CDC Issues Robust Guidance on Personal Protective Equipment for Healthcare Workers

Yesterday, the CDC issued revised guidance ("Guidance") detailing personal protective equipment (PPE) standards, including donning and doffing PPE, for all healthcare workers entering the room of a patient hospitalized with Ebola. These standards, which are based on lessons learned from the recent experiences of U.S. hospitals caring for Ebola patients, emphasize the importance of training, practice, competence, and observation of healthcare workers in correct donning and doffing of PPE selected by the facility. This Guidance references three key principles:

1. prior to working with Ebola patients, all healthcare workers involved in the care of Ebola patients must receive repeated training and demonstrate competency in performing all Ebola-related infection control practices and procedures, and specifically in donning/doffing proper PPE;
2. while working in PPE, healthcare workers caring for Ebola patients should have no skin exposed; and
3. the overall safe care of Ebola patients in a facility must be overseen by an onsite manager at all times, and each step of every PPE donning/doffing procedure must be supervised by a trained observer to ensure proper completion of established PPE protocols.

Infection Prevention Management System

The Guidance calls for a number of controls to ensure that proper procedures and safe work practices are carried out appropriately. These controls, at an administrative level, call for the facility’s infection prevention management system, in collaboration with the facility’s occupational health department, to:

• establish and implement triage protocols to effectively identify patients who may have Ebola and institute the precautions detailed in this document
• designate individuals as site managers responsible for overseeing the implementation of precautions for healthcare workers and patient safety (a site manager’s sole responsibility is to ensure the safe and effective delivery of Ebola treatment and at least one site manager should be on-site at all times in the location where the Ebola patient is being cared for)
• identify, ahead of time, critical patient care functions and essential healthcare workers for care of Ebola patients, for collection of laboratory specimens, and for management of the environment and waste
• ensure healthcare workers have been trained in all recommended protocols for safe care of Ebola patients before they enter the patient care area
• train healthcare workers on all PPE recommended in the facility’s protocols. Healthcare workers should practice donning and doffing procedures and must demonstrate before trained observers during the training process competency through testing and assessment before caring for Ebola patients
• document training of observers and healthcare workers for proficiency and competency in donning and doffing PPE, and in performing all necessary care-related duties while wearing PPE
• designate spaces so that PPE can be donned and doffed in separate areas

Key Safe Work Practices

The Guidance further highlights key safe work practices, which include:

• identifying and isolating the Ebola patient in a single patient room with a closed door and a private bathroom as soon as possible
• limiting the number of healthcare workers who come into contact with the Ebola patient (e.g., avoid short shifts), and restricting non-essential personnel and visitors from the patient care area
• monitoring the patient care area at all times, and logging at a minimum entry and exit of all healthcare workers who enter the room of an Ebola patient
• ensuring that a trained observer watches closely each donning and each doffing procedure, and provides supervisory assurance that donning and doffing protocols are followed
• ensuring that healthcare workers have sufficient time to don and doff PPE correctly without disturbances
• ensuring that practical precautions are taken during patient care, such as keeping hands away from the face, limiting touch of surfaces and body fluids, preventing needlestick and sharps injuries, and performing frequent disinfection of gloved hands using an alcohol-based hand rub (ABHR), particularly after handling body fluids
• disinfecting immediately any visibly contaminated PPE surfaces, equipment, or patient care area surfaces using an *EPA-registered disinfectant wipe
• performing regular cleaning and disinfection of patient care area surfaces, even absent visible contamination (this should be performed only by nurses or physicians as part of patient care activities in order to limit the number of additional healthcare workers who enter the room)
• implementing observation of healthcare workers in the patient room, if possible (e.g., glass-walled intensive care unit [ICU] room, video link)
• establishing a facility exposure management plan that addresses decontamination and follow-up of an affected healthcare worker in case of any unprotected exposure. Training on this plan and follow-up should be part of the healthcare worker training.

PPE

The Guidance also identifies basic principles of PPE use:

• no skin may be exposed while working in PPE
• PPE must be donned correctly and in proper order before entry into the patient care area and not be later modified or adjusted while in the patient care area (as noted donning activities must be directly observed by a trained observer)
• PPE must remain in place and be worn correctly for the duration of exposure to potentially contaminated areas
  • healthcare workers should perform frequent disinfection of gloved hands using an ABHR, particularly after handling body fluids
  • if during patient care a partial or total breach in PPE (e.g., gloves separate from sleeves leaving exposed skin, a tear develops in an outer glove, a needlestick) occurs, the healthcare worker must move immediately to the doffing area to assess the exposure (the facility exposure plan should be implemented if indicated by assessment)
• the removal of used PPE is a high-risk process that requires a structured procedure, a trained observer, and a designated area for removal to ensure protection (a stepwise process should be developed and used during training and daily practice)

While the Guidance notes that double gloving provides an extra layer of safety during direct patient care and during the PPE removal process, additional layers of PPE may make it more difficult to perform patient care duties and CAN put healthcare workers at greater risk for percutaneous injury (e.g., needlesticks), self-contamination during care or doffing, or other exposures to Ebola. (If healthcare facilities decide to add additional PPE or modify this PPE guidance, they are to consider the risk/benefit of any modification, and train healthcare workers on correct donning and doffing in the modified procedures)

Training

The Guidance emphasizes that training ensures that healthcare workers are knowledgeable and proficient in the donning and doffing of PPE prior to engaging in management of an Ebola patient. Comfort and proficiency are only achieved through repeated practice on the correct use of PPE. Healthcare workers should be required to demonstrate competency in the use of PPE, including donning and doffing while being observed by a trained observer, before working with Ebola patients. In addition, during practice, healthcare workers and their trainers should assess their proficiency and comfort with performing required duties while wearing PPE. (Training should be available in formats accessible to individuals with disabilities or limited English proficiency, and it should be targeted to the educational level of the intended audience).

Use of a Trained Observer

Because the sequence and actions involved in each donning and doffing step are critical to avoiding exposure, the Guidance calls for a trained observer to read aloud to the healthcare worker each step in the procedure checklist and visually confirm and document that the step has been completed correctly. This observer is a dedicated individual with the sole responsibility of ensuring that the proper donning and doffing process is followed. The trained observer is to monitor and document successful donning and doffing procedures, providing immediate corrective instruction if the healthcare worker is not following the recommended steps.

Evaluation

The Guidance also recommends a Protocol Evaluation/Medical Assessment following care of an Ebola-infected patient, to include either the infection preventionist or occupational health safety and health coordinator (or their designee) meeting with the healthcare worker to review the patient care activities performed and to identify any concerns about care protocols, as well as record the healthcare worker’s level of fatigue.

Please review the entire CDC Guidance for more specific information regarding designation of space and signage, as well as other specific implementation steps.

Additional Resources

OSHA’s blood borne pathogen requirements are summarized in OSHA’s fact sheet and the full regulations can be found on the US Department of Labor’s website.

The CDC has provided complete information for healthcare workers and settings specific to Ebola, which is available on its website and includes updated standards that apply to direct care provider, environmental infection control, cleaning and waste management, handling of blood specimens and post-mortem care.

Specific planning tools for Ebola-related issues which need to be carefully reviewed by all healthcare providers include the CDC’s detailed preparedness checklists for hospitals and other providers.

In addition, unique to New York providers, the New York State Interim Commissioner of Health has issued an order for summary action for the prevention and control of Ebola that should be immediately reviewed. This document has links to other important referenced resource documents. Additionally, the New York State Department of Health’s Website has a concise listing of other important references.

Conclusion

Hospitals and other healthcare facilities, long before the current Ebola outbreak, should have had emergency preparedness plans in place to deal with infectious disease outbreaks such as pandemic flu, as well as standard protocols and procedures for the management of blood borne pathogens. From time to time, these plans and protocols may become stale, develop gaps, or, in the case of Ebola, require disease-specific updating. Review of these plans should now be underway with an eye towards tailoring them to deal with the unique challenges presented by, and specific guidance offered for, Ebola, a blood born pathogen which poses significant risk to exposed individuals. We encourage facilities and providers to undertake their review in light of the guidance issued by the federal and state authorities related to Ebola.

We will continue to provide additional information to providers to assist them with meeting this health emergency.