by Renze Bais
Since 2014, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has been coordinating an External Quality Assurance (EQA) project in Zambia in conjunction with the Biomedical Society of Zambia.
The purpose of the project is to establish a sustainable EQA scheme in Zambia.
The project measures the performance of the selected laboratories by comparison with other Zambian laboratories enrolled in the program as well as with peer laboratories from around the world. The project also monitors the change in performance of participating laboratories and can provide feedback and educational support.
In 2012, Dr Renze Bais submitted a proposal to the IFCC Executive Board suggesting that the IFCC sponsor EQA programs in developing countries. The basic premise was that the IFCC could form a partnership with International QA providers and run projects as joint ventures. The IFCC would provide the expertise and educational input into such projects.
Dawn Lab making up EQA material Dawn Lab
The proposal was developed from previous experience with projects run in Vietnam for over 10 years and included the following aspects:
Through the contacts made by IFCC Executive Board members, Prof Jocelyn Hicks and Prof Vanessa Steenkamp, Zambia was identified as a potential country where a project could be set up successfully and the President of the BSZ at the time, Hilary Lumano was willing to act as the local coordinator. The concept was supported by the IFCC President, Dr Graham Beastall and the Exective Board.
A meeting was held during Euromedlab in Milan in 2013 with representatives of the IFCC, BSZ and Randox, a major EQA provider. At the meeting Randox agreed to partnering with the IFCC to run an EQA program in Zambia and a Memorandum of Understanding was drawn up between the IFCC, Zambian Ministry of Health and Randox.
The BSZ was officially recognised by the MoH as their representative in the project through a letter from the Permanent Secretary of the MoH.
Randox initially agreed to supply material for 12 months as well as enrol the laboratories in their World-wide QA program free of charge. This phase, which covered 16 laboratories, ran for the 12 months but after reviewing the project, Randox would only continue support if the laboratories paid for enrolment which was not possible for most of them due to the cost.
To enable the project to continue, the IFCC was able to negotiate with an alternative supplier (RCPAQAP Pty Ltd in Australia) who agreed to provide enough material at a significantly reduced cost to enable 25 laboratories to be enrolled. Purchase of material was organised at the end of 2015 and the material shipped to Lucky Kalyapu, Ndola College of Biomedical Science, who agreed to store and distribute the material to the selected laboratories as well as being the local contact. Laboratories were contacted by the BSZ and after acknowledging their willingness to take part, sent a questionnaire regarding their range of tests and instruments they used.
The first samples were analysed in January 2016 with samples tested monthly in laboratories selected by the BSZ from all regions within Zambia. Most laboratories in Zambia have a limited biochemistry menu and the analytes included in the program were chosen because they were performed by at least 5 of the participant laboratories. They were:
Bilirubin - conjugated
Bilirubin – Total
Data was analysed using computer programs written and developed by Dr Renze Bais and laboratories received two types of reports on a monthly basis. One compared their results with the Zambian laboratories in the survey while the other compared their results with those from the World-wide results for the material. In the World-wide survey there are at least 500 results for each analyte. There was no separate analysis for specific instruments or reagents as there would be insufficient data for each group. Reports were returned in the form of pdf files showing Zambian laboratories against their peers and against World-wide laboratories printed side-by-side for comparison. As expected, the statistics for the Zambian laboratories are generally but not always, less precise than for the World-wide result simply due to the smaller number of points in the data. If there are significant discrepancies, it was suggested laboratories compare their results with the World-wide results.
General Findings, 2016.
Laboratories submitted results 94% of the time. The reasons for not returning results were instrument down, EQA sample delivery issues or no explanation. However, much more concerning is that very few times were laboratories able to return a complete set of results for the tests they perform, the main reason being a lack of reagents. From this program what is clear is that the supply of reagents continues to be the biggest issue facing laboratories in Zambia. On average, laboratories returned only 50 - 60% of their results, the low figure almost always due to lack of particular reagents in the laboratory. Another finding from the survey was that 4 laboratories had two different analysers from the start of the program in January but did not return results for the newer upgrade as it has not been made functional even after 12 months. Some laboratories were notorious for submitting results after the cut-off date. We allowed this as this is an introductory and educational program but in a fully-fledged EQA program this would not be permitted. Other issues that arose were at least 4 different laboratories have, on one occasion, prepared the material incorrectly by adding all the diluent instead of the correct amount of 5 ml or laboratories had problems returning results due to issues with their internet connection.
Current Phase 2017 – 2019.
The third phase of the project has just been completed and was coordinated in Zambia by Lucky Kalyapu, who has worked tirelessly to ensure its success. Other members of the BSZ also lend support when required.
In this current phase, there were 36 laboratories enrolled, ranging from major teaching hospitals to remote small rural laboratories. The material for the program was again provided by the RCPAQAP Pty Ltd in Australia at a significantly reduced cost. Results were submitted monthly and reports provided to the laboratories as pdf files. With the addition of ALP, calcium and phosphate, there were 17 analytes for which results were submitted although not all laboratories measure the complete range. As with previous phases, the individual laboratories received a report comparing them to their peer group as well another report comparing them to a World-wide group (> 500 laboratories).
Based on imprecision as assessed by the standard deviation. the analytical performance of laboratories in Zambia compare favourably to the World-wide performance for creatinine, AST, conjugated bilirubin, cholesterol and triglyceride. They perform poorly for sodium and potassium, protein and albumin.
Again, the major finding from this phase is the inconsistent return of results due to poor supply of reagents. Many laboratories run out of reagent for one or more analytes on a regular basis and some can regularly only return 50% of the results. The reasons are being investigated by the BSZ but it appears to be either a lack of money and/or supply chain issues. Of great concern was that a number of the laboratories that had supply issues were major government hospitals in the larger cities. It was also noticed that towards the end of this phase, there was a significant increase in the time laboratory equipment took to be repaired, with some equipment being down for more than 4 months.
An important issue to resolve is how to make EQA a permanent part of laboratory practice in Zambia. The major cost is the material. One possibility is for laboratories to enrol in an established EQA program but all are relatively expensive and probably outside the reach of many Zambian laboratories at this stage of their development. The most appropriate option would be to follow the program set up here but to expand it to include many more laboratories, subject to sourcing suitably priced EQA material.
As with any of these programs in developing countries, sufficient funding is always an issue for continuing the program and there are also other competing disciplines, especially infectious diseases which are chronic in many developing countries. However, because of the commutability of material, a biochemistry program is the easiest to establish and can be used as an introduction to the importance of EQA in a clinical laboratory. Although the BSZ funded the currently cycle from company donations, this is not sustainable and they are currently discussing how to proceed.
A regular EQA program is a major contributor to good laboratory practice as well as being a requirement for any laboratory seeking accreditation. The laboratories in Zambian are at a stage in their development that they should be pursuing such programs in all disciplines but it requires a commitment from all stakeholders, government, laboratory managers, staff and the users, all of whom have an interest in getting the correct result, to the correct patient, in a timely manner.
What has not been followed up is what the laboratories do with the reports when they are received. They should be analysing them and troubleshooting any results that were outside the set ranges. This will need to be surveyed as part of future project development.