UNITED STATES DEPARTMENT OF AGRICULTURE

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

VETERINARY SERVICES

LABORATORY INSPECTION CHECKLIST FOR 

EQUINE INFECTIOUS ANEMIA (EIA) TESTING

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 Number

Laboratory Fax Number

Director Email Address Laboratory Email Address

List all NVSL-trained personnel currently conducting EIA tests at the laboratory, along with the date on which NVSL authorized each person.

NAME DATE AUTHORIZED NAME DATE AUTHORIZED

List 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 NAME DATE AUTHORIZED

SECTION I – BUILDING FACILITY

ITEM YES NO NOTES

1. The building is in good repair and provides a professional appearance inside 

and outside.

2. The building has adequate and functional doors, windows, and screens that maintain 

a clean and climate-controlled environment appropriate for a laboratory.

3. The building has clean, functional restrooms.

4. The building appears free of rodents, insects, and other pests.

5. Refuse is properly contained, removed and is handled in accordance with local 

ordinances.

SECTION II - LABORATORY FACILITY

ITEM YES NO NOTES

6. There is a separate and dedicated room reserved for laboratory use where the EIA 

testing is conducted, with floor- to-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 non-laboratory concurrent use.

7. 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.

8. 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.

9. 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.

Laboratory temperature at time of inspection:

°F

VS 10-17 Laboratory Director/Representative Page 1 

OCT 2020 
SECTION II - LABORATORY FACILITY (CONT.)

ITEM YES NO NOTES

10. 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.

Attach or copy the temperature log.

11. 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.

Attach or copy the refrigerator temperature log.

12. Clean laboratory clothes (coats) are available and required to be worn.

13. 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.

SECTION III – LABORATORY SUPPLIES AND EQUIPMENT

The following equipment must be available and functioning properly for the agar gel immunodiffusion (AGID) test:

ITEM YES NO N/A NOTES

14. High intensity laboratory light that can be focused for reading AGID plates.

15. Blinds on windows or separate room so light can be reduced to read AGID plates.

16. 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.

17. A balance, designed and functioning to read with accuracy to plus or minus 0.1 

gram; maintained and calibrated in accordance with operations manual.

18. Method to remove agar plug (such as a vacuum pump).

19. Equipment to make agar: Graduate measures, flasks, and additional 

appropriate glassware.

20. Source of heat for agar preparation (microwave, hot plate, autoclave).

21. Method for protecting from disturbance and incubating AGID plates on test (a 

room temperature incubator will suffice).

22. Clean or new pipettes for delivery of reagents to wells.

23. Distilled water and chemicals for buffer (ex: sodium hydroxide, boric acid).

24. Noble agar.

25. Disposable 60 mm or 100 mm petri dishes.

26. Materials or equipment to accurately measure pH within 0.2 pH unit.

The following equipment must be available and functioning properly for the enzyme-linked immunosorbent assay (ELISA) test:

27. Incubator (if 37 °C incubation is required for the ELISA test used), functioning 

and properly maintained in accordance with operations manual.

28. Wash bottles, pipetting devices, and plate holders.

29. ELISA washer and reader (optional).

30. Clean or new micropipettes and appropriate tips to deliver reagents to wells.

31. Pipettes must be properly calibrated a minimum of every 12 months, preferably 

every 6 months, and regardless of ISO or other certifications.

32. Maintain pipette calibration records. Attach calibration record log.

IV - CONTROL OF SPECIMENS AND REPORTING

(Only applicable for approved laboratories)

ITEM YES NO N/A NOTES

33. Laboratory should not be accessible to the general public during testing.

34. 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.

Inspector will trace a recent random sample 

through entire process and verify accountability 

and document sample number and compliance.

35. 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.

36. Maintenance of test worksheets and accession paperwork for a minimum of 24 

months. The lab must provide the worksheets at inspection or NVSL request.

37. Specimens not appropriately identified are not tested.

38. The test results for each sample are recorded on a worksheet which should be 

made available for review.

39. 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.

VS 10-17 Page 2 

OCT 2020 
IV - CONTROL OF SPECIMENS AND REPORTING (CONT.)

(Only applicable for approved laboratories)

ITEM YES NO N/A NOTES

40. 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.

41. 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.

42. 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 requestedor 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.

43. 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.

Document the dates on a representative number 

of samples currently stored.

EIA REAGENTS

(Only available to approved laboratories)

ITEM YES NO N/A NOTES

44. 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.

Record lot numbers and expiration dates on 

current reagents or a representative sample.

45. 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.

TEST PROCEDURE

ITEM YES NO N/A NOTES

46. Appropriate SOPs are available in the lab.

47. Records indicate the procedures outlined in the appropriate test protocols are 

being followed.

ADDITIONAL REMARKS

Inspector’s Name Inspector’s Signature Date

Laboratory Director’s Name Laboratory Director’s Signature Date

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

VS 10-17 Inspector posts inspection to Approved Laboratory's electronic record (EMRS or other). Page 3 

OCT 2020