Attachment 12-RFP Questions and Answers11232021docx.pdf

RFP 22-000946 QUESTIONS/ANSWERS AND CLARIFICATION

(Government Response in RED)

1. Attachment 2-PWS, Section 3.0, item #3, page 2: Regarding “The Contractor shall provide a minimum of two (2) qualified technicians to work on-site at DLM… the hours of 7:30 AM and 5:00 PM.”

Do you currently have two technicians (i.e. processors) working on-site at DLM? The incumbent contractor currently provides at least 2 contractors on site in DLM, sometimes 3.

Are the technicians only on-site Monday – Friday? Yes.

2. Attachment 2-PWS, Section 3.0, item #20, page 4: Regarding “the DLM shall be permitted up to 40 blind control samples per month (that is, 480/year) free of charge to monitor any assay suspected as being questionable by the DLM”.

Can you provide examples of which tests DLM has submitted for this purpose? Over the past 4 years, DLM has requested blind controls for the following tests listed from most requested (at the top) to least requested (at the bottom):

• Metanepharines, Free/Fractionated, Plasma

• Cortisol/Cortisone, Free/Random, Urine

• Cortisol, Saliva

• IGF-1, LC/MS, Serum

• Dehydroepiandrosterone, Serum

• Thyroxine Binding Globulin, Serum

• Lipase, Body Fluid

• Catecholamine Fract, Free, Plasma

• T4 (Thyroxine), Free by Dialysis, Serum

• Vitamin E, Serum

• Corticosterone, Serum

• Free Fatty Acids, Total, Serum

• Beta-2 Microglobulin, Urine

• Vitamin A, Serum

• T3 (Triiodothyronine), Reverse, Serum

• Parathyroid Hormone (PTH), Serum

• VDRL, CSF

• RPR Screen, Response to Therapy, Serum

• Potassium, BF

• Chloride, BF

• Sodium, BF

• Alanine Aminotransferase (ALT), Serum

• Adrenocorticotropic Hormone, Plasma

• Androstenedione, Serum

• Immunoglobulin M (IgM), Serum

• 17-Hydroxyprogesterone, Serum

• Testosterone, Total, Serum

• Busulfan, Pharmacokinetics

• Ab to Extractable Nuclear Ag Eval, Serum

3. Attachment 2-PWS, Section 3.0, item #21, page 4: Regarding “NIH will provide the FedEx number and pay for the cost of all shipping for validation and comparison samples”.

Just to clarify, are these samples that the Contractor would send to an alternate lab?

Yes, but also if the vendor would not permit validation/comparison samples to be sent along with the clinical sample courier, it would apply to samples going to the vendor’s lab as well.

4. Who is the incumbent laboratory?

MAYO COLLABORATIVE SERVICES LLC

3050 SUPERIOR DRIVE NW

ROCHESTER MN 559011995

DUNS# 10-849-9682

5. How many employees does the incumbent lab currently have staffed onsite at NIH? Is it the

2 techs referenced in the RFP materials or are there more employees? 2-3 technicians work M-F.

6. What are the expectations for the days of the week the technicians will work on site at DLM?

The technicians are expected to work Monday-Friday.

7. The Contractor’s on-site personnel shall provide any pre-processing of samples as needed.

Would like clarification – is this spinning down or splitting specimens or does this including adding chemicals as needed (i/e/ perchloric acid, adjusting Ph) to the specimens? Spinning down and splitting is performed by contractor staff. Pre-treatment of samples is performed by DLM laboratory staff.

8. Building an interface is dependent, in part, upon resource availability at the IT vendor. If the

Contractor could not build and implement an interface within 30 days after contract award, would this exclude them from being selected? For clarification the PWS, Page 3, Section 3.0 Tasks, Subsection 8, states that the interface must be built within 30 days. A full implementation timeline of the ordering/resulting interface should be communicated as part of the transition plan.

9. Can the contractor enter into non-disclosure agreement on behalf of their employees and not have employees sign NDAs? The contractor and on-site contractors must sign a non-disclosure agreement.

10. Will a proposal that does not include a Subcontracting Plan be considered for this RFP? A subcontracting plan must be submitted in order to be considered for award.

11. How will changing laboratories effect the current clinical trials that are ongoing at NIH?

Changing laboratories may not affect clinical trials, but changing test method could present differences in test reporting that could cause protocol deviations or an inability to accurately track test result data over long periods of time.

12. General question: Please clarify where/how contractors can provide clarifications and proposed modifications to the attachments. Please submit clarification questions regarding the solicitation attachments during the question/answer period that will be extended until Nov 29, 2021, 3:00PM eastern.

13. Attachment 3-Annual Specimen Test Schedule 11.09.21 HC

a. Should testing that originate from various institutes that are not ordered by DLM be included in this RFP? No, please respond to tests listed in Attachment 3 only.

b. Are we able to add additional columns? (i.e., Vendor’s Test Name, Turnaround

Time, Methodology, Test Notes, etc.) Yes, it is OK to provide more information than is being required.

14. Please confirm if Attachment 6 Contractor Non-Disclosure Agreement needs to be included with the documents in our response as it states on the top of the document ‘To be completed by a contractor upon award of contract. The non-disclosure agreement does not need to be included with the proposal.

15. Attachment 7 Security and Privacy Language for Information and Information Technology

Procurement, Section I.1) f., page 4. Please clarify what contract documentation this would include? In other words, what NIH agency documents, templates, policies and forms would the NIH require the contractor utilize? A customized “Memorandum of Understanding” will need to be established between the selected vendor and the NIH Information Security

Department for interfacing. A non-disclosure agreement between the vendor and on-site personnel is also required, along with an Interconnection Security Agreement (ISA).

16. Please confirm that Attachment 8-NIH2043 is applicable to this RFP as it appears to be a summary page for research studies. Attachment 8, NIH2043 is hereby removed as a requirement for the solicitation.

17. Please clarify if the Attachment 10 - Wage Determination is applicable to this RFP, and if it is, please explain what specifically the contractor will need to abide by to ensure compliance with the Wage Determination. Wage determination is applicable to this RFP for on-site contract staff. Please visit www.dol.gov for specific compliance rules for contractors under the Service Contract Act.

18. In the solicitation, RFP 22-000946 Reference Laboratory Testing Services, Section A.8, Page 1, it states that offers will be valid for 90 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

However, in Section L, 2a, 2I COVER PAGE, Page 36, it states that the cover letter must contain a statement to the effect that the offer is firm for a period of at least 150 days from the date of receipt by the Government. Can you clarify if our offer should be held firm for

90 days or 150 days? The offer shall be held firm for at least 150 days. The requirement of the NIH2043 submission is hereby removed.

19. Attachment 11-Invoicing Instructions, Section 1.A, subsection 10 and 12., page 1: How does this apply to tests ordered that are not on the award? The forthcoming contract must be modified to include new tests and pricing before ordering.

20. Attachment 11-Invoicing Instructions, Section 1V. a. through c., page: Is the acce lerated payment to small business subcontractors applicable to this lab testing services agreement?

Yes, accelerated payment to small business subcontractors is applicable to this solicitation.

21. Attachment 2-Performance Work Statement, Section 2.0 Scope of Work, paragraph 2, page

1: Regarding the language that newly added tests shall receive the same price reduction/discount as the contract pricing list, please clarify that the NIH is open to negotiating newly added test prices based on anticipated volumes of such tests. The NIH is open to negotiating newly added test prices based on anticipated volumes of such tests.

22. Attachment 2-Performance Work Statement, Section 3.0 Tasks, Subsection 20, page 4:

Please clarify the intent of this section. Is the NIH indicating that you will be able to send 40 samples to the contractor per month or are you asking that the contractor send 40 samples per month for this purpose? This section applies to DLM’s desire to send up to 40 samples per month to the reference laboratory.

23. Attachment 2-Performance Work Statement, Section 5 Standards For Acceptance of Deliverables, Second paragraph/table, page 9: Please clarify the scope and format of the

Quality Control Plan (QCP).

QCP at a minimum should contain how the vendor plans to provide quality control of the following operational aspects of the contract:

-Pre-analytical sample processing by their on-site (in DLM) contract staff

- Transport of samples from NIH to vendor laboratory via a subcontracted or vendor courier staff -Receipt and distribution of NIH samples at the vendor laboratory

-Testing of NIH samples at the vendor and any 3rd party/subcontracted laboratory sites

-Reporting of NIH sample results into the vendor’s LIS and across the vendor/DLM interface

-Specific format is not required

24. Attachment 2-Performance Work Statement, Section 5 Standards For Acceptance of

Deliverables, Second paragraph/table, page 9: Regarding the Transition Plan, please clarify if the incumbent would need to submit a transition plan if they are awarded the contract. A transition plan is required to discuss the deliverables needed to successful ly transfer into a new contract and begin operations.

25. Attachment 2-Performance Work Statement, Section 9.0 Period of Performance/Place of

Performance, page 11: Please clarify that this entire section is meant to apply to on-site specimen processors.

All reference laboratory testing is to be performed at the vendor’s site or subcontractor site.

On site contractors perform preanalytical specimen processing only on-site at the National Institutes of Health, Clinical Center.

26. RFP 22-000946 Reference Laboratory Testing Services, Article B.5. Advance Understandings, paragraph 1, page 6: In the first sentence it indicates contractor shall use “approved laboratories”. What does “approved” mean in this context? If the contractor does forward testing on to a third party lab at the NIH's request, but does not typically consider such third party lab to be a subcontractor, does the NIH still consider these labs to be subcontractors under this contract? “Approved Laboratories” are those selected by the vendor that are licensed by CLIA. NIH will not directly request the contract vendor to send tests to a third party lab.

27. RFP 22-000946 Reference Laboratory Testing Services, Article C.1. Reporting Requirements, paragraphs 1-3, page 7: please clarify that this language is referring to the test results.

This language is not referring to test results directly but overarching contract activities undertaken during the reporting period and will require information about planned activities for future reporting periods. This could be in regard to testing, IT platforms, contract staff, or various aspects surrounding the contract.

28. RFP 22-000946 Reference Laboratory Testing Services, Article C.1. Reporting Requirements, Subsection 1.b.: Please clarify the scope of this requirement. Is it meant to capture individuals that are on-site at the NIH or any employee at a third-party lab that the contractor may send testing on to? If the latter, it would be almost impossible to police as the contractor would not know specific employees that have access? Is there any reason employees wouldn’t just fall under contractor’s confidentiality provisions? Article C.1.

Reporting Requirements, Subsection 1.b. is meant to capture on-site contractors.

29. RFP 22-000946 Reference Laboratory Testing Services, Section E – Inspection and Acceptance, subsection d., page 10: For the services contemplated under the resulting agreement, will the NIH have the ability to inspect the contractor labs on-site at the

Contractor's place of performance or just the ability to review records? NIH will have the ability to inspect the contractor labs on-site at the Contractor's place of performance and the ability to review records if needed.

30. RFP 22-000946 Reference Laboratory Testing Services, Article G.7 On-Site Contractor Access to Government Property, paragraph 2, page 14: For technicians/processors on-site using government equipment, is the contractor responsible for maintenance of such equipment such as a computer? No, but the contractor would be responsible for maintenance of contractor-provided equipment including computers, printers, faxes, etc.

31. RFP 22-000946 Reference Laboratory Testing Services, Article H.2. Acknowledgement of Federal Funding, page 16: Can you clarify when this will come into play? What are the expectations when contractor bids on other federal work outside of the NIH work?

This article shall come into play when the contractor is issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money. This does not apply to when prospective vendors bid on other federal work outside of the NIH Work.

32. Who is the incumbent? Please provide incumbent company full name who currently performs, or has previously performed these services in part or full, their DUNS, and contract number.

MAYO COLLABORATIVE SERVICES LLC

3050 SUPERIOR DRIVE NW

ROCHESTER MN 559011995

DUNS# 10-849-9682

NIH Contract# HHSN269201600004I

33. Given the extensive list of tests to be performed, is the government amenable to receiving proposals from organizations that can support most but not all 142 tests listed, with the goal of supporting remaining (or any new additions) over time as the program matures? No, the current list was developed from tests requested by NIH at least 5x per month. Therefore, these are all relevant and necessary tests. To reduce our access to current testing would be undesirable.

34. Will the proposal be deemed non-compliant if less than 142 tests are supported initially (goal to support 100% over time)? If not, within what time should 100% of tests be supported?

Yes, the proposed vendor must be able to support all tests in Attachment 3.

35. What is the anticipated award date? The anticipated award date for the contract is by Jan 1, 2022.

36. What is the anticipated date to commence performance? The anticipated date to commence performance is by February 1, 2022.

37. How much time will the awardee have to operationalize from the time performance begins?

For clarification the PWS, Page 3, Section 3.0 Tasks, Subsection 8, states that the interface must be built within 30 days. A full implementation timeline of the ordering/resulting interface should be communicated as part of the transition plan.

38. What is the evaluation criteria for award, including weight by factors? Please see SECTION M - EVALUATION FACTORS FOR AWARD, beginning on page 46 of the solicitation.