LSJ-Roche.pdf

Limited Source Justification

"Source Selection Information - see FAR and

Identification of the agency and contracting activity.

a. Federal agency and contracting activity. Institutes of Health Clinical Center

b. Sponsoring organization. Clinical Center, Dept. of Transfusion Medicine, Infectious Diseases Section (IDS), Transfusion-Transmitted Viruses Lab. (TTV) Lab.

c. Project Officer information.

• Project Officer name. Joni Trenbeath/Lacey Gholson (Alt)

• Mailing address. 10 Center Dr.,

• E-mail lghoson@cc.nih.gov

• Telephone number.

2. Nature and/or description of the action being approved. Provide the following information:

a. Acquisition purpose and objectives. The purpose of this acquisition is for the Transfusion-Transmitted Viruses Laboratory (TTV) Lab. to purchase various reagents and consumables on an as needed basis for various blood testing. These tests are used to monitor the disease status of NIH Clinical Center patients who have Hepatits C (HCV), Hepatitis B (HBV) and/or to determine disease states and drug effectiveness. These supplies are proprietary and must be used with the respective Roche COBAS ®

Roche COBAS ® instrumentation.

b. Project background. The TTV Laboratory performs testing on NIH Clinical Center patients on protocols to screen for Hepatitis C, Hepatitis B and HIV as well as monitor disease states of these viruses. These tests are critical for managing these patients drug regimen. order to support the demands for patient care and research testing, we must have enough resources on hand to support the increasing workload. Without an adequate supply of the necessary proprietary reagent kits and supplies, we would not be able to provide critical hepatitis and HIV results in a timely and usable manner.

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

a. Project title. Reagents, kits and consummates for the Roche COBAS ® and/or Taqman, for the Department of Transfusion Medicine

Project description. Our laboratory can incorporate specialty and routine workloads improving productivity and efficiency. The proposed vendor, Roche Diagnostics Corp., is the sole manufacturer, vendor, and service provider for the COBAS (Serial # 393359) and COBAS ® Taqman 48 (Serial # instrumentation and its The Roche system is not sold in the US by any distributors or other third parties. They have proven reliability and offer specific automated assay testing. Roche Diagnostics is the only vendor who manufactures supplies that can be utilized on the testing instruments, the Roche COBAS ® and the Roche COBAS ©Taqman. And the test kits are specific for the existing instruments. Since the supplies are proprietary to the instruments, there is only one supplier whose products can be utilized on the instrumentation; any other supply or service could cause the cancellation of the protocol/delays in completion of the protocol. These reagents are validated for use on laboratory equipment already validated and in use in the TTV laboratory. No other manufacturer's reagents or consumables for these assays can be used on this instrumentation. In order the physicians to analyze the results of these tests, we must compare values to different dates but on the same assays. It is difficult to compare results based on different assays for continuity of care.

Any other reagent would have to be validated and different instrumentation would have to be purchased in order to use different reagents. This would take many months and additional monies to validate. Also, the Roche COBAS ® Taqman 48 was the first platform that had an HCV licensed assay when we were looking at instrumentation for performing testing. Shortly thereafter they licensed the HBV Test as well. There were other platforms out on the market;

however, none of them at the time had licensed assays. Licensed assays are the preferred assays to use in a CLIA certified laboratory when available.

FDA laws require CLIA laboratories to utilize licensed assays when they are available. Once other platforms and tests were available, we had already validated all of the three assays (Roche COBAS ® Ampliprep HIV, HCV and HBV assays).

• Requirement type. Check the appropriate box:

•Support services (non-research & development) X Supplies/equipment Q Information technology (IT) X Other (specify): via a rental reagent agreement_

• Type of action. Check the appropriate box:

• New requirement Q Follow-on X Other (specifvV Recurring need for specialized supplies

• Proposed contract/order type. Check all that apply:

• Firm-fixed-price

• Time and materials

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

• Other (specify):

• Acquisition identification number. POTS 16-000003

b. Total estimated dollar value and performance/delivery period.

The period of performance for this delivery order is for a twelve month base year and six month option period. The estimated yearly spend for product need is $438,785.56. The total value of the delivery order with the option period shall not exceed $700,000.

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

a. Acquisition authority. Check the applicable block below based on the acquisition circumstance.

• 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 F S S 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(a)(2) [see FAR 8.401 and 8.405-6(g)(1)].

b. Demonstration of the proposed contractors) unique qualifications to provide the required supply or service. Provide the following information, as applicable:

Name and address of the proposed contractor(s). Roche Diagnostics Corp., D. Dawson, Sr. Molecular Acct. Mgr., Hague Rd., PO Box 50457, Indianapolis, IN 46250-0457. Email:

david.dawson@roche.com

c. Nature of the acquisition and proposed unique qualifications. Continuation of Patient Care. These reagents are currently validated for use on laboratory equipment already validated and in use in the TTV Laboratory. The instruments are: COBAS ® Ampliprep (Serial # 393359), and COBAS ® Taqman 48 (Serial # These reagents and consumables can only be used on these equipment. No other source manufactures reagents for these assays that can be used on this instrumentation. In order for the physicians to analyze the results of these tests, they must compare values to different dates but on the same assays. It is difficult to compare results based on different assays for continuity of care.

Any other reagents would have to be validated with different instrumentation purchased. This would many months, SOP changes, retraining, and additional funding.

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 CO will conclude that the order represents the best value (see FAR and results in the lowest overall cost alternative. Additional discounts lower than the GSA rate will be requested from the vendor. We have seen an unexpected increased in testing for Hepatitis C over the last few months which depleted our monies for purchasing all Roche reagents. Our reagent inventory is based on historical knowledge of tests per month

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market was not conducted.

Due to the requirements for Roche COBAS ©Taqman, the Roche COBAS ©Ampliprep, the reagent kits and associated supplies, aside from senior staff researching the current market of instrumentation, additional market research was not conducted. This is due to the fact that they are the only makers of the proprietary reagents in specialized packaging that will fit these instruments. In order to ensure that the maximum number of vendors are notified of the intent to the sole source, the RFQ will be posted to e-Buy along with a justification as required by FAR 8.405-6(g). Additionally, no other reagents or consumables can be used as the supplies in conjunction with the instrument have been validated within the TTV Laboratory.

7. Any other facts supporting the justification. The Roche COBAS Taqman, reagents inventory is specific for the respective instruments indicated and are required by the laboratory accreditation certifying agency that manufacturer guidelines are followed for reporting patient results.

Therefore, any attempt to switch the designated reagent supplier could cause erroneous patient results and cause the laboratory to be cited as failing to be compliant with laboratory guidelines established by the College of American Pathologists Accreditation Agency. 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. There are no plans to change the Roche platform used for this hepatitis and HIV testing in the Transfusion-Transmitted Virus Lab. (TTV) Lab. At this time, due to the proprietary nature of the requirement, there are no other known vendors that can deliver the stated supply. Continued market research will be done to locate alternative sources if feasible. No future purchases will be sought without additional market research.

b. Listing of sources, if any, that expressed an interest, in writing, in the acquisition. No other sources have expressed an interest, in writing, in the proposed acquisition.

9. Program office certification..

This is to certify that the 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 Signature Date

Project Officer Joni Trenbeath, COR & Supv. Med. Techno!., TTVL, P

Project Officer's Immediate Supervisor

Dr. Harvey Alter, Atg.

Chief, Inf. &

Section

••3

Head of the Sponsoring Program Office

Dr. Harvey Klein, Chief, Dept. of Transfusion

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

F Chief of the Contracting Office and Head of the Contracting Act vity signature(s).

12.

Official Name & Title Signature Date

Chief of the Contracting Office

Head of the Contracting Activity