Infectious Disease Laboratory

Specimen Retention Schedule

on this page:
Infectious Disease Testing
Specimen Retention
Definitions
General Specimen Types

Infectious Disease Testing at the Public Health Laboratory

The Minnesota Department of Health Public Health Laboratory Infectious Disease Section receives and tests biological specimens for diagnosis of disease, public health disease monitoring and investigation, special public health projects, and, occasionally, infectious disease research. Specimens are submitted to the laboratory by healthcare providers in order to diagnose infectious disease in individual patients. Specimens may also be submitted by healthcare providers as required by the Infectious Disease Reporting Rule (Minnesota Rules Parts 4605.7000 to 4605.7900), or by individual persons who are part of an infectious disease investigation. These biological specimens are most commonly stool, blood, and respiratory secretions or swabs but might include any tissue, secretion or body fluid. Specimens are tested by the laboratory to detect and characterize infectious disease causing organisms, including bacteria, viruses, parasites, and fungi.

Back to top

Specimen Retention

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. Biological specimens that give the expected positive and negative results are required to be used as control materials in order for day to day testing to be considered valid. When new methods are evaluated, known positive and negative specimens are used to verify required performance of the new method such as accuracy, sensitivity, and specificity. 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.

Back to top

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

Back to top

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.

Diagnostic and Confirmatory Testing
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

Infectious Disease Monitoring and Outbreak Investigation
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

Special Public Health Projects to Monitor Infectious Disease Trends
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

Public Health Research
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

Back to top




Updated Monday, 01-Jul-2013 12:29:34 CDT