Attachment_7_-_Steris_JOFOC_FAR_13_501(a)_v5_Redacted.pdf

they manufacture, including products under the brand names of AMSCO, Finn Aqua, HAMO, Black Diamond Video, Medisage and Cantel/Medivator. All replacement parts manufactured or marketed by Steris are compliant with original equipment manufacturer (OEM) specifications. These parts are sold and shipped directly to the end users of the products. Steris does not utilize a distributor model. Steris has over 950 trained personnel who maintain their equipment through preventative maintenance agreements assuring Steris-manufactured equipment continues to operate in compliance with OEM specifications. A letter from Steris’s Vice President of Service Operations and Installation, Laura Covey, with this information is saved in the official contract file.

NNMC currently owns Steris sterilization equipment along with annual Preventative Maintenance (PM) services required to maintain the functionality of all units. After the one year manufacturer’s warranty, the existing PM services contract with Steris will be modified to remove the old, end of life equipment and add the new equipment. The SPD has received confirmation from Steris that the new equipment can replace the old equipment on the PM contract to avoid additional work for a new PM contract. This allows NNMC to be proactive in planning and avoid future risks for lack of PM coverage.

Furthermore, due to NNMC’s rural location, the water source has a high mineral content that negatively impacts the functionality of the sterilization equipment. It is necessary to upgrade the new equipment with a water system to remove the high mineral content for the sterilization process to prolong the functionality of the equipment. The equipment manufactured by Steris meets the Association for the Advancement of Medical Instrumentation (AAMI) TIR34 / AAMI ST108 standards for sterilization. AAMI TIR34 / AAMI ST108 is a water quality standard for medical device sterilization for the purpose of reprocessing equipment for future use. Water quality is an important consideration in all stages of medical device reprocessing.

Proper water quality is critical for successful sterile processing. It affects cleaning effectiveness and prevents staining or corrosion of instruments. It also impacts manual and automated cleaning and the use of steam. Most U.S. public water systems contain substances like chlorine, dissolved salts, minerals, organic contaminants, bacteria and endotoxins. This contaminated water results in the formation of scale, which leads to stained instruments and inactivates disinfectants.

Therefore, experts recommend reverse osmosis or deionization for the treatment of water used in all sterilization efforts.

Lastly, the new STERIS equipment SPD has the capability to implement an electronic record management system, a feature that comes with each new piece of equipment. The equipment can electronically keep sterilization records and can be downloaded to a computer for record keeping IAW the AAMI standard listed above.

Currently, the system on the existing machines only prints receipts. These are only paper forms and are not currently saved electronically. The outdated nature of the current systems results in administrative challenges (paperwork, efficiencies, etc.)

for a busy medical unit. The new equipment will also have the capability of initiating reminders and steps to proper sterilizing for each cycle. This will also allow the SPD department to prioritize what trays need sterilizing to ensure they are ready for surgeries when necessary. In addition, continued use of Steris BNO equipment allows the Steris systems to work as a cohesive unit and if other brands are used, the system will not function properly to provide the required records.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

In accordance with FAR 12.603, Streamlined Solicitation for Commercial Items, and FAR 13.105, Special Documentation Requirements, a competitive, combined synopsis/solicitation will be issued on beta.SAM.gov. This procedure combines the synopsis required by FAR 5.203 and the issuance of the solicitation into a single document. The approved Brand Name Justification will be made publicly available with the solicitation, IAW FAR13.501(a)(1)(iv).

7. A determination by the contracting officer that the anticipated cost to the

Government will be fair and reasonable.

There is a reasonable expectation, based on market research, that two or more responsible offerors, competing independently, will submit priced offers in response to the solicitation IAW FAR 13.106-3(a)(1). All offers will be evaluated to determine technical acceptability. The presence of two or more technically acceptable offers establishes the determination for price fair and reasonable through competition. In the event two quotes are not obtained to establish a fair and reasonable price determination, other offers analysis techniques may be used IAW FAR 13.106-3(a)(2).

8. A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

To determine whether there were other authorized resellers of Steris equipment, on October 16, 2023, the Contracting Officer issued two sources sought notices to SAM.gov under two different North American Industry Classification System (NAICS), 339112 - Surgical and Medical Instrument Manufacturing and 236220 - Commercial and Institutional Building Construction. No responses were received under NAICS 236220 and only one response was received from Alko Enterprises under NAICS 339112. Additionally, AQD had multiple conversations with the original equipment manufacturer, Steris, regarding capable contractors able to provide this requirement. Steris indicated there are three companies authorized to distribute their sterilizers: ALKO Enterprises, LLC. Native American Owned Small Business (NAOSB), DME, LLC. Woman Owned Service-Disabled Veteran Owned Small Business (WOSDVOSB), and Beacon Point Associates, LLC. (SDVOSB). AQD contacted the two firms that did not respond to the sources sought notice, DME, LLC. and Beacon Point Associates, LLC. via email. Beacon Point Associates, LLC.

indicated they are capable and interested in providing the requirement IAW the Statement of Work (SOW). DME, LLC. did not respond. Additionally, the OEM, Steris, indicated they may also submit an offer. Therefore, there is reasonable expectation of obtaining offers from two or more responsible businesses that are competitive in terms of fair market prices, quality, and delivery.

9. Any other facts supporting the use of other than full and open competition;

such as:

Only Steris and their authorized resellers can meet the Government’s need for the required sterilizing equipment. As indicated in Section 5 above, the required equipment shall meet AAMI TIR34 / AAMI ST108 standards for sterilization and there is no other known equipment brand, other than Steris, that can meet the Government’s requirement.

The Government plans to issue an unrestricted solicitation for installation of Steris brand name equipment.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

Steris Corporation (UEI: UGGQJGGH6846, Large Business) Alko Enterprises (UEI: GB32SMK9WNL9, NAOSB) Beacon Point Associates, LLC. (UEI: L97MMG5VW9N7, SDVOSB)

11. A statement of any actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

The Contracting Officer Representative (COR) and Contracting Officer (CO) will conduct market research to determine if any other sterilizing equipment can meet the Government’s requirements for future acquisitions.

12. Contracting officer certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

Date

11/27/23

13. Requirements personnel certification.

I certify that the technical data which forms a basis for this justification is complete and accurate and meets the Government’s minimum needs.

14. Reviews and Approvals

Concur

Approve

11/28/23

11/28/23

11/21/23