Specimen Retention Schedule for the Infectious Disease Laboratory
Health care providers send specimens to the Infectious Disease Laboratory to detect and characterize infectious disease-causing organisms. Once initial testing is completed, the laboratory may need to perform additional tests on the same specimen to confirm or clarify results.
Specimens that are established to be positive or negative for specific pathogens are valuable tools for measuring and assuring the quality of laboratory tests. Such specimens are used as control materials to validate day-to-day testing.
When new methods are evaluated, known positive and negative specimens are used to verify that a new method is accurate, sensitive, and specific. For new or rare diseases, previously tested biological specimens are often the only source of control material. The authorization for the storage of biological specimens for these purposes is provided for and defined in Minnesota Statutes 144.192, Subd. 3.
General specimen types
Listed below are the general types of specimens that are collected, the reason for collection, and the reason and length of time that they are retained. Specific retention times may vary depending on the nature of the sample, the infectious agent, and the reason to retain the specimen.
Description of material
Biological specimens such as stool, respiratory secretions, swabs, tissue, body fluids, blood, etc.
Laboratory storage – minimum
Until diagnostic testing is complete (2 days to 6 weeks)
Reason to retain specimen
Program operations
- Quality control
- Assessment of test accuracy
- Method development and validation
Public health practice
- Comparing patterns and trends
- Investigating occurrences and outbreaks
- Conducting health improvement activities
Laboratory storage – maximum
Until material is exhausted or no longer useful as control or validation material
Specimens submitted according to Minnesota Rules Parts 4605.7000 to 4605.7900
Description of material
Biological specimens such as stool, respiratory secretions, swabs, tissue, body fluids, blood, etc.
Laboratory storage – minimum
6 months beyond completion of testing or investigation is completed
Reason to retain specimen
Program operations
- Quality control
- Assessment of test accuracy
- Method development and validation
Laboratory storage – maximum
Until material is exhausted or no longer useful as control or validation material
Description of material
Biological specimens such as stool, respiratory secretions, swabs, tissue, body fluids, blood, etc.
Laboratory storage – minimum
Defined by the individual project or investigation
Reason to retain specimen
Program operations
- Quality control
- Assessment of test accuracy
- Method development and validation
Public health practice
- Comparing patterns and trends
- Investigating occurrences and outbreaks
- Conducting health improvement activities
Laboratory storage – maximum
Defined by the individual project or until material is exhausted or no longer useful as control or validation material
As defined in the Code of Federal Regulations 45, part 46, subpart A, section 46.102(d)
Description of material
Biological specimens such as stool, respiratory secretions, swabs, tissue, body fluids, blood, etc.
Laboratory storage – minimum
Defined by the individual project or investigation
Reason to retain specimen
Program operations
- Quality control
- Assessment of test accuracy
- Method development and validation
Laboratory storage – maximum
Defined by the individual project or until material is exhausted or no longer useful as control or validation material
Definitions (from Minnesota Statutes 144.192, Subd.1)
Program operations: actions, testing, and procedures directly related to the operation of department programs including:
- Diagnostic and confirmatory testing
- Laboratory quality control, assurance, and improvement
- Calibration of equipment
- Evaluation and improvement of test accuracy
- Method development and validation
- Compliance with regulatory requirements
- Continuity of operations
Public health practice: actions related to disease, conditions, injuries, risk factors, or exposures taken to protect public health, including:
- Monitoring the health status of the population
- Investigating occurrences and outbreaks
- Comparing patterns and trends
- Implementing prevention and control measures
- Conducting program evaluations and making program improvements
- Making recommendations concerning health for a population
- Preventing or controlling known or suspected diseases and injuries
- Conducting other activities necessary to protect or improve the health of individuals and populations
Research: activities that are not program operations, public health practice, or health oversight and is otherwise defined in the Code of Federal Regulations
Please Contact the Infectious Disease Laboratory with any questions.