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|Year : 2011 | Volume
| Issue : 3 | Page : 237-241
A framework for healthcare quality improvement in India: The time is here and now!
P Varkey1, A Kollengode2
1 Department of Medicine, Faculty Development and Satisfaction, Preventive Medicine and Medical Education, Rochester, MN, USA
2 Department of Quality Improvement, Quality Management Services, Mayo Clinic, Rochester, MN, USA
|Date of Submission||15-Oct-2010|
|Date of Decision||24-Oct-2010|
|Date of Acceptance||28-Mar-2011|
|Date of Web Publication||22-Sep-2011|
Department of Medicine, Faculty Development and Satisfaction, Preventive Medicine and Medical Education, Rochester, MN
Source of Support: None, Conflict of Interest: None
Healthcare in India has been undergoing rapid changes in the last decade. As demand outpaces supply, quality improvement (QI) initiatives and tools can be beneficial to enhance safe, effective, efficient, equitable and timely care. Healthcare quality is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. This article discusses the framework for QI and reviews the Plan-Do-Study-Act (PDSA), Lean and Six Sigma methodologies, and briefly discusses key patient safety and quality measurement concepts. The PDSA cycle assists in testing the ideas through small tests of change or "pilots". Six Sigma aims at reducing variations in processes, and the Lean methodology predominantly focuses on enhancing process efficiency and eliminating non-value added steps in the process. It is likely that such structured problem solving approaches will provide an objective and systematic method of enhancing quality in healthcare institutions across India. As increasing attention being is paid on enhancing the quality of life through the Quality Council of India and accreditation of hospitals in India through the International Organization for standardization and National Accreditation Board for hospitals and healthcare providers, a focus on QI by institutional leaders and healthcare providers is key to enhancing the safety and quality of healthcare in India. Central to this also will be leadership buy-in, identification of a core faculty or team that will be the initiators of change, a respect for the need for faculty training and education in QI, measurement of issues to identify key priorities to focus on, and enhanced information systems where resources permit the same.
Keywords: India, Lean, patient safety, Plan-Do-Study-Act, quality improvement, Six Sigma
|How to cite this article:|
Varkey P, Kollengode A. A framework for healthcare quality improvement in India: The time is here and now!. J Postgrad Med 2011;57:237-41
| :: Introduction|| |
India has made major strides in healthcare in the last 60 years, including increasing life expectancy, reducing infant mortality rates, eliminating leprosy and eradicating small pox and guinea worm. Despite the progress, India's healthcare exhibits stark disparities. On one end of the spectrum is the increase in medical tourism, attracting over 2 lakh patients in 2006 from around the world. On the other hand, preventable diseases such as diarrhea and malnutrition, especially that of children under 3 years, continue to be very prevalent. Similarly, immunizations in India are significantly lower than in other South Asian countries such as Bangladesh, China and Indonesia.  In fact, in 2007, one in three children under 1 year was not immunized for measles. 
It is estimated that the Indian healthcare market will grow from US $20 billion in 2007 to US $280 billion by 2022.  The economic boom since mid 1990s resulted in burgeoning middle class and has created additional healthcare issues including chronic diseases like cardiovascular diseases and diabetes that are rapidly meeting the morbidity burden caused by infectious diseases. At the same time, India is recognized as a world leader in other industries like information systems and telecommunications.
With limited healthcare resources in the setting of increasing population statistics, how can the healthcare system ensure that safe, timely, effective, efficient and patient centered care? With increasing consumer awareness, rising malpractice litigations, rising medical tourism and increasing focus on quality and accreditation, how should the Indian healthcare system respond? We propose the science and methods of quality improvement (QI) as one possible strategy for addressing these issues. By means of this article, we review the basic principles and methodologies for QI.
| :: What is Quality Improvement?|| |
The Agency for Healthcare Research and Quality (AHRQ) defines quality healthcare as: "...doing the right thing at the right time in the right way for the right person, and having the best possible results".  Alternatively, healthcare quality may be looked upon as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. It is no longer adequate to focus on quality assurance, that is, evaluation of products or services against defined expectations or standards; it is also important to focus on QI, which provides tools and methods to enhance the process/product versus analyzing shortfalls.
| :: What are the Various Types of Quality Problems Encountered in Healthcare?|| |
Typically, healthcare quality issues fall into the three categories of underuse, overuse and misuse.  Underuse is the failure to provide a health service when it is indicated; for example, a failure to immunize a child against measles when indicated. Overuse occurs when a health service is provided under circumstances in which it is not indicated under evidence-based medicine; for example, a cesarean section performed on a pregnant woman when medical reasons do not justify the same. Misuse occurs when an appropriate service has been selected, but a preventable complication or error occurs and the patient does not receive full benefit of the service. For example, in a recent study from the Government Medical College in Chandigarh, medication errors were found to be occurring at a rate of 1.5 per neonate patient admitted to the emergency department. 
| :: Measuring Quality|| |
Measurement is an integral and pivotal part of any improvement process. Statistical process control, first introduced by Shewhart,  helped to bring focus on measurements that had a statistical impact on the outcomes. Donabedian emphasized quality as impacted by structure, process and outcomes.  Structural measures relate to the design, policies and procedures used in healthcare delivery (e.g. staff education, experience, availability of equipment, staffing levels, etc). Process measures are commonly used in measuring QI and are used as proxies for desired outcomes. For example, using rates for administration of antibiotics within 60 minutes of incision before surgery is a process measure and proxy for infection reduction. Outcome measures are helpful in assessing the overall quality and measure the end result of healthcare. Examples of outcome measures include patient satisfaction data, morbidity and mortality rates for a specific disease, and 30-day readmission rates.
| :: What are the Steps Necessary for Quality Improvement?|| |
The seven key steps necessary for a QI project are listed in [Table 1]. Multi-pronged interventions are typically more successful than single interventions for practice management.  Common individual strategies that have been described in the literature include academic detailing where trained providers conduct face-to-face visits with stakeholders to encourage adoption of a desired behavior pattern. The use of opinion leaders entails the use of providers of the local system who are influential, irrespective of title. With the use of audit and feedback, a summary of the clinical performance is provided to the respective entity on a regular basis, often with reports that contain anonymous rates of comparable clinics or providers. Reminder systems provide prompt providers to remember information relevant to a particular encounter, patient, or service to influence behavior and are best provided at the point of care delivery. Patient education for self-management of disease and case management can also be used as an intervention strategy, especially in chronic diseases. Financial incentives for achieving compliance have recently received press, especially in the US, and may be another strategy to change behavioral patters.
Regardless of the issue at hand, once the project is identified, it is critical to gather the most effective team that will assist in solving the problem. Effective teams are typically interdisciplinary and multiprofessional, and must consist of representatives with a) authority to institute change, b) technical expertise and c) day-to-day working knowledge of the topic. It is this combination of representatives that will be able to move a process or product change effectively and efficiently.
Once a strategy is identified for enhancing the identified product or process, several tools and methodologies for QI, including Plan-Do-Study-Act (PDSA), Lean, Six Sigma and Lean-Sigma, can be used.  In this article, we will focus on the PDSA methodology,,,,, a simple, yet powerful tool useful for an organization to solve problems in a systematic manner. Nolan improvised the PDSA model for healthcare using the model of improvement by using three key questions in conjunction with the PDSA model  [Figure 1]. The first question, "What is the aim?" facilitates the development of an appropriate scope for the team. The second question, "What will be measured to know the aim has been achieved?" encourages using measurable and easily quantifiable outcomes. The third question, "What are the changes necessary?" helps the team understand the current process and develop innovative solutions that are simple and effective. Once these questions are answered, the PDSA cycle assists in testing the ideas through small tests of change or "pilots". The pilots provide the insights and empower the team with new knowledge to help them prove or disprove their ideas. If the proposed solutions create necessary change, the team can then test the interventions in a larger scale. On the other hand, if the pilots do not produce desired or anticipated results, the team can develop alternate ideas and pilot test them, until optimal results are obtained. The team's ability to succeed with PDSA largely depends on the amount of planning that goes into each phase of the PDSA stages. The following paragraphs offer guidelines on implementing PDSA in an organization.
Plan: One of the first steps for the team is to gain a good understanding of the current process in place for the area that is selected for improvement. If written processes exist for the current process, it is important to check if the process flow in the area matches the written process flow. In the Plan phase, the key people affected either positively or negatively by changes (i.e. the stakeholders) are identified. The measurement tools identified for the study are then defined for the pilot. The team also develops ideas or potential solutions to pilot. The team then creates a plan to test the change including the process or product that is being changed, when the changes will be piloted, where the pilot will be conducted, who is responsible for the changes, who needs to be notified of the changes being made, who collects the data, what is being collected, what analysis will be performed, how the results will be communicated and what the contingency plans are if things do not go as planned.
Do: If enough planning is done earlier, the plan is executed in this phase. Here the pilot is conducted, data gathered, and unintended consequences that need attention are looked for. On many occasions, the team will need to think outside the box to creatively solve problems that arise due to pilot.
Study: In this phase, the data gathered are analyzed to see if the changes made contributed to desired improvements or not. If the improvements made meet or exceed the initial expectations, the team develops next steps, including hardwiring the changes to the process and/or expanding the pilot and/or developing implementation plans in a phased manner. If the improvement interventions do not meet planned outcomes, then the team goes back the Plan stage to develop alternate ideas/hypothesis to test and repeat the Do stage.
Act: If the improvements meet the expectations, the team should develop plans to ensure the improvements are sustained in the long run. This could include developing standard operating procedures, training of key individuals, or evaluating metrics on a regular basis. A periodic review of the metrics used to measure the success of the project is a key tactic to ensure long-term sustainability of the improvements. The team's efforts should be recognized to ensure the culture of continuous improvement is encouraged and sustained in the organization.
| :: Example of PDSA Methodology in Action|| |
A group of physicians in our institution undertook QI project techniques to enhance patients' understanding of diagnosis, management and follow-up at the end of the office visit in an endocrinology clinic specialized in bone disease. Following benchmarking and baseline measurements, the team decided to use the PDSA methodology to solve the problem. Root cause analysis revealed that patients wanted a written summary of the information discussed at the visit. The first PDSA cycle included an information sheet in which the name of the physician, diagnosis, and plan of action could be outlined by the physician. In the next cycle, this form was modified to include physicians' names and contact information, as well as provide a detailed listing of patient education materials. In the next PDSA cycle, the form was modified to include check boxes for diagnosis, laboratory testing and treatment options common to osteoporosis and osteopenia, as the team realized that these two diagnoses were the most common. Based on feedback from patients and providers that detailed listing of patient educational materials were not being utilized effectively, the form was modified in the next iteration to simply mention the Patient Education Center as a patient resource center. In the final iteration of this tool, more check-box items were added to make the process of entering information as efficient as possible for physicians. A print-out of laboratory and imaging studies was also given to patients at the end of the visit. The entire project was completed in about 3 weeks, with each PDSA cycle lasting not more than 48 hours. At the end of the 3 weeks, there was a statistically significant increase in patients' understanding of the management plan, reasons for diagnostic testing, and future follow-up plans.  There was very little resource utilization with the interventions, and it was decided to implement this intervention in all the bone clinics.
| :: Six Sigma|| |
Six Sigma uses a statistical processes to minimize or eliminate variation in processes.  Sigma refers to the number of standard deviations a process is from average performance. A process is said to be at Six Sigma if it is six standard deviations of average performance resulting in about 3.4 Defects (or errors) Per Million Opportunities (DPMO) where the process is close to error free (99.9996%).
The DMAIC framework which includes the phases of Define, Measure, Analyze, Improves and Control is typically used for Six Sigma. The first step entails defining the customer needs, project scope, goals and project timeline. In the second step of Measurement, data are collected to determine the rate of errors or variations (DPMO) in the process or system of interest. In the third step, data are analyzed, and sources of variation are identified to test interventions. In the fourth step, intervention plans are developed and implemented. In the final step of the cycle, the process is controlled by implementing policies, guidelines, and error proofing strategies to make it impossible to revert back to the old process.
| :: Lean|| |
The Lean methodology involves elimination of inefficiencies (also called waste) by eliminating non-value added activities from a customer perspective.  Key steps entail the definition of value from the customer point of view; mapping all steps of the process from the start to the end of the process (called value stream mapping), and developing processes that take the product (or patient) from a push state to a pull state. For example, a signal is sent to the nursing floor when the radiologist is available to image a patient versus patients waiting in the radiology lobby to see the next available radiologist. The use of Lean-Six Sigma methodology entails a blended approach of both methodologies, using six sigma to identify the problems that cause variation and using Lean to implement the interventions.
| :: Exponentially Increasing Outcomes|| |
Cost effectiveness of QI interventions varies by project and type of intervention. The impact of the PDSA can be increased exponentially as the scope of the tests is increased with the iterative nature of the process improvement [Figure 2]. In 2001, Dr. Peter Pronovost at Johns Hopkins Hospital had an idea that following five steps (hand washing of doctor, cleaning patient with chlorhexidine antiseptic, putting sterile drapes on patient, wearing sterile personal protective equipment and applying sterile dressing on catheter site after putting the lines in) would reduce hospital-acquired infection rates.  His first step was collecting data for a month by his nurses to see how often one or more steps were missed. With these data, Pronovost got the approval of hospital administrators to empower nurses to stop doctors if any one of the steps were missed. In addition, he had the nurses enquiring the physicians if the central lines could be removed in a timely fashion. Data were collected on the 10 th day for line infection rates. Infection rates had decreased from 11 to 0%, and this change was sustained for over a year! Additional checklists were developed and piloted for pain management, ventilator-associated pneumonia (use of antacids, elevation of head to 30°), and surgical checklist (check correct side for procedure, correct site, counts of instruments/sponges used in surgery). The checklists were later adapted by an insurance company in the state of Michigan, USA, and later by the country of Spain. In 2009, World Health Organization endorsed checklist for surgery after substantial improvements were made in tests using checklist to prevent surgical errors.
|Figure 2: PDSA cycles and continuous improvement. Adapted from Langley, GJ, Nolan et. al.|
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| :: Is Implementing Quality Expensive?|| |
The cost of implementing quality is usually the sum of appraisal costs, prevention costs, failure costs, internal failure costs and external failure costs. In general, what we spend when the product does not meet the needs or does not provide the expected service or outcomes is the cost of quality. The implication of poor quality goes much farther than just the costs, for example, the loss of patients (customers), loss of reputation, impact on brand, or cost of litigation. The QI tools we discuss here are simple, yet powerful to identify causes, develop solutions and implement through short cycles, often, with minimal resources. Details of finance and economics, as it relates to medical quality management, are beyond the scope of this article and have been discussed elsewhere. 
| :: Medical Errors and Patient safety|| |
The publication "To Err is Human" from the Institute of Medicine in the US brought to light the hitherto unrecognized epidemic of medical errors which cause 44,000-98,000 deaths every year in the US.  With increased media attention and public scrutiny, organizations and accrediting bodies have dedicated significant (varies by country) effort and resources to addressing many of these issues. Although there is limited information about epidemiology of medical errors in India, publications from the US suggest that errors can occur anywhere in the outpatient or inpatient setting. Commonly discussed errors include those related to medications, nosocomial infections, falls, decubitus ulcers, wrong site surgeries  . Common strategies that improve the safety of processes include automation and simplification of processes when possible, standardization to reduce variation, including the use of algorithms, protocols, checklists to guide care management, and improved information systems and using them. 
| :: Role of Technology in Quality Improvement|| |
Technology plays a key role in both QIs as well as the delivery mechanism of optimal healthcare at affordable costs. Technology facilitates communication between patients and healthcare providers as well as among providers. For example, Computerized Physician-Order Entry (CPOE) can reduce errors related to legibility, ambiguity, completeness, accuracy, and provide built-in checks to monitor potential drug-drug interactions and drug allergies.  When rightly used, technology increases safety, speed, accuracy, evidence-based support system and provides meaningful measures to improve care. We believe that India's healthcare would benefit by rapid adoption of technology, enabling point-of-use care like telemedicine and other tele-health consults akin to the cell phone technology that helped India's rapid growth and bypassed the landline model.
| :: Conclusion|| |
As increasing attention is being paid on enhancing quality of life through the Quality Council of India,  and accreditation of hospitals in India through the International Organization for standardization  and National Accreditation Board for hospitals and healthcare providers,  a focus on QI by institutional leaders and healthcare providers is the key to enhancing the safety and quality of healthcare in India. Central to this will be leadership buy-in, identification of a core faculty or team that will be the initiators of change, a respect for the need for faculty training and education in QI, measurement of issues to identify key priorities to focus on, and enhanced information systems where resources permit the same. Standardization of evidence-based practices; infection control issues including those surrounding hospital hygiene, enhancing immunization rates, reduction of postoperative infections, ventilator-associated pneumonia, catheter-related infections and drug-resistant organisms; medication errors including those that relate to prescribing, dispensing, and administration; accurate patient identification and site identification; and reducing pressure ulcers are but a few areas that are definitely in need of QI. We hope that healthcare teams armed with the basic knowledge of QI will be the stimulus to create a revolution of change that is much needed in our healthcare systems.
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