QsandAs for ALS Biorepository.pdf

Questions/Answers received in reponse to solicitation RFP 75D301-20-R-67969

1. Monthly Progress Report due date – on page 10, report is due within 3 days of submission of contractor invoice. Typically, invoices are submitted by the 25th of each month to allow sufficient time for accounting to receive and process all expense for the preceding month. On page 13, the monthly progress report is due no later than the 5th of each month. This conflicts with the instructions on page 10. Can the government provide clarification on when the monthly progress report is due?

The requirement of the monthly report within 3 days of the invoice submission stands. However, the due date for the monthly report is changed from the 5th of each month to within 3 days of the invoice submission. Invoice submission date is the contractor’s decision.

2. Section C.11 Quality Control (page 15) – The RFP provides minimum requirements of the quality control plan:

At a minimum this plan shall address:

* Overall project quality control including any proposed evaluations addressing efforts to reduce errors, data collection specialist, abstractor and monitoring, training and retraining of staff, change control process, planning for cyclical changes in staffing and workload.

* Identification of major data quality indicators that require weekly monitoring during data collection (missing data, response rate)

* Data capture instrument change - question development, programming, if needed, testing and evaluation

* Version control for documentation, forms, and memos, and design changes

* A check list of items to be verified for all data deliverables (is the number of records correct, has benchmarking been completed and if so, what were the results of the benchmarking), has the documentation and cover memo been checked for accuracy)

* Adequate and timely documentation to assure repeatability of all data capture activities

* The development and maintenance of decision logs and procedural manuals for all data coding, data entry, data collection, data editing, data abstraction, and verification activities

* Setting up a structure in which responses to ATSDR Peer Reviews within one month of receipt.

* Supervisor related QC activities

These requirements do not seem applicable to this solicitation as we understand that no data will be collected under this contract, just biospecimens and tissues. Additionally, these requirements not align with the quality standards as stated in section C.10 Government Quality Assurance. Will the government consider removing these requirements and allow the contractor to propose its own quality control standards and requirements in the quality control plan?

This QC plan pertains not only to the collections of bodily fluids and tissues from patients, but the accuracy data/information collected from patients at the time of collections, whether in their homes or other sites. Data quality are critical to ensure that samples collected are matched with patients giving those samples such as name, address, or sex.

3. Page 18, A. Security Requirements for GOCO and COCO Resources – We have multiple questions regarding this requirement:

a. Could the government provide additional guidance on when SA&A is required?

Considering that this contract is focused on the collection of biospecimens and tissues, it is unclear if this clause is applicable to this contract.

The contractor will be collecting specimens, tissues, and associated metadata on behalf of the government. If this information will be stored in an information system, that system must be authorized by the government.

b. If SA&A is required, what is the typical timeframe to obtain an Authority to Operate?

This timeframe could impact how many samples are feasible to collect in the first year.

It usually takes 6-9 months to obtain an authority to operate for a system. The timeframe can be longer if the system is hosted by the contractor.

c. And is it possible for the contractor to be included in an existing ATO (modified submission) or will a stand-alone SA&A be required?

CDC would like to reduce the number of authorized systems. So, consolidating with an existing CDC system would be an option. The government would have to evaluate whether such consolidation would be advantageous.

4. Page 82 Proposal Composition states that the proposal “should comprise of two separate volumes, Volume 1-Technical Proposal and Volume 2-Business Proposal.” Page 82, 5. Proposal Instructions states “Offerors shall present their proposals in two separate documents – Volume 1, Technical proposal, Volume 2, Past Performance, and Volume 3, Price proposal. Can the government provide clarification on if offeror is to submit two volumes or three volumes?

The proposal should consist of 2 separate documents, 1, Technical proposal, and Volume 2, Price.

As indicated on page 97, The Government reserves the right to evaluate past performance of the offeror, the offeror’s proposed employees, and subcontractors using data gathered through CPARS/PPIRS and reported through sam.gov.

5. Page 83, L.6 Proposal Instructions, e) Current GSA Contract Number appropriate to this

Solicitation. Is this RFP a GSA RFP to be issued utilizing the offeror’s GSA schedule?

This instruction was erroneously included and should be disregarded, as this is not intended to be a GSA RFP.. However, Offerors that have a current GSA contract can include this information in the their business proposals to assist the Government in evaluating it.

6. Page 85. 1. Technical Approach: “The Offeror shall provide a Project Plan and a Contract Work

Breakdown Structure (CWBS) describing the process and approach they propose to use in successfully completing this project.” Will the government allow for these items to be included as an appendix and not count against the proposal 25-page limit?

These items may be included as an appendix and will not count against the 25 page limit.

7. Page 88, Methodology: The instructions state to include a discussion of “…EPLC planning and development….”. We understand that EPLC is a framework to guide Information Technology governance. Considering that information technology development is not part of the scope of this solicitation, could the government remove this requirement from the instructions?

This section has been updated to remove EPLC planning and development from the RFP.

8. Page 91, Subcontractors: The instructions state “The proposal should address any special considerations needed to support nay subcontract work within CDC field offices and PEPFAR countries, including how subcontracts are identified and awarded.” We understand that specimen collection will only be conducted domestically and should not involve any CDC field offices. Could the government remove this requirement from the instructions?

The PEPFAR portion of the requirement has been removed.

9. Please confirm our assumption that the page limit for the technical portion is 25 pages

This is correct. The technical volume is limited to 25 pages.

10. Please verify that this is NOT as small business set-aside This IS a small business set-aside

11. Can you please verify our understanding of the scope of the IRB support you are requesting. We understand that we are to demonstrate that we have an FWA before the deadline for proposal submission. We also understand that some of the samples would be acquired from patients that have signed a consent form when they joined the ALS registry. Additionally it is our understanding that the consent forms have evolved and the contractor would be responsible for reviewing the forms on file and facilitate any necessary changes to the consent forms along with gathering new consent form from existing participants as well as facilitating the necessary and appropriate IRB approvals for these new forms if necessary.

Any changes in specimens collected such as in the number of collections tubes or change in venue of collections (e.g., doctor's office), may require IRB approval. The contractor is responsible for providing updates to the government that may require a change in IRB protocols in a timely manner.

12. Can you please provide information surrounding the numbers of samples at each desired storage temperature and the associated sizes (volumes) of the various samples The collection, storage, and transportation of samples must be adhere to industry standards such as the College of American Pathologists (CAP).

13. Will any freezers, or LN2 tanks be transferred along with the samples that will be transferring during the start-up phase? If so, would you please pass along any information on the age of these units?

No, the freezers and or LN2 tanks are rented from the storage facilities in which they are stored.

The age of these units is not applicable.

14. Are the samples currently barcoded? If so can you provide any specifics on labeling Samples are currently barcoded and follow industry wide standards.

15. Can you please elaborate on the database which holds the current sample information. It is assumed the contractor will be expected to maintain/transfer the information, as appropriate.

Samples are currently held at multiple locations using various databases.

16. Page 92 of the RFP refers to transitioning of “incumbent staff” …can you please elaborate on this reference?

Transitioning of incumbent staff is encouraged but not required. This section has been removed from the transition plan.

17. Please verify that item 0002 (option Task 4) is indeed a fixed price budget item. We ask as all the other items are time and material in nature.

This CLIN has been changed to a time and material line item. Please see the new instructions in Section L regarding the pricing of this line item.

18. For general requirement C.5.1.b we assume the contractor is to provide all items required in the collection kits, is that accurate?

Yes, however, some of the metal-free components of the kits are provided by the government to the vendor prior to building the collection kits.

19. Is the expectation that the successful vendor would need to provide phlebotomist sample collection services anywhere in the continental US? or should we be targeting to a specific geographic or urban area?

It could be anywhere in the U.S., however, targets are set and changed as needed as indicated by incoming data and needs.

20. For general requirement C.5.1.c are there specific protocols you can provide, or direct us to, that provide more specifics as to approach and expected turn-around times, that we can refer to in preparation of our approach and budget?

Please see the IRB protocol attachment.

21. For general requirement C.5.Post-mortem item c.- are there specific protocols you can provide, or direct us to, that provide more specifics as to anticipated approach to harvesting, processing and expected turn-around times, that we can refer to in preparation of our approach and budget as it pertains to the processing of the post-mortem samples ?

Please see the IRB protocol attachment.

22. For general requirement C.5.Post-mortem item c, on page 7 of the RFP, references that the post-mortem brain and spinal cord tissue, CSF , bone and muscle samples will be transported to an identified facility that is to be determined by the COR. Can you please clarify if the repository will store all samples (pre and post mortem) as inferred under Optional Task 9 or if the samples will be held in multiple locations as inferred on page 7.

Currently samples are stored in multiple locations as inferred on Page 7 and the repository does store all the samples collected, both pre and post-mortem. Currently post-mortem is stored separately because it is processed in a different location. This is at the discretion of the contractor on how they wish to store both pre and post-mortem samples.

23. Under Task 6 (on page) you reference 10 requests for shipments. How many samples do you expect in each shipment and what type of sample? This will help us determine the type of shipment we will employ and packaging. Also, are there specific locations you would like to see utilized as we prepare our shipping budget?

Number of samples could be anything. The costs incurred will be paid for by the researcher, not the Government.

24. On page 14 under the quality section-there is a reference that “participants are confirmed via DNA”, can you please elaborate on this request?

The contractor is responsible for preparing the samples for transport to the NIH in which laboratory analysis such as genotyping is conducted. This is done each calendar year after collections or as necessary. Estimated annual quantity would be between 150-250 samples.