S02_ Attachment - Pyxis Brand Name Only JOFOC.pdf

OFOC SOP Revision 11 Page 1 of 5 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: Pyxis Med Station – 36C261-21-AP-1102

1. Contracting Activity: Department of Veterans Affairs, VISN 21, San Francisco Healthcare Medical

Center located at 4150 Clement St, San Francsico, CA 94121.

2. Nature and/or Description of the Action Being Processed: The Department of Veterans Affairs San Francisco Healthcare Medical Center requests the purchase of 10 Pyxis Med Stations to deploy to all CBOCs and ambulatory care clinics. The Pyxis machine is an automated medication dispensing system which supports decentralized medication management with various features for safety and efficiency. The additional Pyxis Med Stations must be compatible with the current Pyxis machines that were implemented in July 2019. Pyxis brand is the only brand that is compatible with the existing automated medication dispensing machings. A firm-fixed purchase order will be awarded for this requirement.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Department of Veterans Affairs San Francisco Healthcare Medical Center requests the purchase of 10 Pyxis Med Stations to include 10 towers and 10 refrigerators. The additional automated medication dispensing systems must be the brand Pyxis in order to be compatible with existing Pyxis machines. The estimated delivery date is 90 days ARO. .

4. Statutory Authority Permitting Other than Full and Open Competition:

( x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1; BRAND NAME

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Department of Veterans Affairs San Francisco Healthcare Medical Center requests the purchase of 10 Pyxis Med Stations to include 10 towers and 10 refrigerators. The additional automated medication dispensing systems must be the brand Pyxis in order to be compatible with existing Pyxis machines.

OFOC SOP Revision 11 Page 2 of 5

Revision 11 Date: 02/11/2021

Pyxis - Automated dispensing machines for medications (ADMs) are required by San Francisco VA Health Care System (SFVAHCS) for medication storage and security in patient care areas. At SFVAHCS, automated dispensing machines are deployed throughout the main facility and community based outpatient clinics (CBOCs) and are required to meet Joint Commission standards for medication management, safety, and accountability. Automated dispensing machines were initially deployed at SFVAHCS in 2005 utilizing the AcuDose system (vendor Aesynt). In January 2016, the vendor Omnicell acquired Aesynt and its products, including AcuDose. As of 2018, more than 50% of the AcuDose machines at SFVAHCS were at the end-of-life and no longer covered by service contracts. In FY17, there were 62 required service calls to the vendor for trouble-shooting and repairs. The AcuDose system could not support the long-term needs and requirements for secure Pharmacy Services needs. Pharmacy Servides switched to Pyxis. We currently need additional Pyxis machines, which are compatablie with the current Pyxis machines.

BD Pyxis Enterprise Server (ES) Platform – Active Directory – This is a proprietary web-based function within the ES platform that allows intergration with the facility Active Directory. The Active Directory is maintained by IT and is the main database for managing IT access for employees. When employees are on-boarded at the facility, they are granted active status by IT staff in the Active Directory. When they are separated from the facility, their active status is removed by IT staff. Without Active Directory integration, Pharmacy staff must maintain a separate employee database for active users of ADMs and must rely on communication from individual services with regards to new and separating employees. This requires dedicated time from Pharmacy staff that is not necessary. In addition, failure to communicate to Pharmacy about a separating employee may result in unauthorized access to medications, such as controlled substances. The ES Active Directory Integration functionality provides greater accountability for user access and medication security and has the following specific benefits to the facility, 1) decreased time spent by Pharmacy staff to maintain active user accounts and database and 2) decreased risk for medication access after employee separation.

BD Pyxis ES Link Queue – This is a proprietary web-based function within the ES platform that allows nurses to select and queue medications to be pulled from the automated dispensing machine (ADM) from decentralized locations, such as patient room or other clinical area, rather than selecting medications only from the centralized ADM itself. In order to select appropriate medications to remove from the ADM, nurses must access each patient’s medication profile, individually select and remove each medication. This process can take up to 30 seconds per medication. On a typical acute care ward, a nurse will be assigned 4-5 patients for the shift and may remove 3-5 medications from the ADM at each scheduled dosing time, with approximately 3 dosing times per shift. Without decentralized medication queuing functionality, time spent at the ADM could amount to approximately 35 minutes per nurse per shift. With the decentralized queuing functionality, time spent at the ADM would be for medication removal only, as selection would occur at another location and could decrease time spent by approximately 50% (18 min per shift). While in the patient room, nurses are able to assess the patient for medication needs and determine if the patient will refuse a medication dose prior to medication removal from the ADM. Without decentralized medication queuing functionality, more medications would be removed that are not needed by the patient. Doses that are removed

OFOC SOP Revision 11 Page 3 of 5

Revision 11 Date: 02/11/2021 from the ADM and not administered must either be wasted (controlled substances) or returned to the Pharmacy (non-controlled substances), resulting in extra work and cost. The ES Link Queue functionality provides greater flexibility for nurses in clinical care workflow and has the following specific benefits to the facility, 1) decreased time spent at the ADM to select and remove medications, 2) decreased wait time by nursing staff to access centralized ADM, 3) increased interaction with patients regarding requested doses prior to removal from ADM, and

4) decreased medication waste for doses refused by patients.

BD Pyxis ES Link Waste Module - This is a proprietary web-based function within the ES platform that allows nurses to document wastage of unadministered controlled substances from any internet-enabled computer station. With current ADMs at SFVAHCS, nurses must document wastage of controlled substances only at the ADM from which they removed the medication. For patients who transfer through multiple clinical areas (operating room to recovery room), this requires the nurse to travel to the original ADM to document wastage rather than utilizing mobile point-of-care computers used for patient charting and assessment. The ES Link Waste Module provides greater flexibility for nurses in clinical care workflow and has the following specific benefits to the facility, 1) decreased time spent traveling to and at the ADM to document waste and 2) potential for increased compliance with required wastage documentation.

BD Pyxis CUBIE pockets and drawers – This is proprietary feature to BD Pyxis ES Medstations.

CUBIE pockets are secure, removable pockets that allow Pharmacy staff to securely transport medications between the ADM and Pharmacy. CUBIE pockets can be filled with medication stock within the Pharmacy, utilizing bar code technology for additional safety, and the filled pocket is then delivered to the ADM and loaded into the machine. CUBIE pockets are modular, available in multiple sizes and allow Pharmacy staff to modify the configuration of ADM drawers (number, size of pockets) based on individual unit demand and medication usage reports. Other ADM systems have a set drawer configuration that is determined at initial purchase. Further modification of pockets or drawers requires a vendor visit and additional charges for equipment and labor.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice, 36C261-21-Q-0242, was posted to Opportunities on 1/4/2021. Three (3) vendors responded to the sources sought published to Opportunities. Two (2) of the sources are authorized distributors of Pyxis Machines and SDVOSBs. The manufacturer, Care Fusion LLC, a large business also responded to the sources sought with their capability statement showing they have the ability to quote open market and they also have several SDVOSB/VOSB authorized distributors. All three (3) vendors are authorized and capable of submitting an open market quote.

The appropriate NAICS code of this requirement is 339113 (Surgical Appliance and Supplies Manufacturing). The Small Business Size Standard for the manufacturer is 750 employees. The corresponding PSC is 6515 (Medical and Surgical Instruments, Equipment, and Supplies). U.S. Small Business Administration (SBA) non-manufacturer rule class waiver list searched on 3/10/2020 and does not include a waiver that matches the NAICS 339113, the PSC 6515, and the description of the requirement. The requested supplies/equipment and services are provided by a large business manufacturer and at least two (2) SDVOSB authorized distributors. We cannot set-aside the acquisition for SD/VOSBs because under SBA's rule, SD/VOSB set-asides are not identified as being exempt from the nonmanufacturer rule and the LOS requirements.

A brand name only RFQ will be posted to Opportunites for seven (7) days.

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Revision 11 Date: 02/11/2021

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: It’s anticipated that fair and reasonable pricing will be determinted based on competition.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A sources sought notice, 36C261-21-Q-0242, was posted to Opportunities on 1/4/2021. Three (3) vendors responded to the sources sought published to Opportunities. Two (2) of the sources are authorized distributors of Pyxis Machines and SDVOSBs.

The manufacturer, Care Fusion LLC, a large business also responded to the sources sought with their capability statement showing they have the ability to quote open market and they also have several SDVOSB/VOSB authorized distributors. All three (3) vendors are authorized and capable of submitting an open market quote.

The appropriate NAICS code of this requirement is 339113 (Surgical Appliance and Supplies Manufacturing). The Small Business Size Standard for the manufacturer is 750 employees. The corresponding PSC is 6515 (Medical and Surgical Instruments, Equipment, and Supplies). U.S. Small Business Administration (SBA) non-manufacturer rule class waiver list searched on 3/10/2020 and does not include a waiver that matches the NAICS 339113, the PSC 6515, and the description of the requirement. The requested supplies/equipment and services are provided by a large business manufacturer and at least two (2) SDVOSB authorized distributors. We cannot set-aside the acquisition for SD/VOSBs because under SBA's rule, SD/VOSB set-asides are not identified as being exempt from the nonmanufacturer rule and the LOS requirements.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other facts supporting the use of Other than Full and Open Competition.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Four Points Technology, LLC

DUNS: 089896737

SDVOSB Authorized Distributor

Veterans Healthcare Supply Solutions

DUNS: 964899483

SDVOSB Authorized Distributor

CareFusion, Inc.

DUNS: 832374040

Large Business OEM

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: No other actions need to be taken other than continuing market research to determine if other sources are available to meet the requirement.