Part 1
Healthcare compliance refers to the observance of healthcare guidelines, conventions, and state and federal laws and regulations. Healthcare compliance affects all healthcare organizations and healthcare providers globally, from small independent practitioners to huge conglomerates. The aim of such compliance is to act in an oversight role and impose upon these individuals and organizations, healthcare regulations and guidelines that will improve the quality of healthcare, ease of access to such healthcare and at the same time ensure the affordability and availability of quality healthcare. The government ensures that such compliance is there through certain agencies in order to protect consumers and citizens in general.
There are numerous regulatory agencies tasked with ensuring the compliance of healthcare industries with existing laws and regulations. The Centers for Medicare & Medicaid Services (CMS) is a part of the United States Department of Health and Human Services, known in short as DHHS. It ensures governmental oversight over most regulations in the healthcare system as well as overseeing various healthcare programs. Through these programs, the agency provides government-subsidized medical coverage. The Agency for Healthcare Research and Quality is another agency under DHHS responsible for conducting research aimed at ensuring quality and affordable healthcare while ensuring patient safety (McBride, 2005).
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The CDC or Centers for Disease Control and Prevention is perhaps the most popular regulatory agency, tasked with numerous responsibilities. In more general terms, it ensures public health and safety and warns the public of potential health threats especially from infectious diseases (Christian et al., 2013). The Office of the National Coordinator for Health Information Technology, an agency under the DHSS, facilitates and oversees the development of the national health information technology infrastructure. Other regulatory mechanisms with patient regards to healthcare compliance include Health Insurance Portability and Accountability Act, HIPAA, Health Information Exchange, Meaningful Use and the Office for Civil Rights.
Healthcare laws are an important part of any society. They include federal, state and local laws, rules and regulations designed to provide oversight and control in the healthcare industry. They are essential in ensuring that healthcare providers provide quality and affordable healthcare and proper delivery of healthcare services while adhering to operational, regulatory and transactional legal issues. The law thereby creates certain provisions that promote compliance amongst such healthcare providers. Some of the prevention mechanisms include the threat of brand damage and remediation costs such as fines and penalties. These measures reduce the occurrence of non-compliance with healthcare laws.
Decongestion and simplification of an organization’s portfolio and processes is a good example of a strategy that aids in ensuring compliance. This refers to a wide scope of activities including healthcare quality and affordability, patient safety and care, improvement of facilities, the safety of patient information, being technologically relevant and having experienced and qualified healthcare personnel. These strategies promote compliance with healthcare laws and regulations. The hiring of compliance officers is also instrumental in promoting compliance as they aid in effectively developing, implementing, and monitoring a healthcare compliance program for the organization based on governmental regulatory guidelines.
A patient care committee refers to an interdisciplinary committee comprising of medical, nursing and other healthcare professionals (Lainscak et al., 2011). Their main role is to coordinate and implement the Plan for Provision of Care for all patients as well as ensure that the patients’ bill of rights is adhered to in the provision of medical care (Sheikhtaheri, Jabali & Dehaghi, 2016). The patient care committee’s responsibilities include recommendation of practice standards for patient care, recommendation of clinical policies, ensuring organizational guidance regarding staff training and competency, monitoring and improving patient care as well as ensuring the confidentiality of patient information, patients’ fair treatment and their autonomy over medical decisions as provided for under the patients’ bill of rights.
Part 2
It is only the Centers for Medicare and Medicaid Services that was involved in the case, and perhaps the state’s public health department. CMS is the main agency tasked with the oversight of the provision of healthcare in the US through the Medicare and Medicaid programs. Medicare primarily deals with the provision of healthcare for the elderly and the disabled while Medicaid is for lower-income individuals and families (Kanavos & Gemmill-Toyama, 2010).
The incident at Massachusetts General was brought about by a series of occurrences that eventually led to the tragic death of a patient. The first oversight by the staff of the hospital was that the volume on the patient’s bedside crisis alarm, which alerts the staff to an arrhythmia, was in the ‘off’ setting. This means that even in the event that the patient suffered cardiac arrhythmia, the alarm would not have gone off, thereby alerting the staff of the situation thus saving the patient’s life. A further inquisition led to the discovery of the second problem which was that scrolled volume functions on bedside alarms had an ‘off’ setting that could be applied easily and inadvertently, a fact that is not well known amongst the staff. This example of alarm fatigue led to noncompliance as the proper standards of patient care had not been adequately implemented and adhered to thus leading to poor patient care standards (Drew et al., 2014).
There were no penalties and or consequences. The hospital, Massachusetts General, had fully cooperated and complied with the CMS officials and this is perhaps the reason why the hospital did not face any punishment. Instead, the hospital came up with several solutions and subsequently started on a journey to implement these solutions. These solutions included the disabling of the ‘offsetting’ on more than 1,100 monitors, installation of distributed speakers so that volume settings on alarms do not have to be turned up so high, standardized alarm volumes, and the hospital further instituted a review process for any changes to the default settings. Furthermore, the hospital staff created a training program that reviews monitor technology and formed a committee charged with creating the best practices and standards for alarm use. That team of staff members subsequently reviewed standards to see which patients were in more need of being on the monitors.
In order to avoid the non-compliance, a number of requirements should have been in force in the first place. This includes a compliance or oversight team, preferably a Patient Care Committee which would have ensured, amongst other things, organizational guidance regarding staff training and competency. This would have ensured that the staff of the hospital was aware of the operational functions of the alarms and how easy it was for the alarms’ ‘offsetting’ to be activated. Among other functions of the Patient Care Committee is the provision of direction and guidance to a Critical and Acute Care Subcommittee that should have been created and working in the first place. These subcommittees are essential in providing care and looking after patients who are in critical conditions, such as the patient who tragically died. The development of a quality council would also have been important in preventing the non-compliance. The work of such a unit is to monitor and improve patient care. This would have been helpful in ensuring that all the patients’ needs would have been cared for. This includes the bedside alarms that should have been in a proper working condition.
Proper organizational security practices, such as the implementation of proper policies and use of Information Technology controls in healthcare provision would have aided in promoting compliance. For instance, the monitors would have been more effective with more efficient IT controls.
References
Christian, K., Ijaz, K., Dowell, S., Chow, C., Chitale, R., & Bresee, J. et al. (2013). What we are watching—five top global infectious disease threats, 2012: a perspective from CDC's Global Disease Detection Operations Center. Emerging Health Threats Journal , 6 (1), 20632. http://dx.doi.org/10.3402/ehtj.v6i0.20632
Drew, B., Harris, P., Zègre-Hemsey, J., Mammone, T., Schindler, D., & Salas-Boni, R. et al. (2014). Insights into the Problem of Alarm Fatigue with Physiologic Monitor Devices: A Comprehensive Observational Study of Consecutive Intensive Care Unit Patients. Plos ONE , 9 (10), e110274. http://dx.doi.org/10.1371/journal.pone.0110274
Kanavos, P., & Gemmill-Toyama, M. (2010). Prescription drug coverage among elderly and disabled Americans: can Medicare—Part D reduce inequities in access? International Journal of Health Care Finance and Economics , 10 (3), 203-218. http://dx.doi.org/10.1007/s10754-010-9077-z
Lainscak, M., Blue, L., Clark, A., Dahlström, U., Dickstein, K., & Ekman, I. et al. (2011). Self-care management of heart failure: practical recommendations from the Patient Care Committee of the Heart Failure Association of the European Society of Cardiology. European Journal of Heart Failure , 13 (2), 115-126. http://dx.doi.org/10.1093/eurjhf/hfq219
McBride, G. (2005). The Coming of Age of Multicultural Medicine. Plos Medicine , 2 (3), e62. http://dx.doi.org/10.1371/journal.pmed.0020062
Sheikhtaheri, A., Jabali, M., & Dehaghi, Z. (2016). Nurses’ knowledge and performance of the patients’ bill of rights. Nursing Ethics , 23 (8), 866-876. http://dx.doi.org/10.1177/0969733015584967