VA770-17-R-0409-022.docx

VA770-17-R-0409

OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL

BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SI

GN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGN

ATURE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR

LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

National CMOP

VA770-17-R-0409

03-05-2018 Thurman, Leah, leah.thurman@va.gov 913-684-0136 04-16-2018 12:00 pm CT 00770 Department of Veterans Affairs National CMOP 3450 S. 4th St. Trafficway Leavenworth KS 66048-5581 X 332999 750 Employees N/A X 00770 Department of Veterans Affairs Leavenworth

CMOP

5000 S. 13th Street Leavenworth KS 66048-5580 00770 Department of Veterans Affairs National CMOP 3450 S. 4th St. Trafficway Leavenworth KS 66048-5581

Department of Veterans Affairs

FSC

PO Box 149971 Austin TX 78714-8971 See CONTINUATION Page Contractor shall design and deliver an Automated Prescription Fulfillment System (APFS) to the Leavenworth CMOP. Services inclusive of all supervision, labor, materials, supplies, facilities and equipment necessary to 1 Job provide a fully operational APFS in accordance with the Statement of Requirements.

Period of Performance: The Governments expectation of Final Acceptance is 18 months from time of contract award.

Proposals that exceed 18 months shall be evaluated to determine best value to the Government.

$0.00 See CONTINUATION Page X X X Leah Thurman Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C770 Leah Thurman Department of Veterans Affairs National CMOP 3450 S. 4th St. Trafficway Leavenworth KS 66048-5581

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

FSC

PO Box 149971 Austin TX 78714-8971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2. CONTINUATION PAGE

Contract Administration Data

Period of Performance: The Governments expectation of Final Acceptance is 18 months from time of contract award. Proposals that exceed 18 months shall be evaluated to determine best value to the Government.

Progress Payments Based Upon Stages Of Completion

(a) Definitions: “Progress Payments Based Upon Stages of Completion” means a finance payment based upon approved completion of milestone.

“Milestone Chart or Gant Chart” represents a delivery schedule and shall become part of the contract.”

(b) The offeror shall submit a Gant chart illustrating percentages of completion totaling 100% at final delivery to be approved by the Contracting Officer in their proposal. The Milestone/Gant Bar Chart shall become a part of the successful offeror’s contract. See FACTOR 5 – PRICE PROPOSAL, page 112.

(c) Within 30 calendar days of contract award, the contractor shall submit a performance bond. The contractor may submit other forms of security in lieu of or in addition to the performance bond so long as the value of the offered security is equal to 100% of contract price.

The Contracting Officer shall have the sole discretion to determine whether proposed alternate forms of security are acceptable to the Government.

Based on the accomplishment of milestones that are agreed upon between the Government and Contractor, the Contracting Officer may approve an adjustment to the value of the security periodically during contract performance, as long as it is always equal to or greater than the amount of un-liquidated financing.

(d) To receive progress payments, the contractor shall submit a request for financing payment, upon completion of the indicated milestone, in the amount indicated on the milestone chart based on percentage of total contract price. The request for payment shall be forwarded to the Leavenworth CMOP Contracting Officers Representative (COR).

(e) Verification of the contractor’s entitlement for a progress payment shall be accomplished by the Leavenworth CMOP COR.

(f) The contractor shall receive payment only for items delivered and services rendered and accepted by the Government. The Government shall retain the remaining 20 percent of the purchase price until such time as the installation has been completed, the Government has inspected, tested, and accepted the installed equipment, and the contractor provided on-site training.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

INTENT TO INCORPORATE CONTRACTOR'S TECHNICAL PROPOSAL

All or part of the successful offeror's technical proposal may be incorporated in any contract resulting from this solicitation. The successful offeror's technical proposal may be incorporated by reference. Nothing contained in the successful offeror's technical proposal shall constitute a waiver to any other requirement of the contract. In the event of any conflict between the successful offeror's technical proposal and any other requirement of the contract, the contract will take precedence.

B.4 STATEMENT OF REQUIREMENTS

LEAVENWORTH AUTOMATED PRESCRIPTION FULFILLMENT SYSTEM (APFS)

PART I: BACKGROUND

A. INTRODUCTION

1. The Leavenworth Consolidated Mail Outpatient Pharmacy (Leavenworth CMOP), located in Leavenworth, Kansas, requires an Automated Prescription Fulfillment System (APFS) that fully supports industry dispensing trends, provides improvements in processing accuracy and timeliness of throughput, contains all commercial-off-the-shelf (COTS) as well as commercially available replacement components for follow-on maintenance, and is expandable and configurable to meet future fulfillment needs.

2. The Leavenworth CMOP is one of seven Consolidated Mail Outpatient Pharmacy (CMOP) facilities located across the United States. This Department of Veterans Affairs (VA) program provides prescription fulfillment and mailing for Veteran patients. Advanced automation and equipment systems are used in this highly automated environment to fulfill prescription orders from Department of Veterans Affairs Medical Centers (VAMC) and Community Based Outpatient Clinics (CBOC) throughout the country. Leavenworth CMOP also provides prescription fulfillment and mailing for Indian Health Service Pharmacies (IHS) with the potential for future growth based upon agreements with other Federal agencies.

· In the current CMOP automated production system, the unit-of-use (UUA) automation server searches in a shared directory on the tote controller to find work assigned to it. The Tablet and Capsule Automation (TCA) uses Ethernet connectivity for the production system’s software to reach into and direct the Tablet and Capsule system routing of conveyance devices using barcode scanning.

· Conveyance start-up, routing and tracking are managed through the current production software.

· Background procedures continuously run on a server pulling data from the VA Central Database (CDB) and creating a data file. Induction software utilizes that data file to process orders. The VA CDB and local servers populate the non-automated work areas of the Leavenworth CMOP with orders to be filled.

B. STATEMENT OF NEED

The purpose of this procurement is to obtain a proven fulfillment automation system with no single point of failure for a new facility that meets the accuracy, timeliness, and throughput requirements of the dynamic workload of the Leavenworth CMOP. The Leavenworth CMOP requires a contractor to serve as a systems integrator who will 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 shall be fully functional and fully integrated with the CMOP electronic data structure as outlined in the CMOP Data Interface Control Document R1 3c (See Attachment C). The APFS shall be capable of dispensing 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 are required. Responses shall contain sufficient detail to demonstrate understanding and capability.

C. 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.

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 – 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 pieces to contain the required item count. A UUA prescription may consist of one to many boxes or containers (pieces).

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.

SLIP – Shortest Life Into Production. An acronym used to describe the concept of prioritizing product with a short expiration date for use before the same product with a longer expiration date.

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.

D. 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 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 (1/2017) average Patient Order for Leavenworth 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 pieces to be processed by UUA and tracked through the system..

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

The current average Leavenworth CMOP UUA prescription consists of 1.5pieces 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

A SYSTEM PERFORMANCE AND DESIGN

1. Data Transfer and Acceptance

(a) The APFS shall integrate with the current VA CMOP National data infrastructure which currently operates in an MSSQL 2012 environment in a format and structure specified by the CMOP. The CMOP will provide existing table structure (format) upon award. 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 as outlined in the CMOP Data Interface Control Document R1 3c (See Attachment C).

(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) The APFS shall efficiently utilize automation and workflow algorithms for order fulfillment and provide mechanisms to take independent action (cancel, reallocate, etc.) on individual prescriptions without impacting the remainder of a patient order.

(e) The APFS shall be designed to receive and process data from barcode scans (linear, 2D and any current format at time of acceptance) and RFID input.

2. Software Development and Source Code

(a) The system shall be developed as a distributed architecture. Systems shall be standardized to a Microsoft platform using MS Windows 2012 Server R2 (or newer VA approved version) and Microsoft SQL Server 2012 (or newer VA approved version). VA will acquire rights in data provided by Contractor under the contract resulting from this solicitation in accordance with Federal Acquisition Regulation (FAR) clause 52.227-14.

(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) Software programming shall use standard Windows programming techniques and standard Windows APIs. Programs shall be designed and implemented to run on any machine in the facility that has the necessary hardware components to run that software. (For example, a labeling application shall be able to run on any computer that is connected to the network and has the necessary label and tote identification/scanning equipment).

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

(b) The contractor shall deliver a configured development environment. This environment shall have, at a minimum:

(1) The completed source code, of any developed application, to the CMOP such that VA has unlimited rights per FAR 52.227-14 and can change the source code as needed to improve the throughput of the automated system. This includes all programs, PLC software, etc. developed specifically for the CMOP, as well as any of the contractor’s standard software libraries that are required for this system.

(2) The completed source code shall be clearly documented. PLC/Control code shall include tag names and descriptions on all I/O and internal memory points, as well as descriptions of the purpose and function of each major section of code.

(3) The compiler/development software, PLC programming software, debugger, DLLs, as necessary to modify, compile and link the control system software.

(4) All libraries for third party software to which the contractor’s applications shall link.

(5) Installation batch procedures for all control and workstation computers to load the necessary executables, DLLs, configuration files, etc., that are part of the contractor’s deliverables, that are required to operate that station. It is not required that this procedure load third party software, such as drivers for add-on hardware, database drivers, etc.

(6) Programming software for PLCs, smart motors, robots, scanners, and all other programmable control or IO devices.

(7) The contractor shall provide two (2) complete sets of software, communication cables, cards, and/or converter devices, etc. required for programming of PLCs, smart motors, robots, scanners, and all other programmable control or IO devices. All software and associated programmable devices shall be compatible with current VA OI&T security and group policies.

(8) All computer equipment shall not exceed 60% CPU utilization when running all required applications to support full production including all VA standard desktop environment and servers.

(9) Version control for all software. Each modification of the software module requires a new version number to allow for tracking changes to the software. Version control shall be used to ensure the correct version of the software is running on all systems.

i. The Government will furnish a source code repository such as Microsoft Team Foundation Server in order to track all versions of all code developed by the Contractor.

ii. All Government information, data, and source code will be stored and processed exclusively through the virtual desktop environment whether a Contractor is accessing the Government network through VPN or through access from within a Government facility.

(10) New versions of software shall be capable of being ‘pushed’ out to the appropriated systems using automated tools such as MS SCCM.

(c) 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.

(d) Deliverable documentation will be provided to the COR immediately after installation and prior to system acceptance. Additional documentation requirements are located in PART II, subsection D.4 of this document. Minimum documents include:

(1) Security Feature User Guide

(2) System Administrator Manual

(3) User Manuals

(4) Preventative maintenance tasks, schedules, and recommended parts stock levels

(5) Software and Hardware Testing Procedures and Results

(6) Network Diagram

(7) Site Plan (Floor Plan) Drawings

(8) “As Built” drawings

(9) Process and Instrumentation Piping (P&ID) Drawings

(10) Wiring Diagrams

(11) Control Logic Diagrams

(12) Hardware and Software Inventory

(13) Technical Documentation (i.e. all input/output points, ports, etc. used on the system; software programs for programmable devices including but not limited to PLCs, port expanders, etc.) This documentation shall be as implemented, not as designed, and include but not limited to:

· Detailed Network Diagram

· Software Technical Documentation. This documentation includes software and process flow charts. All source code shall be documented within the code itself. Software shall have version control and be provided to the government in Microsoft Team Foundation Server.

(14) Provide 4 soft copies of documentation on DVD. Soft copy drawings shall be in AutoCad (.dwg) and Adobe Acrobat formats. Documents shall be provided in Microsoft Word and Adobe Acrobat format in the English language, allowing for future edits and updates and providing a table of contents to include jump links.

(15) Provide 4 hard copies of all documents, bound in 3-ring binders.

(16) Provide 4 full size (22” x 34”) copies of the Site Plan and P&ID Drawings.

(17) Provide 4 half size (11” x 17”) copies of all other drawings

3. System Throughput Requirements

(a) The APFS shall accurately process and complete a minimum of 80,000 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. Weekend and Holiday overtime may be required to support additional workload. Any routine system maintenance and back-up shall not impact production or shall be able to be scheduled with VA approval during non-production hours. Any preventative maintenance or routine software/database maintenance that requires off-production hours shall be identified in hours and periodicity.

(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 contractor shall deliver a fully integrated APFS that minimizes the costs associated with prescription fulfillment. The contractor shall provide the cost point of diminishing return for each sub-system and provide the most cost effective balance between automated and manual processes for each APFS area including paperwork print and insertion into parcels, Unit-of-Use Automation (UUA), and other subsystems. The contractor shall propose a cost-effective printer maintenance plan. 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 at the initial pre-proposal site visit or preliminary/conceptual drawing (VA is in the process of acquiring a new, leased facility and “as-built” drawings are not yet available. See Attachment D for conceptual drawing).

(b) The Government will provide 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. The contractor shall utilize the basic workflow concepts detailed in the nominal space plan.

(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. The contractor shall supply life safety drawings/plans delineating compliance with all requirements (i.e. egress paths, travel distances, etc.) in accordance with the latest edition of NFPA 101, Industrial Occupancy classification and include an assessment and design, as required, for high bay storage sprinkler protection in accordance with the latest edition of NFPA 72. The drawings/plans and designs shall be signed and stamped/sealed by a Professional Engineer, Fire Protection, licensed in the state of Kansas.

(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) The APFS footprint shall include storage for stock dispensing areas. Stock dispensing areas are designated for stock that has been assigned to a specific dispensing location(s). The contractor shall provide all appropriate shelves, racks, or other storage systems for each stock storage area for primary (typically a 1 week supply), secondary (typically 10 – 12 days’ supply), and bulk locations (typically 15 – 20 days’ supply), to include storage for palletized items.

(f) The APFS footprint shall also include stock storage locations designated for unopened bulk product storage prior to assignment to a stock dispensing area. The stock storage location shall be physically separate and securable from stock dispensing areas with consideration given to safe and efficient movement from the receiving areas as well as to the stock dispensing areas.

(g) APFS Operation and Staffing Plan shall be submitted with proposal and will be incorporated in final contract. The 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.

(2) Anticipated staffing for APFS routine and preventative maintenance of the APFS including the number and recommended background specialty of required staff.

(3) Estimated annual maintenance cost which includes quarterly visits.

5. Proof of Concept (Shall be submitted with proposal and if accepted will be incorporated in final contract)

(a) Responses shall contain sufficient detail to demonstrate understanding and capability. The contractor shall provide a written proof of 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 shall include workload distribution through all sub-systems and all associated operational costs calculated on an individual prescription basis. The contractor shall be able to state the operational costs of processing throughput per prescription for each production area. The written proof of concept shall become a part of the successful offeror’s contract.

(b) The contractor shall include one dimensional and three dimensional renderings of each type of task station throughout the system and demonstrate how each type of task station ergonomically integrates into the APFS. The offeror’s presentation shall include computer software generated simulations for this requirement.

6. Project Management Plan (Shall be submitted with proposal and if accepted will be incorporated in final contract)

(a) The contractor shall dedicate a Project Manager from contract award through completion of warranty period and detail his/her qualifications. Project manager shall be on-site for milestones, including, but not limited to, design approval, site acceptance, and component delivery through system acceptance. During the installation and pre-acceptance period, on-site technical support and remote assistance shall be available as stipulated in the Warranty (Part II, Subsection D.8) whenever equipment will be energized/pressurized.

(b) The contractor shall provide a detailed Project Management Plan in MS Project format which shall include:

(1) A comprehensive risk assessment and mitigation plan including:

i. Identification of contract vulnerabilities and risks, including, but not limited to, considerations of project scope, personnel required, data interfaces, sub-contractor product deliverables.

ii. Prediction of potential consequences

iii. Proposed mitigation and assignment of responsibility

(2) An Emergency Recovery Plan to address potential interruptions to milestone completion that are outside the contractor’s direct control.

(3) Quality Management Plan to ensure integrity and function of components and systems from delivery through acceptance and includes government inspection and concurrence.

(4) A detailed project timeline with measurable milestones, including activity duration and relationship to other activities with estimated start and completion dates. At a minimum, the contractor shall include the following milestones for government acceptance in the project schedule:

· Milestone major event electrical interface

· Component contractor delivery dates

· Consumable requirements specifications, projected usage (for both testing purposes and once fully operational) and required delivery date(s)

· Component installation

· Component equipment testing to include capacity and documentation of published specifications

· Communication interface of subsystems

· Contractor software installation and testing

· Validation of reporting functions and training of government supervisors and quality support staff

· Integration with current VA CMOP National data infrastructure

· Contractor training of government operations personnel

· Live switch over

· Contractor training of government maintenance staff

· Contractor provided user and maintenance manuals (including periodic maintenance schedule)

· Contractor provided bench stock of repair parts

7. Progress Meetings and Progress Reports

(a) The contractor shall attend progress meetings, frequency depending on milestone(s), but at least twice monthly, to brief Government personnel on the progress of design, installation and integration of the APFS. The contractor shall provide briefing notes after each meeting. Meeting location will be determined by the Government.

(b) The contractor shall attend technical meetings to discuss the technical requirements and…