Upon receipt of the letter requesting admission, the applicant will be sent an admission kit for completion.
Contents of Admission Kit
1. A document stating the parameters of the program including the required methodology and cost of the admittance and maintenance fees. (Due to copyright considerations, the AOAC International method will not be provided. The laboratory must obtain the method itself.)
2. A request for a letter from the laboratory management providing information as to the address, management, current laboratory capabilities, and name of the client requiring laboratory participation in this program.
3. A request for a list of qualified analysts, what they are qualified for, the date they were qualified, and who qualified them. This list should be updated whenever current employees qualify for additional procedures and/or when a new employee is hired. The Program Manager should be notified of these changes when they occur.
4. A general laboratory checklist for completion.
5. A request for the following Standard Operating Procedures:
Analytical methodology - include step by step details to enable any qualified analyst in the laboratory, including newly hired individuals to understand and successfully follow the procedures. Include any control sample requirements as well as any precautions to follow that are mentioned in the official method (i.e. critical control points) and precautions discovered in your own laboratory. Indicate the course of action that should be taken if unexpected results occur.
Quality assurance and quality control - include the use of logbooks, standards, positive and negative controls, frequency of instrument calibration, temperature of equipment monitoring if necessary, sample storage, and critical control points.
Tracking and issuance of results - include logging in samples, laboratory designations, method of tracking samples, chain of custody, reporting results, delivering analytical results to clients, and the appropriate signature of responsible person.
Maintenance and repair of instruments and equipment - include maintenance logbook, frequency of performance evaluation, frequency of professional servicing, and labeling of inoperable instruments.
Calibration of instruments - include frequency of calibration, recording calibration information, and corrective actions taken.
Chemical handling, receipt, and disposal - include logging in chemicals, frequency of preparation, documentation of preparation, storage requirements, handling precautions, pre-use testing, frequency of testing, discard times, methods of disposal, and documentation of disposal.
Training and training documentation - include procedures used to train personnel, documentation of the training procedures, and maintenance of training records.
6. A request for a description of, and the analytical results along with appropriate documentation of the laboratory validation of the method to be used for this program. The following are required: 1) limit of detection: 2) limit of quantitation; 3) percent recovery; 4) repeatability; 5) linearity; and 6) measurement uncertainty.
Review of Submitted Admission Kit
The admission kit is reviewed for completeness and acceptability. If the kit is incomplete or lacking in any area, recommendations will be made to the laboratory to rectify those areas.
Required Sample Testing
After the admission kit of an applicant has been determined to be satisfactory, the laboratory must demonstrate its ability to successfully analyze almonds for aflatoxin. The fees for preparing, shipping, and reviewing sample results for admission into the program must be paid whether the laboratory is accepted into the program or not.
1. Testing of Five Samples Containing Known Levels of Aflatoxin
The applicant is asked to successfully test five samples of almonds containing known (to both AMS and the applicant laboratory) amounts of aflatoxin and demonstrate their ability to detect and quantify aflatoxin in almonds.
Five samples of almonds containing known levels of aflatoxin will be shipped to the laboratory. Samples are to be analyzed by the laboratory and results sent to the Program Manager within five working days after receipt. If samples cannot be analyzed within the time allotted, the laboratory must notify the Program Manager to obtain a waiver from the time requirement.
The sample results are reviewed by the Program Manager and determined if they are acceptable. In order to be acceptable, each sample result must be within 50-120% for <1 ppb, 70 to 110% for 1 to 10 ppb, and 80 to 110% for >10 ppb of the known value of the sample.
If results are not acceptable, the Program Manager will work with the prospective laboratory to determine why the analyses were unsatisfactory. Once the problem(s) is resolved, a second set of known samples may be shipped to the laboratory. If a laboratory fails to successfully analyze the second set of known samples, it may not reapply for admission into the program for at least six months.
2. Testing of Five Samples Containing Unknown Levels of Aflatoxin
Having successfully tested the five samples of almonds containing known amounts of aflatoxin, the applicant then moves to the second stage of testing to demonstrate its ability to detect and quantify aflatoxin in almonds.
Five samples of almonds containing levels of aflatoxin known to USDA but not to the laboratory will be shipped to the laboratory. (Hereafter called unknown samples.) Samples are to be analyzed by the laboratory and results sent to the Program Manager within five working days after receipt. If samples cannot be analyzed within the time allotted, the laboratory must notify the Program Manager to obtain a waiver from the time requirement.
The sample results are reviewed by the Program Manager and determined if they are acceptable. In order to be acceptable, each sample result must be within 50-120% for <1 ppb, 70 to 110% for 1 to 10 ppb, and 80 to 110% for > 10 ppb of the known value of the sample.
If results are not acceptable, the Program Manager will work with the laboratory to determine why the analyses were unsatisfactory. Once the problem(s) is resolved, a second set of unknown samples may be shipped to the laboratory. If a laboratory fails to successfully analyze the second set of unknown samples, it may not reapply for admission into the program for at least six months.
Initial On-site Laboratory Review
An initial on-site laboratory review will be conducted by TSS personnel after the known and unknown samples have been successfully analyzed for aflatoxin. The review will include the following:
1. A Review of the Analytical Process; The analysis of almond samples will be observed in its entirety for adherence to official methodology and for analytical technique. Once a laboratory has been approved for a particular method, subsequent modifications cannot be made to the method.
2. A Review of Quality Assurance and Quality Control (QA/QC) Standard Operating Procedures (SOPs); QA/QC SOPs will be reviewed with regard to their application and documentation.
3. A Review of SOPs on Sample Tracking and Issuance of Results; Sample tracking and issuance of results SOPs will be reviewed as applied and documented in the laboratory.
4. A Review of SOPs on the Maintenance and Repair of Instruments and Equipment; SOPs on the maintenance and repair of laboratory instruments and equipment will be reviewed with regard to the documentation of entries in their respective maintenance and repair logbooks.
5. A Review of SOPs on Calibration of Instrumentation: SOPs on the calibration of instrumentation will be reviewed with regard to the documentation of entries in their respective calibration logbooks.
6. A Review of SOPs on Chemical Handling, Receipt, and Disposal: SOPs on chemical handling, receipt, and disposal will be reviewed as applied and documented in the laboratory.
7. A Review of SOPs on Training and Training Documentation: SOPs on training and training documentation will be reviewed in regard to procedures, documentation, and maintenance of records.
Upon completion of the review, an exit interview will be conducted. A laboratory review report will be written with corrective actions and recommendations for improvements and copies of this report will be sent to the laboratory, the Almond Board of California, and the AMS, Fruit and Vegetable Marketing Order Administration Branch. The laboratory will respond in writing to the report by implementing corrective actions and recommendations. A determination will be made by the Program Manager to accept or reject the laboratory for admission into the program, and the laboratory will receive a letter stating the outcome of the Program Manager's decision.
Payment of Admission Fee
A non-refundable admission fee of $7,200.00 must be paid in full to TSS before a laboratory is admitted into the program. This fee permits the laboratory to operate as an approved laboratory for the analysis of almonds for aflatoxin for one year. The fee will be reviewed yearly, and if necessary, adjusted to meet USDA operational costs.