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CVBSOP0101.04 

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United States Department of Agriculture 

Center for Veterinary Biologics 

Standard Operating Policy/Procedure 

Tests Requested to Assist Investigations – Processes and Responsibilities 

Date: 

Number: 

Supersedes: 

Contact: 

May 30, 2014

CVBSOP0101.04 

CVBSOP0101.03, November 6, 2013 

Douglas C. Murtle, (515) 337-6191 

Approvals: /s/Steven A. Karli Date: 12Jun14 

Steven A. Karli, Director 

Inspection and Compliance 

Center for Veterinary Biologics 

/s/Byron E. Rippke Date: 12Jun14 

Byron E. Rippke, Director 

Policy, Evaluation, and Licensing 

Center for Veterinary Biologics 

/s/Byron E. Rippke Date: 20Jun14 

Acting CVB Director 

Center for Veterinary Biologics 

/s/Rebecca L.W. Hyde Date: 20Jun14 

Rebecca L.W. Hyde, Section Leader 

Quality Management 

Center for Veterinary Biologics 

United States Department of Agriculture 

Animal and Plant Health Inspection Service 

P. O. Box 844 

Ames, IA 50010 

INTERNAL USE ONLY 

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the product by USDA 

and does not imply its approval to the exclusion of other products that may be suitable.
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Tests Requested to Assist Investigations – Processes and Responsibilities

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Table of Contents

1. Scope

2. Background

3. Purpose

4. The Investigation Testing Processes and Responsibilities

5. Documentation of Communication

6. Process Audits

7. Summary of Revisions
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1. Scope

This document describes the processes and responsibilities for reviewing, requesting, 

performing, and reporting testing conducted at the Center for Veterinary Biologics (CVB) in 

support of the Veterinary Biologics Investigative process. The CVB requests tests of veterinary 

biologics to implement the provisions of the Virus-Serum-Toxin Act to ensure veterinary 

biologics available for the diagnosis, prevention, and treatment of animal diseases are not 

worthless, contaminated, dangerous or harmful. 

2. Background 

The Inspection and Compliance Unit (IC) routinely initiates documented investigations 

(Veterinary Biologics Investigations – VBI) associated with the licensed and unlicensed entities. 

Occasionally, to support the investigation, IC may request the CVB Laboratory to perform 

testing. 

3. Purpose

The purpose of this document is to establish and define processes and responsibilities regarding 

special request testing at the CVB as it relates to IC investigations. 

4. The Investigation Testing Processes and Responsibilities

Veterinary Services Memorandum No. 800.1 delegates authority to the IC Director to direct 

investigations of the Virus-Serum-Toxin Act (VSTA) and regulations (title 9, Code of Federal

Regulations (9 CFR), parts 101-121). Specific processes and responsibilities for maintaining 

chain of custody, documentation, and confidentiality of a Veterinary Biologics Investigation 

(VBI) are described in the current version of ICSOP0016, Investigation and Processing of 

Alleged Violations of the Virus-Serum-Toxin Act. 

4.1 Test Determination and Initiation

Based on the evaluation of information available, the Biologics Specialist and Laboratory 

personnel discuss product testing options.

 The Biologics Specialist is responsible for notifying the Laboratory 

Agent/Test Contact of the intent to submit a Special Test Request (STR) and 

to determine the most appropriate test(s) to be conducted.

 Testing of an unlicensed product requires the coordination of the Compliance 

Section Leader, Manager, Director and appropriate Laboratory personnel. 

Testing protocols and procedures must be determined in advance with 

approval of the Compliance Section Leader.
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 The most current filed version of the applicable Outline of Production or

Special Outline, should be used. If a Supplemental Assay Method (SAM) is 

used by the CVB Laboratory, the Laboratory Agent/Test Contact should 

inform the Biologics Specialist. If an APHIS Form 2008 (Form 2008) is 

available, the Biologics Specialist may send a copy to the Laboratory 

Agent/Test Contact if requested.

 When the proposed CVB Laboratory testing deviates from the Outline of 

Production, Special Outline, or published SAM, the Laboratory Agent/Test 

Contact will provide a validated testing protocol to the Biologics Specialist.

 The Biologics Specialist will notify the firm in writing that a released product 

is being placed on-test at the CVB Laboratory and is at risk for regulatory 

action. The notification must be communicated to the firm before testing is 

initiated, unless the investigation warrants testing be done prior to notifying 

the firm. The Biologics Specialist should consult with the Compliance Section 

Leader or Manager prior to initiating the notification as circumstances 

surrounding the investigation may not warrant notification.

 The Biologics Specialist will inform the Laboratory Agent/Test Contact if the 

biologics manufacturer is being informed of product testing. A copy of the 

written notification is forwarded to the Laboratory Agent/Test Contact

through the CVB mail log system.

 The Laboratory Agent/Test Contact is responsible for supplying the 

appropriate test code(s) for the STR and providing the Biologics Specialist the

projected test on and off dates.

4.2 Requesting Special Testing

Step 1. The Biologics Specialist enters a STR into the Licensing, Serial Release, 

and Testing Information System (LSRTIS) following the procedures in the current 

version of ICSOP0043, LSRTIS Special Test Request Procedures for Inspection 

and Compliance. The VBI file number is included in the STR comments.

 The Laboratory Agent/Test Contact checks with the Laboratory 

Resource Unit (LRU) for availability of samples. If samples are not 

available, the Biologics Specialist is responsible for assuring that the 

Laboratory obtains the appropriate samples. The Biologics Specialist 

provides the STR number to the firm to include on the APHIS Form 

2020 (Form 2020) to facilitate routing.

 The Laboratory Agent/Test Contact may contact the firm directly after 

consulting with the Biologics Specialist regarding any needed reagents 

after the firm has been notified of planned testing by the Biologics 
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Specialist, and the Laboratory Agent/Test Contact has received a copy 

of the written notification from the Biologist Specialist.

 In the case of an unlicensed company, the Compliance Section Leader 

will work with Investigative and Enforcement Services (IES) 

personnel or other associated investigative personnel to obtain product 

and/or, in some instances, reagents by appropriate means. 

 The Biologics Specialist initials the original printed copy of the STR

and gives it to the Biologics Compliance Assistant (BCA) assigned to 

the firm, who files one copy in the Firm/Product pending file and an 

additional copy in the VBI file. 

Step 2. The testing Laboratory Section receives a real-time notification from 

LSRTIS indicating that the STR has been entered into the system.

Step 3. If/when samples are available/received in the LRU repository, the 

Laboratory Agent/Test Contact will be notified real-time through LSRTIS.

 The Laboratory Agent/Test Contact enters a response, projected off 

test dates, test code(s), and number of samples needed for testing in 

LSRTIS. The Laboratory response to the STR is updated automatically 

in LSRTIS.

4.3 Performing Testing

The Laboratory Agent/Test Contact or technician conducts the test(s).

 The Laboratory Agent/Test Contact has the responsibility to assure that testing 

is conducted according to an approved test protocol (e.g., current Production 

or Special Outlines, SAM, CVB or firm protocol, standard operating 

procedure (SOP), etc.) and documented in accordance with 9 CFR 

116.1(a)(1)(2).

 The Laboratory Agent/Test Contact will notify the Section Leader and the 

Biologics Specialist responsible for the VBI in a timely manner in the event of 

unsatisfactory results, test delays, or other significant testing concerns to 

discuss further action.

 The Biologics Specialist is responsible for contacting the firm regarding 

testing delays, when appropriate.
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4.4 Reporting Test Results

Step 1. Laboratory personnel enter and validate the test results, as per current 

laboratory SOPs for review and signing of the test results.

 The Laboratory Agent/Test Contact has the responsibility to notify the 

Biologics Specialist when the test has been completed and validated so 

that the Biologics Specialist can expect to print the CVB Laboratory 

test results. The specialist also should be reviewing the expected off 

date in LSRTIS to expect results. 

 The Laboratory Agent/Test Contact is responsible for creating a Memo 

to the Record that specifically documents or addresses all test results 

other than satisfactory (e.g., details of extraneous agents tested, 

clarifications of “no test” or “inconclusive” test results, test system 

limitations, etc.). A copy of this memo must be sent to the Biologics 

Specialist within 7 working days of completion of the test. 

 The Laboratory Agent/Test Contact copies all bench records 

associated with the test and supplies them to the Biologics Specialist 

for inclusion into the VBI record.

Step 2. The Biologics Specialist reviews the current version of ICSOP0043, 

Section 6.

Step 3. The Biologics Specialist obtains copies of all bench records associated 

with the CVB Laboratory testing. Any other copies of records associated with the 

testing can be requested from the Laboratory Agent/Test Contact at this time 

(animal acquisition, calibration substantiation, etc.) The documentation is 

reviewed prior to Step 4 and placed in the VBI folder.

Step 4. When appropriate, the Biologics Specialist notifies the firm regarding test 

results and any compliance action(s), as directed by the Compliance Section 

Leader using the test report or official letter. 

5. Documentation of Communication

Communication processes are critical and must be documented in an auditable fashion. All 

communication records associated with the investigation (originating both from IC and from the 

Laboratory) need to be included in the VBI folder. For example, a telephone log (including 

signature or initials and date) is required to be maintained documenting communication by 

telephone. 
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6. Process Audits

Process Audits will also be conducted if requested by the Directorate when process failures occur 

which have an “across-unit-impact”.

Findings from Process Audits will be distributed to CVB management for review and problem 

solving.

7. Summary of Revisions

Version .04

 1: The scope was updated to be consistent with VSTA language.

 2: References to nonprocedural information was removed.

 3: The purpose of the document was clarified.

 4.1: Section heading changed from “Review of Testing” to “Test Determination and 

Initiation.”

 4.1: Section was updated to provide more precise descriptions and to include needed 

guidance.

 4.4: Added to Step 1, “The Laboratory Agent/Test Contact copies all bench records 

associated with the test and supplies them to the Biologics Specialist for inclusion into 

the VBI Record.”

 4.4: Added to Step 3, “Any other copies of records associated with the testing can be 

requested from the Laboratory Agent/Test Contact at this time (animal acquisition, 

calibration substantiation, etc.).”

 6: Section updated to reflect current practices.

Version .03

 The Contact information was updated.

 Title of the document was updated to reflect that is a policy document.

 1: The scope was clarified further to reflect the purpose of test to assist investigations.

 1: The word “standard operating procedure (SOP)” was removed and replaced with 

the word “document” throughout the document.
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 2: The background was updated to reflect the use of a new electronic laboratory 

information management system. The change from VBIS to LSRTIS was edited 

throughout the document. Procedures specifically for VBIS were changed to 

procedures done in LSRTIS throughout the document. 

 4: The title of ICSOP0016, Investigation and Processing of Alleged Violations of the 

Virus-Serum-Toxin Act, was added.

 4.2: ICSOP0021 was changed to ICSOP0043, LSRTIS Special Test Request 

Procedures for Inspection and Compliance.

 4.2: The acronym BMPS was replaced with the actual acronym for the Laboratory 

Resource Unit (LRU).

 4.4: The processes were clarified to reflect current practices. 

 4.4: The review of test bench records was added as clarification of current practices. 

Version .02

 This version represents a complete revision of the document to further clarify roles 

and responsibilities of involved parties.

 Joseph Hermann has been added as a Contact for this document.

 4: The reference of ICSOP0016 has been added for information on the investigation 

process.

 4.2: The Laboratory will not contact the firm until a copy of the written notification 

from the Biologics Specialist has been received and the Biologics Specialist has been 

notified.