Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa

Introduction Regular participation in external quality assessment (EQA) is critical for maintaining laboratory performance and is required for laboratory accreditation. Proficiency testing (PT) is effective for providing EQA, but available schemes rarely address the range of tests performed by peripheral laboratories in resource-limited settings. The East African Regional External Quality Assessment Scheme (EA-REQAS) was established in 2004 to address this need. Materials and methods Surveys were distributed biannually comprising seven different panel materials and questions addressing laboratory, clinical and public health topics. Preserved materials were prepared using standard procedures and validated by accredited laboratories to establish target values. Survey materials were shipped by courier and results returned by paper copy, email or online. Immediate feedback reports included advice for addressing errors. Composite reports addressing participants’ performance were provided to national quality assurance offices. Results Sixteen surveys were distributed between 2008 and 2015; enrolment increased from 195 to 560 facilities. Mean response rate remained static (56-59%), but overall number of participating facilities increased. Mean performance scores increased from 51% to 68% but remained below the accepted score of 80%; individual facilities achieving 80% or more increased from 0 to 25%. Facilities participating in 10 or more surveys performed better than facilities participating in 5 or less surveys. Conclusion PT can be applied at peripheral level in resource-limited settings and identifies poorly performing areas. PT can also be used to assess performance of equipment and test kits as part of post-market surveillance. Smaller health facilities require additional support to address deficiencies.


Introduction
Health laboratory services are a critical component of national health systems and are central to disease diagnosis, treatment, prevention and outbreak investigation (1). Laboratories meeting International Organization for Standardization (ISO) 15189:2012 standards are required to participate in inter-laboratory comparisons through external quality assessment (EQA). The World Health Organization (WHO) defines EQA as a system for objectively checking a laboratory's performance through proficiency testing (PT) schemes, rechecking samples or on-site assessment. Participation in EQA detects systematic laboratory errors and assesses competency of technical personnel. EQA should address all testing procedures performed in the laboratory (2).
In primary healthcare settings in East African countries, laboratory testing may influence 45% of medical decision-making (3). However, laboratory services in resource-limited settings are often poorly managed and provide results of unknown quality; many clinicians regard laboratory testing as unhelpful (4). The common perception that EQA is costly or unnecessary has hindered widespread Munene S. et al.
A regional PT scheme for peripheral laboratories enrolment of laboratories into these programmes (5).
PT schemes submit samples with undisclosed results to groups of laboratories for analysis. International and commercial PT schemes are costly and may not address the range of basic tests and pathology appropriate for resource-limited settings. The East African Regional External Quality Assessment Scheme (EA-REQAS) was established in 2004 through a joint collaborative initiative of the ministries of health of Kenya, Mainland Tanzania, Uganda and Zanzibar to establish regional standards and provide an appropriate PT scheme for peripheral laboratories (6); Burundi's ministry of health joined the scheme in 2011. A committee comprising two members from each ministry of health was established to govern scheme operations. Amref Health Africa, a health development nongovernmental organisation with an established laboratory programme, was appointed to coordinate the scheme on behalf of the ministries of health. Results were marked according to pre-prepared marking keys. Qualitative results were positive or negative (3 marks for correct results). Semi-quantitative results (AAFB grading; malaria parasite counting) and quantitative results (haemoglobin measurement) were scored with 1-3 marks according to the deviation from target values ( Table  2). Results with dangerous clinical implications scored one negative mark. Facilities were request-A 22-year-old woman visiting the coast from the highlands complains of a two-day history of fever, headache and joint pains. The clinician requests a blood slide for malaria parasites.

Materials and methods
1. Examine the blood slide labelled BS1 and give your findings.
2. Why are both thick and thin blood films prepared for malaria diagnosis?
3. In consultation with your clinician, what other causes of fever might be considered in this patient?
4. What preventive measures should a visitor to a malarial area take?

Results
Sixteen surveys were submitted biannually from 2008 to 2015. The initial 195 enrolled facilities increased to 560 by survey 16; participating health facilities were government, faith-based and privately owned. Mean survey response rate dropped from 66% in survey 2 to 40% in survey 9 but increased to 59% in survey 16 after instituting SMS reminders. Turnaround time was above the expected 30 days in all surveys except in survey 15 (24 days) with a high of 86 days (survey 10) but showed an overall decreasing trend.
The four tests most poorly performed overall were haemoglobin measurement, peripheral blood film examination, Gram stain and examination of bacteriological samples, and malaria parasite counting. Haemoglobin methodologies were compared by grouping into three major categories: auto-analyser, manual colorimetric and visual comparator methods. Taking acceptable performance as < ± 10 g/dL from the target value, performance using visual comparator methods was significantly inferior (χ 2 = 48.291; P < 0.001).

Discussion
Several changes were made to the scheme's operating model during the first eight years of implementation. From survey 6 courier services were contracted to improve timeliness of package delivery and return of paper-based reports using a prepaid system, but this added 32% to operating costs.
To explore reasons for delayed and non-responses, a telephone survey was conducted in 2011 in 47 facilities in Kenya. Reasons given included noncompletion of questions, reagent stock-outs and personnel transfers; these are being addressed  In conclusion, PT is a valuable tool for evaluating laboratory performance, identifying poorly performing areas, assessing instruments and test kits, and influencing national policy. Identified deficiencies need to be corrected for laboratories to benefit from participation. Locally coordinated PT schemes provide relevant survey materials, promote appropriate remedial measures and engage in dialogue with relevant authorities. Governments and health facilities need to appreciate the value of PT participation, and introduce regulations and budgetary provisions to support mandatory participation.