Closing The Compliance Gap

Linda Ratner RN, BSN, MBA, CMPE 

Ratner Consulting

A study published by Johns Hopkins Medicine in 2016 suggested that medical errors are the third-leading cause of death in the United States. The study indicated that more than 250,000 people have died as a result of these errors annually. However, the number is actually higher because national health statistics collected by the Centers for Disease Control and Prevention (CDC) fail to classify medical errors separately on the death certificates. Therefore, “incidence rates for deaths directly attributable to medical care gone awry haven’t been recognized in any standardized method for collecting national statistics,” says Martin Makary, MD, MPH, professor of surgery at Johns Hopkins University School of Medicine and an authority on health reform1. 

More recent studies claim that the number may be as high as 440,000 deaths annually. While all the studies seem to focus on hospital medication errors, it would be interesting to determine how many more sentinel or harmful events may be attributed to errors caused in a private practice setting. Until there is a better way of reporting causes of death, the total number may not be known. 

Most of us enter the healthcare industry to provide quality care to patients. Those of us in a clinical role see ourselves as patient advocates. It is our duty to provide care during illness, protect patients from harm and educate them in an effort to prevent disease. Many healthcare associations proclaim that sentiment in their oaths and vows, such as the Association of American Physicians and Surgeons’ (AAPS) motto, "Omnia pro aegroto,” meaning, “All for the patient,”2 and the National Council of State Boards of Nursing (NCSBN), whose mission is to “provide education, service, and research through collaborative leadership to promote evidence-based regulatory excellence for patient safety and public protection.”3 

Yet something happens when we put our noses to the grindstone and focus on the regulations and demands facing non-hospital-based practices. A gap in compliance emerges, which is the one imperative that fulfills our purpose of protecting patients from harm in our medical practices.

Conduct quality compliance 

 Hospitals spend hundreds of thousands of dollars annually on healthcare quality compliance. Quality care nurses are devoted to making sure hospital staff are appropriately trained in clinical skills, medication administration and management, proper charting and examinations, for example. Despite this, mistakes continue to take too many lives. 

Imagine the impact if quality healthcare measures did not exist? The challenges that doctors, nurses and ancillary healthcare staff face in a hospital setting are different from that of a smaller environment, such as a private practice where people work closely with each other daily. There can be a good deal of unpredictability in a hospital setting based on patient load, acuity, staffing, hours of operation and resources. In a medical practice setting, the environment is much more predictable and reliable, which is the likely reason there aren’t many exciting TV series about primary care practices as there are in ER or hospital settings. 

Independent medical practices may not have the financial resources to hire a designated quality improvement nurse. However, they still need policies, procedures and training programs to keep their patients safe and remain compliant. It is imperative for clinical staff to learn and understand clinical and cognitive skills necessary to keep their patients from potential harm caused by medication and procedural errors. The role of the practice administrator and medical director is to recognize whether their staff possess the skills necessary to perform these functions. If not, a healthcare consultant who is also a registered nurse and has experience in this area should have the wherewithal to do so. A good starting point is to create a drug formulary, which should include the brand and generic name of the drug along with its strength, a preferred route of administration and indicated uses. In addition, possible side effects and modes of storage should be included in the formulary's content. Once the formulary is created, a system should be put in place for storing and monitoring medications. For example, do you have a way to track the prescription of narcotics? Do medications require refrigeration? Is there a temperature log? Moreover, is all this information accessible to the staff? If not, how will the staff be properly educated? 

Modes of administration for each medication should be determined along with the creation of a training program that’s reviewed and updated annually (or more frequently if necessary). A similar system can be created for any laboratory tests performed in the clinic. Protocol must be established to check clinic equipment (clean, calibrate and repair) daily and log that these quality checks are completed. The list of procedures, medications, treatments and tasks for medical assistants varies from practice to practice, but the basics remain the same. Proper handwashing, cleaning of rooms, sterilization of tools, documentation in EHR and monitoring vital signs all require training and regular oversight. For example, with the application of splints, a review list would most likely include: 1) Are the MAs trained on the proper application of a splint (so it is properly fitted to eliminate the risk of sores or circulation issues)? 2) What instructions are being provided to the patient and are the conversations on proper use being documented to establish legal protection for the provider? 

An effective training program will include both didactic and hands-on instruction. The well- known adage of “see one, do one, teach one” is a good rule of thumb. Since most providers are too busy, seem reluctant to perform nursing duties and often never even taught, a registered nurse is the ideal candidate to oversee the training program and create policies and procedures. The clinical skills performed in most clinics fall under the nursing umbrella. Therefore, they may not even be on the doctors’ radar, which is the main reason many clinics don’t have them in the first place. 

To date, state and federal laws require only minimal quality healthcare compliance for independent practices. However, best practice and forward thinking dictate that compliance should be at the forefront of our minds, as keeping patients safe is our priority. 

The government recognizes the importance of patient privacy and data security. in the form of HIPAA laws. Recognizing that patient health is also a priority, there may be formalized guidelines and laws to address this as well. After all, is maintaining patient safety any less important than maintaining patient privacy? 

Notes: 

1. “Study Suggests Medical Errors Now Third Leading Cause of Death in the U.S.” Johns Hopkins Medicine. May 3, 2016. Available from: bit.ly/2iOcECc 
2. “About AAPS.” The Association of American Physicians and Surgeons (n.d.). Available from: bit.ly/2E1TsgC 
3. “About NCSBN.” The National Council of State Boards of Nursing (n.d.). Available from: bit.ly/2DPh73j