registered nurse (huc7j)

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Course Learning Outcomes for Unit VII Upon completion of this unit, students should be able to:

7. Explore quality improvement activities when supervising a health unit. 7.1 Explore the roles of quality management, process improvement, patient safety, and risk

management in health care. 7.2 Identify process improvement techniques and strategies to analyze adverse events used in

health care. 7.3 Demonstrate understanding of key laws and regulations pertinent to coordinating a health care

unit. 7.4 Relate the Health Insurance Portability and Accountability Act (HIPAA) to safety concerns in

hospitals.

Course/Unit Learning Outcomes

Learning Activity

7.1

Unit Lesson Article: “Steps in the Process of Risk Management in Healthcare” Article: “The Role of Hospital Managers in Quality and Patient Safety: A

Systematic Review” Unit VII Research Paper

7.2 Unit Lesson Chapter 24 Unit VII Research Paper

7.3 Unit Lesson Chapter 27 Unit VII Research Paper

7.4 Unit Lesson Chapter 28 Unit VII Research Paper

Required Unit Resources Chapter 24: Methods Improvement: Making Work—and Life—Easier Chapter 27: The Supervisor and the Law Chapter 28: The Manager and HIPAA In order to access the following resources, click the links below. Alam, A. Y. (2016, October 3). Steps in the process of risk management in healthcare. Journal of

Epidemiology and Preventative Medicine, 2(2), Article 13000118. https://www.researchgate.net/publication/308888285_Steps_in_the_Process_of_Risk_Management_i n_Healthcare

Parand, A., Dopson, S., Renz, A., & Vincent, C. (2014). The role of hospital managers in quality and patient

safety: A systematic review. BMJ Open, 4(9), Article e005055. https://www-ncbi-nlm-nih- gov.libraryresources.columbiasouthern.edu/pmc/articles/PMC4158193/

UNIT VII STUDY GUIDE

Legal Aspects, Quality, and Patient Safety

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Unit Lesson The health care industry collectively tries to provide an environment of care and to promote healing and well- being for the patients served. However, it is undeniable that the health care industry is wrought with errors that frequently result in harm to patients. In 1999, the Institute of Medicine (IOM) published a groundbreaking report titled To Err Is Human that found that 98,000 people die annually because of medical errors within health care systems (Haskins, 2019). Read that again. Further, these errors cost upward of $19.5 billion in avoidable health care costs. According to Haque et al. (2018), there are an estimated 1.7 million preventable health care-associated infections per year and more than 770,000 medication errors annually that result in some form of injury and/or death. Because of these astonishing statistics, it is exceedingly important that new health care leaders have a strong grasp of quality management and patient safety techniques that should be a part of every health care unit’s regular activity and ingrained within the culture of the unit. In this lesson, we will explore different but related terms, including quality management, process improvement, patient safety, and risk management. Additionally, different methodologies will be explored to assist health care leaders in learning from and preventing errors. Finally, different laws, regulations, and organizations will be presented to familiarize a new leader with overarching high-risk areas and organizations to provide guidance and information.

Defining Some Important Terms

In the field of quality and patient safety, there are a lot of terms used that can be a bit overwhelming to a new leader. Some common concepts include quality management, process improvement, patient safety, and risk management. You will soon find that these terms are sometimes used interchangeably and not always correctly. The health care industry is by far the most complex but also the most fragmented. Because of this, patients are not always safe, and errors are common. Health care leaders have an inherent role in keeping patients safe. The following will begin to break down the different concepts involved in the moral obligation a leader has to prevent injuries and instill a culture of safety.

Quality Management Quality management is a broad term centered on the various processes in the health care industry and how different processes interact and affect patients (Aggarwal et al., 2019). Although there are many varying definitions of quality in health care, most experts agree that vital components of quality include reliability, assurance, and responsiveness. Reliability refers to the ability of an organization to provide care to its patients consistently and precisely (Chakravarty et al., 2001). Assurance refers to the know-how and consideration of all staff towards patients. Responsiveness refers to the eagerness and efficiency of services provided to patients. Aggarwal et al. (2019) further noted that Avis Donabedian, who is widely accepted as the first expert in health care quality, described seven hallmarks of quality:

• efficacy

• efficiency

• optimality

• acceptability

• legitimacy

• equity

• cost

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Moreover, many years later, the IOM put forth similar definitions of quality that include

• safe,

• effective,

• patient-centered,

• timely,

• efficient, and

• equitable. Given the complexities and intricacies of care provided in hospitals, it is important to denote that most health systems have whole departments responsible for promoting and ensuring quality of care. Quality departments typically work collaboratively with leadership, provide education, audit care provided, and collaborate with health care providers to ensure that care provided meets all the above-stated standards. McConnell (2019) indicates that successful quality management departments utilize a collaborative approach across many disciplines, and opportunities for change are conceived, results are achieved, and new processes employed by those who do the work, which is typically frontline staff. Process Improvement Under the umbrella of quality management is process improvement (PI), which simply put, is an organized process to improve some facet of care or service within an organization. As we will learn in a moment, there are several different methodologies that can be adopted and utilized to drive change. It is imperative that an organization adopt one method and invest in ensuring that leaders and staff understand the method and how to apply it to their work. There are some key concepts at the heart of PI. According to Backhouse and Ogunlayi (2020), PI uses a systematic process of change and strategies to improve clinical outcomes and the patient experience. At the epicenter of PI is iteration and testing different change ideas or learning from differing hypotheses and results of tests to arrive at an improved process. PI should always include frontline staff who should be empowered by their leaders to identify broken processes or opportunities for better, safer, and more efficient ways to do things. Finally, PI uses data to drive change. No matter what methodology is selected and utilized by an organization, McConnell (2019) breaks down the process of PI into basic steps:

1. identify a problem or opportunity for improvement 2. gather facts (data, policies, existing procedures, layout of physical space, etc.) 3. break down the problem into smaller chunks 4. challenge everything (eliminate waste, combine steps, change the sequence of activities, improve the

way things are done) 5. put forth an improved way of doing things 6. implement and follow-up

Patient Safety Another important concept is patient safety. The World Health Organization (as cited in Lawati et al., 2018) defines patient safety as the avoidance of mistakes and adverse experiences encountered by patients when seeking health care. Many times, patient safety is defined by the culture of the organization, or the shared beliefs, mindsets, experiences, abilities, and models of conduct of all staff. However, it is imperative to understand that patient safety in practice occurs where patient care occurs, such as the nursing unit, emergency department, or operating room (Emanuel et al., 2008). However, the frontline care depends on the system to produce an environment conducive to safety such as strong channels of communication, teamwork, and an ability to manage unpredictable events.

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Emanuel et al. (2008) recognize seven factors that impact safety in a health care environment:

• organizational and management factors

• work environment factors

• team factors

• task factors

• individual factors

• patient characteristics

• external environmental factors” (p. 15) Therefore, an organization must be aware of each of the above when developing the patient safety program and cognizant of each as it works towards a culture of safety. Further, a patient safety program must focus on four key components of safety for patients, including employees, patients and those who have stake in the availability of health care, the infrastructure of where health care is provided, and methods for feedback and PI (Emanuel et al., 2008). Further subdivided, Lawati et al. (2018) reports the makeup of a safety culture requires the following:

• an established error reporting system

• well-supported leadership expectations and activities

• organizational learning

• teamwork within units

• communication

• transparency about errors

• blame-free culture

• staffing

• management support

• handoffs and transitions of care Alam (2016) lists major adverse incidents encountered in health care that can negatively impact patient safety, which are known has hospital-acquired conditions (HACs). Examples of HACs include

• medication errors and related events,

• catheter-associated urinary tract infections,

• falls,

• pressure injuries,

• surgical site infections,

• central line associated infections,

• venous thromboembolism, and

• ventilator-associated pneumonia. Risk Management As we have established, the complexity of the health care industry and patient care in general produces conditions ripe for errors and adverse events. Because of this, health care systems are required to have a program in place to track and mitigate these events known as risk management. According to Alam (2016), “Risk is a probability/threat of damage, injury, liability loss that is caused by vulnerabilities and that may be avoided through pre-emptive action” (p. 1). Some key areas for concern that contribute to risk-related issues include communication breakdowns, insufficient flow of information, poor transfer of knowledge throughout the organization, staffing problems, inefficient or ineffective workflows, technical failures, inadequate policies and procedures, and people-related issues. Alam (2016) describes five basic steps in a risk management program that includes establishing the context, identifying risks, analyzing risk, evaluating risk, and mitigating risks. Important tools to assist in identifying risks include

• rounding on staff, physicians, and hospital leadership;

• tracer activities;

• chart reviews;

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• surveys/reports from accreditation bodies;

• incident reports;

• health care-associated infection reports;

• committee minutes/reports;

• executive committee minutes/reports;

• patient complaints, grievances, and satisfaction survey results; and

• blood utilization reports. Another important function of the risk management program is to assign a severity to each incident that occurs. If an adverse incident results in no harm or a very minor injury that does not require any treatment, it is said to have a negligible impact; minor injuries that only require first aid type treatment and/or result in less than 3 days of additional hospital stay are graded as minor; moderate incidents have a significant injury requiring medical treatment such as a fracture and/or result in 3 to 8 additional hospital days; major incidents result in long-term disability such as the loss of a limb; and finally extreme incidents result in major permanent incapacity and/or death.

Techniques Used in Process Improvement and Risk Management

Given all that we have learned to this point about the propensity and magnitude of risk present in the health care industry and the overall importance of patient safety, it should be no surprise that there are many different methodologies in existence that serve as important tools to understand adverse events and drive change. Some common techniques include plan-do-study-act or PDSA (also known as plan-do-check-act or PDCA), process flow diagrams, pareto analysis, root cause analysis (RCA), and failure modes effect analysis (FMEA). The following is a brief description of each methodology, and although there are many others, these are some of the most common in use in most health care systems.

Process Improvement Methodologies The first PI methodology is derived from the engineering world, known as PDSA. During the first and most important phase, the “plan” phase, the problem is identified, and a hypothesis is developed. Essentially, the hypothesis in this context is a change that will result in doing some process better, safer, or more efficiently. During the “do” phase, the change is implemented into practice. The “study” phase refers to collecting data of some sort to evaluate the new process. The “act” phase includes interpreting the data related to the new process and to identify any further modifications that may need to be made to achieve the stated improvement. In this way, PDSA is intended to be a cyclical and iterative process always seeking the best way to complete a process or task (Johnson et al., 2010). Another common PI methodology is process flow diagrams that are used to map each step in a process. Through this mapping procedure, wasted time is identified, as well as the person best responsible to complete each step in the process. Once the current state of a process is mapped out, the next step is to create a future state that represents the new process and new accountabilities and eliminates wasted time (Johnson et al., 2010). An example of a process where a process flow diagram might be useful is the process of a new patient presenting to the emergency department and the steps required to check the patient in, register them, and obtain insurance information. Often, this process is fragmented and can lead to delays in care if not carefully established. Root Cause Analysis Root cause analysis (RCA) is a common tool used in virtually all health care institutions to understand the cause of an adverse event. Because of the complexities in the health care industry, a systematic method to understand the causes, identify lessons learned, and apply change to mitigate further instances of an event is required (Harel et al., 2016). RCA is best undertaken with a group of knowledgeable individuals across all disciplines involved or potentially involved in the incident (Alam, 2016). Some RCA experts advocate asking why no less than five times to establish why an adverse event happened (Johnson et al., 2010). For example, if a patient falls out of bed, the team would ask why the patient fell out bed. If it is identified the bed alarm was not activated, the team would ask why the alarm was not activated. If it is determined that the nursing assistant was last in the room working with patient and forgot to engage the alarm, the team would ask why the nursing assistant did not activate the alarm prior to leaving the patient. If it is determined that the

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nursing assistant is new to the team and did not know how to use the bed alarm, the team would ask why the nursing assistant was not shown how to use the bed alarm during orientation. If it is discovered that it is not included on the new hire orientation checklist for nursing assistants, the team would ask why this is not a standard part of the nursing assistant orientation. From there, the team would ensure that bed alarm instruction would be added to the checklist and become a standard part of the orientation for nursing assistants. It would also be a crucial component of the RCA to ensure this finding and lesson learned is pushed out to all units so that a similar adverse event could potentially be prevented on another unit with another new nursing assistant. Harel et al. (2016) identified tools useful in conducting an RCA, one of which is a fishbone or cause and effect diagram. A fishbone diagram is used to brainstorm about the main reasons a problem occurred. Usually, a fishbone is made by placing the problem in a box to the right, with a line drawn from it across the middle of the page, which represents the spine of the fish. Lines or fishbones are drawn off the central line to identify each category of potential causes that contributed to the problem or adverse event. Below is an example of a common problem—falls in the hospital—involving certified nursing assistants (CNAs), procedures, patients, and more.

Harel et al. (2016) recommend evaluating the following categories fully when deciding on the fishbone groupings:

5 Ps 6 Ms 4 Ss

Patients Machine Surroundings

Providers Method Suppliers

Policies Materials Systems

Processes/Procedures Measurement Skills

Place/Equipment Man -

- Mother Nature -

Clearly, not every adverse event will contain causes from each grouping, and it is up to the risk management expert and RCA team members to identify the applicable groups. While the fishbone diagram provides a wealth of information, it does not rank the causes or provide any sort of prioritization. A pareto analysis or chart is another tool wherein a visual representation of the several most commonly occurring contributors are identified. Unlike the fishbone diagram, a pareto chart does prioritize the causes

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into those most worthy of action. After a list of all potential contributors is identified, the team should rank the causes in terms of most frequently occurring to least frequently occurring. In doing so, the RCA team can then focus on the changes that will bring about the greatest impact (Harel et al., 2016). Failure Modes Effect Analysis Whereas RCA is a tool used retrospectively, failure modes and effects analysis (FMEA) is a tool used to identify problematic areas proactively before patient harm occurs. Johnson et al. (2010) indicate that FMEAs are conducted when there is a process or procedure that is known to be high risk, convoluted, or has otherwise generated concern for patient safety. Team members are assembled to dissect the process into each individual step in the process. Each step is then further dissected to understand where the process might fail at that step. These are known as the failure modes. Each failure mode is then ranked by the team into the probability the failure will occur and the severity of the failure if it does occur. These values are multiplied together to develop an FMEA score. Those steps with the highest score are the steps that should be addressed by the team through a process improvement method such as PDSA discussed above.

Key Laws and Regulations Pertinent to the Health Care Industry

Health care is a very heavily regulated industry, and new leaders must familiarize themselves with a variety of pertinent laws, regulations, and oversight agencies. These laws exist to protect workers, patients, and sometimes both. As such, they must influence the behavior and decisions of health care leaders at times. Further, it is vital that a new health leader recognize that while one must have some level of understanding, many occurrences and/or issues should be co-managed by the leader and the executive team, human resources, risk management, and/or the organization’s legal counsel (McConnell, 2019). Labor-Related McConnell (2019) presents the Fair Labor Standards Act (FLSA), which was enacted in 1938. This is the federal law that governs the majority of the wage and hour laws used by most states. It deals with issues such as exempt versus nonexempt positions and minimum salaries for certain classifications of positions. FLSA further governs overtime pay and on-call pay that is common in the health care industry. Finally, the FLSA prohibits unequal pay for the same positions based on gender. Title VII of the Civil Rights Act of 1964 saw an amendment known as the Equal Employment Opportunity Act of 1972 that prohibits discrimination as it pertains to employment based upon race, color, religion, gender, or national origin. Further, the Age Discrimination in Employment Act of 1967 prohibits discrimination based upon age. Finally, the Americans With Disabilities Act, fully functional as of 1992, requires employers to provide reasonable accommodations for disabled workers who are otherwise capable of performing a job (McConnell, 2019). The Family and Medical Leave Act (FMLA), enacted in 1993, provides protection to employees who have been employed for at least 1 year to take up to 12 weeks of unpaid leave for qualifying family or medical reasons without fear of losing their employment. Some qualifying reasons include one’s own serious medical condition, the birth of a child, or to care for a sick family member. FMLA is complex, and leave decisions are typically managed by the human resources department of an organization. However, a new leader should be aware and able to offer a referral to human resources for employees who are faced with a situation such as those mentioned above. Occupational Safety and Health Act The Occupational Safety and Health Act (OSH Act) of 1971 protects workplace safety and governs employee health at the federal level (McConnell, 2019). The OSH Act exists to protect employees from exposures to dangers such as poisonous substances, noise, unhygienic environments, and/or mechanical threats. The resulting Occupational Safety and Health Administration (OSHA) oversees matters such as ergonomics, personal protective equipment, hazard communications, and education/training (Mahan et al., 2014). Organizations that violate OSHA standards may be sanctioned, fined, or even shut down for workplace conditions deemed unsafe for workers (McConnell, 2019).

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Emergency Medical Treatment and Active Labor Act The Emergency Medical Treatment and Active Labor Act (EMTALA) of 1986 was enacted to protect patient access to emergency care and to prevent the dumping of patients who lack medical insurance (Zibulewsky, 2001). Specifically, EMTALA ensures hospitals

• provide medical screening examinations to any person who presents requesting services;

• provide stabilization or transfer any patient experiencing an emergency medical condition; and

• provide care at facilities with specialty areas such as a burn unit, and receive patients transferred in if there is space to treat the patient.

Zibulewsky (2001) describes an emergency medical condition to include severe pain or conditions such that a failure to provide urgent medical attention will endanger the patient’s health, an unborn child’s health, or result in serious dysfunction of a body system or organ. Here again, health systems found in violation, governed by the Office of the Inspector General of the Department of Health and Human Services, are subject to high monetary fines.

Understanding the Health Insurance Portability and Accountability Act and Your Role The five sections of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 include many areas (McConnell, 2019). For the purpose of this discussion, Title II will be emphasized, which focuses on the prevention of health care fraud and abuse, medical liability reform, and administrative simplification. According to McConnell, Title II in and of itself is very complex and covers subjects such as

• national standards for electronic claims,

• standards for clinical data transmission,

• protection and integrity of electronic health data,

• government enforcement of HIPAA provisions,

• workers’ compensation rules surrounding first report of injury,

• the requirement of using a federal tax identification number as the exclusive identifier for each employer,

• a national identifier for each provider, and

• privacy rule that restricts the disclosure of patient health information. Of this list, the privacy rule is probably the most important for a new health care leader to comprehend. This act regulates the disclosure of protected health information (PHI) by covered entities. Under HIPAA, organizations and their employees are required to protect patient information and prevent unauthorized sharing. HIPAA requires that organizations have specific policies that govern how PHI is handled and require that all health care entities provide training to their employees. Further, organizations are required to perform periodic audits to safeguard against fraud and abuse. Lastly, under HIPAA, health care organizations must have a mechanism to disclose to patients when a breach occurs, and PHI is inappropriately revealed (McConnell, 2019). These activities are overseen by the privacy officer—a position required in every health care organization. McConnell (2019) indicates that patient information must be protected in all forms. This includes but is not limited to

• written documents;

• electronic information;

• discussion in public places such as waiting rooms;

• accidental exposure on social media (posting a picture that accidently contains patient information);

• leaving work computers unattended with PHI on the screen;

• violating the need-to-know portion of PHI, which indicates that only the information necessary to care for the patient should be shared with any given individual; and

• accessing one’s own medical information only through established processes. This means one cannot simply access their own medical record but instead, must comply with the policy of the organization that dictates the process for obtaining the record.

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However, there are instances in which HIPAA does not prohibit sharing PHI. PHI may be disclosed to law enforcement and in response to court orders without fear of repercussion. Information can be disclosed to public health entities when there is concern regarding communicable diseases or an adverse event such as an injury related to food or a malfunctioning of a health care product. PHI may also be shared with those who have a legal right to obtain the information, such as a designated health care proxy, guardian, or the parent of a minor (McConnell, 2019).

Conclusion

As you can see, the health care industry is probably even more complex than you imagined. Many of the regulations and laws exist not only to protect you, but also the patients you serve. A new health care leader is not expected to know everything. However, it is advisable to become familiar with the policies of your organization and ensure that your practice as a leader always adheres to those policies. Further, leaders must know when to collaborate with supporting entities such as senior leadership, human resources, legal counsel, risk management, the infection prevention department, or the quality department. Further, there are many organizations that provide a wealth of information within their websites, which is key for new leaders. Examples include the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare and Medicaid Services (CMS), and any regulatory bodies that provide accreditation for your chosen health care organization. Examples include The Joint Commission and DNV or Det Norske Veritas.

References

Aggarwal, A., Aeran, H., & Rathee, M. (2019, April-June). Quality management in healthcare: The pivotal desideratum. Journal of Oral Biology and Craniofacial Research, 9(2), 180–182. https://doi.org/10.1016/j.jobcr.2018.06.006

Alam, A. Y. (2016, October 3). Steps in the process of risk management in healthcare. Journal of

Epidemiology and Preventative Medicine, 2(2), Article 13000118. https://www.researchgate.net/publication/308888285_Steps_in_the_Process_of_Risk_Management_i n_Healthcare

Backhouse, A., & Ogunlayi, F. (2020, March 31). Quality improvement into practice. BMJ, 368, Article m865.

https://doi.org/10.1136/bmj.m865 Chakravarty, A., Parmar, N. K., & Ranyal, R. K. (2001, July). Total quality management – The new paradigm

in health care management. Medical Journal Armed Forces India, 57(3), 226–229. https://doi.org/10.1016/s0377-1237(01)80049-6

Emanuel, L., Berwick, D., Conway, J., Combes, J., Hatlie, M., Leape, L., Reason, J., Schyve, P., Vincent, C.,

& Walton, M. (2008, July 2). What exactly is patient safety? Agency for Healthcare Research and Quality. https://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patient- safety-resources/resources/advances-in-patient-safety-2/vol1/Advances-Emanuel-Berwick_110.pdf

Haque, M., Sartelli, M., McKimm, J., & Bakar, M. A. (2018, November 15). Health care-associated infections –

an overview. Infection and Drug Resistance, 2018(11), 2321–2333. https://doi.org/10.2147%2FIDR.S177247

Harel, Z., Silver, S. A., McQuillan, R. F., Weizman, A. V., Thomas, A., Chertow, G. M., Nesrallah, G., Chan,

C. T., & Bell, C. M. (2016, May). How to diagnose solutions to a quality of care problem. Clinical Journal of the American Society of Nephrology, 11(5), 901–907. https://doi.org/10.2215/cjn.11481015

Haskins, J. (2019, June 6). 20 years of patient safety. Association of American Medical Colleges.

https://www.aamc.org/news-insights/20-years-patient-safety

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Johnson, C. D., Miranda, R., Aakre, K. T., Roberts, C. C., Patel, M. D., & Krecke, K. N. (2010, February). Process improvement: What is it, why is it important, and how is it done? American Journal of Roentgenology, 194(2), 461–468. https://www.ajronline.org/doi/full/10.2214/AJR.09.3213

Lawati, M. H. A., Dennis, S., Short, S. D., & Abdulhadi, N. N. (2018, June 30). Patient safety and safety

culture in primary health care: A systematic review. BMC Family Practice, 19, Article 104. https://doi.org/10.1186/s12875-018-0793-7

Mahan, B., Morawetz, J., Ruttenberg, R., & Workman, R. (2014, February 1). Workplace safety and health

improvements through a labor/management training and collaboration. NEW SOLUTIONS: A Journal of Environmental and Occupational Health Policy, 23(4), 561–576. https://doi.org/10.2190/NS.23.4.c

McConnell, C. R. (2019). The effective health care supervisor (9th ed.). Jones & Bartlett Learning. Zibulewsky, J. (2001). The Emergency Medical Treatment and Active Labor Act (EMTALA): What it is and

what it means for physicians. Baylor University Medical Center Proceedings, 14(4), 339–346. https://doi.org/10.1080/08998280.2001.11927785