FACTORS AFFECTING QUALITY OF LABORATORY SERVICES AT INFECTIOUS DISEASES HOSPITAL, KANO – NIGERIA
ABSTRACT
Quality laboratory services are essential and integral part of improved health outcome especially for HIV/AIDS patients on ART. We aimed to assess clients‘ satisfaction with laboratory services as an indicator of quality and factors affecting quality of laboratory services from service providers‘ perspective.
We conducted a hospital based cross-sectional study from January-April 2014 among adult HIV/AIDS patients attending IDH Kano, Nigeria. An exit and service providers‘ questionnaires were administered to clients and laboratory service providers respectively. We used SLIPTA laboratory inventory checklist to assess the availability of equipment, reagents, consumables and test profiles for patients on ART.
A total of 212 HIV positive patients attending laboratory for ART monitoring tests at IDH participated in the study. Of these, 65.6% were females. The mean (±SD) age, of the participants was 36.7 ± 10.2 and 36.3% were in the age group (30-39), 58% were married, 10% were single, while 6% and 26% were divorced and widowed respectively. Majority of the clients (70%) were on antiretroviral therapy (ART). The overall level of satisfaction with laboratory services calculated from a single indicator variable was 97.6%. Internal quality control (IQC) is conducted always for chemistry, and CD4 counts as stated by more than 90% of the respondents (records seen) while IQC for haematological indices is done only occasionally due to stock out of control reagents. The equipments used for HIV/AIDS monitoring tests for CD4 count, haematology and chemistry were available and functional but more than 50% were in use for more than 5 years. Repairs and service maintenance are done on site through service contract signed by donor organizations.
In conclusion, the satisfaction level of the clients on laboratory services received was high, which suggested acceptable quality of services offered. Form of visit to HF (follow-up visit), and ―waiting time‖ before clients are attended by service providers, were found to be the factors associated with client satisfaction. Inadequate work force was identified as one of the major factors affecting quality of laboratory services by 80% of service providers, inadequate training of laboratory personnel (72%), lack of EQA and IQC on some tests (45%), interrupted power supply that led to frequent equipment breakdown (86%) and infrastructural inadequacy (space) to accommodate all the equipment, staff, as well as the patients (64%). The clients identified stigma, location of the laboratory distant from the ART clinic and lack of awareness on the
importance of the laboratory tests in the management of the patient as barriers to accessing
laboratory services.
Key words: Quality, laboratory, Kano, Nigeria.
TABLE OF CONTENTS
CHAPTER ONE    
INTRODUCTION    
1.1 Background Information    
1.2. Problem statement    
1.3 Rationale of the study    
1.5.0 GENERAL AND SPECIFIC OBJECTIVES    
1.5.1 General objective    
1.5.2    Specific objectives    
CHAPTER TWO    
LITERATURE REVIEW    
2.1.0 Historical perspectives about Concept of quality    
2.2.0 Quality Systems in Laboratory    
2.2.1 Strengthening laboratory network    
2.2.2 Service quality and customer satisfaction    
2.2.3 Concept of service quality    
2.2.4 Assessment of client satisfaction    
2.2.5 Customer Satisfaction measurement    
CHAPTER THREE    
METHODS    
3.1. Study area    
3.2. Study design ..
3.3. Study population .
3.3.1. Inclusion criteria
3.3.2. Exclusion criteria
3.4 Sample size determination for HIV/AIDS clients
3.4.1 Sampling Technique for study participants – Systematic random sampling
3.5 Sampling technique for laboratory service providers .
3.6 Study Instruments
3.7 Data Collection Methods
3.7.1 Laboratory service provider questionnaire
3.7.2 Client exit interview questionnaire
3.7.3 Facility inventory checklist
3.7.4 Focus group discussion guide: To explore information on barriers to accessing laboratory services
3.7.5 Training of Research Assistants
3.7.6 Pre-test of instruments
3.8.1 Measurement of variables
3.8.2 Scoring and grading of responses on provider knowledge
3.8.3 Statistical Analyses
3.9 Ethical Considerations
3.10 Limitations of the Study
CHAPTER FOUR.
RESULTS
4.1. Baseline socio-demographic data
Table 1: Socio-demographic characteristics of respondents in IDH, 2014 (n=212)
4.2. Other tables based on the specific objectives
Table 2: HIV/AIDS clients’ satisfaction with different aspects of ART lab services in IDH, Kano State,2014
Table 3: Bivariate & logistic regression showing relationship between level of Clients’ satisfaction with
independent variables (n = 212)
Table 4: Distribution of laboratory personnel (conducting assays) by their position in IDH, 2014
CHAPTER FIVE
DISCUSSION    
CHAPTER SIX    
CONCLUSIONS AND RECOMMENDATIONS    
6.1. Conclusions    
6.2. Recommendations    
APPENDICES    
Appendix 1- Informed Consent for laboratory service providers    
Appendix 2 - Exit interview questionnaire for HIV/AIDs clients    
Appendix 3 - Facility inventory checklists    
Appendix 4 - Questionnaire for Laboratory personnel    
Appendix 5 - Focus Group Discussion Guide    
3.9.1. Informed consent    
3.9.2. Risks and discomforts    
3.9.3. Costs    
3.9.4. Anticipated benefits    
3.9.5. Payments for participation    
3.9.6. Confidentiality    
3.9.7. Voluntary participation/withdrawal from the study    
3.9.8. Questions    
Appendix 7 - Copy of Ethical clearance letter    
LIST OF TABLES
Table 1: Socio-demographic characteristics of respondents in IDH, 2014 (n=212)    
Table 2: HIV/AIDS clients‘ satisfaction with different aspects of ART lab services in IDH, Kano
State, 2014    
Table 3: Relationship between level of Clients‘ satisfaction with independent variables (n = 212)
Table 4 Distribution of laboratory personnel by their position in IDH, 2014    
LIST OF FIGURES
Figure 1: Level of knowledge on laboratory processes and procedures among service providers
in IDH, 2014
Figure 2: Availability of laboratory test profiles for HIV/AIDS patients on ART for the past 12
months at IDH, 2014
Figure 3: Percentage of laboratory staff who had at least 1 training within the last 12 months at
IDH, 2014
ABBREVIATIONS
AAVP - African AIDs Vaccine Program
ABU - Ahmadu Bello University
AFRO - African Region
AIDS - Acquired Immunodeficiency Syndrome
ALT - Alanine Aminotransferase
ART - Antiretroviral Therapy
AST - Aspartate Aminotransferase
CBC - Complete Blood Count
CD4 - Cluster of Differentiations
EQA - External Quality Assurance
FCT - Federal Capital Territory
FGDs - Focus Group Discussions
GHAIN - Global HIV/AIDS Initiative Nigeria
GLP - Good Laboratory Practice
HAART - Highly Active Antiretroviral Treatment
HOD - Head of Department
IDH - Infectious Diseases Hospital
IOM -Institute of Medicine
IQC - Internal quality control
LGAs - Local Government Areas
SMoH - State Ministry of Health
OIs - Opportunistic Infections
 PEPFAR  -  President Emergency Program for AIDS Relief
PLWHA - People Living With HIV/AIDS
 PHCs - Primary Health Centres
 SLIPTA - Stepwise Laboratory (quality) Improvement Towards Accreditation
 SOPs - Standard Operating Procedures
TAT  - Turnaround Time
WHO - World Health Organization
 CHAPTER ONE
INTRODUCTION
1.1 Background Information
Medical laboratory services are essential in the diagnosis and assessment of the health of patients. Their services encompass arrangements for requisition, patient preparation and patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent result validation, interpretation, reporting and advice.
1    For people suffering from HIV/AIDS, these services are critical for initial placement of patients on antiretrovirals (ART) and continuous monitoring of disease progression over a period. In the West African region, laboratory services are the most neglected components within the health systems especially regarding HIV/AIDS treatment and monitoring.2 Lack of access to necessary quality diagnostic tests in support of HIV/AIDs treatment and monitoring such as CD4 cell counts, viral load, complete blood count (CBC), chemistry tests, has significantly affected the provision of drug therapy for more than two decades from the emergence of HIV/AIDs in the region.5 This factor alone, served as a catalyst to increased morbidity with increased burden on global public health. 4
In Nigeria, prior to considerable efforts devoted to strengthening laboratory systems under Global HIV/AIDS Initiative, provision of clinical laboratory services was a major issue. All laboratories in hospitals offering ART services faced major challenges including poor infrastructure, inadequately trained personnel and lack of standardized operating procedures that could potentially compromise quality of services to patients.4
In 2004, United State Government under President‘s Emergency Plan for AIDs Relief (PEPFAR) launched a Global HIV/AIDs Initiative in Nigeria (GHAIN) that yielded significant improvements in laboratory service delivery by strengthening the existing network of public sector laboratories at primary, secondary, and tertiary health facilities throughout the country.5 The improved capacity of the upgraded laboratories enabled the provision of HIV services to meet the accelerated rollout of HIV prevention, care and treatment services including TB and other opportunistic infections (OIs). Infrastructure upgrades included structural renovation and repairs to the laboratory buildings; provision of basic amenities to ensure reliable water and power supply, stand-by generators and power inverters; and the provision of equipment necessary for efficient laboratory service delivery to people living with HIV/AIDs (PLWHA), including state-of-art automated equipment and provision of training to selected staff. In all the upgraded laboratories, improvements in work and patient flow and safety were accomplished by creating separate sample collection and patient waiting areas.
The World Health Organization (WHO) defines quality of health care as health care consisting of the proper performance (according to standards) of interventions that are known to be safe, affordable to the society in question, and that have the ability to produce an impact on mortality, morbidity, disability, and malnutrition.5
1.2 Problem Statement
The fight against the HIV/AIDS epidemics in resource-limited countries, particularly in sub-Saharan Africa, has benefited from the recent global funding surge, primarily from the US President‘s Emergency Plan for AIDS Relief; the Global Fund for AIDS, Tuberculosis and Malaria; the World Bank and other donors. The United States spends an estimated $10 billion per year on scaling up HIV/AIDS prevention, care, and treatment programs.1,2 However, rapid program expansion has accentuated a problem that has long plagued the health system and undermined the program goals—weak laboratory services, dilapidated laboratory infrastructures, and non-functioning laboratory networks.3,4 Globally strengthening laboratory systems, infrastructure, and personnel is necessary to achieve universal access to care and treatment.1,3
In 2004, Nigeria initiated the pilot project Global HIV/AIDS Initiative in Nigeria (GHAIN) under President Emergency Plan for Aids Relief (PEPFAR) to scale-up and strengthen laboratory capacity to monitor treatment for people living with HIV/AIDS (PLWHA). The expectation was that this project would provide a more cost-effective means of producing quality laboratory investigations to assist clinicians in taking appropriate decisions before and after initiation of antiretroviral treatment (ART). The project was piloted in six states: Kano, Edo, Lagos, Anambra, Cross Rivers and Federal Capital Territory (FCT) Abuja. In Kano, two secondary health facilities were selected; Murtala Muhammad Specialist Hospital (MMSH) and Infectious Disease Hospital (IDH).4
In 2010, the end of project evaluation revealed that internal quality processes were noted to be poor in all the facilities especially MMSH & IDH and GHAIN has not introduced and institutionalized an internal quality control strategy. The quality of service in terms of documentation & records keeping, turnaround time (TAT) between sample collection and results reporting and patient flow to access laboratory investigations among adult PLWHA declined in 2012 by more than 30% compared with 2006-2010 in the State.4
The identified gaps were; despite huge investment by GHAIN/PEPFAR on ART- laboratories, the number of patients expected to access the services and quality of services keeps on declining. Further research is needed to identify the reasons/barriers to decreased patients‘ turnover and poor internal quality control processes. Information expected to result from the study is clients‘ opinion based on satisfaction with laboratory services offered, service providers‘ skills on ART-laboratory procedures and availability of reagents and equipment. This information will help close the identified gaps by introducing and institutionalizing a quality control monitoring strategy that will improve service quality as well as overcoming the barriers /factors responsible for decreased patients‘ turnover.
1.3 Rationale of the Study
Health system strengthening is a key area of focus for some of the major programs, including the GHI. For example, in 2009, the US President‘s Emergency Plan for AIDS Relief (PEPFAR) dedicated 1.0 to 1.4 billion US Dollars to supporting health systems, of which 6% was earmarked for strengthening laboratory systems.31 The Global Fund to Fight AIDS, Tuberculosis and Malaria has also allocated a similar proportion to strengthening laboratory services.30 In addition, clinical diagnosis without quality laboratory testing often results in significant misdiagnosis and over diagnosis, leading to inadequate or inappropriate treatment, drug resistance, and increased mortality.1, 2
In Nigeria, more than 1.5 million PLWHA require ART services with Kano State contributing about 2.6% out of this figure.4 This indicates invariably that they need Laboratory services before and after treatment enrolment for proper monitoring. Continuous decrease in internal quality control processes coupled with decreased clients‘ turnover due to some factors yet to be identified in all ART-laboratories pose a great public health challenge to the State Government and partners in terms of resources and for sustaining quality to accommodate the increasing number of PLWHA requiring Laboratory services.4
1.4 Research Questions
1.    What is the satisfaction level and factors associated with the quality of laboratory servicesamong adult HIV/AIDs patients attending IDH Kano?
 2.    What are the barriers impeding access to laboratory services among adults HIV/AIDSpatients attending IDH Kano?
3.    What are the factors affecting quality of laboratory services from service providers‘ perspective?
1.5 General and Specific Objectives
1.5.1 General objective
To evaluate the quality of laboratory services among adult HIV/AIDS patients attending infectious diseases hospital (IDH) Kano.
1.5.2  Specific objectives
1.    To assess the satisfaction level and factors associated with the quality of laboratory services among adult HIV/AIDs patients attending IDH.
2.    To determine the barriers in accessing laboratory services among adults HIV/AIDs patients attending infectious diseases hospital (IDH) Kano State.
3.    To identify factors affecting quality of services from service providers‘ perspective.