Justification_and_Approval_Document_Redacted_20181009.pdf

Control Number:18-HRCO-591

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

(25 February 2016)

Justification Review Document for Other than Full and Open Competition

Program/Equipment: 3M Company, Secure Enterprise Dictation and Transcription Solution

(SEDTS)

Authority: The statutory authority permitting other than full and open competition is 10 United States Code (USC) 2304(c)(1) and FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements.

Amount: The total estimated value of this requirement is $9,376,000.00 for a three year ordering period. The resultant contract is considered a supply buy and will not include any options to extend services.

Prepared by:

Typed Name: Phone:

Title: Health Information Administrator Date: 6-22-2018 E-mail:

Contracting Officer:

Title: Chief, Health Readiness Branch Date Reviewed: 6-25-2018 E-Mail:

Technical/Requirements Representative:

Title: Chief, Army Medicine Nursing Information Officer Date Reviewed: 6-22-2018 E-mail:

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

Legal Counsel:

Signature: Date:

(See FAR 2.101 and 3.104-4)

(25 February 2016)

Control Number:18-HRCO-591

3M Company, Secure Enterprise Dictation and Transcription Solution (SEDTS) CONUS and OCONUS

Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: Health Readiness Contracting Office (HRCO), Joint Base San Antonio-Fort Sam Houston, Texas 78234

2. Description of Action: The U.S. Army Medical Command (MEDOM), Office of the Surgeon General (OTSG), is requesting the approval for a sole source contract for the procurement of a medical dictation and transcription product developed by the 3M Company called Secure Enterprise Dictation and Transcription Solution (SEDTS). This is a new requirement for the award of a Single Award Indefinite Delivery Indefinite Quantity (IDIQ) contract with firm-fixed price CLINS in support of the Defense Health Agency’s Military Health System (MHS) Medical Treatment Facilities (MTFs). This award will include up to 25 Medical Treatment Facilities (MTFs), located both CONUS and OCONUS, throughout the following Department of Defense (DoD) Uniformed Services, the U.S. Army, the U.S. Navy, and the U.S. Air Force. Funds will be provided on each individual delivery order. The anticipated funds are Defense Health Program (DHP) funds.

3. Description of Supplies/Services: The Government has a requirement for the purchase of a Commercial Off-The-Shelf (COTS) dictation and transcription software product, to be delivered at the first five sites no later than 30 September 2018. This will allow medical professionals the ability to input voice dictation via landline telephones, mobile telephones, (e.g. cell phones, smart phones, etc.) and personal computers (PC). In addition to the purchase of the required software, the government requires corresponding hardware, installation, training, and annual license renewals

a. The required software shall have the following capabilities:

(1) Windows 10 Compatibility

(2) Secure Remote connection across all military treatment facilities (MTFs) both within the Continental United States (CONUS) and outside of the continental United States (OCONUS)

(3) Back end speech recognition (BESR)

(4) Electronic review and editing of transcribed documentation which includes the ability to have the review and editing of BESR generated notes completed by a transcriptionist.

(5) Electronic Signature Capability with the DoD Common Access Card (CAC)

(6) Dictation and transcription management and reporting tools that allow for detailed analysis of electronically signed documents.

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Control Number:18-HRCO-591

(7) Rapid dictation and transcription turnaround times

(8) Audit trail capabilities to record changes to the dictated and transcribed notes

(9) An electronic document upload interface with the capability to interface with DHA’s inpatient Electronic Health Record (EHR) Commercial off the Shelf (COTS) product Essentris.

(10) A dictation and transcription software platform with the capability to receive an electronic Admissions, Discharge and Transfer (ADT) demographic data feed from the Composite Health Care System (CHCS).

(11) An approved DHA Authority to Operate (ATO) thru the Risk Management

Framework (RMF) process.

(12) An established Business-to-Business (B2B) connection from the Defense Information Systems Agency (DISA)

(13) A security platform that is in compliance with all DHA local security requirements.

(14) Allows a variety of commercial dictation input devices to function with the bundled dictation and transcription solution

(15) Capability for individual site data segregation within a centralized hosted environment

(16) A solution infrastructure that allows an unlimited number of sites to be added without additional hardware purchases after the initial purchase.

(17) A solution infrastructure that allows for resource sharing of transcriptionists in a regionalized manner.

(18) A DoD managed or certified Personal Health Information (PHI) database which allows for granular access to the data to ensure only authorized clinical personnel have viewing capabilities.

(19) Ability for single transcription interface with Cerner’s GENESIS EHR platform once fully deployed across the MHS estimated to be completed by FY 2022.

b. The resultant contract will have a three year ordering period from 1 September 2018 to 31 August 2021, which will allow for orders to be placed as needs are identified across the MHS.

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Control Number:18-HRCO-591

c. The estimated average price per site is $375,040.00 with an anticipated 25 MTFs/sites over the three year ordering period, for a total estimated value of $9,376,000.00. The total estimated price includes the procurement of the dictation software and hardware, installation, training and annual licenses for a two year period at each of the sites.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 United States Code (USC) 2304(c)(1) and FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: Paragraphs 3a(1) through 3(a)(19) identify the minimum mission capabilities for the dictation and transcription software required by the government. In accordance with Department of Defense Instruction (DoDI) Number 8510.01 Risk Management Framework (RMF) for DoD Information Technology (IT), IT products, services, and platform information technology are not authorized for operation through the full RMF process. These types of IT must be securely configured in accordance with applicable DoD policies and security controls and undergo special assessment of their functional and security-related capabilities and deficiencies. The IS security manager (ISSM) (with the review and approval of the responsible authorizing official (AO)) is responsible for ensuring all products, services and platform information technology have completed the appropriate evaluation and configuration processes prior to incorporation into or connection to a DoD information system (IS). The required dictation and transcription software will require installation onto a DoD IS for use.

The Secure Enterprise Dictation and Transcription Solution (SEDTS) is currently the only commercial dictation and transcription software available in the market with an approved DHA Authority to Operate (ATO). The ATO approval process currently averages 12-18 months from start to finish, under the Risk Management Framework (RMF) process. Under the RMF process, there are no Interim Authorizations to Operate (IATOs) issued.

The Secure Enterprise Dictation and Transcription Solution (SEDTS) is a product manufactured by 3M Company. 3M Company maintains proprietary rights on all hardware and software required to utilize the SEDTS System and does not have any authorized dealers or resellers therefore, 3M Company is the only business capable of providing the required dictation software in accordance with the Government’s required delivery date for the initial purchase, 30 September 2018.

6. Efforts to Obtain Competition: In an effort to obtain competition for this requirement, the Government posted a sources sought notice via the Government Point of Entry (GPE) FedBizOpps on 18 May 2018, which requested respondents to this RFI to describe their interest and ability to provide a commercial dictation software solution based on the capabilities identified above. In response to the government’s notice a total of four responses were received;

The responses were reviewed by the technical representatives to determine if the proposed solutions were capable of fulfilling the Government’s needs based solely on the capabilities provided. Of the four responses received

(25 February 2016)

Control Number:18-HRCO-591 only one was determined to meet the needs of the Government, 3M’s Secure Enterprise Dictation and Transcription Solution (SEDTS) offered by 3M Health Information Systems. The remaining responses were determined not to meet the needs of the Government based on the following:

Based on the response provided, the respondents identified solution did not meet the following required capabilities identified in the RFI: Windows 10 compatibility, secure remote connection across all medical treatment facilities (MTFs) both within the Continental United States (CONUS) and outside of the continental United States (OCONUS), electronic signature capability with the DoD CAC, dictation and transcription management and reporting tools that allow for detailed analysis of electronically signed documents, audit trail capabilities to record changes to the dictated and transcribed notes, an electronic document upload interface with the capability to interface with DHA's inpatient Electronic Health Record (EHR) Commercial off the Shelf (COTS) product Essentris, an approved DHA Authority to Operate (ATO) thru the Risk Management Framework (RMF) process, an established Business-to-Business (B2B) connection from the Defense Information Systems Agency (DISA), compliance with all DHA local security requirements, capability for individual site data segregation within a centralized hosted environment, a solution infrastructure that allows an unlimited number of sites to be added without additional hardware purchases after the initial purchase, a solution infrastructure that allows for resource sharing of transcriptionists in a regionalized manner, a DoD managed or certified Personal Health Information (PHI) database which allows for granular access to the data to ensure only authorized clinical personnel have viewing capabilities, ability for single transcription interface with Cerner's GENESIS EHR platform once fully deployed across the MHS estimated to be completed by FY 2022. As a result, the dictation software/solution offered by will not meet the requirements of the government.

Based on the response provided, the respondents identified solution did not meet the following required capabilities identified in the RFI: Windows 10 Compatibility, Electronic Signature Capability with the DoD Common Access Card, an electronic document upload interface with the capability to interface with DHA's inpatient Electronic Health Record (EHR) Commercial off the Shelf (COTS) product Essentris, an approved DHA Authority to Operate (ATO) thru the Risk Management Framework (RMF), an established Business-to-Business (B2B) connection from the Defense Information Systems Agency (DISA), compliance with all DHA local security requirements, ability for single transcription interface with Cerner's GENESIS EHR platform once fully deployed across the MHS estimated to be completed by FY 2022 . As a result, the dictation software/solution offered by will not meet the requirements of the government.

. Based on the response provided, the respondents identified solution did not meet the following capabilities identified in the RFI: Electronic Signature Capability with the DoD Common Access Card, an approved DHA Authority to Operate (ATO) thru the Risk Management Framework (RMF) process, compliance with all DHA local security requirements, ability for single transcription interface with Cerner's GENESIS EHR platform once fully deployed across the MHS estimated to be completed by FY 2022. As a result, the

(25 February 2016)

Control Number:18-HRCO-591 dictation software/solution offered by will not meet the requirements of the government.

a. Effective competition. The Government does not anticipate any competition for this requirement, due to 3M Company’s proprietary rights on all hardware and software required to utilize the SEDTS System.

b. Subcontracting competition. The Government does not anticipate any opportunities for subcontracting for this requirement, this is a supply requirement for the delivery and installation of a commercial product that is governed by the manufacturer’s proprietary rights.

7. Actions to Increase Competition: The dictation and transcription software industry is expanding within the commercial market. The government anticipates that in the future more companies will offer products that align with the government’s dictation and transcription needs.

Over the next several years, the Military Health System will deploy a new clinical EHR system called MHS GENESIS that will be considered an industry standard in EHR systems versus the current electronic medical eco system that exists now using multiple systems built or tailored specifically for the DoD. MHS GENESIS will fully deploy at all military hospitals and clinics by 2022; once fully deployed Genesis will provide a single health record for service members, veterans, and their families. Over the course of this time, this interim strategic contract vehicle will allow vendors in the dictation and transcription industry to meet the required criteria described in this document. In efforts to increase competition for future and follow-on requirements, the Government will solicit industry interest a minimum of 12 to 18 months in advance of the required delivery date. In doing so, the Government will afford interested vendors sufficient time to obtain all of the required security approvals necessary for their software to operate on the Government’s network and align their offered product(s) with the needs of the Government, to include having the capability of interfacing with MHS GENESIS.

8. Market Research: Market research consisted of reviewing products offered by as well as meeting with individuals from these organizations via phone, onsite meetings or at trade shows to determine if their solutions were capable of meeting the Government’s need. In addition, the Government utilized the information obtained from the sources sought notification and previous acquisitions for similar products conducted by other contracting activities (see procurement history below). Market research identified that a commercial off the shelf solution is available within the market to provide the required supplies by the identified required delivery date.

9. Interested Sources: In accordance with the requirements of DFARS PGI 206.302-1 the government posted a sources sought notification which identified the four interested sources, identified above. Of the four interested sources only one was determined to meet the needs of the government. The reason for the rejection of the remaining interested sources is provided above. To date, no other sources have written to express an interest. The notices required by FAR 5.201 shall be published, and that any bids or proposals received shall be considered.

(25 February 2016)

Control Number:18-HRCO-591

10. Other Facts:

a. Procurement history.

(1) W91YU0-15-P-0661 was awarded on 30 September 2015 as a Sole Source to 3M Company, 3M Center Building 220, Saint Paul, Minnesota, 55144-1001. This contract was awarded as a base plus four (4) one-year option periods for SEDTS at Evans Army Community Hospital, Ft Carson, CO.

(2) W911QY-16-P-0005 was awarded on 6 November 2015 as a Sole Source to 3M was awarded as a base plus two (2) one-year option periods for SEDTS at Madigan Army Medical Center, Joint Base Lewis McChord, WA.

(3) W81K00-17-P-0431 was awarded on 1 June 2017 as a Sole Source to 3M Company, 3M Center Building 220, Saint Paul, Minnesota, 55144-1001. This contract was awarded as a base plus three (3) one-year option periods for SEDTS at Carl R. Darnall Army Medical Center, Ft Hood, TX.

(4) W91249-17-P-0280 was awarded on 29 September 2017 as a Sole Source to 3M was awarded as a base plus four (4) one-year option periods for SEDTS at Dwight D.

Eisenhower Army Medical Center, Ft Gordon, GA.

(5) W81K02-18-P-0117 was awarded on 1 May 2018 as a Sole Source to 3M Company, 3M Center Building 220, Saint Paul, Minnesota, 55144-1001. This contract was awarded as a base plus two (2) one-year option periods for SEDTS at Bassett Army Community Hospital, Ft Wainwright, AK.

b. The competitive status of these actions: Sole Source

c. Authority previously cited if less than full and open competition was used. FAR 6.302-1 –

Only One Source Responsible Source and No Other Supplies or Services will Satisfy the Agency Requirements: 10 U.S.C. 2304(c)(1).

d. Circumstances that changed from the previous contract to this current requirement:

Previous contracting efforts were done by individual MTFs, not allowing for the purchasing power of a consolidated contract for all DHS MTFs. This action will provide that leverage with the supplier.

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Control Number:18-HRCO-591

e. Other facts.

(1) Multiple MTFs, including Evans Army Community Hospital, Madigan Army Medical Center, Carl R. Darnall Army Medical Center, Bassett Army Community Hospital and Eisenhower Army Medical Center have completed the procurement process for dictation software in accordance with the specified capabilities and have ended with sole source contracts for the capability being procured. All the cited locations were not able to find a similar product with the required IA certifications and a detailed adherence and compliance with MTF workflows and requirements for the capability. The required dictation solution is being used at both Army and Air Force facilities. As research was performed through Army and AF cybersecurity, a system that complies with DHA ATO RMF cybersecurity requirements was needed in order to ensure connectivity across platforms. The only dictation product that meets DHA ATO RMF cybersecurity requirements with an Authority to Operate is 3M SEDTS.

(2) If full and open competition is conducted, there will be a significant delay of contract award and this will result in (1) no tool being available when required to perform dictation services, or (2) a very costly extension to existing dictation services contract. This would impact the reimbursement for care to the hospital or capturing workload for Relative Value Units (RVUs). It would also create a medical records and coding backlog resulting in a reduction in Data Quality compliance and loss in third party reimbursement. No other assessed product will meet the clinical requirements of the MTFs. This includes the ability to codify transcript notes for reporting in relation to patient safety and quality, the ability to automatically push transcribed notes to the inpatient record and the ability for any provider to use the transcription service and not just those supported by a transcriptionist. In addition, the improvements in accuracy and review will prevent human errors such as uploading the wrong patient’s information into a record.

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.

Date:

Typed Name: Title: CNIO

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.

Typed Name: Title: CNIO

(25 February 2016)

Control Number:18-HRCO-591

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

The government will utilize a price analysis in determining the contractor’s proposed price for this effort to be fair and reasonable. This determination will be based on an analysis of the offer and the independent Government estimate, etc. In accordance with FAR 15.403-1(b)(3) this requirement is exempt from the requirement to provide certified cost or pricing data; however the contracting officer will request other than certified cost and pricing data in accordance with FAR FAR 15.403-3(c).

Typed Name: Title: Chief, Health Readiness Branch

14. Contracting Officer Certification:

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

Typed Name: Title: Chief, Health Readiness Branch

(25 February 2016)

Control Number:18-HRCO-591

Approval

Based on the foregoing justification, I hereby approve the procurement of 3M Company, Secure Enterprise Dictation and Transcription Solution (SEDTS) not to exceed a total price of $9,376,000.00 on an other than full and open competition basis pursuant to the authority of FAR 6.302-1(a)(2) -- Only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Typed Name: Title: Alt. USAHCA Special Advocate for Competition