Laboratory Infrastructure Upgrades: Improving Standards, Quality of Service, Patient Safety, and Care Best Practice I-TECH Ethiopia February 2015 This project was made possible by the International Training and Education Center for Health (I-TECH) with funding from Cooperative Agreement U91HA06801-06-00 with the US Department of Health and Human Services, Health Resources and Services Administration (HRSA), through the US President s Emergency Plan for AIDS Relief (PEFAR). The contents and conclusions do not necessarily reflect the views of I-TECH, HRSA or the US government and are the sole responsibility of the author.
Strategic renovations and equipping of laboratories that considers quality of the service, the working environment and workflow improves service delivery, reliability of the results and reduces turnaround time, that increases patient satisfaction. Wubshet Mamo, I-TECH Ethiopia Laboratory Program Director, November 2007 - September 2015 Prepared by Wubshet Mamo, DVM, MVSc, PhD, Clinical Associate Professor Cell phone: (251) 911 821 624 E-mail: wubshetmam@yahoo.com Skype: Wubshet.mamo1 Addis Ababa, Ethiopia February, 2015 Laboratory Infrastructure Upgrades Page 2
TABLE OF CONTENTS ACRONYMS AND ABBREVIATIONS... 4 INTRODUCTION... 5 OBJECTIVE... 6 IMPLEMENTATION... 6 Physical Infrastructure Assessment... 6 Physical Upgrades of Hospital and Health Center Laboratories... 6 Upgrading Facilities to Set Up Specialized Laboratories... 6 Upgrading and Establishing a Regional Public Health Referral Laboratory... 7 Updating Diagnostic Equipment... 7 Improving Laboratory Setups... 7 Measuring improvement... 8 RESULTS... 9 Infrastructure Upgrades... 9 Establishing a State-of-the-Art Referral Hospital Laboratory... 9 Upgrading and Setting Up Laboratories to Perform Specialized Functions... 10 Establishing a Regional Referral Laboratory in Afar... 11 Upgrading Laboratory Equipment... 12 Shortened Turnaround Times... 13 Quality Improvement Confirmed by SLIPTA Audits... 13 CHALLENGES... 15 LESSONS LEARNED... 16 CONCLUSIONS AND RECOMMENDATIONS... 17 REFERENCES... 19 Laboratory Infrastructure Upgrades Page 3
ACRONYMS AND ABBREVIATIONS ART BSL2 CDC DBS DNA DST EHRIG EID EPHI EQA FMOH HRSA HIV I TECH MDR PCR PEPFAR SLIPTA SLMTA WHO WHO-AFRO Antiretroviral Therapy Biological Safety Level-2 Centers for Disease Control and Prevention Dry Blood Sample Deoxyribonucleic Acid Drug Sensitivity Testing Ethiopian Hospital Reform Implementation Guidelines Early Infant Diagnosis Ethiopian Public Health Institute External Quality Assessment Federal Ministry of Health Health Resources and Services Administration Human Immunodeficiency Virus International Training and Education Center for Health Multidrug-Resistant Polymerase Chain Reaction President s Emergency Plan for AIDS Relief Stepwise Laboratory (Quality) Improvement Process Towards Accreditation Strengthening Laboratory Management Towards Accreditation World Health Organization World Health Organization Regional Office for Africa Laboratory Infrastructure Upgrades Page 4
INTRODUCTION Access to reliable laboratory testing is hard to find in resource-limited countries. This lack of access can result in delayed diagnoses, misdiagnoses, and inappropriate treatment. Underdeveloped lab infrastructure is one of the biggest factors behind limited access to reliable diagnosis and treatment (1, 2). Ethiopia, a country with a population of 90 million, has a decentralized health services system spread out among nine regions and two administrative councils. Laboratories in Ethiopia s public health system are divided into four tiers: peripheral, hospital, regional referral, and national referral labs. Lab services are provided at the national level through the Ethiopian Public Health Institute (EPHI); at the regional level, services are provided through regional referral labs, and labs at regional specialized hospitals, zonal/district hospitals, and health centers (3, 4). In the past, the majority of Ethiopian public health laboratories delivered suboptimal service, and thus were not in a position to contribute to a quality health care system. Many labs performed poorly, hindered by poor infrastructure. Inadequate space, poor design, lack of shelving and file cabinets, aging equipment, and unreliable water and electrical supplies remain major challenges to providing reliable, accurate lab services. Recently, however, significant progress has been made in improving health facility infrastructure, thanks to strong commitment on the part of Ethiopia s Federal Ministry of Health (FMOH), and concerted effort on the part of international organizations and partners, including the International Training and Education Center for Health (I-TECH). Since June 2007, I-TECH Ethiopia, funded by the President s Emergency Plan for AIDS Relief (PEPFAR), through the Health Resource Service Agency (HRSA), has provided technical, clinical and operational support under the framework of Ethiopia s national laboratory strategic plan to 39 district and zonal hospitals, 24 health centers, and four regional referral laboratories in the northern regions of Ethiopia, Afar, Amhara, and Tigray. In partnership with FMOH, and with the oversight of the EPHI and the Centers for Disease Control and Prevention (CDC) Ethiopia, I-TECH Ethiopia has upgraded several health centers and referral laboratories within its areas of operation to help them keep up with the evolving needs of patient care. This strategic renovations program is a signature initiative implemented by I- TECH Ethiopia to improve the quality of service in many of its programs. It involves renovating existing lab facilities and restoring systems to improve workflow, and equipping labs with affordable, up-to-date equipment in order to improve access and quality of testing services. Laboratory Infrastructure Upgrades Page 5
OBJECTIVE To improve laboratory standards and quality of service through laboratory infrastructure upgrades ( strategic renovations ). IMPLEMENTATION Physical Infrastructure Assessment Using a standardized checklist and questionnaire, laboratory facilities were inspected to assess the condition of physical structures, work spaces, safety conditions, and water, power supply, and waste management systems. Those facilities identified as outdated were subjected to renovation. Physical Upgrades of Hospital and Health Center Laboratories Laboratory facilities at referral, zonal, district hospitals and health centers with outdated physical infrastructures were upgraded to provide dedicated lab space, access to clean water and electricity, proper sample storage space, and waste management (disposal) systems meeting established lab standards (4, 5). Figure 1. Hospital laboratory facilities identified as underdeveloped. Antiretroviral therapy (ART) monitoring labs at Dupti (L) and Dessie (R). Upgrading Facilities to Set Up Specialized Laboratories Facilities providing specialized laboratory functions were upgraded to comply with standard requirements for specialized lab functions, specifically pediatric HIV diagnosis (DNA-PCR molecular testing), multidrug-resistant (MDR)-TB diagnosis (liquid TB culture and drug sensitivity testing (DST), biological safety level 2 (BSL2)), adult ART monitoring (CD4 blood counts, chemistry and hematology analysis), viral load testing, and microbiology. Laboratory Infrastructure Upgrades Page 6
Upgrading and Establishing a Regional Public Health Referral Laboratory An existing facility was upgraded to establish a regional referral laboratory that qualifies the standard requirements for a regional referral laboratory (4). Regional public health referral labs play key roles in training, quality assurance, disease detection, research, sustaining health programs, and developing lab capacity throughout the health system in their respective regions. Updating Diagnostic Equipment Laboratories were provided with essential, up-to-date, and affordable diagnostic equipment to improve the quality of lab testing services (Figure 2). Figure 2. Some of the basic essential equipment provided to laboratories. (L to R) Water distiller, automated pipette, digital bench centrifuge. Improving Laboratory Setups Laboratories were supplied with the equipment needed to ensure well-organized workflows and safe work environments, in accordance with WHO standards and recommendations (5). This equipment included standard lab furniture, cold chain management equipment, sample (specimen) storage, and clothing, gloves, and other basic protective gear. Figure 3. A typical underdeveloped laboratory setup in a health center lab before (L) and after (R) upgrade. Laboratory Infrastructure Upgrades Page 7
Measuring improvement Sample turnaround times and the results of SLIPTA quality improvement audits were used to evaluate the impact of laboratory upgrades on the quality of lab services. Our laboratory facility was in bad shape before the upgrade: we had insufficient workspace, an inefficient work environment, and laboratory staff were not motivated, and barely accomplished routine services for patients. Now it is different: we have a facility with sufficient workspace, and a safe and efficient working environment that motivates our staff to provide efficient service. CEO of a zonal hospital Laboratory Infrastructure Upgrades Page 8
RESULTS Infrastructure Upgrades From 2007 to 2014, a total of 28 laboratory facilities (22 hospital labs, 2 health center labs, and 4 regional referral labs) were given major and minor renovations. In general, renovations provided labs with adequate workspace, thereby improving workflow, creating safe and efficient work environments, and ensuring high-quality service and patient care. Figure 4. A laboratory in an I-TECH-supported hospital before (L) and after (R) upgrade. Lab staff and management confirm that these renovations have improved work environments and boosted staff morale. Establishing a State-of-the-Art Referral Hospital Laboratory A modern, state-of-the-art laboratory was established at Debre Berhan Referral Hospital for purposes of improving the referral system, and ensuring the quality of lab services in the eastern Amhara region. It is the first of its kind in Ethiopia designed, furnished, and equipped to provide high-quality services (Figure 5). With its expanded diagnostic capacity, the newly built laboratory serves as a sub-regional referral lab, and a training center for health care professionals (including university/college medical students). Not only does the facility help add to the capacity of zonal labs, it also serves as a networking hub for regional and national public health referral labs. Laboratory Infrastructure Upgrades Page 9
Figure 5. Inside the Debre Berhan Hospital Referral Health Laboratory. The old laboratory is pictured at left; the new facility, middle and right. The laboratory provides service to approximately 2.4 million people. It has the capacity to provide service to 450 patients per day, compared to the 100 patients per day the hospital served before. It also serves as a referral site for three rural hospitals and 86 health centers. Thanks to I-TECH (and the U.S. government), we now have a state-of-the-art referral laboratory. We are happy to work in such a laboratory, and provide a high quality of service. Our staff s confidence and morale have increased, and we have significantly reduced staff turnover. Debre Berhan Referral Hospital laboratory manager While I was on TDY in Ethiopia for SIMS visits we visited Debre Birhan and the lab surpasses all basic expectations. Barbara Aranda-Naranjo PhD., RN, FAAN Senior Advisor, Office of Global Health Affairs Bureau of Health Workforce, Ethiopia Visit: August 24-September 6, 2014 Upgrading and Setting Up Laboratories to Perform Specialized Functions The Mekelle regional laboratory was renovated, furnished, and equipped to enable advanced liquid-tb culture and DST (BSL2) testing. The Bahir Dar regional lab was similarly equipped. These upgraded labs are now able to provide efficient service in the isolation and identification of MDR-TB bacilli from suspected MDR-TB patients a critical contribution to Ethiopia s national TB prevention and treatment program. Together, the two labs serve approximately 30 milliion people in the Amhara and Tigray regions. To expand HIV testing and ART, laboratory facilities were upgraded to accommodate HIV testing. The upgrades included high-technology molecular testing (DNA-PCR) for HIV-exposed infants at Bahir Dar and Mekelle regional labs, along with enough space to ensure unidirectional flow and separation of PCR procedures from sterile (preparation of sterile master mix) to dirty (detection of amplicons), with air conditioning units and sealed windows for appropriate climate control within the lab. Laboratory Infrastructure Upgrades Page 10
Upgrades enabled 12 hospital laboratories and two health centers to add ART monitoring (CD4 counts, blood chemistry, and hematology analysis), three regional referral labs to add viral load testing for HIV patients, and three hospital labs to add microbiology services. Figure 6. ART laboratory in an East Amhara hospital before (L) and after (R) renovations. Upgrading regional referral early infant diagnosis (EID) (DNA-PCR) laboratories led to improved efficiency in the referral system, and an increase the number of infants tested. More importantly, the establishment of these molecular testing labs has made it possible to provide potentially life-saving tests more quickly, ensuring the earliest possible access to pediatric ART and care for HIV-positive infants. Fig 7. A laboratory setup before (L) and after (middle/r) upgrades. Establishing a Regional Referral Laboratory in Afar An existing facility was renovated, furnished and equipped to conform to established standards for regional referral laboratories. It is the first regional referral lab in Afar, and the ninth in Ethiopia (Figure 8). The referral lab plays a significant role in improving lab services in the region, by assuring the quality of lab services through external quality assessments (EQAs), providing referral testing services (strengthening the referral system), supporting the training of lab professionals, conducting disease surveillance, and serving as a hub for operational health research. Before the Afar Regional Referral Laboratory was established, samples from the region had to be sent several hundred kilometers away to the national (EPHI) referral lab in Laboratory Infrastructure Upgrades Page 11
Addis Ababa, creating longer turnaround times for test results, and delays in patient follow-up and care. Figure 8. The Afar Regional Referral Laboratory, renovated, furnished and equipped by I-TECH. More importantly, the regional laboratory supports other labs in the region in their efforts to improve their quality management systems so that they can achieve accreditation under the WHO-AFRO/Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (SLIPTA) program. Our region has now a regional referral laboratory that can oversee the quality of service provided by laboratories in our region, conduct disease surveillance, perform research and do things that we had limited capacity to do before. Afar Regional Referral Laboratory manager Upgrading Laboratory Equipment Between September 2007 and 2014, over 105 types of essential laboratory equipment were procured and supplied to all I-TECH-supported laboratories in Afar, Tigray, and Amhara. These included single- and multi-headed binocular microscopes; bench centrifuges; automated hormone, blood, chemistry, coagulation, and electrolyte analyzers; incubators; water distillers; automated and manual micropipettes; power stabilizers; water baths; room thermometers; sample mixers; refrigerators and freezers for reagent and specimen storage; sterilizers, and more. This equipment enabled the labs to improve service quality and expand diagnostic test services. Laboratory Infrastructure Upgrades Page 12
Figure 9. New laboratory equipment supplied by I-TECH: (L to R) fully automated hormone and immunochemistry analyzer, multi-headed microscope and portable blood coagulation analyzer. The ten-headed microscopes provided by I-TECH to Bahir Dar Regional lab, Gonder University Hospital lab and Mekele Regional Lab were the first in the country that enabled and improved the diagnostic and teaching services. Shortened Turnaround Times Thanks to the upgrades, laboratory workflows improved; average turnaround times were markedly reduced, indicating improvements in service quality. At HIV testing entry points, turnaround times were reduced from two hours to one; for early infant HIV diagnosis (DBS- DNA-PCR testing), from three weeks to 10 days; for ART monitoring, from 12 24 hours to four; and for TB diagnosis (sputum-smear microscopy), from two hours to 45 minutes (Table 1). Table 1: Average Sample Turnaround Times Before and After Laboratory Upgrades Test Before Upgrades Turnaround Time After Upgrades HIV testing 2 hrs 1 hr HIV testing in infants (DBS-DNA/PCR) 3 weeks 10 days ART monitoring (CD4, chemistry, and hematology analysis) 12 24 hrs 4 hrs TB-smear microscopy 2 hrs 45 min Quality Improvement Confirmed by SLIPTA Audits Upgraded laboratories were enrolled in the national SLMTA program (in 2 cohorts) between 2010 and 2012. These labs demonstrated remarkable improvements in quality; this was confirmed by WHO-AFRO/SLIPTA external audit reports. The results suggest that laboratory upgrades are effective in improving the quality of lab services (Table 2). Laboratory Infrastructure Upgrades Page 13
Figure 10. (L) Documents (manuals, guidelines, logbooks) and records are properly maintained for easy access. (R) Proper (cold) storage of samples. The laboratory upgrades improved the ability of labs to maintain proper records and documentation, properly store samples (specimens), and track inventory all of which contributed to the overall improvements in quality shown by the SLIPTA audit results. The upgrades have also enabled easy installation and access of lab information systems. Table 2. Quality Improvement at Laboratories Enrolled in the National SLMTA Program, 2010 2012 SLIPTA Cohort I SLIPTA Cohort II Laboratory SLIPTA SLIPTA Stars 1 Laboratory Stars 1 Axum Hospital laboratory 2 Dupti Hospital laboratory 2 Gondar University Hospital laboratory 2 3 Dessie Hospital laboratory 2 Bahir Dar Regional Referral Laboratory 2 Maychew Hospital laboratory 2 3 Dessie Regional Referral Laboratory 1 Mekele Hospital laboratory 2 Mekelle Regional Referral Laboratory 2 F/Hiwot Lospital laboratory 3 0 1. Each laboratory was awarded a rating of one to five stars, according to the degree of improvement in quality measured by the assessment. The SLIPTA audit checklist covers 12 quality system components. 2. The Gondar University Hospital and Maychew Hospital laboratories were recognized as the best performing labs in the country in the first and second national SLMTA programs. 3. The F/Hiwot hospital laboratory was not upgraded when the SLMTA programs were implemented (2010 2012). If we hadn t had our laboratory upgraded, we would never have been able to improve our quality management system and achieve such a national award as the best performing laboratory in the country, scoring three stars. Gondar University Hospital laboratory manager Laboratory Infrastructure Upgrades Page 14
CHALLENGES The costs involved in renovating older facilities. Identifying qualified contractors with adequate experience in health facility construction. Delays in completing renovation projects. Maintenance procedures at upgraded facilities were not strictly followed. Our laboratory has been upgraded, and I can see the difference in quality of service [before and after]. However, our remaining challenge is to maintain this upgraded facility. Referral hospital laboratory manager Laboratory Infrastructure Upgrades Page 15
LESSONS LEARNED Development and upgrading of effective laboratory infrastructures ( strategic renovations ) is critical to ensure quality of services. Up-to-date laboratory facilities ensure optimal functioning of lab equipment, which in turn ensures that diseases are accurately diagnosed, treated, and monitored. Establishing and upgrading regional referral laboratories is crucial in building regional capacity to promote sustainable regional quality assurance programs, and participation in detection, identification, and surveillance of diseases of importance to public health. Upgrading laboratories to comply with established standards contributed to improvements in workflow, creating safe and efficient work environments, and motivating and creating confidence in laboratory staff. This is expected to have a positive impact on staff retention. Working closely with hospital management from the planning stages, and coordinating work schedules with them is essential, as it promotes receptiveness to renovation plans, and lessens staff turmoil when delays occur. Laboratory Infrastructure Upgrades Page 16
CONCLUSIONS AND RECOMMENDATIONS National laboratory systems ideally, composed of a tiered network of diagnostic and national public health referral labs must be capable of providing accurate, timely, and cost-effective testing services that support the country s health care system goals and clinical interventions, as determined, supported, and coordinated by the FMOH (4). In order to provide quality lab services, one must start with the basic infrastructure (6). In Ethiopia, inadequate laboratory infrastructure remains a huge obstacle to the expansion of public health services. This can be tackled in two ways: renovating or repurposing (remodeling) existing labs, or building new facilities. It is often more cost-effective to renovate existing facilities, but this requires a carefully staged process that minimizes downtime (service interruptions). Since 2007, I-TECH has upgraded 28 laboratories in the three regions in which it operates. The rollout of a quality treatment, care, and prevention program depends on an effective and reliable laboratory infrastructure. I-TECH s support in upgrading labs has improved workflows, created safe and efficient work environments, and enabled labs to provide high-quality testing services to patients. Figure 11. National hospital laboratories in Afar before (L) and after (R) I-TECH intervention (renovation). The establishment of a regional referral laboratory in the Afar region played a significant role in strengthening the referral system and supporting the training of lab professionals. The Afar regional laboratory has begun performing disease surveillance, and serves as a hub for operational health research, overseeing and ensuring the quality of lab services. By conducting EQAs and supporting enrollment in the national SLMTA program, the regional lab is helping other labs in Afar to eventually achieve accreditation through the WHO-AFRO/SLIPTA program. Laboratory Infrastructure Upgrades Page 17
The establishment of the state-of-the-art Debre Berhan Hospital Referral Health Laboratory in the Amhara region was a major achievement, significantly expanding the quality and types of services offered in the region. This lab is now among the best in Ethiopia. Expanding diagnostic capacities by updating laboratory equipment as part of infrastructure upgrades improves the quality of testing services, and ensures adherence to current standards. Laboratory facilities are complex, technically sophisticated, and mechanically intensive structures that are expensive to build and maintain. Therefore, working closely with hospital management to ensure their participation and support is recommended, in order to better address maintenance and sustainability issues. Good planning can reduce construction times and increase productivity, by foreseeing and dealing in advance with such potential bottlenecks as contractor and staff access, construction staging areas, and staff confusion about work areas. In conclusion, a medical laboratory must have the space, equipment, supplies, personnel, and infrastructure necessary to enable fast and accurate testing, and maintain quality of services (5). Laboratory Infrastructure Upgrades Page 18
REFERENCES 1. The Maputo Declaration on Strengthening Laboratory Systems. Presented at the Consensus Meeting on Clinical Laboratory Testing Harmonization and Standardization; January 22 24, 2008; Maputo, Mozambique. Available at: http://www.who.int/diagnostics_laboratory/maputo-declaration_2008.pdf. 2. Burgess D, et al. Global health diagnostics. Nature. 2006;444 (suppl 1):1-2. 3. Ethiopia Ministry of Health. Master Plan for the Public Health Laboratory System in Ethiopia 2009-2013. 2nd ed. Addis Ababa, Ethiopia: Federal Ministry of Health; 2009. 4. Ethiopian Hospital Reform Implementation Guidelines (EHRIG), May 2011, Chapter 9, p. 1 30. 5. World Health Organization Regional Office for Africa. Report on Consultation on Technical and Operation Recommendations for Clinical Laboratory Testing Harmonization and Standardization: Helping to Expand Sustainable Quality Testing to Improve the Care and Treatment of People Affected by HIV/AIDS, TB, and Malaria; January 22 24, 2008; Maputo, Mozambique. Available at: http://www.who.int/healthsystems/round9_9.pdf. Accessed June 21, 2009. 6. Olmsted S, et al. Strengthening Laboratory Systems in Resource-Limited Settings. Am J Clin Pathol. 2010; 134:374-380. Laboratory Infrastructure Upgrades Page 19