Award notice combined.pdf

Contract Opportunity

Award Notice

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7A21

VISN 2 Simplifi 797 w/ Critical Point USP 800 & 795 Compounding Module

12208

36C24221Q0399

N

511210

Department of Veterans Affairs Samuel S . Stratton VA Medical Center 113 Holland Avenue (2-90NCA) Albany NY 12208-3410

Dayna Dickson-Miller 518-626-6649 dayna.dickson-miller@va.gov 518-626-6649

36C24221A0021 36C24221N0427

$115,726.50

Simplifi 797

02-18-2021

PHARMACY ONESOURCE, INC.

030231562

525 JUNCTION RD STE 5000

MADISON

WI

53717 http://vaww.visn2.va.gov/albany/index.asp

New York / New Jersey NC02 Contracting

Dayna.Dickson-Miller@va.gov

Contracting Officer

VHAPM Part 808.405 6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405 6 Limiting Sources Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C242-21-AP-0564

(1) Contracting Activity: Department of Veterans Affairs, VISN 02

VA New York Harbor Healthcare System Manhattan Campus 423 E. 23rd Street New York, NY 10010

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

The Department of Veterans Affairs VISN 2 Pharmacies are requesting a compliance software, Simplifi 797 for their compounded sterile products (CSP) areas. This software system will replace the current burdensome paper filing system that is currently being used at all sites. USP Chapter 797/800 regulations calls for skillful training of personnel who prepare compounded sterile products (CSPs), which should be completed and documented before any preparation of CSPs. These new features in Simplifi 797 will demonstrate compliance with the chapter. The pharmacy managers will be able to track competencies with a redesigned dashboard that separates competencies for each staff member by completion, outstanding or soon expiration dates.

is the only way to consolidate all the contracts for all the VISN2 sites under a single contract. It will allow VISN2 to have a single period of performance each year and one annual set-price for licenses at each site all of which is in the best interest of the government.

Period of performance: This will be a base plus (4) four option year IDIQ contract.

Base Year: 02/05/2021 – 02/04/2022 Option Year 1: 02/05/2022 – 02/04/2023 Option Year 2: 02/05/2023– 02/04/2024 Option Year 3: 02/05/2024 – 02/04/2025 Option Year 4: 02/05/2025 – 02/04/2026

Order against: FSS Contract Number:

Name of Proposed Contractor:

VHAPM Part 808.405 6 Limiting Sources Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

City, State, Zip:

Phone:

(3) Description of Supplies or Services:

Simplifi 797 is turnkey pharmacy compliance software that automates operations required to comply with USP chapters 795, 797 and 800. The customizable interface eliminates the paper and binder clutter of the inspection process, reducing time and effort. The Simplifi 797 is expert content, task management, and alerts to ensure you’re operating safely and compliantly. Simplifi 797 includes Critical Point’s education program, which gives users unlimited access to 42 hours of ACPE-approved continuing education credits supporting compliance with USP Chapter 797/800.

This software compliance tracking program is an interactive, web-based platform that allow staff, supervisors and leadership to:

A. Centrally manage all documents on an electronic platform B. Manage air/surface sampling, daily/weekly/monthly cleaning, humidity/temp/pressure logs, Real-time Out of Limits Alerts C. Access and maintain Standard Operating Procedures, Polices and Procedures D. Oversee and conduct training with continuing education tailored to USP standards E. Manage, schedule and customize staff competencies and track with ease.

The estimated value of the proposed action is The estimated value of the proposed action with options is

Product Specifications:

Simplifi 797 with critical point USP 800 & 795 with compounding records.

Product Pricing:

The cost is broken down per VA site. The price reflects the amount of bed space that each site can hold. There are nine sites that are requesting the Simplifi 797. The prices that are provided reflect has also included a 10% discount since we are purchasing multiple Simplifi 797’s.

Delivery Requirements:

Pre-Implementation Contractor will assign an Application Specialist upon receipt of a signed contract from the Client. Completion of this phase is a pre-requisite for implementation.

Client will ensure necessary resources are made available to complete the pre-implementation on schedule. It is the Client’s responsibility to include all the necessary deliverables by the committed date.

VHAPM Part 808.405 6 Limiting Sources Original Date: 08/30/2017

Pre-Implementation Acceptance Criteria Client has provided the following:

o Diagrams of all compounding areas, indicating workflow and equipment (preparation areas, etc.)

o A Completed Simplifi 797 questionnaire o A Completed configuration documents o A Completed label configuration worksheet

a) The Contractor shall provide all labor, materials, tools, equipment/software and etc. to prepare for and complete the installation of the equipment/software in the space determined by the Government.

b) The Application Specialist will schedule the Implementation kickoff meeting and establish an Implementation timeline that will ensure that Simplifi 797 is integrated into the clinical workflow no later than six weeks from the date of kickoff. Installation and implementation dates are to be coordinated in advance with the Contractor and the COR.

c) The project will transition from “implementation” status to “support” status following facility rollout of Simplifi 797. Further issues raised by the Client will be handled by the

Customer Success Manager and Support and Training team.

I. Places of Delivery/Performance

All quoted items shall be delivered to the following addresses for initial inspection and acceptance:

VISN 2

Place of Performance Address POCs

Albany VA

113 Holland Avenue Attention: Pharmacy Albany, NY 12208

Terri Wank

Finger Lakes

76 Veterans Ave Attn: Warehouse, Bldg. 103

Bath, NY 14810

Jeff Cornish

Buffalo VA 3495 Bailey Ave, Buffalo, NY 14215

Jeremy Zimmer

Syracuse VA

800 Irving Ave Attention: Pharmacy, Rm# B113

Syracuse, NY 13210

Jennie Lynch

Hudson Valley VA

VA HUDSON VALLEY HEALTH

CARE SYSTEM

Castle Point Campus Attn: Pharmacy Services

41 Castle Point Rd Wappingers Falls, NY 12590

Barbara Romeo

VHAPM Part 808.405 6 Limiting Sources Original Date: 08/30/2017

NY Harbor VA 423 East 23 Street, New York, NY 10010

Mikhail Sagun

Bronx VA 130 W Kingsbridge Rd, Bronx, NY 10468

David Kitt

New Jersey VA

385 Tremont Ave East Orange, NJ 07018

Inpatient pharmacy, 8th floor Att: Sunny

Adel Gaballah

Northport VA 79 Middleville Rd, Northport, NY 11768

Alberto Ambizas

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

Simplifi 797 is turnkey pharmacy compliance software that automates operations required to comply with USP chapters 795, 797 and 800. The customizable interface eliminates the paper and binder clutter of the inspection process, reducing time and effort.

VHAPM Part 808.405 6 Limiting Sources Original Date: 08/30/2017

The Simplifi 797 is expert content, task management, and alerts to ensure you’re operating safely and compliantly. Simplifi 797 includes Critical Point’s education program, which gives users unlimited access to 42 hours of ACPE-approved continuing education credits supporting compliance with USP Chapter 797/800.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

using their FSS schedule. Since this software is on their FSS schedule, it has already been determined that the prices are fair and reasonable to the government.

is also offering a 10% discount since we are purchasing in bulk. Awarding to is also the only way to consolidate all the contracts for all the VISN2 sites under a single contract.

(6) Describe the Market Research Conducted: The Department of Veterans Affairs VISN 2 Medical Centers Pharmacies are requesting Simplifi 797 Compliance Software for their Compounded Sterile Products (CSP) area. This system shall replace the current burdensome paperwork system. This software compliance tracking program is an interactive, web-based platform that allow staff and leadership to centrally manage all documents on an electronic platform, manage air/surface sampling, daily/weekly/monthly cleaning, humidity/temp/pressure logs and real time out limits alerts.

After conducting market research, it has been determined that is the only vendor and OEM, who can supply the Simplifi 797 software license. An intent to sole source was posted to Beta/Sam for seven business days with no responses from any vendor. It is recommended that this request for Simplifi 797 is sole sourced directly to using their FSS schedule. Since this software is on their FSS schedule, it has already been determined that the prices are fair and reasonable to the government. is also offering a 10% discount since we are purchasing in bulk. Awarding to is also the only way to consolidate all the contracts for all the VISN2 sites under a single contract. It will allow VISN2 to have a single period of performance each year and one annual set-price for the software at each site all of which is in the best interest of the government.

(7) Any Other Facts Supporting the Justification: The use of GSA provides the best value to procure this software that is needed to consolidate all VISN 2 sites pharmacy data and provide the best possible care to our Veterans.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

VHAPM Part 808.405 6 Limiting Sources Original Date: 08/30/2017

The Department of Veterans Affairs VISN 2 Medical Centers Pharmacies are requesting Simplifi 797 Compliance Software for their Compounded Sterile Products (CSP) area. This system shall replace the current burdensome paperwork system. This software compliance tracking program is an interactive, web-based platform that allow staff and leadership to centrally manage all documents on an electronic platform, manage air/surface sampling, daily/weekly/monthly cleaning, humidity/temp/pressure logs and real time out limits alerts. Establishing a unify VISN 2 contract that allows each site to have the same period of performance and delivery dates will make the entire acquisition process easier in the future.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE

NAME & TITLE

VISN 2 Pharmacy Benefits Management

SERVICE LINE/SECTION

Manhattan VA Medical Center

FACILITY

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE

Syracuse VAMC, NC02

NAME AND TITLE FACILITY/NCO/PCO

VHAPM Part 808.405 6 Limiting Sources Original Date: 08/30/2017

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

NCO2 Supply Branch Chief

Date: 2021.01.29 08:21:00 -05'00'