Dallas CMOP Auto Packer_SOW.docx

STATEMENT OF WORK

1. GLOSSARY OF TERMS;

VA – U.S. Department of Veterans Affairs CMOP – Consolidated Mail Outpatient Pharmacy – VA’s high-volume prescription filling unit.

VISTA/CERNER – VA’s central system for veteran’s EHR information storage & processing CDB (One CMOP) – Central Database hosting the patient orders at VA’s central location COR – Contracting Officer’s Representative APFS – Automated Prescription Fulfillment System AUOU – see UUA above Container – a logistical entity that contains tablet/capsule or a UoU retail pack dispensed on a Rx. Sometimes referred to as Item being dispensed D-CMOP – Dallas Consolidated Mail Outpatient Pharmacy Item – Drug or ancillary item. Sometimes interchangeably referred to as Container. See Container below.

NDC - National Drug Code, a unique 10-digit or 11-digit code and universal product identifier for human drugs dispensed in a pharmacy. NDCs defines a specific manufacture, drug, strength, dosage form, and packaging code/quantity.

NFPA – National Fire Protection Association Package – A collection of one or more patient orders in a shippable form (bag/box/cooler etc.)

Patient Order – Identifies a single order to a specific patient and all the associated RX prescriptions contained in that order. Patient orders are unique to a package and may contain multiple RX prescriptions and multiple containers. For the purposes of this request, it can be assumed that there will be ONLY ONE DELIVERY PACKAGE PER ORDER PIL – Patient Information Literature POS – Pharmacy Operating System PUCK – Plastic carrier that transports vials through the puck system. Each carrier is uniquely identified with a serial number and RFID tag that is read through the puck system.

Single Puck Order – Identifies a single order to a specific patient having a single RX prescription and a single container contained in that order. For the purposes of this request, it can be assumed that each patient finished package will contain one vial and one Patient Information Literature package.

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

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

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. These stations can also be used to pack single vial orders currently. Single vial orders in these stations are manually delivered as “filler work”.

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. For the purpose of this request new and refill RX will be handled the same.

REFILL RX – Refill of existing patient prescription. For the purpose of this request new and refill RX will be handled the same.

PV – Pharmacist Verification 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 (PUCK) – Orders that will reach their pack area in vials; this only includes orders with all RX(s) dispensed at counted tablets or pills that are not dispensed to individual order totes.

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. Comment by Zaritz, Larry M.: I'm not sure this is still applicable. Could remove and just state "commercial Off the Shelf Solution" Currently, the Dallas CMOP processes an average of 80,000 scripts per day. The Dallas facility has transitioned from a single shift to a two-shift operation. Through this transition to two shifts, the facility continues to adjust to the two-shift staffing plan. This is a single facility operation where all pharmacy dispensing operations and pharmacy warehousing are located in a single building. The current APFS in the facility consists of automated tablet dispensing, automated unit of use dispensing, manual dispensing, manual unit of use labeling and manual pharmacist verification. The current packing process is a manual pack process shipping in predominately poly bag mailers. The patient orders are processed, packed in poly bag mailers and consolidated at a 3rd party mailing consolidator located off site.

The Dallas CMOP is nearing completion of a new Tablet Capsule Automation (TCA) or Automated Tablet Dispense (ATD) addition with KNAPP that has altered the pharmacy production floor. This new equipment will increase the flow of single puck orders to the packaging area to be packed in poly bag mailers.

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

The intent is for the facility's single puck packing area to utilize fully automated printing and packing. Suppliers should propose a fully automated solution for packing of single (120 cc) vials.

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

The specific area to add automation are:

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. 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 automated pack stations to increase throughput and productivity of existing stations within a reduced pharmacy footprint.

VA CMOP is requesting a turn-key proposal for the addition of automated packaging machines to service the APFS specifically in Single Puck Order Pack. The scope of this is to determine the number fully automated puck pack stations and the interface to the existing APFS. The number of stations will be driven by the vendor specification rate to meet the design volume and the space available on the existing packing loop. The initial phase of this project will be the installation of one unit fed manually from the existing singles depucker. Subsequent phase(s) will be to add additional units to meet the demand at the design volume.

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.

POS interface is provided by QMSI/Knapp and PingWind manages the software and software upgrades. The specifics of the POS interface are outlined in subsequent sections.

The VA desires a “turn-key” solution for fully automated single puck pack. This includes design engineering, fabrication, factory testing, integration and installation, pneumatic drops from existing lines, power drops, equipment software, documentation, and training. The approved vendor should provide a fully integrated solution that is flexible and can be expanded in future phases.

Facility Location

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

Operation Hours The current pharmacy operating hours are between the hours of 6:00 am to 2:30 pm and 3:30 pm to 12:00 pm Monday thru Friday. Weekend overtime is worked on Saturday.

Confidentiality VA CMOP considers all equipment, systems, distribution processes, and documentation relating to such equipment, systems and processes to be confidential and proprietary information. The Supplier will not distribute, disclose, or disseminate, in any way, such information to anyone except its employees who are involved in this proposal response effort.

All information relating to this Project is considered business confidential information. This includes not only technical and requirements information but also non-technical information such as costs, prices, and sizes of equipment, quantities, material, etc. The Supplier agrees to keep such information in confidence. No information relative to the Project shall be released by the Supplier, either before or after completion of the project, for publication or advertising purposes without the prior written consent of the US Department of Veterans Affairs (VA).

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

The current state drawings are close estimates of current state conditions at Dallas. Suppliers will be afforded the opportunity to visit the Dallas facility in advance of the due date of this proposal.

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

Technical Submissions with the Proposal The Supplier should also recommend content and quantity of spare parts that should be maintained by the VA CMOP with prices and estimated delivery times. This information shall be submitted with the proposal.

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 being elicited in this requirement. Suppliers are advised to respond in as much technical detail as possible with the proposal.

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 VA CMOP’s facility.

The Supplier is to provide training for the VA CMOP 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 proposal. 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 proposal evaluation.

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

Proposal 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 proposal due date.

Prices, Risk of Loss, and Title All prices quoted shall be in US dollars utilized at the date of the proposal. The material shall remain with the Supplier and shall pass to the VA CMOP only upon Acceptance, which will start the warranty period.

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 Proposal.

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 VA CMOP with no impairment to the performance requirements set forth in the RFP. Such modifications shall be presented in the form of an addition, deletion, or substitution to the base bid described in the RFP. Layout and elevation drawings of alternatives or modifications will add clarification to such submittals.

Proposal Contents Suppliers are required to follow the prescribed format and supply all required information to be considered in the evaluation. Furthermore, all proposals must reflect the requirements identified in this request with no deviations. The proposal 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 proposal.

Attachment 3 - Subcontractors and Suppliers A list of all planned suppliers/subcontractors shall be attached to the Proposal Form. The list shall contain the names and addresses of tentative suppliers/subcontractors and identify major components or services that would be provided. The socio-economic status of any proposed subcontractor should be provided. Written confirmation from key subcontractors that they have agreed to be part of the supplier’s team should be provided. Prior to the award of any contract, the VA CMOP must approve the actual suppliers/subcontractors.

Attachment 4 - Supplier Offered Alternatives The base proposal is to be bid, 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 proposal. 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. 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 proposal reflecting total component quantities, required software, delivery weight, and expected number of truckloads to be shipped.

Oral Presentations In addition to the written response Suppliers may be invited to conduct oral presentations, such invitations will be at the discretion of the VA and will take place at the Dallas CMOP.

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 proposal, Suppliers are to provide a proposed schedule for the work. The VA CMOP envisions the schedule below. The Supplier shall perform the work in phases. With the proposal, 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.

PHASING Schedule (Reference Section 3.3):

PHASE I (Automated Packing Station One)

PHASE II (Automated Packing Stations Two & Three)

PHASE III (Conveyor Connection to Automated Packing Station and Package Take-Away Conveyor)

Project Schedule Submissions With the proposal, 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 VA CMOP. This milestone constitutes the approval of the equipment design for the physical layout and mechanical configuration. All design criteria listed in the RFP must be met. This approval does not relieve the equipment Supplier of the responsibility for the operational or structural integrity of the designs. Functional design review/approval meetings will be held at the Dallas CMOP in Lancaster, TX.

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 VA CMOP or VA CMOP’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 VA CMOP 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 VA CMOP 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 VA CMOP shall conduct acceptance testing as defined in this RFP. 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 for Single Vial Orders

The overall current operational flow of the Dallas CMOP is depicted below:

The operational flow begins with dispensing of tablets to vials. Empty vials are labeled and dropped into a puck with an RFID tag. The pucks are conveyed to automated or manual tablet dispensers and filled with the appropriate NDC and quantity. Once the dispense is complete, the puck is conveyed to a PV2 station where the dispense is verified by an RPh Pharmacist and validated. Once the PV2 process is complete, the vial is sent to an automated capper which caps and seals the vial. The vial is now ready for packaging.

Completed vials are separated by single vial orders and multi vial orders. Multi vial orders are sent to sort consolidation lanes where vials are accumulated by patient order. After all vials for a specific order have been accumulated in sequence they are released. Single vial orders bypass the accumulation and consolidation and head directly toward packing.

Multi vial orders are again accumulated for either tote marriage or packing. They are consolidated again with all vials for the order then either released to the manual/semi-automated packing area or they are sent to tote marriage where they are dropped into an order tote for additional UOU dispensing.

Single vial orders are sent to tote marriage to be dropped into an order tote for additional UOU dispensing or they are sent straight to packing. Vials sent to packaging are currently dropped into a bulk tote and the single vials are manually distributed to tote pack and multi-vial pack stations as “filler” work. Once the vial has been removed from the puck carrier the POS loses visibility to the vial location.

Current Pack Process Location Currently, there will be 14 semi-automated and 6 manual tote pack stations and 7 manual and 2 semi-automated puck pack stations in the packing area by the end of FY 2024. 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 pack area:

Current Pack Area

Single vial orders will be manually distributed to any pack station. The single vials are dumped into collapsable totes and manually carried to each station. They are placed in clear plastic bins at the end of the stations.

Single Puck Packing Overview and Current Single Puck Pack Process Single Puck Packing is spread across the available puck and tote pack stations. Single Pucks are automatically dumped into large totes at the end of the conveyor lines. There are 2 depuck stations for singles. The existing station is a robotic depuck station that drops vials into a bulk tote. The second station is a new station that drops vials into a bulk tote using gravity and a pinch belt conveyor that removes the vial from the puck and drops into a tote at the end of the line.

The large bulk totes are dated and stacked on carts. The carts are manually moved to both puck pack and tote pack stations and the totes are evenly distributed between the stations. The operators will pack the single pucks during periods of reduced workflow to create a steady stream of orders to pack.

The operators dump the singles totes into clear plastic bins at the end of the workstations. They pull orders from these bins throughout the day. When the clear plastic bin is empty the operator retrieves another singles tote and refills the clear plastic bin. This continues until all single pucks are packed or the end of the shift is reached.

Current Singles Puck Pack at Manual Station

Current Singles Puck Pack Process Below are the current process steps for completing the packaging of single puck only order:

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

1. Select and open polybag

2. Grab one vial from large tote

3. Scan patient label on vial with barcode scanner

4. Label scan triggers patient literature to print

5. Verify correct item on order with monitor

6. Place vial into polybag

7. Place refill information into bag

8. Wait for patient literature to complete printing

9. Scan patient literature 2X with barcode scanner

10. Fold patient literature and place into polybag

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

12. Retrieve shipping label from label printer

13. Place shipping label on polybag

14. Scan shipping label

15. Place polybag on belt conveyor Proposed Automated Singles Puck Pack Process Below are the proposed process steps for automated single puck only orders' packaging. It is proposed that new automated packing station designs should have the flexibility to be both manually fed with orders from a tote or automatically fed orders from a conveyor without change-over or reconfigurations.

Future Proposed Automated Single Pack Process:

1. If fed by conveyor, vials are removed from pucks prior to packing.

2. Vials enter pack station queue for puck pack from a feed conveyor or are manually placed in the queue from a tote.

3. Triggers patient literature to print ahead

4. Vials released to pack position and presented for pack

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

6. Station selects one vial for pack

7. Scan patient label on vial with fixed barcode scanner

8. Verify correct item on order with monitor

9. Place vial into polybag

10. System directs station to specific patient literature and refill information pre-printed

11. Pull literature packet (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 and place into polybag

14. Bagger automatically seals bag

15. Bagger automatically drops to conveyor with feed to overhead takeaway conveyor or into a bulk mail container.

16. If fed by conveyor, empty pucks automatically released on conveyor

The proposed automated singles 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. An alternative to automatic package takeaway would be to automatically drop packages into a bulk mail container The proposed layout has been developed to fit within the current manual puck pack area and should be considered the maximum footprint for new puck pack fully automation equipment.

Proposed Automated Singles Puck Phased Approach Phase I includes the installation of a single station that can be manually fed from tote at the depuck stations. The first automated single puck pack station will be fed manually and process single puck orders. After packing, the orders will be dumped directly into a bulk mail container on wheels for transport to the dock for shipping and consolidation.

Phase II will include additional automated single puck pack stations that will be connected to the existing conveyor, bypassing the depuck stations. The vials and pucks will be conveyed to the stations and the station must be able to depuck the vials, return the empty puck and pack the order. The subsequent stations will continue to dump completed orders directly into a bulk mail container.

Phase III will connect the first manually fed pack station and provide for an opportunity to dump completed orders onto an overhead takeaway conveyor to merge with the existing overhead package conveyor in the existing pack area.

The project phases are required to allow the VA opportunity to vacate the target space due to other critical operations in that area. Time will be required to reconfigure other areas of the pharmacy to relocate the existing workstations to allow for open space for Phases II and III.

Below is a breakout of Phases I through III:

· Phase I – One(1) AutoPacker Station

· Phase II – One(1) or more AutoPacker Station depending on Operational needs.

Below conceptual illustration of the space provided for Phases I & II:

PHASE II

PHASE I

Below is a concept of the space required for Phase I:

Sample Automated Single Puck Pack

Interface to POS The pharmacy operating interface with the new automated packaging stations should be included. 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 automated 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.

Data Analysis – ORDER profile and throughput Requirements The following section provides the data analysis and specific requirements for the Dallas CMOP facility automated single puck packing requirements.

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

Calculation Assumptions and Methodology

4.1.1 Data Scope:

The scope of this analysis is all order volume processed by the new ATD (Automated Tablet Dispensing) dispensers and the existing IPD (Individual Pill Dispensers) dispensers for the design year 2031.

· The orders for this project include only those orders that contain a single vial prescription order that will be packed out in a single polybag container.

· Does not include vials married to other UOU dispenses.

· Does not include single prescription orders with multiple vials.

· This RFP is only for Phase One, single automated packaging station, due to limited space availability. The data is provided for a holistic view of the workload projections.

4.1.2 Hours of Operation:

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

Note that there are two staggered shifts in the pharmacy, beginning at 6 am/7 am and at 2:30 pm/3:30 pm. Each shift is 8.5 hours from start to finish and includes a 30-minute lunch and two 15-minute breaks. Data assumes 14 total effective hours per day, 7 hours per shift. The following data has been grown to expected levels for 2031 (5% growth, year over year).

4.2 Throughput

Overall Throughput Summary at Design Year 2031

4.3 Projected Growth

The design window is from 2024 to 2031 and has a growth rate of 5% per year. The table below summarizes the projected total throughput on an hourly, shift, and daily basis. Please note that 2024 is considered year 0. Suppliers should assume the order profile remains constant in the forecast shown below. Suppliers should base their proposal on the provided equipment counts but should provide % of orders that can be processed on 2031 volumes with their proposed equipment.

System Requirements General System Requirements Table 1 provides a list of requirements for the Automated Single Puck Packing System Automation Controller.

1.0 Bar Code

2.0 Interface

3.0 Manufacturer Support

4.0 Reports

5.0 Specification

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

Automation Controller Interface to POS All necessary order or work information will be sent from POS to the automation. It is the responsibility of the automation to capture and decode the file from POS prior to giving an acknowledgment (ACK) back to POS of completed, bagged, and labeled orders with applicable Patient Information Literature (PIL).

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

Operate When Interface to Host is Down Loss of the interface with host system should not impede the system from continuing to work until all work that has been received from host system is completed. Once the connection is re-established, new data will be received, and current work status will be uploaded to host system.

Automatically Recover from Downed Interface The automation software should be capable of automatically recovering from a downed interface without requiring manual intervention. A log of the time the interface is re-established should be maintained to help enable pharmacy personnel to investigate/recover any orders that may not have been received.

As part of the automatic recovery, the automation shall be capable of recognizing and consolidating any “duplicate” work. The work in the automation shall be updated to contain the most complete and recent record.

Order Tracking The automation shall be capable of tracking and displaying the status of all work in process. Scanning any item will bring up the status screen showing the current state of all work in process. For automated packaging controllers, the status screen will display all items in the order and the status of each.

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

Support Limiting Functionality Based on “Log-in” The automation controller shall have the capability to limit tasks that can be performed by an individual based on the individual’s log-in and their “rights” (role-based security). The local system administrator will be capable of changing an individual’s rights. At least three different levels (e.g., operator, supervisor, super-user) of rights may be required. Logging-in shall be performed via VA’s single-sign on authentication.

Reporting A suite of reports is to be developed that will support managing the pharmacy. Specific requirements and formats are to be developed during the course of the first installation and approved by the Project Manager or their representatives.

Specific areas that are anticipated to require reports involve:

1. Quality – This report should provide data on the number of wrong scans, by station or function, that have occurred during a configurable period.

2. Productivity - A series of reports should focus on productivity parameters. These include tasks performed by the station and include idle, average, mean, standard deviation, and peak process times. Another report should provide statistical information about the work performed by the station during a configurable period.

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

System Servers It is anticipated that the automated packing system will be supported through existing VA database servers to the maximum extent possible.

LITERATURE Pack Printing Requirements The automated bagging controller is required to print the literature packet required for the patient order. A print packet file (all required drug information sheets required for an order) will be sent to the printer from the POS. First and last sheets in the literature packet are to be scanned to verify packet print and completeness of packet.

Printer Requirements A black and white laser printer is required for each automated pack station. The printer must be capable of a minimum of 600 dpi. The pages to be printed will utilize “normal,” 20-pound, 8-1/2 by 11” paper. The paper cassette should hold a minimum amount of paper to support full operations for four hours. The printer should have multiple paper cassettes with the capability to operate on one of the cassettes while the other is replenished. Printers shall be capable of one or two side printing.

All printers shall be capable of printing 2-dimensional bar codes.

In order to increase the throughput of the printing operation, PILs should be fully printed immediately upon an RFID read of the order tote(s) or puck or the first scan of a label on the veteran’s order.

Backup Printer Should a printer fail, pharmacy personnel shall be capable of changing the failed PIL printer for a backup printer within five minutes. The automation controller should recognize a printer failure and be capable of continuing to operate if the automation has more than one printer, although at a reduced throughput.

BAGGING Requirements Bagging Material Bagging material will be 2.5 mil. The system should be capable of set up for multiple sizes of shipping bags. For instance, some stations may be set up at the beginning of a shift for small single Rx orders, while others could be dictated to orders requiring larger bags for larger Rx orders.

Maximum bag size: 10” wide by 13” high.

Minimum bag size: 8” wide by 10” high Opening of Bags The system will automatically open bags, allowing the station to quickly fill the bag with labeled vial and PILs.

Literature Pack Handling Literature Overview Literature packs are printed for each customer order. The literature packs include general patient and NDC information.

Approximately 30% of prescriptions also require FDA Medication Guides, which are three to four pages each.

Estimate between 4 and 8 pages for each patient literature pack. PILs are standard 11” x 8.5”.

Bagger When all items scheduled for the bag have been verified and placed into the bag, the bagger will seal the bag. The bag will be placed onto the proper takeaway conveyor or into a take away bin by the operator.

Bag Labeler The bag labeler will print either a shipping label and automatically apply the label to the bag or automatically print the label directly to the bag. Bag label printer should support:

Minimum of 300 dpi by 300 dpi resolution Label Size: 3.375” by 2.25” Bar code symbol format: Code 128, up to 50 digit numeric. Carrier specific bar code labels.

A sample label is provided in Figure 2:

Figure 2 Sample Bag Label Shipping labels will be placed onto bags containing complete orders. The bag labeler will have a barcode scanner to confirm that the correct label has been printed and that the label is readable. This concludes the operation and completion of the order should be reported back to the POS.

The Vendor shall provide printing material that ensures that all printing is smudge free for the VA’s current 10” X 13” bag inventory. Bags can be provided upon request for testing. Should the vendor require different bag material and/or bag suppliers to prevent bag printing smudges, any additional logistics costs of such bag stock will be evaluated by the VA as part of the best value determination.

Bagger Vendors should provide a means that allows the VA CMOP to efficiently and safely exchange both bags (in a roll or box) and PIL paper stock. This could include hardware (e.g. additional bag spools), software (e.g. advance notification to operators that supply is running low) or processes (simple layout modifications that allow for rapid change out of stock). Vendors should address how they can facilitate paper and bag stock in their proposals to the Government.

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

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

Safety Standards and Codes All equipment shall conform to appropriate safety requirements. Equipment shall be designed in conformance with the current version of the following standards:

· Occupational Safety and Health Act Regulations (OSHA)

· American National Standards Association (ANSI)

· American Society of Mechanical Engineers (ASME)

· NFPA 79: Electrical Standard for Industrial Machinery

· National Electrical Code (NEC) 2017 or later

· ISO 13849

· UL 508A

· National Electrical Manufacturers Association (NEMA) or equivalent

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

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

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

· The Supplier shall provide proof of calibration status.

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

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

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

1. All materials shall be non-toxic.

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

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

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

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

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

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

8. If applicable, all sprockets shall be keyed.

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

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

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

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

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

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

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

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

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

18. Aluminum machine parts must be clear anodized.

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

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

21. All bearings shall be sealed and preferably lubricated for life. However, if greasing is necessary, the grease fittings shall be clustered and conveniently located on the outside of the machine for easy access. All lubricants used in areas with potential product or component contact must be food grade lithium-based lubricants and should be totally enclosed.

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

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

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

25. All…