Evaluation of Quality Measures for Point of Care Blood Glucose Testing at Kenyatta National Hospital

Abstract

Background: Point of Care Testing (POCT) is defined as a type of laboratory testing that is done close to the patient as opposed to laboratory testing in the hospital’s main laboratory (Shaw, 2015). It is estimated that the POCT market will grow from United States (US) dollars ($) 23.16 in 2016 to US$ 36.96 billion in 2021(Vashit, 2017). Blood glucose is one of the most common POC tests (AACC, 2015). According to Klonoff (2017), POCT is not only used in the determination of blood glucose levels in hospitalized patients but it is also used to make quick medical decisions in response to altered glycemic states. Standards for POCT performance have been established to ensure quality of the results. Objective: To evaluate the quality measures put in place in Kenyatta National Hospital (KNH) to ensure accurate glucose results. Methodology: This was a mixed method study. It was a descriptive cross sectional and phenomenological study to be conducted in the wards on levels 1,3,4,5,6,7,8,9,10, labour ward, GFA, newborn unit (NBU), neonatal intensive care unit (NICU), burns unit, critical care units (CCUs) on the 7th and 8th floor and renal ward; where POC blood glucose testing was done at the KNH. These areas were not under central laboratory management. Study participants included nurse’s performing POC blood glucose tests, as well as nurse managers of the wards. Qualitative data was collected from the nurse managers using a phenomenological tool. For quantitative data collection, the nurses performed POC glucose tests after being given a questionnaire to fill and commercial glucose quality control (QC) material was requested to be analyzed by them on the glucose meter like patient samples. Sample size and sampling procedures: For the cross-sectional study, a total of 230 nurses were selected via convenience sampling, where the nurses on duty at the time were approached and invited to enroll into the study, if they met the inclusion criteria. This was done consecutively till five nurses are enrolled at each site. For the qualitative study, a total of 12 nurse managers were selected by convenience sampling. The nurse manager on duty at the study site was approached and invited to participate in the study. This was done in each site until the sample size was achieved. xiv Data analysis: Data analysis for quantitative data for both the questionnaires and quality control findings were performed using statistical package for social science (SPSS) version 20.0. The data from the questionnaires was presented in tables, bar graphs and pie charts Results of quality control analysis were compared with set target values for analysis of accuracy. Data was presented in line graphs. The researcher analyzed the qualitative data. The data was presented as themes. Results: 230 nurses and 12 nurse managers participated in the study The quantitative data collected from the 230 nurses looking at various aspects such as training, policies/guidelines put in place for POCT blood glucose testing and quality assurance practices. On glucometer training in KNH, it was found out that 43.0% (n=99) of the respondents have been trained on how to use glucometer at KNH. Majority of the participants had not been trained. It was also demonstrated that there was not a well defined quality management system in KNH that encompasses quality policies, SOPs, safety issues and quality assurance It was also demonstrated that only 16.1% (n=37) nurses had heard about the policies ISO 15189 and ISO 22870 that makeup the quality management system guideline and POCT accreditation requirements. On enquiry whether the nurses had an SOP to guide glucose testing using a glucometer 58.3% (n=134) said there was none. Less than a third <33.3% (<n=76) of the respondents ever heard of the terms IQC and EQA. Nurse Managers, on the other hand, using the phenomenological tool demonstrated that they had no knowledge on POC policies/guidelines and they did not quite fully understand their role in POC blood glucose testing For quality control results using the assigned mean, collectively 12 participants were found to be outside ± 3SD. When using the consensus mean, collectively 7 participants were found to be outside ±3SD. Conclusions: The BGMs in use at KNH meet required performance specifications. There is no policy document guiding POC glucose testing at KNH. Only 40% sites had an SOP for glucose testing Only 43% BGM users had received training. Training is not standardized, and trainees are not certified.