Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 1 of 10

1 Purpose

The purpose of this document is to outline the requirements for the Laboratory Approval 

Program for Microbiological Testing of Poultry Products from the Federal Purchase Program

(LAP-FPP). The document describes the technical competency and quality management 

requirements a laboratory must demonstrate to be a USDA-approved laboratory.

The Laboratory Approval Program (LAP) is administered by the Laboratory Approval Service 

(LAS) Branch. LAS is part of the Agricultural Marketing Service (AMS), Science and 

Technology (S&T) Program, Laboratory Approval and Testing Division (LATD).

The LAS approves, or accredits, laboratories to perform testing services in support of domestic 

and international trade. At the request of industry, other Federal Agencies, or foreign 

governments, the LAS develops and administers programs to verify that the analysis of food and 

agricultural products meet country and customer-specific requirements and that the testing of 

products marketed is conducted by qualified and approved laboratories.

2 Scope

LAP-FPP is for a laboratory seeking to obtain and maintain its status as a USDA-approved 

laboratory for the analysis of aerobic plate counts, coliform counts, generic Escherichia coli, 

coagulase positive Staphylococcus aureus, Salmonella species, and Listeria monocytogenes in 

fully cooked, frozen, diced cooked chicken procured for the Federal Purchase Program (FPP) 

based on the stipulations of the Federal Purchase Program Specifications (FPPS) for Diced 

Chicken, Fully Cooked Frozen.

LAP-FPP verifies technical and quality control competencies of a laboratory to meet the 

requirements of this Program. All aspects of a laboratory’s quality management system 

(business processes relevant to the scope of approval) are applicable and critical for ensuring the 

defensibility of the analytical results produced under the LAP.

3 Table of Contents

1 Purpose ........................................................................................................................................................1

2 Scope ...........................................................................................................................................................1

3 Table of Contents.........................................................................................................................................1

4 Glossary of Terms........................................................................................................................................2

5 References ...................................................................................................................................................2

GENERAL REQUIREMENTS...................................................................................................... 4

6 Laboratory Approval Program Administrative Policy.................................................................................4

7 Summary of General Program Requirements..............................................................................................4

8 Mandatory Quality Assurance Practices......................................................................................................5

9 Method Selection.........................................................................................................................................5

10 Demonstration of Method Performance by Validation and Verification Evaluation...................................6
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 2 of 10

11 Analyst Competency and Proficiency Testing.............................................................................................6

TECHNICAL REQUIREMENTS.................................................................................................. 8

12 Performance Criteria....................................................................................................................................8

13 Sample Handling & Preparation ..................................................................................................................8

14 Quality Controls...........................................................................................................................................8

15 Quality Measures.........................................................................................................................................9

16 Official Certificate of Analysis/Report......................................................................................................10

17 Reporting ...................................................................................................................................................10

18 Revision History ........................................................................................................................................10

19 Review / Approvals ...................................................................................................................................10

4 Glossary of Terms

AMS Agricultural Marketing Service

AOAC Association of Official Analytical Collaboration

BAM Bacteriological Analytical Manual, FDA

CFU Colony Forming Unit

CSV Comma Separated Values

FDA Food and Drug Administration

FPP Federal Purchase Program

FPPS Federal Purchase Program Specifications

FSCSD Food Safety and Commodity Specification Division, LP, AMS

FSIS Food Safety Inspection Service, USDA

GD Guidance Document

ILAC International Laboratory Accreditation Cooperation

ISO/IEC International Organization for Standardization/ International Electrotechnical Commission.

LP Livestock & Poultry Program

LAP Laboratory Approval Program

LAP-FPP LAP-Microbiological Testing of Poultry Products for the FPP

LAS Laboratory Approval Service

LATD Laboratory Approval and Testing Division

MLG Microbiology Laboratory Guidebook, FSIS

PM Program Manager

PT Proficiency Test 

S&T Science & Technology Program

SSD Standards and Specifications Division, LP, AMS

US United States

USDA United States Department of Agriculture

5 References

5.1 The following are referenced in this document. Dated references apply to the edition cited 

and undated references apply to the latest edition published (including any amendments).

5.2 Laboratory Approval Program:

a) LAP-PR.05, Laboratory Approval Program – General Policies and Procedures

b) LAP-PR.06, Laboratory Approval Program – Fees. 
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 3 of 10

c) USDA AMS LATD LAS Website, https://www.ams.usda.gov/services/lab-testing/labapproval

5.3 Quality Assurance Standards:

a) AOAC International, Guidelines for Laboratories Performing Microbiological and 

Chemical Analysis of Food, Dietary Supplements, and Pharmaceuticals. Prepared by 

the Analytical Laboratory Accreditation Criteria Committee of AOAC International.

b) ISO/IEC 17025:2017. General requirements for the competence of testing and 

calibration laboratories.

c) USDA AMS Laboratory Standards of Practice.

5.4 USDA Requirements:

a) USDA AMS LP SSD. Federal Purchase Program Specification (FPPS) for Diced 

Chicken, Fully Cooked, Frozen.

b) USDA AMS LP FSCSD. Instructions for the Notification of Pathogen Test Results by 

Email to the Agricultural Marketing Service (AMS), AMS Vendors, and the Food 

Safety and Inspection Service (FSIS).

c) USDA AMS LP, Instructions for the Reporting of Microbiological and Fat Test Results 

in Spreadsheet and Comma Separated Values (CSV) Text File (database) Format.

5.5 Microbiology Methodology:

a) AOAC International Official Methods of Analysis.

b) USDA FSIS Microbiology Laboratory Guidebook (MLG).

c) US FDA Bacteriological Analytical Manual (BAM).

d) FSIS-GD-2019-0008. Foodborne Pathogen Test Kits Validated by Independent 

Organizations, February 2020.

5.6 Additional Resources

a) Eurachem Guides

b) Good Laboratory and Clinical Practices, Techniques for the Quality Assurance 

Professional, edited by P.A. Carson and N.J. Dent, 1990.

c) Guidelines for the Validation of Microbiological Methods for the FDA Foods Program, 

3rd Edition, US FDA, FDA Foods and Veterinary Medicine Science and Research 

Steering Committee, October 17, 2019.
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 4 of 10

GENERAL REQUIREMENTS

6 Laboratory Approval Program Administrative Policy

6.1 A laboratory seeking admission to the LAP must fulfill the requirements and follow the 

process described in the program procedure, LAP-PR.05, Laboratory Approval Program –

General Policies and Procedures. This procedure describes the process for application, 

assessment audits, acceptance, maintaining program status, suspension, withdrawal, 

dismissal, appeals, and fees.

6.2 This program is administered on an annual, calendar year, basis.

6.3 The program procedure, LAP-PR.06, Laboratory Approval Program – Fees explains the 

fees for services.

6.4 The administrative procedures above are available on the LAS website, or contact the LAS 

Program Manager (PM) for the current version.

7 Summary of General Program Requirements

7.1 A laboratory must comply with all requirements set forth in this document to be compliant 

with the LAP. For the laboratory to maintain good standing, each year it must:

a) meet all program requirements relevant to the scope of approval;

b) comply with mandatory laboratory practices based on the ISO/IEC 17025 standard (See

§8);

c) use test method(s) approved by AMS (see §9);

d) validate / verify methods prior to use and ensure the validation / verification data 

package is available for review upon request (see §10);

e) evaluate analyst competency and maintain satisfactory status (see §11);

f) participate in proficiency testing (PT) programs and maintain satisfactory status (see

§11);

g) communicate regularly with the PM to share vital information regarding the laboratory 

and make all information relevant to the LAP available to the PM upon request (see

§5.2.a))

h) notify the PM within 30 days of significant changes relevant to the laboratory’s 

approval status and/or ability to meet the Program’s requirements including, but not 

limited to, legal, organizational, or ownership status; laboratory policies, procedures, 

and resources; change in key managerial personnel and contact persons, and 

signatories; and validation / verification of adequate method performance after a 
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 5 of 10

significant change in method, equipment, facilities, working environment, and location. 

It is at the discretion of LAS whether an onsite visit/audit is required to evaluate any 

significant change that a laboratory undergoes (see §5.2.a)); 

i) be available for a biennial (every other year) re-assessment audit, have actual sample(s) 

ready to demonstrate its competency of performing the test method; and comply with 

requests for documents and records before and during the audit (see §5.2.a));

j) respond to each nonconformance found with a record of an investigation, root cause 

analysis, and correction or, if warranted due to time, a corrective action plan, within 30 

calendar days of being reported (see §5.2.a));

k) resolve each nonconformance in a timely manner, whether identified by LAS audit, 

another organization, or internally (see §5.2.a)); 

l) pay all program fees by the due date on the billing invoice (see §5.2.b)).

8 Mandatory Quality Assurance Practices

8.1 Implement quality assurance and quality control procedures to ensure a validated and 

qualified analysis, prove competence, and ensure defensible data. 

8.2 Maintain formal accreditation to the ISO 17025 standard granted by a third-party that is a 

member of the International Laboratory Accreditation Cooperation (ILAC).

8.3 Maintain each method approved for the LAP on third party-accreditation scope of 

approval.

8.4 LAS uses the ISO 17025 standard to evaluate all laboratory quality systems regardless of 

accreditation status. A nonconformance identified during a LAS assessment audit may be 

cited to the ISO 17025 standard (see §5.2.a)).

8.5 Maintain records for at least three years (see §5.2.a)).

9 Method Selection

9.1 Use analytical testing methods approved by AMS.

9.2 Use method fit-for-purpose based upon the needs of the customer and consistent with 

specified requirements.

9.3 Use methods as validated; for the purposes of this Program, consider methods with 

collaborative studies, specifically those published by USDA FSIS, US FDA BAM, and 

AOAC; and those identified on the list for Foodborne Pathogen Test Kits Validated by 

Independent Organizations as validated methods.
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 6 of 10

10 Demonstration of Method Performance by Validation and Verification Evaluation

10.1 Demonstrate the sample testing method(s) is competently and proficiently performed prior 

to using it for testing and reporting results by using a validation / verification process, 

where: 

a) Validation is the process of demonstrating that a method is suitable for its intended 

purpose, 

b) Verification is the process of demonstrating a validated method can be performed to the 

same level of performance determined during the validation, and

NOTE: It is recognized there are multiple ways to demonstrate performance; therefore, the 

Program does not designate a specific protocol. See §5.6 for resources towards developing 

a suitable validation / verification plan.

10.2 Demonstrate that variations or modifications to a validated method (e.g., different matrix, 

different analyte, etc.) are fit-for-purpose.

10.3 Prepare a Method Validation Data Package to record that the procedure has been 

demonstrated as fit for use.

a) Consolidate pertinent information into an integrated and auditable data package to 

support the objective’s conclusion that includes at least the following: a cover statement 

containing the conclusion of the validation / verification process, test method 

procedure, relevant statistics (e.g., linearity, accuracy, precision, measurement 

uncertainty, etc.), and traceable data (raw and summarized).

b) Send the validation / verification package to the PM for review and approval.

c) Ensure validation / verification data package is readily available at the laboratory for as 

long as the method is utilized, plus three years past the date of last reported results.

d) Ensure official record of approval for method is maintained and readily available. 

11 Analyst Competency and Proficiency Testing

11.1 Analyst Competency:

a) Ensure each key analyst responsible for performing the method(s) participates in a 

competency evaluation, over time, and maintains satisfactory status.

11.2 Laboratory Analytical Proficiency:

a) Evaluate proficiency for each method at least annually.

b) Use a PT program relevant to the approved method in terms of analyte, concentration 

range, and matrix on scope of approval—where possible from an ISO 17043 PT

provider.
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 7 of 10

c) Document and implement a PT program to include comparison of results with other 

laboratories (inter-laboratory) and/or other analysts (intra-laboratory) where available; 

or a defined program that uses an appropriate collection of data used to demonstrate 

process control and validity of results when an appropriate ISO 17043 PT program is 

not available.

d) Review PT report and initiate the corrective action process when unsatisfactory results 

are observed. When Z scores are used, unsatisfactory results and actions to take are 

defined as follows:

z| ≥ 3 Initiate immediate corrective action investigation on the part of the 

laboratory to establish root cause.

2 ≤ |z| ≤ 3 Evaluate the context of other scores obtained in the same test and other 

PTs over time. Investigate to determine the cause and take action as 

needed.

11.3 Submit to PM:

a) Documented proficiency program for review for initial approval.

b) Subsequent changes to the previous PT program(s).

c) Copy of the PT report with analyst name, and PT identifier, within 30 days of receipt.

d) Record of corrective action response for unsatisfactory results, within 30 days of 

receiving the PT report.

e) Record of analyst training when there are changes in analysts running analyses.
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 8 of 10

TECHNICAL REQUIREMENTS

12 Performance Criteria

12.1 Use methods that meet the performance criteria laid out in the Federal Purchase Program 

Specification (see §5.4.a)).

Table 12.1. Testing Requirements for the Microbiological Limits in the Federal Purchase Program Specification for 

Diced Chicken, Fully Cooked, Frozen.

Microbial Test Sensitivity Action Level*

Aerobic Plate Count 10 CFU/g ≤ 1,000 CFU/g

Coliform Count 10 CFU/g ≤ 50 CFU/g

Generic E. coli 10 CFU/g < 10 CFU/g

Coagulase-positive Staphylococcus aureus 10 CFU/g < 10 CFU/g

Salmonella Not detected 0 CFU/g 

Listeria monocytogenes Not detected 0 CFU/g

* USDA AMS LP SSD. Federal Purchase Program Specification (FPPS) for Diced Chicken, Fully Cooked, 

Frozen

13 Sample Handling & Preparation

13.1 Take 25-g from composite sample for Salmonella, Listeria monocytogenes, and coagulase 

positive Staphylococcus aureus analysis.

13.2 Take 50-g from composite sample for Coliform Count, Aerobic Plate Count, and E. coli

(generic), and coagulase positive Staphylococcus aureus analysis.

14 Quality Controls

14.1 Use quality controls to demonstrate testing is performed correctly and factors that could 

negatively impact the results are mitigated.

14.2 Take immediate action prior to continuing testing and or reporting results when any quality 

control does not perform as expected.

14.3 Define and justify what constitutes a batch of samples.

14.4 Include quality controls with each batch of samples and set up in the same manner as 

unknown samples.

14.5 Include at a minimum, a Matrix Spike or Positive Control and a Sterility Control. 
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 9 of 10

14.6 Include at a minimum, the environmental monitoring controls of Surface Swabbing and 

Air Quality Plate Testing at a defined schedule.

14.7 LAS’ interpretation of each quality control and its purpose is defined below. 

NOTE: It is not a requirement for the laboratory to use the same terms for each type of 

control as long as the correct control is used for the correct purpose.

a) Sterility Control: Uninoculated medium. Use as a negative control to verify sterility of 

medium and consumables.

b) Positive Control: Medium inoculated with target control culture organism. Inoculate at 

a low concentration for qualitative methods and a known concentration for quantitative 

methods in the countable range. Use to ensure growth of organism.

c) Matrix Spike: Aliquot of sample prepared by adding a known quantity of target 

analytes to a specified amount of matrix and subjected to the entire analytical 

procedure. Use to establish if the method or procedure is appropriate for the analysis of 

a specific analyte in a specific matrix.

d) Air Quality Plate: Uninoculated medium exposed to laboratory air. Use to ensure the 

laboratory environment does not contain contaminants that may negatively impact the 

test. Use alongside quantitative tests.

e) Surface Swabbing: Swab of laboratory surfaces. Use to verify laboratory surfaces are 

free of contamination by pathogens of interest.

15 Quality Measures

15.1 Evaluate quality controls to identify acceptability of data, trends, and potential problems.

15.2 Take immediate action prior to continuing testing and or reporting results when any quality 

control does not perform as expected.

15.3 Ensure chemicals, media, reagents, immunoreagents, and commercial test kits are not used 

past their expiry date without conducting a suitability verification for their intended 

purpose and use.

15.4 Ensure each batch of medium is tested for sterility and growth promotion / inhibition 

characteristics before use (preferable) or at time of use if the process is clearly 

documented, including how to handle nonconforming medium and when results can be 

reported.

15.5 Record final pH and identifying information for the measurement device and reagents used 

in pH is a critical factor to method performance.
Agricultural Marketing Service

Science & Technology Program

Laboratory Approval and Testing Division

Laboratory Approval Service

Laboratory Approval Program – Microbiological Testing of 

Poultry Products for the Federal Purchase Program

Doc. No: LAP-PR.04

Revision Date: 02/22/23 Page 10 of 10

16 Official Certificate of Analysis/Report

16.1 Meet customer’s requirements for reporting results.

16.2 Meet the ISO 17025 standard for reporting results.

17 Reporting

17.1 Report the results of microbiological analyses in accordance with the current edition of 

“Instructions for The Reporting of Microbiological and Fat Test Results in Spreadsheet 

and Comma Separated Values (CSV) Text File (Database) Format.”

18 Revision History

New Rev. Description of Change Prepared by

03/27/17 Original TSB

09/04/14 ? TSB

02/06/17 ? LAS

04/13/18 Struck out requirements superseded by LAP-PR.05 and LAP-PR.06. Branch Chief, LAS

02/27/19 Changed strike out to green highlight with notations in the margin to improve 

readability. Refer to this version as, “dated 02/06/17 with notes 02/27/9”

Branch Chief, LAS

02/22/23 Updated to align with content and structure of other LAP documents. No 

requirement changes.

Branch Chief, LAS

19 Review / Approvals

Grace Vaillant

Branch Chief, LAS

Approver