United States Department of Agriculture

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Animal and Plant Health Inspection Service

 Veterinary Services

 VS Guidance 15201.1

1

Approval of Laboratories to Conduct Tests for Equine Infectious Anemia

1. Purpose and Background

This document outlines the procedures to initially approve laboratories to test for equine 

infectious anemia (EIA), the requirements to maintain approval, and the requirements for 

laboratories performing EIA tests. 

This guidance document represents the Agency’s position on this topic. It does not create or 

confer any rights for or on any person and does not bind the U.S. Department of Agriculture 

(USDA) or the public. Veterinary Services (VS) may make this information available to the 

public. While this document provides guidance for users outside Veterinary Services, VS 

employees may not deviate from the directions provided herein without appropriate 

justification and VS Equine Health Team concurrence.

2. Document Status

A. Review date: February 27,2023

B. This document cancels and replaces VS Memorandum No 555.16. 

3. Reason for Reissuance 

VS has revised the laboratory approval requirements.

4. Authority and References

A. Authorities (U.S. Code (U.S.C.) and Code of Federal Regulations (CFR)):

• 21 U.S.C. 151-159

• 7 CFR 371.4

• 9 CFR part 75

• 9 CFR 130.30

B. References:

• VS Form 10-11, Equine Infectious Anemia Laboratory Test

• Veterinary Services Processes Streamlining (VSPS) electronic Form 10-11, Equine 

Infectious Anemia Laboratory Test

• National Veterinary Services Laboratories Application for Laboratory Training

• NVSL SOP-EO-0034, “Requirements for Equine Infectious Anemia Agar Gel 

Immunodiffusion (Coggins) and Enzyme-Linked Immunosorbent Assay Testing at 

Veterinary Services Approved Laboratories.” Obtain this document by calling the 

National Veterinary Services Laboratories (NVSL) at (515) 337-7551 or emailing at 

NVSL.DVL.Equine_Ovine@aphis.usda.gov.

• Standardized format for reporting monthly data from EIA laboratories.

• National Veterinary Accreditation Program Reference Guide: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-ReferenceGuide
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• Table of contents: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-ReferenceGuide/Table-of-Contents

• Equine section: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-ReferenceGuide/Equine

• Equine ID:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-ReferenceGuide/Animal-Identification/Equine-Identification

• Appendix: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-ReferenceGuide/Appendix

• Equine teeth and aging: 

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-ReferenceGuide/Appendix/Equine-Teeth-and-Aging

C. Definitions: 

1) Official test

Any test for the laboratory diagnosis of EIA that uses a diagnostic product that is:

a. Produced under USDA license and found to be efficient for that diagnosis under 

the Virus-Serum-Toxin Act of March 1913, and subsequent amendments; and 

b. Conducted in a laboratory approved by the Animal and Plant Health Inspection 

Service (APHIS) Administrator per 9 CFR part 75. 

All EIA tests are official tests; VS strictly prohibits screening or preliminary tests. 

Approved personnel must conduct all official EIA tests at approved facilities, certified 

in accordance with the procedures outlined in this document. 

2) Official test form

The VS Form 10-11 is the official Federal form for EIA test requests. The VS Form 

10-11 serves as the reference standard for all other official EIA test forms. Revisions 

and changes to the official VS Form 10-11 will reflect the most current information 

and data points required, and will supersede the requirements outlined in this 

document. 

a. Information/data points required on the VS Form 10-11:

Form Serial Number (official use only).

1. Laboratory Accession Number (laboratory use only).

2. Date Blood Drawn.

3. Test Requested By Veterinarian: ELISA vs. AGID.
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4. Reason for Testing: Interstate Movement, Within State Use/Annual Testing, 

Change of Ownership/Sale, International Import/Export, Illness/Clinical 

Suspect, Investigation/Exposure.

5. Location of Equine at Blood Draw (name, address, and phone number).

6. County of Equine at Blood Draw.

7. Owner (name, address, and phone number).

8. Accredited Veterinarian:

a) Accredited Veterinarian Name, Address, and Phone Number.

b) Federal Category II Veterinary Accreditation number.

c) Original Signature of Submitting Veterinarian and the Statement (I certify I 

am a Category II Federally Accredited veterinarian, authorized in the 

State where the sample was obtained, by me, from the animal described 

below) from the collecting veterinarian.

d) Signature date.

(Note: VS considers all official EIA form submissions made through the electronic VSPS system 

digitally signed although they may lack a physical signature.)

9. Tube Number (if used).

10. Tag/Tattoo/Brand Number (if present).

11. Name (if named).

12. Color.

13. Horse Breed or Equine Species.

14. Age (XX Y or XX M) or Date of Birth (MM/DD/YYYY).

15. Gender/Sex (M-Male Intact, F-Female Intact, G-Gelding, FS-Female 

Spayed).

16. Microchip, Breed or Registration Number(s) (if present).

17. Written narrative description is REQUIRED. Include distinctive markings, 

unique and permanent forms of identification, when present: Brands, tattoos, 

scars, cowlicks, or whorls and blemishes; 17. Head, 18. Neck/body, 19. Left 

forelimb, 20. Right forelimb, 21. Left hind limb, 22. Right hind limb.

• Record all present unique and permanent forms of identification on the form, including,

but not limited to brands, tattoos, scars, whorls, electronic identification/microchip 

number(s), and biometric identifiers/measurements.

• Line drawings (silhouettes) are valuable and can help to accurately identify equines. 

• Digital photographs, sufficient to identify the individual, may be used; they should be of 

high quality, with sharp focus, adequate lighting, and proper perspective. They should 

include at least three views including frontal, left side, and right side. All three views 

must have all body parts of the animal visible, and no part of the body covered or 

obscured.

• If any field is “none,” write “none” or line through; do not leave fields blank.
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More than one animal may be included on one form if the samples come from equids 

with the same owner and from the same location, collected by the same veterinarian 

on the same date, and received by the laboratory on the same date. The submitting 

veterinarian must provide all the required general information (as above, # 1-9) as 

well as individual animal identification data for each animal/sample (which includes, 

as above, # 10–22 and the narrative written description of unique and permanent 

forms of identification, when present; including but not limited to brands, tattoos, 

scars, whorls, electronic identification/microchip number(s), and biometric 

identifiers/measurements).

VS will consider approving forms produced by individual States, laboratories, or other 

organizations as official EIA test forms. Official EIA test forms, both paper and 

electronic, must contain identical information/data points as the VS 10-11

described above and be approved by VS officials at both the Equine Health Team 

and the NVSL.

Use of these forms must comply with the provisions of this document and must yield 

copies for distribution to the submitting veterinarian, animal owner, and regulatory 

officials, as well as a copy to retain in the EIA testing laboratory. For the purposes of 

this document, the terms “VS Form 10-11” and “official test form” are 

interchangeable.

Paper and electronic EIA test forms, produced by individual States or other entities 

and existing when VS publishes this document, will be granted a 6-month grace 

period following publication of this document, during which they are acceptable and

valid for submission to a laboratory.

3) Laboratory director

The responsible party in a private, Federal, State, university, or military laboratory 

designated as the laboratory director and with supervisory or procedural authority 

over the operation of and testing in the EIA laboratory. In a private laboratory, it may 

be the owner, veterinarian, or other person with legal, financial, or supervisory 

authority over EIA testing and operations.

4) State, Federal, university or military laboratory 

An EIA test facility under the direct oversight of a State animal health official, a 

Federal animal health official, a university laboratory director, or a U.S. military 

laboratory director.

5) Private laboratory

An EIA test facility with no direct oversight by a State, Federal, or university 

laboratory official. 
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6) Mobile laboratory: 

A private, non-stationary, EIA test facility meeting the same requirements for 

approval as a stationary facility.

7) Satellite laboratory: 

An alternate laboratory facility, operating with the approval authority of an existing 

approved stationary EIA laboratory, for use at offsite equine sales venues, auction 

markets, or event facilities to meet the transfer of ownership or interstate movement 

requirements for EIA testing. Satellite laboratories may be within the physical 

structure of the sales venue or may be a mobile unit owned and operated at equine 

sales venues by the approved stationary EIA laboratory. 

5. Audience

Approved and prospective EIA laboratories, VS employees, other Federal and State 

agencies, accredited veterinarians, and members of the public.

6. Guidance

A. Application Process for Initial Laboratory Approval

1) The laboratory director provides a written statement (see VS 10-16: Application to 

Conduct Laboratory Equine Infectious Anemia (EIA) Testing) certifying that he or she 

understands the requirements described in this document and that the laboratory:

a. Has adequate and appropriate facilities as described in this document and per 

the attached inspection checklist (Attachment 1).

b. Has technical personnel suitable to perform official EIA testing after completing 

prescribed NVSL training.

c. Will accept only samples submitted by a Category II federally accredited 

veterinarian, authorized in the State where the samples were obtained, with a 

complete and legible official EIA test form.

d. Understands all EIA tests are official tests; VS strictly prohibits screening or

preliminary tests.

e. Will use only USDA-approved diagnostic test kits with licensed antigen. Will 

conduct all testing in accordance with the official protocols described in this 

document, provided or prescribed by NVSL, or provided in literature 

accompanying the diagnostic test kits.
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f. Understands all non-negative test results (positive, suspect, discrepant, or 

equivocal) will be considered preliminary results and the samples must be 

submitted to NVSL for confirmation.

g. Will be expected to seek proficiency (check) tests and materials, and meet 

annual (check) test proficiency requirements prescribed by NVSL.

h. Expects to perform at least 500 EIA tests per year as necessary to maintain 

testing competency.

i. Has regulatory obligations regarding reporting of all official test results. Has the 

resources available and allocated to provide adequate recordkeeping and to

meet the reporting and summary data requirements described in this document.

j. Receives a satisfactory official annual inspection as required to maintain 

approval.

k. Will maintain current contact information and respond to official requests and 

inquiries.

2) The VS Area Veterinarian in Charge (AVIC) and the State animal health official

(SAHO) will review the written statement, any veterinary accreditation violations 

known to APHIS officials, and any other information the State wishes to consider, as 

is its prerogative, to arrive at a consensus to deny or accept the request. The AVIC

will notify in writing those with denied requests and they may re-apply. Accepted

requests will continue for further processing, as described below.

3) A Federal animal health official (with a SAHO, if available) meets with the laboratory 

director to review the regulatory and technical requirements for conducting EIA tests 

and reporting results. The Federal animal health official reviews with the laboratory 

director: The inspection checklist, standards for accepting samples, conducting 

testing, reporting of results, and the reporting of summary data.

4) The laboratory director, in an interview with the AVIC or his or her delegate (with a 

SAHO, if available), demonstrates a thorough working knowledge of the 

requirements detailed in this document, using the VS Form 10-15, Agreement to 

Conduct Equine Infectious Anemia (EIA) Testing as a guide. The laboratory director 

acknowledges these responsibilities by signing the agreement and providing a copy 

to the AVIC and the SAHO.

5) A Federal animal health official (with a SAHO, if available) performs the initial 

inspection of the proposed physical laboratory facilities and records the inspection 

results on the checklist (Attachment 1). Laboratory inspections are subject to user 

fees for travel and inspection time at the hourly rate as described in 9 CFR 130.30. 

6) After completing steps 1-5 above, the AVIC and SAHO must submit a jointly signed 

Memorandum of Recommendation and Justification for the laboratory, including the 
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originals of completed VS Forms 10-15 and 10-16. Mail the memorandum and 

attachments to: Director, NVSL, 1920 Dayton Avenue, Ames, IA 50010. Laboratory 

personnel are only eligible for EIA training after submitting the Memorandum of 

Recommendation and Justification.

B. Application Process for Laboratory Personnel Training

1) Applicants submit a completed VS Form 4-11, NVSL Application for Laboratory 

Training, to the appropriate AVIC. The application form is available here.

2) The AVIC reviews the VS Form 4-11 application in consultation with the SAHO and 

they must jointly recommend personnel for training. If acceptable, the AVIC forwards

the application to NVSL and sends a copy to the SAHO. If the AVIC or SAHO have 

questions or concerns regarding the application, they will return it to the laboratory 

with comments for revision.

3) Upon notification of final approval for training, the applicant must contact NVSL (see 

final section #7 Inquiries below) for inclusion on the (waiting) list of scheduled future 

training opportunities.

4) Once training dates become available NVSL contacts the applicant to offer training.

5) The laboratory is responsible for all costs associated with the NVSL training course.

C. Final Approval

1) After satisfactorily completing 6. A. Application Process for Initial Approval (steps 1-

6) and the 6. B. Application Process for Laboratory Personnel Training (steps 1-5),

the laboratory is eligible for final approval by the NVSL Director on behalf of the 

APHIS Administrator. If approved, the NVSL Director notifies the laboratory, the 

SAHO, the AVIC, and the Equine Health Team by letter.

D. Training Requirements 

1) Laboratories must pay all costs associated with the NVSL training courses.

2) At all times, in any given physical, mobile, or satellite laboratory, at least one 

laboratory employee actively involved in EIA testing or oversight must be NVSLtrained and authorized.

3) Private laboratories

a. All employees performing or overseeing EIA testing must be NVSL-trained and 

authorized. 

4) Federal, State, military, and university laboratories 
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a. Upon request and pending consensus approval from NVSL, the AVIC, and 

the SAHO, personnel trained and authorized by NVSL to conduct EIA testing 

may train others at that same Federal, State, military, and university

laboratory to conduct EIA testing. After completing the in-house training,

NVSL will provide individual proficiency tests (standard user fees apply) to 

newly trained personnel. Upon successfully completing all the requirements 

described in this document, NVSL will authorize the individual to conduct EIA 

testing only in that same laboratory. If the in-house trained individual fails the

individual proficiency test he or she must retake the training subject to 

additional fees. If any individual fails the proficiency test two successive 

times, he or she must wait 1 year before NVSL will again offer proficiency 

testing to that individual.

b. For in-house training of personnel at a Federal, State, military, or university 

laboratory, the laboratory’s annual proficiency panel may not substitute for an 

individual’s proficiency test. Each newly trained individual must take and pass 

an individual proficiency test and have received a letter from NVSL 

authorizing them to perform EIA testing.

c. If a Federal, State, university, or military laboratory no longer has any NVSLtrained personnel on staff, the laboratory must notify NVSL immediately and 

arrange to send staff to NVSL for EIA training as soon as practicable; within 6 

months at the latest. However, the laboratory may continue to operate with 

the in-house trained and authorized personnel during that time. NVSL will 

notify the AVIC and the SAHO of the laboratory’s status.

E. Training and NVSL Authorization Procedures

1) Whether conducted in-house (if permitted) or by NVSL, the training should cover all 

aspects of testing including accepting samples, diagnostic testing, forms, signatures,

and reporting results and summary data. Training will include the importance of the 

laboratory’s obligations as set forth in this and other pertinent regulations and 

guidance.

2) Whether conducted in-house (if permitted) or by NVSL, laboratory personnel must 

successfully complete an NVSL-administered individual proficiency test upon 

completion of the training.

3) After personnel successfully complete the individual proficiency test, NVSL issues a 

certificate (for NVSL trained) or letter (if trained in-house) authorizing them to 

conduct EIA testing.

4) NVSL-authorized personnel who have not performed EIA testing for more than 1 

year must retake an individual proficiency panel. The laboratory’s annual proficiency 

panel may not substitute for this panel. User fees apply.
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5) Laboratories must notify NVSL if they no longer employ personnel authorized to 

conduct EIA testing. NVSL will suspend or revoke a private laboratory’s approval if 

NVSL-authorized personnel are not available to conduct the tests. NVSL will notify 

the AVIC, the Equine Health Team, and the SAHO regarding the laboratory’s status.

F. Laboratory Standards for Performing EIA Testing

1) The approved EIA laboratory may only test samples collected in the United States 

and submitted by:

a. A federally accredited veterinarian (Category II) authorized to perform accredited 

duties in the State where the sample originated; or

b. A State or Federal animal health official.

2) Samples should be collected, handled, stored, and transported to the laboratory so 

they arrive in good condition, in sufficient volume, and free from heat damage, 

hemolysis, or other degradation or contamination. Samples should be submitted to 

the laboratory as soon as possible after collection. Laboratories must reject 

submissions of samples older than 30 days, as they do not reflect current exposure 

status.

3) A complete and legible official test form (VS 10-11 or VS-approved equivalent as 

described above), which includes all of the data specified in Section C. Definitions, 

2.) Official Test Form, must accompany samples submitted for EIA testing. At the 

laboratory’s discretion, it may process samples accompanied by incomplete forms,

but a laboratory will not release results until the form is properly completed. 

4) Only APHIS-approved and licensed diagnostic test kits can be used for testing. 

5) All EIA tests are official tests; VS strictly prohibits screening and/or preliminary tests.

6) Conduct tests according to the test protocols described in the diagnostic test kit 

literature unless official NVSL protocols direct otherwise. NVSL provides these

protocols during training and notifies all laboratories when it significantly updates 

them. Include the appropriate control samples as specified in the instructions 

accompanying the diagnostic test kit for each test performed. In addition, include a 

weak positive sample, obtained from either NVSL or an approved commercial 

source, each time you conduct an agar gel immunodiffusion (AGID) test. Keep a

written log or electronic record of all tests conducted, including sample ID, test type, 

test kit company name and lot number, results for both control and test samples, and 

the name of the person or persons conducting the test.

7) The laboratory assigns each submission an accession number (specific to that 

laboratory) so it can unequivocally identify each sample. Laboratories may assign a 

single accession number to multiple samples only if the samples come from equids 

with the same owner and from the same location, collected by the same veterinarian
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on the same date, and received by the laboratory on the same date. Each such

sample in the accession number must be uniquely identified (by animal ID) on official 

test forms and on all laboratory records.

8) All samples testing non-negative (positive, suspect, discrepant, or equivocal, as 

defined in the diagnostic test kit or NVSL protocols) on any of the licensed EIA 

diagnostic tests must be immediately recorded on the submission form as

preliminary results and submitted to NVSL for confirmation.

a. NVSL may conduct ancillary testing on these samples or may request additional 

samples, if necessary. NVSL will bear the cost of confirmatory or ancillary testing 

on initial or additional samples, but not the costs of obtaining or shipping 

samples.

b. The referring laboratory, at its expense, must submit the following to NVSL within 

48 hours of obtaining a positive, suspect, discrepant, or equivocal (preliminary)

result:

1. At least 2 ml of serum sample.

2. A photo or electronic copy of the official test form (VS Form 10-11) with 

referring lab’s preliminary results recorded.

3. A completed NVSL submission form (VS Form 10-4) documenting the test kit 

name and lot number(s) and the result(s) obtained at the referring laboratory 

for each referred sample.

c. The referring laboratory retains the original official EIA test form (VS Form 10-11) 

and all paper duplicates until NVSL reports the final result.

d. If NVSL determines a negative final result (e.g., ELISA classified as a false 

positive with the AGID negative):

1. The NVSL-authorized EIA technician at the referring laboratory marks the 

form AGID negative, records the date of the AGID result, and signs the 

official EIA test form (VS Form 10-11).

2. The referring laboratory technician adds: “Result confirmed by NVSL. Test 

Result is (input: positive or negative). This form is not valid without NVSL 

report attached.” The form must also contain the 8-digit NVSL accession 

number (e.g., NVSL 15-001234) in the Remarks section.

3. The referring laboratory appends NVSL results to each copy of the official 

test form. The official EIA test form must include the appended NVSL 

result page to be valid. 
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4. NVSL keeps the photocopy of the official test form filed with the 

corresponding submission form (VS Form 10-4). 

5. The referring laboratory must provide a complete, valid copy of the official 

test form, including the appended NVSL result page, to the submitting 

veterinarian.

8) On each test result report (VS 10-11), include the official name, city, and State of the 

approved laboratory that conducted the test, the test result, and the type of test 

performed (ELISA vs. AGID). Reports must include the handwritten signature (or 

secure electronic signature) of the technician who performed the test and of the 

technician who reported the NVSL result. Stamped or perforated signatures are not 

acceptable. The technician’s initials are acceptable (in lieu of a signature) if the 

initials unequivocally identify the person who performed the test. All laboratory 

information and signature/initials must be legible on all copies of the official test form.

Complete testing and record official results before the reporting technician signs the 

official EIA test form.

9) Laboratories must maintain an original paper or an electronic copy of each 

completed EIA animal test form at the laboratory for at least 24 months after the test 

completion date. 

10) Before distributing the final results the submitting veterinarian may request changes

to the VS Form 10-11 (including address corrections or spelling mistakes) at the 

laboratory’s discretion. The laboratory must document the request and retain that 

document with the laboratory copy of the VS Form 10-11.

11) After distribution of the final results the information recorded on the original VS Form 

10-11 cannot be changed. In that case, take a new sample and submit a new form.

12) Laboratories must retain, and maintain in good condition, all samples received and 

tested for at least 30 days from the date they report results. 

G. Reporting Test Results

1) Negative Test Results: Laboratories should return official negative test results to the 

submitting veterinarian as soon as possible after completing the test. Laboratories 

can mail, email, fax, or otherwise electronically return results to the submitting 

veterinarian. However, if the veterinarian submitted the samples with OMB-approved, 

official paper VS 10-11 forms, then the laboratory must mail paper copies of PART 1 

- VETERINARIAN/SUBMITTER and PART 3 – OWNER to the submitter within 30 

days. Some venues or importing countries may require these paper forms. Some 

practitioners may feel these forms are more secure and prefer their use.

Laboratories should forward official negative test results to the SAHO and AVIC 

where the animal resides and to the submitting veterinarian at least monthly after 

completing the tests. The laboratories can also email, fax, or otherwise electronically 
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forward results, at the AVIC’s or SAHO’s request, provided the information remains 

available for epidemiological investigations and results can be obtained within 2 

working days. Back up these files weekly.

The laboratory must document the reporting described above and retain this 

documentation along with a paper or electronic copy of the negative test results for 

the annual inspection.

2) Non-Negative Test Results: The referring laboratory immediately records results 

(positive, suspect, discrepant, or equivocal) on the official VS 10-11 as preliminary. 

All samples forwarded to NVSL for confirmation (positive, suspect, discrepant, or 

equivocal on any EIA test) require the laboratory to immediately (no more than 24 

hours after the test is completed) notify the SAHOs and the AVIC of the affected 

States. 

If NVSL determines final results on referred samples to be positive, NVSL 

immediately reports the results to the SAHOs of the affected States, the AVIC, the 

referring laboratory, and the Equine Health Team. The AVIC coordinates with the

SAHO and ensures the submitting veterinarian receives notification. NVSL provides

copies of all positive test results as soon as possible to the affected SAHOs.

If NVSL determines final results on referred samples to be negative, NVSL 

communicates the results to the referring laboratory, the SAHO, and the AVIC. The 

referring laboratory’s NVSL-authorized EIA technician will amend (as detailed in E. 8)

d. Laboratory Standards for Performing EIA Testing) the original official test form (VS 

Form 10-11) and initial and date the amendment, which reflects the final negative 

result. On receiving the negative laboratory result form from NVSL, the EIA 

technician attaches the NVSL report to all copies of the official test form. It then 

becomes part of the official record for distribution with the official test form.

H. Reporting Summary Data

Laboratories must provide the VS Equine Health Team and the relevant SAHO with 

reports within 30 days of the close of the previous month. These reports should include

monthly totals of negative and positive EIA tests, grouped by test type (e.g., AGID vs.

ELISA) and by the sample origin State, using the standardized reporting spreadsheet or 

approved equivalent provided by the VS Equine Health Team. Email reports to 

equine.health@usda.gov or electronically transmit to the Equine Health Team via a

method approved by them. The laboratory must document the reporting and retain that 

documentation for the annual inspection.

I. Requirements for Mobile and Satellite Laboratories

1) Mobile laboratories

a. VS does not have to approve a mobile facility.
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b. VS inspects the facility annually. The facility must meet all requirements for a 

stationary laboratory as set forth in the checklist. The facility specifically must be 

able to maintain the appropriate controlled environment for testing and/or 

storage, as indicated in the inspection checklist (Attachment 1).

c. VS conducts annual proficiency testing at this facility.

d. Mobile laboratories performing fewer than 500 EIA tests per year (as 

documented by official test chart records) should justify their approval or renewal 

to the AVIC and SAHO and may be subject to additional inspections or 

proficiency panels initiated by NVSL or the SAHO. If the mobile facility fails to 

maintain standards or proficiency, VS will withdraw approval. Use of a mobile 

facility is restricted to the State VS approved, unless it obtains written 

authorization from both the SAHO and the AVIC of each alternate State or 

States. Submit that authorization to NVSL.

e. Laboratories with both a stationary and mobile capability must be able to 

distinguish laboratory test records for EIA tests completed at the mobile 

laboratory from tests conducted at the stationary laboratory. 

f. Upon request, and at the time of inspection, the laboratory director must provide 

the SAHO, inspecting Federal official, and the appropriate AVIC a chronological

log or clear documentation of all instances and locations of mobile operations. 

2) Satellite laboratories

a. VS does not have to approve a satellite laboratory.

b. VS inspects the facility annually. The facility must meet all requirements for a 

stationary laboratory as set forth in the checklist. The facility specifically must be 

able to maintain the appropriate controlled environment for testing and/or 

storage, as indicated in the inspection checklist (Attachment 1).

c. Conduct proficiency testing at the main or home laboratory. This may include the 

satellite location; there is no separate annual requirement for the satellite 

laboratory.

d. The 500-test minimum guidance applies to the main or home laboratory; there is 

no separate minimum for the satellite laboratory unless the satellite laboratory 

technician does not also perform testing at the main or home laboratory.

e. Use of the satellite facility is restricted to the State VS approved, unless it obtains 

written authorization from both the SAHO and the AVIC of each alternate State or 

States. Submit that authorization to NVSL.
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f. Laboratories must be able to distinguish laboratory test records for EIA tests 

completed at the satellite laboratory from tests conducted at the main or home 

laboratory. 

g. Upon request, and at the time of annual inspection, the laboratory director must 

provide the SAHO, inspecting Federal official, and the appropriate AVIC a 

chronological log or clear documentation of all instances and locations of satellite 

operations. 

J. Maintaining Approval

1) Each approved laboratory must be able to demonstrate and document compliance

with the requirements in this document; failure to meet these requirements will be 

grounds for withdrawal of laboratory approval. 

2) The approved Laboratory Director must know and meet NVSL’s deadlines. He or she 

must request the annual proficiency test, obtain the testing samples or materials, and 

must follow all instructions from NVSL to take and pass the annual proficiency test in 

the allotted time frame. Each laboratory will be proficiency tested once a year 

regardless of how many approved technicians work at the laboratory. Conduct 

proficiency testing for satellite laboratories at the home or main laboratory. This may 

include the satellite location, but additional proficiency testing is not required for 

satellite locations unless the technician does not also perform testing at the main or 

home laboratory. Laboratories must pay for the annual proficiency testing. 

Laboratories must maintain accurate contact information and respond promptly to 

inquiries and requests from NVSL.

3) Laboratories that VS recently approved (within 6 months of the proficiency test 

distribution date) are exempt from participating for that approval year only. 

Laboratories that fail the annual proficiency test will lose approval or undergo other 

corrective action as determined by NVSL. Failing an annual laboratory proficiency 

test twice in 1 year is grounds for immediate laboratory removal. Laboratory 

personnel must retake and pass the NVSL EIA laboratory technician course to regain 

approval. NVSL provides laboratory proficiency final results to the SAHO and AVIC

for laboratories approved in the State.

4) Laboratories must meet their reporting and summary data requirements without 

prompting. They must respond promptly to any NVSL inquiries regarding the number 

of tests performed, ordering proficiency testing, reporting proficiency results, and 

other requested information.

5) Federal, State, university, military, private, mobile, and satellite laboratories must 

undergo a satisfactory official annual inspection conducted by Federal personnel or a 

cooperative team of Federal and State personnel to retain approval. The AVIC or 

SAHO may request additional inspections. Satellite laboratories require inspection 

and approval of each operating site or venue. 
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Official laboratory inspections are subject to user fees. Laboratories are responsible 

for payment before, or at the time of, inspection. 9 CFR 130.30 lists user fees for 

time and travel dedicated to laboratory inspections. User fees specific to EIA lab 

inspection are charged under APHIS service code 2005 “hourly fee (EIA) (BT) (BL)” 

and reported in APHIS Import/Export functional area AP00UFVSIMPEXP00 under 

account code ZXVSICZZZZVSIMPEXEXPTICZZZZ in which “Z” at the beginning of 

the account code represents the last number of the fiscal year and “ZZZZ” relates to 

the cost center for the appropriate State. 

a. Inspection or certification by other organizations or authorities does not negate 

the requirement for this inspection. Inspection by Federal personnel or a FederalState team does not absolve laboratories from other local or State requirements. 

b. Inspectors will:

1. Verify adequate and appropriate facilities as described in this document and 

per the attached inspection checklist (Attachment 1);

2. Verify the laboratory has technical personnel suitable to perform official EIA 

testing who have received and completed the prescribed NVSL training and 

are certified by NVSL;

3. Verify the laboratory accepts only samples submitted by a Category II 

federally accredited veterinarian, authorized in the State where the samples

were obtained, and submitted with a complete and legible official EIA test 

form.

4. Review documents to ensure all EIA tests are conducted as official tests and 

there is no evidence of screening or preliminary tests.

5. Verify the laboratory uses only USDA-approved diagnostic test kits with 

licensed antigen. All testing is conducted in accordance with the official 

protocols as described in this document, provided or prescribed by NVSL, or 

in literature accompanying the diagnostic test kits.

6. Verify all non-negative test results (positive, suspect, discrepant, or 

equivocal) are considered preliminary results and the samples are 

immediately submitted to NVSL for confirmation.

7. Verify the laboratory meets annual check test proficiency requirements 

prescribed by NVSL and continues to expect to perform at least 500 EIA tests 

per year as necessary to maintain testing competency.

8. Verify the laboratory has fulfilled all regulatory obligations regarding reporting 

of all official test results, adequate recordkeeping, and has met the reporting 

and summary data requirements described in this document.
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9. Confirm and update laboratory contact information.

10. Provide the SAHO a copy of the inspection checklist within 30 days of 

completion.

11. Review for proper completion of official test charts and to verify the required 

reporting of both positive and negative test results is documented. 

6) Federal or State officials may inspect an approved laboratory at any time during the 

laboratory’s normal business hours or by appointment. VS may subject laboratories 

with deficiencies in compliance or procedures to corrective actions, as appropriate. 

Inspectors will recommend removing approval for EIA testing for laboratories with 

uncorrected deficiencies. 

7) Laboratories performing fewer than 500 EIA tests per year (as documented by official 

test chart records) should justify their approval/renewal in writing to the AVIC and 

SAHO and may be subject to additional inspections or proficiency panels initiated by 

NVSL or at the SAHO’s request. If the lab fails to maintain standards or proficiency,

VS will withdraw approval.

8) VS tracks EIA lab inspections using an information management system (currently 

the Emergency Management Response System [EMRS]). The AVIC oversees EIA 

inspections: monitoring and scheduling, entering inspection data, attaching

worksheets in EMRS within 30 days of finishing the inspection, and notifying State 

animal health officials of the inspection schedule.

9) The VS Equine Health Team, in cooperation with NVSL and State animal health 

officials, creates and maintains an appropriate EIA laboratory inspection training 

program, and reviews inspections to keep inspections consistent, timely, and 

accurate across the country. If a laboratory’s inspection is reported (in EMRS) as 30 

days past the annual inspection date, VS notifies the AVIC and SAHO.

K. Changes in Laboratory Contact Information, Location, or Ownership

1) The laboratory director must maintain current contact information and inform the 

AVIC and NVSL immediately of any approved personnel name or employment status 

changes, changes of address, telephone, or email information. The AVIC notifies the 

SAHO and VS Equine Health Team of changes. 

2) A change in the laboratory director necessitates a new, signed EIA Agreement. 

3) If the physical location of the laboratory changes (excluding mobile laboratories) 

while the ownership and clientele remain the same, notify NVSL and the AVIC as 

soon as possible. The AVIC notifies the SAHO and the VS Equine Health Team. VS 

will conduct an official inspection and administer a proficiency test in the new facility 

within the first 30 days of operation. Laboratories successfully completing a 
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Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

 Veterinary Services

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17

proficiency panel within 6 months of the annual test distribution are exempt from the 

annual proficiency test for that year only. 

4) Transfers of ownership, relocations out of State, or other moves not covered above 

are considered new laboratory applications and will require the concurrence of the 

SAHO and AVIC as would starting any new approval application.

L. Existing Laboratories

VS will permit approved laboratories operating when VS releases this guidance to 

continue operation with the following provisions: 

1) VS will send existing laboratory directors this guidance document for review.

2) NVSL must receive a new, signed EIA Director’s Agreement that acknowledges 

receipt and an understanding of the requirements before it will make the annual 

proficiency test available to that laboratory. Existing laboratories will have 6 months 

to comply with new requirements in this document.

3) VS will grant 6-month waivers from the requirement for a new EIA Laboratory 

Director’s Agreement, upon request, to those labs with less than 6 months until the 

next annual inspection.

M. Removal of Laboratory Approval

The APHIS Administrator may withdraw laboratory approval when a laboratory fails to 

meet any of the criteria for approval. In all cases, APHIS will notify the laboratory, the 

AVIC, and the SAHO in writing. Find the procedures to appeal laboratory removal in

9 CFR 75.4(d).

APHIS will remove approval in any of the following situations:

1) The laboratory requests removal.

2) The NVSL Director receives a written recommendation for removal by concurrence 

of the AVIC and the SAHO.

3) The laboratory fails to maintain adequate and appropriate facilities as described in 

this document and per the attached inspection checklist (Attachment 1).

4) The laboratory fails to maintain technical personnel with prescribed NVSL training to 

perform official EIA testing.

5) The laboratory fails to accept only samples submitted by a Category II federally 

accredited veterinarian, authorized in the State where the samples were obtained,

and with a complete and legible official EIA test form.
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Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

 Veterinary Services

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6) The laboratory fails to use only USDA-approved diagnostic test kits with licensed 

antigen. 

7) The laboratory fails to conduct all testing in accordance with the official protocols as 

described in this document, provided or prescribed by NVSL, or in literature 

accompanying the diagnostic test kits. 

8) The laboratory fails to conduct all EIA testing as official tests or conducts screening 

and/or preliminary tests. 

9) The laboratory fails to treat all non-negative test results (positive, suspect, 

discrepant, or equivocal) as preliminary results and/or submit the samples to NVSL 

for confirmation.

10) The laboratory fails to seek and meet annual check test proficiency requirements 

prescribed by NVSL and/or fails to perform at least 500 EIA tests per year without an 

official exemption.

11) The laboratory fails to meet the regulatory obligations regarding reporting of all 

official test results and/or fails to meet the reporting and summary data requirements 

described in this document.

12) The laboratory fails to obtain a satisfactory official annual inspection.

13) The laboratory fails to maintain current contact information and/or respond to official 

requests and inquiries.

14) APHIS will also consider any other compliance issues that occurred during the 

previous 12 months.

N. List of Approved Laboratories

The NVSL Director maintains a current list of laboratories approved to conduct tests for 

EIA. NVSL updates the list regularly, and it is available here, on the APHIS Animal 

Health Laboratory Information Services APHIS-Approved Laboratories page.

7. Inquiries

Direct any questions about the laboratory approval process to the NVSL Diagnostic Virology 

Laboratory by telephone at (515) 337-7551, by fax at (515) 337-6508, or by email at

NVSL_concerns@aphis.usda.gov.

Direct all other questions relating to this document to the Equine Health Team at 

equine.health@usda.gov or by telephone at (301) 851-3558.
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Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

 Veterinary Services

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Attachment 1 

Inspection Checklist

Laboratory Name:

Date of Inspection:

Name and Title/Affiliation of Inspector:

State Representative (if present):

Laboratory Director:

Director’s Representative (if 

applicable):

Physical Address of Laboratory (street, 

city, State, and ZIP code (not P.O.

box):

Mailing Address of Laboratory (if 

different):

Shipping Address of Laboratory (if 

different):

Laboratory Phone #:

Laboratory Fax #:

Laboratory Director’s Email Address:

Laboratory/Alternate Email Address:

List or attach a list of all NVSL-trained personnel currently conducting EIA tests at the laboratory 

and the date on which NVSL authorized each person. 

Name Date Authorized

List or attach a list of all in-house trained personnel currently conducting EIA tests at the 

laboratory and the date on which NVSL authorized each person (applies to State, Federal, 

university, or military laboratories ONLY). 

Name Date Authorized
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Laboratory Inspection Checklist for Equine Infectious Anemia (EIA) Testing

Section Item Yes No Notes

Building 

Facility

The building is in good repair and 

provides a professional appearance 

inside and outside.

Y N

The building has adequate and 

functional doors, windows, and screens 

that maintain a clean and climatecontrolled environment appropriate for 

a laboratory.

Y N

The building has clean, functional 

restrooms. Y N

The building appears free of rodents, 

insects, and other pests. Y N

Refuse is properly contained, removed 

and is handled in accordance with local 

ordinances.

Y N

N

Laboratory 

Facility

There is a separate and dedicated 

room reserved for laboratory use where 

the EIA testing is conducted, with floorto-ceiling walls and doors delineating 

that room. The public is denied access 

to the laboratory space. The laboratory 

space may also be used to store 

pharmaceuticals, biologics, or clean 

medical supplies, for example, but 

cannot be used for any animal use, 

eating meals, or other use that could 

create dust, dirt or excessive traffic; 

however all other standards will be 

maintained. While EIA testing is being 

conducted there will be no nonlaboratory concurrent use.

Y N

Adequate open, clutter-free bench 

space (at least 5 feet) is evident. There 

is hot and cold running water with a 

sink in the laboratory area.

Y N

Bright white light is available to the 

bench space. For AGID testing the 

facility must be capable of dimming or 

restricting ambient/daylight to properly 

read the results.

Y N
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 Veterinary Services

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Section Item Yes No Notes

Laboratory temperature is maintained 

at all times between 68° and 77 °F (20° 

and 25 °C) and/or an incubator is 

available to maintain these 

temperatures for the testing, when 

required. The laboratory facility is 

capable of preventing reagents and 

supplies from cold damage or 

overheating in accordance with label 

instructions.

Y N Laboratory 

temperature at 

time of inspection: 

___°F

Mobile and satellite laboratories: When 

operating or supplied with reagents, are 

equipped with a thermometer capable 

of high/low temperature 

memory/recording. A weekly high/low 

temperature record/log is kept.

Y N Attach or copy the 

temperature log.

Laboratory and laboratory equipment is 

clean, functional, and properly stored; 

records indicate it is properly 

maintained in accordance with manual 

of operations.

Y N

Refrigerator is functional, properly 

maintained, and equipped or 

supplemented with a thermometer 

capable of high/low temperature 

memory/recording, and is labeled for 

lab use only; no food or drink. A weekly 

high/low temperature record/log is kept. 

Y N Attach or copy the 

refrigerator 

temperature log.

Clean laboratory clothes (coats) are 

available and required to be worn. Y N

There is no evidence of prohibited 

activities in the laboratory area, such 

as: eating, drinking, applying 

cosmetics, handling contact lenses, or 

storage of food. Appropriate signage is 

clearly visible.

Y N

Y N

Laboratory 

Supplies 

and 

Equipment

The following equipment must be 

available and functioning properly 

for the agar gel immunodiffusion 

(AGID) test: 

Y N

High intensity laboratory light that can 

be focused for reading AGID plates. Y N
 United States Department of Agriculture

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Animal and Plant Health Inspection Service

 Veterinary Services

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Section Item Yes No Notes

Blinds on windows or separate room so 

light can be reduced to read AGID 

plates.

Y N

Medium seven-well immunodiffusion 

template cutter, a center well 

surrounded by six evenly spaced wells. 

Wells are 5.3 mm in diameter and 2.4 

mm apart.

Y N

A balance designed and functioning to 

read with accuracy to plus or minus 0.1 

gram; maintained and calibrated in 

accordance with operations manual.

Y N

Method to remove agar plug (such as a 

vacuum pump). Y N

Equipment to make agar: Graduate 

measures, flasks, and additional 

appropriate glassware.

Y N

Source of heat for agar preparation 

(microwave, hot plate, autoclave). Y N

Method for protecting from disturbance 

and incubating AGID plates on test (a 

room temperature incubator will 

suffice).

Y N

Clean or new pipettes for delivery of 

reagents to wells. Y N

Distilled water and chemicals for buffer 

(sodium bicarbonate, boric acid, 

distilled water).

Y N

Noble agar. Y N

Disposable 60 mm or 100 mm petri 

dishes. Y N

Materials or equipment to accurately 

measure pH within 0.2 pH unit. Y N

The following equipment must be 

available and functioning properly 

for the enzyme-linked 

immunosorbent assay (ELISA) test:

Y N

Incubator (if 37 °C incubation is 

required for the ELISA test used), 

functioning and properly maintained in 

accordance with operations manual.

Y N

Wash bottles, pipetting devices, and 

plate holders. Y N

ELISA washer and reader (optional). Y N
 United States Department of Agriculture

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Section Item Yes No Notes

Clean or new micropipettes and 

appropriate tips to deliver reagents to 

wells.

Y N

Pipettes must be properly calibrated a 

minimum of every 12 months, 

preferably every 6 months.

Y N

Maintain pipette calibration records. Y N Attach calibration 

record log.

Control of 

Specimens 

and 

Reporting

(Only applicable for approved 

laboratories)

Y N

Laboratory should not be accessible to 

the general public during testing. Y N

Records indicate the laboratory assigns 

an accession number with unique 

identification (animal name) to each 

sample. The specimen identity is 

maintained on the sample, worksheets, 

on the petri dish and ELISA 

plates/strips. The accession number is 

recorded on the official EIA reporting 

form. 

Y N Inspector will 

trace a recent 

random sample 

through entire 

process and verify 

accountability and 

document sample 

number and 

compliance.

Test worksheets include appropriate 

and complete information, including 

accession number, animal and sample 

identification, lot numbers and 

expiration dates of reagents used in the 

test, date/time of test start, identity of 

technicians setting up and completing 

test, and date/time of test completion.

Y N

Maintenance of test worksheets and 

accession paperwork for a minimum of 

24 months. The lab must provide the 

worksheets at inspection or NVSL 

request.

Y N

Specimens not appropriately identified 

are not tested. Y N
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Section Item Yes No Notes

Records indicate only specimens with 

properly filled official EIA submission 

forms (with name of the owner, name, 

address, and accreditation number of 

the submitting veterinarian, location of 

animal at the time the test sample was 

obtained, complete animal 

identification, and signed by the 

submitting veterinarian) are 

tested/processed. A minimum of 1 

random accession per month for the 

previous 12 months will be reviewed for 

completeness and compliance and 

accession numbers recorded.

Y N

The test results for each sample are 

recorded on a worksheet which should 

be made available for review.

Y N

The results are recorded on the 

reporting form with a copy kept in the 

laboratory. Results are reported only as 

negative, positive, or no test. 

Y N

Records indicate all positive, equivocal,

or discrepant samples are forwarded to 

NVSL. If a non-negative result was 

found since the last inspection, the 

inspector will trace a sample and 

document NVSL confirmation and 

appropriate notifications to Federal and 

State officials. 

Y N

Records indicate all tests are reported 

regardless of results. No unofficial EIA 

tests are performed to determine the 

status of the animals before the 

“official” test is performed. Each and 

every EIA test is an official test. 

Y N
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Animal and Plant Health Inspection Service

 Veterinary Services

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Section Item Yes No Notes

On a review of reports of test results 

they include the name, city, and State 

of the laboratory, the type of test 

performed, and the handwritten 

signature (or secure electronic 

signature) of the technician who 

performed the test. Stamped or 

perforated signatures are not in use. 

The technician’s initials unequivocally 

identify that person. All laboratory 

information and signature/initials are 

legible on all copies of the official test 

form. A minimum of 1 random 

accession per month for the previous 

12 months will be reviewed and 

documented for compliance.

Y N

Records indicate official test results and 

summary data are reported to the State 

and/or Federal animal health officials 

within the time specified by these 

officials.

• Non-negative test results were reported 

within 24 hours to:

o SAHO where the animals were 

sampled and where laboratory is 

located.

o AVIC where the animals were 

sampled.

o VS Equine Health Team via email.

• Negative test results were reported 

monthly to the SAHO where the 

laboratory is located (as requested or 

required) and the SAHO where the 

animals were sampled (as requested 

or required).

• Negative test results were reported 

monthly to the SAHO in the State 

where the animals were located.

• Monthly summary data is being 

reported to the SAHO and the VS 

Equine Health Team.

Y N

Records or inspection indicate 

specimens are held for at least 30 days 

after results are reported; either 

refrigerated whole blood or frozen

serum with clot removed. 

Y N Document the 

dates on a 

representative 

number of 

samples currently 

stored.
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Section Item Yes No Notes

Y N

EIA 

Reagents (Only available to approved 

laboratories)

Y N

Only reagents licensed by APHIS or 

supplied by NVSL are to be used. Both 

unopened and open/partially used 

reagents must demonstrate current 

expiration dates and be properly 

stored/refrigerated in accordance with 

label directions. 

Y N Record lot 

numbers and 

expiration dates 

on current 

reagents or a 

representative 

sample.

Unused or outdated reagents, other 

chemicals and supplies, and the 

inoculated EIA AGID or ELISA plates 

must be appropriately discarded 

according to local rules and regulations.

Y N

Test 

Procedure

Appropriate SOPs are available in the 

lab. Y N

Records indicate the procedures

outlined in the appropriate test protocol 

are being followed.

Y N
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ADDITIONAL REMARKS

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________ 

Laboratory is: Satisfactory Unsatisfactory (check one)

___________________________________________________________________

Inspector’s Name, Signature, and Date

___________________________________________________________________

Laboratory Director’s Name, Signature, and Date

____________________________________________________________________

Laboratory Director’s Representative Name (if not same), Signature, and Date

Inspector/Federal VMO: Inspection copies to the following; check when completed:

 Laboratory Director/Representative

 Diagnostic Virology Laboratory, NVSL, Ames, Iowa

 State Animal Health Official

 Federal District Office

 Copy uploaded to EMRS

Estimated date of next laboratory inspection: ____________________________________