05. Solicitation Amendment # 0001.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

CC

THIS DOCUMENT SERVES AS AMENDMENT NUMBER 0001 OF SOLICITATION NUMBER HHSN-21-Q-000048. THE

FOLLOWING ITEMS ARE AMENDED:

1) THIS AMENDMENT POSTS ANSWERS IN RESPONSE TO QUESTIONS FROM THE VENDOR COMMUNITY.

2) AN AMENDED PRICE SCHEDULE HAS BEEN INCLUDED.

CC

National Institutes of Health NIH Clinical Center Bethesda, MD 20892-7511

To all Offerors/Bidders

National Institutes of Health NIH Clinical Center Bethesda, MD 20892-7511

HHSN-21-Q-000048

1 5

03/31/2021

03/08/2021

RFQ - HHSN-21-Q-000048 – ASEPTIC PROCESSING FACILITY (APF) CERTIFICATION AND

TESTING PROGRAM FOR THE NATIONAL INSTITUTES OF HEALTH (NIH), CLINICAL CENTER

(CC), OFFICE OF RESEARCH SUPPORT AND COMPLIANCE (ORSC) QUESTIONS AND ANSWERS:

1. Equipment List – The solicitation document identifies an equipment list that is said to be an attachment. I am unable to find any attachments. Can this be provided?

ANSWER: Please see the attachments to the solicitation labeled:

04. Baseline Equipment and Calibration Needs

04. Current and Future APF Room and PEC Needs

2. Frequency – Can NIH provide schedules for the certification/testing/maintenance/qualification activities that identifies quantity and interval for which is required to satisfactorily accomplish the

SOW.

ANSWER: Please see the attachments to the solicitation labeled:

04. Current and Future APF Room and PEC Needs

3. Spare Parts – Solicitation indicates that the contractor is to provide and keep in stock required spare parts.

Can NIH provide a listing that identifies the required inventory?

Does NIH currently maintain a spare part inventory that is to transfer to contractor?

If a list of require spare parts has not been developed to date, can contractor bid as cost plus fee for consumables/replacement parts?

ANSWER: The Spare parts list would be developed by the contractor and approved by the NIH.

4. Contract – Can we as prime contractor subcontract with a strategic partner(s) to provide the best solution for resourcing and breadth of expertise?

ANSWER: Yes. Contractor Team Arrangements are authorized.

5. Contract – how would NIH prefer we budget for future areas that will be added to the scope? Can NIH provide baseline assumption(s) for the purposes of developing a fairly informed budget in our response?

ANSWER: Baseline assumptions for future areas are included in the following document:

6. The pricing bid form may clear this up. Are you looking for unit cost pricing for APF certification/AVS services? Equipment calibration? IQ/OQ/PQ of equipment?

ANSWER: Yes to all.

7. Is there a lab equipment list that will be provided for this RFP?

ANSWER: Please see attachment labeled 04. Current and Future APF Room and PEC Needs.

8. Are you providing floor plans and RCPs for the APFs?

ANSWER: Floor plans will be provided at the time of award.

9. The areas of the RFP for equipment maintenance, calibration, repair and spare parts – this is something that Genesis does not provide. We can sub-contract this work, but again I’m not sure what type of pricing structure you are looking for right now for this RFP. We can go out to some local firms that provide these services, if needed for this RFP to get pricing. Please advise.

ANSWER: Suggestion is to work with local subcontractors for estimated pricing.

10. Does NIH provide the storage space for the equipment/parts or will that need to be bid in?

ANSWER: No, that should be part of the bid.

11. For replacement parts, do you have a quantity we are to bid to replace each year or will this component of the service be bid cost plus markup?

ANSWER: This is a component of the service.

12. For many BSCs are certified per year?

ANSWER: Please complete a thorough review of all attachments to this solicitation to discover the information requested.

13. How many fume hoods are certified per year?

14. How many isolators are certified per year?

15. How many flow benches/LAFW are certified per year?

16. Within the RFP document, does the term PEC represent BSCs, fume hoods, isolators and fume hood?

ANSWER: Yes is the answer to this question.

17. Does NIH follow USP 797 for all PECs/facility certifications (each will be certified twice a year)?

ANSWER: For facilities governed by USP 797 they follow the guidance document (2Xs/year).

18. Please provide SOPs for ISO 14644 certification Specification

ANSWER: The contractor will be required to develop their own SOPs for approval by the Government.

19. Please provide the current schedule that covers when each facility and PEC (fume hood, BSC, isolator, flow bench) is certified.

20. Would the management of the TAB Company be a part of this scope?

ANSWER: Yes is the answer to this question.

21. Please provide SOPs on environmental monitoring.

ANSWER: SOPs on EM will be provided at the time of award. Contractor will be expected to develop EM equipment maintenance SOPs for approval by the Government.

22. If your SOPs do not cover EM frequencies and quantities, please provide this information.

ANSWER: SOPs cover EM frequency and quantities and will be provided at time of award.

23. Please provide Attachment B

ANSWER: This document is labeled 04. Current and Future APF Room and PEC Needs.

24. What services within the RFP are outsourced? Please provide the companies that are currently providing these services.

ANSWER: Information will be provided after award has been made.

25. Please provide the Pricing Excel sheet

ANSWER: The Pricing Excel Spreadsheet was posted to the Solicitation Announcement. The document is labeled “01. Price Schedule.”

26. The sheet is prepopulated with hours. Are we to leave these hours as-is or can we edit them to what we think each line item should take?

ANSWER: The Contractor may edit the hours included in the Price Schedule as seen fit to complete each task.

27. We understand from the RFP that the NIH is looking for a full-time project manager. The top of the pricing sheet has a field for the PM. It also has a field for two (2) support staff. Since the tables below are for the actual work scope execution hours, what is the intent of the two (2) support staff line item at the top? Please clarify this role and this staff requirement.

ANSWER: Support Staff would be responsible for tasks such as document management, protocol development and routing, training, auditing, coordinating work, and other administrative tasks associated with managing the contract.

28. The pricing table includes hourly rate for services that are not purchased ‘by the hour’. For those services, Genesis will have to sub-contract to a testing agency that charges ‘by unit cost of equipment’ or ‘by unit cost for each room’. These would include equipment calibration, PEC equipment certification, cleanroom certification, smoke studies (AVS). For these services we have hourly costs incurred by Genesis personnel to manage/review the work and a subcontracted unit cost for each activity. For example, the room certification firm we use would provide an overall cost broken out for each area shown in the table (E-IVAU, TIL Lab, Sterility Lab, etc….), not an hourly cost. Will the pricing table be updated to reflect how these services are bought out?

ANSWER: We are open to the response including the overall cost instead of hourly with a clear explanation of the difference. The Contractor may update to the Price Schedule to reflect how these services are bought out.

29. There are no fields for travel & living expenses. Where can we provide this estimated cost? Genesis staff and sub-contracted staff will have travel expenses.

ANSWER: The Contractor may add a line item to the Price Schedule for Travel Expenses/Per Diem.

30. The pricing table has a 7.5% “O&M Multiplier” in the tables for Base Period and Option Periods at the bottom of the form. What is this “O&M Multiplier”?

ANSWER: This section of the Price Schedule has been deleted.

31. The pricing table does not have a field for estimated test equipment rental/calibration. To perform a portion of the work, this is an incurred cost that needs to be included. Can the pricing table be updated to include this line item?

ANSWER: We would expect those costs to be part of the normal costs incurred by the company performing the work. However, please add a Line Item to the Price Schedule to account for this work.

32. Section C.4.4 indicates that standard PM tasks are in the contractor’s scope. Genesis would need to subcontract this work to a company that performs this work. Please define what the standard maintenance tasks are for each type of equipment in the scope (maintenance task list or SOPs?).

a. Are the PM tasks assumed to only occur once per year per piece of equipment? Generally a PM schedule and list of PM tasks for each piece of equipment is needed in order to get contractor pricing.

ANSWER: The PM tasks would be part of the project manager’s scope of work and startup of the contract. Details will vary from facility to facility depending on regulatory requirements. Given the list of facilities, the respondent may use assumptions based on the type of facility and requirements.

b. There are no fields in the pricing sheet for this scope item.

ANSWER: The Contractor has the authority to add this item to the Price Schedule as required to ensure accurate pricing is provided.

33. Section C.4.7 (Page 18) indicates that CTU qualifications require temperature mapping and open door recovery testing. Will every single CTU require empty and loaded chamber temperature mapping on an annual basis for the yearly requalification?

ANSWER: This requirement will be refined after contract kick-off meeting and is based upon separate facility and regulatory requirements.

34. Our PM will be traveling to the site on a weekly basis from outside of the area. Is the NIH open to the PM being 2-3 days onsite as a minimum with flexibility to work remotely the other days?

ANSWER: Schedule flexibility will be authorized. Telework hours can be negotiated after award of the contract. The expectation is that during the initial startup phase of the contract, the PM will need to be onsite full-time.