Things you need to know about Upgrading from Quality Control to Quality Management System in the laboratory

Dr. Anuja Chopra

Pathologist and Owner Precision Diagnostics, Ahmedabad

LABORATORY QUALITY

can be defined as accuracy, reliability and timeliness of reported test results. The laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely in order to be useful in a clinical setting.

An accuracy level of 99% may at first glance appear acceptable, but the resulting 1% error can become quite large in a system where many untoward events can occur, such as laboratory testing. If inaccurate results are provided, the consequences can be very significant, including: unnecessary treatment, treatment complications, failure to provide the proper treatment, delay in correct diagnosis, additional and unnecessary diagnostic testing. These consequences result in increased cost in time and personnel effort, and often in poor patient outcomes.

In order to achieve the highest level of accuracy and reliability, it is essential to perform all processes and procedures in the laboratory in the best possible way. The laboratory is a complex system, involving many steps of activity and many people. The complexity of the system requires that many processes and procedures be performed properly. Therefore, the quality management system model, which looks at the entire system, is very important for achieving good laboratory performance

WHAT IS A QUALITY MANAGEMENT SYSTEM?

As defined by the SIO and CLSI, a quality management system is “coordinated activities to direct and control an organization with regard to quality”.

In a quality management system, all aspects of the laboratory operation, including the organizational structure, processes and procedures, need to be addressed to assure quality. In other words, a process control system needs to be in place to ensure that the quality management systems established are working well enough to ensure quality.

Reporting of results includes not just the analytical aspects. It includes the preanalytical and post analytical aspects too. The preanalytical/ pre-examination procedures include an adequate and proper patient preparation, sample collection, personnel competency evaluation, sample packaging and transport, sample receipt and accessioning. While accessioning, special attention needs to be paid to the vaccutainers used for sample collection, ensuring the right anticoagulant being used.

The analytical aspects would include a proper quality control system being in place with internal quality control (IQC) and the external quality control (EQA) system being in place and a thorough quality check being run before actually analysing the sample.

Once the sample is analysed, reporting of results needs a proper report format in which the report is released. A proper record needs to be maintained with a proper LIS in place. It should be ensured that the report reached the patient/ referring clinician in time with special importance being given to the critical / alert range values.

There are many procedures and processes that are performed in the laboratory, and each of these must be carried out correctly in order to assure accuracy and reliability of testing. An error in any part of the cycle can produce a poor laboratory result. A method of detecting errors at each phase of testing is needed if quality is to be assured. The complexity of the laboratory system requires that many factors must be addressed to assure quality in the laboratory.

The concept of the path of workflow is a key to the quality model or the quality management system, and must be considered when developing quality practices. For example, a sample that is damaged or altered as a result of improper collection or transport cannot provide a reliable result. A medical report that is delayed or lost, or poorly written, can negate all the effort of performing the test well. Hence assuring accuracy and reliability throughout the path of workfl ow depends on good management of all of the quality essentials as discussed in the following sections:

1. ORGANISATION:

In order to have a functioning quality management system, the structure and management of the laboratory must be organized so that quality policies can be established and implemented. There must be a strong supporting organizational structure—management commitment is crucial—and there must be a mechanism for implementation and monitoring.

2. PERSONNEL:

A competent, motivated staff is the most important resource that a laboratory needs to function well and ensure quality of reports. The laboratory QMS must addresses all aspects of personnel management keeping in mind the importance of encouragement and motivation.

3. EQUIPMENTS:

Choosing the right equipment, installing it correctly, ensuring that new equipment works properly, and having a system for maintenance are all part of the equipment management programme in a quality management system.

4. PURCHASING AND INVENTORY:

proper management of purchasing and inventory can produce cost savings in addition to ensuring supplies and reagents are available when needed. The procedures for management of purchasing and inventory need to be designed to ensure that all reagents and supplies are of good quality, and that they are used and stored in a manner that preserves integrity and reliability.

5. PROCESS CONTROL:

comprises of several factors that are important in ensuring the quality of the laboratory testing processes. These factors include quality control for testing, appropriate management of the sample, including collection, handling and transportation, and method verification and validation. Process control continues to play a vital role in ensuring accuracy of testing.

6. INFORMATION SYSTEM:

The product of the laboratory is information, primarily in the form of test reporting. Information (data) needs to be carefully managed to ensure accuracy and confidentiality, as well as accessibility to the laboratory staff and to the health care providers. Information may be managed and conveyed with either paper systems or with computers. It is worthwhile to have an LIS in the lab with a proper data back up to ensure that the results of examination carried out in thelaboratory are safe and reproducible.

7. DOCUMENTS AND RECORDS:

Documents are needed in the laboratory to inform the lab personnel how to do things. Records contain the results of the quality controls and examination done and must be meticulously maintained so as to be accurate and accessible.

8. OCCURRENCE MANAGEMENT:

An “occurrence” or “adverse incident “ is an error or an event that should not have happened. A system is needed to detect these problems or occurrences, to handle them properly, and to learn from mistakes and take action so that they do not happen again.

9. ASSESSMENT:

The process of assessment is a tool for examining laboratory performance and comparing it to standards, benchmarks or the performance of other laboratories. Assessment may be internal (performed within the laboratory using its own staff) or it may be external (conducted by a group or agency outside the laboratory). Laboratory quality standards are an important part of the assessment process, serving as benchmarks for the laboratory.

10. PROCESS IMPROVEMENT:

The primary goal in a quality management system is continuous improvement of the laboratory processes, and this must be done in a systematic manner. There are a number of tools that are useful for process improvement.

11. CUSTOMER SERVICE:

Laboratory is a service organization; therefore, it is essential that clients of the laboratory receive what they need. The laboratory should understand who the customers are, and should assess their needs and use customer feedback for making improvements.

12. FACILITIES AND SAFETY:

Many factors must be a part of the quality management of facilities and safety. These include:

Security - which is the process of preventing unwanted risks and hazards from entering the laboratory space.

Containment - which seeks to minimize risks and prevent hazards from leaving the laboratory space and causing harm to the community.

Safety - which includes policies and procedures to prevent harm to workers, visitors and the community.

Ergonomics - which addresses facility and equipment adaptation to allow safe and healthyworking conditions at the laboratory site.

SUMMARY

In a laboratory, a quality management system model should be in place : meaning all 12 quality system essentials must be addressed to ensure accurate, reliable and timely laboratory results, and to have quality throughout the laboratory operations. It is important to note that the 12 quality system essentials may be implemented in the order that best suits the laboratory. Approaches to implementation may vary with the local situation.

Laboratories not implementing a good quality management system are bound to have multipleerrors and problems occurring that may go undetected. Implementing a quality management system may not guarantee an error-free laboratory, but it does yield a high-quality laboratory that detects errors and prevents them from recurring.