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Food, Medicine, Health care Administration and Control Authority

(EFMHACA)
Medium clinic Assessment checklist
The checklist is prepared using the basic components of the regulatory standard, the 4Ps- Practice,
Premises, Professional and Products. The checklist is prepared with an open ended question. Answers
to these questions should be clear and precise.

General Instruction: The team leader shall introduce the team to the head of the facility and briefly
explain the purpose of the visit. To use time efficiently, the team can do the assessment in sub groups
once relevant information is collected. Finally at the end of the visit the team will do Exit Briefing and
collect recommendations.

1. General Information: [Ask CEO/director]


 Region/ Zone/ City: _____________________________________________________
 Name of facility: _______________________________________________________
 Type of Facility: _______________________________________________________
 Facility Address:
o Telephone: _______________________________________________________
o Fax: ____________________________________________________________
o P.O.Box: _________________________________________________________
o E-mail: __________________________________________________________
 Catchment population: _________________________________________________
 Annual patient Load : __________________________________________________

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1. Governance
S. Compliance status Standard to be addressed Remark Score
N
Met Partially Un Practice
met met
1. Technically the medium clinic shall be led/ managed by the Licensee, Critical
i.e., technical manager
2. The medium clinic shall submit periodic reports to the respective Minor
organs to which it is responsible
3. The head of the clinic or the Licensee shall be responsible for: Critical
a) The protection of patients’ health, safety, and well- being;
b) Meeting patient needs;
c) Reporting information on suspect of abuse, neglect and
exploitation for children & people with mental incompetence;
d) Meeting regulatory standards and other relevant laws
e) Responding to reports from the appropriate regulatory body;
f) Total administration of the clinic
2. General outpatient Medical Practices
S. Compliance status Standard to be addressed Remark Score
N
Met Partially Un Practice
met met
1. The medium clinic Provide outpatient care (diagnosis & treatment) for Critical
ambulatory patients
2. Provide outpatient care for ambulatory patients: diagnosis & treatment Critical
of acute conditions
3. Provide assessment, diagnosis, follow up & referral of ambulatory Critical
patients with common and chronic conditions including TB, HIV to
appropriate level
4. Provide basic MCH services: ANC, identifying high risk pregnancy & Critical
referral, post natal care
5. Preventive and health promotive services for patients attending the Critical
clinic
6. The general medical service shall be available in working days for at Critical
least eight hours a day during regular working hours
7. The medium clinic shall have clinical protocols for management of at Minor
least common disease entities like malaria, hypertension and locally
significant diseases
8. The medium clinic shall have clinical protocols for management of Minor
common dental, eye, ENT and mental health problems in line with the
national and or international guidelines
9. The general medical service shall have functional referral system Minor
10. The medium clinic shall have a system to report diseases under Minor
national surveillance to the sub-city/woreda/town health offices

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Minor Surgical service Practice
11. The Medium clinic shall provide minor surgical services for the Major
following conditions:
a) Circumcisions, 
b) Lipoma and simple cyst excisions,
c) abscess drainages,
d) suturing of lacerated wounds ,
e) external immobilization of closed and open fractures,
f) foreign body removal and
g) other minor interventions under local anesthesia
12. The medium clinic shall have clear protocol for minor surgical Minor
procedures to be done at outpatient level
13. Surgical interventions shall be recorded for each patient and Critical
documentation shall be integrated with the patient's medical record
14. There shall be processes and procedures that ensure that minor Minor
surgical procedures shall be done under aseptic technique
15. The medium clinic shall have a copy of management protocols at Minor
least for the following:
a) Acute burn management
b) pain management
c) emergency or acute trauma management
d) emergency resuscitation(CPR)
16. There shall be a written policy about administration of local anesthesia Minor
in the medium clinic
Nursing care service practices
17. Written copies of nursing procedure manual shall be available to the Minor
nursing staff. The manual shall be used at least to:
(a) Provide a basis for induction of newly employed nurse(s),
(b) Provide a ready reference on procedures for all nursing personnel.
(c) Standardize procedure and practice.
(d) Provide a basis for continued professional development in nursing
procedures/techniques
18. The medium clinic shall have established system for verbal and Major
written communication about patient care that involves nurses
Allergies shall be listed on the front cover of the patient's chart or in a Major
computerized system, highlighted on the screen
19. There shall be a procedure for standardized, safe and proper Minor
administration of medications by nurses or designated clinical staff
including proper documentation
Emergency service Practices
20. The emergency service shall be available during the regular working Critical
hours of the medium clinic (working hours of the country)
21. Examination room(s) shall be ready and accessible for emergency at
all times
22. The emergency service shall provide basic life support as indicated for Critical
any emergency cases, which may include one or all of the
followings :
a) Airway management,
b) Bleeding control

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c) Fluid resuscitation
d) Cardiopulmonary resuscitation (CPR)
23. There shall be a written protocol for emergency services and the Minor
provision of this service shall be done in accordance with the clinical
protocols of the service
24. Protocols for initial management of at least the following emergency Minor
cases:
(a) Shock (i) Cereberovascular
(b) Severe Bleeding accident
(c) Fracture and injuries (j) Acute diarrhea ( Severe
(d) Coma dehydration )
(e) Burn (k) Acute abdomen
(f) Poisoning (l) Tetanus
(g) Seizure disorder (m) Meningitis
(h) Hypertension emergencies (n) Severe & complicated
malaria

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Delivery and MCH service practices
26. The medium clinic shall provide delivery service for spontaneous Critical
normal deliveries
27. Except outlet forceps, assisted deliveries are prohibited in medium Critical
clinic
28. The medium clinic shall provide MCH services that include ANC, Major
PNC, Family Planning, Growth monitoring, VCT and PMTCT
services being compliant with the current guidelines prepared for the
respective services
Pharmaceutical service Practices
29. Medium clinics shall have emergency medicines at all times Critical
30. It is prohibited to hold or dispense non-emergency medicines in these Critical
health facilities at any time
31. These health facilities are not allowed to hold or dispense any donated Critical
medications without prior permission of the Authority
32. Emergency medications shall be prescribed by an authorized Don’t
prescriber and administered by nursing personnel with adequate score
information and counseling to the patient or care giver
33. The health facility shall be responsible to report suspected ADR cases Major
to the Authority and all adverse medication effects shall be noted in
the patient’s medication record
34. These health facilities shall keep medication records for emergency Major
medicines which contains at least
a) Name of patient, sex, age and medical record number,
b) Diagnosis and allergy, if any,
c) Name of the drug, strength, dosage form and total dose given and
route of administration,
d) Date dispensed,
e) Prescriber’s name, qualification and signature,
f) Prescriber’s address (name and address of health facility)
35. Disinfectants and other chemicals shall be stored separately from Critical
emergency medicines
36. Medicines shall be kept in a secured, clean, ventilated cabinet and in Major
accordance with the manufacturers’ recommendation for storage
conditions
37. These health facilities shall manage and dispose medicines waste in Minor
accordance with the directive issued by the Authority
Met Partially Un Premises
met met
38. The medium clinic shall have a minimum of 12 rooms. Major
39. The medium clinic facility shall have dedicated territory or compound Minor
with entrances and secured from stray animals
40. The medium clinic facilities shall be well marked and easily Major
accessible for persons with disability
41. The medium clinic shall have IEC and entertaining materials in the Minor
waiting area
42. The medium clinic shall have hand washing basin at patient care Major
rooms (Examination room(s), treatment room, Laboratory, toilet room,
Delivery room if any)
43. The Internal surfaces of the clinic, i.e. of floors, walls, and ceilings Major
shall be:

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 Smooth, impervious, free from cracks, recesses, projecting
ledges and other features that could harbor dust or spillage
 Easy to clean and decontaminate effectively
 Constructed of materials that are non-combustible or have
high fire-resistance and low flame-spread characteristics
44. Potential source of accidents shall be identified and acted upon Critical
(slippery floors, misfit in doorways and footsteps etc)
45. The corridor to examination rooms shall not be less than 1.2m, to Major
allow easy transport of emergency patients
46. Premises required No. of Area required Major
rooms
required
Reception, Registration/ 1 16 sq. m
Recording & Waiting area
Examination room 1 12 sq. m
Laboring, Delivery and Postnatal 3 27 sq.m
rooms
MCH room 1 9 sq.m
Treatment/ procedure/ injection 1 12 sq. m
room,
Laboratory room 1 20 sq. m
X-ray room as per ERPA
requirements(optional)
Emergency resuscitation room 1 16 sq. m
with two beds
Instrument processing room 1 12 sq. m
Staff room 1 9 sq. m
Toilet (Male &Female) 2 8 sq. m
Incinerator
Area for placenta pit
Met Partially Un Professional
met met
47. The medium clinic shall be directed by a licensed Critical
a) General Practitioner with a minimum of 3 years of experience or
b) Generic Health officer or generic BSc Nurse with a minimum of 5
years of experience or
c) Nurse practitioner or post basic BSC nurse or Post basic Health
Officer with a minimum experience of 3 years. These
professionals shall have two years relevant work experience
before joining the Post basic BSc program
48. There shall be written discrete job descriptions that detail the roles and Minor
responsibilities of all clinic personnel
49. Staffs required # required Critical
 GP or HO or Nurse Practitioner or BSc Nurse 1
 Nurse, Diploma 2
 Midwife 1
 Laboratory technician 2
 Radiology professional or Radiographer 1

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 Receptionist 1
 Cleaner 1
Met Partially Un Products
met met
50. Medium clinic shall have the following equipments and supplies Major
a) Diagnostic Equipments d) Instruments
 Stethoscope  Dressing set
 Sphygmomanometer  Minor surgical set
 Thermometer  Delivery set
 Weighing scale  Enema set
 Infanto-meter and height  Specula of different
scale sizes
 Otoscope  Pickup forceps with jar
 Ophthalmoscope  Sterilization drums
 Reflex hammer  Kidney dishes
 Fetosthetoscope  Instrument tray
 Snellen`s Chart  Instrument trolley
 Tuning fork, 500 Hz  Ear irrigation syringe
b) Delivery Equipment  Packing nasal forceps,
 Suction machine  Steri-strip for steam
 Delivery coach autoclave
c) Others  Lumbar puncture set
 Tourniquet (optional)
 Drapes  IV Infusion stand
 Surgical cape e) Medical Equipment
 Surgical mask  Mobile examination
 Kick buckets lamp
 Tongue depressors  Examination couches
 Cabinets and shelves  Sterilizer (steam and/ or
 Time clock dry)
 Refrigerator #2, (LAB &
Treatment room

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3. Laboratory service
S. Compliance status Standard to be addressed Remark Score
N
Met Partially Un Practice
met met
1. Medium clinic shall have a laboratory service during working hours Critical
2. The following list of lab tests shall be available in the medium clinic Major
a) HEMATOLOGY d) CLINICAL
 White blood cell count CHEMISTRY
 Hemoglobin  Glucose
 Hematocrit  Uric Acid
 Differential count  Creatinine
 Hemoparasite  Urea/ BUN
 Platelet  Alkaline
 Erythrocytic Sedimentation Phosphatase
Rate (ESR)  Aspartate
 RBC morphology Aminotransferase(
 Blood group & Rh AST)
b) URINE AND BODY FLUID  Alanine
ANALYSIS Aminotransferase
 Urine analysis Qualitative (ALT)
 Urine Microscopy  Bilirubin, Direct
 Pregnancy test  Bilirubin, Total
c) SEROLOGICAL TESTS e) PARASITOLOGY
 Widal-weli fliex  Direct Stool
 HBsAg Examination
 RPR/ VDRL (syphilis) f) BACTERIOLOGICAL/
FUNGAL
 HIV Ab test (According to the
EXAMINATION
national algorithm
 Gram Stain
 AFB Stain
 KOH
 Wet mount

4. All equipment in the laboratory of medium clinic shall be in good Critical


working order, routinely quality controlled, and precise in terms of
calibration
5. The laboratory shall have written policies and procedures and include Major
at least the followings:
a) Procedure manuals (Standard Operating Procedure, SOP)
b) Report times for results (Established turnaround time),
c) Quality assurance and control processes,
d) Inspection, maintenance, calibration, and testing of all
equipment,
e) Management of reagents:

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f) Procedures for identifying, collecting, processing and
disposing of specimens,
g) All normal ranges for all tests shall be stated,
h) Laboratory safety program:
i) Documentation of quality control data:
6. The laboratory shall have procedures or (SOP) for proper specimen Major
collection
7. There shall be SOP or criteria developed for acceptance or rejection of Major
clinical samples
8. The laboratory shall maintain a record of all samples received Critical
9. Requests for testing shall provide: Major
a) The name of the ordering physician or other person
authorized to order testing,
b) Address of the clinic,
c) Type of sample collected,
d) The anatomic site where appropriate
e) The test requested
f) Patient ID, name, age and sex
g) Clinical Diagnosis: Pertinent clinical information as
appropriate for purposes of test interpretation
h) Date and time of sample collection and receipt in the laboratory
Met Partially Un Premises
met met
10. The medium clinic shall have 1 room with 20 sq. m for basic Major
laboratory service with the necessary space, facilities and equipment
to perform tests.
a) Reception desk with patient waiting area (5 sq. m)
b) Bacteriology, Parasitological and urinalysis section (5 sq. m)
c) Hematology, serology section (5 sq. m)
d) Working area (5 sq. m)
11. The laboratory shall provide safety, adequate lighting, ventilation, Critical
waste and refuse disposal system
12. There shall be cupboard for reagents that shall be kept at room Major
temperature
Met Partially Un Professional
met met
13. The laboratory of medium clinic shall be directed by a licensed Critical
medical Laboratory Technician with 3 years of relevant experience
14. The Medical Laboratory technician shall have a written job Minor
descriptions
Met Partially Un Products
met met
15. The following minimum equipments shall be available Major
 Binocular Microscope #1,  Slides,
 Chamber #1,  Cover Slides,
 Differential counter #1,  Reagents,
 Tally counter #,  Dry oven/ autoclave
 Centrifuge #, (can be shared with
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 Timer #2, general clinic service)
 Refrigerator with  Spectrophotometer
thermometer #1, (semi automated)
 Test tube rack #5,  Shacker #1
 ESR rack of five #2,  Roller #1
 ESR tubes #12,  Water bath #1
 Spirit lamp #1

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Radiography imaging services, Optional
S.N Compliance status Standard to be addressed Remark
Met Partially Un Practice
met met
The medium clinic may have X-Ray service
1. The X-Ray service shall have written policies and procedures Minor
which shall include at least:

a) X-Ray Safety practices;


b) Management of the critically ill patient during
imaging procedures;
c) Infection control, including patients in isolation;
d) Timeliness of the availability of diagnostic imaging
procedures and the results;
e) Quality control program covering the inspection,
maintenance, and calibration of all equipment
2. There shall be a written protocol for managing medical Minor
emergencies in the radiological suite
3. Proper safety precautions shall be maintained against fire and Critical
explosion hazards, electrical hazards, and radiation hazards
4. The Medium clinic shall post in easily accessible place all the Major
necessary signs & the approval certificate from the Ethiopian
Radiation Protection Authority through periodic inspection
5. The medium clinic shall make sure that the radiographer(s) put Major
on personal TLD whenever on operating the radiation emitting
machines
6. The medium clinic X-Ray unit shall keep documentation of the Minor
report for periodic readings of employee’s exposure for
radiation by the use of exposure meters or badge tests
7. X-Ray results films shall be labeled with minimum Critical
information that includes: date, patient’s name, age, sex,
location marks (L/R), name of institute and name of radiology
professional /radiographer
Met Partially Un Premises
met met
8. The premise for X-Ray service shall fulfill the ERPA Critical
requirements & be functional only if licensed/ certified by
ERPA
Met Partially Un Professional
met met
9. The medium clinic shall have a radiology Critical
professional/Radiographer
Met Partially Un Products
met met
10. Imaging equipments which shall be available for x-Ray Critical
services at Medium clinic are indicated below
a) Standard conventional x-ray machine,
b) X-Ray viewing boxes,
c) Radiation protection equipments:

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 lead gloves,
 lead apron
 lead goggle,
 gonad shields
d) Dark room film processing baths if necessary
e) Drier (optional
11. The X-Ray machine shall be regularly inspected, maintained, Critical
and calibrated by licensed organ or ERPA; appropriate records
of maintenance shall be maintained
12. All radiation generating equipments shall be installed within a Critical
room/ building with wall thickness that protects radiation to the
surroundings, i.e., the minimum criteria set by the Ethiopian
Radiation Protection Authority / International Atomic Energy
Agency (IAEA)

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Housekeeping and Maintenance Services
S.N Compliance status Standard to be addressed Remark Score
Met Partially Un Practice
met met
1. The housekeeping service shall have the following activities. Major
a) Basic cleaning such as dusting, sweeping, polishing and
washing
b) Special cleaning of
 Different types of floors
 Wall & ceiling
 Doors & windows
 Furniture & fixtures
 Venetian blinds
c) Cleaning and maintenance of toilet.
d) Water treatment, filtering & purification
2. Maintain an adequate supply of clean white coat and guans at Major
all times
3. There shall be reserve electrical generator for power supply for Don’t
continuous 24 hours score
4. Potable water and electrical services shall be available 24 Don’t
hours a day and 365 days a year through regular or alternate score
sources
5. The maintenance personnel including the management of the Minor
clinic shall take basic trainings on the following issues and this
shall be documented.
a) Building fabrics and utilities
b) Building services and economics
c) Planning maintenance demand
d) Preventive and routine maintenance practice
e) Maintenance with regard to IP and hygiene
6. If the clinic does not have its own housekeeping and Minor
maintenance services; it may have a contract agreement with
external organizations
Met Partially Un Premises
met met
7. There shall be separate space provided for the storage of Minor
housekeeping equipment and supplies
8. Office shall be available for the maintenance and the Don’t
housekeeper score
9. Adequate space shall be available for janitor’s closets and Minor
cleaning equipment & supplies
Met Partially Un Professional
met met
10. The designated officer shall plan, organize, co-ordinate, Minor
control and monitor all housekeeping and maintenance
activities
11. In summary, if the service is not outsourced, the clinic shall Don’t
have score
a) Designated personnel for housekeeping,
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b) General maintenance personnel (electrician, plumber,
painter, building maintenance technician and
c) Biomedical equipment maintenance technician
Met Partially Un Products
met met
12. There shall be appropriate tools and testing equipments for Minor
medical equipment maintenance, calibration and validation
13. The clinic shall have the following tools, equipment & Major
materials for housekeeping services
a) Reserve electrical generator r) Plastic Bucket
b) Floor cleaning brush air s) Plastic drum
c) Floor wiping brush t) Wheel barrow
d) Hockey type brush u) Water trolley
e) Counter brush. v) Ladder
f) Ceiling brush w) Scraping pump
g) Glass cleaning / wiping brush. x) Spraying pump
h) Scrappers y) Flit pump.
i) Dustbins paddles. z) Rate trapping
j) Waste paper basket. cage
k) Plastic Mug aa) Gum boots
l) Floor scrubbing/polishing bb) Gown, Masks &
machine Gloves
m) Wet vacuum cleaner. cc) Torch
n) Dry vacuum cleaner portable dd) Manual sweeping
o) Fumigation machine (Oticare) machine
p) Insecticides & rodenticides ee) Bed pan washer.
q) Stain removal ff) Cleaning material
gg) Deodorants &
disinfectant
hh) Laundry cleaning
material

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Infection Prevention
S.N Compliance status Standard to be addressed Remark Score
Met Partially Un Practice
met met
1. All activities performed for infection prevention shall comply Critical
with the national infection prevention guidelines
2. The following written policies and procedures shall be Minor
maintained:
a) Hand hygiene
b) Transmission-based precautions
c) Post-Exposure Prophylaxis programming (PEP) for some
communicable diseases like rabies, HIV, meningitis
d) Environmental infection prevention
e) Waste management
3. There shall be transmission-based precautions and the medium Minor
clinic shall have its own guideline for the followings:
a) Contact precautions
b) Droplet precautions
c) Airborne precautions (for diseases like SARS ,TB, Swine
flu, etc)
4. Each medium clinic site shall train all staff on how to minimize Minor
exposure to blood-borne diseases
5. The infection prevention committee or designate shall have Don’t
written protocols, procedures score
6. The medium clinic shall provide regular training on infection Minor
prevention and control practice to staff, patients and as
appropriate, to family and caregivers
7. The medium clinic shall have procedures in place to minimize Don’t
crowding and manage the flow of visitors score
Met Partially Un Premises
met met
8. The medium clinic shall have a dedicated office for IP officer Minor
9. The medium clinic shall have a room or area for temporary Critical
storage of waste containers
10. The medium clinic shall have a centralized sterilization room Critical
11. Medium clinic shall have incinerator with ash and burial pits Critical
Met Partially Un Professional
met met
12. The medium clinic shall have a designated staff to serve as IP Minor
infection prevention and control officer
13. The officer shall be IP trained nurse and knowledgeable of Minor
infection prevention principles and health care epidemiology
Met Partially Un Products
met met
14. The medium clinic shall have the following adequate supplies Major
and equipment needed for infection prevention and control
practice
a) Waste management equipment d) Cleaning
and supplies  Mop

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 Safety boxes  Bucket
 Garbage bins  Broom
 Wheelbarrows  Dust mop
 Large garbage bin  Cleaning cloth
 Plastic garbage bags  Detergent
b) Instrument processing:  Bleach
 Autoclaves and steam e) Personal
sterilizers Protective
 Test strips Equipment
 Boiler  Heavy duty
 Oven glove
 Storage shelves for the  Surgical glove
medical equipme Chemicals  Latex or Nitrile
& disinfectants: 0.5% glove
chlorine solution (diluted  Eye shield
bleach)  Goggle
 Brushes (tooth brush for  Visors
small items)  Dust mask
c) Hand hygiene  Respirator
 Sinks (ward & other areas) Other types of
 Water container with faucet face mask
 Soap dispenser  Plastic apron
 Alcohol based hand rub  Other types
 Personal Towels  Boots
 Other
protective shoes
 Caps
 Face shield
 mask

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Sanitation and Waste Management
S.N Compliance status Standard to be addressed Remark Score
Met Partially Un Practice
met met
1. There shall be written procedures to govern the use of Minor
sanitation techniques in all areas of the medium clinic
2. Infectious medical wastes shall be handled and managed Critical
according to the recent Health Care Waste Management
National Guideline
3. Infectious and non infectious medical waste containers shall be Critical
leak proof, have tight-fitting covers and be kept clean and in
good repair until disposal.
4. Placenta disposal pit shall be available in the clinic and shall Critical
be secured
5. Wastes shall be segregated and segregation of healthcare waste Critical
shall include the following procedures,
a) Separate different types of waste
b) The hospital shall provide colored waste receptacles
specifically suited for each category of waste
c) Segregation shall take place at the source, like ward
bedside, OR, laboratory etc
d) There shall be 3 bin systems used to segregate different
types of waste in the hospital
6. All generators of infectious medical waste and general medical Major
waste shall have a medical waste management plan that shall
include the following:
a) Storage of medical waste
b) Segregation of medical waste
c) Transport of medical waste
d) Disposal of medical waste
Met Partially Un Premises
met met
7. The medium clinic sanitary system shall have: Major
a) Adequate flushing toilets and hand washing basins,
b) Plumbing setup stores,
c) Sanitary office,
d) Incinerator (if it is allowed to this clinic by the national
waste management and disposal directives),
e) Plot of land for Safe ash pit, Burial pit, Garbage bins,
f) Secured area for solid waste accumulation
Met Partially Un Professional
met met
8. The medium clinic shall officially designate staff in charge of Minor
handling waste on a regular basis
9. In addition, the medium clinic shall have: Major
a) Housekeeping staff such as cleaners and waste handlers,
b) Gardeners,
Met Partially Un Products
met met

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10. The medium clinic shall have the following equipment and Major
supplies required for sanitation activities but not limited to:
a) Incinerator
b) Safety boxes
c) Leak proof containers for waste
d) Trolley to transport waste
e) PPE (personal protective equipments)
f) Autoclave.
g) Pressure cooker/dry oven.
h) Cleaning supplies (detergents, disinfectants and other
cleaning solutions etc).
i) Mops and dust bins

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1. I confirm that the above filled information/data is true about the facility.
Name of CEO/CCO _____________________________________________________________

Signature ____________________________ Date ____________________________________

2. Assessors inspection comment _________________________________________________


_________________________________________________________________________________
_________________________________________________________________________________
_______________________________________________________________

3. Name of Assessors:
S.N Name Title Sign

1.
2.
3.
4.

Finally, at the end of the visit, thank the management body and all staff who participated in the interview
for their valuable time and comment. Present warm greetings.

NB: This checklist is prepared based on the new medium clinic standard, but it doesn’t represent the
minimum requirement of the medium clinic so that you don’t only stick on this checklist you
better also use the print out medium clinic standard as a reference during training and
assessment.

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