6550--CPT - Immuno-Histochemical (IHC) Staining System 5 Year - Ann Arbor

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 9

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-23-AP-1514

Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, 24 Frank Lloyd Wright Dr., Ann Arbor, MI 48105, in support of the Lieutenant Colonel Charles S. Kettles VA Medical Center 2215 Fuller Road Ann Arbor, MI 48105. 506-23-3-1030-0045.

Nature and/or Description of the Action Being Processed: This is a new requirement in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.510 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. The action will be awarded as a Firm-Fixed Price IDIQ with five 1-year ordering periods. This is a Cost Per Test (CPT) contract to provide immuno-histochemical (IHC) patient specimen testing for the Anatomic Pathology Department of Pathology and Laboratory Medicine Services at Ann Arbor.

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

Period of performance: 5/18/2023 5/17/2028

The procurement is for a CPT contract to provide one automated IHC staining system that performs the staining of human tissue to target specific proteins. The instrument, uninterrupted power supply (UPS), ancillary equipment, printer, toner, quality control material, slides, disposables, consumables, antibodies, reagents, supplies, shipping, and handling costs associated with receipt of reagents, technical manual, service manual, operator training, hardware and software, software updates, preventative and repair maintenance agreement, and operator training in the operation of and performance of preventive maintenance and transportation necessary to perform the preventative maintenance and repair, on the automated IHC system must also be provided to VA Ann Arbor Healthcare System.

Ann Arbor

Immuno-Histochemical Staining

Year

Testing

Estimated Yearly Average

Year 1 FY23

Total Number of IHC Slides

6903

Year 2 FY24

Total Number of IHC Slides

7593

Year 3 FY25

Total Number of IHC Slides

8352

Year 4 FY26

Total Number of IHC Slides

9187

Year 5 FY27

Total Number of IHC Slides

10106

Statutory Authority Permitting Restricted Competition:Â

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

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

During Market Research for the IHC Staining system, there were four main factors which were considered. Different vendors were evaluated for these main factors.

Continuous access to slides and reagents for an uninterrupted workflow and allowing overnight/ weekend runs.

Onboard cooling of reagents to allow for overnight and weekend runs without compromising of reagent integrity and shelf life. Every antibody vendor implicitly state that antibodies should be stored at 2-8 o C.

3. Hazardous and non-hazardous waste separation to reduce technician hazard exposure and reduce waste disposal costs.

4. Ability to measure and record pH of working buffer solutions used in testing.

Dako Omnis

Leica Bond Prime

Roche Benchmark

BioCare Oncore

Continuous access to slides and reagents

Yes

Yes

Yes

No

Onboard cooling of reagents

Yes

No

No

No

Hazardous and non-hazardous waste separation

Yes

No

No

No

Ability to measure and record pH of working buffer solutions

Yes

Yes

No

Yes

Based on this comparison it is noted that Dako Omnis from Agilent is the only product that offers all the four required features and hence would become the best value to the government.

Additional consideration included:

1. Optimization and Validation on every antibody is very costly. It includes, but is not limited to, hundreds of hours of technologist time, for each antibody, as well as many hours of Physician time (Pathologist) reviewing stained slides.

a. Continuation with the same Dako Omnis platform would introduce a huge cost saving as it would only require a minimal re-validation of protocols on the new instrument and established protocol validations, per Joint Commission and College of American Pathologist.

b. A new system would require an investment of thousands of dollars with re-optimization of antibodies and then a full validation. This would require purchasing 1-2 vials of every antibody currently in use, to perform Optimization and Validation.

2. It may be necessary to switch clones of antibodies to adapt to another vendor platform.

Under microscopic evaluation the optics may change slightly or considerably which would necessitate adjustment by our diagnosticians as it may be different from what they have been basing their diagnosis on for the last five years. This has the potential to impact patient care.

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

An intent to sole source was posted to Contract Opportunities with one response from Roche; however, it was found that their equipment did not meet the requirements.

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

Anticipated cost will be considered fair and reasonable in accordance with FAR 13.106-3(a)(2)(ii) based on comparison of proposed prices with prices found reasonable on previous purchases.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

VIP was queried under NAICS 325413 and 41 concerns were found. Keyword histochemical was added to the NAICS and 0 concerns were found. A VetCert search was conducted under NAICS 325413 and 71 concerns were found. Agilent Technologies, Inc. was contacted and they confirmed they do not have any distributors for CPT contracts. An intent to sole source was posted to Contract Opportunities and one response was received from Roche; however, it was determined they did not meet the requirements. The VA Rule of Two cannot be attained. BAA applies as domestic items are available. The procurement will be completed as a sole source in accordance with FAR 13.

Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other supporting facts.

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

Agilent Technologies, Inc.

2850 Centerville Rd.

Wilmington, DE 19808

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:

Should a requisition of this nature recur, the market will be surveyed.

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.

_____________________________ ________________________

Neelam Palande Date

Medical Technologist - COR

VA Ann Arbor Healthcare System

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.

_____________________________ ________________________

Kellie Konopinski Date

Contracting Officer

NCO 10

One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

_____________________________ ________________________

Diana Pittman Date

Supplies Team 3 Branch Chief

NCO 10 Awarded contract 36C25023D0055 to AGILENT TECHNOLOGIES, INC. for unknown amount on 2023-04-27.