Background: The parasite-based diagnosis (malaria microscopy) remains the gold standard method for diagnosis of malaria in endemic areas, where 600 million individuals are infected. Malaria is the most common cause of hospital visits in Sudan. Objective: This study is aimed to assess and evaluate the capacity and quality of the Clinical Laboratories of the private sector at Khartoum State-Sudan, for the parasite-based malaria diagnosis. Method: 70 clinical laboratories form the private sector, were enrolled in this study.The quality and capacity for the study subjects were assessed and evaluated using novel scoring system. Six quality identifiers were selected as key performance indicators. The quality identifiers and their score were as follows: personnel (20%), microscope (25%), staining (20%), blood film and slide (15%), result and report (10%), and Building and safety (10%). For the evaluation of the quality and capacity of study subjects, the cutoff point was identified as (≥ 60%). Results: 64 (91.4%) individuals in this study have a bachelor degree in Medical laboratory sciences; only three of them major in Parasitology. 60 (85.7%) of the personnel have more than three years of experience in malaria diagnosis. Only 10% of the personnel in this study attended in-service training in malaria diagnosis. 58 individuals (83%) scored 10 or more for the total personnel quality score. For the quality of microscope, all the study subjects scored at least 15 points. Almost all the study subjects used Giemsa’s stain, with only 5.7% using Field’s stain. For the staining quality score, 52 subjects (74.2%) scored more than 10 points. Only 35.7% of study subjects reported the species of Plasmodium. 77.1% of study personnel reported the stage. Conclusion: Of the subjects, 88.5% were of a good quality and they were of an acceptable capacity for parasite-based malaria diagnosis. The quality could be improved by implementing an incentive program for quality inspection. Keywords: Capacity, clinical laboratory, khartoum, malaria, microscopy, private sector, sudan, quality
Nearly half of the world population are at risk of malaria infections, with more than 600 million cases with annual death that exceeds one million.[1] In Sudan, where both Plasmodium falciparum and Plasmodium vivax are existed, the number of confirmed cases of malaria reached the ceiling of 85% in high transmission areas,with an annual total number of 3.4 millioncases.[2] Malaria is a leading cause of illness and death in children under five years in Sudan. It accounts for 8.7% of all health facility visits and 11% of all hospital admissions. Malaria diagnosis and treatment annually cost 14 million US$ on an already scarce resource.[3],[4] An accurate and immediate diagnoses of malaria is important for proper case management. It is also crucial for the epidemiological and control surveys. WHO recommends prompt parasite-based diagnosis by microscopy in all patients suspected of malaria before anti-malarial treatment is administered.[5]Microscopy remains the best option for a routine diagnosis of malaria.[6] There are many factors that affect the reliability of parasite-based malaria diagnosis (malaria microscopy), all are about the quality of the lab and the working personnel.[4],[7] Many quality control and quality assurance programs are designed to ensure the competency of microscopy. Most of the recommended quality programs (internal or external) concern the efficiency of microscopy atmosphere.[8-10] However, there are many other key performance indicators for the good quality of malaria microscopy including the quality of personnel and the facility.[11],[12] The private sector shares more that 70% of the health care system in Sudan. This is because of the fact that it is supported by the health insurance companies. Many private sector Companies offer their employees a health insurance of “good quality”, they refer them to the private sector. The current study is aimed to assess and evaluate the capacity and quality of the Clinical Laboratories of the private sector at Khartoum State-Sudan for the parasite-based malaria diagnosis.
Study design and area This is a descriptive cross-sectional and facility-based survey study of a qualitative approach. In this study, a total number of 70 clinical laboratories from the private sector were enrolled. The study subjects were surveyed for their quality and capacity for parasite-based malaria diagnosis (malaria microscopy). This study was conducted between August and October 2015. The subjects were selected randomly from the private clinical laboratories at Khartoum State, Sudan. Khartoum State lies between longitudes 31.5 to 34 E and latitudes 15 to 16 N. It is surrounded by River Nile State in the northeast, in the northwest by the Northern State, in the east and southeast by the states of Kassala, Gedaref and Gezira, and on the west by North Kurdufan. Although it is the smallest state by area (22,142 km2), it is the capital of Sudan and most populous (5,274,321 in 2008 census). It is also the destination of all neighborhood States for medical services. Data collection and analysis For data collection, the study applied structured data Performa. The following variables were investigated: personnel qualification, building basics requirements, availability and quality of microscope and its essentials, quality of stain and staining utilities, blood film preparation, and result management. A novel scoring approach was designed to report the quality of the study subjects. Each variable has given a percentage that represents its weight in relation to the overall quality evaluation. The percentages, which is also equivalent to quality score were as follows; personnel (20%), Microscope (25%), staining (20%), blood film and slide (15%), result and report (10%), Building and safety (10%). For the evaluation of the quality of study subjects, the following are predefined quality level scores; excellent (80% or more), very good (70-<80%), good (60-<70%), and poor quality <60%). For the capacity of selected subjects, we define 60% as a lower limit for acceptance. Data were tabulated, processed, and analyzed using IPM Statistical Package for Social Sciences software (SPSS19.0). Statistical inference was achieved based on the descriptive statistics. Ethical consideration The Ethical Committee of the Board Counsel of the Faculty of Graduate, Al Neelain University, Khartoum-Sudan approved the proposal of this study. An informed consent was obtained from each participant.
Personnel quality Among the study population, 64 (91.4%) individuals have a bachelor degree in Medical laboratory sciences; however, only three of them were major in Parasitology, [Table 1] shows the detailed frequencies for the qualifications of lab personnel. 60 (85.7%) of the personnel have more than three years’ experience in malaria diagnosis; [Table 3] shows the detailed frequencies for personnel experience. Few of the personnel in this study (10%), attended a special in-service training on malaria diagnosis; [Table 2] shows the frequency of in-service training periods among study personnel. 58 individuals (83%) scored 10 or more for the total quality score (full-mark is 20); [Table 4] shows the details of the quality scores for lab personnel in this study.
Microscope The quality of the microscope was determined by the availability and efficiency of its parts and utilities that are essential for proper blood film examination. All the study subjects scored 15 points or more (full mark is 25) [Table 5]: shows a detailed score for microscope quality).
Staining Almost all the study subjects use Giemsa’s stain, with only 5.7% using Field’s stain. Many key indicators were investigated to determine the quality of staining [Table 6] shows the key performance indicators and their frequency among study subjects. Concerning the staining quality score, 52 subjects (74.2%) scored more than 10 (full-mark is 20) [Table 7]: shows the detailed score for staining quality.
Other quality measures include result and report process. Only one-third of study subjects reported the species of Plasmodium, however, 77.1% of study personnel reported the stage; [Table 8] illustrates the detailed frequencies of the quality indicators in regard to reporting of blood film examination for malaria. Few of the studied facilities were adhere to standard safety measures.
The overall quality ranking for the study subjects are illustrated in [Table 9].
There are many benchmarks and quality standards that ensure the readiness for a facility to reach a quality parasite-based diagnosis of malaria. These key performance indicators define the capacity and quality of clinical laboratory for a proper and accurate parasite-based diagnosis of malaria. They ensure good laboratory practice in the same regard.[13] Many researchers do agree with a minimum quality identifiers for a clinical laboratory to be eligible for parasite-based malaria diagnosis. These quality indicators concern the personnel qualtiy interm of training and experience. Also, they search for the availability and efficiency of the microscope and its utilities. The quality of stain and adherence to the standard operation procedure of staining are also highly considered.[14],[15],[16],[17],[18] As shown in the results, the majority of the laboratory personnel in this study have a bachelor degree in Medical Laboratory Sciences. This means that they have spent more than sixty contact hours on malaria diagnosis. However, there is a lack of in-service training. For the private laboratory, there is a challenge of cost and time, because they seek financial profits. The in-service training, unless offered free, remains the least concern of the private sector. There are no rules issued by the authorities to obligate in-service training for the private sector personnel so far. There is a global trend to offer free training for every lab personnel, especially in Africa.[19],[20] The majority of lab personnel in this study have an experince of at least three years on malaria diagnosis. Again, unless it is supported by in-service training, year of experience may be of no greater value.[21],[22] Many countries now are focusing on the strengthening of the personnel quality. They differ in the identification of the quality indicators, however, the baseline-identifiers are the same.[17],[18] In this study 83% of lab personnel were of an acceptable quality, considering the score achieved in regard to quality identifiers. However, only 8.6% of personnel in this study were of a very good quality; those who graduated with bachelor degree major in parasitology and underwent basic and refreshing in-service training. All of the studied facilities use a microscope of at least good quality. As they are private, they have to keep this item on the top of their priorities to maintain market competition. Many quality key performance indicators have been assigned to identify the quality of staining. Almost all the laboratories in the study use Giemsa stain with a variable degree of adherence to its standard operation procedures. None of the study subjects pay attention to the pH adjustment, they are using commerciallyready-made buffer solutions. Also, they are working with Giemsa stain without considering safety precautions. For them, Giemsa stain is safe and the method contains no risk, which is untrue. The rest of the key performance indicators were good enough to ensure that, at least 74.2% of the subjects of this study, were using stain and staining procedure in an acceptable quality. The proper reporting of microscopic examination is one of the quality indicators. Only one-third of the personnel in this study report the species of Plasmodium, although it seems that they know how to do it. They also don’t pay much attention to the density of parasite. They claim that the treating doctors don’t care about the species and density. So, by the time, they report the result in a quality mode. This issue is documented elsewhere of having less impact on patients management.[23] Interestingly, 77.1% of the personnel in this study reported stage of the parasite. In addition, a majority of them maintain archive for results. The identification for the capacity and quality of the clinical laboratories gives an indication for their readiness to achieve reliable parasite-based malaria diagnosis. Some malaria endemic countries reach a level of capacity and quality that fits with the basic requirements of parasite-based malariadiagnosis.[17],[24] Some countries try to adjust,[25] whereas others still struggle to provide basic needs.[26]
In this study, 88.5% of the subjects were of a good quality and they are of acceptable capacity for parasite-based malaria diagnosis. However, this percentage could be increased and the quality could be improved by implementing an obligate program for quality inspection. Acknowledgment We would like to thank all participants in this study. Special thanks are to The College of Graduate, Al Neelain University and also to the Laboratory Administration of Khartoum State-Sudan. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9] |
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