S02 J_A OVER SAT_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Brand Name Justification Under Simplified Procedures For Certain Commerical Items In Accordance With FAR 13.5

Acquisition Plan Action ID: 36C252-21-AP-1673

1. Contracting Activity:

Department of Veterans Affairs Great Lakes Acquisition Center, NCO-12 115 South 84th Street, Suite 101 Milwaukee, WI 53214-1476

Department of Veterans Affairs Clement J. Zablocki VA Medical Center 5000 W. National Ave Milwaukee, WI 53295-0001

Identify purchase request number: 695-21-2-904-0017

2. Nature and/or Description of the Action Being Processed:

This procurement is for Microbiology Automated Processor in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

Furthermore, justification and approval is for Brand Name COPAN Diagnostics, Inc. and will be awarded as a firm-fixed-priced purchase order.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Clement J. Zablocki VA Medical Center located in Milwaukee, Wisconsin is requesting an Microbiology Automated Processor for their Pathology and Laboratory Medicine Services in order to perform plating specimens for microbiology assessment. Contractor will be required to install equipment and provide at least two super-users that will train VA staff on how to troubleshoot and perform maintenance.

Estimated Amount: $X.XX

4. Statutory Authority Permitting Other than Full and Open Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Accordingly, COPAN Diagnostics, Inc. is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements.

Automation of microbiology specimen processing can significantly improve laboratory efficiency, quality and patient safety. Currently, all microbiology specimens are inoculated onto plates (“plated”) manually in labs in VISN 12. Plating is a repetitive and tedious process. Staff must first check a reference chart to ensure the correct plates are being selected for the specimen type. Next, the plates, and possible gram stain slide, must be labeled manually. The plates are then inoculated using a disposable loop or pipetted and streaked. Because this process is manual and labor-intensive, it is error-prone. While standard specimen processing procedures exist within VISN 12, it is difficult to ensure consistency and accuracy on a manual process when numerous specimens are being plated daily. Staff must recall the correct plates for numerous different specimen types.

Choosing incorrect plates can result in a pathogen being missed, potentially causing a patient to be misdiagnosed or treated incorrectly. Plating specimens is time consuming and the repetitive motions involved can result in ergonomic injury. These repetitive tasks can be standardized with automation resulting in reduced injuries, minimization of variation between laboratory staff and minimization of costs associated with human error. Automation also removes the element of human error associated with mislabeled specimens, specimen mix-up, or choosing the incorrect culture plates, all of which have the potential to lead to inappropriate care. Reducing time spent on repetitive tasks through automation allows staff to focus on other critical tasks within the laboratory. Another benefit of automation is improved. quality of plating of specimens. When performed properly, plating of specimens through multiple quadrants on a plate results in isolation and separation of individual microbial colonies. If colonies are not well isolated, subcultures must be performed, since identification methods and antimicrobial susceptibility studies require pure colonies. Performing a subculture due to poor quality of streaking can delay an identification or susceptibility result by at least a day. In addition, an organism may be missed if isolation is poor and multiple organism types with similar colony morphologies are mixed together. For example, Staphylococcus aureus, Corynebacterium species, and yeast all form white colonies on a culture plate. This is also the case for many of the gram-negative organisms, which are the typical cause of urinary tract infections. Numerous studies have pointed out that automated instrument provides higher quality isolation and better organism recovery compared with manual methods.

Without adding any additional staff, Milwaukee took over the urine cultures from FHCC.

Unfortunately, earlier this year facility had to discontinue processing Microbiology cultures from FHCC due to the large workload and inconsistent plate streaking of specimens. A significant amount of time was spent troubleshooting and following up with poorly streaked, incorrectly plated, or sorting unorganized plates. The average was approximately 450 urine cultures a month. This was approximately a 30% increase in workload for Milwaukee Microbiology. Implementation of an automated specimen processing system would allow for Milwaukee to resume performance of FHCC’s urine cultures sustainably, even during staffing shortages at either FHCC or Milwaukee.

COPAN WASP Microbiology automated processor system will process a wide array of different specimen types from different specimen containers. Minimally it will be able to process urines, swabs, and sputum for culture. In addition, system will be able to plate and streak specimens in a sterile manner. Furthermore, system will be able to store multiple types of agar plates for plating.

The system will accept at minimum agar from Remel, BD, and Hardy. The system will allow for different types of commonly used streak patterns (quantitative and semi-quantitative). Quantitative streaking options must include 1:100 and 1:10 options. The system must have a gram stain preparation, vortex, disk application, and enrichment both inoculation options available. The system will have a system where the sample barcode is scanned and data will be transmitted to ensure the correct agar plates and streak patterns are performed for each specimen type. The system must process specimens within a confined space to ensure safe practices and limit contamination. System must be easy to use with a Software interface. The system will fit within the designated space in the General Diagnostics Department and will not require construction. Designated area determined by BioMed is near the urines bench, which is also the most efficient for the Laboratory staff.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

In accordance with FAR Part 10, VAAR 810 and VAAM M810, market research has been conducted for this acquisition. Used VA’s VIP database to identify verified capable SD/VOSBs.

VIP query on March 17, 2021 keyword “Thermo Fisher” revealed one SDVOSB. Contractor A who distributes medical equipment.

Sources Sought notice 36C25221Q0508 was posted to beta.SAM from March 18, 2021 to March 24, 2021. Received one interested SDVOSB Contractor B. who provided an authorization letter from Thermo Fisher Scientific and one non interested SDVOSB Contractor C.

Therefore, the VA Rule of Two has been met. Solicitation will be posted to beta.SAM and will notify potential offerors of open solicitation.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The steps to be taken to find that the price will be determined fair and reasonable will be based on competition and historical data from similar equipment on Federal Procurement Data System - Next Generation (FPDS-NG).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Original Equipment Manufacturer (OEM) for this requirement is COPAN Diagnostics, Inc. who is considered a Small Business (SB) per System for Award Management (SAM) Reps & Certs. Per Matthew Reidy at COPAN email March 15, 2021, COPAN’s authorized vendors are Thermo Fisher Scientific, BioMerieux, Inc., and Beckman Coulter, Inc. Furthermore, Matthew stated that it is his understanding that authorized SDVOSB distributors can provide offers from COPAN’s authorized vendors.

Conducting part number search for 11 CLIN’s in the following engines that revealed zero results:

• GSA Advantage

• National Acquisition Center

• DLA ECAT

• Supply Chain Master Catalog (SCMC)

• National Strategic Source Listing

• NASA SEWP

• CIO-CS NITAAC

VA Rule of Two has been met as there are two or more SDVOSBs and OEM is considered a Small Business per SAM Reps & Certs IAW 13 CFR § 121.406(b)(1) Nonmanufacturer Rule, 38 U.S.C.

8127(h)(1) Priority for Contracting Preferences, and VAAR 819.7005 SDVOSB set-aside.

9. Any Other Supporting Facts:

Based on limited space, equipment cannot be larger than 10’-0” by 11’-0” for designated footprint within the General Diagnostics Lab is located in room 2600.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Company DUNS Size Contractor A XX-XXX-XXXX SDVOSB Contractor B XX-XXX-XXXX SDVOSB

11. 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:

Based upon the market research conducted and the resulting analysis, adequate sources of supply for small business concerns were obtained and after reviewing VA’s VIP database to identify verified and capable SDVOSBs, the data supports setting aside the procurement to Service-Disabled Veteran- Owned Small Business via beta.SAM and will notify potential offerors of open solicitation.

12. 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 and belief.

ES_______________________________________________________

Carl R. Weber Contract Specialist

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

Contracting Officer or Designee’s Certification (required):

I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Thomas H. Chesak Contracting Officer

One Level Above the Contracting Officer (Required over SAT but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

Parris S. Weidenbach Equipment Branch Chief – Contracting Officer