RFP amendment 1.pdf

Amendment #1

RFP # 10-100-SOL-00001

“Laboratory Testing Services”

Amendment to Solicitation No.: RFP # 10-100-SOL-00001

Amendment No.: 1

Amendment Date: February 17, 2010

RFP Issue Date: January 21, 2010

Issued By: Brenda Brooks Contracting Officer

HHS/OS/ASPR/AMCG

330 Independence Avenue S.W., Room 640G Washington, DC 20201

E-Mail: brenda.brooks@hhs.gov

The above numbered solicitation is hereby amended in order to answer questions from prospective offerors, make corrections to the RFP in follow-up to these responses, and extend the due date for receipt of proposals until Monday, March 15, 2010, 3 PM local time. Additionally the RFP issuance date on page 1, block #5, is corrected to list the date as 1/21/2010. Following are the detailed changes to the RFP:

1. The following table lists RFP questions and answers, as well as provides a reference for any applicable RFP changes.

RFP # 10-100-SOL-00001 Page 2

Item No. Questions Responses

Solicitation Revision

Can a research laboratory at a university even become ISO- 9000 accredited? Yes, a research laboratory can be ISO certified. However, ISO 9000 is not the only quality system or regulation that has a 3rd party review or certification and would meet the criteria.

Yes, revision made to page 7, Section C. C.1.F., item #3.

CLIA certification added to example.

Is there any other type of system that can be implemented to meet these standards and if so could you please give me some indication of what that might be?

There are other types of quality management systems that can be implemented. For example, compliance with CLIA regulations, or accreditation by an organization with deeming authority under CLIA (e.g., CAP) would meet requirements.

No

I was wondering if you could clarify what a 3rd party review would consist of?

A third party review can be an audit and/or inspection by an independent party; an internal audit performed by a person or party affiliated with your organization would not normally constitute a 3rd party review.

No

4 Does that mean someone who isn't in our laboratory or someone who is completely unaffiliated with the university?

See response #3 No

5 Are there any examples of quality systems/regulations other than ISO 9000 that you can give me?

See response #2 No

Can it be something as simple as we document our quality control and then show someone in the lab down the hall our data and have them sign off on it

Quality controls are a part of a laboratory quality system. Please see response to items #2 and #3 above.

No

We were wondering if there was anyway you could find out if our accreditation by CAP (College of American Pathologists) for our "clinical laboratory" would meet that minimal qualification criteria for this contract?

Laboratories certified under CLIA, or by a private accrediting organization (such as CAP) would meet the minimum qualification criteria.

No

We have a question regarding the ‘Technical Requirements and Constraints’ on page 6. Item #2 calls for a USDA-approved, BSL- 3 enhanced containment facility. Although we have an enhanced BSL-3, we do not have it in our plans to become UDSA approved due to workflow issues with other programs such as our Laboratory Response Network activities. Is it necessary to meet this requirement to be competitive??

Work with highly pathogenic avian influenza (A/H5N1) requires Select Agent registration under USDA. We have modified the minimal qualifications (Section C1, F, #2 for consistency with M.2 (Mandatory Criteria for Eligibility). An offeror must provide documentation of licenses, certifications, etc. to perform testing with a range of influenza viruses and other respiratory pathogens. Evaluation criteria include recent experience, and complexity of previous work experience; along with the plan for compliance with all safety guidelines and regulations. Some task orders may require capability to work with HPAIV or other USDA-regulated organisms.

Select Agents registration for HPAIV is not required for award; however, some task orders may require work with HPAIV. See response to #10.

Yes, revision made to page 7, Section C, C.1, F, #1. New text indicates that offerors must provide documentation of licenses, certifications, etc. to perform testing with a range of influenza viruses and other respiratory pathogens.

RFP # 10-100-SOL-00001 Page 3

Is the expectation that the “sample task order” for the business plan will be responded to following all of the requirements in Attachment #5, or is just a cost estimate required? (pg 34)

The sample task order should be addressed in offerors’ technical and business proposal. It’s not necessary to follow the format in Attachment #5; however the content should be used as a guide for proposal preparation.

No.

If awarded this contract, would we be required to respond to all ‘Task Orders’ or can we be selective and apply to those that are consistent with our staffing, equipment and facility?

As specified in B.6. Fulfilling Minimum Ordering Requirements, the Contractor must propose on at least one Task Order per year in order to qualify for the “minimum guarantee award amount” during the life of the contract, including all option years, if exercised.

No.

Does a specific amount need to be filled in for items 001 through 003 or is that subject to a response to a specific Task Order? (page 2)

The contract line items are specific to work that is awarded so they do not need to be completed at the time of offerors’ proposal submissions.

No.

Does this mean that the technical proposal should contain reagent and supplies estimates in addition to the direct cost labor categories? If so, is this to be presented in a budget justification type format? (pg 30)

Reagent and supply costs related to the sample task order should be specified in the business proposal.

Yes, revision made to page 34 under Section L, L.5.1. More specific instructions added on pricing the sample task order.

Would it be possible for us to do the BSL-3 work in collaboration with another lab, under my supervision?

It is possible for BSL-3 work to be subcontracted. See FAR 52.244-2 for post-award requirements on requesting consent to subcontract. Also, the business and operational relationship between a successful offeror and any subcontractor or collaborator should be clearly defined and elaborated in offerors’ proposals. Furthermore supporting documentation should be provide to show evidence that the subcontracted laboratory facilities will be available for the duration of the proposed contract, and that the subcontracted facility has the required licenses, certifications, and permits to perform work with novel and highly pathogenic influenza viruses if that is the intended role.

Section C.1., F. Minimal Qualifications, #2 was changed for consistency with statements in L.4 and M.4

Yes, revision made to page 7, Section C1, F, #2. New text indicates offerors must provide documentation assuring availability of laboratory facilities for the duration of the proposed contract.

Are there subsections of the award that will be granted to facilities that will not require BSL-3 containment?

There is a potential for task orders that may not require BSL-3 containment.

Each task order will outline specific work requirements. In general, task order proposals will be solicited from successful contractors, and will be awarded after an evaluation process to one or more laboratory entities that meet specific requirements

Yes, revision made to page 6, Section C1, E, #2. A separate line for each url is now indicated.

Will the testing processes be divided or will the facilities chosen be required to do all testing as outlined in the proposal.

See number 14 No.

We assume that the use of laboratories within two different buildings, with different addresses, but on the same campus on nearby property lots, will be acceptable, and that this requirement precludes the use of sites in different cities. Is this assumption correct? (Pg. 7, F.2)

See number 13

No.

RFP # 10-100-SOL-00001 Page 4

We understand the requirement to comply with the Clinical Laboratory Improvement Act. We assume that this does not require the contractor to be CLIA-certified, but rather to comply with the requirements of CLIA for the purposes of this contract. Is this assumption correct? (Pg. 14, H.2)

CLIA certification is not a requirement for research laboratory testing on human specimens. However, laboratories must comply with a quality system or regulation with third party review and/or certification such as ISO 9000 or

CLIA.

No.

What type of information can be included in the technical volume appendices?

The purpose of the technical appendices is to provide supporting information to supplement the technical information in the proposal, which is limited to only 25 pages (whereas the technical appendix limit is 50 pages).

No.

Please clarify if the Maximum order Limitation of $4.1M set forth in Section B.5 relates to an individual Order or to the Contract Ceiling of contract.

$4.1 million is the contract’s total dollar ceiling.

No.

20 What is the expected Contract Ceiling value of the contract? See item #19 above. No.

21 Are contractors to propose their own labor categories? Correct. No.

Section B.8, Withholding of 20% related to FFP orders.

Milestone payments are normally agreed upon for FFP orders; therefore, payment would not be related to costs incurred. Based on this, withholding should not be applicable since payments are not based on costs.

The first paragraph under this section will be revised to state that withholding on progress payments applies to the time-and-materials task orders only. The second paragraph in the section will remain unchanged.

Yes, revision made to page 8, Section B, B.8.

Page 51, Attachment 5, Task Order Procedures, the requirements set forth in paragraph (vii), itemization of all costs such as fringe benefits and overhead is inconsistent with the requirement to utilize T&M rates as the basis for bidding FFP and T&M orders.

Item vii in Attachment #5 will be revised to make that correction.

Yes, revision made to page 51, Attachment #5.

24 Please confirm that orders will be FFP or T&M; this solicitation notice originally noted orders would be CPFF

Yes, after the pre-solicitation synopsis, it was determined that CPFF task orders would be replaced by T&M orders. No.

Can the government clarify its requirement for T&M and FP rates? Is the government expecting 2 tables, covering T&M and FP rates, or one rate for both contract types?

The labor rate table in B.4. Advance Understanding, item #2, does not need to be completed with the offerors’ business proposal. Rate information will be discussed with offerors in the competitive range.

It’s expected that labor categories to be targeted are key personnel, selected lab staff, and others to be determined. The rate table will then be completed and included in any resulting contract awards.

Yes, revision made to page 2, Section B. B.4.2

Can you confirm that no response is required for B.2.A & B (CLINs), and would they will be completed upon contract/task award.

Yes, offerors are not expected to complete the CLIN’s table in Section B as part of its business proposal. The table will be included in contract documents and will be completed when work is awarded.

No.

RFP # 10-100-SOL-00001 Page 5

Section B.4.2 states that loaded labor rates for key personnel in the base and option years will be determined prior to contract award and listed in the table below. Does this mean the government does not require labor rates for other labor categories that will be used in the performance of the contract?

No, other labor categories besides key personnel may be included in the labor rate table. The reference to key personnel only will be corrected in a RFP amendment. Yes, see response to

#25.

L.5.1 - Sample Task - For pricing purposes, what contract type is desired for the sample task?

The contract type for all items listed in the sample task order is firm fixed price.

Yes, revision made to page 34, Section L, L.5.1..

2. The following table provides specific information on the RFP changes. Text highlighted in yellow indicates revised text or additional text.

Current RFP - language Changes made Page 2, Section B, B.4. item #2, is revised per response #25. The first sentence in this paragraph is superseded by the following :

2.Fully loaded labor rates for selected personnel (key individuals, lab staff and others) in the base and option years will be determined prior to contract award and listed in the below table.

Page 4, Section B, B.8, paragraph 2, is revised per response #22. Under B.8. WITHHOLDING, the first paragraph is revised to read as follows:

“Pursuant to FAR 32.501-1(a), the progress payments for time-and-materials task orders will include a payment-withholding rate of 20% of the task order price for large businesses and 15% of the task order price for small businesses during the base and option periods, if exercised.”

Page 6, Section C.1, E. (Technical Requirement and Constraints), # 2:

Corrected url for Biosafety in Microbiology and Biomedical Laboratories, 5th edition and modified url format for clarity:

http://www.cdc.gov/od/ohs/biosfty/bmbl5/BMBL_5th_Edition.pdf, http://www.ocio.usda.gov/directives/doc/DM9610- 001.pdf http://www.aphis.usda.gov/permits/index.shtml

RFP # 10-100-SOL-00001 Page 6

Current RFP - language Changes made Page 7, Section C.1, F. (Minimal Qualifications), #1: Made text consistent with L.4. Additional Technical Proposal Instructions, and M.2. Mandatory Criteria for Eligibility (p.42):

Offeror must possess necessary licenses, certifications, clearances to perform testing with a range of influenza viruses and other respiratory pathogens.

Offerors must provide documentation of licenses, certifications, etc., to perform testing with a range of influenza viruses and other respiratory pathogens.

Page 7, Section C.1, F. (Minimal Qualifications), #2:

Made text consistent with L.4. Additional Technical Proposal Instructions, and M.2. Mandatory Criteria for Eligibility (p.42):

Offeror must perform laboratory work within the confines of their place of business at one location.

Offeror must provide documentation assuring availability of laboratory facilities for the duration of the proposed contract.

Page 7, Section C.1, F. (Minimal Qualifications), #3:

Made text consistent with L.4. Additional Technical Proposal Instructions, and M.2. Mandatory Criteria for Eligibility (p.42):Offerors must comply to a quality system (e.g., ISO 9001) or regulation with third party review and/or certification (e.g., a copy of the latest quality audit including any adverse findings and corrective action taken).

Offerors must provide documentation of compliance to a quality system (e.g., ISO 9001, CLIA certification) or regulation with third party review and/or certification (e.g., a copy of the latest quality audit including any adverse findings and corrective action taken).

P. 7, Section C.1., F. Minimal Qualifications, 3rd paragraph:

Contractors can receive instructions for obtaining from the U.S.

Government, specific virus samples, or other microorganisms, for seed stock or analytic testing.

Contractors can receive instructions for obtaining from the U.S.

Government, specific virus samples, or other microorganisms, for seed stock or analytic testing, depending on specific task order requirements.

P. 7, Section C.1., F. Minimal Qualifications, 3rd paragraph:

Genetically modified (biosafety level 2) live Influenza H5N1 viruses and other (internal) genes from donor strains can also be available.

Novel influenza viruses and other samples may also be available.

Genetically modified (biosafety level 2) live Influenza H5N1 viruses and other (internal) genes from donor strains can also be available. These may require USDA permitting. Novel influenza viruses and other samples may also be available.

Page 33-34, Section L.4. ADDITIONAL TECHNICAL PROPOSAL

INSTRUCTIONS:

Information regarding ownership/lease of the facility which demonstrates availability for the duration of the proposed contract (included as a Mandatory Technical Evaluation criteria).

Documentation regarding ownership/lease of the facility which demonstrates availability for the duration of the proposed contract (included as a Mandatory Technical Evaluation criteria).

RFP # 10-100-SOL-00001 Page 7

Page 33-34, Section L.4. ADDITIONAL TECHNICAL PROPOSAL

INSTRUCTIONS:

Documentation of training and proficiency with current IAATA and DOT requirements for receipt and shipping infectious substances.

Documentation of training and proficiency with current IAATA and DOT requirements for receipt and shipping infectious substances (included as a Mandatory Technical Evaluation criteria).

Page 33-34, Section L.4. ADDITIONAL TECHNICAL PROPOSAL

INSTRUCTIONS:

Documentation of compliance to a quality system or regulation with third party review and/or certification (e.g., a copy of the latest quality audit including any adverse findings and corrective action taken).

Documentation of compliance to a quality system or regulation with third party review and/or certification (e.g., a copy of the latest quality audit including any adverse findings and corrective action taken) (included as a Mandatory Technical Evaluation criteria).

Page 34, Section L, L5, item #1 on the Sample Task Order, is revised per responses #12 and #28.

The first sentence and second paragraph under Item #1, Sample Task Order Pricing, are revised to read as follows:

The business proposal must contain detailed pricing for the following firm fixed price sample task order:

Acquire and prepare necessary materials, execute and provide data and documentation for the assessment of two rapid influenza tests (in parallel, on the same set of samples). Offerors should provide detailed price breakdowns, to include labor and other costs, for each of the individual items in this sample firm fixed price task order. The same activities should be priced for each base contract year and each option year.

Page 34, Section L, L.5. item #1 on the Sample Task Order - Insert additional item to list

Add the following item as item #i:

i. Propagate and characterize five (5) highly pathogenic avian influenza viruses.

Page 41, Section M2, #2 - Made text and intent consistent with C.1., F and L.4.

Documented assurance that all in-vitro work will be done within the confines of their place of business at one location.

Documentation assuring availability of laboratory facilities for the duration of the proposed contract.

Page 51, Attachment #5, Task Order Procedures, Item vii is revised per response #23.

Item vii is superseded by the following:

(vii) An itemization of costs (i.e. personnel, equipment, travel, supplies, other direct costs, etc.) necessary to complete the work.