The Quality Healthcare and Patient Safety Bill, 2025

SPECIALISSUE

Kenya Gazette Supplement No. 144 (National Assembly Bills No.41)

REPUBLICOFKENYA

KENYA GAZETTESUPPLEMENT

NATIONALASSEMBLY BILLS,2025

NAIROBI,17thJuly,2025

CONTENT

| Bill for Introduction into the National Assembly- | Bill for Introduction into the National Assembly- | |-----------------------------------------------------|-----------------------------------------------------| | | PAGE | | The Quality Healthcare and Patient Safety Bill,2025 | 949 |

MERAJAITA

THEQUALITYHEALTHCAREANDPATIENT SAFETYBILL,2025

ARRANGEMENT OF CLAUSES

Clause

PARTI-PRELIMINARY

1-Short title.

2-Interpretation.

3-Objects of the Act.

4-Guiding principles.

5—Role of the Cabinet Secretary.

6Role of a county government.

PARTII-PATIENTRIGHTSANDSAFETY

7-Realization of the rights and safety of the patient.

8-Right to safe and accessible health facilities.

9- Right to care by a qualified health professional.

10-Right to information and decision-making.

11—Right to safe and quality care.

12-Right to timely and effective care.

13-Right to safe processes and practices.

14-Right to safe and quality health products and technologies.

15—Right to dignity and equity.

16-Right to be heard.

17—Patient rights charter.

18—Patient safety and quality assurance measures.

19-Duty to uphold quality of healthcare.

20Evidence-based practice.

21—Safety and riskmanagement.

22-Quality improvement.

23—Training and competency

• 24-Professional indemnity
• 25-Duty of thepatient.

PART II-ADMINISTRATION OF QUALITY OF HEALTHCARE

• 26—Establishment of the Authority.
• 27-Functions of the Authority.
• 28-Powers of theBoard.
• 29-Board of Directors of the Authority.
• 30-Qualification for appointment as Chairperson or Member of the Board.
• 31-Term ofoffice.
• 32-Committeesof theBoard.
• 33—Conduct of business and affairs of the Board.
• 34—Delegation by the Board.
• 35-The ChiefExecutive Officer of theAuthority.
• 36-Removal from office of the Chief Executive Officer.
• 37-Corporation Secretary.
• 38-Staff of theAuthority.
• 39-Remuneration.
• 40- Protection from personal liability.
• 41-Common seal.

PART IV-REGISTRATION,LICENSING AND ACCREDITATIONOFHEALTHFACILITIES

• 42-Approval of a health facility.
• 43-Registration of a health facility.
• 44Application forregistration.
• 45-Certificate of registration.
• 46-Suspension of the certificate ofregistration.
• 47-Revocation.
• 48-Licence.
• 49-Application for a licence.

• 50-Conditions for grant of licence.
• 51-Validity of the licence.
• 52-Categorization of health facilities.
• 53-Services offered byhealth facilities.
• 54—Suspension of a licence.
• 55—Revocation of a licence.
• 56—Accreditation for quality of healthcare.
• 57-Role of the Authority in accreditation for quality of healthcare.
• 58—Application for accreditation.
• 59-Requirements for accreditation.
• 60-Certificate of accreditation.
• 61—Validity of the certificate of accreditation.
• 62-Renewal of accreditation.
• 63—Suspension of accreditation.
• 64-Revocation of accreditation.
• 65—Quality improvement in a health facility.
• 66-Quality scoring and rating.
• 67-Award of a performance rating.
• 68-Non-compliance with quality standards.
• 69-Monitoring of compliance by the Authority.
• 70-Register of healthfacilities.
• 71—Removal from theregister.

PART V-INSPECTIONS,INVESTIGATIONS AND

ENFORCEMENT

• 72—Appointment of health facility inspectors.
• 73—Inspection objectives and programmes.
• 74-Powers of inspectors.
• 75-Qualifications of inspectors.
• 76—Conduct of inspections.

• 77-Code of conduct for inspectors.
• 78-Obstruction of inspectors.
• 79-Enforcement.
• 80—Oversight role by the Authority.

81—Record keeping.

• 82—Inspection of records.

PARTVI-HEALTH CARE TRIBUNAL

• 83-Establishmentof the Health CareTribunal.

84-Jurisdiction of theTribunal.

• 85-Appeals to the Tribunal.

86-Vacancy in the Tribunal.

PARTVII-FINANCIALPROVISIONS

• 87-Funds of the Authority.

88-Investment of funds.

• 89-Financial year.
• 90-Annual estimates.
• 91-Accounts and audit.
• 92-Annual report.

PART VIII-PROVISION ON DELEGATED POWERS

93-Regulations.

PARTIX-GENERALPROVISIONS

94-Review.

95-Appeal.

96-Confidentiality.

97-Offences.

• 98-General penalty

PARTX-TRANSITIONALPROVISIONS

• 99-Transitional provisions.
• 100-Consequential amendments.

FIRST SCHEDULE

SECOND SCHEDULE

THE QUALITY HEALTHCAREAND PATIENT

SAFETYBILL,2025

A Bill for

AN ACT of Parliament to give effect to Article 43 (1) (a) oftheConstitution; toprovide forthe responsibility ofthe county governments in the realisationof quality of healthcare for patients; to provide for the establishment,powers and functions of the Quality Healthcare and Patient Safety Authority, registration,licensing and accreditation of health facilities; to provide for the setting of standards for quality of healthcare; and for connected purposes

ENACTED by theParliament ofKenya,as follows-

PARTIPRELIMINARY

• 1.This Act may be cited as the Quality Healthcare Short title.
• and Patient Safety Act,2025.
• 2.Inthis Act, unless the context otherwise requires-

"accreditation for quality of healthcare" means a process of attestation that healthcare services, processes, systems, and persons conform to quality healthcare standards, requirements or criteria and attain the ratings prescribed in Regulations under this Act;

"adverse event"means an unintended harm caused by

medical management rather than by a disease process;

"Authority" means Quality Healthcare and Patient

Safety Authority established under section 26;

"Board" means the Board of Directors of the Authority appointed under section 29;

"Cabinet Secretary" means the Cabinet Secretary for the time being responsible for matters relating to quality of

healthcare;

"Chief Executive Officer"means the Chief Executive

Officer of the Authority appointed under section 35;

"clinical guidelines" means evidence-based guidelines

developed and published by the Director-General for the delivery ofhealthcare services under section 20;

Interpretation.

"Director General" means the Director-General for health appointed under section 16 of the Health Act;

Cap.241.

"emergency medical treatment" means the evaluation, treatment and care of an ill or injured person in a situation in which such evaluation,treatment and care is required and the continuation of treatment and care during the transportation of such a person to or between health

facilities;

"healthcare professional" has the meaning assigned to Cap.241. itunder the Health Act;

Cap.241.

"healthcare provider" has the meaning assigned to it under the Health Act;

"healthcare services" has the meaning assigned to it Cap.241.

under the Health Act;

"health facility"" has the meaning assigned to it under Cap.241. the Health Act;

"patient" means a person receiving or seeking a healthcare service from a health facility;

"medical aesthetic procedure" means any procedure or

intervention,whether invasive or non-invasive,performed primarily for cosmetic or appearance-enhancing purposes, which involves the use of medical or quasi-medical techniques, substances, equipment or devices, and which may pose a risk to the health, safety, or well-being of a person;

"patient-centred care"means holistic healthcare that respects and responds to each person's preferences,needs and values by fostering partnerships between healthcare providers and patients, for better satisfaction and health

outcomes;

quality of health care"means healthcare services that are safe,effective, timely,efficient,equitable,and people centered, provided to an individual, that improves health outcomes based on evidence-based standards;and

"Tribunal"means the Healthcare Tribunal established under section83.

• 3.The objects of this Act are to-
• (a) guarantee patient rights and patient safety;
• (b)provide a framework for the setting of standards
• for healthcare services and health facilities;
• (c) improve the quality of healthcare services and health outcomes;
• (d) ensure health facilities provide healthcare services in a manner that guarantees high-quality care,
• safety,effectiveness and efficiency;and
• (e) establish mechanisms for the implementation and
• monitoring of standards of quality healthcare.
• 4.The principles for implementation of this Act shall be-
• (a) equitable,quality, cost effective and accessible health care to all persons;
• (b) protection, promotion, improvement and maintenance of the health and well-being of every person;
• (c) patient-centered care; and
• (d) accountability.
• 5.The Cabinet Secretary shall-
• (a) develop and ensure implementation of policies,
• standards, guidelines and protocols that ensure the provision of quality healthcare services including staffing norms and standards;
• (b) ensure continuous improvement in the quality of healthcare services provided to individuals for,or in connection with the prevention, diagnosis or treatment of illness, or theprotection or improvement ofpublic health;
• (c)ensure continuous improvement in the outcomes that are achieved from the provision of the healthcare services, including——
• (i)the effectiveness of the healthcare services;
• (ii) the safety of the healthcare services;

Objects of the

Act.

Guiding Principles.

Role of the Cabinet Secretary.

• (iii) the quality of the experience undergone by
• patients;and
• (iv) the healthcare provider's experience.
• (d) reduce the inequalities in relation to the benefits that all persons may obtain from the healthcare servicesprovided;and
• (e) take such appropriate steps for the purpose of
• protecting the public from disease or other dangers tohealth including closinga health facilitywhere the closure is required in public interest.

6. A county government shall --

• (a) implement the national government policies, guidelines, protocols and standards prescribed under this Act and other relevant laws;
• (b) promote equitable access to quality healthcare services across all populations within the county;
• (c) support continuous improvement in the safety, effectiveness and responsiveness of healthcare
• services;
• (d) collaborate with the Authority to achieve the objects of this Act;
• (e)monitor the quality of healthcare in all health
• facilities within its jurisdiction,including public, private and faith-based health facilities;
• f maintain a county-level quality improvement program to address service gaps and monitor key performance indicators;
• (g) establish digital reporting systems,integrated to System established under the Digital Health Act, No. 15 of 2023.
• the ComprehensiveIntegrated Health Information to track qualitymetrics and adverse events;
• (h) ensure health facilities and community health services within the county comply with the national standards on quality of healthcare prescribed under this Act and other relevant laws;
• (i) collect and keep a record of quarterly indicators on quality including data on patient safety incidents,

Role of a county government.

• waiting times,clinicaloutcomes and patient satisfaction, through the Comprehensive

Integrated Health Information System;

• G conduct public awareness campaigns to educate communities on patient rights and quality of
• healthcare standards; and
• (k) verify the licensure of healthcare providers employed in county health facilities from the relevantregulatory bodies.

PARTI-PATIENTRIGHTSANDSAFETY

• and county governments shall take measures to progressively achieve the full realization of the rights of the patients set out in this
• 7.(l)Thenationalgovernment Act.
• (2) The Cabinet Secretary shall ensure development, review and implementation of relevant policies,laws and
• programs to give effect to subsection (1).
• (3) The Cabinet Secretary shall make Regulations to give effect to rights of patients set out in this Part.
• 8.(1) Every patient has the right to provision of
• healthcare services in a safe and accessible health facility.
• (2) Every health facility shall-
• (a) implement healthcare standards set out in this Act
• and other relevant laws;
• (b)maintain high standards of cleanliness,ventilation and lighting,water and food safety,sanitation and waste management in accordance with the Public
• Health Act;
• (c) provide ereasonable modifications to enable accessibility by persons with special needs;
• (d) enforce policies to prevent violence, abuse or neglect of patients; and
• (e)provide appropriate nutrition.
• (3) The national and county governments shall develop and implement policies and laws to ensure the realization of this section.

Realization of the rights and safety of the patient.

Right to safe and accessible health facilities.

9. (1) Every patient has the right to quality healthcare providedby qualified and licensed healthcare 2. professional.

• (2) In pursuance of the right to healthcare by a

4. qualified health professional under this section, every patient has theright to healthcare- 5. (a) from healthcare providers with qualifications verified and approved by the relevant regulatory bodies; 6. (b) from healthcare providers licensed by the relevant regulatory bodies; and 7. (c) delivered with respect for human dignity and 8. cultural diversity. 9. 10.(1) Notwithstanding section 8 of the Health Act, 10. every patient has the right to clear,comprehensive,and accessible information about their care to enable them make informed decisions on theirhealth.

• (2) Without prejudice to the generality of subsection

12. (1),every patient has the right to- 13. (a) be provided with comprehensive details on 14. diagnosis, treatment options and health products and technologies prescribed; 15. (b)interpretation or alternativeformatsofinformation for accessibility;and 16. (c) disclosure of risks and benefits of healthcare 17. procedures. 18. 11.(1) Every person has the right to access quality healthcare services that are- 19. (a) safe and dignified; 20. (b) appropriate to their clinical needs; and 21. (c)compliant with quality of healthcare standards prescribed under this Act.

• (2) A person whose right under subsection (l) is violated may lodge a complaint with the Authority or seek redress in accordance with this Act.

23. 12.(1) Every patient has the right to timely and 24. effective healthcare services.

Right to care by a

qualified health professional.

Right to information and

decision-making. Cap.241.

Right to safe and quality care.

Right to timely andeffective care.

• (2) Without prejudice to the generality of subsection

2. (1), a patient has the right to- 3. (a) prompt access to health care to prevent harm; 4. (b) coordinated continuum of care during out-of-hours and post-discharge periods; 5. (c) timely referrals,where appropriate. 6. 13.(1) Every patient has the right to safe clinical 7. processes that ensure safety and efficiency.

• (2) Without prejudice to the generality of subsection

9. (1),every patient is entitled to- 10. (a) accurate identification and documentation using 11. standardized protocols; 12. (b) care adhering to approved clinical guidelines; 13. (c) safe administration ofmedication: 14. (d) safe surgical, medical and diagnostic procedures and infection prevention measures;and 15. (e)appropriatemanagement ofhealth conditions. 14. (1) Every patient has the right to safe and quality health products and technologies.

• (2) Every healthcare provider shall-

18. (a)prescribe,administer and monitor the use of health products and technologies in accordance with 19. relevant laws; 20. (b) prescribe health products andtechnologies approved by the relevant regulatory body; 21. (c) report adverse reactions to the relevant regulatory body in accordance with the Guidelines provided by the relevant regulatory body; and 22. (d)provide patient education and counseling on the safe use and potential risks of health products and technologies. 23. 15.(1) Every patient has the right to dignity and equitable care.

• (2) For the purpose of subsection (l), a patient is

25. entitled to- 26. (a) respectful, person-centered care, including quality 27. palliative and end-of-life care;

Right to safe

processes and practices.

Right to safe and qualityhealth products and technologies.

Right to dignity and equity.

• (b)non-discriminatory treatment regardless of age, sex,disability,ethnicity,health status or socioeconomic status;and
• (c) tailored services for vulnerable or marginalized groups, including women, youth, persons with disabilities and minority groups.
• 16.(1) Every patient has the right to report concerns
• regarding the safety and quality of healthcare arising out of the services offered by a health facility.
• (2) Without prejudice to the generality of subsection
• (1),every patient is entitled to-
• (a)raise concerns in anenvironment free from
• retaliation;
• (b)receive written explanations and redress of their concerns;and
• (c)have complaints involving serious harm investigated and addressed in accordancewith this Act.
• (3) In order to promote efficient redress of complaints, every health facilityshall provide a mechanism,which shall provide for all the matters specified in the standardized template issued by the Authority under subsection (4),for patients to lodge a complaint.
• (4) The Authority shall issue a standardized template of the internal dispute resolution mechanism for health
• facilities.
• (5)TheAuthority shall updatethe standardized template issued under subsection (4) after every two years.
• 17.(1) In order to promote awareness and quality of
• healthcare,every health facility shall develop a patient rights charter which shall provide for all the matters specified in the standardized template issued by the Authority under subsection (3).
• (2) A health facility shall display the patient rights charterin prominent and accessible locations.
• (3) The Authority shall issue a standardized template
• of the charter to promote awareness and quality of healthcare.

Right to be heard.

Patient rights

charter.

• (4) The Authority shall update thestandardized

2. template issued under subsection(3) after every twoyears. 3. 18.(1) A health facility shall- 4. (a) implement measures to ensure patient safety and 5. quality of health care in their health facility; 6. (b) provide healthcare services or perform a medical procedure for which the health facility or healthcare provider at the health facility is duly qualified and licensed under this Act or any other 7. relevant laws; 8. (c) adhere to the scope of practice for the healthcare providers employed or contracted in health 9. facilities as prescribed by the Cabinet Secretary; 10. (d) provide mechanisms for adherence to professional standards;and 11. (e) ensure compliance to training and internship 12. standards and guidelines. 13. (2)A health facility which fails tocomply with the 14. provisions of this section commits an offence and shall be liable,on conviction,to a fine not exceeding fifty million shillings or to imprisonment for a term not exceeding ten years,orto both. 15. 19.(1) Every health facility shall take all reasonable quality of healthcare standards prescribed under this Act.

• (2) The Authority shall enforce the quality of

17. healthcare standards,prioritizing effectiveness,saety,and responsiveness to patient needs. 18. 20.(1) Every health facility shall adhere to clinical 19. guidelines based on scientific evidence including protocols.

• (2) The Director-General shall develop and publish

21. clinical guidelines from time to time. 21. (1) Every health facility shall- 23. (a) implement infection prevention surveillance and control measures as prescribed by the Cabinet 24. Secretary; 25. (b) establish systems for the safe use, storage and administration of] health products and

Patient safety and quality assurance measures.

Duty to uphold qualityof healthcare.

Evidence-based practice.

Safety and risk management.

technologies, integrated to the Comprehensive

• IntegratedHealthInformationSystemestablished under the Digital Health Act;
• (c)report adverse medical or public health events to theAuthority throughthe Comprehensive Integrated HealthInformationSystemestablished under the Digital Health Act;and
• (d) implement procedures for detecting, analyzing and reducing health risks and adverse events.
• (2) Every health facility shall audit the safety of the
• health facility and submit an annualsafetyauditreport to the Authority, setting out measures to improve the safety of the health facility.
• (3)Every healthcareprovider shall report to the health facility, where the healthcare provider has provided a healthcare service, any act, omission or circumstance that may pose a risk topatient safety within the heath facility.
• (4) The Authority shall issue a standardized template for use by healthcare providers to report to the health risk to patient safety,.
• (5) The template under subsection (4) shall make provisionfor anonymous reporting by a healthcare provider of any acts, omissions or circumstances that may pose a risk to patient safety.
• (6) The Authority shall update the standardized
• template issued under subsection (4) after every two years.
• 22.(1) The Cabinet Secretary shall develop a quality
• improvementframeworkforhealthfacilities,which shall-
• (a) set benchmarks for patient satisfaction,clinical
• outcomes,and service efficiency;
• (b) include specific targets for reducing disparities in access, treatment,and outcomes across geographic, socioeconomic and special needs demographics;
• (c) reflect the levels of care and resource availability
• in the different categories of health facilities;and
• (d) incorporate timelines for implementation and review.

No.15of2023.

No.15of2023.

Quality improvement.

• (2) Every health facility shall develop and implement a quality improvement program that shall-

2. (a) monitor key performance indicators as prescribed in Regulations; 3. (b) analyzeall data to address service gaps, prioritizing maternal healthcare, primary healthcare, mental healthcare and emergency medical treatment;and 4. (c) report progress to the Authority each year. 5. (3)Every health facility shall implement a structured quality assurance program including clinical audits,patient 6. feedback mechanisms, peer reviews and outcome analysis.

• (4) Compliance with quality improvement standards shall form the basis for health facility accreditation, performance assessment and access to the Social Health Insurance Fund established under the Social Health

8. Insurance Act. 9. (5)The Authority shall monitor the implementation of the quality improvement framework by health facilities. 10. 23.Every county government and health facility 11. shall- 12. (a) verify thequalificationsand licensure of 13. healthcare providers before employment; and 14. (b)provide periodic training on patient safety,clinical 15. guidelines and quality improvement. 16. 24.(1) Every health facility shall maintain a valid professional indemnity cover to protect the health facility against claims arising from acts or omissions committed in the course ofproviding healthcare services.

• (2) Every health facility shall-

18. (a) verify and ensure that all its employees or contracted healthcare providers are covered under an appropriate professional indemnity cover; and 19. (b) insure the health facility against the professional liability of its staff. 20. 25.Every patient shall- 21. (a) adhere to the rules of a health facility when receiving treatment or using the health services 22. provided at a health facility;

No.16of2023.

Training and

competency.

Professional

indemnity.

Duty of the

patient.

• (b) adhere to the medical advice and treatment provided by a health facility or healthcare
• provider;
• (c) supply the healthcare provider with accurate information pertaining to the patient's health status;
• (d) cooperate with the healthcare provider;
• (e) treat healthcare providers and health workers with dignity and respect;
• (f) if so requested, to sign a discharge certificate or release of liability if the patientrefuses to accept orimplementrecommended treatment.

PARTIII-ADMINISTRATION OF QUALITY OF HEALTHCARE

• 26.(1) There is established an Authority to be known
• as the Quality Health Care and Patient SafetyAuthority.
• (2) The Authority shall be a body corporate with perpetual succession and a common seal and shall, in its corporate name,be capable of-
• (a) suing and being sued;
• (b) taking, purchasing or otherwise acquiring, holding, charging and disposingof movableand immovable property;
• (c) borrowing money;
• (d) entering into contracts; and
• (e) doing or performing all other things or acts necessary for the proper performance of its functions under this Act, which may lawfully be done or performed by a body corporate.
• (3) The Headquarters of the Authority shall be in Nairobi but the Authority shall ensure access to its services in all parts oftheRepublicin accordancewithArticle 6(3)
• of the Constitution.
• 27.The functions of the Authority shall be to-
• (a)regulate thedevelopment of health facilities
• infrastructure;
• (b) register, license and accredit health facilities;

Establishment of theAuthority.

Functions of the Authority.

• (c)regulate the conduct of health facilities;
• (d) enforce compliance with quality of healthcare
• standards;
• (e) inspect health facilities for compliance with the
• quality of healthcare standards;
• (f) undertake or cause to be undertaken, regular inspections,monitoring and evaluation of health facilities to ensure compliance with the provisions
• of this Act;
• (g) establish and implement a system of accreditation of health facilities for quality of healthcare;
• (h)accredit health facilities for purposes of empanelment and contracting under section 33 and 34 of the Social Health Insurance Act;
• maintain a register of registered,licensed and
• accredited health facilities,
• (j)inspect and accredit health facilities for purposes of internship and training;
• (k)promote public awareness on quality of healthcare including on patientrights;
• build capacity on matters related to quality of
• healthcare;
• (m)provide policy advice and make recommendations to the Cabinet Secretary on matters related to quality of healthcare;
• (n) advise the Cabinet Secretary and county governments on the standards of quality of healthcare for health facilities;and
• (o) perform such other functions as may be as necessary for the promotion of the objects of this Act or prescribed by any other written law.

28. (1) The Board shall have all the powers necessary for the proper performance of its functions under this Act

• and any other written law.
• (2) Without prejudice to subsection (1), the Board shall have thepower to-
• (a) manage, control and administer the assets of the AuthorityinaccordancewiththePublic Procurement and Asset Disposal Act;

No.16of2023.

Powers of the Board.

Cap.412C.

• (b) open such bank accounts for the funds of the Authority as may be necessary;
• (c) determine the provisions to be made for capital
• and recurrent expenditure and for the reserves of the Authority;
• (d) with the approval of the Cabinet Secretary for the time being responsible for matters relating to the National Treasury, invest any surplus funds of the Authority not immediately required for the
• purposes of this Act, as the Board may determine;
• (e) receive gifts, grants, donations or endowments made to the Authority or any other monies in respect of the Authority and make legitimate disbursements therefrom in accordance with the provisions of this Act;
• (f)levy orchargefeesfor the servicesrenderedbythe Authority asmay be determined from time to time
• by the Board;
• (g)enter into association, collaboration or partnerships with suchother bodies or organizations, within or outside Kenya, as it may considerdesirable orappropriate and in furtherance of the purposes for which the Authority is established;and
• (h) undertakeanyactivity necessary performance of any of its functions.
• forthe

29. (1) The management of the Authority shall vest in

• a Board of Directors consisting of-
• (a) a chairperson appointed by the President;
• (b) the Principal Secretary in the Ministry for the time being responsible for matters relating to quality of healthcare standards or a representative designated
• in writing;
• (c) the Principal Secretary for the National Treasury or a representative designated in writing;
• (d) the Attorney-General orarepresentative
• designated in writing;
• (e) the Director-General;

Directors of the

Boardof Authority

• (f) one person appointed by the Cabinet Secretary, not being a Governor, nominated by the Council of County Governors with knowledge in matters of health, quality management and quality improvement;
• (g) one person appointed by the Cabinet Secretary,not being a public officer, to represent healthcare providers;
• (h) one person appointed by the Cabinet Secretary to
• represent the public;and
• (i) the Chief Executive Officer, who shall be an ex
• officiomemberof theBoard.
• (2) The appointment of the chairperson and members under subsection (1)(e), (f) and (g) shall be by notice in the
• Gazette.

30. (l) A person shall qualify for appointment as the

• chairperson of the Board,where the person-
• (a) is a citizen of Kenya;
• (b) holds a Bachelor's degree in a healthcare related
• field from a university recognized in Kenya;
• (c) has professional knowledge and experience of at least fifteen years in health governance, health administration, public policy or other health-
• related field;
• (d) has served in a senior management level for a
• period of at least ten years;
• (e) is in good standing with the relevant regulatory body; and
• (f) meets the requirements of Chapter Six of the
• Constitution.
• (2) A person shall qualify for appointment as a member of the Board under section 29(1) (f),(g) and (h) where the person-—
• (a) is a citizen of Kenya;
• (b) holds at least a Bachelor's degree from a
• university recognized in Kenya;
• (c) has professional knowledge and experience of at
• least ten years in matters of finance, social

Qualificationfor appointment as Chairperson or Member of the Board.

• sciences,health administration and management or qualitymanagement and improvement;and
• (d) meets the requirements of Chapter Six of the
• Constitution.

31. (1) The chairperson and the members appointed under section 29 (1) (f), (g) and (h) shall hold office for a term of threeyears and shall be eligible forre-appointment for one further term of three years.

• (2) The members appointed under section 29 (1) (b),
• (c),(d) and (e) shall hold office during their tenure of office unless removed from office by the appointing authority.
• 32.(1) The Board may establish committees for the effectiveperformance ofitsfunctionsunder thisAct.
• (2) The Board may co-opt into the membership of a committee any person whose knowledge and expertise may be necessary for the effective performance of the functions of the Authority in accordance with the Government
• directives.
• (3) A person co-opted into a committee under subsection (2), may attend the meetings of the committee and participate in its deliberations,but shall not vote at such meetings.
• 33.(1) The Board shall conduct its business and affairs in accordance with the provisions of the First Schedule.
• (2) The Board may regulate its own procedure.
• 34.The Board may,by resolution either generally or in any particular case, delegate to any committee of the Board or to any member in writing and by name the exerciseofanyofthepowers or theperformanceofany of the functions or duties of the Board under this Act.

35. (1) The Board shall, through an open, transparent

• and competitive recruitment process, appoint a qualified person to be the Chief Executive Officer of the Authority.
• (2) A person shall qualify for appointment as the Chief
• Executive OfficeroftheAuthority,wheretheperson一
• (a) is a citizen of Kenya;
• (b) holds a bachelor's degree in a healthcare related
• field from a university recognized in Kenya;

Term of office.

Committees of the Board.

Conduct of business and affairs of the Board.

Delegation by the Board.

The Chief Executive Officer

of the Authority.

• (c) is a registered member of a health professional body;
• (d) has had at least ten years professional experience management and and
• inmattersofhealthcare administration, quality management improvement or other managementrelated field;
• (e) has served in a management level for a period of at
• least five years;and
• (f) meets the requirements of Chapter Six of the
• Constitution.
• (3) The Chief Executive Officer shall serve on such
• terms and conditions as the Board may determine.
• (4) The Chief Executive Officer shall hold office for a period of three years and shall be eligible for re-
• appointment for one further term of three years.
• (5) The Chief Executive Officer shall, in the performance of the functions and duties of the office, be responsible to theBoard.
• (6) The Chief Executive Officer shall-
• (a) be the Registrar of the Authority, and shall perform such duties as are prescribed by this Act in connection with the registers maintained under
• this Act;
• (b) be the accounting officer of the Authority;
• (c) be responsible for-
• (i) implementing the decisions of the Board;
• (ii) the day-to-day administration and management of the affairs of the Authority; and
• (iii) the coordination and supervision of the staff of the Authority; and
• (d) perform any other duties as may be assigned by theBoard and any otherwritten law.
• 36.(1) The Chief Executive Officer may be removed from officeby the Board in accordancewith the terms and
• condition of service,for-

Removal from officeof the Chief Executive Officer.

• (a) inability to perform the functions of the office
• arising out of physical or mental infirmity;
• (b) gross misconduct or misbehaviour;
• (c) incompetence or neglect of duty;
• (d) conviction for an offence and sentencedto imprisonmentfor a term exceedingsixmonths, without the option of a fine;
• (e) being adjudged bankrupt;
• (f)being declared as being of unsound mind;
• (g) violation of the Constitution or any other written
• law;or
• (h) breaching any other grounds specified in the terms and conditions of service of the Chief Executive Officer.
• (2) Where the question of the removal of the Chief Executive Officer under subsection (1) arises, the Board shall act in accordance with the principles of fair administrative action prescribed under Article 47 of the Constitution and the FairAdministrativeAction Act.
• 37.(1) The Board shall, through an open, transparent person tobe the CorporationSecretary of theAuthorityon
• and competitive recruitment process, appoint a qualified such terms as the Board may, upon the advice of the Salaries and Remuneration Commission,determine.
• (2) A person shall qualify for appointment as the
• CorporationSecretary if thatperson—
• (a) holds a bachelor's Degree in law from a university recognized in Kenya;
• (b) is an Advocate of the High Court of Kenya;
• (c) is a Certified Public Secretary;
• (d) has at least five years'experience in governance
• matters;and
• (e)meets the requirements of Chapter Six of the
• Constitution.
• (3) The Corporation Secretary shall be the Secretary to
• the Board.
• 38.The Board shall, through a competitive and transparent process, employ such officers, agents and other staff as may be necessary for the proper discharge of its

Cap.7L.

Corporation

Secretary.

Staff of the Authority.

functions under this Act,upon such terms and conditions of service as theBoard may determine.

• 39.The chairperson, members of the Board and staff
• of the Authority shall be paid such remuneration,fees, allowances and such other reimbursements as may be approved by the Cabinet Secretary upon the advice of the Salaries and Remuneration Commission.

40. (1) No matter or thing done by a member of the Board or an officer, employee or agent of the Authority shall, where the matter or thing was done in good faith in the execution of the functions or powers of the Authority, render the member,officer,employee or agent personally liable for any action, claim or demand whatsoever.

• (2) Despite subsection (1),nothing in this section shall exempt a member of the Board, officer, employee or agent of theAuthorityfrom individual responsibilityfor unlawful or criminal act committed by the member of the Board, officer,employee or agent of the Authority.
• 41.(1) There shall be a common seal of the Authority
• which shall be kept in the custody of the Corporation Secretary and shall not be used except on the direction of the Board.
• (2) The affixing of the common seal of the Authority
• shall be authenticated by the signatures of the Chairperson and the Chief Executive Officer and any documentrequired by law tobemade under seal and all decisions oftheBoard may be authenticated by the signatures of the Chairperson and the Chief Executive Officer.
• (3) The Board shall, in the absence of either the Chairperson or the Chief Executive Officer, in any particular matter,nominate one member to authenticate the seal of the Authority on behalf of either the Chairperson or the Chief Executive Officer.
• (4) The common seal of the Authority when affixed to a document and duly authenticated,shall be judicially and officially noticed, and unless the contrary is proved, any necessary order by the Authority under this section shall be presumed to have been duly given.

Remuneration.

Protectionfrom personal liability.

Common seal.

PARTIV-REGISTRATION,LICENSINGAND ACCREDITATIONOFHEALTHFACILITIES

42. (1) A person who intends to construct or operate a health facility shall obtain approval from the Authority before commencing the construction or operation.

• (2) The Cabinet Secretary shall prescribe the requirements for-

3. (a) health facilities; 4. (b) ambulances; 5. (c)medical camps;and 6. (d) such other health facility as may be prescribed by 7. the CabinetSecretary.

• (4) An application for an approval under this section shall be in such form and manner as may be prescribed in

9. Regulations.

• (5) The Authority may, in collaboration with the relevant government agencies, develop frameworks for the purposes of assessing the approval process of health facilities.
• (2) A person who intends to decommission a health facility shall obtain approval from the Authority before

12. the decommissioning.

• (6) The Cabinet Secretary shall develop standards for the construction,operation and decommissioning of a health facility.

14. 43.(1) A person who intends to operate a health 15. facility shall, after acquiring approval under section 42 apply for registration of the health facility with the Authority.

• (2) The registration of a health facility under

17. subsection (l) shall be in the prescribed manner. 18. 44.(1) An application for registration of a health facility shall be made in the prescribed form and be accompanied by- 19. (a) the approval issued under section 42; 20. (b) such description of a health facility specific information oractivity asmaybeprescribed by the Cabinet Secretary; 21. (c) the prescribed fee;

Approval of a

health facility.

Registration of a health facility.

Applicationfor

registration.

• (d) evidence that the health facility is tobe operated or managed by a healthcare professional registered by a relevant regulatory body;
• (e) contact details of the owner, operator or a person having administrative responsibilities at the health facility;and
• (f) any other details as may be prescribed by the Authority.
• (2) The Authority shall before issuing a certificate of registration under this Act,undertake an inspection of the health facility.

45. (1) Where the Authority is satisfied that the health

• facility meets the requirement for registration,the Authority shall issue the health facilitywith a certificate of registration in the prescribed manner.
• (2)The Authority shall issue a health facility
• registered under this Act a certificate of registration upon the payment of the prescribed fee.
• (3) Where an applicant does not comply with provisions of this Act, the Authority may refuse to grant a
• certificate of registration to the applicant.
• (4) Where the Authority refuses to grant a certificate of registration,the Authority shall inform the applicant,in writing,of the refusal and the reasons for the refusal within fourteen daysfrom the date of the decision.
• 46.(l) The Authority may suspend a certificate of
• registrationwhere-
• (a) any information given by the applicant is found to
• be false or misleading;
• (b) the holder of the certificate fails to comply with
• any of the requirements of this Act; or
• (c) any term or condition thereof has not been
• complied with within the prescribed period.
• (2) Where the Authority intends to suspenda certificate of registration under this section,it may,at least twenty-one days before the date of the intended suspension, notify the health facility of such intention,specifying the reasons thereof and shall require the health facility to furnish reasons why the licence should not be suspended, within fourteen days of service of the notice.

Certificate of registration.

Suspension of the certificate of registration.

• (3) A person aggrieved by the decision of the

2. Authority under this section may,within twenty-one days from the day of the notification under subsection (2) lodge an appeal before the Tribunal. 3. (4)The Authority may inwriting,reinstatea 4. certificate of registration suspended under subsection (1) if satisfied that the reasons for the suspension no longer exist. 5. 47.(1) A certificate of registration of a health facility 6. may be revoked,where-— 7. (a)the health facility fails to comply with any of the provisions of this Act and any other relevant laws; and 8. (b) the name of the health facility was fraudulently 9. entered in the register. 10. (2)Where theAuthority intends torevoke a certificate of registration under this section, it may, at least twenty one days before the date of the intended revocation, notify the health facility of such intention, specifying the reasons thereof and shallrequire the health facility to furnish 11. reasons why the licence should not be suspended, within fourteen days of service of the notice.

• (3) A person aggrieved by the decision of the Authority under this section may,within twenty-one days from the day of the notification under subsection (1) lodge an appeal before the Tribunal.
• (4) The Authority shall Gazette the details of a health facility whose certificate of registration has been revoked.

14. 48.(1) A health facility issued with a certificate of registration by the Authority under section 45 shall apply for an annual licence from the Authority.

• (2) The Authority may,before issuing a licence under this section, undertake an inspection of the health facility.
• (3) A person who operates a health facility without obtaining a licence from the Authority under this Act, commits an offence and shall be liable,on conviction,to a fine not exceeding ten million shillings or to imprisonment for a term not exceeding five years, or to both.

17. 49.An application for a licence shall be in the prescribed form and be accompanied by--

Revocation.

Licence.

Applicationfor a

licence.

• (a) a copy of the approval issued under section 42;
• (b) a copy of a certificate of registration issued under
• section45;
• (c) the prescribed fees;
• (d)particulars ofthe healthcareprofessionals employed in the health facility and proof of their
• licensure by the respective regulatory body;
• (e)particulars of non-healthcare professional employees in the health facility;
• (f)particulars of a digital health solution that has been certified by the Digital Health Agency to be used by the health facility;and
• (g) any other requirement as may be determined by
• the Authority.
• 50.A health facility shall be licensed where-
• (a) the premises of the health facility conform to the description, infrastructure and personnel criteria for the respective category of the health facility as set out in the First Schedule to the Health Act and the Regulations prescribed by theCabinet Secretary under this Act;
• (b) the healthcare providers providing services at the health facility are holders of valid practicing licences issued by the relevant regulatory body to
• render healthcare services at the health facility;
• (c) all professional staff working in the health facility
• are qualified and are registered by the relevant regulatory body as required in the relevant law; and
• (d) the quality of health care to be provided at the health facility complies with the quality of healthcare standards prescribed under this Act.
• 51.A licence issued under this Act shall be valid up to the 31st December of each year of issue andmay,upon expiry,be renewed upon the licensee making an application for renewal.

Conditionsfor grant of licence.

Cap.241.

Validity of the licence.

• 52.(1) For purposes of licensing under this Act, the Authority shall categorize registered health facilities in
• accordance with the First Schedule to the Health Act and the Regulations prescribed by the Cabinet Secretary
• (2) Notwithstanding subsection (1), ambulances shall
• be classified into the following categories-
• (a) advanced life support ambulances, that are designedand equipped to provide advanced treatment and monitoring of patients;
• (b) intermediate life support ambulances, that provide limited invasive treatment and monitoring of patients; and
• (c) basic life support ambulances, that provide basic treatment and monitoring ofpatients.
• (3)A licence issued under subsection (2) shall set out
• the category of the ambulance.
• 53.(1) A licence issued to a health facility shall specify the nature of the services that may be provided by the health facility based on the category of the health facility.
• (2) Despite subsection (1), a health facility shall not be accordance with the Regulations prescribed by the Cabinet Secretary.
• (3) The Authority shall publish in the Gazette a list of licensed health facilities and the type and nature of the healthcare services to be provided by the licensed health
• facilities.
• 54.(1) The Authority may suspend a licence issued
• under thisActwhere the health facility-
• (a) willfully neglects or refuses to comply with any of the provisionsof thisAct;or
• (b) obstructs,impedes, or hinders any person carrying
• out any duties or responsibilities under this Act.
• (2) Where the Authority intends to suspend a licence under this section,it may,at least twenty-one days before the date of the intended suspension,notify the health
• facility of the intention, specifying the reasons thereof and

Categorization of

health facilities.

Cap.241.

Services offered byhealth facilities.

Suspension of a

licence.

require the health facility to furnish reasons why the licence should not be suspended,within fourteen days of service of the notice.

• (3) Where the Authority suspends a licence, the

2. Authority shall inform the health facility of its decision and the reasons for the decision in writing as prescribed in Regulations.

• (4) A person aggrieved by the decision of the

4. Authority under this section may,within twenty-one days from the day of the notification under subsection (1) lodge an appeal before the Tribunal. 5. 55.(1) The Authority may revoke a licence issued under thisActwhere- 6. (a) the health facility fails to address the grounds of suspension of the licence; 7. (b) the health facility obtained the licence in a 8. fraudulent manner; or 9. (c) the health facility concealed material information 10. from the Authority.

• (2) Where the Authority intends to revoke a licence under subsection (1), the Authority shall serve the health facility with a notice of the intended revocation specifying the grounds for such revocation and shall require the health facility to, within fourteen days of service of the notice,

12. furnish reasons why the licence should not be revoked.

• (3) Where the health facility fails to give reasons

14. within the specified period under subsection (2), the Authority shall revoke the licence..

• (4) If the health facility furnishes reasons, the Authority shall after considering the reasons decide on

16. whether or not to revoke the licence.

• (5) A person who continues to operate a health facility under a revoked licence commits an offence and shall be liable,on conviction, to a fine not exceeding twenty million shillings or to imprisonment for a term not exceeding ten

18. years, or to both. 19. 56.The Authority shall, for purposes of ensuring quality of healthcare, accredit health facilities.

Revocation ofa licence.

Accreditation for quality of

healthcare.

• 57.(1) The Authority shall accredit a health facility
• registered and licensed under this Act for quality of healthcare in accordance with the quality of healthcare standards prescribed by the Cabinet Secretary.
• (2) The Authority shall,in relation to accreditation of quality of healthcare-
• (a) ensure that the accredited health facilities comply
• with the quality of healthcare standards;
• (b) ensure that the quality of healthcare standards conform to the latest standards prescribed by the Cabinet Secretary;and
• (c)publicize and disseminate the quality of healthcare
• standards.
• (3) The Authority may,in collaboration with the relevant government agencies,develop frameworks for the purposes of assessing the conformity with the applicable quality of healthcare standards.
• 58.(1) A person shall apply to the Authority for
• accreditation of a health facility under this Act.
• (2) A person shall,prior to applying for accreditation under subsection (1),undertake self-assessment on the health facility to be assessed by the Authority for accreditation under this Act using the template developed
• under subsection (3).
• (3) The Authority shall develop a self-assessment template, for purposes of self-assessment under subsection (2).
• (4) The Authority shall update the template developed under subsection (3) after every twoyears.
• (5) The application under subsection (1) shall be
• accompanied by documents including—
• (a) a description of the type and level of health
• facility;
• (b) a description of the category or class of the health
• facility;
• (c) a description of the healthcare services to be
• provided;

Authority in accreditationfor

Role of the quality of healthcare.

Application for

accreditation.

• (d) contact details of the person making the application;
• (e) a self-assessment report;
• (f) proof of licensure by the Authority;
• (g) proof of registration by the Authority;
• (h) proof of listing of the health facility in the facility registry in the Comprehensive Integrated Health Information System established under the Digital Health Act;
• (i) the prescribed fee for accreditation; and
• (j) any other details as may be prescribed by the Authority.
• (6) The Authority shall,on receipt of the application
• under subsection (1),conduct a quality assessment of the health facility,and communicate its decision on the accreditation within ninety days from the date of receipt of the application.
• (7) A person who knowingly supplies false or misleading information under this section commits an offence and shall be liable,on conviction,to a fine not exceeding one million shillings or to imprisonment for a term not exceeding one year,or to both.
• 59.The Authority shall accredit a health facility,
• based on ——
• (a) compliancewith theapplicablequalityof
• healthcare standards;
• (b) conformity to infrastructure standards;
• (C)
• conformity to human resource requirements;
• (d) conformity with disease-specific
• clinical guidelines;
• (e) conformity to health products and technology
• f
• standards;
• the monitoring of patient outcomes;
• (g) the monitoring of satisfaction of patients and healthcare providers;and
• (h) such other criteria as may be prescribed by the Cabinet Secretary.

No.15of2023.

Requirements for accreditation.

• 60.The Authority shall, where the health facility complies with the requirements under this Act,issue a certificate of accreditation to the health facility.
• 61.The certificate of accreditation issued under this
• Act shall be valid for a period of two years from the date of issue.
• 62.A health facility shall, ninety days prior to the expiry of the accreditation make an application for renewal of the accreditation of the health facility.
• 63.(1) The Authority shall suspend the accreditation of a health facility where the-
• (a) healthfacility fails tomeet the qualityof healthcare standards;
• (b) health facility fails to correct identified nonconformities within the stipulated timelines;
• (c)health facility fails to complywith theprovisions ofthisActand anyotherwrittenlaw;and
• (d) licenceof thehealthfacility isrevoked or expired withoutbeingrenewed.
• (2) Where the Authority intends to suspend he accreditation of a health facility under this section, it may, at least twenty-one days before the date of the intended suspension, notify the health facility of such intention, specifying the reasons thereofand shall require the health facility to furnish reasonswhy the accreditation should not be suspended,within fourteen days of service of the notice.
• (3) Where the accreditation of a health facility is suspended under subsection (1),the Authority shall publish the suspension in the Gazette.
• (4) A person aggrieved by the decision of the Authority under this section may, within twenty-one days from the day of the notification of suspension lodge an appeal before the Tribunal.
• 64.(1) The Authority may revoke the accreditation of
• a health facility,where-
• (a) the health facility fails to address the grounds of suspension of the accreditation;
• (b) the accreditation was obtained in a fraudulent
• manner,or

Certificate of

accreditation.

Validity of the certificate of accreditation.

Renewalof

accreditation.

Suspension of

accreditation.

Revocation of accreditation.

• (c) the health facility concealed material information from the Authority.
• (2) Where the accreditation of a health facility is revoked under subsection (1),the Authority shall publish in the Gazette as soon as may be practicable the name of the health facility whose accreditation is revoked.
• (3) A person aggrieved by the decision of the
• Authority under this section may,within twenty-one days from the day of the notification of revocation lodge an appeal before the Tribunal.
• 65.A health facility shall for purposes of quality
• improvement-
• (a) keep records of its quality improvement activities;
• (b) develop a quality improvement program and budget inlinewith theidentified quality improvement priorities;
• (c) evaluate and oversee the implementation of quality
• improvement programs or activities; and
• (d) conduct self-assessments on the qualityof healthcare at the health facility.

66. (1) The Authority shall establish a quality scoring andratingframeworkforhealthfacilities.

• (2) The framework under subsection (1) shall provide for the-—
• (a) quality assessment of health facilities;
• (b) performance rating based on the results of the
• quality assessment; and
• (c) scoring based on the quality assessment of the
• health facility.
• (3) The Authority shall, based on the result of the scoring and quality rating--
• (a)note and commend a health facility on the areas
• that are working effectively;
• (b) identify areas that require improvement and develop,in consultation with the health facility a

Quality improvement ina health facility.

Quality scoring and rating.

• quality improvement program with a defined period on the areas for improvement; and
• (c) in the case of non-conformity with the quality of
• healthcare standards under this Act, allow the health facility to demonstrate compliance within thirty days of the notification of non-conformity by the Authority.
• (4) The Authority shall publish in the Gazette the results of the quality assessment and quality rating of licensed health facilities.
• 67.(1) The Authority shall award a performance rating and a recognition certificate to a health facility in accordancewiththelevel ofthehealthfacility.
• (2) The performance rating under subsection (1) shall
• be-
• (a) assigned based on the results of the assessment for quality of healthcare; and
• (b) used to determine the incentives to a health
• facility.
• (3) The performance rating under subsection (l) may be revised by the Authority from time to time upon the conduct of a further quality assessment of the health facility.
• 68.Where a health facility is found to be noncompliant with the quality of healthcare standards, the Authority shall take necessary actions including—
• (a) issuing warnings for minor non-compliances with
• a clear timeline for rectification;
• (b)requiring quality improvement programs;
• (c) imposing fines or penalties forsignificant violations of quality of healthcare standards or failure to submit required reports;
• (d) suspending or revoking accreditation where the health facility fails tocomply with the qualityof healthcare standards or the corrective actions after several inspections;and
• (e) closing the health facility in cases where noncompliance poses an immediate risk to patient safety orhealth outcomes.

Awardofa performance rating.

Non-compliance with quality

standards.

• 69.The Authority shall monitor compliance with the
• requirements of accreditation for quality of healthcare by health facilities.
• 70.(1) The Chief Executive Officer shall keep and
• maintain a register of health facilities.
• (2) The register under subsection (1) shall contain-
• (a) registered health facilities;
• (b) licensed health facilities;and
• (c)accredited health facilities.
• (3) The register in subsection (1) shall contain
• information on the health facility including their-
• (a)name;
• (b) contact information;
• (c) type and nature of healthcare services provided;
• (d) date of registration;
• (e) license number;
• (f) accreditation number;
• (g) listing number in the facility registry in the Comprehensive Integrated Health:Information
• System established under the Digital Health Act;
• (h) quality rating and scores; and
• (i) compliance level based on the quality assessment score.
• (4) A person may, during normal office hours and on
• payment of the prescribed fee,inspect the register and any document relating to an entry and may obtain from the Chief Executive Officer a copy or extract from the register of any such document.
• (5) The Chief Executive Officer shall annually cause to be published in electronic or print media and in the official communication channel of the Authority, particulars of health facilities duly registered under this Act.
• 71.(1) The Chief Executive Officer may for a specified duration and on the recommendations of the Authority,remove from the register,a health facility-

compliance by the

Monitoring of Authority.

Register of health facilities.

No.15 of 2023.

Removal from the register.

• (a) whose name has been fraudulently entered in the
• register;
• (b)whose name the Board has directed that it should be removed from the register for breach of the provisions of this Act;or
• (c) who has failed to satisfy the requirements for accreditation of quality ofhealthcare for the time being in force.
• (2) Where the Chief Executive Officer establishes that register, the Chief Executive Officer may correct the error
• an entryhas been erroneously orincorrectly entered inthe andnotify the affected person of such corrections.
• (3) The Chief Executive Officermay,at the request of the holder of the certificate of registration, licence or accreditation certificate issued under this Act,remove any entry in the register which has ceased to be applicable.

PARTV-INSPECTIONS,INVESTIGATIONSAND ENFORCEMENT

Appointment of health facility

• 72.(1) The Authority shall,by notice in the Gazette appoint health facility inspectors of such qualifications as inspectors.
• may beprescribed by the Authority.
• (2) An inspector appointed under subsection (1) shall-
• (a) carry out inspections of health facilities and
• healthcare so as to-
• (i) monitor compliance with the provisions of this Act and all applicable Regulations; and
• (ii) compile and submit reports of inspection to the Authority;and
• (b) perform such other functions as the Authority may deem necessary.
• 73.(1) The Authority shall establish a planned and systematic inspection programme consisting of routine and

Inspection objectives and programmes.

• reactive inspections that are announced and unannounced tomonitor compliance with—
• (a) this Act and all applicable Regulations; and
• (b) the terms and conditions of registration, licensing and accreditation issued by the Authority.

• (2) The inspection programme under subsection (1)

2. shall ensure that- 3. (a) health facilities meet the necessary regulatory requirements; 4. (b) healthcare providers possess the competency necessary to carry out their functions;and 5. (c) deficiencies and deviations from standards are remedied without undue delay. 74. An inspector appointed under this Act may -- 7. (a) inspect a health facility for purposes of registration and licensing; 8. (b) enter,inspect and search any health facility which the inspector has reason to believe that 9. (i) the inspection is necessary in order to ascertain whether the provisions of this Act are being complied with,or 10. (ii) an offence is being committed or is suspected tohave been committed; 11. (c) take any equipment or material required for any 12. purpose for which power of entry is being exercised; 13. s and make such 14. (d) carry out such inspections recording as may be necessary; 15. (e) interview the owner or operator of a health facility or any of the employees of the health facility; 16. (f) direct that any part of the facility which the inspector has power to enter, or anything in such a health facility,be left undisturbed for as long as is reasonably y necessary for the purpose of the inspection; 17. (g) take appropriate samples, articles or substances found in any health facility which the inspector has power to enter; and 18. (h) request the production of any records which may be required to be kept under this Act. 75. The Authority shall, by Gazette Notice, appoint 20. duly qualified persons, to be inspectors of the Authority for the purposes of this Act.

Powers of inspectors.

Qualifications of inspectors.

76. (1) An inspector may for the purpose of ensuring compliance with the provisions of this Act, conduct an 2. inspection in a health facility and shall in particular- 3. (a) inspect the conditions and services provided by the health facility;and 4. (b) prepare and submit a report outlining the findings 5. for purposes of- 6. (i) approving a health facility on the basis of the criteria prescribed by the Authority from time 7. to time; 8. (ii) suspending or withdrawing registration or licensing due to non-compliance with the quality of healthcare standards set by the Authority; or 9. (ili) making recommendations on the issuance of a notice of closure of the health facility by the 10. Authority. 11. 77.(l) The Authority shall prescribe a code of Code of conduct 12. conduct for inspectors.

for inspectors.

• (2) For purposes of subsection (1), the code of conduct shall contain rules relating to compliance by inspectors with a set minimum standard of conduct which is necessary to realise the objects of the Authority.

2. 78.(1) A person who- 3. (a) hinders or obstructs the Authority or an inspector 4. in the exercise of their duties under this Act or Regulations made thereunder; 5. (b) fails to comply with a lawful order or requirement made by the Authority or an inspector in accordance with this Act or Regulations made thereunder; 6. (c) denies the Authority or an inspector entry upon any land,premises,vehicle,aircraft or other means of conveyance that the Authority or the inspector is 7. empowered to enter under this Act or Regulations made there under; 8. (d) impersonates the Authority or an inspector; or 9. (e) denies the Authority or an inspector access to records or documents kept pursuant to this Act or Regulations made thereunder, commits an offence.

Obstruction of inspectors.

Conduct of

inspections.

• (2) A person who commits an offence under this section shall be liable, on conviction, to a fine not exceeding two million shillings or to imprisonment for a term not exceeding two years, or to both.

79. (1) Where an inspector determines that the conduct of a health facility is, or a healthcare service is being provided in violation of the provisions of this Act or that the conduct or healthcare service poses an immediate risk of injury or damage to patients, property or the environment, the inspector may — 3. (a) immediately order the temporary suspension of the healthcare service or the health facility, where appropriate;or 4. (b) take any other action as may be prescribed under the provisions of this Act and Regulations.

• (2) An order issued by an inspector under subsection (1) shall continue to be in force unless-—

6. (a) reversed or modified by the Authority; or 7. (b) modified or altered through an administrative or 8. judicial review.

• (3) An inspector who undertakes any enforcement action specified in subsection (l) shall prepare a report indicating the reasons for the action and identifying the evidentiary basis for the findings including measurements, test samples, explanations and any otherrelevant information.
• (4) The report prepared under subsection (3) shall be made available to the health facility who shall have the right to submit explanations or objections within the time specified by the Authority.
• (5) The Authority may prescribe the circumstances

12. under which the prior approval of the Authority shall be specified in subsection (1). 13. section 80 (3), the Authority shall-

Enforcement.

theAuthority

• (a) where the report is accompanied by objections, review the objections and issue such orders as may
• be necessary;
• (b) ensure that relevant measures have been taken against the persons contravening the provisions of
• the Act;
• (c) adopt the immediate remedial
• measures as recommended by the inspector;
• (d) enforce the temporary closure of the health facility; or
• (e) impose a penalty as the Board may prescribe.
• (2) A person subject to the enforcement action shall
• take the necessary measures to—
• (a) remedy compliance as directed by the Authority as soon as it is practically possible; and
• (b) prevent recurrence.
• (3) The Authority may, where the case presents an
• immediate safety or security hazard to people,property or the environment, require the person to suspend its activities or services until the situation has been remedied.
• services offered,recommendations from inspections and mitigation measures,if any.
• 81.A health facility shall keep records of healthcare

82. (1) The Authority may-

• (a) by notice in writing to a health facility, specify the records to be kept by the health facility under this Act; and
• (b) request the health facility to make available to the Authority for its inspection such records as may be
• specified in the notice.
• (2) Any person who fails to comply with a request made under subsection (1) commits an offence and shall be liable, on conviction, to a fine not exceeding one million year, or to both.

Record keeping.

Inspection of records.

PARTVI-HEALTHCARE TRIBUNAL

83. (l) There is established a Tribunal to be known as the Health Care Tribunal for the purpose of hearing and determining complaints and disputes in accordance with this Act or any other written law.

• (2) The Tribunal shall be a successor of the Dispute Resolution Tribunal established under section 44 of the Social Health InsuranceAct.
• (3) Any proceedings before the Tribunal under sub section (2) that have not been concluded at the commencement of this Act shall be determined by the Health Care Tribunal.
• (4) The Tribunal shall consist of-

5. (a) a Chairperson who shall be appointed by the Judicial Service Commission from among persons qualified to be judges of the High Court; 6. (b) three advocates of the High Court of not less than ten years' standing appointed by the Judicial Service Commission;and 7. (c) seven other persons who shall be appointed by the Judicial Service Commission and shall possess knowledge and experience in matters of health, insurance, policy and quality improvement and who are not public officers or employees of the Board and are not health service providers. 8. (5)Themembers of the Tribunal shall hold office for a period of three years and shall be eligible for re appointment for one further term of three years.

• (6) The quorum for a meeting of the Tribunal shall be three members.
• (7) The members of the Tribunal shall be entitled to receive such allowances as the Cabinet Secretary,on the advice of the Salaries and Remuneration Commission,may

11. determine.

• (8) The Cabinet Secretary shall make rules for the operationalization of the Tribunal.

84. (1) The Tribunal shall have jurisdiction to hear and determine all matters referred to it,relating to the health sector arisingunderthisActor any otherAct.

• (2) The jurisdiction of the Tribunal shall not include the trial of any criminal offence.

Establishmentof the Health Care

Tribunal.

No.16 of 2023.

Jurisdiction ofthe

Tribunal.

• (3) The Tribunal shall have original jurisdiction on

2. any dispute between health facilities,patients,healthcare providers and regulatory bodies.

• (4) The Tribunal shall have appellate jurisdiction over body in the health sector and in exercise of its functions,

4. the decisions of the Authority and any relevant regulatory may refer any matter back to the Authority and any relevant regulatorybody in the health sectorfor re-consideration.

• (5) The Tribunal shall have power to grant equitable reliefs including but not limited to injunctions, penalties, damages and specific performance.
• (6) The Tribunal shall hear and determine matters referred to it expeditiously.

7. 85.(l) A person aggrieved by a decision or action made under this Act may, within twenty-one days from the date of the decision or action appeal to the Tribunal for a review of such decision or action.

• (2) The Tribunal may uphold, reverse, revoke or vary the decision or action of the Board.
• (3) A person dissatisfied with an order made by the Tribunal under subsection (2) may appeal to the High Court within thirty days from the date the order is made.

10. 86.The office of a member of the Tribunal shall 11. become vacant if the member- 12. (a) dies; 13. (b) resigns; 14. (c) is unfit by reason of mental or physical infirmity to 15. perform the duties of the office; 16. (d) is convicted of an offence and sentenced to 17. imprisonment for a term exceeding six months, without the option of a fine; 18. (e) has failed to attend at least three consecutive meetings of the Tribunal, without lawful cause; or 19. grounds- 20. (f) is removed from office on any of the following 21. (i) gross violation of the Constitution or any 22. (ii) 23. other written law;or 24. gross misconduct or misbehaviour.

Appeals to the

Tribunal.

Vacancyin the

Tribunal.

PARTVII-FINANCIALPROVISIONS

87. (1) The funds of the Authority shall comprise of- 2. (a) monies appropriated by the National Assembly; 3. (b)monies as may accrue to or vest in the Authority in the courseof the exercise of its powersor the performance of its functions under this Act; 4. (c) gifts, grants, donations or endowments as may be given to the Authority; and 5. (d)moniesfrom any otherlawful sourceprovidedfor the Authority.

• (2) All the funds donated, lent or issued to the Authority under this Act shall be accounted for and appropriated in accordance with the Public Finance Management Act.

7. 88.(1) The Authority may invest monies which are not immediately required in accordance with the Public Finance Act.

Funds of the Authority.

Cap.412A.

Investment of funds.

Cap.412A

• 89.The financial year of the Authority shall be the period of twelve months ending on the thirtieth day of June in each year.

Financial year.

90. (l) The Authority shall, within three months after Annual estimates. 2. the end of the financial year,cause to be prepared estimates of its revenue and expenditurefor that financialyear.

• (2) The annual estimates shall make provision for all estimated expenditureof the Authority for the financial year concerned, and in particular shall provide for the-

4. (a) payment of salaries, allowances and other charges in respect of the staff of the Authority; 5. (b) payment of allowances and any other emoluments 6. to the membersof the Board; 7. (c) payment of pensions, gratuities and other charges inrespectofretirementbenefitswhich arepayable 8. out of the funds of the Authority; 9. (d) proper maintenance of buildings and grounds of the Authority; 10. (e) acquisition, maintenance, repair and replacement of the equipment and other movable property of 11. Authority; or

• (f) creation of such reserve funds to meet future or contingent liabilities in respect of retirement benefits, insurance or replacement of buildings or equipment, or in respect of such other matters as the Authority may consider appropriate.
• (3) The annual estimates shall be approved by the
• Board before the commencement of the financial year to which they relate and after the approval, the annual estimates shall not be increased without prior consent of the Board.
• (4) No expenditure shall be incurred for the purposes
• of the Authority except in accordance with the annual estimates approved under subsection (3).
• 91.(1) The Board shall cause to be kept all proper Accounts and audit. books and records of accounts of the income,expenditure,
• assets and liabilities of the Authority.
• (2) Within three months at the end of each financial year, the Board shall submit to the Auditor-General, the accounts of the Authority togetherwith-
• (a) a statement of income and expenditure of the Authority during the year;and
• (b)a statement of the assets and liabilities of the Authority on the last day of that year.

Cap.412A.

• (3) The accounts of the Authority shall be audited and reported upon in accordance with the provisions of the Public Finance Management Act and the Public Audit Act.

92. (1) The Board shall, within three months after the end of each financial year, prepare and submit to the Cabinet Secretary a report on the operations of the Authorityfor the immediately precedingyear.

Cap.412B.

Annual report.

• (2) The Cabinet Secretary shall, within three months of submission of the report under subsection (1), transmit the report to Parliament.
• (3) The report in this section shall contain-

3. (a) data on quality improvement, patient outcomes, patient satisfaction and health system performance;

• (b) recommendations on specific actions including legal and administrative measures to be taken to address specific concerns identified by the Board; and
• (c) any other information relating to the performance of functions under this Act that the Board considers relevant.

PARTVIII-PROVISIONS ONDELEGATED POWERS

• 93.(1) The Cabinet Secretary may, in consultation with the Board, make Regulations for the better carrying into effectof theprovisions of thisAct.
• (2) Without prejudice to the generality of subsection
• (1),the Regulations may prescribe-
• (a) the fees to be charged under this Act;
• (b) the forms to be used in connection with this Act;
• (c) the procedure for registration and licensing of
• health facilities;
• (d) the procedure for approval, review and assessment
• of health facilities;
• (e) the manner of conducting inspections;
• (f) standards of community health services;
• (g) standards of medical laboratories;
• (h) standards ofpharmacies;
• (i) standards of ambulance services;
• (j) standards of emergency medical treatment;
• (k) standards of telemedicine services;
• (l) standards of alternative medicine and traditional
• medicine;
• (m)standards of medical aesthetic procedures;
• (n) the procedure for accreditation of health facilities for qualityhealthcareprocesses;
• (o) conduct of inspections;
• (p) investigation procedures;
• (q) quality of healthcare standards;

Regulations.

• (r) categories of health facilities;
• (s) quality rating;
• (t) administrative fines for failure to comply with the
• requirements of this Act;and
• (u) any other matter that may be related to quality of healthcare.
• (3) For the purposes of Article 94(6) of the
• Constitution-
• (a) the power of the Cabinet Secretary to make regulations shall be limited to bringing into effect the provisions of this Act and the fulfilment of the objectives specified under subsection (1); and
• (b) the principles and standards set out under the Statutory Instruments Act and the Interpretation and General Provisions Act in relation to
• subsidiary legislation shall apply to regulations made under this Act.

PARTIX-GENERALPROVISIONS

• 94.(1) A person aggrieved by a decision of the Authority under this Act may apply to the Authority for a review of the decision within thirty days ofreceipt of the decision
• (2) The Authority shall within sixty days of receipt of an application for review, make a determination and communicate its decision to the applicant.
• (3) An application for review under this section shall not have the effect of suspending the decision of the

Appeals.

• under this Act may,within thirty days from the date of the decision, appeal to the Tribunal.
• Authority.

95. A person aggrieved by a decision of the Authority 96. The Authority shall keep information acquired for Confidentiality. purposes of the performance of its functions confidential and shall disclosesuch information only to the extent that it considers necessary for the proper performance of the functions of the Authority.

Cap.2A. Cap.2.

Review.

97.(1) A person who-

• (a) obstructs or hinders the Authority in the exercise of itspowers under thisAct;
• (b) without lawful justification fails or refuses to comply with the directions of the Board;
• (c)refuses or fails, without reasonable cause to comply with a request to furnish the Authority with any information or to produce any documents orrecords;
• (d) when appearing before the Board or any of its committees, for examination, makes a statement which the person knows to be false or misleading; or
• (e) in furnishing such information under paragraph (c),makes a statementwhich theperson knows or ought to know to be false,

commits an offence and shall be liable,on conviction, toafine not exceeding one million shillings or to imprisonment for a term not exceeding one year,or to both.

• (2) A person who is convicted of an offence under subsection (l) shall be liable,for any subsequent offence, to a fine not exceeding two million shillings, or to imprisonment for a term not exceeding two years,or to both.

98. A person who commits an offence under this Act General penalty. 3. where a penalty is not provided shall be liable, on conviction,to a fine not exceeding ten million shillings or to imprisonment for a term not exceeding ten years,or to both.

PARTX-TRANSITIONALPROVISIONS

Transitional

• 99.(1) All heath facilities registered before the
• commencement of this Act, shall be deemed to have been registered under this Act.

provisions.

• (2) A person operating a health facility or providing healthcareservicesimmediatelybefore thecommencement of this Act, shall be required to comply with the requirements ofthis Act and apply forregistrationof the

Offences.

health facility under this Act within one year after the

commencement of this Act.

• (3) The Cabinet Secretary may by notice in the

2. Gazette extend the period of registration specified in subsection (l). 100. The laws listed in the Second Schedule are 4. amended in the manner specified in the Schedule.

Consequential amendments.

FIRST SCHEDULE(s.34)

CONDUCTOFBUSINESSANDAFFAIRSOFTHEBOARD

1. Meetings.

• (1) The Board shall meet not less than four times in every financial year and notmore than fourmonths shall elapsebetween the date of one meeting and the date of the next meeting.
• (2) The chairperson may call a special meeting of the Board at any time the chairperson deems fitfor expedient transaction of thebusiness of the Board.
• (3) The notice for a meeting of the Board shall be given in writing to eachmember of theBoard atleast fourteendaysbeforetheday of the meeting.
• (4) In the case of a special, or extra-ordinary meeting, a notice of less than fourteen days'shall be considered sufficient.
• (5) Despite the provisions of subparagraph (2), the chairperson may, upon requisition in writing by at least two thirds of the members, convene a special meeting of the Board at any time for the transaction of the business of the Board.
• (6) The notice to be given under subparagraph (2) and (3) shall state the-

7. (a) venue and time of the meeting; and 8. (b) agenda with sufficient details of business to be discussed at the meeting.

• (7) The chairperson shall preside at every meeting of the Board at which the chairperson is present but in the chairperson's absence,the memberspresentshall electfromamong themselvesachairpersonwho shall,with respect to thatmeeting and the business transacted thereat,have all the powers of the chairperson.
• (8) Unless an unanimous decision is reached, a decision on any matter before the Board shall be by the concurrence of a majority of all the members present and voting at the meeting.
• (9) The Board may, with the approval of the Cabinet Secretary, coopt or invite any number of persons to act as advisors or consultants at any of its meetings or form such committees to perform such functions or duties of theBoard as the Board shall determine.
• (10) Subject to the provisions on quorum, no proceedings shall be invalid byreason only of avacancy among themembers of theBoard.

• (11) Subject to the provisions of this Schedule, the Board may

2. determine its own procedure and the procedure for any committee of the Board.

• (12) The quorum for the meetings of the Board shall be five

4. members. Co-opted or invited persons shall not be counted in the quorum of the meetings of the Board and shall not be eligible to vote.

2.Contracts and instruments.

Any contract or instrument which, if entered into or executed by a person not being a body corporate,would not require to be under seal, may be entered into or executed on behalf of the Authority by any person generally or specially authorized by the Authority for that purpose.

3.Disclosure of Interest.

• (1) If a member of the Board is present at a meeting of the Board or any committee at which any matter is the subject of consideration and in which matter that person is directly or indirectly interested in a private capacity, that person shall as soon as is practicable before the commencement of the meeting,declare such interest.
• (2) The person making the disclosure of interest under paragraph (1) shall not,unless the Board or committee otherwise directs,take part in any consideration or, discussion of, or vote on any question touching on the matter.
• (3) A person who contravenes subparagraph (1) commits an offence and shall be liable, on conviction, to a fine not exceeding one million shillings or to imprisonment for a term not exceeding six months, or to both.
• (4) No member of the Board or officer, employee or agent of the Board shall enter into a servicecontract or tradewith theBoard.
• (5) A disclosure of interest made under this paragraph shall be recorded in the minutes of the meeting at which it is made.

4.Minutes.

The Board shall cause minutes of all resolutions and proceedings of meetings of the Board to be entered in books kept for that purpose.

SECONDSCHEDULE(S.101)

CONSEQUENTIALAMENDMENTSTOOTHERACTS

Amendment of

section 2 of Cap.241.

Amendment of section14of Cap. 241.

• 1.Section 2 of the Health Act is amended by—
• (a) deleting the definition of the term "healthcare provider" and substituting therefor the following new definition-

"health care provider" means a person who delivers

health care services;

• (b) deleting the definition of the term "healthcare services"and substituting therefor the following new definition-

"healthcare services" means the prevention, promotion, education, medical diagnosis, management or alleviation of disease, illness, injury, and other physical and mental impairments in individuals,delivered by healthcare professionals through the health care system's routine health services including mental health services,alternative medicine and traditional medicine,medical aesthetic procedures,community health services,telemedicine services orits emergencyhealth services;

• (c) deleting the definition of the term "health facility" and substituting therefor the following new
• definition-

"health facility" means an institution whether

operating from a fixed physical structure or through mobile and digital platforms,that is established for thepurpose ofprovidinghealthcare services,including hospitals, clinics,pharmacies, medical laboratories,mortuaries,funeral homes and parlours,home care centres,ambulances, mobile medical units,and community outreach programs;

2. Section 14 of the Health Act is amended by deleting 2. subsection (5) and substituting with the following new subsection-.

• (5) Where a health facility fails to resolvea complaint to the satisfaction of the complainant,the

Amendment of section 17 of Cap.

241.

Amendment of section 20 of Cap. 241.

Amendment of section48of Cap. 241.

Amendment of section 60 of Cap. 241.

Amendment of

section80of Cap. 241.

Amendment of section 89 of Cap. 241.

Quality Health Care and Patient Safety Authority established under the QualityHealthcare and Patient Safety Act shall take the necessary action.

3. Section 17 of the Health Act is amended by deleting 2. paragraph (i). 3. 4.Section 20 of the Health Act is amended in- 4. (a) paragraph (d) by deleting the words "national government department responsible for health and relevant regulatory bodies"and substituting therefor the words "Quality Health Care and Patient Safety Authority established under the Quality Healthcare and Patient Safety Act';and 5. (b) paragraph (i) by deleting the words "national 6. government department responsible for health,the Authority and professional regulatory bodies established under any written law" and substituting therefor the words "Quality Health Care and Patient Safety Authority established under the Quality Healthcare and Patient Safety Act". 5. Section 48 of the Health Act is amended- 8. (a) in subsection (1) by-— 9. (i) 10. deleting paragraph (b); 11. (ii) 12. deleting paragraph (c); 13. (iii) deleting paragraph (d). 14. (b) in subsection (2) by—— 15. (i) 16. deleting paragraph (a); 17. (ii) 18. deleting paragraph (b); 6. Section 60 of the Health Act is amended in subsection (1) by deleting the words "The obligation to inspect,monitor and evaluate the standard of performance in all the services regulated and"and substituting therefor the words "The obligation to monitor and evaluate the conduct of'. 7. Section 80 of the Health Act is amended by deleting subsection (3). 21. 8.Section 89 of the Health Act is amended in-

Amendment of section 91 of Cap.

• (a) subsection (1),by deleting the words "appropriate regulatory bodies" and substituting therefor the words "Quality Health Care and Patient Safety Authority established under the Quality Healthcare and PatientSafetyAct"
• (b) subsection (2), by deleting the words "under this
• Act"

9. Section 91 of the Health Act is amended in g regulatory bodies" appearingin paragraph (a) and substituting therefor the words "Quality Health Care and Patient Safety Authority established under the Quality Healthcare and Patient Safety Act"

241.

Amendment of

section 112of Cap. 241.

Amendment of the First Schedule of Cap. 241.

• 10.Section 112 of the Health Act is amended by-
• (a) deleting paragraph (a);
• (b) deleting paragraph (b);
• (c) deleting paragrah(c);
• (d) deleting paragraph (e);
• (e) deleting paragraph (p); and
• (f).deleting paragraph (r);
• 11.The First Schedule of the Health Act is amended in
• the paragraph on LEVEL 3 by deleting paragraph (f).

Repeal of section153 of Cap.242.

Amendment of

section 2of Cap.244.

• 12.The Public Health Act is amended by repealing
• section 153.
• 13.Section 2 of the Pharmacy and Poisons Act is amended by inserting the following new definition in its
• proper alphabetical sequence-

"tribunal"means the Health Care Tribunal established under section 84 of the Quality Health Care and Patient Safety Act

• 14.Section 3B of the Pharmacy and Poisons Act is amended in-
• (a) subsection (2) by deleting the words"pharmacies, including those in hospitals and clinics,and other retail outlets"appearing inparagraph (j);and

Amendment of

section3Bof Cap. 244.

Amendment of section 14 of Cap. 244

Amendment of section15of Cap. 244

Amendment of section 16 of Cap. 244

Repeal of section20 of Cap.244.

Repeal of section23 of Cap.244.

• (b) subsection (3), by deleting paragraph (i).
• 15.Section 14 of the Pharmacy and Poisons Act is amended in-
• (a) subsection (1), by deleting the term "Supreme Court" and substituting therefor the word "tribunal"; and
• (b) subsection (2), by deleting the term "Supreme Court" wherever it appears and substituting therefor the word "tribunal"
• 16.Section 15 of the Pharmacy and Poisons Act is amended by deleting the term "Supreme Court"and substituting therefor the word"tribunal"
• 17.Section 16 of the Pharmacy and Poisons Act is amended by deleting the term "Supreme Court"" and substituting therefor the word"tribunal"
• 18.The Pharmacy and Poisons Act is amended by repealing section 20.
• 19.The Pharmacy and Poisons Act is amended by repealing section 23.

Repeal of section 23A of Cap.244.

• 20.The Pharmacy and Poisons Act is amended by repealing section 23A.

Amendment of section44of Cap. 244.

• 21.Section 44 of the Pharmacy and Poisons Act is amended in subsection (1) by deleting paragraph (mb).

Amendment of

section2 of Cap.248.

• 22.Section 2 of theMental Health Act is amended-
• (a) in the definition of the term "mental health facility" by deleting the words "relevant medical regulatory body" and substituting therefor the words "Quality Health Care and Patient Safety Authority established under the Quality Healthcare and Patient Safety Act";
• (b) by deleting the definition of the term "mental health services"and substituting therefor the followingnew definition-

"mental health services" means the provision of

healthcare services in relation to the mental health of individuals;and

• (c) by inserting the following new definition in its proper alphabetical sequence--

Amendment of section9B of Cap. 248.

Repeal of section 9C

of Cap.248.

Amendment of section46 of Cap. 248.

Amendmentof section55of Cap.

"tribunal" means the Health Care Tribunal established under section84of the QualityHealth Care and PatientSafety Act.

• 23.Section 9B of the Mental Health Act is amended in subsection (l) by deleting the words "relevant medical regulatory body" and substituting therefor the words "Quality Healthcare and Patient Safety Authority established under the Quality Healthcare and Patient Safety Act".
• 24.The Mental Health Act is amended by repealing
• section 9C.
• 25.Section 46of theMental HealthAct is amended-
• (a) in subsection (5), by deleting the words "High Court" and substituting therefor the word"Tribunal";and
• (b)by inserting thefollowing new subsection immediately after subsection(5)-
• "(6) A person who is not satisfied with an order made by the Tribunal under subsection (5) may appeal to the High Court.
• 26.Section55 of the Mental HealthAct is amended by deleting the words "a magistrate" and substituting therefor the term"theTribunal"

248.

Amendmentof

section 2 of Cap.253.

• 27.Section 2 of the Medical Practitioners and Dentists Act is amended--
• (a) by deleting the definition of the term "health institution";
• (b) in the definition of the term "private practitioner" by deleting the expression "section 15" and substituting therefor the words "the Quality of Health Care and Patient Safety Act';
• (c) in definition of the term "register", by deleting the words"and health institutions for public and private practice"; and
• (d) by inserting the following new definition in its proper alphabetical sequence-

"tribunal"means the Health Care Tribunal established under section 84 of the Quality Health Care and Patient Safety Act.

Amendment of 28.Section 4 of the Medical Practitioners and Dentists section 4 of Cap. 253. Act is amended by—

• (a) deleting paragraph (f);
• (b) deleting paragraph (k);
• (c) deleting paragraph (l);
• (d) deleting paragraph (m);
• (e) deleting thewords "and health institutions" appearing inparagraph (o).
• 29.Section 4A of the Medical Practitioners and Dentists Act is amended in subsection (l) by deleting the words
• "inspections" appearing in paragraph (c).
• 30.Section 5 of the Medical Practitioners and Dentists

253.

Amendment of section 4A of Cap.

Amendment of section5of Cap.253.

Amendment of section14of Cap. 253.

Repeal of section15 of Cap.253.

section 15A of Cap.

Amendment of 253.

Amendmentof

section16of Cap. 253.

Amendment of section 17of Cap. 253.

Amendment of section 20of Cap.

253.

• Act is amended in subsection (3) by-
• (a) deleting paragraph (h); and
• (b) deleting paragraph (i);
• 31.Section 14of the Medical Practitioners and Dentists Act is amended in subsection (4) by deleting the word "High Court" and substituting therefor the words "tribunal".
• 32.The Medical Practitioners and Dentists Act is
• amended by repealing section 15.
• 33.Section 15A of the Medical Practitioners and Dentists Act is amended by deleting the words "and every health institution shall in each year insure the health institution against professional liability of its staff' appearing immediately after the word "cover".
• 34.Section16of the Medical Practitioners andDentists Act is amended by deleting the words "or section 15" appearing immediately after the expression "section 13".
• 35.The Medical Practitioners and Dentists Act is amended byrepealing section 17.
• 36.Section 20 of the Medical Practitioners and Dentists
• Actis amended in-
• (a) subsection (6), by deleting paragraph (e);
• (b) subsection (7), by deleting the words "or health institution" appearing immediately after the word "person";

Amendmentof section 22 of Cap. 253.

Amendment of section 23 of Cap.

253.

Amendment of section 2 of Cap. 253A.

Amendment of section5of Cap.

253A.

• (c) subsection (8), by deleting the words "or health institution" appearing immediately after the word "person"; and
• (d) in subsection (9), by deleting the word "High Court" and substituting therefor the word"tribunal".
• 37.Section 22 of the Medical Practitioners and Dentists Act is amended by—
• (a) deleting subsection (4); and
• (b) deleting subsection (5).
• 38.Section 23 of the Medical Practitioners and Dentists Act is amended in paragraph (e) by deleting the words "or a health institution or the employee of a practitioner or health institution" appearing immediatelyafterthewords "incurred by a practitioner"
• 39.Section 2 of the Medical Laboratory Technicians and Technologists Act is amended by inserting the following new definitions in theirproper alphabetical sequence-

"practising certificate"means a certificate issued to a

professional registered under this Act;and

"tribunal" means the Health Care Tribunal established under section84of the QualityHealth Care and Patient Safety Act.

• 40.Section 5 of the Medical Laboratory Technicians and Technologists Act is amended in-
• (a) subsection (1),by deleting the word "business,"and substituting therefor the word"professional";and
• (b) subsection (2),by deleting the word "the business and" appearing in paragraph (d) and substituting therefor the word "professional".

Amendmentof the heading ofPart IVof Cap.253A.

• 41.The Medical Laboratory Technicians and Technologists Act is amended in the heading of PART IV by deleting the word "PRIVATE"and substituting therefor the word"PROFESSIONAL"

Amendment of section 20 of Cap. 253A.

• 42.Section 20 of the Medical Laboratory Technicians and Technologists Act is amended-
• (a) in the marginal note by deleting the word "private" and substituting therefor the word"professional";

Repeal of section 21

of Cap.253A.

Amendmentof

section22of Cap. 253A.

Amendment of

section 25 of Cap. 253A.

Amendment of section30of Cap.

253A.

Amendment of

section40ofCap. 253A.

Amendment of section 2 of Cap.

253B.

(b) in subsection (l) by-

• deleting the word "private" and substituting
• (i) therefor the word "professional";
• (ii) deleting the words "a valid practising certificate and" appearing in paragraph (c); and
• (iii) deleting paragraph (d);
• (c) by deleting subsection (2) and substituting therefor
• the following new subsection-
• (2) The Board shall issue a practising certificate to a person who meets the qualifications under subsection (1).;
• and
• (d) in subsection (3), by deleting the word "private" and
• substituting therefor the word "professional".
• 43.The Medical Laboratory Technicians and Technologists Act is amended by repealing section 21.
• 44.Section 22 of the Medical Laboratory Technicians
• and Technologists Act is amended by-
• (a) deleting the words "and place of business" appearing
• in subsection (1);and
• (b) inserting the word "professional" immediately after the words "suspended from" appearing in subsection (3).
• 45.The Medical Laboratory Technicians and Technologists Act is amended by repealing section 25.
• 46.Section 30 of the Medical Laboratory Technicians and Technologists Act is amended subsection (6), by deleting the word "High Court" and substituting therefor
• the word "tribunal".
• 47.Section 40 of the Medical Laboratory Technicians and Technologists Act is amended by deleting paragraph (g).
• 48.Section 2 of the Nutritionists and Dieticians Act is amended by-
• (a) deleting the definition of the term "health institution" and substituting therefor the following new
• definition-

Amendment of section 21 of Cap. 253B.

Amendment of

section22of Cap. 253B.

Repeal of section 23

of Cap.253B.

Amendment of

section 26 of Cap. 253B.

Amendment ofthe Long Title of Cap.

253C.

Amendment of section 2of Cap. 253C.

Amendment of section6of Cap.

253C.

"health facility" has the meaning assigned to it under

the Health Act;and

• (b) inserting the following new definition in its proper alphabetical sequence-

"tribunal" means the Health Care Tribunal established under section84of the QualityHealth Care andPatientSafetyAct.

• 49.Section 21 of the Nutritionists and Dieticians Act is amended in subsection (1) by deleting the word "High Court"and substituting therefor the words"tribunal"
• 50.Section 22 of the Nutritionists and Dieticians Act is amended -
• (a) in subsection (l), by deleting the word "private" and substituting therefor the word"professional";
• (b) in subsection (2), by deleting the words "on his or herownbehalfor tobeemployedbyaregistered nutritionist or dietician";and
• (c) in subsection (3),by deleting the words "and shall state whether the licensee may practise on his own behalforonemployment"
• 51.The Nutritionists and Dieticians Act is amended by repealing section 23.
• 52.Section 26 of the Nutritionists and Dieticians Act is Court"and substituting therefor the words "tribunal".

53. The Long Title of the Counsellors and Psychologists Act is amended by inserting the word "professional" immediately after the word "licensing"

• 54.Section 2 of the Counsellors and Psychologists Act is amended by inserting the following new definition in its proper alphabetical sequence-—

"tribunal" means the Health Care Tribunal established under section 84 of the Quality Health Care and Patient Safety Act.

55. Section 6 of the Counsellors and Psychologists Act is amended in- 2. (a) paragraph (ja), by inserting the word "professional" immediately after the words"matters related to the; 3. and

Amendment of section 29 of Cap.

253C.

Amendment of section 36 of Cap. 253C.

Amendment of the Long Title of Cap. 253D.

Amendment of

section 2 of Cap. 253D.

Amendment of section4of Cap. 253D.

Amendment of the headingof PartVof Cap.253D.

Amendment of section 24 of Cap. 253D.

• (b) paragraph (k), by inserting the word "professional immediately after the words"conditions of".
• 56.Section 29 of the Counsellors and Psychologists Act is amended in subsection (4) by deleting the word "High Court" where it appears and substituting therefor the words "tribunal".

57. Section 36 of the Counsellors and Psychologists Act

• is amended by deleting the word "High Court" where it appears and substituting therefor the words "tribunal".
• 58.The Long Title of the Physiotherapists Act is
• after the words "to regulate their".
• 59.Section 2 of the Physiotherapists Act is amended by inserting the following new definitions in their proper alphabetical sequence-—

"practicing certificate" means a certificate issued to a

professional registered under this Act;and

Care Tribunal established under section 84 of the QualityHealth Care

"tribunal" means the Health and Patient Safety Act.

60. Section 4 of the Physiotherapists Act is amended in- 2. (a) subsection (1), by inserting the word "professional" 3. immediately after the words "training and"; and 4. (b) subsection (2), by deleting paragraph (f). 61. The Physiotherapists Act is amended in the heading of PART V by deleting the word "PRIVATE" and 6. substituting therefor the word"PROFESSIONAL" 62. Section 24 of the Physiotherapists Act is amended- 8. (a) in the marginal note by deleting the word "private" 9. and substituting therefor the word "professional"; 10. (b) in subsection (1), by deleting the word "private" and 11. substituting therefor the word"professional"; 12. (c) by deleting subsection (2); and 13. (d) in subsection (3), by deleting the word "private" and substituting therefor the word "professional"

Amendment of section32 of Cap. 253D.

Amendmentof section39ofCap. 253D.

Amendment of the Long Title of Cap. 253E.

Amendmentof section 2 of Cap. 253E.

Amendment of

section 16 of Cap. 253E.

Amendmentofthe

headingofPartIVof Cap.253E.

• 63.Section 32 of the Physiotherapists Act is amended in subsection (6) by deleting the word "High Court" and substituting therefor the words "tribunal".
• 64.Section 39 of the Physiotherapists Act is amended in subsection (2) by——
• (a) inserting the words "of approved training institutions"immediately after the word'inspection" appearing in paragraph (g);
• (b) deleting paragraph (h); and
• (c) deleting paragraph (i) and substituting therefor the
• following new paragraph-
• "(i) any other matter related to the professional
• practice ofphysiotherapists"

65. The Long Title of the Clinical Officers (Training,

• Registration and Licensing) Act is amended by inserting regulate their".
• 66.Section2of theClinical Officers Registration and Licensing) Act is amended—
• (Training,
• words "Council" and substituting therefor the words "Quality Health Care and Patient Safety Authority"; and
• (b) by deleting the definition of the term "medical
• centre".
• (c) by inserting the following new definitions in their proper alphabetical sequence-

"practicing licence"means a certificate issued to a professional registered under this Act; and

"tribunal" means stheHealth Care Tribunal established under section 84 of the Quality Health Care and Patient Safety Act.

• 67.Section 16 of the Clinical Officers (Training, Registration and Licensing) Act is amended in subsection (4) by deleting the word"High Court"where it appears and substituting therefor the words "tribunal".
• 68.The Clinical Officers (Training, Registration and Licensing) Act is amended in the heading of PART IV by inserting the word "PROFESSIONAL"immediately after
• the words"LICENSING AND".

Amendment of section 20 of Cap. 253E.

Amendmentof section21 of Cap. 253E.

Amendment of section 22 of Cap. 253E.

Repeal of section 23

of Cap.253E.

section 23A of Cap.

Amendment of 253E.

• 69.Section 20 of the Clinical Officers (Training, Registration and Licensing) Act is amended-
• (a) in the marginal note by deleting the word "private" and substituting therefor the word "professional";
• (b) in subsection (1), by deleting the word "private" and substituting therefor the word "professional";
• (c) in subsection (2) by deleting the word "private";
• (d) by deleting subsection (3);
• (e) in subsection (4), by deleting the words "engages in private practice" and substituting therefor the word "practices";
• (f) by deleting subsection (5);
• (g) by deleting subsection (6);
• (h) by deleting subsection (7); and
• (i) by deleting subsection (8).
• 70.Section 21 of the Clinical Officers (Training, Registration and Licensing) Act is amended in-
• (a) subsection (1), by deleting the word "private"; and
• (b) subsection (3),by deleting the word "certificate"and
• substituting therefor the word "licence".
• 71.Section 22 of the Clinical Officers (Training, Registration and Licensing) Act is amended--
• (a) in subsection (1), by inserting theword "professional" immediately after the words "no person shall engage in the'";and
• (b) in subsection (6), by deleting the word "High Court" where it appears and substituting therefor the words
• "tribunal".

72. The Clinical Officers (Training, Registration and Licensing) Act is amended by repealing section 23.

• 73.Section 23A of the Clinical Officers (Training, Registration and Licensing) Act is amended by deleting the words "and every health institution shall in each year insure the health institution against professional liability of its
• staff' appearing immediately after the word "cover".

Amendment of section 24of Cap. 253E.

Amendment of section 25 of Cap. 253E.

Amendment of section31 of Cap. 253E.

Amendment of the Long Title of Cap.

253F.

Amendment of section 2 of Cap. 253F.

Amendment of section 4of Cap.

253F.

• 74.Section 24 of the Clinical Officers (Training, Registration and Licensing) Act is amended in subsection (3) by deleting paragraph (b).
• 75.Section 25 of the Clinical Officers (Training,
• Registration and Licensing) Act is amended in subsection (6) by deleting the word "High Court" and substituting therefor the words "tribunal".
• 76.Section 31 of the Clinical Officers (Training,
• Registration and Licensing) Act is amended in subsection (2) by inserting the words s"of approved training institutions"immediately after the word "inspection appearing in paragraph (e).

77. The Long Title of the Radiographers Act is amended

• by inserting the word"professional"immediately after the words "to regulate their".
• 78.Section 2 of the Radiographers Act is amended by inserting the following new definitions in their proper alphabetical sequence-—

"practicing certificate"means a certificate issued to a professional registered under this Act; and

"tribunal" means the Health Care Tribunal established under section 84 of the Quality Health Care and PatientSafety Act.

79. Section 4 of the Radiographers Act is amended in- 2. (a) subsection (1), by inserting the word 'professional" immediately after the words"training and";and 3. (b) subsection (2), by deleting paragraph (d).

Amendment of the

heading ofPart IV of Cap.253F.

80. The Radiographers Act is amended in the heading of PART IVbydeleting the word "PRIVATE" and substituting therefor the word "PROFESSIONAL".

Amendmentof section18of Cap. 253F.

81. Section 18 of the Radiographers Act is amended- 2. (a) in the marginal note by deleting the word "private" and substituting therefor the word"professional"; 3. (b) in subsection (1), by deleting the word "private" and substituting therefor the word "professional"; 4. (c)by deleting subsection (2);and

Amendment of section 26of Cap. 253F.

Amendment of section39of Cap. 253F.

Amendment of section2 of Cap. 253G.

Amendment of section 41 of Cap. 253G.

Amendment of section 46 of Cap. 253G.

Amendment of the LongTitle of Cap. 253H.

• (d) in subsection (3), by deleting the word "private" and substituting therefor the word "professional".

82. Section 26 of the Radiographers Act is amended-

• (a) by deleting subsection (4) and substituting therefor the followingnew subsection-
• (4) A radiographer who has been suspended from practice or whose practising certificate has been withdrawn or cancelled shall,from the date of the suspension,withdrawal or cancellation,surrender the registration and practicing certificate to the Registrar;
• (b) in subsection (5), by deleting the words "licence or"; and
• (c) in subsection (6), by deleting the words "High Court" and substituting therefor the words"tribunal"

83. Section 39 of the Radiographers Act is amended in subsection (2) by—

• (a) inserting the words "of approved training institutions"immediately after the word 'inspection' appearing in paragraph (d); and
• (b) deleting paragraph (e).

84. Section 2 of the Public Health Officers (Training, Registration and Licensing) Act is amended by inserting the following new definition in its proper alphabetical sequence-

"tribunal" means the Health Care Tribunal established under section 84 of the Quality Health Care and Patient Safety Act.

85. Section 41 of the Public Health Officers (Training, Registration and Licensing) Act is amended in subsection (6), by deleting the words "High Court" and substituting therefor the words"tribunal". 86. Section 46 of the Public Health Officers (Training, Registration and Licensing) Act is amended in paragraph (g)by inserting the words"as provided in the Public Health Act'immediately after the word "institutions". 3. 87.The Long Title of the Occupational Therapists (Training, Registration and Licensing) Act is amended by

Amendment of

section2of Cap. 253H.

Amendmentof section8of Cap.

253H.

Amendmentof the heading of Part V of

Cap.253H.

Amendment of section28of Cap.

253H.

Repeal of section29 of Cap.253H.

inserting the word "professional"immediately after the words "to regulate their".

88. Section 2 of the Occupational Therapists (Training, Registration and Licensing) Act is amended by inserting the following new definitions in their proper alphabetical sequence-

"licence" means a licence issued to an occupational

therapist registered under this Act; and

"tribunal" means the Health Care Tribunal established under section84of the QualityHealth Care and Patient Safety Act.

89. Section 8 of the Occupational Therapists (Training, Registration and Licensing) Act is amended by- 2. (a) deleting paragraph (c); and 3. (b) deleting paragraph (f). 4. 90.The Occupational Therapists (Training, Registration and Licensing) Act is amended in the heading of PART IV by deleting the word "PRIVATE PRACTICE" and substituting therefor the word"LICENSING". 91. Section 28 of the Occupational Therapists (Training, 6. Registration and Licensing) Act is amended in- 7. substituting therefor the word "professional"; 8. (b) in subsection (2),by deleting the words "on his or her own behalf or to be employed by a registered occupational therapist"; 9. (c) in subsection (3), by deleting the words "and shall state whether the licensee may practice on his own behalfor on employment"; 10. (d) subsection (4),by deleting the word "private"and substituting therefor the word"professional";and 11. (e) subsection (6), by deleting the word "High Court" and substituting therefor the word "tribunal" 12. 92.The Occupational Therapists (Training, Registration 13. and Licensing) Act is amended by repealing section 29.

Amendment of section 30 of Cap. 253H.

Repeal of section31 of Cap.253H.

Amendment of section33of Cap.

253H.

Amendment of section 35 of Cap. 253H.

Amendment of section40of Cap. 253H.

Amendment of section 41 of Cap.

253H.

Amendment of section2of Cap.257

Amendment of section17of Cap. 257.

93. Section 30 of the Occupational Therapists (Training, 2. the words "engage in the". 3. Registration and Licensing) Act is amended in subsection (1) by inserting the word "professional" immediately after 4. 94.The Occupational Therapists (Training,Registration and Licensing) Act is amended by repealing section 31. 95. Section 33 of the Occupational Therapists (Training, Registration and Licensing) Act is amended in subsection (4) by deleting the word "High Court"where it appears and substituting therefor the words "tribunal". 96. Section 35 of the Occupational Therapists (Training, Registration and Licensing) Act is amended in subsection (6) by deleting the word "High Court"where it appears and substituting therefor the words"tribunal" 97. Section 40 of the Occupational Therapists (Training, Registration and Licensing) Act is amended in subsection (2) by deleting the words "privatepracticelicence" appearing in paragraph (d). 98. Section 41 of the Occupational Therapists (Training, Registration and Licensing) Act is amended by deleting the words "carry on business or". 9. 99.Section 2 of the Nurses and Midwives Act is 10. amended by- 11. (a) deleting the definition of the term"health institution" and substituting therefor the followingnew definition

"health facility" has the meaning assigned to it under the Health Act.

• (b) inserting the following new definition in its proper alphabetical sequence-—
• ""Tribunal" means the Health Care Tribunal established under section 84 of the Quality Health Care and Patient Safety Act.

Amendmentof section9 of Cap.257.

• 100.Section 9 of the Nurses and Midwives Act is amended in subsection (1) by-
• (a) deleting the words "and of health care within the
• community"appearing in paragraph (b); and
• (b) deleting paragraph (i).
• 101.Section 17 of the Nurses and Midwives Act is amended-

section 18B of Cap.

Amendment of 257.

Repeal of section22 of Cap. 257.

Amendment of the Long Title of Cap. 539.

Amendment of section 2 of Cap.539.

Amendment of section 21 of Cap. 539.

• (a) by deleting subsection (2);
• (b) by deleting subsection (3);
• (c) in subsection (4), by deleting the words "engage in private"; and
• (d) in subsection (5), by deleting the words "engage in private".
• 102.Section 18B of the Nurses and Midwives Act is amended in subsection (5) by deleting the word "High Court"where it appears and substituting therefor the words
• "Tribunal".
• 103.The Nurses and Midwives Act is amended by
• repealing section 22.
• 104.The Long Title of the Health Records and
• Information Managers Act is amended by inserting the word "professional" immediately after the words "regulate their".
• 105.Section 2 of the Health Records and Information
• Managers Act is amended by-
• (a) deleting the term "health institution" and substituting
• therefor the followingnew definition-

"health facility" has the meaning assigned to it under the Health Act";

• (b) deleting the words "facility in a health institution" appearing in the definition of the term "health records and information management department" and substituting therefor the words"health facility";
• (c) deleting the definition of the word"private practice";
• (d) deletingthedefinitionof the word "private practitioner"; and
• e) inserting the following new definition in its proper alphabetical sequence-

"tribunal" means the Health Care Tribunal established under section 84of the QualityHealth Care and Patient Safety Act.

• 106.Section 21 of the Health Recordsand Information
• Managers Act is amended by-
• (a) deleting subsection (3); and
• (b) deleting subsection (4).

Amendment of the heading of Part IVof Cap.539.

• 107.The Health Records and Information Managers Act is amended in the heading of Part IV by deleting the words
• "PRIVATEPRACTICEAND".

Amendment of section 24of Cap. 539.

Amendment of

• 108.Section 24 of the Health Records and Information
• Managers Act is amended-
• (a) by deleting the marginal note and substituting therefor the following new marginal note-

"24. Licence to practice";

• (b) in subsection (1), by deleting the word "private";
• (c) deleting subsection (6); and
• (d) deleting subsection (7).
• 109.Section 31 of the Health Records and Information Managers Act is amended in subsection (6) by deleting the word "High Court" and substituting therefor the word "Tribunal".

section31 of Cap. 539.

Amendment of 110.Section 2 of the Social Health Insurance Act is section2ofNo.16of 2023. amended by-

• (a) deleting the definition of the term "Dispute
• Resolution Tribunal"; and
• (b) inserting the following new definition in its proper alphabetical sequence-

"tribunal" means the Health Care Tribunal established under section 84of the Quality Health Care and Patient Safety Act;

Amendment of

section5ofNo.16of

• 111.Section 5 of the Social Health Insurance Act is amended in paragraph (d) by deleting the words "certification of the health care providers and healthcare facilities by the relevant body" and substituting therefor the words s"accreditation of health care providers and healthcare facilities by the Quality Health Care and Patient Safety Authority established under the Quality Healthcare and Patient Safety Act".

2023.

Amendment of section33of No.16

of2023. amended in-

• 112.Section 33 of the Social Health Insurance Act is
• (a) subsection (2), by deleting the words "body responsible for accreditation for quality of care" and substituting therefor the words "Quality Health Care

and Patient Safety Authority established under the QualityHealthcare and Patient SafetyAct';

• (b) subsection (4),by deleting the words "body under subsection (2)"and substituting therefor the words "Quality Health Care and Patient Safety Authority"; and
• (c) subsection (5) by deleting the words "body under subsection (2) may appeal to the Dispute Resolution Tribunal" and substituting therefor thewords "Quality Health Care and Patient Safety Authority may appeal to the Tribunal".

Repeal ofPart Vlll of 113.The Social Health Insurance Act is amended by No.16of2023. repealing PART VIll of the Act.

MEMORANDUMOFOBJECTSANDREASONS

The principal object of this Bill is to establish a comprehensive legal framework to promote the improvement of the quality of healthcare in Kenya by establishing standards, accreditation mechanisms and ensuring the protection and promotion of patient rights. The Bill therefore institutionalizes quality health care standards, accreditation mechanisms, and patient rights in Kenya for purposes of improving health outcomes, enhancing accountability in health systems and aligning the existing frameworkswith global bestpractices.

Part I (clause 1 to 6) provides for preliminary matters including the

short title, the objects of the Act and guiding principles on the provides various definitions such asquality of healthcare and accreditation for quality of healthcare among others. It sets out the role of the Cabinet Secretary responsible for health as well as those of the county governments in implementation of the Act.

Part II (clause 7 to 25) outlines the rights of patients who seek healthcare services from a health facility. These rights are to be read with those provided for under the Health Act, Cap.241. The rights include right to safe and quality care, right to timely and effective care, right to safe and accessible health facilities, right to safe processes and practices, right to care by a qualified health professional, right to dignity and equity, right to information and decision making, right to be heard and right to safe and

quality health products and technologies.

Part Ill (clause 26 to 41) provides for the establishment of the Authority as the primary regulator of health facilities for purposes of quality of healthcare, its functions, powers; the composition, term of office,functions and qualifications of the Board of Directors of the Authority. It further provides for the appointment of a Chief Executive

Officer and the staff of the Authority.

Part IV (clause 42 to 71) provides for the process of registration, licensing and accreditation of health facilities including timelines and prerequisites for grant of certificates for registration, licencing and accreditation, the validity period and instances where the Authority can order suspension or revocation of the certificates. It also provides for consequences of operating health facilities which are not registered or licensed. It sets out the quality improvement in a health facility, the procedure for quality scoring and rating, award of performance rating and

monitoring of compliance by the Authority.

Part V (clause 72 to 82) provides for the conduct of inspections and investigations by the Authority including the qualifications and powers of inspectors.

Part VI (clause 83 to 86)provides for the establishment of a Health Care Tribunal, its composition and its role in adjudicating disputes arising out of matters envisaged by the Bill and the administration and enforcement of disputesin thehealthsector once it is enacted.

• Part VIl (clause 87 to 92) provides the sources of funds of the Authority, the modalities on annual reporting by the Authority and handling of the accounts of the Authority including the audit of its

finances.

Part Vlll (clause 93) provides for the delegation of power to the Cabinet Secretary in the Ministry responsible for health,in consultation with the Board of Directors of the Authority,to make regulations for the better carrying into effect of the provisions of the Act and the general provisions such as categorization of ambulances.

Part IX (clause 94 to 98) provides for the right of review of a decision, appeal, offences and the general penalty.

• Part X (clause 99 to 100) provides for the transitional provisions in relation to the registration of existing health facilities as well as consequential amendments to other statutes in light of the introduction of thisBill

The First Schedule provides for the conduct of the business and

affairs of the Board of theAuthority.

The Second Schedule provides the consequential amendments.

Dated the 12th July,2025.

KIMANIICHUNG'WAH,

Leader of the Majority Party.