If patient data are recorded in a paper system, ensure secure and proper storage


All patient data must be stored in such a way that it remains easily retrievable for those who need it. Moreover, patient data is confidential and must be stored in such a way that it remains confidential. Also, it is important to ensure that data are stored in an environment free of insects, dust, humidity, etc.


Patient data is, among others, recorded on Request Forms, work forms, registers, copies of Result Reports, revised Result Reports, Immediate Notification Forms, etc.

In phase 3 the storage facility will be upgraded to prevent deterioration of documents (including patient data) due to physical influences. In phase 3 the laboratory archiving system will also be optimized to ensure that all the laboratory information is easily accessible for those who need it. It is however important that patient data is already securely archived to protect the confidentiality and integrity of this data.

Ensure that all the records containing patient data are stored in a locked cabinet and that this cabinet can only be opened by authorized staff members.

Establish a system for logical and orderly storage of patient data so that if results of a certain patient need to be replaced, this can be done quickly and easily. Make use of numbers or dates to keep all files in a logical order. For example: store patient records in folders categorized per calendar year and sort records within each folder on patient identifier code.

To prevent accumulation of records and full archives a Document Retention List that defines how long each type of record is stored is also needed. This was already done in another activity in phase 2.

In the right-hand column a document on information management and using a paper-based information system from the WHO Laboratory Quality Management System handbook is provided.

How & who

Quality Officer (possibly in cooperation with staff members involved in data management, if applicable):

  1. Design a logical archiving system for patient data such as Request Forms, work forms, registers and copies of Result Reports as described above and in the sheet from the WHO Laboratory Quality Management System (LQMS) training provided in the right-hand column.
  2. Make sure that patient data is stored in a cabinet/room with sufficient capacity, that can be locked and is only accessible to authorized staff members.

Laboratory Manager:

  1. Authorize certain staff members to access the patient data archive. Adapt the Authorization Matrix to include the tasks and responsibilities belonging to staff members who are authorized to access the patient data archive. Also adapt the Personal Job Description of the authorized staff members to include their new tasks and responsibilities regarding accessing and maintaining the patient data archive.

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This activity belongs to the QSE Information Management
ISO15189:2007: 4.13.1 4.13.2
ISO15189:2012: 4.13