SSJ Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval For

Other Than Full and Open Competition

1. Contracting Activity: The Department of Veteran Affairs, VISN 4, VA Medical Center, Philadelphia, PA and Network Contracting Office 4 (NCO4). This is a Justification and Approval for Other Than Full and Open Competition for Evoqua to update current Deionized (DI) Water Generator System for Sterile Processing Services (SPS).

2. Nature and/or Description of the Action Being Processed: The selected vendor/contractor , Evoqua, 258 Dunksferry Road | Bensalem, PA 19020, will provide labor, material, and equipment to replace current DI water system. This contract will be a leased system to include required preventative maintenance to meet American Nationals Standards Institute/Association for the Advancement of Medical Instrumentaiton (AAMI) ST-108.

This is a 3-year service contract for a DI water system, preventative maintenance, and validation system to meet new standards, AAMI ST-108. The performance work statement further outlines specific requirements for the contract.

ST-108 is a fully recognized ANSI/AAMI standard, marking a significant shift in requirements and subsequent testing frequencies. Being a standard, it encourages widespread compliance and carries more regulatory weight. This standard protects patient safety by establishing mandatory minimum water quality requirements for processing reusable medical devices (i.e. – SPS sterilizes these reusable medical instruments). The new ST-108 standard addresses challenges posed by increasingly complex medical devices (with hidden lumens) and antibiotic-resistant "superbugs" (highly resistant to bacteria).

The VA recently adopted this standard to ensure the highest standard of care and management of the inherent risks associated with the patients receiving specifics procedures as described below:

1. Patient Infections: Residual microbial contamination in water can lead to pathogen transfer during surgical and clinical procedures.

o Risk of hospital-acquired infections (HAIs), especially Pseudomonas aeruginosa, Mycobacteria, and endotoxin-related complication

2. Compromised Decontamination:

o Water does not meet microbial and chemical purity standards can:

Leave biofilm or residue on reusable instruments.

Inhibit proper action of disinfectants or cleaning agents.

Cause ineffective disinfection or sterilization, increasing patient risk

3. Damage to Endoscopes and Equipment o High levels of chlorides, hardness, or organic matter can corrode or block internal channels in reusable instruments.

o This leads to equipment failure, frequent repairs, or replacement costs.

o Potential to void warranties on expensive devices due to improper water use

4. Delays in Patient Care o Water non-compliance will lead to procedural cancellation/delays of surgeries, ENT, and

GI, and in urgent diagnostics or treatments (e.g., cancer pathways

5. Outbreak Investigations o Failure to meet ST-108 standards may trigger infection control investigations and clinical incident reports.

o A single infection traced to poor water quality can prompt surgical and procedural closures, retesting, and public health notifications/institutional disclosures

6. Contaminated Instruments Increase SSI Risk o ST-108 ensures water used in SPS processing is microbiologically and chemically pure.

o If that water is contaminated (e.g., high TVCs, endotoxins, or biofilm), residual microorganisms can remain on instruments.

o Even low-level contamination can lead to infection when introduced into sterile surgical fields.

7. Inflammatory Responses o Even if live bacteria are absent, endotoxins from Gram-negative bacteria in water can persist.

o These pyrogens can cause postoperative fever, inflammation, or contribute to wound healing complications.

8.

o Water system failures (e.g., in DI or filtration units) can lead to biofilm formation, which harbors pathogens like Pseudomonas, Mycobacterium, and Legionella.

o Can be dislodged intermittently, contaminating instruments and increasing sporadic SSI events

The IGE estimate for annual cost of this contract is $189,670. This is inclusive of DI water testing to validate preventive maintenance and system performance against the ST-108 standards.

This contract will provide equipment and filtration that can meet the ST-108 standards.

The benefit of including water testing in this new DI Water contract is the contract defines expected outcomes (meeting stringent ST-108 standards). This is validated through water testing. This approach ensures measurable outcomes with this new system

3. FAR13.5 Simplified Procedures for Certain Commercial Items:

This is used in support of medical procedures performed within surgery, ear/nose & throat (ENT) and Gastrointestinal (GI) procedures. Failure to improve DI Water generation would lead to cancellation of complex procedures. Corporal Michael J Crescenz is a Level 1b facility which is classified as the highest complexity designation within the Veterans Health Administration's system, indicating a high volume of patient care and complex cases that relay on DI water to sterilize instruments.

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

a. The performance work statement fully describes the requirements

b. The Michael J Crescenz VA Medical Center, Sterile Processing Services (SPS) requires critical modifications to the existing equipment supplied by Evoqua. These modifications will provide new equipment and additional equipment to adhere to the standards defined by Advancement of Medical Instrumentaiton (AAMI) ST-108.

c. This scope of work is to provide services contract for the initial installation and operations and maintenance lease to Deionized Water for Sterile Processing Services areas (SPS) the VA Medical Center to be compliant with the standards defined in this performance work statement. This service contract will be issued as a 3-Year maintenance contract.

d. This contract is inclusive of DI water testing as defined by ST-108 to validate system is operating as designed.

5. 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.

FAR13.5 Simplified Procedures for Certain Commercial Items: see above

6. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Due to proprietary nature of the work, this will be issued as a sole source to Evoqua. The proposed action is for unique services available from only one source. The DI water system equipment installed in Corporal Michael J Crescenz is owned by Evoqua and leased to this medical center through a maintenance service contract. The DI water system equipment and process is proprietary to Evoqua personnel.

Should Corporal Michael J Crescenz engage alternative vendors in a competitive bid, significant time will be lost in development of proposals, which require design of the system. This will produce duplicate costs for design and installation that would not be expected to be recovered through competition and unacceptable delays.

Evoqua is the original design vendor for the SPS DI water generation system. Evoqua has been instrumental in the current success for maintenance under the DI system that was designed around the previous standards. Evoqua can quickly provide an updated DI system to meet the new standards and reduce the risk of shut down of Sterile Processing and subsequent cancellations of surgeries, ENT and GI procedures. All (3) of these departments utilize instrumentation sterilized in

SPS.

It is essential the DI system is upgraded by the current vendor to maintain operations of SPS thus allow clinical procedures (surgery, ENT, and GI) to be sustained.

7. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The VA intends to provide a permanent system under current Project 642-21- 113 that will be but out for bid in late FY26. Given the phasing of this project, the permanent DI system is expected to be installed late FY28. This permanent system will be competitively bid.

Therefore, this 3-year DI water contract will provide interim operations until the permanent solution is installed in late FY28/early FY29