Attachment_C.pdf

SOLICITATION: 16-223-SOL-00101

TASK ORDER: Attachment C

Statement of Work (SOW) FAERS DMP Task Order

1 BACKGROUND

The FDA’s Center for Drug Evaluation and Research (CDER) and the FDA’s Center for Biologics Evaluation and Research (CBER) perform a crucial part of FDA's mission, specifically pre-market and post-market safety and efficacy assessments of human drugs and biologics. In this context CDER and CBER perform safety surveillance, to include the recording of mandatory and voluntary submission of adverse effect reports, product problem and medication error reports. CDER and CBER review reports for drugs (NDA/ANDA/OTC/Pre-38), biologics such as monoclonal antibodies and interferons (Biologic License Application (BLA) / Product License Application (PLA) / Submission Tracking Number (STN)), blood products, human tissues, and cellular allograft products. FDA authority to conduct safety surveillance is granted by Public Law 109-462 and Section 505(k)(1) of the Federal Food, Drug and Cosmetic Act and the following Codes of Federal Register (CFRs):

• 21 CFR 310.305 -"Grandfathered" drugs (pre-1938)

• 21 CFR 312.32 - Drug and Biologic safety reports (IND Safety Reports)

• 21 CFR 314.80 - post-marketing drugs

• 21 CFR 314.98 - generic drugs

• 21 CFR 371 – OTC drugs

• 21 CFR 600.80 - biologics

• 21 CFR 803.53 - Medical Devices

The collection and analysis of adverse effect and similar reports by FDA staff must occur throughout the entire life cycle of a product in order to identify occurrences associated with the use of a drug or biologic in humans that could not have been predicted by clinical trials and bio-statistical analysis. Stakeholders such as manufacturers, importers, health care professionals, attorneys, patients and consumers report these occurrences to FDA in order for the Agency to carry out its safety surveillance mission. In addition, FDA Safety Evaluators provide follow up information and FDA Field Investigators provide reports.

This task order shall encompass the FDA Adverse Event Reporting System Data Management Program, hereafter referred to as FAERS-DMP. The FAERS-DMP includes FAERS data entry, Drug Quality Reporting System (DQRS) data entry, and any future technology upgrades to these systems (The statutory provisions for DQRS are 21 CFR 314.81(b)(i) and (ii)). The Contractor will not be responsible for upgrading the technology of the systems but shall adapt to any technology upgrades.

The current FAERS system is a modern web application based on a Commercial Off-the-Shelf (COTS) Oracle product. It contains greater than 12 million adverse event reports, supports over 400 users, supports paper data entry operations, and supports electronic real-time data capture and searches. The current FAERS application was released in September 2012.

Adverse event information may be given to the government in a number of different forms. The government has official paper forms like Medwatch form 3500, 3500A, and 3500B for consumer and health care providers.

http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm2007307.htm

They government also provides a web site for consumers to submit individual reports http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm2007307.htm https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

At this time the forms from the website are printed and then data entered. We now have a software system under development that will more directly add this web information to our FAERS databases. T

Companies can also submit reports electronically using the E2B message to our electronic gateway or smaller companies have the option of using our Safety Reporting Portal (SRP) to submit reports http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffect s/ucm115894.htm

The Government requires FAERS data entry support services for reports commonly known as Individual Case Safety Reports (ICSRs) to include tasks such as triaging, registering (logging), tracking, imaging, data entry, coding (of manufacturer and product(s)), validation, MedDRA coding, updating of data records, reviewing, editing, filing, quality control, and quality assurance.

Information about the MedDRA coding taxonomy can be reviewed at :

http://www.meddra.org

The other data entry component of this contract is for the DQRS. DQRS is an important part of the post-marketing compliance phase of regulating pharmaceutical products. It rapidly identifies significant health hazards associated with the manufacturing, potency, packaging, and labeling of pharmaceuticals.

Like FAERS, DQRS accepts MedWatch Forms that have been triaged with potential drug quality problems. Also, DQRS accepts New Drug Application (NDA) Field Alert Reports (FAR), Biologic Product Deviation Reports (BPDR) FDA Form 3331, and a small amount of specialized reports. DQRS processing entails data entry, scanning of reports into the DQRS database, and generating District Memoranda, Office Referral Memoranda (labs), and Manufacturer Follow-up Letters.

2 OBJECTIVES

The primary objectives of this contract are data management services in support of the FDA Adverse Event Reporting System Data Management Program (FAERS-DMP) and DQRS include:

1. Provide timely and accurate data entry and quality assurance of mandatory and voluntary adverse event reports submitted to the FDA into the FAERS data entry system

2. Provide timely and accurate data entry of drug quality reports submitted to the FDA into the

DQRS

3. Implement quality assurance programs for data entry and MedDRA coding

4. Support changes in the data entry process that will lead to greater program efficiency https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm

3 PURPOSE

The purpose of this Task Order is to provide data management support for the FAERS and DQRS systems.

4 SCOPE

The scope includes the full range of data management support services for the FAERS and DQRS systems, which includes data entry, tracking, coding, and validation of post-market adverse event reports. The scope includes configuration updates, training and user acceptance testing of new and updated software to help increase program efficiency. The scope also includes Product, Manufacturer and MedDRA dictionary maintenance, and creation and updates of SOPs.

GENERAL REQUIREMENTS

The contractor shall comply with all facility infrastructure and equipment requirements and all regulatory requirements, per the Appendices FAERS Facilities Requirements and FDA-CDER_DMP IT Facilities Requirements The contractor shall ensure that cleaning of the workplace is done during the day so non-badged employees are not left alone in the work area.

TASKS AREAS

The FDA FAERS-DMP Task Order requirement is divided into the following major task areas:

• Task Area 1: Document Processing, Handling, Correspondence, and Delivery;

• Task Area 2: Transition Work Activities

• Task Area 3: Training

• Task Area 4: Support of updated software for greater program efficiencies

• Task Area 5: Program and Project Management;

4.1 Task Area 1 - FAERS-DMP Document Processing, Handling, Correspondence, and Delivery

The Contractor shall perform the FDA Adverse Event Reporting Systems (FAERS) tasks include triaging, logging, scanning tracking, processing, validation (MedDRA coding), updating of data records, medical coding quality control and assurance, and filing of electronically submitted adverse event reports.

Figure 1 depicts and describes the processes and flow of information including input of adverse event reports to FDA.

US Postal Mail, reports that were sent in error to other centers, physical media from companies, and reports that were sent to us in error are all delivered by a courier. The contractor is responsible to hire a courier service and oversee their work. This is detailed in the SOP in Appendix B and the courier route from the SOPs are found in Appendix C. The cost for the courier is charged on the invoice to FDA and a receipt from the courier service is included in the invoice.

Data entry begins with Individual Case Safety Reports (ICSRs) being entered into the FAERS database.

(see Appendix F for a graphic of this work process ) Regulations enacted in September of 2015 have mandated that all mandatory industry reports be submitted electronically. This may be through the Safety Reporting Portal (SRP) for small companies or traditional Enterprise to Business (E2B) messages through the FDA electronic gateway. Paper processing still occurs in our for our MedWatch Voluntary Reports: Form 3500 for Health Care Professionals and Form 3500B For Patients and Consumers

The electronically submitted files can come in via the FDA gateway as .xml files. Physical media may be submitted when the FDA electronic gateway becomes non-functional. When an electronic record is submitted, it is then uploaded to FDA’s Enterprise Search software tool and becomes available for viewing as images in FAERS. Electronic submissions are then transferred into FAERS. It should be noted that when electronic physical media is submitted, it is delivered from the FDA Central Document Room (CDR) to the FAERS contractor where the reports are then loaded into FAERS.

Each ICSR must be legible, contain at least one identifiable suspect product, an identifiable reporter, identifiable patient, and a minimum of one identifiable event converted by the contractor to a MedDRA term to be entered into FAERS.

Voluntary Reports The MedWatch reports are used for voluntary direct reporting of adverse events, product problems, and product use errors. These reports are also referred to as Voluntary Reports and are submitted using FDA Forms 3500 and 3500B. Form 3500 is used for Health Care Professionals and Form 3500B is used for Patients and Consumers. MedWatch voluntary reports are received by the contractor via mail, e-mail, fax, phone, or internet. Currently known examples of sources of voluntary reports received include:

• Health Care Providers

• Patients

• Attorneys

• Caregivers

• Consumers

• Special Interest Groups o Drug-Induced Liver Injury Network (DILN) o National Cancer Institute (NCI) o Institute for Safe Medication Practices (ISMP) o Medco (a pharmacy benefit manager) o Veterans Administration (VA)

Additionally, the MedWatch-to-Manufacturer Program (MMP) allows manufacturers to receive certain serious adverse event reports, associated with their new molecular entities, which are submitted directly to FDA. The contractor shall provide services for processing reports to manufacturers that register for the MMP, which consists of a minimal volume of reports (10 to 20 per month).

It should be noted that FDA may accept other types of reports in the future. In addition, some of the organizations have developed their own version of Form FDA 3500 and 3500B to facilitate data entry.

These forms are entered into FAERS just like any other paper report.

The following three tables include adverse event reporting metrics and provide a historical glimpse of the scale, complexity, and timeframe of the FDA adverse event reporting data entry and quality control effort. The following table summarizes the total number of reports received from October 1st 2015to December 31, 2015.

TABLE 1: Actual Number of Received Reports Expedited – paper* 472 Expedited – eSubmission 211,130 Voluntary – paper 11,618 Non Expedited – Serious/NME – paper *

Non Expedited – eSubmission 195,806 *In September of 2015 FDA started sending letter letters to companies reminding them that new regulations mandated that industry generated reports had to be submitted electronically. The few industry paper reports that we now receive will probably drop to near zero in the future.

http://www.fda.gov/drugs/drugsafety/ucm400526.htm

The following table summarizes the average number of MedDRA terms recorded per ICSR from October 1st 2015 to December 31, 2015

TABLE 2: Average Number of MedDRA Terms per Report Voluntary Reports 4 Expedited Reports 4 Non Expedited Reports 3

The following table summarizes the average narrative length (in bytes) per ICSR from June 2013 through June 2014.

TABLE 3: Actual Bytes per Report Paper Expedited Reports* 3,025 http://www.fda.gov/drugs/drugsafety/ucm400526.htm

Contractors should understand that the regulatory environment is dynamic and over the course of this contract workload will vary and the contractor will be responsible for providing the appropriate staff for different workload levels.

4.1.1.1 DCC Tasks Document Control Center

The contractor shall establish and operate a DCC that performs the initial sorting, which includes forwarding Voluntary reports to the Central Triage Unit (CTU). DCC’s primary task is to prepare paper copy Mandatory reports for triage, data entry and scanning Among other tasks, DCC also screens for duplicates, batches MedWatch reports, applies bar code labels to batches, and enters report data into the Automated Production Logs (APL) system. The contractor shall perform the following functions in accordance with the DCC SOP attached in Appendix B:

• Sort reports for triage, Exception batch processing, or other disposition.

• Process and mail duplicate reports to FDA

• Prepare report batches for Triage, Data Entry, and APL entry and sort by:

o Report type (i.e. Voluntary, Periodic, Expedited, High Profile, or New Molecular Entities (NMEs) o Product quality issue o Responsible Center(s)

• Send reports to CTU for triage

• Complete APL data entry

• Deliver Exception batches to Data Entry Team Leader

• Deliver batched reports in bins to Data Entry area

4.1.1.2 CTU Tasks

The contractor shall establish and operate a Central Triage Unit (CTU) that performs two primary functions: (1) Triage and subsequently routes Voluntary reports to the appropriate Center and (2) sends Acknowledgement letters. CTU uses the FDA MedWatch Expedited Reporting Information System (MEDEX) program to track reports before data entry into FAERS. MEDEX tracks all voluntary paper reports whether or not they are entered into the FAERS system or sent to other Centers or Offices. It is not unusual to receive reports that are not regulated by CDER. The CTU processing area receives, logs, and routes the reports to FDA Centers. CTU also administers the MedWatch to Manufacturer Program (MMP). MMP is a program in which FDA shares non-confidential Voluntary report information with eSub Expedited Reports 2,865 Voluntary Reports 478 manufacturers. The Contractor shall perform the following activities in accordance with the CTU SOP attached in Appendix B:

• Track all Voluntary reports received from doctors, consumers, medical personnel, caregivers and attorneys in MEDEX. It should be noted that manufacturer reports are not tracked in

MEDEX

o Screen reports to distinguish route of receipt (USPS, Internet, Fax) o Identify cases for Exception Batch processing

• Assign a unique Central Triage Unit (CTU) identification to each Voluntary report received

• Enter data into MEDEX and completely process reports on the day of receipt, for reports received by 2pm

• Route all processed reports to the appropriate responsible Center(s), and shall also route misdirected reports to the appropriate recipient o Document the method used to send each Routing Report to the Center(s), such as fax, mail, and/or courier

• Deliver applicable reports to DCC, and batches of reports to Data Entry, including any

Exception batches for same-day processing

• Generate acknowledgement or rejection letters for all Voluntary reports

• Prepare mail labels and mail the paper acknowledgement letter within one week of receipt of a voluntary report.

• Complete a rejection letter, if applicable, within one week of receipt of a voluntary report

• Provide and maintain routing services for pick-up and delivery of 100% of paper reports on a daily basis

• Provide MedWatch CTU Distribution Report by running SQL statements on the MEDEX program

• Send Non-Expedited cases to FDA Safety Evaluators

• Administer the MedWatch-to-Manufacturer Program (MMP) o Collect qualifying images of Voluntary reports (estimated 10 to 20 per month) o Send these imaged reports to FDA Division of Information Disclosure and Policy

(DIDP) for redaction o Upon return of the redacted ICSRs from DIDP, forward the redacted ICSRs to all registered manufacturers using the following MedWatch-to-Manufacturer Program (MMP) link: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm o Provide ICSRs that are non-confidential to all registered manufacturers

An FDA on-site Representative will monitor all DCC and CTU activities described above.

4.1.2 Case Data Entry of ICSRs

Data Entry Specialists shall process all paper Voluntary reports. It should be noted that reports are also referred to as cases in FAERS. The contractor shall perform the following activities in accordance with the Data Entry SOP included in Appendix B:

• Verify case status as either a New Case or Follow-up Case

• Enter report data o The contractor shall enter data for New and Follow-up Cases of ICSRs into FAERS at or above the rate of 12.5 cases per hour http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm

• Generate bar code labels and affix to each report page. This allows for tracking and accountability of paper copy reports

4.1.3 APL Tracking and Imaging

The contractor is responsible for using the Automated Production Logs (APL), which is a FDA tracking and accountability application. The contractor shall perform the following in accordance with the APL and Imaging SOPs included in Appendix B:

• Receive batches of reports from Case Data Entry area

• Scan the batch and case bar code labels into APL database

• Deliver to Imaging for uploading to the FDA Enterprise Search System for availability in

FAERS

• Image or scan all ICSRs received

• Identify duplication errors, monitor quality of scanned image, purge poor quality images, verify errors, and add any missing images for all reports

• Assign a unique ICSR barcode number for each report

• Manage receipt and accountability for content submitted on physical media

• Box and store processed batches in a secured area, accessible to designated FAERS-DMP staff

• Manage storage, report retrieval and destruction (shredding). The shredding task includes shredding the MedWatch reports or managing the shredding schedule, if another vendor provides that service. Reports shall be retained for 60 days.

4.1.4 Detailed Data Entry of ICSRs

The contractor shall perform the following activities for Detailed Data Entry in accordance with the Data Entry SOP included in Appendix B:

• Enter MedWatch report data into FAERS database o A voluntary report shall be entered into the FAERS database within 7 calendar days of receipt at the central document room o A list of high priority drugs called the C24 list is maintained by FDA. Any report that has one of these drugs listed will be completely entered into the database and available to the safety evaluators in FAERS 24 hours after receipt.

• Submit reports to Coding

• Enter Detailed Data of Voluntary ICSRs into FAERS at or above a performance rate of 4 cases/hour

4.1.5 Coding and Dictionary Maintenance

The coders resolve discrepancies between the data entered in the FAERS database and information submitted on the actual report form. They also validate the report data for each primary and secondary suspect drug product. The Contractor shall perform the following tasks in accordance with the Coding SOP included in Appendix B:

• Reconcile eSub reports without the minimum four data elements (identifiable reporter, identifiable patient, an adverse event, and a suspect product)

• Support FDA with updates and corrections to the FAERS product dictionary. This is usually one worker with specialized training that works closely with FDA dictionary specialists o The contractor shall be responsible for researching and including new drug names into the product drug name dictionary and correcting and updating entries o The contractor’s staff assigned to support dictionary maintenance shall report to the

FDA’s product dictionary group and help with researching and updating manufacturer dictionary entries

• Send any corrections and new manufacturer names in a Drug Manufacturer daily report to the FDA manufacturer dictionary representative. The contractor shall add names to the manufacturer dictionary with direction from the FDA manufacturer dictionary representative.

• Coding shall be performed at or above the performance rates specified below for each report type (coding includes QC of Data Entry and adding manufacturer and product names from FDA dictionaries):

o Expedited 6 cases/hour o Voluntary 6 cases/hour o Non Expedited 8 cases per hour o Expedited eSUB 8 cases per hour o Non Expedited eSUB 10 cases per hour

4.1.6 Validation

MedDRA is a medical taxonomy that facilitates sharing of regulatory information internationally;

MedDRA applies to medical products manufactured for human use. Regulatory authorities, the pharmaceutical industry, research organizations and health care professionals use MedDRA to standardize and abstract safety report narratives by selecting terms from a controlled vocabulary. The contractor shall perform the following tasks in accordance with the Validation SOP attached in Appendix B:

• Utilize MedDRA in the FAERS database to capture reported adverse events, indications, medication errors and product quality issues

• Validate MedDRA preferred term (PTs) coding and MedDRA version discrepancies, which includes:

o Searching MedDRA for an appropriate term or key the term directly into the appropriate FAERS data field o Reporting at least one term that is coded to a MedDRA term before transferring a FAERS case to the FDA Safety Evaluators

• Validation shall be conducted at or above the performance rates specified below:

o Expedited 6 cases/hour o Voluntary 8 cases/hour o Non Expedited 20 cases/hour o Expedited eSUB 8 cases/hour o Non Expedited eSUB 20 cases/hour

• Sample and perform quality control on the MedDRA codes submitted under electronic submission monthly in accordance with the international MedDRA coding guidelines for quality control (Reference: http://www.meddra.org/how-to-use/support-documentation/english). The COR will provide the a spreadsheet of the quality control sample each month. The spreadsheet will have approximately 1,600 records. These records may be made up of different types of reports. These should be validated at a rate of 10 reports per hour o Developing a monthly report that shows:

A list of terms that were missed or incorrect Trend information over time to help FDA understand trends

The COR may increase or decrease the sample size as FDA is trying to determine the most optimal quality control sample for MedDRA coding.

4.2 DQRS Tasks

DQRS functions shall be performed at the FDA facility in White Oak. The Contractor shall perform the following tasks in accordance the DQRS SOP, attached in Appendix B:

• Follow the DQRS SOP for identifying source type, numbering of the reports to facilitate sorting, tracking, and forwarding

• Report each priority 1 report to FDA’s consumer Safety Officer in charge within 24 hours of receipt of the report by the contractor

• Produce an assignment letter for each priority 2 report and for each priority 3 report. The contractor shall produce standard notification letters to manufacturers as determined by DQRS management o Process each assignment letter within 14 calendar days within receipt of report o Send processed assignment letters to the FDA Field Offices

• Provide weekly DQRS Report to the FDA COR for review and approval. The contractor shall develop weekly reports that track all work by:

o Number and type of reports added to the database o Number of reports and letters scanned o Number of letters generated and mailed o Current back-log of all work types o Number of hours worked by each employee

• Schedule and attend meetings with FDA DQRS staff as needed

• Limit the total weekly backlog of all types of unprocessed reports to 50 or fewer reports

The following table summarizes the historical workload of documents entered with DQRS task (Average Workload drug quality report for October 1st, 2015 to December 31st 2015

Table 4: DQRS Historical Data Total number entered 3,067 Daily average 51 Weekly average 255.5 http://www.meddra.org/how-to-use/support-documentation/english http://www.meddra.org/how-to-use/support-documentation/english

Systems & Management Support During the life of the contract FAERS and other software currently used may be replaced and the contractor will be expected to be an active partner during these transitions. The contractor shall support the implementation of new software by development of business rules, perform User Acceptance Testing (UAT), train their staff on existing, new, and updated software, create new SOPs, and update current SOPs.

4.3 Develop and Update Standard Operating Procedures (SOPs)

The contractor shall develop and update both FAERS and DQRS SOPs in coordination with the FDA by performing the following:

• Update, issue, and post legacy SOPs as needed.

• Maintain a change history of all SOPs related to this contract and assure that only current

SOPs are posted on the FDA provided intranet o Ensure Intranet SOPs are consistent with OIMT policies

• Ensure that appropriate FDA personnel review and approve all SOPs prior to issuance

• Perform SOP revisions within 21 days from notification by COR

• Ensure that up-to-date SOPs are available electronically to all contractor personnel and

FDA/CDER intranet users

• Ensure that all hyperlinks used within SOPs are maintained

• Review SOPs on an annual basis and provide COR with a summary of changes needed

The FDA COR and FDA on-site Representatives shall review and approve all new and updated SOPs.

4.4 TASK AREA 2 – TRANSITION WORK ACTIVITIES

Transition - In The purpose of the transition in period of time is to provide adequate time for the contractor to attain full operational capacity and capability. The FDA will grant a 60-day Transition Period in order to transition from contractor to contractor. By the end of the 60-day transitional period, the contractor shall become fully operational to meet the needs of this contract. The contractor shall be responsible for the following activities during the Transition In period:

• Preparation of facilities and coordination with FDA OIMT to ensure operational technology installation

• Establish policies and procedures for FAERS and DQRS tasks, including review and update of current SOPs

• Establish and publish non-attributable aggregate personnel performance metrics based on an accumulation of individual performance metrics

• Scale up to full production performance capacity and capability

• Conduct a Production Readiness Review

The Standard Operating Procedures (SOP) and more in-depth User Training Guides will be used to assist new employees in understanding individual field level job activities. The contractor shall be at full performance at the end of the transition-in period and shall process all incoming reports without increasing the amount of un-entered orders.

Before the end of the Transition Period, the contractor shall maintain, update, create, and post on the FDA website any needed changes to the standard operating procedures (SOPs) for the FAERS-DMP. The contractor shall be responsible for updating the SOP when requested by the FDA COR. All updates must be approved by the FDA COR before they are accepted and posted.

If the current contractor wins the new award and keeps the same physical facility no transition will be needed. If the current contractor wins the new award and changes to a new physical facility a transition of 30 calendar days will be used.

Personnel Onboarding Before any employee starts work they must be properly badged through the FDA security process. The contractor will assist filling out the proper forms and making sure that the employee is on time for their fingerprint appointment.

Transition Out The contractor shall provide support services to the orderly transition of functions from this contract to the FDA and/or successor contractor. FDA will exercise this option during the last period of performance that it intends to fund under this contract. It is the responsibility of both parties (the incumbent and successor) to ensure a smooth transition from this contract to the subsequent contract.

The incumbent contractor shall be the lead on the transition activities during the transition period, leading Technical Interchange Meeting (TIMs) with the successor to impart knowledge transfer of the effort under the scope of this contract. At a minimum, these TIMs will divulge the technology and processes employed, provide licensing requirements/status (if any), and conduct demonstrations of tasks. During this period, there shall be no degradation in support to the Government while the outgoing contractor focuses on contract closeout activities and providing sustainment support to complete the transition. At the COR designated turnover date, approximately 60 days after award, the successor contractor shall assume full responsibility of the contract. Transition Out activities shall include:

• Ensure the accuracy of asset management records, software documentation, and training materials, and delivery of these documents to the Government

• Provide FDA with a list of users (along with their organization/affiliation) granted access to the systems, along with their role

• Ensure that all system documentation is updated as of the most recent release (e.g., system architecture, user guides, release documentation, design documentation, run books)

• Participate in transition meetings as requested by the COR or their designated representative

• Assist with documenting and returning all government furnished equipment as directed by the COR and FDA Property Officer

• Provide information about any changes to staffing to the COR or their designated representative

• Provide Subject Matter Expert (SME) support to the successor contractor

4.5 TASK AREA 3 - TRAINING

The Contractor shall conduct ongoing comprehensive training for all newly hired and existing employees to ensure all employees are qualified to perform their assigned duties for the duration of the contract.

4.5.1 Training Plan

The contractor shall prepare a Training Plan due 10 days after contract award. The training plan shall be in accordance with the processing metrics stated in Sections 6.5 FAERS-DMP Tasks and 6.6 DQRS Tasks.

The content of the Training Plan shall include:

• Training of new employees

• Refresher and advanced training for experienced employees

• A quality assurance program for data entry as described in Section 6.1.1.4.1. Any discussion of data entry shall take into account accuracy, throughput and environment.

• Description of the types of training targeted to data entry, scanning, quality control and coding

• Accessibility to training materials that the employees can access on-line

• Individual testable documented training goals shall be part of the training plan. These will be tailored to each different labor category and will address cross training where possible

• The training plan will be reviewed and approved by the COR before implementation

• Upon award of the contract 95% of the workers will be documented as fully trained within

30 days.

• New workers will undergo and complete documented training within two weeks of being hired.

4.5.2 Training Program

The contractor shall develop employee proficiency standards as part of a comprehensive training program. The training program for data entry, quality control and MedDRA coder personnel is subject to approval by the COR or COR Representative.

4.5.3 Conduct of Training

The contractor shall use the Standard Operating Procedures (SOPs) and more in-depth User Training Guides to assist new employees in understanding individual field level job activities. The contractor shall conduct training in a pre-production environment.

4.5.4 Evaluation of Competency

The contractor shall develop methods to monitor and evaluate competency of data-entry, scanning, quality control, and MedDRA coder personnel. The contractor shall monitor and evaluate competency of data-entry, scanning, quality control, and MedDRA coder personnel. The contractor shall examine pre-production records to assess personnel proficiency levels. Personnel shall demonstrate appropriate proficiency as a pre-requisite to work on production data.

4.5.5 Evaluation of Competency for MedDRA Coders

The contractor shall develop a qualification for a new or existing employee to document the progress of MedDRA coding and provide the qualification results to the COR. The contractor shall double check all MedDRA coding performed during the training period. A MedDRA coder shall be considered qualified only if, in addition to the training requirements for all employees, the employee:

• Passes a written test developed by the Contractor and approved by the FDA COR

• Performs accurately on a simulation test of actual coding

4.5.6 Training Progress Reporting

The contractor shall provide overall employee test results to the COR

Post Training Data Entry

Only Employees who have completed the required training for data entry shall be allowed to enter data in the production system.

4.5.7 On-going Maintenance of Competency

The contractor shall perform on-going assessments of competency for data entry, quality control, and MedDRA Coding personnel. The contractor shall conduct proficiency maintenance training based on:

• Data entry errors derived from FAERS reports and front end queries

• Feedback from the FDA FAERS data quality workgroup

• Feedback from the FDA Quarterly Data Extract quality control group

The contractor’s monitoring of scanning personnel shall include:

• Accuracy of received reports as viewed in the database

• Completeness of received reports as viewed in the database

• Accessibility of received reports in the database

TASK AREA 4: Support of updated software for greater program efficiencies

The FDA currently uses a system to track reports as they move through triaging and the data entry system. This software is called Automated Production Logs (APL). FDA will replace APL with a new Commercial Off The Shelf Software (COTS) product called AgTracker. This software is produced by the

Aris global corporation and will be used to automate the Central Triage Unit and track reports. The new system is currently scheduled to go into production sometime in 2016.

A contract is in place with a software integrator who will be responsible for implementing this product into the FDA production environment. After production technical support will be taken over by the FDA contractor who now does technical support for the FAERS data entry system. Our license for agTracker includes security patches, and normal upgrades

4.6 TASK AREA 5: PROGRAM AND PROJECT MANAGEMENT

4.6.1 Program and Project Management - The Contractor shall provide Task Order program and project management services for this contract. The Contractor shall manage cost, schedule, and quality. The Contractor shall provide all management services necessary to plan, staff, coordinate, schedule, manage, communicate, report, and steward all tasks, activities, and deliverables for the contract throughout the period of performance.

4.6.2 Management Plan - The Contractor shall maintain the Management Plan that addresses all policies, processes, procedures necessary and is inclusive of the following plans: Communication Plan, Risk Management Plan, Staffing Plan, Training Plan, Quality Control, Data Entry and MedDRA Coding Quality Assurance Plans, Contingency Plan and plan for physical FISMA inspection

4.6.3 FDA Mandated Contractor Training - The Contractor shall coordinate all required contractor staff training, to include FDA-mandated training courses such as FDA Records Management Training, Computer Security Awareness Training and IT Security Recertification.

4.6.4 Data Entry Quality Assurance Program

The following constitute the Data Entry Quality Assurance Program for data entry personnel:

• The Contractor shall gather data entry errors by running FAERS reports and front end queries designed for this purpose

• The Contractor shall collect feedback from the FDA FAERS data quality workgroup

• The Contractor shall collect feedback from the FDA Quarterly Data Extract quality control group that publishes FAERS data to the internet

• The Contractor shall document in a Data Entry Quality Report:

o The data entry errors collected o Any correlation among the errors o Any trends among the errors o The actions taken to address making errors less frequent over time

• The Contractor shall deliver the Data Entry Quality Report to the COR at the monthly meetings

• The Contractor shall host short weekly meetings with the staff to go over trends in data entry errors to help improve the accuracy of data entry

• All new data entry personnel will first be trained and certified by the Contractor on a pre-production system before working on a production system

4.6.5 MedDRA Coding Quality Assurance Program

• The Contractor shall work with COR and the FDA head of MedDRA coding to identify updates and changes in the MedDRA coding standard. The Contractor shall periodically inform the MedDRA coders about updates and changes in the MedDRA coding standard

• All new MedDRA coders will be first trained and certified by the Contractor on a pre-production system before working on a production system

• The COR and/or the FDA head of MedDRA coding will report to the Contractor, in writing, any issue noted with MedDRA coding. The Contractor shall develop and implement a plan, to address any issues

4.6.6 Meetings

The Contractor shall participate in the meetings in a variety of roles, such as leading discussions, participating in discussions, contributing questions and answers, raising issues, risks and concerns, developing and giving presentations, and other active oral and written communications. The Contractor shall prepare meeting agendas, minutes, issues, risks and action items. The Contractor can be expected to participate in the meetings and activities listed below. For the meetings identified below, the Contractor shall prepare an agenda before the meeting. After the meeting the Contractor shall publish meeting notes, detailing the discussion, and listing any risks, actions, and/or issues identified during the meeting. Each risk, action, and issue shall have an owner and a target date for decision, resolution or mitigation strategy. The meeting notes shall also identify any decisions that need to be made as a result of the meeting and who has to make the decision. The Contractor shall provide a agenda for each meeting at least two (2) days before the meeting. The Contractor shall provide a copy of those notes to the COR three (3) days after the meeting.

Contractor Meeting Requirements The contractor shall take formal notes at all meeting and send them to the COR within 5 business days

The contractor shall conduct a kick off meeting within 10 days of award. This will include

Computers and badging of employees A Pre-production meeting within 14 days of award and weekly thereafter to address production readiness until full production is achieved.

The contractor may be called upon to have Ad-hoc meetings as needed to discuss and resolve business technical issues

The contractor will have a monthly status and review meeting that will go over the invoice, budget and quality metrics

The contractor will host a formal program review meeting every six months at the FDA White Oak facility to brief key stakeholders and FDA leadership of accomplishments and trends dealing with the contract

4.6.7 Performance Reporting and Metrics

The contractor shall provide all reports listed to the COR for review, approval, and formal acceptance.

The contractor shall provide a recommended format and quality metrics for all requested reports within 60 calendar days after contract award. All reports shall be generated from FDA information systems.

Contractor Reporting Requirements

The contractor shall provide quality metrics reports such as query reports, tables, graphs, performance statistics, issues, ICSR statistics, performance and comparison. These reports will be on an as needed basis

Detailed weekly report of all report types received and processed (separate report for FAERS and DQRS data) see Appendix E

Detailed weekly report of all report types received and processed (separate report for FAERS and DQRS data) see Appendix E

Six month program review reports that include comparison graph of FAERS and DQRS reports received, FTEs, and Cost per report type processed by calendar year

• Initial team and program introduction and familiarization;

• Objectives

• Approach to meeting the performance requirements of the TO

• High level plan and schedule

• Introduction of the Federal Contracting Officer (CO) and COR, as well as the key members of the contractor team

• Questions and answers regarding the engagement

4.6.8 Facility Preparations

The contractor is required at the time of proposal submission to possess the fully improved facility to perform the SOW Task Areas. The contractor shall prepare a Facility Space Plan for the efficient flow of planned work through the facility. The Facility Space Plan shall be delivered as part of the initial proposal and will be modified after award with inputs from the FDA through the COR The Federal Requirements for offsite space and Information Technology Facility requirements are detailed in the appendix titled A. The contractor shall provide appropriate office space for FDA onsite personnel to include a minimum of 2 offices with lockable doors, and designated within the space plan. The facility shall have sufficient document management storage and physical security that aligns with information security policies and procedures, pertaining to both physical and electronic media, to ensure compliance with FISMA requirements. The Facility Space Plan shall detail the physical attributes of the compliance. The contractor shall provide a detailed pictorial representation of all network equipment in the building. If the work area needs to be prepared before FDA personnel can start work a project plan shall show all the steps and dates when each step will be completed. The contractor will not change the place of performance of this contract without the written approval of the COR. To ensure compliance with all security regulations janitorial work will be performed during normal working hours when badged employees are present. The facility should be within a 20 mile radius of the FDA White Oak Campus. The contractor shall provide all furniture and necessary office supplies needed in the performance of the contract.

4.6.9 Infrastructure Setup

After the contract is awarded the contractor shall closely work with FDA to set up the required facilities, infrastructure and security measures as defined in the requirements. The contractor shall work closely with the Office of Information Management and Technology (OIMT) to ensure that the information systems can be accommodated in the Facility Space Plan, sufficient space exists for the workstations, workflow equipment (scanners, printers and other equipment) and other items needed to ensure consistent and timely results to support the performance metrics. The FDA hopes that this contract can be conducted with individual workstations connected through Virtual Private Network (VPN) connections just as home users connect. This has been done successfully with other data entry contracts. However the contractor facility should be able to accommodate and FDA network node which would be a high speed dedicated optical link in case performance becomes an issue with VPN or a policy change where FDA IT may in the future mandate a dedicated line. The contractor infrastructure shall include two different Internet Service Providers (ISP’s) to minimize downtime. The contractor will supply all hardware needed to connect FDA computer equipment to one ISP by traditional wires. In addition the second ISP will use wireless connection for quick switch over in case of primary ISP failure.

contractor shall:

• Conduct weekly facility development and preparation meetings to report status to COR and

OIMT

• Provide equipment list and status (e.g., if currently available or if must be purchased)

• Provide timetable for installation of equipment

The Contractor shall submit the following deliverables to the COR:

Item Deliverable /Event Frequency Timeline Reference 1 Management plan which inludes

Communication Plan, Risk Management Plan, Staffing Plan, Training Plan, Quality Control, Data Entry and MedDRA Coding Quality Assurance Plans, and plan for physical FISMA inspection

One time 30 days after contract award

Section 4.1.2 Management plan

W Contingency Plan One time 30 days after contract award

Section 4.1.2 Management plan

3 Meetings agenda and notes from the meeting ; kickoff, pre-production, ad hoc weekly, monthly, program review

Varies Time varies kickoff is 10 days of award

Section 4.16.

meetings

4 Quality Metrics Reporting Monthly and as needed

After 60 day transition

Section 4.1.7 Performance Reporting and Metrics

7 Data Entry Quality Report Weekly After 60 day transition

Sections 4.1.7 Performance Reporting and Metrics

8 FAERS and DQRS reports for six month program review . See Appendix D

Every 6-months during Program Review

After six months Section 4.1.6 Meetings

9 Facility Space Plan One time Submitted with Contractor’s Task Order Proposal

Appendix A

10 Training Plan One time and update if requested by

FDA

10 days after contract award

Section 4.6.1 Task area 8-training

11 Certification of MedDRA coding Competency

Used for each new MedDRA coder

Before any new MedDRA coder can do production work

Section 4.6.4 Evaluation of Compentency

13 ICSR information submitted to Manufacturers related to the MMP

Ongoing Take over full responsibility at end of transition but will be working on production during transition

Section 4.2.1.2 CTU tasks

Drug Manufacturer Quarterly report

Quarterly Starts at the end of the transition period

Section 4.2 Task Area 2

FAERS-DMP

Document Processing, Handling, Correspondenc e and Delivery

15 Industry MedDRA Coding Quality Assurance Document

Monthly Starts at end of transition period

Section 4.2.6

16 DQRS assignment letters Ongoing ;

weekly to FDA Field offices

Full performance at end of transition period

Section 4.3

5 TASK ORDER PERIOD OF PERFORMANCE

The period of performance end date of this order shall be 12 months from the performance start date.

6 PLACE OF PERFORMANCE

The contractor will be required to work at the contractor site and provide courier services to multiple FDA facilities each weekday. See Appendix C

The contractor may submit a telework plan for COR approval. The plan shall include provisions for the COR to suspend teleworking

7 KEY PERSONNEL

For this contract, the contractor’s project manager and senior level MedDRA coders (subject matter expert III labor category) have been identified as key personnel. The project manager shall be available (on-site or cell phone) 24 hours/7 days/week to address FDA operational shutdowns or emergency situations.

8 TRAVEL

There is no anticipated travel for this effort.

9 GOVERNMENT FURNISHED EQUIPMENT/GOVERNMENT FURNISHED INFORMATION

(GFE/GFI)

FDA will provide any required hardware and software for performance under this task order. Following task order award, contractor shall provide full inventory of government equipment.

Computers assigned to this task order cannot be used for any other work outside this task order. All documents produced by the contractor will be owned by the government and will not be copyrighted by the contractor. The contractor’s company name will not appear on any documents that are produced for the government. All software used on the project shall be owned by the government. Any exception to this must be in writing and signed by the COR.

10 TASK ORDER ADMINISTRATION

The contractual point of contact for this task order is TBD, Contract Specialist. The contact information is below.

Name: TBD (Contract Specialist) Email Address: TBD Phone: TBD

Name: TBD (COR) Email Address: TBD Phone: TBD

LIST OF APPENDICES

Appendix A Facilities Plan Requirements /FDA CDER DMPIT Facilities Requirements

Appendix B Standard Operating Procedures (SOPs)

Appendix C Courier Route

Appendix D Sample Six Month Report

Appendix E Detailed Weekly Reports

Appendix F Graphical Workflow diagram

Appendix A: Facilities Plan Requirements /FDA CDER DMPIT Facilities Requirements facility.zip

Appendix B Standard Operating Procedures (SOPs)

ZIP-Approved SOPs 033115.zip

Appendix C: Courier Route

DCC Courier Route_Update in proc

Appendix D: Sample Six Month Report

Final DSI May 2015 6 Month Review_050615.zip

Appendix E : Weekly reports and SOP on how they are produced weekly_dmp_and_dqrs_reports.zip sop_weekly_reports.zip

Appendix F Graphical Workflow diagram appendix_H_graphical_workflow.zip