P03 PM_Part808.405-6__MPT-SAT.pdf

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

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DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C241-20-AP-1099

1. Contracting Activity: Department of Veterans Affairs, VISN 01, WRJ Medical Center 405-20-3-7077-0081.

Nature and/or Description of the Action Being Processed: The Pharmacy Service at the VA Medical Center, White River Junction VT (VAMC WRJ), requires updated medication automation to help reduce human error and to improve patient care. This purchase is to acquire an automated unit dose packaging machine capable of providing the Pharmacy with an efficient, accurate, state of the art machine to pre-package unit dose medication for distribution to veterans at the White River Junction VA Medical Center facility.

2. Order against: FSS Contract Number: _36F79720D0106

Name of Proposed Contractor: The Chudy Group LLC dba TCGRx Street Address: N 1671 Powers Lake Rd City, State, Zip: Powers Lake WI 53159 Phone: (262) 279-2372 X2380

3. Description of Supplies or Services:

The estimated value of the proposed action is $ 129,807.69

The ATP (Automated Tablet Packager) will provide medication fill throughout the entire medical facility through a 24-hour cart fill and to stock unit-dose medications in our automated dispensing cabinets (ADC). This technology is critical to supporting the VA Mission of providing “Excellence in Healthcare,” equipping the VAMC White River Junction Pharmacy to provide the highest level of customer service to other health care providers and our patients. The requested equipment will meet standards no less than that of the ATP – 192 Mini Narrow and ancillary items from TCGRx.

Specific components for the desired ATP System include: Automated Tablet Packager (ATP2/ATP MINI), 192 Canisters with Unit Dose or Multi-Dose Packaging, 1- HEPA Vacuum for ATP Cleaning, 1- HEPA Replacement Filter, 1- Light-up Tray (ULT) System, ULT Docking Station, ULT Client, Scanner, Touch Screen, Biometric Adjustable Leg Kit, 3 ULT- 64 trays, 1-Canister Calibration Kit, 1-Wide Lower, Packaging Unit (LPU), Include 1 Rolling Tray and Cover, 1- Spool System Automatic Spooler, 1 Tabletop Stand, 1 Rolling Stand, 1 Case of Acrylic Spools, ATP Workflow Unit, 2 Bay Workstation, Biomed Training, On-Site Clinical Training, On-Site Implementation and Installation, and One-Year Warranty.

Revision 01 Eff Date: 04/23/2018

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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. Justifications are listed below:

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

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

5. Rational/explanation to support cited authority:

The ATP system was selected per FAR 8.405-6(b)(1), due to its peculiar technology that meets the performance requirements established by the Pharmacy at VAMC White River Junction VT, and due to greater reliability and efficiency when compared to competing automated tablet packagers in the market. In addition, ATP best interfaces with the Pyxis MedStation ES currently in use at the Pharmacy.

The proposed ATP System will afford efficiency by enhancing current medication dispensing capabilities, reducing risk, downtime, and the time expended for manual medication dispensing. The ATP System also affords economy by reducing costs of carrying additional inventory as it enables multiple and continuous dispensing. ATP reduces waste by increasing accuracy via “light-guided,” automated medication dispensing.

The ATP System is more reliable, more efficient, and more economical than comparable brand equipment such as the Pyxis PharmoPack Unit Dose Packager and the Omnicell Proud Unit Dose Packager. Pyxis and Omnicell are large business manufacturers:

Pyxis PharmoPack:

Consumer complaints for the Pyxis PharmoPack indicate a high level of inaccurate pill dispensing, pill/pouch melts from overheating, packaging paper misalignment, high level of unresolved service calls, inflexible sequencing format requiring additional time for manual sorting, inflexible sequencing for dispensing multiple NDCs (National Drug Codes), manual post-production inspection.

ATP:

ATP systems are highly reliable, allowing flexibility in moving, sequencing, and programming multiple canisters for dispensing of multiple NDCs; and for automatic post-production inspection and recordkeeping with the InspectRx Vision System.

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))

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular 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)).

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Omnicell Proud Unit Dose Packager:

Consumer complaints for the Omnicell Proud Unit Dose Packager include ordering inefficiencies when reordering canisters for NDC changes, software complexities leading to difficulty in incorporating NDC changes or additions, expensive micro-chip technology that limits canister placement, workflow stoppage due to hardware failures, lacks capability to package in a continuous strip, inefficient batch packaging, pill crumbling, and manual post-production inspection.

ATP:

ATP Systems afford flexibility in canister placement, batch sequencing and packaging, user-friendly software easily accommodating NDC changes, affordable ATP2 smart-chip technology affording versatility in canister placement, and for automatic post-production inspection and recordkeeping with the InspectRx Vision System.

Market research indicates that the ATP is limited in the open market. Traditional market research was conducted in accordance with established precedence: VetBiz, Mandatory Sources, SAC, NSSL, NAC, GSA Advantage, GSA E-Library, and the SBA database. In Accordance With (IAW) VAAR 819.7005, 819.7006, and 810.001-70 (Veterans First Contracting Program), no responsible/capable SD/VOSBs were capable of supplying the ATP System. No mandatory sources were deemed capable of fulfilling this requirement IAW FAR 10.001 and FAR 8.002.

Market research was expanded to non-mandatory sources, specifically small business vendors holding GSA FSS contracts. The FSS search located one small business schedule holder: The Chudy Group LLC dba TCGRx capable of supplying the specific ATP brand system. The SBA (Small Business Administration) search revealed no capable sources, other than TCGRx.

The Chudy Group was contacted regarding product features and the distribution status for the ATP System.

Solicitations were not issued as the TCGRx/ The Chudy Group LLC has issued a sole source letter stating that they are the sole distribution source for the ATP product TCGRX is the only responsible source that can fill this requirement via the new FSS Contract: 36F79720D0106. IAW FAR 8.405-6(a)(1)(B) supply capability is unique to TCGRx.

The Chudy Group LLC’s new FSS contract/pricing schedule for the ATP system via Schedule 65II A (Medical Equipment & Supplies), SIN A-92 (Medication and Supply – Packaging and Dispensing Equipment), was awarded 04/01/20. This new FSS contract ends, 03/31/25. TCGRx has provided pricing discounted off the new FSS Contract: 36F79720D0106, to the expiring FSS Schedule pricing: V797D-40054. This pricing provides the best value to the Government, as it provides a discount of $38,602.31 (22.92%) in comparison to open market prices. The Chudy Group LLC is also willing to provide an additional discount of $17,228.54 (12.05%), by discounting the current price index for the new FSS Contract: 36F79720D0106 to the pricing index for the old FSS Contract: V797D-40054.

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). Sole source small business manufacturer; no solicitation issued on e-Buy.

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.

Pharmacist, WRJ VA: Date: 04/30/20 Contracting Officer

Linda J. Ward

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