Redacted_Immucuor_Reagent_J_and_A_PostAward_Redacted.pdf

FA5000-15-R-0040

Immucor Blood Bank Reagents

INDIVIDUAL JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

I. CONTRACTING ACTIVITY

673d Contracting Squadron, Joint Base Elmendorf-Richardson (JBER), AK 99506

II. NATURE AND/OR DESCRIPTION OF THE ACTION BEING PROCESSED

A new, firm-fixed-price, Indefinite Delivery Indefinite Quantity (IDIQ) requirements contract award is anticipated for the delivery of Immucor blood bank reagents required for the Immucor Galileo Echo Analyzer. The contract ordering period is valid for five years at an estimated value of

III. DESCRIPTION OF THE SUPPLIES/SERVICES REQUIRED TO MEET THE

AGENCY’S NEEDS

All reagents provided must meet the following standards:

1. The reagents and supplies requested are required for current established test methods for all Immunohematology tests for ABO/Rh, antibody screen, compatibility testing, antibody identification, phenotype, elution, enzyme treatment of test and patient cells in preparation of specialized tests, direct and indirect antiglobulin tests, neutralizations, quality control to ensure reagents meet regulatory requirements to provide safe transfusion therapy and provides accurate results in determining patient therapy.

2. All reagents must follow regulations stated in the FDA's Current Good Manufacturing

Practices (CGMP), and will be produced, processed, packaged, distributed, and stored in accordance to the CGMP, and will be labeled in accordance to FDA standards (21 CFR Part 864;

Part 864). The vendor shall make deliveries as specified per the provided shipment schedule.

IV. STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN

COMPETITION

41 U.S.C. 1901 as implemented by FAR 13.501(a)(1)(ii) 10 U.S.C. 2304(c) as implemented by FAR 6.302-1 “Only one responsible source and no other supplies or services will satisfy agency requirements.”

V. DEMONSTRATION THAT THE CONTRACTOR’S UNIQUE

QUALIFICATIONS OR NATURE OF THE ACQUISITION REQUIRES THE USE OF

THE AUTHORITY CITED ABOVE (APPLICABILITY OF AUTHORITY)

The Joint Base Elmendorf-Richardson requires the purchase of the sole sourced reagents in order to continue use of the purchased Immucor Galileo Echo Analyzer. The purchased the Echo Analyzer in June 2012 and the analyzer has a life expectancy of ten years.

The above mentioned system is an FDA approved 510K compliant analyzer that is used to perform blood banking testing, to include blood type (ABO/Rh), antibody screens, antibody identifications, and red blood cell antigen typing. These tests are required testing for safely transfusing patients with blood products and are required per regulatory agencies to include FDA, American Association of Blood Banks, College of American Pathologist, and the Joint Commission. Per the FDA approved application, the Echo analyzer requires use of only the reagents that are listed in the Galileo Echo Operator Manual (ECO-001-101).

Only One Responsible Source (FAR 6.302-1)-Based on the FDA 510K approval, only Immucor reagents are authorized to be used on the Echo Analyzer.

VI. DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS DEEMED PRACTICABLE

Market research showed that Immucor, Inc. is the only potential source for this requirement.

VII. DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND REASONABLE

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable by comparison with previous and current pricelists and similar commercial and Government contracts and/or pricelists for the same or similar items. Certified Cost or pricing data will not be required in accordance with 15.406-1(c)(3). However, Other Than Cost or Pricing Data is being requested IAW FAR 15.403-3(a)(1)(ii).

VIII. DESCRIPTION OF THE MARKET RESEARCH CONDUCTED AND THE

RESULTS, OR A STATEMENT OF THE REASONS MARKET RESEARCH WAS NOT

CONDUCTED

Market research was done by reviewing previous acquisitions; searching FBO, EDA, DSBS;

contacting local hospitals that have similar requirements; and internet searches. No other company is able to provide FDA approved reagents for this specific requirement. The Galileo Echo Analyzer is a closed device that may only use reagents made by Immucor, Inc.

IX. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND

OPEN COMPETITION

No additional information is available.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/06.htm

X. LIST OF SOURCES, IF ANY, THAT EXPRESSED INTEREST IN THE

ACQUISITION

No other sources were found. The solicitations FA3047-15-R-0008, W81K02-14-T-M002 and W91YTZ-14-F-0092 were found on FedBizOpps.gov. These solicitations were for sole source to Immucor, Inc. One of the solicitations mentioned that no other sources have expressed an interest in these requirements. Other sources will exist once the Echo Analyzer reaches the end of its lifespan and the equipment itself can be competed. Since the equipment is still in its serviceable life through the duration of this contract there will not be any other sources capable of competing for this requirement to provide reagents in support of the Echo Analyzer.

XI. A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO

REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION BEFORE MAKING

SUBSEQUENT ACQUISITIONS FOR THE SUPPLIES OR SERVICES REQUIRED

The sole source requirements will not end until other reagents become FDA (Food and Drug Administration) approved, the Galileo Echo Analyzer reaches end of service, or Immucor, Inc.

starts using distributors.

XII. CONTRACTING OFFICER’S CERTIFICATION

The contracting officer’s signature on at the bottom of this document evidences that he has determined this document to be both accurate and complete to the best of his knowledge and belief IAW (FAR 6.303-2(b)(12)).

XIII. TECHNICAL/REQUIREMENTS PERSONNEL’S CERTIFICATION

As evidenced by their signatures at the bottom of this document, the technical and/or requirements personnel have certified that any supporting data contained herein, which is their responsibility, is both accurate and complete IAW (FAR 6.303-2(c)).

COORDINATION DATE

APPROVED: