Questions_and_Answers_5-9.pdf

Solicitation 2018-N-67799

Questions and Answers

Respirator Study: Assessment of Elastomeric Respirators in Healthcare Delivery Settings

1. Is this for independent researchers to develop and submit in collaboration with healthcare facilities, or are you soliciting healthcare organizations to be part of a study that NIOSH is leading?

The purpose of this study is to determine the feasibility and capability of U.S. healthcare delivery organizations to routinely use reusable respirators and/or rapidly convert to their use during a public health emergency. The solicitation is seeking U.S.-based healthcare organizations to lead one or more demonstration and research efforts.

The solicitation is seeking researchers, universities, and any other entities that are capable of completing the research tasks outlined in the Statement of Work. NIOSH is not leading the study but will facilitate the study through collaboration.

2. Option B involves SOPs and assessments of disinfection methods for elastomeric respirators. Page 3 of the Solicitation indicates the work will involve two methods of disinfection, while Attachment 1 (State of

Work) on page 22 (Task B2) notes three such methods. Can you clarify whether the work within Option

B will involve two or three disinfection methods?

It will involve two (2) disinfection methods, subject to NIOSH approval.

3. Is there a budget for this contract?

Because this is a competitive contract, the government will not disclose the maximum budget for this effort.

Offerors shall provide their best and final pricing for the successful completion of the services detailed in the

Statement of Work.

To provide some scope to this study, below are the labor categories and estimated labor hours the Government anticipates for the Base Effort, Option A, and Option B. The below estimates are for the labor portion of the requirement and does not include any materials, equipment, supplies, travel, etc.

Base Effort:

Labor Category Number of Hours

Project Manager 48

Assistant Project Manager 240

Research Assistant(s) 760

Option A:

Project Manager 120

Assistant Project Manager 1,000

Research Assistant(s) 3,300

Option B:

Project Manager 120

Assistant Project Manager 500

Research Assistant(s) 2,000

4. Re: personnel, is the expectation that the budget should be developed based on an hourly rate for professional services, or based on percent effort - based on the individual's salary?

The cost proposal can be in any format that is commensurate with the practices of your organization. If the cost proposal is submitted with labor detailed on a percent of effort basis, the individual’s salary and the number of hours worked per week must be included. If the budget is submitted with an hourly rate, the offeror shall indicate whether the hourly rate is fully burdened or provide supporting documentation detailing any G&A, overheard, fringe rates, etc.

5. The contract describes that NIOSH will supply certain resources to the Contractor, and will participate on manuscripts as co-authors. There will need to be statistical analysis involved on these efforts. Is it expected that NIOSH will provide a statistician to review data, or should the Contractor/study team make plans to include a statistician to provide this skill set?

Pursuant to clause H.6 in the solicitation, the Key Personnel required for this effort are (1) Project Manager, and

(2) an Assistant Project Manager. Offerors may propose any mix of labor categories they deem necessary for the successful completion of the effort. After all study sites have finished collecting data, a NIOSH statistician will analyze the data from all sites in aggregate.

6. Other than the description of the format for the Technical/Management Proposal in Section L.10, are there specific forms or templates that should be used to prepare the proposal?

The only required template offerors must complete is the HHS Subcontracting Plan template, which is

Attachment #4 to the solicitation. Offerors are advised to review Section L for required content for the technical and cost proposals.

7. Section 3 – Criterion 3: Staffing Plan (Pages 32 – 33). Are non-key personnel required to be identified by name or can we describe the labor category of these positions?

No, non-key personnel do not have to be named in the cost proposal. A list of labor categories is sufficient.

8. Section 4 – Past Performance (Page 33) The Solicitation reads: “Offerors will submit at least 3 references using the Past/Present Performance Reference Questionnaire (Attachment #3)…” Is there a limit to the number of past performance surveys provided since they do not count against the page limit?

The government will impose a limit of three (3) references for prime contractors and three (3) references for each subcontractor in the interest of time.

9. Section 4 – Past Performance (Page 33) The Solicitation reads: “Page limit: 2 pages for each

Questionnaire” Is the two-page limit just for the questionnaire or does it also include the narrative written to show applicability of the past performance to the project?

The two (2) page limit includes the narrative.

10. Section 4 – Past Performance (Page 33) The directions say that all past performance information does not count towards the page limit. Please clarify that if the narrative does not count towards the two-page limit, since there is not a page restriction on the narrative.

The two (2) page limit includes the narrative.

11. Section M.1 – Basis of Award (Page 38) The language in the Solicitation is as follows: “Award will be made to that responsible Offeror submitting the proposal determined to be the most advantageous and the best value to the Government as evaluated under the criteria described in this section.” Can you please clarify if the government will consider Prime offerors who are not hospital entities, but will subcontract with hospital(s)? Also, please comment if the government has a preference to have a hospital as the prime contractor and what weight that will have in the evaluation process.

Please refer to Question and Answer Number 1 above. The government does not have a preferred prime/subcontract relationship.

12. Section M.6 – Factor and Subfactor Evaluation (Page 40) Under Step 3, the Solicitation reads: “The

Government will then derive a weighted score for the criterion by multiplying the “raw” score assigned for each criterion by the relative weight for the criterion.” To be clear, the score of Criterion 1 and

Criterion 2 will be multiplied by 2, and the score for Criterion 3 will not be adjusted (multiplied by 1).

This would provide a total achievable score of 500 points. Is that correct?

No, that is not the calculation the government will use. However, for comparison purposes, the example you provided is accurate. Each Criterion is weighted based upon importance. According to Section M.5 in the solicitation, Criterion 1 and Criterion 2 are worth twice that of Criterion 3.

13. Section M.6 – Factor and Subfactor Evaluation (Page 40) It is unclear on how the assessment in Step 1

(strength measurement) will be used to derive the quality rating and raw score derived in Step 2. Can you please provide more clarity how the government will use the ratings in Step 1 to derive the numerical value in Step 2?

The number of strengths, weaknesses, significant strengths, significant weaknesses, and deficiencies will determine the Quality Rating/Raw Score for each of the three (3) technical criterion. Please refer to the definitions in Table 2 that detail the strengths, weaknesses, significant strengths, significant weakness, and deficiencies associated with each Quality Rating/Raw Score.

14. Evaluation Process - Factor 2 - Past Performance (Page 41) The Solicitation reads: “In either case, the prime contractor and proposed major subcontractors will be assessed individually and the results will then be assessed in their totality to derive the Offeror’s Past Performance rating.” Can you provide more clarity on how the scores of the Prime and subcontractor(s) will be weighted? Will it be based on percentage of work, an average, etc.?

Past Performance is a standalone criterion and it not weighted between the Prime and Subcontractor(s). The Past

Performance of the Prime contractor and each subcontractor(s) are individually assessed to determine the relative risks associated with the likelihood of success in performing the requirements.

15. Evaluation Process - Factor 2 - Past Performance (Page 41) Are subcontractors required to submit at least three past performance surveys?

Yes. The Evaluation Process for Factor 2 on Page 41 states, “In this context, “Offeror” refers to the proposed prime contractor and all proposed major subcontractors.”

16. Evaluation Process - Factor 2 - Past Performance (Page 41) Is there a limit on the number of past performance surveys a subcontractor can submit?

Please see the Question and Answer Number 8 above.

17. General Question on Past Performance. It is unclear how past performance is weighted in the overall evaluation and scoring. It appears to be a stand-alone criterion that is not part of the weighted score. Can you please provide more clarity on how the government will use past performance to determine the overall rating of the proposals?

Past Performance is a standalone criterion that is not part of the weighted score. Past Performance assesses the relative risks associated with an Offeror’s likelihood of success in performing the requirements.

18. Section 3 – Scope of Work – Option B (Page 2) Will the disinfection procedures be performed by health care workers or by sterile processing personnel?

Offerors should propose disinfection processes, and the personnel who will perform disinfection, using the methods the offerors believe will best accomplish the tasks described in the SOW. Please also refer to the recommended references included in the SOW and other peer reviewed literature about this topic.

19. Section 4 – Tasks to be performed – Task Base 2 (Page 3) Does NIOSH expect the video will to be modified as well? Also, will NIOSH allow the contractor to develop novel training materials, such as mobile apps or web-based training to provide more effective training tools?

NIOSH intends to produce a video that will not need to be modified to complete the studies. Contractors are not required to develop any new video training materials. Whether contractors develop alternative or additional training modules is subject to negotiation with NIOSH. Any digital educational or training tools proposed to be developed by the contractor must meet applicable U.S. government standards and be approved by NIOSH.

20. Section 4 – Tasks to be Performed – Task Option B1 (Page 5) What pathogen or microbial contaminant should the standard operating procedures be designed to disinfect (e.g., Mycobacterium spp., Gram-positive bacteria, Gram-negative bacteria, enveloped viruses, non-enveloped viruses)?

In general, disinfectants should be utilized that are capable of inactivating or killing a range of human pathogens in the health care workplace, including common bacterial and viral pathogens. Selected disinfection methods should be capable of inactivating or killing influenza virus, an emphasis of this solicitation.

21. Section 4 – Tasks to be Performed – Task Option B1 (Page 5) Should both approaches be designed to disinfect the same type of pathogen to determine best practices?

Yes. In general, disinfectants should be utilized that are capable of inactivating or killing a range of human pathogens in the health care workplace, including common bacterial and viral pathogens. Selected disinfection methods should be capable of inactivating or killing influenza virus, an emphasis of this solicitation.

22. Section 4 – Tasks to be Performed – Task Option B2 (Page 5) Since Task Option B3 is focused on determining disinfection effectiveness, is the assessment and comparison of the disinfection methodologies based on logistical considerations only (e.g., ease of use, safety containment)?

In general, disinfectants should be utilized that are capable of inactivating or killing a range of human pathogens in the health care workplace, including common bacterial and viral pathogens. Selected disinfection methods should be capable of inactivating or killing influenza virus, an emphasis of this solicitation. NIOSH seeks proposals that will evaluate both disinfection effectiveness (sometimes called efficacy) and the logistical challenges of performing disinfection in health care delivery settings.

23. Section 4 – Tasks to be Performed – Task Option B2 (Page 5) Once the two methods are compared to determine best practices, will either method be optimized based on those findings prior to the disinfection evaluation performed in Task Option B3?

Contractors may propose ways to optimize methods of disinfection using an iterative or rolling study design, but this is not required, and will be subject to NIOSH approval.

24. Section 4 – Tasks to be Performed – Task Option B3 (Page 5) To assess disinfection effectiveness, is

NIOSH requesting elastomeric respirators be inoculated with viable microorganisms, and/or subsequently sampled post-disinfection to determine the level of viable contamination remaining?

NIOSH seeks to understand the effectiveness of disinfection in fully functional health care delivery where elastomeric respirators are contaminated by pathogens typically found in such settings. Prior and ongoing studies have addressed disinfection methods for elastomeric respirators in laboratory and simulated health care settings.

For this solicitation, NIOSH is interested in assessing feasibility of disinfection processes in fully functional health care delivery settings. Surface sampling of the elastomeric respirators before and after disinfection to determine effectiveness (sometimes called efficacy) would be appropriate in this context.

25. Section 7 – Place of Performance. The SOW reads “Services will be performed at the awardee’s campus.”

Does this language indicate the awardee must be a hospital? Or can the awardee be a research organization and contract a hospital as a subcontractor?

No, the awardee does not have to be a hospital. Please refer to Questions and Answers Number 1 and 11 above.

26. Are the intervention OPTIONS A and B determined by the CDC or are these for us to develop ourselves?

These interventions are to be developed and proposed by the offeror.

27. In Base-Task 4: We are to assess the effectiveness of the training materials – Will NIOSH provide the evaluation tool? Some places it says it will and others it’s not mentioned.

NIOSH will provide a draft evaluation tool to the successful awardee(s) approximately two (2) months after award that may be modified by the contractors to meet study site-specific needs. Contractors will need to collaborate with NIOSH and other study sites (other awardees), if applicable, to ensure training materials are sufficiently similar across all study sites to permit data analysis in aggregate, for peer-reviewed publication, when the studies are complete.

28. Are these existing NIOSH materials currently available for us to review or will they be made available after May 7th? In order to budget staff for implementation of these protocols, it would be ideal to see how long these elements will take to administer?

Links to available resources are included in Section 12 of the SOW titled, “Reference Materials.” Please see

Question and Answer Number 3 above for estimated labor hours the Government anticipates for the Base Effort, Option A, and Option B.

29. In the Technical Management Proposal (Volume I), Section 2 (Criterion 2: Technical Approach) – this asks for the methodology to performing the “requirements”. What is this exactly?

The term “requirements” refers to all of the tasks and deliverables detailed in the Statement of Work.

30. I see in Section 8 – Baseline Security Requirements, Does it mean this section? And/Or other requirements?

Section 8 of the Statement of Work details the IT security requirements that must be followed by all awardees of federal contracts.

31. In the Business Proposal (Volume 2) – Are there specific budget forms that we should use? Are we to follow the NIH budgeting format?

No. There are no forms or templates for the cost proposal. All proposals shall include all required information detailed in Section L of the solicitation.

32. Option A – Task A2 indicates “Provide NIOSH one week to observe” – what does this mean? Will they be onsite?

NIOSH collaborators intend to make contractor site visits to facilitate the conduct of the study.

33. Section 10: Travel – How many from the contract team are expected to travel to Pittsburgh? We are proposing the full application.

The number of individuals an offeror proposes to travel is left to the discretion of the offeror. Any proposed travel costs must adhere to the General Services Administration (GSA) travel costs and approved per diem rates.

34. Would it be possible to get a copy of the draft protocols for base contract Task Base 1 and Base 2 related to the NIOSH proposal “Respirator Study: Assessment of Elastomeric Respirators in Healthcare Delivery

Settings”?

The draft protocols are not available for distribution yet. After contract award, the draft protocols will be made available to the awardees.

35. For Option B – does NIOSH expect that testing should be done with actual microbial agents or with a simulated substance (like Glow-germ)? If done with actual microbial agents, this would seem to require performance in a contained laboratory environment. Should this decontamination demonstration project occur in a laboratory setting or in a hospital unit clinical space – like a nursing unit or in a central supply/equipment sterilization department?

Option B should be conducted in a fully functional health care delivery setting to assess disinfection effectiveness involving human pathogens typically found such settings.

36. What certifications are required to be in the application?

Please review Section K for the required certifications, specifically K.1, K.2, and K.7. Please review Section L for the required contents for the technical and cost proposals.

37. There is so much about subcontractors it reads as if we are required to have them. Are we required to have subcontractors?

No.

38. For the budget can we use the standard NIH budget forms? SF 424 R&R, OSMB 4040-0001 form?

Please refer to Questions and Answers Number 4 and 6 above. Please note that Forms SF 424 R&R and OSMB

4040-0001 are for grants. This effort is a Firm Fixed Price Contract in accordance with Federal Acquisition

Regulation (FAR) 16.202.

39. For the budget/and reporting of other funded work, can we use the standard biosketch format where this is typically listed for all study team members, as well as OSMB Form 4040-0001 (Research & Related

Senior/Key Person Profile form)? If we cannot use the standard NIH forms, what can we use? Please be specific.

Please refer to Questions and Answers Number 4 and 6 above. Please note that OSMB Form 4040-0001 is for grants. This effort is a Firm Fixed Price Contract in accordance with Federal Acquisition Regulation (FAR)

16.202.

40. Is there any stipulation as to the method for fit testing – qualitative or quantitative? Comparison of both?

If quantitative – generated aerosol, ambient aerosol, controlled negative pressure?

Regarding fit testing, offerors may propose qualitative, quantitative, or both methods for the Base Contract. To help control the costs of the study, NIOSH suggests proposing the method of fit testing most often performed during routine operations at the offeror’s health care facility (ies).

41. Is it an allowable expense to purchase apparatus to perform fit testing?

Yes.

42. Please confirm that the elastomeric respirator to be used is approved and commercially available. In other words, we are not using a developmental respirator.

The elastomeric respirator(s) used in these studies will be NIOSH-approved and commercially available in the

United States.

43. As we do not have a large number of patients requiring airborne isolation, would it be permissible in

Option A to have a consenting patient potentially serve as a “mock” airborne isolation patient if we were not able to encounter enough “naturally-occurring” patients needing airborne isolation?

44. In Option B, is there any stipulation on how effective disinfection is to be assessed? (ATP vs surface cultures); is there any interest in performing challenges of the respirator and compare cleaning/disinfection protocols? If so, do these need to be respiratory virus, bacterial challenge, etc.?

Option B should be conducted in a fully functional health care delivery setting to assess disinfection effectiveness involving human pathogens typically found such settings, including influenza virus. The methods and study design should build on previous studies published in peer-reviewed literature.

45. Can we perform Option B during Option A? In other words, during the 2 months when the respirator is in use, can we compare the disinfection regimens during that period while the respirators are in clinical use?

Option A and Option B are options, meaning the government is not required to exercise those options and may be subject to the availability of funds. Pursuant to FAR 52.217-9, the government may choose to exercise either of the options at any time up to thirty days prior to the end of the base period. The exercise of the option(s) may or may not overlap.

46. Is there any prescribed manner in which we assess leadership opinion?

No, offerors should propose time- and cost-efficient methods to assess the views of leadership.

47. Would it be OK to do the base study and Option in different hospitals?