STATEMENT OF NEED 02.docx

STATEMENT OF NEED

PHARMACY AUTOMATED PRESCRIPTION FULFILLMENT SYSTEM (APFS)

PART I: BACKGROUND

A. INTRODUCTION

The Department of Veteran Affairs, Consolidated Mail Outpatient Pharmacy(CMOP) National Office currently oversees seven CMOP facilities located across the United States at the following locations:

3209 Elam Farms Parkway, Murfreesboro, TN 37127-8830

The Department of Veteran Affairs Medical Centers(VAMC), Community Based Outpatient Clinics(CBOCs) and Indian Health Service Pharmacies(IHS), sends pharmaceutical prescription orders to be filled and mailed out to Veteran patients, to the CMOPs. Combined the seven CMOPs mail out, on average 530,000 prescriptions daily through the combined use of advanced automation equipment set up into various subsystems that communicate to form the APFS at each of the CMOPs. Based upon agreements with other Federal agencies, there’s a potential for future production growth.

B. BASELINE

The CMOP vision is to have a contractor whom could serve as a systems integrator who would design a working APFS, procure all subsystems, and configure the APFS to successfully integrate with the current VA CMOP National data infrastructure. Any system, subsystem, or component would need to be fully functional and fully integrated with the CMOP electronic data structure. The APFS includes the dispensing of individual solid dosage forms as well as unit of use products. Ancillary support systems, a robust Warehouse Management System (WMS), and a comprehensive data logging, collection and reporting system. Responses should clearly demonstrate an understanding of automation systems that could be used within a CMOP environment to fulfill prescriptions for Veteran patients.

C. Conceptual Guidelines

a. 45,000 sq ft of production space

b. 20,000 sq ft of warehouse space

c. Formulary, Attachment

d. Baseline Requirements

D. CURRENT CMOP DEFINITIONS

APFS – Automated Prescription Fulfillment System. Acronym used to describe all hardware, software, and integrated components and logic for the entire system.

API - Application Programming Interfaces.

Automated Production System Database Structure – Database tables and electronic data format in a Microsoft SQL Server database structure that provides for two-way data exchange between VA patient orders, the APFS, and the Central Database (CDB).

AVS – Auto Verify Sig

Backordered Prescription – A prescription for an out-of-stock item that is unavailable for fulfillment through the APFS.

Bottle – Refers to the physical container into which solid dosage forms are dispensed.

Bulk location – area in which all items that are contained on pallets will be stored. This will be 15 – 20 days of inventory.

Canister – A sealable container for tablet or capsule storage and delivery of product to a dispenser, conforming to USP-NF 621 standards for storage of pharmaceuticals, and protected with a fail-safe and tamper evident interlock system

Central Database (CDB) – A MSSQL database consisting of all VA CMOP prescription data details required for prescription fulfillment. The CDB resides in Tucson, AZ.

Controlled Substance – A drug or chemical whose manufacture, possession, and use are regulated by the Drug Enforcement Agency (DEA) and Food and Drug Administration (FDA).

COR – Contracting Officer Representative

Drug Enforcement Agency (DEA) – The federal law enforcement agency under the United States Department of Justice tasked with enforcing controlled substance regulations and laws.

De-pucker – An automated process used to remove a vial from a transport puck when the system uses a puck-based transport.

Dispense - An automated process designed to accurately deliver the product. For the TCA, the dispenser will accurately count tablets or capsules prior to dispensing. For the UUA it will dispense pre-packaged unit-of-issue product.

Document Set – Patient specific printed documents that may, but not necessarily, consist of a refill request form, address correction form, and medication instructions and information.

Ergonomic Design – Consideration of the interactions between humans and the APFS that are designed to maximize user interaction with assigned task and system performance while minimizing potential of repetitive strain injuries and inefficient motion.

FIFO – (First in, first out) An acronym used to describe a method of organizing and manipulating data involving patient orders relative to time and prioritization, i.e., what comes in first is handled first, what comes in next waits until the first is finished, etc.

Food and Drug Administration (FDA) – The federal agency under the Department of Health and Human Services, responsible for protecting and promoting public health.

Fulfillment – The complete process from receipt of patient prescription order through processing and packaging.

Item – A Legend or Non-Legend drug or other product for fulfillment. Also a term used within the UUA order management software that refers to a discrete item of throughput. Individual prescriptions may be of a quantity that requires multiple item counts. A UUA prescription may consist of one to many boxes or containers (pieces)

Medication Guides – printed information that may be associated with a specific product or drug class and required to accompany all patient prescriptions for that product.

National Institute for Occupational Safety and Health (NIOSH) – US Department of Health and Human Services non-regulatory agency, part of the Centers for Disease Control and Prevention, whose mission is to develop new knowledge in the field of occupational safety and health and to transfer that knowledge into practice.

National Fire Protection Association (NFPA) - a nonprofit organization devoted to eliminating death, injury, property and economic loss due to fire, electrical and related hazards by developing and publishing Codes and Standards designed to minimize the risk and effects of fire by establishing criteria for building, processing, design, service, and installation.

Non-Legend– A term used to describe a drug or other product that does not require the express written prescription of a health care provider.

Order- See patient order

Order Profile - See patient order

Occupational Safety and Health Administration (OSHA) – A federal agency charged with the enforcement of safety and health legislation.

Operational Costs – The combined expense of personnel and consumable supplies required to achieve APFS throughput at the specified rate. These are typically reported as separate entries. When personnel costs are needed, VA will apply actual labor rates to the recommended staffing profile to establish cost estimates.

Parcel – A completed patient order containing all prescriptions and documentation sealed in an appropriately sized mylar bag or box that is ready for shipment.

Patient Order - A combination of prescriptions, prescribed by a healthcare provider, from a remote site, batched together and electronically transmitted for CMOP fulfillment.

Pharmaceutical Prime Vendor (PPV) – the pharmaceutical drug distribution contractor used by VA.

Pharmacist Verification (PV) – A quality control process where prescriptions are presented to a licensed pharmacist for inspection and approval prior to forwarding for packaging and shipment.

Picker Assembly – A device used in unit-of-use dispensing technology to deliver individual products during the fulfillment process.

Piece – See Item.

Prescription – A unique drug product or supply item ordered by a health care provider for a specific patient.

Primary Location – will house stock that is being dispensed. Area will be able to house a one week supply of all products assigned to that area.

Puck – A weighted and sturdy device, made of plastic or similar material, used to transport upright vials on a conveyor to TCA dispensing units and other applicable routing locations.

Random Inventory Storage – Storage of product (that fits) in any empty storage location that maximizes the use of empty locations and results in higher space utilization and improved labor productivity during stock put-away.

Replenishment – The process of refilling TCA canisters or UUA chutes with product.

Secondary Location – will house stock that will be used to replenish Primary Location. Area will house up to 10 – 12 days of inventory.

Secure Client Software – Software that provides a wireless security solution that meets VA Office of Information & Technology requirements, such as Air Fortress, that covers a broad range of devices.

Split Orders – A term used to describe breaking a single patient order for multiple items into smaller divisions for processing in different production areas.

Stock Keeping-Units (SKU) – A unique item that is associated with a single bar code for identification.

Supertote – A term used to describe a many-to-one relationship of single items for multiple patients dispensed into a single transport container (tote).

Tablet and Capsule Automation (TCA) – Automated dispensing system that directs the filling of prescription orders from induction through sortation and handoff to other automated systems, i.e., controls the vials receiving the dispensed product, applies patient labels, accurately counts product during dispensing, captures and records vial weight, allows pharmacist verification, applies, seals and secures caps on the vials, and sorts patient specific prescriptions utilizing bulk tablet and capsule stock of various sizes, weights, textures, and shapes.

Tote – A container tied to a patient order used to transport one-to-many products on conveyors through the APFS.

UPS – Un-interrupted Power Supply

United States Pharmacopeia and The National Formulary (USP-NF) - a book of public pharmacopeia standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements.

U.S. Pharmacopeial Convention (USP) - a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration

Unit-of-Use Automation (UUA) – A mechanical device that stores and dispenses unit-of-issue medications and supplies in containers of various sizes and shapes.

VA CMOP Production Software– Integrated applications utilizing a Microsoft SQL Server database and associated applications that provide for two-way data exchange between VA patient orders and the APFS.

Vial – A term used within the order management software that refers to a discrete item of throughput. An individual prescription may require multiple items of throughput to contain the required quantity. Each of those items of throughput is tracked separately.

Warehouse Management System (WMS) – An integrated software system that controls the movement and storage of materials within the warehouse and processes the associated transactions, including shipping, receiving, put-away and picking. The system also directs and optimizes stock put-away based on real-time information about the status of product utilization.

E. CURRENT SYSTEM RELATIONSHIPS

1. Patient Order Relationships - A one-to-one or one-to-many relationship exists between a patient order and the final bottle-unit or dispense-unit processed by an APFS. These terms are often used interchangeably, but, depending on the context of use, they may represent significantly different concepts. The following chart demonstrates and defines terms and relationships:

The current average Patient Order for CMOP contains 1.72 prescriptions

Dispense Unit (Vial or piece)

If Drug B is filled from UUA and the prescription order calls for five boxes to complete the requested item count, then this single prescription requires five items to be processed by UUA and tracked through the system..

The current average CMOP TCA prescription consists of 1.060 vials for processing.

The current average CMOP UUA prescription consists of 1.5 items to be counted through UUA system.

2. Product Code – National Drug Code (NDC) Number - Stock Keeping Unit (SKU) Relationship - A one-to-many relationship exists between a product code and a unique SKU in the APFS. The following chart demonstrates and defines terms and relationships:

Drug A from manufacturer Y by be assigned the NDC number 98765-1234-01

A Product Code potentially may have multiple NDC numbers associated with it

Drug A from manufacturer Y may be repackaged and dispensed in pack sizes of 30 count, 60 count, 90 count, etc., for as many pack sizes as may be required for fulfillment of Drug A There may be hundreds of pack sizes or SKU associated with each 9 digit NDC number

PART II: SYSTEM

1) SYSTEM PERFORMANCE AND DESIGN

a) Data Transfer and Acceptance

(a) The APFS shall integrate with the current VA CMOP National data infrastructure which currently operates in an MSSQL environment in a format and structure specified by the CMOP. Any product, subsystem, or system shall be fully functional in this environment.

(b) The APFS shall be capable of 24 hour operational transmitting and receiving of data, to include, but not limited to, accepting electronic patient order information from the National CMOP system database, acknowledging receipt of orders, accurately processing orders in all aspects of automated and manual dispensing, and returning the appropriate data to transmitting site, local database, and CDB without disruption of operations. The APFS shall accept and return patient order data consistent with the electronic data structure.

(c) Electronic transmissions are batched and transmitted periodically throughout the day and consist of orders for multiple patients. Patient orders may consist of single or multiple prescriptions. A prescription may consist of a prescribed quantity of tablets or capsules, unit-of-issue items contained in boxes or bottles, or bulk items that may be boxed. A single prescription may require more than one dispensing unit (vial or piece).

(d)

2. Software Development and Source Code

The system shall be developed as a distributed architecture. Systems shall be standardized to a Microsoft platform using the latest MS Windows (or newer VA approved version) and the latest VA approved version of Microsoft SQL Server.

(1) Software development shall be web enabled/based software produced using the current VA approved Microsoft.Net technology at the time of system go-live. Other software development shall use the current VA approved Microsoft Visual Studio Suite at the time of system go-live.

(2) All workstations shall conform to VA secured standard desktop environment, which is a Microsoft Windows VA approved system.

(a) Audit Trails:

(1) The system shall be able to create, maintain, and protect from modification or unauthorized access or destruction of an audit trail of accesses to the objects it protects. The audit data shall be protected so that read access to it is limited to those who are authorized. Audit logs containing prescription specific data will be available for the life of the prescription fill plus 30 days. A system for archiving the audit logs will be included and shall allow for storing the logs on a removable storage medium.

(2) The system shall be able to record the following types of events with the ability to immediately access the recorded data with real time and archived reports:

· File changes, journal entries, exceptions, validation changes, error reports

· Identify access via the remote diagnostic capabilities

· Identify use of debugging tools, which may modify date, the operating system and application programs

· Identify all commands to enable or disable logging activities

· Identify all detected attempts of unauthorized access including user identification code and invalid password with date, time and location

· Identify all modifications to security settings and parameters

· Identify all changes to access authorities including creating, disabling and deleting user identification codes

· Identify all areas accessed via a communication link

· Identify all users who have signed on the system with date, time and system name or mode of sign on (port, terminal, dial-up or LAN)

· Identify users signed off of system with date, time, and system name of sign off

· Identify all users who have a selected function

· Identify all activity for a given user

(3) For each recorded event, the audit record shall be able to identify the date and time of the event, user, type of event, and success or failure of the event. For identification and authentication events, the origin of request (e.g. terminal id, port, etc.) shall be included in the audit record. For events that introduce an object into the user’s address space and for object deletion events, the audit record shall include the name of the object and the object’s label. The system administrator shall be able to selectively audit the actions of any one or more users based on individual identity and/or object label. The audit system shall raise alarms whenever a threshold is reached with respect to an auditing system resource (disk space in audit log volume) or when auditing has been turned off (either inadvertently or deliberately). It shall also support alarm features, which provide immediate notification of predefined events, including events recorded on the audit log.

3. System Throughput Requirements

(a) Conceptual Guidelines

a. 45,000 sq ft of production space

b. 20,000 sq ft of warehouse space

c. Baseline Requirements

(b) Based on the Conceptual Guidelines, the vendor shall determine the minimum number of prescriptions during each 7.5 hours of operation within an 8.5-hour work shift. Complete is defined as the prescription is filled, verified, packaged, and ready for induction to the delivery stream.

(b) The APFS shall accommodate any system stoppages or other interruptions without requiring any extended cycle-down or cycle-up time (time required to go between system-idle and system-full operation) within a total work shift of 8.5 hours. Extended is defined as more than 60 seconds. Each sub-system shall be capable of independent operation with no single point of failure. The APFS shall provide UPS capacity throughout the system. Replenishment at any point in the APFS shall not degrade system performance.

(c) The APFS shall be designed to ensure throughput is not impacted by rework. Reject rates shall not exceed 0.05% on any subsystem.

(d) Rejects are system generated dead end events that result in restart of a prescription, process, or package and generates wasted product or supplies.

a. Rejects in this sense includes:

i. Vial, label, product waste

ii. RTS that cannot be reused through an automated process

iii. Product/supplies damaged by automation

iv. Spills in conveyance

b. Does not include:

i. Self-correcting operational failures that do not generate waste or restart

ii. Routing recirculation and/or repacks

iii. Operator induced error or failure

iv. Failures related to inventory errors, shortages, or Rx cancellations

4. Footprint for Automation / Workflow Design

(a) The APFS with integrated storage locations for pharmaceutical stock and consumable supplies shall fit within the identified facility space as determined on the preliminary/conceptual drawing.

(b) The Government provided preliminary/conceptual drawing of the available space for the APFS. The Government requires a logical and efficient workflow that begins in receiving and terminates at shipping.

(c) The APFS shall be compliant with National Fire Protection Association (NFPA) codes and all local, state, and federal building codes relevant to the building’s location.

(d) The contractor shall design the APFS with appropriate engineering principles that consider product storage, ergonomic requirements, housekeeping and maintenance access needs and other operational requirements which promote an effective and efficient workflow.

(e) APFS Operation and Staffing Plan shall include, at a minimum:

(1) Anticipated staffing for APFS operation at full capacity, as well as the number and mix of pharmacists, pharmacy technicians, shipper/packers, and any other personnel or disciplines recommended by the contractor for each production and support area.

5. Concept

(a) Responses should contain sufficient detail to demonstrate understanding and capability. The contractor shall provide a concept and provide a presentation that details the automation layout and demonstrates, through a detailed simulation or mathematical process model, the rationale for their concept. This should include workload distribution through all sub-systems.

B. TECHNICAL QUALITY

1. Patient Safety

(b) The APFS design shall fully utilize available technology and accepted standards of practice to ensure all products are accurately filled, labeled, sorted, and packaged for the correct patient and that the product dispensed is without defect, extraneous debris, or other contamination. The APFS shall accept and accurately process 100 percent of all data communicated to it and product selection accuracy shall be 100 percent. Process exceptions that impact patient safety shall cause system rejections with status displays and alerts, and occur in real time as defined. System rejections shall be rerouted for automated correction or routed to Quality Assurance as determined by the Government.

(c) APFS devices designed for holding or storing oral solid pharmaceuticals shall meet or exceed the USP-NF 621 standards for protection from environmental and light induced product degradation.

(d) All APFS dispensing devices shall electronically log all replenishment activities by utilizing a bar code scanner, RFID, or some other reliable electronic means to verify that the correct product is loaded into the proper replenishment device or dispensing location. When an incorrect product is selected for a replenishment action, the system shall alert the operator in real-time and prevent the APFS system from accepting the incorrect replenishment action.

(e) The APFS design shall not permit cross-contamination of product during the filling process. Under no circumstances shall canisters and counting devices for oral solid dosage forms utilize common chutes or funnel devices where particulate or solid matter from one product could be mixed with another product. In addition, under no circumstances shall an open bottle pass under other than the designated output location for the item being dispensed into the bottle. All dispensing devices for solid oral dosage forms shall provide spill-free dispensing of product into the bottle, and ensure positive dispenser/vial contact during dispensing and bump free conveyance of the filled bottle.

(f) The APFS shall eliminate any source of “out of sequence” processing and incorporate safeguards to prevent or detect and reject mismatched bottles and pucks or other transport devices.

(g) All APFS functions that require an operator to handle, manipulate, or otherwise interact with a product shall provide a mechanism that forces correct product selection, labeling, sorting, or other action to prevent or detect and reject incorrect product handling. Such systems shall be electronically driven or shall utilize such technology that ensures all user interactions are tracked and improper user interactions are stopped and logged.

(h) All APFS filled product shall require pharmacist verification, or a certified technological equivalent that is an accepted standard of practice and approved for VA use. For oral solid dosage forms where a bottle is filled within the APFS, an as-dispensed image shall be captured immediately following counting and the bottle shall be capped to include placement of an inner tamper-evident seal as soon as practical post imaging. The bottle and image shall be presented to the pharmacist for comparison to a government supplied reference image. The tamper-evident seal shall be secured post verification to remain in place if the cap is removed from the bottle.

(i) The APFS shall prohibit the packing of prescriptions to the wrong patient.

b) System Accuracy

(a) Product selection accuracy for all systems and sub-systems of the APFS shall be 100 percent with immediate detection and rejection of system failures.

(b) The APFS shall have safeguards in place to prevent or detect any deviation of fill quantity and achieve count accuracy approaching 99.9997 percent on first count with 100 percent detection of miscounts on all automated systems and sub-systems. The TCA shall offer a user adjustable, product specific parameter that will allow the system to accept over count.

(c) Broken oral solid pharmaceuticals in the TCA shall be recognized as damaged and not considered as part of the total fill count.

(d) The APFS shall integrate queue balancing logic to maintain system balance, maximize throughput and prevent any one subsystem from being over or under-utilized, but also permit user defined override capabilities. The APFS shall allow the user to manually reallocate drug orders between subsystems.

c) Ergonomic Design

(a) The APFS shall incorporate ergonomic design in workflow and system operation to minimize the need for physical manipulation of product, operator movement or lifting of transfer devices, and minimize the number of required computer keystrokes or scanner reads for all operator initiated actions.

(b) Task stations shall be of an ergonomic design suitable for the functions of the area. Task stations shall include task lighting and consumable supply storage. Counter top height and placement of computer screens or interface devices shall be fully user adjustable to maximize proper ergonomic placement for each individual operator. Task station design shall minimize the need for operator movement by minimizing reaching, stretching, stooping, twisting, or lifting. Ergonomic interventions and respite devices (for example, foot rests, leaning bars, and ergonomic mats) or ergonomic seating shall be incorporated into the design and function of the area and provided by the contractor.

d) Status Displays and Alerts

(a) Each APFS subsystem shall provide system status alerts, including need for replenishment of consumable supplies, malfunctions, and other system indicators as defined throughout this document that require alerts. Visible warning lights, sufficiently elevated for unimpeded observation, and audible alarms, located in the functional areas, shall be provided by the contractor. The government shall be able to define and select the appropriate type(s) of alert(s) for specific subsystems.

e) Operator Safety

(a) The APFS shall comply with all appropriate OSHA Safety and Health Standards in 29 CFR 1910. Engineering and operational controls shall be incorporated into APFS design to minimize the need for operators to wear personal protective equipment (PPE).

(b) The APFS shall minimize the generation of particulate matter and utilize a system that protects operators from exposure to particulate matter generated by the handling or the processing of oral solid pharmaceuticals by automation.

(c) All items for consideration shall conform to current regulations, codes and standards, to include but not limited to, OSHA, USP, NIOSH, local/state and federal codes, National Fire Protection Association codes, Underwriters Laboratories (UL) 544 and 1950, Medical Device Amendments of 1976, and Safe Medical Device Amendments of 1998.

f) Interchangeability

(a) Although CMOP frequently has mandatory sources for consumables, the APFS system shall be designed to accommodate variation in manufacture and design. CMOP currently uses 120cc and 250cc amber bottles for TCA dispensing. The TCA system shall also allow users to further define other bottle sizes to be incorporated into the TCA. There shall be a single, standard cap size. Capping function shall accommodate, CRC (Child Resistant Caps), non-CRC and convertible caps. TCA and other system tolerances shall be adjustable or designed such that variances in consumables can be easily accommodated, with minimal operator system adjustments and readily available components required. The Government will provide no more than five (5) samples each of the 120cc and 250cc bottles and corresponding caps, upon request..

C. SUBSYSTEM REQUIREMENTS

1. Patient Specific Printed Documents

(a) The APFS shall provide a patient specific document set for insertion into completed parcels prior to shipment to the patient. At a minimum, a document set consists of a refill request form, address correction form, and medication instructions for each item contained in the parcel. A complete document set shall be provided with each parcel. Sample documents will be available upon request.

(b) The contractor shall interface the APFS with the automated production system database structure such that document sets, to include medication guides, when applicable, are printed according to specifications.

(c) Each parcel specific document set shall contain machine readable, order specific identification to ensure that printed materials are correctly married with the correct contents and shipping label for each unique patient order. The APFS shall ensure with 100 percent accuracy that all required documents are printed and packed with the patient specific order with immediate detection and rejection of system failures, such that incorrect or incomplete paperwork cannot be placed into a parcel.

2. Conveyance Systems

(a) Operators shall be alerted to and protected from any hazard points in the conveyance system, through the use of signage, guards, shrouds, or other protective methods including emergency stops and application of positive engineering controls in accordance with OSHA regulations.

(b) All APFS systems and sub-systems shall be designed to minimize noise. Areas in which staff are permanently station and actively involved in order processing shall include mechanisms to further reduce or mitigate noise generation. APFS equipment shall not exceed the OSHA Action Level for an 8-hour time-weighted average (TWA) or transient maximum spike limits for noise levels requiring hearing protection.

(c) The APFS shall utilize a conveyance system to automatically route carrier devices to the proper processing location(s). The conveyance system shall monitor all automation queues and ensure that adequate transport devices are present in each queue to maintain system throughput and balance workflow. Carrier devices shall jam or require stacking in any one production area. Diverts or traffic control mechanisms on the conveyors shall be electronic where practical. Upon request, contractor shall be able to provide cost analysis or rationale where electronic diverts are not used.

(d) The APFS shall provide a complete system of emergency process stops which will disengage and halt the production system or subsystem, as appropriate. The emergency process stops shall be immediately identifiable to the specific area or subsystem where the process was terminated. This system shall be on the production side of the Uninterrupted Power Supply (UPS).

(e) The conveyance system shall collect and record a completed parcel weight and associate it with the parcel identification number. This weight shall be determined in-line as the last step in the fulfillment process before being tendered for shipment. The data file that contains each parcel weight shall be available for download and comparison to corresponding data from shipping consolidator data. The scale sensitivity shall be accurate to +/- 0.5g with an adjustable tolerance to identify any missing or extra items or wrong product in the parcel.

3. Tablet and Capsule Automation (TCA)

(a) The TCA shall label, accurately fill, photograph contents, cap, capture weight, verify, and seal bottle-units at a rate sufficient to meet throughput performance requirements.

(b) The delivered and installed TCA shall consist of distinct dispensing locations for by-unit dispensing of the majority of commercially available oral solid pharmaceuticals. The contractor shall calculate the required number of TCA dispensing devices to meet the required workload throughput with ten (10) percent additional throughput capacity. The additional capacity shall not be used by the contractor to meet TCA and APFS throughput requirements.

(c) The TCA automation shall be designed to identify and utilize the most cost effective configuration of dispensing devices required to deliver the required APFS throughput. Because of the dynamic nature of product mix, contractor shall provide validation and reassessment prior to go-live and a mechanism for CMOP to conduct future reassessment and local adjustment.

(d) Dispensing devices for high throughput products shall hold sufficient product to ensure maximum efficiency and required throughput. Replenishment canisters or other supplemental storage devices for high throughput products used to replenish the dispensing devices shall be of sufficient size to maximize efficiency of the replenishment process. Both the dispensing devices and replenishment canisters shall be constructed of material compliant with FDA light-resistance standards.

(e) For products with lower physical volume or throughput requirements, smaller dispensers and replenishment canisters are permissible. The fulfillment technology for these dispensers and canisters shall fully integrate into the overall TCA application, provide for in-line labeling, and deliver for verification and capping of bottles in the same manner as high volume TCA dispensed items.

(f) The TCA shall select the correct pharmaceutical product, including the correct bottle size by volume, accurately count the pharmaceutical product and, if the count is incorrect, the system will provide an automated method to detect, correct, and electronically capture the error and correction. The TCA shall provide a mechanism to allow the system operator to set acceptable over count parameters. All undercounted items shall be re-circulated for count correction, and over counted items exceeding the parameter shall be routed to a system control operator for adjustment and investigation.

(g) TCA dispensers shall be easy to calibrate on location by operators and designed for on-site maintenance. Ergonomic transport devices shall be utilized to assist personnel handling of dispensers.

(h) The TCA shall ensure that the patient specific label, as designed by CMOP, is applied, in the position and alignment specified, to each bottle. A cross check system shall ensure marriage of labeled bottle to transport device. The bottle handling system shall provide a means to ensure correct bottle orientation and reject incorrectly oriented bottles for reuse. The system shall provide a means to identify and reject bottles with missing labels and immediately alert the operator for investigation and correction. For bottles with incorrectly oriented labels, reject the bottles and provide an operator alert for multiple, sequential rejects.

(i) The system shall provide a mechanism to validate bottle/transport device combination throughout the filling process. Any detection of mismatch shall prevent product dispense and the bottle/transport device combination shall be routed to QA for investigation and correction.

(j) The TCA system shall ensure spill-free dispense and prevent the potential for cross-contamination of pharmaceutical products or product dust.

(k) The TCA shall include a dust control system to minimize personnel exposure to the lowest achievable level, interference with count accuracy and dispenser operation, and meet or exceed regulatory requirements.

(l) The TCA system shall capture an as-dispensed image prior to common conveyance that is displayed with a reference image at verification. As-dispensed images shall be retained and accessible.

(m) Cap shall be applied as closely to the image point as possible to avoid spillage and cross contamination.

(n) The TCA shall accommodate various tamper evident cap designs, and offer the capability to use child-resistant caps, convertible caps, and non-child-resistant caps. The TCA shall provide a mechanism to identify items where non-child-resistant caps are required.

(o) The capping system utilized by the TCA shall include a mechanism that verifies correct cap placement, rejects those bottles where the cap is absent or not correctly fitted to the bottle, and alerts operators of multiple sequential events.

(p) The TCA shall secure a tamper evident seal post verification.

(q) The TCA shall deliver filled, capped, and sealed bottles to appropriate subsystem(s) as appropriate for continued processing by APFS.

4. TCA Replenishment Area with Integrated APFS Functionality

(a) The contractor shall design an area for replenishment of TCA supplemental storage containers. The container filling area may be physically separate from, but shall be in close proximity to, the TCA production area to maximize efficiency of the replenishment process. This area shall meet United States Pharmacopeia standards for storage temperature and humidity. Consideration shall be given to efficient workflow and ergonomic design within the replenishment area to include container cleaning and staging, movement and storage of working stock, and replenishing storage containers. Adequate task lighting shall be provided (minimum shall be in accordance with the VA Lighting Design Manual, December 2015) http://www.cfm.va.gov/til/dManual/dmLighting.pdf.

(b) The replenishment and TCA processes shall take employee protection and engineering controls into consideration by including the use of negative pressure or local exhaust capture ventilation. Negative pressure ventilation and/or local HEPA-filtered capture ventilation is required for hazardous drugs handling according to USP Compounding Compendium Chapter 800 and recommended by NIOSH Guidelines; local exhaust capture ventilation may be used in some areas. However, since the hazardous and non-hazardous drugs are combined within the same production and replenishment process, the negative pressure shall be maintained as long as production is occurring. The contractor shall provide pressure differential monitoring devices in the cabinets and at the replenishment workstations (if practical depending on configuration) that provide a visual meter and local alarm with appropriate set-points.

(c) TCA replenishment actions shall be directed by the APFS inventory management system, utilizing software that prompts operators for proper product selection, quantity, and location. The TCA replenishment system shall maximize efficiency and include forcing functions to ensure 100% accuracy when transferring bulk drug product into storage containers. TCA replenishment software shall provide a straightforward, error-free mechanism to accomplish product (NDC) changes for a specific dispense location to prevent inaccurate dispenser loading. The system shall accurately and electronically assign a canister to a single NDC and its associated dispense location(s), ensuring that only one NDC can be assigned to a canister or dispensing location at a time.

(d)

(e) The replenishment system shall require electronic verification of filled canister to include the generation of a unique identifier which includes NDC, lot/expiration date, quantity, operator(s) and canister fill date.

(f) The APFS shall provide a failsafe mechanism to identify, track, and utilize any product (NDC) designated for return to stock or waste. The APFS shall electronically adjust inventory levels associated with return to stock product transferred to stock or dispenser location, or wasted, as indicated. Include NDC, lot code(s), expiration date(s), and associated cost data, and provide reporting tools. The replenishment system shall provide a mechanism to recycle the contents of eligible filled or rejected bottles back into canisters or stock locations for reuse. A system of barcode scans and other checks shall guide operators throughout the restock process and prevent the bottle contents from being placed in the wrong canister or stock location.

(g) The system shall require an independent NDC scan of each commercial bottle prior to transferring its contents into the canister, and the empty commercial bottle shall be tracked to disposal prior to the system accepting the next commercial bottle.

6. Unit-of-Use Automation (UUA)

(a) The UUA shall pick unit of issue products at a rate sufficient to meet throughput requirements.

(b) UUA shall consist of picking systems with individual item picking/dispensing units (locations) for each item handled. The UUA subsystem shall ultimately introduce picked products into a system-assigned carrier for transport to the next stage of processing.

(c) Provisions shall be made for multiple dispensers for a single product with automatic selection. “Pick” transfer from empty dispenser shall be automatic, with dispensing to continue on an uninterrupted basis until all dispensers for that product are empty.

(d) System detected exceptions shall attempt to retry based on an operator adjustable parameter as appropriate for exception type. A reject lane shall be provided to manually process unresolved system detected exceptions. The UUA shall have a re-picking function that guides operators to add to incomplete requests. Re-work resulting from system failures shall be minimized with the expectation that total APFS system throughput is maintained at the required rate.

(e) The UUA subsystem shall consist of dispensing zones that operate independently of each other. Should there be a failure in any single zone; the other system zones shall remain in continuous operations. The system shall detect zone failures, alert the operator and automatically prevent routing of additional work until the issue is resolved.

(f) An ergonomic storage system shall be provided for back-up stock which maximizes area efficiency. Computer workstations, bar code readers, and task lighting shall be included for all system operation work areas as appropriate.

(g) The UUA dispensing units shall monitor, track, and report on all events which are electronically passed to the operating system upon completion of each event.

(h) The contractor shall calculate the required number of UUA dispensing devices to meet the required workload throughput with twenty (20) percent additional throughput capacity. The additional capacity shall not be used by the contractor to meet UUA and APFS throughput requirements.

7. Automated Labeling/Verification of Unit of Use Items

(a) The government will require automated labeling/verification for unit of use items. Any automated labeling device shall provide an automated mechanism where, for unit-of-use items, medication assessment is accomplished virtually, and physical product is correctly identified, oriented, labeled with a patient specific prescription label, match validated and, if the item was split from an order, combined back with items from the original order for packaging into a single parcel.

8. Refrigerated Item Dispensing

(a) The APFS shall provide an area for dispensing of refrigerated items. Individual items that require refrigerated storage and shipment are split from non-refrigerated items and processed and shipped separately.

(b) Unit-of-Use (UUA) dispensing shall be utilized for refrigerated item processing to the largest extent possible, with sufficient task stations provided for fulfillment of refrigerated items that require manual processing. The UUA shall provide for refrigerated item storage.

(c) The APFS shall provide an area for packing of refrigerated items for shipment. The refrigerated item packaging area shall provide sufficient space for efficient processing and storage space for coolers, frozen gel packs, other packaging supplies and palletized coolers awaiting shipment.

9. Low Volume Dispensing (LVD)

(a) Fully or semi-automated dispensing devices shall be provided for lower volume items. These dispensing devices shall fully integrate with the APFS, minimize order splits, and provide equivalent accuracy checks and monitoring of operational events.

(b) LVD shall be capable of batched item fulfillment based on operator designated parameters for single item order batching.

(c) Suitable space shall be planned in the LVD for storage of working inventory and consumable supplies. The contractor shall provide a stock storage system that efficiently integrates into area workflow, task stations for item processing, and packaging for shipment.

10. Medical Supply Dispensing Area (MSDA)

(a) Medical supplies generally consist of boxed or loose items such as ostomy supplies, catheters, diapers, and nutritional supplements. Since medical supply items may be bulky or heavy, they generally do not lend themselves to automated dispensing. In most instances, medical supply items are split away from larger orders and processed separately for shipment.

(b) The contractor shall provide an area for storage, fulfillment, and preparation for shipment for Medical Supplies. The contractor shall provide a stock storage system that efficiently integrates into area workflow, task stations for item processing and packaging for shipment. The MSDA design shall minimize product movement and handling during the receiving, stocking, order fulfillment, and shipping process.

(c) The physical layout of the MSDA shall incorporate sufficient task stations for estimated workload demands. Capacity shall be expandable.

11. Pharmacist Verification

(a) The APFS shall provide a mechanism for pharmacist review and verification for 100 percent of dispensed items.

(b) Pharmacist verification task stations shall be remote (PV2) and not located throughout the APFS.

(c) The pharmacist verification exceptions process shall be accomplished using scanning technology to minimize keystrokes for routine order processing and allow pharmacist intervention in the case of an exception.

(d) Th pharmacist verification screen shall include and display the VA Medication Image Library (MIL).

(e) The APFS shall display all information required for pharmacist verification including a visual, as dispensed color image of the correct product compared with a visual reference image (MIL) standard, patient name, directions, drug name, quantity requested, quantity dispensed and other information…