ATCH 1 SCHEDULE SALIENT CHARACTERISTICS DELIVERY SCHEDULE AND JUSTIFICATION FOR BRAND NAME 36C24822Q0946.docx

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

AES-7---0H--0N7U0M0B0V MEDSTATION,ES,AUX,7- DRAWER DELIVERY LOCATION: BAY PINES - 4A Contract Period: Base POP Begin: 06-03-2022 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

LOCAL STOCK NUMBER: 324

AES-D-- MEDSTATION,ES,AUX,TOWER, DC

POP Begin: 06-03-2022 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 343

MES-2B--0H--0N2U0M0B0V MEDSTATION,ES,MAIN,2DR -

POP Begin: 06-03-2022 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 323

111-215 CIISAFE, V9.X, DBL IM, BIO, SL

POP Begin: 06-03-2022 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 111-215

MES----S--1A1N0P3M0B PYXIS ANESTHESIA SYSTEM ES

POP Begin: 06-03-2022 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 327

137733-01 PyxisES Ref5CF,LHG-3Deep,6StdB

POP Begin: 06-03-2022 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 137733-01

137727-01 PyxisES Ref 5CF, LHG-9 Std Bin

POP Begin: 06-03-2022 POP End: 09-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 137727-01

3 MONTH SERVICE SUPPORT

POP Begin: 06-03-2022 POP End: 12-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: SERVICE

139402-01 Dispensing Freight Fee (Federal) (1) Lee County (1) BP

POP Begin: 06-03-2022 POP End: 08-30-2022 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing

LOCAL STOCK NUMBER: 139402-01

B.3 DELIVERY SCHEDULE

10000 BAY PINES BLVD

Bldg 110 Warehouse

BAY PINES, FL 33744

USA

727-398-6661

10000 BAY PINES BLVD

Bldg 110 Warehouse

BAY PINES, FL 33744

USA

10000 BAY PINES BLVD

Bldg 110 Warehouse

BAY PINES, FL 33744

USA

10000 BAY PINES BLVD

Bldg 110 Warehouse

BAY PINES, FL 33744

USA

2409 DIPLOMAT PKWY E

LOGISTICS WAREHOUSE 1B155

CAPE CORAL, FL 33909

USA

10000 BAY PINES BLVD

Bldg 110 Warehouse

BAY PINES, FL 33744

USA

10000 BAY PINES BLVD

Bldg 110 Warehouse

BAY PINES, FL 33744

USA

10000 BAY PINES BLVD

BAY PINES, FL 33744

USA

10000 BAY PINES BLVD

BAY PINES, FL 33744

USA

STATEMENT OF NEED:

GENERAL: C.W. Bill Young Veterans’ Hospital, 10000 Bay Pines Blvd ; Bay Pines, Florida 33744 has a requirement for Pyxis - Automated Dispensing Equipment

SCOPE: In order to provide the same level of care, workflow practices, and policies pertaining to the current system used by the Bay Pines VAMC and LCHC locations, the purchase of the automated dispensing system must integrate fully with the current Pyxis equipment.

STATEMENT OF NEED:

1. The contractor shall provide all hardware, tools, or supplies necessary for the configuration, installation, and training for this procurement.

2. Pertaining to “Controlled Substances,” the equipment under the purchase agreement the contractor will follow the mandatory guidelines in the VHA Directive 1108.1.

3. The purchased equipment must interface with the Veteran Health Information Systems and Technology Architecture (VistA).

4. The contractor will provide a one-time training at installation of equipment (if applicable). The government will require additional training if applicable.

5. The contractor will ensure all Preventative Maintenance and/or Updates are current on the device at the point of installation that may have been issued since the device was manufactured and shipped.

6. The contractor will provide to the pharmacy point of contact (POC) all engineering documentation, including but not limited to, mechanical drawings, electrical/wiring diagrams, and support system layouts.

7. The vendor will deliver the equipment to the Bay Pines VAMC and the LCHC Pharmacy at the following addresses:

SALIENT CHARACTERISTICS:

1. The equipment will be fully operational and functioning at the same degree as our current Pyxis Medstations, Anesthesia Carts, Remote Managers, and CIISafe at the Bay Pines VAMC and LCHC locations.

2. The equipment must be sufficient to reduce the time spent by personnel inventorying-controlled substances.

3. The equipment must support the efficient and timely re-supplying of medications with enhanced medication security, and state of the art-controlled substance accountability.

4. The equipment must provide quick access to first doses for stat medication orders.

BRAND NAME PARTS REQUIRED :

i. AES-7---0H--0N7U0M0B0V MEDSTATION,ES,AUX,7- DRAWER (1)

ii. AES-D MEDSTATION,ES,AUX,TOWER, DC (1)

iii. MES-2B--0H--0N2U0M0B0V MEDSTATION,ES,MAIN,2DRv (2)

iv. 111-215 CIISAFE, V9.X, DBL IM, BIO, SL (2)

v. MES S--1A1N0P3M0B PYXIS ANESTHESIA SYSTEM ES (1)

vi. 137733-01 PyxisES Ref5CF,LHG-3Deep,6StdB (1)

vii. 137727-01 PyxisES Ref 5CF, LHG-9 Std (1)

viii. 3 MONTH SERVICE SUPPORT (3)

WARRANTY OF EQUIPMENT: Standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment.

**MANUFACTURE INFORMATION TO BE PROVIDED BY VENDOR**

Please including the following information when submitting your quote:

1. Original Equipment Manufacturer (OEM) Name

1. OEM - UEI Number & DUNs Number

1. OEM Part Number (if different that quoters part number)

1. OEM County of Origin

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

VA INFORMATION CUSTODIAL LANGUAGE:

a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

b. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

c. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

d. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

SECURITY INCIDENT INVESTIGATION:

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH:

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

SECURITY CONTROLS COMPLIANCE TESTING:

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING:

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training before being granted access to VA information and its systems.

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems.

ATCH 1: RFQ 36C24822Q0946 SCHEDULE/SALIENT CHARACTERISTICS/DELIVERY SCHEDULE AND JUSTIFICATION FOR BRAND NAME - PYXIS AUTOMATED DISPENSING EQUIPMENT (2)

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b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

***Brand Name Only***

Acquisition Plan Action ID: 36C248-22-AP-3341

1. Contracting Activity: Department of Veterans Affairs, VISN 08, Bay Pines Medical Center located at C.W. Bill Young VAMC 10,000 Bay Pines Blvd. Bay Pines, FL 33744, Funding: 516-22-3-213-0238

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Bay Pines Veterans Administration Medical Center (VAMC) and the Lee County Healthcare Clinic (LCHC) are required to purchase additional Pyxis equipment and upgrades current Pyxis equipment due to security requirements.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

CareFusion Solutions, LLC, a wholly owned subsidiary of Becton Dickenson and Company (BD), and is the exclusive manufacturer and provider of Pyxis products and services and the sole company capable of performing maintenance and software support. The Bay Pines VAHCS pharmacy and Lee County Healthcare Clinic pharmacy have recently purchased Pyxis Equipment to manage and secure medication. This system was purchased and awarded to Four Points Technology, LLC (SDVOSB) through competition on 09/26/2018 in the amount of $4,299,918.04, contract # VA248-17-F-3233 for both the Bay Pines and Lee County locations. There is now a need for a software upgrade and additional Pyxis equipment.

Bay Pines VAMC utilizes the Pyxis System to maintain and dispense all medications for the Main Hospital Campus and Lee County Healthcare Clinic (LCHC). Due to expansion and security requirements, The pharmacy is seeking to purchase an upgrade to the current Pyxis ES equipment.

CareFusion Solutions, LLC is the only company capable of performing the requirement, however they have three service-disabled veteran owned small business (SDVOSB) that are authorized distributors of their products on the open market.

4. Description of market research conducted and results or statement why it was not conducted:

Based on the market research conducted, only one manufacturer, CareFusion Solutions, LLC, is capable of providing this equipment to match the existing Pyxis system. This is a follow-on to the existing system.

Market research reveals that CareFusion has at least three SDVOSB authorized distributors that can provide these products/software, Four Points Technology, MicroTech and Veterans Healthcare Supply Solutions. This requirement will be solicited brand name only, competed on Contracting Opportunities among SDVOSBs to achieve a fair and reasonable price.

Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

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