Introduction
Many organizations face numerous management and technical issues. Laboratory is the most vital part of a medical organization’s system because it deals with life. This is to mean that any kind of mistake can lead to massive negative effects in both the outcomes of the procedures, and also in the systems. This essay will discuss two types of problems that one may encounter in a laboratory environment; the first issue will involve management processes, and mainly the issue of staff shortage. The other problem that the paper will look at will involve Hyperkalaemia, which is a common technical problem, commonly faced in many labs.
Background
Familiarizing ourselves with the key definitions used in this subject is critical to our understanding of what the paper is going to be about. There are numerous causes of these management and technical issues in an organization. Some of these causes may range from human made, to natural causes, dynamic or reflexive causes to closed and opened causes. Direct causes are those that lead directly to negative effects. In most cases, many effects are as a result of known causes; therefore, managers have to check and pin point the various causes or of the problem. This kind of evaluation is what is commonly referred to as core cause analysis. The main aim of evaluating the cause or source of a problem is to unravel the real cause of the problem and in so doing avert or prevent such problems from taking place again, in which case they might occur at a higher level. Dealing with the sources of problems is a much better way of managing problems than dealing with the problems directly.
Root cause analysis (RCA) is a method used to respond to a challenge; its methods mainly focus on identifying the root causes of the challenge. The importance of this methodology is that one is able to identify the real cause of the problem and therefore, address the problem comprehensively, as opposed to just addressing the symptoms of a problem. By directing corrective measures at root causes, and by correcting the root causes, one reduces the chances of such a problem ever happening again. RCA relies on various basic elements, such as materials, machines, environment, management and methods.
The next term of importance to this paper, is the modification of a corrective action for a management system for the purposes of focusing on the weakness of the system. There are many factors why corrective actions, such as the system to implement customer complaints, do not meet the expected level, or the expectations of an internal audit. Some of these are failure to use the appropriate corrective and preventive measures. It should be noted that these measures are key to good manufacturing practice (GMP) compliance. One way to implement these measures is by inspiring the team to brainstorm for the sole cause and effect of the problem, through a diagram known as the Root. This can help to visually display the many specific problems of an organization or potential causes the problem.
Management problem (Staff shortage):
The shortage in the laboratory staff being witnessed today is not a new phenomenon, it has been there for several years now. It is for this reason that many laboratories are devoid of physicians and technicians. Many laboratory professionals are keen that the lab does not get excused from the current problems being faced in the field. However, it is clear that most laboratories are suffering from insufficient staff members. As a consequence, many laboratory directors are opting for temporary staff because of the crisis in their labs. To solve this crisis, two questions must be looked at carefully by the laboratory management’s people. The first question being; what is the root cause of the shortage in staff? The second question is; how can professions solve this problem?
It has come to the knowledge of lab managers that several challenges are indeed being faced in the sector; problems that have a lot to do with management of inventory, staff, materials among others. With such problems, several steps must be taken to realize a solution. First, the source of the problem should be found. There are numerous potential causes of staffing shortages in laboratory. Reduction in population can be one of the many reasons, lack of job satisfaction, lack of training programs, as well as lack of career awareness. When a fish bone is constructed by the investigators it should be able to show the root causes of staff shortages.
The five whys should also be drawn and answered. In this problem, questions for each cause, and then the sub causes will be constructed to assist with the identification of the problem. First, retirement is one cause of shortage in staff, and sub causes can be viewed, as why does the staff retire? The answer to this sub cause can be; because of retirement age is limited, and this can lead to increase in the number of vacancies in lab. In addition, one could ask; why is the retirement age is limited? It may due to government rules and so on.
Figure (1): this figure shows the fish bone structure that explains staff shortages. It is clear that many causes lead to staff shortage and root causes can be clearly detected and identified through this method.
Secondly, insufficient salary is another cause of shortage of laboratory personnel, as wages and salaries are often a decisive factor in career choices. Job satisfaction is linked to the workload, but also to recognition and salaries. The remaining tests must be carried out as a complete volume, inclusive of the same laboratory staff. This may lead to the identification of fatigue, burnout, as other causes of staff shortage.
Lack of public knowledge about the professional opportunities for laboratory workers is another problem related to shortage of staff in the medical field3. Another problem facing the laboratory is the industry's future; the training programs are generally declining especially because of insufficient enrollment, caused by the high cost. However, laboratory accreditation often involves an ISO standard and ISO 15189 is increasingly popularizing the career.
Labor has become a recent concern for many of us. For example, those of us who have to recruit or retrain in certain geographical or technical area are being faced with numerous difficulties. Most of these problems are due to lack of skills. The Western countries are being faced with another different problem which has a lot to do with the higher expectations found in the country, and the numerous opportunities in education.
What worsens the problem is that our current workforce is not sustainable. The average age of workers is increasing; it is becoming almost impossible to attract staff, transfer them to remote work areas. More disturbing, is the fact that the current situation might deteriorate further. With the implementation of the ISO15189, there is regular assessment of staff, so the ability of Council of Baltic Sea States in 1993, has been renewed. The Committee recently reviewed and approved the NPAAC to implement and maintain these standards.
Hyperkalaemia Is a Technical Operation
In normal serum, potassium concentration is between 3.5 to 5.0 mm, a person with Hyperkalaemia has a level of 5.0 mm or more in serum or plasma; often reflected in the concentration of potassium per liter (mEq / l), milli-equivalent units, rather than in millimolarity unit (mm).
Hyperkalaemia can occur from a number of causes, two causes are however common, one is related to technical problems and the other one is related to clinical issues. Some clinical causes, include too much consumption of potassium in and abnormal renal excretion of potassium; potassium ions leaking into the blood from the cells and tissues; and acidosis. The most common cause of Hyperkalaemia is kidney (or kidney) disease, which causes about three-quarters of the reported cases. Hyperkalaemia can also result to Addison's disease, an adrenal disease.
On the other hand, many technical aspects may lead to increased potassium level such as pre-analytical, analytical and post analytical problems. In pre-analytical case, increased potassium levels may be due to wrong tube used in analysis, patient posture, and transport of sample. Machine control (out or expired), calibration of tests, and contamination, are examples of analytical errors. In the post analytical, the verification of results and reports is the obvious misunderstanding between the laboratory and clinics.
Example of five whys in control and material: why is the control expired? because the inventory was unchecked, why is it not regularly checked? because nobody was assigned to do it, why? because no one is concerned about the inventory. why? because there is a lack of management policies and so on.
Figure 2: this figure shows the principle in root cause analysis in Hyperkalaemia. Five basic causes are identified, and several sub causes are also identified. It may help to detect the origin of problem.
The importance of non-conformance investigation in the overall operation of the laboratory
Non-conform may occur in two different forms; from an audit, behavioral problems, leading to the correction and / or the demand of preventive measures. Second, from a positive audit that should be corrected through the use of preventive measures. Example of a passive audit is from an example from St.
A quality control material from the new batch of results were described in an analyzer display, each of the three levels were about 20% lower than expected (does not meet the entry). Survey (audit) showed that although the freeze-dried material has been reorganized with 5 ml of liquid per documented procedures of the organization, restructuring from the manufacturer occurred without notice, by using the amount of 5 ml, instead of 4 ml. All the bottles were incorrectly labeled; re-deletion was done as a corrective measure. All the involved staff in this incident was notified of all of the personnel matters and procedural changes. These actions will help ensure that examination quality improves. A positive example of the audit is a 'good stewards of the audit and auditing to maintain a continuous improvement plan in the core.
The ISO15189 Standards Require In Terms of Identification and Control of Non-Conformities
ISO 15189:2003 is the international standards followed by all medical laboratories. This is specified in the ISO / meet IEC17025: 1999 and ISO9000: 2000, based on a medical laboratory guidelines, and it is dependent on the standards specifically mentioned in the title of "quality and capability” of the ISO15189 requirements, but not of the ISO / IEC 17025 unity. According to the International Laboratory Accreditation Cooperation (ILAC), Multilateral Recognition Arrangement (MLA), medical laboratories certified by ISO15189 and ISO / IEC 17025 standards are acceptable.
Basically, the management requirements stipulated in ISO15189 and ISO / IEC 17025 standard are identical except that a "continuous improvement “of the new provisions have been included in ISO15189. It introduced similar “Continuous improvement” from the ISO9000: 2000 after a request from the International Standards Organization / meet IEC17025: 1999. The continuous improvement of the quality management system aims to improve the delivery of services and improve service to the level of user satisfaction.
Accreditation of clinical laboratory analysis in its broadest sense is becoming increasingly important as a management tool and as a means of building confidence in results. The international standard ISO / EC 17025:1999 provides general requirements for the system of quality management and technical competence, however, clinical laboratories have indicated that their relationship with patients and clinicians deserve special consideration, especially in pre-analytical and post-analytical phases. Consequently, the Technical Committee of ISO 212 "Clinical laboratory and diagnostic systems in vitro" has created the standard ISO 15189:2003 "Medical laboratories-Particular requirements for quality and competence", which is specific for clinical laboratories.
The management part corresponds to the requirements of certification for quality system, while the technical part describes the requirements for personnel, facilities, equipment, procedures, quality assurance and reporting. The annexes include tables that correlate with the ISO 9001:2000 and ISO / IEC 17025/1999, and recommendations for the protection of laboratory information systems and ethics. The principle aims to meet the needs of any clinical laboratory, specializing in clinical chemistry and especially those working in transfusion medicine and histopathology. It has provided an additional document, “ISO 22869 Guide for the use of ISO 15189” as a specific support for the enormous, but rewarding task of preparing for accreditation.
Management Requirements
Paragraph 4 of the standard, describes the requirements for a quality management system based on ISO 9001:2000, but structured according to ISO 17025/1999. Table A.1 describes the correlation rules between ISO 9001 and ISO 15189.
Organization and management
The objectives of the clinical laboratories are clearly marked, this is shown in the principle that, "The clinical laboratory services, including appropriate interpretation and advisory services will be designed to meet the needs of patients and all clinical staff responsible for Patient Care "(4.1.2). Here described, are the elements of the management responsibility for design, implementation, maintenance and improvement of management system (QMS), including confidentiality, training and appointment of a quality coordinator.
Management system quality
Documentation is an important task which is initially very laborious and surpasses in scope and detail the usual routine paperwork. It includes policies, processes, programs, procedures, and instructions to be communicated and understood, as well as internal quality control and external evaluation procedures. The main document is a quality manual that describes in general, among others: the quality policy (including environment, service standards and adherence to the ISO / IEC 17025), the GSC, the functions and responsibilities of technical management and coordinator of quality, resources, lists and validation of analytical procedures, interaction with the environment, auditing and ethics in a lab. The list of contents is detailed in ISO / IEC 17025.
Control of documents
This subsection is fully detailed in terms of procedures, review, archiving, preservation, corrections and identification. It is very useful when it is implemented and maintained, but cumbersome to implement.
Review of Contract
It should establish measures to ensure that it provides details of the service to date.
Analysis carried out by reference laboratories
A great and delicate responsibility of the contracted laboratory is to define and ensure the competence and quality of reference laboratories and consultants, and convey and discuss their results to the applicant.
References
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