LSJ-Roche_COBAS_Reagents-DLM.pdf

Limited Source

"Source Selection Information - see FAR 2.101 and

Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS, National Institutes of

Health

b. Sponsoring organization. Clinical Center (CC), Department of Laboratory Medicine (DLM)

c. Project Officer Information.

• Project Officer Name. Cheryl Johnson

Mailing address. CC, DLM, Bethesda, M D 20892

• E-mail

Telephone number. 301-496-1299

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. Approval of a task order for Roche Diagnostics Corporation in Indianapolis, Indiana is needed for the operation of the government owned Roche AS 6000 system, proprietary reagents, calibrators, quality control materials, and required laboratory consumables. The existing instrumentation system is important for patient care testing and research protocols for the monitoring of various diseases and compliance to treatment plans to ensure optimum patient care and safety.

b. Project backg round. The Department of Laboratory Medicine provides state-of-the-art laboratory testing in support of the National Institutes of Health as well as a center of excellence in research and training in laboratory medicine.

This instrument contains a platform of over 40 different test methodologies in the Chemistry Service to meet the demands of high volume workloads and rapid turn around times for Immunoassay testing. In order to support these demands, we must have sufficient resources to support the increasing patient care workload and research needs. Without an adequate supply of the necessary proprietary reagent kits and laboratory supplies, we wi l l not be able to provide patient results in a timely, efficient manner required. The alternative plan would be to send out patient care testing requests to a reference laboratory. This would cause an increase in the departmental expenditure costs impacting the financial budget of the National Institutes of Health and patient care treatment.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value). :

a. Project title. Reagents and laboratory consumables for the ROCHE COBAS 6000 instrumentation system for the Department of Laboratory Medicine.

b. Project description. The proposed vendor, Roche Diagnostics, Corp., is the sole manufacturer, vendor, and service provider for the COBAS The system is not sold in the US by any distributors or other third parties.

The COBAS 6000 has proven reliability and offers a large automated immunoassay menu. Our laboratory can incorporate specialty and chemistry testing into routine workloads improving productivity and efficiency. Roche Diagnostics is the only vendor who manufactures supplies that wi l l into the existing government owned testing instrument, COBAS 6000 Immunoassay System. These kits are specific for the existing instrument and cannot be exchanged with another vendor.

Since the supplies are proprietary, there is only one supplier whose products can into the instrumentation; any other supply or service could cause the cancellation of the protocol/delays in completion of the protocol.

This would cause unwarranted expenditure/waste of very limited Government research funds.

c. The Roche Cobas instrumentation package consists of the government owned Roche Cobas 6000 analyzer series c501/e601, calibrators, quality control materials, laboratory consumables, middleware manager software, and personnel training provided at no extra charge. The Roche reagents w i l l be purchased at the agreed pricing stated in the annual contractual agreement which wil l include all the equipment preventive maintenance and technical support service costs.

. Requirement type.

• Support services (non-research & development)

Ef Supplies/equipment

• Information technology (IT)

• Other (specify):

• Type of action. • New requirement

• Follow-on Ef Other (specify): need for specialized supplies

• Proposed contract/order type. Ef Firm-fixed-price

• Time and materials

• Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements):

• Other (specify):

• Acquisition identification number.

c. Total estimated dollar value and performance/delivery period. The dollar value of the acquisition is estimated at 600,000. The award is intended to be made for one base year, and one twelve month option period. Each performance period is intended to spend approximately

4. Identification of the justification rationale [see 8.405-6(a) and (b)j and, if applicable, a demonstration of the proposed contractor's unique qualifications to provide the required supply or service.

a. Acquisition authority.

• This acquisition is conducted under the authority of the Multiple Award Schedule Program. Consideration of schedule contractors will be restricted to fewer than the number required by Federal Acquisition Regulation (FAR) 8.405-6(a)(1) [see FAR 8.401, 8.405¬ 1, 8.405-2, 8.405-6(b), and 8.405-6(g)(1)] (i.e., fewer than three FSS contractors).

This acquisition is conducted under the authority of the Multiple Award Schedule Program. Consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer as provided in FAR 8.405-6(b)(1).

b. Demonstration of the proposed unique qualifications to provide the required supply or service.

• Name and address of the proposed

Roche Diagnostics Corporation, Hague P.O Box 50457, Indianapolis, IN 46250-0457

• Nature of the acquisition and proposed contractor(s) unique qualifications. Due to the reagent consumables needed for the existing government equipment for the COBAS 6000, Roche Diagnostics is the only vendor that can deliver the reagents and supplies needed to into the existing Immunoassay system.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d). Pricing will be evaluated prior to award for the proposed acquisition. By placing an order against a schedule contract using the procedures in FAR 8.405, the ordering activity Contracting Officer has concluded that the order represents the best value (see FAR 2.101) and results in the lowest overall cost alternative. Additional discounts lower than the GSA rate wi l l be requested from the vendor. The Roche Cobas 6000 reagents and consumables and equipment are proprietary.

6. Description of the research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted. Due to the requirements for the Roche COBAS 6000 reagent kits and associated consumable supplies, aside from senior staff researching the current market of instrumentation, additional market research was not conducted, This is due to the fact that the Roche manufacturer are the sole source of the proprietary of reagents which are in specialized packaging that only into the existing government owned Roche COBAS 6000 instrumentation. In order to ensure that the maximum number i f vendors are notified of the intent to the sole source, the RFQ wil l be posted to e-Buy (http://www.ebuy.gsa.gov) along with a justification as required by FAR 8.405-6(g),

7. Any other facts supporting the justification. The Roche Cobas 6000 platform is FDA approved and meets the established laboratory standard of acceptability.

Therefore any attempt to switch the designated reagent supplier would cause erroneous patient results and possibly cause the laboratory to be cited as being noncompliant to the laboratory guidelines established by the College of American Pathologists Accreditation Agency (CAP). Laboratory results are used by the health care providers and investigators to diagnose and provide treatment for NIH patients.

8. 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.

a. Removal of barriers to competition. At this time, due to the proprietary nature of the requirement, there are no other known vendors that can deliver the stated supply,

b. Listing of sources, if any, that expressed an interest, in writing, in the acquisition. There have been no other sources that have expressed an interest in this procurement,

9. Program office certification.

is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government's minimum needs or requirements, or other rationale for limited sources, are accurate and complete.

Official Name & Title

Project Officer

Cheryl D, Johnson, Immunoassay Team Leader Cheryl D. Johnson

5/12/16 Cheryl D, Johnson, Immunoassay Team Leader D, Johnson, signed PIV

Project Officer's

Immediate Supervisor

Jacqueline Ollver-Danna

Chemistry DLM Chief Tech

Head of the Sponsoring

Program Office

MD

Chief, DLM

Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Barbara J, Taylor