SPECIAL ISSUE 1713

Kenya Gazette Supplement No. 31 21st March, 2016

(Legislative Supplement No. 25)

LEGAL NOTICE NO. 46

THE PUBLIC HEALTH ACT
(Cap. 242)
IN EXERCISE of powers conferred by section 153 of the Public
Health Act, the Cabinet Secretary for Health makes the following
Rules:—
THE PUBLIC HEALTH (CHECKLIST FORMS) RULES, 2016
1. These Rules may be cited as the Public Health (Checklist
Forms) Rules, 2016.
2. An authorized person visiting and inspecting any premises
under section 153(1) of the Act shall use the checklist Forms provided
for—
(a) in case of facilities with outpatient services, under Form I;
and
(b) in case of facilities with in-patient services, under Form II,
specified in the Schedule to these Rules.
3. An authorized person may send the checklist Forms to the
facilities at least two weeks prior to inspection and the facilities shall
fill and return the same to the relevant regulatory bodies.
4. The checklist Forms specified in the Schedule to these Rules
shall be used for both pre-registration and post-registration purposes.
5. For the purposes of these Rules, “authorized person” means a
person authorized by the Director of Medical Services under section
153 (2) of the Act to visit and inspect any premises specified under
section 153 (1) of the Act.
 CHECKLIST FOR INSPECTIONS OF PUBLIC AND PRIVATE PROVIDERS BY HEALTH
REGULATORY BODIES UNDER THE MINISTRY OF HEALTH
Section 1: Administrative Information
A. Facility Registration and Location Information
Registration/Gazette name:
Master facility number: Registration number
(for private facilities):
Physical location details Contact details
County: Name of contact:
Sub-County/District: Qualification and designation of contact person:
Address:
Town/Market: Phone number:
Building plot no: Email:
B. Facility Level and Details
1. Facility ownership Government/Public entity Private non-profit Private commercial (for-profit)
Other Specify:

2. Facility type Combined medical facility (outpatient only)

Combined medical facility (outpatient and inpatient)
Medical clinic (stand-alone)
Dental clinic (stand-alone)
Laboratory/diagnostic facility
Pharmacy
Radiology
Nutrition
Other facility, Specify [ ]

3. Level of facility Level 2 Level 3 Level 4 Level 5 Level 6

4. Services offered (to be updated based in current ‘Norms and Standards’ document)

C. Proprietor Information (Write ‘Not Applicable (NA)’ where relevant)

1. Details
Proprietor name: Expiry date of license certificate number:

License certificate number: Indemnity cover number (if available):

D. Health Professionals Information

1. Technical Officer in Charge
Qualification: Designation:

Registration certificate number: Registering authority (Board/Council/Association or Society)

2. Other Medical Personnel

Does the facility have a list of all staff with registration details, including name and cadres? Y N

Does the facility have all staff certificates with registration numbers? Y N

Has the inspection team verified that a sample of 5-10% of facility staff have valid registration numbers? Y N

Please fill out the table below with the cadres available in the facility and corresponding details.
Staff Cadre Number of staff per cadre Do all staff in this cadre have If no, enter the number of staff without valid
valid licenses? licenses.
E. Licensing and Registration with Health Regulatory Authorities
Enter ‘Yes’, ‘No’ or ‘Not applicable (NA)’ for the table below.
Health Regulatory Valid Valid Valid license Valid license Relevant licenses Relevant licenses
Authority registration or registration or available? displayed? available? displayed?
membership membership (for regulators that have (for regulators that
available? displayed? different license classes) have different license
Medical Practitioners
and Dentists Board
Nursing Council of
Kenya
Clinical Officers Council

Radiation Protection
Board
Pharmacy and Poisons
Board
Medical Laboratory
Technicians and
Technologists Board
Kenya Nutritionists and
Dieticians Institute
Score, Score,
Section 2: Health Facility Infrastructure Comments
max actual
35 A. Building
15 1. Signage
3 Y N Does the facility display legible signage?
3 Y N Does the facility display signage that is accurate (relevant)?
3 Y N Does the signage include the facility name?
3 Y N Does the signage include department names and direction?
3 Y N Does the facility have an accessibility ramp for disabled/wheelchair patients?
2. Ventilation
10 Adequate ventilation is defined as at least 5% of the overall wall size of the room, or artificial ventilation. Check across different sections
of the facility and score according to the overall performance.
0 Very dissatisfactory
3.3 Dissatisfactory
6.6 Satisfactory
10 Very satisfactory
3. Lighting
10 Adequate lighting is at least 10% of the overall size of the room. How well does this facility satisfy this criterion? Check across different
sections of the facility and score according to the overall performance.
0 Very dissatisfactory
3.3 Dissatisfactory
6.6 Satisfactory
10 Very satisfactory
35 B. Utilities
15 1. Water
7.5 Y N Is safe, clean water available from a tap or container?
7.5 Y N Is there sufficient storage for the water?
10 2. Electricity
10 Y N Is there a stable source of power?
10 3. Toilet facilities
5 Y N Are clean toilets available for both male and female clients?
5 Y N Is there a cleaning roster displayed?
30 C. Security
10 1. Lockable door
5 Y N Does the facility have a lockable door?
5 Y N Is the door secured with grills or another security mechanism?
2. Fire control mechanism (For this question, if the facility is Level 4 or above then each question is worth 5 points. If the facility is not
10
Level 4 or above, then the question is worth 10 points. The maximum score is 10.)
Y N Does the facility have a fire control mechanism such as a fire extinguisher or sand buckets?
Is the equipment available in the reception area as well as specific departments
Y N N/A
(only Level 4 and above)?
3. Fire assembly point (For this question, If the facility is Level 4 or above then each question is worth 1.25 points. If the facility is not
5
Level 4 or above, then each question is worth 1.67 points. The maximum score is 5.)
Y N Does the facility have a fire assembly point or fire assembly protocol?
Y N Is there a documented fire fighting protocol?
Y N Does the facility display emergency exit?
Y N N/A Does the facility display fire assembly point signage (only Level 4 and above)?
5 4. Security
5 Y N Is there a security system present (e.g. security guard, alarm system)?
100 TOTAL

Score, Score,
Section 3: General Management and Recording of Information Comments
max actual
40 A. General Management
10 1. Strategic Plan
2.5 Y N Does the facility have a strategic plan with its vision, mission, values and objectives?
2.5 Y N Is the plan displayed and shared to all staff?
2.5 Y N Does the facility have an annual work plan or a business plan?
2.5 Y N Is an organizational chart available and approved by management?
15 2. Client Service Charter
1.9 Y N Is a client service charter displayed?
1.9 Y N Is it displayed in all key departments/areas?
1.9 Y N Does it mention common services offered?
1.9 Y N Does it mention obligations to clients?
1.9 Y N Does it mention waiting times for clients?
Does it mention ways to communicate with management regarding problems and
1.9 Y N
complaints?
1.9 Y N Does it mention services offered for free?
1.9 Y N Does the facility have a regular performance review for the charter targets?
15 3. List of staff
7.5 Y N Does the facility have a list of all staff with qualifications and job descriptions?
7.5 Y N Are copies of professional certificates for all staff available at the facility?
20 B. Quality Management
1. Accreditation and certifications (not scored)
-
Please list any certifications or accrediting bodies associated with this facility:
- Y N Does the facility have a quality improvement team?
- Y N Are there minutes for the last meeting (ask for a sample)?
2. Monitoring performance indicators
10
Are the following performance indicators collected and monitored?
2 Y N Infant mortality
2 Y N Immunization
2 Y N Maternal mortality
2 Y N Notifiable diseases
2 Y N Are performance indicators shared with staff and published regularly?
10 3. Client feedback mechanism
3.3 Y N Is there a functional client feedback mechanism (e.g. suggestion box or hotline number)?
3.3 Y N Is client feedback reviewed at least biweekly?
3.3 Y N Are client suggestions documented in a report?
30 C. Medical Records and Information Systems
10 1. Medical records for each patient
3.3 Y N Are medical records kept for each patient?
3.3 Y N Do the records include names and unique patient numbers?
3.3 Y N Are medical records legible and signed?
2. Approved register for all patients
5 (For this question, if the facility has inpatient services then each question is worth 1.25 points. If there are no inpatient services then
each question is worth 1.5 points. The maximum score is 5.)
Y N Are outpatient registers kept?
Y N N/A Are inpatient registers kept (if inpatient services)?
Y N N/A Are inpatient and outpatient records kept separately (if inpatient services)?
Y N Are the registers up to date?
10 3. System for storing medical records
3.3 Y N Is there a system in place for storing medical records?
3.3 Y N Is there a filing and numbering system for easy retrieval?
3.3 Y N Are the records protected in cabinets (if paper) or by password (if digital)?
- 4. Data security (not scored)
- Y N Does a system exist for keeping facility data, which is lockable and password protected?
- Y N Does the system for storing medical records have off-site backup functionality?
5 5. Contribution to external databases and reports
5 Y N Does the facility contribute to HMIS?
- Please specify other external databases to which the facility contributes (not scored):
10 D. Equipment Management
 5 1. Preventative maintenance plan for equipment
2.5 Y N Is there a service contract for maintenance?
2.5 Y N Is there a written schedule (including next service date) for maintaining equipment?
5 2. Calibration and validation
1.7 Y N Is there a written calibration schedule available at the area where equipment is used?
1.7 Y N Is there a document showing regular calibration?
1.7 Y N Are contracts available at the facility administration?
100 TOTAL

Score, Score,
Section 4: Infection Prevention And Control Comments
max actual
80 A. General
20 1. Hygiene protocol
10 Y N Does the facility have a hygiene protocol?
10 Y N Does the hygiene protocol have a dedicated staff roster?
30 2. Solid waste management
10 Y N Is there a standard operating procedure for waste management?
10 Y N Is there an incinerator or contracted waste management company?
10 Y N Does the facility have a waste holding area?
20 3. General facility cleanliness
Facility cleanliness entails the general appearance and odor across various departments, to understand
5
whether the facility is cleaned regularly. How well does this facility satisfy this criterion?
0 Very dissatisfactory
1.7 Dissatisfactory
3.3 Satisfactory
5 Very satisfactory
5 Y N Is the paint work acceptable?
5 Y N Is the floor smooth?
5 Y N Is the ceiling free of cobwebs and dust?
4. General compound cleanliness: (For this question, if all elements are available then each question is worth 3.3 points. If only one
10 (either grass or bushes) is available then each question is worth 5 points. If neither grass nor bushes are available then the remaining
question is worth 10 points. The maximum score is 10.)
Y N N/A Is the grass well maintained?
Y N N/A Are the bushes neatly kept?
Y N Is the site free of odor?
20 B. Sterilization Services
20 1. Central Supply Unit

5 Y N Is there a separate area for cleaning with decontamination and sterilization processes?
5 Y N Are standard operating procedures available for sterilization?
5 Y N Is there storage available for sterile supplies?
5 Y N Are sterile supplies labeled and stored in a designated area?
100 TOTAL

Score, Score,
Section 5: Medical And Dental Consultation Services Comments
max actual
80 A. General
20 1. Triage
5 Y N Does the facility have a triage area with a qualified nurse(s)?
5 Y N Is it located at the first point of contact with patients?
5 Y N Is there a standard operating procedure for triage?
5 Y N Is there a system for coding patients?
20 2. Examination room
6.7 Y N Does the examination room have a coach and a mackintosh?
6.7 Y N Does the room have a consultation table with at least two chairs?
6.7 Y N Does the room have a pedal bin and stepper?
 20 3. Examination equipment
2.2 Y N Is a thermometer available?
2.2 Y N Is a stethoscope available?
2.2 Y N Is a tongue depressor available?
2.2 Y N Is a weighing scale available/accessible?
2.2 Y N Is a blood pressure (BP) machine available/accessible?
2.2 Y N Is a torch available?
2.2 Y N Is a privacy screen available?
2.2 Y N Is a diagnostic set available?
2.2 Y N Is a lamp available?
20 4. Emergency tray and equipment
1.7 Y N Does the facility have an emergency tray available at designated sites?
1.7 Y N Is there a checklist for regular review and updates to the emergency tray?
- Confirm that the emergency tray has the following essential drugs:
1.7 Glucose
1.7 Adrenaline
1.7 Sodium bicarbonate
1.7 Diazepam
1.7 Phenobarbitone
- Confirm that the following emergency equipment is available:
1.7 Ambu bag and mask available in pediatric and adult sizes
1.7 Adjustable bed
1.7 Functional suction machine
1.7 Oxygen cylinder and flowmeter, or piped oxygen
1.7 Endotracheal tubes
20 B. Infection prevention and control
4 1. Hygiene protocol
2 Y N Is there a hygiene protocol?
2 Y N Does the hygiene protocol have a dedicated staff roster?
4 2. Hand washing
2 Y N Is a sink present with running water from a tap or modified storage container?
2 Y N Is soap available at the hand washing area?
4 3. Solid waste management
1.3 Y N Are there at least two color-coded bins (Red, black and/or yellow)?
1.3 Y N Are there coded lining bags that match the color of the bins?
1.3 Y N Are there standard operating procedures for waste management?
4 4. Use of disinfectants
2 Y N Is there evidence of disinfectant use?
2 Y N Are you able to observe disinfectant containers used for cleaning?
4 5. Protective equipment
1 Y N Are gloves available?
1 Y N Are gowns or dust coats available?
1 Y N Are face masks available?
1 Y N Are safety boots available?
100 TOTAL

Score, Score,
Section 6: Labour Ward Comments
max actual
80 A. General
10 1. Labour ward
1.1 Y N Is there privacy in the ward (privacy during delivery)?
1.1 Y N Is a delivery bed available?
1.1 Y N Is a sterile delivery set available?
1.1 Y N Is a vacuum extractor available?
1.1 Y N Is a suction machine available?
1.1 Y N Is an ambu bag and mask available?
1.1 Y N Is a cord ligature available?
1.1 Y N Is there sufficient lighting?
1.1 Y N Are maintenance plans available for all equipment?
10 2. Labour room floor
3.3 Y N Is the floor appropriately covered (e.g. ceramic tiles or terrazzo)?
3.3 Y N Is there a drainage system?
3.3 Y N Is there a cleaning chart?
10 3. Oxygen source
3.3 Y N Does the labour ward have oxygen cylinder or piped oxygen connection?
3.3 Y N Are there standard operating procedures?
3.3 Y N Is there a maintenance plan?
10 4. Procedures for obstetrics emergency
Are there procedures available for handling obstructed labour, foetal distress, eclampsia and
5 Y N
APH/PPH/HELLP?
5 Y N Is a functional resuscitative available with oxygen, suction machine and ambu bags?
10 5. Access to theatre
5 Y N Is an ambulance (or contact details) available?
5 Y N Is a fully equipped theatre near the labour ward?
10 6. Procedure for monitoring labour
1.4 Y N Is a partograph available?
- Confirm partographs have the following information:
1.4 Y N Is contraction properly charted?
1.4 Y N Is cervical dilation recorded?
1.4 Y N Is color coding done?
1.4 Y N Is TPR/BP recorded?
1.4 Y N Is urine output/input charted?
1.4 Y N Are drugs coded?
10 7. New born unit
2 Y N Is a functional incubator available?
2 Y N Does it have a temperature regulator?
2 Y N Does it have an oxygen connection?
2 Y N Are maintenance plans available?
2 Y N Is there a sitting area for nursing mothers?
10 8. Sluice room
2.5 Y N Is a sluice room with a sluicing sink available?
2.5 Y N Does the sluice room have running water?
2.5 Y N Does it have a decontamination bucket?
2.5 Y N Are standard operating procedures available?
20 B. Infection prevention and control
4 1. Hygiene protocol
2 Y N Is there a hygiene protocol?
2 Y N Does the hygiene protocol have a dedicated staff roster?
4 2. Hand washing
2 Y N Is a sink present with running water from a tap or modified storage container?
2 Y N Is soap available at the handwashing area?
4 3. Solid waste management
1.3 Y N Are there at least two color-coded bins (Red, black and/or yellow)?
1.3 Y N Are there coded lining bags that match the color of the bins?
1.3 Y N Are there standard operating procedures for waste management?
4 4. Use of disinfectants
2 Y N Is there evidence of disinfectant use?
2 Y N Are you able to observe disinfectant containers used for cleaning?
 4 5. Protective equipment
1 Y N Are gloves available?
1 Y N Are gowns or dust coats available?
1 Y N Are face masks available?
1 Y N Are safety boots available?
100 TOTAL

Score, Score,
Section 7: Medical And Pediatric Wards Comments
max actual
80 A. General
30 1. Patient oversight
7.5 Y N Are admissions procedures standardized with patient categorizations?
7.5 Y N Are patients in hospital uniform?
7.5 Y N Are there regular ward rounds?
7.5 Y N Are there handover and discharge reports on a standard form?
20 2. Patient records
10 Y N Are patient records kept with unique reference numbers?
10 Y N Is the filing system secure?
30 3. Monitoring equipment
6 Y N Does each ward have a BP machine?
6 Y N Does each ward have a thermometer?
6 Y N Does each ward have a pulse oxymeter?
6 Y N Does each ward have a suction machine?
6 Y N Does each ward have an emergency room?
20 B. Infection prevention and control
4 1. Hygiene protocol
2 Y N Is there a hygiene protocol?
2 Y N Does the hygiene protocol have a dedicated staff roster?
4 2. Hand washing
2 Y N Is a sink present with running water from a tap or modified storage container?
2 Y N Is soap available at the handwashing area?
4 3. Solid waste management
1.3 Y N Are there at least two color-coded bins (Red, black and/or yellow)?
1.3 Y N Are there coded lining bags that match the color of the bins?
1.3 Y N Are there standard operating procedures for waste management?
4 4. Use of disinfectants
2 Y N Is there evidence of disinfectant use?
2 Y N Are you able to observe disinfectant containers used for cleaning?
4 5. Protective equipment
1 Y N Are gloves available?
1 Y N Are gowns or dust coats available?
1 Y N Are face masks available?
1 Y N Are safety boots available?
100 TOTAL

Score, Score,
Section 8: Theatre Comments
max actual
80 A. General
10 1. Receiving area
2.5 Y N Does the receiving area have a barrier?
2.5 Y N Does the receiving area have a shoe rack?
2.5 Y N Does the receiving area have a coach?
2.5 Y N Does the receiving area have adequate lighting?
20 2. Changing rooms and scrubbing area
 2.5 Y N Does the theatre have male and female changing rooms with barrier?
2.5 Y N Do changing rooms have clean clothing?
2.5 Y N Do changing rooms have masks?
2.5 Y N Do changing rooms have caps?
2.5 Y N Do changing rooms have theatre shoes?
2.5 Y N Is there a scrubbing area present?
2.5 Y N Is there a hands-free tap?
2.5 Y N Are there swinging theatre doors?
30 3. Operating area
2.5 Y N Does the operating area have adequate space?
2.5 Y N Does the operating area have adequate lighting?
2.5 Y N Does the operating area have adequate cabinets for non-pharms?
2.5 Y N Does the operating area have adequate sterile gloves?
2.5 Y N Does the operating area have a standard operating table?
2.5 Y N Does the operating area have an adequate functional anaesthetic machine?
2.5 Y N Does the operating area have adequate ambu-bags, both adult and paediatric?
2.5 Y N Does the operating area have adequate monitors?
2.5 Y N Does the operating area have adequate laryngoscopes?
2.5 Y N Does the operating area have adequate endotracheal tubes?
2.5 Y N Does the operating room have a functioning suction machine?
Does the operating room have adequate back-up oxygen, separate from anaesthetic
2.5 Y N
machines?
10 4. Staff requirements
5 Y N Are there at least three nurses (scrub, runner and anaesthetic nurse)?
5 Y N Are nurses skilled with peri-operative training?
10 5. Recovery room
3.3 Y N Does the recovery room have adequate lighting?
3.3 Y N Does the recovery room have a monitor?
3.3 Y N Does the recovery room have a drip stand?
20 B. Infection prevention and control
4 1. Hygiene protocol
2 Y N Is there a hygiene protocol?
2 Y N Does the hygiene protocol have a dedicated staff roster?
4 2. Hand washing
2 Y N Is a sink present with running water from a tap or modified storage container?
2 Y N Is soap available at the hand washing area?
4 3. Solid waste management
1.3 Y N Are there at least two color-coded bins (Red, black and/or yellow)?
1.3 Y N Are there coded lining bags that match the color of the bins?
1.3 Y N Are there standard operating procedures for waste management?
4 4. Use of disinfectants
2 Y N Is there evidence of disinfectant use?
2 Y N Are you able to observe disinfectant containers used for cleaning?
4 5. Protective equipment
1 Y N Are gloves available?
1 Y N Are gowns or dust coats available?
1 Y N Are face masks available?
1 Y N Are safety boots available?
100 TOTAL

Score, Score,
Section 9: Pharmacy Comments
max actual
20 A. General condition of premises
 1. Ventilation
10 Adequate ventilation is defined as at least 5% of the overall wall size of the room, or artificial ventilation. How well does this facility
satisfy this criterion?
0 Very dissatisfactory
3.3 Dissatisfactory
6.6 Satisfactory
10 Very satisfactory
2. Lighting
10
Adequate lighting is at least 10% of the overall size of the room. How well does this facility satisfy this criterion?
0 Very dissatisfactory
1.7 Dissatisfactory
3.3 Satisfactory
5 Very satisfactory

5 Y N Does the pharmacy have adequate space for staff movement in the dispensing area?
20 B. Storage and display of commodities
Does the pharmacy have secure, lockable cupboards for restricted drugs only accessible by
6.7 Y N
authorized persons (e.g. narcotics and psychotropics)?
6.7 Y N Are drugs stored and displayed to good standards?

6.7 Y N Are there standard operating procedures for the storage of medicines?
30 C. Record keeping and documentation
5 Y N Does the pharmacy have a well-explained system for recording prescriptions?
5 Y N Does the pharmacy have standard operating procedures for disposal of expired drugs?
5 Y N Is there a daily updated inventory system showing which commodities are available?
5 Y N Is there documentation showing where medicines are procured?
5 Y N Are there systems for documenting and feeding back medication errors?
5 Y N Are there separate records for narcotic and psychotropic medicines?
10 D. Reference materials and policies
5 Y N Does the pharmacy have reference materials for medicines (e.g. drug index)?
5 Y N Is the staff familiar with these reference materials?
20 E. Infection prevention and control
4 1. Hygiene protocol
2 Y N Is there a hygiene protocol?
2 Y N Does the hygiene protocol have a dedicated staff roster?
4 2. Hand washing
2 Y N Is a sink present with running water from a tap or modified storage container?
2 Y N Is soap available at the handwashing area?
4 3. Solid waste management
1.3 Y N Are there at least two color-coded bins (Red, black and/or yellow)?
1.3 Y N Are there coded lining bags that match the color of the bins?
1.3 Y N Are there standard operating procedures for waste management?
4 4. Use of disinfectants
2 Y N Is there evidence of disinfectant use?
2 Y N Are you able to observe disinfectant containers used for cleaning?
4 5. Protective equipment
1 Y N Are gloves available?
1 Y N Are gowns or dust coats available?
1 Y N Are face masks available?
1 Y N Are safety boots available?
100 TOTAL

Score, Score,
Section 10: Laboratory Comments
max actual
20 A. Policies, guidelines and SOPs
- 1. Laboratory license class:

5 2. Reporting procedures
 Does the laboratory have SOPs and guidelines for reporting lab procedures according to
2.5 Y N
license class?
2.5 Y N Are the SOPs and guidelines for reporting lab procedures displayed?
5 3. Handling, labeling and storage of specimen
Does the laboratory have SOPs and guidelines for handling, labeling and storage of
2.5 Y N
specimens?
2.5 Y N Are the SOPs and guidelines for handling, labeling and storage of specimens displayed?
5 4. Disposal of specimens
2.5 Y N Does the laboratory have SOPs and guidelines for disposal of specimens?
2.5 Y N Are the SOPs and guidelines for disposal of specimens displayed?
5 5. Standard quality operational manual

5 Y N Does the laboratory have standard quality operational manual (SOP of SOPs) available?
30 B. Equipment management program
10 1. Calibration and validation of equipment

5 Y N Does the lab have a system for regular calibration/validation of equipment available?
5 Y N Is the system for calibration/validation of equipment placed close to respective equipment?
10 2. Equipment maintenance documentation
5 Y N Does the laboratory have a systematic, well-documented equipment maintenance schedule?
5 Y N Are service contracts available for all lab equipment?
5 3. System for procurement of equipment
Does lab have a system for equipment procurement that is known by staff (one other staff to
5 Y N
explain to inspection team)?
5 4. Inventory of equipment
2.5 Y N Does the laboratory have a list of all equipment in use?
2.5 Y N Does the laboratory have a functional inventory management system?
10 C. Record keeping and documentation
Does lab have a records system integrated in the facility record system, i.e. Lab Information
10 Y N
Management System (LMIS)?
20 D. Quality control of tests
10 1. Quality control practices
1.7 Y N Are equipment registered, validated and calibrated?
1.7 Y N Is there documentation of quality control of tests?
1.7 Y N Is there a documented system for regular review and improvement of laboratory tests?
1.7 Y N Is there documentation of sample archiving, retrieval and disposal?
1.7 Y N Is Internal Quality Control (IQC) done regularly?
1.7 Y N Is the laboratory enrolled in External Quality Assurance?
10 2. Procurement and storage of reagents
5 Y N Does the laboratory have a functional temperature recording system in place?
Are standards for procurement and safe storage of reagents in place, including an inventory
5 Y N
of all reagents?
20 E. Infection Prevention and Control
4 1. Hygiene protocol
2 Y N Is there a hygiene protocol?
2 Y N Does the hygiene protocol have a dedicated staff roster?
4 2. Hand washing
2 Y N Is a sink present with running water from a tap or modified storage container?
2 Y N Is soap available at the handwashing area?
4 3. Solid waste management
1.3 Y N Are there at least two color-coded bins (Red, black and/or yellow)?
1.3 Y N Are there coded lining bags that match the color of the bins?
1.3 Y N Are there standard operating procedures for waste management?
4 4. Use of disinfectants
2 Y N Is there evidence of disinfectant use?
2 Y N Are you able to observe disinfectant containers used for cleaning?
 4 5. Protective equipment
1 Y N Are gloves available?
1 Y N Are gowns or dust coats available?
1 Y N Are face masks available?
1 Y N Are safety boots available?
100 TOTAL

Score, Score,
Section 11: Radiology Comments
max actual
35 A. Radiation protection
10 1. Personal radiation dose monitoring
Are personal radiation dose monitoring badges worn daily and evaluated monthly by the
10 Y N
Radiation Protection Board?
5 2. Radiation safety service provider
Does the facility have records confirming that there is a radiation safety service provider for
5 Y N
monitoring?
5 3. Adequate number of lead aprons
Is there an adequate number of lead aprons, i.e. a minimum of three: one each for the
5 Y N
patient, patient-guardian and radiographer?
5 4. Radiological examination in pregnancy
5 Y N Is a code of practice for pregnant women available and producible?
10 5. Quality assurance of image processing

Is there evidence of quality assurance of the image processing system (it may be digital,
10 Y N
automatic or manual)?
25 B. Policies, SOPs and registers
5 1. Policies, SOPs and code of practice
1.7 Y N Are standard operating procedures available for radiology and imaging services?
1.7 Y N Is there evidence that they have been reviewed in the past year and reviewed annually?
1.7 Y N Is a code of practice displayed next to the respective device?
5 2. Reporting, testing and calibration
5 Y N Is reporting, testing and calibrating up to date and displayed?
5 3. Register of eradiating activities
5 Y N Is there a register of eradiating activities and a monthly dose report for workers?
10 4. Quality assurance program
2.5 Y N Is there a quality assurance program?
Does the quality assurance program include safety of the patient, worker, environment,
2.5 Y N
security and film storage?
2.5 Y N Is there a designated or appointed quality assurance staff member in the facility?
2.5 Y N Is there updated annual documentation for quality assurance procedures?
C. Radioactive waste management
(For these questions, if the facility produces radioactive waste, then use the scores indicated below for each question. The maximum
20
score for this set of questions is 20. If the facility does not produce radioactive waste, then score the full section (Section 11) out of a
maximum total score of 80.)
10 1. Personal safety measures
5 Y N Does the facility produce radioactive waste?
Are patient and staff safety measures implemented alongside routine waste
5 Y N N/A
management tasks?
5 2. Radioactive waste management programs in place
2.5 Y N N/A Is there designated staff in charge of radioactive waste management?

2.5 Y N N/A Are there records showing that radioactive waste management systems are in place?

5 3. Designated staff for radioactive waste management programs

Does the facility have designated personnel to oversee radioactive waste
5 Y N N/A
management programs?
20 D. Infection prevention and control
5 1. Hygiene protocol
2.5 Y N Is there a hygiene protocol?
 2.5 Y N Does the hygiene protocol have a dedicated staff roster?
5 2. Hand washing
2.5 Y N Is a sink present with running water from a tap or modified storage container?
2.5 Y N Is soap available at the handwashing area?
5 3. Use of disinfectants
2.5 Y N Is there evidence of disinfectant use?
2.5 Y N Are you able to observe disinfectant containers used for cleaning?
5 4. Protective equipment
1.25 Y N Are gloves available?
1.25 Y N Are gowns or dust coats available?
1.25 Y N Are face masks available?
1.25 Y N Are safety boots available?
100 TOTAL

Score, Score,
Section 12: Nutrition and Dietetics Service Unit Comments
max actual
17 A. Nutrition equipment, Tools and Supplies
7 1. Nutrition equipment and tools
1 Y N Is a functional calibrated weighing scale available?
1 Y N Is a stadiometer available?
1 Y N Are Mid-Upper Arm Circumference (MUAC) tapes available?
1 Y N Is a waist circumference tape available?
1 Y N Is a functional blood pressure machine available?
1 Y N Is a functional glucometer available?
1 Y N Are reference charts available?
10 2. Food supplies, formulations and Nutrition supplements
1 Y N Is food store available with evidence of regular stock replenishment
1 Y N Are ‘Ready to Use Therapeutic Foods’ (RUTF) available and accessible?
1 Y N Are ‘Ready to Use Supplementary Foods’ (RUSF) available and accessible?
1 Y N Are the F75 and F100 diet milks available and adequate for clients?
1 Y N Are food fortifiers available and acceptable?
Are nutrition formulations for specialized nutrition support available and accessible when
1 Y N
needed?
1 Y N Are Vitamin A Supplements available for children and expectant mothers?
1 Y N Are iron supplements available in the acceptable form?
1 Y N Are folate supplements available in the acceptable form?
1 Y N Is zinc supplement available?
16 B. SOPs for nutrition care processes and other services
2 Y N Are there SOPs for comprehensive nutritional assessment?
2 Y N Are there adequate guidelines for nutritional diagnosis?
2 Y N Are there guidelines for choice of appropriate nutrition care intervention?
2 Y N Are there adequate guidelines for monitoring patient care?
2 Y N Are there adequate SOPs for food formulations?
2 Y N Are there adequate SOPs for food supplementation?
2 Y N Are SOPs reviewed and regularly updated (within a 5-year framework)?
2 Y N Are staff familiar with the SOPs and guidelines?
10 C. Record keeping and documentation
2.5 Y N Is the system for record keeping linked to the facility information management system?
2.5 Y N Is there a designated person aware of the documentation processes?
2.5 Y N Is there security for the information in the system?
2.5 Y N Is there a documented plan for regular updating?
20 D. Patient feeding
16 1. Inpatient feeding
2.3 Y N Is there an inpatient feeding committee?
 Does the composition of the committee include qualified nutritionist and dieticians licensed
2.3 Y N
by the Kenya Nutritionists and Dieticians Institute (KNDI)?
2.3 Y N Is there a comprehensive protocol for inpatient feeding?
2.3 Y N Is there a food inspection committee with at least one licensed nutritionist?
2.3 Y N Is there a communication link between patients in the ward and the food preparation unit?
2.3 Y N Are there food modification schemes for groups with special needs?
2.3 Y N Is there an option for patients to choose from available sources of foods?
4 2. Maternity feeding
2 Y N Are postpartum mothers fed on an appropriately tailored diet?
2 Y N Is breastfeeding initiated within one hour after delivery?
17 E. Food Preparation Unit
6 1. Kitchen equipment and fuel
1 Y N Is a functional blender available?
1 Y N Is a functional mincer available?
1 Y N Is a functional food weighing scale available and regularly calibrated?
1 Y N Are measuring jars available?
1 Y N Are food trolleys available?
1 Y N Are reliable sources of fuel available?
5 2. Food Preparation Unit layout
1 Y N Is the layout and physical structure of the kitchen adequate?
1 Y N Is a diet therapy kitchen available and separated from normal food kitchen?
1 Y N Is a mini store available in the kitchen for food from the main store?
1 Y N Does the paediatric ward have room to prepare special food?
1 Y N Is there adequate space for storage of food commodities?
6 3. Kitchen personnel
3 Y N Are kitchen personnel qualified caterers and trained cooks?
3 Y N Is the supervisor qualified and licensed by the Nutritionist and Dieticians Institute (KNDI)?
20 F. Infection prevention and control
4 1. Hygiene protocol
2 Y N Is there a hygiene protocol?
2 Y N Does the hygiene protocol have a dedicated staff roster?
4 2. Hand washing
2 Y N Is a sink present with running water from a tap or modified storage container?
2 Y N Is soap available at the hand washing area?
4 3. Solid waste management
1.3 Y N Are there at least two color-coded bins (Red, black and/or yellow)?
1.3 Y N Are there coded lining bags that match the color of the bins?
1.3 Y N Are there standard operating procedures for waste management?
4 4. Use of disinfectants
2 Y N Is there evidence of disinfectant use?
2 Y N Are you able to observe disinfectant containers used for cleaning?
4 5. Protective equipment
1 Y N Are gloves available?
1 Y N Are gowns or dust coats available?
1 Y N Are face masks available?
1 Y N Are safety boots available?
100 TOTAL

Score, Score,
Section 13: Mortuary Comments
max actual
20 A. SOPs for body processing
4 Y N Are there standard operating procedures for receiving bodies?
4 Y N Are there standard operating procedures for identifying bodies?
4 Y N Are there standard operating procedures for storage of bodies?
 4 Y N Are there standard operating procedures for release of bodies, including solid disposal?
4 Y N Are there standard operating procedures for disposal of bodies and body parts?
40 B. Equipment, materials and utilities
10 1. Water and toilets
3.3 Y N Does the mortuary have clean, running water from a tap or container?
3.3 Y N Does the mortuary have access to clean toilet facilities?
3.3 Y N Is a cleaning roster displayed at the toilet facilities?
20 2. Coolers and embalming mechanisms
20 Y N Is the system for preservation of bodies functional (e.g. coolers or formalin technology)?
10 3. Mortuary equipment
5 Y N Is there a body trolley available?
5 Y N Is there a dissecting kit available?
20 C. Mortuary environment and security
10 1. Internal mortuary environment
5 Y N Does the mortuary have a working drainage system?
5 Y N Is the odor from the mortuary reaching patient areas and the public?
10 2. Mortuary location and security
5 Y N Is the mortuary accessible by vehicle for the public?
5 Y N Are there adequate security measures (e.g. locking mechanism, guards)?
20 D. Infection prevention and control
4 1 Hygiene protocol
2 Y N Is there a hygiene protocol?
2 Y N Does the hygiene protocol have a dedicated staff roster?
4 2. Hand washing
2 Y N Is a sink present with running water from a tap or modified storage container?
2 Y N Is soap available at the hand washing area?
4 3. Solid waste management
1.3 Y N Are there at least two color-coded bins (Red, black and/or yellow)?
1.3 Y N Are there coded lining bags that match the color of the bins?
1.3 Y N Are there standard operating procedures for waste management?
4 4. Use of disinfectants
2 Y N Is there evidence of disinfectant use?
2 Y N Are you able to observe disinfectant containers used for cleaning?
4 5. Protective equipment
1 Y N Are gloves available?
1 Y N Are gowns or dust coats available?
1 Y N Are face masks available?
1 Y N Are safety boots available?
100 TOTAL
Section 14: Findings and Recommendations

A. Registered owner of the facility

Name: Designation:
Phone number: Email:
Date: Signature:
B. Inspections team
Name Health Regulatory Authority Designation Signature

C. Findings and recommendations

Health Facility Score Summary Table
Sections
Section Max Score
Completed Total Score
Section Title (Enter max potential score
Number (Tick all completed
in “Total” row)
(Enter actual scores)
sections)

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
Radiology
Section 11 (If the facility does not produce radioactive waste, the 100/80
maximum score for this section is 80.)
Section 12 Nutrition and Dietetics Services Unit 100
Section 13 Mortuary 100
Section 14 Findings and Recommendations -
Total

Overall facility score (numerator): _____________________________________________________________________ [__|__]

Maximum score possible (denominator): ________________________________________________________________ [__|__]

Percent score of the facility (Numerator/Denominator): ____________________________________________________ [__|__]

Risk category of the facility (see risk rating table below for guidance): [_____________________________________________]
Notes on Findings:
Recommendations

Recommended action: incentive or warning/sanction (see risk rating table below for guidance):

[________________________________________________________________________________________]

Notes on recommendations:

Risk rating table to guide decisions on risk categorization of facilities, and accompanying recommended actions
Facility score (% of maximum
Compliance category Warning/sanction/reward
score)

Close facility.
Recommend prosecution where requisite registration and licensing
is absent (as specified by the respective legislation)
0-10% *(or absence of licenses) Non-Compliant
Closed facilities that have a license, may ask for a re-inspection after
corrections for purposes of reopening and re-categorization, subject
to the criteria established by the competent authority.

3-month notice for correction + re-inspection

Facility will be closed if it does not score over 40% of the maximum
11-40% Minimally compliant score in the 3rd inspection.
Facility may ask for re-inspection for purposes of re-categorization
after corrections

6-month notice for correction + re-inspection

Facility will be closed if it does not score over 60% of the maximum
41-60% Partially Compliant score in the 3rd inspection.
Facility may ask for re-inspection for purposes of re-categorization
after corrections

12-month notice for correction + re-inspection

61-75% Substantially Compliant Facility may ask for re-inspection for purposes of re-categorization
after corrections

>75% Fully Compliant No re-inspection for two years

* Other incentives under consideration include client signaling (quality mark and/or SMS feedback mechanism) and insurance recommendation