51185 Malaria Hematology analyzer SSJ.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

CGH/DPDM/Malaria Branch 1600 Clifton Road NE Building 23 Room 10-143, Mailstop H23-10 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch 2

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Sole source acquisition of: Beckman Coulter DXH520 Hematalogy Instrument

b. Procurement Request (PR) Number (if available): 000HCBBCB-2021-51185

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Beckman Coulter, 250 South Kraemer Blvd., PO Box 8000, Brea, CA 92821-8000

b. Estimated Procurement Amount: $19,985.00

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

If yes, provide schedule number: Click here to enter text.

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is:

☒ In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

☐ Urgency

☐ Exclusive licensing agreements/Proprietary data

☐ Brand name required

☐ Industrial mobilization

☒ Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☐ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

☐ Urgency

☐ Only One Source

☐ Logical Follow Up

☐ Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

CDC/CGH requires a hematology analyzer to support in vitro parasite culture activities for malaria. Parasites are cultured using whole blood pruchased from a commercial blood bank: the parasites require very specific parameters to grow optimally, and daily checks on the health of the cultures must be performed. Because the malaria parasite reproduces with the red blood cell, daily readings of red blood cell count, hematocrit, mean corpuscle volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and red cell distribution width are all needed for a clear determination of the health of the culture.

The Beckman DXH520 is the smallest footprint hematology instrument (10.6”x16”x16.9”) that will fit easily in the small culture laboratory, capable of providing fast complete blood count readings (within 60 seconds) with a very small sample size (17μl). The instrument can provide fast and accurate RBC counts and sizing using a proprietary digital pulse counting method. Data quality is increased because the instrument uses dual-count apertures and a wider linearity range than other hematology counters.

Beckman Coulter is the manufacturer of the DXH520 Hematology Analyzer, and will warranty the instrument for the first year if purchased directly from them..

b. What other products/services were considered and why did they not meet the need?

Sysmex manufactures the XN-L hematology analyzer. It has a small footprint and will accept small sample sizes of 20μl, however that instrument requires manual daily washes with bleach, and also the operation of the instrument requires the use of 5 different chemical reagents. CDC/CGH excessed an old analyzer recently because staff do not have the time to perform extensive daily maintenance on a single instrument. The Beckman DXH520 can have daily cleanings pre-programmed for autonomous cleaning and requires only 2 chemical reagents. The Beckman instrument is easier to use and also is more environmentally friendly to run as it creates less chemical waste. CDC Laboratory Quality Management Policy (#CDC-SA-2019-01), together with CDC’s Chemical Hygiene Plan (CDC-001-00354, v.02), places great emphasis on implementing control measures in CDC labs that eliminate the need for hazardous chemicals. Use of the DXH520 will accomplish this by reducing the number of chemicals used in the lab, along with generating less chemical waste. Beckman Coulter will install the instrument free of charge. Manufacturer installation is not available if purchased from a third party.

3. Program Office efforts to seek potential offerors:

We performed web searches for hematology analyzers, and obtained the instrument specifications for compact analyzers available from Beckman (DXH systems) and Sysmex (XN systems) for our comparison.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title:

Center/Institute/Office COR/Program Official Signature:

Certification Date: November 19, 2020

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: LeKeate N. Knox

Contracting Officer Signature:

Certification Date: January 25, 2021