Laboratory process compliance refers to regulatory norms, procedures, and approaches necessary to ensure error-free analytical results. These results are utilized for quality analysis and decision-making.
SOP
Having well-defined Standard Operating Procedures (SOPs) for lab management is the first step to ensuring an error-free process. While making a good SOP document for any process, the things to keep in mind are:
- Make it as simple as possible – A checklist is the best approach.
- Don’t take things for granted – Structure & design the document so an average staff user can understand and follow.
- Be patient-centric – Don’t forget to keep the patient or the customer at the center of any of the processes. It is an assured way to the best outcomes for your lab.
- Be realistic – It is the only way to be reliable while driving productivity with the staff.
- Design for resilience – Have guidelines, especially if things go wrong or there is an error.
- Follow industry norms and safety/quality guidelines – It is an unwritten rule that must be followed. Practice safety measures, quality norms, and guidelines 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 consider if things are being done according to a defined process.
Exception Reports:
Allows you to see if there are any activities that are not supposed to be done other than if there is an exception like Redone tests, Master edits and bill edits.
.png?w=600&ssl=1)
Usually, they also allow you to see where there are scopes for improvement. For e.g. if there are lots of bill edits, it may be because there is some issue with the billing process.
QC:
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 to 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.
Activity Logs:
Having ‘activity logs’ displaying each activity performed in the LIS allows you to analyze the 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
Access Control
Each user ideally should have access to the information at the right time to make the right decision. Usually, a layered approach to access, where each layer has more rights than 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 centers and partners.
Well Defined Masters
A good master has the 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 enable 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 the step-wise activity is recorded. That’s where a good information system can deliver the expected results.
Once this information is recorded, it can be used to analyze 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.
