Improvements in the Manufacturing Industry Versus Health Care Industry

Improvements in the Manufacturing Industry Versus Health Care Industry

1) As health care looks at continuous improvement (as done in manufacturing), one of the most prominent questions that has arisen is, "Can the principles that worked in manufacturing really transfer over to health care? Taking care of a patient is not like building a car on an assembly line. Can standardized processes really work in a setting that focuses on humans and their needs?"
2) Write a paper of 1,000–1,200 words that takes a position on this argument. Justify the rationale for your position.
3) Refer to the assigned readings to incorporate specific examples and details into your paper.
4) Prepare this assignment according to the APA guidelines found in the APA Style Guide, located in the Student Success Center. An abstract is not required.
5) This assignment uses a grading rubric. Instructors will be using the rubric to grade the assignment; therefore, students should review the rubric prior to beginning the assignment to become familiar with the assignment criteria and expectations for successful completion of the assignment.
You are required to submit this assignment to LopesWrite. Please refer to the directions in the Student Success Center.
Materials:
1) Managing change and overcoming employee resistance and fear requires a proactive approach.
mentation approval of the change, to help ensure that the outcome of any change remains as originally intended. In the future, the term may be “change championship,” taking into account the dynamic results of corporate merg­ ers and de-mergers and the human ele­ ment in change management, making the process more holistic and realistic.
This article discusses the regulatory aspects of change management and how it can be used, not only to ensure regulatory compliance, but for con­ tinuous quality improvement.
A validated system may go through more than one change at a single time or at different times during a prod­ uct’s lifecycle. Maintaining proper documentation and an audit trail of all changes is imperative to ensure the continued state of control. FDA ex­ pects pharmaceutical manufacturers to implement a compliant, effective, and efficient change-management system, and its inspectors look for such a sys­ tem during most cGMP inspections.
Priority: m aintaining control
through robust w ritten procedures FDA’s current cGMP regulations 21 Code of Federal Regulations 210 and 211 (2) do not explicitly mandate a change-management system, but they do require establishing written proce­ dures that will maintain a state of con­ trol. Therefore, it is necessary to have a well-designed change-management system in place to comply with the regulations and applicable guidelines.
The FDA Guidancefor Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
(3) and the FDA’s Guidancefor Industry, Quality Systems Approach to Pharmaceu­ tical CGMP Regulations (4) suggest im­ plementing the change control program.
Both of these guidance documents use the term “change control” rather than “change management.” The transition from “change control” to
“change management/change control” can be clearly seen in the FDA Guid­ ance for Industry, Q9 Quality Risk Management (5).
As the ancient Greek philosopher,
pharmaceutical development and man­ ufacturing, where change can result from modification of facilities, utilities, equipment, computer systems, formu­ lations, analytical methods, specifica­ tions, manufacturing and cleaning processes, vendors and components, and documentation.
Depending upon the criticality of the change, some changes may even affect the safety, identity, strength, quality, or purity of the product. Others may trig­ ger the need for new regulatory filings. Managing all this change is perhaps
Parveen Bhandola, PhD, is President, Validation Edge, LLC, An ASQ Certified Quality Engineer. He can be reached
the most important part of any life- sciences quality program.
Change management plays a crucial role in ensuring that processes are, and remain, in control throughout a prod­ uct’s lifecycle. It is, therefore, essential to develop and implement a compliant, effective, and efficient change-man­ agement system in accordance with cGMPs and FDA guidelines, notably the revised process validation guid­ ance of 2011 (1).
The whole concept of managing change has been evolving over the past few years, moving from “change con­ trol,” a term that implied the need to restrict change. Now, the term “change management” is used to describe the oversight of the change process. This oversight must be in place during vi­ sualization, initiation, evaluation, and pre-implementation approval, as well as implementation and post-imple­
500 BC, “The only thing constant is change.” This is especially true for
Heraclitus, wrote back in
6 2 Pharmaceutical TechnoloOgcytober 2ois PharmTech.com
HONG LI/GETTY IMAGES
Quality and Continuous Improvement
Tracing the evolution
of change management
In 2009, the publication of FDA/ ICH’s Q8(R2) Pharmaceutical Devel­ opment (6) signaled further change when it emphasized the idea of a de­ sign space, wherein a change within the design space would not be con­ sidered a change from the regulatory post-approval perspective. This guide­ line expected applicants to develop a data-based design space derived from product and process knowledge gained throughout the product’s lifecycle.
dures to ensure that a company-wide change-management system is in place; individual departments should not have their own change-manage­ ment systems. Depending on the size of the company and the complexity of its processes, the mechanism of im­ plementing the change-management system will vary. Paper-based manual change-management systems may work reasonably well for smaller com­ panies, but software-based electronic systems are generally needed for larger firms.
boards/committees, validation, man­ ufacturing, and engineering are also typically involved in evaluating the change proposals.
Involving the business side
Depending upon the nature of the change, even the marketing, legal, and commercial departments may also be required to evaluate certain changes. The change-management board/committee evaluates all changes to determine whether or not to proceed.
After a change is approved for imple­ mentation, the committee/board also formulates the change implementation action plan. Taking various actions might be necessary to ensure that the change succeeds in achieving the in­ tended purpose while simultaneously preventing unintended consequences.
Tracking. A manual or electronic doc­ umentation system is essential for any change-management system to effi­ ciently track not only the implemented changes, but the data and documenta­ tion that must be generated to support them. Appropriate documentation must support regulatory filing status and a continued state of control, and should allow for full traceability. The supporting documentation should also include data generated to verify the ef­ fectiveness of any change after it has been implemented, as well as training records associated with the change implementation.
Training. All employees involved with the initiation, evaluation, and imple­ mentation of changes must be trained on the change-management procedure.
Records for the training required by the change-management procedure must be appropriately maintained. Furthermore, implementation of some changes may also require some re-val­ idation and revision of such controlled documents as standard operating pro­ cedures and batch records, which may necessitate additional training. Effective training and the documentation of that training are essential for the overall suc­ cess of the change-management system.
The whole concept of managing change has been evolving over the past few years, moving from "change control,"
a term that implied the need to restrict change, to "change m anagem ent..."
In the future, the term may be "change championship"... making the process m ore holistic and realistic.
In the FDA/ICH Guidance for In­ dustry, Q10 Pharmaceutical Quality System (7), there is no mention of the term “change control.” The term has been completely replaced by “change management,” and listed as one of the four key elements of a pharmaceutical quality system, that are capable of en­ suring continual improvement.
The Q10 guidance document dem­ onstrated a complete transition from attempting to control change to man­ aging changes for process improve­ ment. The goals allow pharmaceutical manufacturers, not only to achieve compliance but to gain business ad­ vantage.
Documenting change in a
unified company-wide system Pharmaceutical manufacturers are ex­ pected to implement well-documented, detailed change-management proce­
Any change-management system typically comprises the following es­ sential phases in its development.
Initiation. Once the need for a change is identified, the person who suggested that change should formally draft a proposal for implementing the change. The proposal must define the change clearly and specify the reasons why it should be implemented. This proposal should be reviewed and approved by the head of the initiator’s department before it proceeds further.
Evaluation. Cross-functional teams formally review all proposed changes for the impact that they may have on the state of control as well as the regulatory filing status. Most compa­ nies have formal change-management boards or committees to evaluate the changes. While quality assurance and regulatory affairs departments are the most important members of such
6 4 Pharmaceutical TechnoloOgcyt o b e r 2015 PharmTech .com
Quality and Continuous Improvement
It is... crucial to ensure that the system reflects any changes that might have been made by materials suppliers and equipmentvendors.Vendoraudits should verify that an effective change- management system is in place at the vendor's site.
ing tooling tightness. This change in tightness may require that operating parameters be adjusted after the tool­ ing has been replaced. Overlooking ac­ tions associated with such changes may result in unexpected process variation.
It is also crucial to ensure that the change-management system reflects any changes that might have been made by materials suppliers and equipment vendors. Vendor audits should verify that an effective change- management system is in place at the vendor’s site.
Furthermore, quality agreements should be worded so that suppliers must notify sponsors of any critical changes that they make to the manu­ facturing process and/or specifications as soon as possible. Any changes that are not communicated by vendors may affect processes, jeopardizing the state of control, and the overall change- management system.
Moving awayfrom "command and control"
Until recently, pharmaceutical manu­ facturers were constrained by restric­ tive regulations that did not facilitate the adoption of new technologies. This has caused the life-sciences industry to lag behind other industries in the use of the most modern IT or process- control tools, for example.
This regulatory “command-and- control” approach changed in the last decade, when FDA published
Regulations do not require classify­ ingthechanges,andallchangesthat could affect cGMPs may be treated as equally crucial. It can be helpful, how­ ever, to rank changes in categories such as low, medium, and high, based on the risk they pose to the safety, iden­ tity, strength, quality, or purity of the product, and their potential impact.
Risk-based classification facilitates the development of a rational and data- driven action plan for implementing the changes. Many companies do not require that “like-for-like” changes go through a formal change-management process. For example, the replacement of equipment parts from the same manufacturer, and of the same model with the same specifications, is gener­ ally considered a like-for-like change.
G a g in g
ofchange isn't always easy
6 6 Pharmaceutical TechnologOyc t o b e r 2015 PliarmTech.com
th e
p o te n tia l
im p a c t
Assigning general categories to the
changes based on their potential im­
pact is not always easy. Each change
should also be evaluated individu­ Century—A Risk-based Approach”
ally, because even some like-for-like changes may have an impact on the processes. For instance, some equip­ ment replacement parts may come from the same manufacturer, be built to the same specifications, and based on the same model. Nevertheless, they may vary slightly in performance from piece to piece, depending upon the criticality of the process, and the manufacturing controls that have been exercised by the parts manufacturer.
For example, replacing tablet press dies and punches may result in vary­
(8). This report marked a shift from a restrictive to a more liberal risk-and- science-based regulatory approach, throughout a product’s lifecycle. This new approach facilitated the adoption of constantly evolving technologi­ cal advancements and innovations. A well-designed change-management system should enable manufacturers to leverage opportunities to adopt more modern technologies and implement continuous improvement initiatives. Because flexibility and change are the precursors to improvement, any
“Pharmaceutical cGMPs for the 21st
JOSE LUIS PELAEZ/GETTY IMAGES
Quality and Continuous Improvement
change-management system should be conceived so that it provides an op­ portunity for continuous improvement
Leveraging change management for process improvement can be com­ pared to driving an automobile on four wheels. Each of the wheels must be equally strong and balanced if the ride is to be smooth. For change man­ agement, the wheels are:
As the global business environment continues to become increasingly com­ petitive, life-science companies cannot afford to be content with merely com­ plying with regulations. Such compli­ ance is just the cost of admission, or the minimum requirement, and com­ pliance won’t provide any competitive edge unless it is combined with con­ tinuous improvement.
Some companies are still strug­ gling to understand the implication of FDA’s risk-and-science-based lifecycle approach for adopting technical in­ novations, and fostering continuous improvement. However, others have started taking advantage of this change in thinking by formally incorporating the “process improvement” and “inno­ vation through sound science” concepts into their change-management systems.
A well-conceived change-m an­ agement system will take advantage of, and echo, FDA’s current thinking about risk-and-science-based regula­ tion. Embracing change, and manag­ ing it proactively and well, can help companies go well beyond compliance to continuous improvement.
References
1. FDA,GuidanceforIndustry,ProcessVali­ dation: General Principles and Practices (Rockville, MD, January 2011).
2. Code o f Federal Regulations, Title 21 Food and Drugs (Government Printing Office, Washington, DC), Part 210 and 211.
3. FDA, Guidancefor Industry, Q7A Good Manufacturing Practice Guidancefor Ac­ tive Pharmaceutical Ingredients (Rock­ ville, MD, August 2001).
4. FDA, Guidancefor Industry, Quality Sys­ tems Approach to Pharmaceutical cGMP Regulations (Rockville, MD, September 2006).
5. FDA, Guidancefor Industry, Q9 Quality Risk Management (Rockville, MD June 2006).
6 FDA,GuidanceforIndustry,Q8(R2)Phar­ maceutical Development (Rockville, MD, November 2009).
7. FDA, Guidancefor Industry, Q10 Phar­ maceutical Quality Systems (Rockville, MD, April 2009)
8. FDA “Pharmaceutical CGMPs for the 21st Century—A Risk-based Approach” (Rockville, MD, September 2004) PT
forced by circumstances (e.g., when a vendor of a specific type of equipment went out of business).
Life-sciences companies should empower their employees to look, ac­ tively, for changes that can bring such benefits as improved quality and yield, easier operation and safer processes, reduced cycle time, and manufacturing cost. Product knowledge and process understanding gained throughout the product lifecycle can lead to the proac­ tive changes that can result in process improvement.
Compliance isjust the minimum requirement...and won't provide any competitive edge unless it iscombined with continuous improvement.
•
•
•
• Timeliness.
A wareness
A proactive approach
Interdepartmental communication
Utilizing all four wheels can require a change in mindset. Employees, in­ cluding those in quality assurance and control (QA and QC), can grow so ac­ customed to performing certain activi­ ties in certain ways that they do not like being taken out of their comfort zones.
To minimize resistance to change, managers should make employees aware of the reasons for the change and the benefits that will result from it. This outreach will enable the achievement of process improvement goals.
Employees throughout any orga­ nization should be aware of the con­ nections from change management, to process improvement and business benefits. To minimize resistance to change, managers should make em­ ployees aware of the reasons for the change and the benefits that will re­ sult from it.
Seeing change
in a positive light
Taking a proactive approach is also im­ portant but represents a break from the past, when changes were only accepted when absolutely necessary, or when
Breaking down the silos
that can impede progress
Effective change management also requires breaking down the silos that can separate different departments and functions. Change management is a company-wide effort that requires effec­ tive communication and coordination among various departments. All depart­ ments that would potentially be affected by the change need to be involved in the overall change-management process.
Generally, people want to be associ­ ated with positive activities, and commu­ nication improves when people work on projects that are seen as progressive and constructive. Emphasizing the potential for process improvement resulting from the change will help improve cross-func­ tional communication and cooperation, and help the change-management pro­ cess reach its broader business goals.
Any unnecessary delays during the change-management process can have heavy compliance and business costs. It is essential to ensure that all activi­ ties and timelines are well thought out and planned in advance to prevent missed opportunities.
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2)This tutorial provides a summary of the main elements of change management based on Prosci's benchmarking research over the past two decades.
Defining these change management elements ensures a common understanding of what change management is. Tools or components of change management include:
Readiness assessments
Communication and communication planning
Sponsor activities and sponsor roadmaps
Coaching and manager training for change management
Training and employee training development
Resistance management
Data collection, feedback analysis and corrective action
Celebrating and recognizing success
After-project review
Change Management Process
The change management process is the sequence of steps or activities that a change management team or project leader follow to apply change management to a change in order to drive individual transitions and ensure the project meets its intended outcomes. The below elements have been identified from research as key elements of a successful change management process.
These elements are incorporated into Prosci’s 3-Phase Process. Learn more about Prosci’s methodology and how to apply it to achieve better outcomes.
3_phases
Here are the nine elements of a successful change management process:
1. Readiness Assessments
Assessments are tools used by a change management team or project leader to assess the organization's readiness to change. Readiness assessments can include organizational assessments, culture and history assessments, employee assessments, sponsor assessments and change assessments. Each tool provides the project team with insights into the challenges and opportunities they may face during the change process. What to assess:
Assess the Scope of the Change:
How big is this change?
How many people are affected?
Is it a gradual or radical change?
Assess the Readiness of the Organization Impacted by the Change:
What is the value-system and background of the impacted groups?
How much change is already going on?
What type of resistance can be expected?
You will also need to assess the strengths of your change management team and change sponsors, then take the first steps to enable them to effectively lead the change process.
2. Communication and Communication Planning
Many managers assume that if they communicate clearly with their employees, their job is done. However, there are many reasons why employees may not hear or understand what their managers are saying the first time around. In fact, you may have heard that messages need to be repeated five to seven times before they are cemented into the minds of employees.
Three Components of Effective Communication
Effective communicators carefully consider three components:
The audience
What is communicated
When it is communicated
For example, the first step in managing change is building awareness around the need for change and creating a desire among employees. Therefore, initial communications are typically designed to create awareness around the business reasons for change and the risk of not changing. Likewise, at each step in the process, communications should be designed to share the right messages at the right time.
Communication planning, therefore, begins with a careful analysis of the audiences, key messages and the timing for those messages. The change management team or project leaders must design a communication plan that addresses the needs of frontline employees, supervisors and executives. Each audience has particular needs for information based on their role in the implementation of the change.
3. Sponsor Activities and Sponsor Roadmaps
Business leaders and executives play a critical sponsor role in times of change. The change management team must develop a plan for sponsor activities and help key business leaders carry out these plans. Research shows that sponsorship is the most important success factor.
Avoid Confusing the Notion of Sponsorship with Support
The CEO of the company may support your project, but that is not the same as sponsoring your initiative. Sponsorship involves active and visible participation by senior business leaders throughout the process, building a coalition of support among other leaders and communicating directly with employees. Unfortunately, many executives do not know what this sponsorship looks like. A change manager or project leader's role includes helping senior executives do the right things to sponsor the project.
4. Change Management Training for Managers
Managers and supervisors play a key role in managing change. Ultimately, the manager has more influence over an employee’s motivation to change than any other person. Unfortunately, managers can be the most difficult group to convince of the need for change and can be a source of resistance. It is vital for the change management team and executive sponsors to gain the support of managers and supervisors. Individual change management activities should be used to help these managers through the change process.
Once managers and supervisors are on board, the change management team must prepare a strategy to equip managers to successfully coach their employees through the change. They will need to provide training and guidance for managers, including how to use individual change management tools with their employees.
5. Training Development and Delivery
Training is the cornerstone for building knowledge about the change and the required skills to succeed in the future state. Ensuring impacted people receive the training they need at the right time is a primary role of change management. This means training should only be delivered after steps have been taken to ensure impacted employees have the awareness of the need for change and desire to support the change. Change management and project team members will develop training requirements based on the skills, knowledge and behaviors necessary to implement the change. These training requirements will be the starting point for the training group or the project team to develop and deliver training programs.
6. Resistance Management
Resistance from employees and managers is normal and can be proactively addressed. Persistent resistance, however, can threaten a project. The change management team needs to identify, understand and help leaders manage resistance throughout the organization. Resistance management is the processes and tools used by managers and executives with the support of the change team to manage employee resistance.
7. Employee Feedback and Corrective Action
Managing change is not a one way street; employee involvement is a necessary and integral part of managing change. Feedback from employees as a change is being implemented is a key element of the change management process. Change managers can analyze feedback and implement corrective action based on this feedback to ensure full adoption of the changes.
8. Recognizing Success and Reinforcing Change
Early adoption, successes and long-term wins must be recognized and celebrated. Individual and group recognition is a necessary component of change management in order to cement and reinforce the change in the organization. Continued adoption needs to be monitored to ensure employees do not slip back into their old ways of working.
9. After-Project Review
The final step in the change management process is the after-action review. It is at this point that you can stand back from the entire program, evaluate successes and failures, and identify process changes for the next project. This is part of the ongoing, continuous improvement of change management for your organization and ultimately leads to change competency.
These elements comprise the areas or components of a change management program. Along with the change management process, they create a system for managing change. Good project managers apply these components effectively to ensure project success, avoid the loss of valued employees and minimize the negative impact of the change on productivity and a company's customers.
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3) hospitals in ^
pursuit of excellence
Accelerating PerformanceImprovement
Change Is Constant,
but Improvement Is Rapid
MAULIK JOSHI
Think of some of the changes we have had since the year 2000: The first iPhone was released seven years ago, and more than 160 million were sold just in the last 12 months. Almost 1 billion more people live on Earth. Facebook was created and now has more than 1 billion active monthly users. And health care has made incredible, rapid progress along the Institute of Medicine's six aims — safe, effective, patient-centered, timely, efficient and equitable care. The six IOM aims are still the foundation for health care quality, and we've seen impressive results.
1 1 S A F E : Hospitals nationwide are implementing a culture of safety. Results include a 41 percent decrease in the adult intensive care unit rate for central line-associated blood stream infections, and more than 10,000 harms prevented in the last two years for hospitals in the AHA/HRET Hospital Engagement Network [reports available at www(dot)ahrq(dot)gov.].
2 I E F F E C T IV E : Accountability measures of evidence-based care processes have improved among hospitals. In 2013, the Joint Commission reported that its accredited hospitals "achieved 97.6 per­ cent composite accountability measure performance on 18.3 million opportunities to perform care processes closely linked to positive patient outcomes." The data show an improvement of nearly 16 percentage points since 2002.
3 1P A T IE N T -C E N T E R E D : Manyhospitalstodayareestablishingopen (24/7)visitinghours, creating patient and family advisory councils and using bedside change of shift reports —all of which engage patients and families as active partners on the health care team.
4 1TIMELY: As one example, from 2005 to 2011, the percentage of heart attack patients who received percutaneous coronary intervention within 90 minutes of arrival improved from 42.1 to 93.7 percent, with improvement for all genders and racial/ethnic groups [from the Agency for Healthcare Research and Quality's 2013 National Healthcare Quality Report].
5 I E F F I C I E N T : Hospitals and health care systems are working to reduce preventable readmissions by improving care coordination and transitions of care. More than 1,500 hospitals in the AHA/HRET HEN have prevented more than 60,000 readmissions since 2012.
6 1 E Q U I T A B L E : A recent survey conducted by the AHA's Institute for Diversity in Health Manage­ ment and the Health Research & Educational Trust showed that U.S. hospitals have made progress in several key areas of health care equity, including collecting demographic data and providing cultural competency training. While hospitals have improved quality of care for diverse patient populations, more work needs to be done. As part of the Equity of Care initiative, the AHA and four national partners released goals for the initiative's three core areas, outlined at www(dot)equityofcare(dot)org.
Hospitals and health care systems invest heavily to improve quality, and the current priorities are to accelerate progress in achieving results in efficiency and equity of care. One can only imagine the changes that will rock our globe and the health care field during the next 14 years. By sharing best practices, providing opportunities for peer-to-peer learning and coaching; and building improvement capacity at the hospital and state levels,
i:0
,
NEWS F R O M THEAHA...
Health equity videos
The Equity of Care website features vide vignettes of 19 health care leaders’ sharin their ideas and work to eliminate health car disparities, increase leadership and workforc diversity, and provide culturally compete care. Topics include making the business cas for diversity; developing a diversity dashboar to stratify patient outcomes by race and la guage preference; breaking through cultur barriers to improve outcomes for diabet patients; and assessing the role of women a leaders in health care. All these leaders agre that hospitals have improved quality of care fo diverse populations and increased leadershi diversity, but more work needs to be don View these videos at www(dot)equityofcare(dot)org.
Safe surgery practices
“Reducing the Risks of Wrong-Site Surger Safety Practices from The joint Commissio Center for Transforming Healthcare Project describes the work of seven hospitals an ambulatory surgery centers that measured th risk of wrong-site surgery in their perioperativ processes, pinpointed contributing causes an developed specific solutions to reduce them Targeted solutions were developed in sche uling, pre-op/holding, operating room a organizational culture, and thoroughly teste in real-life situations. A Targeted Solutio Tool was created for hospitals to monitor su gical cases for weaknesses that could resu in wrong-site surgery. Visitwww(dot)hpoe(dot)org an www(dot)centerfortransforminghealthcare(dot)org.
Care transform ation resources Health care leaders have easy access to cas studies, reports and guides, toolkits, webinar and other content for performance improv ment and care delivery transformation on th Hospitals in Pursuit of Excellence websit Resources are organized by topic, resourc type and hospital type. Physicians will fin information on physician- and team-base leadership. HP0E.org links to organization websites and articles, making it a one-sto portal for hospital leaders’ working to tran form care delivery. Visit www(dot)hpoe(dot)org. •
1 4
hospitals can keep making progress. •
Maulik S. Joshi, Dr.P.H., is president ofHRET and senior vice president of research at the AHA.
H&HN / NOVEMBER. 2014 / www(dot)hhnmag(dot)com
e n e d n a i
s e r p e
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e e d
d n d n r
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4)Psychological Services © 2017 American Psychological Association 2017, Vol. 14, No. 3, 307–315 1541-1559/17/$12.00 http://dx(dot)doi(dot)org/10.1037/ser0000142
Actualizing Culture Change: The Promoting Excellent Alternatives in Kansas Nursing Homes (PEAK 2.0) Program
Gayle A. Doll and Laci J. Cornelison Center on Aging, Kansas State University
Heath Rath
Program for All Inclusive Care for the Elderly, Kansas City, Kansas
Maggie L. Syme
Center on Aging, Kansas State University
Nursing homes have been challenged in their attempts to achieve deep, organizational change (i.e., culture change) aimed at providing quality of care and quality of life for nursing home residents through person-centered care. To attain deep change, 2 well-defined components must be in place: a shared understanding of (a) the what, or content goals, and (b) the how, or process of change. However, there are few examples of this at a macro or micro level in long-term care. In an effort to enact true culture change in nursing homes statewide, the Kansas Department for Aging and Disability Services imple- mented the Promoting Excellent Alternatives in Kansas Nursing Homes program. This program is a Medicaid, pay-for-performance program that formalizes the content and process of achieving culture change through person-centered care principles. This article aims to detail the content (what) and process (how) of a model macro-level program of culture change throughout the State of Kansas. Applications to the micro level (individual homes) are presented, and implications for psychologists’ roles in facilitating culture change are discussed.
Keywords: culture change, nursing home, organizational change, person-centered care, pay-for-performance
Recent efforts to shift toward quality care and quality of life for nursing home residents have been called culture change. This has proven to be a challenging process, because nursing homes have been attempting to achieve deep, organizational change. Over the past 20 years or more this movement has been built around innovations, a term that implies changes that are mostly untested and with uncertain outcomes (Rahman & Schnelle, 2008). Na- tional policies such as the Omnibus Reconciliation Act of 1987 and the Patient Protection and Affordable Care Act of 2010, along with the Centers for Medicare and Medicaid’s (CMS, 2015) pro- posed regulatory changes, have created much-needed support for person-centered care (PCC) initiatives that are at the heart of culture change in nursing home care. Despite the momentum, the efforts for culture change and its evaluation at the micro and macro level have been fraught with difficulties, such as nonstandardized definitions, poorly defined implementation processes, and flawed
Gayle A. Doll and Laci J. Cornelison, Center on Aging, Kansas State University; Heath Rath, Program for All Inclusive Care for the Elderly, Kansas City, Kansas; Maggie L. Syme, Center on Aging, Kansas State University.
We would like to acknowledge the support of the Kansas Department for Aging and Disability Services as well as the dedication of the PEAK 2.0 staff, including Jackie Sump, Judy Miller, Samantha Ricard, and Sally Hodges. This project would not be possible without their expertise and support.
Correspondence concerning this article should be addressed to Gayle A. Doll, Center on Aging, Kansas State University, 253 Justin Hall, 1324 Lovers Lane, Manhattan, KS 66506.
outcome measurement (Shier, Khodyakov, Cohen, Zimmerman, & Saliba, 2014; Zimmerman, Shier, & Saliba, 2014). Culture change is a demanding process, and a deep level of change requires a coordinated interdisciplinary effort and a high level of leadership buy-in (Klein & Knight, 2005). This article suggests methods to strengthen the content and process of changing culture at a macro level as well as translating the lessons learned to a micro level, with aims to improve residents’ lives and improve the ability to draw conclusions about culture change. Finally, it discusses the role of the psychologist in playing a significant role in facilitating culture change at the micro and macro levels through clinical practice and research initiatives.
Background and Rationale Traditional Nursing Home Model
Goffman’s (1968) definition of the total institution is a fitting description of the traditional model of nursing home care. In the total institution, all aspects of life are conducted in the same place and under a single authority. Each member of the institution is compelled to carry out daily activities with a large group of similar members who are treated alike and required to do the same things. All activities are tightly regimented and under a single rational plan that seeks to fulfill the official aims of the institution. In these environments, residents’ bodies become the property of the insti- tution (Wiersma & Dupuis, 2010). Residents are trained to be docile, with no input. Their emotional and cognitive experiences are often disregarded, and they lose personal autonomy and con- trol.
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In these traditional environments, residents’ quality of care and life is compromised. For example, older adults living in long-term care facilities have higher fall rates than do persons living in the community (Sorensen et al., 2006), with 10%–25% of falls result- ing in fractures or lacerations (Becker & Rapp, 2010) that may lead to higher costs. Further, pressure ulcers, incontinence, dehydration, errors in medication, poor end-of-life care, and rehospitalization are all prevalent in nursing homes (Barber et al., 2009; Carrier, Ouellet, & West, 2007; Kayser-Jones et al., 2003; Kayser-Jones, Schell, Porter, Barbaccia, & Shaw, 1999; Ouslander et al., 2010; Palmer, 2008; Russo, Steiner, & Spector, 2008). Advocates of culture change contend that many of these factors can be improved with the adoption of PCC practices that are at the heart of the culture change movement. An example of a PCC practice familiar to psychologists is utilizing nonpharmacological or behavioral interventions to manage dementia-related behavioral symptoms instead of using antipsychotic medications (see Kales, Gitlin, & Lyketsos, 2015).
Culture Change: A Promising Solution
Culture change represents a transformation from the traditional to PCC and aims to improve residents’ quality of life by deinsti- tutionalizing nursing home systems and stressing the importance of PCC principles (Zimmerman et al., 2014). Person-centered care principles include (a) resident direction of care and activities, (b) staff empowerment, (c) encouragement of collaboration versus centralized decision making, (d) a homelike versus institutional living environment, and (e) the breakdown of nursing home spaces into small “households” (Miller et al., 2013; Rahman & Schnelle, 2008).
For nursing homes to achieve culture change, they must enact deep, organizational change, or a comprehensive change im- pacting the organizations’ mission, strategy, leadership, and culture (Burke, 2014). Unfortunately, to date, implementation of culture change in nursing homes has been limited both in number of homes and in degree of change (Shier et al., 2014). National surveys have shown a modest adoption of culture change, with one study reporting 31% of directors of nursing (DONs) indicating that culture change was “completely” or “for the most part” implemented (Doty, Koren, & Sturla, 2008, p. 4) and approximately one fourth of DONs reporting some adop- tion. In 2013, Miller et al. found that 33% of the DONs they surveyed reported complete culture change in some or all areas of the nursing home, and an additional 53% reported at least some culture change implementation.
Notably, implementation numbers have been challenged, be- cause implementation has been fraught with conceptualization and measurement issues. For example, Zimmerman et al. (2014) con- ducted a review of culture change studies, intending to examine the extent of implementing six domains of culture change. Of the 36 studies, only nine specifically examined the level of adherence that study participants achieved regarding the domains they intended to implement. This lack of information about the implementation process undermines the ability to generalize such processes to other homes or to discover the extent to which culture change affects outcomes.
It is not surprising that implementation has been a challenge for nursing homes, because culture change is an amorphous term that
has been interpreted and implemented in a myriad of ways. Indi- vidual homes often develop their own definitions of culture change and PCC, which may be skewed (Cornelison, Johns-Dansell, Poey, & Doll, 2015). Further, it is these potentially skewed perceptions of culture change that are being self-reported as degree of imple- mentation of culture change adoption in national studies. Also, measurement of culture change is often aimed at a surface level of culture, as opposed to deep, organizational change, which is meant to be comprehensive in nature (Zimmerman et al., 2014). Although some practices may change within an organization and be mea- sured by these existing culture change instruments, it does not necessarily indicate a shift in organizational culture.
Organizational Change Theory
Organizations must change to remain relevant and survive in the current competitive climate (Burke, 2014). Unfortunately, many changes are small, incremental, planned changes (evolutionary), but rarely do organizations undertake major, intentional organiza- tional change (revolutionary; Burke, 2014). Both forms of change, evolutionary and revolutionary, are important for organizations to remain healthy and relevant (Pascale, Milleman, & Gioja, 2000). What does this mean for nursing homes? For decades nursing homes have remained relatively the same, with small, evolutionary changes occurring across the industry as a whole. This is typical of most organizations, especially those that are highly regulated like nursing homes, unless there is some external force encouraging deeper level change (e.g., leadership changes, financial incen- tives). That being said, true organizational change in long-term care also needs to be revolutionary, or transformational, rather than just evolutionary, or transactional (Burke, 2014). Revolutionary change is essential to the future of nursing home care and may be further facilitated by the recent changes in policy (e.g., the Affordable Care Act) and incentivization of PCC practices (Grabowski, Elliot, Leitzell, Cohen, & Zimmerman, 2014; Ko- ren, 2010).
A key ingredient in the successful implementation of deep, organizational change is a clear understanding of what will be changed. This has to do with the purpose, mission, strategy, and values of the organization (Burke, 2014). Currently, in the culture change movement, the what is somewhat outlined on a macro level, though not yet completely clear and largely missing at the micro, or individual home, level. Culture change is lacking another key element of organizational change: the how. This concerns the implementation and adoption of the change (Burke, 2014). Inno- vative organizations—some of which were early adopters of cul- ture change— have discovered not only the what but also the how and made it work (e.g., Green House model, Pioneer Network). Unfortunately, these examples are rare (Kane, Lum, Cutler, De- genholtz, & Yu, 2007). There are excellent examples of micro- level changes to increase PCC practices, many developed and/or practiced by psychologists, such as PCC approaches to dementia assessment (Mast, 2012) and behavioral interventions for behav- ioral symptoms of dementia (Fossey et al., 2006). However, for organization-wide culture change to take root, there must be an effort to learn from organizations that have enacted deep, organi- zational change by implementing a universal what and how. Then a greater number of nursing homes can embark on the revolution- ary endeavor of culture change.
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Many of the aforementioned issues with defining, operational- izing, and implementing culture change via PCC practices can be addressed at a macro and/or micro level within nursing homes, with key roles for individuals and organizations across disciplines, including psychology. We focus here on macro-level changes by examining how the State of Kansas has endorsed the adoption of culture change for long-stay residents. This was accomplished via the Medicaid pay-for-performance (P4P) incentive program Pro- moting Excellent Alternatives in Kansas Nursing Homes (PEAK 2.0). The PEAK 2.0 program has created an objective framework and shared definition (the what) of PCC and the specific means to implement those practices (the how) in the State of Kansas.
PEAK 2.0: A Model Program for Culture Change
The PEAK 2.0 program is a unique examination of systemwide culture change and is one of few statewide programs implementing culture change. The Kansas Department of Aging and Disabilities Services (KDADS), in collaboration with Kansas State Universi- ty’s (KSU) Center on Aging, has focused its culture change efforts on the PEAK 2.0 program. It began as an award and recognition program for homes making strides in nontraditional models of care. Nursing homes that applied and met the program criteria would be conferred PEAK Home status. This practice was in line with KDADS’s stated intention to be “committed to ensuring high quality services for Kansas nursing home residents” (KDADS, n.d., para. 1). In 2011, the state gathered key stakeholders with interests in long-term care to revamp the program in order to motivate higher levels of involvement and initiate greater adoption of person-centered care practices and thereby achieve culture change. The retooled program would use designated Medicaid P4P incentives to reward nursing homes that demonstrated implemen- tation of PCC practices. To improve rigor and facilitate implemen- tation of the retooled program, KDADS contracted with Kansas State University’s Center on Aging to administer PEAK 2.0 in 2012. This program was designed to solve some of the problems previously faced in culture change implementation.
PEAK 2.0: Program Description
PEAK 2.0 is a Medicaid pay-for-performance (P4P) program aimed at improving the quality of life for residents living in Kansas nursing homes. It is designed to inspire and reward deep organi- zational change through the adoption of PCC practices and is funded through the Quality Care Assessment, or the nursing facil- ity provider tax (K.S.A. 75–7435), designated specifically for improving the quality of life for elders in nursing homes (M. Warfield, personal communication, September 1, 2016). Enrolled homes receive an escalating per diem based upon the level of PCC practices they adopt organizationally. Enrolled homes are evalu- ated by external reviewers and measured upon specified program criteria for PCC. They engage in various opportunities including education, action planning (strategic planning), team engagement, consultation, exposure to PCC in action, and mentoring activities.
The Kansas State University Center on Aging program and research staff implement the administrative functions of the pro- gram—application, training, consultation, and evaluation. In terms of staffing, the program employs one lead program administrator (90% full-time equivalent, or FTE) with a gerontology and social work background; two additional part-time program administrators (25% and 50% FTE), both with extensive long-term care leader- ship experience; and two graduate assistants (50% FTE). During the annual evaluation period, the Center on Aging also provides a small number of volunteer staff to assist. For the State of Kansas, KDADS oversees the program, provides feedback, recognizes homes statewide, and handles the Medicaid reimbursement.
The what of PEAK 2.0. Strengths of the PEAK 2.0 program include the clear, detailed, and organized framework developed to guide statewide implementation of culture change (see Figure 1). Within this framework, the PEAK 2.0 program focuses on five domains essential to PCC and implementation of culture change: The Foundation, Resident Choice, Staff Empowerment, Home Environment, and Meaningful Life. The four primary domains— Resident Choice, Staff Empowerment, Home Environment, and Meaningful Life—were developed through the collaboration of a
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Domain #0: Founda