Essay on Legal and Regulatory Requirements of Health Care System

Published: 2021-07-07
1006 words
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Carnegie Mellon University
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Legal and regulatory requirements form an integral part of health care in the United States. These standards aim at reducing the cost of medical care in the country .Also, they promote positive patient care outcomes such as high-quality and safety. Some of these legal and regulatory requirements include the medication reconciliation requirement introduced by the Joint Commission in 2005, the bar code label rules of the Food and Drug Administration agency (FDA), and safe staffing requirements that have been enacted by states such as California.

Californias Nurse Staffing Rules and Regulations

The staffing rules and regulations were introduced in California introduced to improve patient safety, quality of health care, retain nurses in employment, and reduce patient-to-nurse ratio in the states hospitals (McHugh, Kelly, Sloane, & Aiken, 2011).These requirements came into force against the backdrop of severe health issues that eroded the quality of service delivery in the 1990s.For instance, in the early 1990s, the health sector was restructured and changes introduced in health care financing, resulting in a decrease of caregivers and quality of services in hospitals(Tevington,2011; McHugh et al.,2011).As a result, California Assembly Bill 394 was passed in 1999 to address these challenges. According to Tevington (2011), the law set a minimum, numerical nurse-patient ratio that should be maintained at all times by each unit in hospitals. This numerical minimum was to ensure that patients received prompt care from nurses while ensuring that such medical officers worked in a less-stressful environment.

At the start of the implementation of the nurse-patient ratio requirements, hospital authorities experienced several challenges. Recruiting and retaining registered nurses became a huge problem for hospitals and workloads for registered nurses increased, leading to higher levels of dissatisfaction (Tevington, 2011).These requirements have also been associated with increased medical errors and higher mortality rates (McHugh et al., 2011).However, subsequent changes to the application of these regulations have resulted in positive outcomes that can be emulated by health care providers in other states. For example, the application of the staffing rules has led to increased skill mix between registered nurses and vocational nurses, reduced medical errors, reduced workloads and enhanced the overall safety of patients (Allen, 2013).

The Bar Code Label Requirements

Manufacturers, relabelers, repackers and private label distributors are the major implementers of bar code label regulations. As noted earlier, these regulations were introduced by FDA and require that a barcode is attached to certain human drugs and biological products labels. This is part of the wider mandate of health agencies to protect consumers from medical harm. The rule further requires that machine-readable information be attached to blood and blood component labels (FDA, 2011).According to According to FDA, the aim of the barcode labels is to allow medical professionals to use bar code scanning technology to ensure that the right drug (in terms of dosage and route of administration) is prescribed to the right patient at the appropriate time.

The success of barcode label regulations culminated into the introduction of barcode technology in health care. This technology utilizes the bar code labels and help nurses to carry out their activities in hospital settings. A study conducted by Staggers, Iribarren, Guo and Weir (2015) found that Barcode medication administration (BCMA) has a significant effect on nurse effectiveness and substantially reduce medical errors. This is realized through the provision of cognitive support to nurses which enhances their situation awareness and understanding of the drug administration activities on patients. As such, the integration of the barcode regulations with the BCMA has helped FDA to achieve a huge portion of its safety objective in health care.

Medication Reconciliation

Medication reconciliation was introduced by the Joint Commission on Accreditation of Health Care Organizations (JCAHO).JCAHO emphasizes on the evaluation of health care organizations rather than inspection as a way of ensuring that these organizations provide safe and high-quality care (Barnsteiner, 2008).One of the mechanisms that JCAHO has managed to carry out its mandate to require medical professionals to improve their effectiveness through analysis of historical drug regime of new patients before further prescription of drugs.

Medication reconciliation is the process of drawing comparisons between the patients medication orders with the medication that the patients have been undergoing. Adherence to these rules aims at reducing medical errors such as duplications, dosing errors, omissions or drug interactions (Barnsteiner, 2008).This reconciliation is restricted to the issues that arise during patient transition. According to Barnsteiner (2008), transition occurs when treatment settings change, change of service, level of care or practitioner. This intervention minimizes treatment discrepancies which occur at the time of transition. Medication reconciliation has been supported by a significant amount of research which has suggested that medical discrepancies account for more than half of the medical errors that arise during transitions in health care (Mekonnen, McLachlan, & Brien, 2016) and this approach has significantly reduced such errors(Barnsteiner, 2008).

From the discussion, it is evident that patient-nurse ratio, barcode label and medication reconciliation rules and regulations seek to enhance the effectiveness of medical professionals in the delivery of care. Patient-ratio requirements create a favorable physical and mental climate for decision-making in the provision of health services. Barcode label and medication reconciliation provide the tool that nurses and other officers to determine effectively administer drugs.


Allen, D. (2013). Evidence shows staff ratios can work. Nursing Standard, 27(43), 20-22. doi:10.7748/ns2013.

Barnsteiner, J. H., & Agency for Healthcare Research and Quality. (2008). Patient Safety and Quality: An Evidence-Based Handbook for Nurses.

Food and Drug Administration. (2011). Bar Code Label Requirements. Retrieved from

McHugh, M. D., Kelly, L. A., Sloane, D. M., & Aiken, L. H. (2011). Contradicting Fears, California's Nurse-To-Patient Mandate Did Not Reduce The Skill Level Of The Nursing Workforce In Hospitals. Health Affairs, 30(7), 1299-1306. doi:10.1377/hlthaff.2010.1118

Mekonnen, A. B., McLachlan, A. J., & Brien, J. E. (2016). Effectiveness of pharmacist-led medication reconciliation programmes on clinical outcomes at hospital transitions: a systematic review and meta-analysis. BMJ Open, 6(2), e010003. doi:10.1136/bmjopen-2015-010003

Staggers, N., Iribarren, S., Guo, J., & Weir, C. (2015). Evaluation of a BCMAs Electronic Medication Administration Record. Western Journal of Nursing Research, 37(7), 899-921. doi:10.1177/0193945914566641

Tevington, P. (2011). Mandatory nurse-patient ratios. MEDSURG Nursing, 20(5), 265-268.

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