Patient Safety and Healthcare Worker Safety in Gastrointestinal Endoscopy during COVID-19 Pandemic

Abstract

Patient safety remains a concern worldwide. Failure in executing patient safety measures will result in serious consequences such as diminished patient\'s quality of life, increased morbidity and mortality, increased negative image, and public distrust of healthcare providers. Healthcare worker (HW) safety is also increasingly becoming a concern. During the COVID-19 pandemic, we should implement standards including COVID-19 screening, patient safety, healthcare worker safety, endoscopy room, equipment, and personal protective equipment (PPE). This review is intended to discuss the preparation before, during, and after gastrointestinal endoscopy (GIE) procedures to ensure patient and healthcare worker safety in the era of the COVID-19 pandemic. A literature search was conducted from August 2022 to October 2022 and comprised several journals related to the topic. The literatures were searched on credible platforms such as Google Scholar, PubMed, and Science Direct. Most of the endoscopy units were reducing the performance, down to 50%–90% reductions. The units prioritized cases using time-sensitive factors to urgent, semi-urgent, and elective classification. The endoscopy procedure is performed in accordance with protocols to maintain patient and healthcare worker safety. Adherence of gastrointestinal endoscopy procedure strictly to standards has to be implemented to protect patient and healthcare workers during COVID-19 pandemic.

1. Introduction

Patient safety is an important global issue. It serves as the basis of safe and optimal medical care worldwide [1, 2]. World Health Organization (WHO) defines patient safety as “A framework of organized activities that creates cultures, processes, procedures, behaviors, technologies and environments in health care that consistently and sustainably lower risks, reduce the occurrence of avoidable harm, make errors less likely and reduce the impact of harm when it does occur” [2, 3].

Patient safety forms the foundation of the best practice in providing high-quality medical service. Failure to implement patient safety measures will generate serious consequences such as decreased patient's quality of life, increased morbidity and mortality, increased negative image, and public distrust of healthcare providers. Those situations that may cause or already caused unnecessary harm to the patient are described as incidents [4]. According to WHO, patient safety incidents are classified into three groups: near miss, harmful incidents, and no-harm incidents. Harmful incidents are further divided into two types: adverse events and adverse reactions [3].

The importance of healthcare worker (HW) safety has been increasingly recognized as well, especially after the declaration of the COVID-19 pandemic. Healthcare worker safety is closely interconnected to patient safety [5]. Improving the use of personal protective equipment (PPE) and reporting-analyzing serious safety-related incidents are the most relevant aspects of gastrointestinal endoscopy (GIE) [6].

Gastrointestinal endoscopy (GIE) is one of the fastest-growing procedures, and patient safety undeniably forms the foundation of delivering high-quality GIE. However, patient safety issues are still reported. Correa, et al. [4] stated that there were 111 incidents out of 42,863 (0.25%) GIE procedures in Brazil's tertiary hospitals. The percentage of near misses, no-harm incidents, and adverse event cases were 34.2%, 40.5%, and 23.4%, respectively. Incorrect patient identification was the most prevalent incident [4].

In the early days of the COVID-19 pandemic, GIE practices declined as endoscopists were concerned about SARS-CoV-2 infection. Zein et al. [7] reported that 56.5% of Indonesian GI endoscopists temporarily stopped their endoscopy practice. Han et al. [8] showed that in South Korea, endoscopists decided to perform a limited number of GIE. Endoscopic procedures should be performed with safety precautions for patients and also healthcare workers [9]. Rashid emphasized that the endoscopy unit should be reorganized to facilitate procedures as safely as possible along with general measures and COVID-19 screening [10].

2. Methodology

A narrative review approach was used for evidence synthesis. The current format allowed a comprehensive approach to gain a thorough understanding of the patient and healthcare workers' safety issues. A literature search was conducted during August 2022 and October 2022 and comprised several journals related to the topic. The literatures were searched on credible platforms such as Google Scholar, PubMed, and Science Direct. After further reading and screening, articles related to the topic were narrowed to the specific area of discussion.

3. Safety in GI endoscopy

Gastrointestinal endoscopy procedures should be adjusted to ensure both patient and healthcare worker safety. Many countries have developed their endoscopy management to improve the national quality of endoscopy procedures. In South Korea, The Korean Society of Gastrointestinal Endoscopy (KSGE) has initiated the National Endoscopy Quality Improvement Program to manage programs on endoscopic procedures, includes qualification of endoscopists, improvement of instruments and facilities in endoscopy units, and measurement of outcomes of endoscopy screening [11]. According to World Health Organization (WHO), recommendations to prevent harm during endoscopy include prevention of harm from anesthesia, avoidance of allergic or adverse drug reactions, effective communication among healthcare providers, standardized reporting on procedures, results, and complications [12].

In the era of the COVID-19 pandemic, both patients undergoing GIE and healthcare workers performing GIE are at risk of acquiring infection via direct contact, aerosol, or contaminated body fluid [8]. Most of the endoscopy units were reducing the performance, down to 50–90% reductions. The units prioritized the case using urgent, semi-urgent, and elective classifications [13]. Gastrointestinal endoscopy is performed only on potentially life-threatening conditions (urgent), such as gastrointestinal bleeding, foreign body retrieval, urgent nutritional access, cancer patient, and other conditions that cannot be postponed [9, 10].

To minimize the risk of COVID-19 transmission, some strategies and modifications need to be implemented. To begin with, pre-endoscopic modifications are patient evaluation, COVID-19 screening, healthcare worker (HW) well-being, endoscopy room, equipment, and PPE. While the endoscopic modifications are PPE and restriction in the number of involved healthcare workers in the procedure room during endoscopy. Finally, the post-endoscopic adjustment is recovery room, endoscopic room decontamination, and scope disinfection.

4. Patient safety

Patient safety incidents may occur mostly because of individual error, suboptimal team performance, or task-related problems. Even though the incidents are usually to have minor or do not need immediate treatment, it also has to be prevented for the patients' safety [14].

Patient misidentification is of utmost concern. In 2003, the Joint Commission International (JCI) emphasized patient identification as the first International Patient Safety Goals (IPSG). Adverse events due to treatment errors, transfusion errors, testing errors, and wrong-person procedures mostly stemmed from patient misidentification [15].

Patient safety incidents are varying widely, which may occur on arrival, procedure, or even recovery from sedation. Studies have shown that half of the significant adverse events in GIE are associated with sedation [16]. In 2021, Correa et al. [4] revealed that 40.1%, 24.6%, and 35.3% of all incidents consisted of events that occurred before, during, and after procedures, respectively. The study evaluated 50% of adverse events that occur during and after procedures were due to gastrointestinal perforation and gastrointestinal laceration/bleeding without perforation, 19.2% due to skin lesions, and 11.5% due to falls [4].

Checklist by WHO showed the ability to reduce mortality from 1.5% to 0.8%. It will not prevent every error in GIE, but it can minimize incidents and encourage a culture of safety through improved teamwork in the endoscopy room. It is a simple, inexpensive, and effective tool that has the potential to promote safe GIE procedures [14].

5. COVID-19 screening

Before patients enter the endoscopy room, they should be evaluated. COVID-19 screening and body temperature checking are mandatory. The screening will determine the next step. Symptoms such as fever, respiratory problems, and cough will lead healthcare workers to postpone the procedure and transfer the patient to an infectious disease clinic or emergency department for further treatment.

All patients who will undergo GIE should be tested with a SARS-CoV-2 reverse transcriptase polymerase chain reaction (RT-PCR) swab [10]. According to American Gastroenterological Association (AGA), the suggested testing is nucleic acid examination such as NAAT or rapid RT-PCR for an endoscopy center that implements pre-endoscopic SARS-CoV-2 testing [17]. One study showed that SARS-CoV-2 RT-PCR examination is an effective approach to resume GIE practice in the United States. They recommended that PCR testing should be employed during the pandemic's second phase [18]. Some experts also recommend the chest CT scan because the result may come out first than the RT-PCR SARS-CoV-2 test, but later findings showed that non-severe COVID-19 patients have no radiographic abnormality displayed, so chest CT has limited value in screening for COVID-19 prior to endoscopy [9, 10].

Healthcare workers in the endoscopy unit must take the right and thoughtful decision regarding the urgency of the patient's condition. Urgent patients are related to time-sensitive factors that if the procedure is postponed, then a higher risk of threat to the patient is inevitable (Figure 1). To make it easier, experts recommend using these questions to answer: is the procedure indicated, is the procedure time sensitive, if yes, it has to be done within 2 weeks or 8 weeks, if not time-sensitive, the procedure can be delayed after 8 weeks (Figure 2). In a different study, the classification of the patient condition is divided into three conditions: emergent condition must be performed within 1 week; the urgent condition is performed within 1–8 weeks, and non-time-sensitive can be delayed for more than 8 weeks [19]. This action has to consider the patient’s medical records, laboratory results, cross-sectional images, and endoscopic reports [9, 20].

Figure 1.

Criteria of urgent condition in gastrointestinal endoscopy.

Figure 2.

Prioritization of gastrointestinal endoscopy.

The urgent indication has been classified by some studies and includes gastrointestinal bleeding, perforation treatment, stent insertion for gastrointestinal obstruction, biliary sepsis, acute cholangitis, and other conditions, which met the criteria of an urgent situation. Semi-urgent patient includes endoscopic therapy for neoplasia such as polypectomy, endoscopic mucosal resection or dissection, occult gastrointestinal bleeding, enteroscopy, and endoscopic retrograde cholangiopancreatography (ERCP) for pancreatobiliary malignancy. If the COVID-19 patient's condition is not urgent, then the GIE procedure will be delayed for at least 14 days or after negative RT-PCR testing [9, 20].

The patients who will undergo endoscopy procedure need to fill out the form of travel history, close contact with suspected or confirmed COVID-19 persons, and informed consent for GIE procedure [9]. The consent must be clear and include all procedures and interventions that will be taken or reduced during endoscopy [20]. The patients have to wear a surgical mask and perform hand hygiene; some also recommend wearing gloves. While waiting, the patients are encouraged to minimize close contact and communication. Patients can be accompanied by one adult and no visitors are allowed (Figure 3) [10].

Figure 3.

Workflow of gastrointestinal endoscopy using COVID-19 screening.

6. Patient evaluation

The preparation and precautions for endoscopy procedure are essential for patient safety. In order to reduce incidents, every patient should be comprehensively evaluated before GIE. The American Society of Gastrointestinal Endoscopy (ASGE) recommended that the initial endoscopic procedure is confirming the correct patient and procedure to be performed [21].

Before performing an endoscopic procedure, the patient's identity should be checked. Name and date of birth should be asked and checked on patients’ wristband and medical record or document. The recommendations are confirming the patient by checking a minimum of two data: name and date of birth. The indication and type of the planned procedure should also be verified. The medical personnel, who will perform GIE, needs to deliver essential and relevant information related to the procedure to the patient. Informed consent has to be delivered in every endoscopy procedure [22].

Medical history might affect tolerance to the procedure. Patients’ medical history needs to be checked thoroughly for the patient undergoing without sedation or with sedation, especially in moderate/deep sedation. The medical history will show the presence of respiratory, cardiovascular, neurologic, renal, or other problems [22]. History of obstructive sleep apnea may predict ventilatory function disturbance with sedation [23]. Physical examination should be done, including vital signs, auscultation of the heart and lungs, a baseline level of consciousness, and assessment of airways [22].

7. Healthcare worker safety

Healthcare worker well-being is one pillar that contributes to patient safety [5]. It comprised physical and mental aspects. Healthcare workers should be protected from medical hazards. Standard PPE should be provided by the hospital. Vaccination programs including COVID-19 immunization should be given to all HW. Personal hygiene such as regular handwashing should be enforced according to the WHO protocol [5, 10]. Healthcare workers are working in high-demand and high-risk medical environments in which psychological stress can occur. Their mental problems should be addressed. Psychological support should be provided to ensure HW's well-being [10].

COVID-19 patients are admitted to hospitals with various comorbidities, including GI diseases. Those patients might require GIE for the evaluation and management of digestive diseases [17]. Gastrointestinal endoscopy procedures pose a transmission risk to the HW (endoscopist and endoscopic nurses). Body fluids from COVID-19 patients can spread during the procedure. Saliva can contaminate the pillow during esophagogastroduodenoscopy (EGD), and feces may contaminate the bed during colonoscopy. Prevention of infection to HW is important [24, 25].

The Indonesian Society for Digestive Endoscopy (ISDE) has released a particular recommendation for performing GIE during the COVID-19 pandemic. Their recommendations consisted of patient selection, selection of endoscopy room, medical staff protection, recovery room, and equipment disinfection. The highlights of these recommendations are defined as whether the patient has an indication for urgent, semi-urgent, or elective GIE. It is mandatory to limit the indications for GIE only for emergencies such as acute gastrointestinal bleeding, foreign bodies impaction, acute cholangitis, and cancer care only. All elective cases should be postponed to reduce the SARS-CoV-2 transmission [9].

To minimize the cross-infection, the number of involved HW is recommended to be restricted in endoscopy procedures. The HW should remain to stay in the endoscopy room until the procedure is finished and avoids encountering other staff. The staff restrictions also can be an effective way to wear PPE efficiently, since it is the commodity that is in great demand during the COVID-19 pandemic [10, 26].

8. Personal protective equipment

Personal protective equipment (PPE) is equipment specially designed to protect the HW or other employees who wear it to improve their personal safety against infectious materials. There are various PPE components including masks, gloves, gowns, goggles, face shields, disposable hair caps, and shoe covers [27].

GI endoscopy units have to define the policies in which PPE should be worn during certain exposure. In low-risk exposure, which has no direct contact with contaminated devices, body fluid, and other infectious substances, HW should wear minimum components of PPE (mask, gown, and glove). However, in the high-risk procedure, which has direct contact with a contaminated device, body fluid, and needs direct treatment, HW must wear the full component of PPE. Every personnel has to understand how to do PPE donning and doffing appropriately [27, 28]. Personal protective equipment will be effective if supported with other preventive actions, such as physical distancing, hand wash, and disinfection of medical equipment [26].

When performing GIE in suspected or confirmed COVID-19 patients, the involved HW should wear level 3 biosafety PPE. Those are N95 masks, coverall suits, hair caps, face shields, double gloves, and boots. Prolonged use of N95 for up to 4 hours is tolerable. Level 2 biosafety PPE is recommended to wear for endoscopic staff who performed negative or low-risk COVID-19. The equipment for level 2 includes an N95/FFP2/FFP3 mask, disposable waterproof gown, goggles, caps, and shoe covers. All HWs should be educated to wear proper PPE according to standards to minimize infection because the infection potentially occurs during donning and doffing PPE [9, 29].

In a study related to PPE in GIE procedure, most HW implemented proper hygiene, yet they are not educated enough to perform PPE donning and doffing [13]. The HWs have to discard used PPE properly to the waste container and continue with washing hands and other open body parts after the procedure is done [28].

9. Endoscopy room and equipment

The separation of clean and contaminated rooms should be implemented for the endoscopy room, sign-in room, and recovery room. One-way flow for equipment and patients is the recommended approach [10]. The traffic flow in the endoscopy room should be organized to make efficient and easy movement for patient, HW, and any equipment needed. It also prevents any infection or contamination within the room [30].

The size of the endoscopy room is determined by the complexity of the procedure. A procedure such as ERCP, which needed specialized equipment, requires bigger space. The room has to have enough space and supporting facilities for vital equipment such as oxygen source, suction source, and uninterruptible power supply. The room needs to be checked and monitored periodically even in the external aspect such as temperature and humidity [28]. The recovery room also needs to have appropriate spaces and provide comfortable conditions that can keep the patient’s privacy [28].

For suspected or confirmed COVID-19, GIE is recommended to be performed in a negative pressure room [29]. Endoscopy room surfaces and floor should be disinfected using chlorine after the procedure. New and clean bed sheets should be provided. The endoscopes should be disinfected according to standard protocol [10].

Ventilation in the endoscopy room is important since SARS-CoV-2 spreads into the air. The virus may spread in aerosol-generating procedures such as EGD or ERCP. Negative pressure rooms can prevent the aerosol-containing virus to spread wider in the air. If negative pressure rooms are not available, then portable high-efficiency particulate air (HEPA) filters may be a reasonable alternative [9].

After the procedure is completed, patients will be directed into a recovery room. The patient is provided with a surgical mask and other PPEs depending on their COVID-19 status. It is also recommended to differentiate among patients to prevent cross-infections of COVID-19. The staff who cleaned used equipment and room has to wear PPE including a head cap, gown, surgical mask, face shield, shoe covers, and gloves, since they will be cleaning and potentially contacting with scopes, surfaces, and equipment after procedures [10, 24].

SARS-CoV-2 is reported to be cleared using disinfectant containing hydrogen peroxide, alcohol, and chlorine. Any high-contacted surface and equipment have to be disinfected after each endoscopic procedure. Ultraviolet irradiation and ozone treatment can be advanced sterilization methods in an endoscopy room [10]. The frequency of disinfection can differ regarding the risk of the patient's status. In suspected or confirmed COVID-19 patients (high-risk), at least two times disinfection processing is suggested to minimize contamination; meanwhile, in negative COVID-19 patients (low-risk), it can be done once according to the applicable standard [9].

10. Conclusion

Adherence of GIE procedures strictly to guidelines should be implemented to protect patients and HW during the COVID-19 pandemic. Healthcare workers' well-being and safety are also a priority that cannot be neglected. The COVID-19 pandemic is still unpredictable, so it will need more innovations and dynamic regulations to overcome the problem.