Keeping up with the most recent regulatory accreditation and compliance requirements for medical equipment can be a full-time job. In an effort to save on costs, many hospitals assign this area to the already-taxed clinical engineering staff, which is problematic because it can feel outside their scope of expertise. Risk mitigation includes more than just preventative maintenance – it’s processes and strategies that ensure equipment is appropriate for intended use, proper staff training, current accreditation adherence and patient safety.
Being found in violation of a regulatory requirement is costly – incurring fines, loss of Medicare/Medicaid monies and reputation in the community. So it pays to be prepared. Here are five cost-effective ways your health care organization can achieve excellence in regulatory compliance.
1) Assess your risk.
Using various risk criteria, such as incident and alert monitoring, repair trend analysis, EOC/safety meeting discussions, you can use error monitoring and safety huddle discussions to assess your organization’s risk. Include review of outside sources such as The Joint Commission Sentinel Reports, state regulatory governing bodies, CMS and other accreditation agencies. An assessment will help you identify areas needing attention so you can achieve the lowest potential for adverse impact on the safety and health of patients, staff and others in your facility.
2) Develop a plan.
After you uncover the risks associated with your medical equipment, you can then manage them through a variety of processes and strategies that ensure the equipment is appropriate for intended use, schedules are set to ensure proper operation and patient safety, staff members are properly trained, and the equipment is correctly maintained by qualified individuals.
3) Utilize technology.
Your clinical engineering department may use a computerized maintenance management system (CMMS) to track medical device performance indicators, preventative maintenance schedules, safety issues, equipment recalls and manufacturer recommendations. Tracking this information ensures the highest level of patient safety related to potential device malfunctions and lowest level of risk related to lack of compliance.
4) Execute a mock audit.
You never want to be caught off guard when a regulatory agency comes knocking, and there’s a good chance they will. Failing an audit is first and foremost a threat to patient safety, but can also come with hefty financial penalties. Start now – know what each regulatory agency requires for an audit and gather the necessary materials, create a checklist and perform a mock audit. If you identify gaps, create a plan to mitigate the risk prior to being inspected, so you’re not left scrambling.
5) Find a partner.
Your organization may not be able to devote a full-time employee to regulatory compliance due to budget strain. You also may not have the latest technology in place. In this case, partner with an independent third-party provider that can assist with the staffing and technology you need to avoid large fines and achieve best-in-class regulatory compliance.
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