70RDAD20R00000012 - Attachment A.docx

Department of Homeland Security COVID-19 Testing Solutions Attachment A: Capability Questionnaire

This is the Capability Questionnaire for the Department of Homeland Security (DHS) COVID-19 Testing Solutions Indefinite Delivery Indefinite Quantity (IDIQ) solicitation. All questions pertain to the information provided in the solicitation.

Instructions: The offeror shall not change the text of any questions. Offerors shall provide a questionnaire for each FC and answer each question below using this Microsoft Word document and be sure to enter the information requested in the table. Offerors shall adhere to all additional instructions provided in the solicitation. Graphics, tables, or charts may be inserted as part of your response. The entirety of the offeror's submitted "Attachment A: Capability Questionnaire" shall not exceed 12 pages. 12 pt. Times New Roman font shall be maintained when answering questions 1 through 20 and the additional 3 questions, if applicable.

Offeror Information Table

Response Date:

Company Name:

Company Address:

Company Website:

Country of Origin:

Point of Contact (name, phone, email):

DUNS Number:

Registered in Sam.gov? Yes or No

NAICS Code:

Business Size:

Company Overview (products/services provided by your company) – 200 word limit:

Existing Contractual Vehicles related to this solicitation (provide information such as GSA Schedule No., if applicable)

List of former/ current customers to include POC information (especially if government) using the offered solution or similar testing capabilities:

Any previous business with DHS for similar product/service (list component & description):

Which Functional Category are you Proposing?

All Offerors, please answer the following questions (1-20)

Question 1: What is the name of your test solution?

Question 2: Provide a brief summary of how your test works in layman's terms.

Question 3: Describe your testing method (ensure you also address the following details):

a. Ability to conduct Point-of-Care Testing (if unable to conduct point-of-care testing, describe your testing procedures).

b. Sampling procedures & types (e.g. Nasal, Throat, and Nasopharyngeal).

c. List all materials required for testing (are you able to provide these materials or are they being provided by a subcontractor or teaming partner).

d. Describe how results are presented and how quickly they are provided. Section 4.0 of the SOW indicates a required turnaround time for each FC.

e. Can non-medical personnel administer the tests with the same efficacy?

f. How long would it take to ramp up testing support?

Question 4: For each test kit proposed, how are samples collected? How long does it take to collect a sample? How long does it take to process the sample/specimen and perform the test to obtain a result? How many tests can be performed in parallel?

Question 5: How do you propose to process the test kits? Who do you have a laboratory relationship with for test processing?

Question 6: If your solution entails processing of the specimen at an off-site laboratory, how long will it take to provide a result, once the specimen arrives at the laboratory?

Question 7: Are you the manufacturer of the test kits? If you are not the manufacturer, what is your relationship to the manufacturer?

Question 8: Where are the test kits manufactured/ produced?

Question 9: How many test kits can you provide immediately for an initial order? Can you, your lab, or a subcontractor/teaming partner provide the other materials not included in the kits required to conduct the tests for an initial order?

Question 10: What is your production capability (e.g. weekly production rate)? Describe your capability to scale and provide for mass quantity ordering at regular intervals (weekly, monthly). Are you able to ship to multiple destinations both within the US and its territories? Are you able to manage multiple, simultaneous orders at high volume? Are you able to conduct testing CONUS and OCONUS?

Question 11: Are any warranties beyond those prescribed in FAR 52.212-4(o) included or applicable to the solution you are offering?

Question 12: Does your test solution require the use of one or more instruments or ancillary pieces of equipment? Would they need to be installed onsite (point of collection)? Please list these items and the requirements to operate them (electrical – voltage and wattage, water)?

Question 13: What computer software, equipment, or specialized peripherals are required at a testing site?

Question 14: If Internet connectivity is required, what is the nature and purpose of the connection?

Question 15: Is maintenance required? If so, specify what requires maintenance and the frequency.

Question 16: Do you have a means of collecting patient and test result data? If so, provide details.

Question 17: Does your offering create or store data? Can the data be anonymized or is PII required? Can your solution support receiving anonymized testing subject data and how? How do you handle the collection of PII and how do you process notifications of test results? By what mechanism are the test results available electronically? (i.e., computer to computer transfer)

Question 18: Do you have a 24x7 support line for technical or logistical support?

Question 19: Do you have training/instructional materials available to support the deployment of your solution by a government employee? Please describe.

Question 20: Does your test kit have FDA proof of test performance data submission and validation? If so, please provide.

For Offerors Quoting on the Managed Service Functional Category, please answer these additional questions:

Question 1: On average how long does it take to set up a site and staff it?

Question 2: How does your company propose staffing a managed service testing requirement and what is your ability to scale to staff up nationwide?

Question 3: What is the maximum number of people you can test at an average site your company manages? How is this site staffed and configured?