PWS_for_Pathogen_Detection_Instruments_and_Kits.pdf

Performance Work Statement

Food Safety and Inspection Service

For

Pathogen Detection Instruments and Kits

A. Background

The Food Safety and Inspection Service (FSIS), a public health regulatory agency of the U.S.

Department of Agricultural (USDA), protects consumers by ensuring that meat, poultry, and egg products are safe, wholesome, and accurately labeled. The FSIS Western, FSIS Midwestern, and

FSIS Eastern Laboratories are regulatory laboratories that test meat, poultry, egg products, and environmental samples to ensure that they are free of contamination or adulteration.

The current protocols for analytical tests are required by FSIS regulatory activities on meat, poultry and egg products. Specifically, microbiological methods are presented for sample preparation, isolation and identification of the major foodborne pathogenic microorganisms and their toxins, meat tissue species identification, and the detection of antimicrobial residues.

B. Objective/Scope

The objective of the requirement is to adequately equip all three FSIS Laboratories with Pathogen Detection Instruments and Kits. Through the selection of a single or multiple analytical platforms, the laboratories shall have the capability to test samples for:

a. Salmonella sp.

b. Listeria monocytogenes

c. Escherichia coli O157:H7

d. Shiga toxin-producing Escherichia coli O-groups, O26, O45, O103, O111, O121, and O145.

e. Campylobacter sp.

The laboratories require the latest instrumentation and software available for laboratory testing.

This requirement shall include a service agreement and replacement of equipment, if leased, assets as required for the duration of the resultant contract.

The FSIS Laboratories perform regulatory testing of approximately 100,000 samples per calendar year of meat, poultry and egg products for the presence Salmonella sp, Listeria monocytogenes, Escherichia coli O157:H7, Shiga toxin-producing Escherichia coli O-groups, O26, O45, O103, O111, O121, and O145, and Campylobacter sp.

Due to the large number of samples analyzed daily, and new sampling programs being implemented, FSIS desires to update its current instrument inventory and associated expendable supplies (kits and reagents).

C. Contractor Requirements

The contractor’s equipment and test kits shall meet the following performance specifications:

a) Target pathogens may include Salmonella sp., Listeria monocytogenes, Escherichia coli O157:H7, Shiga toxin-producing Escherichia coli O-groups, O26, O45, O103, O111, O121, and O145, and Campylobacter sp.

b) Sensitivity (90%, or higher)

c) Specificity (90%, or higher)

d) Accuracy, compared to cultural method (90%, or higher)

e) Predictive value positive (90%, or higher)

f) Negative predictive value (90%, or higher)

g) Results for a complete panel of strains for Inclusivity and Exclusivity

h) Limit of detection of at least 104 colonies.

i) Ideally, can test for all STEC targets on a single analytical run

j) Analytical run time cannot exceed three hours in order to meet operational needs.

k) Single analytical batch should approximate 90 samples

l) Current laboratory footprint shall be less than 25 square feet per instrument (due to limited space of FSIS laboratories).

D. Contractor Tasks/ Deliverables:

1. The contractor (s) shall provide documentation to the COR that all parts and materials used for repairs/maintenance shall meet specific analytical platform requirements. The contractor shall maintain an adequate inventory of spare parts to accommodate the repair of equipment within 48 hours.

3. The contractor(s) shall pay charges to ship replacement or repaired equipment to the customer and pay shipping charges for the return of equipment to the contractor.

4. The equipment shall be fully operational according to laboratory methodology and serviceable after installation and completion of maintenance and repairs. The COR or designated representative shall certify the equipment is performing satisfactorily.

5. Help desk support shall be required during normal local business hours for equipment service support. If issues are not fixed within that day of normal business hours, a technician must be dispatched to the lab for servicing.

6 The contractor(s) shall provide the COR with information on the names of all employees who shall require access to the facility, in order to perform work on equipment, including approximate date and time of arrival. All employees provided by contractor shall have valid picture identification before being allowed onto the premises.

7. Maintenance/repair services hours shall be provided during normal working hours, 7:30AM to 5:00PM (local time), Monday through Friday, excluding Federal Holidays (see http://www.opm.gov/Fedhol/ for a listing of the Federal Holidays). If work is required outside of this timeframe then the Contractor and Government shall work out agreeable terms for these instances. Response time should not exceed 24 working business hours and return to functionality not exceed 72 hours unless alternative arrangement with the particular lab is agreed upon,

8. The contractor(s) shall provide training: Lab set-up, equipment validation, and operational training.

9. Shipping: The Contractor shall deliver the equipment within 30 to 60 calendar days after receipt of order.

http://www.opm.gov/Fedhol/

10. The price for the kits and reagents shall be determined based on a minimum number of kits purchased with discounts for additional quantities in 10,000 test increments. For example, Agency shall initially agree to procure a minimum of 75,000 tests in one calendar year

(comprised of combination of Salmonella, Listeria monocytogenes, Campylobacter, STEC, etc.).

Depending on operational needs, the Agency shall then expect progressively reduced price per unit by increasing the requirement in 10,000 test increments.

E. Location of Laboratories

The contractor shall furnish one equipment to test each category of pathogens in paragraph B above to the USDA, FSIS, OPHS Laboratories listed at the locations below.

Eastern Laboratory: 950 College Station Rd, Athens, GA 30605

Midwestern Laboratory: 4300 Goodfellow Blvd. St. Louis, Missouri 63120.

Western Laboratory: 800 Buchanan St., Albany, CA 94710

F. Equipment Lease or Purchase

The determination of purchase or lease shall depend on the price, terms and availability of funding. The instruments shall enable all USDA FSIS Food Safety Laboratories to use Pathogen

Detection Instruments and Kits over the course of five years in accordance with FAR 7.4, Equipment Lease or Purchase.

Period of Performance

The period of performance shall be a Base Year plus four (4) Option Years from the date of award.

G. 508 Compliance Accessibility of Electronic and Information Technology

(a) This SOW is subject to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by the workforce Investment Act of 1998 (P.L. 105-220). Specifically, subsection

508(a)(1) requires that when the Federal Government procures Electronic and Information

Technology (EIT), the EIT shall allow Federal employees and individuals of the public with disabilities comparable access to and use of information and data that is provided to Federal employees and individuals of the public without disabilities.

(b) The EIT accessibility standards at 36 CFR Part 1194 were developed by the Architectural and Transportation Barriers Compliance Board ("Access Board") and apply to contracts and task/delivery orders, awarded under indefinite quantity contracts on or after June 25, 2001.

(c) Each Electronic and Information Technology (EIT) product or service furnished under this contract shall comply with the Electronic and Information Technology Accessibility Standards

(36 CFR 1194), as specified in the contract, as a minimum. If the Contracting Officer determines any furnished product or service is not in compliance with the contract, the

Contracting Officer shall promptly inform the Contractor in writing. The Contractor shall, without charge to the Government, repair or replace the non-compliant products or services within the period of time to be specified by the Government in writing. If such repair or replacement is not completed within the time specified, the Government shall have the following recourses:

1. Cancellation of the contract, delivery or task order, purchase or line item without termination liabilities; or

2. In the case of custom Electronic and Information Technology (EIT) being developed by a contractor for the Government, the Government shall have the right to have any necessary changes made or repairs performed by itself or by another firm for the noncompliant EIT, with the contractor liable for reimbursement to the

Government for any expenses incurred thereby.

(d) The contractor shall ensure that all EIT products that are less than fully compliant with the accessibility standards are provided pursuant to extensive market research and are the most current compliant products or services available to satisfy the contract requirements.

(e) For every EIT product or service accepted under this contact by the Government that does not comply with 36 CFR 1194, the contractor shall, at the discretion of the

Government, make every effort to replace or upgrade it with a compliant equivalent product or service, if commercially available and cost neutral, on either a contract specified refresh cycle for the product or service, or on a contract effective option/renewal date; whichever shall occur first.

The vendor shall comply with the standards, policies, and procedures below. In the event of conflicts between the referenced documents, the SOW shall take precedence.

Rehabilitation Act, Section 508 Accessibility Standards

1. 29 U.S.C. 794d (Rehabilitation Act as amended)

2. 36 CFR 1194 (508 Standards)

3. www.access-board.gov/sec508/508standards.htm (508 standards)

4. FAR 39.2 (Section 508)

5. USDA Standards, policies and procedures (Section 508)

In addition, all contract deliverables are subject to these 508 standards as applicable.

Regardless of format, all Web content or communications materials produced, including text, audio or video - shall conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content shall comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW shall be the responsibility of the contractor or consultant.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

36 CFR Part 1194.21 a - l

36 CFR Part 1194.22 a - p

36 CFR Part 1194.31 a - f 36 CFR Part 1194.41 a – c http://www.access-board.gov/sec508/508standards.htm%20(508

The contractor shall provide a completed Section 508 Product Assessment Template and the contractor shall state exactly how proposed EIT deliverable(s) meet or does not meet the applicable standards.

The following Section 508 provisions apply for software development material identified in this SOW, PWS, or TO:

For software development, software applications, and operating systems the

Contractor/Developer/Vendor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.21 (a – l) 36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources

For web-based applications (intranet, internet information and applications, 16 rules), the

Contractor shall comply with the standards, policies, and procedures below:

36 CFR Part 1194.22 (a – p) 36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

For Telecommunication products the Contractor shall comply with the standards, policies, and procedures below:

36 CFR Part 1194.23 (a – k)

36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards) http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.access-board.gov/sec508/508standards.htm

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

For video and multimedia applications (including training), the Contractor shall comply with the standards, policies, and procedures below:

36 CFR Part 1194.24 (a – e)

36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

For self-contained, closed products, the Contractor shall comply with the standards, policies, and procedures below:

36 CFR Part 1194.25 (a – j)

36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

For Desktop and portable computers, the Contractor shall comply with the standards, policies, and procedures below:

36 CFR Part 1194.26(a – d) 36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.access-board.gov/sec508/508standards.htm

For the purposes of this SOW, the Contractor shall review the complete system for 508 compliance and correct all deficiencies or document exceptions as required by departmental and federal requirements.

All Electronic Information Technology that is subject to the 36 CFR 1194 standards shall have a

Section 508 acceptance test and Section 508 shall be validated upon acceptance.

All maintenance for Electronic Information Technology that requires upgrades, modifications, installations and purchases shall adhere to the Section 508 Standards and 36 CFR 1194.