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NATIONAL LABORATORY INTEGRATION AND STANDARDIZATION STRATEGY 2013-2018 NATIONAL LABORATORY INTEGRATION AND STANDARDIZATION STRATEGY 2013-2018 © 2013 General Secretariat, Supreme Council of Health Published, April 2013 Supreme Council of Health, Qatar P.O. Box 42 Doha, Qatar www.sch.gov.qa Printed in Qatar, 2014 Contents Foreword ............................................................................................................... 01 Abbreviations ..........................................................................................................02 Executive Summary ................................................................................................04 Introduction ............................................................................................................... 07 Current Provision and Plans ...................................................................................... 08 .. 1. GOAL 1: Integrated Services ............................................................................11 1.1 Service Mapping and Projections .....................................................................12 1.2 Service Integration ...........................................................................................15 1.3 Implementation ................................................................................................20 2. GOAL 2: Integrated Information ...................................................................... 21 2.1 LIMS Integration ................................................................................................22 24 2.2 LIMS and HIS Integration .................................................................................... 2.3 Implementation ............................................................................................... 26 3. GOAL 3: Standardized Workforce ................................................................... 27 3.1 Workforce Development ...................................................................................28 3.2 Workforce Regulation ...................................................................................... 31 3.3 Implementation ............................................................................................... 32 4. GOAL 4: Standardized Outputs ........................................................................33 34 4.1 Standardized Processes ..................................................................................... 4.2 Standardized Devices .......................................................................................36 4.3 Standardized Facilities ..................................................................................... 38 39 4.4 Implementation ................................................................................................... Conclusion ................................................................................................................ 40 Appendix 1 ................................................................................................................ 41 Appendix 2 ..............................................................................................................45 Appendix 3 ..............................................................................................................46 Bibliography .............................................................................................................. 48 Acknowledgments ...................................................................................................51 Foreword 01 09 It is my pleasure to present our first National Laboratory Integration and Standardization Strategy. Successful identification and investigation of disease, vaccines, medication, the environment, and food safety, underpin our future model of care, which focuses on enhanced prevention. HE. Mr. Abdulla bin Khalid Al Qahtani This document builds on the remarkable progress of the State of Qatar towards some of the world’s leading and state-of-the-art testing and research facilities. Investment and activity have more than doubled over the last few years. Qatar now has an international lead on genetic, cardiovascular, sports medicine and other testing and research laboratories. This document outlines a work plan towards the integration and standardization of their work, in order to improve the health of individuals, families and communities, in the State of Qatar and beyond. The Supreme Council of Health and I are fully committed to implementing the National Laboratory Integration and Standardization Strategy. As we make every effort to accomplish our future model of care, we will continue our discourse with the public, providers and regulators. His Excellency Mr. Abdulla bin Khalid Al Qahtani Minister of Health, and Secretary General Supreme Council of Health Abbreviations ALT ASCP Aspetar AST CAP CON CPD CSF EHC EHR EQAS FFS FSA GCC HMC HIS ICD ISO IT JCI LIMS LSA MC MoI MMUP MOE NCS NDS NHIC NHS NLC PACS PET-CT PHC PHCC PIS PWA QCHP QF QID QMS QNRF QNRS QNV RT-PCR SHI SCH SCE WHO Alanine Transaminase American Society for Clinical Pathology Qatar Orthopaedic and Sports Medicine Hospital Aspartate Transaminase College of American Pathologists Certificate of Need Continuing Professional Development Clinical Health Services Framework for Qatar Electronic Health Cards Electronic Health Records External Quality Assurance Schemes Fee for Services Food Safety Authority Gulf Cooperation Council Hamad Medical Corporation Hospital Information System International Classification of Diseases International Organization for Standardization Information Technology Joint Commission International Laboratory Information Management System Laboratory Situational Analysis Medical Commission Ministry of Interior Ministry of Municipality and Urban Planning Ministry of Environment National Cancer Strategy (2011-2016) National Development Strategy 2011-2016 National Health Insurance Company National Health Strategy 2011-2016 National Laboratory Committee Picture Archiving and Communications System Positron Emission Tomography – Computed Tomography Primary Health Care Primary Health Care Corporation Pharmacy Information System Public Works Authority Qatar Council for Health Practitioners Qatar Foundation for Education, Science and Community Development Qatar National ID Quality Management Systems Qatar National Research Fund Qatar National Research Strategy Qatar National Vision 2030 Real-Time and/or Reverse-Transcription Polymerase Chain Reaction Social Health Insurance Supreme Council of Health Supreme Council for Education World Health Organization 10 02 Executive Summary The activity of clinical, non-clinical and health research laboratories more than doubled over the last decade, to account for considerable population and investment growth. Growth is set to continue as providers plan further expansion. The rapid expansion has already resulted in duplication and gaps in services, information management and regulations. Current Provision And Plans Over 90 percent of recorded clinical laboratory services are provided in the public sector, where activity grew by over 60 percent between 2005 and 2011. Growth will continue, as at least a further 7 hospitals and 17 primary care centers open by 2015. Almost all non-clinical laboratory services are provided in the public sector, where food, water and sewage testing activity grew by over 90 percent between 2009 and 2011. Growth will continue, with at least a further 8 new laboratories by 2018. Health research laboratory services are provided across all sectors. Government-funded health research, of which three quarters are lab-based, grew by 73 percent between 2009 and 2010 alone. This document makes 46 recommendations, around four Goals, for improved integration and standardization; 04 10 Executive Summary GOAL 1: Integrated Services 1.1 Service Mapping and Projections • Establish a National Laboratory Committee. • Develop policy-relevant service mapping and projections. 1.2 Service Integration • Support appropriate facility-level centralization. • Identify and support intra-provider integration. • Identify facilities and develop processes for centers of excellence designation. • Identify opportunities to serve the region and beyond. • Explore the development of a clinical national reference laboratory. • Implement recommendations for a establishing clinical national reference laboratory services, and nation-wide referral procedures. • Establish a non-clinical national reference laboratory, and referral procedures. • Develop guidelines and referral procedures for overseas reference laboratories. • Develop standardized laboratory proposal evaluation and approval processes. • Increase on-site primary health care diagnostic services. • Identify opportunities for partnerships between the private and public sectors. • Identify opportunities for enhanced geographical access, including the establishment of a community-based clinical laboratory network. • Establish reimbursement mechanisms which dis-incentivize duplication and gaps. GOAL 2: Integrated Information 2.1 Laboratory Information Management System Integration • Support/mandate configurable, bidirectional laboratory information management systems. • Implement configurable, bidirectional laboratory information management systems. • Regulate laboratory patient confidentiality and information protection. 2.2 LIMS and Health Information System Integration • Support and mandate other specific configurable, bidirectional e-health requirements. • Implement other specific configurable, bidirectional e-health requirements. • Implement electronic health records. • Implement electronic health cards. • Identify and mandate other appropriate e-health requirements. • Implement a unified coding system. • Develop and mandate laboratory information reporting requirements. 05 09 Executive Summary GOAL 3: Standardized Workforce 3.1 Workforce Development • Identify future laboratory workforce demand, and ways to meet the demand. • Improve laboratory workforce recruitment and retention. • Optimize laboratory workforce skill mix and roles. • Support and improve scientific and non-scientific laboratory education and training. • Offer training and/or work placements in Qatar’s leading laboratories. • Identify opportunities to fill regional education and training gaps. 3.2 Workforce Regulation • Review laboratory workforce credentialing requirements. • Mandate retrospective verification of laboratory personnel credentials. • Develop laboratory workforce certification requirements. • Review and enforce laboratory workforce registration, licensing and revalidation. • Develop regulatory requirements that do not hinder recruitment and retention. GOAL 4: Standardized Outputs 4.1 Standardized Processes • Mandate appropriate quality management systems. • Mandate appropriate external quality assurance schemes. • Regularly publish laboratory information. • Establish link between provider reimbursement and service quality. • Identify and develop other positive incentives. 4.2 Standardized Devices • Establish diagnostic medical device regulation. • Include appropriate laboratory devices into the Medical Registration Unit’s work. • Establish non-medical laboratory device regulation. 4.3 Standardized Facilities • Mandate and enforce laboratory facility licensure. • Develop and mandate national and/or international accreditation requirements. 10 06 Introduction 07 09 Testing and research laboratory services are vital to the prevention and treatment of ill health. They identify and/or investigate disease, vaccines, medication, food safety, and air quality. Up to 70 percent of medical decisions may be based on laboratory results. [1] Laboratory1 activity in the State of Qatar expanded considerably over the last decade, to account for rapid population growth and investment in a knowledgebased future. The population grew at the world’s fastest rate between 2000 and 2010; and second fastest between 1950 and 2000 [3, 4]. Three quarters of governmentfunded health research between 2007 and 2010 was lab-based, and funding for medical research grew by 73 percent between 2009 and 2010 [5, 6, 7]. Laboratory activity more than doubled between 2005 and 2010 [8, 9]. Growth is set to continue as providers plan significant further expansion. Due to the rapid shift in demand and supply, expansion has been insufficiently coordinated. Gaps and duplication arose in services, information management and regulations. In 2008, the country’s long-term development strategy, Qatar National Vision 2030 (QNV), highlighted the need for an integrated system of health care [10]. The need for standardized diagnostics, and improved coordination and synchronization of non-clinical and research laboratory activity was accentuated in the National Development Strategy 2011-2016 (NDS), and the National Health Strategy 2011-2016 (NHS) [11, 12]. Respondents to a 2012 Study in Qatar rated laboratory services among the most vital. [2] By 2012, the Supreme Council of Health (SCH), Qatar’s highest health authority, established a new NHS Project on Laboratory Integration and Standardization. The Project addresses the issues identified among clinical, non-clinical and research laboratories. This document is the first deliverable of NHS Project 2.6. The Strategy makes 46 Recommendations (Appendix 1), around four Goals: 1. 2. 3. 4. Integrated Services Integrated Information Management Standardized Workforce Standardized Outputs The Strategy is based on work conducted between 2011 and 2012, including: • Consultations with the majority of providers (Appendix 1); • Consultations with key stakeholders (such as relevant NHS Project Managers); • Laboratory Situational Analysis (LSA) of most providers (Appendices 1 and 2); • Advice from subject matter experts (Acknowledgment Section); and • Relevant international best practice. 1) In this document, the word ‘laboratory’ encompasses clinical, non-clinical and health research laboratories (also referred to as testing and research laboratories). Current Provision & Plans 08 10 Clinical Laboratory Services Clinical laboratories typically perform specimen tests for information on patient health, such as blood tests. In 2011, zover 90 percent of these services were provided in the public sector. Seventy-eight percent }of recorded tests were provided by Hamad Medical Corporation (HMC), the country’s largest secondary and tertiary care provider2 [13, 14]. Fourteen percent were provided by SCH3, Primary Health Care Corporation (PHCC), the country’s largest primary care provider, and other public providers4 [13, 14]. 2% 3% 1% 5% 11% SCH PHCC HMC Other Public Semi-Governmental 78% Figure 1. Share of Clinical Laboratory Tests, 2011 [13] Between 2005 and 2011, HMC, PHCC and SCH activity rose by 62, 31 and 12.5 percent, respectively [15, 16]. Their diagnostic capacity will increase by 2015, when they expect to open 7 hospitals, 17 primary care centers, and 2 Medical Commission (MC) units [14]. 3,457,034 4,000,000 3,500,000 3,000,000 2,500,000 2,000,000 1,500,000 1,000,000 2,351,173 324,130 910,959 288,114 694,104 SCH 2,221,945 1,368,955 500,000 PHCC HMC Total 2005 2006 2007 2008 2009 2010 2011 Figure 2. Analyzed HMC Specimens, PHCC Laboratory Analyses, SCH MC Screening, 2005-2011 [15-22] 2) In 2012, HMC hosted 8 of the country’s 12 hospitals, and 83 percent of all hospital beds [14]. 3) The SCH Medical Commission screens expatriates for select communicable diseases prior to residence in the country. 4) Other public providers include Ministry of Interior (tests for workers and prisoners, and Qatar Armed Forces [13]. Current Provision & Plans 09 Non-Clinical Laboratory Services Non-clinical laboratory services include safety tests, such as food and drug safety tests. The majority of these services are provided in the public and semi-public sectors in Qatar. In 2011, 77 percent of recorded tests were conducted by SCH, which inspects drugs, water, sewage and imported5 food [13]. Twenty-two percent were conducted by the Ministry of Environment (MoE), which inspects building materials radiation, agriculture, veterinary and other materials [13]. 76% SCH Central Food Laboratory Ministry of Environment Laboratories SCH Drug Quality Control Laboratory Semi-Public Non-Clinical Laboratories 1% 1% 22% Figure 3. Share of Non-Clinical Laboratory Tests, 2011 [13] Between 2009 and 2011, the SCH witnessed a 91 percent increase in the number of food, water and sewage samples it analyzed [22-24]. Considerable growth is set to continue as HMC plans to conduct food safety and security tests, and the MoE planned a further 8 facilities, to test fisheries, pesticides, toys and other materials, between 2012 and 2018 [13]. 25,000 20,471 20,000 13,766 15,000 10,712 10,000 5,000 Central Laboratory 2009 2010 2011 Figure 4. Central Laboratory Activity, SCH, 2009-2011 [22-24] 5) Domestic food production and processing is conducted by the Ministry of Municipality and Urban Planning (MMUP). A single Food Safety Authority (FSA) is being established by SCH (NHS Project Current Provision & Plans 10 Health Research Laboratory Services This document uses the term health research laboratory to refer to laboratories conducting biomedical/translational research in the field of medicine, including the development of vaccines and medications. Health research laboratory services are provided by all sectors in Qatar. Between 2007 and 2010, laboratory based6 health research represented 74.4 percent of the health research funded by Qatar National Research Fund (QNRF)7 [5]. $Million 74.72 80 70 60 50 40 25.71 30 20 10 Laboratory Based Health Research Non-laboratory Based Health Research Figure 5. QNRF Funding for Heath Research, 2007-2010 [5] Government-funded medical research increased by 73 percent between 2009 to 2010 [6, 7]. Significant growth is set to continue. The HMC, Qatar’s Academic Health System, which conducts basic clinical research and cancer research expects to open its core translational research facilities, the HMC Translational Research Institute, by 2015 [14]. The Qatar Foundation for Education, Science and Community Development (QF), Aspire Zone Foundation and the AntiDoping Lab Qatar all plan increased research on areas such as cardiovascular diseases, biomedicine, sports science and exercise-related research. 25,000 21,442 20,000 15,000 12,384 10,000 5,000 Total Costs (USD '000) 2009 2010 Figure 6. Cost of Government-funded Medical Research [6, 7] 6) The QNRF classifies laboratory based research as research that is at least 10 percent laboratory work [5]. 7) The QNRF was established by Qatar Foundation for Education, Science and Community Development (private, non-profit organization leading Qatar’s human, social, and economic development) to support a knowledge-based future through research support. GOAL 1: Integrated Services 11 Some laboratory service duplication is necessary to provide room for expansion and deal with unforeseen events. This necessary spare capacity also supports increased diagnostic test access and improved turnaround time. However, undesirable duplication can be wasteful and damaging to population health. Over-investment for underutilized laboratories can generate diminishing technical and operational expertise. This can cause substandard test results, with associated reductions in the clinical quality experienced by patients. Undesirable duplication can also be uncomfortable for the patient, and ineffective for the patient history and subsequent clinical decisions. Optimal service integration is therefore necessary for high-quality yet accessible laboratory outputs. This requires the development and implementation of clear integration processes, and appropriate incentives against uncoordinated and fragmented laboratory services. This document adopts the NHS description of [healthcare system] integration. Term NHS Description Integration [Or] coordination, cohesiveness and connectedness, enhances efficiency, quality of care and patient experience. 1.1 Service Mapping and Projections 12 Background Current Status The development and implementation of clear integration processes and incentives require robust and policy-relevant information. This includes mapping current services and projecting future ones to highlight undesirable duplication and gaps. Although significant and detailed health service mapping and future demand modeling is underway, to date there has been no full and policy-relevant laboratory service mapping. This information would then be grouped into policyrelevant categories to inform targeted policies. A common category is the degree of test complexity. Higher complexity tests are generally performed less frequently and require a higher level of expertise to perform properly. The level of complexity then determines the minimum testing volume necessary to sustain adequate technical and operational expertise. • Simple/low-complexity tests do not require highly-skilled personnel, and are often available for over-the-counter sales (e.g., pregnancy tests, dipsticks, and glucometres). • Moderate-complexity tests are usually available on automated laboratory analyzers (e.g., chemistry profile, urinalysis, urine drug screen, and automated immunoassays). • High-complexity tests require laboratory expertise beyond normal automation (e.g., gene chip arrays, cytology, immunohistochemistry, peripheral smears, most molecular diagnostic tests, and viral loads). The complexity construct also allows for a workable structure to determine the appropriate personnel required to perform laboratory tests. It is important to recognize, however, that even simple tests are not “error-proof”. Trained individuals are still required, especially when needed to recognize when automated testing may be yielding problematic answers. Some current and future service duplication and gaps have been highlighted through other work. This includes the following: • The NHS 2011-2016 identified gaps in screening for Qatar’s main diseases, testing for key public health areas, and primary care on-site tests (Table 1)8. It also identified the need for improved coordination and integration of non-clinical and health research activity. • The SCH National Cancer Strategy 2011-2016 (NCS) identified gaps in genetic testing, cancer screening, cutting-edge pathology tests, overall diagnostic capacity and translational research (Table 2) [26]. • The 2012 SCH Clinical Health Services Framework for Qatar (CSF) identified gaps in overall diagnostic services, and non-hospital diagnostic capacity. It projected growth in the private sector (Table 3) [27]. • The 2012 SCH LSA identified gaps in high-complexity tests, primary care on-site medium-complexity tests, and drug, alcohol and cosmetics tests among participating organizations (Table 4). • The 2012 SCH Qatar National Cancer Research Strategy, and QF Qatar National Research Strategy (QNRS), identified research laboratory service gaps [28]. Additional mapping and projections are being conducted as part of other work: • The SCH is mapping and projecting overall clinical diagnostic capacity under the national Healthcare Infrastructure Master Plan (NHS Project 6.4). 8) The QNRF was established by Qatar Foundation for Education, Science and Community Development (private, non-profit organization as well as the need for rapid access to off-site tests [25]. 1.1 Service Mapping and Projections SCH NHS Project 13 Duplication and Gaps Clinical Laboratory Services - Gaps 1.1 Primary care on-site tests, and access to off-site tests9 3.4 Consanguinity screening, to reduce congenital defects 3.5 Follow-up communicable-disease screening, such as among nurses and barbers 3.6 Key chronic disease screening of high-risk groups 3.8 Women screening, such as prenatal screening, osteoporosis, nutritional deficiencies and cancer Non-clinical Laboratory Services - Gaps 3.10 Food safety testing 3.12 Air quality testing and environmental health impact assessments 5.4 Drug testing Biomedical research and equipment 7.1 Biomedical research and equipment Table 1. Duplication and Gaps Identified by the SCH NHS SCH NCS Recommendation Gaps Clinical Laboratory Services - Gaps 4.5 Genetic testing for gene mutations that increase the risk of developing cancer 5.1 - 5.3 Screening for key cancers, such as breast, colorectal and cervical cancers 6.2 Cutting edge pathology tests, such as molecular diagnostics and so on 6.3 Overall diagnostic capacity Research Laboratory Services - Gaps 11.2 – 11.1 Translational research Table 2. Gaps Identified by the SCH NCS SCH CSF Issue Gaps Clinical Laboratory Services - Gaps Present Primary health care diagnostic services Community-based diagnostic services Future Overall diagnostic services Table 3. Gaps Identified by the SCH CSF 9) Rapid access to off-site tests was identified as a gap in the Primary Health Care Strategy [25]. 1.1 Service Mapping and Projections SCH LSA Issue Duplication and Gaps Clinical Laboratory Services Duplication Non-urgent, low-frequency and specialized tests Neonatal screening tests Genetic tests Toxicology tests Private sector Public institution staff tests (potential) Gaps High-complexity tests Real-time and/or reverse-transcription polymerase chain reaction (RT-PCR) Creatinine tests Alanine Transaminase (ALT) Aspartate Transaminase (AST) Molecular diagnosis of leukaemia, lymphoma and other malignancies DNA microarray and its applications On-site PHCC moderate-complexity tests Unequally met need across the country Specialized screening for disease and outbreak prevention, control and surveillance Non-clinical Laboratory Services Duplication Food testing Dioxin tests Testing for containers made of green leaves Alcohol tests (future – potential) Drug tests (future – potential) Gaps Drug tests Alcohol tests Cosmetic tests Black henna testing Industrial toxin and heavy metals testing (benzene, lead etc.) Proteomics laboratory services Transcriptomics laboratory services Table 4. Duplication and Gaps Identified by the SCH LSA New Directions • Establish a multi-stakeholder National Laboratory Committee (NLC) to regularly identify, and advise on, laboratory issues. • Conduct policy-relevant service mapping and projections for clinical, non-clinical, and research laboratory services. This should build on existing work and align with ongoing work, including, but not be limited to, the following: o o o o o o o o o o o o Primary Health Care Strategy (NHS Project 1.1) Consanguinity Risk Reduction (NHS Project 3.4) Communicable Disease Prevention (NHS Project 3.5) National Screening Program (NHS Project 3.6) Women and Child Health (NHS Project 3.8) Healthcare Infrastructure Master Plan (NHS Project 6.4) National Cancer Strategy (2011-2016) Food Safety (NHS Project 3.10) Environmental Health and Air Quality (NHS Project 3.12) Healthcare Product Regulation (NHS Project 5.4) Qatar National Cancer Research Strategy Qatar National Research Strategy 14 1.2 Service Integration 15 Background Service integration requires the development and implementation of clear processes and appropriate incentives. Providers should work together to provide comprehensive services. Regulator should put in place appropriate oversight and enforcement mechanisms, and financial and non-financial incentives to encourage cooperation and integration across providers. National-level integration includes centralization through the establishment of centers of excellence and reference laboratories. • Centers of excellence provide leadership in a selected area. • Reference laboratories receive unusual or specialized tests, act as a backup service, and respond to national outbreaks. • Very unusual or highly specialized tests are often sent to overseas reference laboratories, which are efficient for small countries. In the United States, such testing is sent to a couple of reference laboratories (such as the Mayo Clinic Mayo Medical Laboratories and Nichols Institute). Facility-level service integration includes centralization by merging test menus forappropriate capacities at each facility. This reduces redundancies. Consolidation of laboratories into larger facilities has occurred for over two decades in New Zealand, Canada and the United States. Future integration can be facilitated by approval processes for facility acquisitions, expansions or creations that are based on population needs. This can include a Certificate of Needs (CON), a legal document issued if plans fulfill needs. Integration and coordination between different types of facilities is necessary, and can be achieved through various tools. Between facilities, service level agreements can prevent duplication and capitalize on providers capacity and technical specialization. Between hospital and non-hospital facilities, appropriate coordination can include a proper referral system for rapid access to off-site testing. To further enhance access, many low- and medium- complexity tests are available in primary health care and community-based settings. The latter often offers specimen collection, transportation, reporting and testing services. Despite concerns about human error in transportation [29], community-based laboratories are on the increase in Canada and other large countries. Between private and public facilities, optimal integration is needed, as the private sector responds to demand and the public sector to health needs. If well-regulated and incentivized, the private sector enhances access and quality through competition, efficiencies and rapid mobilization. Private sector involvement can include funding, provision and operations. 1.2 Service Integration 16 Current Status Provider payment mechanisms are an important tool • Facility-level integration deteriorated due for service integration. Depending on the fee level, to rapid expansion. However, enhanced centralization a fee for service (FFS) payment mechanism can and coordination is being considered at several large exacerbate over-provision or duplication [29], while clinical and research service providers. budgets and capitation that are fixed regardless of the • There is some inter-facility integration in the clinical public number of services can generate under-provision or gaps. sector; the SCH receives around 12,000 external test results,10 and the HMC conducts around 300,000 external low-frequency tests [13].11, 12 In British Columbia outpatient laboratory • There is limited inter-facility integration among non-clinical expenditure grew by 44 percent since the providers. However, LSA stakeholders agreed to move introduction of uncapped FFS [29]. services across providers to avert duplication and gaps,13 and some expressed readiness to receive external tests. • There is limited inter-facility integration among research providers, but it is likely improving. Some LSA stakeholders expressed readiness to receive external tests. The SCH is establishing the governance structure 44% and legal framework for improved coordination and 37% oversight (NHS Project 7.1). The QF is establishing the Qatar National Research Observatory, to monitor and direct research activity and measure outcome impact 25% (QNRS Goal EW.2.2) [28]. 23% • There are no processes for establishing and using centers of excellence, despite a growing number of specialized state-of-the-art laboratories, and regionally and internationally leading providers. One was identified as 5% an international reference laboratory for select tests, receiving samples14 from Kuwait, Jordan, Netherlands, the United Kingdom, Canada and New Zealand. • There is no national reference clinical laboratory. However, there may be sufficient need, expertise and critical mass for one, as a result of population growth and a highly transient population. In 2012, Qatar registered Figure 7. Growth in Laboratory Expenditure since FFS two laboratory-confirmed cases of infection with the Introduction, British Columbia, 1997-2002 [29] novel human corona virus [7]. 10) The SCH receives tests from PHC centers, the Police and Army Clinic offering MC services on its behalf. 11) The HMC conducts tests on behalf of SCH MC, PHCC, MoI, Qatar Armed Forces, and the Qatar Orthopaedic and Sports Medicine Hospital (Aspetar) [13]. 12) The HMC, which estimates that 97 percent of its testing is specialized (medium to high-complexity), receives creatinine, RT-PCR and ALT/AST tests, antibody identification, salm/shig serotyping, crossmatching/typing, urine chemistry, cytology, histopathology, microbiology and specialized immunology, vitamin and trace element assays, and specialized hormonal assays [13]. 13) Specific tests include food testing, drug, alcohol, cosmetic and dioxin tests, and testing for containers made of green leaves. 14) These include tests such as PCR-sequencing, genotyping, micodeletion and subtelomeric re-arrangement. 1.2 Service Integration 17 • There is no national reference non-clinical laboratory. One, the National Health Laboratory, is in the design stage by the SCH and the Public Works Authority (PWA/Ashghal). It will include a public health function; namely, disease prevention, control and surveillance services. • There is no national process for selecting overseas reference laboratories; providers conduct their own selection and referrals. LSA stakeholders send around 20,000 tests15 overseas annually.16 From 2013, the SCH and HMC will identify preferred overseas providers and quality criteria (NHS Project 6.2). • Approvals for laboratory facility acquisitions, expansions and establishments are not based on up-to-date information, service needs, and standardized processes. The SCH is establishing a national CON process for healthcare facilities (NHS Project 6.5), and a Capital Expenditure Committee for approving provider requests for public funds (NHS Project 6.5). • There is under provision of clinical laboratory services in primary health care, the third most useful service according to 2012 Qatar Survey participants [2]. The NHS emphasized primary health care as part of strengthened early detection. The LSA and the Primary Health Care Strategy reported gaps in primary care on-site, medium-complexity laboratory tests and rapid access to off-site tests through a proper referral system (NHS Project 1.1) [13, 25]. The PHCC conducts routine tests itself, and sends non-routine tests to HMC [13]. Dental Services 56 Pharmacy Services 38 Laboratory Services 36 Vaccination Services 34 Patient Management 28 Health Education 24 Radiology Services 22 Pregnancy Care Services 20 School Health Services 20 Social Worker Services 18 Home Visits Services 16 Health Promoting Schools Program 15 Medical Commission Services 15 None of the above (%) 13 10 20 30 40 50 60 Figure 8. PHCC Services that would be Useful to Non-Visitors, Qatar, 2012 [2] 15) These include newborn screening, immunoassay, C-peptide, histopathology, cytopathology and other specialized tests. 16) Recipient countries include Switzerland, Germany and the United States. 1.2 Service Integration 18 • As the private sector is paid through FFS, it focuses on high-volume, low- cost provision. Between 2009 and 2011, the number of private hospital tests increased by 51 percent [22], and analysis and X-ray facilities increased by 31 percent [6, 7]. The CSF projected private provision will increase with Social Health Insurance (SHI) [27]. The SCH will outsource two new MC units in 2013. There is an opportunity to outsource public clinical and SCH nonclinical laboratory services to address capacity constraints, increasing demand17 and efficiency gains. 700,000 618,670 600,000 500,000 • Stakeholders reported insufficient geographical coverage. In 2012, three of 13 hospitals and 13 public PHC centers provided comprehensive and point-of-care services outside Greater Doha, a quarter of Qatar’s population [30]. Private providers are largely inactive outside Doha, due to low test volumes. There are no community-based laboratories, which were recommended by the CSF. • Payment mechanisms do not incentivize providers to avoid duplication and gaps. 409,546 400,000 American Hospital 300,000 Al Emadi Hospital 200,000 Doha Clinic 100,000 Al Ahli Hospital 2009 2010 2011 Figure 9. Private Hospital Clinical Laboratory Tests, 2009-2011 [22] o The private sector is paid through FFS (self-pay or private health insurance). Reimbursement is not linked to service necessity and quality, leading to some overprovision or duplication. o The public sector is financed by prospective budgets, based on historical expenditure. Reimbursement is not linked to service necessity, quality and market forces, leading to some under- provision or gaps. o The SCH is implementing SHI across all healthcare providers and the entire population. Payments will be by episode of care, not service per episode of care (NHS Project 6.3). 17) See Current Provision and Plans for public sector clinical and non-clinical laboratory growth. 1.2 Service Integration 19 New Directions • Identify, support and encourage appropriate facilitylevel centralization. • Identify and support improved intra-provider coordination and integration (QNRS Goal EW.2.2; NHS Project 7.1). • Identify laboratories performing specialized or higher-complexity tests, and develop processes for their designation into centers of excellence. • Identify opportunities for serving the Gulf Cooperation Council (GCC) region, and beyond, in carefully targeted service areas. This could include partnerships with internationally recognized organizations. • Explore the development of clinical national reference laboratory services, and nation-wide referral procedures. The policy-relevant service mapping exercise will inform this process (output 1.1.2). • Implement recommendations for establishing clinical national reference laboratory services, and nationwide referral procedures. • Establish a non-clinical national reference laboratory, and nation-wide referral procedures. • Develop nation-wide guidelines and referral procedures for agreed overseas reference clinical and non-clinical laboratories (NHS Project 6.2). • Develop standardized laboratory proposal evaluation and approval processes through the Capital Expenditure Committee and a national CON process (NHS Project 6.5). • Increase, as appropriate, on-site primary health care provision of high- frequency, low- and medium-complexity tests (NHS Project 1.1). • Identify areas for private sector involvement that enhance health outcomes or have financial benefits, including outsourcing public clinical laboratory services and SCH non-clinical laboratory services. • Identify opportunities for enhanced geographical coverage, including the establishment of a community-based clinical laboratory network for select high-frequency tests. • Establish effective laboratory provider reimbursement mechanisms that reduce provider incentives for duplication and gaps. These can be a hybrid between fee-for-service, capitation and risk adjustment to balance the trade-offs between efficiency, quality and equity (NHS Project 6.3). 1.3 Implementation Responsible Organizations • Clinical Laboratories: o The SCH monitors and regulates services. o The SCH and the National Health Insurance Company (NHIC) will determine provider payment mechanisms under SHI. • Non-Clinical Laboratories: o Drugs: the SCH registers and regulates drugs. o Food Safety: the SCH inspects imported food at border checkpoints, screens food handlers, and operates the Central Food Laboratory. MMUP is responsible for domestic food production and processing. The SCH is establishing FSA as the single food safety body (NHS Project 3.10). o Environmental Health and Air Quality: the SCH and MoE share regulation. o PWA, in collaboration with the SCH, is designing a national reference non-clinical laboratory. • Research Laboratories: o The SCH regulates and coordinates health research. o QF is establishing the digital Qatar National Research Observatory on research activity in Qatar. 20 GOAL 2: Integrated Information 21 In most cases, accurately completing a laboratory test is just one step in the process of treating a patient. Unless the outcome of that test can be securely shared with the appropriate clinicians or health professionals in a timely manner, the information cannot be used to effectively diagnose or treat a patient. This means that laboratory services are among the most information-intensive systems. When integrated with hospital information systems, they enable presentation and transfer of electronic test results by laboratory physicians, prescribing by hospital physicians, and retrieval by community pharmacists. Laboratory activity, process and output data is important for laboratory planning, monitoring and regulation. It helps determine the appropriateness and timeliness of results, and utilization and cost trends. 2.1 LIMS Integration 22 Background Laboratory information management systems (LIMS) LIMS contain personal health and other sensitive data. To protect patient privacy and confidentiality, it is important that this data is securely and appropriately stored, transmitted, disclosed and managed [34, 35]. Laboratories can achieve this through implementing standards that cover these areas. Government regulation and guidelines can enable and ensure this is done. manage laboratory information, including information relating to samples, data, documents, workload, equipment, personnel, and regulatory compliance. Paper-based LIMS are difficult to update, share with others, and are vulnerable to physical loss or damage. They often lead to unnecessary test duplication, and can impair patient care. Conventional mail, facsimile, or telephone reports are less timely and complete in disease surveillance than electronic laboratory results reports [31, 32]. The International Organization for Standardization (ISO) has several standards related to information security, including ISO 27799:2008, which is specific to health information. Software-based LIMS are easier to update and share with others, and are less vulnerable. They are also able to directly interface with laboratory equipment and electronically capture test results, which can reduce human error. Configurable software-based LIMS adapt to ever-changing needs, and link with other system versions or systems. Bidirectional software-based LIMS interface with other users and other electronic information systems, such as hospital information systems. These have been proven to have a significant impact on improving patient care [33]. 80% 70% 69% 60% 50% 40% 30% 45% 34% 25% 20% 10% Figure 10. Impact of Software-based Programs Compared with Non-Computer Practices [33] 2.1 LIMS Integration 23 Current Status New Directions • There is limited LIMS integration within and between providers. • Many of Qatar’s laboratories rely on paper-based information systems. Patient tests are often duplicated, and test results are re-inputted manually at different sites. • Often times software-based LIMS are standalone (not configurable or bi- directional). They do not facilitate linking results to specific episode numbers within the systems. • Most providers have plans to introduce or upgrade software-based LIMS, as part of wider information technology plans (see next Section). These plans will allow connectivity between some key providers, like HMC and PHCC. • There is no regulation around personal health data. The Supreme Council of Information and Communication Technology is developing a Personal Data Protection Law. It will include health information.The SCH will develop and implement a health information privacy policy, and is developing a national e-Health Strategy in order to improve connectivity between all stakeholders (NHS Projects 23. and 2.4). It will define policies on health data confidentiality and information security, and recommend national data and information exchange standards. • Support and mandate, as appropriate, the implementation of software- based, configurable, bidirectional LIMS by as many providers as possible (NHS Project 2.4). • Implement, as appropriate, software-based, configurable, bidirectional LIMS. • Regulate laboratory patient confidentiality and information security (NHS Project 2.4). This includes standards for the secure storage, transmission and management of data. 2.2 LIMS and HIS Integration Hospital information systems (HIS) store, retrieve and manipulate administrative and clinical information. When integrated with LIMS, they enable the transfer of electronic test results by laboratory physicians to hospital physicians. 24 When integrated with PACS, LIMS and HIS, pharmacy information systems (PIS), which store medication supply, utilization and management, enable prescribing by hospital physicians, and retrieval by community pharmacists. This helps ensure that patients receive the correct and timely medication. Tools that facilitate and enable HIS include electronic health records, electronic health cards, picture archiving The standardized storage and retrieval of diagnostic information requires consistently described services communications systems, and pharmacy information to minimize error. systems (PIS). Medical records store details of patient history. Electronic medical records, or electronic health records (EHR), enable diagnostic test results to be viewed by different providers simultaneously. 75 Percent of respondents to a 2012 Study in Qatar rated the “quality of medical records‟ as” extremely important‟ [2]. The standard diagnostic tool for disease classification is the International Classification of Diseases (ICD). Electronic health cards (EHC), with unique patient identifier numbers, enable ordering and reporting of test results electronically between institutions. The establishment of information system connectivity requires a common information database and data standards for improved patient care and utilization management. When supported by EHR systems, picture archiving communications systems (PACS), which acquire, sort, transport and sort medical images, allow physicians to view digital images of diagnostic tests from multiple sites. This helps ensure patients have the best possible clinical advice. Images can be re-examined, compared over time, and shared around the world. Integrating and sharing laboratory and hospital information appropriately must also take into account appropriate levels of patient privacy and confidentiality by ensuring data is securely and appropriately stored, transmitted and managed. This includes regulation and guidelines. 2.2 LIMS and HIS Integration 25 Current Status • There is limited LIMS and HIS integration within and between providers. Many of Qatar’s HIS are paper-intensive. Provider information technology (IT) infrastructure is often decentralized, with non-integrated systems. Public providers are implementing a system-wide IT solution (Cerner Millennium), which includes integratable HIS and LIMS. Private providers are also planning to improve their IT infrastructure. • The SCH e-Health Strategy will define the scope of e-health, such as the possible inclusion of EHR, HIS, and PACS (NHS Project 2.4). • Most public and private provider medical records are paper-based. Public provider medical records are not centralized and standardized. Therefore, in some cases, patients have multiple records per provider. Public providers are implementing EHRs. • There are no EHCs. Over the next couple of years, the SCH will introduce EHCs for the entire population through SHI implementation (NHS Project 6.3). The EHCs will be part of the Qatar national ID cards (known as QID cards). • Most providers conduct their own coding, ranging from in-house systems to different international ones. In 2012, the SCH mandated a uniform coding system across all healthcare providers (ICD-10-AM). It is currently supporting provider implementation (NHS Project 6.3). • There is limited collection of laboratory activity, process and output information. The SCH collects data on its laboratory activity, and is developing a national healthcare data warehouse, and the Qatar Health Observatory (NHS Project 2.3). In 2012, the SCH disseminated the first minimum data set requirements for healthcare providers. As this was part of SHI implementation preparedness, it did not extend to laboratory information (NHS Project 6.3). The SCH developed performance agreements with healthcare providers that will include reporting of key performance indicators (NHS Project 2.1). The SCH will further define and disseminate healthcare data reporting requirements, including national nomenclature (NHS Project 2.3). 2.2 LIMS and HIS Integration New Directions • Support and mandate, as appropriate, the implementation of software-based, configurable, bidirectional HIS, PACS and PIS by as many providers as possible (NHS Project 2.4). • Implement, as appropriate, software-based, configurable, bidirectional HIS, PACS and PIS. • Implement EHRs. • Implement EHCs for the entire population (NHS Project 6.3). • Identify other e-health and system requirements beyond LIMS, HIS, PACS, PIS, EHRs and EHCs, as appropriate (NHS Project 2.4). • Implement a unified coding system across all providers for diagnostic and procedure information (NHS Project 6.3). • Develop and mandate relevant laboratory information reporting requirements and standards (NHS Projects 2.1, 2.3, 2.4 and 6.3). 2.3 Implementation Responsibilities • The SCH monitors and regulates healthcare and testing services. • The SCH and the NHIC will establishappropriate systems for the access, management, collection, analysis and use of information. 26 GOAL 3: Standardized Workforce 27 Laboratory services are complex and require a highquality workforce, with standardized knowledge, skills and experience. This is essential for providing adequate and consistent laboratory services. Respondents to a 2012 Study rated the quality/ expertise of medical specialists as the single most important factor in ultimately deciding where to go [2]. A global shortage in laboratory personnel, and Qatar rapid laboratory development, necessitate well-targeted workforce development and regulation processes. Quality/expertise of medical specialists 87 Respect for patients irrespective of race, nationality and religion 84 Quality of services available 81 Availability of advanced medical technology 80 Speed of registration 78 Quality of nursing/auxiliary staff 78 Range of specialties available 77 Doctor's reputation/qualifications 76 Quality of medical records 75 Compassion towards patients 67 Modern facilities 61 Cost 57 Proximity to work/home 40 Recommendations from family/friends (%) 36 0 20 40 60 80 100 Figure 11. Importance of Specific Factors in Ultimately Deciding Where to Go, Qatar, 2012 [2] 1 3.1 Workforce Development 28 Background The laboratory health workforce includes physicians, nurses, and allied health professionals.18 The development of this workforce is informed by workforce planning, which includes examining sector plans, making workforce projections,19 and laying out a framework for recruitment and workforce development. 20 Academic education is an important foundation and requirement for laboratory personnel, building the knowledge and expertise for improved patient outcomes. Specialization areas and definitions differ between jurisdictions and needs. Four main areas of specialization for clinical laboratory personnel are hematology, histopathology, microbiology and clinical chemistry. The American Board of Pathology acknowledges additional ones21, such as cytopathology and blood banking/transfusion medicine [36]. Without appropriate training, the likelihood of erroneous test results increases substantially [37]. Continuing professional development (CPD) consists of profession-specific education and training. It helps professionals stay current on technological advances and best practices. Often employers and regulators have CPD requirements. Cytotechnologists pathologists who additional training diagnostic technology have more consistent and reliable diagnoses that those who did not [38]. Professional training provides technical skills and practical experience. Lab personnel often work with sensitive or hazardous materials, so key training areas include quality management and workplace safety. Other training areas include non-technical skills such as communication, language, business development, information technology (IT) and project management skills. 18) Allied health professionals provide diagnostic, technical and other support services. They include some laboratory personnel. 19) Workforce projections are commonly made for a period of 10-20 years. 20) In this document, workforce development refers to academic education, professional training, and continuing professional development. 21) These include anatomic pathology and clinical pathology, blood banking/transfusion medicine, chemical pathology, cytopathology, dermatopathology, forensic pathology, hematology, medical microbiology, molecular genetic pathology, neuropathology and pediatric pathology [36]. 3.1 Workforce Development 29 Current Status • Qatar’s laboratory workforce grew at an unprecedented rate, and service demand continues to rise (see Introduction). Qatar’s population recently grew at its fastest rate, an 89 percent increase since 2005. However, the number of laboratory technologists more than doubled since 2005 [24]. To ensure the appropriate workforce to meet service demands, the SCH is developing a national health workforce plan for the next five, ten and 15 years, which will include workforce projections (NHS Project 4.1). 1400 1,248 1200 1,026 934 1000 761 800 604 638 2005 2006 600 400 200 2007 2008 2009 2010 Figure 12. Laboratory Technologists, Qatar, 2005-2010 [24] • This growth requires effective recruitment and retention. However, Qatar faces shortages in laboratory personnel, compounded by global shortages and mobility restrictions. LSA stakeholders noted uncompetitive salaries and an unattractiveness for laboratory work. The NHS noted unclear immigration processes, few career progression opportunities and salary caps since 2009. The SCH is identifying ways to enhance recruitment and retention (NHS Project 4.2). • The LSA found no standard roles, terminologies, job titles and descriptions, and skill mixes for personnel between institutions, due to the use of different international best practices. Some institutions follow the British, American or other models. The NHS reported that allied health professionals can be better utilized, and their skill mix and roles optimized. The SCH is exploring way to do this (NHS Project 4.1). • Stakeholder consultations reported limited local and regional opportunities for academic education, professional training and CPD. o There are gaps in the main specialization areas for clinical laboratories; and specialization areas for non-clinical and health research laboratory like bioinformatics, biotechnology, and pharmacology. There is a gap in two- and four-year qualification programs for technicians and technologists. There are insufficient courses and training in quality management, workplace safety and biosafety. o Qatar University is the only Middle East institution offering a personnel certification program, approved by the United States National Accrediting Agency for Clinical Laboratory Science [13]. Sharjah University, in the United Arab Emirates, offers training towards certification by the American Society for Clinical Pathology (ASCP) [13]. o Education, training and CPD in non-scientific skills (e.g., management, IT) were found to be undervalued, though necessary for high- quality laboratory work. o The NHS reported that health care has limited appeal, and that tuition fees are perceived as somewhat high. The SCH is exploring ways to improve the attractiveness of, and access to, advanced education in health-related subjects (NHS Project 4.3). 3.1 Workforce Development New Directions • Develop a laboratory workforce plan and projections for the next five, ten and fifteen years (NHS Project 4.1). This should include appropriate categories of laboratory personnel. o For clinical laboratories, these would need to include laboratory directors/managers, pathologists/clinical, consultants, technical/ non-clinical consultants, laboratory technologists, laboratory technicians, technical assistants and lab aides/assistants. o These should cover at least the four main areas of hematology, histopathology, microbiology and clinical chemistry. o It must cover different levels of seniority (e.g. senior and junior laboratory technologists). o For non-clinical laboratories, these would need to include laboratory directors/managers, scientists/specialists, technologists and technicians. o It must cover different areas and levels of expertise, such as senior scientific or non-scientific supervisor. • Improve the recruitment and retention of relevant laboratory personnel categories (NHS Project 4.2). • Optimize laboratory workforce skill mix and roles for all appropriate personnel categories (NHS Project 4.1). • Support and improve local opportunities for highlighted and additional, scientific and non-scientific, laboratory education, training and CPD (NHS Project 4.3). Qatar University, Carnegie Mellon and Weill Cornell Medical College in Qatar are well-placed to consider extending scientific academic education and training opportunities. • Develop opportunities for Qatar’s regionally-leading laboratories to offer training and/or work placements (NHS Project 4.3). • Identify opportunities to fill regional education, training and CPD gaps (NHS Project 4.3). 30 3.2 Workforce Regulation Background 31 Current Status • The fast growth rate of Qatar’s laboratory personnel has placed considerable strains on the standardization of their knowledge and skills. The NHS reported that nationals comprise only 5-10 percent of Qatar’s healthcare workforce [12]. • The SCH undertakes credentialing for all licensed laboratory personnel. • The SCH is now also conducting retrospective verifications. • The SCH does not mandate certification for any categories of laboratory health practitioners. Several individuals have applied for voluntary certification by ASCP. • The SCH mandates registration and licensing requirements Credentialing establishes the legitimacy of personnel for several categories of clinical laboratory personnel, and qualifications (such as through objective primary source health research laboratory personnel working on human verification). subjects. This applies to laboratory physicians (specialists in pathology, heamatology, microbiology etc.), laboratory Certification is the standardized affirmation of technicians, and laboratory technologists. However, these personnel’s knowledge and experience base by requirements are not enforced at HMC, which conducts its governmental or non- governmental organizations own licensing processes. (usually through an examination). The most common • The SCH determines whether registration and licensing approach is certification through the ASCP Board of are required for practitioners working in other types of Certification (ASCPi designation). laboratories, including health research laboratories, on a case-by-case basis. • The SCH mandates annual licensing revalidation for all Laboratory personnel certification is linked to health care professions, including laboratory health higher quality testing and performance [39]. practitioners (Law No. 2 of 1983). • The SCH is revising healthcare professional regulation, and is establishing Qatar Council for Health Practitioners (QCHP) as Registration affirms personnel’s eligibility to work, the sole regulator for licensing and credentialing all health against minimum professional standards. professionals (NHS Project 5.2). Workforce regulation outlines personnel requirements to ensure high-quality staff. The work of laboratory personnel is key in identifying and investigating disease. Requirements for laboratory personnel differ across personnel categories and jurisdictions. They often include credentialing, certification, registration and licensing. These requirements establish and enforce standards around education, knowledge, skills and experience. Licensing grants personnel with legal authority to undertake approved activities. Renewing licenses periodically, Known as licensing revalidation, ensures practitioner compliance with up-to-date standards. Testing by licensed medical technologists has been found to be superior to that by non-licensed laboratory professionals [40]. Of the six most commonly licensed healthcare personnel categories, four relate to laboratory work (physicians, nurses, medical technologists and radiologic technicians). 3.2 Workforce Regulation New Directions • Review credentialing requirements to cover relevant laboratory personnel categories (NHS Project 5.2). • Conduct retrospective verification of all relevant laboratory personnel categories (NHS Project 5.2). • Develop appropriate certification requirements for relevant laboratory personnel categories (NHS Project 5.2). • Review and enforce registration, licensing and revalidation requirements to cover relevant laboratory personnel categories (NHS Project 5.2). This will include CPD requirements. • Develop regulatory requirements that ensure patient safety while also not hindering recruitment and retention efforts (NHS Project 5.2). 3.3 Implementation Responsibilities • The Supreme Council for Education (SCE) is responsible for overall education and training. • The SCH is responsible for health workforce regulation. • The QCHP will be the sole regulator for licensing and credentialing all health professionals. 32 GOAL 4: Standardized Outputs 33 Standardized laboratory outputs are essential to ensure a common basic level of quality, and protect patient safety. This requires standardized processes, devices and facilities. Health outcomes depend on the accuracy of testing. Incorrect test results can have serious consequences, such as unnecessary or incorrect treatment, treatment complications, failure to provide proper treatment, and delay in the correct diagnosis [41]. Laboratory quality is generally defined by the accuracy, reliability and timeliness of test results. It is directly linked to health outcomes and patient safety [41]. The importance of laboratory quality is wellrecognized. In fact, the quality of services available, including lab tests, magnetic resonance imaging scans and x-Rays, was rated as “extremely important” by over 80 percent of respondents to a 2012 Study in Qatar [2]. Almost all Qatari nationals considered these as “extremely important”. 100% 90% 81% 80% 60% 40% 20% Qatari Respondents Overall Respondents Figure 13. Importance of Quality of Services in Ultimately Deciding Where to Go, Qatar, 2012 [2] 4.1 Standardized Processes 34 Background Standardized laboratory processes enable laboratory quality by ensuring test results are accurate, reliable and timely. This is done by using quality standards, which are voluntary or mandatory requirements that are fulfilled to demonstrate quality. They can cover technical competence requirements and management system requirements. According to the World Health Organization (WHO), laboratories that do not implement a good QMS are guaranteed to have undetected errors and problems [41]. QMS activities include quality assurance, quality control and quality improvement [42]. These activities can be done internally or externally. • Quality Assurance ensures that quality standards will be met. • Quality Control monitors whether quality standards are met. • Quality Improvement increases the ability to meet present and future quality standards. QMS and laboratory quality are evaluated by External Quality Assessment Schemes (EQAS). Some QMS require EQAS for compliance. Laboratories often use internationally- recognized quality standards, as they ensure consistency across countries and a minimum level of quality. Common laboratory internationally-recognized standards include several ISO standards. A best practice to achieve standardized laboratory processes is the implementation of a Quality Management System (QMS). QMS is a system of coordinated activities used to monitor laboratory processes and quality. In Thailand, participation in an EQAS was found to be a key first step to improved laboratory quality [43]. Policy levers can be used to incentivize process and output quality. These include linking provider payment mechanisms to output quality, and making activity, process and output data publically available. This holds providers accountable to the public and enhances patient choice. It also enables and enhances independent research, which supports policy making. 4.1 Standardized Processes 35 Current Status New Directions • There are no mandated QMS for laboratories in Qatar. Some laboratories have their own voluntary QMS. • There are no mandated EQAS for laboratories in Qatar. Some laboratories conduct their own internal or external quality assessments. • The SCH is establishing standards for all health care facilities, including laboratories (NHS Project 5.3) • There are limited policy incentives for improved process and output quality. • Mandate a QMS solution that meets approved international quality standards (NHS Project 5.3). • Mandate routine EQAS that meet approved international quality standards (NHS Project 5.3). This is especially important for the work of private laboratories, which the LSA found stakeholder concerns about. • Regularly publish laboratory quality and other relevant laboratory information (NHS Project 2.1). • Link provider reimbursement to performance, particularly process and service quality (NHS Project 6.3). • Identify and develop other positive incentives for improved laboratory processes and outputs (NHS Project 2.1). o o o There are no output reporting requirements. The SCH performance agreements with healthcare providers will include reporting of key performance indicators (NHS Project 2.1). There are no data publishing requirements for laboratory outputs. For instance, provider reimbursement is not linked to service necessity and quality. Provider payment mechanisms are not linked to performance, or to service process and output quality. 4.2 Standardized Devices 36 Background Diagnostic medical devices include a vast range of equipment, from simple instruments to chemical reagents to complex diagnostic machines. Many of these devices are essential for testing accuracy and patient safety. As such, it is important to assure their quality, including safety, effectiveness and performance. Laboratories must also appropriately use and dispose of these devices. • Pre-market control addresses the production of devices to ensure that devices to be placed on the market comply with requirements (e.g., safety, performance, quality systems and labeling requirements). All devices used for measuring substances must be regularly calibrated, validated and verified to ensure they are accurate and reliable [44]. In the European Union, manufacturers must receive a certificate of compliance for certain devices [47]. Government oversight ensures laboratories have access to high quality diagnostic medical devices. However, not all devices require the same level of regulation. Devices can be classified based on a number of factors, including degree of risk and invasiveness, to determine the level of regulation necessary [45]. • Placing-on-market control addresses the sale of devices to ensure that devices being sold comply with requirements (e. g., establishment registration, device listing and after-sale obligations). Health technology assessment is the evaluation of properties, effects, and impacts of technology. It is closely linked with determining the level of the regulation required for devices [46]. In the United States, certain vendors, including importers, must register with the Food and Drug Administration [48]. Government oversight can involve regulatory intervention • Post-market control addresses after sale obligations along the device’s lifespan, from the manufacturer to the and provides surveillance to ensure the continued vendor to the user. These will depend on the level of safety and performance of devices in use (e.g., regulation required. These interventions are commonly obligations on the manufacturer, vendor, or user to referred to as pre-market, placing-on-market, and report problems with the device). post-market controls [45]; There are other devices used in laboratories (particularly non-clinical laboratories) that are not considered medical devices, but are also essential for testing accuracy and safety. Different levels of regulation of these devices, where appropriate, are also important. For example, laboratories could be required to maintain documentation of device calibration, verification and validation as part of facility regulation. 4.2 Standardized Devices 37 Current Status New Directions • The SCH is responsible for health technology assessment. This includes select diagnostic medical devices. • There is no standardized regulation of relevant diagnostic medical devices in Qatar. Ad-hoc inspection takes place as part of facility regulation. • The SCH has drafted legislation related to the regulation and registration of laboratory and diagnostic kits, and other medical devices (NHS Project 5.4). • The SCH is establishing a medical registration unit (NHS Project 5.4). It is expected to be established by 2016. • The SCH will be establishing a national registry of specialized research equipment for the purpose of coordination among institutions (NHS 7.1). • Review drafted legislation for the regulation and registration of diagnostic medical devices. Determine the levels of regulation and the interventions required for the different types of devices, including establishing pre- market, placing-on-market and post-market controls, where appropriate. • Develop appropriate types of regulation for diagnostic medical devices, as necessary, where gaps exist (NHS Project 5.4). • Ensure the medical registration unit implements and enforces regulations for diagnostic medical devices (NHS Project 5.4). • Establish appropriate mechanisms to regulate nonmedical laboratory devices, as necessary (NHS Project 5.4). 4.3 Standardized Facilities 38 Background Current Status Setting laboratory facility requirements and mechanisms for their enforcement creates standardized facilities, and ensures a standardized level of quality and safety that is both traceable and auditable. • The SCH mandates licensure for some providers. It licenses all private sector clinical laboratories, and research laboratories undertaking clinical work. It requires these licenses to be renewed annually. Other types of laboratories are licensed on a case-by-case basis. • The SCH does not mandate accreditation for any laboratories at this time. This process, known as facility regulation, can include, among other things, requirements around services, information systems, personnel, quality systems, devices, waste disposal and the building environment. Facility regulation involves processes such as licensure and accreditation. • Licensure grants a facility with the legal authority to undertake approved activities. One of its requirements can be accreditation by a particular national or international body. • Accreditation is the formal recognition, usually by an independent body, of a facility’s competency to carry out specific tasks based on standards set by government or an independent body (through a site visit and observation of personnel). Accreditation bodies can use national or international standards. Accredited laboratories tend to perform better |on proficiency testing and are more likely to have a QMS [49]. o o Only a few providers have sought accreditation. They have been accredited by some of the world’s leading organizations, such as the CAP, JCI, and ISO standards (9001:2008). Most key providers have made immediate plans, or are under assessment for, voluntary international accreditation that meet ISO 17025 and ISO 15189 (international laboratory) standards. Sought organizations include Accreditation Canada International, American Association of Blood Banks, American Society of Histocopatibility and Immunogenetics, Association of Official Racing Chemists, CAP, JCI, the World Anti-Doping Agency and the Foundation for the Accreditation of Cellular Therapy. • The SCH has developed plans for a National Accreditation Body, which will offer and support healthcare providers with licensing, national accreditation and international accreditation Facility licenses and accreditations must be revalidated New Directions on a regular basis to ensure continued compliance with requirements. This is commonly done through on-site • Mandate and enforce licensure for all laboratories inspections, audits and other processes. Many in all sectors (NHS Project 5.3). international accreditation organizations require • Adopt appropriate national and/or international revalidation on a biennial or triennial basis. For example, accreditation requirements that meet international the Joint Commission International (JCI) requires it every standards, particularly ISO 15189. These can include two years, and Accreditation Canada International, the not only CAP and JCI, but also the European CoFoundation for the Accreditation of Cellular Therapy, and peration for Accreditation, the South African National the College of American Pathologists (CAP) and require it Accreditation System, and the National Association of every three years [50, 51, 52, 53]. Testing Authorities in Australia (NHS Project 5.3). 4.4 Implementation 39 Responsibilities • The SCH regulates health facilities, and healthcare products. • The SCH is establishing the National Accreditation Body to grant accreditation to health facilities. Conclusion 40 As Qatar’s population continues to grow, its health care system is expanding and adapting to better meet increasing service demands and changing health needs. Informed by the QNV and the NHS, the Government of Qatar is leading this health system reform. The Government is providing enhanced oversight, guidance and support to ensure the quality, safety, effectiveness and appropriateness of current and future services. Laboratories and their personnel have an integral role in the diagnosis and treatment of disease, helping to achieve positive health outcomes and forming an important part of the health care system. The significant increase in laboratory test activity and the sustained shortages in qualified laboratory health personnel have put strains on Qatar’s laboratories. Further Government oversight, guidance and support in this important area are needed to overcome these challenges and facilitate improved services. The National Laboratory Standardization and Integration Strategy 2011-2018 provides this direction through its four goals: the standardization and integration of laboratory services, information management, workforce and outputs. This will maintain and enhance the quality, safety, effectiveness and appropriateness of laboratory services as they expand and adapt within the broader health care system. The recommendations in the Strategy articulate and raise awareness of laboratory-specific reforms that are necessary for the health care system’s success. They also build on existing policies and align with NHS projects. It is envisioned that the Strategy will be implemented in a phased approach, with completion by 2018. This will allow for certain foundational or inter-dependent NHS projects to advance or come to completion. As implementation progresses, the Strategy will be reviewed and, if necessary, refreshed to reflect the changing health care landscape in Qatar and any new Government priorities. This, along with continuous stakeholder engagement, will help establish world-class laboratories that are dynamic, flexible and adaptable to meet Qatar’s population needs. Appendix 1 41 GOAL 1: INTEGRATED SERVICES Recommendation 1.1: Map and Project Services Outputs Timeline Responsibility 1.1.1 - Establishment of National Laboratory Committee. Q3 2013 SCH 1.1.2 - Development of policy-relevant service mapping and projections, which links with existing work. Q4 2013 SCH Outputs Timeline Responsibility 1.2.1 - Support of appropriate facility-level centralization. Ongoing SCH, MoE, QF MMUP, FSA 1.2.2 - Identification and support of intra-provider integration (QNRS Goal EW.2.2; NHS Project 7.1). Ongoing SCH, NLC, QF 1.2.3 - Identification of laboratories, and development of processes for designation into centers of excellence. Q4 2015 SCH, NLC 1.2.4 - Identification of opportunities to serve the GCC region, and beyond. Q4 2016 SCH, NLC 1.2.5 - Exploring of the development of clinical national reference laboratory services, and referral procedures. Q4 2016 SCH, PWA 1.2.6 - Implement recommendations for establishing clinical national reference laboratory services, and nation-wide referral procedures. Q1 2018 SCH, PWA 1.2.7 - Establishment of a non-clinical national reference laboratory, and referral procedures. Q4 2016 SCH, PWA 1.2.8 - Development of guidelines and referral procedures for agreed overseas reference laboratories (NHS Project 6.2). Q4 2016 SCH 1.2.9 - Development of standardized laboratory proposal evaluation and approval processes (NHS Project 6.5). Q4 2014 SCH 1.2.10 - Increase in on-site, appropriate PHC services, and establishment of standard referral and feedback for off-site test (NHS Project) Q4 2013 SCH, PHCC 1.2.11 - Identification of areas for optimal integration and partnerships between private and public sectors. Q4 2013 Ongoing SCH, NLC 1.2.12 - Identification of opportunities for enhanced geographical access, including the establishment of a community-based clinical laboratory network. Q4 2013 SCH, NLC 1.2.13 - Establishment of laboratory provider reimbursement mechanisms which disincentivize duplication and gaps (NHS Project 6.3). Q4 2013 Ongoing SCH, NHIC Recommendation 1.2: Integrate Services Appendix 1 42 GOAL 2: INTEGRATED INFORMATION SYSTEMS Recommendation 2.1: Integrate LIMS Outputs Timeline Responsibility 2.1.1 - Support and mandating, as appropriate, of configurable, bidirectional LIMS (NHS Project 2.4). Q4 2016 SCH 2.1.2 - Implementation, as appropriate, of configurable, bidirectional LIMS. Q4 2016 Providers 2.1.3 - Regulation of laboratory patient confidentiality and information protection (NHS Project 2.4). Q4 2016 SCH Outputs Timeline Responsibility 2.2.1 - Support and mandating, as appropriate, of configurable, bidirectional HIS, PACS and PIS (NHS Projects 2.4). Q4 2016 SCH 2.2.2 - Implementation, as appropriate, of configurable, bidirectional HIS, PACS and PIS. Q4 2016 Providers 2.2.3 - Implementation of EHRs Q4 2016 Providers 2.2.4 - Implementation of EHCs (NHS Project 6.3). Q4 2014 SCH 2.2.5 - Identification and mandating of other appropriate e-health requirements (NHS Project 2.4). Q4 2013 SCH 2.2.6 - Implementation of a unified coding system (NHS Project 6.3). Q4 2014 Providers 2.2.7 - Development and mandating of laboratory information reporting requirements (NHS Projects 2.4 ,2.3 ,2.1 and 6.3). Q4 2015 SCH Recommendation 2.2: Integrate LIMS and HIS Appendix 1 43 GOAL 3: STANDARDIZED WORKFORCE Recommendation 3.1: Improve Workforce Planning and Development Outputs Timeline Responsibility 3.1.1 - Identification of future demand, and proposals for meeting the demand, for laboratory workforce (NHS Project 4.1). Q4 2013 SCH 3.1.2 - Improvement in laboratory workforce recruitment and retention (NHS Project 4.2). Q4 2015 SCH 3.1.3 - Optimization of laboratory workforce skill mix and roles (NHS Project 4.1). Q4 2013 SCH 3.1.4 - Support and improvement in local scientific and non-scientific laboratory education, training and CPD opportunities (NHS Project 4.3). Q4 2016 SCH, SCE 3.1.5 - Offer of training and/or work placements by Qatar’s leading laboratories (NHS Project 4.3). Q4 2016 SCH, NLC 3.1.6 - Identification of opportunities to fill regional education, training and CPD gaps (NHS Project 4.3). Q4 2016 SCH, NLC Outputs Timeline Responsibility 3.2.1 - Review of laboratory workforce credentialing requirements (NHS Project 5.2). Q4 2018 SCH, QCHP 3.2.2 - Retrospective verification of laboratory personnel (NHS Project 5.2). Q4 2018 SCH, QCHP 3.2.3 - Development of laboratory workforce certification requirements (NHS Project 5.2). Q4 2018 SCH, QCHP 3.2.4 - Review and enforcement of laboratory workforce registration, licensing and revalidation requirements (NHS Project 5.2). Q4 2018 SCH, QCHP 3.2.5 - Development of regulatory requirements that do not hinder recruitment and retention efforts (NHS Project 5.2). Ongoing SCH, QCHP Recommendation 3.2: Improve Workforce Regulation Appendix 1 44 GOAL 4: STANDARDIZED OUTPUTS Recommendation 4.1: Standardize Processes Outputs Timeline Responsibility 4.1.1 - Mandating of appropriate QMS (NHS Project 5.3). Q4 2014 SCH 4.1.2 - Mandating of appropriate EQAS (NHS Project 5.3). Q4 2014 SCH 4.1.3 - Regular publication of laboratory information (NHS Project 2.1). Q4 2016 SCH 4.1.4 - Establishment of link between provider reimbursement and service quality (NHS Project 6.3). Q4 2016 SCH 4.1.5 - Identification and development of other positive incentives (NHS Project 2.1). Q4 2016 SCH, NLC Outputs Timeline Responsibility 4.2.1 - Establishment of diagnostic medical device regulation (NHS Project 5.4). Q4 2014 SCH 4.2.2 - Inclusion of appropriate laboratory devices in Medical Registration Unit’s work (NHS Project 5.4). Q4 2014 SCH 4.2.3 - Establishment of non-medical laboratory device regulation, where necessary (NHS Project 5.4). Q4 2016 SCH Outputs Timeline Responsibility 4.3.1 - Mandating and enforcement of laboratory facility licensure (NHS Project 5.3). Q4 2016 SCH 4.3.2 - Development and mandating of national and/or international accreditation requirements (NHS Project 5.3). Q4 2016 SCH Recommendation 4.2: Standardize Devices Recommendation 4.3: Standardize Facilities Appendix 2 The SCH conducted consultations with twenty six representatives from fourteen of Qatar’s leading testing and research laboratory providers. A Laboratory Situational Analysis of their laboratories (over 50) was also conducted. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) (14) Anti-Doping Lab Qatar Aspire Zone Foundation (Aspire Academy for Sports Excellence) Hamad Medical Corporation Ministry of Environment Ministry of Interior Primary Health Care Corporation Qatar Armed Forces Qatar Orthopaedic and Sports Medicine Hospital (Aspetar) Qatar Petroleum Qatar Science and Technology Park Ras Laffan Army Clinic Shafallah Medical Genetics Center Sidra Medical and Research Center Supreme Council of Health 45 Appendix 3 46 LABORATORY INTERDEPENDENCY IN THE STATE OF QATAR: LABORATORY SITUATIONAL ANALYSIS Questions: 1. 2. 3. Details of present laboratories (Name, Laboratory Personnel Headcount, Laboratory Equipment Headcount) Details of future laboratories (Name, Expected Completion Date, Expected Lab Personnel Headcount, Expected Lab Equipment Headcount) Details of Laboratory Analytical Capabilities o Clinical Diagnosis and Metabolic Disorders i. Newborn screening for inborn errors of metabolism (IEM) disorders ii. Organic acid analysis using GC/MS iii. Quantification of amino-acid in blood iv. Quantification of homocysteine in blood v. Analysis of haemoglobin isoforms as a diagnostic approach for thalassemia vi. Clinical chemistry tests or analysis vii. Hormones (immuneassay tests) viii.Bloodgases ix. Hematology tests (CBC) x. Urine analysis xi. Trace elements (lead, mercury, cadmium and copper) xii. Fatty acid xiii.C-peptide xiv. Sickle cell screening xv.Vitamins xvi.DNA xvii.Microbiology xviii.Virology xix.Flowcytometry o Molecular Genetics Tests o Tissue Typing and Tissue Compatibility o PCR o Forensic Analysis and Drugs of Abuse Testing i. Narcotics (including morphine, codeine and heroin (6-monoacetylmorphine)) ii. Amphetamines (stimulants, including methamphetamine, ecstasy (MDMA), MDEA, MDA and ephedrines) iii.Alcohol iv. Marijuana/cannabis (through its metabolites, THC carboxylic acid) v.Benzodiazepines vi.Barbiturates vii. Cocaine (through its metabolite benzoylecgonine) viii.Methadone ix.Propoxyphene Appendix 3 47 o Clinical Toxicology i. Therapeutic drug monitoring of medication with a narrow therapeutic window ii. Quantification of endogenous steroids and hormones required for diagnosis iii. Bioavailability and bioequivalence studies (BABE) of drugs used in the country iv. Quality drug assurance v. Adulterants in herbal and “natural remedies” - aristolochic acid and corticosteroids vi. Drug adulterants in natural products, for example sildenafil, tadalafil and vardenafil in mens’ products o Food Safety and Security i. Analysis of melamine in various food items, such as infant formula and powdered milk, confectionaries and baked food ii. Analysis of acrylamide in processed foods iii. Polyaromatic hydrocarbons (PAHs) iv. Drug residues, including antibiotics like chloramphenicol and nitrofurans, and growth promoters like steroids, stilbenes and agonists. v. 3- Monochloropropanediol (3-MCPD) vi. Quantification of polychlorinated dibenzo-dioxins (PCDDs), polychlorinated dibenzo-furans, (PCDFs) and polychlorobiphenyls (PCBs) in various matrices, including food, airborne particulates, meat and fish, soil and sediments, water, sludge and human milk vii. Phthalates in food and food products viii. Aflatoxins in various grains and nuts ix. Halal testing of food and food products for alcohol or porcine- related components x. Authentication of honey through IRMS analysis 4. 5. o o o o o o o o o o o o o o o Present gaps in provision, and suggestions on addressing the gaps. Information on Clinical/Toxicology Laboratories, Non-Clinical Laboratories (Present, Future), and Research Laboratories Laboratory Accreditation Type of Laboratory (stand-alone, attached to a hospital) Customers Volume of Tests (number of tests per year, other) Location of Tests (in-house; other labs in Qatar, other labs abroad, and which tests, reasons, total annual number) Receipt and Testing of Samples (from own patients alone; from other health care provider labs and which, reasons, total annual number) Readiness to Receive and Test Samples from Other Health Care Providers in Qatar (types of tests, total number, turnaround time for results) Tests Performed and Turnaround Time of Results (routine, specialized) Availability of Point-of-Care Testing in the Health Care Setting, or Mobile Unit Total Budget (in Qatari Riyals) Purchase of Reagents and Consumables (directly from vendor; through intermediary and why) Laboratory State (existing, under construction, planned infrastructure, availability of space for expansion) Hazardous Waste Management (in-house, outsourcing through local company) Present and/or Future Research (type of research, dependency on human samples, use of in-house ethical clearance committee) Availability of a Laboratory Information System Bibliography 48 [1] Harrison, Jeffrey P. and Geoffrey M. 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Last modified May 2012,:http://www.cap.org/apps/docs/laboratory_accreditation/ lap_guide_intl_p art.pdf  Acknowledgments 51 This document would have not been possible without the contribution of the twenty six members of the Laboratory Interdependency Committee. Detailed analysis and comments were provided by the Laboratory Interdependency Sub-Committee members, as follows: 1) Dr. Ahmed Ismail Consultant and Chief Laboratory Services Medical Commission, Supreme Council of Health 2) Dr. Eman Sadoun Manager, Research Division Healthcare Quality and Patient Safety Department Supreme Council of Health 3) Ms. Huda Al-Katheeri Manager, Quality Improvement and Patient Safety Healthcare Quality and Patient Safety Department Supreme Council of Health 4) Dr. Mohamed El Khalifa Senior Consultant and Assistant Chair Department of Laboratory Medicine and Pathology Hamad Medical Corporation 5) Dr. Mohammed Al Sayrafi General Manager Anti-Doping Lab Qatar 6) Ms. Wassan Abdullah Al-Baker Manager, Food Safety and Environmental Health Public Health Department, Supreme Council of Health Specialist advice was provided by Dr. Lee H. Hilborne, Affiliated Adjunct Staff, RAND-Qatar Policy Institute; and Mr. Chris Good Goodman, Chief Executive Officer, Virgin Health Bank, Qatar Science and Technology Park. This document was prepared by Ms. Orsida Gjebrea, Manager, Policy Coordination and Innovation Unit, Office of the Assistant Secretary General for Policy Affairs, Supreme Council of Health. Support was provided by Ms. Chloe Sifton, Researcher, Policy Coordination and Innovation Unit, Office of the Assistant Secretary General for Policy Affairs, Supreme Council of Health. Review of the Strategy was provided by Dr. Salma Khalaf Al Kaabi, Medical Consultant, Office of the Assistant Secretary General for Health Affairs, Supreme Council of Health. Review and guidance were provided by Dr. Faleh Mohammed Hussain Ali, Assistant Secretary General for Policy Affairs, Supreme Council of Health.
