Attachment 10 - TO1 SOW.pdf

ACCESS TO HOSPITAL DRUG UTILIZATION DATA

ATTACHMENT 10: TASK ORDER #1

DRUG UTILIZATION: ACCESS TO HOSPITAL DRUG UTILIZATION DATA

STATEMENT OF WORK

Table of Contents

1. Access Data and Ad Hoc Analyses Task Order

1.1. Objectives

1.2. Task Order Scope

1.3. Pricing Table

1.4. Task 1 Requirements: Data Access

1.4.1. Data Requirements for Accessing Hospital Drug Utilization Data

1.5. Technical Requirements and Capabilities for Direct Access to Data Resources

1.6. Ad hoc Analyses: Custom Reporting and Product Customization

1.7. Custom programming and analytical support

1.8. Onsite Training Programs and Training Materials

1.9. Onsite Kick-Off and Annual Meetings

1.10. Technical Support

1.11. Monthly Usage Reports

1.12. Deliverables

1.13. Period of Performance

1. Access Data and Ad Hoc Analyses Task Order

1.1. Objectives

This Task Order is issued under the Hospital data IDIQ contract in pursuit of obtaining direct access to commercially available hospital drug utilization data and obtain services of the contractor to support FDA in regulatory drug utilization activities. This task order includes the following program tasks:

• Task 1: Direct Access to Hospital Drug Utilization Data

1.2. Task Order Scope

The Contractor shall provide the required personnel, materials, services, facilities, and otherwise do all things required for or incident to the performance of the work as described below.

1.3. Pricing Table

Period of Performance Firm fixed-price Base Year:

Access to Hospital Drug utilization Data including up to 50 hours ad hoc analyses and training

Option Year 1:

Access to Hospital Drug utilization Data including up to 50 hours ad hoc analyses and training

Option Year 2:

Access to Hospital Drug utilization Data including up to 50 hours ad hoc analyses and training

Option Year 3:

Access to Hospital Drug utilization Data including up to 50 hours ad hoc analyses and training

Option Year 4:

Access to Hospital Drug utilization Data including up to 50 hours ad hoc analyses and training

Task Order Total $

Payment Schedule:

The Contractor shall submit invoices in equal monthly installments over the period of performance (i.e.

12 equal monthly invoices per year, each 1/12th of the firm fixed-price for the year). Invoices shall be submitted in accordance with FDA’s Invoicing Procedures outlined in the IDIQ.

1.4. Task 1 Requirements: Data Access

1.4.1. Data Requirements for Accessing Hospital Drug Utilization Data

a. The Contractor shall provide continuous real-time, immediate, multi-user, desktop currently existing, commercially available automated direct access to data resources on hospital drug product usage in adult and pediatric patients throughout the length of the contract. For the purpose of this contract, these data shall meet the need of the FDA to access discharge-level and patient-level data describing adult and pediatric hospital drug use, in short-stay hospitals.

b. The Contractor shall provide information on the size and characteristics of the population of hospitals from which the data are derived since these can affect the quality and usefulness of the data and the validity of national projections from the data. Characteristics of the sample shall minimally include: number of hospitals , size of hospitals, geographic diversity of hospitals (using census regions if available) (See Appendix B), number of discharges per year, demographic distribution of discharges in the sample, numbers and percentages of discharges per year of special populations of interest to the FDA, including children (ages ≤ 17 years ), elderly (ages > 65 years), pregnancies and deliveries, and patients with serious illnesses including HIV/AIDS and mental illness, types of hospitals, and a description of specialty units within sample hospitals. Also, the data shall include the number of unique patients hospitalized per year in the sample and their demographic distribution. The data shall not include the identity of any patient, provider, or hospital. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use, but the methods used to de-identify the data shall be described in the proposal.

c. In addition, the following information shall be provided to the FDA: the number of years of valid data available overall and on-line in real time to FDA personnel; the process and procedures for accessing data that are no longer on-line; the lag time between the date of service for the hospitalization and on-line availability of the data; and data collection and management procedures. These characteristics are essential for determining whether the data continues to meet the needs of the FDA for making timely regulatory decisions based on the most current, scientifically valid information available.

d. The Contractor shall also provide a description of the data acquisition status for all data streams for the adult and pediatric hospital drug utilization and diagnosis data resource. All data flow and management procedures shall be described, including data acquisition, cleaning, and editing procedures, specification and description of all coding systems used for diagnoses, and drugs, methods for coding data, percentage of missing or incomplete information, including strategies to minimize missing or incomplete information and method of coding missing data, availability of raw/sample numbers, as well as projected numbers, and the frequency with which data are updated and methods for updates.

e. The Contractor shall provide a description of quality control measures that will ensure access to valid data that is technically correct and conforms to contract requirements. The description shall include methods and timelines of quality control measures to be conducted by the Contractor. This requirement applies to data procured from subcontractors, as well as the data generated or processed by the Contractor.

f. The data resource shall include access to hospital data that shall be amenable to analysis at the discharge-level and patient-level. Age and gender of the patient during the hospital visit shall be required. Hospital episode data shall be required and include the dates of the hospital visit, the length of stay, all diagnoses, discharge date and disposition. Data related to all drugs administered during the hospital visit shall be required, and include the generic and established name for the drug, strength, dosage form, route of administration, date and time of drug administration, treatment dose and treatment duration. Data related to diagnoses shall be required for all procedures performed during the hospital visit, and shall include the diagnoses coded in the International Classification of Diseases (ICD).

g. The Contractor shall provide access to information relating to the hospital episode, for example operating drug use data (anesthetics, contrast agents, etc.), and information on diagnosis, drugs at admission, and drugs at discharge. A description of data available on diagnosis and drugs administered shall be provided and shall be accompanied by a description of the degree of bundling of this information with other data and any limitations on the usefulness of these data in making national estimates.

h. FDA requires the ability to use these data to estimate drug utilization and diagnosis patterns in the total U.S. hospital population, or to a national sub-population of interest (e.g., children, women of child-bearing age, elderly). This shall require the use of a projection methodology or other appropriate methodology, which shall be valid, reliable, and robust with regard to drug utilization and diagnosis codes, specifically, and the methods shall be fully disclosed.

Demographics and other relevant characteristics for discharges and patients included in the sample to be used for projection, as well as for the proposed universe, shall be included.

1.5. Technical Requirements and Capabilities for Direct Access to Data Resources

The data provided for this Task Order must meet the technical requirements outlined in the IDIQ paragraph 3.6.

1.6. Ad hoc Analyses: Custom Reporting and Product Customization

The Contractor shall provide a maximum of 50 additional hours per year of ad hoc data analyses, custom queries or raw data preparation not available through the data tools

1.7. Custom programming and analytical support

The Contractor shall provide analytical and programming support, to enable FDA personnel to obtain prescriptions, patients, claims and any other utilization metrics not available through the online data tools.

1.8. Onsite Training Programs and Training Materials

The Contractor shall provide training for users of the data, as well as training for FDA personnel who will support use of the data (e.g., technical users). Live or web-based training of FDA personnel shall be required for any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide course outlines for all levels of training offered on site at FDA (Silver Spring, MD) and options for additional “on-demand” sessions either in person or via web-based methods.

1.9. Onsite Kick-Off and Annual Meetings

The Contractor shall participate in a kick-off meeting within two weeks of the IDIQ and Task Order awards and shall conduct an annual meeting on-site at the FDA campus in Silver Spring, MD. The purpose of the annual meeting is to discuss scientific issues of interest to the Agency and relevant work that the contractor has performed, as well as discussing FDA satisfaction with all deliverables.

1.10. Technical Support

The Contractor shall provide a support package comprised of written documentation that includes technical, analytical, and clinical support throughout the length of the contract. The support package shall include any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide ongoing technical, analytical, and clinical support by phone or by e-mail shall be required for all certified users of the data during business hours (9:00 am to 5:00 pm, EST) throughout the length of the contract in accordance with the service levels established in the contract.

To ensure effective communication and access to needed resources, the contractor shall have a dedicated client support personnel to serve as a liaison between the FDA and the contractor.

1.11. Monthly Usage Reports

The Contractor shall provide Monthly Usage Reports by 20th of each month for the previous month data detailing use of the resource by individual FDA users and type of use, clearances, third party agreements.

1.12. Deliverables

BASE YEAR (Deliverable Items) Del. No. Description of Supplies/Service Quantity Unit Delivery Date

0001 Access to Adult and Pediatric Hospital data Resource and Services; Access to patient level dataset extracts; Monthly Usage Reports (by the 20th of each month); Disclosure Clearance and Third Party Agreement Services;

Technical Support; to include Notification of and Access to Upgrades and/or New Releases of the Data and Software; Acceptable Projection or Other Appropriate Methodology; Current and complete Data Dictionary, including updates

Unlimited access for 10 seat licenses

Monthly (12)

Initiated at time of award

0002 Ad hoc Analyses: custom reporting and product customization

50 Hours As specified by the Government

0003 Annual Meeting 1 Annually As specified by the Government

0004 Onsite Training 2 Bi-annually As specified by the Government

0005 On Demand Training 10 (est) As necessary

As specified by the Government

OPTION YEAR 1 (Deliverable Items) Del. No. Description of Supplies/Service Quantity Unit Delivery Date http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection

0006 Access to Adult and Pediatric Hospital data Resource and Services; Access to patient level dataset extracts; Monthly Usage Reports (by the 20th of each month); Disclosure Clearance and Third Party Agreement Services;

Technical Support; to include Notification of and Access to Upgrades and/or New Releases of the Data and Software; Acceptable Projection or Other Appropriate Methodology; Current and complete Data Dictionary, including updates

Unlimited access for 10 seat licenses

Monthly (12)

Initiated at time of award

0007 Ad hoc Analyses: custom reporting and product customization

50 Hours As specified by the Government

0008 Annual Meeting 1 Annually As specified by the Government 0009 Onsite Training 2 Bi-annually As specified by the Government 0010 On Demand Training - Webex 10 (est) As necessary As specified by the Government

OPTION YEAR 2 (Deliverable Items) Del. No. Description of Supplies/Service Quantity Unit Delivery Date

0011 Access to Adult and Pediatric Hospital data Resource and Services; Access to patient level dataset extracts; Monthly Usage Reports (by the 20th of each month); Disclosure Clearance and Third Party Agreement Services;

Technical Support; to include Notification of and Access to Upgrades and/or New Releases of the Data and Software; Acceptable Projection or Other Appropriate Methodology; Current and complete Data Dictionary, including updates

Unlimited access for 10 seat licenses

Monthly (12)

Initiated at time of award

0012 Ad hoc Analyses: custom reporting and product customization

50 Hours As specified by the Government

0013 Annual Meeting 1 Annually As specified by the Government 0014 Onsite Training 2 Bi-annually As specified by the Government 0015 On Demand Training - Webex 10 (est) As necessary As specified by the Government

OPTION YEAR 3 (Deliverable Items) Del. No. Description of Supplies/Service Quantity Unit Delivery Date

0016 Access to Adult and Pediatric Hospital data Resource and Services; Access to patient level

Unlimited access for 10 seat licenses

Monthly (12)

Initiated at time of award http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection

1.13. Period of Performance

The anticipated period of performance of this Task Order is:

Base Year: February 21, 2020 – February 20, 2021 Option Year 1: February 21, 2021 – February 20, 2022 Option Year 2: February 21, 2022 – February 20, 2023 Option Year 3: February 21, 2023 – February 20, 2024 Option Year 4: February 21, 2024 – February 20, 2025 dataset extracts; Monthly Usage Reports (by the 20th of each month); Disclosure Clearance and Third Party Agreement Services;

Technical Support; to include Notification of and Access to Upgrades and/or New Releases of the Data and Software; Acceptable Projection or Other Appropriate Methodology; Current and complete Data Dictionary, including updates

0017 Ad hoc Analyses: custom reporting and product customization

50 Hours As specified by the Government

0018 Annual Meeting 1 Annually As specified by the Government 0019 Onsite Training 2 Bi-annually As specified by the Government 0020 On Demand Training - Webex 10 (est) As necessary As specified by the Government

OPTION YEAR 4 (Deliverable Items) Del. No. Description of Supplies/Service Quantity Unit Delivery Date

0021 Access to Adult and Pediatric Hospital data Resource and Services; Access to patient level dataset extracts; Monthly Usage Reports (by the 20th of each month); Disclosure Clearance and Third Party Agreement Services;

Technical Support; to include Notification of and Access to Upgrades and/or New Releases of the Data and Software; Acceptable Projection or Other Appropriate Methodology; Current and complete Data Dictionary, including updates

Unlimited access for 10 seat licenses

Monthly (12)

Initiated at time of award

0022 Ad hoc Analyses: custom reporting and product customization

50 Hours As specified by the Government

0023 Annual Meeting 1 Annually As specified by the Government 0024 Onsite Training 2 Bi-annually As specified by the Government 0025 On Demand Training - Webex 10 (est) As necessary As specified by the Government http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection http://sharepoint.fda.gov/orgs/CDER/ContractManagementTeam/OUTPATIENT%20RECOMPETE%20%202018/MON_SOW%202_28_18/SOW.docx#Projection