Launch of NABH pre- accreditation entry level certification standards for healthcare organisations

NABH plans to launch pre- accreditation entry level certification standards for healthcare organisations , in resource- challenged situations, as a preparation for full NABH accreditation.

Details at : http://nabh.co/main/publiccomments/PRE_ACCREDITATION_EL.asp

The standards are open for discussion and comment.]

Comments may be sent to:

Jatin Kumar
Assistant Director
National Accreditation Board for Hospitals and Healthcare Providers (NABH)
Quality Council of India,
6th Floor, ITPI Building, 4A, Ring Road, IP Estate
New Delhi 110 002, India
Tel: +91-11-23323416-20; Fax: +91 11 23323415
Email: jatin@nabh.co 

 



 

Reliability: The Next Frontier in Patient Safety

Reliability: The Next Frontier in Patient Safety

by Dev Raheja, MS, CSP

Author: Safer Hospital Care 

(Brief author Bio: Dev  Raheja, MS,CSP, author of Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years.  He applies evidence base safety techniques from a variety of industries to healthcare.He is a trainer on how to come up with elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries and at several universities. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps.  Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance, and at Booz-Allen & Hamilton as Risk Management consultant for nuclear and mass transportation industry.

He has served as Adjunct Professor at the University of Maryland for five years for its PhD program in Reliability Engineering. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management, has authored two more  books Assurance Technologies Principles and Practices , and Zen and the Art of Breakthrough Quality Management. He is Associate Editor- Healthcare Safety for the Journal of System Safety and has written articles for the National Capital Healthcare Executives newsletters. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from System Safety Society.  He is a former National Malcolm Baldrige Quality Award Examiner for the first batch of examiners.

He majored in Human Factors Engineering as a part of master’s degree in industrial engineering, is a Certified Safety Professional through the Board of Certified Safety Professionals, took training in “Perfecting Patient Care” through the Pittsburgh Regional Health Initiative, an organization supported by 40 hospitals, is a member of the American College of Healthcare Executives, and is a charter member of the Improvement Science Research Network (ISRN) at University of Texas Health Science Center. He serves on the Patient and Families Advisory Council of the Johns Hopkins Hospital and its committee on alarms management.)  

Reliability is the next frontier in patient safety according to Dr. Carolyn Clancy, the former Director of the Agency for Healthcare Research and Quality (AHRQ) and current Assistant Deputy Undersecretary for Health, Quality, Safety and Value, veterans Health Administration. She gave this message as a keynote speaker at the Sixth Annual Forum and Gala of the Lucian Leape Institute of the National Patient Safety Foundation, held in Boston on September 12, 2013.

Hospitals are still far from being highly reliable is a similar high level warning from the Joint Commission, the premier hospital accreditation agency. In an article “High-Reliability Health Care: Getting There from Here” written by The Joint Commission President and CEO Mark R. Chassin, M.D., M.P.H., and executive vice president for healthcare quality evaluation Jerod M. Loeb, Ph.D., they urge hospitals to make the substantial changes that will be needed to achieve the ultimate goal of zero patient harm by adapting lessons from high-risk industries. They report that “too many hospitals and health care leaders currently experience serious safety failures as routine and inevitable parts of daily work. To prevent the harm that results from these failures, which affects millions of Americans each year, the article specifies a framework for major changes involving leadership, safety culture and robust process improvement. This framework is designed to help hospitals make progress toward high reliability, which is the achievement of extremely high levels of safety that are maintained over long periods of time —safety comparable to that demonstrated by the commercial air travel, nuclear power, and amusement park industries.”

Reliability Theory Missing in Healthcare

Medical education usually does not cover the theory of reliability. One cannot blame hospitals to be going in different directions. The Institute of Healthcare Improvement (IHI) has taken the initiative to apply industry methods of system reliability to healthcare systems. It defines reliability as “failure-free performance over time^”. This is simple enough to be understood by anyone. The aim is to have no failures over an extended time period in spite of variability in the patient environment. This is in line with the technical definition of reliability as the probability of successful performance of intended functions for a specified length of time under a specified user (patient) environment. In a system where the severity of consequences is high, such as in hospitals, the goal is to achieve reliability as close to 100% as possible. This is called failure-free performance. Some hospitals have achieved this goal for specific medical procedures for several quarters. Can they extend this performance over years instead of quarters? That depends on many factors such as understanding reliability at senior management level, culture of innovation, effective teamwork, etc.

Roadblocks to Use of Reliability

The failures of the U.S. healthcare system are enormous considering the severity of failures. As much as 100,000 patients die each year from hospital mistakes. Another 2.1 million patients are harmed from nosocomial infections (infections acquired during hospital stay). The cost is in billions. There is very little incentive use reliability measures because the variability in healthcare is enormous compared to the aviation and industrial fields. Each customer (patient) is different and each illness is unique in its own way. Then there are interconnecting systems such as cardiology, gynecology, gastroenterology, emergency medicine, oncology, and patient data from various doctors, pagers, computers, vendor software, and intensive care, each operating independently most of the time.

Good Solutions are Available

We like to offer a good solution hoping that it will be good beginning to improve patient outcomes significantly. A good solution may be to apply system reliability methods to each critical intervention so that the variability is known. For example, if a protocol requires that a patient coming to the ED (emergency department) must get attention within ten minutes of arrival, then the performance can be defined as “patient must be registered with the triage nurse within 10 minutes.” A failure can be defined as “patient waiting longer than 10 minutes”. A woman in a New York hospital died while waiting for an hour in the emergency department. A blood clot in her leg traveled all the way to her brain. All 24 hours were recorded on the hospital video.

The time dimension for reliability can be defined in terms of calendar time such as every three months (quarterly) or every 1000 patients. Then reliability can be measured as the percentage of patients receiving service within 10 minutes during the quarter, or per 1000 patients. IHI is taking a similar approach for patients who need antibiotics within an hour after a surgical procedure; then reliability is measured as the ratio of number of patients receiving the antibiotic within an hour and the number of patients requiring this treatment.

Before we define system reliability, we need to define a medical system. It is a composite, at any level of complexity, of medical equipment, caregivers, medical procedures, lab work, environment, communications, and patients with a specified system mission.  Medical equipment includes CT, MRI, ventilators, artificial hearts, and dialysis machines. People include physicians, residents, interns, attendings, nursing staff, med techs, support associates, administrative personnel, patients, visitors.  Medical procedures include diagnosis, surgery, intensive care, intermediate care, lab procedures, intubations, intra-venous fluid infusions, patient visits, admittance, discharge, emergency patient processing, and trauma support. Communications include patient handoffs, verbal communications and communication among pharmacists, doctors, nurses, residents, patients, pagers, telephones, and computer screens.

Obviously, the mission is a safe and positive experience for patients. Therefore system reliability is the function of the integrated performance of all these. This model is pictorially shown in illustration below and is called a series system.  If any block in the system fails, the whole mission fails.

The chain shows that if any subsystem fails, the mission fails.

We can write the system reliability as the multiplication of all the subsystem reliabilities:

System Reliability = R (patient admittance) x R(diagnosis) x R(treatment) x R(post-discharge follow-up)

In this equation R stands for reliability. A hospital may modify the model if this model is not comprehensive. This model assumes that each of these four subsystems is independent of each other and each must work right. If not, the laws of conditional probability apply. For a calculation of conditional probability, please click here. Numerically, the system reliability in the above model for a defined time (yearly, over 3 years, etc) will then be:

System Reliability = (Percent patients admitted without harm or inconvenience) x (percent patients receiving the right diagnosis the first time) x (percent patients receiving satisfactory treatment) x (percent patients who follow the treatment regimen after discharge)

If the reliability of each of these four subsystems is 90 percent, the system reliability (chance that all of these will perform as intended) would be:

            .90 x .90 x .90 x .90 = .656 or 65.6 percent

To our knowledge no hospital is measuring reliability at the system level. Most of them are applying to a component of a system. The IHI is applying reliability measurements to components such as diagnoses, community acquired pneumonia, heart failure, acute myocardial infraction, hip/knee replacements, and bypass graft surgery. The reliability for each is simply the ratio of patients receiving the right care and the number of patients requiring the care. It may be noted that the system reliability model can be applied at the component level also as long as the components are functions of equipment, people, procedures, environments, and communications. The mission is still the same, safe and positive patient experience.

Contact the Author: Dev Raheja can be contacted at raheja@PatientSystemSafety.com

Providing sustainable healthcare

The “Health for All” declaration of the World Health Organization,  brought out in  1978, envisions securing the health and well being of people around the world that has been popularized since the 1970s. It is the basis for WHO’s primary health care strategy to promote health, human dignity, and enhanced quality of life.

With the advent of modern-day healthcare, healthcare costs have been going up exponentially. Thus, the need for devising sustainable healthcare systems is felt. In this backdrop, several low cost healthcare systems such as the Vaatsalya Group, Glocal Healthcare etc, have come into advent. They are focusing on the lower end of the affordability spectrum, depending on volumes to drive business. Some of the key strategies of low cost/ sustainable healthcare systems are:

1.    Fixed salaries rather than bonuses or incentives for doctors

2.    Innovative management of real estate, such as rental of building

3.    Optimal use of technology and low cost of equipment, made possible by aggressive bargaining

4.    Fixed prices for common medical treatments , which keep costs down for patients by preventing doctors from ordering unnecessary procedures

5.    Innovations such as beating-heart procedure and manual excision for cataract procedure

With the extension of modern healthcare into Tier II and Tier III cities, sustainable healthcare is reaching out to the masses. This trend would hopefully grow with time.

Building of a Quality Management System

Today, most hospitals are going in for systems of Quality management, such as ISO, NABH (National Accreditation Board for Hospitals & Healthcare Providers), Joint Commission International (JCI) etc. Quality Management System (QMS) is the backbone of effective running of any hospital.. QMS is broadly defined as “all the procedures explicitly designed to monitor, assess and improve the quality of care. “ Accreditation is a form of self-evaluation and peer review, against explicit standards, and is aimed to enhance quality improvement.

The QMS is the backbone or framework, on which a system of accreditation can be built up. It consists of documents, processes , training plans, Quality Indicators, Committee structure, Incident Reporting System, Audit plan etc. All of these add up and integrate into a common QMS, on which the system of accreditation can be built up.

The essential qualities of a QMS are that the parameters must be

-          Simple

-          Measurable

-          Achievable

-          Reasonable

-          Timeline –bound

-           

i.e. S.M.A.R.T.

The usual components of a QMS, are:

1.       Manuals

-          Quality Manual

-          Quality Policies Manual

-          Infection Control Manual

-          Safety  & Security Manual

-          Laboratory Quality & Safety Manual

-          Radiology Quality & Safety Manual

2.       Departmental  SOPs

3.       Quality  indicators

-          Structural  indicators

-          Process indicators

-          Outcome indicators

4.       Incident Reporting  System

5.       Emergency and disaster management system

6.       Committees

-          Quality Steering Committee

-          Infection Control Committee

-          Facility  Management & Safety Committee

-          Pharmaceutical & Therapeutics Committee

-          Medical Audit Committee

-          Mortality & Morbidity Audit Committee

7.       Annual  training and retraining plan

8.       Internal Audit System

The steps of setting up a QMS, are as follows:

1.       Management and stakeholder adoption of Quality requirements, and Mission & Vision statement

2.       Documentation of Policies, Procedures, SOPs, Manuals

3.       Training of staff

4.       Internal audit and Reaudit

5.       Improvement of the system

Through this process, the QMS can set up and sustained.

The focus of a modern –day QMS should be on Continuous Quality Improvement and Patient Safety. Essential elements of patient safety, including a Patient Safety Plan, must be built into the QMS System.

A QMS focuses on both Clinical and Non-clinical quality. These include Patient assessments, Radiology investigations, Laboratory investigations, Medication management, Infection control, Continuous Quality Improvement, Facility Management, Human Resource Management, Information Management Systems etc.

European countries have taken up Quality management at a national level, aided by a broad policy framework. In Finland, the recommendations for building up the QMS have been outlined as under:

Ø  Customer participation in QMS

Ø  Leadership for the steering of quality;

Ø  Personnel as a prerequisite for high quality;

Ø  QMS for preventive as well other activities;

Ø  Management of processes as a basis for QM;

Ø  Information as a basis for the continuous enhancement of quality;

Ø  Systematization of QM;

Ø  Detailed recommendations and quality criteria support quality management.

In our country, the development of QMS in hospitals has mainly been aided by the growth in demand for ISO, NABH & JCI accreditation. Based on this, QMS systems have been developed, and sustained. It is expected that with the further growth of accreditation in our country, Quality Systems will continue to evolve and flourish, and lead to an exponential improvement in Quality Improvement and Patient Safety.

Sentinel Events in hospitals

A Sentinel Event is defined by the Joint Commission International (JCI) as any unanticipated event in a healthcare setting resulting in death or serious physical or psychological injury to a patient or patients, not related to the natural course of the patient's illness. These are usually the most serious events in hospitals, and include:

Ø  Unexpected death

Ø  Patient suicide

Ø  Wrong patient, wrong side, wrong site surgery

Ø  Infant abduction

Ø  Sexual assault on patient

Ø  Haemolytic blood transfusion reaction resulting from incompatible bllopd transfusion

Ø  Intrapartum maternal death

Ø  Assault, homicide or other crime resulting in permanent loss of function or death

Sentinel events are intensively monitored by the Joint Commission International  ( JCI) and the National Accreditation Board for Hospitals & Healthcare Providers (NABH).Theses events require a Root cause Analysis ( RCA) to detect the underlying causes, and come up with solutions to prevent the recurrence of the event. At the same time, potential measures of improvement, called an “ Action Plan”, are to be implemented.

The Joint Commission disseminates "sentinel event alerts" identifying specific sentinel events, their underlying causes, and steps to prevent recurrence. For hospitals accredited by the JCI, the RCA has to be done within 45 days of the event, and suitable advisory issued accordingly.

Statistics of sentinel events are recorded and published by the FDA's MedWatch program. The JCAHO publishes a great deal of information about sentinel events on their website: www.jcaho.org. They also send out Sentinel Event Alerts that are available to all health care providers and organizations as a means of increasing the general knowledge about sentinel events.

Sentinel events usually point out a system or process defect, rather than a defect related to any one individual. They have to be taken in this context and analyzed thereof.

An example of a Sentinel Event in a hospital:

ROOT CAUSE ANALYSIS
S/ 01/ 11
Type of event	Sentinel event
Event	Inj.Vancomycin given by improper technique ( iv bolus instead of infusion)
What happened?	Patient was scheduled for OMC+ ASD closure.Doctor had prescribed Inj. Vancomycin I gm iv bd without mentioning dilution. Nurse gave the medication as iv bolus after dilution in 20 ml NS, whereas it should have been diluted in 100 ml. Patient developed discolouration of hand- this progressed to thrombophlebitis with left hand pain, burning and blackish discolouration. The operation was cancelled due to this and patient was discharged. At the time of discharge, patient was having discolouration and pain, with flexion problems of the hand. Patient was later readmitted , having suffered deep skin necrosis and underwent debridement and flap cover surgery.
Analysis using the " 5 times why" technique
Why did thrombophlebitis develop?	Due to improper dilution and technique of administration
Why was the improper technique followed?	Since nurse was not aware
	Since doctor had not mentioned it  in medication order
Why was nurse not aware?	Dilution guidelines not available at ward
	Knowledge and training was insufficient
Why had doctor not mentioned in medication order?	Due to oversight
Factors affecting this event ( Ishikawa Diagram) Action and followup 1. The consultant, junior doctor and and nurse were counselled. 2. Nursing managers were instructed to oversee Medication process including indenting and administration, in every shift.     They would be responsible for this process. 3.List of high risk medication prepared by Clinical Pharmacy- to be provided at the Nursing Stations 4. Label of high risk drug is to be provided on each vial of identified drugs. 5. List of drugs requiring dilution is also being prepared by Clinical Pharmacy. This would mention the diluent, dilution factor and     infusion rate. 6. Training of nurses on Medication Management Suggestions 1. Medication management module can be introduced during the induction of doctors and nurses. 2. Regular medication management classes for doctors and nurses 3. The drug company should be communicated with, to provide proper risk identification labelling for Vancomycin, and to mention the dilution factor 4. Identification of high-risk medications to distinguish easily visually Follow-up 1. Medication management classes conducted 2. High risk medication chart and labelling of high risk medications introduced 3. Doctors and nurses are given information on medication management during induction

Use of Information, Communication & Technology ( ICT) in healthcare

Use of Information, Communication & Technology ( ICT)  for enhancing  the  access, quality and reliability of healthcare, is a fairly well-entrenched concept now.

The following article shows how ICT has been radically used by a corporate to enhance the quality of healthcare, in  the state of Odisha in  India.

http://healthcare.financialexpress.com/latest-updates/2503-canara-bank-biocon-foundation-and-ottet-join-handsto-improve-healthcare-delivery