P09_SOW_Final_Q0476_Chelmsford.docx

STATEMENT OF WORK (SOW)

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 Container – a logistical entity that contains tablet/capsule or a UoU retail pack dispensed on a Rx. Sometimes referred to as Item being dispensed 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.

NE-CMOP – Northeast 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 ORDERPIL – Patient Information Literature Project - Pharmacy Printing and Packing Automation POS – Pharmacy Operating System Puck – A puck is a round polyethylene (UHMWPE) 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 container has a unique system ID number and a tote typically contains a single patient order. In some instances, totes can contain multiple, single container customer orders and are referred to as “super totes.”

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 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 Northeast CMOP in Chelmsford, MA processes an average of 47,000 scripts per day. The facility operates a single shift with an average of 10 operational hours per day (peak throughput is 52,000 scripts over 12 hours). 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 Chelmsford facility, specifically in the packaging area. Based on past performance and prior systems experienced by the site, the automation initiatives within the facility will be a limited proof of concept. The goal is to assemble technology solutions in a limited capacity to insure effectiveness prior to full roll-out across the facility. This will allow the existing operations to function with current manual operations as a back-up to the new technology. This RFQ is part of the process designed to increase the level of packaging automation and define the initial proof of concept 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 Quotes 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.

Additionally, the RFQ will add a ten (10) 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.

Quotes 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 Northeast 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 Quote 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 two semi-automated tote pack stations and four semi-automated puck pack stations. In addition, the VA is considering the modification of six tote pack stations that utilize some of the technologies incorporated in fully integrated semi-automated packaging stations. The requested number of stations is driven by the space available to add technology while keeping manual operations and the desire of site leadership for a proof of concept approach. The remaining existing manual stations will remain in place and could be considered for future upgrades 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 Quote 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 Northeast CMOP 10 Industrial Ave.

Chelmsford, MA 01824

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 Chelmsford 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 Chelmsford. 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 photos and videos to explain the applicable operation in the 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 Chelmsford, MA. 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 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. 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 - 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.

Attachment 8 - Bill of Materials A complete Bill of Materials shall be supplied with the quotation reflecting total component quantities, required software, delivery weight, and expected number of truckloads to be shipped.

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 Northeast 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 Northeast CMOP in Chelmsford, MA, 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 Northeast 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 two 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 36 manual tote pack stations and 12 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 Puck Pack Manual Tote Pack Manual Tote Pack Manual Puck Pack

Current Manual Pack Area Tote Pack (Yellow Shaded) Puck Pack (Blue Shaded)

Future Pack Process Location The proposed pack area upgrades are planned for each area of the current manual packing. The upgrades are being added to select stations on a trial basis to test the concept of semi-automated packing and the VA CMOP operation. These select stations will support the current manual operations and are not designed to handle all packaging volume. The layout below shows the selected areas for semi-automated packaging upgrades.

Future State Manual Pack Area Semi-Auto Tote Pack (Yellow Shaded) Semi-Auto Puck Pack (Blue Shaded) Upgraded Manual Tote (Green Shaded)

Manual Puck Packing Overview Manual puck packing is located at each end of the puck dispensing conveyor line. The manual puck pack area is on opposite sides of the conveyor line and each puck pack side has six manual pack stations. Three stations on each side are for multi-puck orders and three stations on each side are for single puck pack or other packing when necessary. It is assumed the other packing will be moved to a separate area of the pharmacy in the future.

All single puck orders are currently automatically de-pucked and sent to the conveyor spur that services the single pucks where they are dropped into a generic tote for manual distribution. These totes are manually distributed to the single puck stations, multi-puck stations (as filler work) and Manual Super Tote stations (as filler work). These large single puck totes are distributed to packing stations on an “as-needed” basis or to balance out workloads between multiple packaging stations.

Single puck totes are staged on the workstation table top and operators select single vials from the totes for packing. The station priority is to pack multi-puck orders first then pack single puck orders.

The multi-puck work stations contain a small order accumulation gravity conveyor and have the ability to hold 4 orders with each order containing 5 pucks. The last order lane has a small shelf that the operator can manually move pucks to for orders larger the 5 vials. This last lane is reserved for these larger puck orders. Completed orders ready for pack are flagged with a light above the order lane altering the operator the order is ready 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 Puck Accumulation Manual Workstation Package Belt Outbound Empty Puck Conveyor Inbound Puck Conveyor

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. Retrieve shipping label from label printer

13. Fold patient literature and place into polybag

14. Place shipping label on polybag

15. Place return label into polybag

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

17. Scan shipping label

18. Place polybag In tote at station

19. Every 10 Orders Dump tote to package 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. Retrieve shipping label from label printer

12. Fold patient literature and place into polybag

13. Place shipping label on polybag

14. Place return label into polybag

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

16. Scan shipping label

17. Place polybag In tote at station

18. Every 10 Orders Dump tote to package 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:

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

Proposed Puck Pack Station (2 Adjacent Stations)

The proposed layout has been developed to fit within the current manual puck pack footprint area while maintaining current manual puck pack stations. This footprint 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 two sides of the APFS tote conveyor loop. There are 22 manual tote pack stations are located on the outside of the APFS loop where totes enter the packaging area from pharmacist verification and 15 manual “super tote” pack stations are located opposite side where the packaging loop exits to return empty totes to dispensing and tote marriage. The 22 manual stations are dedicated to tote orders packed into polybags. Several work stations at the end of the 22 manual station can pack both polybags and boxes. The 15 manual “super tote” stations can pack single unit of use orders, single puck orders from large totes and regular tote orders.

Predominantly orders are packed in poly bags and the bags are placed on a takeaway belt conveyor located in the center of the packaging loop. Box orders are completed and staged on rolling carts directly behind the pack stations. When an order is completed, the operators manually push totes to the empty tote takeaway conveyor.

The station priority is to pack tote orders; however, any 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 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 is centralized in the packaging loop and is connected to the takeaway belts from the other packaging areas overhead. 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 Inbound Tote Conveyor Overhead Package Belt Outbound Empty Tote Conveyor Manual Workstations

Current Manual Tote Pack Station Layout

Current Manual 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. Retrieve shipping label from label printer

13. Place shipping label on polybag

14. Place Return Label into polybag

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

16. Scan shipping label

17. Place polybag on hold back shelf

18. Place polybag on hold back shelf to takeaway belt conveyor

19. Place tote back on conveyor

Proposed 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. This will eliminate the need to “hold-back” the last package prior to placing on the takeaway belt conveyor. The proposed station layout is depicted below:

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

Proposed Tote Pack Station

The proposed layout has been developed to fit within the current manual tote pack station footprint area while maintaining space for current manual tote pack stations. This 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, allow the current manual tote pack stations to be maintained 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.

Interface to POS The pharmacy operating interface with the new packaging stations should be included in the packaging station upgrades. This interface must receive information from the POS and return information to the POS confirming completed order packing.

In addition to reporting back to the POS, the packing stations should have the ability to link to a real-time packing station dashboard to be used by pharmacy management for tracking workflows in the packaging areas and to provide real-time feedback to packaging operators on pack station KPIs.

More details on the system requirements are highlighted in section 5 of this document.

Upgraded Manual Stations Requirements All manual packaging is connected to the system by conveyors, and the system handles the routing of totes and pucks to specific manual work stations. Although the routing of orders is automated within the system, the current manual process contains non-automated tasks, which are non-value-added activities. These include waiting for literature, retrieving totes, manually handling packaging materials, and manual movement of packed orders, which all significantly contribute to packing inefficiencies.

The following section outlines the operational requirements for upgraded packing stations. These upgraded packing stations will be modifications to or upgrades of existing manual bag pack stations in the current CMOP process. The upgrades are aimed at increasing overall productivity, throughput and efficiency while minimizing impact to integrations, system changes and interfaces with current APFS (Automated Pharmacy Fulfillment Systems). There are six (6) upgrades required for tote and four (4) required for puck, a total of ten (10).

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 work station. This reader will automatically read the RFID tag of totes when they are manually placed in the work stations 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 work station if an incorrect scan is made.

Table Top Bagging Machines The pack station should contain and automated table top bagging machine. The machine should fit on the top of the work station 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 table top 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 table top 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 table top 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

· Lit Pack 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 1 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 Control Systems 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 work station

· Currently logged in operator identification

· Operator Logout time at the work station

· Number of orders completed since the last operator login to the work station The workstation will not continue operation should the connection to host system be temporarily disrupted. Reset of the semi-auto packing system will require supervisory intervention.

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

Data analysis shown in this document is intended to provide an estimate of required equipment throughput. The data collected represents the most recent 6-month period prior to the development of this RFQ. The data has been reviewed with key SMEs within the Northeast CMOP facility and is deemed and accurate representation of throughput and patient order profiles moving forward for both pre and post-pandemic operations.

Calculation Assumptions and Methodology Data Scope:

The scope of this analysis is all order volume processed by the Northeast CMOP APFS. The date range for data analysis was completed for the time period beginning July 29, 2020 and ending January 25, 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:

Northeast CMOP pharmacy currently runs a one-shift operation five days per week.

For design purposes the hourly design requirements are calculated as the daily volume divided by 8 hours on average per day over one shifts. The operation runs a staggered shift and operates over a 10-hour day; however, operators work an 8-hour shift.

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/refrigerated 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/refrigerated 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/refrigerated portions of the order are excluded out of scope for this 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…