Amended Approved TCCC Cadaver JA_Redacted.pdf

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FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

Justification and Approval (J&A) for Federal Acquisition Regulation (FAR) Subpart 13.5

Other than Full and Open Competition Sole Source Acquisition

Title: Amended - JA Tactical Combat Care Casualty (TCCC) Whole Cadavers J&A Number: JA-22-0206

Created By: Additional POCs:

1. Identification of the agency and contracting activity:

San Diego Contracting Division

2. Nature and/or Description of Action being Approved:

new contract

3. Description of Supplies/ Services:

Navy Medical Readiness and Training Command San Diego (NMRTCSD) has a requirement for fresh whole unembalmed cadavers to be used in the training and skills sustainment practice of surgeons, residents, and independent practitioners for essential combat trauma care skills as recommended by the Joint Trauma Service Committee on Tactical Combat Casualty Care (TCCC).

The requirement includes delivery, pickup, redelivery (if necessary), cremation and storage of the whole cadavers as well as serological testing for communicable diseases, performed by a Clinical Laboratory Improvement Amendments (CLIA) certified lab. Anatomical material provided by the vendor must test negative for Hepatitis (HBsAg), Hepatitis C (HCV) HIV (HIV 1&2), and COVID. The whole cadavers are required to be delivered within a one-hour period directly to the Bioskills Training Center (BTC) walk-in refrigerator at the Navy Medical Center San Diego (NMCSD) and picked up within a one-hour period at the refrigerator. One-hour delivery is crucial as fresh cadavers must maintain at a maximum temperature of 32 degrees Fahrenheit during transport as to not accelerate the rate of decomposition, the spread of bacteria, or the growth of mold/mildew. NMCSD's BTC's walk-in refrigerator is the primary back-up to NMCSD's morgue walk-in refrigerator.

Therefore, NMCSD requires an alternative walk-in refrigerator for the whole cadavers in the event the mortuary requires use of the BTC walk-in refrigerator or the BTC walk-in refrigerator becomes nonoperational due to extenuating circumstances such as a breakdown or maintenance. Supplier must possess an up-to-date Defense Biometric Identification System (DBIDS) pass to enter the military base.

TOTAL Contract Value

POP: From 9/30/2022 to 9/29/2027

Estimated Value $450,240.00

BASE

POP: From 9/30/2022 to 9/29/2023

Estimated Value $90,048.00

Type of Contract (Primary):

FAR 16.202 Firm-Fixed-Price

Options: Yes

Number of Options: 4

POP (All options): From 9/30/2023 to 9/29/2027

Estimated Value (all options): $360,192.00

Funding Type:

Department of Defense, Veterans Affairs, Joint Incentive-No Year (DoD/VA JIF-NY)

Extension of Services: No

Clause:

Estimated Value:

Number of Months:

4. Statutory Authority Cited permitting other than full and open competition:

41 U.S.C. 1901 Simplified Acquisition Procedures

This Sole Source is authorized under FAR subpart 13.501(a)(ii).

5. Rationale Justifying Use of the Statutory Authority Cited:

The result of the conducted market research revealed that only the University of California San Diego (UCSD) Anatomic Preparation Department (CAGE: 50854) meets the Government’s requirements for fresh unembalmed cadavers while other vendors meet some, but not all, of the Government’s requirements. The features that set UCSD apart from other suppliers is its proximity to NMCSD and refrigerator capacity. UCSD is located within 15 miles of NMCSD and can meet the one-hour delivery and pick-up time-frame needed in order to maintain the fresh cadavers whereas other suppliers are geographically located more than one-hour away from NMCSD. No other suppliers are also able to provide backup refrigeration for NMCSD within the required timeframe. NMCSD has a standing “No Commingling” Policy, which means their program recommends and supports full segregation of postmortem human and pre and/or postmortem tissues used for education and research in laboratory settings through the use of separate storage facilities. In the event that segregation is not practicable, other methodologies should be employed to result in quick recognition of the tissue type. This issue holds true for the BTC walk-in refrigerator which is the primary back-up to NMCSD morgue walking refrigerator. When the morgue walk-in refrigerator goes down with technical issues, the BTC walk-in becomes the primary source of storage. With the “No Comingling” policy, the cadaver supplier must pick up their product while the morgue is in control of the BTC walk-in refrigerator.

Contracting with vendors at a distance greater than one hour from NMCSD would increase the amount of time for the vendor to pick the cadavers up therefore decreasing the storage space available at NMCSD. With UCSD’s close proximity, they can meet the delivery timeline within one-hour to pick-up and house the cadavers allocated to NMCSD, while the morgue is in possession of the BTC walk-in refrigerator and can redeliver the cadavers for scheduled surgical training.

6. Efforts to Obtain Competition:

A sources sought was not contemplated for this requirement since it is commercial and there is sufficient market information on the suppliers of fresh whole unembalmed cadavers.

Since 2017 NMRTCSD has kept up-to-date with the industry and there has been no change in suppliers who are able to meet all the Government’s requirements for the whole cadavers, specifically the one hour delivery and pickup times and backup refrigeration capacity.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable:

The Government has sufficient historical information on the pricing of the fresh whole unembalmed cadavers since this is a follow-on procurement (prior contract N0025920P0426).

Price quotes were also obtained by the requiring activity. These costs will be used to perform a thorough analysis of the contractor's proposed to ensure the price quoted is consistent to the prices in the open market.

8. Market Research:

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Market Research Conducted? Yes When was it conducted? 1/7/2022 to 7/11/2022 Description:

A combined market research was conducted on 11 July 2022 by the NMCSD BTC Manager/Supply Budget Analysis and DHA Western Markets Contracting Division (WM-CD) Contract Specialist reviewing vendor quotes from MedCure, Research for Life, Science Care, and UCSD Anatomic Preparation Department and reviewing current and historical Government contracts. The market research revealed that while most suppliers can provide fresh whole unembalmed cadavers, only UCSD is able to meet the one-hour delivery and pick-up timeframe and backup refrigeration requirement.

9. Other Facts:

N/A

10. Interested Sources:

A sources sought was not published since there is an established pool of vendors for the requirement and it is commercially available in the open market.

11. Actions to overcome barriers:

The BTC is currently working on a walk-in refrigerator expansion. With the expansion, it would enable the requiring activity to accommodate 24-30 cadaveric specimens, which would eliminate the need for the vendor to provide backup refrigeration. NMRTCSD BTC and the DHA WM-CD will continue to survey and engage the market of cadaveric material vendors within close proximity of NMCSD and consider competing future requirements if there are other vend ors capable of meeting the requirement.

Coordination & Approval

12. Technical/Functional Representative:

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

Name: Title:

Approved:

Comments: N/A

13. Requirements Certification:

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

Name: Title:

J-Directorate Office:

Approved:

Comments:

14. Fair and Reasonable Cost Determination:

I have determined that the anticipated cost to the Government for this contract action is fair and reasonable.

Name: Title:

Approved:

Comments:

15. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

Name: Title:

Approved:

Comments:

16. Contracting Officer:

This is an end of FY22 contract action.

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

Name: Title:

Approved:

Comments:

Version: 260.0 Created at 8/9/2022 9:24 AM by Last modified at 9/26/2022 10:38 AM by Workflow

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