P09_SOW_Final_Q0504_Hines.docx

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

GL-CMOP – Great Lakes Consolidated Mail Outpatient Pharmacy 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 ORDERPIL – 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) OrderType 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. It is unknown when this replacement will affect specific CMOPs; however, suppliers should assume that the changeover will not affect the proposed solutions to this Request for Quote (RFP) and that no direct interfaces to the EHR will be required.

Currently, the Great Lakes CMOP processes an average of 95,000 scripts per day across a two-shift operation using a variety of technologies (Baker Cells, A-Frame, ADUs).

Suppliers are advised that equipment proposed under this RFP may be moved in the future as part of an upgrade to the current system. The VA would greatly prefer to maintain a single semi-auto packing equipment vendor servicing both the current manual and future state APFS support operation. Flexibility of the Supplier’s equipment to adapt and support changes in production line layout and operations is of critical importance to the VA.

VA CMOP desires to increase the amount of automation within the Great Lakes location. This RFP is part of the process designed to increase the level of automation at this facility. All automation proposed in response to this RFP shall be designed for durability and a minimal level of maintenance and replacement of consumables.

This RFP is intended to solicit quotes for primarily single bottle RXs packing support (Section 4.5 addresses optional functionality). Fully automated printing and packing are currently NOT desired for this effort. Past performance on fully automated systems 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 as the final automation solution for the facility is developed.

In addition, the RFP is intended to include upgrades for current packing stations where operator-assisted printing and packing are to be provided.

The object of this portion of the RFP is to add equipment to current manual work stations, where possible, 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.

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 GL-CMOP.

The specific area to add automation are:

Semi-Automated Print and Pack – VACMOP is requesting a turn-key quote for the addition of two semi-automated packaging machines to service the following production streams:

· Baker Cells (Single Rx, single container orders only)

· ADU

· CLS Bottles The number of stations required to achieve throughput requirements in Section 5 are a function of the Vendor’s equipment capability.

The Pharmacy Operating System (POS) is the overall pharmacy-control system utilized in the operation's applicable section. POS is also the primary interface to the EHR for this operation.

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 Great Lakes CMOP 5th & Roosevelt Road Hines, IL 60141

Confidentiality VA CMOP considers all equipment, systems, distribution processes, and documentation relating to such equipment, systems and processes to be confidential and proprietary information. The 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 Great Lakes pharmacy are provided to scale in the attached St. Onge Company drawing. Please note that due to COVID travel restrictions, the drawings are only estimates of current state conditions at Great Lakes. 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.

It is anticipated that the system will be installed in the open warehouse area of the facility vs the order filling area due to space limitations in order processing.

Supplier Qualifications Suppliers should recognize that the Purchaser’s selection team may wish to visit one or more installed sites and be prepared to support such requests. In lieu of travel, the Purchaser evaluation team may choose to contact past performance references without the Supplier being present.

Technical Submissions with the Quotation The Supplier shall recommend the quantity of stations required to meet throughput requirements. 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 FOB to the VA Great Lakes CMOP Pharmacy in Hines, IL. 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.

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 6 - 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 7 - Quote Form A copy of the Quote 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 8 - Technical Submissions As described in the related sections of this document.

Attachment 9 - Training, Maintenance and Warranty Submissions As described in the related sections of this document.

Attachment 10 - 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 Great Lakes 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 Great Lakes VA CMOP in Hines, IL 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 SEMI-AUTO PACK PROCESS

The following section describes the design approach to be followed when designing the automation to be applied for this program.

Background/Current State The major portions of the APFS at the GL-CMOP are over 20 years old. A major upgrade or replacement of the existing system is anticipated in the next five years. The system’s age and the need for substantial changes in existing conveyor interfaces precludes an investment in semi-auto packers for the full tote and puck packing operations. As an alternative the VA CMOP program is looking to procure a standalone packing system that would only process single puck orders.

The orders would need to process (at a minimum) filled, capped and labeled 120cc and 250 cc bottles from the Tablet Counting Automation system (commonly known as Baker Singles). The VA also desires the ability to also process pre-filled, labeled manufacturer bottles. Systems will be evaluated on their ability to handle the widest range of bottle sizes.

Source of RXs The source of all single bottle orders to be packed in the system are as follows:

· Baker Singles. Will consist of single, labeled and sealed 120 and 250 cc bottles from the Baker Cell TCA area. Those RXs will be discharged into a tote and manually transported to the auto-packing area. The ability to handle all of these bottles is a minimum requirement for the system.

· CLS Singles. The Check Label System at Hines is an independent area that processes a subset of bottle (between 100ml and 300 ml) and boxed orders. The VA would like the ability to process any single Rx, single container bottle order in the semi-auto packing system. Bottles in this area are manufacturers bottles with patient labels added and can vary in size.

Figure 4-1: Hines CLS Loop

· ADUs are stand-alone devices that discharge and label pre-filled bottles into a tote for subsequent processing at a pack station. The VA desires to process these orders in the semi-auto packers. Bottle size is limited in order to fit in the ADU channels.

Figure 4-2: Hines ADUs Planned Process Flow The GL-CMOP is currently considering two options based on whether peel-off return labels or no labels are to be printed at the packing workstations.

Base Option (No Label Printing) The planned process flow for the stand-alone semi-auto packing system without label printing is as follows:

Figure 4-3: Planned Process Flow (No Label)

Tote Dump The VA would like the ability to manually dump totes of labeled RXs from all three sources into a common reservoir for subsequent automated entry into the semi auto-packing system. The reservoir should be capable of holding approximately 500 bottles (250 cc size) for subsequent processing.

Bottle Descrambler The system should be equipped with a robotic or other means for descrambling or removing individual bottles from the reservoir and orienting them cap side up on a takeaway conveyor for processing.

The VA is not specifying the specific technical approach to this portion of the system but does insist that it does not cause damage to the bottle, caps or labels.

At a minimum the system should process 120 and 250 cc bottles. The ability of the descrambler to process multiple sizes beyond this minimum requirement will be an evaluation factor in the technical review of quotes.

As a secondary goal the system should be able to descramble CLS bottles between 100ml-300 ml in size.

A tertiary goal is handling the largest range of manufacturers bottles possible.

Should such bottle descrambling not be possible or if the operation is severely limited, the VA will consider manually feeding of bottles but will include additional labor in any internal return on investment calculations. Systems which can descramble bottles automatically and place them on the takeaway conveyor is the preferred solution.

3A3.1.3 Bottle Conveyor The system should be responsible for conveying the properly oriented single bottle orders on an infeed conveyor to the semi-auto packing system. Accumulation of orders awaiting processing should be provided.

3A3.1.4 Label Reader Once the bottle are oriented on the conveyor the system will be responsible for reading of all bar codes on the label and providing that information back to the POS. This read will indicate that the order is in the queue for processing and that printing of the PIL can begin.

3A3.1.5 Printer The printing system will allow for pre-printing of PILs for orders that have passed the label reader. PILs will be printed into a dedicated tray. Once an order arrives at the workstation and bottle scanned, the appropriate tray containing that orders PILs will be indicated through light direction or other means. The system should be capable of scanning the first and last pages of the PIL, indicating the PIL is complete.

A minimum of 10 slots for PILs should be provided. That ability to pre-print and stage more than the minimum will be evaluated in the technical quote review.

3A3.1.6 Bag Opener The semi-auto bag system should assist the operator by presenting a pre-labeled (with shipping address) and opened bag. The operator will then remove the bottle from the conveyor, scan the bottle label and drop in to the bag with the folded PIL.

3A3.1.7 Order Confirmation The system will send a signal to the POS indicating that the label and PIL scan (and therefore the order) is now complete.

3A3.1.8 Bag Sealer Upon order confirmation and after initiation by the operator (through positive acknowledgement via push button/foot pedal or other means) the system will seal the bag and drop onto a small takeaway conveyor. The sealer should be provided with safety devices (e.g. light curtains) to prevent injury to the operator during the sealing process.

3A3.1.9 Order Takeaway The final step in the operation is the conveyance of the completed order from the small semi-auto packer conveyor to a larger cleated belt conveyor which will provide the elevation required to dump the order into a Gaylord container for transportation to the shipping department. This cleated conveyor is anticipated to be part of the semi-auto packing equipment and should be included in the quote.

If the small takeaway conveyor not feeding into the cleated conveyor is not viable in the Vendor’s design, the VA will assume the operator will handle and place the completed order on the cleated conveyor. Any such manual effort will analyzed in the government’s review and comparison of quotes.

Option One (Return Label Printing) This alternative flow included the requirement to print peel-off return labels for each order. In this scenario the semi-auto packing system would print shipping labels directly on the poly order bag.

Figure 4-4: Planned Process Flow (Return Label)

Interface to POS Information for orders being routed to the automation stations will be sent from POS to the semi-auto packer workstation controller If the vendor has previously interfaced with POS pharmacy control system, they should propose defining the interface message. The minimum information to be sent from POS for each order is:

1. Order number

2. Complete address including the name

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

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

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

6. Patient label information per Section

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

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

1. Order number

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

a. Patient label ID

b. NDC

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

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

e. If wrong bottle, set QA flag and place order in a tote

f. 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 rights will be assigned in the control system by senior CMOP management.

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

4. Automation station ID that processed this order

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

6. 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.

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

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

3. Automation status – online/offline/maintenance for each work station

4. Currently logged in operator identification

5. Operator Logout time at the work station

6. Number of orders completed since the last operator login to the work station The workstation controller will not be capable of operation should the connection to host system be temporarily be disrupted.

Optional Functionality While processing of bottles product is the primary goal of this system, the VA would like the ability to process CLS labeled cartons (either singles or grouped) at the semi-auto packers. Such cartons would be introduced manually via tote batches and would be removed and scanned manually. The infeed conveyor would not be used. Bagging and label printing would be the same as with standard bottle orders.

This additional functionality is highly desired as a means of level loading the stations but should not be included in the throughput calculations to determine the level of equipment required to meet bottle throughout requirements.

OPERATIONAL REQUIREMENTS MANUAL PACK STATION UPGRADE

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 inefficiency and low pack rates per station.

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 the current APFS.

Overview An overview of the current APFS is provided below. The objective of the overview is to develop an understanding of the current environment in which the station upgrades will be made. This section of the operational requirements is to inform the current state of the manual pack stations in the CMOP APFS.

Aged Systems In the CMOP facilities targeted, the predominate APFS solutions are aged systems that are either mature systems, in operation for 5 + years, or, aged systems near end of life, in operation for 15+ years. The conveyor, controls and other hardware and support systems are early generation technologies (in most cases) and would require substantial upgrades, modifications or replacement to integrate a fully integrated pack station. The idea of the upgrade to the current manual pack stations are to gain benefits of targeted new equipment while keeping the unobtrusive manual interfaces that will ultimately be replaced with a new APFS at some undetermined future date.

Manual Interfaces The key to the implementation is the manual interface. Currently operators pack orders by manually pulling totes from a conveyor or manually delivering totes to pack stations. This manual delivery and selection, while not efficient, does not require major upgrades to control logic, interfaces and hardware to complete the interface. It is highly recommended to keep the manual interfaces to maintain a positive ROI and reasonable implementation plan.

Limited Space The current packing stations are typically space constrained with walk aisles, conveyor loops, pack material storage and other building features that make major conveyor reconfiguration and/or station hardware enhancements difficult. The focus of the upgraded station is to develop enhancements to the current stations without expanding the footprint of the current station. It is anticipated some minor expansion may be required for upgraded printers or packaging material storage local to the station, however the new upgraded stations should fit within the current footprint provided for the existing stations.

Option to Full Integrated Semi-Upgraded Pack Station Stations Currently there is an initiative to develop a fully integrated Semi-Upgraded pack stations in select CMOP facilities. That initiative is completely unrelated to this request and they should be considered parallel paths and no integration or interface with the fully integrated concept should be considered as part of this request.

Current Pack Stations The next section describes in more detail the current pack stations. These stations are designed to be universal packing stations within the pharmacy and can pack bag orders or boxes (if required). The stations predominately pack bags and future upgrades will be focused on bag packing only. Future box orders would be handled by traditional manual stations.

The current pack stations can process patient orders in 3 ways; 1) packing orders in totes, 2) packing orders from an integrated puck sorter (multi-puck orders) where the local station puck sorter is available, and 3) single container orders manually dumped into large totes (super totes) that are typically packed as “filler work” when orders from methods 1 & 2 are not available.

Tote Packing Tote packing is the packing of orders dispensed in RFID tagged totes. These totes contain prescription containers from A-Frames, Manual Dispenses and Automated Tablet Dispenses. These totes have been processed by labeling and pharmacist verification and are ready for packing.

The operators manually pull totes off the conveyor line and place the tote in the workstation. The contents of the totes are scanned which triggers the printing of patient literature packs and a patient shipping label.

The operator manually opens a poly-bag and places the items for the patient order and the patient literature into the bag. The bag is manually sealed by the operator, a shipping label is placed on the outside of the bag, scanned to confirm the label is correct and readable and then placed on an outbound belt conveyor to the shipping area. The empty tote is manually placed back on the conveyor for take-away.

Hybrid Puck (Multis) and Tote Packing Hybrid Puck and Tote Packing is the packing of orders dispensed in RFID tagged totes and/or multiple prescription vials delivered in RFID tagged pucks. These orders contain prescription containers from A-Frames, Manual Dispenses and Automated Tablet Dispenses. These orders have been processed by labeling and pharmacist verification and are ready for packing.

The operators prioritize processing completing Puck Orders first and then Tote Orders. The puck orders are identified by the operator’s monitor as complete. Completed puck orders in the same manner and sequence as tote orders. The operators manually pull totes off the conveyor line and place the tote in the workstation or pull the vials from the pucks and place in the workstation. The contents of the totes or pucks are scanned which triggers the printing of patient literature packs and a patient shipping label.

The operator manually opens a poly-bag and places the items for the patient order and the patient literature into the bag. The bag is manually sealed by the operator, a shipping label is placed on the outside of the bag, scanned to confirm the label is correct and readable and then placed on an outbound belt conveyor to the shipping area. The empty tote is manually placed back on the conveyor for take-away and empty pucks are placed on the empty puck take-away conveyor back to the automated system.

Filler Work Filler work is classified as orders that are single container patient orders placed in large totes. These large totes are dispensed, labeled and pharmacist verified in another part of the pharmacy, placed into a large tote and hand carried to each packing station. The large totes are manually distributed based on current station workloads.

These orders are processed in the same manner as totes and multi-puck orders in the pack stations. The large totes do not contain barcode or RFID identification on the tote and are not serialized or tracked within the POS.

Singles Puck Single Puck orders are dispensed and de-pucked into large totes. The vials are separated from the RFID puck and each vial is a single patient order.

Singles Totes (Super Totes) Singles Totes (aka Super Totes) are single container unit of use items dispensed into a single RFID tote. The totes are sent to labeling stations and then to pharmacist verification. After the pharmacist has verified each item (single patient order) the containers are removed from the RFID tote and placed into a larger tote.

Current Process Steps Current Tote Pack Process Below is 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. Wait for patient literature to complete printing

9. Scan patient literature 2X with barcode scanner

a. Literature scan triggers patient shipping label to print

10. Fold patient literature and place into polybag

11. Remove and Place shipping label on polybag

12. Place return label from original label into bag

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

14. Scan shipping label

15. Place polybag on belt conveyor

16. Place tote back on conveyor Current Multi-Puck Pack Process Below is 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

a. Label scan triggers patient literature to print

4. Verify correct item on order with monitor

5. Place vial into polybag

6. Place empty puck on takeaway conveyor

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

8. Wait for patient literature to complete printing

9. Scan patient literature 2X with barcode scanner

a. Literature scan triggers patient shipping label to print

10. Fold patient literature and place into polybag

11. Remove and Place shipping label on polybag

12. Place return label from original label into bag

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

14. Scan shipping label

15. Place polybag on belt conveyor Current Filler Work / Super Tote Pack Process Below is the current process steps for completing super tote orders at tote stations. Super totes can contain all single unit-of-use container orders or all single puck orders. Unit-of-use and pucks are NEVER mixed in super totes.

Current Single-Puck Pack Process (super tote pack at tote pack):

1. Select and open polybag

2. Grab one vial from off-line tote

3. Scan patient label on vial with barcode scanner

a. Label scan triggers patient literature to print

4. Verify correct item on order with monitor

5. Place vial into polybag

6. Wait for patient literature to complete printing

7. Scan patient literature 2X with barcode scanner

a. Literature scan triggers patient shipping label to print

8. Fold patient literature and place into polybag

9. Remove and Place shipping label on polybag

10. Place return label from original label into bag

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

12. Scan shipping label

13. Place polybag on belt conveyor 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 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 work station if an incorrect scan is made.

Table Top Bagging Machines The pack station should contain and automated tabletop 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

· 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 it’s 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

DATA ANALYSIS

Due to the limited scope and stand-alone nature planned for the system described in this RFP limited data is provided. It will be up to the Vendor to determine the quantity of automation required to successfully pack out the single orders described in this RFP. In no circumstance should less than two systems be proposed.

Orders to potentially be processed in the stand-alone semi-auto pack system include:

· Baker Singles: Orders coming from the Baker Cell TCA that are batched and manually transported to a manual packing station for packout.

· ADUs: Prefilled orders that are currently batched and manually transported to a manual packing station for packout

· CLS Bottles: Single manufacturers bottles that are labeled in the CLS are, then conveyed via tote to CLS packing. If the Vendor’s solution supports a range of bottle sizes, this volume would be shift to the new equipment for packout.

2020 Data Data from the period 10/19/2020-12/30/2020 is provided as the basis of design:

Volumetric Assumptions The following assumptions should be made to determine the level of automation requited at the GL-CMOP:

· A two shift (15 working hours) working day should be assumed with equal…