Limited Sources JA - Chemistry Analyzer Tests BPA.pdf

Limited Sources Justification and Approval (J&A)

CONTROLLED UNCLASSIFIED INFORMATION

April 2024 CONTROLLED UNCLASSIFIED INFORMATION Page 1 of 4

Contracting Activity: 10 CONS/PKB

Purchase Request / Local ID Number: n/a, calls will be paid by GPC

Program / Project (and PE, if applicable): Chemistry Analyzer Tests Blanket Purchase Agreement

Program Type (PEO or Other Contracting): n/a

Authority: Multiple Award Schedule Program (FAR 8.405-6)

Estimated Contract Cost (including options): $950,000.00

Is this a Bridge Action? Yes No

Description of Limitation:

n/a

COORDINATION (DAFFARS 5306.304(a)) ** To remove a row, click the "X" next to the signature block.

** To restore the row, click the appropriate link to the right: CSO Legal COCO CA SCO PEO AQC AQ Blank-1 Blank-2PM CO

Date

11 Apr 2025

Project Lead / Program Mgr / Requiring Activity SrA Katherine Hunt

10 MDSS/SGSM, 719-333-7838

Signature X

Date

13 Apr 2025

Contracting Officer April Delobel

10 CONS/PKB, 719-351-4413

Signature X

Date

06 May 2025

Local Legal Reviewer Jamie McDowell

USAFA/JA, 719-333-3898

Signature X

Date

23 Apr 2025

Flight Chief, Commodities and Services Christian Cornell

10 CONS/PKB, 719-333-8269

Signature X

APPROVAL (DAFFARS 5306.304(a)) ** To remove a row, click the "X" next to the signature block.

** To restore the row, click the appropriate link to the right: COCO CO CA SPEPEO Blank

Date

09 May 2025

Competition Advocate James A. Anderson

USAFA/PK, 719-333-3829

Signature X

April 2024 CONTROLLED UNCLASSIFIED INFORMATION Page 2 of 4

Remove guidance pages.

I. Contracting Activity.

10 CONS/PKB

Contracting Officer April Delobel 719-351-4413 april.delobel.1@us.af.mil

II. Nature and/or description of the action being processed.

This action is a follow-on requirement for Blanket Purchase Agreement (BPA) FA700020A0003, which covered a period of performance (PoP) of 1 Jul 2020 - 30 Jun 2025. This 1-year Firm Fixed Price BPA will have a PoP from 1 Jul 2025 through 30 Jun 2026 and awarded under VA Federal Supply Schedule (FSS) V797P-7347A to Roche Diagnostics Corporation, UEI/CAGE - JDMDFEZBYH36/51169.

III. Description of supplies/services required to meet agency needs.

Three military treatment facility (MTF) laboratories in the Colorado Military Health System (CMHS) require chemistry analyzers to perform essential diagnostic testing with minimal manual preparation. The MTFs include the 10th Medical Group (10 MDG) at the US Air Force Academy (USAFA), the 21st Medical Group (21 MDG) at Peterson Space Force Base, and Evans Army Community Hospital (EACH) at Ft. Carson, who combined support 228K Tricare beneficiaries. The chemistry analyzers enable automated dilutions, bar code scanning, reflex testing, and STAT sample processing, ensuring timely and accurate patient results. The lab tests are accomplished on a cost per reportable result (CPRR) basis and once an agreement is established, the chemistry analyzers are provided by the Contractor.

Without the ability to run chemistry lab tests, patient care would be dramatically diminished at 10 MDG, 21 MDG, and EACH, which would also negatively affect the cadet mission at USAFA. Reliable testing is critical for meeting operational medical requirements and maintaining high-quality healthcare. Its absence would increase reliance of off-base reference labs, leading to longer turnaround time.

The Roche FSS V797P-7347A is located in KT FileShare File Element 210 and includes an extensive list of all tests, reagents, and associated pricing.

IV. Identification of the justification/rationale for limiting sources and demonstration of the contractor's unique qualifications to provide the required supply/service.

FAR 8.405-6 requires an ordering activity to justify its actions when restricting consideration of schedule contractors to fewer than required in FAR 8.405-1 or FAR 8.405-2.

The 1-year BPA to Roche will be established IAW FAR 8.405-6(a)(1)(i)(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, and (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 College of American Pathologists (CAP) in conjunction with the U.S. Food and Drug Administration (FDA), mandate that all medical treatment facilities are accredited and remain in compliance with standards to operate.

To maintain this accreditation, each medical treatment device must perform "Test Method Validation and Verification - Nonwaived Tests." Prior to clinical use of each unmodified FDA-cleared or approved test, the laboratory must perform a verification study and prepare a written assessment of specific method performance specifications, as applicable, using a sufficient number of characterized samples. The validation/verification

April 2024 CONTROLLED UNCLASSIFIED INFORMATION Page 3 of 4 testing standards are in KT File Share File Element 210, examples include:

1. Analytical accuracy

2. Analytical precision

3. Analytical sensitivity

4. Analytical specificity

5. Reportable range

Each medical device has a different amount of time needed to fully execute all validation/verification standards needed to pass. The chemistry analyzers require a period of 6 months to run all tests. The incumbent chemistry analyzer and the successor chemistry analyzer for a future BPA need to run concurrently to execute these tests.

The 1-year BPA with Roche will enable the laboratories to maintain the existing Roche analyzers located at each MTF and allow Contracting time to accomplish a reacquisition to begin around 1 Jan 26 to allow for the 6-month verification/validation process for new analyzers. This 1-year BPA will prevent a lapse in chemistry laboratory testing for patients at 10 MDG, 21 MDG, and EACH. After the 1-year BPA is put in place, the reacquisition process will begin for a potential competitive 5-year BPA for chemistry analyzer testing at 10 MDG. Due to the transition of medical contracts to the Defense Health Agency (DHA), the 21 MDG and EACH will be responsible for working with their local contracting offices for the reacquisition after the 1-year BPA to Roche.

V. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

IAW FAR 8.404(d), the price on the VA FSS was determined fair and reasonable at the establishment of the BPA.

Additionally, IAW Class Deviation (CD) 2014-O0011, the Contracting Officer will make a determination of fair and reasonable pricing prior to BPA establishment. Awarding a 1-year BPA to Roche is necessary to allow for the validation/verification process to take place ensuring there is no break in lab testing for Tricare beneficiaries.

VI. Description of the market research conducted and the results, or explain why market research was not conducted.

The early stages of market research led 10 CONS to meet with the customer/end-user of the chemistry analyzers.

The end-user stated that there is a need for overlap of 6 months from the incumbent machine to the successor in order for the validation/verification process to take place. The PoP for the current BPA was 6 months out and there was not enough time to compete and establish another BPA within regulation. This fact has led to the need for a 1-year follow-on BPA to Roche that would allow time for a new BPA to be awarded and account for the 6 month overlap needed for the validation/verification process.

VII. Other facts supporting the justification.

N/A

VIII. Actions 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.

Prior to meeting with the end-user in Dec 2024, the Contracting team was not aware of the compulsory 6-month validation/verification process for the chemistry analyzers. This 1-year BPA to the incumbent, Roche, is necessary so the MTFs can keep the existing analyzers and continue to run lab tests while a competitive 5-year BPA is established to follow this BPA. Now that 10 CONS is aware that a verification/validation period is necessary for lab analyzers, a transition period can be factored into future BPAs to mitigate the necessity of limiting sources.

April 2024 CONTROLLED UNCLASSIFIED INFORMATION Page 4 of 4

IX. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

X. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.

April 2024 Page of Authority: Multiple Award Schedule Program (FAR 8.405-6) Is this a Bridge Action?

COORDINATION (DAFFARS 5306.304(a)) ** To remove a row, click the "X" next to the signature block.

** To restore the row, click the appropriate link to the right:

APPROVAL (DAFFARS 5306.304(a)) ** To remove a row, click the "X" next to the signature block.

** To restore the row, click the appropriate link to the right:

( See guidance at the end of this document for completing the following sections. ) I. Contracting Activity.

II. Nature and/or description of the action being processed.

III. Description of supplies/services required to meet agency needs.

IV. Identification of the justification/rationale for limiting sources and demonstration of the contractor's unique qualifications to provide the required supply/service.

V. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

VI. Description of the market research conducted and the results, or explain why market research was not conducted.

VII. Other facts supporting the justification.

VIII. Actions 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.

IX. Certification by the Contracting Officer.

X. Certification by the technical/requirements personnel.

GUIDANCE

I. Contracting Activity.

Fully identify the contracting activity responsible for the proposed contracting action. Include the name/phone number of the Contracting Officer. Specifically identify as a “Limited Sources” Justification. Identify purchase request number, if applicable.

II. Nature and/or description of the action being processed.

State whether the action is a new order or by modification to an existing order. Identify the GSA schedule number, the Blanket Purchase Agreement (BPA) number, the order number for the current action, and the Contactor(s). Indicate the Period of Performance (PoP). Also identify the type of the order/line items on the order (e.g. Firm Fixed Price, Labor Hour, etc).

III. Description of the supplies/services required to meet agency needs.

Specifically describe the supplies and/or services to be acquired including the price and quantity of each item in the order and state the total estimated value of the order. For services, state whether the services are performance-based and, if not, provide rationale for not being performance based. Also state the delivery/performance schedule/period for the items under the order.

IV. Identification of the justification/rationale for limiting sources and demonstration of the contractor's unique qualifications to provide the required supply/service.

This section is normally the most detailed part of the justification. To assist you in preparing this justification, an introductory sentence and the four circumstances of FAR 8.405-6 that justify restricting the number of schedule holders are provided below. Select the appropriate cite, then provide, in narrative form, a detailed explanation supporting the specific circumstance cited for limiting the number of schedule holders.

(Introductory sentence) FAR 8.405-6 requires an ordering activity to justify its actions when restricting consideration of schedule contractors to fewer than required in FAR 8.405-1 or FAR 8.405-2.

After selecting the appropriate cite, next select one of the four sentences below and provide a detailed explanation supporting the specific circumstance cited.

FAR 8.405-6(a)(1)(i)(B), “Only one source is capable of responding due to the unique or specialized nature of the work”. (Provide a detailed justification with supporting documentation, as evidence of the “unique or highly specialized” nature of the procurement. The user/customer typically provides this supporting information. Recommend attaching supporting documentation to the back of the document. General statements are not acceptable.)

FAR 8.405-6(a)(1)(i)(C), “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 was not issued under sole source or limited source procedures. (Provide details on the previously competed order and explain how this order is a logical follow-on to that order. Explain fully the connection between the previous work/order and the current one. The user/customer typically provides this supporting information. General statements are not acceptable.)

FAR 8.405-6(a)(1)(i)(A), “An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.” (Provide a detailed justification with supporting documentation that explains the exact urgency of the requirement and the schedule impact if time were to be taken to follow FSS ordering procedures. The user/customer typically provides this supporting information. Recommend attaching supporting documentation to the back of the document. General statements of urgency are not acceptable.)

FAR 8.405-6(b)(1), “The item is peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.” (Brand name specifications should not be used unless the particular brand name, product or feature is essential to the Government's requirements. Therefore, explain why the particular brand item is essential to the Government's requirements, and why other companies' similar items, or products lacking the particular feature, do not meet, or cannot meet, or cannot be modified to meet, the agency's need. The user/customer typically provides this supporting information. General statements are not acceptable.)

V. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

This section needs to be tailored based upon whether the order is for supplies/services not requiring a statement of work (FAR 8.405-1) or if the order is for services requiring a statement of work (FAR 8.405-2).

For FAR 8.405-1 orders the best value determination needs to be based upon the supply or service offered under MAS contracts by surveying at least three schedule contractors through the GSA Advantage! on-line shopping service, or by reviewing the catalogs or price lists of at least three schedule contractors. The ordering Contracting Officer's review of the Contractor's price list(s) and any price reductions sought is also required. (Contracting Officer should seek additional price discounts/concessions based on the specific order requirements on all orders over the micro-purchase threshold.) In addition to price, when determining best value, the ordering activity may consider, among other factors, past performance, special features of the supply or service required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, environmental and energy efficiency considerations, and delivery terms.

When an order contains brand name specifications, the Contracting Officer shall post the Request for Quote (RFQ) along with the basis of the justification as required by FAR 8.405-6(b)(3).

For FAR 8.405-2 orders for services requiring a statement of work, FAR 8.405-2(d) requires that an evaluation be performed based on the criteria provided to the schedule contractors. Therefore, the justification must address how the FAR 8.404(d) requirement for an evaluation of the proposed level of effort and mix of labor will be conducted and include a statement that the Contracting Officer will perform a price reasonableness determination as part of the best value determination.

VI. Description of the market research conducted and the results, or explain why market research was not conducted.

Discuss market research that was conducted among schedule holders and the market research results that led to the conclusion to go sole source or to limit the number of schedule holders to be solicited. The narrative in this section should provide a high level of confidence that the requirements of FAR 8.405-1 and FAR 8.405-2 could not be met. If no market research was conducted, state so and provide the rationale.

VII. Other facts supporting the justification.

When FAR 8.405-6(a)(1)(i)(C) is cited for an follow-on acquisition as the basis for the justification, include an estimate of the cost that would be duplicated and the basis and derivation of the estimate, or provide details on why a delay to solicit additional schedule holders would be unacceptable.

Provide any other facts supporting the Limited Sources Justification.

VIII. Actions 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.

Describe all efforts to be taken to remove or overcome any barriers that preclude the agency from meeting the requirements of FAR 8.405-1and FAR 8.405-2 before any subsequent acquisition for the supplies or services is made. If no actions are planned, so state and provide reasons.

IX. Certification by the Contracting Officer.

The contracting officer's signature on the signature page evidences that he/she has determined this document to be both accurate and complete to the best of his/her knowledge and belief.

X. Certification by the technical/requirements personnel

As evidenced by their signatures on the signature page, the technical/requirements personnel have certified that any supporting data contained herein which is their responsibility is both accurate and complete.

9.0.0.2.20120627.2.874785

10 MDSS/SGSM, 719-333-7838

Name: April Delobel

10 CONS/PKB, 719-351-4413

Name: [ Name ] [ Office Symbol / Phone Number ] Name: Jamie McDowell

USAFA/JA, 719-333-3898

[ Office Symbol / Phone Number ] Name: [ Name ] [ Office Symbol / Phone Number ] Name: [ Name ] [ Office Symbol / Phone Number ] Name: [ Name ] [ Office Symbol / Phone Number ] Name: [ Name ] [ Office Symbol / Phone Number ] Name: [ Name ] [ Office Symbol / Phone Number ] Name: April Delobel

10 CONS/PKB, 719-351-4413

Name: James A. Anderson

USAFA/PK, 719-333-3829

Name: [ Name ] [ Office Symbol / Phone Number ] Name: [ Name ] [ Office Symbol / Phone Number ]