Questions and Answers for Solicitation 36C10XQ0189 _ Quality and Regulatory Support.pdf

Questions and Answers for Solicitation 36C10XQ0189 – Quality and Regulatory Support

1. This Performance Work Statement seems to be limited to regulatory and quality activities around development, production, and FDA clearance or approval of medical devices. Does the contracting officer anticipate the Offeror will need to access protected health information, sensitive personal information, or patient data to complete the tasks outlined in Section 7 of B.2 Performance Work Statement?

Contractor will not need access to protected health information, sensitive personal information, or patient data to complete tasks outlined in this scope of work. Scope of work has been amended to reflect this change.

2. Under B.1 IT Contract Security, Section 4 Information System Design and Development outlines requirements for the design and development of information systems. How is this section anticipated to apply to the B.2 Performance Work Statement? It seems the Performance Work Statement does not include any design and development of information systems or software.

The CO has removed the standard IT Clause at B.1 as Section 12 of the PWS “Security and Privacy Requirements” covers the items required for this effort.

3. Throughout Section B.2: Performance Work Statement, the Task Statements include documentation that will be generated by the contractor or in collaboration with the VA staff and the contractor. If it is understood at this time, how many documents are anticipated to be produced during the period of performance?

Document reviews are mentioned in a number of tasks in this PWS. Based on prior years efforts, VHA anticipates 200 – 300 newly created labelling, process validation, and other Device Master Record (DMR) documents will require regulatory review per annum. Additionally, VHA anticipates reviews during the document change process of 100 - 150 existing quality system documents, a mix of quality system SOPs, Validation Reports, DMR records, and Labelling on an annual basis. Reviews cover technical completeness, validation approach, and determination of effect on existing regulatory clearances. Documentation of reviews occurs as a component of the change control process, where the contractor signs as the regulatory member of the team. Reviews are included as part of the CLIN in which the work occurs (QMS support, Development, or other topic area). Scope of work has been amended to reflect this update.

4. In the Task 7.3.1 Deliverables table on page 19 it seems from the Delivesry Schedule which has a timeline “after exercise of option” that CLIN 0004 and CLIN 0005 are intended to be Optional. In addition, in B.3 Price/Cost Schedule CLIN 0004, CLIN 1004, CLIN 2004, CLIN 3004, and CLIN 4004 are marked as Optional. Could you please clarify if the previously listed CLINs are intended to be Optional?

No, the CLIN is not optional. Delivery schedule has been amended to reflect this change.

5. 7.4.1 Task includes the support of successful installation of new advanced manufacturing technologies to expand PoC manufacturing capabilities within the OAM hub sites. If it is understood at this time, how many new advanced manufacturing technologies are anticipated to need installation guidance during the period of performance?

This support encompasses the 5 different 3d printing technologies currently employed at VHA and anticipate adding 3-4 technologies (Foam printing, Bio-Printing, and Metal printing for example). Task statement amended to reflect this update.

6. 7.5.1 Task includes the development of PoC competencies for VHA staff engaged in medical device manufacturing. If it is understood at this time, how many sites will need training and what is the experience level of this staff with Point of Care manufacturing, a Quality Management System environment, and the product development process for medical devices following 21 CFR 820.30 (Design Controls)?

The primary audience for the training will be mid-career engineering professionals (GS 7-12), with little experience in formal quality management systems or formal design controls (21CFR80.30). The secondary audience will be health care professionals including occupational therapists, physical therapists, clinical engineers (Rehabilitation), and MD’s as examples. We anticipate that the secondary audience has no experience with quality management systems or formal design controls.

Group training audiences of 10 – 20 participants are anticipated; efforts will be made to group teams by either proficiency or job function. Training will encompass 2 to 3 physical locations as well as remote training. Individual training will be performed remotely and we will identify individuals and required competency at the kickoff meeting and review/update quarterly as part of the status report for this CLIN.

Task statement amended to reflect these updates.

7. In B.3 Price/Cost Schedule (page 40-49) CLIN 0007AB, 1007AB, 2007AB, 3007AB, 4007AB asks for a quantity of 6.00 each and notes the option is ordered in tranche of six. Please clarify if, for example 0007AB: Optional - Rapid Response Assessment “Quantity 6 Each” means an option will be executed six times with six assessments in each option for a total of 36 optional assessments possible over the period of performance OR if one option is six Rapid Response Assessments and there would only be one execution of the option for a total of six optional assessments possible over the period of performance.

Price/Cost schedule updated. Only one option to be executed for six Rapid Response Assessments during period of performance.

8. In B.3 Price/Cost Schedule (page 40-49) CLIN 0008AB, 1008AB, 2008AB, 3008AB, 4008AB it asks for a quantity of 2.00 each and the option is ordered in tranche of 2. Please clarify if, for example 0008AB: Optional - Stand Alone Regulatory Assessment “Quantity 2 Each” means an option will be executed two times with two assessments in each option for a total of four optional assessments possible over the period of performance OR if one option is two Stand Alone Regulatory Assessments and there would only be one execution of the option for a total of two optional assessments possible over the period of performance.

Price/Cost schedule updated. Only one option to be executed for two Stand Alone Regulatory Assessments during period of performance.

9. In B.3 Price/Cost Schedule (page 40-49) each option period includes a CLIN for “Expanded Access Strategy”. CLIN 0005 states “Draft or revision to exisiting SOP, to describe our process for developing products intended for Expanded Access. (Expanded Access Strategy)”. Is it expected that the option period CLINs (1005, 2005, 3005, and 4005) would include reviewing and providing potential revision to this SOP or are there additional tasks anticipated with “Expanded Access Strategy” in future potential option periods?

We envision that the Expanded Access Strategy will be a more extensive ongoing task with future variants built of the newly created version depending on situation. We anticipate ongoing activities under CLIN 0005 during the option periods and should not be accounted for in other CLINS. No change to price cost schedule.

10. On page 34, 12.2.3 (8)(i) it seems VA Form 0752 Confidentiality of Sensitive Information Non- Disclosure Agreement applies only to Contractor employees that receive Government furnished laptops. Is this the correct understanding of this section?

Yes, this applies to all Contractor employees that receive Government furnished laptops.

11. For C.13 VAAR 852.219-75 beginning on page 77 it seems none of the boxes are checked in (a)(1)(i through iii). Please confirm if this means they do not apply.

(a)(1)(i) should be marked for services. This has been updated. Please complete the certification section at the bottom of the clause.

12. Since the entity "Vendor" reviews and updates information on SAM.gov annually, is it correctly understood that the only paragraph which requires response in section E.3 2.212-3 is paragraph (b), which directs Offeror to review the registration on SAM.gov to provide any updates? Therefore, if the Offeror is previously registered in SAM.gov and the information is up to date, then section (c) starting on page 93 through the top of page 106 is not necessary to complete. Is this the correct understanding of this section?

Correct. If the information in SAM.gov is current and accurate, a simple statement at the end of paragraph (b)(2) is all that is required. Follow on sections are not required if SAM.gov is current.

13. In past contracts, "Vendor" has used the Tungsten Invoicing System and has not provided a separate invoice outside of the invoice generated by the Government required Tungsten Invoicing System. Under Section C.2 52.212-4 (g) Invoice it seems there are requirements for unique invoices outside of the Tungsten Invoicing System. Would you please clarify if it is expected the Tungsten Invoicing System will be sufficient for invoicing for this RFQ or if unique invoices will also need to be submitted by mail to the invoice mailing address specified in the contract?

FAR Clause 52.212-4 is required for this contract and is not tailorable. However, invoicing shall be accomplished as stated on solicitation page 4 “TUNGSTEN ELECTRONIC INVOICE SUBMISSION.”

14. Typically, resumes or CVs of individuals participating in contracted work are provided to an organization following 21 CFR 820. Would resumes be desired at this time, and if so, would they be included in the page limitations? The qualifications of the individuals are quite extensive and may rapidly reduce available pages to respond either to Technical Capability or Past Performance Volumes.

No resumes required for submission at this time.

15. Volume III – Price component of the submission notes that the contractor shall submit a completed Section B.3 Price/Quote Schedule. Section B.3 is titled Price/Cost Schedule. Would the contracting officer need both Section B.3 table completed and a unique quote from the Offeror, OR only Section B.3 Price/Cost Schedule completed?

Amended to read Section B.3 Price/Cost Schedule. Completing the Unit price and Amount sections of B.3 are all that is required.

16. In Section B.3 Price/Cost Schedule each year has a Yearly Total line. Should this yearly total include the cost of the Optional CLINs?

Yes. Optional CLINs must be included in the Yearly total price. This represents the evaluated price but may not be the obligated price at the time of award. The Government is required to evaluate total price to include optional items to determine fair and reasonable pricing.