36C25024A0001_1.docx

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

GENERAL INFORMATION

Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

POINT OF CONTACT*

Contracting Officer Kellie Konopinski Kellie.Konopinski@va.gov 734-222-4330

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE NAME*

CONTRACTOR’S UEI

ORTHO-CLINICAL DIAGNOSTICS INC

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AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C250-23-AP-3656

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, located at 24 Frank Lloyd Wright Drive, Ann Arbor, MI 48105, in support of Ann Arbor VA Healthcare System at 2215 Fuller Road, Ann Arbor, MI 48105. 506-24-1-1030-0002

(2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). This is a new requirement for an FSS-BPA with a base year plus four 1-year option periods for blood bank immunohematology system for automation in the Blood Bank Department and Laboratory Medicine Services at the Ann Arbor VA Healthcare System.

Order against: |X| FSS Contract Number: V797D-60637 (ex. 7/14/2031 inclusive of options)

(3) Description of Supplies or Services:

The procurement is to provide the Pathology Service with blood bank automation and use the same backup method and reagents, currently in use. The automated blood bank system includes reagents, gel cards, reagent red blood cells, antisera, software, hardware, UPS (uninterrupted power supply), all parts and materials, technical manuals, consumable supplies, shipping, and handling costs associated with receipt of reagents, startup reagents and consumables required to bring the analyzer on operational level, preventative maintenance and emergency repair maintenance agreement, operator training in the operation of and performance of preventive maintenance on the automated blood bank testing system.

Ortho Vision Analyzer – 6904577 – 1 Each Ortho Vision Startup Reagent Allowance – 14572251H – 1 Each Ortho Vision Table – 6904701 – 1 Each Printer (OV) Lexmark – 6986685 – 1 Each

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

|_| FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

|X| FAR 8.405-6(a)(1)(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;

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

1. The system must use gel column agglutination technology. Ortho Vision Swift does use a gel column agglutination technology.

2. Compatibility with the existing and purchased manual backup system, which is from Ortho. We do not have the means nor resources to validate new testing methodology, completely change all Standard Operating Procedures and train all staff within the next fiscal year. Only Ortho Vision Swift is compatible with the existing manual backup system.

3. Midsize instrument that will justify the workload of VA Ann Arbor Healthcare System. System should not be too small and at the same time it should not be too big, requiring re-construction in the blood bank. Vendor must supply an analyzer capable of bench top installation. Ortho Vision Swift is a benchtop and a midsize instrument.

4. The instrument is interface approved for use with CERNER, without a middleware. VA Ann Arbor Healthcare System has been working with Oracle-Cerner EHRM for the last couple years anticipating Ortho Vision as the default automation. Ortho Vision Swift is capable of interfacing with CERNER without a middleware.

The other factors that were considered in source selection were:

1. The ID-Micro Typing System (Gel Column Testing), manufactured by Ortho Clinical Diagnostics has been in use in this laboratory since 1998 using manual method and 2008 using automated methodology.

2. For many years, VA Ann Arbor Healthcare System has used this system as our Primary method for ABO/Rh testing and antibody identification methodologies. The Ortho Vision is compatible with the Laboratory’s existing manual ID-MTS-Gel system/technology (Secondary method) and VA owned equipment currently in use. Both systems use the same reagent and consumables.

3. Ortho Clinical Diagnostics has been the leader in Gel Column Agglutination testing, competitors have not been FDA approved or an industry standard longer than Ortho. Ortho is the gold standard in gel technology. It is also used by the University of Michigan Trauma Center.

4. With a primary emphasis on employee safety, standardization, and sensitivity. VA Ann Arbor Healthcare System relies on this system for ease of use, quicker turnaround times and best standardization of Veteran care. All staff is trained and fully competent with the Gel methodology versus the learning curve and restructuring with other methodologies.

5. The VA Ann Arbor Healthcare System currently maintains a contract for goods and services with Ortho Clinical Diagnostics. This vendor has demonstrated the ability to supply automated and non-automated reagents for blood bank testing under their own brand.

6. Local hospitals within proximity to the VA Ann Arbor Healthcare System use Ortho Vision.

This was convenient during the pandemic. When supply chain issues affected delivery schedules, we had the ability to share reagents and supplies from the same vendor. This bridged the time delay and continued quality care for our veterans.

7. In our current contract, we have seen best performance of the analyzer with very little downtime. Whenever there is a downtime or an issue with the analyzer hindering its operation, the contractor has been very diligent about fixing the issue in a decent and reasonable time frame and helping in providing continuity of best patient care to our veterans. We have seen best customer support from the contractor during the period of FY18 – till date.

8. VA Ann Arbor Healthcare System has been preparing for the Oracle Cerner EHRM Project.

This process has been ongoing for the past 2 years, adjusting workflows and preparing for the transition. Ortho Vision is by far the most common throughout the domain and is currently setup as a default build in CERNER Millennium, though there are several other devices setup too. Switching off the Vision would require a medium amount of rework to ensure the CERNER build is set to accept those results. The transition to CERNER millennium, would benefit from the continued use of Ortho gel methodology.

|_| FAR 8.405-6(a)(1)(C): 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.

|_| FAR 8.405-6(b): Items peculiar to one manufacturer:

|_| A patent, copyright or proprietary data limits competition. The proprietary data is:

|_| 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.

(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:

The Ortho Vision is compatible with the laboratory’s existing manual ID-MTS-Gel system/technology (Secondary method) and VA owned equipment currently in use. Both systems use the same reagent and consumables. With a primary emphasis on employee safety, standardization, and sensitivity, the VA Ann Arbor Healthcare System relies on this system for ease of use, quicker turnaround times and best standardization of veteran care. All staff is trained and fully competent with the gel methodology versus the learning curve and restructuring with other methodologies. Local hospitals within proximity to the VA Ann Arbor Healthcare System also use Ortho Vision. This is a benefit because if supply chain issues affect delivery schedules, we can share reagents and supplies from the same vendor. This bridges the time delay and continues quality care for our veterans. The work with CERNER has been ongoing for 2 years and Ortho Vision is currently being set up as a default build in CERNER Millennium. Switching off the Ortho Vision would require a medium amount of rework to ensure the Cerner build is set to accept those results. The transition to CERNER Millennium, would benefit from the continued use of Ortho gel methodology and would be a cost savings for the government.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

VetCert was searched under NAICS 334516 and 188 SDVOSB/VOSB concerns were found. Searched DSBS under NAICS 334516 and keyword “Immunohematology” and zero concerns were found. NAICS 334516 has a waiver for some items; however, this specific equipment is not listed. Also, Ortho-Clinical Diagnostics is a large business with no SDVOSB/VOSB distributors for this type of contract. The VA Rule of Two cannot be met. Most items are on their NAC contract; however, in accordance with FAR 8.402(f), it is allowable to add open market items to a FSS procurement if it meets the requirements under this section. An intent to sole source was posted to Contract Opportunities from May 25, 2023 through June 2, 2023 with no responses. Ortho-Clinical Diagnostics is the only vendor that can provide these exact items.

(7) Any Other Facts Supporting the Justification:

There are no other supporting facts.

(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:

Should the Government have a future need for this requirement, the Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

Effective Date: 02/01/2022 Page 7 of 7