JOFOC1.pdf

Updated December 2015 1

Attachment 6B

PSC Justification and Approval (J&A) Template and Instructions for a FAR Subpart 6.3 - Other than Full and Open Competition

Completion Instructions: PSC has established a standard template for preparation of J&As required in accordance with FAR Subpart 6.3. Requiring Activities shall prepare the template in accordance with these completion instructions. [NOTE: The requiring activity has responsibility for completing all of the information items included in the template, with any necessary assistance from the cognizant Contracting Officer (CO) and Contract Specialist (CS).]

The instructions for preparing a J&A processing the document for review and approval.

A completed J&A must contain all of the applicable bolded headings in the order specified. Place the required information directly next to, or under, the applicable heading. If a heading does not apply to a specific J&A next to it. Reference and attach any additional information necessary to support the J&A.

J&A under FAR Subpart 6.3 - Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity. Provide the following information:

a. Federal agency and contracting activity. Department of Health and Human Services/Program Support Center/Acquisition Management Services

b. Requiring activity. Office of the National Coordinator for Health IT

(ONC)

c. Requiring Activity Point of Contact (POC) information. Provide the following information:

Name. Carmelita Marshall

Mailing address. 200 Independence Ave SW, Washington, DC 20201

E-mail address. Carmelita.marshall@hhs.gov

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Telephone number. 202.691.2062

2. Nature and/or description of the action being approved. Provide the following information:

a. Project background Acquisition purpose and objectives. State the nature, purpose, and objective(s) of the acquisition and the overall program of which it is a part. Identify the authorizing program legislation, as applicable. :

that should be made electronically available and exchanged through the use of health information technology (IT). The United States Core Data for Interoperability (USCDI) is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. Data reflecting SDOH the conditions in which people live, learn, work, and play remains much more limited across healthcare. There is a growing recognition that by capturing and accessing SDOH data during the course of care, providers can more easily address non-clinical factors, such as food, housing, and transportation insecurities, which can have a profound impact on a elements for potential inclusion in the USCDI in the future.

Specifically, this is a one-year project that will inform:

of tools and resources, such as updates to the Health IT Playbook, to assist health care providers with documenting and acting upon SDOH data specifically as it pertains to use of the open notes

(EHR).;

information including SDOH data that is noted in the clinical notes section of the patient portal; and ree are important to capture and exchange for future data standardization efforts; such as USCDI expansion.

b. Project background. Specify any project background that is important to understanding the acquisition and the need it will satisfy. If the project is a continuation or renewal of an ongoing contract/order, provide the current contract/order number and indicate: (i) the name of the incumbent or predecessor contractor; (ii) the period of performance; (iii) total dollar amount obligated to date; and (iv) whether the initial and any subsequent awards were competed and, for any sole-source or limited competition awards, the basis for the approved J&A. In previous work funded by the Assistant Secretary of Planning and Evaluation (ASPE)researchers conducted interviews with six EHR vendors with large market shares in both ambulatory and inpatient settings. Vendors described a number of places where SDOH data could be collected or

Updated December 2015 3 found. These include EHR specific data sets or forms, problem tables, free-text fields located in various places (e.g., social history section, clinical notes and assessments section, details section of structured and the patient portal. Researchers also found that according to EHR vendors during a clinical encounter, the person collecting and entering SDOH data into the EHR varies based on the available resources of the office, time allocated for the visit, availability of kiosks at check-in, and the sensitivity of the data to be captured. However, this prior work does not explore challenges with the exchange and use of SDOH data in the clinical notes section of the EHR from the perspective of clinicians and patients.

3. Description of the supplies or services needs (including the estimated value). Provide the following information:

a. Project title. Access, Exchange, and Use of Social Determinants of Health Data in Clinical Notes.

b. Project description. Provide a brief (i.e., half-page or less) narrative description of the project

Through qualitative data collection, this one-year project will collect information from health care providers (including behavioral health

DOH data collection and exchange. ONC seeks to obtain information from health care providers and patients to understand:

(1) To what extent do health care providers document and use SDOH information to treat a patient or offer referral services

(2) How do health care providers leverage open text fields to document SDOH data, specifically clinical notes and assessments section of an EHR to document SDOH data;

(3) Challenges clinicians experience when using SDOH data;

including data captured in open text fields;

(4) The types of SDOH data that individuals want to collect, share and use;

(5) Methods individuals currently use or would like to use in the future to collect, share and use SDOH data, including smartphone apps or improvements to patient portals; and

(6) Barriers individuals perceive with the exchange of SDOH data, including privacy and security issues as well as secondary uses of the data.

In addition to facilitating focus groups, the contractor shall conduct qualitative analysis and generate a report that will describe key results

Updated December 2015 4 in the areas of physician and consumer access, exchange, and use of SDOH data as well as barriers that exist.

Provide the following information:

Requirement type. Check the appropriate box:

X Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Proposed contract/order type. Check all that apply:

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. Specify the requisition number, proposed solicitation number, or other acquisition identification number, if applicable.

c. Total estimated dollar value and performance/delivery period.

Specify the total estimated dollar value of the acquisition, inclusive of options, and the total performance/delivery period. $305,632

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

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6.302-2 Unusual and compelling urgency. This acquisition is

U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

X 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is

U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C.

2304(c)(4) or 41 U.S.C. 3304(a)(4).

6.302-5 Authorized or required by statute. This acquisition is

U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C.

1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited. Provide the following information, as applicable:

a. Name and address of the proposed contractor(s).

OpenNotes

133 Brookline Avenue

HVMA Annex, Suite 2200

Boston, MA 02215

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b. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

OpenNotes is an organization committed to spreading the availability of open visit notes and studying the effects.

ready access to clinical notes because access to notes empower patients, families, and caregivers to feel more in control of their healthcare decisions, and improve the quality and safety of care. OpenNotes does not sell software or other products. However, they produce tools and research designed to improve access and use of clinical notes.

Unlike other non-profit research organizations, OpenNotes provides specialized and exclusive expertise in researching the use of clinical notes from the clinician and patient perspective. OpenNotes has published a number of research products exploring how patients and clinicians leverage visit notes. For example, in 2020 OpenNotes researchers authored the article, The Views and Experiences of Clinicians Sharing Medical Record Notes With Patients experiences with sharing clinical notes (open notes) with patients. In this study, the researchers conducted a web-based survey study of physicians, advanced practice nurses, registered nurses, physician assistants, and therapists at 3 health systems in Boston, Massachusetts; Seattle, Washington; and rural Pennsylvania where notes have been shared across all outpatient specialties for at least 4 year. Most viewed open notes positively, agreeing they are a good idea (1182 participants [74%]); of 1314 clinicians who were aware that patients were reading their notes, 965 agreed that open notes were useful for engaging patients. In all, 798 clinicians (61%) would recommend the practice to colleagues. This prior research experience, is critical and directly aligns with the research goals of this project. Moreover, it enables ONC to use previously developed and tested survey questions to inform interview questionnaires.

In add created a number of tools/recommendations designed to improve the use of data within clinical notes. Most recently, OpenNotes conducted a pilot program across 4 sites (Beth Israel Deaconess Medical Center, Dartmouth- Hitchcock Medical Center, the University of Colorado, and University of Washington Medicine). The pilot program, OurNotes, is an intervention in which patients and families co-produce clinical notes with clinicians;

essentially drafting the subjective portion of the clinical note, providing the pre-work related information typically collected by a medical assistant, and setting the visit agenda. Specifically, patients are requested to complete a brief survey two days prior to their scheduled appointment through their portal. Once submitted, the forms are saved separately, and are permanent part of their electronic health record (EHR). The form is w them prior to or during visits, and then either refer to them or incorporate them

Updated December 2015 7 into the note itself by copying and pasting. The results of this pilot project was published in the New England Journal of Medicine. OpenNotes history with creating tools, such as OurNotes, puts them in a unique position to build upon their prior tools to meet one of the goals of this project which is the ultimate creation of tools and resources to inform ONC clinicians and patients through the Health IT Playbook.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under

5.202 applies.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

ONC also conducted an in-depth review of OpenNotes research on the use of clinical notes. Within the last year, OpenNotes researchers have published numerous products in reputable academic journals on topics relevant to the scope of this contract. For example, in the 2020 article, Empowering patients and reducing inequities: is there potential in sharing clinical notes?, authors from OpenNotes explore how increasing access to clinical notes might over time help to address health care disparities. Through research projects such as this, OpenNotes demonstrates their expertise in the technical aspects of clinical notes within an EHR/ patient portal but also the barriers and potential benefits of improving the interactions between patients and providers through health information exchange.

9. Any other facts supporting the use of other than full and open competition.

N/A

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. N/A

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. N/A

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

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Official Name & Title Signature Date

Requiring Activity

POC

Carmelita Marshall, Program Analyst

6/24/2020

POC Immediate Supervisor

Talisha Searcy, Branch Chief

6/24/2020

Head of the Sponsoring

Program Office

13. Contracting Officer certification. The CO shall complete the information required below and sign the certification in the block provided. The certification serves as approval of a J&A over $150,000 but not exceeding $700,000.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

14. Competition Advocate and Head of the Procuring Activity approval. The Competition Advocate and the Head of the Procuring Activity for PSC is the Head of Contracting Activity (HCA). The HCA shall indicate review of, and concurrence with, any J&A over $700,000, but not exceeding $68 million, by providing the information required below and signing in the applicable block.

Official Name & Title Signature Date

Competition Advocate and

Head of the Procuring Activity

15. HHS Senior Procurement Executive approval. The HHS SPE, upon acceptance of the rationale provided in the J&A, shall complete the information

Updated December 2015 9 required below and sign in the block provided as the approving official for any J&A over $68 million.

Official Name & Title Signature Date

HHS Senior Procurement

Executive