Redacted_Life_Tech_Sole_Source_J A_Redacted.pdf

I.

FAR Subpart 13.5 Si_mplified Procedures for Certain Commercial Items - Sole Source Justification and Approval

Program/Equipment: FYI 6 DFSC-FXD Life Technologies Training and Tool

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

Amount: $ 152,309.42.

Prepared by:

Name: Sherrilyn Rice Title: Purchasing Agent Email: Sherrilyn.u.rice.civ@mail.mil

DSN: 780-1832

Comm: 706-791-183 I Date: 8 July 2016

Procuring Contracting Officer:

Name: Suzanne Mattingly Title: Contracting Officer Email: suzanne.e.mattingly.civ@mail.mil

DSN: 780-1833

Comm: 706-791-1833 Date: 8 July 2016

Technical/Requirements Representative:

Name: Brenda Held Title: FXD DNA Technical Lead Email: brenda.c.held.civ@mail.mil

DSN: 797-4868

Comm: 706-791-0062 Date: 07 Jan 2016

Version - MAY 2016 FOR OFFICIAL USE ONLY mailto:Sherrilyn.u.rice.civ@mail.mil mailto:suzanne.e.mattingly.civ@mail.mil mailto:brenda.c.held.civ@mail.mil

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items - Sole

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Small Business Advocate i x Legal Counsel x Director of MICC Ft. Gordon

I x

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items .... Sole

I. CONTRACTING AGENCY: Mission and Installation Contracting Command - Fort Gordon, GA (MICC-Fort Gordon).

2. Description of Action: The Forensic Exploitation Directorate (FXD) request a Firm-Fixed-Price (FFP) contract with Life Technologies Corporation for 3500xl tool kits and three 3500xl advanced training courses. The Government projects award for 15 September 2016 Operations and Maintenance funds will be used.

3. Description of Supplies/Services: 3500xl tool kits and three 3500xl advanced training courses. The 3500 genetic analyzers are the newest version of genetic analyzers offered by Life Technologies. This instrument is replacing the 3130xl genetic analyzers currently in use. The company no longer produces the 3 l 30xl and has replaced it with the 3500 genetic analyzer. The FXD DNA section is transitioning from operating the 3130xl genetic analyzers to 3500xl genetic analyzers and therefore training on the maintenance and repair of the 3500xl genetic analyzers is required. 3500xl advanced training will train the FXD DNA examiners in the maintenance and repair of the 3500xls to meet the ISO 17025 requirement.

Life Technologies has also developed custom tool kits which contain required tools for commonly needed 3500xl service and replacement parts. The training will consist of three different iterations of the same course. This will allow all FXD DNA examiners to attend the training as FXD rotates examiner deployment over the period of a year. The tool kits will be used in the course and then sent to expeditionary laboratories OCONUS to be used in the repair and maintenance of the 3500xls in those locations.

The period of performance for services is 15 September 2016 to 14 September 20 l 7.

Base Period: 9/15/2016 to 9/14/2017 Value: $ 152,309.42

Total: $152,309.42

4. Actions other than simplified acquisition procedures: FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 10 USC 2304(c)(l )

5. Reason for Authority Cited: The Defense Forensic Science Center (DFSC) located at the Gillem Enclave in Georgia, provides forensic laboratory services to the Department of Defense investigative agencies and other Federal law enforcement agencies. The Forensic Exploitation Directorate (FXD) provides forensic services to the Department of Defense in expeditionary environments. The mission of the FXD DNA section is to obtain DNA profiles from captured enemy material for comparison to known profiles and other questioned profiles. The results of these comparisons are then used for targeting and rule-of-law missions in overseas contingency operations.

(a) The Life Technologies 3130xl and 3500xl Genetic Analyzers are used by forensic examiners to separate DNA fragments of varying lengths based on size. This information is used to develop the DNA profile on an individual, which is used in forensic DNA casework. The accurate performance of these instruments is critical to the mission of the FXD DNA section.

The 3500 genetic analyzers are the newest version of genetic analyzers offered by Life Technologies. This instrument is replacing the 3130xl genetic analyzers currently in use. The company no longer produces the 3 l 30xl and has replaced it with the 3500 genetic analyzer. . The FXD DNA section is transitioning from operating the 3130xl genetic analyzers to 3500xl genetic analyzers and therefore training on the maintenance and repair of the 3500xl genetic analyzers is required.

Life Technologies is the sole source of the 3500XL genetic analyzers, associated repair parts and tool kits and provides technical support for them. Only one of their qualified service engineers can perform the necessary routine preventive maintenance and repairs. Life Technologies service engineer courses are not routinely provided to individuals outside the Life Technologies organization. The vendor supplied a proprietary letter. Life Technologies has indicated that no other personnel outside their organization are trained and certified to perform this type of service. Service engineers who leave the company have signed non-disclosure agreements to not service any Life Technologies instruments if not employed by Life Technologies. Solicitation of other engineer services from other companies would invalidate the service warranties and agreements for the instrumentation involved. Life Technology has developed a unique two day course for the FXD> to train the FXD DNA examiners in the maintenance and repair of the 3500xls to meet the ISO 17025 requirement. Life Technologies has also developed custom tool kits which contain required tools for commonly needed 3500xl service and replacement parts. The training will consist of three different iterations of the same course. This will allow all FXD DNA examiners to attend the training as FXD rotates examiner deployment over the period of a year. The tool kits will be used in the course and then sent to expeditionary laboratories OCONUS to be used in the repair and maintenance of the 3500xls in those locations.

Cb) alternatives: Due to the remote overseas locations of some of the FXT laboratories, normal maintenance of instruments can often not be conducted by a Life Technologies trained service engineer as they are not approved to go into these countries or onto the closed military bases. Therefore the FXD DNA examiners need to perform many of the instrument service and repairs themselves onsite in these expeditionary laboratories. Formal training by the vendor for the instruments is required to ensure the DNA examiners obtain sufficient knowledge to successfully maintain and repair these instruments in theater with the correct tools and materials.

(c) Address thefollowing as applicable.

1) The verified minimum requirements of the Government are three sets of tools and three sessions of training to support the three FXT sequentially preparing for overseas deployment rotations. There are no existing tool sets on hand to repair or maintain the 3500XL genetic analyzers.

2) FXD must maintain a maintenance plan and steps taken to ensure that the software is safeguarded from adjustments that might invalidate the results are required to support forensic laboratory accreditation compliance of installed instruments and equipment. (ISO 17025 ANSI-ASQ National Accreditation Board)

3) FXD must maintain compliance with the FBI Quality Assurance Standards. Standard 10 deals with equipment maintenance and calibration for critical instruments within the laboratory.

The 3500xl Genetic Analyzers are considered a critical instrument according to standard 10.2.1.4.

4) The new 3500XL genetic analyzers are being deployed now throughout FXD's forward deployed Forensic Expeditionary Teams (FXT) replacing the existing Life Technology 3 I OOxl series which has reach the end of life for manufacturer's support of service and repair. Life Technologies I Thermo Fisher Scientific is the sole provider of factory-trained service engineers who have exclusive access to manufacturer's proprietary technical manuals, repair and maintenance procedures, and software application updates for this equipment. Life

Technologies maintains intellectual property rights to its software and service tools software.

Third party resellers and service providers are strictly prohibited from accessing, using or selling this software.

5) Failure to obtain this field engineer training and tool sets from the manufacturer will prevent the routine maintenance of the 3500XL genetic analyzers, disrupt and increase the cost of operations and length of time required to provide mission support while the instruments are required to be returned to the U.S. for service, and jeopardize forensic laboratory accreditation. (ISO 17025 ANSI-ASQ National Accreditation Board)

6) Failure to award this contract will result in failure to meet the standard 10.2.l of the FBI

Quality Assurance Standards which require that critical instruments are performance checked at least annually. Failure to meet this standard will negatively impact the Forensic Exploitation Directorate's goal to maintain the accredited laboratory status. Another negative impact would be the possible effect on the data obtained from the instrument in question. The annual preventative maintenance helps to ensure that the instrument is operating accurately and effectively. Failure to perform this maintenance could result in sub-standard performance of the instrumentation resulting in inaccurate data. Inaccurate data could result in samples not being carried forward for further analysis which otherwise would have. This could then result in an individual on the evidence processed not being identified.

6. Efforts to Obtain Competition: A sources sought synopsis was publicized on 14·July 2016 to FedBizOpps as required by FAR 5.201; one response were received but was deemed technically unacceptable. To promote competition the MICC-Fort Gordon will continue to synopsize and conduct market research to ensure there are no other vendors that can provide the requirement. MICC-Fort Gordon will continue to verify that the requirements are still proprietary to Life Technologies Corporation.

7. Actions to Increase Competition: A sources sought synopsis was publicized on 14 July 2016 to FedBizOpps as required by FAR 5.201; one response were received but was deemed technically unacceptable. To promote competition the MICC-Fort Gordon will continue to synopsize and conduct market research to ensure there are no other vendors that can provide the requirement. MICC-Fort Gordon will continue to verify that the requirement are still proprietary to Life Technologies Corporation.

8. Market Research: Extensive market research was conducted (Internet searches, telephonic communications, forensic conference exhibits, electronic communications, and literature searches) to determine the availability of other companies certified by the manufacturer to provide service for the 3500XL .Different options to maintain and repair instruments in OCONUS locations were investigated. It was determined that obtaining Life Technologies I Thermo Fisher Scientific field engineer training and custom tool kits would be the most effective method to maintain instruments where FXD deploys laboratories.

9. Interested Sources: Capability statement was submitted by Franklin Young in response to the sources sought notice. An email was sent to the manufacturer to verify if Franklin Young is authorized to provide the requirement due to receiving a sole source letter from the manufacturer. Life Technologies stated that although they do partner with Franklin Young for certain requirements the 3500xl tool kits and three 3500xl advanced training courses are not among them. An email was send to Franklin Young on the manufacturer response and Franklin Young responded that due to the specialized nature of the training that they could not offer the requirement.

10. Other Facts:

a. Procurement History: no previous contracts for this requirement.

b. Different options to maintain and repair instruments in OCONUS locations were investigated. While some overseas locations had the possibility to utilize third party vendors that are authorized by Life Technologies to assist with maintenance and repair, these foreign vendors were not registered to contract with the U.S. Government and are not permitted on the military bases due to physical security requirements.

11. TECHNICAL/REQUIREMENTS CERTIFICATION: I certify that the supporting data under my cognizance included in this Justification are accurate and complete to the best of my knowledge and belief.

12. MANAGEMENT REVIEW/APPROVAL: The requirement herein described is a valid requirement for the activity named in this Justification. The technical and requirements information contained in this Justification represent the minimum needs of the Government. The only way to satisfy this requirement is by limiting the competition as described herein.

13. FAIR AND REASONABLE COST DETERMINATION: I hereby determine that the anticipated price for this contract action will be fair and reasonable. Certified Cost and Pricing data will not be obtained.

The techniques identified at FAR 15.404-1(b) will be used to ensure award will be at fair and reasonable prices. The Contracting Officer used a comparison of industry cost for similar work. Additionally, the techniques identified at FAR 15.404-l (c)(2)(iii) will be used to further ensure award will be at fair and reasonable prices.

Version - MAY 2016 FOR OFFICIAL USE·ONLY

MATTINGLY.SUZA

Digitally signed by

MATTINGLY.SUZANNE.E.1369558346

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=MATTINGLY.SUZANNE.E.1369558346 Date: 2016.08.19 12:54:03 -04'00'

MATTINGLY.SUZA

Digitally signed by

MATTINGLY.SUZANNE.E.1369558346

DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=USA, cn=MATTINGLY.SUZANNE.E.1369558346 Date: 2016.08.19 12:54:17 -04'00'

NNE.E.1369558346

NNE.E.1369558346

MATTINGLY.SUZA