V797D-70260-009.pdf

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, VISN 04, Acquisition, 1010 Delafield Road, Pittsburgh, PA 15215; VA Pittsburgh Healthcare System, Lab & Pathology Service, Pittsburgh, PA 15240. 646-19-3-080-0637

2. Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). VISN 4 is in need of automated microbiology identification and susceptibility testing. This is a new firm fixed price requirement for 4 month period beginning 5/10/19 – 9/9/19 with a 6 month optional extension if required.

Order against: FSS Contract Number: V797D-70260 Name of Proposed Contractor: Beckman Coulter

Street Address: 250 South Kramer Boulevard

City, State, Zip: Brea CA 92821-6232

Phone: 1.800.526-3821 Ext 423425

3. Description of Supplies or Services:

The estimated value of the proposed action is $86,544.23(4-month period) for

VISN 4 facilities that will be utilizing Microbiology testing. Microbiology testing is currently done on the Beckman Coulter Microscan. The Microscan is used for both microbial identification and susceptibilities. The Maldi analyzer is manufactured by Bruker, but supplied by Beckman Coulter. The Maldi is used only for identification. Some of VISN4 facilities use both the Microscan and Maldi while the remaining facilities only use the

Microscan. Both analyzers are fully automated. The Microscan is invoiced based on cost per test. The Maldi is invoiced based on a flat monthly fee.

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and

(C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

(CHECK ALL THAT APPLY AND COMPLETE)

https://www.gpo.gov/fdsys/pkg/USCODE-2009-title41/pdf/USCODE-2009-title41-chap4-subchapIV-sec251.pdf https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

There is an urgent need for a 4-month task order for microbiology identification and susceptibility testing to sustain testing for patient diagnosis. A blanket purchase agreement (BPA) was issued to Beckman Coulter that supports VISN 4. Currently 4 medical centers (Wilmington, Erie, Pittsburgh, and Wilkes-Barre) have requirements utilizing that BPA. Due to a protest by a competing vendor, the medical centers are not able to perform critical and time sensitive patient diagnostic testing. The changing of instrumentation is extremely complicated and cannot be done in a short amount of time. The current microbiology testing instrumentation can not be replaced without extensive validation studies, training and competencies. In order to change vendors at this point, it would require at least 30 days to complete the required process of validation. The validation process can include testing multiple isolates, ensuring that the system is transmitting correctly to the lab information system (LIS), comparing results with established practices, establishing reference ranges and troubleshooting. Testing personnel would also require at least another 30 days to complete training and perform competencies prior to testing. Replacement of the current instrumentation will take extensive planning prior to any change. Any delay in testing, even for one day, would have detrimental effects on patient care and could cause harm to the Veteran patients.

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; Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources.

In the interest of economy and efficiency, the new work is a logical follow-on 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 order must not have been previously issued under sole source or limited source procedures.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data.

Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH

FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: Award of the described delivery order to Beckman Coulter represents the best value to Government for the following reasons: (1) The price offered by Beckman Coulter has been determined fair and reasonable by a VA contracting officer at time of award of the FSS V797D-70260. (2) The technology used in the Maldi analyzer is considered state of the art. 3) The Infection Control providers have become accustomed to the minimum inhibitory concentrations (MIC) that the Microscan has been validated for to aid in the treatment of Veteran patients.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

Market research was conducted among various FSS schedule holders and open market vendors whom provide microbial testing. Results of market research indicate that Beckman Coulter can supply the required instrumentation, support and materials needed to continue antimicrobial testing without interruption to patient testing.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: N/A

(8) A 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: None at this time.

(9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

SIGNATURE DATE

Jason Tedrow Lead Medical Technologist Pathology & Laboratory

NAME TITLE SERVICE LINE/SECTION

VA Pittsburgh Healthcare System

FACILITY

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP:

a. CONTRACTING OFFICER’S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER DATE

Nancy Porter NCO4 Contracting Officer https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

VHACOAPORTEN

Typewritten Text 05/10/2019