JA 21-RHCO-P-64 Redacted.pdf

Control No: 21-RHCO-P-64 Contractor: Immucor Inc.

Program/Equipment: Complement Control Cells, Fetal Maternal Hemorrhage Rapid Screen Kits, and Reagents

Version – March 2017 FOR OFFICIAL USE ONLY

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: Regional Health Contracting Office-Pacific, Joint Base Lewis McChord Health Contracting Branch (JBLM HCB).

2. Description of Action.

a. This is a recurring requirement. This will be a new contract and follow on to W81K0218F0077. MAMC, Transfusion Services, JB Lewis McChord (Tacoma) WA. Transfusion Services, MAMC currently uses Immucor Complement Control Cells, FMH screening test kits and Reagents to detect and prevent Hemolytic Disease of the Fetus and Newborn (HDFN). Immucor is the only known source for the reagent, a rare anti-serum, used with the FMH screening kits. Immucor has proprietary rights on all supplies associated with its products including the FMH screening kits.

b. HDFN is a blood disorder in a fetus (an unborn baby) or a newborn baby. HDFN may develop when a mother and her unborn baby have different blood types (called ‘incompatibility’). The mother produces substances called antibodies that attack the developing baby’s red blood cells.

c. Anti-D antibodies can cross from the mother’s blood into the unborn baby’s blood and destroy the baby’s red blood cells causing anemia, jaundice and in severe cases brain damage or even death of the baby while in the womb or after delivery. The antibodies remain in the mother’s blood and they may also damage the red cells of a subsequent baby, if he or she has the same blood group as the first.

d. Using Immucor’s reagents with the FMH screening kits increases the accuracy of patient test results. Furthermore, use of the Immucor’s reagents allows MAMC’s Transfusion Services to specialize as a reference laboratory for external smaller laboratories. The same reagent that is used for the FMH testing will also be utilized for all patients seen in the Madigan footprint.

3. Description of Supplies/Services:

This is a recurring requirement. This will be a new contract and follow on to W81K0218F0077. The estimated total value including options $125,573.60. The required supplies will ensure MAMC’s Transfusion Services is providing quality supplies and care to its patients. The supplies which will be provided under the contract are:

Program/Equipment: Complement Control Cells, Fetal Maternal Hemorrhage Rapid Screen Kits, and Reagents

Version – March 2017 FOR OFFICIAL USE ONLY

(a) Complement Control Cells (CCC). CCC are intended for use in confirming reactivity of the anti-C3 component of anti-Human Globulin.

(b) FMH Rapid Screen Kits. FMH Rapid Screen Kits are used to detect D-positive red cells in D-negative mothers.

(c) Reagents. A reagent is a substance or mixture for use in chemical analysis or other reactions.

Estimated Quantity: The estimated quantity of this requirements is 26 Complement Control Cells 1x3mL, 14 Fetal Maternal Hemorrhage (FMH) Rapid Screen Kits, and 30,000 Reagents.

Estimated Price

Period From Date To Date Value Base 1 Oct 20 30 Sep 21 $35,878.18

Option Year 1 1 Oct 21 30 Sep 22 $35,878.18 Option Year 2 1 Oct 22 30 Sep 23 $35,878.18

FAR Clause 52.217-8 option: 1 Oct 23 31 Mar 24 $17,939.09 Total $125,573.60

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other:

5. Reason for Authority Cited:

(a) This acquisition must be accomplished through a sole source solution because:

(1) Immucor continues to maintain proprietary rights its’ products including the FMH screening kits.

(2) MAMC’s Transfusion Services will continue to use Immucor products as Immucor products are deemed to be the best product available to screen MAMC’s patients.

Program/Equipment: Complement Control Cells, Fetal Maternal Hemorrhage Rapid Screen Kits, and Reagents

Version – March 2017 FOR OFFICIAL USE ONLY

(b) Alternatives: There are other CCCs and Reagents on market which can to detect and prevent Hemolytic Disease of the Fetus and Newborn (HDFN). Nevertheless, Government employed Laboratory Specialists have determined Immucor’s CCC, Reagents, and FMH Rapid Screen Kits are the most suitable for MAMC’s lab equipment and best meets the needs of MAMC’s patients. MAMC’s Laboratory Specialists are trained on the procedures for using the Immucor’s products which provide reduced liability risk, and reduces the administrative and training burden which accompanies transitioning to new products. Said reductions, provide a significant cost savings to the Government.

(c) Other Variable Considered.

(1) Impact Statement. FMH screening kits increases the accuracy of patient test results. Furthermore, use of the Immucor’s reagents allows MAMC’s Department of Pathology, Transfusion Services to specialize as a reference laboratory for external smaller laboratories. The same reagent that is used for the FMH testing will also be utilized for all patients seen in the Madigan footprint.

(2) If this J&A is not approved a tremendous amount of time and monetary resources will be required to train Laboratory Specialist on the use of the new products and to procure the new products. Furthermore, quality care for Madigan’s patients would be in jeopardy during the transition period which could result in an unknown number of HDFN cases going undetected. This travesty is easily adverted by continuing to use Immucor’s products.

6. Efforts to Obtain Competition:

(a) The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

(b) Effective Competition: In the future, Joint Base Lewis McChord Health

Contracting Branch along with MAMC’s Transfusion Services will continue to perform market research to monitor any changes in the status of this requirement.

As technology becomes available, research will be performed to consider other possible sources that may meet or exceed this current requirement. However, since this is a sole source action, effective competition is not applicable.

7. Actions to Increase Competition: Currently, Immucor is the only authorized company capable of providing the CCC, FMH screening kits, and Reagents. The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

8. Market Research: Market research for this acquisition was conducted 25-30 June 2020. Market research revealed, Immucor is the only authorized company capable of providing the CCC, FMH screening kits, and Reagents. Additional market research was

Program/Equipment: Complement Control Cells, Fetal Maternal Hemorrhage Rapid Screen Kits, and Reagents

Version – March 2017 FOR OFFICIAL USE ONLY conducted using numerous sources (please refer to the Market Research Report filed in this acquisition’s PCF Cabinet). A summary of research conducted includes:

a. FAR 8.002(a)(1)(i) through FAR 8.002(a)(iv), which addresses supplies (including Federal Prison Industries and Ability One), are not applicable and will not be considered.

b. A review of FAR 8.002(a)(1)(v) was conducted and consideration to General Service Administration (GSA) and/or Federal Supply Schedules (FSS). Required supplies are available through these sources: FSS V797D-70110.

c. FAR 8.003, Use of Other Mandatory Sources does not apply

d. FAR 8.004, Use of Other Sources, and FAR 12.1, Acquisition of Commercial Items, Google search conducted with keywords ““Fetal Maternal Hemorrhage (FMH) Rapid Screen Kits” revealed the kits are available on the open market.

However, only Immucor can provide the FMH Kits because of the proprietary right with held by Immucor.

e. Market Research has been conducted by searching the Dynamic Small Business, GSA and Dynamic Small Business search using NAICS Code: 325413, key word “Fetal Maternal Hemorrhage (FMH) Rapid Screen Kits”. Market research did not locate any businesses that can provide the required products due to the proprietary right with vendor.

f. Market research was conducted by personal telephone contact and internet searches with the potential vendors in the past 90 days.

g. Joint Base Lewis-McChord Health Contracting Branch will continuously monitor any changes in this requirement along with the MAMC’s Transfusion Services, Joint Base Lewis McChord (Tacoma) WA.

9. Interested Sources: Immucor provided a quote dated 9 June 2020. Immucor also provided a sole source letter that articulated Immucor as being the sole owner, producer and Manufacturer of its CCC and FMH Kits. A copy of Immucor’s correspondences in contained in this acquisition’s PCF Cabinet.

10. Other Facts:

a. Procurement History

(1) Contract number, awarded contractor: W81K0218F0077, Immucor Inc.

Description of requirement: In Vitro Testing Reagents.

Method of procurement: Sole Source via Immucor’s Federal Supply Schedule.

Contract type: Firm Fixed Price.

Delivery requirements: As required to MAMC’s Department of Pathology.

Total awarded amount: $151,756.36.

Program/Equipment: Complement Control Cells, Fetal Maternal Hemorrhage Rapid Screen Kits, and Reagents

Version – March 2017 FOR OFFICIAL USE ONLY

Number of option periods: 1.

Number of Offerors: 1.

Source Selection Method: Price Analysis.

Basis for fair and reasonable pricing: In accordance with FAR 13.106-3(a), 15.403- 3(c), or 15.404-1(b) as applied, the proposed/offered price was determined to be fair and reasonable based on previous history of the foregoing evaluation of the non-competitive requirement.

(2) Unusual patterns. No unusual patterns (e.g. several consecutive, urgent buys) were revealed while conducting the market research report and the research conducted to complete the J&A.

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Date:

Signature: _____________________

Typed Name:

TEL:

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Date: Signature: ______________

Typed Name:

TEL:

Program/Equipment: Complement Control Cells, Fetal Maternal Hemorrhage Rapid Screen Kits, and Reagents

Version – March 2017 FOR OFFICIAL USE ONLY

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: price analysis cost analysis IGCE audit: other:

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Signature: _____________________ Contracting Officer

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: _____________________ Contracting Officer

Program/Equipment: Complement Control Cells, Fetal Maternal Hemorrhage Rapid Screen Kits, and Reagents

Version – March 2017 FOR OFFICIAL USE ONLY

Approval Based on the foregoing justification, I hereby approve the procurement of supplies pertinent to Complement Control Cells, FMH Rapid Screen Kits, and Reagents on a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Local Advocate for Competition:

Typed Name:

Signature: _____________________