Contractor Questions and Government Responses - Solicitation HT942525R0037 Amendment 1.xlsx
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- Attached to
- Solicitation HT942525R0037 - Human Subjects Protection Personnel Mgmt and Support Services - USAMRDC OHARO
- Solicitation number
- HT942525R0037
- Issued by
-
Defense Health Agency
About this file
This file is a Contractor Questions and Government Responses document for Solicitation HT942525R0037, covering Human Subjects Protection Personnel Management and Support Services for the U.S. Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHARO). The solicitation is a Firm Fixed Price (FFP) contract with Cost Other Direct Costs (ODCs) for supporting protocol reviews, human subjects protection activities, and administrative support, currently supporting 27 Full-Time Equivalents (FTEs).
Key details include the requirement for multiple review teams (3 review teams and IRR/IRB support), with an average of 470 protocol actions per month for OHARO and 21 actions per month for the Institutional Review Board (IRB). The contract involves using the Electronic Grant System (EGS), participating in working groups, providing training and education, and supporting site assessments. The government will not extend the proposal due date beyond 30 days, requires a Small Business Participation Plan, and expects offerors to propose their best solution with labor mix and quantity. Offerors must submit resumes for key personnel demonstrating experience in human subjects protection support services, with no formal job descriptions provided by the government.
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Sheet1
| Contractor Questions with Government Responses for Solicitation HT942525R0037 | ||||
| Human Subjects Protection Personnel Management and Support Services for USAMRDC OHARO | ||||
| Contractor Question | Contractor Question Reference | Government Response | Government Response Reference | |
| On page 163 of the Solicitation, Section 2.a.(1) Page Limits, the Government provides a list of sections/documents that are not subject to the thirty (30) page limit and provided their own page limits. Question: Will the Government please confirm that the following documents can be placed as Appendices to the Non-Cost/Price Proposal to account for their individual page limits or non-page limits: Transition-In Plan; Resumes/Letters of Intent; Draft PMP; Staffing, Recruitment, and Retention; Past Performance References; OCI Certification; Small Business Participation Plan; and Small Business Subcontracting Plan? | Page 163 of the Solicitation, Section 2.a.(1) Page Limits | The following can be placed as Appendices to the Non-Cost/Price Proposal to account for their individual page limits or non-page limits: Transition-In Plan; Resumes/Letters of Intent; Draft Program Management Plan; Staffing Recruitment, and Retention Plan; Past Performance References; OCI Certification; Small Business Participation Plan; and Small Business Subcontracting Plan. | Solicitation Page 163, Section 2.a.(1) Page Limits | |
| There don’t appear to be labor category descriptions or qualifications provided. Should this information have been provided as an attachment to the RFP? | None Provided | The Government is not providing formal job descriptions or qualifications, or education requirements; however, please see attached HSPS LCAT Overview (Question and Government Response - Attachment 1) for more information. IAW the Solicitation (for Experience), “The Offeror shall submit resumes for Key Personnel in order to demonstrate their experience to perform the PWS tasks. The Offeror shall propose a team with substantive experience in performing HSP support services related to the PWS tasks. The Offeror shall include verifiable examples of experience, education, and training.” | Attachment to Contractor Questions and Government Responses | |
| Given the high number of key personnel requiring both resumes and LOCs, would the government grant a one-week extension to ensure an opportunity for fair competition with the incumbent? | None Provided | No. The RFP will not be extended beyond 30 days. | None Provided | |
| Does the current requirement (incumbent contract) currently support and fund 27.5 FTE? | None Provided | The current contract supports and funds 27 FTEs. | None Provided | |
| Section 1.2.2. describes five teams -- 3 review teams and one administrative support team as well as a fifth team to IRR. Attachment A lists 4 color review teams, as well as boxes for IRR and IRB. Which is the administrative support team referenced in 1.2.2? | SolicitationPg. 4, 1.2.2 OHARO Composition and PWS Attachment A page 43 | The adminstrative team referenced is part of a separate contract, not part of this 27.5 FTE or these PWS requirements. See Revised PWS Section 1.2.2. | PWS Section 1.2.2 and PWS Attachment A - Organizational Chart | |
| To allow us to propose an optimal technical approach, what is the anticipated volume of protocols for each team? | None Provided | The data is not spread out by team but the Government has overall data per action - average is 470 protocol actions per month for OHRO and 21 actions per month for the IRB. | None Provided | |
| How many research protocols are reviewed in each IRBO IRB meeting? | Solicitation 1.3.11: Area 11: IRB Member Consultant Protocol Review, page 6 | Average of 21 actions per meeting. | None Provided | |
| What is the frequency and schedule of USAMRDC IRB meetings anticipated to be for the base year? | Solicitation 3.6.3 Key Task 3, page 22 | Twice per month and the ability to do ad hoc meetings. | None Provided | |
| Section 1.3 Scope references "standardized checklists" in multiple places (1.3.1, 1.3.2, 1.3.3) as well as "Government provided…checklists" in 1.3.6. Similarly, Objectives 1 and 2, Key Tasks 4 indicates a requirement to use standardized checklists. Can the government confirm they number of checklists, scope of each checklists and provide offerors copies of checklists to clarify the PWS scope? | Solicitation 1.3 Scope, page 5 | Applicable deliverables have a checklist. Checklists will be provided after award. | None Provided | |
| Section 1.3.9 requires that "contractor personnel must master entry of protocol-related information into automated information management systems." Does OHARO use a specific information management system, e.g., SharePoint? If so, what is the system? | Solicitation 1.3.9. Area 9: Quality Assurance, page 6 | Electronic Grant System (EGS) | None Provided | |
| What workflows or processes are automated by OHARO's "automated information management systems"? | Solicitation 1.3.9. Area 9: Quality Assurance, page 6 | EGS | None Provided | |
| Section 1.3.10 and 3.10.1 Key Task 1 require that "contract personnel participate in specific working groups". What specific working groups currently exist or are anticipated that contract personnel would need to support and with what frequency? | Solicitation 1.3.10 Area 10: Performance Improvement | Routine EGS work group/ad hoc work groups as driven by the Directors needs. | None Provided | |
| Section 2.13 Monthly Progress Report requires the Contractor to detail the "labor hours expended by labor category for each task" which is inconsistent with the FFP and non-personal services nature of this contract. Please remove this requirement, so that the MPR only requires appropriate progress, accomplishments, and problems/issues encountered to be included. | Solicitation 2.13 Monthly Progress Report (MPR), page 13 | See Revised PWS Section 2.13. | PWS Section 2.13 | |
| Section 2.15 Program Management Plan requires that the PMP identify "milestones where Government information/activity is required". Are there current OHARO program milestones or activities that these should align to? | Solicitation 2.15. PMP; page 14 | Yes, the Deliverables in PWS Section 5.6. Other specifics will be provided after award. | None Provided | |
| Section 2.18.3 indicates a need for "transition of historic data to new Contractor. "What historic data will need to be transition to the new Contractor?" | Solicitation 2.18 Transition-In Plan | OHARO records and reports, and toolkit will be provided to a new Contractor for use. This includes OHARO records and report archives. | None Provided | |
| What do FCMR-RP and FCMR-RPH stand for? | Solicitation PWS Attachment A page 43 | Futures Command Medical Research (FCMR) - Research Protections (RP) and Research Protections Human (RPH). | None Provided | |
| Objective 4, Key Task 1 references an HSP Administrative Support (AS) contractor. Is this an additional LCAT, or is this the same as an HSPS I? | Solicitation 3.4. Objective 4, 3.4.1 Key Task 1, page 20 | HSPS I. | None Provided | |
| Are there existing human subjects protection regulatory compliance education and training programs and training/conferences sponsored by the OHARO that are expected to be supported in 3.8.5. Key Task 5? If so, what are they, how many and when are they held? | Solicitation 3.8.5. Key Task 5, page 23 | Yes, training is held on an ad hoc basis. The Green Team is primarily responsible for training and education activities for OHARO customers. | None Provided | |
| In 3.9.3 Key Task 3, the contractor is required to "assist in the execution of an internal quality control/assurance program." Does internal here mean internal to the contractor team or internal to the OHARO program? | Solicitation 3.9.3. Key Task 3, page 24 | Internal to the Contractor team. The Contractor is required to ensure quality control/quality assurance of their own work. | None Provided | |
| 3.13.11 Key Task 11 requires contractor support for the "OHARO electronic review and archive system." Is there a specific tool or system used for these requirement items? | Solicitation 3.13.11. Key Task 11, page 26 | EGS | None Provided | |
| As it relates to transition-in, are there any hardware warranties and software licenses that will be required to transition to a new Contractor? If so, what are they, so we can properly propose a transition-in plan? | Solicitation Transition In, page 164 | No. Not Applicable. | None Provided | |
| Consistent with FAR 52.219-9 are small business primes exempt from providing a Small Business Participation Plan and the Small Business Subcontracting Plan? | Solicitation 2. Proposal Content and Format Instructions, a. Administrative Format Instructions, page 163 | Please complete the small business (SB) participation plan. If SB, mark SB. SB Subcontracting Plan is N/A for SB IAW FAR 19.702. | None Provided | |
| Do small business primes performing 10% of the total contract value fulfill the 10% requirement outlined in the Small Business Participation Plan? | Solicitation (8) Small Business Participation Plan, page 166 | IAW the Solicitation, Offerors shall propose the level of participation of SB (which includes prime and/or subs). | Page 166, Solicitation Section b(8). | |
| The solicitation states that, "The Government will evaluate … the breakdown for these rates" in c. Cost/Price Proposal Content Instructions. Can the government confirm that the breakdown analysis will be limited to what is requested by the government to be included in the Cost/Price proposal? | Solicitation c. Cost/Price Proposal Content Instructions, page 167 | IAW the Solicitation, a price breakout shall detail pricing by labor category, labor rate (fully burdened - see Supplemental Pricing Sheet), direct labor hours, and other direct costs. | Page 167, Solicitation Section c(2) and Solicitation Attachment 1 | |
| The government states that "Offerors shall define which labor categories will be performed by a subcontractor(s) along with the subcontractor(s) company name." The RFP pricing sheets do not include a space to identify the subcontractor. Can the government amend the sheet or provide guidance where subcontractor should be indicated? | Solicitation Section (2) Pricing Sheet(b), Page 168 | Please identify proposed Prime/Subcontractor labor in the "Labor Category Column (B)" of the Supplemental Pricing Sheet, Solicitation Attachment 1 (i.e. Base Period HSPS I Support Services (Prime - XXX Company) or Base Period HSPS I Support Services (Subcontractor - XXX Company). | Solicitation Attachment 1 | |
| The government states that "The Offeror shall provide a detailed breakdown of the proposed labor rate for all proposed subcontractor labor." Can the government confirm that the breakdown analysis will be the same level of detail as what is requested by the government to be included in the Cost/Price proposal at the Prime level? If more detail is required, would the government accept a sealed bid from our proposed subcontractor, if requested, to protect business sensitive subcontractor information? | Solicitation Section (2) Pricing Sheet(b), Page 168 | IAW the Solicitation, a price breakout shall detail pricing by labor category, labor rate (fully burdened - see Supplemental Pricing Sheet), direct labor hours, and other direct costs. | Page 167, Solicitation Section c(2) and Solicitation Attachment 1 | |
| Can the offeror submit the sections that are not within page count in separate appendices? | Page 163, 2.b | Yes, the Offeror can submit the items listed under the Page Limits section on Solicitation Page 163 as separate appendices to the Non-Cost/Price Proposal. | Solicitation Page 163, Section 2.a.(1) Page Limits | |
| Section 3 of the RFP, Management approach reads " Offeror’s management approach shall include an approach to staffing (to include recruitment and retention), that will lead to the successful accomplishment of the requirement," however the staffing, recruitment, and retention plan also asks for " the Offeror’s staffing and retention practices and how these practices will contribute to program success." Will the staffing and retention language be evaluated twice in the SRP and the management approach section or will it be evaluated only once in the SRP? | Page 165, b.3 | No, will not be evaluated twice. The Staff and Retention Plan (part of Management Approach Factor) is be where the Offeror outlines their staffing and retention practices and how these practices will contributed to program success. | Solicitation Page 165, Section b(3) | |
| The RFP references "The extent to which the Offeror meets or exceeds the goals set forth in Section 5.4. of this solicitation". Section 5.4 does not provide any required small business goals. Please provide clarification of any solicitation small business goals, to include any socio-economic goals. | Page 178, b.5 | 10% Goal. See Instructions to Offerors, "Small Business Participation Plan", Para 8, Solicitation page 167. | Solicitation Page 167, Section b(8) | |
| Throughout the RFP, there is mention OHARO is using information systems in their business practices. Could you provide more details on what those systems are and how they support the various areas in HSP? | Throughout the Solicitation | EGS, Microsoft Office and Teams, Adobe. | None Provided | |
| The RFP states "The contractor shall participate in performance improvement activities and shall task contract personnel to participate in specific working groups to improve and streamline the protocol review and approval processes and provide support for formulating and writing OHARO and OHRO standard operating procedures and work instructions." We realize that PI activities are probably considered an "ongoing" process, but there are some tasks under this objective that appear to be tied to a time segment (e.g., monthly, quarterly, semi-annually). Could you provide some more details regarding this? | Page 24, 3.10.1 | These activities are at the discretion of the Director/COR. The only PI activity that is timed is the EGS work group, annual review of work instructions and tools. | None Provided | |
| It states "The contractor shall be sufficiently qualified to conduct ethical and regulatory reviews through experience, expertise (professional competence), and sensitivity to issues such as community attitudes." How can this be expressed in the proposal and where will it be evaluated? | Page 25, 3.13.2 | The PWS Section is 3.11.2, not 3.13.2. See Revised PWS Section 3.11.2. | PWS Section 3.11.2 | |
| There is mention of supporting / reviewing a group email box - is this already established or will the Contractor need to establish this net-new? | Sec 3.4.2; Page 20 (Objective 4- Admin Support) | All group mailboxes are established. | None Provided | |
| The RFP references providing support to site assessments; although previous language indicates travel is not supported in this contract. Can the government clarify how the Contractor should account for travel to site assessment locations? How many site visits are anticipated during a PoP? | Sec 3.5.3 and 3.5.5; Page 21 (Objective 5) | Travel is supported under this requirement and PWS under Other Direct Costs. Five (5) visits or less per PoP is anticipated. | PWS Section 2.17.1 | |
| The government mentions 120 days to complete orientation for new employees, should this be considered the "Transition In" period for contract award, or for any employees added to support project success during the PoP? | sec 3.13.6; Page 26 | Overall contract transition is 15 days. With regard to orientation of new employees, the contractor shall be afforded 120 days to complete adequate orientation of new | ||
| employees to duties and OHARO procedures when onboarded. See Revised PWS Section 3.13.6. | PWS Section 3.13.6 and 3.18 | |||
| For deliverables 13, 14, and 15 can the government please clarify if existing documents used by the government will be provided to the contractor as they presumably exist already, or will the contractor be requested to either update existing documents and/or create new documents to satisfy these deliverables? | sec 3.5; Page 21 (Objective 5) | Yes, existing Government documents (i.e. templates) will be provided for use. | None Provided | |
| The Government does not call out specifically Risk-Based assessments of the project reviews. Does the Government want these to be included as part of the review process and output? | Page 19, 3.2.3 & 3.2.5 & 3.12.3 | No. | None Provided | |
| Can the Government provide details on any issues that they are having with their current Human Subject Protection Education and Training program? | Page 23, 3.8.1 | None, currently no issues. | None Provided | |
| Can the Government provide details on their current Training Platform? | Page 23, 3.8.3 | Microsoft Teams. | None Provided | |
| Can the Government describe their preferred mode of instruction (i.e. in-person or virtual instructor led, or virtual asynchronous)? | Page 23, 3.8.8 | In person or virtual is acceptable at the discretion of the Government. | None Provided | |
| Can the government clarify in the method in which skills checks are performed (in-person, virtual, or both)? | Page 23, 3.8.8 | Can be either/or, or both. | None Provided | |
| Can the government please confirm that we are allowed to use corporate experience citations where the Offeror served as a subcontractor to another prime? | sec. 2, page 164 (Corporate Experience) | Yes. Please list whether you are a prime or subcontractor accordingly. | None Provided | |
| Can the contractor host a share-point site for the Government, and deliver and store all contract deliverables as an alternate to submitting each deliverable via email? | Page 34-35, Para 5.1 and 5.2 | Yes. | None Provided | |
| Can the Government explain what the Standard for Task 3.13 “100% staffing at all times” means? Can the government verify if this contract is FFP or FFP-LOE? Does this requirement expect that the contractor immediately backfills a staff member, upon their departure? | Page 54 | FFP. The QASP Performance standard is to maximize staffing IAW the reflected standard in Task 3.13. | None Provided | |
| Based on service requirements, will the government consider moving this contract to FFP a contract or time and materials contract? | Page 167, c.2 | This contract is a Firm Fixed Price (FFP) contract w/COST ODCs. | None Provided | |
| Does the government intend to furnish the minimum education, experience and certifications required for the 16 HSPS IIIs, 3 IRB Member Consultant, and 1 Cadaver Use activity Consultant key personnel? Will the government send education, experience and expected qualifications for each level of HSPS labor category? | Page 175, d.3 | The Government is not providing formal job descriptions or qualifications, or education requirements; however, please see attached HSPS LCAT Overview (Question and Government Response - Attachment 1) for more information. IAW the Solicitation (for Experience), “The Offeror shall submit resumes for Key Personnel in order to demonstrate their experience to perform the PWS tasks. The Offeror shall propose a team with substantive experience in performing HSP support services related to the PWS tasks. The Offeror shall include verifiable examples of experience, education, and training.” | Attachment to Contractor Questions and Government Responses | |
| There doesn’t appear to be labor category descriptions or qualifications provided. Should this information have been provided as an attachment to the RFP? Any information you can share is appreciated. | Page 175, d.3 | The Government is not providing formal job descriptions or qualifications, or education requirements; however, please see attached HSPS LCAT Overview (Question and Government Response - Attachment 1) for more information. IAW the Solicitation (for Experience), “The Offeror shall submit resumes for Key Personnel in order to demonstrate their experience to perform the PWS tasks. The Offeror shall propose a team with substantive experience in performing HSP support services related to the PWS tasks. The Offeror shall include verifiable examples of experience, education, and training.” | Attachment to Contractor Questions and Government Responses | |
| Due to the delay in proving LCAT descriptions and because the requirements for education, experience and certifications required for key personnel are not provided, can the government extend the proposal due date by 30 days after those requirements for key personnel are provided? | Page 175, d.3 | No. The RFP will not be extended beyond 30 days. | None Provided | |
| The government says the LOE is an estimate and that "offerors are not bound to propose these labor categories or quantities, rather Offerors are expected to provide their best solution citing labor mix and quantity," But also says that "Offerors shall propose on all contract line items either by price or NSP." Can the contractor alter, add and/or subtract CLINs, based on their specific solution in the pricing template? | Page 168, (4) | Yes. Per the Solicitation "offerors are not bound to propose these labor categories or quantities, rather Offerors are expected to provide their best solution citing labor mix and quantity." | Solicitation Page 168, Section c(4) | |
| It states in this Attachment that each LCAT is associated with a specific team. However, in the pricing template the CLINs are not differentiated by team. Can the government specify which team each CLIN falls under in the pricing template? | PWS, Attachment A | Please propose IAW the pricing sheet. Team assignments will take place post-award during the kick-off meeting. | None Provided | |
| Can the Government confirm that if an organization deems it necessary to create an OCI Avoidance or Mitigation Plan, that the contractor is required to submit the OCI mitigation plan as part of the proposal or post award? | Page 166 - (5) ORGANIZATIONAL CONFLICT OF INTEREST (OCI) CERTIFICATION | If applicable, the OCI Avoidance or Mitigation Plan shall be submitted with the Offeror's proposal. | Solicitation Page 46 Section 6.b.(1)(ii) | |
| Can the Government confirm that if the offeror is required to submit that OCI mitigation plan as part of the proposal response, that the mitigation plan is also excluded from the 30 page limit? | Page 163 - (1) PAGE LIMITS | If applicable, the OCI Avoidance or Mitigation Plan is excluded from the Non-Cost/Price Proposal thirty (30) page limit. | Solicitation Page 46, Section 6.b.(1)(iii) | |
| Please confirm that offerors are allowed to submit the supporting text portion of the Cost/Price Proposal in MS Word or searchable PDF as with the Non-Cost/Price proposal? We understand that the Pricing Sheet and Supplemental Pricing Sheet will be submitted via MS Excel. | Page 163- d. ELECTRONIC SUBMISSION | Yes. See Revised Solicitation. | Solicitation Page 163, Section 1d | |
| Can the government confirm that continuing education and training of contract staff is billable to the government? | Page 23 – 3.8.3. Key Task 3: The contractor shall provide continuing education and training of OHARO and OHRO reviewer staff in current human subjects protection topics at staff meetings. Page 26 - 3.13.15. Key Task 15: The contractor shall ensure continued and up-to-date HSPS professional competency through continuing education and participation in other professional activities. | No, Contractor shall provide at their own expense. | None Provided | |
| Can the Government confirm the requirement to submit labor hours expended, by labor category, for each task in the Monthly Progress report as this would seem to be unnecessary administrative burden for a Firm Fixed Price contract? | Page13– The Contractor shall deliver to the COR a MPR (Deliverable 5) detailing the progress, vice review of the key tasks in Section 3, target completion, labor hours expended by labor category for each task, invoices, and any problems/issues encountered in the performance of this PWS. The Contractor shall work with the COR on the MPR format. | See Revised PWS Section 2.13. | PWS Section 2.13 | |
| Can the government please confirm if the transition in plan is to be finalized 5 or 10 calendar DACA? | Page 37 – DELIVERABLES: For Deliverable 8, The transition in plan, the due date is listed as “Proposal submission and finalized five (10) calendar DACA” | Ten (10) calendar DACA. See Revised PWS Section 5.6. | PWS Section 5.6 | |
| Can the government clarify if there is a size limitation for electronic proposal submissions? | Can the government clarify if there is a size limitation for electronic proposal submissions? | Any emails over 15MG should be divided into separate emails (i.e. 1 of 2, 2 of 2). NOTE: IAW the Solicitation, the Offeror is responsible for verifying receipt by the POC. | None Provided | |
| Can you specify which procedures this requirement will be evaluated under, i.e. either FAR Part 13 or FAR Part 15 procedures? | Page 176 – Evaluation – Commercial Products and Commercial Services | FAR Part 15. | None Provided | |
| Is the scope of the performance an assessment of protocol submitted from past, current, and potential USAMRDC research? If so, would the contractor on this requirement be at risk of conflicts on future procurements for USAMRDC research requirements? | Page 7 and Page 166 - ORGANIZATIONAL CONFLICT OF INTEREST (OCI) CERTIFICATION: The Offeror shall complete the OCI Certification (PWS Attachment B) and provide (if necessary) an OCI Avoidance or Mitigation Plan. | In general, the Government cannot comment on any real or perceived future conflicts of interest, however, it should be understood that an awardee would be prohibited (firewalled) from conducting reviews and/or working on any projects awarded to their employer (company). If an Offeror has or perceives a conflict of interest prior to proposal submission then they shall submit the OCI certification outlining their mitigation of their perceived or actual conflict of interest. | None Provided | |
| Given the commercial nature of this contract, can the contractor include any industry standard contractual terms in their proposal that would typically apply to the commercial services being proposed by the contractor, in order for the inclusion of such terms into the final contract to be considered? | Page 8 – Contract Management | No. | None Provided | |
| Would the contractor or contractor personnel performing this contract require a security clearance? | Page 18 – 4.1 Security and Safety | No security clearances required. | None Provided |
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