QUESTIONS_AND_ANSWERS_FDA-17-RFP-1162339.doc

QUESTIONS AND ANSWERS

SOLICITATION NUMBER # FDA-17-RFP-1162339

Access to Hospital Inpatient and Emergency Department Drug Utilization Data Question 01 (Page 2, Section 1.2 Page 5, Section 2.2 IDIQ Other Services) The government states that, “The contract maximum ceiling amount will be $2,500,000.00 over three (3) years inclusive of options.”

Is this $2.5M ceiling inclusive of the costs to provide access to the required data during the three-year POP as well as the IDIQ services that the government will acquire on an as needed basis during the contract period?

Answer 01 This applies to the IDIQ portion only.

Question 02 (Part 2.2, Page 3-5) For CLINS 0001, 1001 and 2001, there is no requirement for outpatient visit data. This data captures the many procedures that take place in the ambulatory setting, and would allow the FDA to monitor drug utilization in that setting of care.

Question:

Does the FDA desire this data also, or is this effort limited to only Inpatient and ED visit data?

Answer 02 Outpatient hospital data are not required as part of the standard data set. However, submission of this data would go above and beyond the standard minimum requirements.

Question 03 (Part 2.2, Part 3-5) For CLINS 0001, 1001 and 2001, there is no requirement for outpatient visit data. This data captures the many procedures that take place in the ambulatory setting, and would allow the FDA to monitor drug utilization in that setting of care.

Question:

If the outpatient visit data is required, will the FDA issue an amendment to specify what data characteristics, data variables and requirements that should be provided?

Answer 03 There is no requirement for outpatient hospital data. However, submission of this data would exceed the standard requirements.

Question 04 (Part 2.2, Part 3-5) For CLINs 0002, 1002 and 2002, the FDA is requesting Unlimited Direct Access to Hospital Inpatient and Emergency Department Data Resource and Services for Pediatric Patients in Short-Stay and/or Free Standing Pediatric Hospitals.

Question: If an Offeror does not yet have the data or pricing for Hospital Inpatient and Emergency Department Data Resource and Services for Pediatric Patients in Short-Stay and/or Free Standing Pediatric Hospitals available, can this be made an Optional CLIN – to be exercised when the data and pricing is available?

Answer 04 The contractor should only respond to CLINs 0002, 1002 and 2002 if data/pricing is currently available. The contractor has the option of responding to CLINs 0001, 1001 and 2001 and/or CLINs 0002, 1002 and 2002.

Question 05 For CLINs 002, 1002 and 2002, the FDA is requesting Unlimited Direct Access to Hospital Inpatient and Emergency Department Data Resource and Services for Pediatric Patients in Short-Stay and/or Free Standing Pediatric Hospitals.

Question: If an Offeror does not yet have the data or pricing available for Hospital Inpatient and Emergency Department Data Resource and Services for Pediatric Patients in Short-Stay and/or Free Standing Pediatric Hospitals, can an Offeror submit a proposal without proposing on these CLINs?

Answer 05 Yes, because we do not require the contractor to provide data and accompanying pricing for all CLINs since the Program Office envisions the possibility of a multiple award.

Question 06 (Part 1, 2.2, Page 3-5) For CLINS 0003, 1003 and 2003 there is no definition of how many or what kinds of Patient Level Data Extracts are required.

Question: Does the FDA intend for the contractor to provide the extracts?

How many extracts and from what datasets?

Answer 06 CLINS 0003, 1003 and 2003 refer to patient level dataset extracts. A dataset extract is a file of data consisting of de-identified, HIPAA compliant unique patient level records containing the demographic and drug utilization data necessary to address a particular study question. Each dataset extract may contain multiple USC classes, markets or years of data. Yes, FDA intends for the contractor to provide the extract upon request. Up to 2 data extracts are required for the base and all option years of the contract. (We revised the number per year of Access to Patient Level Dataset Extracts from 12 to 2 in CLINS 0003, 1003 and 2003 and added the definition of Dataset Extract in the Glossary in Amendment 2 of the solicitation) Question 07 (Part 1, 2.2 Page 3-5) For CLINS 0003, 1003 and 2003 there is no definition of how many or what kinds of Patient Level Data Extracts are required.

Question: If Patient Level Data Extracts are in fact required by the FDA, in what form should they be provided?

Answer 07 CLINS 0003, 1003 and 2003 are required by the FDA. The means to deliver the data extract file shall be proposed by the contractor.

Question 08 (Part 1 2.2, Page 3-5) For CLINs 0011, 1010 and 2010, the FDA has requested 100 hours for a computer programmer.

Question: Should the Offeror assume the hours are to be utilized by the FDA in the performance of each year and are not optional?

Answer 08 The Program Office envisions that 100 hours will be added to the total estimated proposal cost for the base and all option years. These are suggested labor categories and as such show hourly rate – The computer programmer may or may not be needed.

Question 09 (Part 1 2.2 Page 3-5) For CLINs 0011, 1010 and 2010, the FDA has requested 100 hours for a computer programmer.

Question: Does the FDA intend for the computer programmer to be utilized and priced in the IDIQ CLIN?

Answer 09 The contract was amended on October 25. See amended delivery schedule.

Question 10 (Part 1 2.2 Page 3-5) For CLINs 0011, 1010 and 2010, the FDA has requested 100 hours for a computer programmer.

Question: If the FDA does intend for the computer programmer to be utilized and priced in the IDIQ CLIN, should it be listed as a labor category and priced each year in the provided IDIQ table in the RFP?

Answer 10 Yes. The contract was amended on October 25. See amended delivery schedule.

Question 11 (Part 1 2.2 Page 3-5) For CLINs 0011, 1010 and 2010, the FDA has requested 100 hours for a computer programmer.

Question: : If the FDA does intend for the computer programmer to be utilized and priced in the IDIQ CLIN, how many hours are allocated to the computer programmer labor category per year?

Answer 11 We have indicated for each category no more than 1040 hrs. a year. These are suggested labor categories and as such show hourly rate – The computer programmer may or may not be needed.

Question 11 (Part 1 2.2 Page 3-5) Question: Does the FDA intend for the 100 hours of Computer Programmer and the 100 hours of Ad-Hoc Analyses: Custom Reporting and Product Customization required to be priced and to be utilized each year?

a) Should these two CLINs be added to the total for each year?

b) Should Computer Programmer with 100 hours be added to the Deliverables at 5.1, page 17-19?

Answer 11 The contract was amended on October 25. See amended delivery schedule

Question 12 (Part 3.2 Page 8) In subsection D, the FDA is requiring the ability to download (or using other means that are compatible) large data sets as needed, for the purpose of conducting epidemiological drug safety studies.

Question: Is this the same task as CLIN 0003, 1003 and 2003?

Answer 12 Yes, this requirement is the same as CLIN 0003, 1003 and 2003 Question 13 (Part 3.2 Page 8) In subsection D, the FDA is requiring the ability to download (or using other means that are compatible) large data sets as needed, for the purpose of conducting epidemiological drug safety studies.

Question: How is FDA defining “other means”?

Answer 13 The means to deliver the data extract file shall be proposed by the contractor.

Question 14 (Part 3.3, Technical Requirements and Capabilities)In subsection K., the FDA is requiring detailed inpatient data that are linked with detailed outpatient data, however outpatient data is not requested.

Question: Is detailed outpatient data required, and if so, what is required to be provided?

Answer 14 There is no requirement for outpatient hospital data, this would exceed the standard minimum requirements.

Subsection K refers to the inquiring if the Offeror has the capability to link inpatient data to other data sources.

Question 15 (Part 3.3, Page 15) Task 1 – Access to Patient Level Dataset Extracts requires the ability to download (or obtain in a timely manner) and archive data and the means (query file or search logic) used to create it. The FDA requires that datasets shall be available on demand and without intervention by the Contractor –

Question:

a) What is the FDA definition of “timely manner”?

b) What is the FDA definition of “on demand and without intervention of the contractor”?

Answer 15 Timely manner means promptly or without delay, offeror shall propose timelines for accurate and quality deliverables as requested.

On demand and without intervention of the contractor means the analyst can download the dataset extract independent of the contractor in a format compatible with Section 3.4 subsection C (data downloading).

Question 16 (Part 5.1 Deliverables, Page 17)Will the FDA consider also allowing web-based training if it is determined by the FDA that web based training is preferred in lieu of onsite training for a specific training period?

Answer 16 We would request as part of the contract that 2 on-site training be provided for each year of the contract and any other training would then be web-based.

Question 17 (Part 5.5 Monthly Reports, Page 20) Ad-hoc Dataset Requests (#2 within Section 5.5), depending on what is requested, can often be complex and require more time to compile.

Question: Will the FDA consider changing the 15 day requirement for Ad-hoc Dataset Requests to allow the delivery times to be agreed upon between both the vendor and the FDA once the requirements of the specific Ad-hoc request are established?

Answer 17 No, only because usually if not always, these Ad-hoc requests are needed for a specific reason with a specific deadline

Question 18 (Part 8.1 Contract Clauses Incorporated by Reference, Page 26)FAR 52.211-11 – Liquidated Damages- Supplies, Services or Research and Development is included in the RFP.

Question: Contractors offering a commercially available product for sale to the FDA are unable to accept this clause, as it is punitive and unjustified for this type of procurement. Can the FDA please remove this clause from the procurement in order for commercial Offerors to propose?

Answer 18 No.

Question 19 (Part 10.4 Volume 1 Technical Proposal, Page 37) In order for vendors to successfully address all of the stated requirements within the technical proposal and remain within the constraints of the 30 page response limit, can the FDA please allow for the following documents to be included as appendices outside of the 30 page limit? :

a) Appendix I

b) Appendix C – VPAT

c) QASP

d) Attachment 2 – Subcontracting Plan

Past Performance Project narratives

Answer 19 Yes.

Question 20 (Attachments, Appendix A-Glossary, Last Page) “Unlimited” is defined by the FDA as – authorized FDA personnel shall have the ability to use any data element in the database in any combination or query that is necessary to address a specific issue.

Question: Can the FDA please confirm this is the definition that FDA intends to use for “unlimited”, and that unlimited does not mean an unlimited number of FDA users?

Answer 20 We confirm the definition of the word “unlimited” as defined in the glossary- see Appendix A. It does not mean unlimited number of users.

Question 21 (Part 3.4B-Number of Users, Page 16) The RFP states “The FDA shall purchase one site license that will not be dependent upon the exact number of users. Individuals within the Office of Surveillance and Epidemiology as well as other authorized users within the FDA will need to access these data as appropriate for their work.”

In order to adequately price and ensure the vendor has the required infrastructure in place to accommodate users; vendors often provide tiered licensing, based on the # of users required.

Because the FDA has not provided the exact amount of users (or the minimum-maximum range of users) needed, vendors will have to assume the entire FDA agency (approximately over 14,000 employees and contractors). Providing access to that many employees and contractors will significantly increase the price because the agency is requesting an enterprise license. This will also require significant changes to a vendor’s infrastructure to accommodate that amount of users.

While vendors understand that not all FDA employees and contractors will require access to the tools requested, we will have to make the conservative assumption that all FDA employees and FDA contractors may need access over the life of the contract unless a modification to the RFP language is made.

Question

a) Can the FDA please provide a number of users that will require access to the requested tool in order to reduce the cost to the government?

If the FDA cannot provide a number, can Offerors provide tiered pricing to the FDA based on different numbers of users?

Answer 21 See amended pricing schedule for the purchase of one site license for 20 users Question 22 (CLIN 0002 Hospital Inpatient and Emergency Department Data Technical Requirements and Capabilities – Section M, Page 14) The RFP states “The Contractor shall participate in the CDER secure electronic mail system to protect any sensitive data which may be transmitted electronically between the data vendor and the FDA.”

Question: Can the FDA provide more detail around how the contractor will gain access and any necessary requirements around technology for contractors to gain access into CDER e-mail system?

Answer 22 We confirm the glossary definition of “unlimited”. It does not mean unlimited number of users.

Question 23 (CLIN 0002 Hospital Inpatient and Emergency Department Data Technical Requirements and Capabilities – Section M, Page 14) The RFP states, “Full disclosure of data collection, construction, coding and configuration as well as quality control procedures as required to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology”.

Question: The information requested in this requirement are often proprietary (i.e., patented) by vendors. Can vendors provide non-patented /non-proprietary supporting documentation to the FDA to fulfill this requirement?

Answer 23 No, FDA requires a Full disclosure of data collection, construction, coding and configuration as well as quality control procedures as required to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology for the RFP phase. The Offeror may provide additional non-patented /non-proprietary supporting documentation for the purposes of citation.

Question 24 (Task 1: Access to Patient Level Dataset Extracts, Page 15) The RFP states “For regulatory requirements, the Contractor shall provide the FDA with the ability to download (or obtain in a timely manner using other means) and archive data and the means (query file or search logic) used to create it. FDA requires that datasets shall be available on demand and without intervention by the Contractor.”

Question: Can the FDA please confirm whether this only applies while the contract is active and the FDA will not be able to use data after the contract is terminated?

Answer 24 The dataset extracts are required while the contract is active.

Question 25 (Part 10.4 Volume 1 Technical Proposal) Data Dictionaries are helpful to provide full data variables and characteristics of offered datasets

Question: May offerors provide a data dictionary as an appendix within the technical volume, outside of the 30 page limit?

Answer 25 Yes.

Question 26 (Attachments, throughout document) Within Appendix I, it states, “Complete data dictionary (including percentage of missing or incomplete data):

Question: If the “percentage of missing or incomplete data” is information not available, is it acceptable to the FDA for offerors to provide the data dictionary without this?

Answer 26 No.

Question 27 (Attachments, throughout document) Within Appendix I, it states “Date and time of drug administration (Y/N)” and “Date and Time of procedures related to hospitalization or ED visit (Y/N)

Question: Full date and time are not available in our data offering (by month is only available). Will the FDA accept with the month provided only?

Answer 27 Yes.

Question 28 (Part 3.3-CLIN 0001 Section A)The RFP states, “The Contractor shall provide continuous access to data resources on hospital inpatient and emergency department (ED) drug product usage and treatment procedures in adult and pediatric patients throughout the length of the contract. For the purpose of this contract, these data shall meet the need of the FDA to access discharge-level and patient-level data describing adult and pediatric hospital inpatient, ED drug use and treatment procedures in short-stay hospitals.”

Question: The data we are proposing is collected from Short-Term, General Non-Federal Hospitals (STGNF)

The hospitals we collect from are referred to as “community” hospitals by the AHA.

Excluded from our panel and sample are specialty hospitals such as children’s hospitals. This is because we project raw hospital activity to the universe and these hospitals act differently than others.

Can the FDA please confirm that CLIN 0001 only covers Pediatric patients treated at “community” hospitals, as defined above?

Answer 28 Yes, CLINs 0001, 1001 and 2001 refer to Pediatric patients treated at “community” hospitals

Question 29 (CLIN 0002-Data Requirements: Section B, Page 12)The RFP states, “…Number of discharges per year, demographic distribution of discharges in the sample, numbers and percentages of discharges per year of special populations of interest to the FDA.”

Question: Can the FDA please clarify what demographics information the FDA requires?

Answer 29 See list of demographic information included in Appendix I of the Site Information and Data Characteristics Table

Question 30 (CLIN 0002-Data Requirements; Section G Appendix I, Page 13)The RFP states, “Hospitalization and/or ED episode data shall be required, and include the

Question: Full dates are not currently available in our data offering. Would the FDA please reconsider amending this requirement to replace “dates” with “discharge month”? Note: This would also apply to language included in Appendix I (replacing “FDA Change Admission & ED from “Date” to “Month” dates of the ED visit and/or hospitalization.”

Answer 30 Discharge month is acceptable Question 31 (CLIN 002-Data Requirements: Section H, Page 13)The RFP states, “The Contractor shall provide access to information relating to the hospitalization episode and ED visits, for example operating room and radiology procedures, and drug use data (anesthetics, contrast agents, etc.), treatment procedures, microbiology data (cultures, sensitivities, antigen testing, etc.), information on admitting diagnosis, drugs at admission, and drugs at discharge.”

Question: Can the FDA clarify what is required for “information on admitting diagnosis”?

Answer 31 Information on diagnosis is required.

Question 32 (Attachments, Appendix I, Page 28) Appendix I states, “Past history of scheduled and unscheduled downtime of data”

Question: Can the FDA clarify if they require history of long-term outages only, or should it also include history of short-term tool outages?

Answer 32 Both.

Question 33 (Attachments, Appendix I, Entire Appendix I document) In several sections of Appendix I, it requests “...provide percentage missing for each item.”

While we are able to confirm (Y/N) whether or not our data includes the specified items in the table, we do not have percentages of missing data available to report.

Question: Will providing the confirmation (Y/N) be sufficient for the purposes of completed the table in Appendix I?

Answer 33 No, for every “yes” response that is not complete or whole, an explanation or % missing must be provided

Question 34 Due to the clarifications necessary to develop both a pricing and technical volume, will the contracting office provide a 7 day extension to allow offerors time to recover their proposal drafts once clarifications are provided?

Answer 34 Yes, the response date will be extended to 4:30pm EST, November 21, 2016.

Question 35 (Page 8, Section 3.2 Letter C) The RFP states, “Provide FDA personnel with direct, unlimited, Internet or network-based access via an interface tool to the entire data resource for adult and pediatric hospital inpatient data and emergency department (ED) data in a multi-user environment and in real time.”

(Page 10, Section 3.3 Letter M) .The RFP states, “Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Access shall include all upgrades, enhancements, and modifications to interface software and data.”

Can the government define the term “real-time” as it relates to these requirements? Is it the government’s expectation that they will have direct access to data that’s continuously updated or could this requirement be satisfied by providing quarterly data downloads?

Answer 35 See definition of real-time in Appendix A of the Solicitation

Question 36 (Page 8, Section 3.2 Letter C) The RFP states, “Provide FDA personnel with direct, unlimited, Internet or network-based access via an interface tool to the entire data resource for adult and pediatric hospital inpatient data and emergency department (ED) data in a multi-user environment and in real time.”

(Page 8, Section 3.2 Letter D)The RFP states, “Provide FDA personnel with the ability to download (or using other means that are compatible) large datasets as needed, for the purpose of conducting epidemiological drug safety studies.”

(Page 10, Section 3.3 Letter J) The RFP states, “Access to a data resource for hospital inpatient and ED data for adult and pediatric patients shall be through a currently existing, commercially available, HIPAA-compliant interface tool.”

(Page 10, Section 3.3 Letter M) The RFP states, “Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Access shall include all upgrades, enhancements, and modifications to interface software and data.”

(Page 11, Section 3.3 Letter O) The RFP states, “Access shall be through an interface and this interface shall be user-friendly (easy to understand and methods fully disclosed), transparent and flexible for conducting data queries.”

What is the purpose of the interface tool? Is it acceptable to provide the FDA with the ability to download the datasets quarterly via a link to an FTP site with a password?

Answer 36 FDA requests direct, unlimited, Internet or network-based access via an interface tool to the entire data resource per the RFP. The Offeror may propose an alternative for consideration that must include a hands-on demonstration during the trial subscription.

Question 37 (Page 9, Section 3.3 CLIN 0001, Letter B) (Page 12, Section 3.3 CLIN 0002, Letter B)The RFP states, “The Contractor shall provide information on the size and characteristics of the population of hospitals from which the data are derived . . . Characteristics of the sample shall minimally include: number of hospitals; number and proportion of short-stay hospitals, size of hospitals, geographic diversity of hospitals (using census regions if available), . . . types of hospitals, and a description of specialty units within sample hospitals.”

Does the government require that the data be reported out by facility type (i.e., pediatric hospital vs academic hospital), or only by the specific patient population (i.e., the pediatric population)?

Answer 37 The offeror shall provide information on the size and characteristics of the population of hospitals from which the data are derived, including by facility type (i.e., pediatric hospital vs academic hospital), and by the specific patient population (i.e., the pediatric population). The offeror should state how the data are reported from the tool.

Question 38 (Page 9, Section 3.3 CLIN 0001, Letter D)(Page 12, Section 3.3 CLIN 0002, Letter D) The RFP states, “. . . the following information shall be provided to the FDA: the number of years of valid data available overall and on-line in real time to FDA personnel; the process and procedures for accessing data that are no longer on-line; the lag time between the date of service for the hospitalization and on-line availability of the data; and data collection and management procedures.

Can the government define the term “on-line” as it relates to these requirements?

Answer 38 On-line refers to direct, desktop access to data (raw or sample numbers) for authorized FDA personnel from their own computers (i.e., no special or customized hardware shall be required for access).

Question 39 (Page 36, Section 8.1) Regarding FAR clause 52.211-11 Liquidated Damages-Supplies, Services, or Research and Development (Sept 200):

What, if any, dollar amount for Liquidated Damages is contemplated for this effort? Will the amount be negotiated with the prime at time of award?

Answer 39 $1500.00 per day; The amount will not be negotiated.

Question 40 (Page 37, Section 10.1) Would the government consider extending the submission deadline to November 18, 2016?

Answer 40 Yes, the response date will be extended to 4:30 pm EST, November 21, 2016.

Question 41 (Page 37, Section 10.4) The RFP states, “The technical proposal shall not exceed 30 pages, exluding key personnel information, Non-Public Information Agreements (NPI) for key personnel, cover sheets, table of contents, list of figures, and list of exhibits. Any and all other pages, including charts, exhibits, unmarked pages and any other narrative and attachments to the quotation shall be included in the page calculation.

Are the following items included in the 30-page limit for the technical proposal?

· Site Information and Data Characteristics Table (Appendix I)

· Section 508 Voluntary Product Accessibility Template (Appendix D)

· Quality Assurance Surveillance Plan (QASP)

· Key Personnel Information

· Relevant Past Performance

Subcontracting Plan

Answer 41 The following items above are not included the 30 page limit.

Question 42 (Page 38, Section 10.4 Factor 1) The RFP states, “The Offeror shall submit a completed Quality Assurance Surveillance Plan (QASP) with their technical quote describing their processes for assessing and ensuring consistent work performance that complies with the requirements of the contract.”

(Page 9, Section 3.3 Letter F) The RFP states, “The Contractor shall provide a description of quality control measures that will ensure access to valid data that is technically correct and conforms to contract requirements. The description shall include methods and timelines of quality control measures to be conducted by the Contractor.”

Is there a page limit for the QASP as described in Section 10.4? Is a separate QASP document required to be submitted with the proposal or does our response only have to address the requirements listed in Section 3.3, Letter F above?

Answer 42 Yes, it can be separate from the submitted proposal page limit, please see above.

Question 43 (Page 42, Section 11.3 Evaluation Criteria - Price Proposal:) The RFP states, “The government will evaluate the price based on reasonableness.”

Please clarify how FDA will evaluate the fixed price portion of the contract (CLINs 0001-0010, 1001-1009 and 2001-2009) versus the labor rates from Ad-Hoc Labor Hours (CLIN 0011, 1010 and 2010) and IDIQ Other Services (comprising six labor categories). Will FDA add the prices of all three components to derive a Total Evaluated Price for each bidder or will each of the three components be evaluated separately? If the three components will be evaluated separately, please provide information about the importance of each component relative to the others.

Answer 43 Yes, the FDA will add the fixed price portion and the labor hours (Ad Hoc) and the Labor Hours and total everything to get a Total Evaluated Price from each Offeror.

Question 44 (Page 6, Section 2.2 IDIQ Other Services Pricing Chart) The six labor categories provided in the pricing chart do not necessarily cover all of the potential needs for the task order services listed on Page 15 (IDIQ Other Services). Will the FDA allow new labor categories to be added in the IDIQ response as well as in subsequent task orders?

Answer 44 Please add any other labor categories you feel may be necessary to meet any subsequent task orders with pricing at the time of proposal submission

Question 45 (Page 22, Section 6.6)The government identified the Project Manager as the sole Key Personnel role on the contract, but only listed this role as part of the IDIQ Other Services Pricing Chart on Page 6.

Can the government please clarify whether Project Manager hours are to be included as part of the fixed price portion of the contract for management and oversight of the overall contract and deliverables?

Answer 45 The overall contract and deliverables are based on a firm fixed price for each CLIN and not broken down by labor category and this should be worked into your pricing for each CLIN. However, the IDIQ portion of the contract is determined by LC and as such the Project Manager hours and pricing are determined at that time.