الفهرس 
Materials and MethodsOnly 14 pages are availabe for public view
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Abstract
Nowadays, the problem of medical laboratory errors has recently received a great deal of attention, which will probably increase, a lot of time and resources are used to determine the quality of services.
Medical laboratories are the key partners in patient safety. The importance of quality in health care laboratories is well recognized globally, since laboratory results influence 70% of medical diagnosis. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence.
Medical laboratories exist to transform an authorized health care professional’s order for laboratory services into a tangible report of results and interpretations in support of patient need. The laboratory’s primary customer is the authorized professional who will use the results and interpretations in the patient’s plan of care. The transformation from order to report is realized through a series of work processes that involve health care personnel outside and within the laboratory.
Inaccurate laboratory reports can lead to inappropriate action (like over-treatment, over-investigation or mistreatment of patient), inappropriate inaction (lack of investigation or treatment), delayed action, incorrect follow-up of patient, faulty epidemiological data for health program, loss of credibility of laboratory or legal actions against the laboratory or the hospital.
Because data from clinical laboratories are directly involved in the vast majority of all medical diagnoses and treatments, there is an increasing awareness of the importance of errors in laboratory practice and their possible negative impact on patient outcomes. Many strategies are used to reduce laboratory errors, including internal quality control procedures, external quality assessment programs, certification of education programs, licensing of laboratory professionals, accreditation of clinical laboratories, and the regulation of laboratory services. In the past, laboratory professionals focused their attention on analytical errors and mistakes resulting in adverse events but overlooked errors in the pre-analytical and post-analytical steps. Pre- and post-analytical processes in our laboratory were more vulnerable to errors than the analytical steps.
This study aimed to:
1. To assess the infrastructure of the bacteriological laboratories.
2. To assess performance of laboratory staff “process of services”.
3. To evaluate the outcome of the laboratories “bacteriological results”.
This study was conducted in clinical microbiological laboratories of four MOH (Ministry of Health) hospitals in Alexandria (one laboratory per hospital). The study hospitals included were Fever hospital, Abo-Kir hospital, Ras-El-tin hospital and El-Gomhoria hospital. A total number of 592 samples were collected, 254 were urine samples, 185 were wound samples, and 153 were sputum samples.
The following were subjected to quality control by using reference strains:
• Media, reagents and stains.
• Antibiotic discs.
• All samples (urine, wound, sputum) were collected at the same time and transported as soon as possible to the laboratory using appropriate media as followed:
- In case of urine using MacConkey’s agar and CLED agar for counting.
- In case of wound and sputum using MacConkey’s agar, blood agar and chocolate agar base.
- Any isolated organisms were identified by standard microbiological techniques.
- Any isolates were testes for their antibiotic susceptibility by disc diffusion method described by Kirby-Bauer.
• Equipment also subjected to quality control.
A questionnaire was designed, which included demographic data of the staff and their knowledge about bacteriological analysis. Observation sheets to evaluate structure and process of care (pre-analytical, analytical, post-analytical) of laboratories. Review of records was done for staff policies and SOPs. The laboratory documentations were reviewed for comparing the results of the laboratory with the results of investigator.
The results of this study showed that:
A: Sociodemographic characteristics of the laboratory staff participating in the study:
Among 37 laboratory staff, 17(45.95%) were physicians, 20(54.05%) were technicians, with different scientific degree. Out of 37, 22(59.5%) with more than 10 years of experience. 24(64.86%) had not pre-employment training, while 26(70.2%) had training in – service.
B: Compliance of the hospital laboratories with laboratory standards:
The highest adequacy of facilities, equipment and reagents and media were found in Fever hospital with grade good and mean percent score 55.0%, 67.2% and 51.6% respectively, followed by Abo-Kir hospital, while the lowest with grade poor were in El-Gomhoria hospital and Ras-El-tin hospital.
Staff policies and procedures (SOPs) manual were lack in all hospitals. These differences were found to be statistically significant.
As regards the performance at the three phases (pre-analytical, analytical and post-analytical), the highest mean percent score was appeared in fever hospital with grade good, followed by Abo-Kir hospital with fair grade, while the lowest were in Ras-El-tin and El-Gomhoria with poor grade.
Furthermore, the lowest mean percent score for the performance among all hospitals were in the pre-analytical and post-analytical phase rather than analytical phase. The difference between the performances at three phases was statistically significant.
C: Assessment of knowledge of the lab. staff:
It was found that the highest total level of knowledge about three phases (pre-analytical, analytical and post-analytical) with grade good (41.4%) in Fever hospital, but only (20.0%) good in Abo-Kir hospital, while (100.0%) completely poor total level of knowledge appeared in Ras-El-tin hospital, followed by El-Gomhoria hospital (50.0%).
D: Assessment of the factors affecting staff performance and test results:
On assessing the performance of laboratory staff and their results of analysis, there was many factors affecting staff performance, which include:
1. Sociodemographic characteristics:
Out of 592 samples, 288 samples (48.6%) were examined by physicians where (76.1%) of their results were correct, while (23.9%) correct results examined by technicians. There was significant difference between staff qualification in the performance of analysis.
Also, it was found that the years of experience and training program are significantly affecting the level of staff performance, where the staff who has > 10 years of experience and with training program showed best test results and performance level (55.1%, 69.88.65) and (89.1%, 70.610.3) respectively.
2. Laboratory’s environment:
When the laboratory’s environment under suitable conditions, such as suitable area, availability of facilities, good degree of cleanliness, sufficient lighting and ventilation, the staff performance in these suitable environment was significantly better and the correct test results were (79.7%, 82.6%, 79.0%, 71.0% and 63.8%) respectively.
3. Laboratory’s chemical:
Staff performance is statistically better when chemicals (disinfectant, reagents, stains and media) were available and also give correct results of analysis (81.2%, 83.3%, 78.3% and 73.9%) respectively.
4. Laboratory’s equipment:
It was found that the availability and efficiency of laboratory’s equipment had direct relation with the results of analysis and mean level of staff performance, where the correct results of analysis and mean level of performance were (61.6%, 71.011.02) in case of efficient equipment.
On the other hand, the inefficient equipment showed only (22.5%) correct test results and (43.010.65) mean level of performance. This difference was highly significant.
5. Staff knowledge:
It was found that the percentage of correct test results were higher and the performance was significantly better among staff having good knowledge regarding pre-analytical, analytical and post-analytical were (56.5%, 73.0%11.42), (36.2%, 69.810.9) and 50.7%, 73.1%9.04) respectively.
6. Staff performance (practice):
The level of performance showed a direct relation between test results and macroscopic and microscopic examination, adequate procedures and appropriate media, colony identification after 24-48hrs, biochemical identification, quantitative colony in urine culture and inoculum size standardized, all these steps was done by laboratory staff of Fever hospital, which showed best performance and correct test results rather than other hospitals.
E: Comparing the results obtained by the Ministry of Health laboratory staff and the study results:
By comparing the test results which done by the investigator and laboratory staff, it was found that the highest percentages of agreement with our results were detected in wound samples (36.05%) and (25.0%) of both Fever and Abo-Kir hospital laboratories respectively, followed by urine samples (30.8%) and (21.8%) for both hospitals respectively, while the lowest percentage of agreement appeared in diagnosis of sputum samples among all hospitals.
The wound samples showed statistically significant difference between different samples among both Fever and Abo-Kir hospital laboratories, while there was no statistical significant difference between all types of sample in the two other hospitals laboratory.
Furthermore, among all hospitals, the easily detected microbial isolates were Candida sp. followed by Gram negative bacteria then Gram positive bacteria.
Also, it was found that Klebsiella sp. is the most one easily detected among Gram negative species followed by E. coli, while Citrobacter sp., Enterobacter sp., Pantoea agglumerans were completely missed among all hospitals. Acinetobacter sp. mentioned only by Fever hospital (9.68%).
On the other hand, the Gram positive species were the lowest identified isolates, where S. aureus isolates detected in both Fever hospital and Abo-Kir hospital with percentage agreement (35.8%) and (25.0%) respectively, followed by Coagulase negative staph. (CNS.) for both hospitals(28.9%, 15.4% respectively). Only (26.7%) S. pyogenous and (26.1%) S. pneumoniae were detected in Fever hospital, where other hospitals none.
It was found that all Gram positive isolates were completely missed in both hospitals El-Gomhoria hospital and Ras-El-tin hospital.
Regarding antibiotics sensitivity of the isolates for all types of samples, it was found that the highest percentage agreement was proteus sp. (75.0%) followed by S. pneumoniae (66.7%) then S. pyogenous (50.8%). E. coli, Coagulase negative staph. (CNS), Pseudomonas sp., Acinetobacter sp., Klebsiella sp., S. aureus showed 48.4%, 36.4%, 35.7%, 33.3%, 30.0% and 21.1% respectively. There is no significant difference between Gram positive bacteria and Gram negative bacteria in the agreement of antibiotics.
from the results of the present study, the following could be concluded:
The laboratories of Ministry of Health (MOH) hospitals showed lower concordance with the laboratory standards. Fever hospital shows highest compliance with standards, high level of performance and correct test results.
The main gaps between the accreditation standards and laboratory performance are mainly in the following areas:
• Laboratory infrastructure (facilities, equipment, reagent& media) score were very defective.
• Documentation (SOPs) is deficient in all laboratory areas including policies and procedure for specimen management, test process, quality control, equipment management, reagent management, verbal/telephone orders or reporting system, laboratory safety program, hazardous material and waste management.
• Absence of formal documented training program for orientation of new employees and continuous education and training programs. So, low level of the staff knowledage
• Staff (physicians& technicians) does not follow any standardized measures for bacteriologic examination, which lead to low agreement percentage of the results of any type of specimens.
• Complete lack of a quality management system specially procedures for IQC and EQC in the hospital’s bacteriology laboratory.
• Gram negative bacteria more easily detected than Gram positive b