CES 308 Compulsory

Ethiopian Standard
Second Edition
11-02-2022

Primary Hospital - Requirements

ICS: 11.020
Published by Ethiopian Standards Agency
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TABLE OF CONTENTS

Contents
FOREWORD ........................................................................................................................................... iii
1. SCOPE............................................................................................................................................ 1
2. NORMATIVE REFERENCES........................................................................................................... 1
3. TERMINOLOGIES AND DEFINITIONS ............................................................................................ 1
4. GENERAL REQUIRMENTS............................................................................................................. 1
5. SPECIFIC REQUIRMENTS ............................................................................................................. 1
5.1. OUTPATIENT SERVICES............................................................................................................ 1
5.2. INPATIENT SERVICES ............................................................................................................... 6
5.3. MATERNAL AND CHILD HEALTH (MCH) AND DELIVERY SERVICES..................................... 8
5.4. SURGICAL SERVICES .............................................................................................................. 12
5.5. ANESTHESIA SERVICE ............................................................................................................ 21
5.6. NURSING PRACTICES ............................................................................................................. 26
5.7. EMERGENCY SERVICES ......................................................................................................... 28
5.8. REHABILITATION SERVICES ................................................................................................... 32
5.9. RADIOLOGICAL SERVICES ..................................................................................................... 33
5.10. LABORATORY SERVICES .................................................................................................... 36
5.11. PHARMACEUTICAL SERVICES ............................................................................................ 44
5.12. SOCIAL WORK SERVICES ................................................................................................... 56

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FOREWORD

This Ethiopian Standard has been prepared under the direction of the Technical Committee for Medical Science
& Health care practices (TC 90) and published by the Ethiopian Standards Agency (ESA).
This Ethiopian Standard cancels and replaces ES 3617:2012, Primary Hospital Requirements.
Application of this standard is COMPULSORY with respect to clause 4 and 5. A Compulsory Ethiopian
standard shall have the same meaning, interpretation and application of a “Technical Regulation “as implied in
the WTO-TBT Agreement.
Implementation of this standard shall be effective as of 11-02-2022.

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 ETHIOPIAN STANDARD CES 308

Primary Hospital - Requirements

1. SCOPE
The standard covers the minimum requirements with respect to practices, premises, professionals and products
or materials put into use for primary hospitals.

This Ethiopian standard shall be applicable for all primary hospitals new and existing, governmental and non-
governmental.

2. NORMATIVE REFERENCES
The following documents, in whole or in part, are normatively referenced in this document and are indispensable
for its application. For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
CES 246 - Health institutions–General requirement
3. TERMINOLOGIES AND DEFINITIONS
For the purpose of this standard the following definition shall apply.
3.1
primary hospital
shall mean a health institutions primary level of healthcare which provides promotive, preventive, curative and
rehabilitative services with a minimum capacity of 35 beds and provides at least 24 hour emergency services,
general medical services, treatment of basic acute and chronic medical problems, basic emergency surgical
intervention and Comprehensive Emergency Obstetric Care (CEOC) including laboratory, imaging and pharmacy
services and other related services stated under this standard.
4. GENERAL REQUIRMENTS
4.1 The Primary hospital shall full fill the health institutions general requirement specified in CES 246.
4.2 Glass doors shall be marked to avoid accidental collision.
4.3 Potential source of accidents shall be identified and acted upon (slippery floors, misfit in doorways and
footsteps)
4.4 All rooms shall have safe and continuous water supply, light and ventilation
4.5 The additional number of professionals shall be determined based on the work load analysis of the hospital.
5. SPECIFIC REQUIRMENTS
5.1. OUTPATIENT SERVICES
5.1.1Practices
5.1.1.1 The primary hospital outpatient service shall provide the following core functions:
a) Care of ambulatory patients
b) Examination and management of preadmission patients
c) Follow up of discharged and ambulatory patients
d) Basic ENT, Dental, Eye, Dermatology and Mental health services
e) Pharmacy
f) Laboratory, X-ray, ultrasound and ECG services
5.1.1.2 Outpatient services shall adhere to the standards stated in the CES 246 General Requirements for
Health Institutions in terms of patient rights and responsibilities.

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5.1.1.3 The outpatient service shall have protocol and procedures regarding access, availability of service
and networking and it shall include the Followings
a) The outpatient service shall be available in working days for at least eight hours a day
b) The primary hospital shall have a system for providing after-hour (non- working hour) follow up service.
c) The outpatient service shall be done as per national referral guideline.
5.1.1.4 There shall be medical assessment at outpatient services and includes;
a) Comprehensive medical and social history
b) Physical examination including at least
 Vital sign (BP, PR, RR, To), weight and pain assessment
 Clinical examination pertinent to the illness
c) Diagnostics impression
d) Laboratory and other medical workups when indicated
e) The health professional shall put his name, profession, and sign
5.1.1.5 The outpatient department shall have clinical protocols for management of at least common
disease and locally significant diseases in line with the national and or international guidelines.
5.1.1.6 The range of treatment options and the clinical impression shall be fully described to client and/or
their families and documented accordingly and clearly legible.
5.1.1.7 The prescription shall be legibly and clearly written to be complete.
5.1.1.8 The primary hospital shall have procedures in place to minimize crowding and manage the flow of
patients and visitors. This shall include
a) Patient crowd control
b) Assess urgent and non-urgent cases
c) Patient sign-in
d) Caregiver and visitor control.
5.1.2Premises
Table 1 – Premises Required for Outpatient Service
No Premises required No. of rooms
Area required
required
1 Dedicating entrances
2 Waiting area, reception and recording area/desk/ 50 m2
3 Toilets (flushing or VIP) separate for male , female, 5
disables
4 Triage area 1 12 m2
5 Lesion office 1 8 m2
6 Dedicated patient examination rooms 6 12 m2
2
7 Room for procedures 1 12 m
2
8 Room for providing injections with dressing 1 9m
9 Utility room for cleaning and holding used 1 8 m2
equipments and disposing patients specimen
10 Janitors closet with sink 1 6m2

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5.1.2.1 The room arrangements of outpatient services shall consider proximity between related services.
5.1.2.2 The outpatient department setup shall have easy access to pharmacy, laboratory and other
diagnostic services.
5.1.2.3 The outpatient service shall be well marked and easily accessible for persons with disability, elderly
patients, under five children and pregnant mother
5.1.2.4 The outpatient service shall be located where access for ambulatory patients is the easiest and
where in coming client would not have to pass through other care service outlets (in- patient ,
laboratory etc)
5.1.2.5 The outpatient examination rooms shall promote patient dignity and privacy.
5.1.3Professional
5.1.3.1 The general outpatient services shall be directed by a licensed general Medical
practitioner/Integrated emergency, obstetric and surgical officer/family medicine specialist.
5.1.3.2 The primary hospital outpatient service shall have the following licensed professionals
Table 2 – Professionals Required for the Inpatient Service
Staffs required Number required
General practitioner 05
Family medicine specialist /Integrated emergency, 01
obstetric and surgical officer.
Health officer 02
BSC nurse /clinical nurse 06
cataract surgeon(Optional) 01
Ophthalmic nurse /ophthalmic professional 01
Dental Sciences professional 01
Psychiatric professional 01
5.1.4Products
5.1.4.1 The outpatient service shall have the following materials and equipments
a) Vital sign & measurement equipments
 Resuscitation kits,  Reflex hammer
 Oxygen cylinder with regulator  Weighing scale
 Stethoscope  Infant meter and height scale
 Sphygmomanometer  Light Torch
 Thermometer  Examining coach
 Fetoscope
b) ENT diagnostic equipments
 Otoscope  Tuning forks , 500Hz
 Specula of different sizes  Packing nasal forceps,
 Nasal speculum, (Adult and pediatric size)

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c) Ophthalmic diagnostic products

 Snellen’s chart  Reflector and or Head light
 Ishara color test  Light Torch
 Ophthalmoscope
d) Sterilization equipments
 Sterilization drum with stand
 Sterilizer (steam and dry)
e) procedure products
 Minor surgical set  Stretcher mobile type
 Stand lamp  Antiseptic solutions
 wheelchairs,  Plasters
 Infusion stand  NGT different size
 Kidney basin  Catheter
 Enema set  Closets and shelves
 Splint and wires
5.1.4.2 The dental services shall have the following equipment and instruments
a) The dental units with all accessories (e.g. Low speed, high speed hand pieces, straight & Contra angle
hand pieces etc...)
 Air-water syringes  Dental Chair
 Operating light  Operator’s stool & Central Air compressor
b) Instruments for examining
 Dental mirror, Cotton pliers & Spoon excavator
 Periodontal pocket probe
c) Instruments for filling treatment
 Condenser (serrated & plain, Medium, and big  Matrix retainer (different types tofflemire,
size) ziqueland)
 Amalgam carriers (doubled ended, gun type),  Carriers for restorative materials
& Glass slab  Carvers
 Condenser Beaver tail
d) Forceps for Dental Extractions (Deciduous teeth)
 Upper frontal milk tooth forceps  Lower molar milk tooth forceps
 Upper molar milk tooth forceps  Root forceps milk tooth (Bayonet)
 Lower frontal milk tooth forceps
e) Mandibular (lower jaw) forceps for anterior, posterior teeth & root extraction
 Forceps (incisors, canine & universal forceps)  Forceps for Mandibular root Extractions
 Forceps ( molar & Wisdom forceps )

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f) Elevators for Extraction

g) Maxillar (upper jaw) Forceps for anterior, posterior teeth & root extraction
 Maxillary forceps for anterior teeth
 Forceps (incisors ,canine & Universal forceps)
 Maxillary forceps for posterior teeth (Forceps right and left)
 Forceps (universal forceps for molar & wisdom forceps)
 Forceps for Maxillary Root Extraction: Bayonet forceps
h) Periodontal instruments (scalers)
 Scalers- different types, sickle, Jaquete, Chisel, Hoe, file scaler Curettes (Universal, Gracey)
i) Equipment for dental radiology service
 Dental X-ray unit with lead aprone
 Film processing (developer & fixer)
j) Scissors
 Hemostats (curved , straight ,mosquito, Kelly needle holder)
 Crow scissors
 Ligature scissors & Surgical scissors
k) Hand cutting instruments
 Enamel Hatches, Enamel chisel
 Discoid-cleoid, Dental Hoe
 Gingival margin Trimmer, Angle former
l) Other surgical instruments
 Curettes (Angled, Straight, different Sizes)
 Rongeurs (Bone-cutting forceps)
 Bone-file
 Scalped and Handle for scalped
 Cheek and Tongue retractors
 Bone chisels, Mallets
 Suture needles, Irrigation syringe & Aspirating tip
 Local anesthetic equipment (metal anesthesia syringe)
m) Equipment used for amalgam restoration
 Amalgam mixing machine (Amalgamator)
n) Different operatory cabinets
 Mobile cabinets and/or Fixed cabinet
o) Equipments for sterilization
 Super heated steam under pressure (Autoclave)
 Dry heat sterilization (Oven)

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 Cotton roll sterilizer

 Different pans use for disinfections & sterilization of instruments
5.1.4.3 The hospital shall have all medicines and consumables allowed to this level of care and as per the
national drug list of Ethiopia
5.2. INPATIENT SERVICES
5.2.1Practices
5.2.1.1 The inpatient service delivery shall comply with the patient rights as per CES 246 general
requirement standard.
5.2.1.2 The inpatient service shall be available 24 hrs of a day and 365 days a year.
5.2.1.3 The inpatient service shall have consultation and functional intra and inter facility referral system as
prescribed under the outpatient service requirements.
5.2.1.4 The inpatient service shall include at least the following services for admitted patients:
a) Taking comprehensive medical and social history, comprehensive physical examination and performing
relevant laboratory & other medical workups upon admission and when indicated.
b) 24 hours nursing care services
c) Daily round visit and business round by the attending health professional.
5.2.1.5 The primary hospital shall prepare and implement written policy for inpatient visit
5.2.1.6 The inpatient nursing care shall comply with the national nursing care service standard
5.2.1.7 The inpatient service shall have clinical protocols for management of at least common causes of
admission in the hospital
5.2.1.8 The range of treatment options, plans and the clinical impression shall be communicated to client
and/or their families and documented accordingly
5.2.1.9 The primary hospital shall have written protocol for admission and discharge.
5.2.1.10 The hospital shall provide dietary service for admitted patients based on CES 246 health
institutions general requirements standards
5.2.1.11 The hospital shall provide clean gown/pajamas to admitted patients.
5.2.1.12 The hospital shall secure the properties of admitted patients in a cabinet or room with shelves
5.2.1.13 The inpatient service shall arrange the appropriate post discharge instructions and follow up for
the patient.
5.2.2Premises
5.2.2.1 The primary hospital shall have a minimum of 35 beds capacity for inpatient including maternity
beds.
5.2.2.2 The room used for admission shall have an area calculated using the following specifications
unless otherwise stated in a specific service of this standard
a) Distance of bed from fixed walls shall be 0.5 m
b) Distance between beds shall be 1.2 m
2
c) In case of multiple beds, area per bed shall be 8.6m
5.2.2.3 There shall be isolation room with self contained washing facilities.

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5.2.2.4 The hospital shall have separate rooms for female and male patients.
5.2.2.5 The hospital shall have separate room for children under the age of 14 years
5.2.2.6 In patient room shall have easy access shower and toilet separate for staff and patients
5.2.2.7 There shall be duty rooms (area of 4m2 each) separate for female and male with personal
lockers.
5.2.2.8 There shall be hand washing basins for each room
5.2.2.9 The inpatient service shall have area of 12m2 a nursing station/room that provides space for
chart handling and medication preparation
5.2.2.10 Store and clean utility room area of 8m2
5.2.2.11 Each bed room may have alarm
5.2.2.12 Inpatient ward soiled utility room /shooting system (area of 6m2) with shelves and leak proof
containers with leads shall be available
5.2.2.13 Inpatient ward cleaner’s room (area of 6m2) shall be available with materials and has its own
water pipe, sewerage system.
5.2.3Professionals
5.2.3.1 The inpatient services shall be directed by a licensed general medical practitioner / family
medicine specialist.
5.2.3.2 One nurse for a maximum of five patients shall be available to provide nursing care services.
5.2.3.3 Support staff such as runner and cleaner shall be available for 24 hrs a day
5.2.3.4 Technicians for equipment maintenance and general maintenance (power supply, water supply,
drainage system) shall be available during working hours and shall be also available either on
duty or on call basis during non working
5.2.3.5 Number of professional per shift /every eight hours required:
Table 3 - Professionals Required for the Inpatient Service
Staff required Number
required
General practitioner 2
Health officer/Family medicine specialist 1
Nurse professional 4
nurse level 4 3
Clinical pharmacy /pharmacy professional 1
5.2.4Products
5.2.4.1 Each bed shall have wheels for easy movement and be recline
5.2.4.2 Medicines including emergency drugs as per the drug list of the primary hospital shall be
available
5.2.4.3 The following products shall be available:
a) Bed pans per bed c) Bed pan carriage (trolley)
b) Urinal (male and female) d) Bed pan washer & sterilizer/optional

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e) Bed pan Rack o) Refrigerator

f) One chair and bed side p) Instrument Sterilizer
g) cabinet per bed q) Vital sign set
h) Folding screens r) Patient chart
i) IV (drip. stand for each bed s) Vital sign chart
j) Safety box and dust bins as per the infection t) Instrument and medication trolley
prevention standard u) Suction machine
k) Patient stretcher mobile type v) Resuscitation set
l) Medication Cup board w) Side cabinet,
m) Examination light x) Feeding table,
n) Diagnostic Set y) Wheel Chair,
5.2.4.4 The hospital shall have medicines and consumables as per the national medicines list of Ethiopia
prepared for primary hospital.
5.3. MATERNAL AND CHILD HEALTH (MCH) AND DELIVERY SERVICES
5.3.1 Practices
5.3.1.1 The hospital shall provide delivery services 24 hours a day and 365 days a year
5.3.1.2 Non emergency maternal health services shall be available during regular working hours at MCH
clinics.
5.3.1.3 The primary hospital shall provided MCH services during regular working hours which include:
a) Preconception care
b) ANC and PMTCT services:
 Routine assessment of pregnant women, and lab investigation services according to the national
protocol,
 Close follow up of identified high risk mothers and referral,
 Provision of counseling and health education for pregnant women,
c) PNC services:
 Identification and management of complication after deliveries
d) Immunization service
e) Growth monitoring services:
f) Sick baby clinic/ under five clinic services:
g) Youth and adolescent friendly health service(Optional)
h) Comprehensive Family planning services:
 Counseling on and provision of oral contraceptives,
 Counseling, assessing and provision of injectables and inplants,
 Counseling on and insertion of IUCD,
 Mini-laparatomy for tubal ligation,

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 Comprehensive abortion care: Manual Vacuum Aspiration, Evacuation and curettage as per the
country’s law
 Visual inspection under acetic acid (VIA) for cervical cancer screening
 Cryotherapy for cervical premalignant lession treatment
5.3.1.4 Basic emergency obstetric care shall be available 24 hours a day, 365 days a year at primary
hospital
5.3.1.5 The primary hospital shall have comprehensive essential obstetric care including the following
a) Administration of parenteral sedatives for eclampsia, parenteral oxytocin, antibiotics, anticonvulsants
and anesthesia service.
b) Manual removal of placenta and retained products following miscarriage or abortion.
c) Providing assisted deliveries: forceps delivery, vacuum delivery, destructive delivery and emergency
Caesarean Section.
d) Providing basic neonatal life support.
e) Blood transfusion.
f) Repair to perineal tears
5.3.1.6 The primary hospital shall have the following basic essential gynecologic care services
a) Vaginal bleeding management
b) Emergency surgical intervention/ Laparatomy for ectopic pregnancy, pelvic peritonitis and abscess,
ruptured uterus, ovarian cyst torsion and uterine perforation.
c) Pelvic infection or abscess management
5.3.1.7 The hospital shall provide essential newborn care:
a) New born resuscitation care shall be available 24 hours a day, 365 days a year.
b) There shall be written protocol and procedures for transfer and/ or referral of neonates.
c) Routine examination for detection of congenital anomalies
5.3.2 Premises
5.3.2.1 The hospital shall have separate MCH service unit with the following minimum requirements
Table 4 – Premises Required for the Maternal and Child Health (MCH) and Delivery Services

Premises required Number of room required Area required

Preconception care/ANC/ PMTCT, PNC 2 12 m2 (for each)
services
2
Immunization service, with Cold chain 1 16 m
room/corner,
2
Growth monitoring services, Sick baby clinic/ 1 20 m
under five departments services:
Family planning services, with procedure area 1 14 m2
Procedure room(VIA and CAC) 1 12 m2
Waiting area with shade
Laboring (prenatal room) with 4 beds 1 34 m2
Delivery (second stage room) with 2 coach 1 20m2

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Maternity (post natal room), with 4 beds(with 1 34 m2

self contained shower and toilet):
2
Obstetric admission with 2 bed 1 16 m
2
Midwife station 9m
Duty rooms with changing 9m2(For each)
Staff shower and toilet
Client gender specific toilets
Maternity ward
5.3.2.2 The MCH rooms shall respect the privacy and dignity of clients as per CES 246 general
requirement standards.
5.3.2.3 The room arrangement of the MCH service shall consider proximity between surgical and related
services.
5.3.3Professionals
5.3.3.1 The MCH and delivery services shall be directed by a licensed basic midwifery professional
/Integrated Emergency, obstetric and surgical officer/clinical midwifery professional specialist/
family medicine specialist.
5.3.3.2 The emergency obstetrics and gynecology services shall be rendered by a licensed Integrated
Emergency, obstetric and surgical officer /family medicine specialist/ clinical midwifery professional
specialist.
5.3.3.3 There shall be qualified health professionals (midwifes & nurses) as describe above available 24
hours a day and 365 days a year for MCH and delivery services
5.3.3.4 The primary hospital MCH and delivery service shall have the following professionals:
Table 5 – Professionals Required for the Maternal and Child Health (MCH) and Delivery
Services
Sr.No Professionals required Minimum Number required
1 General practitioner 1
2 Nurse 1
3 Midwifes 10
5.3.4Products
5.3.4.1 The ANC/PMTCT/PNC OPD services shall have the following equipments:
a) Examination coaches i) Fetoscope
b) Stethoscope j) Ultrasound
c) BP apparatus k) Stand lamp/overhead light
d) Thermometer l) HIV Test kits
e) Weighing scale, Adult m) Safety box
f) Weighing scale, baby n) Garbage bin
g) Specula of different size o) All relevant registers
h) Measuring tape
5.3.4.2 EPI and shall have the following products.
a) Weight scale for child b) Vaccine carrier

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c) Thermometer f) EPI monitoring chart

d) WHO standard Refrigerator g) Safety box
e) Cold box
5.3.4.3 The under five OPD and growth monitoring shall have the following products.
a) Weight scale l) Service tray
b) Thermometer m) Measuring Jug
c) Spatula n) Cup
d) BP apparatus pediatrics size o) Spoon
e) Stethoscope p) Examination bed
f) ENT set q) IMNCI chart booklet
g) Torch r) MUAC measuring tap
h) Height/ length scale s) Height scale
i) MUAC tape t) Cooking demonstration kit
j) Length measuring table u) Safety box
k) Growth monitoring chart v) Diaper changing table
5.3.4.4 The Family planning counseling and procedure room shall have the following equipment.
a) Examination couch h) Garbage bin
b) Overhead light i) Alligator forceps
c) Wight scale j) Speculum ( different size)
d) Stethoscope k) Instrument trays
e) Sphygmomanometer l) Shelves or cabinet
f) IUD insertion and removal set m) 3 section screen
g) Implant insertion and removal set n) Safety box
5.3.4.5 The procedure room shall have the following equipments
a) Delivery coach g) BP apparatus
b) Manual Vacuum Aspiration sets h) Speculum of different size
c) VIA set i) Garbage bin
d) Overhead light j) Instrument cleaning Setup
e) 3-section screen
f) Stethoscope
5.3.4.6 The Labor, Delivery and Postnatal service have the following equipments:
a) Delivery coaches with water proof mattress (2) e) Mayo table (overfeeding table)
b) Patient bed 6 with waterproof mattress, f) Stethoscope
Adjustable position, stainless (2 for laboring & 4 g) BP apparatus
for post partum) h) Fetoscope
c) Bedside tables i) Thermometer(adult, neonate)
d) Instrument trolley j) Weighing scale, Adult

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k) Weighing scale, Baby u) Refrigerator

l) Speculum of different size v) Iv stand
m) Sponge forceps w) Instrument tray
n) Episiotomy set x) Autoclave or sterilizer (steam and dry)
o) Delivery sets y) Baby crib
p) Delivery forceps(optional) z) Vacuum extractors
q) Measuring tape aa) Suction machine
r) Infant meter and height scale bb) Resuscitation set (neonatal ambu bag different
s) Suction, manual size, suction bulb, towels)
t) Stand lamp/overhead lig cc) Radiant warmer/heater
dd) Room thermometer kk) Bedpans per bed and couches
ee) Wall clock ll) Personal protective (Cape, google, face mask,
ff) Reflex hammer APRON , boots, delivery gown, gloves)
gg) Oxygen (full set-cylinder, gauge, mask/nasal mm) Instrument processing containers (3)
catheter adult/neonate) nn) Safety box
hh) Electronic fetal monitor- CTG (Cardio oo) Waste container buckets
tocograph)(optional) pp) Standard cord clamp/tie
ii) Supplies (NG tube neonatal, oxytocin, qq) Partograph, safe child birth checklist
ergometrine, misoprostol, IV fluids, canulla, ttc,
vit k, insulin syringe)
jj) Pickup forceps and jar
5.4. SURGICAL SERVICES
5.4.1Practices
5.4.1.1 The surgical service shall be directed by Integrated Emergency, obstetric and surgical officer /Family
medicine specialist
5.4.1.2 Emergency obstetric and surgical service shall be available 24 hours a day,365 days a year
5.4.1.3 The hospital shall make sure the emergency obstetric and surgical services is available, staffed with
the necessary technical staff, equipped with all the necessary facilities including emergency
transfusion, transportation, and electric back up
5.4.1.4 Services for non-emergency elective surgical cases shall be restricted to minor procedures.
5.4.1.5 There shall be written protocols and procedures for admissions and discharges with follow up.
5.4.1.6 There shall be protocols for the management of the emergency obstetric and surgical conditions in
the hospital
5.4.1.7 The admission process for emergency obstetric/ surgery shall be in consultation with the Integrated
Emergency, obstetric and surgical officer /family medicine specialist on emergency surgery.
5.4.1.8 Surgical records shall be kept for each patient and it shall be integrated with the patient’s over-all
hospital record.

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5.4.1.9 All emergency surgical procedures shall be performed only after appropriate history, physical
examination, and indicated diagnostic tests are completed and documented in the patient’s medical
record.
5.4.1.10 The preoperative diagnosis shall be recorded in the medical record for all patients prior to surgery.
5.4.1.11 The patient shall get explanation on the disease condition, possible surgical intervention and outcome
possibilities in clear, simple and understandable terms.
5.4.1.12 Written informed consent shall be obtained for any surgical intervention and this must be documented
in the patient’s medical record. For the case with life threatening condition, consent shall be obtained
from spouse, family, guardian.
5.4.1.13 The nursing care of patients undergoing emergency surgery shall be planned and documented in the
medical record, directed by attending nurse, and includes the following:
a) Pre-operative care,
b) Post-operative care and monitoring needed,
c) Pain management
5.4.1.14 Emergency operation reports shall be written in the patient’s record and in the OR registration book
immediately after surgery and include at least the following:
a) Patient identification,
b) Pre-operative diagnosis,
c) The procedure performed,
d) Findings during surgery,
e) Post-operative diagnosis,
f) Types of anesthesia
g) Patient condition/outcome
h) Date and time operation started and ended,
i) Name of emergency surgeon, anesthetist or nurse anesthetist, scrub nurse, and any assistant
j) Signature of emergency surgeon, anesthetist and the scrub nurse on operation note
k) Immediate post-operative orders explicitly in the order sheet including pain management
5.4.1.15 There shall be processes and protocol defining the appropriate safety before, during and immediately
after surgery, including at least the following:
a) Aseptic technique,
b) Sterilization and disinfections,
c) Selection of draping and gowning,
d) Counting of sponges, instruments and needles
5.4.1.16 There shall be adopted national and international safe surgery checklist to all patient undergo for
surgery
5.4.1.17 There shall be a protocol for preparing and availing appropriate and properly functioning supplies,
equipment, and instruments available for emergency surgery

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5.4.1.18 There shall be a protocol for patient transfer from operation theatre to PACU(post anesthesia care
unit) and in patient ward. This includes;
a) The handover and/or transfer of immediate post-operative patients shall be done between the
anesthetist who administered the anesthesia and the nurse in charge of inpatient ward,
b) The nurse/midwife in the ward shall immediately re-evaluate the condition of the patient when arriving in
the ward,
c) The follow up of immediate post-operative patients in the ward shall be done by the ward nurse/midwife,
procedure attending professional and inpatient attending general medical practitioner or health officer
according to the order and shall be documented accordingly.
5.4.1.19 Post- operative patient in the wards shall get post operative care by ward nurses/midwife. The post
operative care includes to the minimum:
a) Follow up of vital signs and carrying out of post-operative orders shall be done as per the order specified
for individual patients.
b) Evaluation by the Emergency surgical officer or appropriate general medical practitioner or health officer
daily or whenever needed.
5.4.1.20 The hospital shall have clear protocol for minor surgical procedures to be done at outpatient level.
Examples: Circumcisions, lipoma excisions, abscess drainages, suturing of soft tissue injuries, etc.
5.4.1.21 There shall be a mechanism that the duty family medicine specialist/ Integrated Emergency, obstetric
and surgical officer shall be available all time
5.4.2Premises
5.4.2.1 A primary hospital shall have rooms described as below
Table 6 – Premises Required for the Surgical Services

Premises required number of rooms Area required

Operation theatre 2 30 m2 for each
Central sterilization room (CSR), adjacent to OR 1 16 m2
Changing rooms with lockers 2 4m2 for male and
female each
Toilets and showers 2 for each male and
female
Store room, 1 6m2
Clean utility room/ closed cabinet 4m2 (if it is a
room)
2
Soiled utility room and /shooting system 4m (if no
shooting system)
2
Janitors closet with sink 6m
Scrub area
2
Staff room 1 12 m
Nurse station
2
Patient reception or cloth changing room 1 6m
2
Recovery room 1 16 m
Minor OR (separated from the major OR) 1 20 m2

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5.4.2.2 Operation room shall have neonatal resuscitation corner

5.4.2.3 Operation room shall have access- restricted environment where emergency surgical interventions
are performed.
5.4.2.4 Operation Theatre shall have:
a) Washable walls; the vicinity of plumbing fixtures shall be smooth and water resistant
b) Monolithic, scrub-able ceiling and capable of withstanding chemicals. Cracks or perforation in these
ceilings are not allowed.
c) Tightly sealed floors and walls if penetrated by pipes, ducts and conduits,
d) Smooth Floor, easily cleanable, non-slippery and non-staining, which shall not be affected by water or
germicidal cleaning solutions;
e) At least four fixed electric outlets with cover,
f) Self-closing doors for the entrance,
g) Mobile operation lights,
h) Glass cabinet and shelf for storing suture materials and other supplies
i) Heater / or air-conditioner shall be available in the theatre.
5.4.2.5 Scrub area:
a) This area shall have direct access to the operating theatre,
b) There shall be a scrubbing-up area outside but adjacent to the operating theatre(s).
c) It shall be provided with wide sink and taps for running water. The taps for running water for scrubbing
shall be hand free to be manipulated with elbow or knee. (e.g), long arm of valve gate to be manipulated
with elbow or knee joint.
5.4.2.6 Nurse station/ Patient Transfer Area:
a) This area need not be a room, but may form an integral part of the main patient corridor, recovery area
or bed-receiving area.
b) There shall be a corridor or allocated area for keeping charged and empty Oxygen cylinders; the empty
and charged oxygen cylinders shall be labeled clearly,
c) Provided with a chair and table for OR staff,
d) This area shall be large enough to allow for the transfer of patients from a bed to OR stretcher.
e) A line shall be clearly marked in red on the floor, beyond which no person shall be permitted to set foot
without putting on protective clothing and OR shoes (OR attire)
5.4.2.7 Staff Change Rooms
a) Suitable one separate changing room,
b) Shall have two doors, one entrance and the second door accessing into
c) Shall be provided with a locker and shelf for Storage of clean theatre attire and operation theatre gum
boots.
d) Separate storage bin shall be provided for used and soiled theatre apparels.
e) Wash hand basins: Toilets, showers,

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5.4.2.8 Operating theatre mini- store and anesthesia material store

a) There shall be a store room in the operating room that shall be supplied with a sufficient number of
electrical plugs to keep the electrical equipments plugged in, charged and in case of power failure to
work as back up electrical supply/or emergency electrical supply,
b) Equipments shall always be stored at the same space/location, properly labeled and ready to use,
c) Enough Shelves and cabinets shall be available,
5.4.2.9 Central sterilization room/ area shall be available with followings;
a) An area or a room for reception, sorting of equipments; or clothes and documentation process;
b) An area or room for an autoclave, dry oven and or steam sterilizer;
c) The date of sterilization & the name of the instruments shall be written after sterilization.
5.4.2.10 In addition, the hospital shall have minor operation theatre accessible to OPD with hand wash basin.
5.4.3Professionals
5.4.3.1 Surgical services shall be directed by a licensed Integrated Emergency , obstetric and surgical officer
/family medicine specialist
5.4.3.2 The minimum number of professionals for emergency obstetric and other surgical services at primary
hospital to render the services are:
a) Two Integrated Emergency, obstetric and surgical officer /family medicine specialist
b) One Integrated Emergency, obstetric and surgical officer /family medicine specialist/clinical midwifery
professional specialist
c) Assistant GP/HO/ /OR nurse professional
d) Four OR nurse/nurse Professional
e) Minor surgery professional mix
 One Integrated Emergency, obstetric and surgical officer /GP/HO/surgical nurse professional
 One Nurse level 4
f) Recovery
 One nurse
 Licensed anesthetist with experience shall lead anesthesia service
5.4.4Products
5.4.4.1 Operating theatre: Minimum equipment list for a single operating theatre
a) Time clock j) Safety boxes
b) Anesthesia trolley k) Swab rack with drip trays
c) Oxygen cylinders, different sizes. l) Swab count record boards
d) Worktable with laminated top m) Bowls and stands
e) Adjustable Stools n) Instrument tables, Mayo type
f) IV stands o) Framed boards with pencil trays
g) Drums p) Chest tubes with bottles
h) Kick buckets q) Blankets, warming
i) Caps - Mop/Bonnet Type r) Tourniquets

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s) Tongue depressors v) Suction machines

t) Mobile operating lights w) Bottles - Suction - Glass/Plastic
u) Operating table, 3 sections with removable x) Autoclave, hot air and or steam
fixtures
5.4.4.2 Equipment – scrub area:
a) Soap dispenser
b) Scrub-up brushes
c) Sinks
d) Mirror above each sink
5.4.4.3 The hospital shall have consistent electricity (backup generator. and water supply (backup reservoir)
5.4.4.4 Equipment – operating theatre store
a) Drape:
 Surgical, woven(1 x 1 m)
 Surgical, woven(1 x 1.5 m)
 Surgical, woven(1.5 x 1.5 m)(fenestrated
 Surgical, woven(45 cm x 70 cm)(fenestrated)
 Surgical woven (2 x 1.5 m)
b) Patient transfer, stretchers
c) General purpose trolleys
d) IV stands
e) Worktable with laminated top
f) Cabinets and shelves
g) Dressing trolley
h) Instrument table, Mayo type
i) Pillows
j) Surgical Splints
k) Apron,
l) trays
m) Gen.surg- Basic surgery set
n) Gen.surg- C/S set
o) Gen.surg- Laparotomy set
p) Gen.surg- Minor surgical set
q) Gen.surg- Suprapubic puncture set
r) Bedpans
s) Kidney basin, 475 ml
t) Renewable/Consumables for OR
 Guedel airways: size 0, 00, 3, 4 & 5

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 Alcohol Swabs
 Disposable aprons
 Aqua-packs Oxygen humidifier
 Bags – Urine
 Bandages
 Batteries - Medical & General
 Blood Administration Sets
 Cannula - Nasal-Oxygen
 Cannula, IV short, ster, disp, 18G, 20 G, 22 G, 24 G
 Catheter, plain, foley,
 Cleansing Swabs – Sterile and Non-Sterile
 Cold/Hot Packs
 Connectors,
 Cotton
 Draw sheet, plastic, 0x180cm
 Gauze
 Gloves:
o Household Large & Medium
o Surgical Size 6, 6 ½, 7, 7 ½, 8
o Exam, latex, disp, large, medium, small
o Gauntlets
 Hand wash Antiseptic Liquid (Hibiscrub)
 I.V. Sets :
 I.V. Administration Sets – 15 Drop
 I.V. Administration Sets - 60 Drop
 I.V. Set, Infusion “Y”, Luer lock, air inlet
 K.Y. Jelly
 Nail Brushes - Autoclavable
 Needles:
 Disp,15G, 18G, 21G, 22G, 23G, 25G
 Butterfly 23G
 Oxygen T Pieces
 Oxygen Tubing
 Face Masks
 S.G. Meter (Urine Meters)
 Safety Pins Large & Medium

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 Sharps Containers (Safety Box/used syringes and needles)

 Shrouds
 Soap, toilet, bar, approx.110g,wrapped
 Spatulas – Tongue, disposable
 Spigots Large, Medium and Small
 Syringes:
 Volume: 2ml, 5ml, 10ml, 20ml
 Syringes 50 ml Conical Tip
 Syringes 50 ml Luer Lock
 Syringes Insulin
 Tape:
 Elastic Adhesive Plaster - White 5cm and 10 cm
 Micropore tape
 Surgical Adhesive Hypo-Allergenic
 Adhesive, zinc oxide, perforated,10cmx5m
 Adhesive, zinc oxide, 2.5cmx5m
 Clinical thermometer
 Fridge thermometer
 Tourniquet, latex rubber,75cm
 Tubes:
 Endo-tracheal, disp. + connector, neonate mm, w.o balloon
 Endo-tracheal, disp. + connector, balloon, 6.5mm, 7mm, 7.5mm, 8mm
 Suction, L125cm,ster,disp, CH10, CH12, CH16
 Tube, Vacuum 5ml (Vacutainer)
 Tube, Vacuum EDTA 5ml (Vacutainer)
 Tube, Vacuum Heparinised 5ml (Vacutainer)
 Vacutainer holder
 Vacutainer needles, 18-24G
 Compresses:
 Abdominal compress, 40 x 40 cm
 Compress, Swab, 20x 20 cm
 Compress, gauze,10x10cm,n/ster/PAC-100
 Compress, gauze,10x10cm,ster/PAC-5
 Compress, paraffin,10x10cm,ster/BOX-10
 Suturing materials:abs, non abs,various with needles and without needles.
 Abs,DEC1,need 1/2,18mm,round/BOX-36

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 Abs,DEC2,need 3/8 18mm,round/

 Abs,DEC2,need 3/8,26mm,tri
 Abs,DEC3,need 1/2 30mm,round
 Abs,DEC3,need 3/8 50mm,round
 Abs,DEC3,spool
 Abs,DEC4,need 3/8 36mm,tri
 Nonabs,DEC2,need 3/8 13mm,tri
 Nonabs,DEC3,need 3/8 30mm,tri
 Operating Room Linen:
 Apron Surgical, rubber
 Trousers, Surgical, woven, Small, Medium & Large
 Top(shirts), Surgical, woven, Small, Medium & Large
 Gown, Surgical, woven(Plain)
 Cap, Surgical, woven
 Masks, surgical, woven
5.4.4.5 The central sterilization room shall have the following products
a) Autoclaves and steam sterilizers,
b) Test strips
c) Chemicals
d) Commercial steamer
e) Boiler
f) Oven
g) 0.5% chlorine solution (diluted bleach)
h) Storage shelves for the medical equipment
i) Disinfectant chemicals
j) Brushes (tooth brush for small items)
5.4.4.6 The hospital shall have all medicines allowed to this level of care and as per the national drug list of
Ethiopia
5.4.4.7 Operating Room Linen:
a) Apron Surgical, rubber f) Masks, surgical, woven
b) Trousers, Surgical, woven; Small, Medium & g) Bed Sheet
Large h) Sheet, draw, white
c) Top(shirts), Surgical, woven; Small, Medium & i) Cellular Blanket
Large j) Organ protections,
d) Gown, Surgical, woven(Plain) k) Shelves
e) Caps, Surgical, woven l) Cabinets

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5.5. ANESTHESIA SERVICE

5.5.1 Practices
5.5.1.1 There shall be a written protocol about administrations of local regional and general anesthesia.
5.5.1.2 The anesthetist shall ensure that all the necessary equipment and medicines are present and
checked before starting anesthesia.
5.5.1.3 The anesthetist shall confirm the identity of the patient before inducing anesthesia.
5.5.1.4 The conduct of the anesthesia and operation is monitored and recorded in line with the monitoring
standards and formats.
5.5.1.5 Patients shall be managed in a recovery room, except patients requiring transfer for intensive care in
ICU, until overcome effect of anesthetic.
5.5.1.6 Anesthesia services shall be administered in accordance with written protocol and procedures that
are reviewed at least every two years, and revised more frequently as needed. They shall include at
least the following:
a) Anesthesia care, which includes local anesthetic infiltration, spinal anesthesia and general anesthesia
is planned and documented in the patient’s record.
b) A pre-anesthesia assessment shall be done by anesthesiology professional specialist (MSc) or
anesthesia professional or anesthetist or nurse anesthetist prior to the administration of anesthesia.
c) The patient shall be reassessed immediately prior to administration of anesthesia by an anesthetist or
nurse anesthetist. The plan shall be consistent with the patient assessment and shall include the
anesthesia to be used and the method of administration.
d) Prior to administration of any pre-anesthesia medication, a written informed consent for the use of
anesthesia shall be obtained and documented in the medical record.
e) Each patient’s physiologic status shall be continuously monitored during anesthesia or sedation
administration and the results of the monitoring shall be documented in the patient’s medical record on
an anesthesia form, a minimum of :
 Pulse rate and rhythm.  Urine out put
 Blood pressure.  Temperature
 Oxygen saturation.  ECG monitor
 Respiratory rate.
f) The anesthesia record includes:
 Fluids administered.  Any unusual events or complications of
 Medications administered. anesthesia.
 Blood or blood products administered.  The condition of the patient at the
 Estimated blood loss. conclusion of anesthesia.
 The actual anesthesia used.  The time of start and finish of anesthesia.

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 Signature of the nurse anesthetist or

anesthetist.
g) The patient shall be monitored during the post-anesthesia/surgery recovery period and the results of
monitoring shall be documented in the patient’s medical record.
h) The time of arrival to the general ward shall be recorded.
i) The decision of discharge from the general ward shall be done by GP/HO/ Integrated emergency,
obstetric and surgical officer /Family medicine specialist/ midwifery professional specialist.
j) The decision of discharge from post anesthesia care unit shall be done by operating professional and
anesthetist.
5.5.1.7 The anesthetist shall visit the patient before the operation and assess the general medical fitness of
the patient, identifies any medication being taken, and assess any specific anesthesia problems.
5.5.1.8 The anesthetists shall discuss possible plans of management with the patient and explains any
options available, to enable the patient to make an informed choice.
5.5.1.9 The anesthetist shall be present in the operating theatre, around the patient throughout the operation
and transfer from recovery room.
5.5.1.10 The conduct of the anesthesia and operation is monitored and recorded in line with the monitoring
standards and formats, to a minimum these shall include:
a) Continuous pulse oxmeter, ECG monitor, nonvesive blood pressure, pulse rate and rhythm, temperature
and urine output recorded every ten minute exit urine output (at the end of the procedure).
b) A written record of the anesthetic shall be kept as a permanent record in the case notes.
5.5.1.11 Anesthetic agents administered with the purpose of creating conscious sedation, deep sedation,
major regional anesthesia, or general anesthesia shall be in accordance with anesthesia policies
and procedures.
5.5.1.12 Pain shall be assessed and managed.
5.5.1.13 Patients shall be managed in general ward, except for patients requiring transfer to other hospitals,
until overcome effect of anesthesia.
5.5.1.14 The general anesthesia service shall be provided in the Operation theatre (OR), together with the
surgical services.
5.5.1.15 At all time at least two Anesthetists per table shall be assigned for the betterment of patient out
come and prevention of intra operative Morbidity and mortality.
5.5.1.16 The protocols and guidelines used for anesthesia service shall be available and well understood by
the surgical team.
5.5.1.17 There shall be a written protocol to assure that surgery shall not proceed when there are person with
disability alarms on the monitors,
5.5.2 Premises
5.5.2.1 There shall be a mechanism for taking exhaust air from anesthesia machine to outside of OR;
important when performing open system for pediatric anesthesia,

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5.5.2.2 There shall be central oxygen system or a system where there is a continuous supply of charged
Oxygen cylinders
5.5.2.3 Regarding the anesthesia store:
a) The anesthesia store room shall be a minimum of 8 m2
b) The anesthetic shall be kept on shelves and/ or cabinets, separate from medicines, properly labeled
c) There shall be at least 4 electric plugs in the room,
d) Anesthetic equipments shall be stored clean and being ready for use,
e) Ambu bags and resuscitation kits shall be kept labeled in easily reachable place,
f) There shall be separate place for keeping new and rechargeable Batteries and dry cells. Used
batteries and cells shall be stored and discarded properly, refer to IP and waste disposal protocol,
5.5.2.4 Recovery Room shall be sited within the operating suit and has a minimum of:
a) two beds with side protection,
b) resuscitation equipment including a defibrillator on trolley,
c) oxygen source with face mask and or nasal catheter,
d) ensures ease of communication and access for anesthesia department staff for close follow up,
5.5.3 Professionals
5.5.3.1 The minimum number of professionals required for this service:
a) Two (MSc) Anesthesiology professional specialist/ anesthesia professional ( BSc).
b) Two anesthesia professional / nurse anesthetist
5.5.3.2 All anesthesia providers who administer and/or supervise the administration of general anesthesia,
major regional anesthesia, or conscious sedation anesthesia shall maintain current training in
Advanced Cardiac Life Support
5.5.3.3 At all times, at least two Anesthetists per table shall be assigned for the betterment of patient out
come and prevention of intra operative Morbidity and mortality shall be onsite.
5.5.3.4 General or major regional anesthesia shall be administered and monitored only by the following:
a) An anesthesiologist/ Bsc Anesthetist, Msc Anesthetists and nurses anesthetists
b) A registered nurse anesthetist or registered anesthetist or physician resident (anesthesiology), a student
nurse anesthetist, a student anesthetist under the supervision of an anesthesiologist /A Msc Anesthetists
or senior Anesthetists.
5.5.4 Product
5.5.4.1 Anesthesia supplies, equipment and safety systems shall include the following:
a) All medical gas hoses and adapters shall be color-coded and labeled according to current national
standards.
b) An oxygen failure-protection device ("fail-safe" system) shall be used on all anesthesia machines to
announce a reduction in oxygen pressure, and, at lower levels of oxygen pressure, to discontinue other
gases when the pressure of supply oxygen is reduced.
c) Vaporizer exclusion ("interlock") system shall be used to assure that only one vaporizer, and therefore
only a single agent, can be actuated on any anaesthesia machine at one time.

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d) To prevent delivery of excess anaesthesia during an oxygen flush, no vaporizer shall be placed in the
circuit downstream of the oxygen flush valve.
e) All anaesthesia vaporizers shall be pressure-compensated in order to administer a constant non-
pulsatile output.
f) Accurate flow meters and controllers shall be used to prevent the delivery to a patient of an inadequate
concentration of oxygen relative to the amount of nitrous oxide or other medical gas.
g) Alarm systems shall be in place for high (disconnect), low (sub atmospheric), and minimum ventilator
pressures in the breathing circuit for each patient under general anaesthesia.
5.5.4.2 Anesthesia supplies, equipment and patient monitoring shall include:
a) A difficult airway container or trolley shall be immediately available in each anesthesia department for
handling emergencies. The following items are required to be included in the difficult airway container or
trolley:
 resuscitation equipment,
 emergency drugs,
 a laryngeal mask,
 endo-tracheal tube stylet,
 airway, and/or
 Other items of similar technical capability.
b) A precordial stethoscope or oesophageal stethoscope shall be used when indicated on each patient
receiving anesthesia. If necessary, the stethoscope may be positioned on the posterior chest wall or
tracheal area.
c) Supplemental oxygen and a delivery system appropriate to the patient's condition shall be immediately
available for patient transport from the operating room to the general ward
5.5.4.3 Equipments:
a) Time clock
b) Anesthesia machine with ventilator, 2 vaporizers, and gas cylinders
c) Adult and pediatric anesthesia circuits with filters
d) Mechanical ventilators
e) Oxygen cylinders of different sizes, oxygen trolley and oxygen regulator
f) Worktable with laminated top
g) Resuscitation equipments; Ambu bags (adult/ pediatric/ neonates), with inflatable bag,
h) Refrigerator with termometer
i) Stools
j) Clips
k) Weight scale; adult & pediatric
l) Resuscitation trolley as per CES 234 ©ESA 15
m) Syringe pump /infusion pump

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n) Defibrillator
o) Blood gas analyzer
p) Blankets
q) Air conditioner and heater
r) Framed boards with pencil trays
s) IV stands, IV fluid pressure bags, blood warmer and IV fluid warmer
t) Tourniquets, tongue depressors, disposable
u) Dust bin
v) Framed boards with pencil trays
w) IV stands, infusion pumps, IV fluid pressure bags, blood warmer and IV fluid warmer
x) Tourniquets, tongue depressors, disposable
y) Patient monitor
 Pulse oximeter
 Temperature monitor
 Dual head stethoscope
 BP apparatus with different size cuffs
z) Intubation gadgets:
 Airway Guedel, pediatric & adult size
 Laryngeal mask set
 Mask holder
 Cannula - Nasal-Oxygen,
 Face mask- Oxygen,
 Masks – Oxygen 40 %
 Laryngoscope sets with different size blades (Mackintosh)
 Magill forceps (adult & pediatrics)
 Intubation stylet, adult, 15 Ch,/ Endo-tracheal tube guide
 Mouth gauge
 Tube, Endo-tracheal:
o disp. + connector, 3 mm, w/o balloon
o disp. + connector, 3.5 mm, w/o balloon
o disp. + connector, 4 mm, w/o balloon
o disp. + connector, 4.5 mm, w/o balloon
o disp. + connector, 5 mm, balloon
o disp. + connector, 5.5 mm, balloon
o disp. + connector, 6 mm, balloon
o disp. + connector, 6.5 mm, balloon
o disp. + connector, 7 mm, balloon

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o disp. + connector, 7.5 mm, balloon

o disp. + connector, 8 mm, balloon
o disp. + connector, neonate mm, w.o balloon
o disp. + connector, balloon, 6.5mm, 7mm, 7.5mm, 8mm
 Tube:
o Trachea, balloon, int.can, ster, size 6
o Trachea, balloon, int.can, ster, size 8
o Suction,CH08,L50cm,ster,disp, CH08, CH10, CH14, CH16
 Extractor, mucus,20ml,ster,disp
 Safety Pins Large & Medium
 Connectors:
o Biconical, Autoclavable
o Connector, T/Y
o Connectors - Plastic – Tapered
 Braun Splints (Arm)
 Draw sheet, plastic,90x180cm
 Clinical thermometer
 Fridge thermometer
 Tourniquet, latex rubber,75cm
5.6. NURSING PRACTICES
5.6.1Practices
5.6.1.1 There shall be written protocol describing the responsibilities of nurses for the nursing process
(assessment, diagnosis, planning, implementation and evaluation). Such policies shall be reviewed at
least once every two years.
5.6.1.2 There shall be assessable physical resources for nurses to implement the nursing process, as detailed
under the products’ section for nursing services.
5.6.1.3 There shall be appropriate arrangements for nurses to access to clinical supervision, support and
participate in regular clinical services audit and reviews.
5.6.1.4 Nursing care service at different service delivery areas shall be directed by a licensed nurse with a
minimum BSC nurse and has at least two years of relevant experience.
5.6.1.5 Written copies of nursing procedure manual shall be developed and made available to the nursing staff
in every nursing care unit. The manual shall be used at least to:
a) Provide a basis for induction of newly employed nurses,
b) Provide a ready reference on procedures for all nursing personnel.
c) Standardize procedures and practice.
d) Provide a basis for continued professional development in nursing procedures/techniques

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5.6.1.6 The hospital shall have established guidelines for verbal and written communication about patient care
that involves nurses
a) Written communication includes proper use of clinical forms, nursing Kardex, progress notes, and/or
nursing care plan for each patient and discharge instructions.
b) Verbal and/or written communication includes reporting to general medical practitioners; nurse-to-nurse
reporting; communication with other service units (laboratory, pharmacy, X-Ray, social work service.
with patient and family education.
5.6.1.7 There shall be a procedure for standardized, safe and proper administration of medications by nurses
or designated clinical staff including regular checks of patients’ medications and proper documentation
of administered medicines.
Nursing care: general patient services
5.6.1.8 Licensed nurses shall assess and document the holistic needs of patients; formulate, implement goal-
directed nursing interventions and evaluate the plan of nursing care and involve patients, their relatives
or next of kin in decisions about their nursing care. Nurses’ documentation shall include:
a) Medication, treatment, and other items ordered by authorized house staff members.
b) Nursing care needed.
c) Long-term goals and short-term goals.
d) Patient and family teaching and instructional programs.
e) The socio-psychological needs of the patient.
f) Preventative nursing care
5.6.1.9 All patients shall be under the supervised care of a licensed nurse at all times.
5.6.1.10 Implementation of infection prevention procedures and provision of information on IP practices to
patients, clients, family members and other caregivers, as appropriate, shall be done by the nurses;
refers to infection prevention stated under this standard.
5.6.1.11 Nurses shall work with others to protect and promote the health and wellbeing of those under their
care.
5.6.1.12 Nurses shall be open and honest, act with integrity and uphold the reputation of their profession.
5.6.1.13 The nursing care plan shall be initiated upon admission of the patient and shall include discharge
plans as part of the long-term care provision goals.
5.6.1.14 Documentation and completion of all patient’s recording, registers, and reporting formats shall be the
responsibility of licensed nurses in the unit as stated under medical records standards
5.6.1.15 Nurses shall explain and seek informed consent from their patients or their relatives/next of kin (for
incompetent patients) before carrying out any procedure.
5.6.1.16 Nurses shall find solutions to conflicts caused by deep moral, ethical and other beliefs arising from a
request for nursing service through dialogue with patients.
5.6.1.17 Patient discharge instructions shall be documented in the patient’s medical record at the time of
discharge and a copy of such instructions shall be given to the patient or next of kin.

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5.6.1.18 Allergies shall be listed on the front cover of the patient’s chart and/or, in a computerized system,
highlighted on the screen and this shall be posted in the patient’s bed.
5.6.1.19 Patients who require assistance in feeding shall be identified, and there shall be a mechanism in
place to ensure that assistance is provided.
5.6.1.20 For admitted patients, the nursing staff shall take and document the necessary vital signs as ordered
and communicate findings of any deviation from the norm to treating /attending general medical
practitioner immediately.
5.6.1.21 Nurses shall ensure patients on special diets have access to their prescribed dietary regimes and
such patients shall be identified with a visible identifier/ label that are included in their care plan and
on their beds.
5.6.1.22 There shall be a protocol or procedures for nurses to report any suggestive signs of child abuse,
substance abuse and /or abnormal psychiatric manifestations by the patients under their care.
Nursing care services related to pharmaceutical services
5.6.1.23 All medications administered by nursing personnel shall be prescribed by general practitioner or
health office or any other authorized health professional and shall be administered in accordance
with prescriber orders
5.6.1.24 Nurses shall ensure patients under their care swallow their prescribed oral medicines as per general
medical practitioner’s order.
5.6.1.25 Regarding self-administration of medicines, nursing personnel shall directly observe self-
administration and adhere to policies and procedures developed by the pharmacy and therapeutics
committee.
5.6.1.26 There shall be a policy for reporting and documenting medication errors, product quality defect and
adverse drug reactions by attending nursing personnel immediately to the prescriber and ADE focal
person.
5.6.1.27 Nursing personnel shall return unfit for use medicines to the central medical store of the hospital for
disposal
Nursing care: Dying patient
5.6.1.28 The nurse shall give post mortem care
5.7. EMERGENCY SERVICES
5.7.1 Practices
5.7.1.1 The emergency service including emergency surgical interventions shall be available 24hrs a day and
365 days a year.
5.7.1.2 The hospital shall have an emergency triage system.
5.7.1.3 The emergency service shall comply with the patient rights standards as stated under this standard
5.7.1.4 Infection prevention standards shall be implemented in the emergency room as per the IP standards
stated under this standard
5.7.1.5 Every emergency patient shall get the service without any prerequisite and discrimination.

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5.7.1.6 The emergency service shall have functional intra and inter facility referral system which encompasses
SOP for selection of referral cases, referral directory, referral forms, referral tracing mechanism,
feedback providing mechanism, documentation of referred clients and consultation forms.
5.7.1.7 If referral is needed it shall be done after providing initial stabilization and after confirmation of the
required service availability in the facility where the patient is to be referred to.
5.7.1.8 Every procedure, medication and clinical condition shall be communicated to the patient or family
member after responding for urgent resuscitation measures
5.7.1.9 The hospital shall provide a complete emergency service to its level of care
5.7.1.10 The emergency service shall have easy access to pharmacy, laboratory and other diagnostic services
24hrs a day and 365 days a year.
5.7.1.11 The emergency service shall promote the dignity and privacy of patients.
5.7.1.12 There shall be a written protocol for emergency services and the provision of this service shall be
done in accordance with the clinical protocols of the service
5.7.1.13 The emergency service unit shall provide basic life support to its level of care which may include but
not limited to:
a) Cardiopulmonary resuscitation (CPR)
b) Airway management and/or oxygen supply
c) Bleeding control
d) Fluid resuscitation
5.7.1.14 The hospital emergency service shall have protocol for the initial management of at least the following
emergency cases:
a) Shock k) Cereberovascular accident
b) Severe Bleeding l) Acute diarrhea ( Severe dehydration )
c) Fracture and injuries m) Acute abdomen
d) Coma n) Tetanus
e) Burn o) Meningitis
f) Poisoning p) obstetrics and gynecological emergency
g) Cardiac emergencies q) pain management
h) Severe respiratory distress r) disaster management protocol
i) Seizure disorder s) Diabetic keto acidosis
j) Hypertension emergencies
5.7.2 Premises
5.7.2.1 The emergency room shall be located in a place where it is easily recognizable to the public and shall
be labeled in bold.
5.7.2.2 The emergency premises shall be low traffic area and there shall be reserve parking place for
ambulances.
5.7.2.3 The corridor to emergency rooms shall be stretcher friendly and spacious enough/not less than 1.5m
5.7.2.4 The emergency area shall be spacious enough to provide a space for the following tasks:

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a) Triaging
b) Accepting and providing immediate care including emergency procedures
c) Admitting for a maximum of 24 hrs to provide emergency care
d) Access to emergency medicines, supplies and equipments
e) Staff/duty room
f) Toilet facilities
5.7.2.5 Beds shall be arranged as the description of inpatient beds’ arrangement
5.7.2.6 The width of the door for the emergency room shall not be less than 1.5 meter
5.7.2.7 The emergency premises shall allow patient dignity and privacy.
5.7.2.8 The rooms shall be arranged in such a way that the first encounter to an emergency patient coming
from outside will be the examination room or space
5.7.2.9 The emergency room shall have the following facilities
a) Adequate water, light and ventilation.
b) Fire extinguishers placed in visible area
c) Hand washing basin in each room
5.7.2.10 Glass doors shall be marked to avoid accidental collision
5.7.2.11 Potential source of accidents shall be identified and acted upon (slippery floors, misfit in doorways
and footsteps, etc)
5.7.2.12 The emergency service shall have Waiting area for attendants and caregivers.
Table 7 – Premises Required for the Emergency Service
Premises required Minimum area required
Emergency Triage area with couch
Examination room and procedure room with two
couch with hand washing basin Total rooms
Resuscitation area/room with a minimum two area 52 m2
beds
Staff room
Toilet room both patient and staff for male and
female including disables
Hand washing and instrument processing area
5.7.3 Professionals
5.7.3.1 The emergency service shall be directed by general medical practitioner or Health officer
5.7.3.2 The team of emergency shall be changed every 8 hrs as a team and the team composition during
working and non-working hours shall have similar staffing pattern.
5.7.3.3 The emergency service shall be opened for 24hrs a day and 365 days a year being run by an
emergency team. Each team shall contain a minimum of:
a) One General Practitioner

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b) One General Practitioner /Health officer

c) Two emergency and critical nurse professional /professional nurses and two level 4 nurses
d) cleaners
e) runner
f) Integrated emergency, obstetric and surgical officer /family medicine specialist on call basis
g) guards
5.7.3.4 All health professionals working in the emergency room shall be trained on at least cardio-pulmonary
resuscitation
5.7.3.5 Drill-exercise of emergency case management shall be conducted on regular bases among the teams
working in the emergency service.
5.7.3.6 The staff shall have regular supportive supervision by senior staff or peer review or case conferences
every three months and it shall be documented
5.7.3.7 The hospital shall have personnel manual which also covers staff at the emergency services
5.7.4 Products
5.7.4.1 Emergency medicines, supplies and equipments shall be always readily available for emergency
services as per the hospital list.
5.7.4.2 At least the following emergency equipment and supplies shall be available:
a) Suction machine
b) Tracheotomy set
c) NG tube
d) Minor procedure set
e) Mobile examination lamp
f) IV stands
g) Resuscitation set on trolley,(blood pressure different size adult and pediatrics, stetscope, pulse
oxymetry
h) Intubation set
i) Ambu bags, pediatrics-small, medium, large
j) Oxygen supply: oxygen, cylinder with flow meter, trolley and nasal prongs, face mask
k) Dry autoclave (hot air oven.
l) Stretcher,
m) wheelchairs
n) Different types of splints
o) Patient screen, partition curtains
p) IV-Canulla different size
q) Bandage and gauze
r) Patient monitor with ECG
s) Diagnostic set(otoscope, reflex hammer, opthalmoscope
t) Back board

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u) Cervical collar
v) POP
w) Fetus cope
x) Glucometre
y) Per fuser
z) Defibllator/ optional
aa) Delivery set
bb) PEP
5.8. REHABILITATION SERVICES
5.8.1 Practices
5.8.1.1 At least physical therapy/ physiotherapy services shall be available in the hospital
5.8.1.2 There shall be specific treatment and/or procedure protocols for each service available and rendered
in the unit,
5.8.1.3 There shall be a protocol that the therapist (physical therapist/ physiotherapist) shall document the
entire plan in the patient’s medical records. A note shall be entered into the medical record at least
weekly or more frequently if there is a significant change in the patient’s status or treatment needs.
5.8.1.4 The physical therapist shall discuss the plan of care with the patient and family.
5.8.1.5 The physical therapy service shall be available during working time.
5.8.1.6 Visual and auditory privacy shall be offered and provided to all patients during evaluation and
treatment.
5.8.1.7 There shall be training service for patients on copping disability. It includes utilization of prostheses,
orthoses, wheelchairs, and walking aids.
5.8.1.8 There shall be a protocol or policy for safety and ethical practice of physical therapy that complies with
the six precepts for health care (safe, effective, patient-centered, timely, efficient and equitable).
5.8.1.9 There shall be patient education on prevention of:
a) Pressure sores in clients with sensory loss,
b) Contractures in clients with limb and/or trunk paralysis,and
c) Phantom limb pain for amputees,
5.8.2 Professionals:
5.8.2.1 The service shall be directed by a licensed professional physiotherapy
5.8.2.2 In addition, the hospital may have one physical therapist or professional physiotherapy who work
closely with treating general medical practitioner
5.8.2.3 There shall be multidisciplinary team in the rehabilitation service to plan for individual patients.
Referring general medical practitioner/social worker shall be involved in the process.
5.8.2.4 Continued improvement of technical skills and knowledge shall be encouraged and such opportunities
shall be facilitated for professionals by the hospital or health facility.
5.8.3 Premises
5.8.3.1 There shall be at least one physically separated room or area for rehabilitation and therapy

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5.8.3.2 The premise shall have waiting area with shade

5.8.3.3 The premises shall be located with direct access to inpatients and outpatients with clear labels.
5.8.3.4 The premises shall be handicap friendly and smooth pavement rail for wheelchairs.
5.8.3.5 There shall be enough space for assistive devices and appropriate accessories.
5.8.3.6 Private area for patients and staff when they need to change clothing before and after treatment shall
be available.
5.8.3.7 Separate toilet with hand washing facility in an accessible location, handicapped accessible,
handicapped adapted and well-ventilated shall be available.
5.8.3.8 Call bells shall be provided to patients in the physical therapy service who are not under visual
supervision.
Table 8 – Premises Required for the Rehabilitation Service
Premises required Area required
Physiotherapy room with waiting area 20 m2
Toilets Separate for male
and female

5.8.4 Products
5.8.4.1 All equipment shall be clean and functional
5.8.4.2 Equipment shall be stored in a safe and accessible place and shall not be stored in a public walkways
and hallways
5.8.4.3 Standard equipments and consumables which shall be available for rehabilitation services include
a) Physiotherapy mats j) POP cutter
b) Massaging coach k) Pulley
c) Splinting materials l) Chair and table
d) Balance boards m) Shelf for storing reference books and
e) Mirror personal items
f) Walking rail/ parallel bars, adult and n) Disposable glove
pediatric o) Cotton roll
g) Sticks p) Plastic apron
h) Crutches q) POP
i) Walking aids/ walking frames (adjustable) r) bandages (elastic and inelastic)
5.9. RADIOLOGICAL SERVICES
5.9.1Practices
5.9.1.1 The radiology service shall have written protocol and procedures that are reviewed at least once every
three years and implemented. These protocol and procedures shall include at least:
a) Safety practices;
b) Management of the critically ill patient;
c) Infection control, including patients in isolation;

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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
5.9.1.2 Protocol and procedures for radiology services shall be available to all staff in the radiology unit.
5.9.1.3 There shall be a written protocol for managing medical emergencies in the radiological suite. All
radiological staff shall be instructed in this protocol and know their roles in the case of such an
emergency.
5.9.1.4 All radiological examinations shall be seen by the requesting general medical practitioner/Integrated
emergency, obstetric and surgical officer /Family medicine specialist as early as possible.
5.9.1.5 The radiology service of the hospital shall have x-ray, Ultrasound service.
5.9.1.6 The radiology staffs shall make every effort to ensure that patients waiting for radiology services or
transport from radiology are safe while waiting
5.9.1.7 The radiology service unit shall be free of hazards to patients, care giver and staff.
5.9.1.8 Proper safety precautions shall be maintained against fire and explosion hazards, electrical hazards,
and radiation hazards.
5.9.1.9 The hospital shall get approval from the Ethiopian Radiation Protection Authority through periodic
inspection and hazards shall be promptly corrected if identified
5.9.1.10 The primary hospital shall have a protocol that radiology professionals shall use the TLD while in
duty.
5.9.1.11 Radiation workers shall be checked periodically for amount of radiation exposure by the use of
exposure meters or badge tests and this shall be documented
5.9.1.12 Signed reports shall be filed with the patient’s medical record and duplicate copies kept in the
service unit.
5.9.1.13 Requests by the attending general medical practitioner or health officer / Integrated emergency,
obstetric and surgical officer for x-ray, ultrasound examination shall contain a concise statement of
reason for the examination.
5.9.1.14 Reporting form shall have minimum information such as date, patient name, age, gender, findings
and name and signature of radiographer
5.9.1.15 X-ray films shall be labeled with minimum information such as date, name, age, gender, right/left
mark and name of radiographer
5.9.1.16 A radiation safety program including timely reporting of radiation safety findings shall be in place,
followed, and documented.
5.9.1.17 The professional/practitioner who delivered the radiology service shall be responsible for claims
arising from wrong findings
5.9.1.18 Radiology services shall be accessible to all requiring medical service units
5.9.1.19 The calibration of the x-ray and ultrasound shall be done periodically and documented the results.
5.9.2 Premises
5.9.2.1 Minimum number and size of rooms within radiology services are indicated below table

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Table 9 – Premises Required for the Radiological Service

Number of Area required
Premises required room in m2
Conventional x-ray room 1
Dark room, if necessary 1
Toilet for staff and patient As per ERPA
separately 2 standards
Patient dressing rooms 1
Waiting room 1
Duty room 1
Store room 1
2
For Ultrasound 1 10 m
5.9.3 Professionals
5.9.3.1 The radiology service shall be directed by licensed BSC professional in radiology.
5.9.3.2 A licensed radiographer shall be available at all time.
5.9.3.3 Trained dark room technician and cleaners shall be available in radiology service as full time.
5.9.4 Products
5.9.4.1 The following medical equipments shall be available for radiology services.
Table 9 – Professionals Required for the Radiological Service
Product Type Number Required
Standard conventional x-ray machine 1
Mobile x-ray machine (Optional)
Viewing boxes
Computer(Optional)
Ultrasound 1
Coach 1

5.9.4.2 All diagnostic equipment shall be regularly inspected, calibrated and maintained, and appropriate
records shall be documented.
5.9.4.3 All radiation generating equipment shall be installed with a building wall thickness that fulfills the
minimum criteria set by the Ethiopian Radiation Protection Authority.
5.9.4.4 Radiology service equipments shall be installed at central areas to all department services
5.9.4.5 At least the following radiation protection equipments shall be available in radiology services:
a) lead gloves
b) lead aprons
c) lead goggle
d) gonad shield
e) Other shields e.g. for pregnant women (if x-ray is highly indicated)
5.9.4.6 Safety procedures during practices and disposal of unfit for use equipments shall be installed as per
the requirements set by the Ethiopian Radiation Protection Authority during all procedures.

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5.10.LABORATORY SERVICES
5.10.1 Practice
5.10.1.1 The primary hospital laboratory shall have written quality policies for at least the followings:
a) Organization
b) Personnel
c) Equipment management
d) Purchasing and inventory
e) Documentation
f) Facility and safety
g) Occurrence management
h) Process control
i) Process improvement
j) Information management
k) Internal and external assessment
l) Customer handling
5.10.1.2 The primary hospital laboratory shall have written manuals for at least the followings
a) Laboratory safety
b) Specimen management
c) Laboratory handbook
5.10.1.3 The primary hospital laboratory should have adopted/customized guidelines for at least the
followings
a) Safety practice
b) TB Testing
c) HIV Testing
5.10.1.4 The primary hospital laboratory shall have written procedure for at least the followings
a) For all laboratory tests listed on clause 5.10.1.31
b) Turnaround time
c) Internal Quality control
d) Audit, preventive maintenance, and testing/operation of all equipment
e) Management of reagents, including availability, storage, and testing for accuracy
f) For collecting, identifying, processing, transportation and disposing of specimens(Preferred sample
type (venous, arterial, capillary, urine, spinal fluid, Type of anticoagulant, Sample volume considered
acceptable, Patient identification, Requirements for patient preparation and ,Requirements for storage
of specimens.
g) Laboratory disinfection, sterilization and waste management
h) Document and record control
i) Method verification

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j) External quality control

k) Contingency plan
l) Selecting and evaluating referral laboratories and consultants
m) Resolution of compliance
5.10.1.5 The primary hospital laboratory shall have periodic calibration report from authorized body as per
quality manual.
5.10.1.6 The hospital shall have standardized data collection instruments/forms and including at least the
followings:
a) Laboratory request forms
b) Laboratory report forms
c) Laboratory specimen and results registers
d) Quarterly/monthly reporting forms including
 Summary of tests conducted
 Summary of tests referred
 Summary of quality assurance report
e) Equipment and supplies inventory registers
f) Quality assurance record forms
g) Referral forms
5.10.1.7 The hospital shall develop monitoring and evaluation tools to assess at least once a year.
a) adherence to SOPs
b) adherence to safety guidelines
c) QA activities
d) Laboratory performance and workload
e) Laboratory services
5.10.1.8 The hospital shall have laboratory services including the emergency services for 24 hours a day
and 365 days a year.
5.10.1.9 Policies and procedures shall be documented and communicated to all personnel.
5.10.1.10 The laboratory shall conduct routine quality assessments to ensure reliable and cost-effective
testing of patient specimens.
5.10.1.11 Laboratory management shall review all operational procedures at regular intervals. The frequency
should be every four month (at least annually).
5.10.1.12 The process of analysis shall be specified by validated written or electronic procedures maintained
in and by the laboratory.
5.10.1.13 Laboratory staff shall test quality control materials as per manufacturer’s instruction and document
in combinations suitable to detect analytical error.
5.10.1.14 Request paper for testing shall provide:
a) Name of patient

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b) Medical recording number/unique identifier

c) Patient gender
d) Age
e) The name of the ordering physician or other person authorized to order testing
f) The clinician’s working address
g) Type of primary sample collected
h) The anatomic site where appropriate
i) The test requested
j) Pertinent clinical information as appropriate for purposes of test interpretation (Clinical Diagnosis)
k) Date and time of sample collection and receipt in the laboratory
l) Name of the laboratory
m) TAT
5.10.1.15 There shall be SOP or criteria developed for acceptance or rejection of clinical samples
5.10.1.16 The primary hospital laboratory shall monitor the transportation of samples to the laboratory such
that they are transported, within time frame, within temperature interval specified in the primary
sample collection manual or SOP and in a manner that ensures safety for carrier
5.10.1.17 The laboratory shall maintain a record of all samples received.
5.10.1.18 Laboratory shall have a procedure for storage of clinical samples if it is not immediately examined.
5.10.1.19 Patient samples shall be stored only for as long as necessary to conduct the designated tests (or
other permitted procedure) according to fixed storage times, and shall be destroyed safely and
confidentially after storage.
5.10.1.20 Once a sample is used, it shall be maintained in the laboratory for a specified period of time (or as
required by regulation) and at a temperature that ensures stability of the sample in the event the
sample is needed for retesting.
5.10.1.21 All primary hospital laboratory report:
a) Shall have reference (normal) ranges specific for age and gender.
b) Shall be retained by the laboratory such that prompt retrieval of the information is possible. The length
of time that reported data are retained shall be 10 years for legal reason minimal errors or loss of
patient test results.
c) Reports shall be filed with the patient's medical record and duplicate copies shall be filed in the
laboratory in a manner which permits ready identification and accessibility and with appropriate backup.
d) In the case of laboratory tests performed by an outside laboratory, the original report from such
laboratory shall be contained in the medical record.
e) Quality assured test results shall be reported on standard forms with the following minimum information
 Patient identification (patient name, age, gender,)
 Date and time of specimen collection
 The test performed and date of report.

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 The reference or normal range

 The laboratory interpretation where appropriate,
 The name and initial of the person who performed the test, and the authorized signature of the
person reviewing the report and releasing the results.
 Hospital address
f) Laboratory results shall be legible, without transcription mistakes and reported only to persons
authorized to receive.
g) The laboratory shall have policies and procedures in place to protect the privacy of patients and
integrity of patient records whether printed or electronic. Policies shall be established which define who
may access patient data and who is authorized to enter and change patient results, correct billing or
modify computer programs.
5.10.1.22 When reports altered, the record shall show the time, date and name of the person responsible for
the change.
5.10.1.23 Safe disposal of samples shall be in line with standards prescribed under infection prevention
5.10.1.24 Policies shall be established which define who may access patient data and who is authorized to
enter and change patient results, correct billing or modify computer programs.
5.10.1.25 No eating, drinking, smoking or other application of cosmetics in laboratory work areas or in any
area where workplace materials are handled.
5.10.1.26 No food and drink to be stored in the laboratory and safety signage shall be posted
5.10.1.27 The medical laboratory shall have safety guideline. In addition, the laboratory shall protect the
environment and public by assuring the health laboratory waste is disposed of legally and an
environmentally friendly manner.
5.10.1.28 Wearing of protective clothing of an approved design(splash proof), always fastened, within the
laboratory work area and removed before leaving the laboratory work area
5.10.1.29 The laboratory shall meet regularly with clinical staff regarding services and clinical interpretations
and documented.
5.10.1.30 The laboratory must keep a record of the complaint. The record shall include the nature of the
complaint, the date of occurrence, individuals involved, any investigations undertaken by the
laboratory and resolution.
5.10.1.31 The laboratory shall do the following tests:
a) Clinical chemistry:
 Blood glucose
 Uric acid
 Electrolyte
 Liver function tests
o ALP o ALT
o AST o GGT

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o Total bilirubine o Total protein

o Direct bilirubine o Albumin
 Renal function tests
o Urea
o Creatinine
b) Parasitology:
 Stool microscopy
 Blood film for malaria and other hemoparasite/ Malaria Rapid Test
c) Urine and body fluid analysis:
 Urine microscopy
 Urine chemical test
 Body fluid analysis ( cell count with diff , glucose, protein, , Acid Fast Stain , Gram stain)
d) Hematology:
 Complete blood count
 Peripheral morphology
 Blood group and RH
 Coagulation profile (PT, aPTT, INR,)
 Erythrocytic Sedimentation Rate
 Blood compatibility test(cross match)
e) Mycology:
 KOH test
 Indian Ink
f) Serology:
 Widal-weli felix  HCG
 H.Pylori Test ag/ab  ANA (Antinuclear Antibody)
 RPR (syphilis)  Fecal occult blood test
 C-reactive Proteins  Hcv
 ASO  HBv
 RF (Rheumatoid factor)  HIV rapid test
g) Bacteriology:
 Gram Stain
 AFB Stain
5.10.2 Premises
5.10.2.1 The hospital shall have a well organized, adequately supervised and staffed clinical laboratory with
the necessary space, facilities and equipment to perform those services commensurate with the
hospital’s needs for its patients.

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5.10.2.2 The laboratory working environment shall be kept organized and clean, with safe procedures for
handling of specimens and waste material to ensure patient and staff protection from unnecessary
risks at all time.
5.10.2.3 The laboratory shall have space allocated so that its workload can be performed without
compromising the quality of work, quality control procedures, and safety of personnel or patient
care services.
5.10.2.4 The laboratory shall have adequate lighting, ventilation, water, waste and refuse disposal. Work
areas shall be clean and well maintained. Precautions must be taken to prevent cross
contamination.
5.10.2.5 The laboratory shall have controlled temperature of refrigerator for reagents, blood sample,
calibrator, control materials which affect the analytical results.
5.10.2.6 Facilities shall provide a suitable environment to prevent damage, deterioration, loss or
unauthorized access.
5.10.2.7 The laboratory shall be located and designed to:
a) provide suitable, direct access for patients
b) Allow reception of deliveries of chemicals
c) Allow safe disposal of laboratory materials and specimens.
5.10.2.8 Doors shall be located in places where entry and exit is easy and does not interfere with the
laboratory benches or equipment. Laboratory doors shall not be less than 1 m wide to allow easy
access of equipment. In some areas, double doors, 1.2 m wide, shall be provided for passage of
large equipment, such as deep-freezes. All doors shall be opened towards the corridor.
5.10.2.9 The primary hospital laboratory shall have the following premises setup.
Table 10 – Premises Required for the Laboratory Service
Premises required No of rooms Area
required required
waiting room area 1 16 sq. m
Specimen collection room 1 12 sq. m
Hematology
Clinical chemistry 1 room 24sq m
Serology
Emergency shower and eye wash area
Parasitology, urine & body fluid analysis
Laboratory mini Blood bank room 1 12sq.m
Mycology and bacteriology 1 9 sq. m
Laboratory mini Store room 1 12 sq. m
Staff changing room /area with locker
Laboratory manager office ,Safety & Quality officer office 1 12 sq. m
Duty room 1 8 sq. m
Toilets for patients (Separate, 1 for Male and 1 for 2 2 sq. m each
female)
Toilet with shower for staff (Separate for Male and 2 2 sq. m each
female)

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5.10.2.10 The primary hospital may arrange the laboratory service in one main working room except
bacteriology with access to emergency shower, staff room, waiting area, store and toilets
5.10.2.11 The laboratory facilities shall meet at least the following:
a) The laboratory shall have a reliable supply of running water. At least two sinks shall be provided in each
room, one for general laboratory use and the other reserved for hand washing and shall have access to
hospitals reserve tank whenever there is water interruption.
b) Continuous power supply
c) Working surface covered with appropriate materials
d) Suitable stools for the benches. Bench tops shall be impervious to water and resistant to moderate heat
and the organic solvents, acids, alkalis, and chemicals used to decontaminate the work surface and
equipment.
e) Internal surfaces, i.e. of floors, walls, and ceilings shall be :
 Smooth, impervious, free from cracks, cavities, 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
f) Laboratory furniture is capable of supporting anticipated loading and uses. Spaces between benches,
cabinets, and equipment are accessible for cleaning.
g) Lockable doors and cupboards
h) Closed drainage from laboratory sinks (to a septic tank or deep pit)
i) Deep pit to discard contaminated material or access to a simple incinerator
j) Separate toilets/latrines for staff and patients
5.10.2.12 Emergency of safety services such as deluge showers and eye-wash stations, fire alarm systems
and emergency power supplies shall be included in the laboratory services design specifications
5.10.3 Professionals
5.10.3.1 The Primary hospital laboratory services shall be directed by a licensed medical laboratory
technologist with 2 years of experience.
5.10.3.2 Medical Laboratory staff shall be present at the hospital to provide laboratory service at all times.
5.10.3.3 Students and other staff on attachment shall work under the direct supervision of a licensed
medical laboratory technologist.
5.10.3.4 The Laboratory service shall have and maintain job descriptions, including qualifications to perform
specific functions.
5.10.3.5 The Laboratory management shall provide adequate training, continuing education or access to
training for technical staff, and assess staff competency at regular intervals. and documented
5.10.3.6 Laboratory staff shall, at all times, perform their functions with adherence to the highest ethical and
professional standards of the laboratory profession.
5.10.3.7 The primary hospital shall have the following minimum laboratory staffing requirements.

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a) Medical Laboratory Technologists (BSc): #5

b) Medical Laboratory Technologist (BSc) for QC/QA: #3
c) Additional Laboratory technologist and technicians (depending on the work load)
d) Supportive staff (clerk, cleaner)
5.10.4 Products
5.10.4.1 Laboratory shall be furnished with all items of equipment required for the provision of services.
5.10.4.2 All equipment shall be in good working order, routinely quality controlled, and precise in terms of
calibration & Maintenance.
5.10.4.3 Laboratory shall establish a programme that regularly performs proper calibration and function of
instruments and monitors demonstrates reagents and analytical system and this shall be
documented.
5.10.4.4 When equipment is removed from the direct control of the laboratory or is repaired or serviced, the
laboratory shall ensure that it is checked and shown to be functioning satisfactorily before being
returned to laboratory use or operation.
5.10.4.5 Laboratory shall have a documented and recorded programmed of preventive maintenance which
at a minimum follows the manufacturer’s recommendation.
5.10.4.6 Equipment shall be maintained in a safe working condition. This shall include examination of
electrical safety, emergency stop devices. Whenever equipment is found to be defective, it shall be
taken out of service and clearly labeled.
5.10.4.7 There shall be a written chemical hygiene plan(material safety data sheet) that defines the safety
procedures to be followed for all hazardous chemicals used in the laboratory. The plan defines at
least the following:
a) The storage requirements
b) Handling procedures
c) Requirements for personal protective equipment
d) Procedures following accidental contact or overexposure
e) The plan is reviewed annually, and updated if needed, and is part of new employee orientation and
the continuing education program.
5.10.4.8 The following minimum equipments and consumables shall be available in the hospital laboratory.
a) Autoclave i) Slide
b) Clinical chemistry analyzer(Automated or j) Staining reagents
semi automated) k) Rapid test kits
c) Glucometer l) CSF analysis reagents
d) Power surge protectors m) KOH
e) Weighing balance n) Haemoglobinometer
f) Micropipettes of different volumes o) Hematology analyzer ( Automated)
g) Timer with alarm p) Blood roller/mixer
h) Microscope q) Water bath

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r) Refrigerator y) Deep freezer

s) Binocular microscope x10, x40, x100 z) Centrifuge
t) Haemocytometer aa) Distillation unit
u) Microhematocrit centrifuge bb) All serological test kits
v) Microhematocrit reader cc) Shaker
w) Differential counter dd) All necessary bacteriology equipment
x) Tally counter
5.11.PHARMACEUTICAL SERVICES
5.11.1 Practices
5.11.1.1 Dispensing and Medication Use Counseling
5.11.1.2 Standard operating procedure for dispensing and medication use counseling shall be established to
ensure patients’ safety and correct use of medications.
a) Dispensing prescriptions shall be legible, written by authorized prescriber and complete. Complete
prescription must contain at least the following information and the prescriber shall complete all these
information:
 Name of patient, sex, age, weight and card
 Diagnosis and allergy
 Name of the medicine, strength, dosage form, dose, frequency, and route of administration
 Duration of treatment
 Prescriber’s name, qualification
 Dispenser’s name, qualification
b) The containers used for dispensing shall be appropriate for the medicines dispensed and all containers
intended for medicines shall be protected and kept free from contamination, moisture and light.
c) All medicines to be dispensed shall be labeled and the labels shall be unambiguous, clear, legible and
indelible. The following minimum information shall be indicated on the label/sticker:
 The generic name of the medicine or each active ingredient, where applicable;
 The strength, dose, frequency of administration and total quantity;
 The name of the person for whom the medicines are dispensed;
 The directions for use and route of administration tailored to patient or caregiver literacy and
language;
 The name of the dispenser;
 Date of dispensing;
 Expiry date
 Special precautions as applicable
d) Filled prescriptions shall be signed and accountability must be accepted by the evaluator and counselor
pharmacist.
e) Each primary hospital shall establish and implement policies, guidelines and/or procedures for reporting

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any errors or any suspicion in administration or provision of prescribed medications. The individualized
information for patients with chronic illnesses medication program using standardized information
tracking formats and update patient medication profile during each refill visit shall be kept in the
pharmacy.
5.11.1.3 Control of Drug Abuse, Toxic or Dangerous Drugs
a) The primary hospital shall establish Policies and procedures to control the administration of narcotic
drugs and psychotropic substances with specific reference to the duration of the order and the dosage
in accordance with relevant laws.
b) A record of the stock on hand and of the dispensing of all these drugs shall be maintained in such a
manner that the disposition of any particular item may be readily traced.
c) All controlled substances (narcotic and psychotropic drugs) shall be dispensed to the authorized health
professional designated to handle controlled substances by a licensed pharmacist in the hospital. When
the controlled substance is dispensed, the following information shall be recorded into the controlled
substances (proof-of-use. record)
 Name and signature of pharmacist dispensing the controlled substance
 Name and signature of authorized health professional receiving the controlled substance.
 The date and time controlled substance is dispensed.
 The name, the strength, and quantity of controlled substance dispensed.
 The serial number assigned to that particular record, which corresponds to same number recorded
in the pharmacy’s dispensing record.
d) When the controlled substances are not in use, they shall be maintained in a securely locked,
substantially constructed cabinet or area. All controlled substance storage cabinets shall be
permanently affixed. Controlled substances removed from the controlled substance cabinet shall not be
left unattended.
e) The administration of all controlled substances to patients shall be carefully recorded into the standard
record for controlled substances and returned back to the pharmacist upon refill of controlled
substances. The following information shall be recorded during administration to patients.
 The patient’s name, card number
 The name of the controlled substance and the dosage administered.
 The date and time the controlled substance is administered.
 The signature of the practitioner administering the controlled substance
 The wastage of any controlled substance, if any.
 The balance of controlled substances remaining after the administration of any quantity of the
controlled substance
 Day-ending or shift-evening verification of count of balances of controlled substances remaining
and controlling substances administered shall be accomplished by two (2) designated licensed
persons whose signatures shall be affixed to a permanent record.

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f) All partially used quantities of controlled substances shall be recorded in to the control substance
record and returned back to the responsible pharmacist for disposal.
g) All unused and unopened quantities of controlled substances which have been removed from the
controlled substance cabinet shall be returned to the cabinet by the practitioner at the end of each shift.
h) Any return of controlled substances to the pharmacy in the hospital shall be documented by a licensed
pharmacist responsible for controlled substance handing in the hospital.
i) The hospital shall implement procedures whereby, on a periodic basis, a licensed pharmacist shall
reconcile quantities of controlled substances dispensed in the hospital against the controlled substance
record. Any discrepancies shall be reported to the Director of the respective medical services and to the
Chief Clinical Officer/Chief Executive Officer of the hospital. Upon completion, all controlled substance
records shall be returned to the hospital’s pharmacy by the designated responsible person.
j) The hospital shall submit regular report to the appropriate organ regarding the consumption and stock
of controlled drugs.
k) The hospital through drug and therapeutic committee shall establish policies and procedures for the
provision of Inpatient Pharmacy Services, Emergency Pharmacy Services, outpatient pharmacy
service respectively which shall comply with the standards stated under dispensing and medication use
counseling when appropriate
l) The hospital shall have one inpatient pharmacy managed by a licensed pharmacist.
m) Medication education shall be delivered to patients or their caregivers upon discharge by the
pharmacist as appropriate.
n) The drug and therapeutic committee of the hospital shall develop/adopt and implement antimicrobial
prescribing, dispensing and usage policy
o) Emergency pharmacy service shall be available for 24 hours a day during non-working hours the
pharmacist shall prepare and complete the emergency trolley.
p) Orders received by words of mouth or through telephone during emergency (in case of immediate
administration is necessary, no appropriate alternative treatment is available and when it is not
reasonably possible for the general medical practitioner to provide a written prescription prior to
dispensing) shall latter be endorsed by the prescriber and be documented in writing within 24 hours.
The quantity shall be limited to emergency period only.
q) The responsible pharmacist shall who represented all pharmacy service take the duty to coordinate and
prepare medicines lists and ambulance kits for the hospital based on national primary hospital’s
medicine list and he/she has to exert all the necessary efforts to ensure continuous availability of
medicines for each unit and hospital ambulances.
r) Each pharmacy, in the hospital dedicated to supply of medicines, shall record patient medication
information and ensure correct use of medications.
s) The drug shall be dispensed until 1month for normal prescription 15days for narcotic and psychotropic
prescription

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5.11.1.4 Adverse Drug Event/ Pharmacovigilance

a) The primary hospital pharmacy shall appoint an ADE (adverse drug event) focal person responsible for
the collection, compilation, analysis and communication of adverse drug reaction, medication error and
product quality defect related information to the DTC and appropriate organ.
b) Health professionals of the hospital shall be responsible to report suspected ADE cases to the ADE
focal person.
c) The primary hospital DTC shall discuss and make necessary recommendations to the hospital
management for decision on adverse drug event reported within the facility.
d) The primary hospital pharmacy shall consistently update the safety profile of medicines included in the
formulary list for immediate medicines use decisions and consideration during the revision of the list.
e) Adverse medication effects shall be noted in the patient’s medication record
f) All the ADE reports, patient identity, reporters and medicine trade names shall be kept confidential
until verified by concerned authority.
g) The reporting of ADE shall be done by the national ADE prepaid yellow form prepared by regulatory
5.11.1.5 Medicines Supply and Management
a) A drug and therapeutics committee (DTC) representing different service units of the hospital shall be in
place for selection of medicines and other medical items and developing the formulary list as well as
policies and guidelines on managing medicines based on the medicine lists for primary hospitals.
b) The purchase of medicines shall be the responsibility of a pharmacist who is assigned to manage and
control the hospital pharmaceutical supply and
c) The primary hospital shall have written policies for the procurement of medicines from government and
private suppliers. These policies shall be prepared by the DTC and approved by the
management/board of the hospital. The procurement policy must ensure at least:
 The right source of medicines
 Medicines availability
 Safety, quality and efficacy of medicines
 Transparency of the procedure and documentation
 Minimal decision points
 Flexibility to respond for emergency situations
 Compatibility with the state and national laws of the country
 Effective batch recall of medicines when necessary
d) The hospital central medical store shall be responsible to display or disseminate new arrivals or
alternative medicines to each service delivery points.
e) The hospital shall be responsible to make sure that medicines promotion made by suppliers or
manufacturers in the hospital premises is made by a licensed pharmacist in accordance with the
country’s laws.
f) The hospital shall be responsible to make sure that donation of medicines has been made in

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accordance with the country’s laws.

g) There shall be a pharmacist assigned as medicine Supply Management Officer that is responsible for
the procurement, stock management, warehouse management, distribution of medicines and disposal
of medicine waste. There shall be also a responsible pharmacy personnel assigned for receiving,
storage, issuing, recording, monitoring and reporting.
h) The storage condition shall provide adequate protection to the medicines from all environmental factors
until the medicines is delivered to the patient.
i) The primary hospital shall ensure all areas where medicines are stored are of acceptable standards
(palletized or shelved, easy for free movement, ventilated, rodent free, temperature and moisture
controlled and others. for a medicine store.
j) Hospital store shall ensure that all medicine storage areas are inspected regularly to ensure that:
 Medicines are stored and handled in accordance with the medicines manufacturer’s requirements
and this standard
 Expired or obsolete medicines are stocked separately until disposition
 Medicines requiring special environmental conditions shall be stored accordingly
 Temperature and humidity are maintained according to manufacturer’s requirement
 Stock levels are adequate to ensure the continuous supply and acceptability of medicines at all
times, including the availability of essential medicines.
 Inflammable substance are stored separately and in an appropriate manner
 Disinfectants and preparations for external use are stored separately from medicines for internal
use
k) Special storage conditions shall be maintained for medicines requiring cold chain system, controlled
substances, inflammable substances and medical gases, if any.
l) Firefighting equipment or system shall be installed to medicines storage places
m) Distribution of medicines within a hospital shall be under the direction and control of a pharmacist who
assigned as DSM focal person and must be in accordance with the policy developed by DTC. All
issuing activities shall be made using official and serially numbered vouchers.
n) There shall be written SOPs on how supplies of stock are to be obtained from the medical store.
Procedures must define normal action to be taken by pharmacy personnel for routine stock
replacement and action to be taken in the case of incomplete documentation or other queries.
o) Written procedures shall be available for the return of expired, damaged, leftover and empty packs from
outlets to medical store to prevent potential misuse.
p) Daily medicine consumption at different outlets of the hospital shall be recorded, compiled and
analyzed for the appropriate supply and use of medicines.
q) The hospital pharmacist who is responsible for the management of medicines should conduct regular
medicine use studies to ensure maximum patient benefit from the formulary list
r) The DTC should be responsible for developing policies and guidelines on how to organize and conduct

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medicines use studies.

5.11.1.6 Extemporaneous Pharmaceuticals Preparations /optional/
a) Written procedures/SOPs for center based pharmaceutical preparations shall be established for
preventing errors, drug-drug interactions and drug contamination. This SOP shall contain an approved
Master Formula for each type of preparation that shows the list of ingredients and their quantities
required for the formulation of a specified amount of the preparation
b) The pharmacist responsible for pharmaceutical preparations shall ensure that quality is built into the
preparations of products.
c) Ingredients used in preparations shall have their expected identity, quality, and purity and shall be from
legally licensed sources.
d) Pharmaceutical preparations shall be of acceptable strength, quality and purity, with appropriate
packaging and labeling, and prepared in accordance with good compounding practices, international
standards, and relevant scientific data and information. Labels on compounded products for individual
patient shall have a minimum of the following information:
 Patient's name
 Name of the compounding pharmacist
 Name and address of the compounding institution
 A complete list of ingredients and preparation name
 Strength
 Quantity of each ingredients and total quantity
 Directions for use
 Date of preparation
 Beyond-use date
 Storage condition
 Batch number
e) Critical processes shall be validated to ensure that procedures, when used, will consistently result in the
expected qualities in the finished preparation.
f) Appropriate stability evaluation shall be performed or determined using international standards for
establishing reliable beyond-use date to ensure that the finished preparations have their expected
potency, purity, quality, and characteristics, at least until the labeled beyond-use date.
g) Written procedures and records shall exist for investigating and correcting failures or problems in
compounding, testing, or in the preparation itself. Pharmaceutical preparations compounded in the
center shall be packaged in containers meeting standard requirements mentioned under the official
national or international standards for such preparations.
5.11.1.7 Clinical Pharmacy Services
a) The primary hospital shall establish policies and procedures for the provision of clinical pharmacy
services through drug and therapeutic committee.

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b) Patient-specific medication therapy information must be evaluated and a drug therapy plan shall be
developed by the pharmacist mutually with the patient, the prescriber and nurse as appropriate.
c) The pharmacist shall review, monitor and propose for modification and decide of the therapeutic plan
in case of adverse effects, patient non compliance and evidence-based efficacy problem and as
appropriate, in consultation with the patient, prescriber and nurse.
d) Through prescription and medication history monitoring, the pharmacist shall identify problems or
opportunities for optimizing treatment and hence safeguard the patient and ensure the optimal use of
medicine.
e) The primary hospitals (drug and therapeutic committee) shall develop/adopt and implement policy on
antimicrobial prescribing, dispensing and usage.
f) As a member of the health care team, the pharmacist shall attend and participate at multidisciplinary
ward rounds/morning meetings and contribute to patient care through the provision of medicine
information, dose calculations and adjustment, assisting in the rational prescribing decision, alternative
regimens and reducing the frequency and duration of medication errors
5.11.1.8 Medicine/Drug Information Services
a) The hospital pharmacy shall be responsible to provide medicines information services to hospital staff
and patients
b) The medicine information service shall be part and parcel of the day-to-day activities of the hospital
and shall provide relevant and unbiased information to health care professionals and the public.
c) The medicine information service shall include provision of reference materials such as medical and
medicines related books, journals, medicine profiles, electronic information, CD-ROM, relevant
formularies and manufacturers’ information and updated list of medicines available in the hospital
central medical store to health care professionals
d) The service shall be available at least during normal pharmacy working hours.
5.11.1.9 Medicine Waste Management and Disposal
a) The disposal of medicine wastes shall be in compliance with the medicines waste management and
disposal directives issued by regulatory
b) The primary hospital shall take responsibility, through supportive policies and procedures for the
environmental and societal safety by efficiently managing the medicines wastes.
c) All personnel’s involved in medicines waste handling shall be trained and/ or well informed about the
potential risks of hazardous medicines waste and their management.
d) All personnel’s involved in handling medicines waste shall wear protective devices like apron, plastic
shoes, gloves, head gears and eye glasses when appropriate.
e) General wastes shall be collected daily from the pharmacy and placed in a convenient place outside
the pharmacy to facilitate coordinated disposal by the hospital.
f) Solid wastes from the pharmacy shall be categorized as “hazardous” and ‘non-hazardous” and shall
be collected separately for proper treatment.

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g) All hazardous chemicals spills shall be immediately reported to head of the pharmacy or responsible
person for safety (if available) to minimize the risk and take immediate action.
h) Spillages of low toxicity shall be swept into a dust pan and placed into a suitable container for that
particular chemical and dispose accordingly.
i) medicines in single dose or single use containers which are open or which have broken seals,
medicines in containers missing medicine source and exact identification (such as lot number., and
outdated medications shall be returned to the pharmacy for disposal.
j) The hospital shall form a medicines disposal committee to ensure safety, accountability and
transparency.
k) Disposal of medicines waste shall be supported by proper documentation including the price of the
products for audit, regulatory or other legal requirements.
5.11.1.10 Recording
a) Each hospital shall maintain records to assure that patients receive the medications prescribed by a
medical practitioner and maintain records to protect medications against theft and loss.
b) There shall be a standardized Prescription Registration Book for recording prescriptions and
dispensed medicine. A computerized dispensing and registration system with backup can be used
instead if available.
c) Each patient with a chronic disease shall have a separate Patients Medication Profile Card (PMP) that
should be filled appropriately with all the relevant information for each patient. A computerized system
with backup can be used instead if available.
d) Controlled and non-controlled prescriptions shall be documented and kept in a secure place that is
accessible only to the authorized personnel for at least five and three years respectively.
e) Patient and medication related records and information shall be documented and kept in a secure
place that is easily accessible only to the authorized personnel
f) Every transaction related with medicines should be recorded on stock control cards and/or
computerized stock control system in the medical store and dispensaries.
g) medication prescription shall be stored for 2year for normal prescription and 5year for narcotic and
psycotropic prescription
5.11.1.11 Billing
a) Medicines shall be received and issued using standard receiving and issuing vouchers with serial
number licensed by the appropriate finance bureau of the government. Issuing and receiving of
medicines has to be signed by both the receiver and issuer and approved by an authorized
pharmacist. Receiving and issuing vouchers shall have the following minimum information.
 Name of medicines received and issued
 Unit of measurement, quantity and source (supplier’s or manufacturer’s name) of medicines
 Expiry date and batch number
 Unit and total prices

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 Date received and issued

 Name and signature of receiver and issuer
 Address of the hospital
b) All medicines issued from the dispensary shall be dispensed/sold using standard sales ticket with
serial number licensed by the appropriate finance bureau. Sales tickets have to be signed and
stamped.
c) Dispensing pharmacies shall use a standard stamp and seal for approving legal transactions
d) Writing one bill for two clients shall be forbidden
e) The consumer has the right to know the exact price of a prescription before it is filled
f) The hospital shall ensure that each customer has the right to get receipt which has the following
minimum information about medicines dispensed
 Name of patient
 Name and dosage form of medicines dispensed
 Unit of measurement and quantity
 Unit and total prices
 Date
 Signature of dispenser and cashier
 Address of the hospital
g) The patient has the right to return drug wrongly dispensed even after receipt is given
h) Medication price list shall be prepared by central drug store manager, verified by pharmacy
accountant approved by pharmacy head and posted for the community and professional with
authorized stamp.
5.11.1.12 Organization Management and Quality Improvement
a) A multidisciplinary drug and therapeutic committee chaired by the medical director and supported by a
licensed pharmacist representing the hospital pharmaceutical services as a secretary must be
functional for the overall improvement of pharmaceutical services in the hospital
b) The pharmaceutical services shall be represented by a licensed pharmacist in every management
meetings of the hospital.
c) Customer satisfaction survey on pharmaceutical services shall be conducted at least once in a year
and measures shall be taken in accordance with survey findings.
d) There shall be a program of continuous quality improvement for the pharmaceutical service that is
integrated into the hospital continuous quality improvement program and includes regularly collecting
and analyzing data to help identify pharmaceutical service problems and their extent, and
recommending, implementing, and monitoring corrective actions on the basis of these data.
e) The pharmaceutical service shall have in effect a patient profile system for monitoring medicine
therapy. This system shall be used by the hospital to identify inappropriate prescribing practices and
develop interventions.

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f) The medicines supply and management officer shall inspect all patient care areas in the hospital,
where medicines intended for administration to patients are stored, dispensed, or administered at least
once every two months. The pharmaceutical service shall maintain a record of the inspections and
action taken for identified problems
g) Validity of prescription shall be verified by pharmacist according to prescription completion mentioned
5.10.1.2a .If not He/she shall return the prescription until it is completed
h) pharmacy service(product +service) shall be audited every six month.
5.11.2 Premises
5.11.2.1 The design and layout of the pharmacy shall permit a logical flow of work, effective communication
and supervision and ensure effective cleaning and maintenance and must minimize the risk of
errors, cross-contamination and anything else which would have an adverse effect on the quality
of medicines and service delivery.
5.11.2.2 The area(s) of counseling and evaluating shall be arranged or constructed in such a manner that it
provides adequate space, have professional look and ensure reasonable privacy to the patient at
all times and eliminate background noise as much as possible
5.11.2.3 Dispensing counter shall be designed to secure patient privacy and confidentiality
5.11.2.4 All parts of the premises shall be maintained in an orderly and tidy condition.
5.11.2.5 The external appearance of pharmacies shall be painted white and inspire confidence in the
nature of the health care service that is provided and portray a professional image.
5.11.2.6 Entrances, dispensing counters and doorways shall be accessible to persons with disability.
5.11.2.7 The dispensing environment (dispensing counter and counseling area and evaluator area) shall
ensure confidentiality and allow simultaneous service delivery for multiple customers by multiple
providers.
5.11.2.8 A waiting area(s), which is under cover, shall be situated near the dispensing area, areas for
counseling/consultation and the provision of information.
5.11.2.9 The pharmacy premises shall be clearly demarcated and identified from the premises of any other
business or practice. The location of the pharmacy premises shall take into account patient
convenience and ease of loading and unloading of medicines.
5.11.2.10 Careful consideration shall be given to the overall security of the pharmacy. It must be lockable
and shall prevent any unauthorized entry
5.11.2.11 A security policy shall be implemented which is designed to ensure the safety of both staff and
medicines, and shall take account of local crime prevention advice.
5.11.2.12 The responsible pharmacist of a pharmacy shall ensure that every key which allows access to a
pharmacy is kept only with him/her or the designated personnel.
5.11.2.13 A procedure shall be in place to ensure access to pharmacy premises in an emergency situation.
5.11.2.14 Ceilings, floor and walls of dispensaries and store shall be constructed to protect safety of
medicines from burglary, rodents, direct sunlight, moisture and damages.

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5.11.2.15 Medicines shall be shelved a minimum of 20cm above the floor, 1mwide between shelves and
50cm away from the wall and ceiling. If pallets are used, there shall be 20cm above the floor, one
meter between pallets and 50cm away from the wall
5.11.2.16 The pharmacy premises shall have the following minimum space
a) Waiting area for OPD pharmacy
b) Emergency pharmacy room-20 m2(optional)
c) Inpatient dispensing room-20 m2
d) Outpatient dispensing with counseling room-25 m2
e) Compounding room-20 m2 (optional)
f) Cashier area separate
g) Medical store intended for medicines, vaccines, lab reagents and medical equipments storage-40 m2
h) DIC room-9 m2
i) Office
5.11.3 Professionals
5.11.3.1 The overall hospital pharmaceutical services shall be directed by a licensed pharmacist with
minimum of 2 year experience
5.11.3.2 The pharmacist shall make sure that the patient has all supplies, information and knowledge
necessary to carry out the drug therapy plan
5.11.3.3 In addition, the hospital shall be coordinated by licensed pharmacists for each of the following
pharmacies:
a) Outpatient pharmacy 3 pharmacist
b) Inpatient pharmacy1
c) Central medical store 1 pharmacy technician
d) DIC and ADR focal
e) Clinical pharmacy 1
f) Pharmacy director /DSM Officer 1
5.11.3.4 The dispensing of all prescriptions and medication use counseling shall be carried out by licensed
pharmacists and pharmacy technicians to their levels.
5.11.3.5 The hospital pharmacy shall have pharmacy clerks, cashiers, cleaners and porters.
5.11.3.6 The pharmacy professionals shall ensure that written job descriptions are prepared for all staff and
that all staff are acquainted with their job descriptions and responsibilities
5.11.3.7 The requirements of the national and/or state medicine related laws with respect to persons
handling medicines and related products shall be adhered.
5.11.3.8 The pharmacy professionals for the practical training of pharmacy students shall comply with the
necessary duties and responsibilities stated in the country’s medicines related laws.
5.11.3.9 The pharmacy personnel shall wear white gown or any color accepted by the hospital with easily
readable name tag (badge) that include their name and status, such as junior pharmacist, senior
pharmacist, pharmacy technician or any other.

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5.11.3.10 The pharmacist for clinical pharmacy services shall have access to patient specific
medication therapy information sheet to follow the patient medication
5.11.3.11 The clinical pharmacy professionals shall attend ward round and outpatient department service
with medical team
5.11.4 Products
5.11.4.1 The hospital may have its own medicine list in accordance with the prevailing diseases
epidemiology and within the framework of the national primary hospitals medicine list prepared by
Ethiopia regulatory body.
5.11.4.2 All hospital’s pharmacy service shall have fire extinguisher, refrigerators, deep freezers, security
alarms and racks/ shelves.
5.11.4.3 The medicine information service in the pharmacy shall maintain a current collection of reference
materials such as books, journals, drug profiles, electronic information, relevant formularies and
manufacturers’ information and other furniture.
5.11.4.4 Hand-washing facilities shall be provided in the toilet area together. Facilities must include readily
available water, soap and clean towels or other satisfactory means of drying the hands.
5.11.4.5 The hospital pharmacy shall be provided with consistent electricity, telephone, office furniture and
internet services, computers and other necessary supplies.
5.11.4.6 In summary, minimum standard for pharmacy equipment and facilities at different service delivery
points shall be as follows.
Sr.No Equipment and facilities Pharmaceutical Service Delivery Points
Outpatient and Inpatient pharmacy Medical
emergency Store
Pharmacy
1 Refrigerators and deep freezers X X X
with thermometer
2 Wall thermometers X X X
3 Ventilator or AC as required X X X
4 Tablet counter X X
5 Scientific calculator X X X
6 Table and chair X X X
7 Scissors X X X
8 Adult and pediatric weighing balance X X X
9 Electric light X X X
10 Tap water access X X X
11 Toilet and shower X X X
12 Telephone line X X X
13 Internet facility access For DIS Book, X X X
journal, brochure
14 Bean balance(optional)
15 Log book (optional)
16 Fixed cabinet for preparation
(optional)

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5.12. SOCIAL WORK SERVICES

5.12.1 Practices
5.12.1.1 This service shall provide in Comprehensive specialized hospital, General hospital, Primary hospital
and medical plaza health institutions.
5.12.1.2 The social work service shall have written policies and procedures that are reviewed regularly.
5.12.1.3 The policies and procedures concerning the social work services shall address the following areas:
a) Counseling,
b) Discharge management and planning,
c) Social work assessment
d) Consultation and referral to support groups, centers and/or organizations
e) Patient advocacy
f) Community liaison and education.
5.12.1.4 The social work service shall have a protocol to ensure that social work services are offered to all
needy patients.
5.12.1.5 The social work services shall have criteria for identifying at the time of admission and promptly
assessing high-risk patients in need of psychosocial intervention and/or discharge planning.
5.12.1.6 There shall be a system for clinical staff to refer patients directly to the social work service
5.12.1.7 Patient’s families or guardians should be included in services provided by the social work service
unit, where indicated.
5.12.1.8 The social work service unit shall assist patients directly or indirectly in identifying the need for
implementing and verifying guardianship as part of discharge planning.
5.12.1.9 The social work service unit shall report victims of abuse to the appropriate body.
5.12.1.10 When a patient is transferred or linked to another health care facility after discharge, the social
work service unit shall assure that relevant social work service documentation or information is
provided to the facility in order to assure continuity of care.
5.12.1.11 The hospital shall have a program of continuous quality improvement for social work that is
integrated into the hospital continuous quality improvement program and pertains to the scope of
social work services provided.
5.12.1.12 Adoptions by individuals or groups shall abide the laws and regulations of the country.
5.12.2 Premises
5.12.2.1 The hospital shall have a well organized, adequately staffed separate social work service unit or
area for Patient and family interview, Handling of confidential phone calls & archive
5.12.3 Professionals
5.12.3.1 All social work services given by the hospital shall be under the direct supervision of a social
worker or sociologist or psychologist or a professional nurse with experience in social work.
5.12.3.2 All the social work staff shall be given multidisciplinary patient care training and the information
about their training shall be documented.

56 © ESA
 CES 308

5.12.4 Products
5.12.4.1 The social work service unit shall have the following products and facilities:
a) Telephone
b) The necessary forms and documenting means for referral, adoption and transfer
c) Computer
d) Filing cabinet

© ESA 57
CES 308

Bibliography
 Ethiopian Food, medicine and Healthcare Administration and Control Proclamation No. 661/2009
 Ethiopian Food, Medicine and Healthcare Administration and Control Regulation No. 189/2010
 Federal Hospitals Administration Council of Ministers Regulation No. 167/2009
 The Ethiopian Hospital Reform and Implementation Guidelines, March 2010
 National Health Policy of the Transitional Government of Ethiopia, 1993
 National Drug Policy of the Transitional Government of Ethiopia, November 1993
 Commercial Code of Ethiopia
 Criminal Code of Ethiopia
 Medicines Waste Management and Disposal Directive No 2/2011
 Ethiopian National Guideline for Health Waste Management, 2008
 Ethiopian Building Proclamation, No. 624/2009
 National referral guideline
 National nursing care service standard

58 © ESA
 Organization and Objectives
The Ethiopian Standards Agency (ESA) is the national standards body of Ethiopia
established in 2010 based on regulation No. 193/2010.ESA is established due to the
restructuring o f Quality a nd Standards Authority o f Ethiopia ( QSAE) w hich w as
established in 1998.

ESA’s objectives are:-

 Develop Ethiopian standards an d establish a system that enable to

Ethiopian Standards Agency
የኢትዮጵያ የደረጃዎች ኤጀንሲ

check whether goods and services are in compliance with the

required standards,
 Facilitate the country’s technology transfer through the use of
standards,
 Develop national standards for local products and se rvices so as to
make them competitive in the international market.
Ethiopian Standards
The Ethiopian Standards are developed by national technical committees which are
composed of different stakeholders consisting of educational Institutions, research
institutes, government or ganizations, certification, inspection, and testing
organizations, regulatory bodies, consumer association etc. The requirements and/
or recommendations contained in Ethiopian Standards are consensus based that
reflects the interest of the TC representatives and also of comments received from
the public and other sources. Ethiopian Standards are approved by the National
Standardization Council and are kept under continuous review after publication and
updated regularly to take account of latest scientific and technological changes.
Orders f or a ll Ethiopian Standards, International Standard and ASTM standards,
including electronic versions, should be addressed to the Documentation and
Publication Team at the Head office and Branch (Liaisons) offices. A catalogue of
Ethiopian Standards is also available freely and can be accessed in f rom our
website.
ESA has the copyright of all its publications. No part of these publications may be
reproduced in any form without the prior permission in writing of ESA.
International Involvement
ESA, representing Ethiopia, is a member of the International Organization for
Standardization ( ISO), and Codex Alimentarius Commission ( CODEX). It also
maintains close working relations with the International Electro-technical
Commission (IEC) and American Society for Testing and Materials (ASTM).It is a
founding member of the African Regional Organization for standardization
(ARSO).

More Information?
Contact us at the following address.
The Head Office of ESA is at Addis Ababa.

 011- 646 06 85, 011- 646 05 65

 011-646 08 80
 2310 Addis Ababa, Ethiopia
E-mail: info@ethiostandards.org,
Website: www.ethiostandards.org
Standard Mark