12347_Questions_and_Answers.docx
DOCX document 14 KB Posted
- Attached to
- Validation study on ICD-9 or ICD-10 codes for chlamydia, gonorrhea, and syphillis Federal contract opportunity
- Solicitation number
- 2017-Q-67119
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Request_for_Quotation.doc | DOC document |
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Text version
Page / Section
| Language Requiring Clarification |
| Question |
| Govt Response |
General
| Is this a new requirement? |
| This is a new contract, not an extension of an existing contract. |
General
| If this is not a new requirement, what is the name of the incumbent contractor? |
| This is a new contract, not an extension of an existing contract. |
| Page 4 Par B |
| Review current literature related to STD-related studies using claims data and claims data validation studies using a structured approach with search terms and key words that are approved in advance by CDC |
| Do you want the contractor to review relevant literature or to create some sort of searchable document with approved search terms and key words? |
| The statement of work indicates that the search should be structured and use approved search terms and key words, and that a summary of the search should be provided to CDC. |
Par 4 – 5 Par C i Upon approval by CDC of the study design and analysis plan, secure whatever independent review board (IRB) or other human subjects approvals may be required external to CDC. CDC will manage the human subject approvals required by CDC; the contractor will support CDC’s efforts by providing any documentation relevant to study design or population that may be required by CDC in order to approve the project.
| Please confirm that the contractor will not be involved in any sort of patient care for any possible human subjects? |
| Human subjects will not be directly involved in the work associated with this contract. This will be an analysis of existing data and no direct interaction with patients will occur. However, an external organization may have procedures in place requiring a review and approval process before existing data can be used for any purpose. The contractor will be responsible for securing such approval(s). |
CDC may require information regarding methods for building the analytic data set for the internal CDC review process; the contractor will be expected to provide any information or documentation needed for that process, as well.
| Multiple |
| EMR |
| What is the EMR from where the data will be pulled? |
| The CDC is not specifying a particular EMR platform that must be used. |
| Multiple |
| Patient Systems |
| What are the data systems from which the datasets will be pulled? |
Claims Data?
Lab Data?
Prescription Data?
In order to complete the tasks in the contract, the contractor will need access to claims, lab, prescription, and EMR data that can be linked. These will be used to construct the analytic data set that will be delivered to CDC.
| Multiple |
| (the number of patients with STD diagnoses will be smaller than 250,000; this minimum total sample size is to ensure that sufficient STD diagnoses will be available in the population for analysis purposes). |
| Will the contractor pull the sample audit size from the 250,000? |
Does CDC have a preferred sampling percentage for the audit? OR will the Contractor validate all STD Claims from the 250,000 sample size Because not everyone in a patient population will have an STD diagnosis, CDC is requiring that the total patient population from which the STD claims will be drawn be at least 250,000.
If the contractor has data for >250,000 total patients from which to draw STD claims and would like to use a sampling process, this can be discussed with CDC, subject to CDC’s approval of the analysis plan as described in the statement of work.
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