The aim of this paper is to create a regulatory requirement proposal to reduce door-to-balloon (D2B) time in STEMI patients. It will outline the steps that must be taken to communicate and implement this regulation successfully. Moreover, the paper will provide a basis for ensuring regulatory compliance. It will also review three regulatory requirements at the federal, state, and local levels and discuss how they can be implemented and evaluated.
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Federal, State, and Local Regulations
The Privacy Rule of HIPAA, or the Standards for Privacy of Individually Identifiable Health Information, is a legislative act that regulates standards for the protection of health information at the state level. The legislation was created to “define and limit the circumstances under which an individual’s protected health care information (PHI) may be used or disclosed” (Liginlal, Sim, Khansa, & Fearn, 2012, p. 206) by health care professionals or other legal entities covered by the law. Other requirements connected to HIPAA include the Gramm-Leach-Bliley Act (GLBA) and the Sarbanes-Oxley Act (SOX) (Chowdhury et al., 2013). The Contextual Integrity (CI) framework can be used to both implement and evaluate the implementation of this regulation (Chowdhury et al., 2013).
To enhance understanding of the regulatory framework that governs nursing practice in the state of Florida, Rule 64B9-5.013 was enacted on April 21, 2013 (Florida Board of Nursing, 2013). The rule was proposed by the Florida Board of Nursing and requires Licensed Practical Nurses (LPNs), Registered Nurses (RNs), Clinical Nurse Specialists (CNSs), and Advanced Registered Nurse Practitioners (ARNPs) to “complete a two-hour course on the laws and rules that govern the practice of nursing in Florida” (Florida Board of Nursing, 2013, para. 1). To implement and evaluate this requirement, it is necessary to mandate “a CE provider approved by the Board of Nursing” (Florida Board of Nursing, 2013, para. 1) to disclose information on its enrollees to the board.
Policy #3 issued by the Accreditation Commission for Education in Nursing (ACEN) outlines the requirements a nursing program must meet in order to be eligible for accreditation. The policy was created to ensure that nursing education organizations follow certain eligibility criteria necessary for being approved by the board to grant “a diploma, certificate, associate degree, baccalaureate degree, master’s degree, or clinical doctorate in nursing” (ACEN, 2016, p. 8). Implementation and evaluation of the requirements are conducted by ACEN on an individual basis.
This proposal calls for the creation of universal national guidelines that regulate how PCI is conducted to reduce D2B time. D2B time is a measure of the response of a medical team to patients who have suffered a myocardial infarction (MI) with ST-segment elevation (Ellahham, Aljabbari, Mananghaya, Raji, & Zubaidi, 2015). If D2B time is less than 90 minutes, it is possible to substantially reduce the negative health outcomes for patients with this cardiovascular condition (Wilson et al., 2013). Currently, there are many strategies for the reduction of D2B time that have been developed by organizations such as the Society of Cardiovascular Patient Care and the American Heart Association. However, all existing STEMI systems are based on state regulatory frameworks as well as ACC/AHA guidelines (Krumholz et al., 2011). These regulations are concerned with data registries, D2B measures, and the designation of STEMI facilities, among others. However, despite significant national progress in providing care for patients undergoing primary PCI, there is still room for improvement (Krumholz et al., 2011).
The adoption of universal national protocols for the reduction of D2B time should be supported by procedural documents that provide health care institutions with the necessary process, outcome, and efficiency measures. These measures will help control the implementation of regulation and can be used internally by institutions for the improvement of their health outcomes. The communication of the regulation will be conducted by the ACCF/AHA using their current methodologies. The ultimate goal of this proposal is to create a regulatory framework that can provide health care organizations with directions for conducting and measuring the outcomes of PCI for patients with STEMI. Therefore, it is necessary to outline the proper use of cardiovascular technology such as remote defibrillators and to define a specific structure and safety measures (Thylén, Ericsson, Angerud, Isaksson, & Lawesson, 2015). The regulation should also include universal appropriate use criteria as well as competency and training documents specifying the volume of training and specific knowledge that members of emergency response teams should possess. Furthermore, the regulation has to address the issue of the creation of universal national guidelines for the preparation of Cath Labs for emergency departments. ACCF/AHA practice guidelines can serve as a model for developing a legal structure that will provide the basis for determining regulatory compliance. It will help ensure that all health care organizations that conduct PCI for patients with STEMI follow the regulation.
This paper outlined a regulatory requirement proposal for the creation of a framework that can provide health care organizations with directions for conducting and measuring the outcomes of PCI for patients with STEMI. It addressed the issues of implementation and documentation, as well as the assessment of regulatory compliance.
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Thylén, I., Ericsson, M., Angerud, K. H., Isaksson, R. M., & Lawesson, S. S. (2015). First medical contact in patients with STEMI and its impact on time to diagnosis; an explorative cross-sectional study. BMJ Open, 5(4), 59-62.
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