Gabriela Villarmarzo, CHC

HRPLabs Compliance Officer,

Clinical laboratory and full pathology services


The Seven Elements of a Compliance Program:

During the month of November the week dedicated to compliance is celebrated. But what does compliance mean in the health field?

Having a compliance program ensures that we have an infrastructure which allows the personnel who work there to know the standards and procedures that help prevent and detect any non-compliance with state and federal laws and regulations which govern the health field.

Every organization must ensure that within its facilities a culture of ethics and commitment to compliance is promoted. No matter how small the organization is, 20 employees or 200, it must demonstrate the same level of commitment to promoting ethical conduct within its environment.

When we talk about compliance, we are talking about seven key elements that must be implemented within the compliance plan of any organization. We list them below.

The Seven Elements of a Compliance Program are:

  1. Politics and procedures
    For this, annual risk examinations are carried out which help us to identify vulnerable areas within the organization. Once these areas have been identified, we move on to the phase of creating the policies and procedures that address those specific areas. When we talk about policies, we refer to the actions that must be carried out in the day-to-day running of the organization to ensure we are in compliance. Procedures are the methods that must be used to comply with these policies. It is important to emphasize that an organization’s code of conduct must refer to these policies and procedures.
  2. Assign a compliance officer
    When it comes to large organizations, it is of the utmost importance that this position is assigned to someone who can dedicate time to monitoring compliance within all areas of the organization. The primary role of the compliance officer is to serve as a catalyst for:
  • Develop a sense of responsibility and ownership for the compliance program throughout the institution.
  • Identify vulnerabilities
  • Make sure management responds to needs
  • Establish controls to ensure that all risks are mitigated
  1. Audits and Monitoring
    We should not confuse what is an audit with what is monitoring. The audit is a formal process where certain areas identified as risk areas are selected and metrics are used to evaluate them. The auditor has to select the method to be used to select the number of samples to be audited, whether it will be based on judgment, probability / statistics or systematic. On the other hand, monitoring is an ongoing, constant process, which is used to ensure that the organization’s policies and procedures are being complied with and usually the approach is based on the results of previous audits.
  2. Training and Education
    It is important that staff are annually educated and re-trained regarding the specific laws that affect the health field such as HIPAA, Anti-Kickback Statute, The Stark Law, CMS billing and patient safety requirements, etc. . The health field is increasingly regulated and these regulations are in constant review, which is why the compliance officer and specialized personnel must always be aware of any changes that may affect the internal policies and procedures of the organization.
  3. Establish Lines of Open Communication
    The organization must establish a culture of open communication where the employee feels confident to go to a superior and express any concerns they have regarding ethics and compliance violations. This should be encouraged by creating a clear non-retaliation policy within the institution and establishing communication channels that, if necessary, protect the identity of the employee.
  4. Application of the Disciplinary Guidelines
    Staff must have access at all times to the conduct manual which establishes the policies and procedures that inform staff about what is expected of them and the consequences of deviating from the expected conduct. The code of conduct must establish the disciplinary consequences of failing to comply with any of these policies so that staff are informed from their hiring of the possible repercussions of not following the policies and procedures within the organization.
  5. Corrective Action Plans
    Once a violation of the code of conduct and the organization’s policies and procedures occurs, it is essential that the pertinent corrective action is carried out with the personnel involved. Once the investigation is concluded, then the next step is to create a corrective action plan for the personnel involved, which establishes the steps to follow to avoid a recurrence of the identified behavior.At HRPLabs, the creation of our compliance program never ends as it is always in constant development and evolution. It is our commitment to protect our organization and its employees and at the same time, ultimately protect the patient.