1. Russian Academy of Medical Science Moskow June 5 2012
PATIENT SAFETY:
International Quality Perspective and
JCI Accreditation
Carlo Ramponi, MD, Joint Commission International,
Europe Office: Milano Italy
First do not harm, is the hippocratic say that should be always considered by the doctors before any decision on patient status; and so should be for any other healthcare professionals and for the entire healthcare organization.
For sure with the advancement of knowledge and research, with the new technology development, curing people has become much more complex than in the past; clinical process decision making needs to take into consideration many more information than ever, legal and ethical issues are more and more influencing doctors decisions; it is time for a deep revision of healthcare organizations towards a better quality on all aspects of process care.
Patient safety is the hottest topics in quality.

2. A quick overview of our organization
The Joint Commission
Leading accrediting body for health care institutions in the US
Founded in 1951
>17,000 accredited institutions
JCR
Non-profit affiliate of TJC
Quality and safety innovations
Accreditation resources
Quality and safety risk areas
Founded in 1986
Transforming patient safety and quality of care
First let me introduce my organization
JCI
JCI is the international arm of the Joint Commission
Improving the quality and safety of patient care and achieve peak performance in the international community
Work with health care orgs, NGOs, and governments
420+ JCI accredited organizations

3. We’ve worked in more than 85 countries
Countries with current JCI accredited organizations
Head office
Headquarter is in Chicago area; four international offices Total of accredited and certified programs = 448 In 48 countries
418 accredited programs of which, 330 accredited hospitals Also have 28 certified programs.
Back to the topics
In October 2004, WHO launched the World Alliance for Patient Safety in response to a World Health Assembly Resolution (2002) urging WHO and Member States to pay the closest possible attention to the problem of patient safety The Alliance raises awareness and political commitment to improve the safety of care and facilitates the development of patient safety policy and practice in all WHO Member States
In 2005 the World Health Organization identified six action areas One of these action areas is the development of "Solutions for Patient Safety".
In the same year, The World Health Organization (WHO) designated the Joint Commission and Joint Commission International (JCI) as the world's first WHO Collaborating Centre dedicated solely to patient safety Main objective was identification of affordable solutions to the most important and spread patient safety issues Since then JCI has introduced in all its accreditation programs, 6 specific patient safety related goals, called International Patient Safety Goals, which have become integral components of the requirements for getting the accreditation status.

4. Adverse Events in Healthcare
The problem of adverse events in health care is serious
10% of hospital patients suffer an adverse event each year (UK, New Zealand, Canada and Europe)
16.6% of hospital patients suffer an adverse event (Australian study)
98,000 hospital deaths every year through medical error (USA)
1.4 million hospital patients worldwide acquire HAI (at any given time)
UK: 100,000 cases of HAI lead to 5,000 deaths a year
USA: 1 out of every 135 hospital patients acquires HAI
There is an ever increasing incidence of adverse events in healthcare.
Various studies have investigated the extent of adverse events around the world and the depth of the problem is deep and understanding of them is murky at best. The IOM’s study – To Err is Human captured the attention of the American media “Up to 98,000 unanticipated and unnecessary deaths per year – the 7th leading cause of deaths in America.” Many challenged the figure. The report also caused a stir internationally with some suggesting that this was a further indictment of the US healthcare system But errors in health care know no borders.
As other countries – United Kingdom, Australia, New Zealand, Denmark – found, the frequency of preventable adverse events among hospitalized patients ranged from 10% to 16.6%.
The UK department of health in its 2000 report, estimated that 1 in every 10 hospital patients experiences and adverse event
2) Similar rates were also found in studies in other countries such as New Zealand and Canada and also in Europe's Working party on Quality Care in Hospitals report
3) The problem of health care-associated infection also poses a serious threat to patient safety: at any given time 1.4 million people have acquired a HAI in the world In the UK there are 100,000 case of HAI e year and 5000 deaths. In the US 1 out of every 136 patient acquires a HAI. .
The situation in developing countries is far more serious, although there is less data, with millions of child and adult patients suffering from ill health, disability and death caused by unsafe vaccinations, infections, unsafe blood, inadequate infection control and lack of hygiene practices in health care, and many other factors. Some data include:
i) developing countries account for 77% of all reported case of counterfeit drugs
ii) About 50% of medical equipment is non-usable of faulty

5. Economic Impact The economic impact is important:
UK: costs as high as US$6 billion a year
USA: about US$29 billion a year
The problem of adverse events in health care is even more serious in developing countries.
Less data is available
Failures in patient safety result in an enormous number of human deaths and also in suffering but they also have
a huge economic impact.
In the UK additional hospitalisation, litigation claims and hospitals –associated infection cost about US$6 billion a year.
In the US disability costs, additional medical expenses and lost income can be as high as US$29 billion a year.
The costs of HAI are also very high. Studies in the UK have shown that HAI cost UK about 1 billion a years and in the US between billion each year

6. What we know is far less reality..
And what it is known seems like the tip of an iceberg insetad of real world
In Europe for example it is estimated that from 8 to 12 % of inpatients experience an adverse event, [1].
The European Center for prevention and control of diseases estimates that, on average, one in 20 hospitals inpatients get an HAI during the stay. Which means 4.1 milions patients per year in the EU and deaths as a result of HAI as a prime cause.
[1] Technical report "Improving Patient Safety in the EU" prepared for the European Commission, published 2008 by the RAND Cooperation.

7. In USA, TJC has set up , year 1995, a program to collect adverse events data (including near misses) from accredited hospitals, on a voluntary basis.
Scope of the program was on one side the development of standards more focused on patient safety, on the other side help hospitals to learn from their errors and experience, implementing the ROOT CAUSE ANALYSIS METHODOLOGY.
TJC SISTEMATICALLY REVISES ALL THE DATA SUBMITTED, EITER FROM HOSPITALS AND FROM OTHER SOURCES; takes into consideration only sentinel events and provides a thorough revision of the case. Here the statistics colelcted in 7 years, sorted by frequency.
COMMENTARE

8. Outcomes
Same period time: outcomes of the previous cases: 62% with the worst outcome, death; around 10% permanent loss of functions and around 30% with psycologica consequences, extende care, unexpected additional care with financial consequences
As already said, this data base is buildt on a voluntary basis and represents only a small portion of the real number of adverse events; it is estimated that they represent only 1-2% of the real figures; for this reason those data do not have any epidemiological value; no conclusion can be drawn about the real frequency of those adverse events and their trends. The question that can be raised at this point is: are those data useful? What is their value? How can they be used?
The best answer is that we can learn from them if we dig in depth trying to find the root cause of the adverse event, the cause that can be considered at the origin or that is of paramount importance together with others .

9. WHERE TO START
Let’s imagine that in a hospital several adverse events happened and the leadership problem is: Where to start:
WHERE THE URGENCY IS THE HIGHEST, NO MATTER HOW MUCH IT COSTS , for example
Adverse events
Hospital Aquired Infections (HAI)
Adverse Drug Events
Adverse Events associated with Surgery
Pressure Ulcers
Patient Falls
In this case, after a thorough RCA, a further help may come by the use of WHO patient safety solutions, developed by JCI and addressing the most important patient Safety Goals
Where the scientific evidence is higher for poor quality and high costs and high potential saving:
The first case is better addressed using the priority setting matrix; the second case based on a quality to cost evaluation model, complements the first tool and allows leadership to make rational decisions on the patient safety field.

10. From Knowledge to Proposition: International Patient Safety Goals
Identify Patients Correctly
Improve Effective Communications
Improve the Safety of High-Alert Medications
Ensure Correct-Site, Correct-Procedure and Correct-Patient Surgery
Reduce the Risk of Health Care-associated Infections
Reduce the Risk of Patient Harm Resulting from Falls
THOSE IPSG have been identified by WHO and included amongst the JCI international standards for Hospitals accreditation.

11. IS THIS APPROACH GOOD ENOUGH?
RCA enlightes that many causes –common and special- may concur to an ADE occurrence
Similar ADE occurrence in different hospitals may have a different mix of causes
Relative importance of same causes may vary for the same ADE occurrence
Effectiveness of available solutions may vary as well amongst different hospitals
RCA enlightes that many causes –common and special- may concur to an ADE occurrence
Similar ADE occurrence in different hospitals may have a different mix of causes
Relative importance of same causes may vary for the same ADE occurrence
Effectiveness of available solutions may vary as well amongst different hospitals

12. So What?
A systemic approach to Patien Safety is better because Prevention is better than Cure and because it allows
mapping the organizational risks
prioritizing risk management and minimizing consequences of failures
developing and sharing a culture of safety
A systemic approach to Patien Safety is better because Prevention is better Cure and because it allows
mapping the organizational risks
prioritizing risk management and minimizing consequences of failures
developing and sharing a culture of safety
If the Patient Safety strategy is shaped to chase contingent solutions to each individual ADE, there will be an inefficient , non homogeneous organizational development; the outcome might be an increase in beaurocracy, new procedures attempting to address special cases, but no consideration for the hospital as a whole. RCA is a helpful tool, but it might be inappropriately used. In fact a root cause analysis helps identifying deep, hidden systemic problems. Solutions for those causes , to be effective , must be system-wide.

13. JCI Accreditation as a Risk Prevention Tool
Accreditation process deserves a special mention as a tool for improving Patient Safety because
It is an overall risk prevention tool
It uses a system-wide approach
It considers all stakeholders rights
It implies a culture of transparency and ethics
It is based on international evidence based clinical and managerial standards
Does Accreditation process deserve a special mention as a tool for improving Patient Safety, overall quality and at the same time saving money?
It is an overall risk prevention tool
It uses a system-wide approach
It considers all stakeholders rights
It implies a culture of transparency and ethics
It is based on international evidence based clinical and managerial standards
Accreditation preparation is a quality improvement process based on compliance with international standard that require use of different tools, like statistics, RCA, FMEA;
Relations between standard compliance and patient outcomes have been widely demonstrated. Accreditation process works through different influences: leadership and staff involvement, continuous quality improvement, systemic approach, priority improvement setting, measurements.

14. Accreditation – A Definition
A government or non-government agency grants recognition to health care institutions which meet certain standards that require continuous improvement in structures, processes, and outcomes
Usually a voluntary process
This is a traditional definition of accreditation
Voluntary – although come countries it is mandatory.
Includes recognition given to health care organizations who meet the standards. Public recognition via certification/announcement, financial or requirement that one is accredited. In order to do something else, have a nursing or medical school, insurance discount.
Philosophy commonly includes improvement – continuous improvement over time – not a one time effort.
Not any one “right” definition. Accreditation must be relevant to unique characteristics of each county’s heath care system, financial reimbursement/payment scheme, culture, level of care provided.

15. A statement of the safety
What is a standard?
A statement of the safety
and
quality expected
Accreditation is based on setting and measuring compliance to standards. What is a standard? It can be as simply put as “a statement of the quality expected”.
Standards always exist whether they are written or not. An implicit standard can be described as a practice that is simply “understood”.
Ask the group: Each of you have been trained in various schools. How many of you would say that each of you would carry out a given procedure (could give an example) exactly the same way?
Why is that? (Each school teaches a different approach).
That is not to say that you were taught wrong, just a different way. What is the hazard of everyone doing things a different way? (potential for errors, lack of continuity)
We all, then, have a set of standards. However in order to provide the best quality care, we should all be working under the same standards. These standards need to be based on current research, often referred to as “evidence-based”. And these standards must be written - an explicit standard.

16. Standards Content Each JCI standard contains three components:
The standard represents the principle
The intent describes the rationale of the standard
The measurable elements are the detailed requirements from the standard and intent that are scored

17. Standards Components

18. IPSG FUNCTIONS PCI MMU ASC QPS GLD PFE PFR COP ACC MCI FMS AOP SQE
MCI management and communication of information
FMS
AOP
SQE

19. International Patient Safety Goals since 2007
Identify Patients Correctly
Improve Effective Communications
Improve the Safety of High-Alert, High Risk Medications
Eliminate Wrong-side, Wrong-patient, Wrong-procedure Surgery
Reduce the Risk of Health Care-acquired Infections
Reduce the Risk of Patient Harm Resulting from Falls

20. Patient centered Functions 4th edition
ACC: Access & Continuity of Care 22 std
Anesthesia & Surgical Care std
Medication Mngm.t & Use std
PFR: Patient & Family Rights 30 std
AOP: Assessment of Patient 43 std
COP: Care of Patient std
PFE: Patient & Family Education 7 Std

21. Organizational Functions 4th edition
GLD: Governance, Leadership, Direction 27 std
QPS: Quality Impr.nt and Patient Safety 23 std
PCI: Prevention & Control of Infections 24 std
FMS: Facility Management & Safety 27 std
SQE: Staff Qualification & Education std
MCI: Management of Communication & Information std

22. Potential Return on Investment
I tried here to give a qualitative evaluation of the relative importance of each item for different satkeholders, trying to consider their perspective.
This grid can be also read as a way of identifying different drivers for the accredtitation process; the main drivers being revenues, safety, costs. Drivers may change according different aspects, like ownership, regulations, payment systems, culture, values.
Several comemnts can be made on this grid; just would underline the first sided column which is getting more and more value for several hospitals in Europe.
And then look at the second colum from left –medical staff. Engaging doctors in an accreditation process should be easy if their specific culture is considered, and also if their professional risks are considered.

23. Reduction of Complications at “Istituto Giannina Gaslini” NI/PICU
* Mortality (%) from hosp acq. Infections
** Hosp acq. Infections (per 1000 pt days)
*** Hosp acq. Pneumonia (per 1000 pt days)

24. Reduction in Radiology Film Costs in Hospitals in Qatar%
Percentage of Radiology films needing repeat

25. Conclusions
Hospital Patient Safety issue is far from being worked out
Patients do have different needs and expectations
New knowledge, new technologies, new equipments do help meeting new needs, but bring new questions
Specialization increases process efficiency but it increases integration needs
The Whole Organization Accreditation Program is the most rational answer
Hospital Patient Safety issue is far from being worked out
Patients do have different needs and expectations
New knowledge, new technologies, new equipments do help meeting new needs, but bring new questions
Specialization increases process efficiency but it increases integration needs
The Whole Organization Accreditation Program is the most rational answer

26. Thank you For more information:
On JCI accreditation and advisory services and publications
On JCI Europe Office