JOFOC_-_Life_Technologies_(Keary_-_May2016).doc

5/18/16 From:

Jodie Keary, Team Lead, Hematology Service, DLM

Subject:

SOLE SOURCE JUSTIFICATION AND APPROVAL

To:

NIH, CLINICAL CENTER, CONTRACTING OFFICER

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

Requiring Activity:

National Institute of Health, Clinical Center, Department of Laboratory Medicine, Molecular Hematology 9000 Rockville Pike

Bethesda, MD 20814

), Administrative Officer

Contracting Activity:

NIH Clinical Center

Office of Purchasing and Contracts

6707 Democracy Blvd

Bethesda, MD 20892

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

This is a sole-source procurement to Life Technologies to supply Molecular Hematology, Department of Laboratory Medicine, Clinical Center, National Institutes of Health with a service contract covering the 3500 Genetic Analyzer s/n 26105-180 for a period of 1 year, from July 8, 2016 to July 7, 2017.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED TO MEET THE AGENCY’S NEEDS

This service contract coverage includes the 3500 Genetic Analyzer with one Computer Workstation (excluding printers), travel expenses and parts (excluding consumable items), for the following:

· A preventive maintenance visit, which will cover over all performance plus Spectral dye calibration and supplies for calibration.

· Certificate of Calibration

· Onsite Priority Response with guaranteed 2-business day response.

· Certification documentation that the instrument is in good working order.

· Labor & Travel Fees must be included for repair and planned maintenance.

· Replacement Parts are covered under the agreement - All parts are certified and guaranteed to optimize instruments performance and reliability.

· Quick telephone response for technical questions at no additional cost.

· Cover the computer and computer hardware replacement.

4. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION.

X FAR 13.106-1(b) (1): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available (e.g. urgency, inclusive licensing agreements, brand name, or industrial mobilization).

FAR 13.501 (a) (1) (ii) &2(i): For actions for commercial supplies or services greater than the SAT but not exceeding $6.5M, the citation is: Test Program for commercial Items, Section 4202 of the Clinger-Cohen Act of 1996.

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED Life Technologies does not authorize any third-party service provider to perform maintenance and repair on Life Technologies instruments. Life Technologies is the only manufacturer authorized service provider for LT instruments. Life Technologies maintains IP rights to its collection software and service tools software. Third party resellers and service providers are strictly prohibited from accessing, using or selling this software.

Only Life Technologies service engineers go through a multi-step process in order to obtain factory certification to work on LT instrumentation and software. This certification is renewed every two years to ensure that service engineers maintain this standard of excellence.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE

In accordance with FAR 5.203, an announcement will be publicized on the Federal Business Opportunities website at www.fedbizopps.gove, stating the intent to enter into sole source procurement with the Life Technologies. Since no other entity is authorized to work on this instrument, no other offers will be considered

7. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. A fair and reasonable determination is made based on the cost of not having a service contract. To go without a service agreement or contract would risk prolonged down time, increase the risk of erroneous results due to preventable performance issues and prolong diagnosis for our patients.

8. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED

Life Technologies is the sole manufacture and servicer of this instrument. They do not authorize any other party to perform serve, nor do they license the proprietary software needed to complete the service to any other vendor.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPEN COMPETITION.

In accordance with FAR 6.303-2(iii), the nature of harm that would be brought to patient care and NIH CC DPM if NIH does not have continuity of service in place would be that NIH CC patients could stand the risk of not receiving the best possible treatment. The health care providers and investigators, to diagnose and provide treatment, for NIH patients, use the results obtained with this instrument. Many of these patients are here at the NIHCC for research/testing due to their unique conditions/diseases. Any delay in service would exponentially delay the reporting of critical patient results and possibly delay patient care. Any reduction in maintenance and service of this instrument would risk laboratory certification by causing the laboratory to be cited as failing to be compliant to laboratory guidelines established by the College of American Pathologists Accreditation Agency, The Joint Commission, and CLIA.

10. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THE ACQUISITION.

Life Technologies does not license any third party to work on their instruments with proprietary software.

11. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE REQUIRED SUPPLIES OR SERVICES.

There are no plans to acquire service for the 3500 Genetic Analyzer except from the offerings of Life Technologies. They are the sole vendor who provides the supplies needed for the instrumentation. By attempting to use other vendors, there is risk of damage to the instrument, as well as invalidating the data generated.

12. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Kathy Hilburn Administrative Officer

13. CONTRACTING OFFICER’S CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”.”

[NAME AND SIGNATURE]

Contracting Officer