Policy responses for Italy - HSRM


Policy responses for Italy

2. Ensuring sufficient physical infrastructure and workforce capacity

ENSURING SUFFICIENT PHYSICAL INFRASTRUCTURE AND WORKFORCE CAPACITY is crucial for dealing with the COVID-19 outbreak, as there may be both a surge in demand and a decreased availability of health workers. The section considers the physical infrastructure available in a country and where there are shortages, it describes any measures being implemented or planned to address them. It also considers the health workforce, including what countries are doing to maintain or enhance capacity, the responsibilities and skill-mix of the workforce, and any initiatives to train or otherwise support health workers.

2.1 Physical infrastructure

On 26th April, the Prime Minister announced that for Phase 2, the maximum price for surgical masks will be set at EUR 0.50 per piece and that the government is currently working on applying a zero VAT rate on such products. The draft of the Phase 2 Decree also includes the obligation to wear PPE in closed spaces accessible to the public, including public transport and in all occasions where interpersonal distance cannot be safely maintained. Children under the age of six and people with disabilities that do not allow a continuous use of face masks are not subject to the obligation.

To avoid crowding within healthcare facilities and ensure social distancing in common areas, the Ministry of Health has recommended effective logistical and organizational re-thinking. In particular, with the "Guidelines for the reorganization of deferrable elective activity during the COVID-19 emergency" issued on 1st of June, it suggests to:
• Define separate pathways, with particular attention to fragile and immunosuppressed patients, for example those in oncologic treatment and paediatric or geriatric patients.  
• Define separate routes for accessing and exiting the structures;
• Re-organize patient flows in waiting rooms according to the available space to guarantee social distancing;
• Extend opening hours to better distribute appointments throughout the day.

- http://www.quotidianosanita.it/governo-e-parlamento/articolo.php?articolo_id=84554&fr=n
- Decree 26th April 2020 n° 108 - “Additional implementing provisions for  Law-decree N° 6 of 23rd February 2020, regarding Urgent measures to contain and manage the epidemiological emergency due to COVID-19, applicable to the entire national territory”
- Circular n° 0011408, 1st June 2020 - "Guidelines for the reorganization of deferrable elective activity during the COVID-19 emergency", Ministry of Health. [Available at: http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=74374&parte=1%20&serie=null]
- ALTEMS, Instant REPORT#26: Analisi dei modelli organizzativi di risposta al Covid-19, 29th October 2020 [Available at:

ICU beds
Despite the enormous efforts made to increase physical infrastructure during the first wave, Italy is once again facing a scenario of ‘ICU capacity saturation’. By the end of October, most regions were still below 30% saturation of ICU capacity, which is the ‘alarm’ threshold indicated by the Ministry of Health. However, three regions out of twenty (two in the North and one in the South) have surpassed this limit and one central region, Umbria, has reached 53%, exceeding the saturation level reached on 3rd April, when the country reached its ICU peak level of stress of 43% (ALTEMS, 2020). The ICU additional capacity saturation rate at 28th October 2020, which measures the saturation rate of the extra capacity (set-up during the emergency specifically for Covid-19 patients mostly by Legislative Decree (DL) 34/2020) in terms of intensive care beds, indicates how many of these are occupied by COVID-19 patients.  Eight regions have already saturated the capacity of ICU beds requested by DL 34 and therefore are currently using structural capacity that should be dedicated to non-Covid – 19 patients.

Information released on 12th November 2020 by the Extraordinary Commissioner on the free distribution to Regions and Autonomous Provinces, for use by health personnel, Public Administration, law enforcement agencies, public service providers, nursing homes, local public transport and police have reached totals of:
• Almost 1 040 million  face masks, of which 57 million  over the last 7 days;
• Almost 70 million gloves, of which  6 million over the last 7 days;
• More than 17 million lab coats and gowns, of which almost 3 million over the last 7 days;
• Over 3 700 ICU ventilators, of which 396 over the last 7 days; 
• 1 550 Sub ICU ventilators, of which 121 over the last 7 days

The contribution of the Armed Forces during the second wave
Additional resources as of 2nd November, have been provided by the Armed Forces:
• 150 beds, of which 50 are sub-intensive or IC beds at the Military Hospital in Rome;
• 50 beds for Covid patients at the Military Hospital in Milan;
• 20 places for Covid patients and 2 resuscitation beds (which can be raised to 8 at the Military Hospital of Taranto);
• 4 temporary hospitals built in fields
• 18 structures with over 2000 vacancies and 830 rooms for civilian personnel in quarantine / isolation;
• Inflatable triage tents on the basis of Local Health Units requests
• 73 airplanes of the Armed Forces have been made available for transport and 285 vehicles with ventilators, medical equipment and PPEs.

- Department of Civil Protection, Analisi Distribuzione Aiuti, !2th November 2020 - http://www.quotidianosanita.it/allegati/allegato7212812.pdf
- http://www.difesa.it/Primo_Piano/Pagine/difesa_ancora_in_campo_per_lotta_al_covid_19.aspx 

Overall capacity
According to data published in 2017 (latest available) by the Ministry of Health’s statistics unit, hospital care in the country was provided in 1000 institutions with 191,000 ordinary inpatient beds. Although provision is uneven among regions, this means an average of 3.6 beds per 1000 inhabitants. Emergency Departments (EDs) were present in 55% of public hospitals and more than half of these institutions (65.4%) were equipped with a Reanimation Centre.

Italy had a total of 5 090 intensive care unit (ICU) beds (8.42 per 100 000 inhabitants) with an average utilization rate of 47.8% . Nevertheless, although the availability of ICUs beds increased from 2010 to 2018,  the “stress test” of Covid-19 on the Lombardy Region required doubling the activity of ICUs: from an average number of 680 discharges per month from 2013 to 2017, to 1 350 patients in March 2020.

Hospitalization and ICU use rates
According to WHO, approximately 40% of COVID-19 patients in Italy have been hospitalised, and close to 7% admitted to an ICU. A study published in the Lancet by the Mario Negri Institute (MNI) for Pharmacological Research (Milan), had initially assessed that between 9 to 11% of COVID-19 cases require ICU care. On 29th March 2020, the number of positive cases was 73 880, meaning that, according to the MNI estimate, around 7 380 ICU beds are needed, amounting to almost 70% of the bed capacity for 2017; however, by 3rd April, it was registered that 4068 patients had been admitted to ICU, of which 2842 in the North, occupying 113% of their bed capacity. In fact, in those stages, although contrary to the stated aims of the health care system and Italy’s principle of universal health coverage, ICU specialists have no choice but to deny ventilation to the frailest and give priority to those who are more likely to benefit and survive. At the beginning of March, Lombardy, the most affected region, had a total ICU capacity of 724 beds. By March 16th, this number increased to 1100, of which 898 were exclusively for COVID-19 patients (there is also a shortage of 500 doctors and 1,200 nurses).

To date, Lombardy has increased its initial ICU bed capacity by 86% thanks to key contributions from the private sector (responsible for 30% of the increase in ICU beds).

Pressure on hospitals and capacity surge, examples from Lombardy
In general, the design and organization of operative healthcare contingency plans is the responsibility of the regions. At the beginning of the crisis, those put in place by the most affected areas (Lombardy, for example) became obsolete after two days due to the drastically high demand for ICU beds, PPE, ventilators and human resources. After the first cases of hospitalization, which started on 20th February, Lombardy rapidly organized its ICU services by setting up an “ICU Network” of 15 hospitals, which expanded to 72 facilities in the following weeks. They were chosen either for their expertise in treatment of infectious diseases or because they were already part of the so-called Veno-Venous ECMO Respiratory Failure Network (RESPIRA).

The first step for these hospitals was to group and isolate ICU beds for COVID-19 patients to minimize in-hospital transmission between patients. Secondly, a triage area was set up for patients to receive mechanical ventilation while waiting for the result of their diagnostic tests. Local protocols for triage of patients with respiratory symptoms were formalized and the PPE supply and distribution chain was reorganized along with personnel training. Every suspected or positive case in critical condition had to be reported to the regional coordinating centre, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinic. Non-urgent elective procedures were cancelled and 200 ICU beds were set up in 10 days. In the first 18 days of the crisis, the network introduced 482 new ICU beds. A study published by JAMA on 6th April analysed a set of 1591 Covid-19 patients admitted to the ICU network and found that the average length of stay in IC was 10 days, reaching 15 to 20 days in several cases.

The city of Milan has been converting large existing industrial spaces or trade fair buildings into hospitals. For example, on 5th April, it opened a brand new hospital in its Exposition Palace, which has now become the largest ICU hospital in Italy, with 200 ICU beds and diagnostic facilities. Set up in record time, it has led the government to consider replicating the model with 2 additional hubs located in the centre and in the south of Italy. In some cases, discharged patients requiring low intensity surveillance are being sent to re-adapted hotels or dormitories. In Bergamo, on 1st April, the Alpine Brigade, one of the Great Units of Italy’s Armed Forces, opened a field hospital with 142 beds, out of which 72 are ICU beds.

These positive developments are addressing the significant demands being placed on hospitals in the region. A paper published on 21st March by NEJM Catalyst recounts in vivid detail the extreme pressures facing facilities by describing the situation at a brand-new state-of-the-art facility with 48 ICU beds, the Papa Giovanni XXIII Hospital in Bergamo (Lombardy), a city that has been severely hit by the pandemic. Out of a total of 900 beds in this hospital, 300 are occupied by COVID-19 patients and 70% of the ICU beds are reserved for critically ill patients who have a chance of survival. In the surrounding area, according to the article, most hospitals were next to collapse and overcrowded. Pharmaceuticals, ventilators, oxygen, and personal protective equipment (PPE) were out of stock. Doctors had no choice but to lay their patients on floor mattresses. The struggle affects even regular services such as pregnancy care and child delivery. Cemeteries are unable to cope with the demand. The entire country has limited access to PPE, putting healthcare facilities at the risk of being important vectors of infection. In the case of face masks, the shortage is world-wide. In some cities, in-home visits have been halted due to the lack of face masks and other protective devices.

Measures to reinforce physical infrastructure
In response to such dramatic needs, on 17 March, the national government issued Legislative-Decree n° 18 (“Cure Italy decree”) which focused on the capacity of the National Health Service in terms of physical infrastructure, financing an increase of beds in ICUs, Pneumology and Infectious Diseases in derogation from budget limits. The decree also requests that for the duration of the emergency, private facilities should make available their healthcare professionals, facilities, equipment and transport vehicles, designating EUR 340 million for this purpose (see also Section 4.1). According to a report by I-COM (September 2020), private healthcare providers played a fundamental role especially during peak times when urgent interventions were needed in response to hospital overcrowding. In many regions, coronavirus patients were hosted by private clinics, easing the pressure on public facilities, thanks to special agreements with Regional Health Systems that checked structural and safety requirements. Such collaboration was also fundamental later on, during Phase II, for the progressive resumption of ordinary activities as it allowed for the continuation of undeferrable surgical services.

In the most severely affected areas, the Department of Civil Protection set-up military camp hospitals with additional ICU or semi-ICU beds and lower intensity care beds for those in recovery. When regional capacity is saturated, the Italian army transfer patients in need of intensive care to other regions by helicopter/airplane with the support of the army.

Measures to address the shortage and distribution of medical devices and PPE
The National Institute for Insurance against Accidents at Work (INAIL) has been attributed extraordinary competences for the duration of the emergency to respond faster to the shortage of PPE. On 27th March, it authorised a fast track process to produce, import and commercialize such devices in terms of timeliness (but not compromise quality standards).

Invitalia, the National Agency for Inward Investment and Economic Development, has been authorized to release subsidized loans and non-refundable aid to companies converting their production to fast-track production of medical devices and PPE for a total of EUR 50 million (an initiative known as #CuraItalia Incentive). On 7th April 2020, 486 applications were submitted, some of which proposed to repurpose their production (77%) and the others proposed to expand existing production (23%). Currently, 36 investments have been approved and require a total of EUR 16.3 million (17 companies will expand production and 19 will repurpose). Parmon, for example, which already manufactures personal hygiene goods, is currently producing 350 000 face masks per day and will increase to 600 000 in the upcoming weeks. All products will be delivered to the Department of Civil Protection. Other companies involved in similar sectors have been authorised to increase their production volume: Fater and Conservice will make 250 000 masks daily and Fippi will manufacture 900 000.

Confindustria, the General Confederation of Italian Industry, by means of its Emergency Management Programme (EMP), has been closely involved and active in supporting industrial repurposing, in ensuring the continuity of the country’s productivity flow and in identifying PPE and medical device suppliers for the Department of Civil Protection, by mapping and reaching out to existing producers. On 3rd April, it signed an agreement with Domenico Arcuri, the appointed Extraordinary Commissioner, to simplify the procurement of masks for the industrial healthcare sectors. The agreement establishes that 20% of goods ordered on behalf of Confindustria will be donated to the Extraordinary Commissioner directly from the importer after quality checks. Confindustria can already count on the support of Genertec (medical and pharmaceutical devices), Giglio Group (e-commerce and fashion) and Promo Gift (packaging), implying that in the next few days about 2 million masks will be made available.

On 29th March, Invitalia stated that it had delivered 2.3 million surgical masks and 1.7 million (FFp2 and FFp3) facemasks for healthcare professionals. From 23rd to 29th March, 318 ICU ventilators were distributed to regions by means of five airplanes provided by the military and the defence and security company Leonardo; however, the government’s aim is to increase the number of ventilators by a total of 5,000 (at a cost of EUR 185 million). Data on distribution of PPE to regions has been made public by the appointed Extraordinary Commissioner. Overall, numbers state that, in the month of March, 39.2 million masks were distributed (although the monthly supply needed is estimated at 90 million) together with 1,231 ventilators.

The Department of Civil Protection is authorised to seize medical and surgical aids and other movable property from privates and public bodies, if deemed necessary. Hotels, or buildings with similar features, could be requested to make available their facilities to host infected cases requiring lower intensity care or healthcare professionals to safeguard their families (EUR 150 million). 

By 22nd July, almost 695,641,281 medical devices and protective equipment have been distributed to the entire country, of which around 100,000,000 in Lombardy and Veneto and around 800,000,000 in Emilia Romagna and Tuscany. Most of these (637,935,382) are face masks and gloves (23,976,490). For further detail, please refer to: 

A total of 38 Italian Covid-19 patients have been (4th April) hospitalized in ICUs located in German hospitals after being transferred by airplane, thanks to the Italian and German Air Force.

EU President von der Leyen also announced that through the European Civil Protection mechanism Denmark is donating ventilators and a mobile field hospital to Italy.

On 25th March 2020 Huawei and Fastweb donated 500 tablets and smartphones to hospitals in Lombardy and Veneto, equally divided between the two regions, so that patients affected by Covid-19 can communicate virtually with family members. On 17th April Linkem S.p.A and Huawei donated tablets to the Spallanzani Infectious Disease Hospital in Rome, and plan on distributing others to other COVID centers in Lazio Region.

The Italian ICT infrastructure has released regular updates regarding epidemiological statistics relative to the pandemic on several publicly available websites at national and regional levels. Collecting and disseminating data for policy assessment and evaluations, however, has suffered from data scarcity in the initial phases of the epidemic. Some experts conjecture that the inability of hospital ICT systems to record and signal initial extraordinary infection peaks may have facilitated an invisible spread of the virus in the first months of 2020.

Another area where data measurement needs to be strengthened was pointed out on 2nd April by Silvio Brusaferro, President of the ISS, when he specified that the total number of deaths may be underestimated as Covid-19 patients dying in long-term care facilities or at home are not recorded as deaths imputable to Covid-19 as, in most cases, they are not tested.

Furthermore, significant differences in mortality rates within Italian regions, not yet fully explained by different testing approaches, are showing the consequences of differences in micro-level data quality within and between regions. These two weaknesses in the country’s ICT infrastructure have impacted on the management of the pandemic due to the lack of truly comparable data not only within Italy but, consequently, also across countries, complicating appropriate resource allocation and the identification of what measures are actually working. It highlights that the health system’s digital infrastructure would benefit from substantial reinforcement.

On 21st May, the Italian National pension fund (INPS) released an analysis on mortality that suggest the total number of deaths in Italy attributed to COVID-19 might have indeed been significantly underestimated. More specifically, INPS suggests that there might be up to 19,000 deaths mostly concentrated in the northern regions that could have been caused by Covid-19 that were not accounted for, after comparing mortality rates across years and geographical areas. This may be explainable considering that the methodology used by the Civil Protection to count Covid-relate deaths included only those who were tested by means of a swab, whereas  many died at home and without being tested at all.

- Ministry of Health, 2017. Statistical SSN Yearbook – Organizational framework, activities and productive factors of the SSN. http://www.salute.gov.it/imgs/C_17_pubblicazioni_2879_allegato.pdf 
- https://www.lavoce.info/archives/64538/ospedali-dove-e-perche-si-e-tagliato/
- Remuzzi, Andrea & Remuzzi, Giuseppe. (2020). COVID-19 and Italy: what next?. The Lancet. 10.1016/S0140-6736(20)30627-9. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext
- Nacoti M., et al. (2020). “At the epicenter of the Covid-19 pandemic and humanitarian crises in Italy: Changing perspectives on preparation and mitigation.” NEJM Catalyst: Innovations in Care Delivery, March 21, 2020. Available at https://catalyst.nejm.org/doi/full/10.1056/CAT.20.0080.
- http://www.salute.gov.it/portale/nuovocoronavirus/dettaglioNotizieNuovoCoronavirus.jsp?lingua=italiano&menu=notizie&p=dalministero&id=4247 
- https://www.inail.it/cs/internet/docs/alg-istruzione-operativa-emergenza-covid-19.pdf 
- https://www.inail.it/cs/internet/comunicazione/avvisi-e-scadenze/avviso-dl-17320-dpi.html
- https://hbr.org/2020/03/lessons-from-italys-response-to-coronavirus
- Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. Published online March 13, 2020. doi:10.1001/jama.2020.403
- Grasselli G, Zangrillo A, Zanella A, et al. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. Published online April 06, 2020. doi:10.1001/jama.2020.5394
- https://www.invitalia.it/cosa-facciamo/emergenza-coronavirus/incentivi-curaitalia/numericuraitaliaincentivi
- https://www.ilsole24ore.com/art/accordo-confindustria-arcuri-continuita-produttiva-imprese-ADLd42H 
- EMERGENCY MANAGEMENT PROGRAMME, Confindustria Piccola Industria. http://www.confindustriapge.it/allegati/Piccola%20Industria%20PGE_PROGRAMMA%20GESTIONE%20EMERGENZE.pdf 
- https://www.lavorolazio.com/stamane-consegnati-a-spallanzani-i-tablet-donati-da-linkem-e-huawei-italia 
- WHO regional office for Europe - An unprecedented challlenge, Italy’s first response to COVID-19. World Health Organization 2020
- https://www.inps.it/nuovoportaleinps/default.aspx?itemDir=53705
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