Laboratory process compliance refers to regulatory norms, procedures and approaches necessary to ensure error-free analytical results that are utilized for quality analysis and decision making.
Having well defined SOP’s or Standard Operating Procedure for lab management is the first step of any good process. While making a good SOP document for any process, the things to keep in mind are -
- Make it as simple as possible - Usually in forms of checklist is the best approach.
- Don't take things for granted - Design the document so that an average staff user can understand and follow.
- Be patient centric - Don’t forget to keep the patient or the customer at the centre for any of the process, only then it will lead to the best outcomes for your lab.
- Be realistic - There is only that much your staff can do.
- Design for resilience - Have guidelines, especially if things go wrong or there is an error.
- Follow industry norms and safety/quality guidelines - We don’t need to say this one. Practice safety measures, quality norms and guidelines for labs, as stated by your country.
Monitoring and Troubleshooting
A good process is only good until it's followed. A lab manager would need to monitor activities in the lab regularly. The following are vital to use, if things are being done according to a defined process.
Allows you to see if there are any activities which are not supposed to be done other than if there is an exception things like- Redone tests, Master edits, bill edits.
Usually they also allow you to see where there are scopes for improvement, like if there is a lot of bill edits, it may be because there is some issue with the billing process.
The importance of monitoring quality control data cannot be understated. Keeping the logs for audit is one thing but monitoring the data for irregularities and following the quality guidelines is the key for delivering accurate results for your patients.
You can monitor the QC data from the Levy Jennings charts but also from the LIS waiting list. Using this data, the doctor (when approving the report) can see the details of the last QC performed.
Get your laboratory staff trained for QC management here.
Having logs for each activity performed in the LIS allows you to analyse information when anything goes wrong. You can use it for an RCA analysis in case of errors and, data from this can be used to build robust processes.
Best Practices for Information systems
Each user ideally should have access to the information at the right time to make the right decision. Usually in layered approach to access, where each layer has more rights than the before, is much better than an all or nothing approach, which may be inefficient or even dangerous (if not handled correctly). Role-based access allows efficient management and better control over staff, organisation, outsourced centres and partners.
Well defined Masters
A good master has following characteristics -
- Should not have duplicates
- Easy to update
- Can be understood easily and allow interactions with other systems
Process and information systems should go hand in hand
Information systems when combined with good processes can make the workflow streamlined and allow efficient workflows while minimizing errors. When designing a process it's important to not only take into consideration how it's going to be done but also how information about step-wise activity is recorded. That's where a good information system can help.
Once this information is recorded, it can be used to analyse the process and fine tune it to get the best results.
You can use the analytics section to find out trends and insights, which can help improve the process or optimize the costs so that the resources can be better utilized.