Stesura Seveso 67Archivio Italiano di Urologia e Andrologia 2020; 92, 2 ORIGINAL PAPER No conflict of interest declared. DOI: 10.4081/aiua.2020.2.67 INTRODUCTION This document was based on the review of information materials from AGENAS (Agenzia Nazionale per i Servizi Sanitari), SIU (Italian Society of Urology), SAGES (American Rosario Leonardi 1, Piera Bellinzoni 2, Luigi Broglia 2, Renzo Colombo 3, Davide De Marchi 2, Lorenzo Falcone 1, Guido Giusti 2, Vincenzo Grasso 1, Guglielmo Mantica 4, Giovanni Passaretti 2, Silvia Proietti 2, Antonio Russo 2, Giuseppe Saitta 2, Salvatore Smelzo 2, Nazareno Suardi 4, Franco Gaboardi 2, UrOP Executive Committee * 1 Musumeci GECAS Clinic, Gravina di Catania, Catania, Italy; 2 Department of Urology, San Raffaele Turro Hospital, Milan, Italy; 3 Department of Urology, San Raffaele Hospital, Milan, Italy; 4 Department of Urology, IRCCS Policlinico San Martino Hospital, University of Genova, Genova, Italy; Hospital care in Departments defined as COVID-free: A proposal for a safe hospitalization protecting healthcare professionals and patients not affected by COVID-19 The COVID-19 pandemic influenced the normal course of clinical practice leading to significant delays in the delivery of healthcare services for patients non affected by COVID-19. In the near future, it will be crucial to identify facilities capable of providing health care in compliance with the safety of healthcare professionals, administrative staff and patients. All the staff involved in the project of a Covid-free hospital should be subjected to a diag- nostic swab for COVID-19 before the beginning of healthcare activity and then periodically in order to avoid the risk of con- tamination of patients during the process of care. The modifica- tions of various activities involved in the process of care are described: outpatient care, reception of inpatients, inpatient ward and operating room. For outpatient care, modality of appointment procedure, characteristics of waiting room and personal protective equipment (PPE) for healthcare profession- als and administrative staff are presented. Reception of inpa- tients shall be conditional on a negative swab for COVID-19 obtained with a drive-in procedure. The management of the operating room represents the most crucial step of the patient's care process. The surgical team should be restricted and moni- tored with periodic swabs; surgical procedures should be per- formed by experienced surgeons according to standard proce- dures; surgical training experimental treatments and research protocols should be suspended. Adequate personal protective equipment and measures to reduce aerosolization in the operat- ing room (closed circuits, continuous cycle insufflators, fume extraction) should be adopted. Prevention of possible transmis- sion of the virus during procedures in open, laparoscopic and endoscopic surgery is to use a multi-tactic approach, which includes correct filtration and ventilation of the operating room, the use of appropriate PPE (FFP3 plus surgical mask and pro- tective visor for all the staff working in the operating room) and smoke evacuation devices with a suction and filter system. KEY WORDS: COVID-19; Pandemy; Surgery; Endoscopy; Filtration. Submitted 20 April 2020; Accepted 21 April 2020 Summary Society of Gastroenterology Endoscopic Surgery), EAES (European Society of Endoscopic Surgery) and Italian Society of Endoscopic Surgery. Prevention measures, personal pro- tective equipment (PPE) and protocols for healthcare professional, administrative staff and patients have been included trying to implement the best prevention meas- ures against COVID-19 infection in public or private healthcare facilities. The COVID-19 pandemic influenced the normal course of clinical practice through multiple mechanisms lead- ing to significant delays in the delivery of healthcare services. The possibility of meeting the demand for healthcare in the near future will depend on the duration of the epidemic, its economic and social consequences, and also on changes of the population caused by the infection itself. In consideration of the awareness that for many months we will still have to live with the presence of the virus among the population, it becomes mandato- ry an immediate rationalization of resources in order to ensure continuity of healthcare for patients not affected by COVID-19. It is crucial to identify facilities capable of providing health care in compliance with the safety of healthcare professionals, administrative staff and patients who need medical treatment. The triage of med- ical and surgical procedures must take into account the heterogeneity of the pathologies to be treated, the vari- ability of the timing useful for effective treatment, the different surgical approaches and non-surgical alterna- tives. It should not be forgotten that the epidemic has heterogeneous loco-regional outbreaks with differentiat- ed measures from local government authorities. Although there is no official data, it has been reported that a new health migration is underway, with a flow of patients moving from high endemic areas to areas where they can obtain adequate care (AGENAS-SIU). This document aims to provide indications in the triage of patients and in the optimization of the resources available in this difficult moment. As a precondition, all the staff involved in the project of a Covid-free hospital should be subjected to a diagnostic swab for COVID-19 before the beginning of healthcare activity. The swab should be Archivio Italiano di Urologia e Andrologia 2020; 92, 2 R. Leonardi, P. Bellinzoni, L. Broglia, et al. 68 repeated every two weeks in order to avoid the risk of con- tamination of patients during the process of care. If reliable tests will be validated, able to replace the swab in the diag- nosis of COVID-19, these tests could be considered as faster and less expensive screening procedure to monitor the absence of infection in the medical staff and hospital nursing. We divided the text into several chapters concerning the various activities involved in the process of care: – Outpatient care – Reception of inpatients – Inpatient ward – Operating room. Outpatient visits Appointment procedure The outpatient visit should be booked through a tele- phone triage. Exclusion criteria: – Coming from high endemic areas (red areas) – Referred flu symptoms (sore throat, cough, rhinorrhea) – Temperature – State of quarantine or cohabitation with subjects in compulsory quarantine. Patients must be informed that they must access to the office equipped with a surgical mask. The patient can be accompanied by a person who how- ever will not enter in the office at the time of the visit. If it is necessary to provide information to the companion, this will be convened separately so that the criteria for social distancing are respected within the office. Upon entering in the facility it would be useful to per- form a body temperature measurement. Waiting room In relation to the size of the waiting room, one or more patients can be accepted. It is mandatory to maintain a distance between the patients and their companions of at least two meters. Healthcare professionals Healthcare professionals must be equipped with Personal Protective Equipment (PPE) including FFP3 mask and protective goggles or visors. Administrative staff (payment of outpatient service) Must be equipped with PPE (FFP2 mask). Note: It is important that the area of the consultations must be separated from the area of hospitalization. Hospitalization of the patient for surgery Indispensable condition for taking care of the patient (swab testing) An indispensable condition for the patient to be candi- date for surgical treatment is that of being subjected to a swab for COVID-19 before entering the facility. How and how long before admission, it depends on the structural and organizational characteristics of the hospi- tal and the time needed to obtain the result of the swab. Our suggested option is the drive-in swab. A protected area (parking) must be identified where the car with the patient on board can stop for the time necessary to per- form the swab. The staff responsible for the procedure must be provided with the maximum individual protec- tion (suit, FFP3 mask, protective visor and gloves). In the case that the Hospital could arrange a special area for pre-hospitalization the patient could be accepted after the swab in this area of the hospital to wait for the response. General criteria Protect the patient from potential Covid infections in the hospital setting. Protect staff and other patients from contamination, including mutual. The surgical team should be restricted and monitored with periodic swabs; surgical procedures should be per- formed by experienced surgeons according to standard procedures; surgical training experimental treatments and research protocols should be suspended. Admission of the patient to the hospital for elective surgery The call of patients for elective surgery must take place through a telephone interview to rule out a possible con- tagion from Coronavirus SARS-CoV-2: – clinical criteria: cough, rhinorrhea, body temperature rise, pharyngodynia, abdominal pain, conjunctivitis – epidemiological criteria: direct contact with positive COVID-19 patient (cohabitation/interview for more than 15 minutes in the same environment, attendance at hospital facilities); origin from high endemic geo- graphic areas identified by current epidemiological data The patient must be informed that the following steps will be followed on the day of the call to enter the hospital: – arrival at the facility will take place starting at 7.30 with a staggering between one patient and the other of about 15 min – arrival by car and parking in the drive-in swab area. – return to his/her home where the patient must respect strict self-isolation until he/she receives the call from the triage staff who communicates the outcome of the swab – as an alternative (especially for patients domiciled far away from the hospital), the hospital could offer hos- pitality in a separate area with hotel service in indi- vidual rooms with private bathroom (nursing and service staff of this area must wear suitable personal protective equipment including gloves, FFP2 mask, plus surgical masks, if the former are equipped with an exhalation valve, waterproof gown for contacts, and protective visor) – any kind of personal contact of the patient with the other patients has to be avoided – in the case of a delayed result of the swab, food must be delivered out of the room in disposable tray with a sealable bag where the patient should pour food waste including the tray – food waste must be handled as special hazardous waste – room must undergo sanitization at the end of the stay – in the event of a negative outcome of the swab, the patient can be admitted to the ward, staying fasting, to start the acceptance and hospitalization procedure – in the event of a positive outcome, the patient is invit- ed to inform the competent health authorities to arrange for self-isolation at home or hospitalization in the Covid ward. The patient can be accompanied by a family member or friend who will be able to assist him/her in the swab pro- cedure and in the subsequent phase of hospitalization but who will not be admitted to the wards. Both the patient and the companion, in the various stages of the swab procedure and hospitalization must be equipped with a mask. Entry of the patient to the facility Waiting room Waiting room must be organized taking into account social distancing. Administrative staff appointed to accept the patient Front-office administrative staff must carry out their activity protected by a transparent glass barrier and equipped with PPE (FFP2 mask). Medical and nursing staff appointed to accept the patient Collection of clinical history, compilation of the clinical records and administration of the informed consent must be done with compliance of the distancing measures. Discussion of consent to surgery should include an illus- tration of the risk of COVID-19 exposure and its poten- tial consequences on clinical outcomes. Personnel dedicated to blood sampling for blood chem- istry and to cardiological and anesthesiological evalua- tion must be equipped with PPE (FFP2 masks with or without surgical mask based on the presence or absence of an exhalation valve, protective visor, gloves and water- proof gown). Everything can take place in a dedicated area where the rules of social distancing are respected or directly in the hospital room. Note: The attending physician and/or the patient's refer- ence specialist should be invited to inform the head of the anesthesia department or his/her delegate, before the hos- pitalization phase, if there are, in his/her opinion, patholo- gies that may contraindicate the intervention or that could request diagnostic investigations before hospitalization. In this case, the patient should be booked for an anesthe- siological outpatient visit in a reasonable time before admission. Entry of the patient into the ward After the acceptance phase and the first phase of evalua- tion in preparation for the surgical procedure, the patient is sent to the hospital ward and housed in a single room with personal bathroom. The medical and nursing staff, in this phase, must always wear suitable personal protec- tive equipment (gloves, FFP2 mask, plus surgical masks, if the former are equipped with an exhalation valve, waterproof gown for contacts, protective visor). Management of the operating room General considerations Management of the operating room represents the most crucial step of the patient's care process. Even if the patient underwent a swab the day before with a negative result, this is not sufficient to safely exclude a positiviza- tion in the following day. In the operating room for a whole series of conditions related to intubation and to the use of endoscopic and laparoscopic surgical instruments, the risk of transmis- sion is maximum. For this reason, the most effective PPE systems must be adopted and it is necessary to imple- ment well-coded behaviors that can be summarized as follows: – the surgical team should be restricted, monitored with periodic swabs and subjected to restrictive measures to limit the risk of infection – there should be no change of staff in the room – surgical procedures should be performed by experi- enced surgeons to reduce operating times and the risk of complications (therefore, the suspension of surgical training is recommended – the standard approach should be maintained, in order not to compromise the outcome and standardize the operating room times – surgical staff should not stay in the operating room during intubation maneuvers, waiting a few minutes from their conclusion before entering, leaving any infected droplets to settle – it would be desirable for intubation and extubation to take place inside a negative pressure room (https://www.asahq.org/in-the-spotlight/coronavirus- COVID-19-information) (1, 2) – all measures should be put in place to reduce the risk of contagion among healthcare professionals by adopting adequate personal protective equipment. All members of the operating room staff must use PPE (FFP3 mask). Appropriate clothing and face shields must be used. These measures should be used during all pandemic surgical procedures, regardless of known or suspected Covid status. The positioning and removal of PPE must be performed according to the World Health Organization (WHO) and Centre for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov) – measures to reduce aerosolization in the operating room should be considered (closed circuits, insuffla- tors continuous cycle, fume extraction). Note: Remember that the virus has been isolated very frequently in respiratory secretions, saliva and feces, rarely in the blood, exceptionally in the urine. Specific technical considerations There is very little evidence regarding the risks of virus spread related to the use of the laparoscopic surgical tech- nique compared to the open approach (3). Emerging evi- dence and regular updates are provided by the website https://siceitalia.com/covid19/ It is recommended, however, to seriously consider the possibility of viral contamination of operating room per- sonnel during surgery, be it open, laparoscopic or robotic. It is advisable to actively monitor strict application of pro- tective measures for the safety of the operating room staff. Although previous research has shown that the laparo- scopic technique can favor the aerosolization of pathogens present in the blood (Corynebacteria, Papillomavirus and HIV) (4-6), there is no evidence to indicate that this effect 69Archivio Italiano di Urologia e Andrologia 2020; 92, 2 Hospitalization during Covid emergency Archivio Italiano di Urologia e Andrologia 2020; 92, 2 R. Leonardi, P. Bellinzoni, L. Broglia, et al. 70 is also possible for the coronavirus, nor that the risk can be confined exclusively to minimally invasive surgical proce- dures. However, as a precaution, coronavirus should potentially be considered capable of aerosolizing. For this reason, the use of devices to filter CO2 should be strongly considered. For further information https://eaes.eu/eaesand-sages-rec- ommendations-regarding-surgical-response-to-covid-19-crisis/ The proven benefits of minimally invasive treatment in terms of reduced duration of hospitalization and reduction of complications, as well as the potential advantages in terms of ultrafiltration of most or all aerosol particles, must be strongly considered. In fact, the filtration of aerosolized particles can be more difficult during open surgery. There may be an increased risk of virus exposure for endoscopists during upper gastrointestinal tract and air- way procedures. When these procedures are necessary, the rigorous use of PPE of greater protection is recom- mended. The complete mask with FFP 3 should be con- sidered for the whole team, following the guidelines of CDC (https://www.cdc.gov) or WHO (https://www. who.int) (5, 6). Filtration The smaller droplets, in contact with the ambient air (aerosol) can transmit the infection from one individual to another via the respiratory tract (within a certain dis- tance). Currently, the "droplet" diameter classification system (from 5 to 10 μm) represents the unit of meas- urement used to evaluate the transmission mode of an infectious disease. Filtration can be an effective means of protection from virus release during minimally invasive surgery and endoscopy. Masks such as N95 respirators are designed to filter 95% of 0.3 micron and larger par- ticles. Respiratory masks of protection class FFP3 offer the maximum possible protection from the pollution of breathing air with a protection of at least 99% from par- ticles up to 0.6 μm in size. Purified air respirators (PAPR) can be useful for intuba- tion, extubation, bronchoscopy, endoscopy and tra- cheostomy. Intraoperatively, filters are used to remove smoke and particles including viruses. Air particulate fil- ters (HEPA) have a minimum efficiency index of 99.97% for the removal of particles with a diameter greater than or equal to 0.3 microns (6). ULPA (Ultra-Low Particulate Air) filters can remove 99.999% of airborne particles with a minimum particle penetration size of 0.05 microns. The Association of periOperative Registered Nurses (AORN) guidelines define ULPA as filters capable of removing particles of 0.1 microns (7). Filtration is also essential on a large scale in positive pressure operating rooms. HEPA filters positioned in the ceiling provide terminal cleaning. Currently, the best practice to reduce the possible trans- mission of the virus during procedures in open, laparo- scopic and endoscopic surgery is to use a multi-tactic approach, which includes correct filtration and ventila- tion of the operating room, the use of appropriate PPE (FFP3 plus surgical mask, plus protective visor for all staff working in the operating room) and smoke evacua- tion devices with a suction and filter system (8). Practical filtration measures during laparoscopic surgery 1. The pneumoperitoneum must always be safely evacu- ated from the trocar connected to the filtration device before removing the trocars, extracting the operating piece or converting by laparotomy. 2. Once the trocars are positioned, their valves should not be opened during surgery, if possible. If it is necessary to change the insufflation site on another trocar, the valve must be closed before disconnecting the tubing and the valve of the new trocar must remain closed until the insufflation tubing has been connected. The insuf- flator must be activated before the new insufflation valve is open. This is to prevent the backflow of gas into the insufflator itself. 3. During the desufflation phase, all gas and exhaust fumes must pass through an ultra-filtration system, possibly activating the desufflation mode on the insuf- flator, if this mode is available. 4. If the insufflator in use does not have a desufflation function, it must be ensured that the valve that is used for insufflation has been closed before the CO2 flow is deactivated (even if there is a filter in line with the tube). Without taking this precaution, contaminated intra-abdominal CO2 can be pushed into the insuffla- tor when the intra-abdominal pressure is higher than the pressure inside the insufflator. 5. The patient must be on the level at the time of desuf- flation. 6. The workpiece(s) must be extracted once all the CO2 gas and smoke have been evacuated. 7. Drainage pipes should only be used if absolutely nec- essary. 8. The methods of closing the accesses of the trocars with the use of sutures that allow the escape of gas and residual fumes must be avoided. The fascial plane must be closed after complete desufflation. 9. Laparoscopic hand-assisted techniques can lead to sig- nificant CO2 and smoke losses and should therefore be avoided. A protection system can be positioned after complete desufflation to remove more volumi- nous operating pieces and protect the wound. The piece can then be removed and closed. Systems for the evacuation of smoke and gas Below is a list of commercially available products that could potentially be used to filter CO2 gas or smoke evacuated during surgical procedures (Table 1). The list was provided by SAGES and EAES that stated they do not promote any of the following products. SAGES and EAES specify that they have sought informa- tion by contacting the known manufacturers, but the possibility is recognized that there are many other com- panies that may have similar products on sale. Surgeons should be aware of the characteristics of the products used in their facility and contact the product representa- tive or refer to the product instructions for their use. For a consultation of the smoke and gas evacuation sys- tems currently on the market, refer to the links: https://www.sages.org/resources-smoke-gas-evacuation-during- open-laparoscopic-endoscopicprocedures/https://www.sages. org/wp-content/uploads/2020/03/Summary-of-Commercially- AvailablePneumoperitoneum-Smoke-Evacuation-Systems.pdf In addition to the smoke evacuation products, the Ultravision system can minimize aerosolized particles inside the pneumoperitoneum (https://www.sages.org/ wpcontent/uploads/2020/03/Ultravision-as-an-adjunct. pdf). Electrosurgical and laser units The electrosurgical units and lasers must be pro- grammed to the lowest possible settings for the desired effect and for the correct execution of the surgery. The use of monopolar electrosurgery, ultrasound dissec- tors and advanced bipolar devices and lasers can lead to aerosolization of the particles. If available, the use of monopolar electrosurgical units with integrated smoke aspirator is recommended (9-15). During their use, the rules of maximum protection of the medical nursing staff apply as required for all procedures in the operating room. Measures to be put into practice during laparoscopic surgery 1. The skin incisions should be as small as possible to allow trocars to pass and at the same time prevent CO2 losses around the trocars. 2. The CO2 insufflation pressure should be kept to a minimum and, if available, ultra-filtration (smoke evacuation or filtration system) should be used (https://www.sages.org/resources-smoke-gas-evacuation- during-open-laparoscopic-endoscopicprocedures/). 3. All pneumoperitoneum must be safely evacuated through a filtration system before removal of the tro- cars, extraction of the surgical piece, or conversion by open surgical procedure. Measures to be put into practice during digestive endoscopy procedures (https://www.asge.org/home/joint-gi-society-message-covid- 19) (16, 17). 1. In the absence of the ability to control the aerosolized virus during endoscopic procedures, all members of the endoscopy room or operating room must wear appropriate PPE (FFP3 mask, appropriate clothing and face shields). The positioning and removal of PPE must be carried out according to the CDC guidelines (https://www.cdc.gov). 2. Since patients can present with gastrointestinal mani- festations of COVID-19, all endoscopic procedures in an emergency regime should be considered high risk. 3. Since the virus has been found in multiple cells of the gastrointestinal tract and in all fluids (saliva, enteric content, feces and blood) surgical energy must be minimized. 4. Endoscopic procedures that require additional insuf- flation of CO2 or ambient air should be avoided until we have a better understanding of the aerosolization properties of the virus. This includes many of the endoscopic mucosal resection procedures and endo- luminal procedures. 5. 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Correspondence Rosario Leonardi, MD (Corresponding Author) leonardi.r@tiscali.it Lorenzo Falcone, MD Vincenzo Grasso, MD Department of Urology and Andrological Surgery Musumeci GECAS Clinic Gravina of Catania, Catania (Italy) Piera Bellinzoni, MD Luigi Broglia, MD Davide De Marchi, MD Guido Giusti, MD Giovanni Passaretti, MD Silvia Proietti, MD Antonio Russo, MD Giuseppe Saitta, MD Salvatore Smelzo, MD Franco Gaboardi, MD Department of Urology, San Raffaele Turro Hospital, Milan (Italy) Renzo Colombo, MD Department of Urology, San Raffaele Hospital, Milan (Italy) Guglielmo Mantica, MD guglielmo.mantica@gmail.com Nazareno Suardi, MD Department of Urology, IRCCS Policlinico San Martino Hospital, University of Genova, Genova (Italy) * UrOP Executive Committee Giuseppe Ludovico 1, Angelo Cafarelli 2, Ottavio De Cobelli 3, Ferdinando De Marco 4, Giovanni Ferrari 5, Stefano Pecoraro 6, Angelo Porreca 7, Domenico Tuzzolo 8 1 Department of Urology, “F. Miulli” Hospital, Acquaviva delle Fonti (BA), Italy; 2 Department of Urology, Villa Igea Clinic, Ancona, Italy; 3 Department of Urology, European Institute of Oncology, IRCCS - Department of Oncology and Hemato-0ncology, University of Milan, Milan, Italy; 4 Department of Urology, “INI” Italian Neurotraumatological Institute, Grottaferrata (Roma), Italy; 5 Department of Urology, CURE, Modena, Italy; 6 Department of Urology, Malzoni Clinic Neuromed, Avellino, Italy; 7 Department of Urology, Policlinico Abano Terme, Abano Terme (PD), Italy; 8 Department of Urology, “Casa del Sole” Clinic, Formia (LT), Italy.