Phadia Bridge Justification and Approval_Redacted.pdf

Control No: 20-RHCO-C-124 Immunodiagnostic Analyzers and

Reagents/consumables for Various Allergens Bridge

Version – September 2018 FOR OFFICIAL USE ONLY

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS-SOLE SOURCE JUSTIFICATION AND

APPROVAL

Program/Equipment: Bridge contract with Phadia, Inc., for the procurement of immunodiagnostic analyzers and reagents/consumables for various allergen and asthma assays William Beaumont Army Medical Center, El Paso, Texas

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount: 8.

Prepared by:

.mil

Contracting Officer:

Contracting Officer Date: 11 March 2020 Email: sharod.i.holmes.civ@mail.mil

Technical: T Caitlin Gabor Phone (915) 742-2395

Chief Microbiology Date: 11 March 2020

Email: caitlin.e.gabor.mil@mail.mil

Requirements:

@mail.mil

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items

– Sole Source Justification and Approval

1. Contracting Activity: Regional Health Contracting Office-Central

2. Description of Action: The Regional Health Contracting Office – Central requests approval for a firm-fixed-price bridge contract with Phadia, Inc., for immunodiagnostic analyzers and reagents/consumables for various allergen and asthma assays for William Beaumont Army Medical Center, El Paso, Texas. The period of performance is 1 April 2020 to 30 September 2020 utilizing fiscal year 2020, DHP Operations and Maintenance funds will be used.

X An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B

3. Description of Supplies/Services: William Beaumont Army Medical Center (WBAMC) requires immunodiagnostic analyzers and reagents/consumables for various allergen and asthma assays.

a. The Contractor shall provide one immunodiagnostic analyzer and reagents/ consumables for various allergen and asthma assays on a cost-per-test arrangement.

These supplies are necessary to ensure the continuity of operations of essential patient testing currently being performed by the Department of Pathology, William Beaumont Army Medical Center (WBAMC), El Paso, TX.

b. The following contractor shall provide the testing system includes at a minimum, analyzer and peripherals to include: Uninterruptable Power Sources (UPS), instrument specific computers, Central Processing Units (CPU’s), printers, barcode scanners, terminals, monitors, etc. Testing system shall be delivered and installed at WBAMC, El Paso, TX.

Delivery Period: 1 April 2020 to 30 September 2020. Total Value:

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

X Other: Federal Acquisition Regulation 13.501(a) (1) (ii), sole source

(including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: Current contract W81K00-19-P-M031 provides for

Reagents/consumables for Various Allergens Bridge

Version – September 2018 FOR OFFICIAL USE ONLY immunodiagnostic analyzers and reagents/consumables for various allergen and asthma assays, which expires 31 March 2020. A complete package for the re-solicitation of this requirement that will allow for more competition, subject to the availability of Fiscal Year 2021 funds, is currently being worked by the requiring activity. Industry has indicated that a 30 to 60 day validation correlation process is required. This is necessary to deliver, install, validate and correlate the system prior to becoming fully operational. Additionally, with the RMF requirement, and if the potential new vendor does not have a current ATO, the timeframe needed is substantially longer. In order to continue providing for immunodiagnostic analyzers and reagents/consumables for various allergen and asthma assays, that is critical to the Department of Defense mission of providing access to patient care, a bridge contract is required. Phadia, Inc., is the only company that possesses the ability to immediately support the continuation of this requirement, because they are the incumbent and the required analyzers are currently in use.

6. Efforts to Obtain Competition: The Contracting Officer published the Notice of Intent to Sole Source, as required by FAR 5.201, on 3 March 2020 to 5 March 2020. No responses were received. It is not feasible to solicit a bridge contract with any other source other than the incumbent contractor without there being a lapse in the support because of the 30 to 60 day validation correlation process. Phadia, Inc., has the capability to provide a continuation of these critical services with the existing analyzers without a break in service. Award to another vendor would result in a significant delay because of the procurement process and in providing the critical patient testing/diagnosis because of the amount of time that would be required for the delivery, installation, validation/correlation studies and training for staff on new instrumentation.

Subcontracting competition. In accordance with FAR Subpart 19.705-2, the Contracting Officer has taken actions to determine whether the proposed contractual obligation requires a sub-contracting plan. According to FAR Part 19.702(a)(1)-Statutory Requirement, the incumbent contractor is required to have a subcontracting plan in place. Phadia, Inc., will be required to submit their subcontracting plan.

7. Actions to Increase Competition: Previous solicitations indicate that adequate competition exists. The re-solicitation for the long-term follow-on requirement will be competed. The solicitation will afford interested vendors the opportunity to compete for the long-term requirement.

8. Market Research: Based on market research, there are other vendors capable of providing chemistry and immunoassay testing under a cost-per-test arrangement.

However, due to the extreme time constraint to re-solicit the requirement, evaluating and awarding the new contract, along with the aforementioned delivery/install/validation process, it is not possible for any other vendor to fully support this effort and meet the requirements of this bridge contract.

9. Interested Sources: A pre-solicitation notice was posted on FBO on 3 March 2020 to 5 March 2020. There were no responses. However, previous solicitations indicate that adequate competition exists. The re-solicitation for the long-term follow-on requirement will be competed, which will afford interested vendors the opportunity to compete for the long-term requirement.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement History:

(1) Contract numbers and dates of the last several contracts for these same requirements.

W81K00-19-P-M031, period of performance: 1 October 2019 to 31 March 2020, W91YU0-15-C-0007, period of performance: 1 April 2015 to 30 September 2019, five-month base and four 12-month options. Contract W91YU0-11-P-0774, period of performance: 1 October 2011 to 30 September 2012, with two 12-month options.

(2) The competitive status of these actions.

Contract W81K00-19-P-M031 was awarded as a sole source bridge requirement to Phadia, Inc. Contract W91YU0-15-C-0007 was competed as a full and open requirement and awarded to Phadia, Inc. Contract W91YU0-11- P-0774 was awarded to Phadia, Inc, competitive status unavailable.

(3) Authority previously cited if less than full and open competition was used.

W81K00-19-P-M031: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. W81K00-19-P-M031:

previous solicitations indicate that adequate competition exists. The re-solicitation for the long term requirement will be competed, which will afford interested vendors the opportunity to submit proposals.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Contract W91YU0-15-C-0007 was competed as a full and open requirement and awarded to Phadia, Inc.

Bridge contracts were awarded to Phadia because of the customer could not develop a complete requirement due to time constraints. Also, no vendors with the capacity to fully provide the requirements expressed interest in response to the Notices of Intent.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. W81K00-19-P-M031 was

Reagents/consumables for Various Allergens Bridge

Version – September 2018 FOR OFFICIAL USE ONLY awarded as a sole source bridge contract to prevent a break in service of patient care due to the time constraints customer faced in preparing package.

b. Class J&A: This Class J&A will cover all future actions for these items/services (as appropriate). Each action will be supported by a memorandum for record stating the action is within the scope of the class J&A in each contract file. Not applicable

(End of page)

Reagents/consumables for Various Allergens Bridge

Version – September 2018 FOR OFFICIAL USE ONLY

11. Technical Certification: I certify 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.

Typed

12. Requirements Certification: I certify 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.

Reagents/consumables for Various Allergens Bridge

Version – September 2018 FOR OFFICIAL USE ONLY

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: ☐ cost analysis ☐ price analysis

☐ should cost ☒ IGCE ☐ audit: ☐ other

As a part of this basis, certified cost or pricing data:

☐ will be required.

☒ will not be required and the following exception applies (FAR 15.403):

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☒ A commercial item is being acquired.

☐ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.