About the author
Silvio de Almeida Basques
Author of materials on internal quality control and information systems for laboratories.
Training and experience
Doctor, with residency and postgraduate degree from the Federal University of Minas Gerais and specialist title from the Brazilian Society of Clinical Pathology. Retired professor at the UFMG Faculty of Medicine.
Introduction
You may sometimes ask yourself: Why should I do Quality Control, when I see so many professionals who shorten this task, simplifying it and, sometimes, not even carrying it out? I have all this work!
We've heard questions like this, fortunately few times, since we've been working with software for IQC. Our relationship has been very productive with more than 1,000 laboratories and three times more professionals. We are optimistic about the concern of thousands of professionals with the quality of their results. But, as citizens and as health professionals, we believe that we must reflect on the doubts of some and on what was published by Jornal Folha de São Paulo on 03/26/2012, when it reported that only half of Brazilian laboratories carry out quality control.
There are professionals who “believe” they are carrying out Quality Control, when in fact they are working in the wrong way. They just use “run the control and compare with a range”, or make comparisons with manufacturer-assigned values.
We modestly address the reflections we make in this article to the other half, the one that does not carry out quality control. We would like to be able to debate this subject, creating a learning substrate for new generations, for undergraduate students in life sciences, who will be involved in some way with diagnostic activity, in their future professional activity.
For beginners it may seem at first that taking care of quality means a lot of effort and that because quality is something abstract, it could perhaps be dispensed with, or practiced through more empirical and less “expensive” means. Some believe that taking care of control can be a simple, partial thing, with half measures and half controls. They always want to do something simpler.
We defend that Quality Control is a serious matter and must be approached correctly and effectively. Doing it just for the sake of doing it is a waste of time. Doing it incorrectly is a waste of time and money and means disrespect towards the customer.
It is already widely debated that in most analyzes in a laboratory, quality is quantifiable and investing intelligent efforts in this aspect is inherent to daily practice. It is essential to take care of the quality of the results and consider that the great role of each professional in society makes the efforts to obtain it and to make the most honest and valuable contribution to the excellence of diagnoses and medical procedures insignificant.
Quality does not happen by chance. It is the result of an intelligent effort.— Ruskin
Why and why do Quality Control?
This question can have two approaches:
- What drives us, what induces us or forces us to carry out IQC?
- What are the benefits and advantages for me and my laboratory when I actually implement and perform IQC?
We have listed the most significant items to establish the rational foundations because clinical laboratory professionals must engage intensely in activities for the quality of the fruits of their labor.
1. Professionalism
Anyone who works in clinical laboratories is a very differentiated professional and a provider of information. His training made him that way. Its main role is to use specialized information, serve the customer and obtain appropriate samples, analyze biological materials with good methodologies and deliver quality information.
In our experience as a university professor, we always emphasize the differentiating impact of the college period on the training of professionals. The aspect of differentiation of the individual who undertakes to graduate was discussed, developing the characteristics of the professional he aspires to be. During this period in which he gains training, he assumes a clear asymmetrical position in the formation of knowledge in relation to other members of society: he begins to hold information and knowledge in his area, fundamental elements for future activity.
The citizen will also become a PROFESSIONAL in that area.
In the healthcare segment, professionals make a lot of effort to improve the receipt and search for contextualized information. With this knowledge, which reinforces the difference and asymmetry with other members of society, he values himself as a citizen dedicated to highly specialized work and with the responsibility to carry it out in the best way possible. He is the professional that society will trust, because he prepared himself for it.
The laboratory professional builds information from raw data, obtained from analysis methodologies that he takes care to maintain stable and with recognized performance. The good development of these processes is what guarantees the quality of your results and your work.
The DICE sequence of information
Data
It is the primary element in the knowledge formation process — usually a number. It has no explanatory framework. In the clinical laboratory, the data may be the result of an analysis.
Example: 136
Information
It is the contextualized data. It has an explanatory framework that allows interpretation and decision-making by those trained to do so.
Example: Glucose (serum): 136 mg/dl
(Reference values: 60–99 mg/dl)
Knowledge
The doctor evaluates the result along with the patient's clinical signs. If the result is higher than 126 mg/dl in two tests, it will confirm the diagnosis of diabetes and establish therapeutic approaches.
Experience
The laboratory professional must ensure, through its Quality Management system, that the result is as close to the patient's reality, considering the variability inherent to analytical systems.
Note that the data previously presented is part of the information, given context in the report, in such a way that it allows interpretation and decision making. However, it is important to note that this must be done by someone who is trained to do so. Different people will read this information differently:
The laboratory professional will consider that the result represents an abnormality for the patient, because he knows that the sample was collected under defined fasting conditions, was processed properly, analyzed in a stable system and under internal control and that until the end, in the printed result, there was no error. It must be able to ensure, through its Quality Management system, that the result is as close to the patient's reality, considering the variability inherent to analytical systems. This is what patients and attending physicians expect from him.
The patient who receives this report will immediately classify their result as altered, based on the information provided by the laboratory. In conversations with people you will conclude that “you are diabetic”. It is worth the prudent observation added to most results: “Only your doctor is able to evaluate this result adequately.”
The requesting physician will evaluate the result and, based on his knowledge of the patient's symptoms and signs, the World Health Organization criteria and other contexts, will treat this information with professional care. You must request a new test and, if the result is also higher than 126 mg/dl, you will confirm the diagnosis of diabetes, expanding the diagnosis based on your Professional Experience to establish propaedeutic, therapeutic and educational approaches.
The best attitude of the laboratory professional obliges him to ensure the quality of the information he delivers and thus contribute to the excellence of the doctor's practice.
2. Favorable Technological Advancements
Laboratory professionals are privileged to be able to count on statistically validated measurement instruments, supported by statistics and computers, with the aim of ensuring the quality of their work.
In 1998, based on a suggestion from Dr. José Carlos Basques, the first Brazilian software for Statistical Control of Analytical Processes for Internal Quality Control emerged, incorporating the Levey-Jennings chart, Westgard's Multiple Rules and the calculation of the Coefficient of Variation.
It is necessary to think about quality in quantitative terms. You must use the correct and validated control method, or you will only believe that you are doing IQC, not the real thing.
3. Laboratory Management
The practice of internal control allows for in-depth knowledge of the analytical technique and verification of the performance of equipment, reagents, calibrators and operators.
It is possible to detect, through quantitative indicators, the needs for calibrations, maintenance and replacement of analytical systems. All of this backed by numbers that will support your arguments with superiors and suppliers.
IQC can help identify the advantages and disadvantages of replacing reagents, based on evidence about what is fundamental: the quality of your results.
What cannot be measured cannot be managed.— Peter Drucker
4. Ethics
We included this item because we understand that ethical practice is an inseparable component of the professional's work and gives it aggrandizement. Ethics requires in-depth philosophical studies, debates and understandings about responsible and professional action, but it is also, in our modest understanding, a respect for others, others and ourselves.
Acting ethically is establishing criteria, processes and attitudes that represent the highest sense of what we propose to do — the best we can do, the best we are expected to do. Dedicating yourself to controlling the quality of tests is one of the great ethical commitments of our time.
5. Laboratory Accreditation
According to the ABNT NBR ISO/IEC 17011:2005 standard, accreditation is the formal recognition by an independent specialized body that an institution meets previously defined requirements and demonstrates that it is competent to carry out its activities safely. Accreditations in the health sector certify institutions that demonstrate that they have actions and processes that prioritize safety and quality in patient care based on the best current international practices.
According to the General Requirements for Accreditation Bodies, the definition of accreditation is “third-party attestation related to a conformity assessment body, communicating formal demonstration of its competence to perform specific conformity assessment tasks.” (Source: Wikipedia)
The oldest and most respected health accreditor is the Joint Commission International (JCI), represented in Brazil by the CBA. Brazil has the National Accreditation Organization (ONA). In the laboratory area there are two programs: PALC, led by the Brazilian Society of Clinical Pathology/Laboratory Medicine, and the DICQ National Accreditation System, of the Brazilian Society of Clinical Analysis. Membership is voluntary, which is a strong feature of accreditation programs around the world.
Knowing that you are recognized by third parties is a factor in professional satisfaction. Investing in the pursuit of accreditation is a strong reason to take care of quality.
Today the word accreditation has definitively entered the national agenda, and we have all the evidence that the recognition of a provider will be based on their qualifications.— Luisane Vieira
6. Legal Compliance
Historical context of the revoked standard. The normative instrument cited in this historic edition was the Technical Regulation for the Operation of Clinical Laboratories, approved by ANVISA-MS — RDC 302/2005. It was based on this document that municipal and state health agents assessed whether the laboratory had the minimum conditions for its operation.
Unlike the accreditation process, participation here is not voluntary and the health authority can severely punish a laboratory that fails to comply with the standards.
Compliance with legal compliance is, in addition to being mandatory, a positive factor for improving quality and fulfilling the laboratory's social responsibility.
Benefits and advantages of IQC
- Contributes to ensuring quality in the service you provide, resulting in benefits for patients and recognition of your work.
- Helps manage the performance of analytical systems, collecting indicator elements to approve or challenge equipment and reagents.
- It is an important factor to increase your safety and peace of mind when carrying out professional diagnostic work.
- Develops a quality culture among its employees, providing understanding of analysis processes and developing clear and uniform language.
- Supports you to have conviction in assuring clinicians of the value of the test results you deliver when questions arise.
- Can add legal support to your defense in cases of legal challenges.
- Contributes to your good participation in accreditation programs and the relationship with Health Surveillance agents.
- It is important to continue competing in the market.
Conclusion and Additional Resources
There is a notable movement towards quality in the healthcare sector and what is expected is that each professional takes upon themselves the responsibility of applying the best practices to obtain their results. Quality Specifications must be addressed by laboratory professionals in order to increase quality management.
More and better resources must be sought so that the efforts used translate into structuring and lasting improvements for the completeness of work in the health diagnostics area.
Quality is not an act, it is a habit.— Aristotle
Did you like it? Share this content
Published July 2012
Bibliography
- Cline RJ, Haynes KM. Consumer health information seeking on the Internet: the state of the art. Health Educ Res. 2001 Dec;16(6):671-92.
- Renahy E, Chauvin P. Internet uses for health information seeking: A literature review. Rev Epidemiol Sante Publique. 2006 Jun;54(3):263-75.
- Purcell GP, Wilson P, Delamothe T. The quality of health information on the internet. BMJ. 2002;324(7337):557–8.
- Basques, JCA. Using Controls in the Clinical Laboratory. Labtest Diagnóstica, 2009.
- CLSI C24-A3. Statistical Quality Control for Quantitative Measurement Procedures. Clinical and Laboratory Standards Institute, Wayne, PA, USA, 2006.
- Westgard JO et al. Basic QC Practices 3rd ed. Madison WI: Westgard QC, 2010.
