Regulatory Compliance Requires Strong Management
Nature is full of unforeseen peril. Poorly designed or ineffective regulatory controls and processes devised with the best intentions can cripple hospitals that aren’t prepared for it.
Keeping Clients Compliant
CompleteRx is instrumental in keeping clients compliant with current and imminent regulatory and government standards. We proactively support our facilities with operations reviews, audits and training programs that address changing health care requirements.
Each year our Patient Safety and Compliance team members conduct a “fresh eyes” audit of our client facilities, called the Operations Standards Review. The audit is based on standards outlined by:
hese three-day onsite assessments cover approximately 250 compliance indicators. An action plan is developed to correct any deficiencies identified. CompleteRx then deploys supplemental resources to the location to help implement the actions identified.
In addition, we conduct gap analysis reviews for regulations like the USP, USP, Drug Supply Chain and Security Act (DSCSA) and more. We help hospitals create a plan of action for implementing new policies, procedures and facility upgrades to ensure compliance with new regulations that are proposed and released each year.
We also have developed a program to prepare clients for 340B audits, ensuring the hospital follows the guidelines correctly, captures all related 340B costs and avoids government fines.