P03 HCA-Signed LSJ Over SAT - Simplifi FSS-BPA 3.0 - POC Signed 2.doc_Rev 3_Maletta-Signed_09-22-21.pdf

LIMITED SOURCES

JUSTIFICATION ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-AP-2587

1. Contracting Activity: Department of Veterans Affairs, VISN 1 (NCO 01) and VISN 4 (NC04).

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). This is a new multi-VISN requirement to establish a single award, Base + Four (4) FSS (Federal Supply Schedule) - BPA (Blanket Purchase Agreement) to expand, improve, automate, and optimize compliance and workflow of its Pharmacy Compounding Operations and Systems across VISN 1 (New England) and VISN 4 (Pennsylvania and Delaware).

Order Against: GSA/FSS Contract Number: 47QTCA20D0034

Name of Proposed Contractor: Pharmacy OneSource Inc.

Street Address: 525 Junction Road, Suite 5000

City, State, Zip: Madison, WI 53717

Phone: (608) 829-7328

3. Description of Supplies or Services: The estimated value of the proposed action is $ 1,700,000.00.

VISN 1 and VISN 4 are seeking to establishing a Base Plus Four-Year BPA that covers all VA Medical Centers (VAMCs) in New England (VISN 1) and VAMCs in VISN 4, as listed below. The BPA will streamline procurement via individual Task Orders placed against the BPA, according to the pre-determined amounts allocated to individual VAMC sites. The contractor shall include all software, accessories, materials, installation services, training services, and licensing/subscriptions specified in this Performance Work Statement (PWS) document.

The following VISN 1 and VISN 4 VAMCs currently have Compounding Medication Systems: VISN 1: Bedford, Boston (Three Sites), Central Western Massachusetts, Manchester, Newington, Providence, Togus, West Haven, and White River Junction. VISN 4: Altoona, Butler, Coatesville, Erie, Philadelphia and Wilkes Barre, PA; and Wilmington DE.

The total estimated cost for the proposed BPA is as follows:

Base Cost Based on Per Bed FSS Rate: $1,213,797.58 Simplifi and Med Storage for Eighteen (18) Sites for Five (5) Years: $ 453,135.84 Total Estimated Cost: $1,666.933.38

Total Estimated Need (Rounded): $1,700,000.00

The cost estimates were derived by gathering initial data from all eighteen (18) sites to determine the need for each site, based on the number of In-Patient beds supported per site. The FSS rate was discounted according to pricing levels based upon count ranges and the total number of participating sites. The total projected costs for potential storage and maintenance costs were added in. The $1.67M projection was rounded to $1.7M.

All new software and services must be compatible with existing systems owned by the VISN sites listed above.

Software/licensing must be purchased through the original equipment manufacturer (OEM): Pharmacy OneSource, a Large Business (LB) subsidiary of Wolters Kluwer Inc.

VISN 1 and VISN 4 are seeking a contractual tool to ensure a direct, streamlined supply of Simplify 797 Systems and Software, that can be procured simply, efficiently, and expediently from the OEM, via follow-on orders placed against the GSA (General Services Administration) FSS/ BPA. This multi-VISN BPA serves to enable VISN 1 and VISN 4 the capability to optimize and standardize Pharmacy Compounding Operations, primarily Omnicell IVX Workflow Systems, across the enterprise.

The Simplify 797 System will also facilitate the addition of Compounding Medication Operations for sites seeking to standardize to Omnicell Systems, which are predominant throughout VISN1 and VISN 4, as required. The clinical footprint for the Simplifi 797 System is already in place across both VISNs. Advantages of standardization are listed below:

More consistent patient experience across all VISN 1 Pharmacies

Increased efficiency for Clinical Engineering support and maintenance

Increased employee efficiency by reducing learning curves when going to different sites

Optimization for the use and replacement of integrated equipment, lessening adverse impact to patient services

Increased compliance with USP standards

4. IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and

(C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays.

Only one source can provide the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

The Simplifi 797 system is a proprietary software that can only be installed, maintained, upgraded, replaced, or expanded upon by the OEM. Third party providers do not have the technical knowledge or levels of support to maintain these critical systems. Only Wolters Kluwer, via their OEM subsidiary Pharmacy OneSource, has the expertise and services required to maintain the integrity of the pharmacy software, provide adequate clinical and technical training, and meet the VA Affairs) needs. This proprietary expertise is peculiar to the OEM:

Pharmacy OneSource, Inc. OneSource is a subsidiary of Wolters Kluwer; it was acquired by Wolters Kluwer in November of 2019.

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.

Items peculiar to one manufacturer:

Simplifi 797 is proprietary to Pharmacy OneSource Inc., the LB OEM subsidiary of Wolters Kluwer. A Sole Source Letter has been provided by the OEM attesting to the exclusivity of the Simplifi 797 technology and indicates that distribution and servicing, including software upgrades, licensing, and maintenance are exclusive to Pharmacy One Source. The Simplify 797 System and software are compatible in all aspects: (form, fit and function) with existing systems presently installed/performing any new Pharmacy compliance. This includes Omnicell IVX Workflow and DSS Rx Framework. The software is compatible with existing Pharmacy equipment, including the Omnicell and DSS Systems. Both systems will work in conjunction with the Simplifi 797 System.

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:

Simplifi 797 best-satisfies a clinical requirement and offers a standardized USP compliance solution for VISN1 and VISN 4. Wolters Kluwer and Pharmacy OneSource jointly hold a GSA/FSS contract: 47QTCA20D0034, that reflects deep price discounts off Open Market pricing. It is anticipated that the proposed multi-VISN BPA will afford larger discounts with regard to similar VISN 1 FSS-BPAs for other products/services, as well as when compared to FSS/BPAs previously negotiated by VISNs 17, 22, and 23. The discount applied will be 15% off the established FSS IDIQ Price throughout the BPA Period of Performance (POP): 09/20/21-08/31/26. The FSS/BPA will afford the Government the best value.

6. DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

The following were considered during the market research phase. Initial Market results are as follows:

Pharmacy Stars: Does not hold FSS contracts.

Simplifi 797: Simplifi 797 offers software currently deployed at the Providence VA, originally purchased for Providence via contract VA24117P1356. Providence has provided positive feedback regarding the PharmacyOne Simplify 797 solution/software. The Wolters Kluwer brand is proprietary and is solely distributed/delivered via its LB subsidiary: Pharmacy OneSource Inc.

Simplifi 797 offers a cost effective, superior, reporting software that monitors and confirms compliance with USP standards. Pharmacy OneSource is well-known for its advanced technical expertise and carries integrated product lines that have proven to effectively align with VISN 1 Compounding Pharmacy Equipment.

Research conducted by staff at VAMC Providence indicates that Simplifi is used by two of the largest hospitals in the state of Rhode Island: Rhode Island Hospital and Kent Hospital. The Simplifi 797 system provides peculiar technological features that other brands do not offer:

The Simplifi System offers continuing education programs, updated frequently, that enable staff to obtain credits in pharmaceutical compounding.

Simplifi 797 incorporates policies and procedures created that can be utilized as is, or, can be rewritten to fit VISN 1 compounding practices.

The Simplifi 797 System allows for full accountability of individuals performing certain cleaning tasks, providing reports and alerts. Simplifi 797 also affords the addition of recipes for compounding products.

Nurses, Physicians, Clinical Engineering, and Pharmacy Staff have determined that Simplify 797 offers the optimal capability for standardization across VISN 1 and VISN 4.

Contracting conducted extensive market research, according to policies and procedures outlined below :

FAR 10.001: Market Research Policy All indications from VetBiz, SAC, NAC, GSA, FPDS, and the SBA DSBS indicate that distribution for the Simplifi 797 in the market is restricted. No SD/VOSBs or SBs are authorized to distribute Simplify 797. None are authorized to provide servicing or software upgrades/licensing.

A price analysis was conducted; the FSS/BPA IDIQ offers the best value to the Government via the tiered discount. The projected discount is 15%.

FAR 8.002: Exclusion of Mandatory Sources No mandatory sources are authorized by the OEM to distribute/deliver the Simplifi 797 product.

No VA or Inventories of Other Agencies store the Simplifi 797 System or software.

FAR 8.004: Non-Mandatory GSA FSS, NAC, and other Contracts There is a Wolters Kluwer/Pharmacy OneSource FSS IDIQ MAS Contract for NAICS 511210.

This FSS IDIQ offers pricing advantages for Simplifi 797.

The five-year BPA qualifies VISNs 1 and 4 for an additional discount of 15%.

FAR 19.202-2: Providing Small Business Preference NMR does not apply to the Service NAICS

511210.

The proposed BPA will include a Software Contract over SAT and a Service Contract over

$2,000.00; LOS applies.

The parent company Wolters Kluwer and the subsidiary OEM: Pharmacy OneSource are both large businesses.

No SB vendor is similarly situated with the LB OEM.

No SB vendor is authorized to distribute Simplifi 797.

VAAR 810.007-70: Compliance with VFCP First Contracting Program) A VetBiz search was conducted using NAICS 511210 and the Keywords: Omnicell

Pharmacy Interface, to locate potentially capable VIP-Verified suppliers.

Six (6) VIP SDVOSB potentially capable vendors were identified.

None are authorized to distribute Simplify 797.

VFCP cannot be applied.

VAAR 813.003-70(c): VFCP and the Rule of Two Fair & Reasonable Offers The OEM is a LB.

No SD/VOSB vendor is similarly situated with the LB OEM.

LOS cannot be satisfied; VFCP cannot be applied.

There is no opportunity for at least two fair and reasonable offers.

VAAR 819.202: Providing SD/VOSB Preference Per VAAR 852.819.10(v), VFCP can only be applied if the NMR and LOS are satisfied.

No SD/VOSB can meet NMR or LOC The SD/VOSB preference cannot be applied.

LOS (Limitations on Subcontracting)-13 CFR 125.6:

This requirement is expected to exceed SAT.

This requirement contains a Service component exceeding $2,000.00.

No SD/VOSB or SB can satisfy LOS.

No SD/VOSB or SB legally supply or service Simplifi 797.

FAR 8.405-6(b)(1): Pharmacy OneSource is unique in their capability to supply the Simplify 797 BPA.

Proprietary rights and technical expertise are peculiar to them as the OEM.

7. ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

The recommendation is a Sole Source Award to the OEM: Pharmacy OneSource, for the following reasons:

1) LOS applies, Simplifi 797 is not manufactured by a SD/VOSB or a similarly situated SB.

2) There are no SDVOSB or SB Distributors; distributorship is proprietary to the OEM.

3) The recommended award strategy would be to issue an unrestricted solicitation or to place an order against an established IDV.

a. SD/VOSB and SB distributors are non-existent; there are no authorized SD/VOSB or SB

OEM Distributors.

b. Per a Sole Source Letter provided by the OEM, Distribution and Service are proprietary to

Pharmacy OneSource.

c. We cannot compete unrestricted; there is an established IDV.

d. Wolters Kluwer and Pharmacy One Source are joint holders of a non-mandatory GSA FSS

IDIQ under MAS 511210: 47QTCA20D0034.

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:

Extensive market research was conducted to identify potentially capable SD/VOSB and SB vendors. There are no OEM-authorized distributors/deliverers in the SD/VOSB or the SB class. GSA lists an established MAS 511210, FSS contract: 47QTCA20D0034, jointly held by Wolters Kluwer and Pharmacy OneSource. The current Period of Performance (POP) for 47QTCA20D0034 is: 12/10/19 12/09/24.

Pricing on this contract vehicle is reasonable, particularly when compared to standard Open Market and other preferred pricing tiers. Wolters Kluwer has authorized an additional 15% discount off the established GSA FSS rates, which will afford exceptional savings for both VISNs.

The proposed BPA Agreement will leverage the pricing advantages offered by the GSA FSS Schedule and will offer a deep discount at 15%. In accordance with FAR 8.405-3 (d)(3), the duration of the BPA will extend from the date of award to five (5) years thereafter, unless the BPA is cancelled or expires. The BPA Period of Performance extends five years from the date of award through the expiration of the FSS contract. This includes the exercise of any options as per the GSA Schedule. Per the GSA Schedule, the ultimate contract end date for GSA FSS Schedule 47QTA20D0034, is 12/09/2039.

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 FSS contractors to fewer than the number required by FAR Subpart 8.4.

9/9/2021 Michael Ambrosi Date:

Biomedical Engineer VAMC West Roxbury

MICHAEL Digitally signed by MICHAEL

AMBROSI 1577562

AMBROSI 1577562 Date: 2021.09.09 16:02:11 -04'00'

10. APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP:

a. CONTRACTING CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date:Tammy Fox

NC01/RPO1 East

APPROVAL (Required for orders over $700,000):

b. ONE LEVEL ABOVE THE CONTRACTING OFFICER: Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Date:William A. Nalls Director of Contracting:

NC01/RPO1 East

c. VHA SAO HCA REVIEW AND APPROVAL (Over $700,000 to $68 Million) : I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

Joseph P. Maletta Date:

Executive Director, SAO East VHA Head of Contracting Activity (HCA)