S03_DRAFT STATEMENT OF WORK_Q0462.docx

DRAFT STATEMENT OF WORK

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 CDB –Central Database hosting the patient orders at VA’s central location APFS – Automated Prescription Fulfillment System AUOU – see UUA above BULK – Non-NDC or high unit count pharmacy items on a prescription.

Container – a logistical entity that contains tablet/capsule or a UoU retail pack dispensed on a Rx. Sometimes referred to as Item being dispensed CS – Control Substance Prescription D-CMOP – Dallas Consolidated Mail Outpatient Pharmacy 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.

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 TCA - Tablet and Capsule Automation Subsystem Throughput – The amount of material or items passing through a system or process.

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 ORDER – Single mailing unit to patient with all requested items/prescriptions 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 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:

AUOU-Automated Unit of Use Dispensing ATD-Automated Tablet 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 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. 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.

Currently, the Dallas CMOP processes an average of 60,000 scripts per day. The Dallas facility has recently transitioned from a single shift to a two-shift operation (within the last 8 months). Through this transition to two shifts, the facility continues to adjust to the two-shift staffing plan. This is a single facility operation where all pharmacy dispensing operations and pharmacy warehousing are located in a single building. The current APFS in the facility consists of automated tablet dispensing, automated unit of use dispensing, manual dispensing, manual unit of use labeling and manual pharmacist verification. The current packing process is a manual pack process shipping in predominately poly bag mailers. The patient orders are processed, packed in poly bag mailers and consolidated at a 3rd party mailing consolidator located off site.

VA CMOP desires to increase the amount of automation within their Dallas facility, specifically in the packaging area. This RFQ is part of the process designed to increase the level of packaging automation at this facility. All automation proposed in response to this RFQ shall be designed for durability and a minimal level of maintenance.

This RFQ is intended to solicit proposals for the facility's manual packaging area where operator-assisted printing and packing are to be provided. Fully automated printing and packing are currently NOT desired for this effort. Suppliers may propose a fully automated solution as an alternative, but past performance on such a system across the CMOP network is poor. A semi-automated solution is highly desired due to this past performance and the possibility that printing, and packing stations may need to be relocated in the future as upgrades to the current APFS may be possible.

In addition, this RFP is to add a defined number of upgraded manual pack station equipment to current manual work stations, as defined, to increase the productivity and performance while maintaining ultimate flexibility to move the station to other places in the facility should this be required for future transition planning.

The key elements of this upgrade will be automatically reading totes with RFID, improved scanning of dispensed item barcodes, improved printing of patient information literature and automated opening, sealing and shipping label printing of polybags.

Proposals will be evaluated to select the best, most reliable automation support, and the most cost-effective means of providing the best value solution for the Dallas CMOP.

The specific area to add automation are:

Semi-Automated Print and Pack – Packing is completed after PV2, where Patient Information Literature (PIL) sheets are generated, scanned and added to the bag, and the order sealed. For large volume orders, some of the manual packing stations will pack into corrugated boxes; however, most orders are packed into bags. Sealed bags are placed in a bulk mail center containers for transportation to a third-party facility for manifesting and mailing to the veteran (typically via USPS carrier). It is the intent of this solicitation to upgrade the current manual process to add a select number of semi-automated pack stations to increase throughput and productivity of existing stations within the same pharmacy footprint.

VA CMOP is requesting a turn-key proposal for the addition of semi-automated packaging machines to service the APFS specifically in Puck Pack and Tote Pack. The scope of this is limited to 8 semi-automated tote pack stations and 2 semi-automated puck pack stations. The requested number of stations is driven by the space available on one of the two sides of the existing packing loop. It is not anticipated that the requested number of stations will be able to process the full puck and tote volume of the facility. The remaining existing manual stations will remain in place and could be considered for future upgrade with positive performance within the scope of this initial effort.

Select areas in the pharmacy receive work from POS, process the work, and report back to POS. This is the desired approach for the printing and packing automation to be added to the pharmacy. 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 close out the order.

Upgraded Manual Pack Station – In the VA CMOP, product is picked and dispensed manually and automatically then sent to labeling and pharmacist verification (PV2) stations via a conveyor system. Packing is completed after PV2, where Patient Information Verification (PIV) sheets are generated, added to a bag, and the order sealed. For large volume orders, some of the manual packing stations will pack into corrugated boxes; however, generally orders are packed into polybags. Sealed orders are placed in a bin or bulk mail container for transportation to a third-party facility for mailing to the veteran (typically via USPS).

VACMOP is requesting a turn-key proposal for the upgrades to manual packaging machines to service the existing pharmacies. Full integration with the existing system is required, including order complete confirmation and verification.

Facility Location

US Department of Veterans Affairs Dallas CMOP 2962 S Longhorn Drive Lancaster, TX 75146

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 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 Dallas pharmacy are provided to scale in the attached drawing file. 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 Dallas. Suppliers will be afforded the opportunity to visit the Dallas facility in advance of the due date of this proposal, subject to public health restrictions. Should such restrictions not support a visit, CMOP will take steps through photos and videos to explain the applicable operation in the Dallas facility.

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 should also 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.

Quotation Submittal Time Frame Quotations shall constitute an offer to do business that shall remain open for acceptance for a period of 120 days after the quotation due date.

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 Lancaster, TX. 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.

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 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.

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:

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 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.

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.

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 Mid-South region are preferred but need not be limited to this geographical area. If applicable, federal government procurements should be included.

Attachment 6 - Proposal Form A copy of the Proposal Form to be used for this project is contained in the RFQ. Spaces are provided in the form for information on total price, price breakdown, and schedule. All blanks must be completed.

The Supplier is to provide specific prices for materials, delivery, and installation, as indicated. The pricing must include the loading of equipment at the Supplier factory, delivery, and unloading at the customer’s site.

Attachment 7 - Technical Submissions As described in the related sections of this document.

Attachment 8 - Training, Maintenance and Warranty Submissions As described in the related sections of this document.

Attachment 9 - 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.

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 Dallas 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.

PROJECT SCHEDULE

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.

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 Dallas CMOP in Lancaster, TX, 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 Project Manager.

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 at this time. 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

Current Process Flow and Operations The overall current operational flow of the Dallas CMOP is depicted below:

The operational flow begins with dispensing of tablets to vials and vial are married to totes for combo orders or empty totes are conveyed to unit of use dispensing in A-frames and/or manual dispense areas. The tote orders are sent to labeling and pharmacist verification and then on to packing. The current packing process is manual and there are separate packing stations that handle tote orders and puck orders.

Currently puck orders with 2 or more pucks are sent to dedicated manual puck pack stations for multi-puck orders. All single puck orders are robotically de-pucked into generic large totes and manually distributed to the puck pack stations or to tote pack stations to manually balance the packing workload.

Tote orders are manually pulled from the conveyor and manually packed in dedicated tote pack stations. The orders are pulled randomly as they pass work stations and there is no dedicated divert to move totes from the main conveyor into a specific workstation.

Current Pack Process Location Currently, there are 42 manual tote pack stations and 8 manual puck pack stations in the packing area. The packing area is located at the end of the APFS and is connected through tote conveyor and puck conveyor. The drawing below illustrates the location of the current manual pack area:

Manual Tote Pack Manual Puck Pack

Current Manual Pack Area

Manual Puck Packing Overview Manual puck packing is located at the end of the manual packing area conveyor line. The manual puck pack area is on opposite sides of the conveyor line and each puck pack side has five manual pack stations. The stations are dedicated to single puck orders and multi-puck orders. The station priority is to pack multi-puck orders first then pack single puck orders. The work stations contain a small order accumulation gravity conveyor and have the ability to hold 5 orders with each order containing 4 pucks. Single puck orders are robotically de-pucked prior to the packing operation and placed into large generic totes. These large single puck totes are manually distributed to packing stations on an “as-needed” basis or to balance out workloads between multiple packaging stations. The single puck totes are staged on the workstation table top and operators select single vials from the totes for packing.

The takeaway belt conveyor for finished packages is located between the stations on each side. The operators manually toss the finished packages onto the belt conveyor and the packages are conveyed to a large gaylord at the end of the line where they waterfall over the conveyor into the gaylord.

Below is a graphical description of the puck packing flow:

Single Puck Pack

Multi Puck Pack

Current Puck Pack Layout Package Belt Outbound Empty Puck Conveyor Inbound Puck Conveyor Manual Workstation Puck Accumulation

Current Puck Pack Station Layout

Current Puck Pack Station

Current Puck Pack Process Below are the current process steps for completing the packaging of puck only orders for multi-puck orders and single puck orders.

Current Multi-Puck Pack Process:

1. Select and open polybag

2. Grab one vial from puck in order queue

3. Scan patient label on vial with barcode scanner

4. Label scan triggers patient literature to print

5. Verify correct item on order with monitor

6. Place vial into polybag

7. Place empty puck on takeaway conveyor

8. Repeat steps #2 through #7 for each vial on patient order

9. Place refill information into bag

10. Wait for patient literature to complete printing

11. Scan patient literature 2X with barcode scanner

12. Fold patient literature and place into polybag

13. Peal polybag seal, close and seal polybag and place waste material in trash

14. Retrieve shipping label from label printer

15. Place shipping label on polybag

16. Scan shipping label

17. Place polybag on belt conveyor

Current Single-Puck Pack Process (singles at puck pack station):

1. Select and open polybag

2. Grab one vial from large tote

3. Scan patient label on vial with barcode scanner

4. Label scan triggers patient literature to print

5. Verify correct item on order with monitor

6. Place vial into polybag

7. Place refill information into bag

8. Wait for patient literature to complete printing

9. Scan patient literature 2X with barcode scanner

10. Fold patient literature and place into polybag

11. Peal polybag seal, close and seal polybag and place waste material in trash

12. Retrieve shipping label from label printer

13. Place shipping label on polybag

14. Scan shipping label

15. Place polybag on belt conveyor Proposed Puck Pack Process Below are the proposed process steps for completing puck only orders' packaging for multi-puck orders and single puck orders. It is proposed that new packing station designs should have the flexibility to pack both order types without change-over or reconfigurations.

Future Proposed Multi-Puck / Single Pack Process:

1. Pucks enter local pack station queue for puck pack

2. Triggers patient literature to print

3. Pucks released to pack position and presented to pack operator

4. Bagger automatically indexes bag, laser prints patient shipping label on bag and scans shipping label to confirm correct label and readability.

5. Operator selects one vial from puck

6. Scan patient label on vial with fixed barcode scanner

7. Verify correct item on order with monitor

8. Place vial into polybag

9. Repeat steps #5 through #8 for each container on patient order

10. System directs operator to specific tray with patient literature and refill information pre-printed (tray will also have light indicator)

11. Pull literature packet from tray with fixed upper and lower scanners (scan top of first page and bottom of last page simultaneously)

12. Pull return label from label printer located in pack station

13. Fold patient literature with return label and place into polybag

14. Bagger automatically seals bag

15. Bagger automatically drops to conveyor with feed to overhead takeaway conveyor

16. Empty pucks automatically released on conveyor

The proposed puck pack station eliminates the manual handling of bags, shipping labels and return of empty pucks to the conveyor line. In addition, the proposed stations will automatically convey the finished packages to the takeaway belt and out of the pack area. The proposed station layout is depicted below:

Printer Auto Bagger Package Belt Package Belt Puck Accumulation Inbound Puck Conveyor Outbound Empty Puck Conveyor

Proposed Puck Pack Station

The proposed layout has been developed to fit within the current manual puck pack area and should be considered the maximum footprint for new puck pack operator assisted automation equipment. The concept has been developed to limit the impact to the current APFS system and allow for similar interfaces between the current APFS and the packing stations.

Manual Tote Packing Overview Manual tote packing is located along both sides of the tote conveyor at the end of the APFS and 4 stations are located on return side of the tote conveyor at the very end of the packaging lines. The manual tote pack area is on opposite sides of the conveyor line and each tote pack side has 19 manual pack stations. The stations are dedicated to tote orders packed into polybags. The work stations contain a small area to hold a single tote that would be manually removed from the conveyor. When the order is completed, the operators manually push totes to the empty tote takeaway conveyor.

The station priority is to pack tote orders; however, each station has the capability of packing single puck orders if required. Each station can handle single puck orders from large generic totes placed on the workstation. These large single puck totes, also described in 3.2.1.1, are manually distributed to tote packing stations on an “as-needed” basis or to balance out workloads between multiple packaging stations. The single puck totes are staged on the workstation table top and operators select single vials from the totes for packing using the same process as puck pack stations.

The takeaway belt conveyor for finished packages is located between the stations on each side. The operators manually toss the finished packages onto the belt conveyor and the packages are conveyed to a large gaylord at the end of the line where they waterfall over the conveyor into the gaylord.

Below is a graphical description of the tote packing flow:

Tote Pack

Current Tote Station Layout Package Belt Inbound Tote Conveyor Inbound Tote Conveyor Outbound Empty Tote Conveyor Manual Workstations Outbound Empty Tote Conveyor

Current Tote Pack Station Layout

Current Tote Pack Station

Current Tote Pack Process Below are the current process steps for completing the packaging of tote orders for unit of use only and marriage (unit of use and puck) orders.

Current Tote Pack Process:

1. Grab tote from conveyor and place to staging area

2. Select and open polybag

3. Grab one container from tote

4. Scan patient label on container with barcode scanner

a. Label scan triggers patient literature to print

5. Verify correct item on order with monitor

6. Place container into polybag

7. Repeat steps #3 through #6 for each container on patient order

8. Place refill information into bag

9. Wait for patient literature to complete printing

10. Scan patient literature 2X with barcode scanner

11. Fold patient literature and place into polybag

12. Peal polybag seal, close and seal polybag and place waste material in trash

13. Retrieve shipping label from label printer

14. Place shipping label on polybag

15. Scan shipping label

16. Place polybag on belt conveyor

17. Place tote back on conveyor

Proposed Semi-Auto Tote Pack Process Below are the proposed process steps for completing the packaging of tote orders and super tote orders. It is proposed that new packing station designs should have the flexibility to pack both tote types without change-over or reconfigurations.

Future Proposed Tote Pack Process:

1. Tote enters local queue for tote pack station

a. Triggers patient literature to print

2. Tote enters pack position and is presented to pack operator

3. Bagger automatically indexes bag, laser prints patient shipping label on bag and scans shipping label to confirm correct label and readability.

4. Operator selects one container from tote

5. Scan patient label on container with fixed barcode scanner

6. Verify correct item on order with monitor

7. Place container into polybag

8. Repeat steps #3 through #6 for each container on patient order

9. System directs operator to specific tray with patient literature and refill information pre-printed (tray will also have light indicator)

10. Pull literature packet from tray with fixed upper and lower scanners (scan top of first page and bottom of last page simultaneously)

11. Pull return label from label printer located in pack station

12. Fold patient literature with return label and place into polybag

13. Bagger automatically seals bag

14. Bagger automatically drops to conveyor with feed to overhead takeaway conveyor

15. Tote is automatically released on conveyor

The proposed tote pack station eliminates the manual handling of bags, shipping labels and return of empty totes to the conveyor line. In addition, the proposed stations will automatically convey the finished packages to the takeaway belt and out of the pack area. The proposed station layout is depicted below:

Inbound Tote Conveyor Outbound Empty Tote Conveyor Tote Work Queue Package Belt Package Belt Auto Bagger Printer

Proposed Tote Pack Station

The proposed layout has been developed to fit within the current manual tote pack area and should be considered the maximum footprint for new tote pack operator assisted automation equipment. The concept has been developed to limit the impact to the current APFS system and allow for similar interfaces between the current APFS and the packing stations. The current proposed layout has the operator assistive automation on the outside tote pack line keeping the inside stations as manual stations for packing back-up and box orders.

Manual Tote Pack Upgrade Targeted Improvements The upgraded packing stations are being proposed to improve the efficiency and rates of the existing manual pack stations with specific targeted improvements. The upgraded pack station equipment must address the following targeted improvements.

Automatically Read Tote RF Tags The pack station upgrades must include an RFID tag reader into the workstation. This reader will automatically read the RFID tag of totes when they are manually placed in the workstation in a designated tote work location. This automatic read will automatically trigger the printing of patient literature, reducing operator wait time, and the automatic printing of a shipping label on a poly-bag and automatically opening the bag for the operator to fill.

High Speed Printer with Patient Information Literature Pack Scans The pack station must include upgraded printers with multiple trays to handle multiple orders. These printers must print duplex and have the ability to print 30 PPM or faster. The printer trays should be identifiable that the system can direct the operator to a specific tray through a light system or numbering schema. The printers must be affixed with barcode scanners to automatically read barcodes on the top of the first page and bottom of last page when the operator removes the patient literature pack from the print tray. The scanners should lock the station if an incorrect literature package is pulled from the wrong tray. Specific printer requirements will be detailed in a subsequent section.

Fixed Barcode Scanner for Patient Labels The pack station must contain an overhead barcode scanner directly over the automated bagging machine that will allow the operator to scan items directly as they are placing the items into the poly-bag. The scanner should record each scan and lock the workstation if an incorrect scan is made.

Tabletop Bagging Machines The pack station should contain and automated tabletop bagging machine. The machine should fit on the top of the workstation and be at an ergonomic height for the operator to place items into the bag. Specific bagging requirements will be detailed in a subsequent section.

Automatically Print Shipping Labels on Bags The tabletop bagger should automatically print the patient shipping label on the bag when the order is read. In addition to printing the label, the bagger must have a fixed scanner to read the shipping label barcode to confirm the correct label has been printed and the label is scan readable. Specific labeling requirements will be detailed in a subsequent section.

Automatically Open Bags The tabletop bagger should automatically open the bag and present a clear and complete opening to the bag to allow the operator to place items into the bag.

Automatically Close and Seal Bags The tabletop bagger should automatically close and seal the bag when the order has been verified as complete, with all scans being completed and a trigger from the operator to close and seal the bag.

Automatic Reporting Back to Pharmacy Control System The pack stations should have the ability to collect all packaging information from the order to include the following scans:

· RX Patient Label Scans – All Containers

· Patient Literature Scans – Front and Back

· Shipping Label Scan After all confirmed scans are recorded, the station should confirm a good bag seal and report back the following information to the pharmacy control system:

· Patient Order Number

· Date Packed

· Items Packed

· PIL Scanned

· Shipping Label ID

· Operator ID

· Pack Time More details will be provided in a subsequent section.

General Requirements The following are general requirements for the packing station upgrades. These requirements are guidelines for the upgrades and should be minimum targets for the packaging station upgrades.

Packaging Speeds The upgraded packing stations should be able to process between 175 and 200 patient orders per hour. This should be a sustained rate under normal working conditions.

Ergonomics The packaging stations should be configured to accommodate a standard operator between the height of 5ft 2in and 6ft. The station should minimize the amount of twisting, turning, bending and walking to complete the packaging process. The station should meet all OSHA guidelines for operator safety.

Portability The packing stations should be portable, meaning the packing station can be easily “unplugged” and moved to another part of the pharmacy, “plugged back in” and be operational in less than one hour.

Flexibility The pack station should be flexible and handle all manually bagged orders from totes, pucks, and super totes. There should be accommodations or features of the station that can make the station adaptable to each order type with minimal changes or modifications to the stations.

Safety Features Each station should have safety features that prevent operator injury or bodily harm. This may include light curtains, positive safety switches or foot pedals that allow full operator control. In addition, a safety shut-off switch should be easily reachable for the operator in the event of a malfunction or emergency.

Interface to Pharmacy Operating System Information for orders being routed to the automation stations will be sent from POS to the upgraded workstation controller. When the order has been bagged and released to the mailing conveyor or placed back into a tote, the upgraded workstation controller will return the order information back to POS.

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

1. Tote ID (read by RFID)

2. Order number

3. Complete address including the name

4. Return Address (unique to VA Medical Centers and clinics originating the Rx)

5. Bar code ID to print on the mailing label (unique to the order)

6. Pages to print for the Patient Information Literature (PIL) pack (including med guides), including the bar code for first and last page.

7. Patient label information per Section

8. Any other data elements as requested by the Semi-Auto Packer workstation controller to perform its task.

9. The minimum information to be returned from the Semi-Auto Packer workstation controller to POS for each bag (order) is:

10. Order number

11. Confirmation scan of bar code of each bottle placed into the bag

12. Patient label ID

13. NDC

14. If bottle missing, place order into a tote, identify missing item

15. For no-read bottle, set an item no-read flag

16. If wrong bottle, set QA flag and place order in a tote If incorrect scans occur, the system shall be designed to prevent processing any future orders until the problem order is resolved or overridden by supervisory personnel. Personnel with override rites will be assigned in the control system by senior CMOP management.

1. Confirmation scan of each UOU item being placed into the bag or tote

2. Patient label ID

3. NDC

4. UPC barcode of UoU item

5. If UOU is not placed into bag or tote, set item missing flag

6. Bar code of first and last PIL printed page in the bag

7. Automation station ID that processed this order

8. Date/Time the order was completed (released to the mailing conveyor)

9. Operator ID that processed this order at this station In addition to the two messages above, the following messages should also be supported by the interface.

· Heartbeat (to verify the connection between the systems)

· 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).

· Automation status – online/offline/maintenance for each workstation

· Currently logged in operator identification

· Operator Logout time at the workstation

· Number of orders completed since the last operator login to the workstation

DATA ANALYSIS – ORDER PROFILE AND THROUGHPUT REQUIREMENTS

The following section provides the data analysis and specific requirements for the Dallas CMOP facility semi-auto packing requirements.

Data analysis shown in this document is intended to provide an estimate of required equipment throughput needs but the Vendor should be aware that the data in this section does NOT yet include a fully operational second shift. That second shift started operations in October 2020 and was in a ramp up period during the date range of data.

Calculation Assumptions and Methodology Data Scope:

The scope of this analysis is all order volume processed by the Dallas CMOP APFS. The date range for data analysis was completed for the time period beginning October 2, 2020 and ending February 1, 2021.

Additionally, orders/containers that meet any/all of the following criteria are out-of-scope for any proposed equipment:

· Orders Dispensed Outside APFS Equipment

· Med Surg Orders

· RXs Filled in Bulk Work Area

· RXs Filled in the Refrigerated Area

· Orders/RXs packed out in non-bags (i.e., ambient box or cold chain box)

· Heavy/Bulky packages Hours of Operation:

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

Hourly design requirements are calculated as the daily volume divided by 16 hours on average per day over two shifts.

Order Splitting Calculation Assumption:

Orders containing RXs from an automated work area within the APFS (either ATD or AUOU), the manual dispense work area, and/or the bulk area are currently treated as separate orders for operations. The ATD/AUOU portion of the order is filled, labeled, packed, and shipped in the APFS area of the pharmacy, the non-APFS portion of the order is completed in a separate work area, and the bulk portion of the order is completed in a third work area in the pharmacy. The (up to) three portions of an order are not married prior to packing/shipping; instead, they are shipped to the patient as separate packages.

The number of occurrences for this type of order are exceptions and not considered standard practice or accepted practice. It is assumed in future pharmacy operations these will be treated as separate and independent patient orders and the manual or bulk portions of the order are excluded from the scope of the solicitation.

VA CMOP Data Analysis Only tote and puck orders from POS historical data are used in the calculations in this section.

Order Profile Overall Order Profile:

Overall Order Profile

Order Profile by Order Type:

Order Profile by Order Type

Throughput Profile Hours of Operation:

The table below shows operations information as it relates to the hours worked per day. Note that there are two staggered shifts in the pharmacy, beginning at 6 am/7 am and at 2:30 pm/3:30 pm. Each shift is 8.5 hours from start to finish and includes a 30-minute lunch and two 15-minute breaks.

Operations Info

Overall Throughput Summary:

Packing Daily Throughput Requirements

Packing Hourly Throughput Requirements

Throughput by Order Type:

Daily Throughput Requirements by Order Type

Hourly Throughput Requirements by Order Type

New vs. Refill Throughput Summary:

Hourly Throughput Requirements by Order Type

Packing Profile Orders can be packed into bags, ambient boxes, or cold chain boxes. The profile for package type and containers per package by order type is shown below.

Order Profiles by Containers per Order:

Overall:

Pack Type Profile - OVERALL

Packing Profile – Containers on Order OVERALL

Tote Orders:

Pack Type Profile - Tote

Packing Profile – Containers on Order TOTE

Puck Orders:

Pack Type Profile - Puck

Packing Profile – Containers on Order PUCK

The semi-auto packers must be capable of handling the bag volume; the daily throughput required for this volume is shown below:

Projected Growth The design window is from 2021 to 2027 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. Suppliers should base their proposal on the provided equipment counts but should provide % of tote and puck volumes that can be processed on 2027 volumes with their proposed equipment.

Dallas Forecasted Semi-Auto Packer Volume