20-RHCO-P 549 JA-FAR 8.4 (FSS) Limited Source Justification - COVID 19 Urgency signed.pdf

Control Number: 20-RHCO-P 548

For Official Use Only (See FAR 2.101 and 3.104 4)

(March 2020)

Justification Review Document

FAR 8.405-6 LIMITED SOURCES JUSTIFICATION

UNDER THE MULTIPLE AWARD SCHEDULE PROGRAM

URGENT AND COMPELLING – COVID-19

Program/Equipment: CEEP # 20-0236 3D Printed Part Development for Expeditionary Abdominal/Thoracic Surgical Set and 3D Printed Part Development for N95 Type Respirator Mask.

Authority: Title III of the Federal Property and Administrative Services Act of 1949 (41U.S.C. 251, et. Seq) and Title 40 U.S.C 501, Services for Executive Agencies, as implemented by FAR 8.405-6.

Amount: $80,000.00

Prepared by:

Typed Name: Walter J. Bischoff

Title: Purchasing Agent, JBLM-HCB

E-mail: Walter.j.Bischoff.civ@mail.mil

Requirements Representative:

Typed Name: Michael P. Rivard

Title: Clinical Investigations, Administrative Officer

Email: Michael.p.Rivard.civ@mail.mil

Contracting Officer

Typed Name: Scott A. Barr

Title: Contracting Officer, JBLM HCB

Email: Scott.a.Barr.civ@mail.mil

Control Number: 20 RHCO P 548

(See FAR 2.101 and 3.104 4)

(March 2020)

FAR 8.405-6 LIMITED SOURCES JUSTIFICATION

UNDER THE MULTIPLE AWARD SCHEDULE PROGRAM

Urgent and Compelling – COVID-19

1. Contracting Activity: Regional Health Contracting Office-Pacific, Health Contracting Branch, Joint Base Lewis-McChord (JBLM), 673 Woodland Square Loop SE, Lacey WA 98503

2. Description of Action Madigan Army Medical Center, Tacoma WA; Department of Clinical Investigations is requesting an urgent Covid-19 one-time purchase requirement of 3D Printed Parts Development of 2 products for use in providing safe patient / staff care and treatment options during the Covid-19 Pandemic.

3. Description of Supplies/Services: 3D Printed Part Development for Expeditionary Abdominal/Thoracic Surgical Set, and 3D Printed Part Development of N95 Type Respirator Mask.

Period of Performance: or Delivery: 15 September 2020 Total Value: $ 80,000.00

*Note: Option quantities or performance periods are typically not allowed in justifications citing urgency. The total period of performance of a contract awarded using this authority may not exceed the time necessary to meet the requirements of the work to be performed and for the agency to enter into another contract for the required goods or services through the use of competitive procedures.

4. Authority Cited: Title III of the Federal Property and Administrative Services Act of 1949 (41U.S.C. 251, et. Seq) and Title 40 U.S.C 501, Services for Executive Agencies, as implemented by FAR 8.405-6 and substantiated by the following: FAR 8.405- 6(a)(1)(i)(A). An urgent and compelling need exists, and following the procedures would result in unacceptable delays.

5. Reason for Authority Cited:

41 U.S.C. 1903 Special Emergency Procurement authority is authorized because the President of the United States made an emergency determination under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121- 5207 (the "Stafford Act") in response to the COVID-19 pandemic on 13 March 2020.

Madigan Army Medical Center, has a public responsibility to comply with the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) guidance to prevent further spread of COVID-19. They are also required to comply with Department of Defense and U.S. Army Europe guidance to implement plans to ensure compliance with directed force health protection measures throughout the area of

(See FAR 2.101 and 3.104 4)

(March 2020) operations in order to prevent an outbreak of COVID-19 within U.S. personnel (service members, civilians, contractors, and dependents) or confine it to as small a population as possible. In order to comply and put protective measures in place, (Insert customer unit) has an urgent need for (insert list of supplies/services). These supplies/services are required in order to protect the public from the spread of (or isolate people infected with) COVID-19. This requirement will (insert the description of how this will protect public health and safety and try to do it in the same terms of the WHO/CDC guidance in the market research section).

Every day that passes confirmed COVID-19 cases spike and the death toll increases. It is imperative that these supplies/services are obtained as quickly as possible to protect public health. The U.S. Government cannot apply standard procurement times to an acquisition of this urgent nature. Even the short time-lines of 30-60 days to award, could result in hundreds of thousands more being infected and thousands more dying.

Name of Intended Contractor: RE: 3D, Inc Street Address: 1100 Hercules Ave, Ste 220 City, State, Zip: Houston, TX 77058 Phone: (512)730-0033

6. Efforts to Obtain Competition: A variety of hardware and related supplies are available through other sources, only this vendor, through research is well known for its use of additive manufacturing and has a high confidence of surgical solutions that can be printed, due to significant experience working with multiple DOD facilities that are already leveraging the FFF process. This is a very unique capability and to my knowledge and research, no other vendor possesses the experience in with biomedical engineering processes, particularly with printing of medical prosthetics. This vendor possess expertise in material engineering, with specific knowledge of the materials required to achieve printing of medical instruments that can withstand sterilization.

7. Actions to Increase Competition: In accordance with FAR 5.201 this action with the J & A will be posted to Beta SAM FBO as a Notice of Intent.

8. Market Research: This requirement for unique medical printed instrument sets and supplies are; FSC 6515 (Class VIII). Detail, including key work searches described in the Market Research which supports this J & A can be found in the PCF File under Market Research. Market Research has been conducted by searching the Dynamic Small Business Search (DSBS) using NAICS Code: 333318. Results from this search did not locate any small businesses that could provide the above products meeting the salient characteristics, as determined by the customer. In addition, the intended contractor is the only available source capable of meeting the Surgeons requirements for the prescribed patients.

(See FAR 2.101 and 3.104 4)

(March 2020)

In December of 2019 an outbreak of COVID-19 was reported in Wuhan City, Hubei Province, China. The World Health Organization (WHO) states COVID-19 is the infectious disease caused by the most recently discovered coronavirus. They also state in humans, several coronaviruses are known to cause respiratory infections, ranging from the common cold to more severe diseases, such as COVID-19. The WHO states:

“Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness.

People with fever, cough and difficulty breathing should seek medical attention.”

The WHO declared the global COVID-19 outbreak a pandemic on 11 March 2020, stating it is a “public health crisis”. The following is information from the WHO website.

The WHO is recommending all countries activate and scale up their emergency response mechanisms utilizing a four-pronged approach. First, prepare and be ready. In other words, prepare your people and your health facilities. Second, detect, prevent, and treat. Utilize surveillance to find, isolate, test and treat every case in order to break the chain of transmission. Third, reduce and suppress. Reduce transmission by finding and isolating as many cases as possible and quarantining their closes contacts. Protect health facilities, old age homes, and other vital areas. They recommend testing all suspected cases. Fourth, innovate and improve. Find new ways to prevent infection, save lives, and minimize impact. Utilize personal protective equipment. Utilize the WHO training programs, technical guidance, studies, protocols, and preparedness and response plans.

The 3D Printed Part Development Surgical Set and N95 Mask will allow the Surgeons multiple use of these specially designed printed items in a quick turnaround process of sterilization in the care and treatment of surgical patients, and provide both the patients and medical staff the safety that is necessary as part of the overall healthcare mission in this period of the Global Pandemic.

On January 31, 2020, the United States Department of Health and Human Services Secretary Alex M. Azar II declared a public health emergency (PHE) for the United States to aid the nation’s health care community in responding to COVID-19. On 13 March 2020, the President of the United States of America declared COVID-19 an emergency IAW 42 U.S.C. 5122 (the Robert T. Stafford Disaster Relief and Emergency Assistance Act) which allows for Special Emergency Procurement Authority IAW 41 U.S.C.1903. On 18 March 2020, the President invoked his authority IAW the Defense Production Act. The Act allows the President, where necessary to promote the national defense, may require acceptance and performance of contracts orders by any person he finds to be capable of performing them.

(See FAR 2.101 and 3.104 4)

(March 2020)

Based on the guidance issued by the WHO, CDC, U.S. Government organizations, and other State Departments throughout the world, people are stocking up on specialty PPE supplies, so there is a worldwide shortage of the required supplies.

9. Other Facts:

a. Procurement history. No previous award history.

10. Technical Certification: Include the following statement:

I certify 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.

Signature: ________________________________Date: __________

Typed Name: Michael P. Rivard

11. Requirements Certification: Include the following statement:

I certify 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.

Signature: ________________________________Date: __________

Typed Name: Michael P. Rivard

12. Fair and Reasonable Cost Determination: Include the following determination:

It is determined that the anticipated cost to the Government for this contract action is fair and reasonable based on the uniqueness of manufacturing of printed 3D medical PPE equipment and supplies.

Signature: ________________________________Date: __________

Typed Name: Michael P. Rivard

RIVARD.MICHAEL.

P.1131998402

Digitally signed by

RIVARD.MICHAEL.P.1131998402

Date: 2020.08.31 09:16:57 -07'00'

RIVARD.MICHAE

L.P.1131998402

Digitally signed by

RIVARD.MICHAEL.P.1131998402

Date: 2020.08.31 09:17:32 -07'00'

RIVARD.MICHAE

L.P.1131998402

Digitally signed by

RIVARD.MICHAEL.P.1131998402

Date: 2020.08.31 09:18:08 -07'00'

(See FAR 2.101 and 3.104 4)

(March 2020)

13. Contracting Officer Certification: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval. Include the following statement:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: ________________________________Date: __________

Typed Name: Scott A. Barr, Contracting Officer, JBLM-HCB

BARR.SCOTT.A.10

78903208

Digitally signed by

BARR.SCOTT.A.1078903208

Date: 2020.08.31 10:49:49 -07'00'