FACTORS AFFECTING QUALITY OF LABORATORY SERVICES AT INFECTIOUS DISEASES HOSPITAL, KANO – NIGERIA

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PROJECT TOPIC AND MATERIAL ON FACTORS AFFECTING QUALITY OF LABORATORY SERVICES AT INFECTIOUS DISEASES HOSPITAL, KANO – NIGERIA

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• Name: FACTORS AFFECTING QUALITY OF LABORATORY SERVICES AT INFECTIOUS DISEASES HOSPITAL, KANO – NIGERIA
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TABLE OF CONTENTS

Contents
DECLARATION ……………………………………………………………………………………………………………………………. ii
CERTIFICATION ………………………………………………………………………………………………………………………….. iii
DEDICATION ……………………………………………………………………………………………………………………………… iv
ACKNOWLEDGMENTS …………………………………………………………………………………………………………………. v
TABLE OF CONTENT …………………………………………………………………………………………………………………… vi
LIST OF TABLES ………………………………………………………………………………………………………………………….. ix
LIST OF FIGURES …………………………………………………………………………………………………………………………. x
ABBREVIATIONS ………………………………………………………………………………………………………………………… xi
SUMMARY ………………………………………………………………………………………………………………………………..xiii

CHAPTER ONE ……………………………………………………………………………………………………………………………. 1
INTRODUCTION ………………………………………………………………………………………………………………………….. 1
1.1 Background Information ……………………………………………………………………………………………………… 1
1.2. Problem statement ……………………………………………………………………………………………………………. 2
1.3 Rationale of the study …………………………………………………………………………………………………………. 4
1.5.0 GENERAL AND SPECIFIC OBJECTIVES ……………………………………………………………………………………… 5
1.5.1 General objective …………………………………………………………………………………………………………….. 5
1.5.2 Specific objectives ……………………………………………………………………………………………………… 5

CHAPTER TWO …………………………………………………………………………………………………………………………… 6
LITERATURE REVIEW …………………………………………………………………………………………………………………… 6
2.1.0 Historical perspectives about Concept of quality ………………………………………………………………. 6
2.2.0 Quality Systems in Laboratory …………………………………………………………………………………………. 11
2.2.1 Strengthening laboratory network …………………………………………………………………………………… 12
2.2.2 Service quality and customer satisfaction …………………………………………………………………………. 15
2.2.3 Concept of service quality ……………………………………………………………………………………………….. 16
2.2.4 Assessment of client satisfaction ……………………………………………………………………………………… 18
2.2.5 Customer Satisfaction measurement ……………………………………………………………………………….. 20

CHAPTER THREE ……………………………………………………………………………………………………………………….. 23
METHODS ………………………………………………………………………………………………………………………………… 23
3.1. Study area ……………………………………………………………………………………………………………………… 23
3.2. Study design …………………………………………………………………………………………………………………… 23
3.3. Study population ……………………………………………………………………………………………………………… 24
3.3.1. Inclusion criteria ………………………………………………………………………………………………………… 24
3.3.2. Exclusion criteria ……………………………………………………………………………………………………….. 24
3.4 Sample size determination for HIV/AIDS clients ……………………………………………………………………. 24
3.4.1 Sampling Technique for study participants – Systematic random sampling …………………………… 25
3.5 Sampling technique for laboratory service providers …………………………………………………………….. 26
3.6 Study Instruments …………………………………………………………………………………………………………….. 26
3.7 Data Collection Methods ………………………………………………………………………………………………………. 26
3.7.1 Laboratory service provider questionnaire ……………………………………………………………………… 26
3.7.2 Client exit interview questionnaire ……………………………………………………………………………….. 27
3.7.3 Facility inventory checklist ………………………………………………………………………………………….. 27
3.7.4 Focus group discussion guide: To explore information on barriers to accessing laboratory services ………………………………………… 27
3.7.5 Training of Research Assistants ……………………………………………………………………………………. 28
3.7.6 Pre-test of instruments ………………………………………………………………………………………………… 29
3.8.1 Measurement of variables …………………………………………………………………………………………… 29
3.8.2 Scoring and grading of responses on provider knowledge ……………………………………………….. 29
3.8.3 Statistical Analyses ……………………………………………………………………………………………………… 30
3.9 Ethical Considerations ……………………………………………………………………………………………………….. 30
3.10 Limitations of the Study …………………………………………………………………………………………………… 30

CHAPTER FOUR ………………………………………………………………………………………………………………………… 31
RESULTS ………………………………………………………………………………………………………………………………….. 31
4.1. Baseline socio-demographic data ………………………………………………………………………………………. 31
Table 1: Socio-demographic characteristics of respondents in IDH, 2014 (n=212) ………………………….. 31
4.2. Other tables based on the specific objectives ……………………………………………………………………… 33
Table 2: HIV/AIDS clients’ satisfaction with different aspects of ART lab services in IDH, Kano State, 2014 ………………………………………………… 33
Table 3: Bivariate & logistic regression showing relationship between level of Clients’ satisfaction with independent variables (n = 212) ………………………………………………………………………………………………. 34
Table 4: Distribution of laboratory personnel (conducting assays) by their position in IDH, 2014 …….. 35
CHAPTER FIVE ………………………………………………………………………………………………………………………….. 43
DISCUSSION ……………………………………………………………………………………………………………………………… 43

CHAPTER SIX …………………………………………………………………………………………………………………………….. 48
CONCLUSIONS AND RECOMMENDATIONS ……………………………………………………………………………………. 48
6.1. Conclusions ……………………………………………………………………………………………………………………. 48
6.2. Recommendations …………………………………………………………………………………………………………… 48

APPENDICES …………………………………………………………………………………………………………………………….. 56
Appendix 1- Informed Consent for laboratory service providers ………………………………………………….. 56
Appendix 2 – Exit interview questionnaire for HIV/AIDs clients ……………………………………………………. 57
Appendix 3 – Facility inventory checklists ………………………………………………………………………………….. 61
Appendix 4 – Questionnaire for Laboratory personnel ………………………………………………………………… 65
Appendix 5 – Focus Group Discussion Guide ……………………………………………………………………………… 72
3.9.1. Informed consent ………………………………………………………………………………………………………. 76
3.9.2. Risks and discomforts ………………………………………………………………………………………………… 76
3.9.3. Costs ……………………………………………………………………………………………………………………….. 76
3.9.4. Anticipated benefits …………………………………………………………………………………………………… 76
3.9.5. Payments for participation …………………………………………………………………………………………. 76
3.9.6. Confidentiality …………………………………………………………………………………………………………… 76
3.9.7. Voluntary participation/withdrawal from the study ………………………………………………………. 77
3.9.8. Questions ………………………………………………………………………………………………………………… 77
Appendix 7 – Copy of Ethical clearance letter …………………………………………………………………………….. 78

LIST OF TABLES
Table 1: Socio-demographic characteristics of respondents in IDH, 2014 (n=212)………………… 31
Table 2: HIV/AIDS clients‘ satisfaction with different aspects of ART lab services in IDH, Kano State, 2014…………………………………………….. 33
Table 3: Relationship between level of Clients‘ satisfaction with independent variables (n = 212)…………………………………………………………… 34
Table 4 Distribution of laboratory personnel by their position in IDH, 2014 ……………………………………………………………… 35

LIST OF FIGURES
Figure 1: Level of knowledge on laboratory processes and procedures among service providers in IDH, 2014………………………………………..36
Figure 2: Availability of laboratory test profiles for HIV/AIDS patients on ART for the past 12 months at IDH, 2014………………………………..38
Figure 3: Percentage of laboratory staff who had at least 1 training within the last 12 months at IDH, 2014 ………………………………………….. 39

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.

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 services among adult HIV/AIDs patients attending IDH Kano?
2. What are the barriers impeding access to laboratory services among adults HIV/AIDS patients 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.

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