36C24121Q0567.docx

Presolicitation Notice Presolicitation Notice

GENERAL INFORMATION

CLASSIFICATION

SET-ASIDE

POSTAL CODE

COUNTRY

CONTACT INFORMATION

VAMC White River Junction 215 North Main Street White River Junction VT 05009

POINT OF CONTACT*

Contract Specialist Deidra Thomas deidra.thomas@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

PRE-SOLICITATION NOTICE: INTENT TO SOLE SOURCE

NOTICE OF INTENT TO AWARD A SOLE SOURCE_SIMPLIFY 797 BPA: 36C24121Q0567

This is a Notice of Intent to Sole Source. This is not a request for competitive proposals. This is not a solicitation or request for offers. No solicitation package is available and telephone requests will not be honored.

The Department of Veterans Affairs, VISN1 and VISN4, intend to award a Firm Fixed Price, Sole Source, Five (5) -Year BPA for the Simplifi 797 Web-Based Quality Management System.

VISN 1 locations include:

VISN 4 locations include:

VAMC Lebanon PA

Pharmacy One Source Inc. located at 525 Junction Rd., STE 5000, Madison WI 53717-2154, is the Sole Source Distributor/Deliverer for the Simplify 797 Web-based quality management system that seamlessly aligns all of its parts to help to meet the requirements of USP Chapters 795,797 and 800 for sterile and nonsterile compounding. A Sole Distributor/Deliverer Letter has been provided by the Original Equipment Manufacturer (OEM): Wolters Kluwer .

Per the Sole Source Letter from Wolters Kluwer, Pharmacy One Source Inc, is the sole OEM Distributor/Deliverer to the US Government. The authority for applying the Simplified Procedures for Commercial Items of FAR 13 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

The intent is to procure these services on a sole source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 511210, Software Publishing and Affiliated Support. The most current Business Size Rating for this NAICS is $41.5 million.

Interested parties may identify their interests and capability to respond to this requirement by July 27th at 11AM (EST).

A determination by the Government not to compete this proposed award upon response to this notice is solely within the discretion of the Contracting Officer.

Performance Work Statement: VISN 1 and VISN 4

Privacy Statement:

Contractor shall adhere to all VA Privacy & Security, and Privacy Act and HIPAA requirements if exposed to protected health information (PHI) or when obtaining or reviewing information. This includes all log files, error traps, screen capture images and database query results used to aid staff with product troubleshooting or product support activities.

BAA Statement:

A National BAA is required.

Background:

VISN 1 and VISN 4 are seeking to expand, improve, automate, and optimize the workflow of its Pharmacy Compounding Operations and Systems throughout the VISNs by establishing a blanket purchase agreement (BPA) that covers all VA Medical Centers in VISN 1 and 4. The contractor shall include all software, accessories, materials, installation services, training services, and licensing/subscriptions specified in this Performance Work Statement (PWS) document.

Pharmacy compounding workflow automation serve the following primary functions:

1. Ensure patient safety due to automated quality control of proper compounding of medications

2. Ensure compliance with current USP (United States Pharmacopeia) standards

3. Improve pharmacy workflow and efficiency

At the time of trade-in and/or disposal of existing pharmacy systems, all hard drives will be retained by the site for proper disposal.

Period of Performance:

The intent of the Government is to establish a Blank Purchase Agreement (BPA) with a period of performance of five years from the date of award. This BPA is to have firm fixed pricing per the price schedule.

Contractor Responsibilities:

· Implementation services shall include the following:

· A centralized project manager POC who will oversee all facilities in the VISN for consistency

· Detailed project timeline with defined roles and responsibilities (including vendor and VA resources). Must be approved by VA

· Schedule can be created using any project software e.g. MS Project and should contain milestones and deliverable dates for each facility. Milestones will include delivery, training, go-live, trade-in return

· Installation coordination of all software and accessories, a training plan, and schedule for go-live Meetings should be scheduled with sites for implementation, initial deployment, and through the completion of the delivery.

· The vendor shall provide access to software, clearly labeled with the OEM’s name, version number, delivery order number, and VA purchase order number.

· If products do not meet criteria, VA Clinical Engineering site POC will reach out to COR and COR will contact the Vendor Project Manager for replacement of that software

· Vendor shall assist in any issues related to accessing website links (e.g. whitelisting) in conjunction with the use of the product

· The vendor shall provide the latest approved software version and coordinate any applicable upgrades with Clinical Engineering site POC

· All on-site installation services, if applicable, shall be vendor-provided by technical staff (not sales reps) fully trained to service and install Wolters Kluwer products as specified.

· Vendor shall provide Critical Point

· Vendor shall provide modules related to USP 795, USP 800, and USP 797

· Vendor shall provide modules related to compounding

· Vendor shall provide modules for high risk if requested by site

· Vendor shall provide upgrades during the renewal of an option or unless approved by the vendor. Upgrades will be specifically identified by the vendor as they become available

· Vendor software shall integrate with current Pharmacy equipment and/or software

· Vendor shall allow VISN 1 and VISN 4 sites to order products using this agreement if it is in the best interest of the VA; the vendor shall allow this BPA to supersede other arrangements already in place for current VISN sites

· Vendor shall provide subscription and licensing as necessary to the site(s) in order to use the product as specified

Contractor Responsibilities (Cont’d):

· The vendor shall provide the following documentation for the proposed Wolters Kluwer configuration and setup:

· Hard and soft copy of operator’s/user’s manual

· Hard and soft copy of technical service manuals including troubleshooting guides

· DVD or web-based training if available

Government Responsibilities:

· Each VA site is responsible for inventorying materials prior to acceptance of order.

· Each VA site shall reject items that do not conform to requirements above.

Software shall be checked upon first use to ensure it complies with above requirements. If non-compliance is observed, VA Clinical Engineering POC will reach out to COR. COR will contact Vendor Project Manager for replacement of that equipment.

Training Requirements:

· The vendor shall provide technical training to ensure Clinical Engineering staff at each facility have the ability to service and support Wolters Kluwer software/equipment at an equivalent level of a vendor-provided fully trained service technician. All costs and expenses for the contractor to provide the technical training required shall be included with each purchase.

· The vendor shall provide pharmacy end user training to ensure pharmacy staff can properly utilize and operate Wolters Kluwer software/equipment. The training should provide staff the knowledge and skill set at an equivalent level of a vendor-provided fully trained pharmacy staff. All costs and expenses for the contractor to provide the technical training required shall be included with each purchase.

· The vendor shall provide super user training to ensure pharmacy and clinical engineering staff can properly utilize and operate Wolters Kluwer software/equipment. The training should provide staff the knowledge and skill set at an equivalent level of a vendor-provided fully trained super user. All costs and expenses for the contractor to provide the technical training required shall be included with each purchase.

· The vendor shall provide any special service tools and/or test equipment comparable with that provided to the OEM’s service personnel.

· Troubleshooting and support shall be provided by vendor if required

· Upon install of Wolters Kluwer products, certified instructors must provide user training for staff on day, evening and night shifts at times to be determined by each facility.

· All staff need to be trained prior to go-live. Training must be flexible based on day, evening, night and weekend shifts. All times to be determined by each facility.

· There shall be an initial go-live training at initial install and at a minimum, an annual follow-up refresher training for all staff types.

· Training modules for USP 800, USP 795, and USP 797 shall be included

· Training education for Critical Point shall be included

· Training for additional USP standards shall be included as applicable, e.g. radiopharmaceuticals

· Training for high risk shall be included as applicable

Trade-In or Disposal:

· If applicable, all hard drives will be maintained by the local site and properly disposed.

Presolicitation Notice