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• Squaring the circle • Time to stop doing more of the same • SLIPTA and LQMS-SIP, the companions of SLMTA • Evident evidence and the up-shot • SLMTA, nearing the tipping point? • Conclusion • Acknowledgements • Competing interests • Authors’ contributions • Disclaimer • References |
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In developing countries, QA in laboratory medicine has been severely neglected and has become a serious impediment to effective healthcare delivery and disease surveillance.4,5,6 In fact, a vicious cycle has been established whereby most physicians in developing countries rely on history-taking and physical examination for patient management, since they have little confidence in laboratory test results, even if laboratory facilities exist.5 As such, inadequate resources are allocated to laboratory services, which in turn results in less-than-optimal quality-assured results, further leading to the neglect of laboratory systems (Figure 1). Nonetheless, many countries are currently making great strides in implementing quality management systems (QMS), which is leading to laboratory accreditation to international standards.7,8 The importance of quality in laboratory medicine cannot be overstated: it adds significant value to patient outcomes and management;9 reduces wastage, minimises sample rejection and enhances client satisfaction;10 prevents unneeded diagnostic testing; improves turnaround times for accurate diagnosis; and reduces the use of inappropriate treatment. Because laboratory errors occur at a rate of 32% – 75% in the pre-analytic phase, 13% – 32% in the analytic phase and 9% – 31% in the post-analytic phase,11,12 it is vital that assuring the quality of laboratory medicine be considered a continuum of a total testing process of all analytical phases. Errors that occur in the pre-analytical phase in the spectrum of laboratory testing can have a direct effect on patient outcomes in the post-analytical stage.
Squaring the circle Because of the acute challenges of implementing QA in laboratory medicine, healthcare providers in developing countries have unwisely neglected the important role of laboratory diagnosis in patient care. As a result, achieving the International Organization for Standardization (ISO) 15189 requirements for clinical laboratory has become a lofty aspiration. Understandably, but unfortunately, these countries seem to find themselves at an impasse of practising laboratory medicine in the 21st century by squaring the circle: relying on inadequate quality-assured test results or empiricism for patient management, resulting in disproportionate administration of antibiotics and high cost to patients.5 In the last decade, there has been a massive focus on global health, with funding reaching an unprecedented US $28.2 billion in 2010.13 The surge in funding has resulted in the recognition that strengthening health systems, including laboratory services, is critical to healthcare delivery. Thus, an unparalleled opportunity has presented itself to strengthen quality-assured laboratory medicine, using innovative approaches to addressing old, neglected challenges. Time to stop doing more of the same Increased funding for global health has placed a sense of urgency on stakeholders to act now and collectively, but in a different manner.4 Previous approaches that attempted to strengthen QMS did not use a holistic approach, focusing rather on individual activities: QA, proficiency testing and theoretical concepts. This approach has shown severe limitations with regard to advancing quality-assured laboratory medicine in developing countries. To continue with such strategies would be analogous to pounding square pegs into round holes. Rather, novel holistic approaches that place emphasis on task-based and results-driven quality improvement projects are needed urgently. To achieve these goals, laboratory medicine in developing countries must innovate and create performance-enablers that would both incentivise and energise the field, thereby facilitating adoption. Successful performance-enablers must focus on four chief aspects: implementation, measurement, reward and improvement. In order to ensure a sustainable culture of the practice of quality-assured laboratory medicine, countries need to embrace innovative QMS programmes, which require commitment to the process of continuous quality improvement of laboratory medicine. Some countries have made remarkable progress by using innovative approaches to implementing laboratory accreditation. For example, between 1961 and 1998, South Korea endorsed the Laboratory Accreditation Program (LAP) of the College of American Pathologists (CAP); however, during that time only 11 laboratories were accredited.15 Because of the challenges in implementation of LAP, in 1999, South Korea modified the CAP-LAP into a step-wise laboratory accreditation process known as the Korea Laboratory Accreditation Process (KLAP). In KLAP, laboratories with a score of > 90% received a two-year certificate; laboratories with scores between 60% and 89% received a one-year certificate; and those with a score of < 60% failed the certification. As a result of KLAP, 227 laboratories were certified between 1999 and 2006 and many laboratories were enrolled in the programme across the country. In 2001, Thailand established a step-wise national accreditation programme as a local alternative for improvement of laboratory quality. The accreditation programme was established with standards based on ISO 15189 and, from 2003 to 2009, 724 (50.6%) of 1432 laboratories in Thailand were assessed. Of these, 197 (27.2%) were accredited, primarily in the government sector.16 The programme has thus far been affordable, feasible, scalable, sustainable and effective.16 Over the past five years, through global partnership, innovative performance-enablers have been developed to guide the implementation of a sustainable QMS leading to accreditation in developing countries: (1) the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA);17 (2) the Caribbean Laboratory Quality Management System – Stepwise Improvement Process (LQMS-SIP) towards Accreditation;18 and (3) the task-based Strengthening Laboratory Management Toward Accreditation (SLMTA) programme.19 SLIPTA and LQMS-SIP, the companions of SLMTA Both SLIPTA and LQMS-SIP are innovative performance-enabling tools and companions of SLMTA. These tools were designed to motivate the implementation of QMS with measurable delivery through SLMTA.SLIPTA is a framework endorsed by the World Health Organization Regional Office for Africa (WHO AFRO) and jointly implemented by the African Society for Laboratory Medicine (ASLM) for improving the quality of public health laboratories in African countries to achieve accreditation to the ISO 15189 standard. The WHO AFRO SLIPTA Checklist is based on ISO 15189/17025, with 111 items and a possible 258 points, which are further divided into five star levels: one to five.17 LQMS-SIP has been endorsed in the Caribbean region and consists of a three-tiered system: the first tier represents the minimum requirements that correspond to mandatory criteria required for the granting of a licence based on legislation enacted by the Ministries of Health. The next two tiers are quality-improvement levels representing achievements in meeting specific requirements of a QMS. The Caribbean Regional Organization for Standards and Quality hosts the LQMS-SIP secretariat and works directly with countries and other laboratory stakeholders to coordinate the rollout and implementation of the regulatory activities and the recognition process. The Caribbean Public Health Agency (CARPHA) helps with the coordination of the Caribbean Public Health Laboratory Network and participates in the development of quality standards.
In the 21st century, as the economies of developing countries continue to grow, many individuals will begin to seek affordable quality-assured healthcare; as such, there is bound to be increasingly consumer-oriented healthcare that holds physicians and laboratory workers more accountable for errors. Because of improved quality-assured laboratory medicine, healthcare providers will broaden their practice from using laboratory tests to confirm clinical diagnoses to using tests to detect clinically unapparent diseases, as well as to support outbreak surveillance responses, such as the recent outbreak of Ebola virus in West Africa. In order to meet this demand, both SLMTA and SLIPTA will need to be rolled out in developing countries so as to stimulate healthcare service providers to focus on a systematic work flow for quality services rendered to patients, resulting in increased efficiency and quality whilst lowering waste and cost and improving safety. Critically, a patient-centered continuous quality improvement approach will become indispensable. Hospital accreditation, as in Thailand, will most likely drive the need for laboratory quality, as active involvement of managers will create collective organisational commitment of quality improvement and a focus on patient-oriented thinking.
2.Institute of Medicine. To err is human: Building a safer health system [document on the Internet]. c1999 [cited 2014 Sep 22]. Available from: http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf 3.Committee on Quality of Health Care in America. Crossing the quality chasm: A new health system for the 21st century [document on the Internet]. c2001 [cited 2014 Sep 20]. Available as ebook from: http://www.nap.edu/openbook.php?record_id=10027 4.Petti CA, Polage CR, Quinn TC, et al. Laboratory medicine in Africa: A barrier to effective health care. Clin Infect Dis. 2006;42(3):377–382. http://dx.doi.org/10.1086/499363 5.Polage CR, Bedu-Addo G, Owusu-Ofori A, et al. Laboratory use in Ghana: Physician perception and practice. Am J Trop Med Hyg. 2006;75(3):526–531. 6.Nkengasong JN, Nsubuga P, Nwanyanwu O, et al. Laboratory systems and services are critical in global health: Time to end the neglect? Am J Clin Pathol. 2010;134(3):368–373. http://dx.doi.org/10.1309/AJCPMPSINQ9BRMU6 7.Luman ET, Yao K, Nkengasong JN. A comprehensive review of the SLMTA literature part 2: Measuring success. Afr J Lab Med. 2014;3(2), Art. #276, 8 pages. http://dx.doi.org/10.4102/ajlm.v3i2.276 8.Yao K, Luman ET, SLMTA Collaborating Authors. Evidence from 617 laboratories in 47 countries for SLMTA-driven improvement in quality management systems. Afr J Lab Med. 2014;3(2), Art. #262, 11 pages. http://dx.doi.org/10.4102/ajlm.v3i2.262 9.Carter JY, Lema OE, Wangai MW, et al. Laboratory testing improves diagnosis and treatment outcomes in primary health care facilities. Afr J Lab Med. 2012;1(1), Art. #8, 6 pages. 10.Zeh CE, Inzaule SC, Magero VO, et al. Field experience in implementing ISO 15189 in Kisumu, Kenya. Am J Clin Pathol. 2010;134(3):410–418. http://dx.doi.org/10.1309/AJCPZIRKDUS5LK2D 11.Leatherman S, Ferris TG, Berwick D, et al. The role of quality improvement in strengthening health systems in developing countries. Int J Qual Health Care. 2010;22(4):237–243. http://dx.doi.org/10.1093/intqhc/mzq028 12.Bonini P, Plebani M, Ceriotti F, et al. Errors in laboratory medicine. Clin Chem. 2002;48(5):691–698. 13.Institute for Health Metrics and Evaluation. Financing global health 2012: the end of the golden age? [report on the Internet]. c2012 [cited 2013 Feb 05]. Available from: http://www.healthmetricsandevaluation.org/publications/policy-report/financing-global-health-2012-end-golden-age 14.Nkengasong JN. A shifting paradigm in strengthening laboratory health systems for global health: Acting now, acting collectively, but acting differently. Am J Clin Pathol. 2010;134(3):359–360. http://dx.doi.org/10.1309/AJCPY5ASUEJYQ5RK 15.Shin BM, Chae SL, Min WK, et al. The implementation and effects of a clinical laboratory accreditation program in Korea from 1999 to 2006. Korean J Lab Med. 2009;29(2):163–170. http://dx.doi.org/10.3343/kjlm.2009.29.2.163 16.Wattanasri N, Manoroma W, Viriyayudhagorn S. Laboratory accreditation in Thailand: A systemic approach. Am J Clin Pathol. 2010;134(4):534–540. http://dx.doi.org/10.1309/AJCPZYY19WMKMAZT 17.World Health Organization Regional Office for Africa. WHO guide for the stepwise laboratory improvement process towards accreditation in the African Region (with checklist) [document on the Internet]. c2011 [cited 2013 Aug 05]. Available from: http://www.afro.who.int/index.php?option=com_docman&task=doc_download&gid=8642&Itemid=2593 18.Pan American Health Organization. Regional Office of the World Health Organization. Caribbean guidance on the stepwise improvement process for strengthening laboratory quality management systems towards accreditation [document on the internet]. c2012 [cited 2014 Sep 10]. Available from: http://www.cmedlabsfoundation.net/images/standards/Guidance%20Stepwise%20Final%20-%2004%2010%202012.pdf 19.Yao K, Maruta T, Luman ET, Nkengasong JN. The SLMTA programme: Transforming the laboratory landscape in developing countries. Afr J Lab Med. 2014;3(2), Art. #194, 8 pages. http://dx.doi.org/10.4102/ajlm.v3i2.194 20.Eno LT, Asong T, Ngale E, et al. Driving hospital transformation with SLMTA in a regional hospital in Cameroon. Afr J Lab Med. 2014;3(2), Art. #221, 5 pages. http://dx.doi.org/10.4102/ajlm.v3i2.221 |
