Secure and proper storage means protection from:
Some general knowledge on information management can be found in the WHO LQMS training toolkit. This toolkit also elaborates on a paper-based laboratory information system.
Activities related to Phase 2 - Information Management
Weekly backups should be made. This can be on CD-rom, (external) hard disks or a server (if present).
Store backups in another building than the building the laboratory is situated in, so that, in case of an emergency (e.g. a fire) the backups will not be destroyed.
Make sure that the data and backups are secured from unauthorized access to protect the patient privacy. This can be done by storing the backups in the same way the laboratory records are stored: in a cabinet that can be locked (physical protection). Also think of protecting the backups virtually by password (if possible).
The WHO LQMS training toolkit contains some general information on computer-based laboratory information systems.
Each personnel member needs to sign a confidentiality agreement which needs to be stored in his/her personnel file. This regulation is aimed at protection of sensitive data (such as patient information).
Three example generic Employee Confidentiality Agreements have been added that are not laboratory specific. These documents could be used to extract parts from that apply to the laboratory. Don’t forget to add parts that are specific to the situation of the laboratory and are not included in these generic confidentiality agreements. The assistance from a legal person (e.g. a lawyer) could also be requested for formulating a template confidentiality agreement specific for the laboratory.
Generic Confidentiality Agreement III (provision as part of the complete employee contract).
The format of the results report should be standardized. The report should clearly and unmistakably provide the results on the requested examinations to the requester and contain at least the following information:
- Identification of the examination;
- Laboratory name and details;
- Identification of the patient;
- Name and details of the requester;
- Dates and times of sample collection and receipt at the laboratory;
- Primary sample type;
- Room for remarks when quality of the primary sample was too low but the sample was still analysed (e.g. saliva instead of sputum);
- Results of the examinations performed;
- Critical/biological reference intervals for easy reference by the clinician;
- Interpretation of the results where possible;
- Space for comments of the laboratory technician and the second reader;
- Identification of the person authorizing the report;
- Signature of the person authorizing the report.
In templates provided in the activity requiring the development of a standardized request form under 2.6 Process Control, you could see that combinations between request forms and report forms can also be made. On such a form the first part is reserved for the request and on the second part the laboratory can insert the results and copy and return the form to the requester. See what the most optimal solution is for the local situation.
In addition some general information from the WHO/CDC/CLSI LQMS training toolkit is provided on forms used in the laboratory including more details on the reporting form.
Write an SOP on reporting of results that standardizes the complete process from obtaining the examination result to delivering this result to the requester, including translation of the interim report to the final result report, monitoring of correct transfer of the result reports to the requester and the correct archiving of copies of result reports.
Include a policy on releasing the results directly to patient, to make sure the results are correctly understood.
Special attention should be paid to reporting of results through the telephone. Extra verification should be used to ensure that results transferred via the telephone are received correctly by the requester, and that the person calling is indeed the requester.
Alteration of reports is also a topic that needs extra attention. When alterations to reports are made, the date, time, and name/signature of the person altering the report should be indicated. The release of the report should be authorized again after alteration. In electronic reports the alterations should also be clearly indicated.
Ensure to include specific procedures regarding the following:
- Ensuring that results are always clear, in a language understood by the customer of the laboratory
- Reporting results according to WHO standards
- Who is authorized to release the report and what is the appropriate moment and method of releasing the reports
- Turnaround time for reporting the results of different examinations
- Immediate reporting in case of examinations with urgency (include alert/critical results intervals, for example of an XDR result).
- Transcription of report (including verification) from reports of referral laboratories
- Reporting of results from samples that were of inadequate quality but were still analyzed (adding a note that caution is required when interpreting the results).
- Procedure for alteration of reports
- Storage of (altered) reports, amendments, referral laboratory reports, etc.
- Reporting of results via telephone
Make sure that this SOP is read by all relevant personnel members.
Most of the forms and documents developed and implemented in the laboratory ask for a sign or signature of personnel members. Therefore a signature list is needed with the name, sign and signature of every personnel member working at the laboratory. This enables linking of signs and signatures on forms and other documents to personnel members.