Maintenance of laboratory records that are accurate and relevant requires good management practices and a clear designation of responsibilities. The success or failure of any public health or disease control initiative depends on establishing and maintaining a good information exchange system, with accurate and timely data being provided for appropriate action. The importance of good laboratory data management cannot be overstated.
In order to create an efficient data management system, the following operational consideration should guide decision-making:
- The meaning of the information generated
- What information needs to be provided outside of the laboratory
- Who needs the information
- How frequently the information needs to be transmitted
- How frequently the data is analysed, summarised and distributed
Every laboratory will need to determine the processes and documentation required to transform data, records, and related laboratory activities into:
- Test results, provided in a report form, to the EPI programme and to the submitter or the organization that requested the testing
- Annual reports or progress reports for the director or head of the institute
- Summary reports consisting of activities and data that help justify continued support and funding
The documentation that is required to meet the goals above should be concise and complete, avoiding unnecessary information and excessive data entry to reduce omissions and errors.
The next step in data management is to decide how the information should be physically recorded and stored. All laboratories maintain laboratory results books or ledgers. These are often in the form of paper records, recorded line by line, with information entered into specific columns. Such records, or line-listings, contain all the information relating to the specimen or case.
For laboratories with a small workload, paper records are sufficient to meet all the reporting requirements. For laboratories with larger workloads it is often more convenient to establish a computer record system. In accordance with Regional network requirements, a simple spreadsheet system (using software such as Excel), reflecting the line-listing of paper records, may be sufficient for some laboratories. Although useful for some types of analysis, computer spreadsheets are not very easy to manipulate when using large amounts of information. For large amounts of information, it is better to establish a computer database.
The software and hardware selected to computerize laboratory record keeping is beyond the scope of this manual. However, the manager should seek out available options that provide low cost and that can be maintained through local expertise. At a minimum, the system should be user-friendly, allow rapid and accurate access to selected records, have the capability to perform simple calculations, such as frequencies and time intervals, and have functions available to create tables and graphs. Data entry should include drop-down menus where feasible.
Ideally, laboratory records systems should include:
- The ability to detect errors in the information entered
- Routine backup of data
- Routine analysis and reporting
In designing any recording and reporting system for laboratory results, it is essential to request input from colleagues in all areas related to disease surveillance and control so that the system is understood and functions well across departments and to higher levels of the organization. The information flow should be clearly established from one level to the next so that none of the intended recipients are missed. Information can also be “broadcast” or sent to several recipients at different levels at the same time.
Once a pattern of information flow is established, it is very important that it be followed without exception. The system should undergo review periodically to make sure that it is functioning well and whether improvements can be made. If any changes are made to the system, it is essential that all parties involved are informed of the changes and agree to them.