JA-Hologic Maint-Redacted.pdf

Control Number: 21-RHCO-P-502 CUI//SP-PROCURE

Maintenance and Repair of Hologic Mammography System, BDAACH-Korea

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Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office-Pacific (RHCO-P), 146 Clark Road, Building 339, Fort Shafter, Hawaii 96858

2. Description of Action: This approval is for a new, firm fixed priced contract utilizing Operation and Maintenance funds.

3. Description of Supplies/Services: Maintenance and Repair of Hologic Mammography System at Brian D. Allgood Army Community Hospital (BDAACH), Korea. The estimated total value of includes a one-year base period, four one-year option periods, and 52.217-8 six-month extension period.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited:

a. JW Medical Corporation is the only authorized service provider for the Hologic Mammography System installed at BDAACH. JW Medical is located in South Korea and is able to meet the required on-site response time of within 8 hours for emergency repairs and within 24 hours for regular repairs.

Hologic Inc., headquartered in Marlborough, Massachusetts is the developer of the Hologic Mammography System. In 2018, an International Distribution Agreement was established between Hologic Inc. and JW Medical to appoint JW Medical with the exclusive right to service Hologic customers located in the Republic of Korea. Due to the proprietary nature of the system, which includes new replacement parts, software updates, license, and patents covering the intricate designs of the instruments, no other known sources are authorized or possess the knowledge necessary to maintain the system.

The Hologic Mammography System provides diagnostic testing for women’s health that is vital in detecting potentially fatal health hazards at their earliest stage. Without a properly maintained system, BDAACH would not be able to maintain the unit to manufacturer’s specifications. This could result in miss diagnosis, resulting in severe patient harm and possibly death in some cases.

b. Alternatives. Suspension of the Hologic Mammography System service contract would drastically impact BDAACH’s Radiology and Women’s Health Programs. Without the Hologic system receiving regular maintenance services from JW Medical

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technicians, the system would no longer meet the specific compliance standards established by the Joint Commission, DHA, HIPAA, and the NFPA 99 Standard for Health Care Facilities.

In-house personnel cannot be utilized as training is not offered to non-JW Medical technicians.

The Government is unable to identify any other private hospitals or organizations utilizing an alternative manufacturer of mammography systems, thus replacing the current Hologic system is not viable.

6. Efforts to Obtain Competition:

a. Effective Competition. The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered. A Sources Sought Notice was posted on sam.gov on 21 Jun 2021 inviting all possible sources to submit a capability statement. It closed on 28 Jun 2021 with no responses.

b. Subcontracting Competition. JW Medical is the exclusive service provider for Hologic Mammography Systems in Korea, and due to the proprietary nature of their products and services, JW Medical would not be able to subcontract for the required services. In addition, in accordance with FAR 19.702(b)(3), subcontracting requirements and plans do not apply to contracts that are performed entirely outside of the United States and its outlying areas. In consideration of the above, the contracting officer has determined that subcontracting possibilities do not exist.

7. Actions to Increase Competition: The government conducted ongoing market research of the industry to determine if there were new entrants into the local market to meet the government’s requirements. Market research conducted within the past 12 months revealed that there were no new entrants. Based on this, it has been determined that JW Medical is the only contractor that can fulfill the government’s requirements. The government will continue to conduct ongoing market research of the industry to determine if there are new entrants into the local market to meet the government’s requirements.

8. Market Research: Market research was conducted within the previous 12 months as required by AFARS 5153.303-5, para 8. It is a commercial practice for each manufacturer to provide these types of services for their own systems or by their authorized service providers. After contacting multiple vendors in Seoul, it was found that no vendors have the authority to service Hologic systems. The list of vendors contacted are as follows:

-INSEONMEDICS – Dongil-ro 179-gil, Nowon-gu, Seoul, Korea

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-SEOLIN SYSTEM – Yeongdoong-daero 137-gil,Gangnam-gu, Seoul, Korea

-Shin Ki Commercial Co., Ltd. – Gangnam-daero 34-gil,Seocho-gu, Seoul, Korea

-BMI Seoul – Gaepo-ro 20-gil, Gangnam-gu, Seoul, Korea

-Philips Electronics Korea – Sowol-ro 2-gil, Jung-gu, Seoul, Korea

9. Interested Sources: To date, no other sources have written to express an interest.

10. Other Facts:

a. Procurement history:

(1) Previous contract: W81K02-14-P-0078 JW Medical Corporation. 15 Jul 2014 – 14 Oct 2019.

(2) The previous contract was competed.

(3) There was no authority for sole-source previously cited.

(4) There was no justification prepared to support the previous procurement.

(5) Previous contract was competed in 2014 using full and open competition, however only one offer, from JW Medical, was received. In 2018, an International Distribution Agreement was established between Hologic Inc. and JW Medical to appoint JW Medical with the exclusive right to service Hologic customers located in the Republic of Korea.

(6) There are no unusual patterns that are revealed by the history of this requirement.

(7) There were no circumstances justifying a sole-source procurement before this one.

b. There are no other facts to list in this justification.