N0025918RCD0270-Attachment_V-J&A-Sterile_Processing_Services-SPSA-NMCSD_Redacted.pdf

LOG# 18-10068

Sterile Processing Services/SPSA-NMCSD Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD on behalf of Naval Medical Center San Diego (NMCSD) to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for a contract to provide sterile processing services for NMCSD. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Sterile Processing Services of America, LLC.

(SPSA) of 2240 E Artesia Blvd, Long Beach, CA, 90805-1739.

3. Description of the supplies/services required.

The Main Operating Room requires off-site contracted sterilization services for the surgical instrument sets used for surgical procedures at NMCSD. Requirement is for proper receipt and handling, transport to the sterile processing facility, performance of sterile processing, proper wrapping and protection, and sterile delivery back to NMCSD.

Services shall be performed in accordance with Joint Commission regulations and AAMI guidance for sterilization and handling of sterile surgical instruments, which are the BUMED standards for these materials. The department requires expedited next-day/overnight services for the sets, with no greater than a 24 hour turn-around time.

Contractor shall pick-up, process, and deliver in less than 24 hours as a next-day service. The department can make allowances for extended timeframes on some sets. All items being returned to NMCSD shall be transported and delivered in manner preserving sterility.

Sterilization shall be comprehensive in nature and make use of steam sterilization processes (no ethylene oxide or gamma radiation). In addition, services shall also include proper decontamination, washing, wrap/prep, and steam sterilization in accordance with all federal and state laws/guidelines, and comply with AAMI standards for those processes.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.501(a), Only One Responsible Source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

SPSA is the only vendor that has been identified in Southern California that can provide the needed services in an expedient manner. They have the ability to provide next day services for surgical sets, and can meet the BUMED/Joint Commission/AAMI sterilization technical requirements.

Due to the previous procurement being a sole source, a Request for Information (RFI) was posted to FBO from 14 June 2018 – 19 June 2018. A response was received from Proxy Personnel. The response was sent to NMCSD for review. It was determined that the response was unacceptable as it does not meet the requirement. The response only speaks to staffing a current sterile processing location rather than also providing the ability to pick up, process and deliver instrumentation/equipment for sterile processing. In addition, Proxy Personnel doesn’t have its own processing site.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the NECO and/or FedBizOpps in accordance with FAR 5.202.

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7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

NMCSD contacted Naval Hospital Camp Pendleton (NHCP) and can shift some of the requirement to NHCP, however, the support they can provide is extremely limited due to their own surgical needs and the limited processing capability. The same situation is the case with the Veterans Administration (VA) Hospital.

An internet search did not yield any direct, clear results. The following websites were reviewed but the results of this research were not conclusive given the requirement to provide next day services for surgical sets, and the ability to meet the BUMED/Joint Commission/AAMI sterilization technical requirements:

http://www.medical-equipment-and-supplies.com/category/sterile-processing-infection-control/instrument-cleaning https://www.mpo-mag.com/contents/view_features/2006-06-12/sterilization-service-providers

SPSA

Currently, services are being provided on a temporary, emergent basis by SPSA. SPSA can do steam sterilization out of their Long Beach location which is acceptable for the NMCSD instrumentation.

Steris https://www.steris.com/healthcare/sterile-processing/ Steris was contacted and provided a quote. Steris has Ethylene Oxide (ETO) sterilization services in San Diego, but this method is not acceptable for NMCSD instrumentation and creates additional handling problems due to the caustic nature of the gas. Everything available locally is ETO, gamma radiation, or e-beam. Steris' only in-San- Diego sterilization is ETO.

Sterigenics https://sterigenics.com/sterilization_technologies.php Sterigenics only offers gamma irradiation, ethylene oxide, and electron beam sterilization processes. None of these are suitable for medical instrumentation or create additional problems (ETO) that make them unsuitable for the Main Operating Room. Additionally, turnaround time with these methods is significantly longer than steam sterilization.

Not a suitable source.

Belimed http://www.belimed.com/en-us/services-support/services/ Belimed POCs confirmed they do not provide sterilization services.

Synergy Health https://www.synergyhealthplc.com/us/hospital-sterilization-services Contacting this website and inquiring about sterilization services redirects to Steris at the following website:

https://www.steris-ast.com/. Synergy Health website states right on the page that they have combined with Steris.

Getinge https://www.getinge.com/us/contact/ Getinge does not offer the services required.

Other companies examined include:

http://www.cmpcontractservices.com/ www.ethoxint.com http://www.medical-equipment-and-supplies.com/category/sterile-processing-infection-control/instrument-cleaning https://www.mpo-mag.com/contents/view_features/2006-06-12/sterilization-service-providers https://www.steris.com/healthcare/sterile-processing/ https://sterigenics.com/sterilization_technologies.php http://www.belimed.com/en-us/services-support/services/ https://www.synergyhealthplc.com/us/hospital-sterilization-services https://www.getinge.com/us/contact/ http://www.cmpcontractservices.com/ http://www.ethoxint.com/

Sterile Processing Services/SPSA-NMCSD Page 3 of 4 1 Nov 12 www.qtspackage.com http://www.bluelineeto.com/ https://gibraltarlabsinc.com/services/sterilization-services/sterilization/

Services offered by these firms are either for custom sterile kits intended for single-use items, typically for medical device manufacturers or distributors. All use electron beam, radiation, or ethylene oxide sterilization, which is intended for creating sterile, single-use, products.

A Request for Information (RFI) was posted to FBO from 14 June 2018 – 19 June 2018. A response was received from Proxy Personnel. The response was sent to NMCSD for review. It was determined that the response was unacceptable as it does not meet the requirement. The response only speaks to staffing a current sterile processing location rather than also providing the ability to pick up, process and deliver instrumentation/equipment for sterile processing. In addition, Proxy Personnel doesn’t have its own processing site.

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

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of 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.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Approval is Derek Bell, who may be reached at (301) 619-6914.

http://www.qtspackage.com/ http://www.bluelineeto.com/ https://gibraltarlabsinc.com/services/sterilization-services/sterilization/

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TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)