The Biogene Lab

Follow Us

QUALITY

Quality Laboratory Service

We at Ideal Clinical Laboratories are committed provide Quality Medical
Laboratory Services by providing professional health services and reliable
patient reports on time, using appropriate technology and International
Standards through committed, trained and competent laboratory staff

QUALITY

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 or public health setting.

A quality management system can be defined as “coordinated activities to direct and control an organization with regard to quality”. This definition is used by the International Organization for Standardization (ISO) and by the Clinical and Laboratory Standards Institute (CLSI). 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.

We Ideal Clinical Laboratories are ISO certified.

As per the World Health Organization, the complexity of the laboratory system requires a few important factors that must be addressed to assure quality in the laboratory. We at Ideal adhere to the following processes:
§ the laboratory environment
§ quality control procedures
§ communications
§ record keeping
§ competent and knowledgeable staff
§ good-quality reagents and equipment.

In the quality management system model, the 12 quality system essentials need to be addressed to ensure accurate, reliable and timely laboratory results, and to have quality throughout the laboratory operations and may be implemented in the order that best suits the laboratory. Approaches to implementation will vary with the local situation.

THE QMS MODEL

The 12 quality system essentials

According to World Health Organization, 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.

Ideal Clinical Laboratories maintains the same guidelines from WHO

The most important laboratory resource is competent and motivated staff. The quality management system addresses many such elements of personnel management and oversight, and reminds us of the importance of encouragement and motivation.

The laboratory must make sure that every equipment that they use for diagnosis and testing must be functioning effectively and efficiently. Choosing the right equipment, installing it in proper manner , ensuring that new equipment works properly, and having a  system for regular periodic maintenance are all part of the equipment management programme in a quality management system.

Our Management System has all its equipment properly, effectively and efficiently maintained.

A proper management of purchasing and inventory can produce cost savings along with ensuring supplies and reagents is a primary requirement of a Clinical Laboratory Quality Management. The procedures that are a part of management of purchasing and inventory are designed to ensure that all reagents and supplies are of good quality, and that they are used and stored in a manner that preserves quality, integrity and reliability.

Process control is comprised 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 samples, including collection and handling, and method verification and validation.  Quality control was one of the first quality practices to be used in the laboratory and continues to play a vital role in ensuring accuracy of testing.

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; both will be discussed in the section on information management.

Records and Documentation must be meticulously maintained so as to be accurate and accessible.  Documentation should allow you to easily review and track your laboratory’s activities. It provides an audit trail for competent authorities to verify that requirements have been met. It is also especially useful when a problem arises.

An “occurrence” is an error or an event that should not have happened. A proper system process has to be implemented to detect such occurrences.  It is of utmost importance that the lab should be able to handle them properly, and to learn from mistakes and take action so that they do not happen again.

The process of assessment or audit is a tool for examining laboratory performance and comparing it and confirming whether the performance adhere to defined standards, benchmarks or the performance as described by the health authorities. Assessment may be internal  or it may be external. Laboratory quality standards are an important part of the assessment process, serving as benchmarks for the laboratory.

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 available that each laboratory has to choose based on the situation,  that are useful for process improvement.

The concept of customer service has often been overlooked in laboratory practice. However, it is important to note that the 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.

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

  • ADHICS – (Abu Dhabi Health Information and Cyber Security”). Healthcare facilities are required to meet the standard requirements laid down by the Government of Abu Dhabi, to standardize the Health Infrastructure of the Emirate.  The ADHICS policies  outlines the control mandates essential to protect health information during its creation, maintenance, display, processing, usage, transmission and disposal, and to maintain the information’s confidentiality, integrity and availability (including authenticity, accountability and auditability).  Ideal Clinical Laboratories has been  audited and approved by ADHICS policies and guidelines.
  • 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 healthy working conditions at the laboratory site.