Mario Plebani, an internationally recognized expert on laboratory quality management and patient safety says that the development of Quality Indicators is a fundamental step in providing sound evidence of quality in all processes and procedures of Total testing and plays a key role in ensuring targeted continuous improvement activities aiming to reduce risk of errors.
The Institute of Medicine defined Quality Indicators as objective measures evaluating critical health care domains.
Every organization should develop their own Quality Indicators. Pertaining to the laboratory it is important that all 3 key phases of the laboratory testing process are addressed – the pre analytical, analytical and post analytical .This is also mentioned in the ISO 15189:2012 standard in clause 4.12 talking about continual improvement activities affecting relevant areas and outcomes of patient care as well as in Clause 4.14.7 which talks about how to go about planning indicators.
6 basic steps are involved in developing a good quality indicator.
- Defining the Objective of the indicator – what is to be measured
- Understand the Methodology used to define the indicator. What data needs to be captured, how often and identify the numerator and denominator
- Establish Benchmarks or Acceptable Upper and lower Limits
- Present the data in a statistically acceptable way so that the performance can be easily monitored.
- Interpret the long term trend to see whether the quality is within acceptable limits.
- Develop an action plan if the Quality indicator results are not acceptable.
In the Pre analytical area it is possible that a number of parameters for which Quality indicators can be established are suchas:-
- Wrong or missing patient Identification
- Inadequate sampling
- Inappropriate containers
- Specimen adequacy
Let me give you an example: Blood samples are rejected if there is evidence of hemolysis – so the Quality indicator would be:Proportion of samples rejected due to Hemolysis at the time of sample accessioning at the Laboratory.
The Data to be captured i.e. the Methodology:No of samples hemolyzed /Total number of samples
Benchmark defined would be the Rejection rate below 1%
Interpretation:Potential causes for hemolysis such as inexperienced phlebotomist and Nurses.
Limitations due to difficult collection such as:Elderly,children, Chemo patients. Inappropriate use of existing venous line.
Presentation should ideally be as a linear graph on a monthly basis
Action Plan of the analysis would include -location of sample collection, identity of the venipuncturist, type of container used,transport time.
It is important to identify the reason and institute corrective and preventive measure such as Training, improving transportation etc.
This is just an example of how QI’s can be developed to cover the entire testing process.
Once the target is consistently being achieved, increase the stringency of the target or look at new indicators to monitor – therefore its good not to get tied to your indictors, use it only as long as it provides you with useful information.
Additional surrogate markers which are not in the testing cycle can also be planned such as completeness of documentation of equipment records, personnel records, document control effectiveness, safety and environmental effectiveness, complaint resolution etc.
To conclude, developing quality indicators is important as part of improving lab quality and are indirect drivers for improvement of patient care.
By Dr.AnilaMathan, MD,MAMS,
Senior Consultant Lab, Haematology and Transfusion Medicine,
Apollo Speciality Hospitals, Vanagaram