36C24124Q0566_1.docx

SUBJECT*

VISN 1 B 3 Zoll Defib-AED BPA: Mod Intent to Single Source Clarification: SDVOSB Single Source

GENERAL INFORMATION

BASE NOTICE TYPE

SET-ASIDE

VAMC White River Junction 215 North Main Street White River Junction VT 05009-0001

POINT OF CONTACT*

Contracting Officer Deidra Thomas deidra.thomas@va.gov

PLACE OF PERFORMANCE

200 Springs Rd

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Modification to a Previous Notice Modification to a Previous Notice MODIFICATION: INTENT TO SINGLE SOURCE CLARIFYING FAR 819.7008 SDVOSB SINGLE SOURCE

Modification to a Previous Notice

INTENT TO SINGLE SOURCE: ZOLL DEFIBRILLATOR-AED BPA: BASE+3 YEARS

THIS IS NOTICE OF INTENT TO SINGLE SOURCE FOR ZOLL BRAND DEFIBRILLATOR-AED (AUTOMATED EXTERNAL DEFIBRILLATORS) BPA: 36C241-24-AP-3768: 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 VISN 1 New England intends to award a four (4)-year, Base-Plus-Three (3)-Year, Firm Fixed Price, Consecutive, Single Source BPA (Blanket Purchase Agreement) to sustain streamlined procurement of Zoll R Series® ALS and Plus Defibrillators and Zoll AED 3® devices, to After Action Medical and Dental Supply LLC (After Action), a SDVOSB (Service-Disabled Veteran-Owned Small Business); IAW 819.7008. An NMR Waiver applies for NAICS 334510.

After Action is the sole, OEM (Original Equipment Manufacturer)-authorized distributor to the Government for the Zoll brand Defibrillators and AEDs. The OEM, Zoll Medical Corporation (Zoll) no longer holds a GSA (General Services Administration) FSS (Federal Supply Schedule) contract for the required Zoll Defibrillators and AEDs. The sole FSS contract holder for the required defibrillators and AEDs is After Action. Zoll has provided a Letter of Distribution designating After Action, as the sole, OEM-authorized distributor to the Government. Per the letter provided by Zoll the OEM, there is only one (1) known, OEM-authorized SDVOSB distributor for the required defibrillators and AEDs.

VISN 1 has standardized to the Zoll brand Defibrillators via the previous Zoll Defibrillator BPA. VISN 1 has also standardized to the Zoll AEDs via separate procurements during the last three (3) years. VISN 1 has invested approximately $2.5M to date via the former Zoll Defibrillator BPA. The proposed consecutive BPA for Zoll brand Defibrillators and AEDs will afford direct replacement of end-of-life units. New acquisitions for Zoll brand Defibrillators/AEDs will afford direct integration and compatibility in form, fit, and function with the existing fleet of Zoll Defibrillators and AEDs and are compatible with the existing systems with which they will integrate.

Proposed VISN 1 Zoll BPA Defibrillator and AED Parts Listing: B+3

The authority for applying this statute implemented for restricting competition on this procurement is FAR 8.405-6(b) per the requirements established in FAR 6.302-1(a)(2)(i) regarding limited sources.

The intent is to procure the services mentioned above on a single source basis. No solicitation will be posted to Contract Opportunities. The primary North American Classification System Code (NAICS) is 334510: Electromedical and Electrotherapeutical Manufacturing, which includes the Defibrillators and AEDs. The most current Business Size Rating for this NAICS is 1250 employees.

Capable parties may identify their interests and authorization to respond to this requirement by September 16th, 2024, at 16:30 PM (EDT).

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.

LIMITED SOURCES JUSTIFICATION ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C241-24-AP-3768

(1) Contracting Activity: Department of Veterans Affairs, VISN 01, NCO1 RPO_E

(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). This requirement is to establish a consecutive, single-award, Base-Plus-Three Year (B+3), Zoll Defibrillator/AED (Automated External Defibrillator) BPA (Blanket Purchase Agreement). The former Zoll Defibrillator BPA: 36C24121A0083 expired on 02/14/24, coincidently with the previous FSS (Federal Supply Schedule) contract: V797D-40111. The proposed BPA will afford continuation of streamlined acquisition for replacement and upgrade for the aging fleet of Zoll Defibrillators throughout VISN 1 (New England). A consecutive BPA will provide continuity of emergent care via new acquisitions for replacement and upgrades for Zoll Defibrillators and for new procurement of AEDs. After Action Medical and Dental Supply LLC (After Action), a SDVOSB (Service- Disabled Veteran-Owned Small Business) is the sole, Zoll-authorized distributor to the Government. The BPA Period of Performance (POP) will be 09/20/24-09/19/28.

Order Against: FSS Contract Number: 36F79724D0071.

(3) Description of Supplies or Services: The proposed Zoll Defibrillator/AED BPA will provide Zoll Defibrillators, AEDs, Device Accessories, Case Reviews, and corresponding Defib Dashboard Subscriptions to afford continuity of emergent healthcare throughout VISN 1 medical facilities. VISN 1 standardized to the Zoll Defibrillators via the previous Base-Plus-Two (2) -Year BPA. VISN 1 intends to replace/upgrade approximately 145 defibrillators. The Zoll AEDs are a new addition to the subsequent BPA. VISN 1 plans to purchase approximately 375 AEDs, which will be purchased in addition to the replacement/upgrade for existing defibrillators. The Zoll Defibrillator and AED purchases will afford VISN 1 medical facilities mobile capabilities for response to SCAs (Sudden Cardiac Arrest) events in remote locations.

The Zoll brand of Defibrillators and AEDs are desired to maintain continuity of brand to leverage operational and economical efficiencies via a streamlined procurement of Zoll Defibrillators, AEDs, and Accessories. VISN 1 has standardized to Zoll Defibrillators. The Zoll brand is essential to critical and emergent coronary care for VISN 1. Switching to a brand other than Zoll would impact the quality of patient care by reducing efficiency for emergent care. Continuity of high-quality emergent care depends on the ability to leverage the acquired clinical knowledge of Zoll functionality and from the ease of transference of training on Zoll equipment. Streamlined operations arising from skilled, knowledgeable, and trained staff in rapid response to coronary emergencies will minimize patient risk with increased accuracy, expediency, and improved outcomes for SCA emergencies.

The Zoll R Series® Defibrillators offer continuity for critical, life-saving options for managing SCAs. Zoll defibrillators and AEDs include a one-step electrode system offering live performance tracking during CPR (Cardio-Pulmonary Resuscitation). The critical options offered by a Zoll Defibrillator/AED BPA will sustain high-quality emergent care enabling VISN 1 medical teams to offer rapid defibrillation, and live monitoring and feedback via the Defib Dashboard and Code Review Software. The Defibrillator/AED options will improve patient safety and resuscitation outcomes, guiding clinical teams via real-time feedback resulting in optimal resuscitation outcomes. Zoll Defibrillators and the new AEDS are compatible with existing Zoll Defibrillator devices and will afford a seamless transition for emergent care. Replacing and upgrading aging Zoll defibrillator devices with an alternate brand of product would also increase costs die to implementation costs and due to the cost of additional training.

Procurement of Zoll brand defibrillators and AEDs will be via individual Task Orders placed against the BPA. The BPA will streamline the systematic replacement and upgrade for aging defibrillators in use at eleven (11) VISN 1 VAMCs listed below, and their affiliated CBOCS (Community-Based Outpatient Clinics)/Super-CBOCS. The BPA will also provide ease of acquisition for the procurement of new AED devices required for VISN 1 medical facilities.

Last

Updated:

02/01/2022 Page of The following VISN 1 VAMCs currently have Zoll Defibrillator Devices:

· VAMC Bedford MA

· VA BHS (VA Boston Healthcare System) MA

· VAMC Brockton

· VAMC Jamaica Plain

· VAMC West Roxbury

· VAMC Central Western Massachusetts

· VAMC West Haven CT

· VAMC Manchester NH

· VAMC Providence RI

· VAMC Togus ME

· VAMC White River Junction VT

(4) Identify the Authority and Supporting Rationale:

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 can provide 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: The manufacture of the Zoll R Series® Defibrillators and the AED3® devices is proprietary and peculiar to the large business (LB) OEM (Original Equipment Manufacturer): Zoll Medical Inc (Zoll). The Defibrillators and AEDS are manufactured domestically in Chelmsford, MA. Zoll has issued a distributor letter designating After Action as its sole SDVOSB distributor to the Government. After Action offers all Zoll R Series® Defibrillators and the Zoll AED 3®s via its NAC (National Acquisition Center)/FSS contract: 3679724D0071.

The Zoll Series R ALS® and Plus® Defibrillators and the new line of devices include peculiar technological features that offer real time visibility and feedback regarding compression depth, compression rates, and high-definition visibility of a patient’s response to CPR, to provide best outcomes for resuscitation events, saving patient’s lives. VISN 1 has standardized to the Zoll R Series® Defibrillators. VISN 1 has been using Zoll defibrillators for over six (6) years. Most of the current fleet was purchased via the original, B+2- Year BPA:36C24121A0083, which ended 02/14/24. The purpose of that BPA was to facilitate the replacement/upgrade for 400 Zoll brand defibrillators, throughout VISN 1 and VISN 4. Over the past three (3) years VISN 1 replaced and upgraded 155 aging Zoll Defibrillators. VHA Boston and a few other medical facilities did not replace their aging fleet of Zoll defibrillators prior to the expiration of that BPA. At current, approximately 145 aging Zoll Defibrillators requiring replacement over the next four (4) years. This number could increase slightly depending on new devices required for Community-Based Outpatient Clinics (CBOCs) and Super-CBOCs. VISN 1 plans to purchase approximately 275 new AEDs via the new and consecutive BPA. The Zoll brand AEDs will easily integrate with and will be compatible with the Zoll brand defibrillation array currently used throughout VISN1. The replacements/upgrades for aging Zoll Defibrillators and the addition of the Zoll AEDs, will enable the VISN 1 VA Medical system to maintain system compatibility and will afford continuity in the quality and flow of emergent healthcare throughout VISN 1.

· A patent, copyright, or proprietary data limits competition. Zoll Defibrillators and AEDs are registered under the Zoll Trademark.

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

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

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

· Fit: The proposed Zoll Defibrillator R Series replacement/upgrade and the addition of the Zoll brand AEDs will allow for continued standardization to the Zoll brand Defibrillators and will provide for future standardization to the new AEDs. Zoll Defibrillators have been in use throughout VISN 1 for over six (6) years. The proposed Zoll Defibrillator and AED devices will afford efficiency due to ease of integration. The Zoll Defibrillator has an established VISN 1 server in place which will support the facility Defibrillator Dashboard and Case Review software. The existing VISN 1 network will afford ease of new defibrillator and AED device connections to the Defib Dashboard and Code Review software applications, via device dashboard subscriptions offered on the BPA. Acquiring a different defibrillator brand would require re-equipping each VISN VAMC with new software systems and new servers, to achieve a compatible workflow and would increase cost.

· Form: The current make and model defibrillator bears the same footprint as the new model affording a seamless transition to the code cart configurations, while eliminating the need to replace the current defibrillator storage methods. This is a financial benefit as well as a safety benefit. In the event of a rapid emergency, the staff will be able to perform resuscitation with expediency when using equipment that has no structural configuration changes.

· Function: Zoll Defibrillator devices have been vetted to meet the needs of the clinical staff by offering specific features that meet the 2015 AHA (American Health Association) Guidelines that advise clinical users to use feedback devices and systems and which monitor performance of CPR in real time. Zoll defibrillators and AEDs are FDA Approved.

(5) Describe Why You Believe the Order Represents the Best Value Consistent with FAR 8.404(d) ) consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The BPA pricing will be indexed against the NAC/GSA (General Services Administration) FSS contract: 36F79724D0071, via the Zoll SDVOSB distributor, After Action. Supplies offered are listed at a fixed price. BPA pricing for the first three (3) years: Base Year (09/20/24) through Option Year Two (2) (09/19/27), will be consistent throughout the period. Option Year Three (3) will show a price increase based on the projected FSS increase for the period covered: 09/20/27-09/19/28. Prices are deemed reasonable IAW (In Accordance With) FAR 8.404(d). GSA has already determined that the prices of supplies under schedule contracts to be fair and reasonable. BPA pricing is indexed against the After Action FSS contract and will include additional discounts through 09/19/228. This pricing offers the best value to the Government.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: Research into other brands of defibrillators was conducted prior to the award of the previous Zoll Defibrillator BPA 36C24121A0083: 09/27/21-02/14/24. The Zoll brand was originally selected due to Zoll’s strict compliance regarding the clinical and technical requirements associated with Zoll brand Defibrillator and AED devices. The Series R ALS and Plus devices are unique in their capability to fully-integrate with the Zoll Code Review and the Defibrillator Dashboard System. The Zoll Code Review and the Defibrillator Dashboard System have been in use prior to the establishment of the previous BPA in 2021. Continuing with the Zoll brand affords an efficient and streamlined workflow resulting in better outcomes for emergent healthcare across VISN 1 due to VISN 1’s standardization to the Zoll brand of defibrillator; VISN 1 seeks to maintain high-quality healthcare by adding Zoll AEDs. Replacing and upgrading aging devices to the new Zoll R Series defibrillators, accessories, and the Zoll AEDs offers the best opportunity to sustain continuity of emergent care throughout VISN 1 medical facilities.

Contracting conducted additional market research to research alternatives in the market and to gather information regarding the level to which the VA in general has standardized to the Zoll product. According to the analytics firm TractManager, the Zoll Series R Defibrillators outpace competitor brands in all sectors of the market. Per this report, the Zoll Series R Defibrillators are preferred by 40% of medical institutions throughout the United States. FPDS (Federal Procurement Data System) and GSA Advantage searches also indicate a preference for Zoll Defibrillators.

Process:

· FAR 10.001: Market Research Policy: In accordance with FAR 10.001, market research was conducted to locate capable sources in the market, beginning with mandatory sources.

· VAAR 819.202: Providing SD/VOSB Preference: A VetCert search was conducted using NAICS 334510; there were 312 results. Only one (1) SDVOSB, After Action was verified in the VetCert search. After Action is the sole OEM-authorized SDVOSB distributor to the Government. A subsequent VetBiz search was conducted using the NAICS 334510 and the keyword: Defibrillators. There were only two (2) results. After Action is the only SDVOSB listed on VetCert, authorized to distribute Zoll Defibrillators and AEDs to the Government.

Process (cont’d):

· FAR 8.002: Exclusion of Mandatory Sources: No mandatory sources within the VA or other government agencies are capable to provide Zoll defibrillators.

· FAR 8.004: Non-Mandatory GSA FSS, NAC, and Other Contracts: The Supply Chain Master Catalogue (SCMC) was searched to locate existing SAC (Strategic Acquisition Center) contracts. Zoll Defibrillators are not available via SAC contracts. There were two (2) regional BPAs located on the SCMC. These BPAs are specific to a local VISN. After Action holds a NAC/FSS contract for Zoll Defibrillators and AEDs: 36F79724D0071. According to the GSA E-Library, under Schedule 65 II A: Medical Equipment and Supplies and SIN A-59: Defibrillators, there are twelve (12) contractors holding GSA Contracts. Procurement for defibrillators and AEDs in the market is limited. The number of A-59 contractors has decreased from seventeen (17) to twelve (12) since 2021. Zoll the LB OEM no longer holds an FSS contract.

· VAAR 810.007-70: VFCP (Veterans First Contracting Program): The proposed BPA cannot be directly set aside; the Rule of Two (VAAR 813.003-70(c)/38USC 8127(d)) cannot be met. However, a VFCP sole source can be applied IAW VAAR 819.7008.

· 13 CFR 125.6: Limitations on Subcontracting: The BPA requirement will exceed SAT (Simplified Acquisition Threshold). LOS (Limitations on Subcontracting) applies but is satisfied per the NMR Waiver for NAICS 334510, which includes products for emergency coronary care. All prongs of the NMR are met.

· FAR 8.405-6(b)(1): Limited Source: The proposed BPA is for streamlined procurement of Zoll Brand Series R® ALS and Plus Defibrillators. AEDs, Accessories, and associated Defibrillator/AED device Case Reviews and Dashboard Subscriptions. The Zoll brand defibrillators and the corresponding technology are proprietary and peculiar to Zoll. Zoll has provided a Letter of Authorization (LOA) indicating that Zoll Series R Defibrillators can only be distributed to the Government (Veterans Affairs) by its authorized SDVOSB OEM-Distributor, After Action.

(7) Any Other Facts Supporting the Justification: Zoll Resuscitation Equipment contains technological features that are peculiar and proprietary to the OEM Zoll Medical Inc. After Action, the sole OEM-authorized SDVOSB distributor, holds the only NAC/FSS contract carrying the required Zoll brand Defibrillators, AEDs, and Accessories. Due to the previous Zoll Defibrillator BPA, Zoll Defibrillator devices are well-integrated and extensively implemented throughout VISN 1. The Zoll Series defibrillators have become the standard for resuscitation events. Switching to a different brand after several years of standardization is not economical nor operationally efficient.

(8) A Statement of the Actions 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: VISN 1 has standardized to Zoll Defibrillators, AEDs, and accessories. The Zoll brand offers best value via their reliability, durability, and record of high performance. Even with current standardization, market research is ongoing. The VA clinical and contracting services, continually monitor the market for products that best support the VA’s commitment to excellence in healthcare, while providing contracting opportunities to leverage competition via VFCP or via small business to the maximum extent practicable. Contracting will continue to apply small business preference.

(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.

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