الفهرس 
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Abstract
SUMMARY AND CONCLUSION
Clinical microbiology laboratories play an essential part in both the detection and prevention of diseases. This starts with doing the right test, at the right place, at the right time and achieving the right result because their performance play a fundamental role in the quality and effectiveness of healthcare.
There are many procedures and processes that are performed in the clinical microbiology laboratory, and each of these must be carried out correctly in order to assure accuracy and reliability of testing. An error in any part of the cycle can produce a poor laboratory result. A method of detecting errors at each phase of testing is needed if quality is to be assured.
Quality management is a system which ensures that the quality in the process, product or services provided are according to the standard. The major elements of the quality management, are quality assurance and quality control. Quality Assurance, assures that the right production process is performed in the right manner. Quality Control, on the other hand, ensures that the product will match the requisite standard. Quality Assurance and Quality Control are the two tools which help to provide quality service to the customers.
Quality assurance comprises administrative and procedural activities implemented in a quality system so that requirements and goals for a service or activity will be fulfilled. It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention. This can be contrasted with quality control, which is focused on process output.
The quality of results from the laboratory is significantly influenced by many pre-analytical and post-analytical factors which needed attention. This indicated that standardization and monitoring of each step in the total testing process is very important and is associated with the most efficient and well-organized laboratories.
This study aimed to:
1- To evaluate pre-analytical, analytical, and post-analytical procedures followed in these laboratories according to lab quality standards.
2- To apply an intervention program including the necessary corrective actions to be taken by the laboratories under study.
3- To assess the impact of the intervention program on implementation of laboratory quality standards.
This study was conducted in clinical microbiology laboratories present in four hospitals represent different healthcare sectors in Alexandria, Egypt.
The work was through assessing the current situation of clinical microbiology lab regarding the state of lab. Quality management related to quality essentials that routinely existed. These selected essentials for evaluation were chosen depending on their important role in modifying Lab quality practice status, taking the international lab quality standards as reference for assessment, these aspects of quality management including facilities, personnel, equipment, reagents and culture, sampling, tests performance, reporting, infection control, safety, and clinician satisfaction.
Our study was consisted of three distinct phases:
1. Phase I: Assessment phase to detect the implementation of quality control standards and the Pre-analytical, analytical, and Post-analytical current situation in microbiology laboratories under study (January 2015 till Apri.2015).
2. Phase II: Intervention phase for laboratories staff awareness and education about lab quality standards implementation and laboratory quality management system .It started from May 2015 till August 2015.
3. Phase III: post-intervention phase to evaluate the impact of the intervention program on the quality assurance in the laboratories using the same checklists that were used in the first assessment phase. (Started from September 2015 till December 2015)
For pre and post intervention assessment, checklists were designed according to the recommendations of the following international guideline: ISO 15189 laboratory standards, accreditation for Microbiological Laboratories recommendations, College of American Pathologists (CAP) Laboratory Accreditation Program, WHO Laboratory Assessment tools. The questions were classified into groups focused on ten major essentials of laboratory quality management system; each group contained a number of questions concerning one of the pre-analytical, analytical, and post-analytical activities assessment.
Review of records was done for: microbiology lab. staff rules, duties, training, and responsibilities, also for policies and procedures of lab. activities processes.
A questionnaire was designed to test the knowledge and attitude of the lab workers before the intervention program and the same test was applied to them immediately after the intervention program. The Intervention program was constructed to explore the effects of lab quality management system to the lab workers so as to raise their knowledge and try to modify their attitude towards the importance of its applying. This was done through lectures, posters, and pocket fliers.
The results of this study showed that:
The laboratories staff improved significantly in their knowledge as their mean score improved from( 57.5% to 85% ) for all studied persons in four hospitals mainly in lab(B)and (D), also in their readiness to implement the policies and procedures laid down in the laboratory , where personnel requirements scoring raised from 76.8% in phase I to 92.5% in phase II mainly in Lab(A) and(B).
That sequentially had better effects on compliance of quality essentials related to pre-analytic sample management which was 78.5% in phase I, then became 96.1% in phase II especially in lab (B).
Analysis performance was 74.2% in pre intervention phase, then increased to 92.1%, with marked improvement in lab (B).
This had led to reasonable significant scoring change 13.9% of post-analytic assessment which was 82.1% firstly then 96% after intervention, and this was noticed in lab (B).
Compliances of the tested hospital microbiology laboratories with laboratory standards:
As regard terms of the infrastructure components, the results of 4 studied hospital laboratories in phase 1 was 74.2%, whereas in phase II 77%, there was a significant impact of intervention in some defected items with a percentage of 2.9%; (P 0.039), that change only occurred in lab (B),where the three other labs. Not affected by intervention due to already established organizations.
Furthermore, among all Laboratories, the result in this study of lab quality standard implementation concerned reagent and media was (82.9%) in phase I, then became (96.7%) in post intervention phase II, which is significant difference, except lab (A) recorded initially high score.
On the other hand our significant result of implementation of lab quality standard concerned equipment was (83.9%) in phase I, then became (89.8%) in post intervention phase II, in lab (B) due to implementation of quality required elements, while the other labs. Were already achieve high degree of assessment.
It was found that our study results in first assessment for infection control compliance was (88.2%), which already reasonable and not statistical significant changed where was (90.2%) in post-intervention phase.
Also, it was found that the result of lab safety procedures implementation was (61.3%) in phase I, then was (66.3%) in phase II, with no significant change .That is due to presence of qualified safety committee in hospitals (A, C, D) and responsible for applying safety policies and procedures in all hospitals departments including lab, except lab (B) score was low in both assessment.
As regard clinician satisfaction:
Hospital (D) reached to 100% in pre and post-intervention assessment because of good communication with clinician and ready for provision of information rapidly due to using of computerized information system. Similarly Hospital (A) was not affected by intervention because it already got high score in assessment. Hospital (C) showed minimal increase and reached to 100% after intervention phase which lead to elevation of lab staff accessibility in hospital (B) by indicating the importance of communication between lab and other hospital clinical departments.
Comparing the results obtained by the four studied microbiological laboratories:
In pre-intervention assessment of the four hospital lab included in our study their scores arranged as follow: Lab C(89%), A(88.4%), D(82%), then B(55.8%).
Post –intervention assessment revealed the sequence of scoring as B (93.85), A(93.5%), C(91.7%), then D (86.9%).
from the results of the present study, the following could be concluded:
- According to WHO Laboratory Assessment Tool: below 50%, requires significant improvement, between 50% and 80%, some improvement is necessary, above 80%, the laboratory is in good standing, so analysis of the results showed that three of our studied hospital labs were in good standing.
- The impact of intervention on Hospital (B)lab. Improved its level to a good standing.
- Laboratory efficiency is an outcome of a good quality system and this can be achieved with the active involvement of all staff members.
- The impact of intervention program on the behavior of lab staff in the commitment of implementing the quality standards and analysis performance. That is the aim of this study to achieve.
- The impact of intervention was significantly apparent on quality requirement regarding sampling and reporting in the four studied hospital labs.
- Quality assurance of clinical microbiology lab. achieved by good communication between lab staff and clinicians in hospital.
- Implementation of lab. infrastructures essentials should be fulfilled in primary lab construction .
- Lab. quality essentials of infection control and safety required qualified infection control and safety committees in hospital.