Regulatory Standards
Do they promote continuous quality improvement!
Presented by
Salma Jaouni, CEO, Health Care Accreditation Council
First Dubai Health Regulation Conference
for the MENA region
22-23 October , 2014
Some standards are more comprehensive others less!
High Alert Medication
JFDA
HCAC Standards
MM.7.2 A system to control the use and distribution of
high alert medications is in place according to laws and
regulations.
Article (74):
The pharmacist in charge, who is licenced to dispense
narcotics and hallucinators, may dispense those items
prepared for medical use to the following persons:-
_ Critical
Measurable Elements:
 There is a policy/procedure to control the use and distribution of high
alert medications, which includes::
 List of high alert medications
 Procedure for storing, securing of high alert medications
 Safety practices have been implemented to reduce harm associated
with high alert medications including removing high alert medication
from patient care units or limit or standardize their numbers.
 Strategies have been developed to identify and mitigate errors
associated with high alert medications when they occur.
 The policy has been communicated to relevant staff members.
Article (75):
A -It is prohibited to dispense any special medical
prescription containing any narcotics or hallucinators
unless such prescription has met the following terms:
BTaking into consideration the provisions of
clause (8) of paragraph (A) of this article, the pharmacist
in charge must not dispense any prescriptions containing
any narcotics and hallucinators to cancer patients except
when the following terms are fulfilled:Article (76):
In case any special medical prescription does not fulfill
any of the provisions specified in article (75) of this law, or
in case the pharmacist is doubtful of its authenticity, he
then must not dispense the same and must
 The policy/procedure is carried out
Article 77-87
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Some standards are more comprehensive others less!
Infection Control
HCAC Standards related to a regulation
Additional standards on the same topic
HRM.7 The hospital has a process, defined in writing
for verification of the license, education, experience,
and certification for all licensed professional staff.
IPC.7 Isolation precautions are in place when
indicated.
MM.1 Pharmacy services and medication
management processes within the hospital comply
with applicable laws and regulations.
IP.1.3 Infection prevention and control activities are
in compliance with laws and regulations.
IPC 6.6 The surveillance data results and reports
are disseminated to senior management and
concerned department or units to be utilized for
improving the quality of care.
ST.1 The hospital has a central sterilization
supply department (CSSD).
ST 1.1 Sterilization processes are managed by
individual who is qualified by training and
experience.
3
Quality improvement is an activity that requires a continuous
cycle of assessment re-asseessment checking double checking
implementing feedback and updating
4
In any type of standard development, there should be room for
revision, growth and raising the bar
HCAC Standards Development
Needs
Assessment
Review
of
literature
to
develop
first draft
Step 1
Step 2
Review first draft
by a local experts
Task Force to
determine:
• Appropriateness
for Jordan & the
region
• Clarity and
correctness of
wording
• Classification of
standards
(critical, core,
stretch)
Step 3
Review
second draft
by an
external
committee
of experts to
ensure that
the standards
are
internationally
acceptable
Step 4
Field test
the third
draft by to
ensure
applicability
and
smoothness
Step 5
Review fourth
draft by the
HCAC Board
Technical
Committee and
recommend
approval to the
full board
Step 6
Translate
into
Arabic
and send
for ISQua
accredita
tion
Step 7
Collect feedback, Q&A, and assess implementation review and update every 3 years
5
In accreditation standards, there is a consultative process that
ensures many qualities to the standards
Standards reflect legislative requirements, safety and good practice
Standards should be relevant, understandable, measurable, beneficial and achievable.
 Reviewing other accreditation and certification
organization standards
 Involving stakeholders in standards development
committees and working groups
 Incorporating legislative, technical and safety
requirements
 Developing the measurement system for measuring
compliance with/achievement of the standards
 Incorporating best practice where evidence is
available
 Testing the standards and the way they are rated
through self-assessment, pilot surveys
 Ensuring the standards are client focused, cover the  Using feedback from testing to improve the
functions or systems of a whole organization or
standards and rating system
service, address the dimensions of quality and
 Developing guidelines to assist users to interpret and
support quality improvement
apply standards
 Consulting stakeholder groups, including and
 Get standards approved by accreditation
consumer groups
organization governing body
6
Accreditation standards differ from regulatory ones in referencing
criteria and measurement systems
HCAC PRIMARY HEALTH CARE STANDARDS
Each Cluster is composed of 4 line items
Standards
Statements
Classification
 Critical (24 Standards):
Address laws and regulations and, if not met, may
cause death or serious harm to patients, visitors,
or staff
 Core (98 standards):
Address systems, processes, policies and
procedures that are important for patient care
 Stretch (7 standards):
Important standards, but not easy to implement
due to time or resource constraints, or a need for
culture change
Survey Process
Measurable
Elements
Requirements of the standard that will
be reviewed and assigned a score
during the accreditation survey
process
7
Accreditation standards also have characteristics that are at the
core of their aim
HCAC STANDARDS
Characteristics of
Standards
What is Patient Centered Care?
 Provide guidelines for
quality patient care
 Dignity and respect:
Values, beliefs and cultural
backgrounds
 Are not prescriptive in
nature
 Information sharing:
Share perspectives & questions
 Are Patient centered
 Are educational in aim
 Participation:
Patients and families
 Continuity:
Continuum; designing systems that
promote seamless transitions
8
Accreditation Standards also have dimensions that are crucial to
their applicability
Characteristics of Good Standards
Valid
Based on scientific evidence or other acceptable experience, expert
consensus at a minimum
Reliable
Leads to the same result each time it is applied by anyone who uses it.
Clear
Understood in the same way by everyone; not
subject to misinterpretation
Realistic
Can be achieved with existing resources, suited
to the setting
Measurable
Can be quantified or count
9
This is what makes accreditation a continuous quality
improvement process
HCAC Accreditation Model
Continued
reporting
Mystery client
Un-announced
midpoint
assessment
Contiguous
engagement
New standards
every other
year
10
This does not mean that regulatory standards can not promote
continuous improvement!
Ireland: http://www.hiqa.ie/
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As long as the standards follow the characteristics, but more
importantly continue to progress in a process!
 Developed based on evidence based practice in
both clinical and managerial aspects
Consultative
 Updated frequently and when needed
 There is a system that ensure the implementation
that:
 enforce the development of organizational P&P
that translate the requirements into practice
Needs
assessment
Evidence
based
 include active monitoring system of
implementation by auditing or frequent
submission of related indicators
 The intent of the regulatory system foster quality
improvement and patients safety:
measured
implement
-ed
 promote the quality cycle component (PDSA:
plan, do, study, act)
 Covered all quality principles and aspects
requirements
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Questions and Comments
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Thank You