SAP Sole Source Just Accu-Check Inform II Signed CO.pdf

SIMPLIFIED ACQUISITION SOLE SOURCE JUSTIFICATION

FOR ACQUISITIONS USING SIMPLIFIED ACQUISITIONS

Activity: The Department of Health and Human Services, Indian Health Service (IHS) proposes to enter into a purchase order on a basis of other than full and open competition for the following acquisition as implemented by FAR Subpart 13.5.

1. Requisition#: IHS1515781

2. Description of Supplies or Services:

The Phoenix Indian Medical Center, Laboratory Department is procuring for Accu-Chek Inform II System & accessories only for Ak-Chin Indian Community Clinic. The Accu-Chek Inform II glucose meter is utilized for optimal treatment & plays an important role in decisions for diabetic care within outpatient & inpatient care services. The point of care test provides blood glucose measurement to assist physicians manage, track affect & dose of diabetes medicine, & also aides in critical responses for diabetic patients. This is a hand-held device & allows testing throughout departments. The meters are linked to COBAS IT 1000 connectivity solution for managing the Roche Diagnostics Accu-Check Inform II whole blood glucose meters used for Roche Diagnostics Accu-Check Inform II whole blood glucose meters used for testing patient diagnosed with Type I and II diabetes. The server is located at Phoenix Area Office IT Department and it is managed by the Office of Health Programs Laboratory Consultant. The COBAS IT 1000 laboratory glucose meter interface middleware Software, Hardware and Support are under PO No. 75H71221P00211.

Requirement: MFG: Roche Diagnostics

1. !-EA, Catalog No. 04884671001, Code Key Reader NGBG

2. 25-EA, Catalog No. 05060303001, Accu-Chek Inform II Meter Kit+ RF

3. 25-EA, Catalog No. 05501300001, ACCU-CHEK INFORM II BASE UNIT VIR KIT

4. 25-EA, Catalog No. 07671717190, Accu-Chek Inform II Base Unit Kit

5. 25-EA, Catalog No. 08692432160, Handheld Power Supply FW8001M/12,12V

3. Estimated Value of Procurement:

Base Year: $26,339.00

4. Recommended Sources:

Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46256-1025

UEI SAM: JDMDFEZBYH36

5. Reason for Sole Source/Limited Sources/Expedited Processing:

[X] Only one source (unique capabilities), FAR 6.302-1 [ ] Proprietary drawings, specifications, and/or engineering data, patents, copyrights.

[ ] Brand Name essential to the Government’s needs.

[ ] Standardization Program supported by Agency Head Determination and Findings (D&F).

[ ] Unusual and Compelling Urgency (limited sources) [ ] Authorized or required by statute

6. Justification Narrative:

There are five Phoenix Area Office IHS Service units currently using the COBAS IT 1000 connectivity solution for managing the Roche Diagnostics Accucheck Inform II whole blood glucose meters used for testing patient diagnosed with Type I and II diabetes. The server is located at the Phoenix Area Office Information Technology department and it is managed by the Office of Health Programs Laboratory Consultant. Each of the service units have both the Supervisor and an assistant point of care coordinator that are able to access the software to manage the point of care testing program. The interface was completed in 2019 and once the glucose meter is docked onto its base meter, it automatically downloads and transmits whole blood glucose results to the patient’s electronic health record so that the medical providers can quickly review their tests results that affect patient care decisions. The software allows management of testers by setting their dates of certification and monitoring their work as well as capture quality control data and proficiency test results. This has transformed the point of care programs for our service units to be more effective and efficient. The COBOS IT 1000 Software, Hardware, Support and Upgrade is under contract number 75H71221P00211 for contractor Roche Diagnostics.

7. Impact to the Government if not awarded in accordance with the above:

An open competition to complete the work would cause intolerable delay to the Phoenix Indian Medical Center Laboratory Department and would cause undiagnosed patient health risk to the Indian Health Service patients. The requirement cannot be modified in any manner to increase competition due to patient health risk.

8. Program Office Certification This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs or requirements, or other rationale for limited sources, are accurate and complete.

Official Name & Title Signature Date Project Officer Adrienne Frazier, Laboratory Manager

Project Officer’s Immediate Supervisor

Charisse Holiday, Chief Professional Officer

9. Contracting Officer Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name Signature Date Contracting Officer Jeremy Steel, CO, PAO

Division of Acquisition Management

10. OPDIV Competition Advocate Approval

This is to certify that the justification and find that it adequately supports other than full and open competition.

Official Name Signature Date

*See Attached Applicable FAR References 11.104, 11.105, 6.302-1, 6.303-1 & 6.303-2

*6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

(a) Authority.

(1) Citations: 10 U.S.C. 2304(c) (1) or 41 U.S.C. 253(c) (1).

(2) When the supplies or services required by the agency are available from only one responsible source, or, for DOD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

(i) Supplies or services may be considered to be available from only one source if the source has submitted an unsolicited research proposal that-

(A) Demonstrates a unique and innovative concept (see definition at 2.101), or, demonstrates a unique capability of the source to provide the particular research services proposed;

(B) Offers a concept or services not otherwise available to the Government; and

(C) Does not resemble the substance of a pending competitive acquisition. (See 10 U.S.C. 2304(d)(1)(A) and 41 U.S.C. 253(d)(1)(A).)

(ii) Supplies may be deemed to be available only from the original source in the case of a follow-on contract for the continued development or production of a major system or highly specialized equipment, including major components thereof, when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition;

or

(B) Unacceptable delays in fulfilling the agency's requirements. (See 10 U.S.C. 2304(d)(1)(B) or 41 U.S.C. 253 (d)(1)(B).)

(iii) For DOD, NASA, and the Coast Guard, services may be deemed to be available only from the original source in the case of follow-on contracts for the continued provision of highly specialized services when it is likely that award to any other source would result in-

(A) Substantial duplication of cost to the Government that is not expected to be recovered through competition;

or

(B) Unacceptable delays in fulfilling the agency's requirements. (See 10 U.S.C. 2304(d)(1)(B).)

(b) Application. This authority shall be used, if appropriate, in preference to the authority in 6.302-7; it shall not be used when any of the other circumstances is applicable. Use of this authority may be appropriate in situations such as the following (these examples are not intended to be all inclusive and do not constitute authority in and of themselves):

(1) When there is a reasonable basis to conclude that the agency's minimum needs can only be satisfied by-

(i) Unique supplies or services available from only one source or only one supplier with unique capabilities; or

(ii) For DOD, NASA, and the Coast Guard, unique supplies or services available from only one or a limited number of sources or from only one or a limited number of suppliers with unique capabilities.

(2) The existence of limited rights in data, patent rights, copyrights, or secret processes; the control of basic raw material; or similar circumstances, make the supplies and services available from only one source (however, the mere existence of such rights or circumstances does not in and of itself justify the use of these authorities) (see Part 27).

(3) When acquiring utility services (see 41.101), circumstances may dictate that only one supplier can furnish the service (see 41.202); or when the contemplated contract is for construction of a part of a utility system and the utility company itself is the only source available to work on the system.

(4) When the agency head has determined in accordance with the agency's standardization program that only specified makes and models of technical equipment and parts will satisfy the agency's needs for additional units or replacement items, and only one source is available.

(c) Application for brand name descriptions. An acquisition that uses a brand name description or other purchase description to specify a particular brand name, product, or feature of a product, peculiar to one manufacturer does not provide for full and open competition regardless of the number of sources solicited. It shall be justified and approved in accordance with FAR 6.303 and 6.304. The justification should indicate that the use of such descriptions in the acquisition is essential to the Government's requirements, thereby precluding consideration of a product manufactured by another company. (Brand-name or equal descriptions, and other purchase descriptions that permit prospective contractors to offer products other than those specifically referenced by brand name, provide for full and open competition and do not require justifications and approvals to support their use.)

(d) Limitations.

(1) Contracts awarded using this authority shall be supported by the written justifications and approvals described in 6.303 and 6.304.

(2) For contracts awarded using this authority, the notices required by 5.201 shall have been published and any bids and proposals must have been considered.