Att-Statement of Work-75N95024Q00388.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Accuracy of the New Diagnostic Code to Identify Primary Sclerosing Cholangitis in Archived Electronic Health System Data

Statement of Need and Purpose:

To conduct electronic health record reviews to validate the new code for primary sclerosing cholangitis (PSC)

Background Information and Objective:

PSC presents as an autoimmune cholangiopathy causing fibroinflammatory damage to the biliary tree, precipitating multifocal fibrotic biliary strictures. The underlying pathophysiology of PSC remains elusive, with prevailing theories implicating intricate interactions between environmental factors and dysregulated immune responses. This interplay potentially involves compromised defense mechanisms against bile acid injury, an exaggerated immune response to microbial triggers, and perturbations in gut microbiota, all contributing to the chronic injury of bile ducts. The consequential cholestatic liver damage often culminates in end-stage liver disease. Notably, PSC is commonly asymptomatic at onset and is often incidentally diagnosed through routine blood tests revealing a cholestatic liver profile. Importantly, individuals with PSC face an escalated risk of developing malignancies, including cholangiocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, and gallbladder cancer.

Health administrative databases house extensive, routinely collected real-world health data that can be used for conducting disease epidemiology, outcomes research, healthcare cost/utilization trends analysis, and other healthcare investigations. Unfortunately, research on PSC using these resources was hampered by the lack of a PSC-specific ICD code until the introduction of the ICD-10 code for PSC in 2019, which standardized diagnostic codes, facilitating research opportunities. Before the introduction of a dedicated ICD-10 code in 2019 (K83.01), cases were often miscoded under general or unrelated liver conditions, which may have skewed previous studies and healthcare resource allocation. However, the accuracy of the PSC-specific ICD code has not been evaluated.

Period of Performance:

36 months from the date of the award

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The Contractor must have substantive expertise in PSC research and algorithm development, as demonstrated by publications. The contractor will review electronic health records to validate the PSC diagnosis.

TASK 1 – OBTAIN INSTITUTIONAL APPROVALS AND DATASETS

The Contractor shall obtain approvals from the relevant institutional review board (IRB) and other institutional officials, if required. The Contractor shall obtain approval, for extracting relevant data from computerized databases and preparing analytic files suitable for epidemiologic research. All data will be queried from the hospital database. These data will include clinical diagnoses, procedures, medications, and other data elements. The Contractor shall be the sole party responsible for communications with any IRB or other institutional officials and shall regularly communicate the status of the approval process to the Government.

TASK 2 – ESTABLISH TARGET SAMPLES AND CREATE PROTOCOL FOR REVIEW

The Contractor will work in collaboration with the NIA to identify records for review and create a case report form (CRF). Discussions regarding the selection of variables and the formatting of data collection are also required.

TASK 3 – CHART REVIEW AND CONSTRUCT DATASET

The Contractor will examine the electronic health records of the targeted individuals to identify PSCs, adhering to the guidelines outlined in the created CRF.

TASK 4 – CONDUCT ANALYSIS

The Contractor shall collaborate with the NIA to conduct the statistical analysis following the plan proposed by the NIA. The Contractor will provide a cloud-based platform to share the anonymized data for the NIA to access for analysis.

TASK 5 – PREPARE REPORT

The Contractor shall collaborate with the NIA project officer to interpret the results and prepare a scientific report containing the methodology as well the aggregated results. There is no page limit for the document.

LEVEL OF EFFORT:

Institutional approval, data acquisition, construction and analysis

GOVERNMENT RESPONSIBILITIES

The contractor will not require access to any government facility.

DELIVERY OR DELIVERABLES

The contractor will deliver the electronic copy of results within 36 months from the date of award.

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT

REQUIREMENTS

DUE DATE

#1 (Task 1) Obtain IRB and institutional approvals required for this requirement. Contractor shall confirm approval via e-mail to the NIA officer.

30 calendar days after award.

#2 (Task 2) Regularly communicate with NIA personnel to develop the CRF and protocols.

Weekly calls during the first two weeks after award

#3 (Task 3) Chart review following CRF and protocols 180 days prior to expiration of the period of performance

#4 (Task 4) Collaborate with the NIA to conduct the statistical analysis following the plan proposed by NIA investigators.

Monthly calls after award

#5 (Task 4) Provide summary tables (MS word or Excel format) for publication

60 days prior to expiration of the period of performance

#6 (Task 5) Provide draft report submitted in MS word format.

45 days prior to expiration of the period of performance.

#7 (Task 5) Provide final report submitted in MS word format.

15 calendar days prior to expiration of the period of performance.

REPORTING REQUIREMENTS

The contractor should report any problems encountered and progress on the resolution.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

Contractor shall provide a dedicated project manager to the government as a contact point for the services.

Information System Security Plan:

No personal identifications will be accessed by the contractor.

Data Rights:

The government has the sole right regarding the use, production, and disclosure of the data generated.

Section 508—Electronic and Information Technology Standards:

The contractor is not required to develop, procure, maintain, or use Electronic and Information Technology in the performance of the SOW. However, all reports and deliverables shall be submitted electronically and shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents,"Create Accessible Documents."

Publications and Publicity:

The contractor may participate as a co-author of the articles to be published as a result of the requirements of the SOW.

Confidentiality of Information:

No personal identifications will be accessed by the contractor. The data will be delivered via the NIH Box.