The patient care compliance initiative has its roots in the abhorrent conditions that some nursing home residents have suffered over the years. We have all heard the heartbreaking stories of the elderly with bedsores eating through their frail skin. The government’s case is based upon a theory that suggests that nursing homes and the clinicians who work there are paid to provide appropriate and medically necessary medical services. Providing adequate nutrition and turning patients over in bed so they do not suffer from bedsores are integral to providing appropriate and medically necessary services. Failure to provide services that the government has paid for is a false claim and therefore actionable using the government’s enormous arsenal of weapons including the False Claims Act.

Review of JCAHO and CMS standards and your hospital’s compliance with them is a valuable first step in assessing compliance with patient care standards. Once you have taken an inventory of these policies and procedures, it is advisable to interview various clinical and administrative staff members to discuss how they implement these written standards in the course of a typical workday. Some of the questions that might be asked include:

· Have you reviewed Policy No x within the past year?

· Has anyone reviewed this policy within the last year in light of recent regulatory updates?

· How are employees (especially the clinical staff) trained on these written requirements?

· How is compliance with these requirements monitored on an ongoing basis?

· How do you implement these procedures in your department?

· Are the members of your department cooperative with these requirements?

· Are you aware of any violations of these requirements?

· Is there a disciplinary process in place to deal with violations of these policies and procedures?

· In your opinion, how can these policies and procedures be improved?

· Are you aware of the legal requirements for patient care compliance for your department?

· What type of training would you deem beneficial to adequately prepare the clinical and administrative staff about the laws and regulations that affect your department?

This list of questions is not intended to be exhaustive but gives a place to begin the process. Some of the individuals you may consider interviewing include the president of the medical staff, members of the Quality Committee, the director/VP of Nursing, members of senior management, select physician members of the medical staff policies and procedures committee, the environmental health and safety officer, the individual responsible for operating room compliance, the head of the emergency department, administrative and clinical staff members in charge of the outpatient facilities, the director of risk management, just to name a few.

A comprehensive risk assessment is not complete without a walk-through of various patient care locations including two or more wings of the hospital, the emergency department, outpatient physician locations, the operating room areas, two or more nursing stations, and the location of physician dictation.

The preceding overview of the patient care risk assessment process is a good starting place, but is really only the beginning of the process. Some of the particular areas of patient care compliance exposure include, but are not limited to:

· The initial patient assessment and documentation associated with the history and physical.

· Suspected child abuse or neglect, or failure to detect.

· Suspected family violence or failure to detect.

· Ordering of tests and procedures, nurse practitioner/physician assistant ordering, verbal orders.

· Administration of medications to patients, tracking medication orders not administered yet billed, documenting partial dosage, patient medication brought into the hospital, medication samples, medication expiration dates.

· Specimen labeling.

· Handling of controlled substances.

· Adverse drug reaction reporting.

· Use of restraint devices.

· Withholding of cardiopulmonary resuscitation.

· Use of seclusion.

· Patient transfers.

· Confidentiality of medical records.

· Amending or correcting the medical record.

· Tracking attending physicians upon admission and discharge.

· HIV and Bloodborne Pathogen compliance.

One way to track and assess patient care compliance is to track a patient through your organization from the time of admission (or emergency department visit), to the time of discharge and any follow-up outpatient visits. Literally walking a patient through your institutional process allows you to gain a true sense of what procedures are followed and which ones are not. Often, it is not feasible to track a patient through the process, but it is always possible to conduct walkthrough surveys of various departments. If you spend an hour or so in the Emergency Department for example, it is easy to determine how the process is working. Is signage visible to patients as required by EMTALA? Are urgent patients treated without regard to insurance status? Are patients with no insurance coverage sent to other facilities? How long do emergency patients wait in the waiting room (on average) before they see a clinician? Lack of appropriate care is a patient care compliance risk, a medical malpractice risk, a risk of loss of accreditation status and simply poor practice overall.

Other items to assess include: Who conducts the patient assessment when patients present to the Emergency Department – a registrar? A licensed clinician? Are the physician extenders (physician assistants, nurse practitioners, etc.), residents, and fellows appropriately supervised by an attending physician? Looking at the medical record documentation, are the attending physicians appropriately documenting their supervision of these individuals? Is the facility billing for services provided only by physician extenders without evidence of appropriate supervision by a licensed medical doctor? This, of course, is the classic case of billing fraud and would be treated very vigorously by government enforcement agencies.

Some of the areas listed above have been the source of many a malpractice actions and the government has taken a great interest is using its enforcement power to translate these cases into false claims with civil and criminal fines and penalties.

Another area of high exposure for any hospital is the pharmacy and the administration of medications. Often, medications are ordered by physicians pursuant to standard protocols developed for certain maladies. In many cases, patients improve and do not require all of the medication ordered per the established protocol. Many hospital information systems (order entry systems) do not track the patient’s care and these medications are often billed yet never administered to the patient. Failure to track dispensing of medications can result in potential false claims (billing for items not administered to the patient) as well as malpractice risk. Having a policy in place requiring ongoing monitoring of medication orders is critical for ongoing patient care compliance.

Medications can be a source of compliance exposure if they are mislabeled, not dosed correctly, not stored correctly, or if there are no controls around patients who bring medications into the facility. For example, there are numerous documented instances of drug abuse in hospitals and physician offices when medications are not stored in appropriately controlled areas. All of these areas require detailed policies and procedures, ongoing training and periodic monitoring.

It is not unusual to find cases when a physician assistant or nurse practitioner orders something for a patient (either pursuant to a protocol or otherwise) and it is not countersigned by a physician as required by most state laws and for billing purposes under Medicare and Medicaid. It is not unusual to learn that verbal physician orders are not countersigned by the ordering physician as required by state law and for billing purposes under most government programs. Again, there is patient care exposure and potentially billing exposure for these risks. It is imperative that the organization has detailed written policies and procedures requiring countersignatures in accord with legal and billing requirements. It is critical to implement training programs on these issues for physician extenders and for the physicians so that they understand the rules. Finally, the process must be monitored on an ongoing basis by performing chart audits looking for required countersignatures.

A patient care compliance risk assessment would not be complete without an assessment of confidentiality of medical records. All consent forms should be reviewed continually to ensure that they meet the necessary standards and uses for which records may be disclosed in a typical patient care situation (i.e., consulting physicians, outcomes measurement, etc.). If medical records are electronic, it may be important to obtain an accounting of all persons who accessed a patient’s medical record to ensure that all disclosures were allowable. Again, detailed policies and procedures, training and monitoring in this case is the only way to ensure ongoing compliance.

HIPAA has increased the oversight of patient record confidentiality when such records are transmitted electronically. HIPAA requires providers, payors and clearinghouses to strengthen controls around electronically transmitted patient identifiable information. The Administrative Simplification Provision of HIPAA requires, among other things, that patients be provided an accounting of all individuals accessing their medical records. This will require institutions to investigate the capabilities of their information systems to determine if they will allow for this type of accounting.