Attachment 4 - Sample Task Order A-01.pdf

ATTACHMENT 4: SAMPLE TASK ORDER ASSOCIATED WITH TASK AREA A: BACTERIA,

FUNGI, AND TOXINS

IN VITRO ASSESSMENTS OF ANTIMICROBIAL ACTIVITY

SAMPLE TASK ORDER A01

“Determination of In Vitro Efficacy of Antibacterial or Antifungal Candidates”

NOTE: Offerors proposing for Task Area A must include in their proposals a response to either Sample Task Order A01 or A02. There is no added value in submitting multiple proposals in a single Task Area. The Offeror should be encouraged to submit its best proposal – i.e., the one for which it has the highest qualifications and capabilities.

Offerors proposing for Task Area A must submit a proposal that includes information pertaining to Task Area A only.

The following Sample Task Orders are provided to assess the Offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under contracts awarded in response to this solicitation. Although the Sample Task Order will NOT be executed nor will awards be made for the Sample Task Order, Offerors are to include in their proposals a response that specifies the methods by which each Sample Task Order would be accomplished and include an associated budget.

Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

1. PRICES

This is a firm-fixed price type task order.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

STATEMENT OF WORK

I. SCOPE

Determination of the Minimal Inhibitory Concentration (MIC) and 90% MIC (MIC90) of candidate test articles against a bacterial or fungal pathogen.

Note: Offerors should select either anti-bacterial or anti-fungal in the sample task order scope statement and prepare the response using a pathogen from Table 1.

II. TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

The requirements for Task Area A defined in the base Statement of Work apply to all work performed under this Task Order.

In addition to the requirements laid out in the base Statement of Work, the Contractor shall perform the following:

1. Minimal Inhibitory Concentration (MIC) Testing

a. The Contractor shall store and maintain of all candidate test articles provided to the Contractor by the Government or through a third-party under conditions specified by the COR.

b. The Contractor shall perform 200 MIC determinations of test articles under appropriate BSL conditions and in accordance with CLSI guidelines.

i. The MICs will be determined against a panel of strains of one of the pathogens listed in Table 1 depending upon the scope selected (i.e. bacterial or fungal).

ii. Appropriate positive (i.e., first line anti-fungal or anti-bacterial article) and negative controls must be included.

iii. Panels of bacteria for the MIC 90 determinations shall consist of at least 10 strains per bacterial species from Table 1and must include strains from geographically diverse sites across the USA representative of the known/reported/published resistance profile for infections caused by those species in the USA.

c. The Contractor shall complete testing of candidate test articles within 30 days of their receipt.

d. The Contractor shall report the results of all determinations performed for each test article in accordance with the reporting requirements and delivery schedule described herein.

2. Communication and Reporting

a. The Contractor shall conduct monthly teleconference calls with the COR to report on progress and provide minutes of each teleconference in accordance with the Reporting Requirements and Delivery Schedule.

b. The Contractor shall provide a Final Report in accordance with the Reporting Requirements and Delivery Schedule.

Table 1 – Pathogens

SECTION D – PACKAGING, MARKING, AND SHIPPING

There are no additional D. clauses applicable to this Task Order beyond those in the base contract.

SECTION E – INSPECTION AND ACCEPTANCE

There are no additional E. clauses applicable to this Task Order beyond those in the base contract.

SECTION F – DELIVERIES OR PERFORMANCE

1. PERIOD OF PERFORMANCE

The period of performance for this Sample Task Order is ten (10) months.

2. TASK ORDER REPORTING REQUIREMENTS AND DELIVERABLES

Technical Reports

Fungi Bacteria

Apophysomyces sp. Neisseria gonorrhoeae Aspergillus flavus Klebsiella pneumoniae Aspergillus fumigatus Enterococcus faecalis Blastomyces dermatitidis Staphylococcus aureus Candida albicans Streptococcus pneumoniae Candida glabrata Streptococcus pyogenes Candida auris Streptococcus agalactiae Candida guillermondii Pseudomonas aeruginosa Candida parapsilosis Escherichia coli Coccidioides sp. Enterobacter spp Cryptococcus neoformans Bacillus anthracis Fusarium sp. Yersinia pestis Histoplasma capsulatum Francisella tularensis Rhizopus oryzae Burkholderia mallei Saksenaea sp. Burkholderia pseudomallei Scedosporium sp.

All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

1. Final Report

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved and shall include:

• Assay format

• Test article preparation and use

• Growth media and culture conditions

• Specific strains used

• Controls used

• MIC results

The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this task order.

Other Reports and Deliverables

All reports required herein shall be submitted in electronic format.

1. Compound Test Result Reports For each testing run, the Contractor shall prepare and submit a Compound Test Result Report and Table in accordance with the Delivery Schedule.

The Compound Test Result Report shall include:

a. A title page containing:

i. Task Order Number and Title

ii. Compound identifier(s)

b. Results of all determinations performed including supporting data for each test compound;

c. Documentation of preparation, lot number, and use of test substances, bacterial growth media and culture conditions, and control compound(s);

d. Description of any technical or performance problems encountered, along with proposed corrective action taken; and

e. Description of origin and susceptibility profile of strains used in the study, if known.

http://www.hhs.gov/web/508/index.html

f. Reference MICs for each control compound against each strain in the panel.

g. Description of attempts to remedy any measured control MICs more than 2-fold different from reference values.

h. Compound Test Result Table shall be in Excel format and include one row per MIC test (strain) and one column for each of the following:

i. Isolate ID/Number

ii. Organism ID

iii. Phenotype

iv. Resistance Determinants

v. Test Date

vi. MICs in ug/mL for Candidate Compound(s) Tested

vii. MICs in µg/mL for control compounds

2. Monthly Teleconference Minutes

The Contractor shall provide and deliver, in accordance with the Delivery Schedule, minutes of the monthly teleconferences which include the following:

a. List of action items (including who is responsible for the action item).

b. Summary of any high-level decisions made during the teleconference.

c. Number of assays performed and committed to date as well as remaining number of assays.

d. Summary of concerns raised during the teleconference and the plan to address these concerns.

e. Appendix including all Compound Test Result Reports finalized during that month.

TASK ORDER DELIVERY SCHEDULE

Item Report Recipient Delivery Schedule

1. Final Report 1 electronic copy to COR and CO.

Due on/before the completion date of the task order.

2. Compound Test Result Report

1 electronic copy to COR and CO.

Due on/before 30 calendar days following completion of testing on a compound.

Compounds completed during the final 30 days of this task order shall be submitted on the expiration date of the task order

3. Monthly Teleconference Minutes

1 electronic copy to COR and CO.

On or before 7 calendar days following the teleconference

SECTION G – TASK ORDER ADMINISTRATION DATA

There are no additional G. clauses applicable to this Task Order beyond those in the base contract.

SECTION H – TASK ORDER ADMINISTRATION DATA

There are no additional H. clauses applicable to this Task Order beyond those in the base contract.