The first “Law of Medicine” clearly stated by Hippocrates (circa 460-377 BC) was “As to diseases, make a habit of two things—to help, or at least to do no harm.” This is often quoted in Latin as Primum non nocere—“First, do no harm.” In the 2,000 plus years since these thoughts were first recorded, it has become increasingly necessary to recognize and heed their meaning and import.
As medical technology and science has become increasingly complex, this complexity has brought increasing probability of error and harm. In 1998 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)—now The Joint Commission—started to place great emphasis on patient safety requiring the reporting of sentinel events, defined as “a medical error or serious event that caused death or serious injury to a patient.”
In response, a November 1999 Institute of Medicine (IOM) report, titled “To Err Is Human: Building a Safer Health System,” was released, which called on the science, medical, and government communities to focus on reducing or eliminating actions or situations that resulted in sentinel events. In 2007, JCAHO updated the definition of sentinel event.
The Centers for Disease Control and Prevention (CDC) estimates that between 50 and 70 million adult Americans out of a population of 310 million have some type of sleep disorder. That means that between 16% and 23% of the US adult population may be candidates for testing in a sleep disorders lab. Given the many potential patients, the risk of safety problems is large and is an area that needs investigation. A comprehensive literature search revealed sparse information. This paper is intended to raise concerns about and provide a baseline dialog about these issues.
A May 13, 2012 search of the US Department of Health and Human Services’ Agency for Healthcare Research and Quality Patient Safety Net (PSNet) data revealed 5,712 documents (print and online journals, newspapers, and URLs) when searched for “patient safety in the sleep lab.” The vast majority of these references dealt with medical house staff work hours and sleep deprivation. No articles were noted to discuss actual sleep laboratory safety issues. Within the last year, some articles are beginning to appear in the professional literature discussing this situation. To ensure that the potential for adverse outcomes is minimized, safety in the sleep laboratory should encompass several areas of focus that include both patients and technical staff. Sleep laboratories should have a well-established culture of safety in which all personnel demonstrate a commitment to a safe environment.
The safety of patients is the responsibility of the entire sleep center team from the physician to the night technician directly monitoring the patient. Safeguards should be in place at every level of contact with the patient to ensure minimal risks for harm.
Preventing and Managing Medical Emergencies. Patients presenting to the sleep laboratory frequently have comorbid conditions that put them at risks for a medical emergency. Decreasing the risk of a medical emergency begins with the appropriate review of the patient’s medical record to identify possible risk factors including but not limited to cardiac arrhythmias, oxygen requirements, and fall risks. The technician is responsible for close monitoring of the patient and has sufficient training to recognize potential emergencies such as life-threatening cardiac arrhythmias. The technician should monitor for signals by the patient that they may be in distress. This can be verbal as well as behavioral. Testing rooms should have video/sound monitoring and a call system in place for the patient to communicate with the technician. All sleep laboratory staff should have current certification in basic life support (BLS). An automated external defibrillator should be on-site as well as an airway emergency kit with oral airways, bag-valve-mask resuscitator, oxygen, and suction.
The sleep laboratory should have a comprehensive policy and procedure manual in place that details the technician’s response to various medical emergencies including cardiac arrest, seizures, and psychiatric situations. The manual should have a detailed description of each technician’s responsibilities in the event of an emergency. Phone numbers of important contacts should be posted in the technicians’ work area and include the appropriate emergency response team, which will be 911 in many labs, as well as the medical director and lab manager. The medical director should be accessible at all times during the night for consultation and notification in the event an emergency response has been initiated. A thorough review of an emergency should be performed following the incident to evaluate effectiveness of the response and make changes as needed. It is good practice to conduct mock emergencies on a regular basis. Records should be kept for both actual and mock emergency incidences.
Adequate Staffing. Staffing of the sleep laboratory should be based on ensuring both patient safety and quality outcomes. The number of testing rooms in the sleep laboratory generally dictates the staffing requirements. The normal staffing pattern utilized by most laboratories is a 2:1 ratio (two patients to each technician). This is normally adjusted to a 1:1 ratio for infants and young children and for older children and adults with special needs requiring greater technician intervention or more intensive monitoring.
Many sleep laboratories are two-bed facilities and are staffed by one technician per night with a typical 2:1 patient to technician ratio. In the event of an emergency or the need for more intensive care for one patient, the other patient is left unattended, possibly leading to inadequate data collection or treatment titration. There also may be a reduced ability to respond to the emergency effectively when the patient requires medical care and emergency personnel need to be called, directed, and allowed access to the facility. There is the potential for the technician to have a medical emergency especially with an aging sleep laboratory workforce. In this event, there may be no one to call a response to the technician’s emergency or attend to the patients. Access to freestanding sleep labs by EMS crews should be addressed before an emergency occurs. Access could be provided by remote control or by electronic locks.
Medication Management. The majority of patients seen in the sleep laboratory are taking medications for various medical reasons. Medications are generally taken on a regular schedule. Although some medications can be missed without harm to the patient, many medications are required on a regular basis to adequately treat medical conditions including but not limited to cardiac disease, diabetes, seizures, and psychiatric disorders. It is generally the policy of the sleep laboratory not to dispense medications. Patients are required to bring their own medications and take them according to their scheduled time. It is good policy to have an accounting of the patient’s medications before they arrive at the sleep laboratory and to ensure they have brought any medications they are scheduled to take during their stay.
Patient Safety Upon Leaving Sleep Laboratory. A seldom recognized aspect of patient safety is ensuring they leave the laboratory with adequate sleep quantity to safely drive home or to work. This is at times difficult to manage as sleep studies are inherently disruptive to sleep. Sleep lab personnel should make every effort to allow the patient to get an adequate amount of sleep. Most laboratories have a policy that ensures the patient is in bed for a minimum of 7 hours. It is good policy to assess the patient in the morning for level of sleepiness and to recommend that they do not drive if the patient and/or technician feels the patient is too sleepy to drive safely.
There are several situations that can threaten the safety of both the technician and patient including weather, fire, and spread of infection. Policies and procedures should be in place that address each of these areas.
Weather-related Emergencies. There should be a detailed procedure in the event of threatening weather including tornados, high winds, and flooding. There should be a plan on moving patients to a safe location that will provide protection against damaging weather. Many labs have a policy canceling patient appointments when there is the threat of severe weather, or weather such as snow or ice that would make the patient’s drive to the lab too hazardous.
Fire. There should be a policy in place on the procedure for initiating a code red and an evacuation plan in the event of a fire in the sleep laboratory or facility housing the sleep lab. There should be both a primary evacuation route and a secondary evacuation route if the primary route is blocked. These routes should be diagrammed and displayed for easy access by laboratory personnel.
Infection Control. Infection control should be a standard practice in the sleep laboratory. Guidelines exist for effective hand sanitization and equipment disinfection to prevent the transmission of germs that can lead to infection. Hand sanitation should be performed before and after contact with each patient. Locating sanitation stations at convenient locations throughout the laboratory will encourage use. A combination of universal precautions and body substance isolation should be included in the standards for infection control in all sleep laboratories. As sleep labs use bed linens, used linens suspected of having been soiled with body fluids should be handled in a manner that prevents contamination to the lab and other patients. Arrangements should be in place for washing and disinfecting bed linens for freestanding laboratories.
Technician Safety. There may be situations in which the safety of the technicians is at risk. This would primarily involve mentally unstable or confused patients who may become agitated and display aggressive behavior. A policy should be in place and mock situations should be practiced to give the technicians the competencies to respond to and diffuse any aggressive situations.
Quality Control Activities. Quality improvement activities should be ongoing to ensure that the sleep laboratory provides an environment that maximizes the safety of both the patients and laboratory personnel. Policies and procedures should be reviewed on a yearly basis and updated to reflect current standards. Accreditation by the American Academy of Sleep Medicine or The Joint Commission will help ensure safety standards are met as these are extensively reviewed prior to certification.
Record Retention and Security. Medical records used and generated in the sleep laboratory fall under the rules of the Health Insurance Portability and Accountability Act (HIPAA), which requires the safe and secure storage of medical records. With the rapid growth of the electronic medical record (EMR), there has evolved a growing concern for the control of access to these documents and the safety and security of the records. At the same time, criminal and civil legal actions against those who breach or allow breaches in EMR security have become more common. Fines of over a million dollars have been reported along with lengthy jail sentences. Sleep labs must ensure the retention and safe storage of the information entrusted to them.
Robert Whitman, PhD, DASM, RRT, RPFT, is director, sleep disorders center, pulmonary diagnostics, cardiopulmonary rehab at University of Kansas Hospital, Kansas City; Paul Mathews, PhD, RRT, FCCM, FCCP, FAARC, is associate professor of respiratory care education at the University of Kansas School of Allied Health in Kansas City. For further information contact [email protected].
References and Readings
AHRQ PSNet. Best Practices in the Sleep Lab. AARC Times. May 2012:14-15. http://psnet.ahrq.gov/Anderson F. Policies and Procedures for a Sleep Lab. www.ehow.com/about_5556722_policies-procedures-sleep-lab.html. Accessed March 19, 2012.
Barrett D. Risk Management Strategy & Techniques for Sleep Center Staff. Focus Journal. Spring 2011:28-29. (Scenarios 1 and 2 are especially instructive.)
Berry E. Steep fine sends message on patient protection. www.ama-assn.org/amednews/2012/04/02/bisc0402.htm. Accessed April 2, 2012.
Miller M. Patient Safety in the Sleep Lab. Sleep Tech Tip of the Week. www.sleepvirtualnews.com/patient-safety-in-the-sleep-lab. Accessed April 2, 2012.
Patient Safety. en.wikipedia.org/wiki/Patient_safety. Accessed March 21, 2012.