I.            PURPOSE

This directive provides procedures for billing non-Federal laboratories for accreditation under the ALP.

II.            CANCELLATION

This directive cancels FSIS Directive 3300.4, Revision 1, dated 3/17/94.

III.            REASON FOR REISSUANCE

This directive updates Attachments 1 and 2 to show the current annual accreditation fee, which has g been reduced from $3,500 to $2,500.

IV.            REFERENCES

7 USC 138f            Food, Agriculture, Conservation, and Trade Act of 1990
9 CFR 391.5          Laboratory Accreditation Fees
21 USC 601           Federal Meat Inspection Act
21 USC 451           Poultry Products Inspection Act

V.           FORMS AND ABBREVIATIONS

The following will appear in their shortened form in this directive:

ALP           Accredited Laboratory Program
CFR           Code of Federal Regulations
NFC           National Finance Center
USC           United States Code

Form AD-496-4        Bill for Collection
Form AD-844           Billings and Collections Account Maintenance

VI.           RESPONSIBILITIES

A. Quality Systems Branch, Chemistry Division.

1. Receives applications and collects accreditation fees from non-Federal laboratories. (NOTE: Accreditation fee is non-refundable.)

2. Documents and processes applications for accreditation.

3. Prepares and issues annual bills to non-Federal laboratories accredited under the ALP.

4. Maintains individual files for each accredited laboratory.

5. Provides non-Federal laboratories with an initial set of accreditation check samples to analyze.

6. Notifies accredited laboratories of expiring accreditation dates. Cancels accreditation of laboratories when fees are delinquent or for unsuccessful performance.

7. Conducts administrative reviews.

8. Maintains audit and other records for review by inspectors in the Office of Inspector General.

9. Answers questions concerning the ALP.

B. Management Support Staff.

1. Assigns a block of debtor account numbers to Quality Systems Branch for Form AD-844.

2. Maintains a record of debtor numbers.

3. Maintains liaison with Quality Systems Branch.

VII.           PROCESSING APPLICATIONS FOR ACCREDITATION

A. Quality Systems Branch.

1. Receives application requests for accreditation under ALP.

2. Prepares Form AD-496-4 (see Attachment 1) and Form AD-844 for each application received. Enters debtor number on Form AD-496-4 and the check. NOTE: Debtor account numbers are non-transferable. A new number is assigned when there is a change in ownership of a laboratory.

3. Insures that application is complete and that the payment covers the specific types of accreditation requested. (See Attachment 2 for fees and a listing of accreditations.)

a. Reviews attached check to insure it is made payable to “Food Safety and Inspection Service, USDA.”

b. Stamps the laboratory’s copy of Form AD-496-4 “PAID” if payment is correct.

c. Discards pink copy.

4. Distributes Form AD-496-4 following directions contained in Attachment 1 except for yellow copy. Sends the yellow copy and check to:

5. Provides copies of Forms AD-844 and AD-496-4 to Management Support Staff.

B. Management Support Staff.

1. Establishes and deletes debtor account information with NFC.

2. Maintains a record of debtor numbers.

3. Reviews and maintains copies of Forms AD-844 and AD-496-4.

VIII.           MODIFYING OR CORRECTING FORM AD-496-4

To modify or correct a previously submitted and unpaid bill (Form AD-496-4), the Quality Systems Branch:

A. Prepares a replacement Form AD-496-4 using a new bill number.

B. Forwards the original and yellow copy with an explanation of the correction to the laboratory.

C. Retains the green copy with appropriate documents.

D. Discards the pink copy.

IX.           BILLING FOR UPCOMING ACCREDITATION YEAR

The Quality Systems Branch bills the non-Federal laboratories and notifies them, if applicable, of expiring accreditation as follows:

A. Issues bills (Form AD-496-4) to accredited laboratories on the anniversary date of each accreditation. Bills are payable upon receipt and become delinquent 30 days after the date of the bill.

B. Distributes Form AD-496-4 following directions contained in Attachment 1. Sends laboratories a reminder note to add the debtor number on the check and to mail the payment to the address contained in Attachment 1.

C. Issues notice of termination to the laboratory when payment is not remitted within 30 days.

X.           ACCREDITATION CHECK SAMPLE

The ALP requires that a non-Federal laboratory successfully analyze an initial set of accreditation check samples before accreditation by FSIS. The Quality Systems Branch:

A. Sends laboratories an initial set of accreditation check samples to analyze and return.

B. Insures that laboratories analyze the initial check sample following specific guidelines. Laboratories have two opportunities to correctly analyze the check samples to demonstrate analytical proficiency.

C. Notifies laboratories of the results of the performance check. Laboratories that successfully analyze the samples receive accreditation.

D. Cancels an application when a laboratory fails two performance checks. Informs laboratories of the mandatory 60-day waiting period and the procedure for reapplying for accreditation after the 60-day waiting period.

XI.           ONSITE INSPECTION FEES

A non-Federal laboratory may request FSIS to perform an onsite inspection. The laboratory is responsible for the actual costs of reasonable travel and necessary expenses. The Quality Systems Branch prepares and sends Form AD-496-4 to the laboratory requesting reimbursement. The appropriate travel authorization number is noted on Form AD-496-4. (The billing procedures are the same as those established for accreditation fee billing.)

XI.           INQUIRIES

The ALP requires that a non-Federal laboratory successfully analyze an initial set of accreditation check samples before accreditation by FSIS. The Quality Systems Branch:

A. Quality Systems Branch handles inquiries on ALP.

B. NFC responds to inquiries on Form AD-496-4.

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