Internal Audit Procedure in Healthcare and Pharmaceutical Sector

Focusing on compliance is critical to ensuring compliance with regulatory standards and corporate policies during internal audits in the health care sector. The audit assesses various aspects including Patient data privacy (HIPAA), medical coding accuracy (ICD-10), billing integrity, clinical protocols and infection control measures.

The affordable care act (ACA) of 2010 introduced further regulatory changes, emphasising quality of care and financial integrity. Overall, compliance in the health sector in the 2000s has seen an evolution toward more comprehensive regulation, increased enforcement, and an emphasis on transparency and accountability to ensure the best possible standards of care and protection for patients and stakeholders alike.

Risk Management

The process of risk management involves measuring or assessing risk and developing strategies to manage risk within the risk appetite in a structured, consistent, and continuous manner. The process involves identifying, assessing, mitigating, planning, and implementing risks, as well as developing an appropriate risk response policy.

Risks associated with Health Sector

Types of risks involved in health and pharmaceutical sector are as follow:

• Clinical Risks: Patients safety and medical errors are involved in these risks. Mistakes in diagnosis, treatment or surgery can lead to harm or even death. Inadequate infection control, medication errors, and complications during medical procedures are examples.
• Operational Risks: Supply chain disruptions, equipment failures, staffing storages, and facility management challenges are just some of the risks related to day-to-day operations.
• Public Health Risks: Outbreak of infectious diseases, pandemic and public health emergencies can strain health care systems, overwhelm resources and pose risks to both patients and healthcare workers.
• Regulatory Risks: Health organisations must adhere to numerous regulations and standards, such as HIPAA for patient data privacy, FDA regulations for drugs and medical devices, and CMS guidelines for billing and reimbursement. Failure to comply can lead to legal actions and financial penalties.
• Environment Risks: Environmental risks, such as pollution and chemical exposure, hazardous emissions, etc., can lead to legal liability, reputational damage, and financial penalties for organisations.
• Financial Risks: Healthcare organisations' financial stability can be influenced by changes in insurance policies, fluctuating healthcare reimbursement rates, and the rising cost of medical supplies. Economic uncertainties and changes in government funding are both factors that lead to financial risks.

To protect assets, ensure accurate financial reporting, promote compliance, maintain efficiency, and manage risk, internal controls are a set of processes in the hospital industry. Segregating tasks, approval processes, reconciling, access control, data security, stock management, care standardisation, quality control, billing accuracy, and revenue cycle management are key controls. Patient care is improved, assets are protected, and compliance is promoted through internal controls.

Internal auditors review various aspects of expenses in the health sector, such as clinical supplies, labour costs, administrative overhead, patient care services, and technology investments, to ensure compliance with budgets, regulations, and operational efficiency.

Moreover, they examine vendor relationships, contract compliance, and potential cost-saving measures. Maintaining financial integrity, optimising resource utilisation, and enhancing healthcare service delivery while safeguarding financial sustainability are all essential reasons for conducting these audits.

Types of Expenses in Healthcare Sector

During internal audits in the health sector various types of expenses are evaluated to ensure financial accountability, compliance and operational efficiency. The expenses assessed typically include:

• Operating Expenses: The healthcare facility's daily expenses are linked to its normal operations. Salaries of staff, utilities and supplies, maintenance and other costs related to hospital needs to keep the staff running are included in operating expenses.
• Medical Supplies and Pharmaceuticals: To ensure proper procurement practices, inventory management, and cost efficiency, auditors review the expenses related to medical supplies, medications, and pharmaceuticals.
• Equipment and Capital Expenses: This category includes all the expenditure related to purchasing, maintaining, and upgrading medical equipment and facility infrastructure. Auditors assess whether these investments align with the healthcare facility’s long-term goals and provide value for money.
• Patient Care Costs: Auditors evaluate expenditures related to direct patient care, such as diagnostic tests, treatments, surgical procedures and consultations.They may review whether these costs are appropriately billed and reimbursed.
• Labour Costs: Internal auditors examine the allocation of labour costs, including salaries, benefits, overtime, and other compensation-related expenses. This ensures compliance with labour laws and regulations.
• Administrative Expenses: Non-clinical functions like billing, coding, administrative staff salaries, and office supplies are covered by administrative expenses.These expenses are reviewed by auditors to ensure accuracy and efficiency.
• Compliance Costs: The purpose of these expenses is to ensure that healthcare regulations, privacy laws, and quality standards are adhered to.Auditors evaluate spending on compliance activities and verify compliance with legal and regulatory requirements.
• Marketing and Promotion Expenses: Auditors may assess expenditures related to marketing and promotion activities conducted by hospitals to ensure transparency, proper use of resources and compliance with ethical standards.
• Training and Professional Development: The auditors examine expenditures related to staff training and professional development to ensure that investments help improve patient care and organisational effectiveness.
• Emergency preparedness Cost: Auditors may evaluate expenses related to emergency preparedness and response, ensuring that the facility is adequately equipped to handle unforeseen situations.

IT assessment during internal audits in the healthcare sector is a crucial process that evaluates the information technology systems, infrastructure and practices within healthcare organisations.

This assessment is to ensure that IT resources are effectively managed, data security is maintained, and regulatory compliance is upheld. IT evaluation usually occurs during internal audits in the health care sector as follows:

• Scope Definition: Internal auditors collaborates with IT Experts to define the scope of the assessment. This includes identifying the systems, networks, applications and processes that will be evaluated. The scope may cover electronic health records (EHR) systems, patient data management, network security, software applications and more.
• Regulatory Compliance Review: Auditors assess whether the organisation’s IT practices comply with relevant regulations and standards in the healthcare sector.This includes evaluating compliance with regulations like HIPAA, HITECH Act, and the General Data Protection Regulation (GDPR), if applicable.
• Data Security Assessment: The Internal Auditor examines organisation’s data security measures to protect patient’s sensitive information and unauthorised access, breaches and cyber threats. This involves reviewing encryption practices, access control, authentication methods and vulnerability management.
• Electronic Health Records (EHR) Audit: If the organisation uses an EHR system, then the auditor must review accuracy, completeness and security of patient’s records stored in these systems. They should ensure proper documentation and data integrity controls are in place.
• Network and Infrastructure Evaluation: The organisation's network infrastructure, including firewalls, routers and servers is assessed for vulnerabilities and security measures. Auditors verify that the network is properly segmented to prevent unauthorised access.
• User access and authorisation: Auditors evaluate the users access controls to ensure that employees have appropriate access privileges based on their roles. They check for inactive accounts and unauthorised attempts to access.
• IT Governance and Policies: The organisation’s IT governance framework is assessed, including IT policies, procedures and controls. Auditors verify that IT practices align with organisational goals and industry best practices.

Hospitals prioritise patient’s safety in internal audits to ensure that the highest standard of care has been provided to the patients. Audits evaluate adherence to clinical protocols, medication management, infection control, patient identification, medical records, communication, emergency preparedness, staff training, patient involvement, informed consent, privacy protection, event reporting, and investigation, etc.

In healthcare, the multifaceted nature of expenses, ranging from personnel costs to patient care and compliance expenditures, demands vigilant oversight. Internal audits in the healthcare and pharmaceutical sector not only safeguard against financial mismanagement but also ensure that each dollar invested resonates in improved healthcare delivery. Likewise, within the pharmaceutical realm, the scrutiny extends to aspects like research and development costs, quality assurance, and regulatory adherence, crucial in fostering innovation while safeguarding public health.

Internal audits in the pharmaceutical industry are essential for ensuring compliance, safeguarding public health, and fostering innovation. These audits assess critical areas such as research and development costs, quality assurance, and regulatory adherence.