REPOSITIONING OUR CLINICAL LABORATORIES FOR EFFECTIVE AND EFFICIENT HEALTHCARE DELIVERY. By Prof. Ibironke Akinsete Chairman PathCare Nigeria

REPOSITIONING OUR CLINICAL LABORATORIES FOR EFFECTIVE AND EFFICIENT HEALTHCARE DELIVERY. By Prof. Ibironke Akinsete Chairman PathCare Nigeria

Overview of Clinical Laboratories The duties of clinical laboratories consists essentially of analysis of biological samples for purposes of screening, diagnosis, follow-up, treatment and prevention of diseases The aim of the laboratory is to provide not only accurate results but also to do so within a reasonable turn-around time with traceability of laboratory procedures, a respect for ethics and to assure the safety of patients and staff

Cont As human error is always a possibility, it is important to design processes to prevent mistakes from occurring, or at least minimize the risk of errors occurring Implementing a quality system in a medical laboratory should be viewed as a means of improving the service offered to patients, clinicians, and other healthcare organizations The goal should be to provide some guarantee to clinicians and patients that the service they will receive is of high quality

Clinical Laboratory Departments and The laboratory is divided into 2 sections: Anatomic Pathology: Histopathology, Cytopathology, Electron Microscopy Clinical Pathology: Clinical Microbiology, Clinical Chemistry, Haematology, Genetics, Reproductive Biology (Semen Analysis, Sperm Bank, Assisted Reproductive Technology) Units

Human Resources in the Clinical Laboratory Clinical Laboratory Staff Pathologist Clinical Biochemist Pathology Assistant Medical Laboratory Scientist Medical Laboratory Technician Phlebotomist Transcriptionist Secretary Laboratory Management Laboratory Medical Director Laboratory Manager Technical Supervisor Quality Managers

Food for Thought!!! Is there a National Policy and Strategic Plan for clinical laboratories in Nigeria (Public & Private)? Have relevant stakeholders conducted a situation analysis of current state of laboratories in Nigeria? How many laboratories are registered in Nigeria? Who heads these laboratories? How many laboratories are accredited? What standards are employed for accreditation? What is government standard for laboratory performance? What does Act No. 11 of 2003 of the FRN entail?

Issues and Challenges Lack of implementation of National Policy and development of Strategic Plan for laboratory services Insufficient funding Inadequately trained laboratory staff at all levels Weak laboratory infrastructure Old or inadequately serviced equipment Lack of essential reagents and consumables Limited Quality Assurance and control protocols Low priority and recognition for laboratories in most national and state health delivery systems De-emphasis of laboratory testing Insufficient monitoring of test quality

Sources of Laboratory Errors: Pre-Analytical Patient identification Interference from patient medication Patient preparation Specimen Collection-Specimen drawn from wrong patient Specimen mix up wrong name on tube Specimen transport- Deterioration due to heat, light, time Specimen separation / aliquoting- put in wrong tube Data input errors Transcription errors Lack of Standard Operating Procedures

Sources of Laboratory Errors: Analytical You can have the best instruments in the world, but if; SOP s are not followed Poor methodology used Competence compromised Incompetent analyst Control material expired- or infrequent use Accuracy cannot be guaranteed- do not make use of EQA Poor calibration expired calibrators Failure to recalibrate on reagent change Poorly maintained equipment Sampling errors clot in tube -air bubble-insufficient sample then analytical errors will occur.

Sources of Laboratory Errors: Post - Analytical Transcription errors Wrong calculation Results on wrong form TAT Wrong patient results phoned out Incorrectly heard phone call

Practical Scenario 1 Data show that more than two thirds of pediatric febrile illnesses in Africa are not malarial and that accurate diagnosis could drastically reduce the unnecessary use of expensive combination anti-malaria therapy and help ensure that patients receive the correct treatment

Practical Scenario 2 It is estimated that more than 95% of patients with multidrug resistant TB globally are not treated with appropriate second-line drugs, because they are not checked for drug resistance, as mainly only cultures are done

WAY FORWARD: Proposed action to strengthen laboratories in Nigeria.

1. Situation Analysis Need for situation analysis to collect quantitative and qualitative data on the current status of laboratory services on which to base the strategic plan and laboratories

2. Revision & Implementation of Existing National Laboratory Policy Focusing on Laboratory organisation, structure and coordination Staff motivation and retention Integration of services Essential facilities Equipment and maintenance Biosafety and biosecurity Staff training requirements and continuing education Minimum essential techniques S.O.P s for equipment and technologies at each level

3. Formulation of a National Laboratory Strategic Plan (NLSP) It is important to develop a strategy that forms the basis for harmonised planning and realistic annual operational plans Issues to be addressed: Technical Legal Quality Financial Logistical matters Such a plan will implement the National Laboratory Policy to ensure the delivery of effective, efficient, accessible and affordable quality laboratory services at all levels (Private & Public)

4. Establish & Strengthen Laboratory Leadership This is critical for the effective operation and sustainability of laboratory services Laboratory leadership: Is it the Pathologist? Is it the Laboratory Scientist?

5. Set up a National Public Health Reference Laboratory Will operate as a centre of excellence for laboratory services and must be ISO15189 accredited Coordinate National Laboratory Networks Diagnose pathogens causing major outbreaks including handling and shipping of highly infectious and dangerous pathogens Provide training and continuing education Provide reference testing Establish and coordinate the National Quality Assessment Scheme

6. Strengthen Laboratory Supply and Distribution Systems To ensure continuous laboratory supplies It is necessary to establish a demand driven system where laboratories specify and quantify their needs based in standards defined at national levels Logistics for distribution at both national and state levels

7. Establish and Strengthen Laboratory Quality Assurance Systems THIS IS THE BACKBONE OF QUALITY LABORATORY PERFORMANCE

8. Strengthen Laboratory Staff Training Staff training as well as training of trainers with standard training manual appropriate to all levels It must be a continuous process Need for periodic M&E

9. Maintenance of Laboratory Equipment Ensure preventive rather than corrective maintenance Basic training is required for laboratory technicians for preventive maintenance Manufacturer/Engineers should only attend to serious equipment problems Service Level Agreement for regular maintenance of equipment

10. Strengthen Laboratory Management Information Systems Non-existent in most laboratories A strong computerised laboratory MIS provides regular and accurate data for evaluating and planning quality laboratory services (PathCare-Meditech) Must include: Collection of appropriate information Analysis and utilisation of results at all levels Periodic reporting on equipment and supplies Financial reports Summary of testing processes Quality assessment reports (Levi Jennings Charts etc) and inventory

11. Monitoring & Evaluation of Laboratory Services M&E systems with targets and measurable indicators will improve the delivery of quality laboratory services M&E must incorporate laboratory activities such as: Adherence to SOP s Safety guidelines Quality assessment activities Laboratory performance and workload Utilisation of supervisory tools

12. Ensuring Adequate Funding Funding should be through several mechanisms: 1. Government budgetary provisions 2. Dedicated grants 3. Income generating services 4. Public-Private Partnerships with government establishments, International Organisations e.g. Global fund for HIV/AIDS, TB & Malaria, CDC, WHO etc.

Accreditation What is Accreditation as regards Clinical Laboratory? Accreditation is a process in which an entity, separate and distinct from the Clinical Laboratory, usually nongovernmental, assesses the laboratory to determine if it meets a set of requirements designed to improve quality of care In some countries, accreditation is a mandatory requirement for testing operations, while in other countries, accreditation is voluntary and driven by market incentives.

Accreditation vs. Certification Certification is the procedure whereby a third party gives assurance that a product, process, or service conforms to specific requirements. (Management) ISO 9000 Certification in Healthcare in Nigeria Accreditation is awarded to a laboratory only if they comply with international criteria and is competent to carry out their daily tasks. Accreditation confirms technical competence

Benefits of Accreditation The benefits of having our clinical laboratories accredited for quality services cannot be overemphasised. It does not only ensure quality service, it promotes international recognition and confidence Improve the quality of health care for patients through the reduction of testing errors Accredited laboratories are more accountable Allow laboratories to demonstrate high standards of service delivery Provide an effective mechanism for health system improvement yielding long-term benefits in the quality, cost-effectiveness, and sustainability of public health programs

Impact of Laboratory Accreditation on Patient Care and the Health System The interaction between HIV clinical management and diagnostic testing. Incorrect test results at any one point can prevent patients proceeding further through the HIV care and treatment program. These blockages limit successful treatment and the number of patients proceeding healthily into and through antiretroviral therapy (ART) AmJ Clin Pathol 2010.

Internationally Accredited Laboratories in Africa Internationally accredited laboratories in Africa. Few laboratories in Africa (only 340) are currently accredited. The majority of the accredited laboratories are in South Africa; only 28 (8.2%) are in sub-saharan Africa. Of the accredited laboratories in South Africa, fewer than 10% are public sector laboratories. AmJ Clin Pathol 2010 PathCare was the 1 st accredited ISO15189 laboratory in W. Africa

WHO African Region Laboratory Accreditation Process Few developing countries have established laboratory quality standards that are affordable and easy to implement and monitor WHO Regional Office for Africa (WHO AFRO) established a 5-star scale, to the fulfilment of ISO 15189 standard rather than the pass-fail grading

WHO African Region Laboratory Accreditation Process Laboratories that fail to achieve an assessment of score of at least 55% will not be awarded a star ranking WHO AFRO s accreditation process is not intended to replace established ISO 15189 accreditation schemes, but rather to provide an interim pathway to the realization of international laboratory standards

Landmark Events that promoted accreditation of laboratories in Africa January 2008 (Maputo, Mozambique): 33 countries with the WHO, World Bank, and Global Fund for AIDS, Tuberculosis and Malaria issued the Maputo Declaration to strengthen laboratory systems in developing countries Nigeria has already started the process with the 1 st ISO accredited laboratory in 2006 April 2008 (Lyon, France): WHO & US CDC called on countries in SSA to consider a staged approach towards laboratory accreditation. National laboratory standards were to establish minimum requirements for all laboratories, while national reference laboratories must meet international standards ISO 15189 July 2009 (Kigali, Rwanda): WHO AFRO, in collaboration with the CDC, the Clinton Health Access Initiative, the American Society for Clinical Pathology, and other partners, launched a stepwise laboratory accreditation process in the presence of government health officials from 13 African countries

WHO AFRO Accreditation Scheme WHO AFRO accreditation scheme showing the stepwise recognition of laboratory performance. Based on the percentage score, laboratories are assigned an accreditation level, based on 1 to 5 stars. Laboratories that receive a 5-star rating are strongly encouraged to transition to an internationally established accreditation scheme.

WHO AFRO Accreditation Checklist The checklist s 12 sections provide assessment on the basis of 110 clauses and 250 total possible points. Each item has been assigned a weighted value of 2, 3 or 5 points based on complexity and/or relative importance. ISO15189 has 23 quality systems essential

These are: Building Blocks of WHO AFRO The role of WHO AFRO Accreditation Process Not an accrediting body Standards and assessment tools Assessors and assessor training Only assessors from a different African country will be utilised and there will be no financial compensation Equipment calibration and biosafety Laboratory management training Proficiency Testing provider

Benefits of WHO AFRO Accreditation Accessibility: The stepwise approach makes WHO-AFRO accreditation process accessible to public sector hospitals Affordability: WHO-AFRO is available to countries free of charge, eliminating critical barrier to enrolment Scalability: The stepwise approach and limited cost to the user make it feasible for MOH to develop plans that, for example, involve their regional, provisional and district laboratories in the space of a few years Sustainability: Each of the 3 previously described advantages makes the WHO-AFRO program a sustainable means for promoting laboratory accreditation

Is this Achievable and Sustainable? YES!!! Provided

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