Project Title: Purchase of Pharmacy TPN/Dialysis Compounder

Department: NIH Clinical Center,
Pharmacy Department

Project Officer: CAPT Richard DeCederfelt,
Chief, Pharmaceutical Procurement Section, Pharmacy Department
NIH Clinical Center

1. Background

1.1 The Clinical Center (CC) is the clinical research facility of the National Institutes of Health (NIH) and serves as the premier center for clinical research. It provides patient care, services, training, and the environment in which NIH clinicians-scientists translate emerging knowledge into the better understanding, direction, treatment, and prevention of human diseases. The CC, through NIH's Intramural Research Program, provides patient support services for the 15 NIH Institutes that admit patients and health volunteers for the purpose of participating in the more than 1,000 intramural biomedical research studies that cover a wide spectrum of common and rare diseases. More information about the NIH Clinical Center may be found at http://clinicalcenter.nih.gov.

1.2 The CC Pharmacy employee's approximately 45 staff inpatient and outpatient pharmacists and approximately 35 staff inpatient and outpatient pharmacy technicians. The inpatient section is further divided into Unit Dose and IV Additive Unit. The pharmacy is open 24 hours a day, seven days a week. Pharmacists and pharmacy technicians cover approximately 30 or more different shifts during this time period. The Unit Dose section of the Pharmacy Department dispenses, on average, 40,000 unit dose medications per month. The IV Additive Unit is responsible for the compounding of any total parenteral nutrition (TPN) and dialysis preparations. On average, the unit has 12-15 patients on TPN and potentially 2-4 patients on complex dialysis solutions. An automated compounder is critical to the manufacture of these items which cannot be made manually.

1.3 Currently the Pharmacy Department leases a Baxter EXACTAMIX 2400 compounding system for preparation of all TPN solutions (EM2400). This unit is also utilized on an as needed basis to assist in the compounding of certain dialysis solutions.

2. STATEMENT OF OBJECTIVES

2.1 This request is for a new lease contract for a TPN automated compounder for the duration of no less than 1 year with the inclusion of 4 option years

3. STATEMENT OF WORK

3.1 Automated compounder capable of TPN manufacturer as well as cardioplegia and continuous renal replacement therapy (CRRT).
3.2 Interface with TPN calculation software

4. Specific Requirement

4.1 24 lead compounder (plus a back-up) capable of pumping 24 separate ingredients
from plastic, glass or syringe containers.
4.2 System offers on-site training for compounder
4.3 Interfaces with ABACUS TPN Calculation software
4.4 Perform gravimetric check following compounding operation.
4.5 0.2ml minimum pumping volume
4.6 Self-calibrating pump
4.7 Ability to detect air and occlusion within the tubing sets.
4.8 Electronic Y-sites to minimize source container changeovers.
4.9 Warning indicator for incompatible mixing sequences.
5. Integrated scale to weigh product.
6. Closed system type.
6.1 System must be able to produce a record of mixing activity for audit and quality assurance purposes.
6.2 System can track component Lot numbers and expiration dates
6.3 Calibration report produced by the system meets United States Pharmacopeia Chapter 797 recommendations (USP 797).
6.4 System to utilize a laser barcode reader (plus back-up) to verify additive components and final product label.
6.5 System to utilize color monitor (plus back-up)
6.6 System to include an electronic weight scale (plus back-up)
6.7 System interfaces with printer for report generation
6.8 System must be capable of generating a zebra or equivalent type label
6.9 Software must be compatible with Microsoft Windows operating system
7. Systems barcode reader shall be able to interface with current medication order entry system.
7.1 System shall include dedicated computer for operation with color capable
monitor.
7.2 Lease contract for compounder that also includes the ability to purchase any necessary supply items

5. Deliverables
5.1 Lease contract renewal with ability to continue to use current compounder on site.

6. Period of Performance
6.1. Base Period September 7, 2016 through September 6, 2017
6.2. Option Year 1 September 7, 2017 through September 6, 2018
6.3. Option Year 2 September 7, 2018 through September 6, 2019
6.4. Option Year 3 September 7, 2019 through September 6, 2020
6.5. Option Year 4 September 7, 2020 through September 6, 2021

7. Selection Criteria
7.1. Product compatible with department's current ABACUS compounding software. 20 points
7.2. Vendor's product meets above requirements concerning TPN compounding.
20 points
7.3. Vendor's product can be leased for a period of 1 year with additional renewals up to a maximum of 5 total years.
20 points
7.4. Past performance of packager as evidenced from previous clients going back 3 years
30 points
7.5. Best value to the NIH including lease price, terms and conditions, supply item pricing and any applicable discounts.
10 points

9 Include the following information for each contract or subcontract:

Name of contracting organization
Contact number (for subcontracts, provide the prime contact number and the subcontract number)
Contract type
Total contract value
Description of requirement
Contracting Officer's name and telephone number
Program Manager's name and telephone number

10 Each offeror will be evaluated on its past performance under existing and prior contracts for similar products and services. Performance information will be used for both responsibility determinations and as an evaluation factor against which offeror's relative rankings will be compared to assure the best value to the Government. The Government will focus on information that demonstrates quality of performance relative to the size and complexity of the acquisition under consideration.

11 The Government is not required to contact all references by the offeror. Also, references other than those identified by the offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the offeror's past performance.

12 The vendor scoring the highest point total will be awarded the contract.