What is the risk for practices who are not compliant by December 1?
First and foremost, there is the continued risk that you are potentially exposing your staff to hazardous materials without proper safety precautions. This alone could trigger concerns and potential auditing from local, state, or national entities. Regulatory agencies such as the Occupational Safety and Health Administration (OSHA), the FDA, as well as the Centers for Medicare & Medicaid Services (CMS), have the authority to inspect your facility based on receiving a report or complaint, clinical trial participation, or services being provided to Medicare or Medicaid patients. Individual states may pass legislation to give this authority to already established regulatory bodies within the state, such as the State Board of Pharmacy, and could begin enforcing penalties for practices who are found in violation of these standards.
Whether your practice feels confident or unsure of where you stand, now is the time to ensure that you have made any necessary changes or have a plan in place to update your physical environment, policies, procedures, training and monitoring as necessary to meet these standards.