HeFRA


SPECIFIC REQUIREMENT FOR A PRIMARY HOSPITAL

A Hospital shall have the following minimum requirements under the sections of personnel, premises, safety and equipment.

Personnel

• At least two Medical Doctors ( must have at least five years post qualification experience and to be in good standing with the Medical and Dental Council of Ghana)
• At least eight registered nurses/ nurse practitioners/midwives (must have at least five years post qualification experience and in good standing with Nursing and Midwifery Council.)
• 2 Part Time Specialists
• 1 Pharmacist (must have at least five years post qualification experience and to be in standing with the Pharmacy Council of Ghana.)
• 4 Hospital Assistants
• 4 Nurse Assistants (must be in good standing with Nursing and Midwifery Council.)
• 1 Radiographer (must have at least five years post qualification experience and to be in good standing with the Allied Health Professionals Council of Ghana)
• 1 Physiotherapist (must have at least five years post qualification experience and to be in good standing with the Allied Health Professionals Council of Ghana)
• 1 Laboratory Scientist (must have at least five years post qualification experience and to be in good standing with the Allied Health Professionals Council of Ghana)
• 1 Anesthetist ((must have at least five years post qualification experience and to be in good standing with approved Council of Ghana)

Service
• First line treatment
• Primary Health Care Service
• Health Promotion
• Out-Patient Services for general, medical, surgical, pediatric and maternal care.
• In-patient services, for general, medical, surgical, pediatric and maternal care.
• Laboratory services
• Pharmacy services
• X-ray services
• Blood Bank
• Specialty health services (Optical, Dental Psychiatry etc.)

Premises
1. Waiting and reception area of at least 4 x 3 metres size with seating facilities, a reception table, a registration table, medical record keeping facilities, a wheel chair/ patients’ trolley, adequate ventilation, a weighing scale and stadiometer for heights.
2. Nurses bay
3. Doctors rooms
4. Consulting rooms of least 4×3 meters with an examination couch, a wash hand basin, thermometer, good light source, stethoscope, diagnostic set, sphygmomanometer, table and chairs and adequate ventilation;
5. Treatment rooms of at least 2×3 metres with instruments cabinet, with washable floors and floor drains.
6. Separate wards for male, female, children and maternity with locker and over-bed table for each bed, ward screen
7. Operating theatres with sluice, washable floors and floor drains.
8. X-ray rooms with protective gear and changing area.
9. Clean patients’ toilet and bath facilities with adequate water supply.
10. Central sterile supply department
11. Medical records department with up to date records.
12. Mosquito proof doors and windows
13. Washable floors with floor drain
14. Clean patients’ toilet and bath facilities with adequate water supply
15. Constant electricity supply with alternative power supply in good working condition
16. Adequate general water supply.

Equipment
1. Dressing trolley/tray with cotton swab, needles and syringes, galipot dressing, forceps needle holder, antiseptics and disinfectants, gauze/bandages, disposable gloves, injection trolley and equipment, wash hand basin and dressing stool.
2. Sterilizer/autoclave.
3. Emergency tray containing needles and syringes, scalp vein needles, iv giving set, injection hydrocortisone, injection adrenaline, 5% dextrose, normal saline, injection aminophylline, gloves;
4. Suture kit containing needles, nylon, analgesics, iodine, gauge etc
5. Resuscitative equipment including ambubag, oxygen trolley, suction machine( auto or pedal) and drip stand;
6. Possession of appropriate equipment and staff to render services in the fields of specialization;
For the following units/clinics please refer to the specific requirements for the respective facilities
1. Laboratory unit of a Hospital
2. Eye clinic of a Hospital
3. Maternity ward of a Hospital
4. Dental clinic of a Hospital
5. Psychiatric clinic of a Hospital
6. Pharmacy of a hospital
7. Diagnostic Units of a Hospital ( X-ray, MRI, Ultrasound, CT, Mammography, bone Densitometry

OPERATING THEATRE OF A HOSPITAL
Personnel
• At least two Medical Doctors (must have at five years post qualification experience and to in good standing with the Medical and Dental Council of Ghana)
• At least two registered nurses/nurse practitioners/midwives (must have at five years post qualification experience and in good standing with the Nurses and Midwifery Council.)
• 1 Anesthetist ((must have at least five years post qualification experience and to be in good standing with approved Council of Ghana)
Services
• Major Surgeries
• Minor Surgeries
Premises
1. Standard theatre room
2. Operating table
3. Autoclave
4. Adequate air conditioning units
5. Operating light source
6. Washable floor

Equipment
1. Autoclave
2. Adequate resuscitative equipment
3. Anesthetic machine.

Blood Bank in The Hospital
1. Blood bank fridge
2. Transfusion records book
3. Blood Donors card.
Or an arrangement with a nearby healthcare facility with a blood bank

SAFETY (Sections 1 to 13)
1. Structural
a. Unobstructed access to facility
b. Easily accessible to the disable and aged
c. Parking area
d. Roof and ceiling intact
e. Windows and Doors for facility intact with mosquito netting
f. Facilities for storage of outer garments and personal items away from work area
g. Clear separation of different general areas (reception, registration, laboratory)
h. Separation of storage from process areas
i. Separation of areas for different individual laboratory procedures
j. Adequate working space
k. Separate work and storage areas are provided within the laboratory for administration tasks and associated paperwork/reference materials

2. General
a. Non-slip floors
b. Unobstructed walkways, paths and corridors
c. Adequate illumination
d. Adequate ventilation

3. Signage
a. Department/Unit identification signs
b. Directional signs
c. Warning signs
d. Health promotion posters
e. Emergency evacuation diagram clearly displayed in all areas
f. Entry and exit signs
g. Hazard/safety signage on entrance/s clearly visible and contains information including
I. Authorized access only
II. No food or drink
III. Type of chemicals
IV. Lab. Supervisor details.

4. Hygiene
a. Fairly distributed number of pedal operated dust bins
b. Means of decontamination of hands
c. Posters on appropriate handwashing technique
d. Posters on appropriate use toilet facilities
e. Signs of disposal of different types of waste.

5. Clothing/Gear
a. Aprons
b. Masks
c. Goggles/protective eye gear
d. Gloves
e. Covered shoes
f. Protective hair nets
g. Protective laboratory coats
h. Protective feet covers
i. Provision for washed and clean linen

6. Biohazards
a. Sharps disposal
b. Consumable disposal
c. Biological waste disposal
d. Incineration procedures for biological waste
e. Protocols and procedures for managing accidents with sharps
f. Protocols and procedures for managing cross contamination
g. Protocols and procedures for managing infections samples.

7. Emergency
a. Exit doors clearly marked and can be opened from inside ( not padlocked)
b. Exit doors unobstructed from inside and outside the building
c. Fire equipment (fire blanket, extinguisher, hoe reel) is accessible and clear of obstruction.
d. Fire equipment (fire blanket, extinguisher, hoe reel) have been inspected/tagged within the last 6 months
e. Fire exit and escape ( for structure 2 storey and above) clearly marked and devoid of obstruction
f. Smoke detectors are working and clear of obstruction.
g. A first aid kit is located in the near vicinity
h. Safety shower and emergency eye wash station is functional and easily accessible.
i. Experiments in progress are labeled with procedures outlining response in case of emergency.

8. Biosafety
a. Procedures in place to account for all samples or materials
b. Appropriate biosafety signage at the laboratory entrance and storage rooms/vessels
c. Biosafety cabinets, fume cupboards, and hoods present (if applicable)
d. All cultures or biohazardous materials are correctly labelled.
e. A supply of disinfectant for decontamination purposes is available and is clearly labelled.
f. Diluted bleach is stored away from heat and is kept in lightproof containers with the preparation date displayed.
g. A supply of hospital grade antiseptic for washing hands is available at laboratory exit.
h. Laboratory gowns stored in manner that prevents cross contamination.
i. All keyboards have protective covers
j. Protocols in place for safe storage, handling and transport of dangerous substances and of waste containing dangerous substance.

9. Biosecurity
a. There is appropriate signage at the entrance to all areas
b. All GMO and Quarantine samples labelled appropriately.
c. All samples are secondary contained (fridge and freezers count as secondary containment with a lab)
d. Security arrangements are in place and the area has restricted access.
e. Procedures are in place for the transport materials.
f. All surfaces (including furniture) within the laboratory are smooth, impermeable to water and resistant to any decontaminant materials.
g. There are locks on fridges and freezers.
h. There are appropriate pest control procedures in place (spraying, weeding etc.)
i. All windows and walls are intact and sealed and there are no gaps.

10. Chemicals, Handlin G And Storage
a. Chemicals stored in appropriate containers.
b. Containers are labelled correctly ( e.g. not handwritten, label contains minimum chemical name and pictogram depicting hazard level)
c. Chemicals are stored according to compatibility.
d. Compatibility chart is readily available.
e. Dangerous goods are stored under COSHH guidelines ( control of substances Hazardous of Health). COSHH cabinets must be used, labelled and maintained in accordance with COSHH practices and other international best practices including but not limited to:
I. Self-closing and close fitting doors
II. Locking automatically (flammable)
III. Locking mechanism in 2 or more places ( flammable/corrosive)
IV. Self-releasing locking mechanism (oxidizing agents and organic peroxides)
V. Clearance from ignition/heat source (flammable, oxidizing agents, organic peroxides)
VI. Ventilation
VII. COSHH approved labels for various hazards (toxic, danger to environment, corrosive etc.)

11. Flammable Liquids (If Applicable)
I. Must be stored in suitable closed vessels in limited quantities in fire resistant cabinets or bins designed to retain spills.
II. Cabinets to be located in designated well ventilated areas away from the immediate area for processing but not placed in a way to jeopardize the means of escape from the area.
III. Must be stored away from other dangerous substances that can increase the risk of fire or compromise the integrity of the storage container or cabinet.

12. Compressed Gas (If Applicable)
a. Compressed gas cylinder contents are appropriately identified.
b. Cylinders are secured appropriately by bracket chain.
c. All cylinders are at least 3 metres away from ignition sources, combustible materials and are stored according to dangerous goods class with compatible gases.
d. Empty cylinders are separated from full cylinders and clearly labelled.
e. Appropriate resources (e.g. cylinder trolley) are available for transporting gas cylinders.
f. The regulator is appropriate for the gas being used ( e.g. stainless steel for corrosive gases, brass for non-corrosive gases)
g. Gas lines are labelled and free of leaks kinks, signs of wear and tear.
h. Gas use is confined to areas with good local exhaust ventilation.

13. Radiation
a. Access to Designated Radiation Areas limited only to authorized persons.
b. Suitable radiation/contamination monitoring equipment is available and in working condition.
c. X-ray and other radiation producing equipment is kept in a room solely dedicated to it.
d. Lionizing equipment is contained in appropriate enclosures.
e. Enclosures have interlocks preventing users from being within the confines of the enclosure.
f. Visible and audible signals are provided inside and outside enclosures to provide warning before and during irradiation.
g. Fail-safe mechanisms provided to prevent generation of X-rays.
h. The laboratory is secured against unauthorized access.
i. Radiation storage sites are lockable, secured and shielded as required.
j. All work with radioactive material is segregated from other work.
k. Spill trays and absorbent bench coverings are available.
l. The counting apparatus is in a separated room.
m. All containers are labelled appropriately.
n. The monitoring equipment has been calibrated and up to date.
o. The radioisotope laboratory is placarded with:
I. The identification of the laboratory,
II. Main potential hazards.
III. Personal protective equipment is to be worn.
IV. After hours contact name and phone number.

SPECIFIC REQUIREMENTS FOR CLINIC
A clinic shall have the following minimum requirement under the sections personnel, premises, safety and equipment.

Personnel
The minimum personnel requirement for the practitioner in charge shall be
• At least one Medical Doctor (Doctor ( must have at least five years post qualification experience and to be in good standing with the Miedical and Dental Council of Ghana)
Additional staff
• At least two registered nurses/ nurse practitioners/ midwives ( in good standing with Nursing and Midwifery Council.)

Service
• First line treatment.
• Primary Health Care service
• Invasive Procedures
• Minor Surgical procedures such as suturing
• Basic laboratory services
• Dispensary services
• Health promotion
• Others (optional)

Premises
1. Waiting and reception area of at least 4 x 3 metres size with seating facilities, a reception table, a registration table, medical record keeping facilities, a wheel chair/ patients’ trolley, adequate ventilation, a weighing scale and stadiometer for heights.
2. Consulting rooms of least 4×3 meters with an examination couch, a wash hand basin table and chairs and adequate ventilation
3. Observation ward with minimum of 2 beds, locker and over-bed table for each bed, ward screen.
4. A treatment room of at least 2 x 3 metres with instruments cabinet
5. A laboratory
6. A Dispensary
7. Medical records department with up to date records.
8. Washable floors with floor drains
9. Clean patients’ toilet and bath facilities with adequate water supply
10. Constant electricity supply with alternative power supply in good working condition.
11. Adequate general water supply.

SAFETY ( Refer to Sections 1 to 9 below)

1. Structural
a. Unobstructed access to facility
b. Easily accessible to the disable and aged
c. Parking area
d. Roof and ceiling intact
e. Windows and Doors for facility intact with mosquito netting
f. Facilities for storage of outer garments and personal items away from work area
g. Clear separation of different general areas (reception, registration, consulting treatment, observation)
h. Adequate working space
i. Separate work and storage areas are provided within the clinic for administration tasks and associated paperwork/reference materials
j. Separation of areas for different laboratory procedures
k. Separate work and storage areas are provided within the laboratory for administration tasks and associated paperwork/reference materials

2. General
a. Non-slip floors
b. Unobstructed walkways, paths and corridors
c. Adequate illumination
d. Adequate ventilation

3. Signage
a. Department/Unit identification signs
b. Directional signs
c. Warning signs
d. Health promotion posters (HIV, Malaria, Tuberculosis etc.)
e. Emergency evacuation diagram clearly displayed in all areas
f. Entry and exit signs
g. Hazard/safety signage on entrance/s clearly visible and contains information including
I. Authorized access only
II. No food or drink
III. Medical Doctor(s) details
IV. Lab. Supervisor details.
V. Dispensary technician/ pharmacists details

4. Hygiene
a. Fairly distributed number of pedal operated dust bins
b. Posters on appropriate handwashing technique
c. Posters on appropriate use toilet facilities
d. Signs of disposal of different types of waste.

5. Clothing/Gear
a. Aprons
b. Masks
c. Gloves
d. Covered shoes
e. Protective hair nets
f. Protective laboratory coats
g. Protective feet covers
h. Provision for washed and clean linen

6. Biohazards
a. Sharps disposal
b. Consumable disposal
c. Biological waste disposal
d. Incineration procedures for biological waste
e. Protocols and procedures for managing accidents with sharps
f. Protocols and procedures for managing cross contamination

7. Emergency
a. Exit doors clearly marked and can be opened from inside ( not padlocked)
b. Exit doors unobstructed from inside and outside the building
c. Fire equipment (fire blanket, extinguisher, hoe reel) is accessible and clear of obstruction.
d. Fire equipment (fire blanket, extinguisher, hoe reel) have been inspected/tagged within the last 6 months
e. Fire exit and escape ( for structure 2 storey and above) clearly marked and devoid of obstruction
f. Smoke detectors are working and clear of obstruction.
g. A first aid kit is located in the near vicinity.

8. Biosafety
a. Procedures in place to account for all samples or materials
b. There is appropriate biosafety signage at the laboratory entrance and storage rooms/vessels
c. All cultures or biohazardous materials are correctly labelled.
d. A supply of disinfectant for decontamination purposes is available and is clearly labelled.
e. Diluted bleach is stored away from heat and is kept in lightproof containers with the preparation date displayed.
f. A supply of hospital grade antiseptic for washing hands is available at laboratory exit.
g. All keyboards have protective covers

9. Biosecurity
a. All GMO and Quarantine samples labelled appropriately.
b. All samples are secondary contained (fridge and freezers count as secondary containment with a lab)
c. Security arrangements are in place and the area has restricted access.
d. Procedures are in place for the transport materials.
e. All surfaces (including furniture) within the laboratory are smooth, impermeable to water and resistant to any decontaminant materials.
f. There are locks on fridges and freezers.
g. There are appropriate pest control procedures in place (spraying, weeding etc.)
h. All windows and walls are intact and sealed and there are no gaps.

Equipment
1. Thermometer
2. Good light source
3. Stethoscope
4. Diagnostic set
5. sphygmomanometre
6. Dressing trolley/tray with cotton swab, needles and syringes, galipot dressing, forceps needle holder, antiseptics and disinfectants, gauze/bandages, disposable gloves, injection trolley and equipment, wash hand basin and dressing stool.
7. Sterilizer/autoclave.
8. Emergency tray containing needles and syringes, scalp vein needles, iv giving set, injection hydrocortisone, injection adrenaline, 5% dextrose, normal saline, injection aminophylline, gloves;
9. Suture kit containing needles, nylon, analgesics, iodine, gauge etc
10. Resuscitative equipment including ambubag, oxygen trolley, suction machine( auto or pedal) and drip stand;

SPECIFIC REQUIREMENTS FOR A MATERNITY HOME
A maternity home shall have the following minimum requirements under the sections of personnel, premises, safety and equipment:

Personnel
• A registered midwife (5 years post qualification experience and in good standing with Nursing and Midwifery Council of Ghana) shall be in charge of the midwifery services and the facility.
Additional staff
• At least one administrative staff and one medical records officer.
• At least one registered practicing midwife.
• Proof of access to medical practitioner
• At least two hospital assistants
• At least two registered nurses
• Any other personnel that may be prescribed by the Board
Service
• Infant deliveries
Premises
1. Waiting and reception area of at least 4 x 3 metres size with seating facilities, a reception table, a registration table, medical record keeping facilities, a wheel chair/ patients’ trolley, adequate ventilation, a weighing scale and stadiometer for heights.
2. A consulting rooms of least 4×3 meters with an examination couch, a wash hand basin table and chairs and adequate ventilation
3. Observation ward with minimum of 2 beds, locker and over-bed table for each bed, ward screen.
4. A treatment room of at least 2 x 3 metres with instruments cabinet
5. A pharmacy
6. Medical records department with up to date records.
7. Washable floors with floor drains
8. Clean patients’ toilet and bath facilities with adequate water supply
9. Constant electricity supply with alternative power supply in good working condition.
10. Adequate general water supply.
11. Any other requirement that may be prescribed by the Board
SAFETY (Section 1 to 12)
1. Structure
a. Unobstructed access to facility
b. Easily accessible to the disable and aged
c. Parking area
d. Roof and ceiling intact
e. Windows and Doors for facility intact with mosquito netting
f. Facilities for storage of outer garments and personal items away from work area
g. Clear separation of different general areas (reception, registration, wards)
h. Separation of storage from process areas
i. Adequate working space
j. Separate work and storage areas are provided within the facility for administration tasks and associated paperwork/reference materials

2. General
a. Non-slip floors
b. Unobstructed walkways, paths and corridors
c. Adequate illumination
d. Adequate ventilation

3. Signage
a. Department/Unit identification signs
b. Directional signs
c. Warning signs
d. Health promotion posters
e. Emergency evacuation diagram clearly displayed in all areas
f. Entry and exit signs
g. Hazard/safety signage on entrance/s clearly visible and contains information including
I. Authorized access only
II. No food or drink
III. Type of chemicals
IV. Mid-wife details

4. Hygiene
a. Fairly distributed number of pedal operated dust bins
b. Means of decontamination of hands
c. Posters on appropriate handwashing technique
d. Posters on appropriate use toilet facilities
e. Signs of disposal of different types of waste.

5. Clothing/Gear
a. Aprons
b. Masks
c. Goggles/protective eye gear
d. Gloves
e. Covered shoes
f. Protective hair nets
g. Protective laboratory coats
h. Protective feet covers
i. Provision for washed and clean linen

6. Biohazards
a. Sharps disposal
b. Consumable disposal
c. Biological waste disposal
d. Incineration procedures for biological waste
e. Protocols and procedures for managing accidents with sharps
f. Protocols and procedures for managing cross contamination
g. Protocol and procedures for managing infectious samples

7. Emergency
a. Exit doors clearly marked and can be opened from inside ( not padlocked)
b. Exit doors unobstructed from inside and outside the building
c. Fire equipment (fire blanket, extinguisher, hoe reel) is accessible and clear of obstruction.
d. Fire equipment (fire blanket, extinguisher, hoe reel) have been inspected/tagged within the last 6 months
e. Fire exit and escape ( for structure 2 storey and above) clearly marked and devoid of obstruction
f. Smoke detectors are working and clear of obstruction.
g. A first aid kit is located in the near vicinity

8. Biosafety
a. Procedures in place to account for all samples or materials
b. Appropriate biosafety signage at the laboratory entrance and storage rooms/vessels
c. Biosafety cabinets, fume cupboards, and hoods present (if applicable)
d. All cultures or biohazardous materials are correctly labelled.
e. A supply of disinfectant for decontamination purposes is available and is clearly labelled.
f. Diluted bleach is stored away from heat and is kept in lightproof containers with the preparation date displayed.
g. A supply of hospital grade antiseptic for washing hands is available at laboratory exit.
h. Gowns store in manner that prevents cross contamination
i. Protocols in place for safe storage, handling and transport of dangerous substances and of waste containing dangerous substances.
9. Biosecurity
a. There is appropriate signage at the entrance to all areas
b. All GMO and Quarantine samples labelled appropriately.
c. All samples are secondary contained (fridge and freezers count as secondary containment with a lab)
d. Security arrangements are in place and the area has restricted access.
e. Procedures are in place for the transport materials.
f. All surfaces (including furniture) within the delivery rooms are smooth, impermeable to water and resistant to any decontaminant materials.
g. There are locks on fridges and freezers.
h. There are appropriate pest control procedures in place (spraying, weeding etc.)
i. All windows and walls are intact and sealed and there are no gaps.

10. Chemicals, Handlin G And Storage
a. Chemicals stored in appropriate containers.
b. Containers are labelled correctly ( e.g. not handwritten, label contains minimum chemical name and pictogram depicting hazard level)
c. Chemicals are stored according to compatibility.
d. Compatibility chart is readily available.
e. Dangerous goods are stored under COSHH guidelines ( control of substances Hazardous of Health). COSHH cabinets must be used, labelled and maintained in accordance with COSHH practices and other international best practices including but not limited to:
I. Self-closing and close fitting doors
II. Locking automatically (flammable)
III. Locking mechanism in 2 or more places ( flammable/corrosive)
IV. Self-releasing locking mechanism (oxidizing agents and organic peroxides)
V. Clearance from ignition/heat source (flammable, oxidizing agents, organic peroxides)
VI. Ventilation
VII. COSHH approved labels for various hazards (toxic, danger to environment, corrosive etc.)
11. Flammable Liquids (If Applicable)
I. Must be stored in suitable closed vessels in limited quantities in fire resistant cabinets or bins designed to retain spills.
II. Cabinets to be located in designated well ventilated areas away from the immediate area for processing but not placed in a way to jeopardize the means of escape from the area.
III. Must be stored away from other dangerous substances that can increase the risk of fire or compromise the integrity of the storage container or cabinet.
12. Compressed Gas (If Applicable)
a. Compressed gas cylinder contents are appropriately identified.
b. Cylinders are secured appropriately by bracket chain.
c. All cylinders are at least 3 metres away from ignition sources, combustible materials and are stored according to dangerous goods class with compatible gases.
d. Empty cylinders are separated from full cylinders and clearly labelled.
e. Appropriate resources (e.g. cylinder trolley) are available for transporting gas cylinders.
f. The regulator is appropriate for the gas being used ( e.g. stainless steel for corrosive gases, brass for non-corrosive gases)
g. Gas lines are labelled and free of leaks kinks, signs of wear and tear.
h. Gas use is confined to areas with good local exhaust ventilation.

Equipment
1. Resuscitative equipment including, oxygen, suction machine resuscitative table, oropharyngeal tube, disposable gloves, needle & syringe, 50% dextrose, scalp vein needles 21G, 23G, I/V giving set, normal saline, dextrose saline;

2. Dressing trolley/tray with cotton swab, needles and syringes, galipot dressing, forceps needle holder, antiseptics and disinfectants, gauze/bandages, disposable gloves, injection trolley and equipment, wash hand basin and dressing stool.
3. Sterilizer/autoclave.
4. Emergency tray containing needles and syringes, scalp vein needles, iv giving set, injection hydrocortisone, injection adrenaline, 5% dextrose, normal saline, injection aminophylline, gloves;
5. Suture kit containing needles, nylon, analgesics, iodine, gauge etc

SPECIFIC REQUIREMENTS FOR A CLINICAL AND BIOMEDICAL LABORATORY
A Laboratory shall have the following minimum requirements under the section of
Personnel, premises, safety and equipment.
Personnel
The minimum personnel requirement for a person in charge of a laboratory shall be
• A qualified medical laboratory scientist with a minimum of a first degree certificate as a medical laboratory scientist (with 5 years post qualification experience and in good standing with Allied Health Professions Council of Ghana)

Services
• Hematology
• Clinical chemistry:
• Medical microbiology (Bacteriology, Virology, Parasitology, Mycology)
• Pathology
• Blood serology:

Premises
1. A Waiting and reception area
2. A functional laboratory with the relevant units
3. Washable floors with floor drains
4. Clean patient’s toilet and bath facilities with adequate water supply:
5. Constant electricity supply with alternative power supply in good working condition
6. Adequate general water supply
7. Standard Operation Procedures
8. Calibration and maintenance schedule for equivalent must be in peace

Safety (Sections 1 to 12)
1. Structural
a. Unobstructed access to facility
b. Easily accessible to the disabled and aged
c. Parking area
d. Roof and ceiling intact
e. Windows and Doors for facility intact with mosquito netting
f. Facilities for storage of outer garments and personal items away from work area
g. Clear separation of different general areas (receptions, registration,. Laboratory)
h. Separation of storage from process area
i. Separation of areas for different individual laboratory procedures
j. Adequate working space
k. Separate work and storage areas are provided within the laboratory for administration tasks and associated paperwork/reference material.

2. General
a. Non-slip floors
b. Unobstructed Walkways, paths and corridors
c. Adequate illumination
d. Adequate ventilation

1. Signage
a. Department/Unit Identification signs
b. Directional signs
c. Warning signs
d. Health promotions posters
e. Emergency evacuation diagram clearly displayed in all areas
f. Entry and exit signs
g. Hazards /safety signage on entrances /clearly visible and contains information including :

I. Authorized access only
II. No food or drink
III. Type of chemicals
IV. Lab supervisor details

2. Hygiene

a. Fairly distributed number of pedal operated dust bins
b. Means of decontamination of hands
c. Posters on appropriate handwashing technique
d. Posters on appropriate use of toilet facilities
e. Signs for disposal of different types of waste

3. Clothing /Gear
a. Aprons
b. Mask
c. Goggles/protective eye gear
d. Gloves
e. Covered shoes
f. Protective hair net
g. Protective laboratory coats
h. Protective feet covers
i. Provision for washed and clean linen

4. Biohazards
a. Sharp disposal
b. Consumables disposal
c. Biological Waste disposal
d. Incineration procedures for biological waste
e. Protocols and procedures for managing accidents with sharps
f. Protocols and procedures for managing cross contamination
g. Protocols and procedures for managing infectious samples

5. Emergency
a. Exist doors clearly marked and can be opened from inside (not padlocked)
b. Exist doors unobstructed from inside and outside the building
c. Fire equipment (fire blanket, extinguisher, hose reel) is accessible an clear of obstruction
d. Fire equipment (fire blanket, extinguisher, hose reel) have been inspected/tagged within the last six months
e. Fire exist and escaped (for structures 2 storey and above ) clearly marked and devoid of obstruction
f. Smoke detectors are working and clear of obstruction.
g. A first aid kit is located in the near vicinity.
h. Safety shower and emergency eye wash station is functional and easily accessible.
i. Experiment in progress are labeled with procedures outlining response in case of emergency.

6. Biosafety
a. Procedures in place to account for all samples or materials
b. Appropriate biosafety signage at the laboratory entrance and storage rooms /vessels
c. Biosafety cabinet ,fume cupboard ,and hoods present(if applicable)
d. All cultures or biohazardous materials are correctly labeled.
e. A supply of disinfectant for decontamination purposes is available and is clearly labeled.
f. Diluted bleach is stored away from heat and is kept in lightproof containers with the preparation date displayed.
g. A supply of hospital grade antiseptic for washing hands is available at laboratory exist.
h. Laboratory gowns stored in manner that prevents cross contamination
i. All keyboards have protective covers.
j. Protocols in place for safe storage ,handling and transport of dangerous substance and of waste containing dangerous substances

7. Biosecurity
a. There is appropriate signage at the entrance to all areas.
b. All GMO and Quarantine samples labeled appropriately
c. All samples are secondary contained (fridges and freezers count as secondary containment within a lab)
d. Security arrangements are in place and the area has restricted access
e. Procedures are in place for the transport of materials
f. All surfaces (including furniture) within the laboratory are smooth impermeable to water and resistant to any decontaminant materials
g. There are locks on fridges and freezers
h. There are appropriate pest control procedures in place spraying ,weeding etc.)
i. All windows and walls are intact and sealed and there are no gaps.

8. Chemicals handling and storage
a. Chemicals stored in appropriate containers
b. Containers are labeled correctly (e.g. not handwritten, label contains minimum chemical name and pictogram depicting hazard level).
c. Chemicals are stored according to compatibility.
d. Compatibility chart is readily available.
e. Dangerous goods are stored under COSHH guidelines ( control of substances hazardous to health).COSHH cabinet must be used, labeled and maintained in accordance with COSHH practices and other international best practices including but not limited to
I. Self –closing and close fitting doors
II. Locking automatically flammable
III. Locking mechanism in 2 or more places (flammable/corrosive )
IV. Self –releasing locking mechanism (flammable, oxidizing agents, organic peroxides)
V. Clearance from ignition/heat source (flammable oxidizing agents. Organic peroxides )
VI. Ventilation
VII. COSHH approved labels for various hazards (toxic, danger to environment).

9. Flammable liquids (if applicable)
I. Must be stored in suitable closed vessels in limited quantities in fire resistant cabinets or bins designed to retain spills
II. Cabinet to be located in designated well ventilated areas away from the immediate area for processing but not placed in a way to jeopardize the means of escape from other areas
III. Must be stored away from other dangerous substances that can increase the risk of fire or compromise the integrity of the storage container or cabinet

10. Compressed gas (if applicable)
a. Compressed gas cylinder contents are appropriately identified.
b. Cylinders are secured appropriately by bracket or chain.
c. All cylinders are at least 3M away from ignition sources, combustible material and are stored according to dangerous goods class with compatible gases.
d. Empty cylinders are separated from full cylinders and clearly labeled.
e. Appropriate resources (e.g. cylinder trolley) are available for transporting gas cylinders
f. The regulator is appropriate for the gas being used (e.g. stainless steel for corrosive gases brass for non –corrosive gases )
g. Gas line are labeled and free of leaks, kinks, signs of wear & tear.
h. Gas used is confined to areas with good local exhaust ventilation

11. Equipment
1. Cubicle with a screen for attending to patients;
2. Couch ;
3. Microscope; weighing balance
4. Water bath;
5. Centrifuge ;
6. Analyzers (Hemoglobin electrophoresis etc)
7. Wester green tubes and stand;
8. Bunsen burner and gas cylinder
9. Microbiological culture media ;
10. Biochemistry reagents
11. Disposable gloves
12. Laboratory glassware
13. Serology kits;
14. Spectrophotometer;
15. Improved neubauer counting chamber;
16. Refrigerator;
17. Pipettes;

REPUBLIC OF GHANA
HEALTH FACILITY REGULATORY AGENCY
(HEFRA)
Office: Plots 4 & 5, 4th Circular Road, Cantonments, Accra.
Postal address: Ministries Post Office, Box MB 534, Accra
Telephone: 0302900995/03039711848/0303973698/3032904026/0302904027
Licensing of health facilities under Act 829
Section 11 (1 and 2) of Act 829 (2011) provides:
1. That a person shall not operate a facility unless the facility is licensed under this Act.
2. That a person shall not operate equipment in a facility specified in the first schedule unless the facility in which the person operate is licensed under this Act.
FIRST SHEDULE (SECTION 11(2) Facilities to be licensed by HEFRA under ACT 829
• Medical and Dental (Health centres, Clinics and hospitals)
• Eye care clinic
• Convalescent and nursing homes
• Geriatric homes
• Maternity homes
• Occupational therapy clinic
• Physiotherapy clinics
• Dental technology laboratory
• Clinical and biomedical laboratory
• Medical assistant clinic
• Diagnostic- imaging technology clinic
• Pharmacist and chemical shops
• Osteopathy clinic
• Prosthetics and orthotics clinic
• And any other facility that the Minister deems necessary to be licensed.

LICENSED PROCESS
1. The process of licensing begins with the purchase of an application form from HEFRA. ( The applicant has a 90 day period within which to submit the completed application form with all required documents)
2. Following completion of the submission process, an inspection letter is issued to the facility to prepare for an inspection to be carried out.
3. New facilities are not allowed to operate until they have been accredited.
4. If HEFRA confirms a positive recommendation for the facility to operate, then a license is issued to enable the facility to operate.
5. In case where HEFRA finds the inspection report unsatisfactory, a period of time is given to the facility to address these issues satisfactorily for re-inspection.

Application for a license to operate a facility (General Requirement)
To register to operate a facility:
1. A person shall apply to the Agency for a license at HEFRA office address indicated above or if possible at a HEFRA approved office within the area in which the practice is to be operated in the form determined by the Board.
2. There shall be attached to the application:
a. The block plan of the facility for the practice.
b. Preliminary approval from the District/Municipal/Metropolitan planning authority of the District/Municipal/ Metropolitan Assembly on the suitability of the land or facility to be used for the practice;
c. Clearance from the Environmental Protection Agency.
d. Plans for the disposal of medicals waste
e. Copies of certificates of proposed practitioners in the practice and proof of their up to date registration with their professional bodies
f. List of the types of services to be rendered
g. List of equipment (see attached)
h. Evidence of financial capability for the ownership and operation of the practice applied for (audited accounts, statement of account)
i. The prescribed fees (see attached)
j. A yearly retention fee will be paid depending on the type of facility (see price list attached)
k. Original copies of business registration Certificates from the Registrar General Department.
l. Approved certification for facilities with X-ray imaging from the Nuclear Regulation Authority.
m. Evidence of continues submission of Health Service data to Ministry of Health every 3 months. (Existing facilities only)
n. A clearance certificate from Ghana Fire Service
o. A valid work permit issued by ministry of interior (non-Ghanaian only

The Board may on its own or on the recommendation of zonal committee revoke or refuse to renew a license for a practice.
The state of the facility disqualifies the licensee from being granted a license or it has reasonable grounds to believe that the continues operation of the practice by the licensee will create a risk to public health, public safety or is indecent (Act829,11:15a,b).
NOTE: a license issued shall be displayed in a prominent place which is accessible to patients and the general public in the premises of the practice

CREDIT :HeFRA Secretariat