Outpatient registration Audit checklist

Specifications
Federal Decrees, Circular No.
or International Standards
(GPP,GSP,GDP)
1
A registered pharmacist must be
present and assigned to the facility.
2
Pharmacist shifts and working hours
are relevant to employed staff ratio,
operational capacity and existing
labor laws. As a 24 hr. pharmacy
Labor laws, GAHS 1-05 staffing
plan SS/PD/PHA. HAAD 24 hour’s
pharmacy criteria.
3
Staff wear proper uniform, and have
legible name badges (facility
badges).
HA-AD policy- Dress code - good
practice guidelines for healthcare
providers- PPR/HCP/P0031/08.
circular no 1/2005
4
The facility must be clean and neat.
GPP, GAHS 1X -07 pharmacy
infection control and sterile
technique PP/PD/PHA
5
Facility shall have a minimum area of
30 square meters to ensure safe and
proper storage, dispensing and /or
compounding of medicines
MOH 72/1988
Article No. 19
HA-AD circular (4) 2007
1 JOPR/HSC/PA/2012/1.1 Requirements are not
met
S.N.
Article No. in
the pharmacy
law of 1983
Requirements are met
Outpatient registration Audit checklist Remarks
Outpatient registration Audit checklist 6
The floor must not be below the
public road level.
MOH 72/1988
7
Facility must not be connected to, or
have access to any other activity
(Residence, Pharmacy, clinic, shop,
etc.). It is permitted however for the
pharmacy to be located inside a
shopping mall.
MOH 72/1988
The area where prescription only
medicine, controlled drugs and
refrigerator must only be accessible
to authorized personnel.
GPP, Guide to management of
controlled drugs in private sector ,
2007/Healthcare facilities manualAdditional requirements for
controlled drugs(4)/HA-AD circular
HPR/5/2006,circular no 32 for
2007
8
9
10
11
License Frames must be posted in a
visible and accessible area (to be
used for posting pharmacy license
and licensed staff licenses).
The Facility signboard is clean and
legible. Facility name is printed
visible in Arabic and English letters
on a board fixed in an unobstructed
view and the working hours (24hrs,
for example) are displayed.
The recommended ceiling height of
the facility is ≥ 2.7 meters, but it
shall never be below 2.5 meters. The
ceiling must provide acceptable
insulation to medications from
Circular No. 1 for 2005
Article No. 24
HA-AD Circular No7/2006. MOH
decree72/1988
HA-AD facility licensing
requirements –Section 9 (NFA).
HA-AD requirements. MOH
72/1988
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13
14
humidity, rain and heat.
Floor shall be made of easily
washable and fire resistant material;
preferably be made of ceramic tiles
The exterior walls of the facility must
be built out of secured, solid, fireresistant, humidity-resistant and
sealed walls; suitable to isolate the
facility from illegal entry, heat, rain,
and humidity. A certificate from a
licensed consultant stating these
qualities of the wall must be
presented.
Facility walls shall be painted with
proper anti-bacterial paint with no
sharp edges. A certificate from the
contractor who carried out this work
stating the quality of the paint must
be presented.
15
Illumination is satisfactory and
proportionate to the scope and
range of activities /services
provided.
16
Facility must be well ventilated with
a proper air conditioning system
capable of maintaining the inside
temperature between 20°C- 23°C.
GPP. MOH decree 72/1988
HA-AD facility licensing
requirements –Section 9 (NFA).
MOH decree 72/1988
GPP, GSP
GPP, Environment, Health and
Safety Management System for
the Health Sector- Management
and Administration Manual HAAD/HSED/ST/0000/HS_EHSMS,
HCPDM ch 6 environment health
and safety management
GPP, Environment, Health and
Safety Management System for
the Health Sector- Management
and Administration Manual HAAD/HSED/ST/0000/HS_EHSMS,
3 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist HCPDM ch 6 environment health
and safety management. MOH
312/1989
17
There are distinct storage spaces for
storage of Controlled Medicines. The
cabinet must be; made of steel with
internal hinges; securely fixed to the
wall or floor; Not visible or accessible
to the public; connected to the
establishment’s security system. N.B:
If controlled medications are not
being handled by the facility, an
official document/ letter must be
provided to HAAD in order for the
facility to be exempted from the
above controlled medications
storage requirements. Note:
Narcotics for being dispensed
through outpatient pharmacies is
subject to having exceptional
approval from HAAD.
Circular No. 32 for 2007, Guide to
management of controlled drugs
in private sector, 2007/GAHS VII
drug distribution services 02
Narcotic and controlled drug
management, HCPDM chapter 4
medical products. Federal law
articles no 75/ 72/1988. Federal
Law 14/1995
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19
20
Humidity and internal temperature
inside the facility must be monitored
with digital thermo-hygrometers
distributed uniformly all around the
facility (depending on the structure
and design) with a minimum of 3
units (1 unit per 10 m2) with
separate log sheets for each unit.
.Readings per each unit must be
logged on a separate sheet at least
twice daily. Records of such are
maintained. A documented
procedure on how to handle
temperature excursions must also be
maintained.
Designated cabinet or adequate
arrangements for the storage and
dispensing of 'High-Alert
Medications’ are in place and
conform to the requirements of
Institute for Safe Medication
Practices (ISMP).
Facility must contain a special cabinet
labeled “Expired Items, Not for Sale"
or any other arrangement for
physical isolation of all expired items
from the valid stock.
GPP, Circular No. 4 for 2007.
Circular No7/2006
GSP. ISMP
Article No. 31
GSP
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Facility shall have a public source of
water drained to a rust-resistant sink
with provision for hot and cold
water. The sink must be surrounded
with ceramic tiles, and drained to
public sanitation network.
GPP. MOH72/1988
22
First aid kit must be available in the
facility and shall include all necessary
updated items.
GPP, HA-AD Standard for
‘Minimum Preparedness for
common medical emergencies in
the ambulatory care settings’
23
24
25
Pharmacy has a computer system
with internet access
Pharmacy has a dedicated fax
machine and a fax line.
Facility must have a direct telephone
line
Circular No.1/2005
Circular No.1/2005
Circular No.1/2005
26
The facility has a dedicated
pharmaceutical refrigerator (in good
working condition) for the storage of
temperature sensitive pharmaceutical
products. If storing vaccines, a
dedicated refrigerator must be
installed that meet the requirements
of HAAD policy.
GSP. GPP3.8./MOH, HA-AD
circular 4/2007, Standard for Safe
Vaccine Handling and Cold Chain
maintenance in the Emirate of Abu
Dhabi-HAAD/VHCC/SD/0.9, GAHS
V-01 drug procurement and
storage (2), GAHS 1X -07
pharmacy infection control and
sterile technique
27
Facility shall maintain a patient
counseling area, designed to ensure
an acceptable degree of privacy
(facilitating confidential
communication with customers).
GPP
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30
31
32
Facility must have sufficient number
of rust-free shelves and cabinets for
storing medicines and other
consumables. Euro pallets could be
used for temporal separation of
medications from direct contact with
the floor.
Facility must have at least two
covered waste containers. One shall
be located in the pharmacy
professional service area while the
other is kept in the customer waiting
area
Compounding medicine (if done)
must adopt Good Compounding
Practices for sterile and non-sterile
items in reference with (GCP) manual
and USP 797guidlines. If not willing
to perform compounding, a letter
must be submitted to HAAD in this
regard.
If a facility is utilizing the services of
an internal Drug Information Center
(DIC), a designated area shall be
maintained with proper policy and
procedures.
If a facility is pre-packing/re-packing,
designated area and equipment shall
be maintained to fit the purpose.
Records of maintenance, register of
pre-packing/re-packing and labeling
GSP. MOH72/1988
GPP, HA-AD policy on Medical
waste management in Healthcare
facilities PPR/HCP/P0002/07
GCP. BP. USP. GPP, GAHS
SS/PD/PHA V11 -03
Extemporaneous Compounding of
Pharmaceuticals. MOH 72/1988
GPP
GCP. BP. USP. GAHS V11 03-007
labeling standards
7 JOPR/HSC/PA/2012/1.1 Outpatient registration Audit checklist system must be maintained.
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34
35
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If a facility is using a unit-dose
system of dispensing/ distribution,
proper policy and procedures
concerning all aspects of operation
must be available and implemented
Red and black fire extinguishers must
be distributed all around the facility,
or a sparkling fire system must be
installed.
Facility must maintain an up-to-date
copy of pertinent laws/regulations
on the pharmacy practice issued by
MOH or HAAD. Electronic copies or
accessibility thereto is acceptable
Facility shall maintain at least one
valid scientific pharmaceutical
reference that covers each area of
practice.
Maintain a valid contract or adequate
arrangement for waste-management
and disposal.
GAHSV11-03-001 repackaging of
oral and liquids in single use units
and unit dose single units
GSP
GPP, Circular No. 1 for 2005
Circular No. 1 for 2005
HA-AD policy on Medical waste
management in Healthcare
facilities PPR/HCP/P0002/07. HAAD requirement for “Renewal of
healthcare facility license’
accessible online www.haad.ae
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The facility has a valid contract or
other alternative arrangements for
pest and rodents control (copy is
acceptable).
Maintain box file for keeping copies
of facility and staff licenses along
with their renewals. Alternatively,
electronic storage arrangements
could be utilized.
GPP 3.15, HAAD infection control
facility audit check list
GPP, HAAD Circular 1/2005.
Ministerial decree No.1470 year
1986
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