Ijcmph-12844 o
Ijcmph-12844 o
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
http://www.ijcmph.com pISSN 2394-6032 | eISSN 2394-6040
DOI: https://dx.doi.org/10.18203/2394-6040.ijcmph20242537
Original Research Article
1
Department of Health Systems Management, Kenya Methodist University, Kenya
2
Department of Academics, Riara University, Kenya
3
Department of Population Health, Medical College, Aga Khan University, East Africa
4
Department of Economics, Mount Kenya University, Kenya
*Correspondence:
Ali Ahmed Mohamed Qadar,
E-mail: qadarow100@hotmail.com
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Background: Health professional regulatory bodies oversee and enforce standards in healthcare to safeguard patient
safety and prevent harm. However, international consistency in these regulations remains limited. The Kenya health
sector relies on various bodies to enforce standards among professionals and institutions, albeit constrained by
financial and human resources that hinder effective oversight. This study aimed to assess how regulatory practices-
such as licensing, training oversight, inspection of practice, and quality assurance mechanisms- affect the quality of
healthcare provided by private providers.
Methods: The study targeted 108 healthcare providers from 36 private health facilities, primarily nurses and clinical
officers. A sample of 86 participants was drawn using purposive sampling. The data were collected using a structured
questionnaire.
Results: The licensing of health professionals, training, inspection of practice, and quality assurance mechanisms
collectively influenced 47.9% of the variation in service quality. Statistical analysis revealed significant associations
between licensing (p=0.003), practice inspections (p=0.01), quality assurance (p=0.001), and service quality.
Conclusions: Regulatory bodies play a crucial role in ensuring healthcare standards; however, their effectiveness
hinges on tailored strategies that address local challenges and foster collaborative efforts towards sustainable quality
improvement in healthcare services. Routine inspections, conducted in a supportive manner, are likely to ensure
ongoing adherence to standards. Moreover, adequate resource allocation for regulatory compliance and continuous
quality improvement activities, including the formation of internal quality improvement (QI) teams and the
maintenance of regular QI meetings and assessments, was deemed essential.
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3404
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
impacts the quality of health services provided. healthcare services to ensure practitioner quality and
Regulatory bodies oversee professional practices to public safety, despite challenges in enforcement due to
ensure effective health service delivery. limited funding for regulatory entities.
Globally, health regulatory bodies play crucial roles in Regulation poses significant challenges in low- and
safeguarding patient safety, assessing the competence of middle-income countries’ (LMICs) health systems,
health professionals, ensuring quality in education and impacting quality and safety. Strengthening regulatory
training, managing professional registration, enforcing frameworks could address these issues, but poor
guidelines and standards, and fostering relations with enforcement due to resource constraints, weak
health professions.3 However, across Europe, there is governance, and corruption hinders effectiveness; hence,
significant inconsistency in the scope and focus of these more research is crucial to strengthen LMIC healthcare
regulatory functions, with some emphasizing healthcare regulation and enhance health system resilience.10 In
quality and safety and others prioritizing professional Kenya, gaps in regulatory requirements for private health
reputation and trust.4 These disparities impact facilities persist, necessitating action from regulatory
professional mobility, patient safety, and overall quality agencies and the Ministry of Health (MoH). For instance,
of healthcare delivery. inadequate legislation to address negligence and
malpractice in private healthcare is a notable issue, and
In Africa, the African Health Profession Regulatory regulatory agencies such as the PPB often overlook
Collaborative (AHPRC) for Nurses and Midwives gathers engagement with pharmacies, which negatively impacts
leaders responsible for health regulation from 14 pharmacovigilance efforts.11 Moreover, leniency in
countries in East, Central, and Southern Africa. This disciplinary actions against malpractice further
collaboration seeks to strengthen the regulatory capacity undermines regulatory effectiveness.10 This study focused
of medical professional organizations, ultimately on the role of professional regulatory bodies in promoting
improving the regulatory framework for professions quality healthcare among private facilities in Wajir
throughout the African region.5 Ensuring effective health County, Kenya- a challenging area due to its remoteness,
regulation and enhancing regulatory performance are key complicating regulatory oversight. The key areas of focus
priorities for National Regulatory Authorities (NRAs) and included licensing, training, inspection of practice and
governments globally.6 With government support, NRAs quality assurance mechanisms and how these practises
oversee the promotion and protection of public health by influence provision of quality health services by private
ensuring the implementation of regulatory standards and healthcare providers.
overseeing the supply of safe, effective, and high-quality
medical products that meet international standards. Most METHODS
African countries have National Regulatory Authorities
(NRAs) with varying structures and operations- some are A cross-sectional analytical research design was used in
under health ministries, while others are this study. The study was undertaken in Wajir County, in
semiautonomous. Since 2018, the African Medicines northern Kenya. The target population was private
Agency (AMA) has proposed the aim of enhancing NRA healthcare providers. There are 36 private health facilities
capabilities, addressing gaps to boost public health and in Wajir County.12 The study targeted at least three
pharmaceutical sector growth.6 healthcare workers in each facility, for a total of 108
health providers. This study adopted the Krejcie and
In Kenya, healthcare governance is overseen by multiple Morgan formula for determining the sample size from a
bodies at the national and county levels, encompassing finite population.13 The sample size was therefore 86
structures, policies, legislation, intergovernmental health care workers. The sampling procedure for this
forums, and regulatory bodies that enforce technical study was purposive sampling. Purposive sampling was
standards and compliance among health professionals and informed by the sparse location of private health facilities
institutions. The Health Act of 2017 centralized the in Wajir County. Primary data were collected from 86
oversight of health professionals to enhance coordination private health care workers drawn from 36 health care
and reduce redundancy.7 Regulatory bodies such as the facilities. The research data were acquired in September-
Kenya Nutritionists and Dieticians Institute (KNDI), November 2023 using a structured questionnaire. The
Radiation Protection Board (RPB), Public Health Officers data were coded and analysed using the Statistical
and Technicians Council (PHOTC), Pharmacy and Package for Social Sciences (SPSS) version 24. Bivariate
Poisons Board (PPB), Kenya Medical Laboratory analysis and multivariate regression were carried out to
Technicians and Technologists Board (KMLTB), Clinical determine the associations between the study variables.
Officers Council (COC), Medical Practitioners and
Dentist Board (MPDB), and Nursing Council of Kenya Inclusion criteria
(NCK) oversee licensing and ensure quality assurance. 8
The government has established professional councils and Health workers drawn from private health facilities that
medical boards for self-regulation within their professions had been in operation for more than one year at the time
and for medical facility registration, aiming to streamline of data collection, as they were likely to have been
regulation.9 Legislation specifies standards for private inspected by a health professional regulator.
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3405
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
SD D NS A SA
Statement
N (%) N (%) N (%) N (%) N (%)
I am registered with a health regulatory body - - 2 (2) 32 (39) 49 (59)
I am aware of the penalty of practicing as an unregistered and
- - - 34 (41) 49 (59)
unlicensed person
Licensure and registration promote public safety 2 (2) - 2 (2) 39 (47) 40 (48)
I have renewed my professional license 2 (2) - 2 (2) 40 (48) 39 (47)
Regulatory agencies investigate disciplinary cases - 4 (5) 3 (4) 37 (45) 39 (47)
Regulatory agencies administering disciplinary actions against
- 4 (5) 5 (6) 28 (34) 46 (55)
health professionals who are found culpable
Regulation of health professional training The survey results suggest a mixed perception among
respondents regarding the roles and effectiveness of
The training regulation of healthcare workers was regulatory agencies in healthcare training and oversight.
assessed against the accreditation of training institutions, Most respondents agreed that regulatory agencies inform
student enrolment in training institutions, and internship practitioners about industry changes (87%), approve
and licensing examinations (Table 3). training institutions (68%), and expect institutions to seek
accreditation (98%). However, opinions vary on whether
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3406
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
agencies consistently inspect institutions (98%) and should set minimum entry requirements (93%) and issue
review curricula (93%) before accreditation. Fewer unique index numbers (98%). However, fewer
respondents believe that inspections are consistently respondents indicated undergoing Ministry of Health
conducted (75%) and that agencies track student internship postings (89%) or licensing examinations after
performance through indexing (90%). Regarding training (96%).
regulatory control, there is an agreement that agencies
SD D NS A SA
Statement
N (%) N (%) N (%) N (%) N (%)
Regulatory agencies provide practitioners with information about
2 (2) 2 (2) 7 (8) 53 (64) 19 (23)
industry changes
Training institutions are accredited by regulatory agencies - - 2 (2) 57 (69) 24 (29)
Inspection of training institutions is a random continuous activity
- 4 (5) 12 (15) 34 (41) 33 (40)
to promote quality training of health professionals
Regulatory agencies control minimum entry requirements of
4 (5) - 2 (2) 35 (42) 42 (51)
students into various programmes
I underwent internship posting by the Ministry of Health after
2 (2) 7 (8) - 39 (47) 35 (42)
training
SD D NS A SA
Statement
N (%) N (%) N (%) N (%) N (%)
Medical Practitioners and Dentists Board and other regulatory
2 (2) 2 (2) 4 (5) 35 (42) 40 (48)
bodies inspect health facilities including this facility
The health care regulatory agencies monitor practitioners and
- 2 (2) 2 (2) 43 (52) 36 (43)
facilities for compliance
The inspections are scheduled on a routine/regular basis 2 (2) 4 (5) 11 (13) 37 (45) 29 (35)
We have the resources to ensure regulatory compliance - 4 (5) 13 (16) 33 (40) 33 (40)
Facility is often given feedback on areas to make improvement
- 4 (5) 4 (5) 33 (40) 42 (50)
after inspection
The inspection officials are often very friendly and supportive 2 (2) 4 (5) 6 (7) 36 (43) 35 (42)
The health inspectors often harass and instil fear to private
3 (4) 18 (22) 4 (5) 33 (40) 25 (30)
health care providers
The inspections are undertaken to promote public safety 2 (2) 2 (2) 4 (5) 45 (54) 30 (36)
Facilities found to operate illegally are often closed 2 (2) 4 (4) 2 (2) 44 (53) 31 (37)
Practitioners found to operate illegally are often taken to court
2 (2) 4 (4) 4 (4) 45 (54) 28 (34)
and charged
Inspection of professional practice with some respondents feeling consulted (91%) but others
less so (82%). There is a mixed perception of inspection
This variable was assessed against whether the officials’ demeanor, with some finding them supportive
inspections were periodic, if feedback was given to (87%) and others feeling harassed (56%). Despite this,
healthcare providers after inspection and whether there there is strong agreement that inspections aim to promote
was enforcement for noncompliance (Table 4). The public safety (90%). Responses also indicate confidence
results highlight perceptions about regulatory inspections in regulatory actions against illegal operations, with
and compliance in healthcare facilities. The respondents closures of facilities (89%) and legal actions against
generally agreed that regulatory bodies conduct practitioners (88%) being reported.
inspections (87%) and monitor compliance (95%).
However, opinions vary on the frequency of scheduled Quality assurance mechanisms
inspections (80%) and whether facilities have adequate
resources for compliance (73%). The feedback The study also assessed the quality assurance mechanism
mechanisms seem inconsistent, with fewer facilities put in place by private health care providers. The study
reporting regular feedback after inspections (91%). assessed the existence of standards and guidelines and
Stakeholder consultation also received mixed feedback, quality improvement (QI) teams (Table 5).
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3407
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
SD D NS A SA
Statement
N (%) N (%) N (%) N (%) N (%)
The facility has standard treatment guidelines (STGs) to manage
- - 4 (4) 52 (63) 27 (33)
various illness
Patients are managed in line with the STGs for various conditions - - 8 (10) 51 (61) 24 (29)
Medicines and health commodities are ordered in line with the
- - 9 (11) 50 (60) 24 (29)
STGs
We utilize National essential medicines list in ordering our supplies - - 7 (8) 44 (53) 32 (39)
The facility has an internal quality improvement team - 4 (4) 12 (15) 41 (49) 26 (31)
The QI team has an annual implementation plan - 6 (7) 13 (16) 42 (51) 22 (27)
The facility always has a QI plan and a budget for QI activities - 4 (4) 12 (15) 41 (49) 26 (31)
The facility has regular QI meetings - 2 (2) 18 (22) 41 (50) 22 (27)
There exist minutes of the QI meetings held on a regular basis - 2 (2) 16 (19) 42 (51) 23 (28)
The QI team often conduct health facilities self-assessments - 2 (2) 12 (15) 45 (54) 24 (29)
The facility has a QI champion - 2 (2) 18 (22) 43 (52) 20 (24)
SD D NS A SA
Statement
N (%) N (%) N (%) N (%) N (%)
Safety
Patient safety is our priority 3 (4) 5 (6) 2 (2) 33 (39) 40 (49)
We have segregated waste disposal mechanisms - - - 26 (31) 57 (69)
We have clean running water to keep the facility clean 5 (6) 2 (2) - 31 (38) 45 (54)
Sometimes patients report adverse drug events - 9 (11) 2 (2) 37 (45) 35 (42)
The facility has medical error reporting tools 5 (6) 5 (6) 9 (11) 25 (30) 39 (47)
We sometimes experience medical errors in this facility 5 (6) 10 (12) 13 (16) 20 (24) 35 (42)
Medical errors are reported in a timely manner - 2 (2) 9 (11) 38 (46) 34 (41)
We have experienced cases of accidental falls of patients in this
3 (4) 11 (13) 17 (21) 26 (31) 26 (31)
facility
We have experienced cases of hospital related infections - 16 (19) 11 (13) 26 (31) 30 (36)
Patient Centered Care
Patients’ preferences are taken into consideration during
3 (4) 3 (4) 2 (2) 49 (57) 27 (33)
treatment
Staff often inform patients on how to prevent future
3 (4) 3 (4) 2 (2) 36 (43) 45 (55)
occurrence of their illness
The environment is clean and comfortable 3 (4) 3 (4) 2 (2) 46 (55) 32 (35)
The responses reflect the implementation and perception Provision of quality health services
of quality improvement (QI) practices in a healthcare
facility. It appears that while the majority agree that The dependent variable, provision of quality health
standard treatment guidelines (STGs) are in place for services, was measured against safety and patient-
managing illnesses (92%) and that patients are managed centered care (Table 6).
accordingly (90%), there is less certainty about ordering
medicines and health commodities in line with STGs The survey results reflect perceptions regarding safety
(89%) and using the National Essential Medicines List protocols and patient-centered care in healthcare
(92%). Regarding QI practices, there is an facilities. Patient safety is considered a priority by most
acknowledgement of an internal QI team (86%) and an respondents (88%), but there are concerns about
annual implementation plan (78%). However, fewer infrastructure, such as segregated waste disposal (69%)
respondents reported having a dedicated QI budget (77%) and clean water availability (92%), for maintaining
or regular QI meetings (72%). The frequency of health facility cleanliness and infection prevention. The
facility self-assessments by the QI team also varies adequacy of personal protective equipment for staff is
(83%), and fewer facilities have a designated QI acknowledged by many (97%). In terms of medical
champion (76%). errors, while there are reporting tools available (83%),
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3408
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
there is variability in reporting frequency (87%) and involving family in decision-making (98%) show varying
subsequent action to reduce errors (87%). Instances of degrees of consistency. Overall, while the facility
patient falls (62%) and hospital-related infections (67%) demonstrates efforts toward patient safety and patient-
were reported. Patient preferences (90%) and dignity centered care, there are opportunities to improve
(98%) are considered during patient-centered care. infrastructure, enhance medical error reporting processes,
However, communication on managing current and ensure more consistent patient engagement and
conditions (88%), preventing future illnesses (97%), and communication practices.
Unstandardized Standardized
Collinearity statistics
Model coefficients coefficients t Sig.
B Std. error Beta Tolerance VIF
(Constant) 69.963 11.215 6.239 0.000
Licensing -0.528 0.172 -0.309 -3.071 0.003 0.628 1.592
1 Training regulation 0.020 0.223 0.010 0.089 0.929 0.546 1.832
Inspection of practice 0.362 0.137 0.299 2.639 0.010 0.493 2.027
Quality assurance 0.860 0.163 0.568 5.292 0.001 0.552 1.811
a Dependent variable: provision of quality health services.
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3409
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
associated with the provision of quality health services inadvertently limit practitioner numbers and exacerbate
(Table 8). healthcare access disparities, especially in underserved
areas. Financial barriers associated with licensing costs
DISCUSSION could dissuade potential healthcare professionals,
particularly those from marginalized backgrounds, from
Health regulatory agencies regulate institutions, entering the field or maintaining their licenses.
professionals, and the market. Professional regulation Navigating these complexities is crucial to strike a
includes accreditation, licensure, registration, balance between regulatory requirements and ensuring
certification, and recertification.14 These regulations and equitable access to quality healthcare services,
standards are widely seen as crucial for enhancing particularly in LMICs. The move towards online
professional practice and patient care. However, their licensing and continuing professional development (CPD)
enforcement remains inadequate in LMICs, primarily due platforms is seen as a positive step for efficiency and
to insufficient financial and human resources.15 Health compliance.10 However, healthcare providers in Kenya
professional boards bear the responsibility for overseeing and Uganda have expressed concerns about regulatory
health worker training, licensure, and practice, yet efforts effectiveness and proposed decentralizing regulatory
to advance health worker education and practice have not oversight as a potential solution, despite acknowledged
been comprehensive across regulatory bodies, implementation challenges.15
professional associations, and academic institutions. 16
Responsive regulation emphasizes a balanced approach of The regulation of training by health professionals was the
persuasion and punishment, necessitating resources, second independent variable. More than 80% of the
expertise, and constructive regulatory relationships to respondents and their respective facilities seem to have
effectively ensure compliance, detect noncompliance, and complied with the professional regulatory requirements
refine regulatory strategies.10 Critics argue that regulators on training.8 However, there was no significant
often seem disconnected from local realities, particularly relationship between training and providing quality
in remote areas, with frontline healthcare providers healthcare. Overall, while training health professionals is
feeling that regulators prioritize fee collection over undoubtedly essential for ensuring competency and skills
upholding professional standards and ethics. Health development, its direct impact on the delivery of quality
professional regulation could be strengthened through healthcare may be influenced by various contextual,
enhanced social accountability by simplifying procedures organizational, and systemic factors.22 Inadequate
for reporting malpractice and negligence and responding regulation of health professional training is seen to lead to
promptly to such reports by the community.10 an increasing lack of knowledge, skills and ethics among
some new doctors and nurses/midwives in Uganda and
The provision of quality health services was the Kenya.10 Medical and nurse training schools over-enrol
dependent variable of the study and was assessed through students, consequently providing insufficient mentoring,
providers’ perceptions of safety and patient-centered care. supervision and practical experience. Furthermore,
The findings indicated disagreement regarding the undertaking CPD has been reported to be superficial
reporting of medical errors for safety monitoring. because, for the sole purpose of collecting CPD points to
Research suggests that approximately 10% of patients renew licenses, calling for regulators needs to ensure that
suffer harm during medical care, with half of these CPD courses genuinely develop professionals’ knowledge
incidents preventable.17,18 Adverse events occur across and skills.10 The regulation of medical education and
different levels of care: primary care, long-term care health professionals is an important aspect of the
settings and medical care.19 Over 90% agree that patient governance of health systems. This has been an area of
preferences are considered in patient-centered care, which concern and institutional weakness in many LMICs. The
aims to tailor care to individual and family preferences, underfunded public sector, poorly regulated private
needs, and values.20,21 sector, and expanding role of commercial actors in
healthcare and medical education have posed major
The study investigated health professional licensing as the regulatory challenges.23 There are also related concerns
first independent variable, emphasizing its regulatory about poor regulation and standards of health professional
processes and impact on service quality. Licensing education and training in LMICs, particularly in private
involves rigorous assessments of training, conduct, and universities and training colleges.15 Professional
clinical performance before practitioners are registered regulators and training schools are advised to improve
and assigned unique numbers.8 This process ensures communication about what professional standards mean
ongoing quality control through active registry updates in practice to increase compliance and the quality of
and mandatory credential updates. The absence of professional practice.10
regulatory oversight undermines professionalism and
compliance, impacting nursing standards and license The inspection of professional practice was the third
validity.10 Interestingly, the study identified a significant independent variable. This showed a significant positive
but negative relationship between licensing and the relationship with the quality of healthcare provision.
provision of quality health services. Stringent licensing Regulatory oversight ensures adherence to standards and
requirements, while aiming to uphold standards, may promotes safety, benefitting both patients and healthcare
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3410
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3411
Qadar AAM et al. Int J Community Med Public Health. 2024 Sep;11(9):3404-3412
International Journal of Community Medicine and Public Health | September 2024 | Vol 11 | Issue 9 Page 3412