Despite state and federal regulations, and private hospital accreditation programs that try to ensure high-quality care, errors occur in hospitals that result in patient injuries.

Many errors are due to process failures rather than unpredictable accidents. Process failures can result in harm or, at best, missed opportunities to provide good care. Managers must remain vigilant by employing comprehensive monitoring programs that ensure protocols don't slip.

More Federal Inspection

The Centers for Medicare & Medicaid Services (CMS) has defined, through the Conditions of Participation (CoPs), what it considers to be minimum standards of care. As these are minimum standards, CMS expects consistent, 100 percent compliance with CoPs. Private accreditation organizations like the Joint Commission and the Healthcare Facilities Accreditation Program survey hospitals to assure compliance with CoPs.

But Congress has lingering concerns about an apparent conflict of interest: Hospitals pay these accrediting organizations. Consequently, Congress requires CMS to validate the organizations' findings by conducting surveys for a sample of hospitals.

To that end, the federal government has built its own hospital inspection program using state departments of health as the auditing arm of the federal government. CMS provides the funds for states to conduct inspections, in addition to defining survey methods and providing training to state surveyors. CMS inspections also are generated by patient or staff complaints.

Although public data are not available, there appears to be an increase in the number of department of health surveys resulting in a requirement for submission of a corrective action plan. It seems that the era of greater federal inspection of health care organizations is upon us.

Consequences of Immediate Jeopardy

Because many hospital leaders have not been subjected to adverse findings from inspections, they do not consider CoPs compliance to be a management priority. But that is likely to change when hospitals experience surveys that identify condition-level deficiencies — or worse, immediate jeopardy conditions. A finding of immediate jeopardy indicates the presence of conditions that pose an immediate threat to the lives or safety of patients.

In these situations, the hospital is placed on a timeline for termination from Medicare and Medicaid unless an acceptable corrective action plan is submitted and a repeat survey validates that the deficiencies have been corrected. In the case of immediate jeopardy findings, hospitals have only 23 days between the end of the survey and Medicare termination. If the immediate jeopardy is not abated within that time, the hospital's participation in Medicare is terminated. This "never event" affects the whole hospital.

Condition-level deficiencies and immediate jeopardy findings do not occur only in poorly managed hospitals. Several "name-brand" hospitals have found themselves in a state of panic after an immediate jeopardy finding. In fact, self-reporting of problems, required in many states, can generate a CMS survey that results in a finding of immediate jeopardy. There is no grace for self-reporters.

The biggest mistake hospitals make is assuming that, after a policy is written and the staff are informed, compliance with the policy is consistent and complete. Without constant attention, employees will forget to follow all the steps. Processes will drift if the managers lose their focus.

Comprehensive Monitoring

Comprehensive preparation is the best way to avoid compliance problems or limit their extent. Such preparation requires careful planning. An often overlooked component of preparation is developing a comprehensive compliance surveillance plan that enables organizations to monitor what is going on. Compliance monitoring programs should be built using active, investigative surveillance — looking for problems and banning the idea that no news is good news.

A good example of the importance of comprehensive monitoring is the use of restraints. We have found that hospitals that have gotten into trouble over the use of restraints do not practice active, investigative surveillance. Because hospitals know that there are tight rules about the use of restraints and seclusions, employees keep logs on these actions.

Unfortunately, many hospitals do not use these logs to review whether all requirements for caring for patients in restraints were met. More importantly, many hospitals fail to verify that restraints were applied to patients who are not recorded in the logs. Such unrecorded instances of restraint can occur when employees address patient safety concerns with patient movement restrictions that qualify as restraints.

Active, investigative surveillance seeks problems such as these with the same rigor as a CMS-trained surveyor.

Governing Board Oversight

The other important element of preparation is ensuring that the board is involved in regulatory compliance. This should not be a passive involvement in which board members are informed of problems after they arise. Instead, the board should receive regular and comprehensive compliance surveillance reports and engage in meaningful discussion of the findings, implications and corrective action plans.

To underscore this idea, CMS has written its regulations in such a way that governing body deficiencies usually arise when other (clinical) deficiencies are detected. This structure reflects CMS' view that the governing body is responsible for all policies and procedures in the hospital.

The implications for governing body performance are very different if an individual failed to follow well-designed rules than if the proper rules were not in place to begin with. Therefore, savvy hospital leaders will pay attention not only to the mechanisms that their organizations use to monitor and root out noncompliance, but how lapses in compliance are reported and acted upon when they are discovered.

The potential consequences stemming from condition-level finding and immediate jeopardy citations are dire. If current trends persist, public and governmental scrutiny of hospital care only will increase in coming years. Comprehensive monitoring and board involvement are powerful tools for health care leaders as they prepare for regulatory surveys and prevent the hospitalwide never event of immediate jeopardy.

Cary Gutbezahl, M.D., is the president and chief operating officer of Compass Clinical Consulting in Cincinnati. Amanda Brown, R.N., B.S.N., M.S.M., C.I.C., is the accreditation and compliance practice leader for Compass Clinical Consulting.