REPUBLIC OF KENYA IMPLEMENTATION GUIDELINES CHECKLIST FOR SINGULAR OR JOINT INSPECTIONS FOR PUBLIC AND PRIVATE PROVIDERS BY HEALTH REGULATORY BODIES UNDER THE MINISTRY OF HEALTH 2015 1
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 2
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 3
Abbreviations COC HMIS HR IFC IHR JHIC KLTTB KNDI KQMH LR MOH MPDB MR NGO NHA NHIF NHSSP PHA PPB RPB SMS TWG Clinical officers Council Health Management Informational System High risk (facility categorization) International Finance Corporation Imminent high risk (facility categorization) Joint Health Inspection Checklist Kenya Medical Laboratory Technicians & Technologists Board Kenya Nutritionists and Dieticians Institute Kenya Quality Model for Health Low risk (facility categorization) Ministry of Health Medical Practitioners & Dentists Board Medium risk (facility categorization) Non-Governmental Organization National Hospital Accounts National Hospital Insurance Fund National Health Sector Strategic Plan Public Health Act Pharmacy & Poisons Board Radiation Protection Board Short message service (mobile phone messaging) Technical Working Group 4
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 5
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. 6
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 Public Private non-profit Private commercial Description Includes Ministry of Health (MoH) owned referral facilities, County health facilities, facilities owned by government agencies, armed forces and parastatals Includes facilities owned by faith-based organizations (FBOs), non-governmental organizations (NGOs), facilities registered as Charities under the law Includes all facilities registered as commercial enterprises under the Kenyan laws, and operated for commercial (profit) purposes Facility types Facility type Combined medical facility (outpatient) Combined medical facility (Inpatient) Medical clinic (stand-alone) Dental clinic Laboratory/ diagnostic facility Pharmacy Radiology Nutrition Other facility Description 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 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 Clinician or nurse-run clinics that offer consultation services (both general and specialist clinics) Dental clinics, both general and specialist All types of laboratory and/or diagnostic facilities that operate independent of medical facilities All types of pharmacies that operate independent health facility (serve walk-in retail clients) All types of medical radiology centres that operate independent of medical facility All types of nutrition clinics/centres that operate independent of medical facilities Any other facility not included in the categorization: Specify [ ] Facility levels Facility level Level 2 Level 3 Level 4 Level 5 Level 6 Description Dispensaries and Clinics Health Centres and Maternity and Nursing homes Primary Hospital (Sub-County Hospitals and medium-sized private hospitals MPDB category II) Secondary Hospitals (County Referral Hospitals and large well-established private (non-teaching) hospitals MPDB category I). Training for paramedical staff Tertiary Hospitals (National Referral Hospitals and large teaching private hospitals) 7
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 25 th percentile (25 percent of the total points allocated to the item), while the Satisfactory rating scores the 75 th percentile (75% of the points allocated to the item). 8
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. 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 9
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 of the checklist; scores a total of 100 Sub-section A of section 2. Scores a total of 35 Specific items to be scored using equal weighting. The four elements will share the 15 points equally (each scores 3.75). SECTION 2: HEALTH FACILITY INFRASTRUCTURE Yes No Score Comments A. Building Element 1 of sub-section A Scores a total of 15 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 10
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 ). 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. 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. 11
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 12
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. 13
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 Risk category Compliance Warning/sanction/reward score category 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 61-75% Medium risk Substantially 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 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 14
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 reinspection. 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 Risk category Compliance Warning/sanction/reward score category 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 61-75% Medium risk Substantially 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 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) 15