SOL-NC-15-00006_Technical_Questions_&_Answers.pdf

Technical Questions

SOL-NC-15-00006

Operation, Maintenance & Modification of the Human Studies Facility, Chapel Hill. North Carolina

1. (SOW, Section D. Task 2, p.8) Under Item 2, “Data Management,” the SOW references an attached QAPP in Attachment 5 containing a “summary of the data validation process.”

Attachment 5 is not a QAPP, but rather a QASP that does not contain data validation information, but contains performance standards for facility operations. Is this correct, or should a QAPP be included as Attachment 5?

Answer: The reference to the Quality Assurance Project Plan (QAPP) has been removed from the Performance Work Statement, see attached revised PWS.

2. (Section L.16 (b), p.81) Will the Government specify the number of days allotted for contract transition, assuming a 10/01/15 start date (per Clause F.3, p.15), so that the contractor can adequately respond in the required Transition Plan? We recommend at least a 15 day transition window to allow for 10-day post-debrief periods to pass.

Answer: The offeror should assume a 30 day transition period.

3. (Section L.16) Providing page limitations offers the Government a more level competitive field.

Did the Government intend to establish page limitations for the OM&M HSF proposal sections (excluding QMP)? If so, please provide the page limitations for each section.

Answer: There is no page limitation.

4. (Section L.16, p.79) Section B “Quality Assurance” of the Technical Proposal references the qualification process of subcontractors “especially with regard to clinically recognized certifications of outside testing laboratories and service providers.” Is this referring to ISO 15189 requirements or CLIA certifications? The Centers for Medicare & Medicaid Services (CMS) “regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).” Please verify that these requirements and/or certifications are/are not what the Government is referring to and if exposure testing performed by this facility is covered by these requirements.

Answer: Compliance with ISO 15189 and CLIA is not required for exposure testing and is not being referred to or required by the Government offeror.

5. (Section L.16) Section B “Quality Assurance” of the Technical Proposal references outside laboratories. Could the Government specify what types of tests require outside laboratory testing?

Answer: Testing of exposure gas cylinder compositions and concentrations.

6. (Section L.16, p.82-83) Under FIXED PRICES, (ii), the Government asks for the price for the option for additional work. If additional work is required by the Government and expected to be costed in an Offeror’s proposal, then will the Government supply the type and quantity of work to be performed, especially since requiring Offerors to cost the option for additional work at a fixed price.

Answer: The reference to additional work in provision L.16 has been removed, see attached revised provision.

7. ( L.7, p. 74 and Attachment 8, Client Authorization Letter) RFP Section L.7 states that “Client Authorization Letters should be mailed or e-mailed to individual references no later than 5 working days after proposal submission.” In Attachment 8, Client Authorization Letter, the RFP states that “EPA has requested receipt of this information by close of business June 9, 2015.”

Please clarify the date that the Client Authorization Letter must be e-mailed to our references – is it five days after the current proposal due date of June 9, 2015?

Answer: The due date for the receipt of past performance information has been changed to 10 calendar days after proposal submission, see revised attachment 8.

8. (Attachment 8, Client Authorization Letter) In Attachment 8, Client Authorization Letter, the RFP states “Attached is the Government’s Past Performance Questionnaire.” Please clarify if offerors should e-mail both the letter and questionnaire to all references.

Answer: The offeror should email both the Client Authorization Letter and Past Performance Questionnaire to its past performance references.

9. (Attachment 9, past Performance Questionnaire) Is the Government expecting the Offeror to instruct our references to send completed questionnaires back to the Government or will the Government contact our references to obtain questionnaire information? If the Offeror is to follow up to ensure the questionnaires are sent back to the Government, what completed questionnaire due date should we provide our references?

Answer: 1) The Client Authorization Letter is sent by the offeror to past performance references and states “Please complete the attached questionnaire(s) to aid the Government in its evaluation of our past performance and email to Ancharski.judy@epa.gov”. The due date for the receipt of past performance information has been changed to 10 calendar days after proposal submission, see revised attachment 8. 2) The Offeror is not required to follow up to ensure the reference is sent back to the Government, however you are encouraged to do so.

mailto:Ancharski.judy@epa.gov