762-25-901 - VACMOP TUCSON - Vial Labelers and Puck Pond 2025_03_17.pdf

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Southwest VA CMOP Functional System Description & Performance Work Statement

(PWS) –

Vial Labelers & Puck Pond Upgrade for Tablet Counting Automation Area

Tucson, AZ

Updated - DATE: 21 February 2025

Site: Southwest VA CMOP, Tucson, AZ - 85706

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i Southwest VA CMOP –System Description – Tucson, AZ

TABLE OF CONTENTS

1. GLOSSARY OF TERMS

1.1. General Terms

1.2. Operational Terms

1.3. Order Type Definitions:

1.4. Area Definitions:

2. OVERVIEW

2.1. Facility Location

2.2. STATEMENT OF NEED

2.3. Operation Hours

2.4. Confidentiality

2.5. Drawings Supplied

2.6. Supplier Qualifications

2.7. Technical Submissions with the Quotation

2.8. Training, Maintenance, and Warranty Submissions

2.9. Prices, Risk of Loss, and Title

2.10. Exceptions and Alternates

2.11. Proposal Contents

2.11.1. Attachment 1 - Project Overview

2.11.2. Attachment 2 - Product Information

2.11.3. Attachment 3 - Subcontractors and Suppliers

2.11.4. Attachment 4 - Supplier Offered Alternatives

2.11.5. Attachment 5 - References and Qualifications

2.11.6. Attachment 6 - Technical Submissions

2.11.7. Attachment 7 - Training, Maintenance and Warranty Submissions

2.11.8. Attachment 8 - Bill of Materials

2.12. Oral Presentations

3. PROJECT SCHEDULE

3.1. Project Schedule Requirements

3.2. Project Schedule Submissions

4. OPERATIONAL REQUIREMENTS

4.1. Overall Pharmacy Process

4.1.1. Current Automated Tablet Dispensing Line

4.2. Current Tablet Dispensing Flow and Process

4.3. Labeling, Tare Weight and Conveyor Design Requirements

4.3.1. Centralized Support Operations

4.3.2. Redundancy

4.3.3. In Line Weighing

4.3.4. Raised Working Platform

4.3.5. Flexible Labeling Capabilities

4.3.6. Puck Size

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ii Southwest VA CMOP –System Description – Tucson, AZ

4.3.7. Puck Identification

4.3.8. Puck Weight

4.3.9. Equipment Noise Exposure

4.3.10. Preferred Puck Conveyor Design Requirements

4.4. Proposed Upgrades to the Vial Labeling Area

4.4.1. Puck Pond & Conveyor Re-Routing

4.4.2. Equipment to Be Removed

4.4.2.1. Puck Pond

4.4.3. Proposed Vial Labeler Upgrades

4.4.4. In-Line Weighing Loop

4.5. Transition Planning

4.6. Interface to PMS

5. AUTOMATION DESIGN AND FABRICATION REQUIREMENTS

5.1. General Design Criteria

5.1.1. Safety Standards and Codes

5.1.2. Quality Requirements

5.2. Mechanical

5.2.1. Guarding

5.2.2. Supports and Connectors

5.2.3. Mechanical Requirements

5.2.4. Material Requirements

5.2.5. Dimensions and Tolerances

5.2.6. Sensor Mounting

5.2.7. Compressor/Air Lines

5.2.8. Labeling

5.2.9. Welding

5.2.10. Touch Up

5.2.11. Installation Factors

5.2.12. Electrical and Control System Requirements and Architecture

5.2.12.1. Power Distribution

5.2.12.2. Device Layer

5.2.12.3. Control Layer

5.2.12.4. Control Cabinets and Enclosures

5.2.12.5. Information Layer

5.2.12.6. SCADA Layer

5.2.12.7. Interconnects

5.2.13. Electrical/Control Requirements

5.2.13.1. Static Electricity

5.2.13.2. Location of Controls

5.2.14. Equipment Control Concepts

5.2.14.1. Emergency Stops (E-Stops)

5.2.14.2. Interlocks

5.2.14.3. Separate Zone Stop and Emergency Stop Circuits

5.2.14.3.1. Emergency Stop Circuits

5.2.14.3.2. Emergency Stop

5.2.14.3.3. Restart

5.2.14.4. Wiring

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iii Southwest VA CMOP –System Description – Tucson, AZ

5.2.14.4.1. Grounding

5.2.14.4.2. Terminations

5.2.14.4.3. Protection

5.2.14.4.4. Wire Color Codes

5.2.14.4.5. AC and DC Wiring Separation

5.2.14.4.6. Low-Voltage Signal Wiring

5.2.14.4.7. Conductor Sizes

5.2.14.4.8. Spare Wires

5.2.14.4.9. Conduit

5.3. PLC Hardware

5.3.1. PLC Preferred Suppliers

5.3.2. Electrical Noise Immunity

5.3.3. Hard-Wired Circuitry

5.3.4. Control Circuit Ground

5.3.5. Spare Capacities

5.3.5.1. Free I/O Requirements

5.3.5.2. Free Memory Requirements

5.3.6. Rack Grounding

5.4. System Installation and Cabinet Construction

5.4.1. Recommended Hardware

5.4.1.1. Switches:

5.4.1.2. Sensors

5.4.1.3. Contactors and Power Switching Devices

5.4.1.4. Labeling

5.4.1.5. Enclosures, Operator Panels, and Wire Troughs

5.4.1.6. General Wire and Wiring Conventions

5.4.1.7. Standard Numbering Convention for Control Wiring

5.4.1.8. Motors and Clutches

6. INSTALLATION REQUIREMENTS

6.1. Installation and Technical Support

6.2. Use of Premises by Supplier Personnel

6.3. Coordination of Laydown

6.4. Delivery and Unloading

6.5. Site Cleanliness

6.6. Site Storage

6.7. Trash Removal

6.8. Sanitation

7. INSTALLATION SITE WORKING CONDITIONS

7.1. Purchaser Access and Cooperation

7.2. Protection of Persons and Property

7.3. Equipment Supplier's Personnel and Workmanship

7.4. Working Hours

7.5. Materials Handling and Unloading

7.6. Site Cleanliness and Order

7.7. Use of Premises

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iv Southwest VA CMOP –System Description – Tucson, AZ

7.8. Temporary Storage

7.9. Safety

8. DOCUMENTATION

8.1. Pre-Installation Drawings and Specifications

8.2. Drawing Submittal Requirements

8.3. As-Constructed Drawings

8.4. Required Final Documentation

8.5. Maintenance Instructions and Manuals

8.6. Documentation Submittals Summary

9. PURCHASER TRAINING

9.1. User Training

9.2. Control System Training

10. SYSTEM WARRANTY, RELIABILITY, MAINTAINABILITY AND SUPPORT

10.1. Warranty

10.2. Customer Support

10.3. Customer Support Program (Technical)

10.4. Telephone Support

10.5. On-Site Support

11. TESTING AND VALIDATION REQUIREMENTS

11.1. Functional Equipment Testing

11.2. Site Acceptance Tests

12. PROJECT MANAGEMENT REQUIREMENTS

12.1. Project Schedule

12.2. Implementation Requirements

12.3. As-Constructed Drawings

12.4. Required Final Documentation

12.5. Maintenance Instructions and Manuals

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5 Southwest VA CMOP –System Description – Tucson, AZ

1. GLOSSARY OF TERMS

1.1. General Terms

VA – U.S. Department of Veterans Affairs

CMOP – Consolidated Mail Outpatient Pharmacy – VA’s high-volume prescription filling unit.

SW-CMOP – Southwest Consolidated Mail Outpatient Pharmacy, Tucson, AZ

VISTA/CERNER – VA’s central system for veteran’s EHR information storage & processing

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

CO - Contracting Officer

COR –Contracting Officer’s Representative – Local VA official who acts on behalf of the Contracting Officer and is the primary point of contact for the VA Team.

COTS – Common off the Shelf for parts and assemblies.

APFS – Automated Prescription Fulfillment System

NFPA – National Fire Protection Association

PMS – Pharmacy Management System [this includes sub-systems such as control systems (PLCs) and routing logic]

PWS – Performance Work Statement which outlines the requirements and functionality of a new or upgraded system for consideration.

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 https://www.ergo-plus.com.

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 https://www.ergo-plus.com/

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6 Southwest VA CMOP –System Description – Tucson, AZ documents. The team will also determine validation processes for final acceptance for each step of the FMEA process.

FTP – File Transfer Protocol IEC - International Electrotechnical Commission IT – Information Technology SCADA – Supervisory Control and Data Acquisition SFTP – Secure File Transfer Protocol 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 UPS - Uninterruptable Power Source with surge suppression protecting all connected automation equipment.

1.2. Operational Terms

AUOU – Automated Unit of Use -Typically refers to dispensing of manufacturers packaged items or prepacked single unit dispense of NDCs from A-Frames or automatic dispensing system.

UOU – Unit of Use Container (ex: retail pack format)

Container – a logistical entity that contains tablet/capsule or a Unit of Use retail pack dispensed on a prescription. Sometimes referred to as Item being dispensed.

Item – Drug or ancillary item. Sometimes interchangeably referred to as Container. See Container.

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.

RPh or PharmD– Abbreviation for Registered Pharmacist or Doctor of Pharmacy

Package – A collection of one or more patient orders and/or prescriptions 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

RX – Referred to as a Patient Prescription, is a formal written, electronic, or verbal order from a licensed healthcare provider that directs the dispensing, administration, or use of medication for a patient. Prescriptions serve as a communication between the prescriber, pharmacist, and patient, ensuring that the patient receives the appropriate medication and instructions for its use.

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7 Southwest VA CMOP –System Description – Tucson, AZ

PV or PV2 – Referred to as Pharmacist Verification, is the process where an RPh reviews a patient order prior to packaging and confirms the accuracy and quality of the order. The RPh insures to proper drugs, quantity and dosages have been dispensed, the correct patient identification is on the prescription and the prescription is complete. This is a requirement before ANY patient order can be packed complete.

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

TOTE – Plastic container that transports patient orders through the tote system. Each carrier is uniquely identified with a serial number and RFID tag that is read through the tote fulfillment system.

UUA - Unit of Use Automation. Typically, an A-Frame or Automated Dispense System

ACK - Acknowledge

ORDER – Single mailing unit to patient with all requested items/prescriptions. SEE PATIENT ORDER

NAK – Non-Acknowledge

PUCK – Single container carrier for tablet/capsule countable prescriptions counted into a vial. Can be TCA or Manual Vial Dispensers

Tablet/Capsule Vial (ex: countable pills in a bottle)

1.3. Order Type Definitions:

MANUAL – Orders filled entirely in manual work area currently

PUCK – Orders filled entirely in tablet counting automation area.

TOTE – Orders that will reach their pack area in totes; this includes orders with:

UOU: >=1 UOU containers dispensed from the AUOU work area

COMBO: >=1 UOU container and >=1 TCA container dispensed from AUOU/ATD, respectively

1.4. Area Definitions:

AUOU-Automated Unit of Use Dispensing

ATD-Automated Tablet Dispensing

MTD – Manual Tablet Dispensing

MUOU – Manual Dispensing for Unit of Use Items

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8 Southwest VA CMOP –System Description – Tucson, AZ

2. OVERVIEW

The United States Department of Veterans Affairs Consolidated Mail Outpatient Pharmacy (VA CMOP) processes over 500,000 prescriptions per day at seven regional sites. Prescriptions are entered into the patient’s Electronic Health Record (EHR) at VA hospitals and clinics, then transmitted to the assigned CMOP for processing and mailing to the veteran.

Currently, the SW CMOP processes an average of 80,000 scripts per day. The facility operates on a two-shift operation. The current APFS in the facility consists of automated tablet dispensing, manual tablet dispenses, automated unit of use dispensing, manual unit of use dispensing, manual unit of use labeling and manual pharmacist verification and a mix of manual and semi-automated packing predominately in poly bag mailers. The patient orders are processed, packed in poly bag mailers and consolidated at a 3rd party mailing consolidator located off site.

The SW CMOP has recently engaged in a project to make considerable upgrades to tablet dispensing operations and particularly the vial labeling step of the process at the head of the line. The upgrades will include the following:

New automated vial labelers

New plastic chain conveyor systems for vial pucks

New accumulation table for vial pucks (“Puck Pond”)

New raised platform for vial labelers

New plastic chain (FlexLink or equivalent) line with inline weighing stations and associated connections to main line

New accumulation and batching software for tablet dispensing

These upgrades are expected to be completed in fiscal year 2026. The upgrades to the automated tablet dispensing line will modernize the vial labeling process, provide at the source quality controls, and increase the rate of availability of vials by improving the batching logic.

It is the intent of this PWS to replace and centralize the existing vial labelers, add an empty puck buffer conveyor table, and install a new inline weighing system to support future volume and throughput increases expected for SW CMOP operations.

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9 Southwest VA CMOP –System Description – Tucson, AZ

2.1. Facility Location

US Department of Veterans Affairs

Southwest CMOP

3675 East Britannia Drive

Tucson, AZ 85706

2.2. STATEMENT OF NEED

The purpose of this procurement is to obtain the following items from qualified suppliers with proven track record of professionally handling the decommissioning and removal of obsolete delivery and installation, commissioning and integration with the existing pharmacy management system of new equipment including:

1. Proven industry standard plastic chain conveyor to replace the old plastic chain conveyor at the facility

2. Proven industry standard vial empty puck accumulation conveyor (“Puck Pond” / “Puck Buffer”)

3. Upgrades to empty puck return lines to centralize empty puck accumulation conveyor.

4. New puck cross-over conveyor to expedite pucks from central vial labeling to all dispensing areas.

5. Inline tare weighing stations for empty vials

6. Inline automated vial labelers with OCR Label Scanning and Imaging of Labels

7. Control Software Dashboard to control and monitor vial labelers from central command center.

8. Raised platform for vial labelers and empty vial point of use inventory storage

In addition to the installation of new equipment, the selected vendor will be required to disconnect, remove and disposal of existing equipment that is being replaced or upgraded. The equipment to be removed will include:

1. All Existing Vial Labelers

2. (East/West) Dispensing Areas

3. All Existing Tare Weight Scales (in-line with existing vial labelers)

4. All Existing plastic chain conveyor feeding existing vial labelers.

5. All Existing plastic chain conveyor required to provide space and connections to new equipment (new puck pond, new labelers, new scales).

The remainder of this document will describe the functional, technical and compliancy requirements for the items being sought by the VA.

2.3. Operation Hours

The current pharmacy operating hours are between the hours of 6:00 am to midnight Monday thru Friday. Tucson is a two-shift operation. The facility is on Mountain Standard Time year-round. The Automated Tablet Dispensing lines run continuously from 7 am to 11 pm. The shifts are 8.5 hour

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10 Southwest VA CMOP –System Description – Tucson, AZ staggered starts and breaks allowing each shift 9 hours of production including lunches and breaks.

There are a total of 18 operational hours per day. Weekend overtime is often worked on Saturday.

2.4. 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 Supplier will not distribute, disclose, or disseminate, in any way, such information to anyone except its employees who are involved in this proposal response effort.

All information relating to this Project is considered business 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 Supplier agrees to keep such information in confidence. No information relative to the Project shall be released by the Supplier, 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).

2.5. Drawings Supplied

Plan views of the existing and planned Tucson pharmacy Automated Tablet Dispensing areas are provided to scale in the attached drawing file. The drawings will highlight the areas of plastic chain conveyor to be modified, existing vial labelers to be removed and replaced with upgraded equipment, and the planned locations of the new puck pond and inline weighing system loop. These will show an approximate location for the new equipment location.

The provided drawings are close estimates of current state and expected future conditions at Tucson. Suppliers will be afforded the opportunity to visit the facility in advance of the due date of this proposal to make field measurements of the existing equipment and facility.

2.6. Supplier Qualifications

Suppliers should recognize that the Purchaser’s selection team may desire to visit one or more installed and operational sites in an analogous environment and should be prepared to support these requests. In lieu of travel, the Purchaser evaluation team may choose to interview past performance references without the presence of the Supplier.

2.7. Technical Submissions with the Quotation

The Supplier should also recommend the content and quantity of spare parts that should be maintained by the Purchaser with all prices and estimated delivery times. This information shall be submitted with the quotation.

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

Mechanical and electrical requirements (power, air, voltage, current, etc.) of the Supplier’s proposed solution should be provided.

Any and all control software / systems and its interfaces to operating the Supplier’s equipment should be clearly specified and identified in the solution provided.

Numerous requirements are elicited in this PWS. Suppliers are advised to respond in as much technical detail as possible with the quotation.

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11 Southwest VA CMOP –System Description – Tucson, AZ

Submissions shall contain a supplier-developed plan view and elevations to demonstrate the supplier proposed equipment installation details. The plan view and elevations should be in AutoCAD .dwg format and be provided electronically with the submission. They supplier may use other drawing programs to illustrate or explain the solution, however the final submission must be in AutoCAD. The equipment provided in the drawing should match exactly the Supplier’s proposed solution.

2.8. Training, Maintenance, and Warranty Submissions

Suppliers 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 Purchaser’s facility.

The Supplier is to provide training for the Purchaser in the proper repair and preventive/corrective maintenance of the equipment. . In addition, the Supplier shall provide at least 3 copies of all manuals and support documents. The Supplier shall also provide 24/7 Customer Call Center Support.

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

The equipment shall be warrantied for workmanship, materials, design, installation, and performance for a period to be agreed upon from day of beneficial use at the SW 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), vendors should provide information from subcomponent suppliers on the anticipated life cycle of each key subcomponent. Warranty offerings will be considered in the quotation evaluation.

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

2.9. Prices, Risk of Loss, and Title

All prices quoted shall be in US dollars utilized at the date of the quotation. The pricing proposed is to be FOB to the SW CMOP in Tucson, AZ. Notwithstanding the FOB point, risk of loss, or damage to the materials and title, the material shall remain with the Supplier and shall pass to the Purchaser only upon Acceptance.

2.10. Exceptions and Alternates

Exceptions taken to the base scope, technical requirements, working conditions, project management requirements, or commercial terms and conditions are to be clearly noted in the Supplier Quotation.

Suppliers are encouraged to present, as alternatives, any changes or modifications that would improve the overall operations or offer a cost-reduction potential to the Purchaser with no impairment to the performance requirements set forth in the PWS. Such modifications shall be presented in the form of an addition, deletion, or substitution to the base bid described in the PWS.

Layout and elevation drawings of alternatives or modifications will add clarification to such submittals.

2.11. Proposal Contents

Suppliers are required to follow the prescribed format and supply all required information to be considered in the evaluation. Furthermore, all quotations must reflect the requirements identified in this request with no deviations. The quotation format will be as follows:

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12 Southwest VA CMOP –System Description – Tucson, AZ

2.11.1. Attachment 1 - Project Overview

A narrative summary identifying the Supplier’s understanding of the job content and an overview of the proposed system shall be provided.

2.11.2. Attachment 2 - Product Information

All available product literature, including technical literature relating to the equipment and operating software required for this project, shall be supplied as part of the quotation.

2.11.3. Attachment 3 - Subcontractors and Suppliers

A list of all planned suppliers/subcontractors shall be attached to the Proposal Form. The list shall contain the names and addresses of tentative suppliers/subcontractors and identify major components or services that would be provided. The socio-economic status of any proposed subcontractor should be provided. Written confirmation from key subcontractors that they have agreed to be part of the supplier’s team should be provided. Prior to the award of any contract, the Purchaser must approve the actual suppliers/subcontractors.

2.11.4. Attachment 4 - Supplier Offered Alternatives

The base quotation is to be bid per this RFQ, which should include all “standard” equipment and will consist of the “minimum” design requirements set forth by this request. HOWEVER, SUPPLIER-OFFERED ALTERNATIVES ARE SOLICITED WHERE THE SUPPLIER FEELS THE

PERFORMANCE OF THE SYSTEM CAN BE IMPROVED. A DESCRIPTION OF THESE OPTIONS AND THE

COST IMPACT OF EACH MUST BE CLEARLY IDENTIFIED AS AN “ADD,” “DEDUCT,” OR

“ALTERNATIVE” FROM THE BASE QUOTATION.

2.11.5. Attachment 5 - References and Qualifications

A list of current and/or recently completed projects of similar scope and nature showing contract value, type of system supplied, and when completed, shall be provided in the quotation. A contact’s name and phone number for each project shall be included. A minimum of three such projects are to be listed. Contacts provided should be knowledgeable in the history of the installation, operating performance, and maintenance history of the installation. Contacts in the Southwest region are preferred but need not be limited to this geographical area. If applicable, federal government procurements should be included.

2.11.6. Attachment 6 - Technical Submissions

As described in the related sections of this document.

2.11.7. Attachment 7 - Training, Maintenance and Warranty Submissions

As described in the related sections of this document.

2.11.8. Attachment 8 - Bill of Materials

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.

2.12. Oral Presentations

In addition to the written response Suppliers may be invited to conduct oral presentations. Such invitations will be at the discretion of the VA and will take place at the SW CMOP or remotely.

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13 Southwest VA CMOP –System Description – Tucson, AZ

Travel and labor funding for oral presentations will be the responsibility of the Supplier. The Government will not provide any reimbursement for oral presentations.

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14 Southwest VA CMOP –System Description – Tucson, AZ

3. PROJECT SCHEDULE

3.1. Project Schedule Requirements

As part of the quotation, Suppliers are to provide a proposed schedule for the work. The Purchaser envisions the schedule below. The Supplier shall perform the work in phases. With the quotation, the Supplier shall submit a firm schedule for the system delivery and installation. As a minimum, this schedule shall detail the elements and duration relating to the following milestones. It is expected that fabrication, shipment, and installation will be overlapping and concurrent activities.

Event Date

Post RFP on SAM.gov TBD

Industry Day Visit TBD

Proposal Due Date TBD

Oral Presentations (if required) TBD

Final Award Date TBD

Functional Design Review and Approval TBD

Functional Equipment Testing TBD

Installation Transition Plan Approval TBD

Start Delivery to Site TBD

Installation and Training Complete TBD

Beneficial Use of the Equipment TBD

Complete Acceptance – Warranty Period Begins TBD

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15 Southwest VA CMOP –System Description – Tucson, AZ

3.2. Project Schedule Submissions

With the quotation, the Supplier shall submit a firm schedule for the equipment being quoted. At a minimum, this schedule shall detail the elements and duration relating to the following milestones:

1. Functional Design Review and Approval by Purchaser. This milestone constitutes the approval of the equipment design for the physical layout and mechanical configuration. All design criteria listed in the PWS must be met. This approval does not relieve the equipment Supplier of the responsibility for the operational or structural integrity of the designs. Functional design review/approval meetings will be held at the SW CMOP or remotely.

2. Installation Transition Plan. This milestone constitutes a schedule sequence approval for the installation and the plan to maintain continuous operations on the automated tablet dispensing line. This plan shall be reviewed and updated by the Supplier with approval by the VA COR.

3. Fabrication Timeline. This milestone constitutes a schedule approval for the procurement and fabrication of major components. This schedule shall be reviewed and updated by the Supplier with approval by the VA COR.

4. Functional Equipment Testing – FET (or Factory Acceptance Testing) - Reduced scale system testing of key components (major components and limited conveyors and diverts) at the Supplier’s facility prior to shipping to the site if required.

5. Shipment to Site. This milestone constitutes the approval by the Purchaser of the scheduled delivery date(s) to the job site. Any deviations from the required schedule defined in this document are to be approved in writing at least ten working days prior to shipment.

6. Installation Timeline. Upon receipt at the facility, the equipment components will be unloaded by the equipment Supplier. The Purchaser reserves the right to make a complete inspection of the delivered materials. Upon Purchaser approval, the Supplier shall begin or continue installation, training, and commissioning as required for the respective system.

7. Acceptance. The Purchaser shall conduct acceptance testing as defined in this PWS. The Supplier shall be responsible for a quality, reliable product that meets the criteria, capacity, and loading described in all sections of this request. Beneficial use of the equipment may take place before full project installation and acceptance are complete.

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16 Southwest VA CMOP –System Description – Tucson, AZ

4. OPERATIONAL REQUIREMENTS

4.1. Overall Pharmacy Process

The Southwest Consolidated Mail Outpatient Pharmacy (SW CMOP) is part of network of automated pharmacies that fills and mails prescriptions for the Department of Veterans Affairs (VA). The operation fills prescription of counted tablets in vials and/or unit of use drugs in manufacturer’s 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 future state fulfillment process within the SW CMOP facility:

Southwest CMOP – General Pharmacy Flow Diagram

This project will address puck conveyor that brings empty pucks to the vial labeling system, removing and replacing the existing automated vial labelers, installing a new empty puck accumulation zone or table, installing a new inline vial weighing system to establish tare weight, and upgrading the existing order processing and batching logic. This project will centralize the vial labeling and puck tare weighing operations for the pharmacy.

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17 Southwest VA CMOP –System Description – Tucson, AZ

4.1.1. Current Automated Tablet Dispensing Line

Below is the Current Southwest CMOP automated tablet dispensing line and overall pharmacy layout with the areas highlighted for upgrade in this proposal.

Vial Labelers

Vial Labelers

Plastic chain Conveyor

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18 Southwest VA CMOP –System Description – Tucson, AZ

4.2. Current Tablet Dispensing Flow and Process

• Tablet Dispensing Area Setup o The current automated tablet dispensing is bifurcated into East and West side dispensing areas. Both areas are capable of all TCA processes to include labeling, tare weighing, and dispensing both 120cc and 250cc vials, PV, fill weighing and imaging, capping and sealing. Each side can process vial prescriptions, and each side is connected by conveyor cross-over that pucks can travel between the east and west side if required. Currently, there are automated vial labelers for both size vial in each dispense area.

o Directly following the vial labelers are inline scales to record the tare weight of the vials and pucks. There are a total of five labelers, three on the north end of the tablet dispensing area and two on the south end of the tablet dispensing area. Each labeler area is approximately 150 feet apart from one another, divided by the dispensing areas. Each labeling area has at least one 250 cc vial labeler.

• Puck Dispatch and Vial Labeling o The automated tablet dispense orders are batched by the PMS and empty RFID enabled pucks are queued for each vial labeler line. Each vial labeler has a dedicated inbound and outbound line of plastic chain conveyor. The vial labeler places a patient label on the vial, scans the label barcode, reads the current puck RFID tag in place and the system associates the dispensed order information to the puck RFID. Each puck is tracked in real-time by RFID readers throughout the system at various points.

• Tare Weight Check o After the label is applied, the puck moves to the inline weighing station where the tare weight is recorded. After weighing the vial and puck are transported to dispensing. Currently, the vial labelers on the north side of the tablet dispensing area feed the west side dispensing fingers and the vial labelers on the south side of the tablet dispensing area feed the east side dispensing fingers.

• Tablet Dispensing o After the tare weight, it is sent to the dispensing fingers where it is filled by tablet counting automation or sent to the manual stations for manual tablet dispensing.

After the tablets are dispensed, the filled vial moves along to the image capture and weighing line where each vial is imaged by a camera and weighed by an inline scale.

This check point is to assist pharmacists in the verification process and confirm the contents of the vial to ensure that the correct tablet count (through weight), and drug type (through image) are a match for the prescription. Any vials that an image or weight are not captured or do not match expected weights from tare weight calculation are diverted to an exceptions processing station.

• Pharmacist Verification o After the vials pass the scan and weight station, they are conveyed to the pharmacist verification (PV) stations where they are manually inspected and verified by a pharmacist. Vials that fail the PV process are routed to an exception station where the error is resolved, and the vials re-entered to the line.

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19 Southwest VA CMOP –System Description – Tucson, AZ

• Cap & Seal o After a vial passes pharmacist verification, it is conveyed to automatic in line cappers where it is capped, sealed, and retorqued. Capped vials are conveyed to puck pack stations or tote marriage where they are depucked.

• Packing & Outbound o Orders for vials only are collated and packed in the semi-automated puck pack area.

Orders that have a combination of vials and unit of use (“Combo Orders”) are conveyed over to the tote marriage area where they consolidated and depucked into order totes. The empty pucks are conveyed on return lines to both the north and south vial labeling lines where the process begins again. The site will be adding semi-automated packing capability in summer 2025 to the puck line.

There are four main types of vial orders handled by the tablet dispensing lines. The four types of orders are the following:

1) Single Puck Orders – these are orders where the prescription is for a single vial of tablets only.

This is the most common type of order in the automated tablet dispensing area.

2) Multi Puck Orders – these are orders where the prescription is for more than one vial of tablets. These vials can be for the same NDC or multiple different NDCs.

3) Combo Orders Single Puck – these are orders where the prescription is for one vial of dispensed tablets and at least one unit of use items. These orders are married in a tote and packed in a separate area of the pharmacy on the tote line.

4) Combo Orders Multi Puck – these are orders where the prescription is for multiple vials of dispensed tablets and at least one NDC of unit of use. Like the Single Puck Combo Orders, these orders are married in a tote and packed in a separate area of the pharmacy on the tote line.

Note: The current methods and equipment used for depucking will be modified in late CY 2025.

Peak System Demand for Tablet Dispensing Area

CONT/SHIFT CONT/HR

Puck Only Single Puck 11,965 1,595 Puck Only Multi Puck 4,754 634

Combo Single Puck 6,099 813 Combo Multi Puck 6,094 813

28,912 3,855

Peak System Demand

TOTAL

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20 Southwest VA CMOP –System Description – Tucson, AZ

Peak Flow by Area

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21 Southwest VA CMOP –System Description – Tucson, AZ

West Kalish 318 vials per hour

Per Finger

North Vial Labeling 2,005 vials per hour

South Vial Labeling 1,850 vials per hour

Tote Marriage 1,626 vials per hour

East Kalish 371 vials per hour

Per Finger West PV2

2,005 vials per hour

East PV2 1,850 vials per hour

IA Robot 376 vials per hour

Manual Dispense 39 vials per hour

East Pack 1,070 vials per hour

West Pack 1,159 vials per hour

Visual Diagram of Peak Flow by Area

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22 Southwest VA CMOP –System Description – Tucson, AZ

4.3. Labeling, Tare Weight and Conveyor Design Requirements

Puck conveyor is envisioned to be compatible with existing puck conveyor already installed in the Tucson facility. Currently, pucks come in two sizes and are Ultra-High Molecular Weight (UHMW) plastic carriers for 120 cc and 250 cc vials. The outside of the pucks are similar and the inserts are fitted to each vial size. Each puck is embedded with an RFID tag that is tracked by the conveyor system in real time.

Currently the SW CMOP would like to reduce complexity and simplify the puck operation by utilizing a single vial and puck size. After detailed analysis, the additional volume of pucks will not adversely increase, and the current desire is to move to a single 120cc vial size and associated puck for all tablet dispenses in the Tablet Counting Automation.

4.3.1. Centralized Support Operations

Centralizing the puck labeling area to a single zone on the north end with centralized support operations for tablet dispensing provide synergy with labeling and weighing operations. A new centralized puck pond will provide a cost-effective means of accumulating and buffering empty pucks prior to labeling.

4.3.2. Redundancy

The puck labeler and tare weight equipment require independent conveyor lanes to decouple flow by providing equipment redundancy when any machine is off-line. The volume can be rebalanced to active machines. This design allows flexibility that underutilized lines can be offline during low flow periods to perform regular cleaning and preventative maintenance.

4.3.3. In Line Weighing

Current in line weighing is a constraint for the operation. The current in-line weighers are slow and limit the speed of the vial labelers. The new in-line weighing loop will increase the overall system throughput, decouple weighing from the vial labeling, and balance the vial flow through the labeling and weighing processes. This design concept supports the redundancy required of the vial labelers.

4.3.4. Raised Working Platform

The raised working platform serves the purpose of placing vial labelers physically above the puck conveyors and creating a central point of use inventory location for boxes of empty vials. As envisioned by the design, operators will access the platform through a stairway on the southwest side to bring empty vials to the inventory locations, replenish empty vials into labeler hoppers, and perform repairs or preventive maintenance to the vial labelers or conveyors.

4.3.5. Flexible Labeling Capabilities

The current plan for future operations at the Tucson facility is to run 120cc vials only. Additionally, the labeling machines must work independently and have thew ability to handle any script dropped from the system. The overall batching should be done at a machine group level and in the event a single vial labeler goes off-line, subsequent prescriptions would be re-routed to the other available labelers..

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4.3.6. Puck Size

Current puck size is 3” in diameter and 2” high. Prescription vials can be up to 3.5” high. The current pucks must be used in any upgraded conveyor solution and should be considered a hard requirement for any vendor design solutions. Samples can be provided for bidders.

4.3.7. Puck Identification

Pucks will be identified with a 4-digit puck ID and each puck will have an RFID chip located in the center of the puck bottom that will be readable from the underside of the puck.

4.3.8. Puck Weight

The maximum weight of any order puck is expected to be less than 800 grams.

4.3.9. Equipment Noise Exposure

The SW CMOP is committed to limit noise exposure within the pharmacy consistent with OSHA standard per 29 CFR 1910.95 "Occupational Noise Exposure". The OSHA guidelines for permissible exposure limit (PEL) is 90 decibels (dBA) for an 8-hour time-weighted average (TWA).

If noise levels reach or exceed an 8-hour TWA of 85 dBA, employers are required to implement a hearing conservation program. It is the desire of the SW CMOP to go beyond the OSHA standard and any new conveyor system should not exceed 80 dBA for an 8-hour TWA.

4.3.10. Preferred Puck Conveyor Design Requirements

The requirement for future puck conveyors are prescribed below. These requirements should apply to any puck conveyor unless otherwise noted on the drawings. These requirements include:

• High throughput – The conveyors must have the ability to process 4,000+ pucks per hour.

The system should handle, in aggregate, over 70 pucks per minute.

• Variable Speed Conveyor – The conveyor speeds should have the capability of operating at a range of speeds adequate to handle the volume of pucks traveling. The conveyor speed should match the throughput requirements listed above and identified by each processing area.

• Appropriate gapping of pucks – Conveyors should be able to appropriately gap or hold back pucks for diverts or merges Gapping or hold backs will be required to ensure correct and smooth diverting or merging of pucks, reducing puck conveyor jams, blockages and a reduction in puck recirculation.

4.4. Proposed Upgrades to the Vial Labeling Area

This section outlines upgrades to the vial labeling area to enable higher throughput throughout the pharmacy. The vial labeling area is the starting point of the tablet dispensing process and effectively is the first area in which vial orders are processed. The legacy vial labeling system is outdated and has limited capacity to support continued growth in total pharmacy operations.

The proposed upgrades will consist of the following major areas:

Puck Pond, Puck Buffer & Puck Conveyor Re-Routing

Upgraded Vial Labelers

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24 Southwest VA CMOP –System Description – Tucson, AZ

Upgraded In-Line Weighing Loop

The following sections will address each area to be upgraded. Each area ties into the main puck line and is an integral piece to vial order processing and completion. Since the vial labelers, in-line weighing loop, and puck pond are at the start of the puck loop, all pucks will flow them.

4.4.1. Puck Pond & Conveyor Re-Routing

Currently, empty pucks are returned to the start of the vial labeling operation and runs of plastic chain conveyor are used as accumulation for empty pucks. The vial labelers are in two areas at the north and south of the operation. In the future, this will be changed to a single, consolidated vial labeling operation at the north side of the tablet dispensing area. The current south vial labeling units and conveyor shall be removed and all connecting conveyors disassembled. With all vial labelers at the north side of the area, the conveyors that move empty pucks to the south shall be rerouted to run empty pucks to the new vial labeler area. This will include any upgrades or improvements to all conveyors handling empty pucks to the new vial labeler area.

Additionally, a puck pond buffer shall be installed to accumulate the empty 120cc pucks prior to being released to new vial labelers. This puck pond is envisioned to be several lengths of metered accumulation conveyor however if a more effective alternative design or technology can be utilized in the space provided, alternate designs will be considered.

Finally, with the centralization of labeling and tare weight, there will need to be a new bypass to allow pucks and vials to travel both dispensing areas without traveling the entire length of the dispense to connect to both sides. This will be a new conveyor to directly connect the centralized vial labelers and tare weight equipment with the West Side dispensing area to reduce the travel time from labeling and tare weight to the dispensing locations. This new conveyor length and location will be recommended by the vendor.

The conveyor sections to be replaced and puck pond will meet the following requirements:

• Puck Pond Staging: Must have the ability to stage empty pucks without stopping the puck return lines. The design is envisioned to use pin stops to hold pucks back with the conveyor moving continuously underneath the pucks.

4.4.2. Equipment to Be Removed

Equipment Location Quantity

Vial Labelers North Corner 3 units

Vial Labelers South Corner 2 units

NEDCO Conveyor South Puck Return Line ~150 linear ft.

In Line Check Weighers North Corner 3 Units

In Line Check Weighers South Corner 2 units

NEDCO Conveyor North Labeler Line ~250 linear ft.

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25 Southwest VA CMOP –System Description – Tucson, AZ

NEDCO Conveyor South Labeler Line ~65 linear ft.

The removed conveyors and vial labelers will include:

RED Blocks indicate equipment to be removed and replaced

South Vial Labelers

North Vial Labelers

Empty Puck Return Lines

Estimated New Cross-over Line

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26 Southwest VA CMOP –System Description – Tucson, AZ

West vs East Puck Distribution

Vial Labeler Images:

West Puck Area

East Puck Area

West Puck Area dispenses about 56% of the total Rxs.

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27 Southwest VA CMOP –System Description – Tucson, AZ

South Side Vial Labelers to be Removed

South Side Empty Puck Return Lines to be Removed

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North Side Empty Puck Return Lines to be Upgraded & Reconfigured

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North Side Vial Labelers to be Removed and Replaced

Future Site of Puck Pond (Current North Side Puck Accumulation)

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30 Southwest VA CMOP –System Description – Tucson, AZ

Future Site of In-Line Weighing Loop (Kalish Dispensers on Right will STAY)

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31 Southwest VA CMOP –System Description – Tucson, AZ

Puck Conveyor Detail

NOTE: The puck conveyor linked plastic sections and is 5” wide. The bumper guardrails are 2” above the conveyor bed and the current clearance is 7” from the rails or 9” from the conveyor bed. IT IS

HIGHLY…