36C25519Q0491-000.docx

FedBizOpps Sources Sought Notice

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* = Required Field FedBizOpps Sources Sought Notice Rev. March 2010 VISN 15 Pharmacy Software 66048 36C25519Q0491 06-07-2019 N 334614 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 Denise Maynard denise.maynard@va.gov

VISN 15

Kansas City, MO, St. Louis, MO, Columbia, MO Poplar Bluff, MO, Marion, IL, Wichita, KS Topeka, KS, Leavenworth, KS This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does no obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified businesses.

Responses to this notice shall include:

1. Company Name

2. Address

3. Point of Contact

4. Phone, Fax, and Email

5. DUNS number

6. Must provide a capability statement that addresses the organizations qualifications and ability to perform the work in the Statement of Requirements.

See Attached:

1. Statement of Requirements

2. Gray Market Goods

Please respond whether you can or cannot provide.

All responses due by 4:00pm CST, Friday, June 07, 2019 Denise Maynard Contract Specialist denise.maynard@va.gov 913-946-1975 Network Contracting Office 15

See attached documents: Statement of Requirements Gray Market Goods

GRAY MARKET LANGUAGE

The Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that the OEM warranty and service are provided and maintained by the OEM. All warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The vendor shall provide new items ONLY; no remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty.

Statement of Work VISN 15 USP Compliance Documentation System VISN 15 Pharmacy Services

A. PURPOSE

a. The purpose is to provide access to a web-based software program for all facilities who do sterile compounding within VISN 15 Pharmacy Services. Users encompass those who perform duties and tasks related to compounding, and USP Chapter 797 and 800 quality assurance monitoring within VISN 15 facilities.

B. SCOPE OF WORK

a. The contractor shall provide access to a customizable web-based software program that will offer VISN 15 Pharmacy Services all they need to perform and document CSP primary and secondary engineering controls certifications, personnel competency training, risk management, and quality assurance (QA) practices necessary for a USP 797/800 compliant, safe, and efficient sterile compounding environment. All products must meet all salient characteristics, training, and system requirements, as defined in this section.

b. SALIENT CHARACTERISTICS/REQUIRED FEATURES

i. Access by All VISN 15 facilities/users, including pharmacists, pharmacy technicians, designated housekeeping and other staff involved in maintaining CSP program.

ii. Ability for VISN staff to access each facility’s documentation and run facility level and VISN level monitoring and trend reports

iii. Ability for facility staff to access their documentation and run facility level monitoring and trend reports

iv. Pre-built USP 797 and 800 required tasks, including, but not limited to, environmental documentation, sampling, and cleaning

v. Alert notifications for overdue tasks or out-of-range results/readings and ability to document corrective actions for these findings. Ability to transmit alerts via email to individual users and/or specified groups.

vi. Pre-built observational competency assessments (i.e. donning, doffing, aseptic technique, etc.) and USP 797 and 800 Pharmacy competency exams, with the ability to custom build and add additional assessments and exams.

vii. Pre-built CSP Standard Operating Procedures and Policy templates customizable by the client

viii. System provides online, comprehensive, multimedia compounding training resources and assessment resources and offers continuing education credits for staff who complete the training.

ix. Includes pre-built hazardous drug risk assessments, customizable by the customer

x. Includes pre-built compounding logs, customizable by the client

xi. Ability to create form to document ward inspection, including CSP medication storage areas within the pharmacy as required by

xii. Management of personnel certification status and re-certifications and alerts to compounding employees and supervisors when certifications are coming due or are overdue

xiii. Facility dashboard providing an overview of all activities in a given time frame

xiv. Canned and customizable reporting capabilities for all aspects of the compounding program

xv. All data and reports are exportable in a variety of formats, including XLS/XLSX, PDF, and DOC/DOCX.

xvi. Ability to attach files to documentation forms in the system, allowing for review by other system users, and a document repository to upload and organize training materials, SOPs, primary and secondary engineering controls certification reports, environmental and surface sampling results, gloved fingertip testing and media fill testing results, and various other materials for user access

xvii. Ability to save the IV room configuration/setup pictures for each facility

xviii. Ability to store smoke study or other video documentation done as part of the certification process

xix. System is regularly maintained and up-to-date with all USP standards; provides continual support in all pre-built tasks, risk assessments, training, etc. even when revisions to USP standards are published

xx. Vendor must demonstrate successful system implementation with a similar size health system and provide three references of existing customers.

c. TRAINING

i. The contractor shall provide full service setup and ongoing support, including guidance on how to properly setup the accounts for VISN 15 Pharmacy Services. This guidance will include either group or one-on-one web sessions so the end-user knows how to properly access, document, build, and customize features within the software program. An online tutorial will also be embedded in the software for ease of access by the user.

ii. The contractor will be responsible for coordinating training with pharmacy and other designated staff involved in maintaining CSP program and management in order to ensure a successful implementation by including extensive product training and ongoing support. Multiple online trainings to allow all end users at the VISN 15 facilities to receive training will be provided by the contractor. Sufficient evening and weekend trainings will be offered to allow all staff to obtain the necessary training.

iii. The contractor will provide training and support for Pharmacy staff on risk management and quality assurance practices necessary to establish and maintain a safe and efficient IV compounding environment.

d. SYSTEM REQUIREMENTS

i. The program shall allow pharmacy staff to keep real-time QA data on environmental testing programs revolving around USP Chapter 797/800 rules and regulations related to clean room maintenance.

ii. The program shall provide reporting capability to identify and mitigate ongoing risks that may occur within our customized QA programs and respond quickly to day-to-day deviations from our programs with real-time alerts on facility and system-level compliance risks.

iii. The program shall provide easy access to reports on compliance trends and issues for hassle-free inspections by auditing agencies, in addition to a unit inspection product for managing JCAHO required ward inspections as required for all pharmacy medication storage areas per VHA Directive 1108.06 ‘Inpatient Pharmacy Services’. Reports on environmental testing compliance shall be readily retrievable for management oversight purposes. VISN-wide ad-hoc report generation shall be available. All reporting will need to include timely data that includes trending and analysis reporting by person, site, location, activity, and compounding area.

iv. The program must be an online application that does not require any hardware investment or IT resources to maintain software functionality. Implementation of the software application must be straightforward and user friendly.

v. The program shall require passwords to be at least eight characters long and include alphabetic letters, numeric characters, and at least one punctuation mark or symbol.

vi. Any installation services will be scheduled with a contact person as assigned by the Contracting Officer’s Representative (COR), Point of Contact (POC), or designee for performance on site.

vii. Contractor will assign an account representative to receive trouble reports and coordinate timely resolution, same day if possible.

C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

a. USP 797/800 documentation software access for all VISN 15 facilities

b. Software training and manuals

D. PERIOD OF PERFORMANCE

a. Base year beginning April 1, 2019

b. Up to four additional option years, exercisable dependent upon VISN 15’s need

E. GENERAL REQUIREMENTS

a. The contractor shall furnish all necessary materials, supplies, equipment, personnel, and supervision to provide site license services via web-based software applications.

b. Contract Type: firm-fixed-price

F. SECURITY REQUIREMENTS

a. GENERAL

i. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject the same federal laws, regulations, standards, and VA directives and handbooks as VA and VA personnel, regarding information and information system security

ii. The COTR and the Contractor will assure that:

1. No other information except what is in this contract will be shared with the contractor in any follow-up communication

2. None of the information in this contract includes entry or documentation of Protected Health Information (PHI) or Individually Identifiable Information (III) into the USP 797/800 documentation system.

3. Contract performance does not require access to VA systems.