D.03._SSJ_Redacted.pdf

Control No: JA-19-06-0151 Contractor: Siemens

Equipment: CT Scanner

Version – March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS –

SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: The requiring activity for this action is the Defense Health Agency (DHA), Armed Forces Medical Examiner System (AFMES) requires a CT-Scanner to have the ability to perform x-rays to view foreign objects that may be lodged in the body of the individual.

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. as implemented by

FAR 13.5.

Amount:

Prepared by:

Contracting Officer:

Technical:

Requirements:

Reviews: I have reviewed this justification and find it adequate to support sole source.

Program Manager:

Legal Counsel:

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items –

Sole Source Justification and Approval

1. Contracting Activity The Contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Description of Action AFMES requests a firm-fixed-price contract with Siemens. The Government projects award for September 2019 and fiscal year 2019 Operations and Maintenance funds will be used for the procurement, delivery and installation of the CT Scanner.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

FAR 13.501(a)(1)(i) approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B) on 07/18/19).

The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting approval.

3. Description of Supplies/Services The Somatom Confidence RT Pro provides all the functionalities of a CT simulator, which produces images that are used to define the target and organs. The new Somatom Confidence RT Pro features iMAR metal artifact reduction capabilities. Additionally, it provides great image quality, thanks to the new detector and iterative reconstruction methods, which is needed for contouring.

CT scanning is also useful in cases of gunshot injuries and bombs. The projectile can easily be found, the bullet tract can often be visualized, and the shot angles can be measured. In cases where the deceased needs to be identified, CT scanning gives a quick overview of the body, revealing old fractures, transplants, dentition, and the like. CT scanning is especially useful in identification of mass-disaster victims. This new requirement will consist of equipment, installation and include maintenance, support and training.

AFMES current Computed Tomography Scanner (CT-Scanner) is past its end of life cycle. CT- Scanners should be replaced every ten (10) years. AFMES has used the current CT Scanner for seventeen (17) years. It crashes and stops working during Autopsies. The current CT Scanner is costing the Government over $190,000.00 a year in repair costs. Examination of deceased individuals benefit from modern imagining techniques such as CT Scanning. The CT Scanner contributes to the medicolegal death investigations by providing new information that could not be obtained by an autopsy alone and allows investigation of anatomic regions that are not easily available by autopsy.

AFMES is procuring one (1) CT Scanner to include maintenance for a period of five (5) years.

The estimated value of the CT Scanner to include delivery and installation is approximately

The maintenance plan for the option years will use future Fiscal Year funding not current funds.

Maintenance will begin after installation and the initial warranty period ends. The estimated timeframe for the maintenance plan along with the value for each year is as follows:

Base Period: 09/15/19 to 09/14/20 Value Option Period I: 09/15/20 to 09/14/21 Value Option Period II: 09/15/21 to 09/14/22 Value Option Period III: 09/15/22 to 09/14/23 Value Option Period IV: 09/15/23 to 09/14/24 Value

The total estimated value to include delivery, installation and maintenance for five (5) years is

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5:

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other: Only one source reasonably available (including brand name)

5. Reason for Authority Cited AFMES mission requires medical examiners to use precision and accuracy when performing autopsies. It’s imperative for the medical examiners to have the ability to perform a single x-ray.

This feature is necessary when recovering shrapnel from a bomb or locating bullets. Siemens is the only vendor with a CT-Scanner that can meet the Government’s requirements.

The Medical Examiners require a CT scanner that has 16 (sixteen) slices minimum. Most medical establishments want 32 slices or better. With that said the specific bore size required of the medical examiners is eighty (80) centimeters. CT scanners with an 80 cm bore size often times has more than 16 slices which is beyond the requirement of the medical examiners.

However, Siemens has CT scanner with 16 slice and 80 cm bore size.

It was also a requirement for the CT scanner to have dual energy. Most CT scanners provide dual energy CT scanner with a 32 to 64 slice scanner minimum. This option was not available with any company other than Siemens which does provide dual energy with a reduced slice scanner.

6. Efforts to Obtain Competition The equipment must be maintained within the original equipment manufacturer (OEM) specifications, in like new or better condition; therefore, no effort will be made to solicit offers from any other potential sources as there is only one known source capable of providing the required equipment maintenance service. No effective competition is anticipated. The Government will continue to monitor the market conditions to identify other companies that might satisfy the requirement in the future.

The Contracting Officer shall publish the notices required by FAR 5.201.

7. Actions to Increase Competition Siemens is the only company that can provide the required CT scanner equipment, maintenance and installation required by AFMES, while ensuring the instrument’s performance, calibration, and functionality are not compromised. The Government will continue to monitor the market conditions to identify other companies that might satisfy the requirement in the future.

8. Market Research Market research included internet searches on Google and the other companies that can provide the required CT scanner, maintenance services, while ensuring the instrument’s performance, calibration, and functionality are not compromised. Most CT scanners provide dual energy CT scanners with a 32 to 64 slice scanner minimum. It is not the need of AFMES to have a multi-slice of this significance. AFMES requires a CT scanner with 16 slices. This option was not available with any company other than Siemens which does provide dual energy with a reduced slice scanner. Additionally, the market research revealed that most medical establishments seeking a CT scanner want a multi-slice of 32 slices or better. With that said the specific bore size is larger. The requirement bore size of the medical examiners is eighty (80) centimeters. CT scanners with an 80 cm bore size often times has more than 16 slices which is beyond the requirement of AFMES. Siemens has a CT scanner with 16 slice and an eighty (80) cm bore size.

9. Interested Sources To date no other source has expressed an interest in the acquisition.

10. Other Facts

a. Procurement History

(1) Contract numbers and dates of the last several contracts for these same requirements.

-- The current system was purchased in 2002 no contract numbers available.

(2) The competitive status of these actions.

--NA

(3) Authority previously cited if less than full and open competition was used.

--NA

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

--NA

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

--NA

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

--NA

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

--NA

b. Class J&A

c. Discuss any other facts that should be addressed to support this action.

11. Technical Certification 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.

12. Requirements Certification 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.

13. Fair and Reasonable Cost Determination I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following:

Price analysis Cost analysis

IGE

Audit:

Other:

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

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

Approval

Based on the foregoing justification, I hereby approve the procurement of the CT Scanner on a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.