operational logs, databases, or metrics

Review of operational logs, databases, or metrics

Review of operational logs, databases, or metrics

Review of operational logs, databases, or metrics

OPERATIONAL REQUIREMENTS

Existing Pharmacy Process

The Great Lakes CMOP fulfills prescription medications from the VA Health Facility Network to patients via mail order prescription fulfillment. The operation handles drugs as either counted tablets in vials and / or unit of use drugs in manufacturers packaging. Each prescription is dispensed, labeled with a unique patient label, is pharmacist verified, is consolidated / sorted (if required), and is packaged for shipment.

The diagram below graphically illustrates the fulfillment process within the Great Lakes CMOP facility:

This project will address the Tablet and Capsule Automation (TCA) System in addition to Automatic Printing and Packing. Currently, the CMOP’s TCA system is at end-of-life and the Packing component has a large manual demand that reduces efficiency of the process.

The following sections describe the overall pharmacy operations and design approach to be followed when designing the TCA and Auto Pack to be applied for this project. The overall pharmacy operations are provided as general background for a complete understanding of the fulfillment process and flow throughout the facility.

The goal of the VA is to increase the productivity and capacity of the TCA and packing areas. This will allow for more production from the same or reduced footprint. This would be accomplished through the elimination of manual tasks over time currently performed in these areas.

The VA wishes to improve quality and to reduce the potential for errors that could ultimately go to the customer patients. Safeguards must be added to remove the risk of wrong product dispensing and mixed drug dispensing when bottles are filled at a cell and while the bottle is traveling on the conveyor without a cap. A bottle must have neither a resting stop, nor travel that is under any other cell while being moved or awaiting fill at a designated cell. There must not be an open channel for pouring into or out of, which would increase the chance for loose pills to fall into an unintended bottle when refilling cells is completed. Additionally, a single level of cells on the floor level is preferred over multiple levels of cells above the floor level cells. If multiple levels of cells are required to meet the space requirements in the CMOP, then there must be safeguards and detection systems in place to reduce the risk of a loose pill falling from upper levels or tiers into a bottle on lower levels or tiers. Additionally, the system must recognize if mixed dispensing occurs. If spill prevention plates or trays are installed, then they must clean easily in a manner that prevents loose pills from falling into another bottle during that process. Additionally, there must be minimal chance a small pill will get caught on any piece of the equipment, which would increase the chance it would fall into any open bottle creating a mix.

Quality concerns for accurate filling of both drug product and quantity are important. The use of verification scans, system safeguards, lockouts, and other safety features, which can be built into the automation is needed to greatly improve quality, safety, and the overall confidence in automation for dispensing pharmaceuticals.

Current Pharmacy Layout (This is a Tentative Conceptual Design)

Below is the current Great Lakes CMOP pharmacy layout (green areas are existing storage space).

Operational Option Areas (This is a Tentative Conceptual Design)

Below is a layout illustration and tentative conceptual design example. Please reference the CAD file for 3D dimensions. Floor placement may vary but needs to fit into an approximate floor space area of 120’ x 190’.

General Equipment Requirements

Preferred Tablet Counting Automation Requirements

The new tablet counting equipment must utilize a control system platform that is open source and can be accessed by the CMOP engineers for troubleshooting. It is preferred that a Rockwell Automation controls system or equal/equivalent be used to better facilitate integration with the upstream and downstream equipment. The equipment PLC will be required to integrate with an independent supervisory PLC.

The preferred communication protocol is Ethernet/IP. The new tablet counting equipment must be able to communicate with the plant network and allow for the exchange of data between the equipment PLC and plant servers. Handshakes with upstream and downstream equipment will be handled via this Ethernet/IP protocol. Use of SFTP is required and FTP is not authorized for use with data exchange on the network.

Current Packaging Process and Capabilities

The current packaging process at the Great Lakes CMOP is a manual process. Orders are manually packed in polybags or boxes for shipment via truck. There is no pre-sorting of packages prior to shipment. All packages are placed in bulk mail containers or hand stacked on pallets, which transports packaged orders for outbound manifesting for shipment. These containers or loaded pallets are transported to a third-party mail processor for sorting and shipment manifesting.

The packaging areas handle both puck and tote packing. Each pack station contains a work surface, storage for packaging materials, a printer for patient literature, a printer for patient package ID shipping labels, a tethered barcode scanner, and a workstation computer terminal with a monitor.

Each packing area has an outbound package belt conveyor. The tote area and puck area packing areas utilize the same package belt conveyor to a single bulk mail container. Currently, there is a total of 3 Pharmacist workstations, 12 Pharmacy Technician work areas, and a maximum of 38 Shipper-Packer multi-use workstations in the existing TCA.

Tablet Counting Automation

Process Overview

Tablet counting automation is currently located opposite the order packing stations and adjacent to the SI A-Frame system. The process starts when an order is assigned to the tablet counting automation system, a bottle label is printed (standard size or a long sig label), and applied to either a 120CC or 250CC bottle (depending on product and quantity). The labeled bottle is placed in a puck appropriate for that size bottle and through RFID scanners on the conveyor line, it is directed to the cell needed to fill that order. The current equipment has 333 cells with a 2000 CC capacity. Of those, 222 of the cells utilize mechanical tablet counting technology and 111 of the cells utilize photo eye tablet counting technology. The cells are dedicated to a single product and cannisters are verified via barcode scanning during replenishment of the cells. Once successfully filled, the bottle is manually inspected for pharmacist verification before it is capped. If the bottle belongs to a single order, it is directed towards packing. If the bottle belongs to a multi-order that has no other tablet counting bottles needed, it will be capped, removed from the puck, and put into a tote that is then assigned that order number. If the bottle belongs to a multi-order that has additional tablet counting bottles needed, it will be placed in a que in the conveyor loop area until all tablet counting bottles are assembled. After all the needed bottles for the order are assembled, they will be put into a tote and the order number will be assigned to that tote.

Current Tablet Counting Automation Layout

Tablet Counting Assembly Process

The process will remain very similar to the current process described above. Some of the elements that need to be captured are:

· The TCA must have an area designed and built for replenishment of TCA supplemental storage containers/canisters to prioritize replenishment workflow and ensures optimal dispensing of TCA system throughput. The container filling area may be physically separate from (but shall be in close proximity to) the TCA production area maximizing efficiency of the replenishment process. Consideration shall be given to efficient workflow and ergonomic design (meeting OSHA Pharmacy ergonomic standards) within the replenishment area to include container cleaning, staging, movement, and storage of working stock, and replenishment storage containers. TCA replenishment software must provide an error-free mechanism for replenishment actions. The TCA replenishment system shall maximize efficiency and include forcing functions ensuring 100% accuracy when placing containers in the TCA and subsequently transferring drug product into TCA containers. The system requires an independent NDC scan of each commercial bottle prior to transferring its contents into the container, and the empty commercial bottle shall be tracked through disposal prior to the system accepting the next commercial bottle. The replenishment system requires electronic verification of filled canister to include a mechanism to assign and track status for each canister (e.g. assigned, complete, verified/staged, loaded, released, and ready) and record the NDC, lot/expiration date, quantity, operator(s), and the canister fill date.

· Fill and conveyor speed capabilities must support the design summary model table on page 33.

· Tablet counting automation stations to support a minimum of 800 product codes. The CMOP currently supports a minimum of 300 unique product codes on the CMOP’s existing tablet counting automation equipment.

· Tablet counting technology that is capable of minimal dust and able to count accurately in a dusty environment. This is the preferred tablet counting technology due to the potential for process dust.

· Counting technology is capable of detecting two products falling together and senses broken tablets.

· The drive chute is capable of sealing the product’s path to the bottle.

· Fail safe technology that verifies correct product is in the canister when refilled and emplaced and is capable of sensing that the correct product is refilled in the canister.

· Design must incorporate features to protect the contents from contamination (from dust and foreign particles) to include, but not limited to all OSHA safety standard and codes. The TCA processes shall take employee protection and engineering controls into consideration by including the use of local HEPA filtered capture ventilation. Additionally, use of HEPA-filtered capture ventilation is required for hazardous drugs handling according to USP Compounding Compendium Chapter 800 and recommended by NIOSH Guidelines.

· Safeguards must be added to remove the risk of wrong product dispensing and mixed drug dispensing when bottles are filled at a cell and while the bottle is traveling on the conveyor without a cap. A bottle must have neither a resting stop, nor travel that is under any other cell while being moved or awaiting fill at a designated cell.

· A single level of cells on the floor level is preferred over multiple levels of cells above the floor level cells.

· The numbers of cells in the new equipment must be optimized based on the facility’s NDC count, production goals, and allowable space and height provided in the production space.

· The TCA is capable of working with between 840 canisters up to 920 canisters with the number of cells in the new equipment must be optimized based on the CMOP’s National Drug Code (NDC) count, CMOP production goals, and allowable square footage and height of the available production area.

· Cannisters need to protect medications from UV light.

· Dispensing cannisters are to be a minimum of 4000 CC and capable of handling 8000 CC cannisters and must be capable of sustaining no spills when cannisters are replaced.

· This site requires the ability for 100% non-remote and remote pharmacist verification throughout the process. Conceptually, this accounts for twelve pharmacist stations.

· The TCA must contain sufficient bottling and prescription labeling components (simultaneously handling 120 cc and 250 cc bottles and long sig labels) with bottle descrambling.

· All patient labels must include all required elements needed for dispensing and the printing must be clear and applied correctly to vials (straight and upright).

· The TCA must be capable of dispensing the correct drug and correct quantity with no spills.

· Conveyance system does not induce spills and handles prioritization of work according to First-In-First-Out (FIFO).

· 120 CC and 250 CC bottles are to be capped using a capper capable of capping mixed 120cc and 250cc bottles simultaneously and immediately after Pharmacist verification and final weight. Contractor is responsible to provide all components of the overall system including hardware and software, such as conveyance, sorters, diverts, labeling (this includes standard and long sig labels), scales, cameras, remote pharmacist verification equipment and software (VA images computers), proper queueing, 120 CC and 250 CC pucks (if required), and integrated associated components needed to produce a turnkey TCA system with no single point of error.

· After capping the TCA system must be able to adjust for easy open or safety - capable of segregating filled prescription bottles needing caps set to an easy open mode-configuration (outer ring of cap is raised to its highest position on the cap or have the cap’s safety snap ring (outer ring of the cap) removed and then packaged.

· Capability to expand the tablet counting system in order to handle mixed orders with Unit of Use products and other islands of automation needs to be integrated with the TCA with future updates of connected systems.

· Bottle fill processes are to not have bottles pass directly under other filling cells.

· Conveyor speed but allows for in person Pharmacist verification.

· Must include integrated automated quality check system components with a check weigher, exception stations, QA camera checks, pharmacist verification inspection, and cap inspection operating below failure rates of .05%.

· Sufficient controls for motor, conveyor operations, and holdbacks must exist to prevent vials (120cc & 250cc) from getting bunched up. Reachable and adjustable parameters controlling the movement of vials through the TCA to final packaging are required.

· Remote pharmacist verification hardware and software must be provided (imaged by the VA).

· Each component must be capable of independent operation with no single point of failure.

· Commercial Off The Shelf (COTS) parts supporting the TCA and the automatic packing stations are desired.

· Offline PV capable with easy access for easy modification.

· Direct access to the TCA Operator Menus and communications is required.

· System is capable of processing Hazardous Pharmaceuticals without effecting other pharmaceuticals dispensed from the TCA.

· The system is capable of exchanging data with current and future automated logistics systems with the warehouse.

· Capable of using an RFID puck (if required) system to marry other dispensed orders into a single tote.

· If possible, maximize vertical space to increase the number of cells while minimizing floor space while remaining accessible to conduct routine and unscheduled maintenance.

· Capable of seamless interface with Rockwell automation and communications controls.

· TCA lanes with all TCA components are controlled by dedicated server(s) that is protected with an UPS and the server quantity is determined by the Contractor to support an hourly production rate of a minimum of 8,948 bottles per hour.

· Integrated scales must be capable of calibration while on the TCA line.

· Training Package – that has all components of functional design specifications, hardware design specifications, component and assembly connections and interconnections, and software design specs (FDS, HDS, and SPS) with an IT Signal and Data Flow chart showing all interconnections.

· Integrates servers and computer workstations (includes remote pharmacist workstation computers) to control input, processing, and output of all data to intercommunicate between all components in the TCA with the semi-automatic and automatic packers.

· Automation – Software design should include handshake between vendor system and VA data for SQL data needed for fluid data intercommunication (between VA database and vendor equipment). Software documentation is required demonstrating how this design operates (Refer to Interface to POS on page 27).

· Admin. Privileges on vendor equipment is only available on vender equipment, no software should run under administrator rights. Administrator rights for the vendor must be removed after installation.

· No sensitive or patient information (printer information) is to be stored or passed through the TCA contractor system. After all printing is complete then all flat files are removed

· Spare parts package for one year of parts.

· The TCA must have anti-vibration engineering to dampen or shield vibration of the component scales to sustain accurate scale calibration.

· Go live testing must allow for inclusion of subject matter experts from existing contractors to participate, which support the Great Lakes CMOP outbound shipments. This includes exchange of information regarding updated equipment or software changes or printing changes that effect outbound shipments.

Automated Packing Process Overview

The current packing process is a manual process that is located opposite of the tablet counting automation and final pharmacist checks. A packing associate collects a tote off the conveyor line and scan the first item they grab to pull up the order on the computer at their station. The order details will provide the type of material needed to pack the order (i.e., mailer, bubbler, small case, large case, etc.) and the package ID shipping label and any printed instructions will be printed at the station. The associate scans all items in the order to confirm they are accounted for and correct, then packs the items in the packing material with the printed instructions and seals the package before placing the package ID shipping label on the package. Once that is complete, the package is placed on an outbound conveyor that collects the orders in a gaylord that is then loaded onto a truck to be sent to a third-party mailer for sorting, distribution, and application of a shipping label.

Current Manual Packing Layout

Automated Packing Requirements

The automated packing for this portion of the project is to focus on tablet counting bottle packing. This will include single and multi-bottle orders. Some of the elements that need to be captured in the Statement of Requirements are as follows:

· Bottle packing and conveyor speed capabilities to support a total unit goal of up to 80,000 prescriptions per each 7.5 hour shift with an automated packing rate of 400-500 per hour per packing station.

· The automatic packing must be capable of supporting a minimum hourly rate of 8,948 bottles per hour without creating any TCA system backup or production flow stoppages.

· Automatically reads tote RFID tags to automatically trigger the printing of patient literature, and print a package ID label on a poly-bag or print directly on a poly-bag, and fills the bag with the matching prescription and seals it for shipping.

· Printing must be clear without smears or smudges. The full package ID number must be printed with the barcode being readable by the mail consolidator…