Other Laboratory Operations
Food and Drug Administration
When needed for laboratory use, the Analyst obtains a stored sample from the sample custodian, and the transfer/change of custody of the sample is documented using FACTS or LIMS.
The analyst verifies that the physical sample received matches that described in the Sample Packages section of the FACTS or LIMS "Lab Receipt of Sample" record. Any observed discrepancies (e.g., package number, condition, seal inscription, seal condition) are documented using the Laboratory's Complaint and Corrective Action Procedures.
The analyst verifies that the physical sample received matches that described in the FACTS or LIMS “Sample Transfer” record. Any discrepancies (e.g., quantity, unit, split number) between the sample and that described in the FACTS or LIMS “Sample Transfer” record are immediately reported to the Sample Custodian. Discrepancies are reconciled and, if needed, the FACTS record is corrected.
If FACTS or LIMS is unavailable, (e.g. computer server is down) at the time of the sample transfer, the laboratory uses its Computer Contingency Plan in order to document the sample transfer operations.
After receiving custody of a sample, the analyst performs the following functions:
- breaks the Official Seal (if present); and
- opens the package, and inspects the sample.
126.96.36.199 Breaking Official Seals
For samples, Form FDA-415a is the Official Seal. A numbered self-locking "US Food and Drug" metal seal may be used where a paper seal is not possible or practical. This seal is effective for use on metal drums and baskets where the FDA-415a cannot be used.
Once the sample is packaged for transport to its designated laboratory, it is sealed so that it cannot be opened at any point without evidence of tampering.
The Investigations Operations Manual (IOM) Chapter 4, Subchapter 4.5.4 Official Seals, discusses the following:
- application of official seals,
- sealing methods,
- protecting the official seals,
- broken official seals and temporary seals, and
- metal seals.
The seal is initialed and dated in ink in the space provided and, when possible, is broken across the section showing the sample number, date, and signature. In the designated area at one end of the paper seal, it is initialed and dated in ink by the analyst and broken across the section showing the sample number, date and signature of the Collector. It is acceptable to break the paper seal in another location, if necessary. See IOM Exhibit 4-17. When breaking a metal seal, a sharp metal tool is used to scratch initials and date on the seal.
Generally, original seals are not to be removed from the sample package. If removed, the broken seal is submitted with the Analyst Worksheet as an attachment, and the fact the original seal is submitted is quoted on the Analyst Worksheet, Item 11, Reserve Sample. The entire seal, with the investigator's inscription, analyst's initials, and dates, easily visible, are attached to mounting paper. The mounting paper is identified with the Attachment number, sample number, date, and initials in the upper right corner. See ORA Laboratory Manual, Volume III, Section 3.3, Completing Worksheets and Continuation Sheets.
188.8.131.52 Opening the Package and Inspecting the Sample
After breaking the Official Seal (if present) and opening the package, the analyst removes and inspects the sample.
Using the Laboratory's "Complaint/Corrective Action" Procedure, the analyst documents any discernible abnormalities, discrepancies, and problems such as the following:
- discrepancies between the sample received from the sample described in the FACTS "Collection Report" or any other record,
- broken paper seals without initials or date in the designated area,
- damaged sample or sample package,
- records failing to describe type of analysis requested, and
- sample inappropriate for sample analysis requested.
The report is immediately forwarded to his/her Supervisor for follow-up.