36C24419Q1187-001.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 3 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C244-19-AP-5037

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Wilmington VA Medical

Center, 1601 Kirkwood Hwy, Wilmington, DE 19805.

PR: 460-19-4-3384-0158

2. Description of Action: This action is being submitted as an emergency request for brand name TCGRx Automated Tablet Packager2 320 system (ATP2).

Order against: FSS Contract Number: V797D-40054

Name of Proposed Contractor: The Chudy Group LLC. DBA TCGRx Street Address: N1671 Powers Lake Road City, State, Zip: Powers Lake, WI 53159 Phone: 262-279-5360

3. Description of Supplies or Services: This brand name request for the ATP2 320 system will provide Pharmacy with an efficient, accurate, state of the art machine that can fill medications for the entire medical facility through already in place automated dispensing cabinets. The automated solution must meet Joint Commission Standards. This will include shipping and handling of the items, pricing at the contracted government rate, and installation and training. Additionally, this shall be a one-time purchase with no option periods to follow.

The vendor will deliver and install 1 each of the TCGRx ATP2 320 system, components include:

ATP2 320 Canisters with unit dose packaging ATP2 Narrow Lower Packaging Unit for ATP2 (includes 1 rolling tray and cover) Canister Calibration Kit including AVF-1 Bullseye Kit (10 canister, database card, barcode scanner, cleaning brush & pen) HEPA vacuum for ATP cleaning HEPA replacement filter ATP2 equipment interface to pharmacy information system On-site implementation and installation training package for ATP series Shipping & Handling included.

VHAPM Part 808.405-6 Limiting Sources Page 2 of 3

Revision 01 Eff Date: 04/23/2018

The estimated value of the proposed action is $178,973.28

The requested item is for use in the ICU, PACU, and GI labs, other areas of the hospital (OR suites, anesthesiology, etc.) already have automated dispensing cabinets installed.

Additionally, this will eliminate our current process that involves a manual packaging machine that lacks automated safety measures that can lead to multiple medication errors if not caught prior to distribution throughout the hospital.

4. Authority:

ORDER AGAINST FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

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;

(FAR 8.405-6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rational/explanation to support cited authority:

The current automated tablet packager is out of service support and has been experiencing unscheduled downtime which has led to increased staffing demands due to manually packaging medications and has resulted in near-misses with medication errors. The TCGRx Automated Tablet Packager (ATP) unit dose packager is the only packager that has the option of having a Lower Packaging Unit (LPU) option. This allows for a redundancy program. The LPU is swappable with the current unit which allows most hardware issues to be resolved in a matter of minutes. It greatly reduces downtime. The canisters that come

VHAPM Part 808.405-6 Limiting Sources Page 3 of 3

Revision 01 Eff Date: 04/23/2018 with the packager are also unique that allows self-calibration of the canisters. With constant change in formulary and drug pricing, this will allow us to self-calibrate the canisters on-site to fit with the changing inventory. We do not have to have a third party re-calibrate the canisters for us. To reduce medication costs, pharmacy is often buying one strength of medication and splitting the tablet to desired strength. The Bullseye automatic tablet splitter is specific to TCGRx that allows for more precise tablet splitting that is automated, which will save on manual splitting.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Ronald J. Kline Darlene Seminko Contracting Officer, NCO4 Branch Chief, NCO4 Date: _______________ Date: _______________

9-11-19