JA Advanced Sterilization REDACTED.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Other Than Full and Open Competition

1. Contracting Activity: Department of Veterans Affairs, Network 16 Contracting Activity, Biloxi Medical Center. Justification for Other Than Full and Open Competition for 2237#

2. Nature and/or Description of the Action Being Processed: This sole source request ensures the facility maintains compliance with reprocessing procedures, national standardization and manufacturer integrity of the Sterrad sterilizers. Currently, the Sterrad and Steris series of hydrogen peroxide gas plasma sterilizers are the only FDA approved and cleared medical devices for use in healthcare facilities. This requirement is for the PM&R of the Sterrad

Sterilizers. Endoscopes and most other RME equipment are made of materials that require low temperature sterilization. Hydrogen peroxide gas plasma (H202) sterilization is an advanced technology that allows for safe and optimum performance in processing of these type medical devices at low temperatures.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The Gulf Coast Veterans Health Care System in Biloxi, MS has a requirement for preventive maintenance and repair of the Sterrad Sterilizers manufactured by Advanced Sterilization

Products a Johnson & Johnson company. The Sterrad sterilizers use hydrogen peroxide gas plasma sterilization technology. Preventive maintenance service includes replacement of all wearable parts, system calibration, and system diagnostics. The system has proprietary software which requires service access software from ASP. All labor, time, and materials for corrective maintenance are required. Approximate cost per year is $50,925.00.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4

( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority):

VHABILIMPEYD

Typewritten Text 520-24-1-076-0001

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Only One Responsible Source (FAR 6.302-1) – Advanced Sterilization Products (ASP) is the only known FDA approved vendor that can supply Preventive Maintenance services on the

Sterrad Systems. They are currently one of two FDA approved vendors who supply Hydrogen

Peroxide gas plasma technology for instrument sterilization; therefore, they are the only qualified vendor to provide competent and proprietary service on equipment they manufactured.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: N/A

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The estimated value of this solicitation to include base period and the four year option period is $274,995.00. Based on market research and comparison of pricing among other VA’s the contracting officer believes ASP pricing will be fair and reasonable. ASP holds a VA federal supply schedule awarded by the National Acquisition Center (NAC). The contracting officer also believes Sterrad would not jeopardize their corporate governance by offering unfair or unreasonable pricing.

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: :

Market Research revealed no SDVOSB, VOSB, or small businesses authorized or capable of providing the preventative maintenance and repair. Historically, the services have been provided by Advance Sterilization (ASP). Advance Sterilization is the OEM and has proprietary ownership of all hardware, software and firmware.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

“ see section VI above.”

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any

Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Full and open competition can be sought when the hardware and software require for the equipment are no longer proprietary.

12. Requirements Certification: I certify that the requirement outlined in this justification is a

Bona Fide Need of the Department of Veterans Affairs and 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.

Jay D. Tripp Date

Chief, Engineering Service

GCVHCS – BILOXI MEDICAL CENTER

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/af_afmc/far/Far06.doc#b63021

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VHABILIMPEYD

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13. Approvals in accordance with FAR 6.304

a. Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date

CONTRACTING OFFICER

BILOXI, NETWORK 16 CONTRACTING ACTIVITY

Date4_af_date: 5/3/23