REDACTED_18-0061_Sole_Source_JA_iMed_Consent.pdf

Justification and Approval for Other than Full and Open Competition

J&A Tracking No. JA 18-0061

1. Identification of the agency and contracting activity:

Agency: Defense Health Agency (DHA).

Requiring Activity: Defense Health Agency, Solution Delivery Division (SDD) – 5109

Leesburg Pike Suite 809, Falls Church VA 22042.

Contracting Activity: Contracting Operations – Health Information Technology (CO-HIT)

Defense Health Agency, 4130 Stanley Road, Suite 208 Joint Base San Antonio TX 78234.

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

Approval is being requested for a new firm-fixed price contract using FY18 Operations and

Maintenance (O&M) funds for the procurement of Informed Medical Consent (iMedConsent) content subscription and enterprise-level application maintenance support to be awarded on an other-than-full-and-open competition basis to Taylor Communications, Inc., 600 Albany Street, Dayton, OH 45417. Taylor Communications, Inc., as the Original Equipment Manufacturer

(OEM) as well as holder of proprietary rights to iMedConsent, is the only vendor capable of providing needed iMedConsent subscription and maintenance support.

3. Description of Supplies/Services:

iMedConsent is a software application that helps clinicians manage the informed consent process electronically. For treatments and procedures requiring signature consent, practitioners use iMedConsent to generate a customizable and patient-friendly electronic consent form that is automatically populated with information about the selected treatment or procedure. Features include patient education materials, drug information, pre-and-post operative patient instructions, and anatomical diagrams. The program also supports electronic access, completion, signing, and digital storage of documents, such as advance directives. On 14 September 2013, Naval Medical Logistical Command issued contract

N62645-13-F-0049 to Standard Register, Inc., (now doing business as Taylor

Communications) to procure iMedConsent license, content subscription, and application maintenance for 28 Navy Medical Treatment facilities (MTFs). These 28 MTFs are now under DHA. In order to support these MTFs, the DHA requires procurement of the above listed iMedConsent subscription and support in order to:

Maintain the current DoD approved template (OF522) to meet various state requirements;

Maintain pertinent State Risk library and insure inclusion in consent for appropriate medical procedures;

Maintain production and test servers for application; and

Provide Customer/Technical support for application and end-users.

The expected period of performance will occur on 30 September 2018 for a period of one year with four (4) option years; however, new market research will be conducted before exercise of each option to ensure that circumstances have not changed (i.e., this requirement is still under a sole source environment) and that the exercise of the option is the most advantageous method of meeting this requirement. The FAR Extension of Services clause

52.217-8 will be included in the contract with a not-to-exceed ceiling of , if exercised.

The Government intends to negotiate a new firm-fixed price contract using FY18 Operations and Maintenance (O&M) funds.

The total estimated price of this effort including all options years and the Extension of Service

Clause, is

CLIN Description Duration

Base Year iMedConsent Content Subscription and Enterprise

Application Maintenance Support 30 Sep 18 – 29 Sep 19

Option 1 iMedConsent Content Subscription and Enterprise

Application Maintenance Support 30 Sep 19 – 29 Sep 20

Option 2 iMedConsent Content Subscription and Enterprise

Application Maintenance Support 30 Sep 20 – 29 Sep 21

Option 3 iMedConsent Content Subscription and Enterprise

Application Maintenance Support 30 Sep 21 – 29 Sep 22

Option 4 iMedConsent Content Subscription and Enterprise

Application Maintenance Support 30 Sep 22 – 29 Sep 23

52.217-8 iMedConsent Content Subscription and Enterprise

Application Maintenance Support 30 Sep 23 – 29 Mar 24

4. Statutory and Regulatory Authority Permitting Other Than Full and Open Competition

(see FAR 6.302), or the Specification of the Statutory and Regulatory Provision Providing

Exception to 8(a) Program Competitive Requirements (see FAR 19.805-1): 10 U.S.C.

2304(c)(1) 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will

Satisfy Agency Requirements

5. Rationale Justifying Use of the Statutory Authority Cited:

The Informed Medical Consent (iMedConsent) is a web-based patient consent system to provide Medical Treatment Facilities (MTFs) automated applications that allow the users to meet and follow all applicable state laws when requesting informed consent from patients.

Under the Federal Tort Claims Act, State laws often determine possible tort liability; hence, the

Government must adhere to state laws in regard to informed consent. Patient informed consent is obtained through a process defined by the hospital and carried out by trained staff in a manner and language the patient can understand. Informed consent is obtained before surgery, anesthesia, procedural sedation, use of blood and blood products, and other high-risk treatments and procedures. Patients and families must receive adequate information about the illness, proposed treatment(s), and health care practitioners so that they can make informed care decisions. On 14 September 2013, the Navy paid a one-time licensing fee in the sum of

$644,000.00 for 28 MTFs to Taylor Communications to utilize iMedConsent under contract

N62645-13-F-0049. The purpose of this action is to allow these 28 MTFs to continue access to iMedConsent now that they are under the DHA.

As the proprietary owner of iMedConsent, Taylor Communications is the sole provider of license, subscription, and application maintenance support for iMedConsent. Per market research discussed in Section 8, no resellers are available for iMedConsent. Without iMedConsent, the 28 MTFs in question will have to return to manual documentation which will require additional time and dedicated administrative manpower to track patient data, document patient care information delivery, and record patient consent as separate activities, which the

MTFs no longer possess. In other words, without iMedConsent, the additional administrative burden will cause the quality of patient care to suffer at the MTFs as well as potentially placing the affected MTFs at risk of violating Federal Tort Claims Act by not acquiring the necessary patient consent on a timely basis.

To date, per SDD market research results discussed in Section 7, there is no alternative found on the market to meet or can be modified to meet the needs of a fully-managed library for all surgical/medical procedures, along with the ability for that information to be embedded on-the-fly with the DoD approved forms. Additionally, the capability for capturing signatures electronically within the application and the company’s management of specific state content which is embedded on the documents (based on procedure) is unique and no other product has been found to meet these needs. Although market research found related products on the market, none met the Government’s requirements (see Section 7). The only viable alternative to return to manual documentation which will require additional time, infrastructure, and dedicated administrative manpower to track patient data, document patient care information delivery, and record patient consent as separate activities; the MTFs no longer possess this level of manpower to perform all these tasks. This process of manual documentation processing, tracking, recording, and retention with available staff will result in significant and unacceptable delays in fulfilling mission-essential and legally mandated patient care documentation requirements.

6. Efforts to Obtain Competition:

The requested contract will be awarded on a sole source basis to Taylor Communications. At this time, no effort will be made to solicit from multiple offerors, due to the fact that iMedConsent cannot be delivered and/or maintained by any other vendor. Taylor

Communications does not authorize any other entity to resell, distribute, or maintain this product. Furthermore, the other alternative in increasing competition for hardware/software requirements, finding a different product, also does not apply for this acquisition. Per Market

Research conducted by SDD and discussed below, no viable alternative exists on the market.

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

The Contracting Officer hereby determines that the anticipated cost to the Government will be fair and reasonable through on comparison and analysis of proposed prices with historical prices paid, the Contractor’s list prices, and the Independent Government Cost Estimate.

8. Market Research:

In January 2018, SDD conducted market research through “Federal Interagency Contracts

Directory” and “Small Business Administration – Dynamic Small Business” to assess the market for potential viable alternatives to iMedConsent. This market research effort resulted in two potential products: “My Informed Choice” from Medical Animatics LLC and

“Advanced Medical Visualization” from Amerra Inc. In further review, “My Informed

Choice™” combines medical animation and video into an easy-to-use interactive design; in addition, the product incorporates innovative learning solutions that combine the art and science of visual media with the latest in computing technologies. However, this product is more focused on the learning tools but not Medical Consent documentation. Therefore, it was determined to be not suitable for DHA needs. Advanced Medical Visualization by

Amerra Inc is an online solution that can support conversion of documents into other languages; however, this products depends on the user to develop every consent form.

Furthermore, Advanced Medical Visualization is still under development and not yet self-ready. SDD’s market research effort concluded that no product available on the market can match the packaged resources that iMedConsent currently delivers for the MTFs’ requirements:

Generate customizable and patient-friendly electronic consent forms that are automatically populated with information about the selected treatment or procedure.

Delivery of patient education materials, drug information, pre-and-post operative patient instructions, and anatomical diagrams.

Electronic access, completion, signing, and digital storage of documents.

Translation of document language into other languages.

Additional market research was conducted to assess the market place for potential resellers of iMedConsent. Neither iMedConsent, nor any other Taylor Communications products or services, are available on GSA Advantage and NASA SEWP. On 12 June 2018, a Sources

Sought was posted on Federal Business Opportunities to check if any authorized resellers exist on the market. On 18 June 2018, when the Sources Sought closed, no authorized reseller could be found. On 20 June 2018, Taylor Communications submitted a letter stating that iMedConsent is a proprietary application that can only be provided and maintained by

Taylor Communications. Taylor Communications is the sole provider of iMedConsent.

9. Other Facts:

a. Taylor Communications, Inc. is the sole provider of iMedConsent.

b. Historical data. N/A.

c. Unusual and compelling urgency. N/A.

10. Interested Sources:

To date, there are no other sources that can provide this type of software maintenance support.

11. Actions to overcome barriers:

The Government will continue to monitor the IT market place to products that can perform similarly and on par with iMedConsent applications. The Project Manager will review potential alternative products as they appear on the market place and determine if the potential alternative can replace existing iMedConsent. If and when suitable alternatives are identified, consideration will be given to the most competitive approach in order to provide the best value to the Government.

COORDINATION:

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.

Click here to enter a date.

Contracting Officer Representative

13. Requirements Certification:

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

Contracting Officer Representative

14. Fair and Reasonable Cost Determination: : In accordance with FAR 15.404-1(b)(2)(ii), the Contracting Officer hereby determines that the anticipated cost to the Government for this contract action will be fair and reasonable based on comparison and analysis of proposed prices and historical prices paid and prices made available through market research, for the same or similar items.

Contracting Officer, Contracting Office - Health Information

Technolgy

15. Legal Review: I have reviewed this justification and have found it to be legally sufficient.

Office of General Counsel

16. Contracting Officer: I certify that this justification is accurate and complete to the best of

Contracting Officer, Contracting Office - Health Information

Technolgy

APPROVAL:

17. Competition Advocate:

Based on the foregoing justification, I hereby approve the procurement of iMedConsent Content

Subscription and Enterprise Application Maintenance Support from Taylor Communications on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1), subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

Competition Advocate (J-4)