Attachment J - Past Performance Questionnaire.doc

Attachment J Solicitation No. 75F40123R00015 FDA Adverse Event Reporting System (FAERS) Data Management Program (DMP) Support Services

PAST PERFORMANCE QUESTIONNAIRE

Please complete the following questionnaire and return via email: Please reference “Past Performance Questionnaire, FAERS DMP Support Services, Solicitation No. 75F40123R00015” in the subject line. Send to Nicholas Bisher, Contract Specialist, at Nicholas.Bisher@fda.hhs.gov, and cc: the Contracting Officer, James Whitt, at James.Whitt@fda.hhs.gov.

Contract Specialist, Nicholas Bisher by February 6, 2023, 3:00 PM, Eastern Time

(Name)

(Title, Name)

(Date & Time) Contracting Officer, James Whitt

(Title, Name)

The U.S. Food and Drug Administration (FDA) intends to award an Indefinite Delivery-Indefinite Quantity (IDIQ) type contract with 5-year ordering period, for the contractor to process FAERS reports, submitted by the public, by entering and coding the reports in a timely manner. This process is critical to ensure that the data can be reviewed by the FDA safety evaluation team to identify safety issues and respond to public health incidents to meet its regulatory mission. As a result, the FAERS data management services are required to achieve the results as follows: (1) Collect, receive and process mandatory and voluntary safety reports to make it available to the FDA Safety Evaluation Teams; (2) Establish quality assurance and training programs for the data entry process and management of coding services to enhance the quality of data for the FDA review and analysis; (3) Ongoing review of case processing activities for process improvement and program efficiency. The contractor shall perform these functional DMP services as follows:

1) Performing services within the FDA Standard Operating Procedures (SOP) requirements.

2) Development and enhancement of SOPs.

3) Program management services for the oversight of data management operations, contractor staff training, records management, courier services and regular metrics reports.

4) Receiving data in a variety of physical and electronic formats.

5) Scanning physical documents into electronic formats, reviewing electronic submissions, and making the required corrections.

6) Entering, registering, and processing data into the FDA computer system.

7) Performing data analysis on case processing metrics, tracking services, and stakeholder/user support.

8) Sorting and routing this data to the correct work area or correct FDA Center that regulates the product described.

9) Medical coding of reports using various taxonomies (e.g., MedDRA).

10) Performing quality assurance and quality control on data.

11) Participating in the testing and validation of new software systems used to support new and more efficient data entry systems.

Your agency/business has been selected as a past performance reference. Please take a moment to complete this past performance questionnaire using the ratings described below to answer each question; you may provide additional information. Please provide a justification for the ratings provided.

This survey pertains to Contractor: ________________________

Department/Component:

Contract Number: Date of Survey: ________________ Name of Person Completing Survey: ______________________________________ Your Company/Agency: ________________________________________________ Your Role in this Contract (circle one):

Contracting Officer Contract Specialist Project Officer Other Contract Value (including options): $_________________________________ Performance Period: _____________________________________________

(Including option periods) Type of Contract:

Approximate percentage of work being performed (or completed) by subcontractor(s): %

Information on subcontractor(s) (where more than 50% of work was completed by the subcontractor):

________________ Subcontractor

Program Manager

Phone

General description of products/services required under the contract:

RATINGS

Please answer each of the following questions with a rating that is based on objective measurable performance indicators to the maximum extent possible. Commentary to support rating shall be noted on page 4.

Assign each area a rating of, 1 (Poor), 2 (Fair), 3 (Good),or 4 (Excellent). Use the attached Rating Guidelines as guidance in making these evaluations. Circle the appropriate rating. If you do not have enough personal knowledge or feedback from internal customers who directly received products and services from the contractor to make a determination on any of the performance criteria below, please circle "N/A" (not applicable/no opinion).

BUSINESS RELATIONS

1. Contractor provides knowledgeable, experienced, trained and qualified personnel.

N/A

3.

Effective management, including management of subcontracts

N/A

4.

Reasonable/cooperative behavior

N/A

5.

Responsive to contract requirements

N/A

6.

Notification of problems

N/A

7.

Flexibility

N/A

8.

Pro-active vs. reactive

N/A

QUALITY OF SERVICE

1.

Compliance with contract requirements

2. Contractor is responsive to technical direction.

N/A

Accuracy of reports

N/A

Effectiveness of personnel

N/A

Technical Excellence

COST CONTROL

Record of forecasting and controlling target costs

N/A

2.

Current, accurate and complete billings

N/A

Relationship of negotiated costs to actuals

N/A

Cost efficiencies

TIMELINESS OF PERFORMANCE

Met interim milestones

N/A

2.

Reliability

N/A

Responsive to technical direction

N/A

Completed on time including wrap-up and contract administration

N/A

Contractor Met contract delivery schedules/deadlines

N/A

6.

Contractor provided sufficient notification of contract problems to appropriate government personnel.

1 2

N/A

7.

Contractor is pro-active and is reasonable/cooperative

N/A

8.

Liquidated damages assessed: Yes No (circle one)

CUSTOMER SATISFACTION

The contractor is committed to customer satisfaction. Yes No (circle one) 2.

Would you recommend this contractor for award (Yes or No)? Please explain.

Yes No (circle one)

3. Are you satisfied with the service you received and would you hire the contractor again (Yes or No)? If not, why not? Please be specific.

4.

Do you feel the quality of the services received was worth the cost/price? Please circle one of the statements below.

A). Extremely well worth the cost.

B). Well worth the cost.

C). Worth the cost.

D). Cost was more than the value received.

E). Cost was greatly in excess of value received.

F). Government derived no value from cost spent.

ADDITIONAL COMMENTS:

RATING GUIDELINES

service/ administrative issues is marginally effective

inquiries, technical/ service/ administrative issues is somewhat effective

errors have been identified

inquiries, technical/ service/ administrative issues is usually effective

inquiries, technical/ service/ administrative issues is effective