Solicitation Brand Name Justification.pdf

SIMPLIFIED ACQUISITION BRAND-NAME JUSTIFICATION

FOR ACQUISITIONS UNDER $250K

Activity: The Department of Health and Human Services, Indian Health Service (IHS) proposes to enter into a delivery order on a basis of other than full and open competition for the following acquisition as implemented by FAR Subpart 13.106(b)(1)(i) Brand-name.

1. Requisition#: TBD

2. Description of Supplies or Services: dental sterilizers

3. Period of Performance: date of purchase

4. Estimated Value of Procurement: Deleted Intentionally

5. Recommended Sources: Deleted Intentionally

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

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

[x] Brand Name essential to the Government�s needs.

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

[ ] Unusual and Compelling Urgency [ ] Authorized or required by statute

a. Justification Narrative:

The Government, Yakama Service Unit, uses Tuttnauer sterilizers given their greater capacity to accept numerous cassettes of instruments to go through the sterilization process. Sterilization is a process that destroys or eliminates all forms of microbial life, such as bacteria, fungi, spores, and viruses. A sterilizer takes our dirty instruments and will sterilize them, so they can be used on another person. Most smaller clinics (under 6 chairs) can use a small autoclave to meet their lower daily sterilization volume. A large clinic like the Yakama Service Unit (12 chairs) has more volume of patients and more items to sterilize daily. Some of our cassettes that Yakama SU sterilizes instruments for treatment are unable to fit in smaller sterilizers, or smaller sterilizers could only fit 1- 2 cassettes at a time. We would need to buy more than 7 smaller sterilizers to match the present capacity of the (2) Tuttnauer sterilizers in use. Each sterilizer needs daily biological testing every day. The more sterilizers you have, the more testing and cleaning are done weekly by Dental staff.

This would cause a less efficient means of sterilization. The Government maintenance staff are trained with the Tuttnauer units. Acquiring different brands will require additional training and maintenance which will cause administrative burden to the Government and increase the potential for errors. The Government would need to purchase more supplies to maintain and clean along with checking biological indicators for every unit. Changing to a different brands can bring chance of errors to increase. Biological indicators (BI) are test systems that contain living organisms, usually bacterial spores, that are resistant to sterilization methods. They are used to monitor the effectiveness of sterilization processes for steam, ethylene oxide, and hydrogen peroxide. BIs are more reliable and accurate than chemical indicators.

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

There would be a less efficient method of sterilization that would have to be adopted increasing staff time in the sterilization process, and not chair side providing dental assistance.

It may require limiting appointments for dental procedures done based on the cassettes that are sterilized. It usually takes about 2 hours for an instrument turnover. A mistake in sterilization could cause a patient to have nonsterile instruments used on them. This would be highly detrimental to safe patient care. Staff would need to be trained on proper care and operation of a different model of numerous count. We would need to buy more supplies to maintain and clean along with checking biological indicators for every unit (changing from 2 to 7 or more). We may also need to buy different cleaning equipment base on manufacturer instructions for use. We would all need to make sure we have settings correct for multiple different units (7 or more). This would prove to be more administrative work then needed. A change to a less efficient sterilization method due to small sterilizers of lower capacity, would almost require increasing employees to a full-time sterilization staff member to make sure the books are accurate for sterilization logs. Thorough log systems are required for sterilization for each autoclave to meet accreditation standards. A high number of sterilizers increase the chance of error, increases cost of supplies as each time we change a temp on a sterilizer a new biological indication needs to be ran, and decreases efficiency requiring additional staff.

7. 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.

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8. 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

Official Name & Title Signature Date Project Officer Joe W. Nieto, DDS Dental Supervisor 11/26/2024

Project Officer�s Immediate Supervisor

Jay Sampson, CEO, Yakama S.U. Di

JAY M. SAMPSON -S -S

Da itally signed by JAY M. SAMPSO te: 2024.12.12 16:54:50 -08'00'