RFP - Hospital Drug Data final.pdf

Solicitation Number: 75F40120R00009 Page 1 of 77 Hospital Drug Utilization Data

Access to Hospital Drug Utilization Data

Table of Contents

Section 1 - Solicitation Information

1.1 Background

1.2 Notice of Combined Synopsis/Solicitation

1.3 Notice of FAC

1.4 Notice of NAICS Code

Section 2 - Pricing and Ordering of Services

2.1 Overview of Pricing Schedule

2.2 Pricing Terms

2.3 Contract Type

2.4 Minimum and Maximum Contract Value

2.5 Ordering

Ordering Procedures Authorized Ordering Activities Content of Task Orders

Section 3 - Description of Requirements

3.1 Background

3.2 Purpose and Objectives

3.3 Scope

3.4 Data Requirements - Unlimited Access to Hospital Drug Utilization and Diagnosis Data

3.5 Regulatory Drug Utilization Services

3.6 Technical Requirements and Capabilities

3.7 FDA Technical Environment

3.7.1. Internet Access

3.7.2. Number of Users

3.7.3. Data Downloading

3.7.4. Local Area Network (LAN) Configuration

3.7.5. Software Security

3.7.6. Virtual Private Network (VPN)

3.7.7. Custom Programming and Analytical Support

3.8 Contract Management Requirements

3.8.1. Management Plan

3.8.2. Quality Assurance Plan

3.8.3. Performance Evaluation

3.9 Labor Category Descriptions

Program/Project Manager:

Senior Computer Analyst:

Application Programmer:

Statistician:

Pharmacist:

Senior Training Specialist:

3.10 Deliverables

Section 4 - Delivery and Acceptance

4.1 Packaging, Marking and Shipping Instructions

4.2 Inspection and Acceptance

4.3 Period of Performance

4.4 Place of Performance

4.5 Deliveries

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4.6 Observance of Government Closures

Section 5 - Contract Administration Data

5.1 Contracting Officer (CO)

5.2 Contract Specialist (CS)

5.3 Contracting Officer’s Representative (COR)

Contracting Officer’s Representative’s Authority:

IDIQ Contracting Officer’s Representative (IDIQ COR):

Task Order Contracting Officer’s Representative (TO COR):

5.4 Technical Direction

5.5 Invoicing procedures

5.6 Government Furnished Property

5.7 Post-Award Evaluation of Contractor Performance

Section 6 - FDA Contract Requirements

6.1 Contractor Advance Understanding

6.2 Collaboration and Publication

6.3 Security Requirements for Procurements Requiring Information Security and/or Physical Access Security . 25

A. Baseline Security Requirements B. Training C. Rules of Behavior D. Incident Response E. Position Sensitivity Designations F. Homeland Security Presidential Directive (HSPD)-12 G. Contract Initiation and Expiration H. Records Management and Retention

6.4 Security Requirements for Procurements Involving Information Processed on Government-Owned Contractor-Operated (GOCO) or Contractor-Owned Contractor-Operated (COCO) Resources

A. Security Requirements for GOCO and COCO Resources

6.5 Accountability and Security

6.6 Briefings

6.7 Organizational Conflicts of Interest

6.8 Government-Furnished Data and Materials

6.9 Travel

6.10 Other Direct Costs

6.11 Reporting Matters Involving Fraud, Waste, and Abuse

6.12 Contractor Conformance with Applicable Laws, Regulations, Policies, and Standards

6.13 Contractor Advertising of Contract Award

Section 7 - Contract Clauses

7.1 FAR 52.252-2 -- Clauses Incorporated by Reference (Feb 1998)

7.2 HHSAR Clauses Incorporated by Reference

7.3 FAR Clauses in Full Text

FAR 52.216-18 – Ordering (Oct 1995) FAR 52.216-19 – Order Limitations (Oct 1995) FAR 52.216-22 – Indefinite Quantity (Oct 1995) FAR 52.217-8 – Option to Extend Services (Nov 1999) FAR 52.217-9 – Option to Extend the Term of the Contract (Mar 2000) FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (Jan 2020)

7.4 HHSAR Clauses in Full Text

HHSAR 352.237-75 – Key Personnel (Dec 2015) HHSAR 352.239-74 – Electronic and Information Technology Accessibility (Dec 2015)

Section 8 - Representations and Certifications FAR 52.212-3 – Offeror Representations and Certifications – Commercial Items (Dec 2019)

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FAR 52.204-16 - Commercial and Government Entity Code Reporting (Jul 2016) FAR 52.209-7 – Information Regarding Responsibility Matters Oct 2018)

Section 9 - Provisions and Proposal Instructions

9.1 FAR Solicitation Provisions

FAR 52.252-1 – Solicitation Provisions Incorporated by Reference (Feb 1998) FAR 52.216-1 – Type of Contract (Apr 1984)

9.2 Solicitation Inquiries and Questions

9.3 Proposal Submission

9.4 General Proposal Information

A. Communications prior to Contract Award B. Release of Information C. Preparation Costs D. Restrictions on Disclosure

9.5 Proposal Format and Instructions

General Format of Proposals Cover Letter Volume I – Technical Proposal Volume II – Business Proposal

Section 10 - Evaluation Factors for Award

10.1 FAR 52.212-2 – Evaluation-Commercial Items (Oct 2014)

10.2 Evaluation Factors

10.3 Responsibility

Section 11 - List of Attachments

Solicitation Number: 75F40120R00009 Page 4 of 77

SECTION 1 - SOLICITATION INFORMATION

1.1 BACKGROUND

The mission of the Food and Drug Administration (FDA) is to protect the health of the American public (www.fda.gov). The mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate drug risks and promote the safe use of drugs by the American people. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products.

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is of paramount importance to the overall public safety. Continued access to these data complement and strengthens the utility of the passive reporting system currently in place by providing estimates of the numbers of adult and pediatric patients exposed to drugs nationwide in the hospital setting. These data resources provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the hospital setting. Access to these data also increase the FDA’s ability to request regulatory impact studies such as those authorized under Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) to better understand the usefulness of drug labeling to clinicians. This can be done by examining actual use of products in hospitals in relation to recommended labeling. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process.

To strengthen the Drug Utilization Program, the Food and Drug Administration (FDA) requires continual direct access to commercially available hospital drug utilization data and regulatory drug utilization services.

It is the FDA’s intent to award an indefinite delivery-indefinite quantity (IDIQ) contract, with a performance period of five (5) years. The Government anticipates awarding an IDIQ contract with a ceiling of $9,000,000.00 and a guaranteed minimum of $5,000.00.

1.2 NOTICE OF COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a request for proposal (RFP) for commercial items IAW the procedures of FAR Part 12 – Acquisition of Commercial Items in conjunction with FAR Part 15 – Contracting by Negotiation.

1.3 NOTICE OF FAC

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-04, effective January 15, 2020.

http://www.fda.gov/

Solicitation Number: 75F40120R00009 Page 5 of 77

1.4 NOTICE OF NAICS CODE

The associated NAICS code is 518210 (Data Processing, Hosting, and Related Services), with a small business size standard of $35 Million. Offerors must have an active registration in SAM.gov (https://beta.sam.gov/), with completed representations and certifications, by the close date of the solicitation. Proposals submitted by offerors not registered in SAM.gov will not be considered.

SECTION 2 - PRICING AND ORDERING OF SERVICES

2.1 OVERVIEW OF PRICING SCHEDULE

Offerors shall propose unit pricing for the seat licenses for access to the required data. In addition, offerors shall propose labor categories and labor rates as a completed version of Attachment 9 – IDIQ Pricing Worksheet to be included in the “Volume III – Business Proposal” submission (see Section 9.5).

Access to Data Unit

Fixed Unit Price

Year 1

Fixed Unit Price

Year 2

Fixed Unit Price

Year 3

Fixed Unit Price

Year 4

Fixed Unit Price

Year 5 Unlimited Adult and Pediatric Hospital data resource and services; Unlimited Access to patient level dataset extracts;

Unlimited Access to Outpatient Medical Claims; Monthly Usage Reports;

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.

Kick-off Meeting/Annual Meeting, Onsite Training and On-Demand Ad-hoc Training, Quality Assuarance Plan, and Past Performance requirements

1 lot (10 seat licenses)

Ad-hoc Analyses: custom reporting and product customization (Up-to 250 total hours over 5 years)

50 hours $ $ $ $ $ https://beta.sam.gov/

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Labor Category Fully Burdened

Hourly Rate Year 1

Fully Burdened Hourly Rate

Year 2

Fully Burdened Hourly Rate

Year 3

Fully Burdened Hourly Rate

Year 4

Fully Burdened Hourly Rate

Year 5

Option to Extend IAW

FAR 52.217-8

Project Manager $ $ $ $ $ $

Senior Computer Analyst $ $ $ $ $ $

Application Programmer $ $ $ $ $ $

Statistician $ $ $ $ $ $

Pharmacist $ $ $ $ $ $

Senior Training Specialist $ $ $ $ $ $

The Contractor’s pricing schedules for labor categories shall contain fully burdened hourly rates. The fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative, and profit. Hourly rates shall apply to services at both Government and non-Government sites.

By mutual agreement of the parties, additional labor categories may be added to this IDIQ to support the tasks of this contract.

2.2 PRICING TERMS

The Contractor shall comply with FAR 52.232-7, Payments Under Time-and-Materials and Labor-Hour Contracts (Aug 2012), with regard to the ceiling price for each labor-hour or time-and-materials type task order.

The total amount specified in Firm-Fixed Price (FFP) task orders shall be fixed for the task order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the order. The Contractor shall comply with FAR Clause 52.232-1 Payments (Apr 1984) in regards to the firm-fixed-price for the individual task orders.

2.3 CONTRACT TYPE

It is anticipated that a single-award Indefinite Delivery-Indefinite Quantity (IDIQ) type Contract will be awarded as a result of this solicitation. The quantities of services ordered under this contract shall be accomplished by the issuance of task orders that will describe the contract type, objectives, scope, period of performance, and deliverables. All task orders are subject to the terms and conditions in the IDIQ base contract. Authorized contract types under this IDIQ are: Labor-Hour (LH), Time-and-Materials (T&M), and Firm-Fixed-Price (FFP). Option periods may be included in task order awards.

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2.4 MINIMUM AND MAXIMUM CONTRACT VALUE

IDIQ Minimum: The minimum guarantee for this IDIQ is $5,000.00 and will be met by the award of the initial task order.

IDIQ Maximum: The maximum aggregate dollar value of all task orders awarded over the 5-year ordering period of this IDIQ cannot exceed the IDIQ ceiling amount of $9,000,000.00.

See FAR Clause 52.216-19 for individual order limitations.

2.5 ORDERING

Ordering Procedures A request for task order proposal (RFTOP) will be issued via email by the Contracting Officer or authorized ordering activity. The contractor will typically have a minimum of five (5) business days to respond to any RFTOP. The Contractor shall prepare and submit a task order proposal within the time period as specified in the RFTOP. Proposals submitted in response to a RFTOP must utilize the Ordering Period rates listed in Section 2 based on the performance start date of the task order, and that rate must be used for the duration of the task order performance period. No payment will be made to the Contractor for costs to prepare, submit, and/or negotiate a task order proposal. The Government shall evaluate the task order proposal for technical acceptability and price reasonableness. It is the Contractor’s responsibility to maintain an ‘Invoice Log’ which each activity in the Item Number.

RFTOPs may include option periods in accordance with FAR clause 52.217-9. However, the following limitations apply to task orders with option periods:

• Option periods must utilize the Ordering Period rates listed in Section 2, based on the performance start date of the option period

• The performance end date of the last option period cannot exceed 12 months past the performance end date of the IDIQ contract.

These Ordering Pricing terms and conditions apply to all task orders issued against this IDIQ.

Authorized Ordering Activities A Contracting Officer of the FDA may place orders under this IDIQ contract. Except as otherwise specifically stated therein, whenever the words, “Contracting Officer” are used in the schedule of this contract, they shall be deemed to mean the Contracting Officer of the ordering activity, or which the Contracting Officer has full responsibility for administering all contractual actions arising from any task order issued by the ordering activity. The Contracting Officer whose signature appears on the contract has the sole responsibility and authority to make any changes to the provisions of this contract.

Content of Task Orders Each task order place under this contract shall include the following information:

1. The contract number, task order number, and date of order

2. Applicable accounting and appropriation data and invoicing instructions

3. Item number and description, quantity and unit price

4. Cost and hours (as negotiated), extended amounts, fee (if applicable), and total

5. Delivery or performance date

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6. Place of delivery or performance (including consignee)

7. Packaging, packing, and shipping instructions, if any

8. Such other terms and conditions as may be pertinent and peculiar to the particular tasks thereby ordered, urgent task orders may cite particular terms and requirements.

9. Particular requirements of the individual order.

SECTION 3 - DESCRIPTION OF REQUIREMENTS

3.1 BACKGROUND

A vital part of FDA and CDER’s mission is to protect the public health. The mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate drug risks and promote the safe use of drugs by the American people. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products.

In early 2005, FDA commissioned the Institute of Medicine (IOM) to conduct a study to examine the U.S.

drug safety system. In September 2006, the IOM report entitled, “The Future of Drug Safety: Promoting and Protecting the Health of the Public” was released and outlined numerous ongoing and future activities designed to continue to strengthen the FDA’s drug safety program. OSE contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. Specific recommendations in the IOM report addressed modernizing the drug safety program including activities for the expansion of database resources.

In addition, Title IX of the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) contains numerous provisions related to post-marketing safety and communication of safety information. A subset of those provisions calls for enhanced authorities for accessing disparate data sources, establish and improve procedures to identify drug use data trends on a national-level in the hospital setting.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

The 21st Century Cures Act which was enacted in December 2016 also contains provisions for the FDA to increase surveillance and monitoring of certain medications such as opioids which aligns with CDER’s mission. This section of the Act encourages the use of real world evidence in the analysis of post market surveillance data to enable the Agency to respond promptly to serious public health issues.

https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is of paramount importance to the overall public safety. Continued access to these data complement and strengthens the utility of the passive reporting system currently in place by providing estimates of the numbers of adult and pediatric patients exposed to drugs nationwide in the hospital setting. These data resources provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the hospital setting. Access to these data also increase the FDA’s ability to request regulatory impact studies such as those authorized under Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) to better understand the usefulness of drug labeling to clinicians. This can https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf

Solicitation Number: 75F40120R00009 Page 9 of 77 be done by examining actual use of products in hospitals in relation to recommended labeling. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process.

The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by FDAMA, Section 406, Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. The funding of " Hospital Drug Utilization Data" would serve as a mechanism for FDA to respond expeditiously to serious public health, regulatory issues, and legislative mandate. FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data.

FDA's authority to fund research projects is set out in section 301 of the Public Health Service Act (PHSA 42 U.S.C. 241).

3.2 PURPOSE AND OBJECTIVES

This requirement seeks to obtain direct access to commercially available hospital drug utilization data and obtain services that support regulatory drug utilization activities . Specifically, the objectives are to:

A. Provide FDA personnel with immediate automated access to a currently existing, commercially available data resource for adult and pediatric drug utilization data in short-stay hospitals with the capability of providing counts of discharges and patients utilizing drugs and diagnosis data

B. Provide FDA personnel with the ability to use these data to describe national patterns of drug utilization and diagnosis data in the adult and pediatric hospital settings through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel;

C. Provide FDA personnel with direct, unlimited, Internet or network-based access via an interface tool to the entire data resource for adult and pediatric hospital data in a multi-user environment and in real time; and, D. Provide FDA personnel with the ability to download (or obtain in a timely manner using other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies.

3.3 SCOPE

Independently and not as an agent of the Government, the Contractor shall furnish the required personnel, materials, services, databases, facilities, and otherwise to do all things required for or incident to the performance of the work as described in this Statement of Work.

3.4 DATA REQUIREMENTS - UNLIMITED ACCESS TO HOSPITAL DRUG UTILIZATION AND DIAGNOSIS

DATA

A. The Contractor shall provide continuous 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.

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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. 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.

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

Solicitation Number: 75F40120R00009 Page 11 of 77 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.

3.5 REGULATORY DRUG UTILIZATION SERVICES

The Contractor shall provide Drug Utilization Services as specified in individual task orders. These services may include:

A. Feasibility studies – studies that are conducted as initial pilot studies to determine if the scope of a study is practical, achievable and likely to involve a large population size to determine a significant association or non-significance association between exposure and outcome;

B. Customized Studies – Provision of datasets that endeavor to answer a specific question that require additional tools and resources beyond the current interface tool that is provided by the database;

C. Risk management studies – studies that endeavored to ascertain if a specific risk management program is effective to ensure that the benefits of the drug outweigh the risks;

D. Validation studies – studies conducted to establish the validity of exposure or outcome ascertainment method. For example, to establish the validity of specific diagnoses recorded in the database as discharge claims as compared to the diagnoses recorded in medical record data from hospitals;

E. Active Surveillance – Inclusion of dataset as part of a data warehouse for active surveillance with prior approval from data provider.

F. Training services – training staff from who a specific service is required. For example, training medical records abstractors on the pertinent information required for abstracting medical record data based on medical record abstraction form.

G. Ad Hoc Analyses – The Contractor shall provide additional hours of ad hoc data analyses or custom queries not available through the data tool.

3.6 TECHNICAL REQUIREMENTS AND CAPABILITIES

The Contractor shall provide drug utilization data that meets the following technical requirements and capabilities:

A. Access to a data resource for hospital data for adult and pediatric patients shall be through a currently existing, commercially available, HIPAA-compliant interface tool that shall provide immediate automated access with the capability of providing counts of discharges and patients utilizing drug products in the hospital setting and characterizing the hospital episode in short-stay hospitals. Provide FDA personnel with the capability to access detailed hospital data (including drug utilization and diagnosis data) that are linked with detailed outpatient data (including drug utilization and diagnosis data);

B. Access to the data resource shall be immediately after award;

C. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Access shall include all upgrades, enhancements, and modifications to interface software and data;

D. Access shall be via secure internet or network-based methods and shall be in a multi-user environment. The network-based methods shall not necessitate any additions to the FDA

Solicitation Number: 75F40120R00009 Page 12 of 77 communications infrastructure. Methods for access in order of preference are: 1) secure internet access, and 2) firewall-to-firewall virtual private network (VPN). FDA shall not support modem-based or dial-up access. Additionally, FDA shall not support or maintain Contractor’s equipment or personnel on premises;

E. Access shall be through an interface and this interface shall be user-friendly (easy to understand and methods fully disclosed), transparent and flexible for conducting data queries. The interface shall provide both predefined (e.g., canned) and custom reports. The interface shall also include access to national estimates of adult and pediatric discharges and patients stratified by patient demographics [including age in months for pediatric patients < 2 years old], primary and secondary diagnoses, , length of stay, length of therapy, location of service, time period (month, quarter, year, moving annual total, aggregate time) and hospital characteristics (e.g. region, teaching status, bed size, urban vs. rural). Data related to the drug product shall display the generic and established name of the drug, strength, dosage form, route of administration, and NDC code (if available);

F. The Contractor shall provide the FDA with the ability to make national estimates of hospital drug use using a projection or other appropriate methodology, which shall be valid, reliable, and robust with regard to drug utilization specifically, and the methods fully disclosed and shall be available at contract award;

G. Full disclosure of data collection, construction, coding and configuration as well as quality control procedures as required to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology;

H. A complete data dictionary shall be provided to FDA in an electronic format. An updated dictionary shall be provided within 30 days of changes which affect the data elements contained within the tools or data streams accessed by the FDA;

I. The Contractor shall notify FDA within five business days of any changes in their business agreements with their data suppliers. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics;

J. For regulatory requirements, the Contractor shall provide the FDA with the ability to download (or obtain in a timely manner using other means) and archive data and the means (query file or search logic) used to create it. FDA requires that datasets shall be available on demand and without intervention by the Contractor;

K. The Contractor shall provide additional analytical and programming support, to enable FDA personnel to obtain patients, discharges, and any other utilization metrics not available through the online data tools. The Contractor shall provide 50 ad-hoc hours, with option for additional ad-hoc hours as required in individual task orders and provide criteria for the level of effort and the billing against the bank of hours.

L. The Contractor shall ensure that all data are HIPAA-compliant. No patient, practitioner, or health plan-specific identifiers will be required by FDA. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use;

M. As part of its regulatory activities, FDA shall, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data, the Contractor shall accept and adhere to the FDA Data

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Disclosure Clearance Procedures and Form found in Attachments 4 and 5 unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA;

N. As part of its regulatory activities, FDA shall, at times engage in collaborative research projects with third parties outside of FDA for specific research projects of public health importance that are initiated by and for the benefit of FDA. These collaborations shall require FDA to have the ability to share project specific aggregated or raw data with third parties for collaborative research projects.

For activities that require disclosure of aggregated data the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and Form found in Attachments 4 and 5 unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. These procedures include terms and conditions for third-party collaborations;

O. The FDA shall require continuation of services to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the task order period. After Ordering Period 4, the FDA will notify the Contractor of the aggregated data release and accept the Contractor’s requested revisions, however, will not require formal approval for release;

P. The Contractor shall provide a kick-off meeting within 30 days upon award of IDIQ contract. In addition, the Contractor shall conduct an annual meeting on-site at the FDA campus in Silver Spring, Maryland. 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.

Q. The Contractor shall provide two on-site training sessions per year offered at FDA facilities (Silver Spring, MD). Training shall be provided for users of the data, as well as training for FDA personnel who will support the 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.

Course outlines and written documentation related to using the data shall be provided. Options for additional “on-demand” sessions via web-based methods shall be provided. The training shall be initiated 30 days after receipt of award and continues throughout the duration of the contract;

R. 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 support shall be provided by phone or by e-mail for all certified users of the data during business hours (9:00 am -5:00 pm EST) Monday through Friday excluding federal holidays 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;

S. The Contractor shall be required to conduct on-site annual meetings for the purposes of discussing contract performance, product enhancements, annual updates (data characteristics, data elements) to the data source and FDA satisfaction with all deliverables;

T. The Contractor shall provide Monthly Usage Reports by the 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, number of ad hoc programming hours used and project title.

• The Monthly Usage Report shall include the number and type of data queries by individual FDA user.

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• Clearance Requests shall include type of data submitted, project title, FDA requestor, date of request, and approval date.

• Third-Party Agreement Requests shall include third-party collaborator, project title, FDA principal investigator, date of request, approval date, and expiration date.

• Ad hoc Dataset Requests shall include the number of technical support programming hours used, project title, FDA requestor, date of request, and date received.

• Notifications of any circumstances resulting in loss or lack of data streams, or any data enhancements or data errors that would impact access to data from the data resource(s).

U. The Contractor’s software and interface tools shall be in full conformance or level of conformance with Section 508 standards (See HHSAR 352.239-74).

3.7 FDA TECHNICAL ENVIRONMENT

3.7.1. Internet Access

The required mechanism for data access is via internet. The FDA has direct, desktop access to the Internet. The system shall be web-based and be compatible with commonly used web browsers including Internet Explorer 9 and above, Firefox 23 and above, Chrome, and Safari 4 or higher. The Contractor’s proposal shall specify any additional software and/or hardware (name and version) necessary to access the data.

3.7.2. Number of Users

The FDA may purchase a range of seat licenses, a minimum of 5 to a maximum of 10 for the direct unlimited access to the data. The unit price for 1 lot (10 seat licenses) shall be established in the IDIQ.

The specific number of seat licenses required will be specified in individual task orders.

3.7.3. Data Downloading

The FDA uses standard statistical and data management software, such as SAS, Access and Excel, PDF, ASCII, and shall require the ability to download or export data in formats that are compatible with these packages.

3.7.4. Local Area Network (LAN) Configuration

The FDA uses a central-server network model. The configuration is a wide area network with transmission control protocol/Internet protocol (TCP/IP) running on a 10/1000 Mbs network. The FDA shall not provide a diagram of the network. FDA shall not support dial-in or modem-based access.

3.7.5. Software Security

Any client software that is required to be installed on any FDA computers for the purposes of accessing the data shall not use key-logging and/or network capturing functionality to transmit any data from the FDA system except for login information specific to the data and data (e.g. SQL queries or similar methods) accessing the Contractor’s application data sets. Such software add-ons or plugin shall be approved prior and must be approved by the FDA IT department. The contractor is responsible for providing the needed documentations to assist in the approval process. The license shall include post-production maintenance that includes patches, upgrades, and bug fixes if required.

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3.7.6. Virtual Private Network (VPN)

The FDA utilizes the virtual private network to establish a trusted, encrypted TCP/IP tunnel for accessing data from a remote location. The VPN shall be a firewall-to-firewall encrypted tunnel utilizing commercially available software and industry standard IPSEC protocols.

3.7.7. 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.

3.8 CONTRACT MANAGEMENT REQUIREMENTS

3.8.1. Management Plan

The contractor shall provide a management plan for organizing, staffing, and managing the tasks for this requirement, documenting roles and responsibilities and timeliness of services to include data access, training, technical support, monthly reports disclosure clearance and third-party collaborations, and ad hoc analyses.

3.8.2. Quality Assurance Plan

The Contractor shall provide a Quality Assurance (QA) Plan detailing procedures and guidelines to ensure the required performance standards or services levels are met throughout the life of this contract. The QA Plan shall describe the systematic methods used by the Contractor to monitor performance, identify required documentation, and allocate resources. The Government reserves the right to alter or change the surveillance methods in the QA Plan at its own discretion.

3.8.3. Performance Evaluation

Performance shall be evaluated to determine whether or not the Contractor meets the threshold of the agreement. When the performance threshold is not met, the FDA Contracting Officers Representative (COR) will notify the Contract Specialist/Officer. The Contractor shall reply to all performance inquiries listed below with a resolution within 15 business days of receipt. Failure to meet the Acceptable Quality Level shall be captured as non-performance and provided to the Contracting Officer for action. Failure to meet the described performance standards will directly affect the Contractor’s annual performance evaluation and may result in a poor performance rating and influence potential future contract award decisions.

Required Service Standard Acceptable

Quality Level

(AQL)

Method of Surveillance

The Contractor shall provide Disclosure Clearance and Third- Party Agreement Service

The turnaround time for urgent clearance requests is 24 hours; 48 hours for standard clearance requests; and 72 hours for third-party agreements

Standard shall be fully met at 100%

COR and FDA staff shall maintain a clearance tracking log with turnaround times

The contractor shall provide an acceptable Quality Assurance Surveillance Plan (QASP)

The Contractor Shall provide a QASP with a description of quality control measures that will ensure access to valid data that is technically correct

Standard shall be met at 100%

COR and FDA staff shall monitor adherence to acceptable QASP

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Required Service Standard Acceptable

Quality Level

(AQL)

Method of Surveillance and conforms to contract requirements.

The Contractor shall provide Unlimited Direct Access to Data Resource and Services

The Contractor shall notify the FDA 48 hours in advance of any circumstances resulting in loss of access to the data source due to planned downtime The Contractor shall notify the FDA within 30 minutes (Monday-Friday, 9:00 AM – 5:00 PM Eastern Time) from the onset of unplanned downtime with an estimate of time as to restoration of access

Standard shall be fully met at 100%

COR and FDA staff shall monitor database access, notification and restoration times

The Contractor shall provide Ad-hoc Analyses:

custom reporting and product customization

The Contractor shall provide the FDA ad-hoc data results within 15 business days of receipt

Standard shall be fully met at 100%

COR and FDA staff shall monitor turnaround times from the Contractor’s monthly report

The contractor shall provide a resolution plan and shall include a timeline for resolving any circumstances resulting in loss of, or lack of, access to data or any data errors/loss from the database(s)

Within five business days of Contractor’s knowledge of the loss or lack of access to data or any data errors/loss from the database(s) and shall be documented in the Monthly Report

Standard shall be fully met at 100%

COR and staff review of data quality (i.e., variance in data runs)

The Contractor shall guarantee timely access to hospital analytical datasets

The mutually agreed upon dataset parameters (max. size, data elements) and turnaround time to be negotiated at the time of award

Standards shall be fully met for access to all analytical datasets

COR and staff review of dataset quality and turnaround times

3.9 LABOR CATEGORY DESCRIPTIONS

Program/Project Manager:

• Leads team on large projects or significant segment of large complex projects

• Analyzes new and complex project related problems and creates innovative solutions involving finance, scheduling, technology, methodology, tools, and solution components

• Project manager shall have a minimum of a master’s degree or an equivalent certification and at least 5 years of experience managing projects.

Senior Computer Analyst:

• Analyze science, engineering, business, and other data processing problems to implement and improve computer systems. Analyze user requirements, procedures, and problems to automate or improve existing systems and review computer capabilities, workflow, and scheduling limitations.

May analyze or recommend commercially available software.

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• The individual shall have the required certification with a minimum of 8 years of experience in the field.

Application Programmer:

• Devises or modifies procedures to solve complex problems considering computer equipment capacity and limitations, operating time, and form of desired results

• Designs, codes, tests, debugs, and documents

• Application programmer shall have the required certification with a minimum of 5 years of experience in the field

Statistician:

• At least 10 years of experience and training in economics, finance, statistics, or related areas.

Demonstrated record of supporting development and delivery of presentations, publications, and reports on specific programs or technically complex subjects

• An Economist/Statistician is responsible for performing work of a technically complex nature in the areas of economics and statistics, including cost-benefit and regulatory impact analysis, financial analysis, risk assessment, statistical analysis, sampling, survey design and implementation; and for reviewing the work of other staff

Pharmacist:

• Dispense drugs prescribed by physicians and other health practitioners and provide information to patients about medications their use. May advise physicians and other health practitioners on the selection, dosage, interactions, and side effects of medications

• Pharmacist shall be a registered in any state with a minimum of 10 years of experience in the field

Senior Training Specialist:

• Assesses, designs, and conceptualizes training scenarios, approaches, objectives, plans, tools, aids, curriculums, and other state of the art technologies related to training and behavioral studies

• Identifies the best approach training requirements to include, but not limited to hardware, software, simulations, course assessment and refreshment, assessment centers, oral examinations, interviews, computer assisted and adaptive testing, behavior-based assessments and performance, and team and unit assessment and measurement

• Develops and revises training courses. Prepares training catalogs and course materials

• Trains personnel by conducting formal classroom courses, workshops, and seminars

• Training Specialist Senior shall have a minimum of eight (8) years of experience in the field or in a related area.

• Educational requirement is a Bachelor's degree in a related area or equivalent.

3.10 DELIVERABLES

Additional deliverables may be specified in individual task orders.

Deliverable No. Description of Supplies/Service Frequency Delivery Date

0001 Kick Off/On-site Annual Meeting Once Initiated within 30 Days of IDIQ award

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SECTION 4 - DELIVERY AND ACCEPTANCE

4.1 PACKAGING, MARKING AND SHIPPING INSTRUCTIONS

A. All non-electronically submitted deliverables required under this contract shall be packaged, marked and shipped in accordance with the requirements and specifications contained herein this contract. At a minimum, all deliverables shall be marked with the Contract Number and Contractor Name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

B. Reports not submitted electronically shall be delivered F.O.B. Destination, as set forth in FAR Clause 52.247-35, F.o.b. Destination, Within Consignee’s Premises, and as specified in the delivery schedule.

4.2 INSPECTION AND ACCEPTANCE

A. The Task Order Contracting Officer’s Representative (COR) or duly authorized representative will perform inspection and acceptance of materials and services to be provided in each task order. For the purpose of this section, the Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer.

B. Acceptance may be presumed within 10 days of receipt, unless otherwise indicated in writing by the Contracting Officer or duly authorized representative (COR). Unless otherwise specified in the task order, inspection and acceptance will be performed at the Place of Performance in Section 4.4.

4.3 PERIOD OF PERFORMANCE

The anticipated period of performance for this contract will be a five (5)-year period of performance.

The anticipated ordering periods are:

Ordering Period 1: February 21, 2020 – February 20, 2021 Ordering Period 2: February 21, 2021 – February 20, 2022 Ordering Period 3: February 21, 2022 – February 20, 2023 Ordering Period 4: February 21, 2023 – February 20, 2024 Ordering Period 5: February 21, 2024 – February 20, 2025

4.4 PLACE OF PERFORMANCE

The place of performance will be identified in individual task orders but is expected to occur primarily at the Contractor’s facility. Onsite meetings shall take place at the FDA’s main campus, located at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, or other FDA locations in the Washington, D metropolitan area.

0002 Quality Assurance Surveillance Plan Annual Initiated at time of award and updated as needed thereafter.

0003 Program Management Plan Annual Initiated at time of award and updated as needed thereafter.

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4.5 DELIVERIES

Specific deliverables and schedule of deliverables shall be identified in each task order.

Satisfactory performance of this contract shall be deemed to occur upon performance of the work and upon delivery and acceptance by the COR or the duly authorized representative.

A. Deliveries required by the Contractor shall be made F.o.b. Destination, as set forth in FAR Clause 52.247-35, F.o.b.