The Initial Environmental Analysis can be described as a diagnosis that identifies the relationships between the assets of a “site” and the surrounding environment, considering legislative, socio-economic and trading framework in which the company is included.

The stages of development of the IEA are:

• General overview of the site (area where the business takes place).
• Preliminary analysis of the asset and the production processes, identifying factors of environmental impact.
• Environmental legislation references.
• Environmental impact of the processes and the activities of the productive site.
• Methodology for the analysis of impact factors.
• Sum-up and parameterization of the available informations.
• Evaluation of the sensitivity factors.
• Verify compliances and identify priorities for continuous improvement.

Each deficiency is detected both in administrative and formal way, critical areas of vulnerability within the territory are identified, the environmental efficiency in the production processes is highlighted, the precision of the structured organization model of environmental management is underlined by single issues and deficiencies, the level of specific training of staff are established.

Data collected can be further extended for the identification of the general costs for environmental protection of the organization, with particular focus on technologies, products, raw materials, customers and suppliers. This can be useful for a comparative analysis of the environmental performance of other similar activities.

Once these steps are completed, a final report is written, which will be the actual representation of the environmental situation of the considered site, so the analysis of each single impact factor can be subsequently developed.

When the collection of data with other relevant information is concluded, an important step regarding SUMMARY and PARAMETRIZATION of the available informations is reached: by the use of algorithms applied to standard schemes of evaluation, the semi-quantitative descriptors can be obtained.

The relevant parameters related to Environmental Impact for each factor are:

• Regulatory compliance (application of relevant laws and regulations related to the environment).
• Relevance (essential feature of the environmental impact factor of a site that describes the potential risk-danger of causing a negative consequence on the environmental components, or indirectly on productive activities of the site, considering the vulnerability and specific sensitivity of the site area).
• Efficiency (capacity to manage the various environmental issues also in function of their relevance).
• Specific sensitivity of the territory.

To measure these indicators, functions of interpretation, quantifying and communication are established within a “four level” different score, that vary from “1” (best situation) to “4” (worse situation). The “0” level is bound to the situations in which the assessment procedure is “unappliable”, as well as in which the specific impact factor does not exist.

After conclusion of the production framework stages and assessment of environmental impact factors, the procedure goes on deepening the relationship between the site and the surrounding area, characterizing and analyzing actions and factors that upset the individual environmental components.

This is to identify the corrective and crucial actions, in order to ensure regulatory compliance and to set the engagements for continuous improvement of the environmental performance of the site.

The algorithm to calculate the main concern actions (priorities) is given by the product of the levels assumed by the three parameters (relevance-Lr, efficiency-Le and sensitivity- Ls), according to the following formula:

Lp = Lr * Le * Ls

The result of this product leads to the parameter PRIORITY, according to the following scheme:

0 < Lp < = 4 means NO PRIORITY (NONE PRIORITY) and LONG term Actions

4 < Lp < = 8 means LOW PRIORITY and MEDIUM-term Actions

8 < Lp < = 16 means MIDDLE PRIORITY and SHORT Actions

Lp > 16 means HIGH PRIORITY and Urgent Actions

In the Oncology Reference Center (ORC) of Aviano Environmental Management System study, a semi-quantitative assessments for each environmental impact factor in terms of level of “compliance”, “relevance”, “efficiency” and “sensitivity”, have been performed, in this paper the only basics of waste impact analysis are reported.

In Anticancer Drugs Unit section (Fig. 3), the drugs arrive in an open space “in- patient area” in packaged pieces and are delivered to the Storage Drugs area (monthly supply) for the accommodation on shelving.

Fig. (3) General plan of the Center.

Hazardous substances are carried out in the warehouse, a sort of “Preparatory Office of pharmacy and storage solutions ADU” (placed on basement area) for the preparatory operations to the stages of processing in the Unit Anticancer Drugs at the first floor.

The large volume of non-hazardous substances is transported directly to the first floor in the room “Deposit drugs” in front of the local “Preparing chemotherapy” ADU, where the drugs are processed on the basis of a pathway that is customized to each patient's data.

The wastes from drug processing/preparation coming daily from the ADU are hazardous medical waste and must be collected in rigid polyethylene containers, labelled as toxic and harmful product and with self-sealing lid. Each container is then introduced in a larger 50 litres yellow one, stored temporarily and at the end of the closing and identification, encoded (with other waste of the whole ORC structure) before the allocation in the proper outdoor area (thePitch Ecological Hospital area, as Italian regulation requires). According to the instructions on the European list, Annex D of Part IV of D.Lgs. 152/2006 [17D.Lgs. 3-4-2006 n. 152, "Norme in materia ambientale", modificato dal D.Lgs. 16-1-2008 n. 4: “Ulteriori disposizioni correttive ed integrative del D.Lgs. 3 aprile 2006, n. 152, recante norme in materia ambientale”.], these wastes are identified within the European Waste Catalogue (EWC) 18.01.08* (cytotoxic and cytostatic medicines in the health sector or related research activities). In addition, some filters contaminated by hazardous substance are collected and disposed with the identification code EWC 15.02.02* in similar way.

From the data analysis of the amounts of drugs used in the ADU during the three years 2009-2012, a characteristic description of raw materials drugs frequently used was found (Fig. 4).

Fig. (4) ADU - Quantities of raw materials drugs used in the years 2009-2012.

The high quantity of Fluorouracil in 2009 is the result of actual prescribed doses, the application cycles, and/or the different types of therapies applied to patients.

Considering the identification codes, the types of incoming materials from the local “Preparation chemotherapy” U.A.D. were also carried out, as shown in the following graphs (Figs. 5 and 6).

Fig. (5) ADU Waste produced in the years 2009-2012 (EWC 18.01.08*).

Fig. (6) ADU - Waste produced in the years 2009-2012 (EWC 15.02.02*).

Higher values rising in the first two years (2009-2010) than in other years (2011-2012) are to be considered as a first good result in developing a active management of waste.

Starting from this collection of data with other relevant information, a standardized method to improve waste management was searched and found in the IEA basic application: operations of SUMMARY and PARAMETRIZATION have assisted the development of methods of analysis, regarding regulatory compliance, relevance and efficiency (only main results of the evaluation are here reported for brevity).

Data processing and assessment showed that ADU have reached a relevant and complete regulatory compliance, as required by ordinary European laws and environmental regulations.

Because of this whole compliance, the Level 1, which is the highest in the range [0-4], has been conferred in the IEA analysis.

The value representing the relevance (Lr) was obtained considering and comparing the total annual quantity of waste products (1), the waste similar to municipal waste (2), the hazardous waste (3) and pollutants present into them (4). This global observation led to highlight the factor “special waste” describing a potential risk of causing adverse effects on other environmental components, considering the specific sensitivity and vulnerability of the area. The analysis also brought to a value for the relevance level (Lr) assumed equal to 2.25, that was the average of the four values assigned to the items (1-4), as specified above [16M. Casciani, A. Del Sorbo, and M. Dubini, "G.E. Galotti U", In: I.P. Servizi, Ed., Manuali per l’Ecogestione dell’Impresa – Metodologie per l’Analisi Ambientale Iniziale. Italian: Milano, Milan.].

The evaluation of the efficiency (Le) was carried out based on information about the use of “clean technologies” and the best available technologies (BAT), on the formalization of performances about, roles and responsibilities related to technical and administrative management of waste, presence of Maintenance Plans, inclusion in the company budget cost of the waste management, etc.

Using a particular algorithm, a value of 2 was obtained for the level of efficiency applied by the ORC Health Structure in managing the various environmental issues, also considering their relevance.

The characteristics of “sensitivity” and “vulnerability” of the area affected by the impact “solid waste”, allowed to identify the priorities for actions to be taken to mitigate the direct and indirect environmental effects.

In order to set a sensitivity level (Ls), factors of environmental sensitivity, such as biotic components (flora and fauna) and protected areas (parks and reserves) and the existence of areas that use water for irrigation of crops or livestock, were considered. It was also confirmed that no relevant protests or signs of impatience about the problem of hospital solid waste were highlighted by the population or authorities. Finally, a sensitivity factor value of 2 was assigned corresponding to the number of positive responses given from an evaluation board [15 Eco-Management and Audit Scheme (EMAS). Available from: http://ec.europa.eu/environment/emas/index_en.htm.].

The basic algorithm for the calculation of the priorities of improvements, considering the set period of time, was applied according to the above remembered formula: Lp = Lr*Le*Ls. The result was a value of 9 revealing a “MID/LOW” priority level, with improvement actions to be carried out on the short/medium time. In the following, the summary table Table 1 of priorities is reported visualizing all environmental impact factors. As already underlined above, only the “waste” impact factor within the ADU - local called “Preparing for Chemotherapy” has been considered because selected as the most important in the IEA basic application.

Table 1
Summary of priority table for local “Preparing for Chemotherapy”.

Such a final summary sheet is a mean to start a discussion within the responsible staff of the various activities,to verify by the administration the consistency of the IEA and to set the environmental policy, as well as the operational plans with improving actions to be taken.

In this part of the case study, the need to reduce the quantities of hazardous sanitary chemical waste produced in the local “Preparation chemotherapy” highlighted and solutions were supposed. For example, having already provided for the replacement of the bottles/glass ampoules containing the parent drug with the bottles/vials plastic, it was suggested the introduction of specific guidelines in waste management for each operational phase of the local, in accordance with the operational needs of Healthcare Management and General Management Structure of ORC.

Possible areas for general improvements were also proposed:

To introduce a registration schedule of medical waste produced during the “Preparing chemotherapy” on-site by the ADU, rather than during the delivery to the waste treatment plant; to separate container weighing of waste produced during the “Preparing chemotherapy” by the ADU (mainly consisting of sharps and pungent ampoules/vials that contained the drug), before the temporary storage in the room located on the Ground basement of the “lock-patients,” with the other waste of the whole ORC structure; to separate container weighing of waste produced in the preparation of cytostatic-cytotoxic therapies (70% in day hospital and outpatient, 30% in the operating departments) mainly consisting of gauze, tubing, fittings, absorbent drapes, Personal Protective Equipment, etc.

For Nuclear Medicine and Metabolic Radiotherapy Unit, a similar IEA basic application has been arranged with a description of the procedures of radioactive waste in the solid and liquid (excreted patients) state, considering the quantity produced/disposed of hazardous and infectious waste during all the medical processes.

In Nuclear Medicine department of ORC, the use of radioactive substances for diagnosis and therapeutic rules, takes place on an outpatient basis, otherwise in Metabolic Radiotherapy, drugs are given in inpatient protected form.

All radioactive substances used in the two departments are characterized by half-lives shorter than 75 days. In the department of Nuclear Medicine, Fluoride-18 (T/2 = 1.8 hours) and Technetium 99^m (T/2 = 6 hours) in liquid form for intravenous administration are mainly used.

In the department of Metabolic Radiotherapy, only Iodine-131 (T/2 = 8 days) in solid form (capsules) for oral administration is used.

In the department of Nuclear Medicine, the prescription-processing phase involves fractionation of the drug, for the personalized dose and administration (approximately 93% in outpatients and 7% in-patient departments). In the Metabolic Radiotherapy department, the radiopharmaceuticals are in capsule form ready for patients administration.

Both the activities of Nuclear Medicine and Metabolic Radiotherapy lead to the production of radioactive wastes in solid and liquid form.

The waste generated by Nuclear Medicine outpatient consists of solid waste coming from fractionation and administration, solid waste from diagnostic investigations and waiting patients. The waste regarding the inpatient includes solid waste due to the hospitalization of the patient and liquid waste excreted by patients. Likewise, the waste generated in Metabolic Radiotherapy division by admitted patients include solid waste due to the hospitalization and excreted liquids.

Fig. (7) Raw materials radiopharmaceuticals used in the 2009-2011 period.

Data and information collected from the two departments of Nuclear Medicine and Metabolic Radiotherapy showed that the main quantities of raw materials used are: Fluorine-18 for medical use and DRYTEC (Molibden 99) Tc-99m generator in a liquid form, Iodine 131 in solid form.

The graph below (Fig. 7) shows the data presentation of the quantities of radiopharmaceuticals entered in the hospital for the period 2009-2011.

The solid waste of Nuclear Medicine and Metabolic Radiotherapy are encoded with the EWC 18.01.03* (infection medical waste at risk). Figs. (8 and 9) report the quantity of solid waste (put in cartoons and plastic containers) coming from the two departments in the years 2009-2011.

Fig. (8) Solid wastes from the Department of Nuclear Medicine in the period 2009-2011.

Fig. (9) Solid wastes from the Department of Metabolic Radiotherapy (2009-2011).

Fig. (10) Liquid waste collected in the tanks of decay in the period 2009-2011.

A slight increase can be noted in the case of Nuclear Medicine, a mild reduction can be noted in the Metabolic Radiotherapy.

The medical waste in the liquid form (liquid excreta) produced by outpatients and inpatients in the department of Metabolic Radiotherapy, are handled and controlled in 5 tanks for radioactivity decay (Fig. 10). A minor part of liquid waste is discharged in sewerage, as well as carried out in regional and national residences of patients (yearly about 57% of patients are coming from the Region of Friuli Venezia Giulia compared to other Italian regions and foreign countries).

As above, starting from this collection of data with other relevant information the IEA basic application led to the operations of SUMMARY and PARAMETRIZATION, allowing the development of the analysis of regulatory compliance, relevance and efficiency (also in this case only main results of the analysis are here reported for brevity).

From the data and information gathered on regulatory compliance, it was found that the Operating Unit of Nuclear Medicine and Metabolic Radiotherapy applied all the relevant and comprehensive laws and regulations relating to the environment, therefore, for regulatory compliance is assigned the value 1.

For the value representing the relevance (Lr), the total quantity of waste produced yearly, as well as the hazardous waste and pollutants present, have been considered and compared each other. In this situation the importance of the factor “radioactive waste”, describing the potential risk of causing an adverse effect on other environmental components was highlighted, thinking about the specific vulnerability and sensitivity of the area..

Following the method mentioned above, a value of Lr = 2.6 was obtained from the mean of the four values assigned to the items specified.

The evaluation of the efficiency (Le) was accomplished, taking in particular attention to the formalization of tasks, roles and responsibilities in relation to the technical and administrative management of waste, maintenance plans and the budgetary cost of waste management companies. The value Le = 2.5 of efficiency of this Health Structure was assigned in this analysis.

Assessing relationships between the site and the surrounding area, an estimation of the “sensitivity” and “vulnerability” of the case study was reached, intended for the specific impacts of the Operating Unit of Nuclear Medicine and Metabolic Radiotherapy. The factors of environmental sensitivity near the area were also check examining the biota (flora and fauna), protected areas (parks and reserves) and the presence of regions that use the water for irrigation of crops or livestock. None protests or signs of impatience about the problem of waste by the population or legal authorities were confirmed, so a sensitivity factor value of Ls= 2 was assigned Table 2.

Table 2
Summary of priority table for Nuclear Medicine and Radiation Metabolic Therapy.

According to the formula: Lp = Lr*Le*Ls the result of the analysis leads to a value of 13 indicating a MEDIUM priority actions to be carried out on the short time.

Indeed, the final summary sheet was revealing potential environmental improvements and useful to start a discussion with the staff responsible for the various activities, in order to verify the purpose to develop and decide a good environmental policy with an operational plan of action to be succeded.

From these reflections, some possible topics for general improvement came out:

to prepare a registry for provisions and requirements of Single Unit Operation/Activity with specific procedures; to improve working practices within the functional areas of collection, identifying waste by types and quantities with specific guidelines for the correct management; to stimulate and encourage the collection of homogeneous flows of waste; to reduce the quantity of liquid waste (excreted) with the installation of mixers and dosing devices for water of toilets; to built new greater storage tanks to prevent any problems of malfunctioning and for more effective decay checking of the radioactive compounds.