Assessing The Challenges Faced By The Medical Laboratory For ISO 15189, Accreditation In The Gozo General Hospital

LITERATURE REVIEW

Introduction

When sending me a draft chapter, always send your draft title page, draft table of contents, and any previous draft chapters together in the same file.  That will give me helpful context.

Good length for Ch 2 at 4,600 words.  This ch is normally the longest so you can add more.

This study has been focusing on the importance of ISO 15189 concerning the Gozo General Hospital. To support the structure of the study, this chapter is providing a review of related literature stating the functions that have been performed in any medical laboratory in addition, its significance has also been discussed in this chapter. Furthermore, factors that have been affecting the competence and quality of medical laboratories are also highlighted in this study. Moreover, role, implementation, and challenges have also been discussed in this chapter. However, in the last section of this chapter, an effective strategy to cope up with the challenges of ISO 15189 has also been provided and supported with the theoretical framework. Using the factors identified in this chapter, a conceptual framework has been made right before the conclusion of this chapter.

The first section 2.1 should give the reader a short preview of the topics you plan to cover, and, in particular, *why* you are going to cover them, which means explaining how reviewing these topics will take you forward towards achieving your objectives.   

Functions Performed In Medical Laboratories 

Medical laboratories are facilities where various medical tests are carried out by various specialists to get the relevant data and information regarding the health conditions of a patient in relevance to the treatment, diagnosis, and prevention of the disease (Neubauer and Heurix, 2011). Any research or study in the medical field or clinical trial cannot be completed without a clinical or medical laboratory.

There are various functions performed in Medical laboratories which include the examination and analysis of the components of blood, tissue, urine, body fluid, blood grouping, matching, screening, and RH typing. (Gargis et al, 2012). Moreover, the various analyses may be qualitative and quantitative testing which are performed in clinical or medical laboratories for various research and study purposes (Harmening, 2018). Qualitative analysis is done in clinical or medical laboratories to know and determine the substance constituents and mixtures whereas quantitative analysis is done in these laboratories to calculate and analyze the amounts and ratios and proportions of these constituents of substances and mixtures used in testing and experimenting (Bishop, Fody and Schoeff, 2013). Various medical studies emphasize the critical role and major contribution of medical laboratories in conducting medical tests and research where medical or clinical laboratories are considered the foundation of medical research and studies (Shieh, Wu, and Huang, 2010).  Very good analytical style and nice to see the high citation rate.

A wide range of investigations and studies are conducted in medical laboratories in different areas of laboratory science such as hematology, clinical chemistry, coagulation, transfusion medicine, immunology, histology, microbiology, and molecular diagnostics. (McGinnis, 2012). These laboratory science areas all lead to the development of various lifesaving and curing medicines which are developed after extensive research and experimentations conducted in medical laboratories based on which it can be said that medical or clinical laboratories are the pillar of all the experimentations, testing, researches for drug and medicine developments.  Hence makes it essential for medical or clinical laboratories to upgrade their methodologies and equipment from time to time to perform their functions in an effective manner (Shieh, Wu, and Huang, 2010).  In a nutshell, it can be analyzed that medical laboratories perform five core functions which include research related to public health, response to various communicable diseases occurring in emergencies, diagnostic testing, integrated data management related to diseases, and environmental health and food safety (Amato et al, 2013).

Significance Of Quality And Competence In The Healthcare Sector

Something to think about is the 2nd level section titles.  In all parts of the dissertation, they should convey information to the reader.  But this is particularly true in Ch 2. Your choice of section titles gives the reader a lot of information about the structure and sequence of your ideas.

Quality and competence in the healthcare sector can be illustrated as the application, implementation, and demonstration of an appropriate and suitable set of skills, knowledge, and behaviors in the clinical environment (Morgan, Ensor, and Waters, 2016). Competency and quality are both focused on certain accurate behaviors and actions based on extensive knowledge and high skills in the normal clinical setting and also in various critical situations ensuring that the competency level is high in these situations where the quality of treatment and healthcare services remains standardized (Büyüközkan, Çifçi, and Güleryüz, 2011). Quality and competence in the healthcare sector are very much significant as it is related to the service quality and the care of patients through following various aspects. Due to the rapid change and advancement in the healthcare sector because of the advancing technology and increasing demand for healthcare quality, various organizations operating in the healthcare sector have now realized the significance of quality and competence in their operations and services providing ineffective treatments, medicines and healthcare services (Berendes et al, 2011).  Very good.  Get the paragraph spacing consistent.

Healthcare organizations understand that there is a strong need for competence as the healthcare industry has become more focused on giving patients quality healthcare through their competent staff members including nurses, doctors, and healthcare facilitators that are more focused on delivering a patient-centric value to patients in hospitals through technology, effective treatments and accurate reporting (Morgan, Enso,r and Waters, 2016). Competency and quality are also significant in coping with different challenges occurring in the clinical environment that help the staff members implement effective strategies to maintain the healthcare treatment and service quality and to treat patients with their effective skills and knowledge (Chahal and Bala, 2012). Along with the change in nature of the healthcare industry and its delivery of services in terms of medication, treatment, and patient healthcare consistently, these developments in the healthcare industry ideally lead the organizations operating in the healthcare industry to review various competency programs, competency assessment objectives, and goals and also lead towards developing various competency strategies in the organization to build and maintain an advanced and a skilled workforce and also to maintain the effectiveness of treatments and other healthcare services (Büyüközkan, Çifçi, and Güleryüz, 2011). Nice to see long paragraphs.  As there is normally one big idea per paragraph, longer paragraphs indicate more developed thinking.  But don’t make them too long, as very long paragraphs are harder to read.  As always, it’s a matter of balance.

The significance of quality and competence can also be analyzed through various laws and regulations imposed in the healthcare sector related to ensuring quality and a high level of competence in their medical treatments and healthcare services (Das, 2011). Moreover, based on its significance, there are a set of core competencies that these organizations follow as per the regulations regarding quality and competence in the healthcare sector which include providing patient-centered care, working in interdisciplinary teams with an integrated approach, applying evidence and experience-based practice in healthcare organizations, developing strategies for advancement and treatment quality improvement consistently and lastly utilizing informatics to communicate, mitigating risks and errors and to making effective decisions in different situations using information technology (Alizadeh and Chavan, 2016). This set of core competencies defines the importance of quality and competence in the entire healthcare sector and is being followed in various healthcare organizations currently. Looks good.

Impact of quality and competence in the Medical Laboratories 

There has been a broader impact on quality and competence in medical laboratories in terms of their used equipment, clinical settings, and the methodologies of testing and research conducted in clinical laboratories (Mosadeghrad, 2012). In this era, there are certain defined priorities in medical laboratories such as laboratory automation, molecular diagnostics, laboratory consolidation, imaging analysis, and accreditation of clinical laboratories to improve the quality and competence of patient care and conducting different tests and research on clinical species including urine tests, blood tests and other relevant researches (Talib, Rahman, and Azam, 2011). The main indicators impacting quality in medical laboratories are population health, equal opportunities in accessing healthcare, effective delivery of healthcare services, effectiveness and accessibility of the systems, and the results and reporting provided related to the healthcare (Plebani, 2012). Moreover, population lifestyle, genetic and environmental factors also have a higher influence on the population health than the quality and competence in healthcare itself in terms of its impact on people's health factors (Plebani et al, 2013). Moreover, due to the regulations regarding the quality and competence in medical laboratories and the whole healthcare sector which is based on accreditation, quality monitoring, certification, patients’ rights, standard and advanced operation processes and standards of health care quality also have an influence impact on the quality and competence in medical and clinical laboratories (Gargis et al, 2012). 

Laboratory medicine is considered the backbone of the healthcare sector including in all medical treatments, diagnoses, and prevention that influence the whole hospital healthcare sector decision-making process and determining the costs of their operations and giving treatments to patients (Beastall et al, 2005). Furthermore, the impact of quality in medical laboratories can also be assessed through the influence of technology in terms of its advancement in equipment. The techniques used for different types of medical tests and most importantly the reduction in errors and to cope with any lacking in the health processes and treatments. Quality also effectively ensures the management of time to perform the functions in health care organizations specifically in the medical laboratories (Plebani, 2012). As organizations have started giving importance to quality and to increase the competence level which has directly led towards making a strong focus on quality while performing tests and research and also while performing other functions in the medical laboratory which shows that quality and competence have impacted the medical laboratories and the entire healthcare system (Gargis et al, 2012). Seems very good so far.  As you are writing, keep checking back to your objectives defined in Chapter 1.  Everything you write should support your objectives.  If it doesn’t, it shouldn’t be here.

Factors affecting quality and competence in Medical Laboratories

Various factors are having a significant effect on the quality and competence of Medical laboratory services (Mosadeghrad, 2014). However, the quality and competence have been emphasized to be followed consistently by the regulations and laws related to the quality and competence in the health care sector specifically in medical laboratories but certain factors have an influence over quality and competence which include poor staff motivation, lack of knowledge and appropriate skills, using non-calibrated and non-updated equipment in medical laboratories and lack of management support (Mosadeghrad, 2014).

Poor Staff Motivation

Poor staff motivation can affect the quality and competence in medical laboratories as it has a direct impact on the workforce working in the healthcare sector specifically in the clinical laboratories (Brown and Busman, 2003). Various studies have indicated something like that should be followed by a citation fairly close and I see you have one a couple of lines down. that poor staff motivation affects the efficiency of working with quality and with an increasing level of competence in laboratories which might affect the service quality in conducting research and testing ultimately (Chhea, Warren, and Manderson, 2010). There is a higher impact on the services and functioning of the laboratories as their functions mainly depend upon the staff working in these medical laboratories.

Lack of Knowledge and Appropriate Skills

Having appropriate skills and extensive knowledge regarding the functions and medical aspects is very much essential for performing the functions in the medical laboratory (Houghton et al, 2012). However, having a lack of knowledge and appropriate skills affect the quality and competence level in medical laboratories which increases the chances of decreasing quality in the delivery of medical services and decreasing competence in the workforce working in medical laboratories (Rosenzweig et al, 2012). Moreover, it can also lead to the ineffectiveness in conducting research and tests which can ultimately be serious for healthcare organizations and for the patients getting treated within that healthcare organization (Houghton et al, 2012).

Using non-calibrated and non-updated equipment

Using an English-style point of view, I’d avoid starting paragraphs with -ing words. non-calibrated and non-updated equipment in medical laboratories can also be one of the factors that hurt the quality and competence in a clinical setting. Equipment that does not fit into the clinical setting and is old cannot give the proper outcomes and can also lead to a decrease in efficiency and effectiveness in performing the functions in medical laboratories which ultimately reduces the quality and give inappropriate results in form of numerous errors while performing tests and researches in a clinical setting (Ferrari et al, 2010).

Lack of management support

Management support is very much significant in the healthcare sector which leads to the functions effectively performed in medical laboratories and also increases staff efficiency (Olmsted et al, 2010). However, lack of management support can have negative impacts on a clinical laboratory which can be in form of insufficient budgets, not providing required equipment and tools, and not focusing on staff satisfaction which directly impacts the quality and competence in medical laboratories and affects the accuracy in performing the laboratory functions (Marinucci et al, 2013). Moreover, lack of management support can also result in ineffectiveness in treatments provided to the patients (Olmsted et al, 2010).

Role of International Standards in the Laboratory Operations

According to the study which has been conducted by (Antonelli, et al, 2017), it has been observed that operations that have been performed at medical laboratories require the staff to handle the operations with care. As it has been observed that the functions of the medical laboratories are to deal with the samples of patients who have been suffering from various diseases, therefore the staff of the medical laboratory should be dealing with the sample in a way that the staff of the lab should not be exposed to those samples which are of serious diseases such as Hepatitis, AIDS or some other diseases. In another study which has been conducted by (Chapman and Himmerick, 2017), it has also been observed that there is several cases have been reported in which medical lab technicians have been exposed to a sample of serious diseases and had to face the consequences. Therefore, in such an environment it is the responsibility of the management of the medical laboratory to provide an environment where the staff would be able to manage their work in the way that it should be.  Good. You can enhance your review with the careful use of direct quotations.  Used sparingly, they add color and the change of style makes the chapter easier to read.   And sometimes it can help the reader to see the actual words from the source, rather than your summary of them. But don’t make them too long, and don’t use too many or they will drown out your voice as an author. And of course, put them within quotation marks, cite and reference.  Good direct quotations are like sauce in a meal; they are never the main ingredient.

In the light of the study that has been conducted (Sikaris, 2017), it has been observed that the function of the medical laboratory includes testing the sample of the patients and their report decides whether the patient has some disease or not. Based upon this the doctors proceed with their treatment and continue the process of medication. Therefore, it has been observed that in such an environment where the medication process of the patient is always dependent on the report of the medical laboratory it is necessary to maintain the quality and competence of the medical laboratory to provide quality standard services. According to the study which has been conducted by (Plebani, et al, 2015), it has been studied that some standards have been approved by the International Standardizations Organisation that is necessary to be followed by the respective divisions. Similarly, there are some of the standards that have been defined by ISO and these standards should be followed by the respective organization. OK.

It has been observed that the focus of ISO 15189 is to maintain the quality and competencies of the medical laboratory, therefore, there is a process that has been followed by the medical laboratory to comply with the requirement of ISO. This process is consist of four steps that fulfill the requirement and checklist of the ISO, the process starts from the strategic management of the medical laboratory, and then the stage of designing, planning, and controlling the process comes.  Later to that, an analytical process should be followed that whatever strategy has been followed by the organization is contributing to the quality management system or not. If there is a gap for improvements, then the management of the organizations should consider and redesign their strategy keeping the gap under consideration. Furthermore, the last stage of the strategic planning is to be continued for till the organization is functional, processing evaluation, and improving the management.  Try to work in some criticism e.g. question the assumptions behind the writers you are citing.

Implementation of ISO 15189 in Medical Laboratories

According to the study that has been conducted by (Antonelli, et al, 2017), it has been observed that there are some requirements that the medical laboratory should fulfill before the implementation of ISO 15189. These requirements are majorly the responsibility of the managerial personnel of the organization as it has been observed that the major requirement of ISO15189 is the organization and management that in a case of misconduct, there should be some of the personnel who have been already identified as the responsibility for any kind of misconduct. Policies and rules and regulations of the organization should be designed under the supervision of that particular person who is going to take all of the responsibilities later (Misganaw, 2016).  The second requirement for the implementation of ISO 15189 is the quality management system, where the process of documentation should be managed suitably and the roles of each person in the lab should be predefined by the management of the organization.  There should be document control and review of a contract, as the documents in any lab regarding their legal issues or the patients should be handled with care and it should also be organized.  Moreover, the contract of the lab should also be reviewed periodically to check whether there is any need for amendment or not.

Furthermore, it has also been observed that ISO 15189 has one of the requirements regarding the referral of the laboratory. For example, a lab has been referring the patient to any other lab. It should be considered that both the referring and the referral lab should be meeting the criteria of ISO 15189. In another study that has been conducted by (Oosterhuis, et al, 2018), has been observed that there should be a predefined criterion in the lab for the acceptance, rejection, and evaluation of the material that they have been procuring from outside resources. Staff should also be available to provide advisory services for the patients that what service of the laboratory they should be using, what is the procedure, and how it would be beneficial for them. Another requirement of ISO 15189 is that there should be a significant mechanism available in the lab to rectify the problems that patients have been facing in the laboratory (Nasser, et al, 2018).  The lab should be maintaining a record of the complaints which should contain the details regarding the root cause of the complaint, its analysis, and the corrective action that the management has taken against the complaint. There should be preventive action in addition to corrective action that the management of the lab should have their strategy to be amended in a way that a similar issue should not occur again. Furthermore, the management should review the process and the operation of the lab and conduct an internal audit as well. Lots of “should” here but I suppose they are justified by the subject matter.

In addition to the managerial requirement, there are some technical requirements as well, as it has been observed that the lab obtaining the ISO 15189 should have technically trained professionals to deal with the equipment at the lab. The operations of the lab should be executed in a way that should not be providing any harm to the environment.  Equipment of the laboratory should be updated and properly maintained and checked periodically whether it is functioning properly or not. Any sample coming to the medical lab has three stages that are pre-examination, examination, and post-examination, all three stages should be handled with care as every patient should be provided the right service in the right manner and their report should also be error-free.  Reporting of the result is one of the most important stages in the whole process of medical labs as no report should be missed or contain errors in case the patient would have to face serious consequences. Very good.

Challenges of Accreditation of ISO 15189 faced by Medical Laboratories

According to the study that has been conducted by the wrong form of Harvard citation (Jones and Jackson, 2016), it has been observed that there are some of the challenges that the medical laboratories have been facing during the process of obtaining accreditation of ISO 15189 from the international standardization organization. As there are two types of requirement for the accreditation of ISO 15189 which is managerial requirements and technical requirements, both the requirements have various elements that should be taken care of to obtain the accreditation smoothly. It has been observed that the major challenge that the laboratories have been facing in the process is the skilled and responsible staff to execute the operation efficiently. Most of the time laboratories fail to provide the environment healthy services as the waste product of the medical laboratories should be disposed of responsibly as it contains various bacteria which may cause serious diseases among the people who would have encountered ?? with those bacteria. Another study stated that there are issues of referral as it has been observed that it is quite difficult for any laboratory to provide all of the services on their own, therefore they would be referring patients to other laboratories for any specific test. In such a case, when the laboratories are referring the patient sample, they must keep it under consideration that the lab where they have been referring the patient should also have the accreditation of ISO 1519. 

Some of the times there is an issue with the documentation of the lab, it has been observed that medical labs usually fail to maintain the record of the complaints and the corrective measure that they have taken before. During the application for accreditation of ISO 15189, the lab must have been maintaining the record of their complaints and they should have taken the corrective measure which is to be documented. Moreover, the preventive measure that the lab has been taking should also be documented otherwise the lab would not be able to obtain the accreditation of ISO 15189. Another study that has been conducted by Tembuyser, et al, (2016), shows that there are issues that have been reported regarding the accreditation of ISO that usually labs avoid the internal audit or there is a discrepancy in the records of the lab. Moreover, some of the times it has also been observed that the challenges that the lab has been facing for the accreditation of ISO are the financial constraints as it has been observed that ISO requires that the equipment of the lab should be updated and the staff operating it should be skilled to use the equipment which means that they would be paying the higher salaries. Collectively these problems and challenges make the process of accreditation of ISO 15189 more difficult for the labs.  Good.

Effective Strategies to Sustain the Challenges of Accreditation of ISO 15189

As it has been observed that there are two types of issues that the labs usually face for the accreditation of ISO 15189, the first is financial constraints and other managerial issues. Although, it is dependent on the situation of the lab that how much finance they can arrange for their operation. However, the labs can resolve their managerial issues and cope with the challenges of accreditation. It has been observed that when there is a requirement for skilled and competent staff the companies have suggested training their former staff instead of hiring new ones (Hillary and Balu, 2018). As it has been observed that when the organization has been providing training for their former staff instead of hiring new, they feel more valued by their organization and try to work efficiently and it would be easier for the organization to ask them for their contribution to which they would have to go out of the box. Before submitting your final dissertation, make sure your in-text citations tie-up with your list of references at the end.  What does this mean?  It means that each citation should point to a listed reference, and each listed reference should have at least one citation pointing to it.  From an academic point of view, this is quite important.

The managers of the lab should be focused on the documentation process and each nominal detail should be documented and periodic maintenance and quality check should be conducted. They should also focus on the internal audit and the report generation process of the lab. Moreover, the managers of the lab should also evaluate the gaps for improvement before applying for the accreditation and should try to fix all the issues once everything has been resolved they should apply for it. 

Consistent spacing

Theoretical Framework <- is good.

 It has been observed that medical laboratories have been facing managerial issues to get the accreditation of ISO 15189. Therefore, the principles of administrative management by Henri Fayol are the best appropriate principles for the issue ?? (Peaucelle and Guthrie, 2015). As it has been observed that the principles of administrative management by Henri Fayol provide that five steps should be followed by the managers of any organization which would be helpful for them to rectify the issues that they have been facing.  The first step that has been identified by Fayol is planning, it has been observed that planning before any project is one of the necessary aspects that should be considered. Later to that organizing the necessary arrangements are a most important element as it has been observed that the execution of any plan is impossible without efficient organization (Fayol, 2016).  After arranging the necessities, commanding, coordinating, and controlling are the things that never end for managers.  Following the principles of administrative management by Henri Fayol, the process of obtaining accreditation for the managers of the medical laboratories would be easier.   Are you sure about using Fayol?  Of course, he’s a very famous management writer – one of the seminal theorists – but his work was done a long time ago.

In addition to the principles of administrative management, managers of the medical laboratories should also be using the contingency theory as it helps them to deal with their employees and the technology that they have been using. As it has been observed that there is a need for technological updates in the requirement of ISO 15189 and the medical laboratories, therefore, have to manage their workforce accordingly. This theory helps managers to deal with their employees and bring the element of leadership to all levels of their organization (Otley, 2016). Therefore, the incorporation of contingency theory is one of the best theories that can help them to cope with the issues of medical laboratory and become fulfill the requirement of ISO 15189. So are you saying these theories will influence your research?  If so, how?  Do you expect these theories to influence your data gathering and how you organize the discussion of findings?

The question of whether “theoretical framework” and “conceptual framework” mean the same is contested but the arguments are frankly difficult to follow.  I recommend, at this level, you assume they *are* the same.  If not, you will open a whole can of worms.  So I think you should have one or the other.  I’ve been doing this for 10 years and you’re the first-ever student I’ve supervised who’s had both.

Conceptual Framework

This is nice and clear.  What about a caption?

Factors that have been identified affecting quality and competence in medical laboratories are seen impacting it on a higher level. The independent factors which have been identified are poor staff motivation, lack of knowledge and appropriate skills, non-calibrated and non-updated equipment, and lack of management support whereas the dependent factor is quality and competence in medical laboratories. Poor staff motivation has a significant relationship with quality and competence which leads to a decrease in quality and competence in a clinical setting. Lack of knowledge and appropriate skills are also significantly associated with quality and competence in medical laboratories which have a higher impact on the quality and competence showing that quality and competence decrease with lack of knowledge and appropriate skills. Non-calibrated and non-updated equipment also have a direct relationship with quality and competence in medical laboratories that has a higher impact on the reduction of quality and competence in performing functions in a clinical setting. Lastly, lack of management support has a highly significant relationship with quality and competence in medical laboratories having the highest impact on the entire clinical setting and may lead to highly negative outcomes and lack of efficiency and effectiveness in the service quality and competence in medical laboratories. Very good

Conclusion

This chapter of the study has been providing a detailed literature review regarding the issues and challenges that the medical laboratories have been facing for the accreditation of ISO 15189. Can you think of a clearer way to write that? In addition to it, the significance and the impact of ISO 15189 have also been discussed along with the factors affecting the quality and competence of medical laboratories.  Furthermore, the role of ISO has also been studied and the theory of management has been identified as the most appropriate theory regarding the issues in the medical laboratory. In the last section of the chapter conceptual framework has also been provided showing the relation of the identified factors to the quality and competence of the medical laboratory. Good.

Very good draft chapter. I didn’t see much criticism though.

Shane