ORA Laboratory Policies
Food and Drug Administration
The General Services Administration (GSA) has established government-wide minimum physical security standards for federal facilities. Due to the differences found in federal facilities, (e.g. size of the facility, number of employees, use and mission of the agencies) there are five security levels based on minimum standards for each security level. The categories range from Level I (e.g. a leased space with ten or fewer employees) to level V (e.g. a large building with many employees and a critical national security mission as found in the Pentagon).
The FDA Physical Security Staff (HFA-204) maintains a database for all FDA facilities, their assigned security level, and the physical security standards associated with each security level.
The FDA Staff Manual Guide f:2280.2, Physical Security in Field Activities, provides additional instructions for physical security in FDA field offices. This includes building security, protection of official samples, visitor control, document security, controlled substances (Schedule I and II), alcohol (95% and absolute) and other laboratory items such as platinum dishes, United States Pharmacopoeia (USP) reference standards, National Institutes of Standards Technology (NIST) test weights, and syringes (1 mL to 20 mL).
126.96.36.199 Controlled Areas
The following areas are designated as controlled areas within the laboratory and need additional protective measures to ensure the integrity of the security interest involved:
- Drug vault/storage area;
- Solvent storage area;
- Alcohol storage area;
- Sample storage area;
- Radioactive Material Area;
- Infectious Materials Room;
- Sterility Testing Room;
- PCR Room;
- Document room;
- Computer room; and
- Mail room
For these controlled areas, the following additional protective measures are provided:
- Access is limited to only those employees who need access in the performance of their official duties.
- Entrances are secured at all times or monitored by an authorized employee or security guard.
- Doors are equipped with high security locks or card readers with alarm contacts. High security locks are keyed "separately" from the building master key system. Card readers are keyed "alike."
- Controlled areas are cleaned only during normal working hours and under the supervision of an authorized employee or security guard.
- Locks or their combinations are changed if the key or combination has been compromised, if the area has been discovered unsecured or unattended, or when an employee no longer needs access due to transfer, termination, retirement.
188.8.131.52 Custodial Storage of Samples
The Sample Custodian is responsible for the initial and final stages of sample storage. Samples are secured in a storage area where additional security measures can be effectively implemented in accordance with Section 184.108.40.206 Controlled Areas.
220.127.116.11 Analyst Storage of Samples
The analyst is responsible for the integrity, security, and proper handling of the sample while it is in his or her possession. All portions of the sample in the analyst's possession are kept in locked storage (e.g., analyst's lockable cabinet) when not under the analyst's control. The analyst can use temporary seals when appropriate.
18.104.22.168 Temporary Sealing of Samples
When locked storage is not possible (e.g. sample needs refrigeration and is stored in an unlocked, "common" laboratory refrigerator overnight), a temporary seal is used to demonstrate that sample integrity was maintained. The temporary seal is an Official Seal (FDA-415a) used for securing a sample for a short period. When the temporary seal is broken, the seal is initialed and dated.
The temporary seal and the following information are submitted with the worksheet:
- the fact a temporary seal was used,
- how the temporary seal was used, and
- the quoted temporary seal.
22.214.171.124 Import Samples
Import Samples are Official Samples and require the same integrity as domestic Official Samples. Import Samples need not be sealed, unless District Policy dictates, as long as the integrity of the sample is maintained. (See Investigations Operations Manual, IOM Chapter 4, Subchapter 4.1.4 -Official Samples)
126.96.36.199 Controlled Substances (Schedule I and II drugs)
Controlled substances are secured in a drug storage vault/area where additional security measures can be effectively implemented in accordance with Section 188.8.131.52 Controlled Areas. After issuance, additional security controls, (e.g. sample storage, inventory) are implemented.
When a Sample Custodian or analyst receives a sample for analysis, he or she assures that the product is provided proper environmental storage. Samples are stored at frozen, refrigerated, or ambient temperatures, depending on the type of sample and the analysis that is being conducted.
Environmental storage conditions are in accordance with those instructions:
- received with the sample,
- described in the FACTS or LIMS record for the sample, or
- instructed by the Laboratory Supervisor or Analyst.
Samples are maintained at the following temperatures:
- frozen samples are maintained at -28 to -18 °C;
- refrigerated samples are maintained at 2 to 8 °C; and
- ambient samples should be protected from heat and moisture.
Refrigerated and frozen sample storage location temperatures are recorded daily. Various temperature measurement devices (e.g. calibrated thermometers, thermocouples interfaced with computer systems and temperature recorders) may be used to monitor temperature control. All sample storage temperature information is recorded daily on temperature monitoring forms in accordance with the laboratory's local Standard Operating Procedures (SOP) or work instructions. See ORA Laboratory Manual, Volume II, ORA.LAB 5.3 Facilities and Environmental Conditions for general laboratory requirements.