Global accreditations are the means to urging laboratories
to provide the patient with the most accurate medical results
Accurate diagnosis of the medical condition is key to patients receiving appropriate treatment, thus having a speedy recovery. Hence, the importance of laboratories and medical examinations, which are the first steps taken by the patient towards his recovery. Doctors require a series of medical tests in order for them to know what is happening inside the patient’s body; and based on the test results, they choose the appropriate treatment.
Based on the importance of lab work and its vital role in accurate diagnosis, specialized accreditations for medical labs have been established. Today, advanced laboratories are subject to a series of procedures that allow them to obtain international accreditations. According to WHO, laboratory quality can be defined as accuracy, reliability, and timeliness of the 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. When all of the laboratory procedures and processes are organized into an understandable and workable structure, the opportunity to ensure that all are appropriately managed is increased.
Medical laboratories in the world always strive to provide correct and accurate analytical results in order to prove the level of accuracy and validity that characterize their results. This is achieved through the application of quality assurance systems and the introduction of quality control mechanisms into daily analytical operations in a systematic and organized manner.
Quality control programs are therefore a tool for evaluating the validity and comparability of analytical results. Hence, the application of quality control systems is one of the most important ways to obtain reliable and credible results.
Quality in laboratories
Obtaining accurate results that enable the doctor to build a suitable method to treat the medical condition requires the use of top quality methods in measuring the performance of medical laboratories, through the collection of data to assist in the statistical control of the processes that can be monitored in the medical analyses provided. These tools are not only used to solve problems but also create an incentive for quality in every business. Thus, the use of these tools should be an integral part of a future plan aimed at implementing Top Quality Management (TQM) in all medical laboratories to provide a high-quality model of health services to contribute to reaching the level of progress in patient service. Quality in laboratory work is not an end in itself, but is mainly a means to improve the level of performance of the services provided as well as the level of professional performance of employees, in addition to the optimal use of material and human resources while maintaining the safety of lab workers and patient safety in addition to achieving absolute and continuous satisfaction.
In order to obtain international accreditation, the high-quality medical lab should be designed appropriately to perform the required tasks, in addition to providing the necessary means of protection for lab technicians during their work as well as training them on how to use them.
An in-house ventilation and lighting system must be provided, as well as a fire alarm system, a fire extinguishing system, which must operate in accordance with the general characteristics of the laboratory, its programs and the level of risk.
Laboratory safety precautions and guidelines should also be put in place by suspending signs or plates inside and outside the laboratory in order to minimize accidents that may be experienced by individuals by increasing their awareness of the various hazards.
First-aid materials and facilities must be readily available to deal with different accidents that may occur due to exposure to chemicals, electric shocks, or mechanical, physical or biological hazards.
On installation (commissioning), the laboratory staff must check that the equipment achieves the agreed and specified performance (validation). A record of the commissioning process as well as validation must be kept and subsequent performance must be continuously monitored by the laboratory staff. Validation should be conducted regularly and at least on an annual basis, and as and when maintenance or repairs have been done.
Transport must be safe for the carrier, the general public and the receiving laboratory, and adhere to national or accepted regulatory requirements. Liquid specimens, including blood specimen bottles and tubes, should be transported upright and secured in a screw-cap container or in a rack in a transport box. Containers with liquid specimens should be wrapped in absorbent paper to soak up the liquid in case of spillage. Appropriate protective clothing must be worn at all times in the laboratory, and gloves should be worn when required.
The patient is reassured once he knows that he underwent his blood tests in a world-class lab, which also received accreditation. To be accredited, quality control and quality assurance programs must be in place for all aspects of the laboratory operations. All facilities and equipment are tightly scrutinized to assure adequacy for intended applications. An accredited laboratory has demonstrated that it can produce accurate, high-quality results on a consistent basis.
The ISO accreditation is a global initiative that aims at creating standard measure of quality in medical laboratories. The standard has developed initiatives to promote competence and responsibility in medical laboratory processes, equipment and outcomes. ISO 15189 was developed by the International Standards Organizations Technical Committee and has been implemented in over 200 countries. The process involves testing of the effectiveness of laboratory equipment and the impact those particular equipment have on the processes in the labs and their outcomes.
ISO certification has a unique set of advantages and its main objective is quality assurance. This also clarifies the requirements of the quality system (based on ISO 9001) and standards of technical competence (based on ISO / IEC 17025) of medical laboratories.
It is an initiative that presents a global concerted approach in creating a standardized measure for management practices in medical laboratories. An ISO 15189 certification has been seen as a critical initiative towards harmonizing global practices in medical laboratories towards a common measure of quality assurance and safety. The approach takes into account a lot of perspectives, including the interpretation of test results, the method patient samples are actually collected as well as the time required for the tests to be carried out.
An ISO 15189 certification promotes development of an international reputable image for your organization through Quality Assurance and Management Systems. It promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective, fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery. The certification program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs. It ultimately promotes the growth of customer satisfaction in organizations involved in medical laboratory testing.
The College of American Pathologists (CAP’s) Laboratory Accreditation is as important as the ISO Certification. The specifications, standards and requirements of the CAP system are also as important as ISO in terms of applying the highest international standards of quality and accuracy in all stages of laboratory work.
The CAP is widely considered the leader in laboratory quality assurance; it is an advocate for high-quality and cost-effective medical care. It also offers an accreditation service to help laboratories earn accreditation under ISO 15189 Medical Laboratories. The College of American Pathologists (CAP’s) Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous customized checklist requirements.
The Laboratory Accreditation Program inspects a variety of laboratory settings from complex university medical centers to physician office laboratories, and covers a complete array of disciplines and testing procedures. CAP Laboratory Accreditation helps laboratories ensure compliance through the guidance of the most comprehensive scientifically endorsed laboratory standards, maintain accuracy of test results and ensure accurate patient diagnosis and increase the value they bring to organizations, customers and patients.
To be eligible for CAP Laboratory Accreditation, the laboratory must have a qualified laboratory director, participate in proficiency testing/external quality assurance, and perform patient testing.