Laboratory Accreditation in Thailand A Systemic Approach

Kigali Conference / Laboratory Accreditation in Thailand Laboratory Accreditation in Thailand A Systemic Approach Naiyana Wattanasri, MSc, Wannika Manoroma, MSc, and Somchai Viriyayudhagorn Key Words: Quality improvement; Laboratory standard; Laboratory accreditation; Thailand Abstract Improvement of quality standards for health care service delivery has been a commitment of the Ministry of Public Health in Thailand for more than 2 decades; however, laboratory quality systems in Thailand did not become a focus until 10 years ago. International accreditation can increase recognition of laboratory quality, but it is difficult to reach for many laboratories, especially those in remote areas. This article describes Thailand s experience in developing a national laboratory standard and establishing a national laboratory accreditation program to guarantee the quality of laboratory services. The Thai laboratory standard derived from multiple international standards, retaining the most important elements yet making the standard applicable to Thailand. The national accreditation program was established as a local alternative for improvement of laboratory quality. The program is affordable, feasible, scalable, sustainable, and effective. Laboratory services are an integral part of clinical decision making and contribute to various aspects of health services, including diagnostic and therapeutic decisions for patients and disease monitoring and prevention. Clinical laboratory certification and accreditation have served an organizational commitment to ensure the validity of laboratory system management and to promote continuous quality improvement (CQI) of services. With the rapid expansion of laboratory support systems in response to the HIV/AIDS epidemic in Thailand in the 1990s, it was a challenge for Thailand, as a resourcelimited country with underfunded medical services and limited number and capacity of health personnel, to improve and sustain a high-quality laboratory system. In response to the demand for reliable laboratory diagnostics, various government agencies have had a role in the laboratory quality improvement program Figure 1. The Ministry of Public Health supports in-service training and promotes improvement of the quality of laboratories. Professional organizations, including the Association of Medical Technology of Thailand (AMTT) and the Medical Technology Council (MTC), support technical training and promote networking among medical technologists. The MTC, a legal organization, also monitors medical technology performance and promotes a national system for laboratory accreditation. This article describes Thailand s experience in developing and implementing a Thai national laboratory standard and a national laboratory accreditation (LA) program to ensure the quality of laboratory services. 534 Am J Clin Pathol 2010;134:534-540 Downloaded 534 from https://academic.oup.com/ajcp/article-abstract/134/4/534/1760240

Kigali Conference / Special Article MTC ISO 15189 LA NHSO Infrastructure Financial support Laboratories Preservice training In-service training University MTC/AMTT PT/EQA and IQC MT standard MTC Figure 1 Network diagram of stakeholder relationships in a laboratory quality system in Thailand. AMTT, Association of Medical Technology of Thailand; EQA, external quality assessment; IQC, internal quality control; LA, laboratory accreditation;, Ministry of Public Health; MTC, Medical Technology Council; NHSO, National Health Security Offices; PT, proficiency testing. Development and Implementation of Laboratory Quality Systems in Thailand Quality Standards Quality management was introduced into laboratories as a part of the Thailand Hospital Accreditation (HA) program beginning in 1997, but there were no standard practices for laboratories. In 1999, an MT standard was developed by the AMTT to standardize technical and professional practices of laboratories and to improve the quality of the entire laboratory system to provide reliable laboratory testing regardless of test type. Implementation of the standard was voluntary, but laboratories were encouraged to participate for the benefit of patients. The voluntary nature of the program helped ensure program sustainability by ensuring that hospitals themselves were motivated to participate and saw the value to them of implementing the standard. The MT standard is in compliance with international standards and includes at least minimal requirements for clinical laboratories to ensure reliable laboratory results under safe working conditions. However, the language of the standard was simplified from the international version to make it easy to understand. The MT standard was first developed based on ISO/IEC Guide 25 1 in 1999, and revised in 2001 based on ISO/DIS 15189:1999, in 2003 based on ISO 15189:2003, and in 2008 2 based on ISO 15189:2007. 3 The quality concepts of the MT standard were developed from Clinical and Laboratory Standards Institute/National Committee for Clinical Laboratory Standards quality management system model for laboratory services (GP26). 4 The standard covers 10 quality system essentials (QSEs) including organization, personnel, equipment, purchasing/ inventory, process control, documents/records, occurrence management, internal assessment, process improvement, and service satisfaction, excluding laboratory safety and laboratory information system (LIS) Figure 2. LIS was not included as a separate QSE because most laboratories in Thailand do not have information systems and LISs are costly to implement. However, laboratory information management is integrated into QSE-6 (documents/records). Laboratory safety system is one of the most emphasized aspects of the Thai program; however, for many laboratories, safety requirements for physical separation of work areas are difficult to achieve and rely on hospital policy and funding. Nevertheless, most safety issues are incorporated into QSE-5 (process control), and laboratories are encouraged to meet the safety standards. The QSEs were modified to be appropriate to Thailand and applied at each stage (preanalytical, analytical, postanalytical, Quality System Essential (QSE) 1. Organization 2. Personnel 3. Equipment 4. Purchasing/Inventory 5. Process control 6. Documents/Records 7. Occurrence management 8. Internal assessment 9. Process improvement 10. Service and satisfaction Laboratory processes Preanalytical Analytical Postanalytical Information management Figure 2 Structure of the Thailand Quality System. All 10 QSEs were applied to each stage of the process. Downloaded from https://academic.oup.com/ajcp/article-abstract/134/4/534/1760240 Am J Clin Pathol 2010;134:534-540 535 535 535

Wattanasri et al / Laboratory Accreditation in Thailand and information management), focusing on laboratory equipment and process control (Figure 2). The standard was piloted, and all public health stakeholders approved. A 100-laboratory assessment checklist was modified from ISO 9001:1994, based on the MT standard, and was designed to be simple, complete, and easy to use. The checklist was also pilot tested for validity. The checklist is grouped according to activities and is scored based on the relative importance of each accreditation requirement. The checklist is used as a regulatory requirement for LA and for laboratory self-assessment to monitor and evaluate laboratory quality in preparation for accreditation. Accreditation Despite the recognized value of LA and the existence of ISO 15189 3 in Thailand, the ISO 15189 scheme is resourceand effort-intensive. As a result, Thailand, similar to many countries, 5-8 recognized the need to develop a comparable and cost-effective approach to LA. In 2001, the Thai LA program was established by the AMTT based on the MT standard using ISO 9001:1994 9 and Thailand HA certification models. All assessors were ISO 9001 lead assessors. In 2004, the MTC was established based on the Medical Council Act of 2004 and has since been responsible for the MT standard and LA. In Thailand, most laboratories are hospital-based and have a high workload. The varying resources, experience, and knowledge of laboratories and their personnel make it challenging to prepare them equally for accreditation. For example, small community hospitals with few staff and less experience have a more difficult time reaching accreditation than do larger laboratories with adequate human resources and financial support. However, participation in a laboratory network and assessment by peers are requirements for LA, and this helps small laboratories receive support and resources from larger laboratories. Technical and financial support is also provided by allowing participation in the national external quality assessment (EQA) programs and laboratory instrument calibration with a secondary standard from recognized organizations. The MTC is a professional, nonprofit organization, and, thus, the cost of assessment and operation is lower than in international accreditation programs. Quality management was initially new to laboratories in Thailand, and it was necessary to ensure that all laboratories and stakeholders were aware of the needs and the importance of laboratory quality systems. The implementation plan for accreditation was divided into 4 phases to provide sufficient time for stakeholders to develop knowledge, technical competence, and systems. Phase I focused on the identification of knowledge and service gaps and on work priorities and design to ensure that staff had a clear understanding of quality issues and the requirements for a laboratory quality management program. More than 60 basic quality management system training courses were provided throughout Thailand. Training was designed to sensitize laboratory staff and stakeholders and to encourage acceptance and effective implementation of the program. It was crucial that rural and central laboratory capacity be strengthened. This helped overcome the feeling that quality systems or accreditation were for large laboratories only. Incorporation of new procedures into the existing hospital management system was emphasized to ensure sustainability. In addition, because an understanding of the importance of quality systems preceded official policies or requirements for accreditation, laboratories were able to shape the process themselves and the policies were a result of what was thought by the implementing laboratories to be important and feasible to achieve. Phase II focused on the development and implementation of a demonstration laboratory network. The technical and financial challenges for accreditation for small laboratories were significant. To address this issue, a laboratory network for LA was started in northern Thailand in 2003 to allow resource sharing among large and small hospitals. The first network included 29 government and private hospitals from 2 provinces. The strategic plan included the following elements: (1) The MTC provided awareness training focusing on the requirements of laboratory standards and monitoring and self-assessment for CQI. (2) The regional laboratory served as the primary coordination center of the network and communicated with the higher authorities and provided support to small laboratories. (3) The network was divided into groups, and a more experienced hospital in each group served as a mentor for the group. (4) The regional laboratory organized regular meetings, provided reference and control materials, and helped calibrate equipment. (5) Coordinators provided guidance on the quality management system and supported internal quality assessments within the network. The SWOT (strengths, weaknesses, opportunities, and threats) analysis and the balanced score card technique, 10-13 2 management tools widely used in business management for strategic planning processes to evaluate organizational performance, were used to determine weaknesses and threats and provided overall direction for the network. Quality improvement activities were proposed by the network members so that they were suitable to the local setting but guided by the MTC staff. The monitoring results and obstacles to implementation were discussed by the laboratories and networks, and solutions were proposed by the laboratories themselves. Issues frequently addressed included how and where to calibrate equipment and how and where to get control materials. Proposed solutions included having mentor laboratories support small laboratories for equipment calibration, sharing control materials among hospitals, having the network share the cost of purchasing commercial control 536 Am J Clin Pathol 2010;134:534-540 Downloaded 536 from https://academic.oup.com/ajcp/article-abstract/134/4/534/1760240

Kigali Conference / Special Article materials, an interlaboratory comparison program when no EQA program was available, and exchanging lessons learned and experiences to improve the performance and quality of laboratories. Internal quality assessments among the groups were performed using the checklist, with results reviewed and gaps addressed as part of a CQI cycle. Phase III included the expansion of laboratory networks for accreditation across the country. Using the same collaborative approach as in the demonstration model, a regional or provincial hospital served as a coordinating center for local administrative communication, and the MTC and Ministry of Public Health provided technical support. In 2007, a national laboratory forum was held to share stakeholders views on the implementation of LA nationally and to enhance coordination and information sharing among stakeholders. The meeting resulted in a commitment to support development of a national laboratory system and a roadmap to voluntary LA using the MT standard or ISO 15189, whichever is most applicable to the individual laboratory setting and needs. 7 Phase IV strengthened and further expanded the accreditation program nationally. Laboratory quality scores are one of the CQI indicators for health care facilities, and a majority of laboratories integrated laboratory quality into their strategies; however, support from hospital administrators to increase the number of laboratory personnel and to resolve safety problems remained an issue. Some administrators successfully advocated with the national government to provide additional physical infrastructure and human resources. As the accreditation program expanded, there continued to be flexibility in the program that allowed laboratories to improve quality systems regardless of their capacity. The flexibility of the scoring system according to the national laboratory guidelines gave laboratories the opportunity to meet the standard requirements in a context appropriate to their laboratory setting. For example, even though laboratories may get high scores on some QSEs and low scores on other QSEs, if laboratories demonstrate overall improvement in quality systems, they may receive accreditation. Within the MT standard, there are 4 levels of quality development that laboratories can implement in compliance with the MT standard: level 1, quality score less than 50%; level 2, quality score 50% to 70%; level 3, quality score higher than 70% (laboratories qualified to apply for LA assessment by the MTC); and level 4, laboratory receives Thai LA by the MTC. The MTC also supported a disease-specific certification program before laboratories were accredited, especially for HIV laboratories performing CD4 and HIV testing. Accredited laboratories are encouraged to request annual monitoring by the MTC and renewal every 3 years in accordance with the HA program. An added benefit is that accredited laboratories gain recognition from their peers and increase policymaker satisfaction, leading to increased support from hospital administrators. Training and Assessment Process for Accreditation Knowledge and skills of laboratory personnel are fundamental for the implementation of a laboratory quality management system, and training sessions were offered by the MTC, private sector, and other stakeholders. Training emphasized the MT standard requirements and other basic elements of laboratory safety, method validation, control materials, and quality indicators, with the goal of building and strengthening the foundations of a quality laboratory system. The MTC assessor training sessions were conducted annually to eligible MTs, using the checklist as a tool in addition to the MT standard requirements; assessor training included the development of clear and transparent assessment guidelines and information on requirements for regulatory authorities and guidelines for assessments. The trainees were eligible to perform interlaboratory assessments within the network. The interlaboratory assessment is a requirement for LA, an important tool to evaluate laboratory performance, and can lead to broader understanding of the laboratory system. For new trainees, the assessment is performed by the trainee under supervision of the MTC assessor but is later done independently. The selection of an official MTC assessor is based on background and experience, competency, and commitment and attitudes toward the LA program. The potential assessor must undergo a series of training sessions and meet specific qualifications to become a full MTC assessor. Currently, there are 42 official MTC assessors. They are volunteers and are MT professional peers with years of experience in clinical laboratories. Results of Implementation The first laboratory network model in northern Thailand showed that many laboratories had markedly improved performance. For example, in a 7-month period from May through November 2005, the average quality score of 10 hospitals improved in almost every element Figure 3, including QSE-2 (personnel) which improved from less than 50 to nearly 80 after 7 months of implementation. Some laboratories received accreditation, and all laboratories in the network improved their quality by at least 1 level. As of 2009, 14 of 29 laboratories in the first demonstration network were accredited, and the network is still active. From 2002 to 2009, 724 (50.6%) of 1,432 laboratories in Thailand were assessed, and of these, 197 (27.2%) were accredited, primarily in the government sector Figure 4, and the remainder of the MTC-assessed laboratories were at levels 3 and 4. The cost of a laboratory assessment by the MTC Downloaded from https://academic.oup.com/ajcp/article-abstract/134/4/534/1760240 Am J Clin Pathol 2010;134:534-540 537 537 537

Wattanasri et al / Laboratory Accreditation in Thailand A QSE 10 QSE 9 QSE 8 QSE 7 QSE 1 100 80 60 40 20 0 QSE 2 QSE 3 QSE 4 QSE 5.1 B QSE 10 QSE 9 QSE 8 QSE 7 QSE 1 100 80 60 40 20 0 QSE 2 QSE 3 QSE 4 QSE 5.1 QSE 6 QSE 5.2 QSE 6 QSE 5.2 QSE 5.7 QSE 5.3 QSE 5.6 QSE 5.4 QSE 5.5 QSE 5.7 QSE 5.3 QSE 5.6 QSE 5.4 QSE 5.5 Figure 3 Improvement of 10 laboratories in Thailand 7 months after pilot implementation (May [A] and November [B] 2005). Each spoke in the wheel is 1 quality system essential (QSE), and the laboratory score is measured on the ring. No. of Laboratories 160 140 120 100 80 60 40 20 0 2 1 47 2002 3 2 58 4 2 76 7 12 72 2003 2004 2005 Year 5 6 81 6 21 92 16 32 95 10 59 142 2006 2007 2008 2009 Accredited private laboratories Accredited government laboratories Assessed laboratories with level 3 and 4 Figure 4 Number of assessed and accredited laboratories for Thailand national laboratory accreditation. varied based on the size of the laboratory; assessor fees ranged from $345 to $685 per assessment with 2 to 5 assessors. To improve the assessment process, a customer satisfaction survey was collected after the laboratory assessments. The purpose was to assess the performance of assessors and the assessment process. The results from 2006 to 2009 indicate increased satisfaction Figure 5. The 42 assessors also met annually to share their experiences and to improve the assessment process. Overall, implementation of an LA program in Thailand improved the quality of participating laboratories. The number of laboratories participating in national EQA/proficiency testing programs increased; laboratories improved safety practices using universal precautions; the number of laboratories with nonconformance decreased; and customer (patient, nurse, and physician) satisfaction improved. A B Mean Score (range, 1-4) 3.9 3.8 3.7 3.6 3.5 3.4 3.3 3.2 3.1 E1 E2 E3 E4 Survey Elements 2006 2007 2008 2009 E5 E6 E7 E8 Mean Score (range, 1-4) 3.9 3.8 3.7 3.6 3.5 3.4 3.3 3.2 3.1 E1 E2 E3 E4 2006 2007 2008 2009 Survey Elements E5 E6 E7 Figure 5 Satisfaction of surveys of laboratory assessment processes in Thailand, 2006-2009. A, E1, Time needed to complete the assessment; E2, assessor s skill; E3, assessor s knowledge of medical technology (MT) standards; E4, assessor s understanding of quality assurance elements and laboratory setting; E5, clarity of assessor s explanations: problems and resolutions; E6, assessor s reference to MT standards and guidance; E7, assessor s personality; E8, suitability of assessor s suggestions. B, E1, Assessor s opening technique; E2, assessor s approach to the laboratory; E3, assessment environment comfort level; E4, usefulness of assessor s questions; E5, appropriateness of assessor s questions; E6, assessor s recording of findings; E7, assessor s closing technique. 538 Am J Clin Pathol 2010;134:534-540 Downloaded 538 from https://academic.oup.com/ajcp/article-abstract/134/4/534/1760240

Kigali Conference / Special Article Discussion The successful development and expansion of an LA program in Thailand is a result of several factors. A network strategy provided opportunities for all members to share their experiences and resources, to identify problems, to resolve problems, and to develop goals and action plans for improvement of laboratory quality within their network. The strengths of the laboratory network model include the following: (1) the regional or provincial hospital as a coordinator for each network to facilitate member communication; (2) clear lines of responsibility among the laboratories and a quality advisory group to monitor, guide, and follow up with member laboratories for continued cooperation; (3) commitment from all participating laboratories; (4) skilled and experienced laboratory assessor teams and a supportive environment for network members; (5) accredited laboratories as laboratory mentors; (6) network coverage of private and public laboratories; (7) knowledge and resource sharing to minimize cost and time and steer the group clear of pitfalls for better work models; and (8) a potential benefit from advocating similar issues to policymakers. While some laboratories have made significant progress, they still require a lot of support technically and financially from hospital administrators. However, by 2015, all laboratories in Thailand are anticipated to participate in the LA program and be at least a level 3, and more than 50% of laboratories are anticipated to be accredited. The quality, capacity, and readiness of laboratories throughout Thailand vary widely. Even though Thai LA is feasible, to improve the quality of all laboratories requires immense effort and poses enormous challenges, particularly for small laboratories in remote areas with few MT staff and limited resources. A laboratory network model is a helpful strategy for decentralization of LA so that laboratories assist each other or accredited laboratories support less experienced laboratories in administrative and technical aspects of accreditation. Self-assessments or interlaboratory assessments help ensure continuous performance improvement among network laboratories. These assessments provide an effective tool to evaluate compliance with the standard requirements and to identify weaknesses and opportunities for improvement. Internal quality assessments can minimize the expense of an official assessment by the MTC by allowing the laboratories to determine their progress and readiness for accreditation before formally requesting an assessment. Positive attitudes and good skills of assessors help motivate laboratories to participate in LA. Assessors must be able to encourage, communicate, and indicate failure to meet the requirements as opportunities for improvement and not as punishment. Dedicated people and commitment of senior administration and policymakers contribute to the success of the program. The implementation strategies are flexible and depend on many factors such as the working culture of the country, the capacity of laboratories, resources and budget, and personnel knowledge. Conclusions Thailand laboratory standards were developed in compliance with international standards but with a focus on priorities and available resources in Thailand. This standard provides direction and a framework to laboratories on appropriate country-specific aspects of laboratory quality. The national LA program also provides an opportunity for rural laboratories with limited financial and human resources to implement or improve their laboratory quality to achieve their goals for accreditation. Accreditation with international standards may occur later, when the laboratories are ready. The national program has been successfully developed and implemented using a stepwise approach and a laboratory network model. However, cooperation and input from many stakeholders are also required, and the next step is to strengthen and expand the network laboratories. As in other resource-constrained countries, a successful accreditation program depends on knowledge and attitudes of personnel on laboratory quality; human and financial resources for personnel, equipment, and other infrastructure; and most important, a commitment from leaders. However, with a flexible and feasible national program, laboratory quality systems have become part of all laboratories with gradual improvement of the whole laboratory management system. In short, the Thai national accreditation program has been developed to be feasible, scalable, and sustainable in the Thai setting. From the Thailand Medical Technology Council, Bangkok. Address reprint requests to Naiyana Wattanasri: Medical Technology Council of Thailand, The Government Complex Commemorating His Majesty the King s 80th Birthday Anniversary 5th December, B.E.2550 (2007) 120 Moo 3 Chaengwattana Rd, Lak Si District, Bangkok 10210 Thailand. Acknowledgments: We thank the Global AIDS Program, Thailand Ministry of Public Health-United States Centers for Disease Control and Prevention Collaboration (TUC), especially Michelle McConnell, MD, for critical reviews of the draft article, and members of the Laboratory Services section for their consistent support for the national laboratory accreditation program. References 1. International Organization for Standardization. Information technology: interpretation of accreditation requirements in ISO/IEC Guide 25: Accreditation of Information Technology and Telecommunications testing laboratories for software and protocol testing services. Geneva, Switzerland: International Organization for Standardization. Downloaded from https://academic.oup.com/ajcp/article-abstract/134/4/534/1760240 Am J Clin Pathol 2010;134:534-540 539 539 539

Wattanasri et al / Laboratory Accreditation in Thailand 2. Standards for Clinical Laboratories: Thailand Medical Technology Standard: 2008. The Medical Technology Council. http://www.mtcouncil.org/index. php?components=mtc_document&file=20. 3. International Organization for Standardization. Medical laboratories: particular requirements for quality and competence, 2nd ed. Geneva, Switzerland: International Organization for Standardization; 2007. ISO document 15189: 2007. 4. Berte LM, Boone DJ, Cooper G, et al. Application of a quality management system model for laboratory services; Approved guideline. Third ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2004. Document GP26-A3. 5. Slagter S, Loeber JG. Accreditation of medical laboratories in the Netherlands. Clin Chim Acta. 2001;309:155-161. 6. Dhatt GS. Accreditation of medical laboratories in South Africa. Accreditation Qual Assur. 2002;7:290-292. 7. Mazziotta D. Accreditation of clinical laboratories in the Latin-American region. Clin Biochem. 2009;42:309. 8. Manzoor A, Farooq AK, Sadia AA. Standardization of pathology laboratories in Pakistan: problems and prospects. Clin Biochem. 2009;42:259-262. 9. International Organization for Standardization. Quality systems: model for quality assurance in design, development, production, installation and servicing. Geneva, Switzerland: International Organization for Standardization; 2007. ISO document 9001:1994. 10. Have S, Have W, Stevens F, et al. Key Management Models: the Management Tools and Practices That Will Improve Your Business. London, England: Financial Times/Prentice Hall; 2003. 11. Kaplan RS, Norton DP. The balanced scorecard: measures that drive performance. Harvard Bus Rev. January-February 1992:71-79. 12. Kaplan RS, Norton DP. Using the balanced scorecard as a strategic management system. Harvard Bus Rev. January- February 1996:75-85. 13. Karra ED, Papadopoulos DL. Measuring performance of Theagenion Hospital of Thessaloniki, Greece through a balanced scorecard. Operational Res. 2005;5:289-304. 540 Am J Clin Pathol 2010;134:534-540 Downloaded 540 from https://academic.oup.com/ajcp/article-abstract/134/4/534/1760240