FAR_8_LSJ_Signed_Final_GSA_Posting.pdf

Limited Sources Justification and Approval (J&A)

Contracting Activity: Department of Air Force, 502d Contracting Squadron, JBSA Randolph, TX 78150-4525

Purchase Request / Local ID Number: Medical Stock Funds

Program / Project (and PE, if applicable): Roche Reagents and Consumables

Program Type (PEO or Other Contracting): Other Contracting

Authority: Multiple Award Schedule Program (FAR 8.405-6)

Estimated Contract Cost (including options):

Description of Limitation:

IAW FAR 8.405-6(a)(1)(i)(B), requesting the acquisition of a sole source Blanket Purchase Agreement (BPA) to Roche Diagnostics Corp to furnish all labor, materials, equipment, preventive maintenance of equipment, transportation, consumables, installation/removal of equipment and incidental repair services of equipment as necessary to provide and deliver Roche reagents on a cost-per-reportable (CPRR) reagent or cost per kit (CPK) reagent basis in support of performing clinical chemistry and immunoassay analysis on currently utilized Roche Cobas 6000, Modular Pre-Analytics EVO 7 Plus System and Accu-Check Inform II System(s).

COORDINATION (AFFARS 5306.304(a) )

APPROVAL (AFFARS 5306.304(a) )

( See guidance at the end of this document for completing the following sections. )

I. Contracting Activity.

Department of Air Force, Air Education and Training Command, 502d Air Base Wing, 502d Contracting Squadron, JBSA Randolph, is executing this Limited Source Justification for a Blanket Purchase Agreement (BPA) under the authority of FAR 8.405-6(a)(1)(i)(B) on behalf of 59 Medical Wing, Wilford Hall Ambulatory Surgical Center (WHASC), JBSA Lackland, TX and North Central Federal Clinic

(NCFC)

II. Nature and/or description of the action being processed.

This Limited Source Justification will be to establish a new one (1) year Blanket Purchase Agreement with Roche Diagnostics Corp in support of WHASC and NCFC. This action will be utilizing the Veteran Affairs Federal Supply Schedule No. V797P-7347A. The period of performance will be 1 May 2016 - 30 April 2017. The Blanket Purchase Agreement will be established on a firm-fixed price basis.

III. Description of supplies/services required to meet agency needs.

59 MDTS / Laboratory Flight has requested a BPA for one (1) year from 1 May 2016 - 30 April 2017 with a master dollar limit of $475,000.00 and a maximum call limitation of $25,000.00. A certified medical stock funds letter will be used to fund orders for necessary reagents and consumables in support of the chemical and immunoassay analysis testing. This requirement is inclusive of a wide range of chemical and immunoassay reagents and consumables to perform analysis on patients' blood samples to aid in early detection and accurate diagnosis of diseases leading to proper treatment and management of patient care.

List and description of reagents and consumables are attached under Attachment #1.

IV. Identification of the justification/rationale for limiting sources and demonstration of the contractor's unique qualifications to provide the required supply/service.

FAR 8.405-6 requires an ordering activity to justify its actions when restricting consideration of schedule contractors to fewer than required in FAR 8.405-1 or 8.405-2, and it is concluded that IAW FAR 8.405-6(a) (1)(i)(B), “Only one source is capable of providing the supplies/services required at the level of quality required because the supplies/services are unique and highly specialized.”

The San Antonio Military Health System (SAMHS) has made significant investments to the standardization of healthcare. The Wilford Hall Ambulatory Surgical Center as well as the North Central Federal Clinic currently utilize the Roche Diagnostics Corp platform as it pertains to the chemical and immunoassay analysis. Standardization using the Roche platform allows the SAMHS facilities to enhance patient care through the establishment of agreeing normal ranges, improved the quality and reliability of instrumentation and assays, helps to optimize resources, allows for easy expansion and/or reconfiguration, improves inventory control, provides consistent and accurate laboratory results for patients serviced throughout Joint Base San Antonio.

This acquisition is for the establishment of a sole source Blanket Purchase Agreement with Roche Diagnostics Corp to furnish all labor, materials, equipment, preventative maintenance of equipment, transportation, consumables, installation/removal of equipment and incidental repair services of equipment as necessary to provide and deliver Roche reagents on a cost-per-reportable (CPRR) reagent or cost per kit (CPK) reagent basis in support of performing clinical chemistry and immunoassay analysis on currently utilized Roche Cobas 6000, Modular Pre-Analytics EVO 7 Plus System and Accu-Check Inform II System(s).

Market research indicates Roche Diagnostics Corp is the only known source with the capability of providing the reagents and consumables required to implement the chemical and immunoassay testing undertaken by WHASC and NCFC. Roche Diagnostics Corp is the only source that can provide the totality of the requirement from the reagents/consumables to the maintenance of the Roche Diagnostic Corp's equipment, which are currently in place and in use at WHASC and NCFC. No other source can provide the unique and sophisticated requirements.

Furthermore, other comparable clinical chemical and immunoassay analyzer products were considered by the requiring activity because of the integrated clinical chemical and immunoassay platforms and the approximate size/sample test volumes. The results concluded that the other comparable products reviewed could not perform the necessary testing required by the Government, did not utilize the primary tubes as required nor could fit within the clinic without extensive renovation to the facilities. Due to the unique and highly specialized characteristics of Roche Diagnostics Corp's instrumentation and platform analyzer, it provides the required level of quality for the Government as it has the capabilities to perform the entire spectrum of required testing to facilitate the necessary patient analysis to support the San Antonio Military Health System mission.

These chemistry analyzers, Roche Cobas 6000, Modular Pre-Analytics (MPA) Evo 7 Plus Check and Accu-Check Inform II Systems, are fully integrated and combines vital technology on a single platform to perform chemical and immunoassay analysis concurrently. With these unique systems, a sample is passed completely through the system from centrifugation through allocating and analysis to final report. This requirement is inclusive of a wide range of chemical and immunoassay reagents and consumables to perform analysis on patients' blood samples to aid in early detection and prevention of diseases for proper diagnosis, treatment and management. Roche Chemistry Analyzers and reagents have proven to be instrumental to the management of patient care, as they have fully automated the handling and testing of specimens received for chemical and immunochemical analysis. Sample splitting and manual sample manipulation within the serum work area can be avoided, bringing significant improvements in result availability and turnaround time. Pre-analytical automation using the MPA optimizes labor resources the use of barcode technology to provide positive identification, eliminate multiple opportunities for errors, inaccuracy, and significantly reduce exposure of laboratory staff to biohazards. The MPA is customized to work with the workflow and is an extension of the analytic instruments increasing safety of operation and quality of results.

Furthermore, the Government personnel at WHASC and NCFC have been fully trained on using the Roche Diagnostics Corp analyzer systems mentioned above. To replace the existing system with an alternate product would result in additional costs to the Government in the form of time and human resources required to retrain all relevant personnel as expected in the transitioning period.

V. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with

FAR 8.404(d).

Price analysis techniques, outlined in FAR 15.404-1(b), will be conducted to ensure the Government receives fair and reasonable prices in accordance with Class Deviation 2014-O0011 - Determination of Fair and Reasonable Prices When Using Federal Supply Schedule Contracts. Additionally, IAW FAR 8.405-3, discounts will be sought prior to the establishment of the Blanket Purchase Agreement.

VI. Description of the market research conducted and the results, or explain why market research was not conducted.

The Ordering Activity conducted market research utilizing commercial and government databases, including FedBizOpps, GSA Advantage!, Google, Air Force (AF) Advantage, AbilityOne and Dynamic Small Business Search Website. Furthermore, a search was conducted on the GSA Advantage! website, specifically under category 66III, "Clinical Analyzers, Laboratory, Cost-per-Test," Category 605-1A, High Maintenance/Complexity Analyzers. An overview of the vendors, indicates that there are eight (8) schedule contractors, and only one (1) was annotated as a small business. Additionally, chemical reagents were not present on the the AbilityOne mandatory procurement list. As a result, the market research indicates Roche Diagnostics Corp is the only known source with the capability of providing the required testing platform and the reagents/consumables required to implement the chemical and immunoassay analysis required by WHASC and NCFC.

VII. Other facts supporting the justification.

Since Roche Diagnostics Corp provides the complete testing analysis platform (range of tests analysis) required by the Government as explained under Section IV above, Roche Diagnostics Corp's reagents/ consumables must be utilized to maintain the level of quality required by the Government. Roche Diagnostics Corp is the original manufacturer and sole vendor for these products. This manufacturer is the only known source capable of providing the necessary capabilities that the Roche chemical and immunoassay analyzers require due to propriety and compatibility issues. Integrating another manufacturer's brand of reagents into a Roche Diagnostics Corp analyzer does not provide the same quality of results as the Roche reagents as they were specifically designed for the Roche analyzer systems.

Additionally, Roche Diagnostics Corp will not warranty the accuracy or precisison nor provide customer service support for any 3rd party reagents being utilized in the Roche Diagnostic Corp analyzers. Utilizing any other reagents that are not manufactured by Roche Diagnostics Corp will have an adverse impact to our customer delivering an acceptable level of patient care.

VIII. Actions 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.

Until it is determined that the current chemical and immunoassay testing platform (range of tests analysis) required do not meet 59 Medical Wing, Wilford Hall Ambulatory Surgical Center (WHASC), JBSA Lackland, TX and North Central Federal Clinic (NCFC) requirement(s), reagents/consumables must be continued to be procured from Roche Diagnostics Corp. To ensure the above is met, the agency will continue to evaluate the capabilities of other vendors and manufacturers through continuing market research and meeting with other vendors and the demonstration of their products. Continued efforts in this regard will ensure that the Government is receiving the best value at a fair and reasonable price ensuring the Government utilizes the most efficient and economical means possible.

IX. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

X. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.