RFP 75D30123R72635 CDC PPRL QA 1 05.22.2023.pdf

RFP# 75D301-23-R-72635

Q&A 1 - Issued 05/22/2023 via www.sam.gov

Question Number

RFP

Reference

(if applicable) Question CDC Response

C.4, Pp. 12, Task 1

Task 1 states that the contract “shall include all recorded data from December 2018 forward, for all available medical claims (including insurance provider and type), pharmacy claims (including insurance provider and type), chargemaster, and EMR data in the data ecosystem. The contractor shall deliver analysis-ready unique patient ID linked data that are interoperable using a token. The unique patient ID shall be linkable a) longitudinally over time and b) within specific data sources, and C) across different data sources.” Should the contractor assume that the Task 2 cohort is a subset of this comprehensive cohort in Task 1 but will only be provided once per year?

While a portion of data (records) included in Task 2 may also be included in Task 1, Task 2 shall not be exclusively a subsample of Task 1. Task 1 shall provide data for a large, representative catchment of the U.S. population (i.e. a representative sample of outpatient and inpatient healthcare visits occurring nationally and regionally - at a minimum at the U.S. Census Region level -- see Section C.2 of RFP). Task 2 is independent of Task 1. Task 2 shall provide data for a cohort of patients with a particular priority disease state to be determined during contract performance. As such, Task 2 data delivery is expected to contain data (records) that are not included in the Task 1 data delivery.

C.4, Pp. 12, Task 2

In Task 2 the government states that “ The contractor shall provide CDC with the data ecosystem for patients who have been tested for (negative or positive result), treated for, or diagnosed with COVID-19 or other priority surveillance-indicated disease states, or who have symptoms or syndrome indications (fever, cough, shortness of breath or difficulty breathing, fatigue, sore throat, muscles or body aches, headache and or new loss of normal-state function) reported in a medical encounter.” Please specify exactly what vendors should include as “other priority surveillance-indicated disease states”.

Offerors shall refer to solicitation Amendment# 1, published in conjunction with this Q&A. Several sections of the RFP have been revised to provide better clarity. CDC is requesting separate pricing for three specified cohorts at the stated frequency: Task 2.1 COVID- 19 cohort (quarterly data delivery), Task 2.2 birth defects screening cohort (annual data delivery), and Task 2.3 an unspecified cohort (size up to 1 million patients; quarterly data delivery). Possible examples for the "unspecified cohort" include patients with certain infectious diseases (e.g., influenza, HIV, viral hepatitis) or non-infectious conditions (e.g., cancer).

C.4, Pp. 12, Task 2 In Task 2 – are these “other priority surveillance-indicated disease states, or who have symptoms or syndrome indications” only related to COVID-19? If no, please specify what chronic or acute conditions, syndromes and symptoms are in scope for this task.

Please refer to the Government's response to Question# 2.

Privacy-Preserving Record Linkage (PPRL) of Patient-Level Real World Healthcare Data

F2.1 FAR 52.212-2, Pp. 33 and Section G, Additional Instructions, Pp. 37

Is the government requesting the contractor to submit CPARS directly to the government as part of this submission? Is so, how many projects should be submitted? No.

C.4, Pp. 12, Task 1 Does CDC require the monthly patient cohort data updates defined in Task 1 to be provided in the native or OMOP format?

The contractor shall provide the Government with data that follow commercially acceptable data standardization principles and criteria.

If the contractor has the capacity to provide data in the OMOP format, then both the native and OMOP may be provided.

6 C.4, Pp. 12, Task 2 Does CDC require the patient cohort defined in Task 2 to be provided in the native or OMOP format? Please refer to the Government's response to Question# 5.

C.4, Pp. 13, Task 5

For Task 5 - Linkage of Additional Laboratory Data, does CDC require laboratory NAAT/PCR tests identified for genomic sequencing for SARS-Cov-2 only? Does CDC require tests data for other infectious agents (viruses, bacteria or fungi) and if so, which agents and tests are in scope for Task 5?

For Task 5, CDC presently only requests linkage capability supporting token generation for NAAT/PCR tests identified for genomic sequencing for SARS-CoV-2. Offerors shall refer to solicitation Amendment# 1, published in conjunction with this Q&A

8 General

We would like to know if this is a brand new contract OR if there is (was) an incumbent performing these services.

If not brand new, could you please provide the current / previous contract number?

This is a new contract. Similar services are currently provided by HealthVerity, Inc. pursuant to Contract# 75D30121C11559.

Right to retain data and delete/dispose data after contract period – Can you please clarify if the data will be retained only for the 12-month period following contract completion i.e., end of grant and will be disposed at the year 1 post contract completion

The data may be retained for more than 12 months following the end of the contract based upon the research and information needs of CDC and/or to comply with applicable records retention laws and regulations.

10 Task 8 – Is listed as optional, so is it safe to read this as not a requirement for the RFP No. Offerors shall provide a proposal that encompass all contract tasks whether they are optional or not.

Service Pricing – can you please clarify the term “Quantity”- is this the time period of the contract

Q y pp the extent that this question refers to the "QTY / UNIT" section of each line item, offerors are advised that each line item is segmented by the number of requested data deliveries during each 12-month contract period. For example, Line Item 0001 requests 12 deliveries per 12-month period while CLIN 0002 requests 1 per 12-month period.

Service Pricing – Same question on Unit, is this the number of times a task will be required in the set contract time period. So Quantity/Unit. Please refer to the Government's response to Question# 11.

Service Pricing- the Extended Year column, is that referring to Year 2 Note that the term "Extended Year" does not appear in the solicitation. To the extent that this question refers to the "EXTENDED PRICE" section of each line item, this section encompasses the total pricing for each individual line item.

14 Page 11, Bullet 11

Bullet 11 on page 11 calls out the need to access HIV and Viral Hepatitis data. Does CDC require an HIV / Viral Hepatitis task or is the expectation that the required data would fall under Task 1?

Task 1 shall include persons with HIV and viral hepatitis as part of the representative sample. CDC may request data on specific diseases or conditions, such as HIV and viral hepatitis, as part of Task 2. Please refer to the Government's response to Question# 2.

15 Task 1, Page 12

Are there specific disease types that CDC wants to be included in the data under Task 1, or is CDC looking for a more generalized set of data for which you can study multiple disease types?

Task 1 data are NOT based on specific diseases or conditions. Task 1 data are based on a representative sample (at national and regional -at a minimum of U.S. Census Regions) of inpatient and outpatient healthcare visits. This representative sample should include information on >75 million lives.

16 Section F-2.3

PAST PERFORMANCE: Section F-2.3 on page 35 of the RFP indicates that the CDC will use the Federal past performance system CPARS to check Past Performance. May commercial references of similar scope and scale to the RFP requirements be submitted with a proposal?

The Government has not requested that offerors provide past performance information as part of their proposals. Lack of CPARS records is neither a benefit nor a detriment, and will not result in either a positive or negative Past Performance evaluation.

17 Pricing

PRICING: Pages 12-13 of the RFP describes the scope and content of each Data Cohort. Page 36 describes Data Pricing “for each required data set per contract period”. The Pricing Tables (pages 3-6), however, refer to quantities of 12 EA, 1 EA, 4 EA, etc. If the Comprehensive cohort includes data on all 75M+ population, what does the quantify of 12 EA refer to? Perhaps the pricing model refers to the number of CDC systems that the contractor would need to “link” to but that is unclear. Please clarify.

Each "Unit" is a data delivery. Please note that 12 EA means the data shall be delivered monthly.

18 New or Existing Requirement

NEW OR EXISTING REQUIREMENT: Is this is a new or existing requirement? If existing, who is the incumbent contractor, what is the contract number, and what is the existing contract value?

Please refer to the Government's response to Question# 8. As this is a new contract requirement with a different scope, current/previous pricing will not be provided in this Q&A.

19 Estimated IDIQ contract value Does the Government have an estimated value of this IDIQ?

Please be advised that this solicitation is not for an ID/IQ. The Government will not provide a pricing estimate to offerors.

C.4, Pp. 13, Task 5

How many years of history does CDC require for the lab data for SARS-Cov-2 under Task 5 - Linkage of Additional Laboratory Data?

Are any other infectious diseases in scope for Task 5 and if yes, which and with what history?

CDC requires data from December 2018 forward or from the availability of the laboratory test in the case of SARS-CoV-2 viral genomic sequencing data. Please refer to the Government's response to Question# 7.

General What evidence should vendors provide about their process and solutions for expert determination on patient re-identification risk assessment and prevention?

The contractor shall provide (a) a clear description of the process by which it has determined re-identification risk and (b) metrics (preferably quantitative) associated with that assessment. Per section G.1 of the RFP: "Offerors shall describe their individualized approach to medical record linking and de-identification, HIPAA compliance, and measures to restrict re-identification of individual patients."

General How many CDC users will be accessing the transactional level data?

CDC does not have a limit on the number of individuals accessing the line-level data. Access to the data will be governed using established controls and processes to ensure security requirements are met and in alignment with contractual data use specifications.

General Will the transactional level data be made available to contractors, CDC grantees and/or academics? If yes, how many contractors, CDC grantees and/or academics will be accessing the transactional level data? The Government intends to provide line-level data access to CDC contractors and/or CDC fellows with applicable CDC access credentials to the extent that these entities may be considered "authorized individuals." CDC will not provide line level data to external partners without the express written approval of the contractor.

General

Will the transactional level data be made available to government agencies outside of CDC? If yes, please specify the government agencies that will receive access to the transactional level data. Please refer to the Government's response to Question# 23.

General

Please explain CDC's expectation for contractors to conduct patient privacy assessments before de-identifying, tokenizing and linking the requested data. When linking these many data sources will require patient privacy rules to be applied to reduce the risk for patient reidentification.

Note that CDC expects to receive de-identified data for the data deliverable. The data should be linkable through masked-identifiers only (whereby the actual person cannot be identified). When disseminating/sharing findings from the data the CDC may apply other restrictions (e.g., not publishing information for cell sizes of <5) as applicable and appropriate to ensure protection of privacy.

General Given the complexity of this RFP and the Memorial Day Holiday, we respectfully request an extension to June 9, 2023.

Please refer to the amended solicitation, posted concurrently with this Q&A. The Government has extended the time for offerors to respond up to and including 10:00 AM EDT on 06/05/2023.

27 Other Administrative Data Is there a page limit for the other administrative data volume? No.

28 General Do the following documents count against the page limit in the technical proposal?

Cover Page. Table of Contents. References Cited.

No. The Cover Page, Table of Contents, and References Cited do not contribute to the technical proposal page limit.

General Can vendors include the data dictionaries for all proposed data assets as appendices and not count against the page limit?

Yes.

C.4, Pp. 13-14, Task 6, Data Dictionaries and Metadata

For the data catalog, does the CDC prefer a software solution with a user interface to support searching, filtering, tagging, personalization, and other data exploration capabilities or a simple file such as excel?

CDC is requesting a simple file approach for this solicitation.

C.4, Pp. 13-14, Task 6, Data Dictionaries and Metadata

Can the CDC provide information about the current Enterprise Data Catalog, i.e., is it a commercial product? If so, which one? Or is it a custom built solution?

CDC s Enterprise Data Catalog (EDC) is an inventory of CDC s most important data assets, an exploratory search engine that may provide results relevant to your work and research, and a communal space to encourage collaboration amongst staff and researchers. By cataloging program’s most valuable datasets it can help to speed up discoverability and access to critical data in times of emergency response, help leadership take inventory of their C/I/O’s and program’s data assets to inform key decisions, and help CDC staff find relevant data that can enrich their analysis and research. EDC is a commercial product developed by Alation and customized for CDC environment.

NOTE: The Enterprise Data Catalog does not store any actual data from the underlying datasets, however, it provides the structure of

C.4, Pp. 13-14, Task 6, Data Dictionaries and Metadata

For integration with the CDC Enterprise Data Catalog, will direct access be granted or is there some other standard that must be followed? No. The Government will not provide direct access to the CDC

Enterprise Data Catalog (EDC). The Government requires metadata in electronic form, such as Microsoft Excel, Microsoft Access, or other widely available applications with similar capabilities, that can be easily and seamlessly ingested into the EDC information housing and management application.

C.4, Pp. 13-14, Task 6, Data Dictionaries and Metadata

Is there an expectation to represent the data dictionary and/or the metadata data lineage in a visual fashion?

No.

C.4 Pp. 14, Task 8 - Bridge Files for Linkage to Other...

Does the CDC expect certain authorized individuals to participate in the bridging process, i.e., to assist in stewardship decisions? Or is the expectation that is delivered completely as a man angled outcome?

The Government does not understand this question and declines to provide a response.

C.4 Pp. 14, Task 8 - Bridge Files for Linkage to Other...

Does the CDC expect to audit how the bridging process is executed? i.e., not see the actual data, but understand the underlying algorithms derived to perform matching, etc.

The contractor shall provide the Government with detail sufficient to fully understand the matching process.

RFP