Leading Tools in Healthcare Compliance Audits

Leading Tools in Healthcare Compliance Audits

15 March, 2024

Regulatory compliance is a vitally important function in healthcare. Organizations that maintain compliance ensure that patients and providers are safe, respected and treated fairly. There are many examples of regulatory compliance programs in the global and national healthcare sectors. In the United States, HIPAA guidelines protect and secure patient data and, by extension, keep patients safe from invasions of privacy, fraud and theft. FDA regulations strictly guide the development and production of drugs and medical devices, meaning that patients can access quality medical products with as few adverse effects as possible, significantly improving public health. On a global level, the World Health Organization’s Good Manufacturing Practices quality assurance standards confirm that vaccines and medications are produced in accordance with standards.

In addition to securing patient and provider safety and quality of life, the regulations governing the healthcare sector help maintain public trust in the medical system. For example, vaccines like Gardasil for HPV may have had long-lasting negative public perception had they not been produced to follow the standards set by regulatory bodies, such as the FDA’s Center for Biologics Evaluation and Research.

That said, healthcare professionals have to consider a vast amount of complicated healthcare regulations, which have variances at the state, national and international levels. The healthcare sector needs professionals who, as Joshua Abrams, adjunct professor at Northeastern University School of Law, says, “understand [that] the vocabulary of healthcare is critical to being able to effectively participate in healthcare compliance audits.” One way to gain this vocabulary is through a Master of Legal Studies with a Health Law concentration. 

In this article, we explore various tools that simplify compliance processes in healthcare:

• Compliance Roadmaps
• Risk Assessment Matrices
• Computer-Assisted Audit Techniques (CAAT)
• Compliance Training

A compliance roadmap outlines how an organization and its employees will maintain compliance with specific processes or regulations. In a healthcare regulation setting, this means adhering to the legal and ethical regulations that dictate how organizations should operate. A healthcare compliance roadmap should contain a linear progression of steps dictating what, when, why and how a healthcare organization and its employees will adhere to related laws and regulations.

A compliance roadmap should include:

• Clear policies, procedures and codes of conduct for staff, including processes that outline how to report violations.
• An outline of the organization’s training and teaching methods that are relevant to new hires and existing staff, including training mandated by law and training specific to the organization.
• A summary of the organization’s auditing and risk assessment procedures.

The U.S. Department of Health and Human Services lists seven components that it recommends healthcare organizations incorporate into their compliance programs. Three key points related to compliance roadmaps include:

• Designating a specific person to serve as an internal compliance officer or point of contact
• Developing appropriate methods of corrective action for compliance issues
• Ensuring disciplinary standards related to compliance are well publicized

Risk Assessment Matrices

A risk assessment matrix helps organizations spot and address risks early on to avoid becoming liabilities. Created by collecting and analyzing cross-department data, the purpose of the matrix is to:

• Reveal potential risk areas and their causes 
• Determine the likelihood of each risk
• Clearly indicate the severity of consequences
• Suggest solutions
• Identify accountable parties 

Most risk assessment matrices use a 5×5 grid format, with one axis charting probability and another indicating the severity of impact. The format is flexible though, and each organization, facility or department can modify the specifics according to their needs.

In healthcare settings, risk assessment matrices can identify issues such as regulation adherence, data security, billing, sanitation, biohazard management, waste disposal and occupational health and safety. For example, the Agency for Healthcare Research and Quality’s risk assessment toolkit can help healthcare facilities assess the safety of their design. Risk assessments can also account for relevant regulations that may not be top of mind for healthcare professionals, such as the General Data Protection Regulation. 

Computer-Assisted Audit Techniques (CAAT)

CAAT is a method of gathering, reviewing and analyzing masses of electronic records. For healthcare compliance purposes, CAAT may be used by internal auditors to identify outright compliance issues or reveal trends that imply subtler issues.

CAAT saves time, reduces errors and can discover trends — positive or negative — that may have otherwise gone unnoticed. In healthcare settings, CAAT can spot anomalies in several areas, such as:

• Patient records and admissions
• Physician records
• Medical coding
• Billing 
• Inventory
• Staffing
• Facility accommodations

Regularly scheduled compliance training keeps providers, staff and administrators up-to-date on the laws, rules, regulations, policies and procedures that govern their daily work. Compliance training can be complicated, but following best practices when developing training programs is deeply important both for educating healthcare workers and to secure Medicaid/Medicare/CHIP eligibility as established in Section 6401 of the Affordable Care Act. Similarly, remaining compliant with HIPAA and OSHA regulations requires annual training.

Healthcare organizations should maintain records of their training programs so that they can prove their compliance in the event of an audit. Recording training scores and similar metrics can also reveal how well staff members understand the regulations associated with their roles.

Understanding Healthcare Regulations

Healthcare organizations and regulatory bodies alike need people who have specialized insight into the regulatory landscape.

Abrams teaches a number of courses in Northeastern Law’s online Master of Legal Studies with a concentration in Health Law, including Patient Records and Privacy and Wages and Benefits. As he says, “By understanding the history and details of medical record confidentiality, on both the State and Federal levels, and the interaction between State and Federal laws in this area, all provided in the Patient Records and Privacy course, students can navigate this complicated area of law and healthcare.”

About the Master of Legal Studies Program at Northeastern University

This distinctive online Master of Legal Studies is for non-lawyer professionals who do not wish to practice law but would like to use the law as a means to achieve their goals in environments where legal knowledge is an asset.

Northeastern University is a leading institution that ranks among the nation’s top 10 Most Innovative Schools according to the U.S. News & World Report. In 2024, The National Jurist/preLaw awarded Northeastern Law an A+ grade for practical legal training.

In this program, you can earn your degree in less than two years as a part-time student. The curriculum offers courses in areas such as Law and Organizational Management, Data Regulation and Compliance, Negotiation and Advocacy, and Law and Strategy.

Designed for non-lawyer professionals, the online MLS helps leaders in highly regulated industries gain the expertise to excel in their careers. Choose a general course of study or select one of five concentration options:

• Business Law
• Health Law
• Human Resources Law
• Intellectual Property Law
• Public Law and Policy