1

IMPLEMENTATION GUIDELINES

CHECKLIST FOR SINGULAR OR JOINT INSPECTIONS

FOR PUBLIC AND PRIVATE PROVIDERS BY HEALTH

REGULATORY BODIES UNDER THE MINISTRY OF

HEALTH

2015

REPUBLIC OF KENYA

2

Table of Contents

Preamble ......................................................................................................................... 3 Abbreviations .................................................................................................................. 4 Introduction ..................................................................................................................... 5 Part 1: Facility Classification Information ......................................................................... 6 Part 2: Types of items and response styles ..................................................................... 8 Part 3: Scoring and risk rating of health facilities ........................................................... 10

A. Scoring methodology ............................................................................................................ 10

B: Assigning facilities into risk categories ................................................................................. 11

Part 4: Warnings and sanctions to accompany the Joint Inspection Checklist .............. 14 Appendix: Worked example .......................................................................................... 15

3

Preamble

The Joint Health Inspections Checklist aims to streamline the process of inspections, make more

transparent assessment criteria, and enhance communication and accountability between inspectors

and health facilities. This is a key step towards guaranteeing compliance with minimum standards of

quality of care and patient safety standards across both public and private health care providers.

The Constitution of Kenya 2010 mandated the right to the ‘highest attainable standard of healthcare’ for

all Kenyans. This means that the health care patients receive at any health facility that they attend

should be of a good standard: safe for health care service users, who should be able to expect and ask

for a basic minimum quality of care. Quality of care and patient safety in this regard covers a wide range

of topics related to the minimization of unsafe care and the optimization of processes that ensure that

care is delivered systematically, responsibly and with responsiveness to user needs.

The Kenya Quality Model for Healthcare (KQMH) is a continuous quality improvement framework that

provides health facilities with a comprehensive pathway towards greater implementation of quality

standards. However, before these levels of care are even pursued, systems MUST be put in place to

ensure service providers meet certain basic minimum standards, below which they pose risks to clients.

This is the primary role of the inspections process.

The Joint Health Inspection Checklist combines basic minimum requirements of individual regulatory

bodies into one tool, hence making the inspections processes easier. The checklist’s contents were

proposed by representatives of the respective regulatory agencies.

This document accompanies the Joint Health Inspection Checklist as an implementation guide, providing

overall guidance on how to fill in the checklist, how to score the facilities, and how the facility scores

inform decisions on warnings, sanctions and incentives (where applicable).

The Joint Health Inspection Technical Working Group was formed by heads of Health Regulatory Boards and Councils in Kenya, with

representation from the Ministry of Health and the private health sector, to spearhead the process of developing instruments to use during

Joint Health Regulatory Inspections. Representation was drawn from the Medical Practitioners and Dentists Board, the Nursing Council of

Kenya, the Pharmacy and Poisons Board, the Kenya Medical Laboratory Technicians and Technologists Board, the Clinical Officers Council, the

Radiation Protection Board, the Kenya Nutritionists and Dieticians Institute and Public Health Technical and financial support was provided by

the World Bank Group’s Health in Africa Initiative

4

Abbreviations

COC Clinical officers Council HMIS Health Management Informational System HR High risk (facility categorization) IFC International Finance Corporation IHR Imminent high risk (facility categorization) JHIC Joint Health Inspection Checklist KLTTB Kenya Medical Laboratory Technicians & Technologists Board KNDI Kenya Nutritionists and Dieticians Institute KQMH Kenya Quality Model for Health LR Low risk (facility categorization) MOH Ministry of Health MPDB Medical Practitioners & Dentists Board MR Medium risk (facility categorization) NGO Non-Governmental Organization NHA National Hospital Accounts NHIF National Hospital Insurance Fund NHSSP National Health Sector Strategic Plan PHA Public Health Act PPB Pharmacy & Poisons Board RPB Radiation Protection Board SMS Short message service (mobile phone messaging) TWG Technical Working Group

5

Introduction

The joint health inspections instruments were designed for joint and singular inspection of health

facilities. This means that the tool can be used both by joint inspection teams, and by individual

regulators seeking to inspect singular health business facilities.

There are two checklists: a general checklist combining outpatient and inpatient facilities, and a checklist

for those facilities that only offer outpatient services. The two tools are described briefly on page 6.

The provisions outlined in the checklist represent the minimum requirements facilities are expected to

comply with, failure to which certain sanctions may be deployed.

The following are guiding principles important to note when using the Joint Health Inspections Checklist:

This checklist is NOT powered for pre-licensure inspection of new health facilities, which typically

requires a more detailed assessment by the respective regulators, and may require compliance to

additional provisions such as membership to professional bodies.

The checklist is not designed for inspection of pre-service training facilities by the regulatory

agencies. Inspection for training purposes typically varies from inspection for trade purposes, and

will usually require a more detailed assessment by the respective regulatory agencies.

This checklist covers key departments and is designed to ease inspections by focusing on elements

that directly affect patient safety. However, it is not designed to override provisions of laws

governing different regulatory agencies. A regulator may re-inspect a facility with more detailed

tools, if they deem that necessary, following inspection with the Joint Health Inspections Checklist.

This Guideline Document specifically provides the following information to accompany the Checklist:

Part 1: A description of the types of facilities covered by the checklist

Part 2: An explanation of the types of items included in the checklist and response styles

Part 3: An explanation of the scoring methodology applied to the Checklist, and how the scores are used

to put facilities in different risk categories based on their performance (risk classification of facilities)

Part 4: Warnings, sanctions and rewards (if applicable) to accompany the risk categorization of facilities

The current Joint Health Inspections Checklist is an improvement of an earlier version that was gazetted

under the Medical Practitioners and Dentists Act in 2012. This version specifically includes:

Structural and content improvements informed by field experiences that followed the

implementation of the initially Gazetted checklist

Inclusion of more detailed definition of individual items to facilitate the inspection process

Inclusion of a new scoring methodology that gives equal weighting to individual items measured

6

Structure of the General Checklist covering inpatient and outpatient facilities

This tool has 14 sections, 12 of which are scored. The sections appear as follows:

Section Number Section title Section score

Section 1 Administrative information -

Section 2 Health Facility Infrastructure 100

Section 3 General Management and Recording of Information 100

Section 4 Infection Prevention and Control 100

Section 5 Medical and Dental Consultation Services 100

Section 6 Labour Ward 100

Section 7 Medical and Paediatric Wards 100

Section 8 Theatre 100

Section 9 Pharmacy 100

Section 10 Laboratory 100

Section 11 Radiology 100

Section 12 Nutrition and Dietetics Services Unit 100

Section 13 Mortuary 100

Section 14 Findings and Recommendations -

A facility with all twelve sections present can achieve a maximum total score of 1,200.

Structure of the Outpatient Checklist covering facilities that only offer outpatient services

The outpatient checklist has 9 sections, 7 of which are scored. The sections appear as follows:

Section Number Section title Section score

Section 1 Administrative information -

Section 2 Health Facility Infrastructure 100

Section 3 General Management and Recording of Information 100

Section 4 Infection Prevention and Control 100

Section 5 Consultation Services 100

Section 6 Pharmacy 100

Section 7 Laboratory 100

Section 8 Radiology 100

Section 9 Findings and Recommendations -

A facility with all seven sections present can achieve a maximum total score of 700.

IMPORTANT NOTE: Facilities will only be scored based on the departments they have that are

operational. If an outpatient facility, for instance, does not have a radiology department, it will be

scored in six sections, not seven. Such a facility can achieve a maximum possible score of 600, not 700.

7

Part 1: Facility Classification Information

Health care facilities are classified by ownership and type. The joint inspections include public and

private facilities falling in the different categories (types) and levels.

Facility ownership

Owner Description

Public Includes Ministry of Health (MoH) owned referral facilities, County health facilities, facilities

owned by government agencies, armed forces and parastatals

Private non-profit Includes facilities owned by faith-based organizations (FBOs), non-governmental organizations

(NGOs), facilities registered as Charities under the law

Private commercial Includes all facilities registered as commercial enterprises under the Kenyan laws, and operated

for commercial (profit) purposes

Facility types

Facility type Description

Combined medical facility

(outpatient)

All types of facilities that offer combined services. These could include consultation services,

certain diagnostic tests, pharmaceutical services etc, but all provided at an outpatient level

Combined medical facility

(Inpatient)

All types of facilities that offer combined services. These could include consultation services,

certain diagnostic tests, pharmaceutical services etc, but all provided at an inpatient level

Medical clinic (stand-alone) Clinician or nurse-run clinics that offer consultation services (both general and specialist clinics)

Dental clinic Dental clinics, both general and specialist

Laboratory/ diagnostic facility All types of laboratory and/or diagnostic facilities that operate independent of medical facilities

Pharmacy All types of pharmacies that operate independent health facility (serve walk-in retail clients)

Radiology All types of medical radiology centres that operate independent of medical facility

Nutrition All types of nutrition clinics/centres that operate independent of medical facilities

Other facility

Any other facility not included in the categorization: Specify [___________________________]

Facility levels

Facility level Description

Level 2 Dispensaries and Clinics

Level 3 Health Centres and Maternity and Nursing homes

Level 4 Primary Hospital (Sub-County Hospitals and medium-sized private hospitals – MPDB category II)

Level 5 Secondary Hospitals (County Referral Hospitals and large well-established private (non-teaching)

hospitals – MPDB category I). Training for paramedical staff

Level 6 Tertiary Hospitals (National Referral Hospitals and large teaching private hospitals)

8

Part 2: Types of items and response styles

The questions in the Joint Health Inspection Checklist have three main types of items:

a. Items that only require a ‘Yes’ OR ‘No’ type of response, or a ‘Yes’ OR ‘No’ or ‘Not applicable’

response

b. Items that require a likert type of response

c. Items that require direct entry of information (names and/or numbers)

a. Items that require a ‘Yes’/‘No’/ ‘Not applicable’ type of response

This forms the bulk of items in the Checklist. The response would typically be a ‘Yes’ OR ‘No’, simply

because there would be no other possible response. The inspector is expected to mark the appropriate

response (putting a ‘Tick’ in the box).

However, there are some items that may not apply for all facilities or departments. For these items, the

option of ‘Not applicable’ (NA) has been included. An example is the item asking about certain types of

licenses, which may not apply to certain types of facilities.

b. Likert type of responses

This applies to items that require a graded type of response, and may not work with a ‘Yes’ and ‘No’

type of response. The inspector is required to rate the performance on a likert scale that allows one to

express a range of opinions as follows:

A ‘Very dissatisfactory’ rating scores zero, while a ‘Very satisfactory’ rating scores the maximum possible

points allocated to the item. A ‘Dissatisfactory’ rating scores the 25th percentile (25 percent of the total

points allocated to the item), while the ‘Satisfactory’ rating scores the 75th percentile (75% of the points

allocated to the item).

9

c. Items that require direct entry of information (names and/or numbers)

These items require that a response is entered directly by the inspector onto the checklist. The

information required may be in form of written words or numbers.

Example: Section 1 of the checklist

IMPORTANT POINT TO NOTE

Inspection team members are expected to physically check for the availability of respective

equipment, materials and/or records where applicable. This applies across all items that ask

for ‘availability’ or ‘presence of’.

For records, inspection team members MUST check a sample of entries before recording on

the checklist.

10

Part 3: Scoring and risk rating of health facilities

On completing the joint health inspection exercise, the inspections teams will be required to score each

facility, and place the facility into a risk category based on the overall score.

A. Scoring methodology

The checklist is divided into 14 sections, 12 of which are scored. The first section collects general

information and registration and licensing details of the facility, while the last section collects

information on the inspection team and overall comments.

Each of the 12 scored sections scores a possible maximum score of 100 points (totalling to 1,200 points

for facilities that have all 12 departments).

Each scored section has a sub-section, under which there are a number of elements. Each sub-section

and element has a maximum score value that was set based on the relative importance of the items

under the respective subsection/element, as determined by representatives from the respective

regulatory agencies (see example 1).

Example 1

SECTION 2: HEALTH FACILITY INFRASTRUCTURE

Yes No Score Comments

A. Building 35.00

1. Signage 15.00

Does facility display legible signage?

☐ ☐ 3.75

Does facility display relevant signage?

☐ ☐ 3.75

Does signage include facility names?

☐ ☐ 3.75

Does signage include department names?

☐ ☐ 3.75

Section ‘2’ of the

checklist; scores a

total of 100 Sub-section ‘A’ of section ‘2’.

Scores a total of 35

Element 1 of sub-section

‘A’ Scores a total of 15

Specific items

to be scored

using equal

weighting. The

four elements

will share the

15 points

equally (each

scores 3.75).

11

Specific items to be scored are included under each element. Each item carries a maximum possible

score that is equal to that of the other items. For instance, under example 1, the specific item labelled

‘Does the facility have signage’ carries the same maximum weighted score as the next item labelled

‘Does facility display legible signage’.

Individual items under each subsection receive an equal-weighted score, adding up to the total score

per section. In example 1, individual items score 3.75, which is equivalent to 15 (maximum element

score) divided by 4 (number of specific items under the element labelled ‘Signage’).

A percentage score is then computed per facility, with the numerator being the total score accumulated

across all sections, and the denominator being the maximum possible points, which will depend on the

number of departments inspected (Maximum 1,200 points for facility with all 12 departments).

B: Assigning facilities into risk categories

There are five risk categories that a facility may be placed into, depending on the overall percent score:

Very High Risk (VHR); High Risk (HR); imminent high risk (IHR); Medium Risk (MR); Low risk (LR). For

purposes of reporting compliance to patient safety standards, corresponding groups were created each

of the five risk categories as follows. The five compliance categories were: Non-Compliant; Minimally

Compliant; Partially Compliant; Substantially Compliant; and Fully Compliant.

The categories are discussed in more detail below:

i) Very High Risk (VHR): Facilities deemed to pose an immediate danger to the public. Facilities that fall

in this category MUST not be allowed to continue operating, and MUST be closed immediately. Where

requisite licenses are absent, prosecution should be recommended as outlined in the laws.

For purposes of compliance to patient safety standards, facilities in this category will be categorized as

‘Non-Compliant’. Facilities in this category have failed to show any meaningful effort towards

compliance to minimum patient safety standards.

During inspection, the team members will NOT be expected to compute the values for each item. Instead,

they are only required to tick the ‘YES’ box for items that they agree with, and tick the ‘NO’ box for those that

they disagree with. As the scoring is equal weighted, the total scores per section can be computed at the end

of the inspection exercise.

12

ii) High Risk category (HR): Facilities deemed to pose a danger to the public, but have requisite licenses.

Facilities in this category can be given up to four weeks to institute recommended changes.

For purposes of compliance to patient safety standards, facilities in this category will be categorized as

‘Minimally Compliant’. Facilities in this category have requisite licenses and meet the very minimal

structural requirements needed to ensure compliance to patient safety standards.

iii) Imminent High Risk (IHR) category: Facilities deemed to be on the path to being a danger, unless

immediate remedial action is instituted. Such facilities may be allowed to continue operating, but MUST

institute changes in areas that pose imminent risk within three to six months.

For purposes of compliance to patient safety standards, facilities in this category will be categorized as

‘Partially Compliant’. Facilities in this category are on the pathway to compliance, but still have a

considerable amount to do to ensure sustained compliance to patient safety standards.

iv) Medium Risk (MR) category: Facilities deemed relatively safe, but in need of some remedial actions.

Such facilities may be given up to one year to correct areas deemed to be unsatisfactory.

For purposes of compliance to patient safety standards, facilities here will be categorized as

‘Substantially Compliant’. These facilities have made substantial progress towards compliance, and only

need to institute certain measures to attain full compliance.

v) Low Risk (LR) category: Facilities deemed to pose little or no risk to the public. Facilities in this

category may be exempted from inspections for up to two years.

For purposes of compliance to patient safety standards, facilities in this category will be categorized as

‘Fully Compliant’. Facilities here have satisfactorily demonstrated compliance to patient safety

standards, and are on the continuous quality improvement pathway.

Facilities will be given the following provisional risk ratings depending on the overall score:

An overall facility score of 0-10% (and/or absence of licenses) – Very High Risk (VHR) category

An overall facility score of 11-40% - High risk (HR) category

An overall facility score of 41-60% - Imminent high risk (IHR) category

An overall facility score of 61-75% - Medium risk (MR) category

An overall facility score of 76-100% - Low risk (LR) category

13

It is these risk categories that will inform the next steps to be taken, and in particular, what types of

warnings/ sanctions or incentives would be deployed.

Decisions on registration and licensure status

The scoring and risk rating of facilities DOES NOT include measurable risk based on the availability or lack

of the requisite registration and licensing documents.

Decision on registration and licensing are based entirely on provisions of the respective legislation, which

typically require that NO FACILITY BE ALLOWED to operate without the required licenses.

However, the decision on what effect the closure of one non-compliant department at a facility, should

have on the overall operations of the facility will depend on what the respective Boards and Councils deem

appropriate. It may be that some departments are vital to the entire facility, and that if they do not have

the requisite licenses, then the entire facility MUST be closed down. On the other hand, some departments

may be closed down without affecting the operations of the entire facility.

14

Part 4: Warnings, sanctions and rewards to accompany the Joint Inspection Checklist

Table 1: Relationship between facility performance and risk categories/warnings and sanctions

Facility score

Risk category Compliance category

Warning/sanction/reward

0-10% *(and/or absence of licenses)

Very High Risk

Non-Compliant Close facility. Recommend prosecution for cases where requisite registration and licensing is absent (as specified by the respective legislation)

11-40% High Risk Minimally compliant 3 months notice for correction + re-inspection Can ask for re-inspection for purposes of re-categorization after corrections

41-60% Imminent High Risk

Partially Compliant 6 months notice + re-inspection HF will be re-classified as High Risk if non-compliant HF ask for re-inspection for purposes of re-categorization after corrections

61-75% Medium risk Substantially Compliant

12 months notice+ re-inspection HF will be re-classified as Imminent High Risk if non-compliant HF ask for re-inspection for purposes of re-categorization after corrections if improvement occurs before 12 months

>75% Low Risk Fully Compliant Insurance recommendation No re-inspection for two years Other incentives will also be considered (if such mechanisms exist), including client signaling (quality mark and/or SMS feedback mechanism)

* - All facilities and/or departments that fail to meet the licensing requirements will be closed in compliance with

the relevant legislation. However, the modalities will be guided by the respective Boards and Councils.

Possibility for sharing certain regulatory functions with County Management Teams

Regulatory enforcement remains a function of the National Government.

HOWEVER, there are discussions to explore the potential to share certain roles with the County Health

Management. This may include follow-up re-inspection of facilities following an inspection by the Joint

Health Inspections team.

Should such arrangements be formally agreed, they will be communicated appropriately, and the Implementation

Guidelines updated accordingly

15

Appendix: Worked example

Worked example of scoring and risk rating a facility

Gower Level 5 Hospital was inspected and scored 600 out of the possible 1,200 (facility had all 12

departments). The facility was found to have the requisite personnel and facility licenses.

Step I: Facility score

Overall facility score will be:

(600/1,200) x 100 = 50%

Step II: Facility rating

Gower Hospital will be given a categorization of ‘IHR’ (remember: facilities that get an overall score of 41-

60% are categorized as ‘Imminent High Risk’ or ‘IHR’ facilities).

Step III: Deployment of warnings/sanctions or incentives

The inspectors will give Gower Hospital up to 3 months to rectify its insufficiencies and request for re-

inspection. An SMS-enabled feedback mechanism may be deployed in future to enable members of the

public to check the risk categorization of the hospital. This is an incentive for Gower Hospital to quickly

comply and ask for re-inspection. See table below, relevant area highlighted in yellow.

Facility score

Risk category Compliance category

Warning/sanction/reward

0-10% *(and/or absence of licenses)

Very High Risk Non-Compliant Close facility. Recommend prosecution for cases where requisite registration and licensing is absent (as specified by the respective legislation)

11-40% High Risk Minimally compliant 3 months notice for correction + re-inspection Can ask for re-inspection for purposes of re-categorization after corrections

41-60% Imminent High Risk

Partially Compliant 6 months notice + re-inspection HF will be re-classified as High Risk if non-compliant HF ask for re-inspection for purposes of re-categorization after corrections

61-75% Medium risk Substantially Compliant

12 months notice+ re-inspection HF will be re-classified as Imminent High Risk if non-compliant HF ask for re-inspection for purposes of re-categorization after corrections if improvement occurs before 12 months

>75% Low Risk Fully Compliant Insurance recommendation No re-inspection for two years Other incentives will also be considered (if such mechanisms exist), including client signaling (quality mark and/or SMS feedback mechanism)