Tucson TW and Camera SOW.docx

B.2 STATEMENT OF WORK

1. 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 EHR information storage & processing APFS – Automated Prescription Fulfillment System AUOU – see UUA above 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/KO-Contracting Officer COR – Contracting Officer’s Representative CS – Control Substance Prescription Item – Drug or ancillary item. Sometimes interchangeably referred to as Container. See Container below.

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.

SW-CMOP – Southwest Consolidated Mail Outpatient Pharmacy 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 Project - Pharmacy Printing and Packing Automation POS – Pharmacy Operating System. Currently a McKesson system with some customization by QMSI. There are no plans to change the POS.

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 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.

TCA - Tablet and Capsule Automation Subsystem 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 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 UoU – Unit of Use UUA - Unit of Use Automation.

Operational Terms:

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

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 currently 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 The United States Department of Veterans Affairs Consolidated Mail Outpatient Pharmacy (VA CMOP) processes over 500,000 prescriptions per day at seven regional pharmacies. 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. The current EHR is an older, homegrown, legacy system called VistA that will be phased out during this decade and replaced by a new, Cerner-based, Commercial-off-the-shelf (COTS) solution. Current estimates are to have all VA facilities fully operational on Cerner by 2028. It is unknown when this replacement will affect specific CMOPs; however, suppliers should assume that the changeover will not affect proposed solutions to this Request for Quote (RFQ) and that no direct interfaces to the EHR will be required.

Currently, the Southwest CMOP processes an average of 82,000 scripts per day in a two-shift operation. The VA CMOP desires to increase the amount of automation within the Tucson location to as much as 110,000 scripts per day in a two-shift operation. This RFQ is designed to support that initiative. The VA recently purchased the building in which the SW CMOP resides. This has allowed the VA to take a longer-term approach to increasing throughput and labor efficiency in the facility. This procurement effort is design to support that initiative.

This RFQ is intended to solicit Quotes for the facility's current post tare weight (check weigher) and camera system areas. Fully automated system is meant to increase throughput and accuracy. Suppliers may propose an in-line or other type of solution, but performance must meet the system requirements laid out in this scope of work. In-line solution is highly desired due to its performance and ability to meet the minimum pass-through quantity.

Quotes will be evaluated to select the best, most reliable automation support and the most cost-effective means providing the best value solution for the Southwest CMOP. The specific area to add automation is:

Post Tare-Weight (check weigher) and Cameras – Orders are dropped to vial labelers and married to a puck with an RFID chip. The puck with the married vial then goes to a pre-fill tare weight scale and then proceeds for picking. Picking is completed after being filled at Kalish cells, manual fills, or by the Innovations PBLR (ROBOTS) Units. Once picking is complete the vial in the puck are ready for a post fill tare weight and image of the vial and its contents. There are two different vial sizes (120cc and 250cc) so to accommodate them both, there are inserts in the puck allowing for the 120cc to run through the same line as the 250cc vials. This insert adapts so that all vials are as close as possible in height and diameter. Post fill tare weight and camera system is part of its own conveyor loop and consist of 2 tare weights and camera locations per loop (one loop on West and one on East) TCA. The cage has a separate single conveyor line with one post tare weight and camera and only contains 120cc vials and their associated pucks. Existing systems have holdbacks, RFID readers and image eyes to manage traffic flow and identify puck for communication with PLC and POS. The intent of this solicitation is to upgrade the current slow system with an inline tare weight system and camera system to increase throughput productivity and clarity of images of existing stations within the same pharmacy footprint.

Current system sends and receives through serial port connection to POS. Desire is to move to ethernet connection vice the current outdated serial connection. This requires an interface to POS both to receive information defining the work to be done and to return the completed work information back to POS to validate weights and image.

Upgraded Conveyor – The Southwest CMOP is considering upgrades to the conveyor in the post tare weight and camera loops. The conveyor upgrades are considered separate if the current conveyor can support the new proposed solution. It is the Southwest CMOPs intent to consider the upgrades to these areas as separate line items to the main tare weight and camera quotation. Vendors should include these upgrades as options, if needed, to the quotation and will be considered as a required element if the new tare weight and camera systems require the change of the existing line. The existing conveyor solutions on hand are NEDCO and FLEXLINK. FLEXLINK is the preferred solution moving forward.

Facility Location

US Department of Veterans Affairs Southwest CMOP 3675 East Britannia Drive Tucson, AZ 85706

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 Quote response 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 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).

Drawings Supplied Plan views of the existing and planned Tucson pharmacy are provided to scale in the attached drawing files. An approximate location and quantity for the equipment is identified.

Please note that due to COVID travel restrictions, the current state drawings are close estimates of current state conditions at Tucson. Suppliers will be afforded the opportunity to visit the facility in advance of the due date of this Quote, subject to public health restrictions. Should such restrictions not support a visit, CMOP will take steps through images and videos to explain the applicable operation in the facility. See Section B.

Supplier Qualifications Suppliers should recognize that the Purchaser’s selection team will 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.

Technical Submissions with the Quotation

· The Supplier is to recommend content and quantity of spare parts that should be maintained by the Purchaser with 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, 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 equipment should be clearly specified and called out.

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

· Submissions shall contain a supplier-developed plan view and elevations as required to demonstrate the supplier proposed equipment installation details. The equipment numbers provided in the drawing should match the Supplier’s proposed solution.

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.

· 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 of time to be agreed upon from day of beneficial use at 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), 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.

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 FREIGHT ON BOARD (FOB) to the VA CMOP Pharmacy in Tucson, AZ. Notwithstanding the FREIGHT ON BOARD 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.

Exceptions and Alternates

· Exceptions taken to the base scope, technical requirements, working conditions, project management requirements, or commercial terms and conditions as written 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 RFQ. Such modifications shall be presented in the form of an addition, deletion, or substitution to the base bid described in the RFQ. Layout and elevation drawings of alternatives or modifications will add clarification to such submittals.

Quote 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:

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.

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.

Attachment 3 - Subcontractors and Suppliers A list of all planned suppliers/subcontractors shall be attached to the Quote 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.

Attachment 4 - Supplier Offered Alternatives All quotes 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.

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.

Attachment 6 - Technical Submissions As described in the related sections of this document.

Attachment 7 - Training, Maintenance and Warranty Submissions As described in the related sections of this document.

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 Southwest CMOP, unless public health conditions dictate doing so remotely.

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

Quote Options The Quote should be broken into the following options for consideration:

Base Tare Weight and Camera Systems The option should include the following areas:

· Tare Weights (check weighers)

· Dwg Includes need for 2 stations in West TCA, 2 stations in East TCA, 1 in Cage and 1 for ready spare swaps (not included in dwg) for a total of 6 stations

· Capable of handling 80 pucks per minute with a 99.7% reliability and accuracy

· Must include new PLC hardware, the ability to communicate over ethernet and work with current conveyor speed of 47.5’ per minute (with ability to increase conveyor speed up to 80’ per minute)

· Camera Systems

· Dwg Includes need for 2 stations in West TCA, 2 stations in East TCA, 1 in Cage and 1 for ready spare swaps (not included in dwg) for a total of 6 stations

· Capable of handling 80 pucks per minute with a 99.7% reliability and accuracy

· Ability for continuous motion imaging system capable of formulary imaging of all NDCs in the 120cc and 250cc vials/pucks

· Continuous learning (Artificial Intelligence) for all NDC storing and adjusting to last known best focal point

· Must include new PLC hardware, the ability to communicate over ethernet and work with current conveyor speed of 47.5’ per minute (with ability to increase conveyor speed up to 80’ per minute)

Puck Conveyor to Support new tare weight and camera systems

· Puck conveyor solution shall keep all functionality of current line (recirculation, dedicated lanes, etc.,)

· Will include new PLC and motor controls for conveyor system

· Handle a minimum weight of approximately 200 pucks (~200 lbs.) with filled vials without hesitation/stuttering of line Project Schedule Project Schedule Requirements (Provide Schedule in Section B.4 – Delivery) 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.

Project Schedule Submissions With the quotation, the Supplier shall submit a firm schedule for the packing automation 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 RFQ 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 Southwest CMOP in Tucson, AZ, or remotely if public health conditions dictate.

2. 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 Purchaser or Purchaser’s COR.

3. Factory Acceptance Testing – FAT- System testing at the Supplier’s facility prior to shipping to the site.

4. 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.

5. 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 approval, the Supplier shall begin or continue installation, training, and commissioning as required for the respective system.

6. Acceptance. The Purchaser shall conduct acceptance testing as defined in this RFQ. 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.

operational Requirements General Pharmacy Process The Southwest 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 TCA fulfillment process within the Southwest CMOP facility:

Southwest CMOP – General Pharmacy Flow Diagram

This project will address the Post Tare Weights and Camera system for each of the three TCA areas (East, West, and Cage) prior to the Pharmacist Verification process for pucks, depending on the order requirements. Currently, the current system runs with a rotating cylinder with grippers that takes puck off the main line and places on to the tare scale. Once weighed, the rotating cylinder with grippers moves the puck from the scale back onto the main line and then passes through the camera system for images. In addition, there is a serial interface connection for the tare weight and camera systems with limited feedback on system communications.

The conveyor system is NEDCO and consists of lanes for each area. These lanes contain diverts, holdbacks and image-eyes along with turn tables for recirculating pucks.

The VA wishes to improve quality and reduce the potential for errors that could ultimately go to the customer patients. Pharmacist Verification depends on the images and weights provided by the system and improving the quality and communication with the POS will greatly improve quality and safety and the overall confidence in automation.

Current Pharmacy Layout Below is the Current Southwest CMOP pharmacy layout with the areas highlighted for upgrades in this Quote.

Operational Option Areas Below are the current layouts illustrations for each area of this Quote.

West TCA Tare Weight and Camera System The West TCA existing conveyor, tare weights, and camera systems are highlighted below:

East TCA Tare Weight and Camera System The East TCA existing conveyor, tare weights, and camera systems are highlighted below:

Cage TCA Tare Weight and Camera System The Cage TCA existing conveyor, tare weights, and camera systems are highlighted below:

General Equipment Requirements Preferred Puck Conveyor Requirements Puck conveyor is anticipated to be primarily 4.5-inch wide motor driven belt conveyor used to transport pucks throughout TCA lines. New conveyor must be able to handle the weight and traffic of approximately 200 pucks (~200 lbs.) with filled vials per area without hesitation/stuttering of the line. Conveyor needs to handle two vial sizes, a 120cc and a 250cc vial.

All puck conveyor will be equipped with side rails as required to ensure puck remain in the system.

Transition Planning The selected vendor will need to provide a complete transition plan for any recommended solutions after award. The transition plan must contain the following elements.

1. Phased Layout of Equipment Installation

2. Detailed Project Plan and Timeline

a. Equipment Removal

b. Equipment Installation

c. Systems Integration

3. Support Required from Southwest CMOP Operations in Transition Plan

4. Facility Upgrades to Support Transition

5. Risk Assessment and Contingencies for Transition The transition planning may be at a high level for response to this RFQ, but the components of the transition must be detailed after award. The transition planning must support continued operations and be “as least impactful to operations as possible”. The planning should include expected pharmacy output during the phases of transition and account for any risks associated with the transition, strategies employed for managing the risks and the contingency plans in place reduce the impact of the risks.

Southwest CMOP Implementation Phasing Vendors will need to coordinate with the COR to develop an effective integration and implementation plan that will minimize interference with existing operations. This may require off-hours and weekend installation.

Interface to POS The pharmacy operating system will maintain all data required for processing patient orders. Any software required for operating pack stations, de-puck or conveyor routing logic should not permanently contain any PII (Patient Identifiable Information) or HIPAA (Health Insurance Portability and Accountability Act of 1996) related information for patient privacy and security of information. Any HIPAA data entered into software should be purged immediately after the order has been completed.

Information for orders being routed to the automation stations will be sent from POS to the tare weight and camera system controllers/workstation. When the order has been weighed, image taken, and information successfully transferred to and from POS.

If the vendor has previously interfaced with the Southwest CMOP POS pharmacy control system, they should propose defining the interface message. The minimum information to be sent from POS for each order is:

1. Puck ID (read by RFID)

2. Order number

3. Product Description (Assist Camera AI)

4. Quantity Picked (Assist Camera AI)

5. Any other data elements as requested by the tare weight and camera workstation controller to perform its task.

The minimum information to be returned from the tare weight and camera workstation controller to POS for each puck weight and image:

1. Puck ID

2. Weight (in grams)

3. In focus Image

4. Confirmation of communication “handshake”

5. Automation station ID that processed this order

6. Date/Time the puck was weighed, and image taken

7. Tare weight and camera ID In addition to the above, the following messages should also be supported by the interface.

1. Heartbeat (to verify the connection between the systems)

2. ACK and NAK message to indicate receipt of messages (a NAK should trigger a re-send for a settable number of times before a fault is generated and the controller requests assistance).

3. Automation status – online/offline/maintenance for each workstation The POS upstream will be coding any exception to the process into the puck record as an Exception Flag which will require the puck be sent to the pharmacist exception station.

Data Analysis – ORDER profile and throughput Requirements The following section provides the data analysis and specific requirements for the Southwest CMOP facility semi-auto packing requirements.

Data analysis shown in this document is intended to provide an estimate of required equipment throughput needs.

Calculation Assumptions and Methodology Data Scope:

The initial scope of this analysis is all Southwest CMOP volume processed by the APFS. Date range for data analysis was completed for the time period from May 17, 2019 to December 26, 2019.

Hours of Operation:

SW CMOP pharmacy currently runs a two-shift operation five days per week.

Hourly design requirements are calculated as the daily volume divided by 7.5 working hours times two shifts.

Projected Growth The design window is from 2021 to 2032 and has a growth rate of 2% per year. The table below summarizes the projected orders, RXs, and container requirements year-over-year. Please note that 2020 is considered year 0. Suppliers should assume the order profile remains constant in the forecast shown below.

System Requirements General System Requirements Table 1 provides a list of requirements for the Semi-Auto Packing System Automation Controller.

1.0 Bar Code

2.0 Interface

3.0 Manufacturer Support

4.0 Reports

5.0 Specification

Table 1 Automation Control System Requirements Automation Control System Data Accessibility Requirement As part of the ongoing process-improvement initiatives, access to all processing data from the automation controller is essential. Therefore, it is required that all data captured and stored by the automation be open to external analysis and available for full downloads in an Open Database Connectivity (ODBC)-compliant, unencrypted format.

Automation Controller Interface to POS All necessary order or work information will be sent from POS to the automation. It is the responsibility of the automation to capture and decode the file from POS prior to giving an acknowledgment (ACK) back to POS of completed, weighed, and image provided for all pucks read.

Provide Audible/Visual Signal if Interface is Down The interface to POS is a two-way interface. This provides the opportunity for the interface to go down and prevent POS from passing down or receiving work complete information. The automation controller shall provide a visual indication when the interface is down.

Maintain Complete Work History The automation controller will keep a record for each item processed. The record shall include the workstation where the work was performed and date/time stamps for each activity required to complete the work. The data shall be searchable by various parameters, such as workstation, puck ID, order, date/time period, etc.

System Updates All system updates will be entered solely by VA personnel authorized to make such changes. UNDER ANY CIRCUMSTANCE, SYSTEM SHOULD NOT PERMIT ANY AUTOMATIC UPDATES TO THE SOFTWARE OR FIRMWARE WITHOUT VA APPROVAL.

System Servers It is anticipated that the tare weight and camera system will be supported through existing VA database servers to the maximum extent possible.

Automation DESIGN AND FABRICATION requirements General Design Criteria Vendor-proposed deviations from material specifications presented in this section must be explained in the Quote submittal response. The materials provided by the Vendor must meet the performance requirements of this specification.

Work that fails to conform to the Design Criteria shall be repaired or replaced in an approved manner to assure design strength and function. Such work shall be executed by the Vendor at no additional expense to the Purchaser and shall include laboratory tests and costs for re-examination if the Purchaser deems it necessary.

Safety Standards and Codes All equipment shall conform to appropriate safety requirements. VA reserves the right to require documentation related to the various codes and standards listed be provided for review to ensure proposed equipment meets the requirements. Equipment shall be designed in conformance with the current version of the following standards:

· Occupational Safety and Health Act Regulations (OSHA)

· American National Standards Association (ANSI)

· American Society of Mechanical Engineers (ASME)

· NFPA 79: Electrical Standard for Industrial Machinery

· National Electrical Code (NEC) 2017 or later

· ISO 13849-1 and ISO 13849-2

· UL 508A

· National Electrical Manufacturers Association (NEMA) or equivalent

· All applicable Federal, State, and Local Codes, Laws, and Regulations Quality Requirements The equipment Supplier will maintain an in-process and end-item quality control program to ensure shipments to the Purchaser do not include defective or non-conforming items. The Purchaser reserves the right to review and evaluate the program and to conduct periodic inspections. Items furnished under the contract are subject to inspection and test at all reasonable times and all reasonable places, including but not limited to the manufacturing plant, shipping point, depot, and installation site.

The Purchaser, its nominees, or representatives shall be permitted to enter the equipment Supplier’s facility and any other site or facility where a portion of the work is being performed by or on behalf of the Supplier to inspect and/or examine the Supplier’s progress. Such inspections are not intended to disrupt or interfere with the normal business operations at the facility. Any such inspection shall be without prejudice whatsoever to any right or remedy to which Purchaser shall be under the Contract.

Calibration Devices and/or instruments that shall be relied on for quality critical data and decisions shall be calibrated.

· The Supplier shall provide proof of calibration status.

· The Supplier shall provide the recommended calibration method and frequency.

· Calibrated devices and/or instruments shall be located within the system in such a way that they can be easily re-calibrated in the future.

Mechanical The following general requirements apply to the equipment and system being provided:

1. All materials shall be non-toxic.

2. All materials shall be new; all cuts are to be made square with work free from lips, burrs, or projecting sharp edges.

3. All exposed corners of steel members shall be rounded and smooth to remove accident hazards.

4. All holes for connection of one section to another, for securing bearings, take-ups, or other machine parts shall be drilled or punched and be clean and free from burrs.

5. All bolted connections shall include lock washers or approved locking hardware.

6. All sprockets, chains, and gears subject to personnel contact shall be fully enclosed in readily removable split-type guards. Belt and belt drive units shall be easily replaceable without the use of tools

7. If applicable, all meshing gears shall be marked with a permanent, easily detectable notch for gear alignment.

8. If applicable, all sprockets shall be keyed.

9. The mechanical and electrical design should be of modular design for ease of maintenance and repair.

10. The system shall be appropriately guarded such that components or products cannot be added or removed from within the confines of the guarding when the equipment is running.

11. The equipment design will include a focus on ease of cleaning.

12. The system shall not damage, scuff, mar, or constitute any aesthetic or structural damage to the in-process or finished product.

13. The system shall be finished in such a manner as to avoid rusting, corrosion, and/or excessive wear and tear.

14. The system shall be vertically adjustable (at least ± 2”) to allow for leveling.

15. If a surface is painted, it must be an epoxy-based steel-it paint. This does not apply to standard product that is already painted.

16. All welds on product contact surfaces shall be continuous and ground smooth.

17. All exposed surfaces of non-stainless type steel or other corrosive materials shall be painted with corrosion-resistant paint or anodized.

18. Aluminum machine parts must be clear anodized.

19. Steel machined parts, not coated, must be nickel-plated.

20. Wood and fiber products are not permitted, except as approved by the COR.

21. All bearings shall be sealed and preferably lubricated for life. However, if greasing is necessary, the grease fittings shall be clustered and conveniently located on the outside of the machine for easy access.

22. Nameplates shall be located directly above or below the associated component. Nameplates shall be provided that identify starters, switches, push-buttons, pilot lights, relays, and other components. They shall be mounted immediately above or below the device. Nameplates shall be engraved and attached using screws or rivets.

23. Motor(s) shall have a nameplate giving the manufacturer’s name, serial number, HP, rpm, service characteristics, and other data as listed in NEMA Standard MG-1, Part 10.

24. The Supplier’s nameplate shall be mounted on the HMI and the main electrical cabinet. The Supplier’s nameplate shall include contact information and system make, model, and serial number, at a minimum. All plates shall be attached via rivets or screws.

25. All machine guarding shall be clear. No graphics or tinting shall obstruct the view of the equipment.

26. As reasonable, components shall be designed to be maintenance-free.

27. All items that require preventive maintenance shall be readily accessible.

28. The system material handling scheme shall not damage, scuff, dent, or mar any components.

29. Critical detection systems shall be designed so they cannot be bypassed in normal run mode.

30. Part numbers must be indelibly marked on all parts.

Guarding The Supplier is responsible for all equipment guards or barriers required to protect people from the equipment's operation. All sprockets, chains, gears, and belts subject to personnel contact shall be fully enclosed in readily removable split-type guards. All guards must be easily removable for repairs and maintenance. All guards are to be “bolt-on” construction. Bolts must not interfere with the movement of product. If robotic guarding is required, it must be integrated into the controller to ensure its presence during automated operation. Selected other guarding (specified elsewhere) is also required to be integrated into the controller to ensure its presence during operations.

All equipment guarding shall conform to current OSHA requirements and ANSI/ASME Safety Standard for Conveyors and Related Equipment B20.1 and ANSI/ASME Standard for Mechanical Power Transmission Apparatus B15.1.

Supports and Connectors All equipment or equipment supports will be supported from the floor.

If applicable, Suppliers are responsible for supplying all support columns or upright supports, horizontal support bracing, and hanging steel.

Major component assemblies are to be connected using a positive connector employing a bolt and locking device.

Mechanical Requirements

1. The system shall not damage either the product or system components in any mode of operation.

2. The system shall be of a “clean” design. Consideration during the evaluation will be given to designs that prevent the collection of debris and that clean easily.

3. The system shall be serviceable. The mechanical and electrical design shall be of a modular configuration for ease of maintenance and repair. Motors and drives shall be mounted to allow for primary access from planned operator areas.

4. The system design shall avoid excessive noise generation and be such that hearing protection equipment shall not be required for Purchaser's employees. All equipment shall operate at or below 80 dBA, measured at the operator's work-station or the nearest workstation, traffic aisle, or pedestrian access. These will be measured on the “A” scale. It is highly desirable to provide a system with a much lower noise level than 80 dBA. Preference will be given to equipment that is demonstrated to be less than 74 dBA so that normal conservation can occur next to the system throughout the pharmacy.

5. All equipment must be sized for receipt through doors 6’ wide by 80” high.

6. The minimum factor of safety base yield strength shall be 1.65.

Material Requirements

1. All material and equipment shall be new, unless otherwise specified, and any procured source material or components shall be the product of a reputable manufacturer.

2. All cuts are to be made square with the work.

3. All cuts, edges, holes, and assemblies are to be free of burrs and sharp edges. All exposed corners of metal members shall be rounded and smooth to remove accident hazards.

4. All holes for anchoring or connecting one member to another for assembly and securing parts shall be pre-drilled or punched and be free and clean from burrs.

5. All metal parts must be painted or treated to resist corrosion. Paint chip(s) of the standard color must be submitted with the Supplier’s Quote.

6. A primer coat is required, if specified by the finish-coat paint manufacturer standard.

7. If required paint shall be applied in strict accordance with the paint manufacturer’s instructions. Minimum dry film thickness of 1 1/2 to 2 mils.

8. After installation, components shall be field painted as described above to cover any areas that have been rubbed, scratched, blemished, etc., during shipment and/or installation.

9. All bolted connections shall include lock washers or approved locking hardware.

10. Bolt lengths used as fasteners must be sufficient such that at least two threads project past the ends of fasteners.

11. No bolt heads or other projections may protrude in such a way as to possibly snag or hinder the movement of pallets, cartons or create a hazard for proper maintenance of these fasteners.

Dimensions and Tolerances

1. Tolerances shall be in accordance with quality workmanship (e.g., parts dimensionally correct, square, straight, etc.).

2. Where supports are floor mounted, the support feet shall be anchored to the floor with a minimum of ½” x 2-3/4” long expansion shields with lag bolts (1 per support leg - minimum). Anchor holes will be drilled deep enough to drive anchors flush with the floor.

3. It is understood that shimming may be required to achieve exact tolerances. No gap greater than ¼” prior to lagging will be accepted.

Sensor Mounting All sensors (proximity switches, etc.) must be adequately secured to prevent movement or loosening by vibration. Proximity switches must be held near the center of the threaded barrel. Sensors shall be affixed in a manner to provide for direct mechanical interchange among compatible sensors. Sensors shall not be mounted using uni-strut.

Compressor/Air Lines The Vendor is to supply the entire air system from an airdrop near the automation. A mutually-agreeable location within the pharmacy will be selected for the airdrop.

1. The system shall be designed to operate on 80psi, dried and non-lubricated plant air. The air system shall regulate and accommodate air up to 140 psi.

2. Airline piping should follow a path parallel with electrical whenever possible.

3. All air lines shall include proper filters, regulators, etc., for proper control and operation.

4. Manual shut-off valves shall be placed where applicable.

5. Cylinders shall conform to ANSI standards wherever practical.

6. Where the cylinder heads are used as a positive stop, adjustable cushions or external deceleration control shall be provided.

7. Valves shall be manifold or sub-plate mounted.

8. Flexible hose or plastic tubing shall be used between moving elements, oil resistant and restrained 12” of each termination to eliminate the hazard of pressurized lines whipping should they come loose.

9. The system shall monitor the air pressure provided by the Supplier.

10. Air pressure outside the desirable limits shall prevent the automation from operating.

11. One main disconnect shall remove all air from the automation and any associated subsystems, unless this requirement violates any relevant code requirements and/or poses a direct threat to the health and safety of an operator and/or technician.

12. Air lines shall be color-coded and labeled at each end. All pressure lines and exhausts shall be readily identifiable by color.

13. Any location where air comes in direct contact with product or containers, a one-micron filter must be used.

Labeling All equipment switches, motors, valves, regulators, etc., must be clearly labeled to identify the associated function for reference to maintenance and operator manuals.

Labels are to be permanently attached to or near the device. Dyno-type labels are not acceptable.

Welding All welding shall fully comply with the requirements of the American Welding Society's codes as amended to date. All welding shall be under the direct supervision of qualified personnel. Welding operators shall have been qualified within twelve months prior to work on this project, except that personnel continuously employed as welders may be accepted on the basis of satisfactory reports dated not more than two years prior to project start. Safety regulations and fire codes must be adhered to stringently.

Touch Up After installation, components shall be cleaned, and any areas that have scratches, blemishes, or the finish rubbed off will be touched up to match the original paint quality.

Installation Factors The Vendor is responsible for supplying all system supports. No overhead supports (attached to building roof joist or above head flooring systems) will be permitted in this system.

Electrical and Control System Requirements and Architecture Power Distribution The Vendor is responsible for running all power and air lines required for the system from their master control panel. The Vendor is responsible for submitting power and compressed air requirements to the project engineer for approval during the process design review and approval.

All installation work must be performed with the system deenergized.

Device Layer The device layer shall include any and all input/output devices (hereafter I/O) used within the project.

1. Emergency stop (hereafter E-stop) circuitry shall be included in the device layer.

2. E-stop circuit(s) shall be hardwired.

3. E-stop circuit(s) shall not depend on software interaction to properly…