Sleep Laboratory Regulatory Readiness

A polysomnography, a sleep study, is a diagnostic test used to evaluate sleep patterns and identify potential sleep disorders. It involves monitoring physiological functions while the patient sleeps, including brain activity, heart rate, breathing, and oxygen levels.  As these studies require extended periods to complete, along with the patient being in a vulnerable sleep state, organizations must consider the potential patient safety risks and avoid complacency in their Sleep Laboratory.

First steps should include an overall risk assessment of the Sleep Laboratory environment and its processes to identify actual and/or potential risks.  A multi-disciplinary team should undertake this, including representatives from Facilities Engineering, Sleep Laboratory Technicians, Sleep Laboratory Director, and Infection Control.  Additional stakeholders should be included as determined by your organization based on environmental and process factors.  If your Sleep Laboratory is certified by the American Academy of Sleep Medicine (AASM), there are specific safety requirements that must be met and can be integrated with your overall risk assessment.  Your risk assessment may include review of vulnerabilities with medical emergencies, cleaning and disinfection, fire safety, nutrition safety, medication management, falls, and personal safety. Here are considerations of these and other criteria that should be reviewed as you assess your Sleep Laboratory:

Patient Onboarding and Assessment:

When bringing patients in for sleep studies, a comprehensive onboarding process should be employed.  This provides an opportunity to assess the patient for risks and ensure they are safely prepared for the study.  Administrative tasks should be reviewed to ensure that essential processes are completed.  Health assessments should be completed to provide adequate information for staff to ensure safe treatment.

First, ensuring proper patient identification is crucial to ensure the correct patient is undergoing the sleep study.  Patients should be banded with their identification in the event of emergency and they cannot respond.  Review your process for identification and ensure that staff are trained and evaluated for compliance.

Evaluation of the patient’s preference for language should be conducted.  Patients who do not speak or read English should have accommodations in place for interpretive services.  These services should be available after hours, as most sleep studies occur at night to maintain the patient's circadian rhythms.  Considerations should be made for having written instructions and information translated into the languages of the patient population.

The use of video monitoring is a key component of sleep studies.  Patients must consent to being monitored by video and video recording, to ensure they understand the implications for their privacy.  Ensure that consent documentation is completed per your policy.

Patients should be evaluated for potential risks, including falls, which are a leading cause of patient harm in hospitals.  Organizations should ensure they identify patients at risk for falls and implement safeguards as needed.  This should include educating patients about requesting assistance to get out of bed to access the restroom.  Additionally, any medical conditions requiring monitoring, such as blood glucose, should be assessed and addressed.

Patients should bring any prescribed medications approved for use during the study.  Staff should validate their approval, as they may interfere with the study.  These medications should be documented in the medical record and readily available.

Medical Emergencies and Safety Protocols:

As with any patient care area, the sleep laboratory should have detailed plans for various medical emergencies, including cardiac arrest and psychiatric situations. Policies and procedures should have a detailed description of each technician’s responsibilities in an emergency.  Phone numbers of essential contacts should be posted in the technicians’ work area and include the appropriate emergency response team, the medical director, and the laboratory manager. The medical director should be accessible at all times during the night for consultation and notification if an emergency response has been initiated.

Patients who undergo studies frequently present with comorbidities that put them at risk for a medical emergency.  Decreasing the risk of a medical emergency begins with the appropriate review of the patient’s medical record, as mentioned above.  However, there should be procedures in place to recognize and respond to emergencies that may occur.  Emergency equipment, such as a defibrillator/AED, oxygen, and other supplies, should be readily available.  Staff should be trained in medical emergency response procedures and equipment use.  Periodic drills should be in place to test the response.

The sleep laboratory technician is responsible for closely monitoring the patient and should monitor for signals by the patient that they may be in medical distress. Testing rooms should have video/audio monitoring and a call system for the patient to communicate with the technician. Technicians should be trained and competent in monitoring patients and follow established procedures to notify providers when monitoring parameters are exceeded or in the event of an emergency.  All sleep laboratory staff should have current certification in basic life support.

Technician Safety:

There may be situations where the safety of the technician is at risk. This could involve mentally unstable or confused patients who may become agitated and exhibit aggressive behavior. Policies and staff training should be implemented to guide employees in defusing aggressive patients and responding to those who cannot be calmed down.

A review of workplace safety for staff and patients from external threats should be considered.  Patients often arrive after hours for their study, which could place them at risk for assault if the testing center is located in an area with high crime.  Access control should be maintained to prevent unauthorized individuals from entering the laboratory.  Patients should be provided with instructions on how to access the sleep laboratory.  Ensure a review of response procedures has been made for opportunities.

Infection Control:

Infection control affects all patient care areas and should be addressed with all practices in the sleep laboratory.  An Infection Control Risk Assessment should be conducted to determine risks, including risks from patients, cleaning and disinfection of equipment, storage of supplies, hand hygiene, and other practices.  As sleep laboratories use bed linens, the process of handling used linens suspected of having been soiled with body fluids, protocol should that prevents contamination to the laboratory and other patients. Arrangements should be made for washing and disinfecting bed linens for freestanding laboratories.  Guidelines for screening patients for infectious processes should be determined and put in place to protect other patients and staff.  Cleaning and disinfection should always follow the equipment manufacturer’s instructions for use.

Adequate Staffing:

Sleep laboratory staffing models 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. Most laboratories' normal staffing pattern is a 2:1 ratio (two patients to each technician). This is often adjusted to a 1:1 ratio for infants, young children, and adults with special needs requiring greater technician intervention or more intensive monitoring.  Ensure state regulations are reviewed for any prescriptive staffing requirements.  Have a process in place to evaluate individual patients for the need for additional staffing to support safety.

Many sleep laboratories 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 modification. Additionally, the ability to respond to the emergency effectively is reduced when the patient requires medical care, and the emergency response is overwhelming for the one technician. Organizations should evaluate their staffing and consider if additional staffing resources are immediately available to assist with an emergency response.

An often overlooked issue is the potential for the sleep laboratory technician to have a medical emergency, especially with an aging workforce. Consequently, there may be no one available to respond to the technician’s emergency or attend to the patients.  Organizations should evaluate laboratory technician safety and address how they will ensure that they are supported in the event of incapacitation.

Fire Safety:

Fire safety must be a priority for any organization.  With patients being at their most vulnerable state, it’s imperative that organizations adhere to local codes, have clear and effective fire response plans, including evacuation, and ensure staff are trained and drilled on emergency procedures.

Patient Safety Upon Discharge:

Organizations must ensure that patient safety extends past the actual exam.  Specifically, an often neglected aspect of patient safety is ensuring they can leave the laboratory with adequate sleep to safely drive upon discharge.  This is sometimes difficult to manage as sleep studies are inherently disruptive to regular sleep.  Organizations must ensure that every effort is made to allow the patient to get adequate sleep. This may require setting a minimum amount of sleep for each study.   There should be a process in place to assess the patient in the morning for their level of sleepiness and to recommend that the patient not drive if the technician feels the patient is too sleepy to drive safely.  This assessment should be standard and documented.

Quality Control Activities:

Quality assurance and process improvement (QAPI) are significant focuses of regulatory agencies.  QAPI activities ensure that the sleep laboratory provides an environment that maximizes the safety of patients and laboratory personnel. Organizations should review their QAPI measures and ensure that they reflect monitoring higher-risk processes and critical outcomes.

Summary:

Organizations must ensure that a proactive and in-depth review of their sleep laboratory activities and processes is conducted to identify potential and actual vulnerabilities in their patient safety program.  This review must be ongoing to maintain compliance with regulatory and safety requirements.

For questions or to learn more contact the C&A team at 704-573-4535 or email us at info@courtemanche-assocs.com.

Courtemanche & Associates specializes in Healthcare Accreditation and Regulatory Compliance Consulting Services. With over 30 years of being in business and 100+ years of healthcare experience amongst our consulting team, we are ready to assist with your accreditation and regulatory compliance needs.

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