P03 LSJ Redding 57 Pills Machine Redacted.pdf

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

VHAPM Part 808.405 6 Limiting Sources Page 1 of 4 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: 36C261 20 AP 4262

(1) Contracting Activity: Department of Veterans Affairs Program Contracting Activity Central (PCAC) is procuring this proposed action on behalf of VA Northern California Health Care System for the activation of the new Redding Community Based Outpatient Clinic (CBOC). The assigned 2237 for this acquisition is 612 20 3 775 0085.

(2) Description of Action: Justification and approval for the purchase of Synmed automated blister card machine required for the Pharmacy Integrated Locally Labelled Supply (PILLS) program.

Order against: FSS Contract Number: V797D 36F79720D0022 Name of Proposed Contractor: Synergy Medical USA Inc.

Street Address: 2915 Ogletown Rd. Suite 2565

City, State, Zip: Newark, DE 19713

Phone: 816 589 4455

(3) Description of Supplies or Services:

The estimated value of the proposed action is

This acquisition is for the purchase of the SynMed XF system, SynMed Image module, and SynMed assist. These are commercial items available through the above VA issued federal supply schedule. The SynMed XF system is a pharmacy automation system that dispenses solid oral medications into blister packs to organize patient medication into a calendar for safe and accurate dosing. The use of blister packs has been shown to increase patient adherence to prescriptions. SynMed XF uses Pick & Place technology to fill fifty five doses per minute, which translates to approximately eighty five single dose cards per hour or thirty multi dose cares per hour, depending on the number of prescriptions per patient.

VHAPM Part 808.405 6 Limiting Sources Page 2 of 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

Item Description/Part Number* Qty

1SM9900 SYNMED XF SYSTEM Consisting of the following items: 400 calibrated containers, complete set of calibrated covers for containers, SynSoft Software from Synergy Medical, Dell Optiplex series with monitor, Wireless Honeywell barcode scanner, Lexmark black and with laser printer, Zebra thermal printer model TLP2824 plus, Biometric unit, and two positioning trays 1

1SM9910 SYNMED IMAGE MODULE Consisting of the following items:

Lexmark color laser printer, Medication image update 1

1SM9911 SYNMED ASSIST Consisting of the following items: Dell OptiPlex All In One, Biometric unit, Honeywell barcode scanner 1

4 Installation 1 5 Training – three days of onsite training for two operators 1 6 One Year Warranty and Service Package 1

(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; Synergy medical is the sole supplier of Synmed Blister Packing System. The Synmed Blister Packing System is the only completely automated system that operates with the use of negative pressure. Use of negative pressure is required when dispensing medications on the USP800 list. VANCHS intends to use the system to dispense USP800 listed medications.

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.

VHAPM Part 808.405 6 Limiting Sources Page 3 of 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

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

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

Additionally, the manufacturer is the only source capable of satisfying the requirements.

(6) Describe the Market Research Conducted: A Notice of Intent to Sole Source was posted to Beta.Sam. No responses were received. The manufacturer was also contacted to inquire if there were any authorized distributors for the required equipment. The manufacturer confirmed they had no authorized distributors and stated they are the only capable source of providing the required equipment.

No other manufacturers meet the government requirements, such as the need for large blister cards, speed at filling the cards, accuracy reports with medication errors, compliance with USP 800 standards, multiple storage systems that can hold larger tablets and capsules for continuous fill.

Most Automated pill packing systems are built to suit Long term care facility needs. Synmed is built specifically for outpatient pharmacy needs.

(7) Any Other Facts Supporting the Justification: None

(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: The government can continue to monitor the marketplace for similar equipment using Requests For Information (RFI) to verify if any competition exists for the subject equipment.

(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 DATE

Carl Chaker / Program Manager Office of Assoc Director Redding CBOC

NAME AND TITLE SERVICE LINE/SECTION FACILITY

Carl Chaker 955558 Digitally signed by Carl Chaker 955558 Date: 2020.08.24 09:24:33 -07'00'

VHAPM Part 808.405 6 Limiting Sources Page 4 of 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

(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 DATE

Roberto Dejesus, Contracting Officer Program Contracting Activity Central

NAME AND TITLE FACILITY/NCO/PCO

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

Grace Kelly Burnsworth, Supervisory Contract Specialist

NAME AND TITLE

Program Contracting Activity Central

FACILITY/NCO/PCO

Roberto DeJesus 694052

Digitally signed by Roberto DeJesus 694052 Date: 2020.08.24 14:07:21 -04'00'

Grace E. Kelly-Burnsworth 1384242

Digitally signed by Grace E. Kelly- Burnsworth 1384242 Date: 2020.08.24 15:27:57 -04'00'