§ 439.20 - Criteria for maintaining accreditation.

§ 439.20 Criteria for maintaining accreditation.

(a) Criteria. To maintain accreditation, an analytical laboratory must fulfill the requirements of paragraphs (b) through (i) of this section.

(b) Official samples.

(1) An accredited laboratory must expeditiously report analytical results, in the analyte category for which accreditation was granted, of official samples on designated forms to the Data Center Staff, USDA/FSIS Eastern Laboratory, Russell Research Center, P.O. Box 6085, Athens, GA 30604 (for U.S. Postal Service delivery), or Data Center Staff, USDA/FSIS Eastern Laboratory, Russell Research Center, 950 College Station Road, Athens, GA 30605 (for commercial carrier delivery). When so provided for by FSIS, analytical results may be reported to the Data Center Staff by facsimile at [phone], or electronically. The Federal inspector at any establishment may assign the analysis of official samples to an FSIS laboratory if, in the inspector's judgment, there are delays in receiving test results on official samples from an accredited laboratory.

(2) Every QC recovery associated with reporting of official samples must lie within ranges established by FSIS. Supporting documentation must be made available to FSIS upon request.

(c) Records. An accredited laboratory must

Records. To demonstrate traceable and appropriate application of equipment, standards, procedures, analysts, and approvals related to accreditation, an accredited laboratory must:

(1) Maintain laboratory quality control records for the most recent three years that samples have been analyzed

under this Program

.

(2) Maintain complete records of the receipt, analysis, and disposition of

official

samples for the most recent three years that samples have been analyzed

under this Program

.

(3) Maintain in a secure electronic format or in a standards book,

which is preferably a permanently bound book with sequentially numbered pages,

all records, readings, and calculations for

standard solutions. All entries

prepared standards. Entries are to be dated and

signed by

the analyst

immediately upon completion

identified at the time of the entry, and manual calculations verified and documented by the supervisor, or

in the absence of the supervisor

by the supervisor's designee, before use of the standard

solution but no later than within one week

. The standards

book is

records are to be retained for three years after the last recorded entry. The certificates of analysis are to be kept on file for purchased standards for at least the period of time that the materials are in use.

(4) Maintain records

and supervisor approvals

of

recoveries, and of

instrument maintenance and calibration. The records are to be retained for three years after the last recorded entry.

(5) As provided in paragraph (

f

e) of this section, records

should

are to be made available for review by any duly authorized representative of the Secretary of Agriculture, including ALP personnel or their designees.

(

d)Check samples

c) Inter-laboratory accreditation maintenance proficiency testing sample.

(1) An accredited laboratory must analyze

interlaboratory

inter-laboratory accreditation maintenance

check

proficiency testing samples and return the results to

FSIS within

the ALP by the due date, which is usually within approximately three weeks of sample receipt. This must be done whenever requested by FSIS and at no cost to FSIS.

(2) Results must be those of the accredited laboratory. Analyses of

maintenance check

proficiency testing samples

shall

must not be contracted out by the accredited laboratory.

(

3) As provided by the requirements in paragraph (h) of this section, a check sample report will be considered complete only if laboratories report all analytes present in the check sample for the analyte category in which accreditation was granted.

(e)

d) Corporate changes. The ALP must be informed within 30 days of any change of address or in the laboratory's ownership, officers, directors, supervisory personnel, or other responsibly connected individual or entity.

(

f

e) On-site review. An accredited laboratory must permit any duly authorized representative of the Secretary to perform both announced and unannounced on-site laboratory reviews of facilities and records, both hard copy and electronic, during normal business hours, and to copy any records pertaining to the laboratory's participation in the ALP.

(

g

f) Analytical test procedures. An accredited laboratory must use analytical test procedures designated by the FSIS ALP as being acceptable.

(h

FSIS and some AOAC analytical test procedures are acceptable.

(g) Quality assurance levels.

(1)

An accredited laboratory must demonstrate

an ability

the capability to maintain quality assurance levels that are within acceptable limits

for systematic laboratory difference, variability, and individual large deviations

as evaluated by the ALP in the analysis of

interlaboratory check

inter-laboratory accreditation maintenance proficiency testing samples for the analyte category for which accreditation was granted. An accredited laboratory will successfully demonstrate the maintenance of these capabilities if its

analytical

results from

interlaboratory

inter-laboratory accreditation maintenance

check

proficiency testing samples satisfy

the criteria presented in this paragraph (h). All statistical computations are to be rounded to the nearest tenth, except where otherwise noted.

(2) In addition, a laboratory accredited for a specific chemical residue or a chemical residue class:

(i) Must satisfy criteria presented in this paragraph for chemical residue recoveries and proper identification;

(ii) Must demonstrate the maintenance of its capabilities by reporting its analytical results for each specific chemical residue found above the minimum proficiency level; and

(iii) Must, if accredited for the analysis of chlorinated hydrocarbons, obtain analytical results that collectively satisfy the criteria.

(3) Systematic laboratory difference: The standardized difference between the accredited laboratory's result and the comparison mean for each interlaboratory accreditation maintenance check sample is used to determine two CUSUM values, designated as CUSUM-P and CUSUM-N.

(i) When determining compliance with this criterion for all chlorinated hydrocarbon results in a sample collectively, the following statistical procedure must be followed to account for the correlation of analytical results within a sample: The average of the standardized differences of the analytical results within the sample, divided by a constant, is used in place of a single standardized difference to determine the CUSUM-P (or CUSUM-N) value for the sample. The constant is a function of the number of analytical results used to compute the average standardized difference.

(ii) Positive systematic laboratory difference: This value is computed and evaluated as follows:

(A) Determine the CUSUM-P increment for the sample.

(1) The CUSUM-P increment for food chemistry, as defined in § 439.1 of this part, is set equal to:

2.0, if the standardized difference is greater than 2.4,

−2.0, if the standardized difference is less than −1.6, or

the standardized difference minus 0.4, if the standardized difference lies between −1.6 and 2.4, inclusive.

(2) The CUSUM-P increment for chemical residues is set equal to:

2.0, if the standardized difference is greater than 2.5,

−2.0, if the standardized difference is less than −1.5, or

the standardized difference minus 0.5, if the standardized difference lies between −1.5 and 2.5, inclusive.

(B) Compute the new CUSUM-P value. The new CUSUM-P value is obtained by adding, algebraically, the CUSUM-P increment to the last previously computed CUSUM-P value. If this computation yields a value smaller than 0, the new CUSUM-P value is set equal to 0.

(C) Evaluate the new CUSUM-P value. The new CUSUM-P value must not exceed:

(1) 5.2 for food chemistry.

(2) 4.8 for chemical residues.

(iii) Negative systematic laboratory difference: This value is computed and evaluated as follows:

(A) Determine the CUSUM-N increment for the sample.

(1) The CUSUM-N increment for food chemistry is set equal to:

2.0, if the standardized difference is greater than 1.6,

−2.0, if the standardized difference is less than −2.4, or

the standardized difference plus 0.4, if the standardized difference lies between −2.4 and 1.6, inclusive.

(2) The CUSUM-N increment for chemical residues is set equal to:

2.0, if the standardized difference is greater than 1.5,

−2.0, if the standardized difference is less than −2.5, or

the standardized difference plus 0.5, if the standardized difference lies between −2.5 and 1.5, inclusive.

(B) Compute the new CUSUM-N value. The new CUSUM-N value is obtained by subtracting, algebraically, the CUSUM-N increment from the last previously computed CUSUM-N value. If this computation yields a value smaller than 0, the new CUSUM-N value is set equal to 0.

(C) Evaluate the new CUSUM-N value. The new CUSUM-N value must not exceed:

(1) 5.2 for food chemistry.

(2) 4.8 for chemical residues.

(4) Variability: The absolute value of the standardized difference between the accredited laboratory's result and the comparison mean for each interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-V.

(i) When determining compliance with this criterion for all chlorinated hydrocarbon results in a sample collectively, the following statistical procedure must be followed to account for the correlation of analytical results within a sample: The square root of the sum of the within sample variance and the average standardized difference of the sample, divided by a constant, is used in place of the absolute value of the standardized difference to determine the CUSUM-V value for the sample. The constant is a function of the number of analytical results used to compute the average standardized difference.

(ii) The variability value is computed and designated as follows:

(A) Determine the CUSUM-V increment for the sample. The CUSUM increment is set equal to the larger of −0.4 or the absolute value of the standardized difference minus 0.9. If this computation yields a value larger than 1.6, the increment is set equal to 1.6.

(B) Compute the new CUSUM-V value. The new CUSUM-V value is obtained by adding, algebraically, the CUSUM-V increment to the last previously computed CUSUM-V value. If this computation yields a value less than 0, the new CUSUM-V value is set equal to 0.

(C) Evaluate the new CUSUM-V value. The new CUSUM-V value must not exceed 4.3.

(5) Large deviations: The large deviation measure of the accredited laboratory's result for each interlaboratory accreditation maintenance check sample is used to determine a CUSUM value, designated as CUSUM-D.

(i) A result will have a large deviation measure equal to zero when the absolute value of the result's standardized difference, (d), is less than 2.5, and otherwise a measure equal to 1−(2.5/d).

(ii) The large deviation value is computed and evaluated as follows:

(A) Determine the CUSUM-D increment for the sample. The CUSUM increment is set equal to the value of the large deviation measure minus 0.025.

(B) Compute the new CUSUM-D value. The new CUSUM-D value is obtained by adding, algebraically, the CUSUM-D increment to the last previously computed CUSUM-D value. If this computation yields a value less than 0, the new CUSUM-D value is set equal to 0.

(C) Evaluate the new CUSUM-D value. The new CUSUM-D value must not exceed 1.0.

(6) For chemical residues:

(i) Each QC recovery must lie within ranges established by FSIS.

Supporting documentation must be made available to FSIS upon request.

(ii) Not more than one residue misidentification may be made in any two consecutive check samples.

(iii) Not more than two residue misidentifications may be made in any eight consecutive check samples.

(i) Fees. An accredited laboratory must pay the required accreditation fee when it is due.

(j) Probation. An accredited laboratory must meet the following requirements if placed on probation pursuant to § 439.51 of this part:

(1) Send all official samples that have not been analyzed as of the date of written notification of probation to a specified FSIS laboratory by certified mail or private carrier or, as an alternative and as directed by FSIS, to a laboratory accredited by FSIS for the designated analyte(s). Mailing expenses will be paid by FSIS.

(2) Analyze a set of check samples similar to those used for initial accreditation, and submit the analytical results to FSIS within three weeks of receipt of the samples.

(3) Satisfy criteria for accreditation check samples specified in § 439.10 of this part.

ALP evaluation criteria based on the ISO 13528 standard, to include performance evaluation by z score statistics.

(h) Fees. An accredited laboratory must pay the annual required accreditation fee when it is due.

(i) Probation. If placed on probation, an accredited laboratory must meet the ALP requirements as prescribed in this section in order to remove the probation status.

(1) The laboratory must successfully analyze a set of initial accreditation proficiency testing samples for the analyte(s) that triggered the probation and submit the analytical results to FSIS by the due date, which is typically within approximately three weeks of receipt of the samples.

(2) Similarly satisfy criteria for accreditation maintenance proficiency testing samples specified by the ALP in this part.

(3) Provide written corrective action documentation, related to the issue that triggered the probation, to the ALP by the date required.

(j) Suspension. If placed on suspension, an accredited laboratory must meet the ALP requirements as prescribed in this section in order to remove the suspension status. If the laboratory is unsuccessful in meeting the requirements to remove the suspension status, accreditation will be revoked.

(1) Laboratories that are suspended due to performance or response issues enter a waiting period of 60 days from the effective date of that action. After the 60-day period has passed, if the laboratory wishes to pursue reinstatement to the ALP, the laboratory must submit a written corrective action plan specifying what corrections were made and illustrate to FSIS that the corrections are effective or would reasonably be expected to be effective.

(i) After the corrective action plan has been accepted by the ALP, the laboratory must successfully analyze a set of initial accreditation proficiency testing samples for the analyte(s) that triggered the suspension and meet all other program requirements including payment of any annual fees that are due. The ALP may perform an on-site inspection at the laboratory's facility and/or require the laboratory to provide documentation to confirm that it meets the requirements of the program.

(ii) The suspended laboratory is allowed two attempts to successfully analyze the initial accreditation proficiency testing set(s) of samples.

(2) Laboratories that are suspended due to indictment or charges as described in § 439.52 may not seek removal of suspension status until being cleared of said indictment or charges.