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Taking a Seat at the Quality Assurance Table Quality assurance and performance improvement are here, and pharmacists need to have a place at the table. This requires understanding the principles of quality improvement, how to track and analyze data effectively, conduct root-cause analyses, and work with the interdisciplinary team to make systems and process changes that improve quality and prevent recurrence of problems and incidences. KEY WORDS: Performance improvement, Pharmacist, Quality assurance, Quality improvement, Root-cause analysis. ABBREVIATIONS: ACA = Affordable Care Act, CMS = Centers for Medicare & Medicaid Services, MDS = Minimum Data Set, PIP = Performance Improvement Project, QAPI = Quality assurance and performance improvement, RCA = Root-cause analysis.

Joanne Kaldy

Introduction

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articipating in a quality assurance and performance improvement (QAPI) program or project is like going to a good potluck dinner. Everyone brings something different to the table, there is lots of sharing, everyone enjoys something new, and all go away satisfied. Not only is QAPI—quality assurance (QA) and performance improvement (PI)—becoming the law of the land, but facilities have also discovered that approaching problems from a systems perspective with a focus on root-cause analysis (RCA) solves individual situations and enables long-term, facility-wide solutions.

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“There is a real desire and need for pharmacists to be involved in QAPI, but nursing facilities don’t always know how to include these practitioners,” said Mark Coggins, PharmD, CGP, FASCP, senior director of pharmacy services, Diversicare, Spartanburg, South Carolina. “Pharmacists should be asking facilities about their needs and providing feedback. This is a powerful opportunity to have a tremendous impact on care, costs, and the facility’s viability.”

QAPI’s Life Story QAPI is a provision of the Affordable Care Act (ACA), signed into law in 2010. ACA states that the Secretary of Health and Human Services “shall establish and implement

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a QAPI program for facilities that includes development of standards relating to QA and PI through regulations.” It also requires that the Secretary make technical assistance available to facilities to assist them with the development of best practices to meet the standards. The provision mandated that every facility have a QAPI plan in place a year after the QAPI final rule is released. This had many facilities scrambling when ACA came out. However, five years later, although providers are still waiting for the final rule, they haven’t waited to implement some form of QAPI in their facilities. The Centers for Medicare & Medicaid Services (CMS) hasn’t left providers dangling in the wind. They’ve provided a tremendous amount of guidance and even have a Web site dedicated to QAPI (http://www.cms.gov/ Medicare/Provider-Enrollment-and-Certification/QAPI/ nhqapi.html). The agency also identified five elements as a strategic framework to help facilities develop, implement, and sustain QAPI. A facility’s plan should address all of these. The five elements are: 1. Design and Scope. The facility’s QAPI program must be ongoing and comprehensive, dealing with all services offered and including all departments. It should address all care systems and management practices, as well as clinical care, quality of life, and resident choice. 2. Governance and Leadership. The governing body or facility administration should develop a culture that involves the facility’s leaders and seeks input from staff, residents, families, and others. This body also ensures adequate resources are available for QAPI, leadership and facility-wide training covering staff time, equipment, and technical training. In addition to fostering a culture where QAPI is a priority, the governing body must sustain this commitment in spite of staffing changes and turnover. 3. Feedback, Data Systems, and Monitoring. The facility must implement systems to monitor care and services, drawing data from multiple sources. There must be a system of feedback that seeks input from staff, residents, families, and others. This element includes the use of performance indicators to monitor care processes and outcomes. Findings must be reviewed against benchmarks or targets established by the facility. Every

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adverse event must be investigated and an action plan implemented to prevent recurrence. 4. Performance Improvement Projects (PIPs). Every facility must conduct PIPs—concentrated efforts on a particular problem either in one area of the facility or facility-wide. This involves gathering information systematically to clarify issues or problems and intervene for improvements. The issues to be addressed by PIPs will depend on the facility’s type, demographics, and scope of services. 5. Systematic Analyses and Systemic Action. The facility must use a systematic approach that uses data to determine the root cause of a problem and implications of a change. There must be a complete approach to determine if a problem may be caused or heightened by how care or services are organized or delivered. The facility will be expected to develop policies and procedures and demonstrate proficiency in the use of RCA, a problemsolving method designed to dive down well below the surface of a problem to the root causes. These efforts should lead to systemic actions to prevent future events and promote sustained improvement.

The facility must use a systematic approach that uses data to determine the root cause of a problem and implications of a change.

CMS also suggested several QAPI action steps: • Step 1. Ensure leadership responsibility and accountability. Create a culture to support QAPI efforts that begin with leadership. • Step 2. Develop a deliberate approach to teamwork. This is where the pharmacist’s role lies and where he or she can have the greatest impact. • Step 3. Take your QAPI “pulse” with a self-assessment. • Step 4. Identify your organization’s guiding principles. • Step 5. Develop a QAPI plan. QAPI combines two complementary approaches to quality management—quality assurance and performance

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improvement—that differ from each other (Table 1). Done right, QAPI has many sustaining benefits. For instance, staff obtains competencies that equip the care team to solve quality problems, prevent their recurrence, and identify and embrace opportunities to set and achieve new goals. QAPI also enables caregivers to become active partners in performance improvement.



Hammers, Nails, and Other Tools Central to any QAPI effort is RCA. This is a problemsolving method designed to find the factors that cause a negative variations. Once identified, this negative variation can be eliminated, and resulting problems no longer will occur. There are many useful tools to help QAPI teams identify root causes, analyze data, and seek solutions (Table 2). Among the most popular: • The Ishikawa diagram is useful for RCA. It also is called a fishbone diagram because it is shaped like



the skeleton of a fish. This enables the user to list as many causes as possible of a specific event and group them into major categories. It is designed to encourage a focus on causes and not symptoms. The fishbone diagram is especially useful to trigger brainstorming when the team is stuck or stalled (Figure 1). The “Five Whys” is a tool of the Six Sigma management philosophy and involves repeatedly asking “why” to find the root cause of a problem. It starts with writing down the problem and asking why it happened. This tool is popular because it is relatively simple to use and can be completed without statistical analysis. It is most useful when the problem involves human factors. The Pareto Principle, or 80/20 Rule, says that 20% of causes generate 80% of results and enables users to analyze the frequency of problems. This tool enables the team to prioritize things that need to be changed by identifying problems that will be solved by making these changes. Using the tool involves six steps: identify

Figure 1. Example of Fishbone Diagram

Used by permission. Carver County Public Health, Chaska, Minnesota.

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Table 1. Quality Assurance Versus Performance Improvement Quality Assurance

Performance Improvement

Motivation

Measuring compliance with standards

Continuously improving processes to meet standards

Means

Inspection

Prevention

Attitude

Required, reactive

Chosen, proactive

Focus

Outliers: “Bad Apple” individuals

Processes or systems

Scope

Medical provider

Resident care

Responsibility

Few

All

Source: Reference 1.

Table 2. Tools to Build Strong QAPI Interventions to Reduce Acute Care Transfers (INTERACT): Quality Improvement Program Version 3.0 Tools

http://healthinsight.org/nv-providers/182-nursing-homes/452-interventions-to-reduce-acutecare-transfers-interact-quality-improvement-program-version-3-0-tools

Fishbone (Ishikawa) Diagram

http://asq.org/learn-about-quality/cause-analysis-tools/overview/fishbone.html https://www.moresteam.com/toolbox/fishbone-diagram.cfm

Quality Improvement Tools

http://esrdnetworks.org/mac-toolkits/download/download-toolkit-and-write-able-forms-qapitoolkit/qapi-toolkit/view

Flowcharts

http://www.ihi.org/resources/Pages/Tools/Flowchart.aspx

What Is a Process Flowchart?

http://asq.org/learn-about-quality/process-analysis-tools/overview/flowchart.html

Pareto Chart

http://asq.org/learn-about-quality/cause-analysis-tools/overview/pareto.html http://www.isixsigma.com/tools-templates/pareto/pareto-chart-bar-chart-histogram-andpareto-principle-8020-rule/

Determine the Root http://www.isixsigma.com/tools-templates/cause-effect/determine-root-cause-5-whys/ Cause: The Five Whys Plan-Do-Act-Study Worksheet

http://www.ihi.org/resources/Pages/Tools/PlanDoStudyActWorksheet.aspx

QAPI Tools

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/qapitools.html

Abbreviation: QAPI = Quality Assurance Performance Improvement.

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and list problems, identify root cause of each problem, score problems, group problems together by root cause, add up the scores for each group, and take action. A Pareto analysis is useful when you only have time or resources to focus on one issue. • Plan-Do-Check-Act Cycle. This is also called the Deming Cycle, after W. Edwards Deming, known as a quality management pioneer. This tool is designed to help ensure that the solution you reach is the right one. The cycle includes four phases: Plan (identifying and analyzing the problem), Do (developing and testing possible solutions), Check (measuring the test solution’s effectiveness and how it possibly could be improved), and Act (fully implementing the final solution). This is useful when you want to be highly methodical about your problem solving. • A flowchart, which is a representation of a process, shows steps as boxes that are connected by arrows. The team can use this to diagram a solution to a specific problem. It is useful when you need a visual story that takes you through the steps from problem to solution. • Sparkline is a small line chart, usually without axes or coordinates. It is designed to show the movement of a variation over time in some measurement (such as dollars). This can be useful for you want to isolate a variation and address specific characteristics, but it is more commonly used in business than health care. “Tools are tremendously effective to help others understand what you are doing and why,” said Coggins. For example, he showed a fishbone diagram addressing an issue to his CEO. “I was able to objectively break down the issue. It took away the finger pointing.” This is important, he said, because pharmacists often are afraid to tell people that they’re doing something wrong. “When you use these tools, it takes the emotion and the blame out of the picture.” As a result, he observed, the team can focus on problem solving and working together. Pharmacists need to familiarize themselves with RCA and use these resources to support their efforts (Table 3). “It is critically important for the pharmacist to know this stuff. You have to be able to example why outcomes are occurring. You need to be able to give an explain quality

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improvement processes to others and examine issues globally,” Coggins said.

Data Collection and Analysis Pharmacists should be prepared to collect (as appropriate) and analyze data. There are dozens of sources of data, so it is most expedient to focus on the specific subjects and to use keyword searches and other means to gather information. Of course, techies or those with access to cuttingedge technology may have an easier time. For example, some companies use Microsoft Amalga, a platform that can retrieve patient information from many sources, including scanned documents, X-rays, and laboratory results, Coggins said. “This takes information from any electronic data source and compiles it into one database. For example, if I want to focus on patients being discharged from the hospital with gastrointestinal bleeds, I can use this system to find every patient in the facility on coagulants, for example. It makes data-mining much easier.” Fortunately, a growing number of facilities have some form of electronic health record, and this can be used to collect some data, such as medication records, diagnoses, and laboratory results. “And you can’t discount the MDS [Minimum Data Set, compiled by CMS]. The data may not be current, but it can help you identify big issues,” he said. It isn’t necessary to be a data expert, Coggins stressed. “All organizations have IT [information technology] experts you can talk to. You just need to understand what data you need and be able to explain to the IT expert what you want to accomplish with it. In reality, the IT team is a big player on the QAPI team. They hold the key to our ability to access information.” Some organizations have developed their own useful tools. Al Barber, PharmD, CGP, FASCP, director of pharmacy services, Alixa Rx, Kent, Ohio, said, “When I was at Golden Living, we developed a tool—a medication safety assessment.” This requires the pharmacist to look at all medication-use systems in the facility each quarter and report on any deficits. It addresses issues such as medication availability and seeks to determine

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Table 3. Quality Improvement and QAPI Resources What Is Quality Improvement?

http://patientsafetyed.duhs.duke.edu/module_a/introduction/contrasting_qi_qa.html

Quality Improvement in Nursing Facilities

https://www.ascp.com/articles/quality-improvement-nursing-facilities

The Falls Management http://www.ahrq.gov/professionals/systems/long-term-care/resources/injuries/fallspx/ Program: A Quality Improvement Initiative for Nursing Facilities QAPI

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/nhqapi.html

QAPI at a Glance

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/Downloads/ QAPIAtaGlance.pdf

The CMS QAPI Guide: http://www.ohiokepro.com/shopping/pdfs/8772.pdf What You Need to Know Nursing Home Quality Initiatives: Questions and Answers

https://nhqualitycampaign.org/files/FAQ_Aligning_NH_Quality_Initiatives_3-3-2015.pdf

QAPI Toolkit

http://esrdnetworks.org/mac-toolkits/download/download-toolkit-and-write-able-forms-qapitoolkit/qapi-toolkit/view

Abbreviation: QAPI = Quality Assurance Performance Improvement. Source: Reference 1.

if medication errors are reported in a timely manner including if and when RCAs are done. Barber noted, “It looks at processes in the facility, with an eye toward identifying and rectifying medication use issues from the initial order through medication receipt, storage, administration, follow-up, monitoring, and so on. This fits in nicely with QAPI.”

You’re So QAPI, You Don’t Know It In truth, QAPI isn’t new for most pharmacists. As Barber explained, “The pharmacist’s medication management review essentially is a patient-focused QAPI. You are using data and information from various sources to identify problems and recommend changes to reduce risks and improve clinical outcomes for a patient.” That is the essence of QAPI,” he said. “Most

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pharmacists understand that role very well.” Coggins actually worked on his QAPI project years ago, although they didn’t call it QAPI at the time. He recalled, “I was working with a facility that had several issues. We wanted to study the impact of the pharmacist being more active on the interdisciplinary team; we really wanted to focus on quality improvement.” Coggins and his team decided to target psychotropics, including antipsychotics, anxiolytics, antidepressants, and sedative hypnotics. “We called a mega-meeting. We split the facility up into four quadrants, and each week we would focus on patients in a different quadrants,” Coggins said. Because many of the patients on psychotropic medications also triggered problems such as weight loss, the team included dietary staff in addition to nurse managers and MDS coordinators, among others. They talked about the potential that these

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patients had unmet needs, and they drilled down and identified pain management as a likely culprit. Patients with no pain meds were prescribed Tylenol, and those on opioids had their dosages increased. The team also referred appropriate candidates for pain assessments. “Once we got pain under control, we moved to other reasons for psychotropic use. We looked at possible incidences of untreated or undertreated depression and addressed these.” Before long, patients started to feel better; they gained weight and became more active. Pressure ulcers started to heal. And, as a result of all of this, psychotropic use went down. This project took time and money, he said, but they were able to achieve results that not only improved patient outcomes and quality of life, but also had a positive financial impact on costs of care. “We reinforced the value of the pharmacist’s involvement. This is something I’m really proud of,” Coggins said. “This was truly a QAPI project, although we didn’t call it that at the time.” He added, “The facility was having problems with several issues, but we identified the area where we thought we could make the greatest improvement. This is a perfect example of how QAPI should work.”

Early detection of potential problems is a key part of QAPI.

A QAPI project can take many forms. One of Barber’s initiatives started with admissions coming from the hospital on sliding-scale insulin. He worked with one physician to convert all of her patients to basal bolus insulin. Next, he sent a letter to other prescribers in the facility explaining what was done and why. The letter outlined the benefits of making this change and cited key literature. Then, one by one, Barber worked with each physician to change his or her prescribing habits. Barber used a similar approach to reduce antipsychotic use. “We have a large population of geropsych patients, and two years ago 40% of them were on antipsychotics.

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We started a process where once a week would have a ‘Wounds, Weights, and Behaviors’ program, where I would present 1 to 10 patients for whom I wanted to reduce or eliminate antipsychotic medications.” This initiative involved team members, including nurses, caregivers, social workers, and others, who offered their insights, observations, and other information. Then Barber was able to go to the physicians with a recommendation based on a holistic picture of the patient and not just his bias or even the literature or the regulations. The result was impressive—antipsychotic use dropped from 40% to 19% within a year. “When pharmacists bring issues to the team for intervention, they can accomplish much that they can’t accomplish on their own,” Barber said.

Come to the Party “Pharmacists need to invite themselves to the party,” said Coggins. “Be an active member of the interdisciplinary team.” He suggested letting the nursing staff and others know that you are willing to work with them on QI. “Tell them how they can reach you. Encourage them to contact you between visits about problems they notice or concerns or questions they have, so that you can address these promptly and prepare effectively for your next trip to the facility.” When there is an issue, such as patients coming from the hospital on a proton-pump inhibitor, Barber said the pharmacy has a couple of options. “You can write up a note for each patient and get each patient’s regimen changed. Or you can bring up the issue at a QAPI meeting and say, ‘Here is something that could we can do to improve care, prevent survey citations, and protect our [Medicare] Five-Star rating,’” he said. He stressed that pharmacists can suggest QAPI for any issue related to medication use or clinical outcomes, including unlocked medication carts and improper disposal of unused medications. Gathering information from the pharmacy literature on how others have addressed this issue also can be helpful to increase staff buy-in. Early detection of potential problems is a key part of QAPI. Barber said, “As the consultant pharmacist, you are an early-warning sign of sorts. If you can be an advocate for early

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detection and prevention in the facility, you have a real value.” If they are to be seen as QAPI masters, pharmacists have to be comfortable with a little self-promotion. “Pharmacists often assume that everyone knows how they’re trained and what they can contribute; but that is far from the truth,” he said. Unless pharmacists are aggressive about putting forth their contributions, their facility leadership and staff may not know what they can do or even who they are.” He suggested arranging one-on-one meetings with the facility medical director and other team leaders. “Find out what keeps them up at night and what medication-related problems you can help them resolve.”

“The pharmacist’s medication management review essentially is a patient-focused QAPI. You are using data and information from various sources to identify problems and recommend changes.”

Go, Team QAPI With antipsychotic reduction and reduced readmissions a top priority for everyone, the pharmacist plays an important role in solving quality problems. “QAPI is a team effort, and the pharmacist is an important part of that,” said Karyn Leible, MD, CMD, medical director at Jewish Homes in Buffalo, New York. Having that medication management/review piece is essential for QAPI. “Pharmacists can identify areas of concern for QAPI projects, and they help with education,” she said, adding, “Pharmacists need to think of themselves as a member of the team and not an outsider. What they bring is invaluable.”

Think, Talk, Act QAPI Pharmacists should get in the QAPI habit, Coggins suggested. “Be thinking about QI when you do your medication regimen reviews. Consider problems or errors not simply as isolated problem, but part of broader systemic issues,” he said. “Find the actual root causes, and provide feedback and strategies and ways to change

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processes that will prevent problems from occurring in the future.” Coggins now uses a QAPI approach every day. “I tackle issues now by drawing a fishbone diagram. I use this, for example, to come up with 15 to 16 possible reasons why medications weren’t delivered. Each time a medication didn’t come, I would drill down for a cause.” He added that this helps him prioritize next steps and identify root causes and possible solutions.

Boon or Burden Pharmacists may see involvement in QAPI as one more thing for which they have to make time in their already overbooked schedules. But, Barber said, it ultimately can be a time saver. While he spends time in meetings discussing quality issues, for example, he gets information about patients that save him time later when he’s doing his reviews. “I know which patients to zero-in on, and my time is more cost-effective,” he said. “I’m also more visible, and staff are more comfortable approaching me with problems or questions.” Lieble noted that pharmacists also can use QAPI principles to improve the rate of acceptance for their recommendations to physicians. “They can conduct a rootcause analysis to identify possible reasons that physicians aren’t accepting their recommendations, And they can use this information to work more effectively with physicians on medication issues.“ While there is no direct reimbursement for the pharmacist’s role in QAPI, pharmacies increasingly are charging for the pharmacist’s time in the facility, and facilities recognize the tremendous return on investment they get from the pharmacist’s services, Looking ahead, Barber noted that reimbursement increasingly will be based “on how well your population does, not on how many scripts you fill. And the more effective you are, the more in demand you’ll be.” At the same time, QAPI can be a career builder. Reflecting on his psychotropic-reduction project, Coggins said, “It changed my career. I was already successful, but this raised my profile, enabled me to obtain my certified geriatric pharmacist credential, and

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it opened the door to new job opportunities.” Whatever their level of experience, pharmacists need to embrace QAPI…and soon. “This isn’t going away,” said Leible. “Yes, it’s more to do, but we have an opportunity to go beyond paper compliance and make lasting improvements in the lives of our elders.” Pharmacists need to step up and be prepared to contribute to the QAPI feast. n

Joanne Kaldy, a freelance writer, lives in Harrisburg, Pennsylvania. Disclosure: The author has no potential conflicts of interest. Consult Pharm 2015;30:312-20. © 2015 American Society of Consultant Pharmacists, Inc. All rights reserved. Doi:10.4140/TCP.n.2015.312. Reference 1. QAPI at a Glance: A Step by Step Guide to Implementing Quality Assurance and Performance Improvement (QAPI) in Your Nursing Home. Available at http://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/QAPI/Downloads/QAPIAtaGlance.pdf. Accessed April 14, 2015.

1/2 PAGE AD TK Call For Manuscripts

The Consultant Pharmacist welcomes reports of original, welldesigned research and clinical reviews that are applicable to consultant pharmacy and senior care practice. The journal also encourages submission of literature reviews, case reports, and opinions on important clinical or professional issues.

Sharing research findings, clinical innovations, and practice management insights in the journal is an excellent way to expand the knowledge base of those working to improve the lives of seniors.

The Consultant Pharmacist seeks manuscripts on: • Medication therapy management • Consultant pharmacy services in the assisted living setting • Innovative programs to improve medication management during transitions of care • Health care needs of elderly in various community based and long-term care settings • Medication-related problems in the elderly in a wide range of settings The journal also accepts letters to the editor, opinion pieces, and discussions of personal experiences in care of the elderly.

The journal, indexed by MEDLINE, the Cumulative Index of Nursing and Allied Health, EMBASE.com, Excerpta Medica, and International Pharmaceutical Abstracts, offers an efficient peerreview process. Approved manuscripts generally are published within nine months of acceptance. For author and submission instructions, visit tcp.msubmit.net For additional information, contact: H. Edward Davidson, PharmD, MPH Editor-in-Chief The Consultant Pharmacist [email protected] 757-625-6040

Taking a Seat at the Quality Assurance Table.

Quality assurance and performance improvement are here, and pharmacists need to have a place at the table. This requires understanding the principles ...
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