Attavhment No. 5 - Statement of Work.pdf

Attachment No. 5 - Statement of Work Food and Feed Laboratory Annual Proficiency Testing

Background:

Proficiency Testing (PT) programs are an external quality control to measure a laboratory’s proficiency. FDA field laboratories must maintain ISO 17025 accreditation. According to ISO 17025 requirements and AOAC guidelines, laboratories are required to participate in relevant and available proficiency testing provided by accredited proficiency testing providers administering acceptable proficiency testing programs which are conducted yearly.

Objectives:

The Food and Drug Administration (FDA) / Office of Regional Affairs/Office of Regulatory Science (ORS)/ HFC-140 has a requirement for the purchase of ORS Food and Feed Laboratory annual Proficiency Testing for the following three programs:

1. Standard Microbiology

2. Pesticide Residue in Fruits and Vegetables

3. Nutrients in Infant Formula and Adult Nutritional’s

Scope:

ORS requires PT services, from an ISO 17043-accredited provider whose accreditation scope includes, at a minimum: Microbiology in Foods, Pesticides in foods, and Vitamins and Nutrients in Infant Formulas. The selected provider must conduct accredited Proficiency Testing in all three programs listed in this Statement of Work (e.g. the Standard Microbiology Program, Pesticide Residue in Fruits and Vegetables, and Nutrients in Infant Formula and Adult Nutritionals) for laboratories that conduct analyses in the area of food safety as specified below:

1. Standard Microbiology Program – Proficiency Testing in this program must demonstrate proficiency in detection of pathogens (including Salmonella, E.

coli O157:H7, and Listeria), as well as quantifying E. coli, Coagulase Positive Staphylococcus, yeast and mold, and aerobic organisms. The selected provider must provide test samples, qualitative and quantitative, at a frequency of four shipments per year to each lab. Evaluation of O and H antigens is to be included for Salmonella and identification of Listeria species.

2. Pesticide Residues in Fruits and Vegetables - Proficiency Testing in this program must identify the proficiency of laboratories that conduct analyses in the area of food safety that test for possible pesticide residues in fruit and vegetable matrix.

3. Nutrients in Infant Formula and Adult Nutritionals - Proficiency Testing in this Program must identify the proficiency of laboratories that conduct analyses in the area of food safety that test for vitamin A, vitamins B1, B2, B3, B6, B12, B5 Pantothenic Acid, vitamins D, D2, D3, vitamin E, vitamin K1, fatty acids, iodine, nucleotides (total), chromium, selenium and molybdenum (UTM) and myo-inositol.

4. PT Samples, whose expected values are to be unknown to the labs, are to be shipped to identified FDA labs by the selected provider. Labs are to analyze the PT samples and return their results electronically to the selected proficiency provider. The selected provider will collect the returned results and review them to determine whether each participating laboratory passes or fails established performance levels, A performance evaluation will then be issued to both the evaluated lab and to designated Project Officer. The cost of all shipping and handling of PT test materials is to be included as part of the total contract cost and paid by the selected service provider.

Requirements:

The selected vendor will independently and not as an agent of the Government, furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incidental to the performance of the work as described below:

A. Detailed Description The selected provider will conduct Proficiency Testing for Microbiology, Pesticides in Fruits and Vegetables, and Nutrients in Infant Formula and Adult Nutritionals as follows:

Microbiology Proficiency Testing Rounds Frequency: Four (4) rounds per year at 3 to 4 month intervals to each of the labs identified in Table 1 Microbiology below.

Tests Required:

Identification of pathogens - Salmonella, E. coli O157:H7, Listeria species Quantification –E. coli, Coagulase Positive Staphylococcus, yeast and mold aerobic organisms.

Stereotyping – O and H antigens for Salmonella.

Matrix: mashed potato Reporting: Results reported electronically online to a secure and confidential website. Electronic Reports must provide z-scores, statistics, and graphs used for the evaluation of results and trending of data.

Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol

Distribution: Proficiency testing rounds must be shipped to seven (7) different locations as follows:

Table 1 Microbiology Program Site Location and POC Information FDA/Arkansas Laboratory 3900 NCTR Rd, Bldg 26 Jefferson, AR 72079-9502 POC to be determined at time of award

FDA/Northeast Food and Feed Laboratory 158-15 Liberty Ave Jamaica, NY 11433-1034 POC to be determined at time of award

FDA/Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021 POC to be determined at time of award

FDA/Pacific Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612 POC to be determined at time of award

Southeast Food and Feed Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC to be determined at time of award

FDA/San Francisco Laboratory 1201 Harbor Bay Parkway Alameda, CA 94502 POC to be determined at time of award

FDA/Denver Laboratory 6th Ave. & Kipling Building 20 W10 Denver, CO 80225 POC to be determined at time of award

Pesticide Proficiency Testing Rounds Frequency: Two (2) rounds per year with at least 3-month intervals between rounds to each of the labs identified in Table 2 Pesticide below.

Tests Required: Three (3) major pesticide groups covered with a variety of different compounds

Carbamates Organophosphates Chlorinated Hydrocarbons

Matrix: Vegetable and/or fruit matrix Reporting: Results reported electronically online to a secure and confidential website. Electronic Reports must provide z-scores, statistics, and graphs used for the evaluation of results and trending of data.

Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol

Distribution: Proficiency testing rounds must be shipped to five (5) different locations as follows:

Table 2 Pesticide Program Site Location and POC Information FDA/Pacific Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612 POC to be determined at time of award

FDA/Arkansas Laboratory 3900 NCTR Rd, Bldg 26 Jefferson, AR 72079-9502 POC to be determined at time of award

FDA/Kansas City Laboratory 10749 W. 84th Terrace Lenexa, KS 66214 POC to be determined at time of award

FDA/Pacific Northwest Laboratory 2201 23rd Dr. SE Bothell, WA 98021 POC to be determined at time of award

FDA/Northeast Food and Feed Laboratory 158-15 Liberty Ave Jamaica, NY 11433-1034 POC to be determined at time of

Nutrients Proficiency Testing Rounds Frequency: Three (3) rounds per year with 3-4 month intervals to laboratory identified in Table3 Nutrition below.

Tests Required –This program will include vitamin A, vitamins B1, B2, B3, B6, B12, B5 Pantothenic Acid, vitamins D, D2, D3, vitamin E, vitamin K1, fatty acids, iodine, nucleotides (total), chromium, selenium and molybdenum (UTM) and myo-inositol Matrix: Infant Formula/Adult Nutritionals matrix

Reporting: Results reported electronically online to a secure and confidential website. Electronic Reports must provide z-scores, statistics, and graphs used for evaluation of results and for trending of data Statistics: Statistical analysis on participant results must be performed in accordance with the ISO Standard 13528 and/or 2006 IUPAC Harmonized Protocol Distribution: Proficiency testing rounds must be shipped to one location as follows:

Table 3 Nutrition Program Site Location and POC Information Southeast Food and Feed Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC to be determined at time of

Reporting Requirements A.

Reports

For the Standard Microbiology Program, the selected provider must provide the individual labs an electronic copy of their individual results, which is included in the participant cost of the program. There must also be a compiled summary report for each of the four (4) shipments per year for this program.

For the Pesticide Residue Program, the individual labs will receive an electronic copy of their individual results, this is included in the participant cost of the program. There must also be a compiled summary report for each of the two (2) shipments per year for this program.

For the Nutrients in Infant Formula and Adult Nutritionals Program, the individual lab will receive an electronic copy of its results, this is included in the participant cost of the program. There must also be a complied summary report for each of the three (3) shipments per year for this program.

B. Compiled Reports Base Year

The contractor shall provide a “Compiled Summary” for all Proficiency Testing, for each proficiency round. Each consolidated report will consist of an individual report for each of the three programs, that includes the testing results from all labs included in a specific program. Reports are to be presented to the Project Officer, (to be identified at time of award) as an electronic document within 30 business days following the end of each proficiency sample round.

Each report shall include all results from ALL individual labs participating in each of the three program areas. A total of four (4) quarterly reports for the microbiological area; three (3) reports for the nutritional area and two (2) reports for the pesticide area will be compiled in the base year.

Option Years

The contractor shall provide a “Compiled Summary” for all Proficiency Testing, for each proficiency round. Each consolidated report will consist of an individual report for each of the three programs, that includes the testing results from all labs included in a specific program. Reports are to be presented to the Project Officer (to be identified at time of award) as an electronic document within 30 business days following the end of each proficiency sample round.

Each report shall include all results from ALL individual labs participating in each of the three program areas. A total of four (4) quarterly reports for the microbiological area; three (3) reports for the nutritional area and two (2) reports for the pesticide area will be compiled in each of the option years.

Delivery Instructions for Reports

Unless otherwise specified, all reports or copies of reports shall be delivered to:

E-mail:(to be identified at time of award) Deliverables:

Base Year - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

3 30 Days after end of PT round

Option Year 1 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

Option Year 2 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

Option Year 2 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritionals Program

1. Infant Formula/Adult Nutritionals Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

Option Year 3 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

Microbiology Program

1. Microbiology Proficiency Testing Sample Round to each lab

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

2. Electronic report of the lab results for each lab.

7 FDA Food and Feed Laboratories

*See Table 1 Microbiology above for a list of participating FDA Labs

4 3 to 4-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

4 30 Days after end of PT round

Pesticide Program

1. Pesticide Proficiency Testing Sample Round to each lab

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

Option Year 3 - Proficiency Testing

Deliverable Quantity Location Frequency per year

Deliverable Time Period

2. Electronic report of the lab results for each lab.

5 FDA Food and Feed Laboratories

*See Table 2 Pesticides above for a list of participating FDA Labs

2 At least 3month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

2 30 Days after end of PT round

Infant Formula/Adult Nutritional’s Program

1. Infant Formula/Adult Nutritional’s Proficiency Testing Sample Round to each lab

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

2. Electronic report of the lab results for each lab.

1 FDA Food and Feed Laboratory

*See Table 3 Nutrition above for a list of participating FDA Labs

3 3-month intervals

3. Electronic compiled summary Report for all rounds for all participating labs.

1 Project Officer

**To be identified at the time of the award of the contract

Place of Performance/Shipping Destinations

The Place of Performance is the Contractor’s Place of Business.

Shipping Destinations:

See laboratory addresses in tables in Scope section.

Period of Performance

Base Period – March 8, 2024- March 7, 2025 Option Year 1 – March 8, 2025 – March 7, 2026 Option Year 2 – March 8, 2026-March 7, 2028