131
1 NATIONAL COMMISSION FOR STRATEGY AND PROGNOSIS Annex Substantiation study “DR. CALISTRAT GROZOVICI” MULTIFUNCTIONAL CLINIC BUILDING A and BUILDING B 2018

Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

  • Upload
    others

  • View
    4

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

1

NATIONAL COMMISSION FOR STRATEGY AND PROGNOSIS

Annex

Substantiation study “DR. CALISTRAT GROZOVICI”

MULTIFUNCTIONAL CLINIC BUILDING A and BUILDING B

2018

Page 2: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

2

CONTENTS

1. General information on the investment objective 1.1. Designation of the investment objective

1.2.General description of the project

1.3. Opportunity to execute the project

1.4. Proposals in terms of public partners

1.5. Investment beneficiary

1.6. Project execution estimated duration

2. Current status and the need to execute the project

2.1. Presentation of the current context 2.2. Analysis of the current status and identification of deficiencies 2.3. Analysis of the demand for goods and services, including long-

term forecasts

3. Patient flow description 4. Main technical, financial and contractual features of the project

4.1. Technical description of the project 4.2. Current general conditions

4.3. Description of medical flows and the provision of equipment

4.4. Current technical conditions (placing the objective under the general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment objective is mandatory/implied, etc.)

Page 3: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

3

5. Studies and analyses on the project execution manner 5.1. Differences between PPP and a traditional public procurement 5.2. Main contractual stages 5.3. Presentation of project costs and incomes, the payment

mechanism, the private partner’s incomes 5.3.A. Building A 5.4. Benefits provided by the execution of the project 5.4.1.A. Building A environmental benefits 5.4.2.A. Building A economic benefits 5.4.3.A. Building A social benefits 5.5.A. Building A sensitivity analysis 5.3.B. Building B 5.4.1.B. Building B environmental benefits 5.4.2.B. Building B economic benefits 5.4.3.B. Building B social benefits 5.5.B. Building B sensitivity analysis 5.6. Risk analysis 5.7. Penalty system 5.8. PPP contract cessation and payable compensations

6. Conclusions

Page 4: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

4

Substantiation study “DR. CALISTRAT GROZOVICI” MULTIFUNCTIONAL CLINIC -

BUILDING A ANDBUILDING B 1. General information on the investment objective

1.1. Designation of the investment objective: “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B

1.2. General description of the project The project falls within the healthcare system development strategies

and policy implemented by the Ministry of Health in Romania, in line with the medical service requirements of the population concerned, in accordance to the Government strategy and policy intended to provide and secure public health.

The objective is part of the 2014-2020 National Healthcare Strategy and 2014-2020 Action Plan for implementing the National Strategy, which intend to improve the quality of medical services, by rehabilitating the infrastructure of healthcare services and providing and monitoring the quality of public and private healthcare services, to promote healthcare research and innovation, intersectoral collaboration for better public health, particularly within vulnerable groups, to streamline the healthcare system, by accelerating the use of information technology and modern communications, to develop the infrastructure at a national, regional and local level.

National Strategyfrom November 18, 2014

Strategic areas for the healthcare sector: Strategic area 1: Public health. Strategic area 2: Healthcare services:

• a system of basic community support services dedicated to groups;

• increasingthe effectiveness and a diversification of primary healthcare services;

• strengthening thequality and effectiveness of the services provided within the specialised outpatient units;

Page 5: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

5

• increasing public safety by consolidating the integrated emergency response system and providing access to adequate emergencyhealthcare services in a fair manner;

• regionalisation/concentration of hospital-based healthcare andcreation of reference regional networks, with hospitals and laboratories with various degrees of expertise, interconnected with the primary and specialised outpatient healthcare sector;

• increasing access to recovery, palliative and long-term care services. Strategic area 3 - Cross-cutting measures:

• strengthening the administrative capacity at a national, regional and local level and communicating change;

• implementing a sustainable policy intended to secure human resources in the healthcare sector;

• implementing a sustainable policy intended to securefinancial resources in the healthcare sector, ensure cost control and financial protection for the population;

• ensuring and monitoring the quality of public and private healthcare services;

• developing and implementing a medicine policy intended to ensure the population’s fair and sustainable access to evidence-based medication;

• promoting research and innovation in the healthcare sector; • intersectoral collaboration intended to improve the public state

of health, particularly that of vulnerable groups; • enhancingthe healthcare system effectiveness byspeeding up

the use of information technology and modern communications (E-health);

• developing an adequate infrastructure at a national, regional and local level in order to decrease unequal opportunities in accessing healthcare services;

• creating a “modern – technological – effective” picture of a “Profesor Dr. Matei Balş” National Institute of Infectious Diseases;

• creating an independent building, easily identifiable from Dr. Grozovici street access route;

• integrating the new building in the context of the current location, without disturbing any existing medical activities;

• amajor item within the conception of the new hospital is architectural compliance, intended to ensure the observance of adequate hospital rules on nosocomial infections:

o theprovision of numerous handwashing stations,

Page 6: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

6

o the choice of materials and the smooth surfaces of walls, floors and ceilings shall allow the easy cleaning and decontamination of all hospital parts,

o the provision of easy access for the inspection and maintenance of the technical equipment (for example: waste chutes), allowing periodic cleaning and disinfection;

• observing the population’s right to healthcare services; • guaranteeing the quality and safety of medical care; • ensuring accessibility to healthcare services; • recognition of professional expertise and encouragement

ofspecialisations; • creation of new jobs, made possible by implementing the

project; • theexecution of this bundle of works shall directly influence and

improve the entire medical activity across the entire hospital.

1.3. Opportunity to execute the project Historical context

1880 – “Colentina Hospital” is established 1880 – the year when the first contagious disease isolating

barrackswere built within “Colentina Hospital”, a member of the Vestry of Civil Hospitals, an establishment founded as early as 1864. 14 years later, the few initial barracks became two pavilions.

In the beginning, thesehad a 40-bed capacity. In 1921 the 3rd pavilion is added, hosting 25 additional beds, which is how the newest hospital for contagious diseases in the country was created. Consulting physician Calistrat Grozovici (1862-1919) is the first personality to have managed the “Colentina contagious disease department”from 1900 to 1919. In 1938 the contagious diseases discipline designation is coined and the dedicated clinic is set up.

The hub of “Colentina Hospital School of Infectious Diseases” is created, primarily focused on creatively combining clinical and laboratory diagnostics.

“Colentina Hospital School of Infectious Diseases”, initiated by professor Mironescu and his disciples, cemented itself in 1941, when the management of the “Adult contagious patient ward” was taken over by professor doctor Matei Balş. The main concern of professor Balş was the struggle to master the etiological diagnosis and therapy of infections. He is the founder of the Romanian modern school of clinical bacteriology, a laureate of the 1st class State Awardfor the discovery of nitrofurane and its

Page 7: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

7

use against typhoid fever. A significant year in the history of “Colentina Hospital” is 1950, when education and healthcare reforms had direct consequences upon the academic and medical environments. Three distinct university clinics were set up within “Colentina contagious disease department”, with their own count of beds and in-house teaching staff. Moreover, the separation from “Colentina Hospital” took place at the same time, as the ward became standalone and received the designation of “Colentina Clinical Hospital for Infectious Diseases”. The new hospital unit hosted a few hundred beds, numerous laboratories and three clinics.

An important moment in the history of this hospital unit was in 1999, when “Profesor Dr. Matei Balş” National Institute of Infectious Diseases was established. This step secured the continuity of the prestigious “Colentina Hospital School of Infectious Diseases”. The scientific research in the field of infections has been, since those early days, one of the major paths of the Institute. It encompasses the development and streamlining the immunology, cellular biology, molecular genetics, epidemiology, hepatology, HIV/AIDS-related virologic, immunologic and psychosomatic diagnostic areas.

Current context

• The existence of a significant amount of young medical staff, capable to undergo continuous training, in line with the healthcare reform demands.

• The possibility of attracting national and European funding to support national programmes and develop new services.

• The technical platform of the CRCBMBI project. • Possibilities of interdisciplinary collaboration with other

hospitals. • Scientific collaboration with other Universities, via the Infectious

Diseases Discipline of “Carol Davila” University of medicine and Pharmacy, the European HIV/AIDS and Infectious Diseases Academy and the scientific research hub within the Academy of Medical Sciences.

• Improvement of the legislation on the offer of integrated services for associations and companies.

• Partial outsourcing and activity expansion (home care services, in conjunction with specialised associations or foundations).

• Diversification of medical services across three types of packages (basic, national programmes and complementary private insurance).

Page 8: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

8

Technical context The issue identified as a priority is the need to develop hospital

infrastructure so as to improve the clinical and financial performance of the activities carried out by the institute, which would lead to higher patient safety and degree of satisfaction.

In that respect, the institute has to enhance its capacity of providing a response to the patients’ needs in terms of the high incidence of cases handled, its treatment and research components, in accordance to the strategy to develop the institute over the forthcoming period.

This infrastructure has to be developed since the medium- and long-term requisites are for a new multifunctional medical concept, adapted to the present-day healthcare requirements.

Under these conditions, the new architectural concept shall providea fluid and functional internal flow of both patients and medical, healthcare and auxiliary staff.

This way, the diagnostic and treatment centres shall allow the separation of procedure flows according to the types of conditions, by means of a logical sequence of medical acts/healthcare, both for healing and clinical research purposes.

Issue prioritisation matrix/multi-criterion matrix

Area Criteria Development of new services in the hospital

High incidence of cases

Access Importance for patients

Importance for the hospital

Costs Total

Intensive care 2x0,25 2x0,25 3x0,5 2x0,5 2x0,75 5

Research unit 4x0,25 3x0,25 3x0,5 3x0,5 4x0,75 7,75

Upgrade to hotel accommodation facilities

3x0,25 4x0,25 4x0,5 4x0,5 4x0,75 8,75

Surgery, infectious pathology services

1x0,25 1x0,25 2x0,5 1x0,5 4x0,75 5

4 – maximum priority; 3 – medium priority; 2 – low priority; 1 – non-priority.

I Hotel

accommodation upgrade

II

Research unit

III

Intensive care

IV Surgical services

against infectious diseases

Page 9: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

9

1.4. Proposals in terms of public partners The Ministry of Health by means of “Profesor Dr. Matei Balş” National Institute of Infectious Diseases

1.5. Investment beneficiary The project company–over the course of the contract performance. Upon the completion of the contract,the beneficiary of the newly

created objective shall be the public partner.

1.6. Project execution estimated duration The project execution (design, construction and operation) is

estimated to last 17.5 years, 30 months of which will be required for the actual execution (design and construction).

2.Current status and the need to execute the project

2.1. Presentation of the current context

The land reserved for the future “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, which is the subject of this substantiation study, stretches along 1 Dr. Grozovici street, District 2, Bucharest and has three access routes for pedestrians and vehicles.

The following premises are currently present on that land: - Pavilion 6 building - groundfloor building with a sloping roof, - the chapel-ground floor building with a sloping roof - integratedinto

Pavilion 6 building, - parking area for 25 vehicles, - two ground-floor buildings- forthe guards who provide surveillance

on the two access routes from Dr.Grozovici street. All these buildings are currently in an advanced state of degradation

andpose potential dangers in case of earthquake or fire, taking into account the significant age of the electrical installations in service.

Pavilion 6 building is non-functional and not fit for hospital-related functions.

From an architectural standpoint, pavilion 6 and the two security buildings have no aesthetic appeal.

In conclusion,the demolition of these structures is required as the only solution for the creation of two new buildings: Building A and Building B, interconnected and connected to the existing Pavilion 3.

Page 10: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

10

Urban integration

The newly proposed buildings shall be functionally and logistically independent from the existing buildings.

The newly proposed buildings are separated from the existing hospital, standing at least 8 m away, to allow adequate natural lighting for all the interior spaces and protectionagainst fires.

At the 1st floor there a connection between the existing pavilion no. 3 and the new buildings of“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B.

Volumetry of“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B

“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building Bshall be technological – modern – effective, adapted to the land layout, without disturbing the buildings in its immediate proximity. The frontages shall be smooth so as to avoid dust deposits.

With the future in sight, the image falls within the landscape and the built framework in its close vicinity.

All the works to be carried out within the hospital land, in consecutive stages, shall take place so as to allow the permanent operation of any possible hospital-related buildings, during the entire existence of the construction site, without diminishing their functional capacity. Moreover,at least one of the current access route shall be kept unrestricted for a better operation of the hospital unit.

Prior to commencing any type of works, that might have an impact upon the existing and future buildings of the hospital, a “preparatory stage”shall be undergone in order to secure the following:

A. Soil remodelling across greenfield areas: - enclosureof the land plot reserved for the construction of the new “Dr.

Calistrat Grozovici” Multifunctional Clinic - Building A and Building B,

- verification of the cadastral survey plan and consultations with ADP (Public Domain Administration).

B. Reorganisation and preparation of future connections for the final stage:

- power lines, - usedwater and rainfall removal, - heating installations, - hot household water supply installations, - water connections of adequate capacities,

Page 11: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

11

- methane gas, etc. branch pipes, - futurelocation of medicinal fluids, - preparation of any existing networks (according to the plans) in order to have them decommissioned/protected. Over the duration of the “preparatory stage”, all the required current

installations shall be maintained in working order. All the works, regardless of their type, shall be carried outas per the

permits issued and the rules in effect in Romania.

2.2. Analysis of the current status and identification of deficiencies "Prof. Dr. Matei Balș" National Institute for Infectious Diseases in

Bucharestis,according to art. 1 in GD no. 1106/2002, a healthcare unit of national interest. The institutes houses several functional departments, with a total number of 680 beds for the permanent adult and children wards, 20 beds in 2 day care wards (adults and children), 50 beds for companions, clinical and paraclinical investigation laboratories, 2 intensive care wards, an administrative pavilion, a research and education centre,as well as spaces dedicated to related medical activities and technical areas.

The activity of the institutetakes place under hospital conditions, 24/7, within a complex of buildings spread out as pavilions.

"Prof. Dr. Matei Balș" National Institute for Infectious Diseases, the largest infectious pathology treatment and prevention centre in Romania, of a strategic national interest, has an old, pavilion-style layout. In recent years, some of the existing buildings have been renovated and new ones have been added, erected and designed with the latest technological input from the medical field.

From the current conditions the following deficiencies, which make the investment necessary, have been identified:

- the existence of pavilions with an obsolete structure; - a high number of consultations in the emergency department,

requiring a significant supplementation of medical activities; - increased hospitalisation periods caused by changes in the

admitted patients’ pathology (endocardites, enterocoliteswith Cl. dificile, osteodiscites, etc.), the costs of which are not among thereceived DRG figures ("high outliers");

- a relatively low number of beds which cannot always meet the medical care and isolation requirements for severe cases;

- high bed usage rate -occurrence risk in the case of nosocomial infections and the impossibility of admitting new cases which require hospitalisation;

Page 12: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

12

- funding strictly through the DRG system, which may lead to a significant financial deficit;

- a lack of interconnections among pavilions via easy and quick access routes,to maximise access and shorten waiting times of paraclinical and specialised laboratory investigations;

- the inadequate use of the medical staff,given the need to supplement human resources for transporting patients and biological samples;

- the lack of a pneumatic system designed to transport biological samples from the pavilions to the central laboratories.

The following threats are added to these deficiencies: - high patient turnover ratein the emergency departments (non-

hospitalised patients),for whom the possibility of having their services deducted by CASMB (Bucharest Health Insurance House)is absent – over 600/day;

- the migration of medical and paramedical staff to other units or abroad, due to the limiting wage policy;

- difficult procedures for replacing obsolete medical equipment; - a potential increase in the number of refugees, who might

disseminate microorganisms,affecting public health.

2.3. Analysis of the demand for goods and services, including long-term forecasts

The proposed objective subscribes to supporting institutional performance by ensuring the continuous and stable medical activity of the entities with regard to the pathology associated to the infectious diseases, the correlation of medical and scientific activities with other services form the scope of medicine. The new clinic creates optimum conditions for the treatment, screening, diagnosis and monitoring of treatments and developments of infectious diseases, as well as for research and studies in the field. The objectives of the investment proposed in the field of infectious diseases are among those proposed in the Strategy of "Prof. Dr. Matei Balș" National Institute for Infectious Diseases for the 2017-2020 period,which applies at a national andinternational level and is bound to be aligned to the recommendations made by European Union competent bodies on the public health management strategies.

According toLaw no. 95/2006 on the healthcare reform,the institute fulfils a role of methodological (technical and professional) forum for the

Page 13: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

13

scientific and professional elaboration of healthcare policy strategies in the field of infectious diseases in Romania, struggling to improve the medical act and increase the quality of the medical services provided to the public.

The 3rd millennium has brought along a new approach in the pathology of infectious diseases, translated into the increased establishment of infectious disease specialities in European Union countries such as Austria, France, etc.

In this context, Romania is a frontrunner, having a well-structured network of infectious diseases units, coordinated by "Prof. Dr. Matei Balș" National Institute for Infectious Diseases.

The investment objective–“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, is included in the 2014-2020 strategic development plan of "Prof. Dr. Matei Balș" National Institute for Infectious Diseases. The investment goal is to enhance the clinical and financial performance,by identifying the efficient practices, using adequate resources and providing high-quality medical care, with as few errors as possible, followed by the provision of certain competitive advantages to the hospitals within the national state system coordinated by the Ministry of Heath, as part of the competition on the healthcare service market. All of these will be achieved by implementing standards of excellence in the provision of medical care,underpinned by innovative clinical research aspects. A second goal of this project is to consolidate the national reputation of INBIMB ("Prof. Dr. Matei Balș" National Institute for Infectious Diseases), which has over time become a reference centre created to address the Romanian population’s medical issues in terms of infectious pathology, increasing the power of negotiating competitive prices among the healthcare system providers and the capacity to attract young medical talents who will be motivated to acquire high-level specialised training in our country. To determine de need for and the opportunity of carry out the investment, the beneficiaryhas drawn up a study which analyses the current state and comprises the minimum measures that the investor has to take in to account for the proper operation of INBIMB, pursuant to the current national and European regulations. The study demonstrates the advantages of a monoblock-type construction, as opposed to the pavilion-type system,in order to enhance the clinical and financial performance, and proposes the replacement of the old pavilions from buildings C2, C4, C8 and C14 with“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, the investment objective,for which the present Substantiation study is drawn-up. The Institute is accredited by ANMCS (National Authority for Quality Management in Hospitals), ISO and RENAR (Romanian Accreditation

Page 14: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

14

Association) (SREN ISO 9001:2001, 9004:2001, 9001:2008, 9001:2015), affiliated to international institutes for the supervision of infectious diseases – ECDC (European Centre for Disease Control) and Euro AIDS, and takes part in the international plan of measures onthe emergence and re-emergence of infectious and contagious diseases (SARS, flue, haemorrhagic fevers, bioterrorism, etc.). ("Prof. Dr. Matei Balș" National Institute for Infectious Diseasesensures patients’ access to the latest type ofemergency medical care in the field ofinfectious diseases and related intensive care, both for adults and children. The Institute has state-of-the-art, high-performance equipment that is minimally invasive for patients and provides early and highly accurate etiologic diagnosis. All of these characteristics are extremely important, particularly to critical patients, whose chances of survival depend on each minute.

INBIMB is a single-profile, 1M class, multi-pavilion healthcare unit which fulfils 4 major functions:

• specialised medical care; • scientific research; • graduate and postgraduate studies • methodological forum in the field ofinfectious diseasesat a national

level. Meeting the quality requirements and, in operational terms, reaching

the INBIMB management performance benchmarks shall secure for the institute the status of:

• active and efficient regional and nationalconstructor of an European medical academic sphere in the field of infectious pathology, acknowledged for its medical act quality;

• the national centre for the supervision of infectious diseasesand HIV/AIDS;

• higher medical education unit of graduate, postgraduate and academic recognition;

• national methodological forum in the specialised area of infectious diseases and HIV/AIDS;

• a scientific research centre capable of issuing pertinent opinions at a national and international scale.

As part of the 2014-2020 INBIMB strategic development plan, the Project “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B is a priority. The plan consists in erecting a building fitted so as to meet the current requirements in terms of professional and financial performance within the healthcare system, while focusing on patient safety. To implement this concept, it takes a generalised integration within the already existing structures, the most important considerations on optimising accommodation and technological investment,all of which should secure

Page 15: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

15

the lowest possible operational costs correlated with significantly improved clinical and therapeutical performance. 3. Patient flow description

The patient flow and traffic should take place as follows: • theaccess of patients on stretchers - patients on stretchers

coming from outside shall reach the ambulance and emergency reception area and be transferred, after registration, to the adequate functional sections;

• the traffic of patients on stretchers – inside the clinic, patients on stretchers shall be transported on several routes, depending in the medical care requirements;

• mixed traffic–patients on stretchers, under a normal state of supervision, are transported to the accommodation rooms or, depending on the needs, to other clinical areas;

• patient traffic in outpatient units - patientswill be able to access the outpatient units through the main lobby, to the consultation rooms or the accommodation rooms;

• medical staff traffic - the medical staff may usually enter any room, except for a number of restrictions imposed by hygiene measures that have to be observed; traffic areas with restrictions for the medical staff are fitted with additional lockers (for example: operating room unit, AIC, sterilization, systems with antechamber);

• traffic of medical materials and carts used to carry the patients’ meals –this is a mixed traffic linking the logistics area (pharmacy, warehouses, workshops,etc.) to the functional sections and the hospital accommodation rooms;

• visitor traffic - thistraffic shall be physically separated from the traffic of patients on stretchers and the logistics traffic;

• trafficin the logistics area–the traffic pertaining to the logistics area shall be separated as follows:

o cleantraffic – deliveries of sterile materials, pharmacy, food, clean bed sheets, etc.,

o dirtytraffic – waste disposal, dirty laundry traffic, access to workshops and technical areas;

• elevators– elevators shall be fitted to service all the floors according to the hospital needs and depending on the traffic study carried out by each tenderer, and located as follows:

o elevatorsfor the public and the medical staff – 8 elevators carrying 600 kg,

Page 16: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

16

o elevators for patients on stretchers – 6 elevators carrying 2000 kg,

o elevators for the staff, transporting materials and meal carts,pharmaceutical items, clean bed sheets, etc. – 4 elevators carrying 2600 kg,

o elevator for the maintenance staff, transporting the materials used, dirty beds, dirty bed sheets, litter/waste, etc. – 2 elevators carrying 2600 kg.

4. Main technical, financial and contractual features of the project“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B

4.1. Technical description of the project Particular details of the location

“Profesor Dr. Matei Balş” National Institute of Infectious Diseasesis located in an area bordering the central ring of Bucharest municipality, in district 2, in the vicinity of Ștefan cel Mare Rd., being part of a mixed public service area.

Vicinities: - to the south: Colentina Clinical Hospital, with which it shares the land it owns as per the deed of donation issued by regnant Grigore Ghica in April 1858, - to the west, north-west and partially to the north: Circului Park, - partially to the north: land plots with private dwellings, - to the east: Dr. Calistrat Grozovici str.

The land taken by "Prof. Dr. Matei Balș" INBI (National Institute of Infectious Diseases), belonging to the Romanian state, has a total area of 31810sq m (as per the measurements), whereas the current built area is 8360 sq m. The land reserved for the future construction, which is the subject of the present project, takes (within the general land plot held by “Prof. Dr. Matei Balș” INBI, an area of around 7000 sq m, representing the area to be affected by underground and overground works. The separation of the land area affected by the works, within the global location, takes the following into account:

- the lateral boundaries of the property, - the minimum distances to the neighbouring buildings present within the location perimeter, - the digging and bracing works at the ground level, - maintaining easy access to the existing pavilions during the entire execution,

Page 17: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

17

- the exterior fit-outs foreseen to be required upon the completion of works, - pollution sources present in the area.

Considering the location,the pollution sources are the usual ones, present all over the city,to which one may add hospital-specific waste. In terms of environmental protection, all the necessary measures, described in the subsequent chapters, shall be taken.

4.2. Current general conditions Land area St =31,810 sq m. Existing built area =8,908 sq m. Current gross area= 31,644 sq m. Existing LOP (land occupation percentage)= 28% Existing LUC (land use coefficient) = 1 Existing height classification = B (basement)+ GF (ground floor)+4F (floors)+5RF (receding floors).

Description of functional and spatial-volumetric configuration of the existing buildings

Across the area of the land to be affected by the works and in its immediate proximity there are currently several buildings, some of which will be decommissioned as they no longer comply with current requirements.

The buildings no longer complying with the functional requirements shall be decommissioned (decommissioning and demolition permits have been issued) have the following characteristics:

• C2 - pavilion no. 6 (decommissioning and demolition permit no. 207/6G from 27.04.2011), with height classification: ground floor, a built area of 1271 sq m,a gross area of 1,271 sq m;

• C4 - pavilion no. 2 (decommissioning and demolition permit no. 569/27G from 02.11.2017, jointly issued for pavilions C4, C8 and C14),with height classification: ground floor, built area and gross area of 368 sq m;

• C8 - pavilion no. 1with height classification: ground floor, built area and gross area of368 sq m;

• C14 –molecular genetics pavilion, with height classification B+GF, a built area of 163 sq m and a gross area of 281 sq m;

• the other buildings shall be maintained in their current form.

Page 18: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

18

Below is the current status of the buildings within the perimeter:

Construction code

Building footprint area

(sq m) Remarks

C1 37 Control station - Ground floor;GBA (gross building area)=37mp

C2 1271

Pavilion no.6 - ground floor;GBA=1271mp Decommissioning and demolition permit no. 207/6G from 27.04.2011

C3 433 Administrative pavilion - GF+2F; GBA=1299mp

C4 368

Pavilion no.2 - Ground floor;GBA=368sq m;Decommissioning and demolition permit no. 569/27G from 02.11.2017

C5 386 Pavilion no.3 - GF+2F+G(garret); GBA=1544mp

C6 749 Food storage and cooking premises _B+GF+1F;GBA=2247mp

C8 368

Pavilion no.1 - Ground floor;GBA=368sq m;Decommissioning and demolition permit no. 569/27G from 02.11.2017

C9 82 Transformer station - Ground floor;GBA=82mp

C10 1946

Pavilion no.4; GBA=9775sq m.It comprises sections: A1 - B+GF+2F, A2 - B+GF+3F+G, A3 -B+GF+3F+G (extended over C31 -vegetablestorage cellar, which was automatically decommissioned), B1 - B+GF+3F+G, B2 - B+GF+3F+G

C11 770 Pavilion no.5 - B+GF+3F+G; GBA=4615mp C12 12 Water tank–underground construction; GBA=12mp C13 82 Greenhouse - Ground floor;GBA=82mp

C14 163

Molecular genetics pavilion -B+GF; GBA=326sq m.Decommissioning and demolition permit no. 569/27G from 02.11.2017

C15 357 Laundry - GF+1F;GBA=714mp C16 39 Small greenhouse - ground floor;GBA=39mp

C17 12 Incinerator flue with medical waste incinerating facility- decommissioned; GBA=12mp

C18 581 Education and accommodation areas (the former archive) – SB(semi-basement)+GF+3F; GBA=2950mp

C19 34 Oxygen bottle warehouse - Ground floor;GBA=34mp C21 126 Workshop -Ground floor;GBA=126mp C22 154 Workshop -Ground floor;GBA=154mp C23 71 Workshop -Ground floor;GBA=71mp C24 121 Workshop -Ground floor;GBA=121mp C26 7 Shed -Ground floor;GBA=7mp C27 63 Shed -Ground floor;GBA=63mp

Page 19: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

19

C28 10 Shed -Ground floor;GBA=10mp C29 22 Shed -Ground floor;GBA=22mp C30 12 Shed -Ground floor;GBA=12mp C32 43 Package warehouse - Ground floor; Sc.=43mp C33 41 Provisional outbuilding - Ground floor;GBA=41mp

Total Built area=8908

sq m Gross area=31644 sq m

Climatic data and relief particularities

The climate is mild continental, with hot summers and often harsh winters, the air temperature range being generally different for the actual city area in comparison with the areas outside of it.

In Floreasca, Tei and Pantelimon areas, the average annual temperature has been 10.5°, sometimes with strong winds, with low pollution levels in comparison to the city centre, with frequent fog occurrences and a rainfall volume below 500–600mm a year.

Due to the climatic characteristics, district 2 suffers from a humidity deficit as opposed to the optimum average value, which creates a state of physical discomfort.

This humidity deficit has been partly compensated by the creation of the ring of lakes within the urban area, which favour water evaporation and humidify the air in the neighbouring areas

In relation to the urban networks crossing the perimeter,which might require relocation/protection, to the extent to which they can be identified, they shall be accurately mapped and subsequently arranged along a common course, to be as simple and as protected as possible.

Geophysical characteristics of the land within the premises -

extractfrom the provisional geotechnical study In terms of the importance category defined in the classifications of

ch. 3 in normative P11-1/2013, the constructions fall under category II.The constructions were designed and executed in 1930.

The peakground acceleration value in case of earthquakes withIMR (average standard recurrence interval)=100years=0.24and a corner seismic zone (corner period) of the response spectrum Tc=1.6sec.

In accordance to STAS (Romanian standard)no.11100/77,Bucharest is subject to the MSK-81 macroseismic degree scale, according to the Richter scale, whereasSTAS no.6054/77 indicates for Bucharest a freezing depth of 80-90 cm.

Preliminary data on the nature of the foundation ground and the

conventional pressure

Page 20: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

20

• accordingto the geotechnical study

Maximum level of phreatic waters • undergroundwaters are closely related to the

morphological characteristics and the geological composition of the soil;

• the depth where the water-bearing bed is found will generally vary depending on the features of the relief and the aquiferous deposits;

• the water-bearing bed in the area is found at depths between 20 and 30 meters.

“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, on the premises of“Prof. Dr. Matei Balș” INBI,shall cover a land area of approximately 8800sq m,on the eastern side of the INBIMB premises, and shall have the following layout: Building A:

- to the east: along the property border towards C. Grozovici str., - to the north:withdrawn by 8.30 m in relation to the property border, - to the south:withdrawn to 15m from the property border, - to the west:attached to pavilion 3.

Building B: -to the east:a withdrawal of 27,30m from the border near the street, - to the north:partially attached toBuilding Aandthe existing Building C6, to at least 14.70 mfrom Building C5, - to the south:partially attached to Building C3, from which it will be separated by a yard at least 3 m wide,

- to the west:withdrawal of at least 8m fromBuilding C10.

Page 21: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

21

Rules and normatives in effect defining the field

- Law 95/2006 on the healthcare reform,republished, as subsequently amended and supplemented, Title VII, Hospitals,

- Decision no.1028 fromNovember 18, 2014,on the approval of the 2014-2020 National Healthcare Strategy and the2014-2020, Action Plan for implementing the National Strategy;

- GD no. 144/2010 on the organisation and operation of theMinistry of Health, as subsequently amended and supplemented;

- Decision no. 907 fromNovember 29, 2016 on the collaboration stages and the framework contentof the technical and economic documentations pertaining to the investment objectives/projects financed from public funds;

- Law no. 500/2002 on public finances, as subsequently amended; - Order no. 1232 fromOctober 9, 2006 on the approval of the Rules on

suspending the activities of hospitals which fail to meet the requirements stipulated in the sanitary permit to operate;

- Orderno. 914/2006 for the approval of the rules on the requirements a hospital must meet in order to obtain the sanitary permit to operate;

- Order no. 1101/2016 fromSeptember 30, 2016 on the approval of the Rules for the supervision, prevention and containment of infections related to medical care in healthcare units;

- Normative NP-015-1997 on the design and verification of hospital-related buildings and installations;

- Normative NP-021-1997 on the design of health centres and polyclinics based on performance requirements;

- Normative onthe fire protection of constructions - P118/1999, P118-2/2013, P118-2/2015;

- Normative NP 127-2009 on the fire safety of underground parking lots for motor vehicles;

- Normative NP 051-2012 on adapting civil buildings and urban areas to the individual needs of persons with disabilities; I7-2011 – Normative on the design, execution and use of electrical installations specific to buildings; NTE 007/08 – Normative on the design and execution of electrical cable networks; Normative on the calculation methodology for short circuit currents inpower grids with a voltage under 1 kV - NTE 006/06/00; NP-061-02 - Normativeon the design and execution of artificial lighting systems inside buildings;

Page 22: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

22

Fire prevention and firefighting rules applied in the design and execution ofconstructions, installations and other fit-outs; Law 10/1995 on quality in constructions,republished, as subsequently amended and supplemented; C 56-2000 –Normative on inspecting the quality of construction works and installations; NP I18/1/2001 - Normativeon the design and execution of telecommunications and signalling installations in civil and production buildings; NP I18/2/2002 - Normativeon the design and execution of fire signalling installations and alarm systems for breaking and entering fitted to buildings; Law no. 333/2003 on the security of objectives, commodities, valuables and personal protection, republished, as subsequently amended and supplemented; GD 301/2012 - Methodologicalrules for implementing Law no. 333/2003 on the security of objectives, commodities, valuables and personal protection. SR EN 54. Fire detection and alarm systems; Law no.307/2006 on the protection against fires; General fire prevention and firefighting rules approved as per MIA (Ministry of Internal Affairs) orderno. 163/28.02.2007; EIA/TIA-568-A (Commercial Building Telecommunications Cabling Standard) and TSB 36 and TSB 40A specifications; EIA/TIA-569 (Commercial Building for Telecommunications Pathways and Spaces); EIA/TIA-606 (Administration Standard for Telecommunications Infrastructures of Commercial Buildings); Law 319/2006 – Law on occupational health and safety and methodological rules for implementation, as subsequently amended; Own internal instructions occupational health and safety for the transportation and distribution of electricity IPI – 2007 and others.

Presentation of the investment entitled“Dr. Calistrat Grozovici”

Multifunctional Clinic - Building A and Building Band the main characteristics of the building (annex):

Building A: Built area 2444 sq m, Gross building area = 27520sq m, Height classification = 2B+GF+2F+3-7RF, Importance category– B(acc. to Romanian Government Decision no. 766-1997),

Page 23: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

23

Importance class– I(acc. to Normative P100-1/2013), Fire resistance degree– I(acc. to P118-1999, P118-2/2013, P118-3/2015), Fire behaviour code - 2 (acc. to Normative P118-1999, P118-2/2013, P118-3/2015), No.of parking spots– 278, No.of beds– 256, No. of rooms within the operating room unit– 5.

Building B Built area 3533 sq m, Gross area = 23685,6sq m, Maximheight classification = 2B+GF+5E+6-8RF, Importance category - B (acc. to Romanian Government Decision no.766-1997), Importance class - I (acc. to Normative P100-1/2013), Fire resistance degree - I (acc. to P118-1999, P118-2/2013, P118-3/2015), Fire behaviour code - 2 (acc. to Normative P118-1999, P118-2/2013, P118-3/2015), No.of parking spots– 190, No. of beds– 380.

“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and

Building Bis a public construction comprising 2 individual buildings, A and B, having the function of medical and research clinic. The construction shall have a maximum height classification of 2B+GF+8F. The proposed load bearing structure includes diaphragms interworking with reinforced concrete frames. The proposal for basements includes a premises on bored piles. The reinforced concrete foundation plate shall be built on top of the bored piles premises.

The structure of the basements shall have a greater stiffness in comparison with thesuperstructure.The reinforcements employed have C ductility class.

Description of activities and functions Building A: - general reception lobby, - emergency-temporaryaccommodation with 6 beds for admissions/discharges, - consulting room/ physician’s offices / 5 rooms for on-call physicians,

Page 24: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

24

- imaging procedures, - radiotherapy centre, - sterilization, - morgue, - chapel - pharmacy, - 6 accommodation units with 30 beds each, - 1 accommodation unit with 26 beds, - 1 outpatient unit with 18 beds, - 2 AIC units with 16 beds each, - operating room units with 5 rooms and 2 AIC beds for cardio/neurologic procedures, - various logistics/technical spaces, - amphitheatre with 250 seats, classrooms for students, meeting rooms, - heliport -the platform shall be built on the highest terrace of the new hospital, allowing the landing of medical helicopters for emergency cases. Building B - reception lobby, traffic paths for the medical staff, separate traffic

paths for visitors, - admission/discharge service, - outpatient unit, - consulting room/ physician’s offices- 23 rooms, - rooms for on-call physicians - 6rooms, - laboratories, rooms for sample drawings and analyses- 27 rooms, - registered nurses’ consulting rooms - 26 rooms, - nurses’ rooms - 15 rooms, - accommodation spaces- 125 2-bedprivate rooms and 130 single-bed

private rooms (380beds in total), - students’ reporting rooms– 15 units, - visitor areas, - medical staff’s lockers, - pharmacy, - sterilization room - 6 units, - research section with laboratories/consulting rooms / auxiliary

spaces grouped according to research groups - 24 units, - various/logistics spaces, maintenance and repair workshops - technical spaces (thermal power plant, ventilation and climate control

plants, electric generator set, general electrical board, wastewater treatment room, etc.),

-civil protection shelter (air-raid shelter),

Page 25: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

25

- parking lot for 190 motor vehiclesetc.

Current status of utilities and consumption analysis; The buildings are fitted with all required utilities. For proper operation purposes, the buildings are fitted with the

required regular installations: - the water supply and wastewater drainage shall be possible via

connections to the existing networks inside the premises; - heating shall be provided via a connection to the thermal substation

within the premises, with measures allowing adaptation to the “eco-friendly house” concept;

- electricity shall be provided via connection to the new transformer stations that are to be installed;

- the natural gas supply shall be possible via connection to the existing networks on the premises;

- the recyclable industrial waste shall be taken over by a specialised company;

- the medical waste shall be disposed of as per the service contract forthe collection, transportation and final disposal of hazardous medical waste, concluded with a specialised company;

- the collection, transportation and final disposal of hazardous chemical substances shall be carried out by a specialised company;

- the oxygen supply shall be possible via connection to the existing oxygen generator;

- the chlorination shall remain in the same location and its capacity shall increase depending on the calculated requirements,

- the microclimateshall be provided by the operation of the climate control installations, in line with the provisions ofLaw no. 84/1993 and of Order 536/1997 issuedby the Ministry of Health.

Environmental impact By observing the security requirements in effect, the new buildings

produce an insignificant impact upon the environment. Implementing the “eco-friendly house” concept ensures high energy

efficiency, low water consumption, increased interior comfort and low noxae emissions, a minimum impact upon the environment and maximised user wellness.

The performance of activities in secure conditions complies with the applicable provisions in SR ISO 15190/2005 standard.

Toxic substances and drug precursors shall be kept in secured areas, according to the legislation in force.

Page 26: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

26

Access to the working spaces is allowed to the authorised personnel and strictly during the working hours.

If the situation so requires, or the entry from outside is necessary, access shall be allowed over a determined period and only in the presence of an employee.

Patient access is only allowed within the spaces intended for them and strictly during the working hours.

The legal representative is bound to ensure the implementation of security measures,by having breaking and entering alarm systems fitted so as to correspond to the importance and specificity of the objectives and the property that requires protection.

4.3. Description of medical flows and the provision of

equipment

The technical documentation drawn up to date underpins the provision of specific equipment to the medical departments and wards, as part of the spatial and functional reorganisation of “Profesor Dr. Matei Balş” National Institute of Infectious Diseasesand the construction of“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B.

The hygiene and asepsis criteria, specific to hospital units, shall be determined in the selection of the functional and technological solutions, both for the entire hospital, as well as for each of the medical sectors and compartments.

The principles employed in designing the spaces and structuring the functional compartments,based on the hygiene and asepsis criteria, shall be the following:

• the separation and grouping of medical spaces based on the allowed contamination risk (septic, aseptic, sterile);

• differentiation ofcircuits (medical/non-medical, septic/aseptic, open/closed, etc.);

• interposition of barriers – control and hygienisation filters – at crossings between areas with different contamination levels;

• the use of special equipment and installations for treating, cleaning and disinfecting all the parts of the hospital internal environment which may act as infection spreading carriers(air, water, emissaries, persons, food items, pharmaceutical products, instruments, bed sheets, etc.)

The clustering scheme of the functional units relies on their systematisation based on user categories (patients, medical staff, paramedical staff, companions, next of kin and visitors, students, course attendee) and the types of activities (medical – consultations,

Page 27: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

27

investigations, treatments; complementary to the actual medical process – supervision of and medical care for patients, study and documentation, elaboration and registration of medical documents, sterilization) and shall be used to structure design topics.

The layout of the functional compartments within the hospital and the organisation of traffic paths shall take into account certain criteria:

- thechoice of layout for the functional compartments, - the degree of accessibility,depending on the user categories, - the system of relationships with the other compartments and sectors, - the optimum location in relation to the access to and the common

traffic paths of the building, - otherspecial restrictions.

The area-based clustering shall focus on separating the functional units presenting same-space operation incompatibilities and lead to the natural differentiation of traffic paths that have to be protected. Within certain areas, separations into subareas are necessary, depending on the hierarchies of criteria(septic/aseptic subareas, subareas for the staff/patients).

According to the hospital-related normatives, the list of the main groups and functions (sectors) and the list of the included functional units, respectively, is the following:

- A. Hospitalisation sector - A1. Medical wards with beds, comprising care units; - A2. Daytime hospitalisation unit (as the case may be); - A3. Patient admission and discharge service.

- B. Outpatient sector (for non-admitted patients)

- B1. Consulting and treatment rooms; - B2. Medical records, appointments and information compartment.

- C. Technical and medical diagnosis and treatment services

- C1. Sector forprocedures - treatmentsperformed on/provided to the hospitalised patients:

C1a) Operating room unit, C1b) Anaesthesia and intensive care (AIC) service, C1c) Delivery unit;

- C2. Sector forfunctional investigations - explorations(common for patients who are admitted and in outpatient units):

C2a) Medical test laboratory, C2b) Radiodiagnostic laboratory,

Page 28: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

28

C2c) Functional exploration laboratory, C2d) Pathological anatomy laboratory, C2e) Nuclear medicine laboratory (as the case may be); - C3. Therapy sector (for patients who are admitted and in

outpatient units): C3a) Emergency service, C3b)Medical recovery and physiotherapy service, C3c) Renal clearance compartment, C3d) Radiotherapy compartment (as the case may be).

C3e) Psychotherapy and ergonomics compartment(as the case may be),

C3f) Other special therapy compartments, depending on the hospital medical structure; - C4. Auxiliary technical and medical services (not directly intended for patients):

C4a) Central sterilization service, C4b) Pharmacy,

C4c) Blood bank (station), tissue banks (as the case may be),

C4d) Pathological anatomy (morgue). - D. Household services - D1. Kitchen, food offices and food warehouses; - D2. Laundry and bed sheet warehouse; - D3. Decontamination station – bed sterilization station. - E. Medical executive management and administration - E1. Medical executive management; - E2. Administrative offices; - E3. Medical records and archiving service; - E4. Information and document processing compartment; - E5. Meeting room. - F. Related services for the personnel - F1. Lockers for the medical and technical personnel; - F2. Medical documentation point (library).

- G. Social and related spaces for patients, next of kin, visitors - G1. Wardrobe; - G2. Information and query service;

Page 29: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

29

- G3. Buffet and sale point (flower shop, gift shop, newspaper stand); - G4. Various services provided–barber shop, hair stylist’s, post office (as the case may be);

- G5. Chapel. - H. Technical and utility services - H1. Technical plants and stations: H1a) Thermal power plant, H1b) Water plant and hydrophore, H1c) Transformer station and electric generator set, H1d) Ventilation and air treatment plants, H1e) Refrigeration plant (as the case may be),

H1f) Stations for oxygen, compressed air, other medicinal fluids,

H1g) Telephone switchboard, H1h)Internal communication stations (closed-circuit TV, personnel search, wire broadcasting),

H1i) Effluent pumping and treatment stations, H1j) Technical stations for machinery and elevators, H1k) Technical stations for specific medical equipment,

H1l) Othertechnical stations pertaining to installations (distribution points, electrical board rooms, inspection galleries,etc.),

H1m) Complete integrated eco-friendly house system, H1n) Integrated digital hospitalisation system;

- H2. Dispatcher’s offices for supervision, control and warning on the operation of equipment and installations; - H3. Equipment maintenance and servicing service (workshops);

- H4. Warehouses for various items; - H5. Solid waste collection and treatment station; - H6. Garages; - H7. Gate control system.

Both for the hospital design and fit-out it is recommended to

simultaneously apply spatial and functional organisation criteria, leading to a general zoning model, valid in general hospitals, as well as certain speciality hospitals, as follows: -the “clean” area,in terms of hygienic and sanitary conditions: with compartments intended strictly for admitted patients, with severe requirements on hygiene and asepsis, to be preferably located far away from the hospital main traffic paths, includes:

Page 30: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

30

a) the operating room unit, the AIC service, centralised sterilization,

b) the medical wards with beds; - the “dirty” area (or with “dirty” subareas),in terms of hygienic and sanitary conditions: it is located so as to operate as a hospital interface area in relation to the locality’s technical and function-based services, to the units providing materials and products, to various urban utility networks. This area comprises compartments that are clearly separated from the asespsis requirements areas, closed to the access of patients and other staff categories,outside the unit’s own staff, usually located in the semi-basement (on the ground floor) of hospital buildings, as well as inside attached isolated structures, and includes the following: a) certain technical and medical services (pathological anatomy, pharmacy), b) household area, c) technical services; - the “neutral” area,in terms of hygienic and sanitary conditions: it is positioned so as to represent the hospital interface, of the medical component, for the contact with patients, the next of kin and visitors, and has a direct view towards the traffic paths for pedestrians and motor vehicles in the public area of the hospital premises. The compartments included in this area should be located on the ground floor or the mezzanine and comprise: a) an emergency service; b) a daytime hospitalisation ward; c) an outpatient unit; d) the patient admission and discharge service; - the “intermediate” areain terms of hygienic and sanitary conditions: the compartments grouped in this area have intermediate positions along the hierarchy of hygienic and sanitary conditions, while also adding that the laboratories area and the administrative shall not be accessed by patients or next of kin, unless this happens in contact points (the sample drawing point and the secretariat), and shall be located peripherally to the main traffic paths of these users.

The neutral area comprises the following compartmentsandservices: a) the laboratories; b) the centralised service and the functional exploration units; c) the centralised service and theRoentgen diagnosis units; d) administration and related services for the staff. - the operating room unit and AIC unit areas(including the central sterilization department);

- the hospitalisation areas(wards with beds)shall be located on the lower floors of the building, away from the common traffic

Page 31: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

31

paths,higher than the ground floor, as they are intended for hospitalised patients with dire hygiene and asepsis requirements.

Building A

The operating room unit shall be located on the 2nd floor, together with the central sterilization station and a two-bed AIC unit, intended exclusively for cardiology, whereas the AIC ward shall be located on the 3rd floor (vertically collinear with the operating room location).

The medical wards shall be located on the 1st,4th, 5thand 6th floors. • The Operating room unitcomprises all the operating rooms required

for various medical specialities (profiles). In general hospitals, the medical profiles that use the operating room unitare: general surgery, orthopedics, trauma, the burns unit, cardiology, gastroenterology, urology, obstetrics, gynaecology, ophthalmology, ENT, paediatrics, oncology and the emergency service.

Depending on the number of surgical bedsand taking into account the specific medical activities undertaken, certain wards(compartments) may benefit from their own operating rooms, besides the centralizedoperating room unit, as is the case with the obstetrics-gynaecology ward, the ophthalmology ward, the ENT ward, the burns unit, the emergency service. Sizing the operating room unit, as in determining the required number of operating rooms, is done in relation to the number of beds in the surgical wards and compartments relying on it: a) one operating room for30-35 surgical beds; b) one operating room for 25 beds intended for surgical specialities (transplant, burn injuries).

Depending on the size and medical structure of the hospital, thecentralized operating room unitmay comprise 2-10 operating rooms.

The spatial and functional layout of operating room units differs depending on their size. Small operating room unitswill comprise 2-4

Page 32: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

32

operating rooms, whereas largeoperating room unitswill host more than 6 operating rooms.

The layout of the spaces and the traffic paths inside the operating room unitshall be zone-based and shall comply with the asepsis requirements, with a gradual passage from the “neutral” spaces (regular hygienic and sanitary conditions for the healthcare environment),through the “clean” ones (with special hygienic requirements), to the aseptic ones: a) the area of access filters and the area of related functions (surgical protocol, secretariat, transfusion point, laboratoryfor emergency determinations, etc.) are included in the “neutral” area; b) the “clean” area comprises the patient pre-surgery preparation room, the patient awakening room, the registered nurses’ work area, the physicians’ on-call room, the casting room, the surgical material storage area, etc.; c) the aseptic area comprises the operating roomand the surgical team washing and sterile fit out area. The operating room unitwithin “Profesor Dr. Matei Balş” National Institute of Infectious Diseases shall comprise 5 operating rooms, o post-surgery awakening room with 10 beds and one AIC unit with 4beds (also for septic/SIRS patients – difficult and extensive intensive care).

In addition to the above listed spaces, the operating room unit shall be fitted with the following: - alaboratory foremergency determinations,with minimal equipment such as:automatic biochemistry analyser for modern clinical laboratories, with a wide range of tests; haematology analyser; semiautomatic coagulometer; portable ECG, etc.,

- storage spaces forsterile and pharmaceutical materials, - spacefor the preparation of materials, - space for apparatus storage - disposal of used materials, disposal of operating room unit waste, - litter/waste, - bedpans - 2 pcs, - surgical protocol room, - physicians’/registered nurses’ consulting rooms, - on-call room for physicians/registered nurses, - lockers.

The operating roomsshall comply with the requirements specific to modern surgical procedures,for pathologies with a predominant infectious disease component.

Eachoperating room shall comprise adjacent spaces for:

Page 33: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

33

• pre-surgery preparation (fitted with patient wheeled stretcher, in-transit vital signs monitor, a medication cart and a small mobile stainless steel table);

• surgeon preparation (fitted with at least 2 electrical sterile water washbasins for surgical washing);

• asterile deposit communicating with the related room through a window;

• a disposal, cart-based system for hermetically sealed waste. The five operating roomsshall be as follows:

o 1 hybrid operating roomfor interventional cardiology / cardiovascular surgery,

o 1 operating roomfor neurosurgery, o 3 operating roomsfor general surgery.

Based on this structure of the operating room unit,one shall keep in mind that the equipment in the five rooms must be compatible and allow their use in spite of a necessary transfer from one room to another.

Eachoperating roomshall be fitted with a digital system ensuring the interconnection of equipment, the video and audio signals broadcasting inside the hospital, as well as remotely.

The digital system shall make it possible to connect to the hospital PACS system or a different, more advanced system.

Patient entry and exit flow into and from the operating room unit

The focus shall lay on the patient and the medical team. In that respect,the patient shall benefit from transfer from the ward, the emergency admission unit or the heliport to the operating room unit,through a transfer antechamber.

To avoid handling/transferring critical patients across several stages, the entire operating room unitshall be fitted with multipart operating tables that allow detaching the patient platform.

These operating tables shall comprise: • table stem; • patient platform containing 8 segments – 2 pcs; • mobile cart to be used to handle the entire table or strictly

the patient platform – 2 pcs.

Description of items inside the operating rooms

A. Cardiology operating room

The operating roomfor cardiovascular procedures shall be an integrated room, designed to provide the setting for carrying out

Page 34: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

34

conventional procedures, as well as fluoroscopy-guided procedures that employ angiographic imaging.

The hybrid operating roommay also be used by other surgical specialities: neurosurgery, traumatology, orthopedics, urology and general surgery.

Interdisciplinarity is taken into account when fitting the operating room unit with equipment.

Careful planning and professional experience are key factors for each hybrid room project.

Prior to planning a hybridoperating room, one needs to formulate a clear vision concerning its use.

The current operating rooms require a concept able to satisfy the requirements and needs of various surgical procedures and specialities.

Workflow efficiency is a key success factor for the hospital and the surgical program. A minimum number of shifts and optimum processes are required over the course of the entire surgical workflow and the actual surgical procedure.Therefore, the hybrid operating roomshall be integrated in the cluster of the other four operating rooms.

Some additional planning aspects regard the material supply processes, the materials in question being necessary for procedures, treatment and supervision of post-surgery intensive care.

Due to the high costs, the operating room facilities are jointly distributed among several specialities.

Anoperating roomwith highly flexible appearance and design allows necessary relocations of devices and room layout changes.

This is important,particularly given the ever more frequent use of the new technologies,with space limitations in most operating rooms.Appearance and design have to be ergonomic and accommodate the workflow.

For thehybrid operating room, the addition of an angiography system becomes even moreimportant, as it often involves non-standard facilities and products.The choice of imaging system for the hybrid operating room depends on the intended use of the room.

The experts’ consensus is that the performance of mobile C-shaped arms inside hybrid operating roomsis insufficient and recommends floor-mounted systems for hygiene-related purposes.

In fact, certain hospitalsdo not allow directly actuating parts above the surgical area as dust might fall into the wound and cause infections.

Since any ceiling-mounted system includes mobile parts hanging above the surgical area and affects the laminar air flow, such systems do not provide a proper option forhospitals applying the highest hygiene standards.

Page 35: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

35

Ceiling-mounted systems require a considerable area across the ceiling and, therefore, reduce the options of fitting surgical arms and lights. Nevertheless, many hospitals opt for ceiling-mounted systems,as they cover the entire body, have higher flexibility and, most importantly, do not require moving the table.

Moving the table is, at times, a difficult and dangerous task to perform during surgery, as numerous cables and catheters have to be moved.

Still, switching from a stationary position to a working position during surgery is easier with a floor-mounted system, as the C-shaped arm turns from the side and does not cross paths with the anaesthesiologist.

Unlike this, the ceiling-mounted system will move with difficulty during the surgical procedure, but without bumping into anaesthesia equipment.

In a highly-populated environment such as the operating room, biplane systems increase the complexity and interfere with anaesthesia, except for neurosurgery, where the anaesthesia tools are not placed near the head extremity.

Monoplane systems are, therefore, clearly recommended in rooms mainly used for cardiac surgery. In brief, mobile C-shaped arms are generally considered insufficient for cardiovascular imaging and do not comply with the cardiac imaging international standards. The room fit-out list comprises:

• robotic angiography system; • electromechanical operating table system with detachable patient

platform and 360° radiotransparent carbon benchtop for specific cardiovascular surgical procedures;

• surgical light with satellite, integrated video camera, display arm and a 26" display;

• integrated digital system foroperating room + voice control system • anaesthesiologist control panel; • surgeon control panel; • complex ofHDTV cardio endoscopy units/devices (on the surgeon’s

control panel); • anaesthesia machine; • Cell Saver system; • 4-ended extracorporeal circulation machine; • mobile C-shaped arm; • electrosurgical platform with smoke exhaust system; • anaesthesia depth measuring system; • cerebral perfusion monitoring device; • in-surgery microvascular blood flow and tissue perfusion viewing

system;

Page 36: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

36

• device for minimally invasive monitoring of cardiac output; • ECMO – extracorporeal life support device: artificial heart and lungs

(+/- counterpulsation balloon); • single-chamber external pacemaker; • two-chamber external pacemaker; • blood gasometry and haemogram device; • internal-external defibrillator; • 12-pump infusion tower (8 syringe infusion pumps + 4 infusomats); • in-surgery ECG device with transesophageal tube; • patient cooling system; • IV fluid and blood heating system ; • venous stasis prevention device; • aspirator chirurgical; • cardiovascular surgery toolkits (two kits per surgeon – since

sterilization takes a full day); • frontal light; • video-guided difficult intubation system; • operating room furniture set.

B. Neurosurgery operating room

Thisoperating roomshall host neurosurgical procedures.The room shall be fitted with a neuronavigation system that ensures the accurate planning and performance of specific interventions, and a high-performance in-surgery microscope.

The list of equipment items required to carry out high-quality procedures comprises:

• in-surgery mobile CT scanning system; • electromechanical operating table system with detachable patient

platform for neurosurgery, a radiotransparent benchtop compatible with the mobile CT equipment and carbon neurosurgery accessories, including Wilson bridge;

• surgical light with satellite, integrated video camera, display arm and a 24" display;

• anaesthesiologist control panel; • surgeon control panelfor laparoscopy tower; • smart operating roomintegration system; • anaesthesia machine; • neurology in-surgery microscope; • neuronavigation system + on-the-wall/in-the-wall viewing system; • HDTV-quality endoscopy complex unit for neurosurgery • intracranial neuroendoscopy system;

Page 37: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

37

• spinal lumbar endoscopic surgery system; • spinal cervical endoscopic surgery system; • skull base (endonasal) neuroendoscopy system; • mobile C-shaped arm; • electrosurgical platform with smoke exhaust system; • anaesthesia depth measuring system; • cerebral perfusion monitoring device; • device for minimally invasive monitoring of cardiac output; • blood gasometry and haemogram device; • 12-pump infusion tower (8 syringe infusion pumps + 4 infusomats); • internal-external defibrillator; • patient cooling system; • IV fluid and blood heating system ; • aspirator chirurgical; • neurosurgery toolkit; • frontal light; • endoscopic video-guided difficult intubation system; • operating room furniture set.

C. General surgery operating room

In order to provide medical care under the best possible conditions, the room shall be fitted with:

• operating table system withgeneral surgeryaccessories – 3 pcs; • procedural stretchers that allow positioning the patient prior to

coupling the benchtop to the operating room table stem – 2 pcs; • scialytic surgical lamp with two lighting fixtures and video system – 3

pcs; • integrated digital system for equipment control – 3 pcs; • high-performance anaesthesia machine– 3 pcs; • digital mobile X-ray scanner – 1 pcs; • surgeon control panel – 3 pcs; • anaesthesiologist control panel – 3 pcs; • portable video-laringoscope kit for difficult intubation, video-guided –

3 pcs; • front light – 6 pcs; • videobronchoscope set for adult use – 3 pcs; • magnification system for open surgery, with video documentation

function – 3 pcs; • laparoscopy device forgeneral surgery – 3 pcs; • electrosurgery platform including a vascular sealing unit and an argon

coagulation unit – 3 pcs;

Page 38: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

38

• cerebral perfusion measuring device – 3 pcs; • bilateral system foranaesthesia depth measuring – 3 pcs; • in-surgery microvascular blood flow and tissue perfusion viewing

system r - 1 pcs; • venous stasis prevention device – 3 pcs; • patient cooling system – 1 pcs; • blood and IV fluid heating system – 3 pcs; • mobile surgical aspirator with 2l aspiration containers – 3 pcs; • 12-pump infusion tower (8 syringe infusion pumps + 4 infusomats) –

3 pcs; • general surgerytoolkit – 3 pcs; • mobile stand for laminar flow instruments – 3 pcs; • stainless steel furniture set for the operating room – 3 pcs.

The multipart operating tables shall be radiotransparent and completely electrically actuated for all the functions, being intended for use with patients of up to minimum 350 kg and shall be accessorised accordingly.

The surgical lamp systems with LED lights, comprising 2 domes, each with an intensity of at least160,000 lux, shall be adapted to the laminar flow ventilation system.The surgical lights shall be fitted with 3D sensors which permanently analyse the emitted light beam and automatically keep the set up parameters:light intensity, colour temperature and light field diameter, regardless of the shadows projected by the surgeons or the working distance to the dome.Both light domes shall have a preinstalled camera preparation module and each lamp system shall be fitted with a full HD wireless video camera, a display and a broadcasting system, making it possible to export the images recorded in theoperating room, in real time, straight to the surgical protocol and monitoring room. Eachoperating room shall be fitted with patient post-surgery removal spaces that host patient transportation wheeled stretchers,one for each room, which may also be found in the waiting area for lying-down patients. The plate washing area in the operating room unitshall be fitted with steam-based cleaning and disinfection device and a mobile cart for the optimum sanitation - cleaning and disinfection - of the operating table stem. The area reserved for organ storage and the blood bank shall be fitted with special freezers, medical refrigerators and stainless steel cabinets

In addition to the previously detailed proposal forminimum equipment, one must also consider, forthe operating rooms, the need to install high-tech oncological equipment,as follows:

• in-surgery system for peritoneal hyperthermia –HIPECtechnology – 1 pcs;

Page 39: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

39

• in-surgery IR viewing system for the blood perfusion; • video-endoscopy systems for laparoscopic surgery with infrared

visualisation • in-hospital robotics system

D. The post-surgery awakening section shall be shall be fitted with:

• universal digitalelectrical bed – 10 pcs; • patient vital function monitoring device designed to monitor the

patient’s vital parameters: HR, Resp, NIBP, Temp, BIS – 10 pcs; • medium-performance mechanical ventilator – for the emergency

switch to assisted mechanical ventilation of decompensated patients keeping critical patients under mechanical ventilation – 2 pcs;

• medication cart fitted with multiple sized drawers – 2 pcs; • stainless steel cabinet for medication and sterile materials – 2 pcs; • small mobile table for instruments – 2 pcs; • mobile storage cart – 2 pcs; • supportfor waste collection bags- 2 pcs.

E. The AIC cardiology unitshall be fitted with2-4AIC beds, each having glass walls

Access to each of the AIC spaces shall only be possible through a special filter area – the chemical decontamination antechamber with Door Airlock system,intended to limit the contamination risk. The AIC beds shall be fitted with:

- completely electrical functions, complex control elements – quickand easy to actuate, - memorised emergency positions, - totally radiotransparent surfaces, - integrated weighing system, - active mattress with an embedded compressor.

Each AIC bedshall be fitted with the following equipment required to maintain the vital signs of critical patients:

- mechanical ventilator, - 12-pump infusion tower (8 syringe infusion pumps + 4 infusomats), - patient vital function monitor (ECG ,SpO2, NIBP, RESP, 2xTESQ

M, 2xIBP , EtCO2, etc.), - portable aspirator,

Page 40: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

40

- IV solution heating module.

The entire AIC unit shall also benefit from the following equipment, required for patient accurate diagnosis and immediate adequate treatment:

• peritoneal dialysis device and the related kit – 1 pcs; • hemodiafiltration and plasmapheresis + liver dialysis device – 1

pcs; • ECMO • portable video-laringoscope kit for difficult video-guided

intubations – 2 pcs; • CO2 purging and extracorporeal oxygenation device – 1 pcs; • cerebral perfusion monitoring device NIRS – 1 pcs; • portable multidisciplinary ultrasound device – 1 pcs; • patient heating system – 2 pcs; • blood and IV fluid heating system – 1 pcs; • resuscitation cart – 1 pcs; • defibrillator – 1 pcs; • medication cart – 1 pcs.

The AIC auxiliary compartment de ATI shall be fittedthe following equipment:

• patient data whiteboard • AIC-connected telephone • cabinet for medication and medical supplies – 1 pcs; • medical refrigerator – 1 pcs; • small mobile stainless steel table – 1 pcs; • mobile storage cart – 1 pcs; • support for waste collection bags – 1 pcs, • bedpan - 1 pcs.

The entireoperating room unitshall be organised according to Order 914/ July 26, 2006 for the approval of the rules on the requirements a hospital must meet in order to obtain the sanitary permit to operate.

F.Central sterilization station

Medical procedures entail the use of various instruments, materials and equipment. These may be disposable (they are thrown away immediately after use) or reusable (they require going through certain well-established steps prior to being cleared for reuse).

Page 41: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

41

The Central Sterilisation Station (SCS) is the place where reusable medical devices end up after being used; here, they undergo cleaning, inspection, disinfection and sterilization processes and are subsequently stored in special rooms, from where they are sent to the requesting units. The Central Sterilisation Station (SCS) shall be located in the vicinity of the vertical traffic hub so as to ensure a separate access for the delivery of materials that are to bereprocessed (sterilized) and the delivery of treated materials to all the functional units of the hospital. In the hospital, the sterilization activities shall primarily cluster as part of thecentral sterilization service (SCS).

The central sterilization serviceshall have a closed traffic path for persons, with sole access from the hospital general traffic paths plus pass-boxes and UV decontamination systems.

The central sterilization serviceshall be attached to the operating room unitand be linked to the unit by way of specific means within interior areaswhere it meetsits traffic paths (through the door, to the “neutral” area, and through the window, to the “clean” area of the operating room unit.

G. Cleaning area

This area is necessary for: • reprocessing of medical devices; • centralizing and automating the activity of cleaning medical

devices for operating roomsandpatient care units; • reducing microbial contamination to the lowest possible levels;

protecting the staff and the environment; cleaning recipients, transport carts and workboots used in operating rooms.

Operations to be carried out in this area:

• receivingthe instruments that have gone through the pre-disinfection stage and collecting such instrumentsfrom patient care wards and operating rooms;

• actual cleaning.

The cleaning area includes: • the receipt area – sorting – documentingmedical devices; • the area for the inspection of medical devices of entry; • the actual cleaning area (washing and disinfecting machine,

ultrasonicbath / tank, cleaning recipient) comprising the double-door technical wall of the washing and disinfecting machine);

Page 42: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

42

• the area where transport carts are cleaned. Once it has been cleaned, the instruments are sent to the sterile material distribution area, located at the end of the sterilisation chain. The discharge area of the washing and disinfecting machine shall serve as an intermediate area between the cleaning area and the packing area, where medical devices can be dried after being removed from thewashing and disinfecting machine.

Manual cleaning: Manual cleaning is facilitated by a workstation with two adjoined baths, for immersing and rinsing medical devices that do not fit into thewashing and disinfecting machine. These baths must be adequately sized. The washbasins must be scratch-resistant. Semiautomatic cleaning in the ultrasonic bath: Certain microsurgical or ophthalmological medical devices require an ultrasonic bath to ensurethe efficient cleaning of these devices. The area where the bath(s) is/are installed must be fitted with a device that directly disposes of the bath contents (or an ultrasonic bath mounted on a plane surface or a bath mounted on a flat platform).

Automatic cleaning of medical instruments in washing and disinfecting machines: It is recommended that washing and disinfecting machines be fitted with two doors, allowing loading on the cleaning side and unloading on the packing side. The area upstream from the washing and disinfecting machine loading areahas to be sufficiently large to allow positioning a transfer cartthat can facilitate the sterilization staff’s work, particularly when lifting heavy loads. The recommended number of washing and disinfecting machinesshall depend on the weight to be processed and the packing method used.

Transport cart washing machine: It is recommended that washing and disinfecting machine be fitted with two doors, allowing loading on the cleaning side and unloading on the packing side.

Page 43: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

43

The area upstream from the washing and disinfecting machine loading area has to be sufficiently large to allow positioning a transfer cart for medical supplies. The transport cart washing and disinfecting machineis designed and built as a compactmultifunctional device, fitted with an efficient hot-air forced drying system. The thermal disinfection version is tested in accordance to standard UNI EN ISO 15883-1/2.

H. Packing area The area is used for packing medical devices that require sterilization in separate packs, containers, bags, etc. This packing area shall comprise two different spaces:

• anarea where medical devices are packed, the cleaned medical devices are tested prior to being packed; individual workstations for each activity type (bags for instruments, recipients for instruments, etc.); computer-fitted tracking workstation;

• receipt area for linen drapery; verification and folding of woven fabric items;

Mobile workstation(s) for preparing medical devices Theseworkstationsmay be made of stainless steeland also useother materials compatible with the various detergents used in the cleaning area. For the storage of the various products used in machines, and to avoid placing these products on the floor, several racks shall be fitted. The workstations is fitted with the accessories required to verify and pack medical instruments, as well as with a device that detects proteins using fluorescence.

The equipment items proposed for the central sterilization station: • double-access autoclave with manual loading and automatic

unloading – 2 pcs; • double-access plasma sterilizer – 1 pcs; • washing machine for medicalinstruments,with double access

doors – 2 pcs; • high-capacity ultrasonic cleaning machine – 1 pcs; • transport cart washing machine – 1 pcs; • fluorescence-based protein detection device – 1 pcs; • UV device,recommended to be used on the premises of

medical units – 1 pcs;

Page 44: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

44

• rotating sealing machine, gluing speed of at least 10m/min – 1 pcs;

• rotating sealing machine with cutting system – 1 pcs; • workstation – 2 pcs; • chair – 2 pcs; • handgun connected to the compressed air source - 1 pcs; • stainless steelwashbasin with at least 2 vats and cleaning gun –

1 pcs; • fixed work table – 2 pcs; • mobile work table – 2 pcs; • paper support for packing – 1 pcs; • storage shelf – 6 pcs; • cart for decontamination and transportation of instruments on

site: – 5 pcs; • vats with covers – 10 pcs; • closed transport cart – 3 pcs; • set of steam sterilization containers – 1 set; • water treatment station – 1 pcs; • medical instruments tracking system.

I. Anaesthesia and intensive care (AIC) service

Itcentralizes all the severe medical cases that require 24/7 continuous supervision and intensive care. The size of the service (the number of beds) varies depending on the hospital capacity and specialities, as follows:

a) small AIC services (under 15 beds), as well as those for specialised hospitals, are located within either the septic or the aseptic area;

b) large AIC services, in multi-profile hospitals, are organised into distinct sectors (units), based on the medical profile or the severity of cases, also containing an adequately fitted compartment for septic cases.

The optimum manner of structuring a care unit is as a cluster of rooms (compartments) with1-2 beds, grouped around the medical team’s monitoring station, fitted with glass windows and passage gaps. The hospitalisationsystems relying on large wards with 5-7 beds, separated by curtains or light panels, is not recommended, being less hygienic. Regardless of the layout solution applied, each AIC unit shall contain at least one private room with restroomfor cases requiring strict epidemiological isolation. The area intended for the AIC ward shall comprise modern, state-of-the-art equipment compliant with the standards in force.

Page 45: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

45

Itshall be divided into 2 AIC units with 16 beds each,to be in their turn divided into two sectors. One sector with 10 isolated individual wards and 3 wards with 2 beds each. EachAIC sectorshall be fitted withthe following equipment, required for patient accurate diagnosis and immediate adequate treatment:

• patientcooling system (for the cooling non-invasive treatment of cardiac arrest patients, cerebrovascular accidents, traumatic brain injuries, acute myocardial infarction) – 1 pcs;

• peritoneal dialysis device and the related kit – 2 pcs; • hemodiafiltration and plasmapheresis + liver dialysis device – 2

pcs; • CO2 purging and extracorporeal oxygenation device – 1 pcs; • portable video-laringoscope kit for difficult video-guided

intubations – 2 pcs; • devicewhich determines the acid-base balance and blood gas

values – 1 pcs; • haemoglobin determination and measuring device – 1 pcs; • coagulation and cardiac markers analyser – 1 pcs; • cerebral perfusion monitoring device NIRS – 2 pcs; • patient heating system – 2 pcs; • blood and IV fluid heating system – 2 pcs; • resuscitation cart – 1 pcs; • defibrillator – 1 pcs; • medication cart – 1 pcs.

The following equipment shall also be included in a complete AIC unit:

• system for difficult endoscopic video-guided intubations – 1 pcs; • portable bronchofiberscopeset with LED light source – 1 pcs; • mobile X-ray scanner – 1 pcs; • portable multidisciplinary ultrasound device – 1 pcs; • steam-based cleaning and disinfection device – 1 pcs.

Both AICcompartments ATI shall be fitted withthe following auxiliary

equipment: o bactericide light, o cabinet for medication and medical supplies, o medical refrigerator, o small stainless steel table, o mobile storage cart, o support for waste collection bags,

Page 46: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

46

o bedpan, o steam-based cleaning and disinfection device.

J. Hospitalisationarea (wards with beds)

The hospitalisation areas shall be easily accessible from the main lobby,by means of the vertical traffic hub, both by patients, visitors and the medical staff as well as for the logistic supply and waste disposal flow.

These areas shall comprise: • oneaccommodation unitwith 26 beds, located on the 1st floor,

partitioned as follows:8wards with 2 bedsand10single-bed private rooms;

• threeaccommodation units with 34 beds each, located on three separate floors, namely the 4th,5th and 6th floors, partitioned as follows: 10wards with 2 beds each and14single-bed private rooms.

K. The accommodation units shall comprise:

o patient wards, o care room, o nurse station, o pharmacy, o materials warehouse, o bedpan, o office/kitchen, o clean bed sheets, o dirty bed sheets, o on-call physicians’ office, o registered nurses’ office, o head of department office with restroom, o nurse manager’s office with restroom, o physicians’ office, o cleaning room, o litter/waste, o visitor restroom, o medical staff restroom.

The care roomshall be fitted with:

• electrical treatment couch with adjustable height and head rest;

Page 47: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

47

• medication cart fitted with multiple sized drawers, dispenser for medication and accessories such as: glove supports, container for sharp waste; vial opener; plastic waste bin; catheter container, infusion stand;

• stainless steel cabinet for medication and sterile materials, fitted in the upper part with 2 swinging glass doors and drawers and a metallic door in the lower part;

• small mobile stainless steel table for instruments, fitted withat least 2 shelves;

• mobile storage cart, fitted with stainless steel baskets, on a mobile stand, for storingsterile materials;

• supportfor waste bags – a stainless steel mobile frame, with three compartments for3 waste collection bags carrying at least 80l, each compartment beingfitted with a coloured lid and actuated by a pedal / proximity sensor.

Patient wards– theseshall be divided into 1-bed and 2-bed wards. All

the wards shall be fitted withentry antechamber and a restroom comprising: toilet seat, washbasin and shower + system for persons with disabilities. The areas of the emergency sector and the daytime care ward, the outpatient and the admission service areas, the main access area, the area with visitor servicesand the TESA (technical, clerical and administrative staff) area, relatively neutral in terms of hygienic and medical requirements, are hospital interface areas between its medical component and patients, next of kin and visitors.

As such, these areas shall be located primarily on the ground floor, directly facing the motor vehicle and pedestrian traffic paths in the public area of the hospitalpremises, whereas the 1st floor shall contain 5 consulting rooms of various specialities.

L. Emergency service

The emergency service is organised depending on the hospital type: • emergency service organised as emergency admission unit

(EAU); • emergency admission compartments(EAC).

The emergency admission compartment shall comprise:

o ambulance antechamber, o patient care areas: - waitingarea for lying-down

patients/abled patients/companions; patient examination

Page 48: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

48

room; - deshocking room with 2 beds; - room for minor procedures; - orthopaedics room; - care room; - temporary accommodation; - patient shower,

o areasintended for the medical staff: - physician preparation; - medical materials/gypsum warehouse; -nurse station; -pharmacy; - clean bed sheets warehouse; -dirty bed sheets warehouse; - sterile materials; - bedpan,

o administrative spaces: - reception lobby; - secretariat/Reception;

o physicians’, registered nurses’ offices; - IT room; - office/kitchen; - material warehouse; - carts/beds warehouse; - cleaning room; - litter/waste; - restrooms for w/m/disabled persons; - restroom forw/m/medical staff.

The orthopaedics roomshall be fitted with: • scialyticLED lamp with a light intensity of at least 160,000 lux; • special casting table; • stainless steel casting preparation table, fitted witha special vat

and a drainage system; • negatoscope; • single-vat electrically actuatedwashbasin for surgical washing

with sterile water; • medication cart fitted with multiple sized drawers, dispenser for

medication and accessories such as: glove supports, container for sharp waste; vial opener; plastic waste bin; catheter container, infusion stand;

• stainless steel cabinet for medication and sterile materials, fitted in the upper part with 2 swinging glass doors and drawers and a metallic door in the lower part.

Outpatient unit

The hospital outpatient sector provides medical services, according to the specialities covered by its profile, to patients whose state does not require or no longer requires admission.

The outpatient accommodation unit shall comprise 6 1-bed wards. The location of the outpatient sector inside the hospital shall facilitate easy links toinvestigation, exploration servicesand treatments, as well as to the daytime care compartment.

Page 49: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

49

The outpatient accommodation unit shall be easily accessible from the main lobby via the vertical traffic hub, both by patients, visitors and the medical staff as well as for the logistic supply and waste disposal flow.

The outpatient unit shallinclude:

o patient wards, o care room, o nurse station, o pharmacy, o materials warehouse, o bedpan, o office/kitchen, o clean bed sheets, o dirty bed sheets, o offices, o cleaning room, o litter/waste, o visitor restroom, o medical staff restroom.

The care roomshall be fitted with:

o electrical treatment couch with adjustable height and head rest,

o medication cart fitted with multiple sized drawers, dispenser for medication and accessories such as: glove supports, container for sharp waste; vial opener; plastic waste bin; catheter container, infusion stand,

o stainless steel cabinet for medication and sterile materials, fitted in the upper part with 2 swinging glass doors and drawers and a metallic door in the lower part.

The patient wards – they shall be divided into 1-bed wards with medical gas ramp.Each wardshall be fitted with:

o individual washbasin,located in the ward entrance antechamber, for the hygienic hand washing of both the medical staff and patient companions,

o each washing unitshall be fitted withliquid soap dispenser, disposable paper tissue dispenser and alcohol dispenser,

o universal digital electrical bed with medical nightstand.

Page 50: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

50

o floor fitted with fall sensor o embedded digital system – vital signs, etc.

The bed shall be fitted witha 4-part patient platform (adjustable back and thigh sections), adjustable in height, with detachable and folding side panels, complex control tools (remote control, central control panel, patient control tools, pedals), special memorised functions: CPR, cardiac chair, emergency TR, examination position. The bed shall provide mobility assistance, secure comfortable and optimum positioning for the patient and shall be fitteda passive mattress designed to prevent bed sores.

M. Consulting rooms

The role of consulting rooms within “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building Bshall be that of conducting examinations of both external patients and patients admitted in the newly created accommodation units.

This sector shall be easily accessible from the main lobbyby means of the vertical traffic hub, shall be located on the 1st floor andshall comprise 5 consulting roomsfor various specialities.

• Imaging compartment

The role of this compartmentshall be to examine, by way of various imaging examinations performed in combination with complex image analysis methods, based on artificial intelligence techniques,in order to provide decision-making assistance in medical diagnosis algorithms. The high-performanceimaging models employed by this departmentare as follows:computed tomography, magnetic resonance, digital radiology, ultrasound and bone densitometry, bioimpedance, and shallenhance safety in the diagnostic placement and/orconfirmation process.

One necessity is to fit thecompartmentwith PET-MRI–a state-of-the-art product which integrates high-definition PET detectors in the powerful magnetic field of MRI, thus providing the most accurate imaging equipment for cancer diagnosis.

It has its own structure and specialised personnel, in accordance tothe specific rules in the field of imaging - CNCAN. The location of the department in hospitalshall allow direct collaboration with the emergency admission service, the specialised outpatient unit, as well as the other departments, and can be easily accessed fromthe main lobbyby external patients and, separately, by

Page 51: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

51

immobilised patients in the emergency sector, as well as by patients from the hospitalaccommodation units. Magnetic resonance

• Radiotherapy centre

The location of the service inside the hospitalshall allow direct collaboration with the admission service, as well as quick links to the operating room unit, the intensive care service, the Roentgen diagnosisand functional exploration services, the medical test laboratory. This sector shall be accessible in the basement -1 area, located in the close vicinity of the main lobby and benefit from a separate, British yard access path.

Whereas:

- oncological conditions account for world’s second most common death cause, preceded only by the cardio-vascular system diseases;

- according to NHIH(National Health Insurance House) data, more than 90,000 new oncology patients are diagnosed every year in Romania;

- accordingto medical reports, more than 60% of these patients should have radiotherapy included as a treatment method;

[CATEGORY NAME] has nearly 50% more

centres than theoretically necessary

[CATEGORY NAME] has only 28% of the

accelerators required by the population-100%

-80%

-60%

-40%

-20%

0%

20%

40%

60%

European radiotherapy centres vs. the need for such centres 2013 Cancerworld Magazine statistics

Page 52: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

52

Switz

erlan

d

Finlan

d

Swed

en

Denm

ark

Belgi

um

Norw

ay

Holla

nd

Irelan

d

Fran

ce

Spain

Gree

ce

Italy

Portu

gal

Germ

any

The C

zech

Rep

.

Austr

ia

Grea

t Brita

in

Polan

d

Bulga

ria

Hung

ary

Roma

nia

- severaltreatment types are available for cancer patients:

surgical, chemotherapeutic, radiotherapeutic;

Most times, these methods overlap or are applied simultaneously.

76

5

0

2

4

6

8

Radioterapie Chirurgie Chimioterapie

Treatment types reported, on average, for 10 cancer patients

Western Europe level 58-60%

No accurate exists for Romania, but the

estimated amount is less than 20%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Estimated amount of cancer patients treated with radiotherapy

Radiotherapy Surgery Chemotherapy

Page 53: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

53

The U

nited

Stat

es

Holla

nd

Switz

erlan

d

Austr

alia

Denm

ark

Cana

da

Sing

apor

e

Swed

en

Grea

t Brita

in

Fran

ce

Germ

any

Italy

South

Kor

ea

Japa

n

Polan

d

Mexic

o

China

Russ

ia

India

The P

hilipp

ines

Vietn

am

Alge

ria

Radiotherapy has been used as cancer treatmentfor around 100

years, after the discovery of X rays by Wilhelm Roentgen in 1895. The modernisation of this technique took place primarily in the 1900s, when the famous Marie Curie, the first female Nobel Prize laureate discovered the radioactive elementsPolonium and Radium.

Radiotherapy is a therapeutic method with local and regional impact, which uses ionising radiations to destroy malignant tumour cells with minimum side effects for the healthy organs or tissues in the proximity of the tumour and without major influences upon patients’ quality of life and, in addition to treating certain forms of cancer, in relatively limited cases and in small doses, it can be used for its inflammation decreasing properties to treat degenerative inflammatory joint conditions.

Modern radiotherapy is distinct from previous radiotherapy techniques with its high irradiation precision and a significant reduction of treatment intervals.

Radiotherapy has a two-fold impact upon these cells: - direct – it directly destroys the cancer cells; - indirect – it causes changes in the cancer cell metabolism, changes leading to its demise. Due to its accuracy and efficiency at a cancer cell level, more than

60% of the cancer cases in Europe are treated with radiotherapy.

In general, radiations are directed towards the tumour and the area in its immediate vicinity, destroying the primary tumour and decreasing the risk of spreading to the neighbouring organs. The state-of-the-art IMRT-RapidArc/VMAT technology allows modulating the total dose of radiations, so that the primary tumour should be treated with large doses and the neighbouring healthy tissues should be as protected as possible.

In order to obtain a benefit/risk ratio in favour of the patient, the total radiation dose shall be administered over several consecutive days, using on a daily basis small amounts of radiations; in general, radiations are administered 5 days/week (from Monday to Friday) with a 2-day break, so that the healthy tissues may recover.

Radiation therapy treatmentcomes in two varieties: curative and palliative. Curative radiotherapyis applied when cancer can be cured and is intended to completely destroy cancer cells. It can be administered at various times, by itself or together with another treatment,prior to surgical intervention, in order to reduce the tumour size or, post-surgery, to stop the

Page 54: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

54

growth of possibly remnant cancer cells. It can also be administered prior to, during or after chemotherapy or hormone treatment in order to improve the general results.

Palliative radiotherapyis used when total cancer removal is no longer possible, but alleviating symptoms can bring more comfort to the patient and reduce their pain.

The decision to treat a tumour with radiations relies on locating the primary tumour and is made depending on the present or absent radiosensitivity of tumour cells.

Radiotherapyfor curative purposes is used to treat certain cancer forms, most times being an integral part of the treatment, in addition to chemotherapy, surgery and hormone therapy.

In the case of radiosensitive tumours, radiotherapymay be the only treatment required to treat and cure them, as they show a prompt reaction and regression when moderate radiation doses are administered. Extremely radiosensitive cancer types are leukaemia (blood cell cancer) and lymphoma (lymph node system cancer). Among other radiosensitive tumours there are cervical, larynx, breast and prostate cancers.

The cancer types with the highest incidence in Romania, fit for radiotherapy, are: breast cancer, cervical cancer, brain tumours and/or metastases (sometimes as the only treatment alternative), uterine (endometrial) cancer, prostate cancer, colorectal cancer, bone cancer and metastases, stomach cancer, lung cancer.

Romania: high risk for lung cancer

and lower risk for prostate cancer

(possible inaccurate

screening in RO)

-

10,0

20,0

30,0

40,0

50,0

60,0

70,0

80,0 Males: Cancer incidence rate per 100,000, in 10 of the most important body locations

RomaniaTari mai dezvoltateRomania More developed countries

Page 55: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

55

Lung

s

Pros

tate

Colon

Stom

ach

Liver

Oeso

phag

us

Urina

ry bla

dder

Non-

Hodg

kin

lymph

oma

Leuk

aemi

a

Lips

and

oral

cavit

y

Brea

st

Cervi

cal

Colon

Lung

s

Stom

ach

Uter

ine

Ovar

ian

Liver

Thyro

id

Leuk

aemi

a

Males:high mortality rate and high lung cancer rate in comparison to Switzerland and Western Europe

Romania incidence 271

mortality 175

Romania: higher risk risc for cervical

as opposed to uterine cancer (one

of the most affected body

locations in EU) and lower risk for breast cancer

(possible inaccurate screenig in RO)

-

10,00

20,00

30,00

40,00

50,00

60,00

70,00

80,00

Sani Col uterin

Colon Plamani Stomac Cancer uterin

Ovare Ficat Tiroida Leucemie

Females: Cancer incidence rate per 100,000, in 10 of the most important body locations

RomaniaTari mai dezvoltateRomania More developed countries

Page 56: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

56

Switzerland

incidence 338 mortality 113

Western Europe

incidence 335 mortality 131

- 20 40 60 80 100 120

Plamani

Colon

Prostata

Stomac

Vezica urinara

Ficat

Pancreas

Laringe

Faringe

Buze si cavitatea bucala

- 20 40 60 80 100 120

Prostata

Plamani

Colon

Vezica urinara

Melanomul de piele

Ficat

Limfom non-Hodgkin

Leucemie

Rinichi

Testicule

Lips and oral cavity Pharynx

Larynx Pancreas

Liver Urinary bladder

Stomach Prostate

Colon Lungs

Testicles Kidneys

Leukemia Non-Hodgkin lymphoma

Liver Skin melanoma Urinary bladder

Colon Lungs

Prostate

Page 57: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

57

Females:low incidences of breast cancer (lack of tests), high cervical cancer rates

Romania incidence 191

mortality 89

Switzerland incidence 246

- 20 40 60 80 100

Prostata

Plamani

Colon

Vezica urinara

Rinichi

Limfom non-Hodgkin

Leucemie

Stomac

Melanomul de piele

Testicule

- 20,0 40,0 60,0 80,0 100,0 120,0

Cancerul de san

Col uterin

Colon

Plamani

Ovare

Pancreas

Stomac

Cancer uterin

Cerebral si sistemul nervos

Leucemie

Ficat

Testicles Skin melanoma

Stomach Leukemia

Non-Hodgkin lymphoma Kidneys

Urinary bladder Colon Lungs

Prostate

Liver Leukemia

Brain and nervous system Uterine

Stomach Pancreas

Ovarian Lung

Colon Cervical

Breast cancer

Page 58: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

58

mortality 77

Eastern Europe

incidence 259 mortality 84

Radiotherapy side effects vary significantly depending on the location of the treated tumour, the anatomic structures in its immediate vicinity, the total administered radiation dose and, last but not least, the sensitivity of each individual patient. Other conditions of the patient may influence the side effects of radiotherapy.

- 20,0 40,0 60,0 80,0 100,0 120,0

Cancerul de san

Plamani

Colon

Melanomul de piele

Cancer uterin

Ovare

Pancreas

Limfom non-Hodgkin

Leucemie

Tiroida

- 20,0 40,0 60,0 80,0 100,0 120,0

Cancerul de sanPlamani

ColonMelanomul de piele

Cancer uterinOvare

PancreasLimfom non-Hodgkin

RiroidaCol uterin

Thyroid Leukemia

Non-Hodgkin lymphoma Pancreas

Ovaries Uterine cancer

Skin melanoma Colon Lungs

Breast cancer

Cervical Thyroid

Non-Hodgkin lymphoma Pancreas

Ovaries Uterine cancer

Skin melanoma Colon Lungs

Breast cancer

Page 59: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

59

There are 4 types of radiotherapy: • external radiotherapy(transcutaneous or teleradiotherapy)– the radiation

source is outside the body, in the form of a device (linear accelerator) emitting radiation beams directed at the tumour target after it crosses the superficial tissues;

• endocavitary/interstitial radiotherapy(brachytherapy)– the radiation source is inside the body, in the form of radioactive emitters placed inside or near the tumour, designed to administer a large dose of radiations within the tumour volume, while also reducing the radiation exposure of healthy tissues; brachytherapy may be used to heal cancer tumourswhen these are small or only locally developed, provided that the disease does not produce metastases (masses spread in other areas of the body);

• radiosurgery –it is a special radiotherapy technique, used in treating tumours in a strong, non-invasive and efficient manner. The most advanced form of radiosurgery uses the Cyberknife system - beinghighly accurate, it emits radiations from more than different 1,600 angles towards the tumour target and facilitates treatment;

• metabolic radiotherapy– the administration of radioactive substances within the circulatory system – it is a radiotherapy form used particularly to treat multiple bone metastases extended across the entire skeleton or in some form of thyroid cancer.

Currently, there are modern 3 external radiotherapy techniques: • 3D CRT –3Dconformational radiotherapy;

• IMRT – intensity-modulated radiation therapy, with fixed treatment beams, where modulating the irradiation beam intensity is done by changing the position of the MLC collimator leaves (multileaf collimator);

• RapidArc/VMAT – volumetric modulated arc therapy, is it the latest IMRT innovation, the rotational radiotherapy technique with modulated intensity, where the accelerator spins around the patient to target the radiation upon the affected tissue from different angles; modulation is created by overlapped arches.

Other technologies are employed, as well, such as 2D radiotherapyor cobalt machines, but they are seriously obsolete in comparison with the evolution of current devices. In Romania, the most commonly used irradiation technique is the 2D one, whereas the integration of a computer system for scheduling treatments and a simulating CT scanner is absent.

The state-of-the-art IMRT – VMAT technology ensures one of the most efficient radiotherapy treatments available anywhere in the world. It comes with the following advantages:

• thepossibility of customising treatment and adapting it to the tumour form, being a highly compliant radiotherapyvariety;

Page 60: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

60

• the short duration of a radiotherapy session, of no more than 5-7 min/session, which increases patient comfort and irradiation accuracy;

• the additional amount of freedom provided by the irradiation source rotation around the irradiated patient and its rotation speed, making it possible to approach the tumour at 360 degrees;

• the possibility of changing the radiation dose flow rate during irradiation; • the accuracy of radiation beams directed at the tumour target and a

decreased irradiation of normal tissues, which decreases the risk of acute and chronic adverse reactions;

• the possibility of administering optimum therapeutic doses within the target amounts, as well as of having within the target amount areas with different doses, which secures treatment effectiveness and increases the tumour control odds.

Radiotherapyis administered in outpatient units, and the number of treatments the patient will require depends on several factors of its state and the cancer type affecting them.

Estimated population of Romania: 22mil. inhabitants, 20 LINAC units, 873 USD per capita spent in 2012.

Local authorities have repeatedly made efforts to develop new radiotherapy centres and have looked for various funding solutions both from the Ministry of Health and from possible private partners. The significant amount required to implement these projects has rendered the private partners unable to invest in this area. According to recent data, the need for radiotherapyincreases by 3% every year.

According to the methodological rules for implementing the framework agreement on the requirements for granting medical care as

[CELLRANGE]

[CELLRANGE][CELLRANGE][CELLRANGE] [CELLRANGE]

[CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE] [CELLRANGE][CELLRANGE][CELLRANGE]

[CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE]

[CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE]

[CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE][CELLRANGE]0

2

4

6

8

10

12

0 1000 2000 3000 4000 5000 6000 7000

Medical care expense per capita expressed in USD

LINAC units / millions of inhabitants

Page 61: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

61

part of the national health insurance scheme for the 2014–2015 interval, the ceiling for 3D irradiation treatment is 320 lei for one session and 640 lei for the IMRT procedure and, considering that the average number of sessions per patient is 30, we have a total per patient that may lead to an encouraging calculation for a private investor.

Technical data The investment consists in building a premises to operate as a

medical unit intended for the diagnosis and complete/specialised treatment of oncology cases, but also of other types of chronic pathologies.

One of the significant objectivesof the project consists in erecting and fitting with state-of-the-art equipment a premises that would operate as a medical unit intended for the diagnosis and complete/specialised treatment of oncology cases, by means of its qualified medical personnel.

The investment shall be carried out via a series of specific objectives: − enhancingthe capacity of providing early diagnostics of

oncological conditions; − increasing to a greater extent the public awareness in regard to

theimportance of cancer-preventing measures; − increasing the numberof persons (at least 500 patients/year)

who will have access to modern technologies designed to treat oncological conditions;

− increasing the number of cured patients; − creating and improving public health conditions; − improving the treated patients’ living conditions –the premise for

achieving sustainable development in the region from an economic and social standpoint;

− increasing and diversifying the employment options on the local labour market, so as to decrease the unemployment rate, the migration rate and improve the living standard by lifting the wage levels;

− developing the infrastructure of public interest at a local level; - drawing in additional funding to the budget; - attracting private capital into solid economic initiativesintended

to satisfy certain needs of local communities and elevate their degree of civilisation and comfort, with a positive impact in developing the infrastructure of public interest;

- developing an educational foundation for the training of interns, resident physicians and registered nurses, as well as for medical scientific research, both consolidating the quality of medical acts, while observing patient rights and medical ethics and deontology;

Page 62: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

62

- subscribing to the European Union standards and regulations in effect in the field.

Radiotherapyis a particularly significant treatment method against malignant tumours. It is effective and its costs are relatively low as opposed to chemotherapy, being suitable to a larger proportion of affected patients.

Improvements in radiotherapy results rely on the procurement of new radiological data and particularly on technical developments which implement the new High Dose High Precision Radiation concept.

A previously set up radiotherapy centre may treat under optimum conditions at least1,000 patients/year.

Assessment of the environmental impact ofradiotherapy The technology inside a radiotherapyand medical imaging centre

shall not have an environmental impact if the normatives in force in regard to the hygiene of ionising radiations, the recommendations of equipment manufacturersand the good medical practices are complied with.

These types of activities shall be authorised by a well-established body,the National Commission for Nuclear Activities Control (CNCAN), subordinated to the Romanian Government, this being the only body that can authorise imports of such equipment toRomania, their installation in spaces designed by a CNCAN-authorised expert and their use as per a permit issued by the same body pursuant to: Law 111/1996, GD 1627/2003 on theOrganisation and Operation Regulation of the

said body the CNCAN security rules and regulations stipulating the following

mandatory documents: - radiological security permit issued by the equipment supplier, - location and construction permit, - possession permit issued to the owner, - operation permit.

Without the observance of these permits, the equipment remains non-functional and the medical services rendered using this equipment cannot be settled by NHIH.

Types of radiations that can cause a significant impact upon the environment and individuals.

In terms of protection against radiation, there are 2 radiation categories: non-ionising and ionising.

When radiations hit an atom, they transfer a part of their energy to it. If the energy transferred by the radiation is sufficiently significant, the process that occurs is ionisation- anelectron is removed from the atom,

Page 63: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

63

leaving behind 2 electrically charged particles – one electron and one positive ion.

The presence in large numbers of such electrically charged particles may leads to the destruction of living tissues.

Radiations that can transfer sufficient energy to achieve that are called ionising radiations, whereas those with a lower energy level are non-ionising. Although certain types of non-ionising radiations may be harmful in large doses, ionising radiations are usually much more dangerous. When people talk about radiations, they usually refer to ionising radiations.

Matter comprises atoms that combine in order to form molecules. An atom comprises a very small, but relatively heavy nucleus, surrounded by very light electrons. The nucleus contains a certain number of protons, each of them with a positive charge, and the numberof negatively charged electrons is equal to the number of protons, rendering the atom neutral. The atom is the smallest particle that maintains the physical and chemical properties of a chemical element.

Types of ionising radiations and their penetration power Various sources emit differenttypes of ionising radiations: • alpha (α) radiations, in fact the helium atoms, interact with numerous

atoms over a very short distance, produce ions and consume all their energy over that small distance; most alpha particles will deplete all their energywhen crossing a simple sheet of paper; the main effect upon health, correlated with the alpha particles, occurs when alpha-emitting materials are ingested or inhaled, and the energy of alpha particles affects internal tissues, such as the lungs;

• beta (β) radiations comprise electrons – light negatively charged particles; they move over a slightly longer distance through air and can go through paper, but cannot go through skin; the effects of beta particles upon health occur mainly when beta-emitting materials are ingested or inhaled;

• gamma (γ) radiations exist as electromagnetic waves or photons emitted by the atom nucleus; they can completely cross the human body, being stopped only by a concrete wall or a 15-cm thick lead plate; gamma radiations are stopped by: water, concrete and, in particular, by dense materials such as lead, used as protection against exposure to this radiation type; the effects of gamma particles upon health occur mainly when gamma-emitting materials are outside the human body;

• X-rays are low-energy gamma radiations; in the case of the human body, they can penetrate muscle tissues, but cannot go through bones, which makes them useful in medicine(X-ray scans).

Page 64: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

64

The equipment to be installed in radiotherapyand imaging centre emit X and Y (gamma) radiations

Possible negative effects: Ionising radiations may be harmful to humans. Just as the sun can

burn the skin, ionising radiations may cause damage to the body. On their path, ionising radiationsrelease a sufficient amount of energy to be able to remove one or several electrons from the atoms of irradiated atoms, consequently disturbing the balance of their normal chemical activity within living tissues. When these chemical processes reach a certain imbalance degree, living cells can no longer regenerate themselves by natural means and remain permanently imbalanced or die (the case of DNA destruction).

The severity degree of radiation effects depends on: • exposure duration, • radiation intensity, • radiation type.

Exposure to a very elevated dose of radiations may shortly lead to skin burns, nausea and internal haemorrhages; the body is unable to generate new cells over a short amount of time. Extended exposure to smaller doses of radiations may cause the delayed occurrence of cancer and, possibly, of hereditary diseases, a phenomenon noticed especially among survivors of the Hiroshima and Nagasaki bombings.

Radiation dose The radiation level a person is exposed to and the risk resulted from

exposure is measured using the concept of “dose”which is, is simple terms, a measure of the energy delivered by the respective radiation to the human tissue. The simplest form of expressing the dose is the absorbed doze, defined as the energy absorbed by the radiation within a kilogram of tissue. The dose unit absorbed is expressed in Joules per Kilogram (J/kg) and is called gray (Gy). The tolerated unit of absorbed dose is the rad (radiation absorbed dose).

1 Gy = 100 rad. Sincean absorbed dose, in the case of alpha radiations, causes more

damage within living tissues than the same doseof beta and gamma radiations, the absorbed dose is multiplied by a constant (which is 20 for alpha radiations and 1 for gamma and beta radiations) in order to obtain the equivalent dose. This equivalent dose is measured using the following units – Sievert (Sv) or rem (1 Sv = 100 rem). 1 Sv represents an extremely high dose and, therefore, the doses are often expressed in mSv (thousands of Sievert).

For example, a normal person, who is not exposed to additional natural or artificial sources of radioactivity, receives a dose of natural radiations between 2 and 3 mSv a year. The sensitivity of human tissues to

Page 65: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

65

radiations differs depending on the tissue, for instance, one dose of 1 Sv is more harmful for the reproductive organs than it is for the liver. The actual dose is calculated by applying the weighting factors to the equivalent doses, for each organ, and by totalling the inputs from various organs. The measuring unit for the effective dose is, once again, theSievert (Sv). The effective dose is the weighted sum of the equivalent dosesoriginating from external and internal exposures, calculated for all the tissues and organs in the human body. The effective dose is the same Sievert. The tolerated unit of equivalent dose is the rem (röntgen equivalent man). 1 Sv = 100 rem. Examples of doses: Activity Equivalent dose received by a person Average world dose from all sources 2.8 mSv a year Round trip by plane Europe - the USA 0.1 mSv Pulmonary X-ray scan 0.1 mSv High-dose medical procedure 5-10 mSv

Measures intended to prevent negative effects: Safety measures will also be taken so that none of the equipment

items should emit into the environment polluting agents. Measurements shall be carried out by the CNCAN expert to check the designed bunkers, periodic inspections shall be performed and the equipment operation status shall be analysed.

The personnel designated to operate this machinery shall be trained, shall receive protection items and observe all the requirementsso that the devices should not display any functional issues. The nuclear security policy shall govern the attitudes and behaviours of the entire staff concerning nuclear security. Within the organisation and the entire staff a nuclear security culture compliant with the requirements shall be set up and documented in the policy statements. The nuclear security culture shall be permanently assessed and improved.

The external skin contamination assessment is done using a portable contaminometer/dosimeter.

Other practical measures The personnel can protect themselves against radiations by observing the implemented procedures that rely on the radiological safety rules in effect and good radiological practices. As such, they shall shield themselves against and keep their distance from the source, combined or otherwise, so that the radiation level should drop as they move away from the source.

Page 66: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

66

International principles Given the assumption that any radiation dose poses certain risks and

the permanent presence of background radiations in nature, it is not possible to eliminate all the risks associated to these radiations. In order to keep this risk at the lowest possible level while also allowing the beneficial use of radiations and radioactive materials, a series of protection principles for those activities has been drawn up so that the doses received by people may be safely increased:

• these activities shall be carried out only if the positive effects exceed the negative ones, that is, if the benefits resulted from such practices exceed the generated risks;

• the radiation risks – related to a certain activity – must not exceed the specified limits;

• evenbelow these limits, radiation risks must be kept at the lowest possible level - ALARA (as low as reasonably achievable), meaning that measures must be taken to reduce risks as much as possible, save for the case when they are too costly or too difficult in comparison with the possible dose reduction.

Limits In the case of radiation sources that can be controlled, there are limits

for the doses that individuals can receive. A person must not be exposed to more than 1 milisivert a year from all nuclear units and other radiation-emitting activities.

This does not include the doses received by a person from natural radiation sources or for medical purposes. An employee working with radiations must not receive more than 20 mSv a year from the respective activity.

There are special restrictions regarding pregnant women working with radiations, intended to guarantee the protection of the foetus. One must also mention that these are upper limits, but complying strictly with these limits is not sufficient.

The doses must be maintained at the lowest possible value, within reasonable limits, which usually means they are significantly below these limits. In fact, people living near the respective facilities must not receive additional doses in comparison with the rest of the population. Moreover, most employees in the nuclear industry must not receive more than a few

Page 67: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

67

mSv a year, whereas employees from other fields – such as the airline or the staff – should receive similar doses in their professional activity.

• Radiotherapy compartment Itshall comprise:

o 2 treatment rooms (bunkers) mirroring each other, o 2 control rooms attached to the treatment rooms, o CT scanner simulator room, o CT scanner simulator control room, o patient care areas: - waiting area for lying-down

patients/abled patients/companions; patient examination room,

o areas intended for the medical staff: - physician preparation; - medical materials warehouse,

o spaces for treatment planning (physicists’ office), o space reserved for preparing casts required by patient

anchoring systems during treatments, o area reserved for the medical archive, o area reserved for the oncology computer system (IT room),

including a special room for the database server, o administrative spaces: - reception lobby; -

secretariat/reception; - physicians’, registered nurses’ offices; - IT room; - office/kitchen; -material warehouse; - warehouse for carts/beds; - cleaning room; - litter/waste; - restrooms for w/m/disabled persons; - restroom for w/m/medical staff,

o accommodation unit for temporary patients. Note: the radiotherapyward shall be organised as per the provisionsof MoH (Ministry of Health) Order no. 914/07.2006 andLaw 95/14.04.2006, and the spacesshall be fitted withadequate furniture, whereas the surfaces shall be finished as per the provisions in force.

Each treatment room shall be fitted with: o protontherapy system o linear high-energy particle accelerator, o laser system used to check patient positioning, o ventilation system designed to cover at least 6-8

exchanges/hour so that the ionised air should be exhausted under maximum safety conditions both for the medical staff inthe departmentand the patients under treatment,

o shall be connected, by means of related installations, to an independent cooling system, to be located in the immediate proximity of the treatment room (the outer area), thus allowing an easy access,

Page 68: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

68

o audio-video communication/patient monitoring system, o specific furniture for storing radiotherapy accessories, o mobile screen compliant with radiation protection rules in

force, ensuring a controlled access. o specific warning systems in accordance to the legal

provisions in force.

The CT scanner simulator roomshall be fitted with:

o CT scanner simulator, o laser system used to check patient positioning, o furniture specific torelated accessories, o mobile screen compliant with radiation protection rules in

force, ensuring a controlled access, o specific warning systems in accordance to the legal

provisions in force.

CT scanner simulator control room The control room shall be exclusively used by the medical staff in department.

The control room shall be fitted with: o specific furniture for positioning the control panel and the

related equipment, o CT scanner simulator control and command unit, o audio-video communication/patient monitoring system.

Temporary accommodation unit The accommodation unit shall be easily accessible from the main lobbyof the basement -1 level 1 by means of the vertical traffic hub, both by patients and visitors and by themedical staff. This unit shall comprise anaccommodation unitwith 10 beds and transport chairs of the armchair-sofa type that can accommodate patients over the entire duration of examination protocols, as well as of minor emergency procedures. The space intended for the oncology computer system (IT room), including a special room for the database server, shall be fitted with:

o IT oncology system database server, o climate control system specific to the server room, o computer network required to process and send the date

within the department, o furniture specific tothe computer network layout.

Estimates indicate a total minimum built area of 1,500 sq m / a net area of 1,100 sq m,and cost for the space of approximately 2-2.5 mil. Euro.

Page 69: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

69

Regarding the linear particle accelerators, they should be identical so that they may be used without recalculating the treatment plan should one of them suffer malfunctions – approximately 2 mil. Euro LINAC 1 andapproximately 1.5 mil. Euro LINAC 2.

Simulation CT scanner – 350,000 Euro. Dosimetry equipment – 300,000 Euro. Other equipment items (computers, servers, etc.) 100,000 Euro. We are, therefore, looking at an investment amounting to a minimum

estimated total of 4.75 million Euro, according to a previously conducted study. The staff involved in radiotherapy treatment During the treatment undergone at the cancer treating centre, thepatient shall be monitored by a certain number of doctors and registered nurses. All shall be able to answer to treatment-related question or refer to the person capable to provide answers to the patients’ questions.

The medical staffrequired to adequately carry out the activity: • oncologists: physicians specialised in treating cancer, also making

treatment-related decisions; • radiation therapists: in charge with planning and conducting ionising

radiation therapy; • registered nurses and technicians:they monitor and provide support

to the patient over the entire treatment duration; • physicists: experts in planning radiation treatment; • nutritionists: they manage the oncology patients’ nutritional needs; • counselling psychologist for patients and their familiesprovide support

to individuals with emotional issues.

The 7th floor shall host the spaces for educational and teaching purposes within “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B.

They shall be organisedas follows: o amphitheatre, o room for practical presentations/seminars, o activities room, o professors’ offices, o didactic information centre/library, o others (lobbyand wardrobe, storage area, buffet, restrooms).

All these spacesshall be fitted withspecific furniture and equipment.

Page 70: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

70

There will be at least one amphitheatre included, together with a room forpractical presentations/seminars, fitted with avirtual (holographic) anatomy interactive didactic system, etc. The areas of the otherauxiliary technical and medical services (pharmacy, morgue), the household and technical services area are “dirty” areas, closed for patients and other staff categories outside their own staff and strictly separated from areas subject to asepsis requirements; they are hospital interface areas in relation to the locality’s technical and function-based services, to the units providing materials and products, to various urban utility networks; the compartmentscontained shall be directly accessed from the service area of the hospital premises. They shall be located on the semi-basement (on the ground floor) of hospital buildings, as well as inside attached isolated structures.

Inside“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, the areas reserved for such spaces – the pharmacy and the morgue – shall be located on the building ground floor and have a restricted access as opposed to the other hospital compartmentsand units.

The pharmacy is the service providing to admitted patients medical care in the form of medicine for human use.The pharmacy performs the qualitative and quantitative acceptance of medicines and other products for human use, their preservation, the release of medication and other products for human use as per the prescription registers, is in charge with preparing and releasinggeneric and prescription-based pharmaceutical compounds.

The pharmacy shall run a department-based automated distribution system for the medication prescribed in the computer system –in-hospital robotics.

The pharmacy shall be located in adequate areas, away from sections that may contaminate or negatively influence the quality of medicines.

The pharmacy must have good connections to all the medicalservices ofthe hospitaland have the best possible access from the vertical traffic hub.

The pharmacy shall be located on the ground floor of the new hospital and be easily accessible from outside for supply purposes, as well as from themain lobbyby external patients.

Eachward and compartmentshall have operational pharmaceutical points coordinated via a central in-hospital medication management and tracking computer system.

Page 71: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

71

This system allows both the control of the medication administered to patients, reducing medical errors and securing the risk medication, as well as a more streamlined inventory management, significantly decreasing long-term hospital costs.

Both the storage spaces and the department-based medication distribution points shall benefit frommobile cabinets and medication carts fitted with a secured electronic modular system and efficient partitioning for storage purposes.

By means of the barcode system, pharmaceutical items can be tracked warehouse release untiladministration to patients, inside a single pharmaceutical management system that facilitates an automated and computerised logistics management of medicines.

The automation and IT system covering all the processes related to the clinical and logistics management of pharmaceutical products and the complete system for the management of medicines and consumables (hereafter called “pharmaceutical products”or just “products”), employed in medical care institutions, allow total identification and tracking of products during any stage of the logistics process.

The system allows the user to managepharmaceutical products wither in their original packingand/or in tailored packing,with a highly accurate tracking degree characteristic of medication management.

In addition to complete tracking for each box of medicines up to the patient’s bed, required in the global control of all products, this solution drastically reduces the time reserved for repetitive logistics, often handled by qualified staff such as pharmacists.

The introduction of computer-based network (e-prescription) and digital medication-administering system (e-administering) ensures the accurate invoicing in real time of each medicinal product specific to a particular patient, as well as the effective management of the entire hospital stocks, reducing medication errors and the related costs while also avoiding the following aspects:

- product waste (for instance, due to the wrong administration of a potentially harmful medicine, which can ultimately no longer be invoiced or reassigned to another patient);

- subsidizing requests (which, in general, lead to costlier insurance policies);

- admission period extensions (to treat adverse effects),highly unlikely to the covered by patients or insurance funds.

The pathological anatomy service(the morgue) shall operate inside a space on the premises ground floor. The location of this compartmentin the hospitalshall provide separate access for the family of the deceased, from the hospital main lobby, without intersecting the other hospital flows.

Page 72: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

72

The pathological anatomy service (the morgue) shall host the following activities:

- the autopsy and embalming of the corpses of patients deceased in the new hospital, - the bodies of patientsdeceased in the hospital are collected 2-4 days after their demise, except for those with no next of kin, which are kept for 10 or over 10 daysor those requiring the observance of protocols for infectious diseases, - teaching activities for students.

The morgue compartmentshall comprise: o defunct display room, o waiting lobby for families, o corpse preparation room, o autopsy room, o anatomical pathology laboratory, o corpse preservation, o decontamination area, o bedpan, o materials warehouse, o anatomopathologist’s/registered nurses’ office, o restrooms, o cleaning room, o waste/litter area.

Autopsy and laboratory determination operations generate noxae (smells, releases of toxic vapours) and entail an infection hazard. Laboratory hoods shall be installed. Mechanical ventilation of the rooms is mandatory.

The walls of the roomsshall be flat, smooth, with a self-cleaning system. The floor shall be fitted with a drainage siphon and a drainage gradient connected to the sewage network. The residues shall be disinfected prior to discharge. The rooms shall be fitted withhot and cold water installations, electrical installations and staff showers. The location of this service shall ensure the direct access form outside for next of kin and body collection. The area of this access shall include a space to park the hearse, hidden from the sight of patient wards. The access from the hospital shall benefit from a hygienic-medical filter that would make it possible to isolate the internal traffic of the service from the other traffic paths in the hospital. This access route will have direct

Page 73: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

73

links to the operating room unitand the vertical traffic hub of the hospitalisation sector.

The o corpse preparation room shall be fitted with: o corpse washing tables, with a stable stainless steel structure,

hydraulically adjustable in height and TR/ATR tiltable; fitted witha rolling frame for washing plates; fitted withdrain,

o mobile, stainless steel corpse transportation tables, fitted with detachable surfaces and cover lids,

o stainless steel washing station, with elevated edges, drain connected to the station sewage system and hot/cold water mixer tap, including a hand shower with a 3-m hose – to be used both with corpse washing tables and transportation tables.

The o corpse preservation room shall be fitted with: o onestorage and refrigeration unit with 10 slots and individual

doors, o onestorage and refrigeration unit with4 slots and 2 doors.

The slots have minimum dimensions of 720 x 500 mm. The unit walls are clad and benefit from antimicrobial protection.

The autopsy roomshall be fitted with: o electrical stainless steel autopsy table, adjustable in height, with

a 180° rotation capacity, perforated drain area, elevated edges, continuous washing system cu water jets mounted under the work area, having at one end a water tank fitted with an overflow valve, as well as water connection, shower with hose; it is knee-actuated and can be connected to the ventilation system,

o autopsy table lighting system, made ofstainless steel, capable of providing daylight-like lighting,

o 2 stainless steel scales columns suspended from the ceiling, onefitted witha weighing shelf and theother with a hook and tray,

o stainless steel mobile table for instruments, with detachable benchtop, hydraulically adjusted height and a drainage sluice valve,

o stainless steel organ table, fitted with a drain slot and a special polyethylene area for organ dissection

Page 74: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

74

o 2-vat stainless steel washbasin, o medication cart fitted withdrawers of several sizes, dispenser of

specific substances and accessories such as: glove supports, container for sharp waste; vial opener; plastic waste bin; catheter container, infusion stand,

o stainless steel cabinet for specific substances and materials, fitted in the upper part with 2 swinging glass doors and drawers and a metallic door in the lower part,

o mobile storage cart, fitted with stainless steel baskets on a mobile stand, for storingspecific materials,

o support for residue collection bags – a stainless steel mobile frame, with three compartments for3 waste collection bags carrying at least 80l, and eachcompartmentshall be fitted with a coloured lid actuated by a pedal/proximity sensor.

The anatomic pathology laboratoryshall be fitted with:

o stainless steel orientation table with aspiration function, placed along the wall; fitted witha washbasin with hot and cold water taps, shower-and-retractable-hose washing system; vapour aspiration system; work area made of perforated stainless steel plates; continuous washing system with water jets placed under the work area; fitted witha formaline vat; fitted witha mobile aspiration unit

o orientation and standardisation plate; plate surface fitted with graduated metallic rulers, for two orthogonal sides, and special accessories for standardised orientation,

o floor-mounted tissue processor for tissue processing inside a hermetically sealed vat; capacity ofapproximately 150 biopsy de cassettes, hermetically sealed system with active carbon filter for filtration and water bath,

o station for submerging samples into paraffin, comprising a thermostat storing module, the paraffin dispenser with adjustable flow rate and a cooling plate,

o manual rotary microtome forresection in paraffin, with an 0,5-60 µm adjustment for the section thickness, resection with microtome blades, universal vice for biopsy cassette fixing,

o thermostatic heating plate, rectangular section, adjustable temperature, overheating protection,

Page 75: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

75

o flotation bath for drawing samples, in paraffin, on histology lamellae; circular section, adjustable temperature, overheating protection,

o automatic colouring machine – linear two-stage automatichistokinette,

o lamella film-covering automatic machine, o laboratory microscopes for histology and cytology diagnosis,

fitted with transmission LEDlighting, digital image acquisition and analysis system and PC.

o Modular cabinet for histology lamellae and paraffin blocks, o stainless steel cabinets for materials, fitted in the upper part

with 2 swinging glass doors and drawers and a metallic door in the lower part.

Bedpans shall be used to empty, wash, disinfect and dry the instruments used for patient hygiene. They are used together with a cutting/shredding device for patient urine and secretion collection bags: urine bags, Redon tubes, etc., providing safety conditions for the operator and significantly reducing the amount of infectious waste. It shall be installed in a purposely reserved space and requires connections to running water, electricity and sewage utilities. As part of the washing process, the equipment can be loaded at least with one bedpan and one urinal or with 3 urinals. The system employed to organise traffic paths inside the building shall have to meet the following requirement: the transit of patients (hospitalised or treated in outpatient units) from first entering the hospital until the time of discharge, going through all the medical, diagnosis and treatment compartments, has to occur in a continuous flow, along clearly-defined paths, accessible under equally safe conditions, both for trips on foot and trips in wheelchairs, on a wheeled stretcher or bed. The general traffic path system shall be operated in a manner that allows the placement of control and filter points at crossings to the various areas or compartments with traffic restrictions. One shall keep in mind that their location must not block the main traffic flows which should normally remain open. Depending on the user categories, access paths from outside into the building can be: common (the main access path, the access path to the outpatient sector), restricted - tocertain user categories (the service access path, the access to the emergency sector, the access for fast response

Page 76: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

76

teams), orspecialised- onlyintended for a particular staff or material category (supply access paths for the pharmacy, thekitchen, the nuclear medicine laboratory). Building B

On the ground floor one shall find spaces reserved for consulting rooms, internal and international multi-centre clinical trial, sample drawing rooms and the laboratory, as well as for functional explorations, the pharmacy, medical study rooms, the archive and related spaces (warehouses for sterile supplies, the wardrobe, etc.). The 6th, 7th and 8th floors are exclusively reserved for scientific research laboratories– fundamental research in particular, whereas the remaining floors, 1st – 5th, host generous accommodation areas. Consulting rooms–there shall be 8 of these, for various intended purposes. Each one shall be fittedout depending on the speciality covered. Additionally, 3 patient closed-circuit consulting roomsshall be included. Each consulting roomshall be fittedwith an electrical, height-adjustable examination couch; examination LED lamps; cabinet for medication and medical supplies; physician’s desk and chair; washbasin for hygienic medical staff hand washing, fitted with dispenser liquid soap, dispenser of disposable paper tissues and alcohol dispenser All theconsulting rooms shall be fitted withmedical gas machines.

Additionally, each speciality shall benefit from its own specific and required stainless steelfurniture.

- the cardiology consulting roomshall be fitted with a 12-lead ECG device with display and interpretation software; a stress testing system and Holters to monitor BP and ECG device connected to the electronic patient chart.

- the gynaecology consulting roomshall also be fittedwith an electrical couch for gynaecological examinations with embedded colposcope and HD display – in Building A .

Functional explorations – this service comprises, focused around the clinic, a wide variety of investigation techniques that are based on the use of high-tech specialised devices and make it possible to obtain data on the functional potential of various organs and systems in the human body. The service shall be located in the vicinity of the Roentgen diagnosis service and the medical test laboratory. A direct link shall be provided with the emergency service, the outpatient sector and the daytime care compartment. There will also be an area fitted with ECG, multidisciplinary ECG device, a stress testing system, TA-monitoring HolterandECG, EEG+EMG, devices for spirometry, cardiac and haemodynamic monitoring, etc.

Page 77: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

77

The consulting roomshall be fitted with an electrical, height-adjustable consultation couch; examination LED lamps; cabinet for medication and medical supplies; physician’s desk and chair; washbasin for hygienic medical staff hand washing, fitted with dispenser liquid soap, dispenser of disposable paper tissues and alcohol dispenser. Each activity sector (consulting rooms, sample drawing rooms, laboratory, care units, etc.) shall be set up as per Order 914/July 26, 2006 for the approval of the rules on the requirements a hospital must meet in order to obtain the sanitary permit to operate. All the spaces shall be fitted with equipment specific to each activity: bed sheet carts, transportation carts, pedal-and-lid waste bins, cleaning carts, supports for residue collection bags, liquid soap dispensers, disposable paper tissue and alcohol dispensers. Specific and research laboratories, as large spaces intended for scientific research and innovations, shall be located on the upper floors.

These shall contain the dedicated spaces:

6TH FLOOR

- Fuzzy logic laboratory, - Analytical chemistry laboratory, - Organic chemistry laboratory, - Quantum physics laboratory, - Departmentsfor research+security solutions, - Room for reports on evolutionary stages, - Organic chemistry study, - Experiment room, - Flammable substance room, -Special material study, cubicals, Head of analytical chemistry office, Boolean materials study 1, 2, - Others: general research reception, maintenance materials department, research materials department, library, machinery and device department, offices, on-call rooms, meeting room, staff restrooms, warehouses.

7TH FLOOR

- Biophysics laboratory - Cybernetics laboratory - Crystalogy laboratory - Electrical engineering laboratory

Page 78: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

78

- Nanotechnologies laboratory - Proteomics laboratory - Metabolomics laboratory - Molecular genetics laboratory - Inorganic chemistry laboratory - Cybernetics study, Head of biophysics study, Biostatistics study, Electrical engineering study, General statistics study, Head of biology study, Head of scriptology study, Head of statistics study, Inorganic chemistry study, - Others: department for research materials+devices/machinery, biological system writing, restrooms, storage, cleaning equipment department, flammable substance department, devices/machinery department.

8TH FLOOR

- Stop codon system laboratory. - Inductive system laboratory. - Regressive system laboratory - Storage laboratory. - Pharmacology and pharmacogenomics laboratory. - Paradigm-related contradiction laboratory. - Bacteriological system laboratory. - Virology system laboratory. - Parasitological system laboratory. - Mycological system laboratory. - Biological signalling system laboratory. - Translational system laboratory. - Paradigm-related contradiction study, Head of pharmacology study, Head of virology systems study, Head of bacteriology systems study, Head of mycological systems study, Head of biological signalling system study. - Others:biological system decoding, brainstorming room, IT rom, warehouses, restrooms, device/machinery department, flammable substance department.

Patient traffic path -hospitalisation

Page 79: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

79

Daytime care

The patients admitted in the daytime care unit are taken over, after they have been registered in the hospital database, by the registered nurse handling their supervision at this stage, and led to the ward. At the end of the hospitalisation period, patients are discharged by the discharging office within“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B.

Patients are registered in the database of “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building Band, as per the appointments, are taken over by the consultant in the outpatient unit. After the examination, the patient is informed on the following steps and is scheduled for the subsequent consult.

Radiotherapy department Patients are registered in the database of “Dr. Calistrat Grozovici”

Multifunctional Clinic - Building A and Building B and, as per the appointment and therunning number, are led by the nurse to theRadiotherapy department area, where are taken over by the physician or technician in charge with administering the treatment. Upon treatment completion, the patient receives the information required for the following stage and is scheduled as per the physician’s instructions.

“Clean items” circuit “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and

Building Bshall have its laundry service performed as per a service contract concluded with an authorised company. The clean items of the clinic shall be individually packed in white bags marked with the “clean items” message. The clean items are taken over by the staff and stored in the basement, in the purposely reserved space –Clean items warehouse. The storage shall observe the hygiene rules along the clean items circuit, as well. From the central clean items warehouse, depending on the requirements of each department, they are transferred using elevator for clean items – in-hospital robotic system. Bed sheets are changed for newly admitted patients, when necessary and at least every 3 days

“Dirty items” circuit

Page 80: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

80

The clinic shall have concluded a service contract with an authorised company for the performance of laundry services. The dirty items from the departmentsare temporarily stored in purposely outfitted areas (dirty items lodge). Every day at 20:00 or whenever necessary, they are taken over by nurses and transported along the clinic “dirty items” circuit, using the elevator for dirty items, in the basement, in the purposely reserved space (clinic dirty items warehouse). The dirty items are packed in yellow bags marked with the “dirty items” messageand taken over by the in-hospital robotic system in order to be transported and taken over by the laundry service contractor.

Waste circuit The waste produced by the clinic activities comprises:

- householdwaste, - infectious waste, - sharp waste, - toxic waste, - radioactive waste.

The waste is collected as per MoH Order 219/2002 in bags of various colours, in line with the colour code for each type of waste. At a department level there shall be a purposely fitted space – the lodge for temporary collection and storage of waste. The waste is collected at least twice a day or whenever necessary and transported in a special cart tothe waste lodge. When the bag is filled to a maximum of ¾ of its volume, it is sealed and transported along the dirty items circuit, with the dirty items elevator, to the purposely reserved space at the back of the building. The space displays, according to the rules, a perimeter closed with a “padlock”, controlled access, floor drainage siphon and a water source. From there, the infectious, hazardous, sharp medical waste is taken over, whereas household waste is transported to the waste ramp, where they are taken over, as provided in the contract, by the waste disposal company. Prior to being taken over, the waste is weighed. The resulted amounts are reported to DSP (Public Health Directorate) - amounts of infectious, sharp and toxic waste, and to the environmental protection agency - amounts of household waste. Radioactive waste (as the case may be) are subject to a special handling, storage and disposal regime in line with the regulations in force and internal procedures. Waste transportation recipients are washed and disinfected prior to reaching each compartment. Every 2 days, the space reserved for temporary storage shall be washed and disinfected -automatic decontamination system (self-cleaning).

Page 81: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

81

Waste handling is carried out in compliance with the personal protection rules. Waste transportation and storage containers shall observe the colour code and be marked according to the rules. Medication circuit The pharmacy is organised as closed-circuit pharmacy, managing and providing the required medication. The pharmacy medication supplies are brought from outside, by way of direct communication with the pharmacy warehouse.

Supplies are taken over after they are checked for quality and compliance. The supplies and medication used shall comply with the regulations in force. The warehouse is organised in a manner allowing the separate storage of different product categories with/without special storage requirements. Access to the warehouse is restricted and only allowed to the authorised personnel. The medicine requirements in each department are estimated by the department nurse manager based on physician-issued prescriptions. Medications prescribed for the outpatient unit are provided directly inside consulting rooms. The medication is prepared in the pharmacylaboratory and the Prescription-based formulation section, from where it is transferred to theStorage and preparation section, then once again transferred, through the prescription receipt and delivery area, to the medical staff in charge with this activity in each ward – in-hospital robotic system. The medication is transported on the “clean items” circuit.

Supply circuit The materials used in hospital-related activities are:

- general-use supplies, - medical supplies: sterile and non-sterile.

The provision of supplies is carried out depending on the requirements estimated during normal operating conditions. They are taken over by the head of the supply department, taken by elevator to and stored in purposely outfitted areas in the building basement. Storage conditions shall take into account the type of supplies and the suppliers’ storage requirements. After storage, the supplies are transported, as per the requirements in each ward, using carts, along the “clean items” circuit of the clinic.

Page 82: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

82

4.4. Current technical conditions (placing the objective under the

general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment objective is mandatory/implied, etc.)

Basically, implementing the Project does not require fundamental changes from an institutional standpoint. The PPP contract is virtually considered a PPP contract for public works, considering that its scope of works is, essentially, the conclusion, early during the contract term, of a contract for works with a significant value, and the services to be rendered by the private partner (operation and maintenance of a medical unit) can only be provided after the completion of these works and not by exclusively using the current facilities. As regards the institutions playing a part in signing and the performance of the contract, in accordance with the legislation in force, the PPP contract shall be signed by the National Commission for Strategy and Prognosis and shall be performed by the Ministry of Health by means of“Prof.Dr.Matei Balș” National Institute of Infectious Diseases. The process of monitoring the contract development shall mainly be carried out by the National Commission for Strategy and Prognosis, together with representatives of the Ministry of Healthand “Prof.Dr.Matei Balș” National Institute of Infectious Diseases. The private partner shall provide the project funding (from their own resourcesand/orresources provided by certain donors, according to art. 11 in GEO no. 39/2018 on the public-private partnership) and shall manage the construction and operation activities, including those subcontracted to a different contractor / operator. The environmental issues shall not constitute a major chapter of the technical project. The natural and the cultural environments shall be protected during both construction and operation. The environmental permit defines the requirements that have to be met concerning the construction and operation of the medical unit. The PPP contract holder shall be, according to chapter 1.4. in the Substantiation Study, the Ministry of Health by means of"Prof. Dr. Matei Balș" National Institute for Infectious Diseases. 5. Studies and analyses on the project execution manner

5.1. Differences between PPP and a traditional public procurement

Page 83: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

83

In order to set forth the relative merits of the project development alternative methods, the method employed as part of the substantiation study relied on comparing the project development costs in a PPP scenario with the project development costs in traditional public procurements. This analysis will generally follow the previously used methodology to generate a comparison that is relevant enough to adequately confirm the results obtained in the past.

Therefore, on the whole, there are two options for the execution of“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B:

a) awarding a design and works execution contract for the construction of the clinic and, subsequently, upon completion, maintenance and operation contracts;

b) awarding a PPP contract for public works, which would cover the entire life cycle of the project, from carrying out the design and acquiring funding to the execution of the works and the following permanent maintenanceof the medical unit, in the form of a public-private partnership.

Selecting either of the two options relies on an analysis (a substantiation study) set to reveal whether the execution of the project under a PPP regime is more economically efficient than executing the project as a classic public procurement.

The following sections present the differences between the two procurement options.

The traditional method for public procurements In the field of infrastructure, depending on the specific infrastructure a

public authority intends to build/rehabilitate, the public authority will usually choose between:

– a procurement based on the Contractual Conditions for Constructions (the “Red Book”) issued by FIDIC (the International Federation of Consulting Engineers),

– a procurement based on the Contractual Conditions for Equipment and Constructions, including Design(the “Yellow Book”) issued by FIDIC (the International Federation of Consulting Engineers).

The basic hypothesis is that all the financial means (except for income originating from certain fees charged by the medical unit in accordance to the current legislation) shall be provided by the government in the form of “revenues” for the project, depending on the requirements and in accordance tothe provisions ofGEO no. 39/2018 on the public-private partnership.

On the other hand, when the project is approached as part of a PPP, the payment requirements is divided into periodic instalments distributed over the entireoperational period, pursuant to thePPP contract.

Page 84: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

84

A schematic presentation of the contracting method under a public procurement regime is rendered in the diagram below:

Company I Company II Company III

Company A Company B Company C

Public Authority Financers Contracted loan

Interest and reimbursement

Contract for any operation & maintenance works not executed

by the Public Authority

Contract for any operation & maintenance works not executed

by the Public Authority

Contract for any operation & maintenance worksnot executed

by the Public Authority

Operation and Maintenance (O&M)

Design and Construction

Design & Construction contract for a portion of

the construction

Design & Construction contract for a portion of

the construction

Design & Construction contract for a portion of

the construction

Page 85: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

85

Public-private partnership In the case of the PPP project, it is assumed that the private partner shall cover the execution and funding of the project from their own sources, without the direct involvement of the public authority. Nevertheless, the project company/SPV providing the service will generate profits, to be distributed to equity providers and will thus generate a cash flow back to the public authority in the form of income tax. Although there clearly are, across the entire economy, other potential effects caused by the project upon the collection of taxes, it was assumed that these effects are generally specific to both purchasing methods and, therefore, unable to generate differences between the two. The model compares the net cash flows in the case of PSC (Construction Trade Association) and PPP, expressed as total NPV (net present value) of the total cash flows, for each category of costs. Since the model uses nominal cash flows, the regular nominal discount rate employed for income and expenses is 8%. Therefore, the significant differences between purchasing under a PPP regime and the traditional public procurement method consist in:

– the responsibility of conducting the maintenance and operation works belongs to the same company in charge with the design and construction, which leads to streamlining these two activities during the project life span;

– the private partner is a project company (designated in the literature “Special Purpose Vehicle” - SPV) whose objective is to fulfil the obligations deriving from the contract;

– the funding of this company is non-recourse or limited recourse and exclusively relies on the future estimated cash flows to be obtained from the activity conducted by this company for the sole purpose of implementing the contract and used to reimburse the funds made available (equity plus the contracted loan);

– the involvement of the project company’s shareholders is generally limited to funding the project company by way of contributions to the share capital and shareholder loans;

– the actual design, construction, operation and maintenance activities are conducted by the privatepartner/subcontractors, project company affiliates, acting as performance endorsers in favour of the project company;

– the payments to the private partner are made exclusively based upon and depending on the road availability and the quality of the services rendered during the contract term, construction quality being thus secured based on the commercial interest; the availability-based payment to be made by thepublic partner is known, from the awarding procedure phase, as part of a

Page 86: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

86

competitive selection process, also based on price; as a consequence, when the multifunctional clinic operation and maintenance contract is signed, the use and maintenance costs are known, unlike the traditional public procurement procedure, where decisions on the performance of operation and maintenance activities are made at future points in time, after the infrastructure has already been set up, thus resulting for a PPP a much higher cost predictability than in the case of a project carried out as a classic procurement;

– the availability-based payments to be made by the public partner are made during the operation period, at the end of construction and take into account the private partner’s performance level in rendering the services;

– most risks are allotted to the private partner, the rule being that the public partner shall exclusively bear the risks expressly allotted to them according to the contract.

- in comparison with the traditional purchase process, the private

partner’s financing costs can be higher in the case of a PPP project; on the other hand, the purchase of related services under a PPP regime as opposed to the purchase of distinct contracts, will, accordingly, lead to a high level of risk transfer to the private

Design, Construction, funding, Maintenance and Operation

Public Authority

Investors Main financers

Subcontractor for construction works

Subcontractor for maintenance & operation works

Own funds

Shares in the Romanian company

Construction contract

Maintenance and Operation

contract

PPP contract / concession

Reimbursements+interest

Main debt contracting based on future

estimated cash flows

Page 87: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

87

partnerand, possibly, to savings in their case, which can translate in bidding with prices deemed competitive for the public partner, as well as in the existence of adequate incentives for the private partner to perform the contract within the contractual deadlines and costs set forth (otherwise their capacity to reimburse the loan being jeopardised due to the lack of income and the project fails to advance to the exploitation stage within the deadlines set forth with the contracting authority and the financers), which would also make it possible to obtain the intended economic and social benefits.

– considering the focus laid upon the private partner’s performance in providing services during the entire operational stage of the project, as per the nature of PPP contracts, it is essential to pay attention to the investment end user.

5.2. Main activities carried out during each contractual

stage/period Main contractual stages In order to implement the public-private partnership contract, the

project company is set up according to the provisions of Law no. 31/1990, republished, as subsequently amended and supplemented.

The public partner’ cash contribution to the share capital of the project company is the minimum amount stipulated by the requirements of the legislation in force.

The PPP contract is structured into two main stages, as follows: - the design and execution period, lasting 30 months after the signing

of the contract, - the operating stage, lasting up to 15 after the construction period

completion date. If the works are completed before the end of the 30-month

periodreserved for the design and execution works, the private partner shall receive from the public partner a successful completion bonus equivalent to the one-year share of frontloading period, the total annual amount of the of the successful completion bonus being 20% of the investment value.

If the completion of the design and execution period is marked by delays, the private partner shall pay the public partner a fine corresponding to the one-year share of the delay period, the total annual fine being 20% of the investment value.

The public partner’s contribution share in the performance of the investment, represented by financial resources different from non-

Page 88: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

88

reimbursable external funds, and the national contribution related to such funds may not exceed, as perGEO no. 39/2018 art. 12. par. (2), 25% of the investment total value.

The risk of occupation below the nominal number of beds may, however, translate either into availability-based payments or a contract term extension if, at the end of the initial term, the private partner has failed to obtain, due to a lower number of patients, the forecast profit.

The availability-based payment calculation is done based on the results of the activities conducted during the preliminary period, activities showing the private partner’s cash outputs and inputs that will also be included in their financial model. An annual payment during the operation period, not exceeding 2.5 million Euro. This payment is a contribution in terms of investment return on investment, since the bed occupation rate and the operating period of only 15 years might not allow the entire investment to be recovered over the term of the public-private partnership contract while also securing a reasonable profit for the private partner. The estimated value of the invested may be amended depending on the progress of medical technologies. In this case, the private investor may increase their funding share, reaching, or failing to reach, with the public partner an agreement based on which the latter would contribute, as well, to the funding amount increase.

Preliminary period During the preliminary period the following categories of activities shall

take place: a) Land investigations and design activities

Considering the changes carried out in order to optimise the alignment and the technical solutions as compared to those in the feasibility study, it is necessary to perform adequate land studies across the new alignment for the purpose of adjusting the construction price, set forth based on the geotechnical conditions resulted from specialised investigations to be carried out on site.

The land studies are to be conducted by a specialised entity under the control of both parties to the PPP contract – the public partner and the private partner, whereas the amounts due to it shall be paid by both parties, in equal proportions, to ensure impartiality in the performance of its activities.

After the performance of land investigations and updating the environmental permit, the construction cost shall be updated, as well.

Page 89: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

89

The update is a mathematical process, is not subject to negotiations between the parties and is conducted by applying the unit prices in the final quotation, specific to the land conditions ascertained (difficult, intermediate, easy), depending on their weight.

The construction price quoted by the winning company/consortium was set forth by means of quoting unit prices based on the above mentioned land conditions and established by the public partner. Therefore, the construction price shall be adjusted by:

- applying the unit prices quoted by the winning tenderer to the actual land conditions determined as a result of investigations,

- automatically recalculating the construction total price. The initially presumed land conditions were determined by the public

partner so as to better compare the tenders by taking into account pessimistic scenarios, so that grounds should exist for any possible reduction of the construction final price following this process.

Not all elements based on which the construction price quotation was formulated, elements set forth by the public partner, are subject to the revision process, but only those likely to depend on actual conditions.

Moreover, as opposed to the investigations carried out in order to adjust the construction cost, one shall also conduct all the land investigations required for the detailed design and to obtain the permits and approvals necessary in the execution of the works.

b) Activities performed to obtain funding for the entire project

At the time of concluding the PPP contract, the private partner shall have secured private funding in order to carry out the activities of the preliminary stage. Considering a new possible alignment and a new possible technical solution resulted from the dialogue stage and the investigations conducted during the preliminary stage, a fixed firm construction price shall be set forth by applying the adjustment mechanism based on these aspects, at the end of this period, whereas funds from financers would subsequently be obtained in that respect. Therefore, chronologically speaking, the activities directly aimed at obtaining funding are to be carried out during the preliminary period, after the previously mentioned investigations have been performed, and shall focus on providing the construction price resulted by applying the adjustment algorithm. Similar to the land conditions, the funding conditions were initially established by the private partnerin order to better compare the quotations, and were taken into account and included as such in the winning tenderer’s financial model.

Page 90: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

90

The financing structure of the entire project shall be set up as part of a competitive funding that is to take place according to the rules provided in the PPP contract and will aid in setting forth the effective financing costs provided by the financial markets at that time.

Competitive financing is a process in the performance of which the funds required to implement the project are to be obtained at the most convenient available financing cost, under current market conditions.

The procedure will be carried out by the private partner, under the public partner’s supervision. The procedure shall comply with the principles and practices of project funding on the European market and shall secure a fair and transparent competition among the financing sources available on the European market in the area of funding infrastructure projects.

At the end of thecompetitive financing, subsequent to the existence of an agreement regarding the financing structure, the financing contracts for the entire project shall be signed between the private partner and the financers. The procedure applied in order to sign the financing contracts, that is to initially draw the funds based on the financing contracts, is generically called the financial closure procedure.

Considering that the candidates’ tenders relied on the financial hypotheses taken into account, the PPP contract includes a detailed procedure which comprises the mechanism for adjusting the availability-based payment in relation to the differences in funding costs between the costs presumed by the public partner and the costs actually resulted from the competitive financing process.

The general purpose of the adjustment procedure is that the amount of the availability-based payment be adjusted in such a manner that any change in the costs related to external funding, when placing the initial hypotheses of the contracting authority in relation to the actual funding conditions, valid on the financial closure date, should not lead to a profit increase for the private partner and any savings achieved should be transferred to the contracting authority. This adjustment procedure will provide assurances that the public partnerand the private partner will not find themselves, at the time of the financial closure, on inferior or superior positions, in terms of project financial balance, than those at the time of the final bid.

In addition to the adjustment based on a comparison with the financing costs, the availability-based payment shall be adjusted at the end of the preliminary period, by being compared to the actual construction cost produced by the land investigations.

Page 91: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

91

c) Construction activities In parallel with the activities mentioned at letters a) and b) above, the private partner shall commence during the preliminary period the actual construction of the two buildings, A and B. The solution focuses on optimising the multifunctional clinic construction programme so that the private partner should benefit from the funds already made available. At the end of the preliminary period, the private partner shall obtain funding for the objective. The Financial closure shall be finalised within 3 months from the PPP contract signing date, a deadline that may be extended by 3 additional months.

To the extent to which the availability-based payment would increase after the preliminary period, the public partner is entitled to terminate the PPP contract.

Moreover, if the private partner fails to obtain funding for the entire project, the PPP contract shall be terminated.

The construction period The construction period commences on the financial closure date (the

date when funding is obtained for the entire project) and lasts 30 months(no more than 6 months for design and no more than 24 months for the actual construction), in which time the private partner is bound to finalise the construction of the objective in its entirety.

The operation period The operation period commences on the construction completion

date of“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, and shall last 15 years, a period in which the private partner is bound to operate and maintain the objective in accordance with the performance standards stipulated in the PPP contract.

The private partner’s obligation to operate and maintain “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B comprises all the activities required to permanently render afully functional and high-quality objective for its users.

The private partner must demonstrate frequently, during the contract term, that the operation and maintenance requirements are met.

If the personnel should fail to meet the requirements stipulated for the operation and maintenance of “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, they shall be penalised by the public partner, according to the provisions detailed in section 5.7.

The activities carried out by the private partner are intended to primarily ensure the health and safety users of services provided by “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, over the entire term of the PPP contract.

Page 92: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

92

5.3. Presentation of project costs and incomes, the payment

mechanism, the private partner’s incomes The total value of the investment for “Dr. Calistrat Grozovici”

Multifunctional Clinic- Building A and Building Bwas estimated, at the end of last year, to 650,709,389 lei (VAT-exclusive), out of which the value of construction and installation works was 379,453,978 lei (VAT-exclusive), and comprised:

-building A: investment value 359,170,601 lei (VAT-exclusive), out of

which the value of construction and installation works was 203.934.208 lei (VAT-exclusive).

-building B: investment value 291,538,772 lei (VAT-exclusive), out of which the value of construction and installation works was 175.519.770 lei (VAT-exclusive).

The structure of the capital expenses required to carry out the

investment objective is detailed below for each individual building. 5.3.A. Building A:

VAT 19% lei/Euro =4,6315 asat 11.12.2017

No. Designation of

expense category and subcategory

Value (VAT-exclusive) TVA Value (VAT-inclusive)

Lei Euro Lei Lei Euro 1 2 3 4 5 6 7

1ST CATEGORY Expenses required to acquire and set up the land 1.1 Land acquisition. 0 0 0 0 0 1.2 Land set-up. 0 0 0 0 0

1.3

Set-ups for environmental protection and rehabilitation to the initial state.

278,538 60,140 52,922 331,460 71,566

1.4

Expenses required to relocate/protect utility services (deviations of utility networks within the premises)

0 0 0 0 0

Total Cat. 1 = 278,538 60,140 52,922 331,460 71,566 2ND CATEGORYExpenses required to secure the utilities necessary for the objective

2.1 Connection networks, utility services for the objective.

8,733,428 1,885,659 1,659,351 10,392,779 2,243,934

Page 93: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

93

2.2 Machinery installation 0 0 0 0 0

2.3

Machinery, technological and functional equipment plus installation

2,246,067 484,955 426,753 2,672,820 577,096

Total Cat. 2 = 10,979,495 2,370,613 2,086,104 13,065,599 2,821,030 3RD CATEGORYExpenses for technical design and support

3.1

Land studies: geological, topographic.- tests of materials

65,180 14,073 12,384 77,564 16,747

3.2

Fees to obtain permits, permissions, authorisations and other similar expenses covered by the investor.

61,771 13,337 11,736 73,507 15,871

3.3 Design and engineering 15,295,066 3,302,400 2,906,062 18,201,128 3,929,856

3.4 Organisation of procurement procedures

324,706 70,108 61,694 386,400 83,429

3.5 Consultancy 4,078,684 880,640 774,950 4,853,634 1,047,962 3.6 Technical assistance 2,039,342 440,320 387,475 2,426,817 523,981

Total Cat. 3 = 21,864,749 4,720,878 4,154,302 26,019,051 5,617,845 4TH CATEGORYExpenses for the main investment

4.1 Constructions and Installations 189,842,575 40,989,436 36,070,089 225,912,664 48,777,429

4.1.1 Clinic, maximum height classification B+GF+6F

154,929,428 33,451,242 29,436,591 184,366,019 39,806,978

4.1.2 Parking lot 11,877,861 2,564,582 2,256,794 14,134,655 3,051,852 4.1.3 7th floor + Heliport 23,035,286 4,973,612 4,376,704 27,411,990 5,918,599

4.2 Technological machinery installation 1,184,834 255,821 225,118 1,409,952 304,427

4.3

Machinery, technological and functional equipment plus installation

20,179,896 4,357,097 3,834,180 24,014,076 5,184,946

4.4 Installation-free machinery and equipment

0 0 0 0 0

4.5 Facilities and furniture 984,182 212,497 186,995 1,171,177 252,872

4.6 Equipment, medical facilities and furniture 99,578,408 21,500,250 18,919,898 118,498,306 25,585,298

Total Cat. 4 = 311,769,895 67,315,102 59,236,280 371,006,175 80,104,971 5TH CATEGORYOther expenses

5.1 Construction site organisation: 1.677,902 362,280 318,801 1,996,703 431,114

5.1.1 – Construction works + installations 1,648,766 355,990 313,266 1,962,032 423,628

5.1.2 – Construction site organisation related expenses

29,136 6,291 5,536 34,672 7,486

5.2 Fees, taxes, rates according to the law, …costs

4,115,184 888,521 781,885 4,897,069 1,057,340

Page 94: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

94

5.2.1 - Fees, taxes and rates according to the law

0 0 0 0 0

5.2.2 –Cost of the loan 0 0 0 0 0

5.3 Miscellaneous and unforeseen expenses 10 %

8,484,853 1,831,988 1,612,122 10,096,975 2,180,066

Total Cat. 5 = 14,277,939 3,082,789 2,712,808 16,990,747 3,668,519 6TH CATEGORYCommissioning-related expenses

6.1 Operating staff training. 0 0 0 0 0

6.2 Technological trials and tests 0 0 0 0 0

Total Cat. 6 = 0 0 0 0 0 GENERAL TOTAL = 359,170,616 77,549,523 68,242,417 427,413,033 92,283,932

Out of which C+ I(constr. + install.)= 203,934,208 44,032,000 38,747,500 242,681,708 52,398,080

Operating (recurring) costs

Operating costs are those costs generated during current operation, as a result of implementing the project. In order to determine the financial indicators, two options shall be incrementally assessed:

- option 0 - no investment – (the current state); - option 2 - maximum investment.

The incremental analysis shall strictly focus on the changes occurred following project implementation.

Regardless of the option selected, one shall emphasize the fact that the defining element in the process to be completedshall not be the private investor’s efforts to make a profit, but providing medical care to patients the Institute has been created for.

Electricity costs The status of electricity costs, in the zero investment scenario, is the

following:

Page 95: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

95

In the scenario without a project, the monthly average electricity costs amount to around 103,730.70 lei/month, VAT-exclusive. Following the project implementation, the estimates, based on the installed capacity and specific consumptions of the new facilities/equipment, are for an additional monthly electricity consumption of around 333,334 kWh. The kwh/hourcost isapproximately 0.41lei/KWh, which provides an estimated monthly cost, for option 2, with a maximum investment, of 136,666.94 lei. According to the incremental principle, the increase of electricity-related costs shall be approximately 395,235 lei/year.

INVOICE NO. ISSUANCE DATE INVOICE AMOUNT INVOICED PERIOD

VAT-inclusive

5FM08589194 5.08.2015 70,143.87 1.07-2015-01.08.2015 5FM09407074 3.09.2015 59,851.73 1.08.2015-01.09.2015 5FM09781031 8.09.2015 80,559.22 01.09.2015-30.09.2015 5FM13275783 7.12.2015 52,898.14 01.11.2015-01.12.2015 5 MF13280444 9.12.2015 80,559.22 01.12.2015-31.12.2015 5MF03095820 23.03.2015 46,648.18 01.02.2015-01.03.2015 5 MF03842129 7.04.2015 48,370.95 01.03.2015-01.04.2015 5MF03848910 10.04.2015 81,821.51 01.04.2015-30.04.2015 5MF01159231 05.02.2015 63,685.18 01.01.2015-01.02.2015 5FMF01529874 10.02.2015 81,801.60 01.02.2015-28.02.2015 5 MF00375852 13.01.2015 80,911.19 01.01.2015-31.01.2015 5 MF00370454 08.01.2015 54,463.88 01.12.2014-01.01.2015 5MF08619143 11.08.2015 80,559.22 01.08.2015-31.08.2015 5MF10942875 5.10.2015 43,105.14 01.09.2015-.1.10.2015 5MF05010258 12.05.2015 81,821.51 01.05.2015-31.05.2015 5 MF06967249 03.07.2015 44,864.80 01.06.2015-01.07.2015 5 MF10947852 09.10.2015 80,559.22 01.10.2015-31.10.2015 5 MF11736134 4.11.2015 39,994.87 01.10.2015-01.11.2015 5 MF12115983 11.11.2015 80,559.22 01.11.2015-30.11.2015 5 MF02681525 05.03.2015 46,648.18 01.02.2015-01.03.2015 5 MF06166449 05.06.2015 19,066.78 01.05.2015-01.06.2015 5 MF06174948 15.06.2015 81,821.51 01.06.2015-30.06.2015 5 MF07342098 09.07.2015 80,559.22 01.07.2015-31.07.2015

TOTAL/year(VAT-EXCLUSIVE.) TOTAL/year (VAT-INCLUSIVE)

1,244,768.35 lei

1,481,274.34 lei

Page 96: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

96

INVOICE INVOICE NO. ISSUANCE DATE AMOUNT INVOICED PERIOD M3/YEAR

VAT-inclusive ANB150015827 20.01.2015 49,792.05 09.12.2014-13.01.2015 6,770 ANB150770163 17.11.2015 48,583.83 10.10.2015-09.11.2015 6,595 ANB150861104 22.12.2015 37,516.54 10.11.2015-10.12-2015 5,032 ANB150621784 17.09.2015 43,189.20 12.08.2015-08.09.2015 5,859 ANB1505444184 18.08.2015 50,219.89 10.07.2015-11.08.2015 8,370 ANB150696571 19.10.2015 47,847.42 09.09.2015-09.10.2015 7,975 ANB150091119 18.02.2015 42,516.53 14.01.2015-10.02.2015 5,764 ANB150163255 18.03.2015 40,045.33 11.02.2015-10.03.2015 6,674 ANB150239027 17.04.2015 37,606.86 11.03.2015-08.04.2015 5,062 ANB150316509 19.05.2015 43,115.18 09.04.2015-12.05.2015 5,797 ANB150392591 17.06.2015 35,298.52 13.05.2015-10.06.2015 4,736

TOTAL/YEAR (plus VAT-24%) TOTAL/YEAR (VAT-exclusive)

475,731.35 383,654.31

Water supply costs

The status of running water and sewer water costs, in the scenario without a project, is as follows:

In the scenario without a project, the monthly average costs for the supply of running and sewer water are around 31,917.20 lei/month (VAT-exclusive). Following increases in the number restrooms and the patient flow, the daily consumption is estimated to grow by approximately100m3, the equivalent of 3,000m3/month. The price of a cubic meter of water is approximately 6lei, resulting a cost of 18,000lei/month. The incremental consumption of running water and sewer water amounts to around 216,000 lei/year.

Telephone/internet subscription costs

Given the increasing number of medical personnel, it is estimated thatupdating the subscriptions to the local internet and telephony provider networks shall lead to an additional cost of approximately 3,450 lei/month. According to the incremental principle, the telephone/internet subscription costs shall increase by around 41,400 lei/year.

Staff-related costs The forecast is that, in comparison with the current situation, the

following jobs shall be created:

Page 97: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

97

- 85 physicianswith a monthly average gross salary of approximately 24,126lei/month;

- 401 registered nurseswith a monthly average gross salary ofapproximately8,032 lei/month;

- 65nurseswith a monthly average gross salary ofapproximately3,581 lei/month;

- 205 caretakerswith a monthly average gross salary ofapproximately3,526 lei/month;

- 5 pharmacistswith a monthly average gross salary ofapproximately8,576 lei/month;

- 40 medical statisticianswith a monthly average gross salary ofapproximately3,205 lei/month;

- 48 stretcher bearerswith a monthly average gross salary ofapproximately3,413 lei/month;

- 59 workerswith a monthly average gross salary ofapproximately2,818 lei/month;

- 20 TESA employeeswith a monthly average gross salary ofapproximately5,500 lei/month.

Costs related to the newly employed staff buildings A + B

Staff No. of jobs Monthly average net salary

Annual cost (lei)

PHYSICIAN 85 24,126 24,608,520 REGISTERED NURSE 401 8,032 38,649,984 NURSE 65 3,581 2,793,180 CARETAKER 205 3,526 8,673,960 PHARMACIST 5 8,576 514,560 MEDICAL STATISTICIAN 40 3,205 1,538,400 WORKER 59 2,818 1,995,144 TESA 20 5,500 1,320,000

Total/year 880 80,093,748

The annual incremental labour costs shall be of around80,093,748 lei/year.

The Romanian Government and the Ministry of Healthare bound to supplement the current staff according to the requirements.

The new structure created as such has to be able to employ personnel, over fixed/unlimited terms,in accordance tothe normatives in force on the respective hiring dates.

The personnel structure must meet the healthcare-related requirements, depending on the severity of the cases and the level of dependence upon bed care and bed rest.

Page 98: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

98

The staff may be hired by both the public and the private partners and the related aspects shall be regulated as per the PPP contract to be concluded.

Maintenance costs Maintenance costs are those costs emerging as a result of using the

equipment and consumables. They comprise the following categories:

Costs to purchase consumables Following the project implementation, there will be additional costs to

purchase consumables, given the increase of the number of patients and the new equipmentprovided in the project. We estimate an additional total annual cost of 108.000 lei/year.

Sanitation services– we estimate an incremental annual cost of

24.000 lei/year.

Repair costs Repair costs are costs occurring as a result of normal wear and tear

of finishes or damage caused by weather conditions and acts of vandalism. We estimate additional costs required by repairs, in comparison with the option without a project, of 0.1% of the value of construction and installation works. The resulting annual cost for maintenance and repairs is 135.252 lei/year.

Replacement costs The costs required to replace equipment, medical facilities and

furniture, fitted during the project implementation, are costs occurring as a result of normal wear and tear and obsolescence, as well as of acts of vandalism.

We estimate the following replacement costs: - thespecialised furniture and the additional facilities have a lifespan

between 10 and 20 years. We estimate that these replacement costs shall be 0.2% during the 3rd year, 0.5% during the 7th year and1% during the 11th year of operation, respectively, since not all the equipment items are likely to last until the end of the nominal term.

Value acc.to general cost estimate

Medical equipment, facilities and furniture

100,562,590 lei

3rd year 0.2% 201,256 lei 7th year 0.5% 502,813 lei

11th year

1.0%

1,005,625

lei

Page 99: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

99

Miscellaneous and unforeseen costs We estimate that the miscellaneous and unforeseen costs will amount

to 1% of the average figure of all annual recurring costs.

The general objective of the project is to improve the quality of medical services by executing the objective, “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, and outfitting it with high-performance and state-of-the-art equipment.

The necessity of this project is justified by the current state of the hospital, the needs of the target groups, the fulfilment of objectives, etc.

In this context, implementing the project in question shall settle certain matters of effectiveness, efficiency, healthcare continuity, patient safety, medical team competence, satisfaction manifested by patients, but also by the medical staff, as well as the environmental issues identified in this area.

Financial analysis The purposes of the financial analysis are to determine the cash

flows generated by the project, updated using a discount rate, and to find out whether a project is viable from a financial standpoint.

The net present valuerepresents the sum of future cash flows, as cash inputs and outputs, updated using a discount rate, so that their current value may be obtained. The net present value is calculated as follows:

The internal rate of financial returnis the discount rate whichbrings the updated project costs and the incomes it produces at equal levels. The rate of financial returnis the discount rate where we obtain NPV=0.

Financial sustainabilityis determined via the analysis of all annual cash flows. The project is deemed feasible and the intervention is justified if it generates cumulated cash flows higher than or equal to zero over the entire period after implementation.

The benefit-cost ratio is calculated as a ratio between the total receipts and the total payments made during the respective year. The benefit-cost ratio must be higher than or equal to zero for the project to the deemed viable in the future, and lower than one in order to deem the intervention necessary. The economic analysis, including the calculation of the economic performance indicators: the net present value, the internal rate of returnand the benefit-cost ratio.

NPV

Page 100: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

100

The financial analysis by itself is not sufficient to identify whether a project is efficient from a funding standpoint. Considering that most public utility projects are not focused on producing income, one must identify all the financial aspects or the financially quantifiable aspects pertaining to their implementation.

The incremental method involves determining the costs and economic benefits generated by the project implementation, by analysing the options without a project and the project-based ones. It requires calculating the economic efficiency indicators strictly relying on the cost increases or the additional incomes generated by the project.

The economic analysis identifies all the elements ensuring the welfare of the region and attempts to quantify in monetary terms the social, environmental, etc. implications.

The economic analysis requires applying certain adjustments namely: -fiscal adjustments–considering that public institutions obtain money from taxes, fiscal adjustments are absolutely necessary as they represent shifts of certain amounts within the same budget; as such, one must eliminate VAT and other taxes that generate outgoing cash flows, on the one hand, and incoming cash flows, on the other hand. -adjustmentsof external factors– they entail identifying the external benefits and costs received by the other participants in social life, different from the requesting authority; -the conversion of market prices into accounting prices -a conversion of this kind is required by the fact that actual current prices are unable to reflect their social value as a result of market distortions (monopoly regime, commercial barriers, etc.), rendering skewed analysis results. Accounting prices solve this issue as they dispose of such distortions, reflecting the social opportunity costs of resources.

These market distortion elements can be adjusted using the shadow prices.

The economic impact estimates have identified the following types of adjustments applicable to building A:

Fiscal adjustments The investment cost is affected by several taxes/levies: VAT, permit-

related levies, levies to ISC (State Inspectorate for Constructions) and CSC (Builders’ Social Fund). The investment value after applying the fiscal adjustment is the following:

Page 101: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

101

Adjustments of external factors These may have:

- negative influences, included in the analysis as economic costs; they occur both during construction and during the project lifespan;

- positive influences, included in the analysis as benefits; all these influences shall be divided according to their nature (environmental, economic, social).

5.4. Benefits attached to carrying out the investment 5.4.1.A. Environmental benefits The impact upon the environment is a positive one. The investment objective shall rely on the concept of “eco-friendly”

building, entailing a new, sustainable, long-lasting, non-toxic construction, with a minimum environmental impact, high energy efficiency, low water consumption, increased interior comfort and low toxic emissions. To achieve this goal: the system to be installed shall have water-to-water heat pumps –with

a great depth drilling of 80-120 m, water reinjection at a depth of 40 m, depending on the results obtained by the test drilling and the hydrological study, a system to be connected in the pump chamber, and a heat exchanger which subsequently distributes heat to the heating/cooling (climate control) systems present in the building;

a BMS-type advanced management system shall be fitted for building centralised control, designed to monitor the consumptions in the building–including protection and anti-breaking and entering systems;

Fiscal adjustment in lei

Indicator Investment Adjustment value

Investment value 427,413,033 VAT elimination -85,482,607

Tax elimination

-1,976,617 Adjustments sum -87,459,224 Adjusted value 339,953,809

Page 102: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

102

the interior lighting facilities shall be managed, as well, for increased efficiency purposes (reduction of consumptions);

toincrease energy efficiency, one shall install passive awning systems that provide solar protection during summer (decrease of climate control consumptions) and a sun-based heat source during the cold season;

the building terrace shall host photovoltaic solar panels, with a self-cleaning and deicing system, designed to ensure the electricity requirements for the operation of hospital-based equipment, climate control systems, elevators and other consumers during daytime; the option of a partnership for cogeneration with energy surplus shall be explored;

to render consumptions more efficient,LED lighting fixtures shall be used;

the green spaces and gardens shall host local resistant species and a green space management system shall be provided in order to reduce the water consumption impact and the maintenance requirements;

the building enveloping systems shall be made of highly efficient insulating materials designed to lower climate control consumptions;

the layout of the buildings shall ensure natural lighting, whereas the view from the inside shall not be blocked by tall buildings, which are absent from the area;

the materials employed shall not contain VOCs (volatile organic compounds) and shall incorporate, wherever possible, at least 20% recycled items.

5.4.2.A. Economic benefits

One of the most important benefits of the project is in the form of time savings, following a decreased hospitalisation time of medical cases requiring admission, considering the modern equipment and devices provided in the project.

Time savings are quantified for persons who employed people who are admitted for in-bed hospital care.

The average cost of a work hour has been estimated to 15Euro/hour. According to the project, 256 beds are reserved for Building A. The estimated average annual occupancy degree is estimated at95%, resulting an annual number of hospitalised persons of approximately89.462, out of which 75% are fit to work.

Page 103: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

103

Considering time savings of 4h/day/person, the annual benefit resulted is 18,645,342 lei.

Another benefit is the decrease of hospitalisation costs, considering that the prices charged in private hospitalsareapproximately750 lei/day.

The main incomes shall be provided by the National Health Insurance House.

However, it is estimated that 25% of the persons admitted every year shall bear the costs of their own hospitalisation(excluding pensioners, insured individuals, pupils and studentsor surgical procedures which are, according to the law, tax-exempt). The unit would thus gain an annual benefit of 20,128,838 lei.

Based on the data from previous years, the cost of a five-day hospitalisation, settled byNHIH, isapproximately 2,930 lei/bed.

Therefore, if75% of the 256 bedsin Building A are 95% occupied by insured patients, the resulted estimated annual income from NHIHis around39 million lei.

To this we can add healthcare subscriptions which physical persons or legal entities may conclude with “Dr. Calistrat Grozovici” Multifunctional Clinic, as well as amounts resulted from insurance contracts concluded by insurance companies with physical persons and/or legal entities.

Moreover, incomes can also be obtained from charging the approximately 300 parking spotsavailable to patients and their companions.

5.4.3.A. Social benefits

A positive impact occurring both during the investment implementation period, as well as pre- and post-implementation, is represented by the newly created jobs. It is estimated that, during the works execution stage, approximately 200 workers shall be employed and would subsequently contribute to the state budget witharound18.000,000 lei, benefits that could not be generated if the project were not implemented. According to estimates, during the operating stage 880 new jobs will be created, out of which: 85 upper-t ier staf f (physicians) and 795 medium-tier and auxiliary staff. These, too, shall generate incomes of approximately 36.042.187 lei/year from labour taxes and levies, benefits that would be equally impossible to generate if project were not implemented.

5.5.A. Sensitivity analyses Conversion of market prices into accounting prices

Page 104: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

104

In addition to fiscal distortions and influences from external factors, there are other factors that shift prices outside a competitive market:

- the existence of a monopoly regime, - the legal regulations applicable to the labour market (for instance, the

minimum wage), protection- or subsidy-based government policies. These market distortion elementscan be adjusted using the shadow

prices. Shadow prices must reflect the opportunity cost and the consumers’ willingness to pay for the goods and services provided by the respectiveinfrastructure.

It is considered that the economic price is determined as follows: - in the case of tangible assets, their economic value is rendered by the international parity cost (the import price); - in the case of production factors, their economic value is rendered by the opportunity cost.

The shadow prices are calculated by applying certain conversion factors to prices used in the financial analysis and, in this case, to simplify the calculation, the average value of the standard conversion factor used was around 0.64. The conversion factor for the workforce is determined taking into account the regional unemployment rate and the labour tax levels. For a 6% unemployment rate and a level of income tax paid by the employee of45%,the conversion factor is 0.40, keeping in mind the shift of payment tasks. The initial investment involves a 99% use of merchandises from the European Union, as a conversion based on import prices is not applicable. Starting from these values, the following rates are calculated for investment costs:

Cost structure Weight Conversion factor Shadow price rate Labour 25% 0.40 0.10 Materials 68% 0.80 0.54 Business owner’s profit 7% - - Total 100% 0.64

Maintenance costs

Cost structure Weight Conversion factor Shadow price rate

Labour

30%

0.40

0.12

Materials

60%

0.80

0.48

Business owner’s profit

10%

-

-

Page 105: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

105

Total

100%

0.60 Indicators resulted from the economic analysis:

Internal rate of return Indicator Obtained value

Internal rate of return 6.47 % Net economic present value 25,284,475

Financial sustainability (Benefit-cost ratio) 2.17

Specific costs of the investment in relation to the number of jobs and the gross area:

Beds =256

curs =4.6315 lei/Euro

Investment value (VAT-exclusive) Cost for 256 beds (VAT-exclusive)

lei Euro lei Euro

Investment value = 359,170,616 77,549,523 1,403,010 302,928

out of which Value C+I = 203,934,208 44,032,000 796,618 172,000 Machinery and equipment = 20,179,896 4,357,097 78,828 17,020

Equipment, medical facilities, furniture = 99,578,408 21,500,250 388,978 83,985

Other expenses = 14,277,939 3,082,789 55,773 12,042

Area = 27.520 sq m

Exchange rate=4.6315 lei/Euro

Investment value (VAT-exclusive) Cost for 256 beds (VAT-

exclusive)

lei Euro lei Euro

Investment value = 359,170,616 77,549,523 13,051 2,818

out of which Value C+I = 203,934,208 44,032,000 7,410 1,600 Machinery and equipment = 20,179,896 4,357,097 733 158

Equipment, medical facilities, furniture = 99,578,408 21,500,250 3,618 781

Other expenses = 14,277,939 3,082,789 519 112

(C+I) – construction and installation works

Page 106: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

106

Sensitivity analysis The sensitivity analysis is a technique used to investigate the impact of changing certain factors upon the main project indicators.

Normally, one would only analyse the unfavourable variations of these critical variables.

The purposes of the sensitivity analysis are: - to contribute to the identification of key variables with a significant influence upon the costs and benefits generated by the project; - to investigate the consequences of unfavourable changes of these critical variables; - to assess whether the decisions to be made as part of the project may be affected by such changes; - to identify the actions intended to prevent or limit possible unfavourable effects upon the project. The conclusion of the benefit-cost ratio analysis relies on a single set of values for each factor or variable. However, a series of factors might undergo changes during the project, which is why we need to test the sensitivity of the project efficiency values (NPV,IRR) to changes in the values of these factors.

Relevant critical elements of the sensitivity analysis are: - investment costs –ifthese increase by more than 30%, they will render the investment unfeasible. The impactis minor. We do not believe that this scenario is plausible since the prices employed are current market prices, whereas the contract awarding bidding shall pursue a minimal value. Sensitivity analysis in relation tothe investment Higher investment costs 5% 20.00% 30.00% 40.00% 60.00% ENPV (economic net present value) 6,339,222

-50,496,536

-88,387,042

-126.277.547

-202,058,558

EIRR (economic internal rate of return) 5.8643% 4.3487% 3.5360% 2.8412% 1.7151% B/C (benefit-cost ratio)

2.13 2.03 1.97 1.91 1.82

It is noticeable that the investment is sensitive to cost increases,

which is why cost efficiency has to be increased and the chosen solutions have to avoid the increase of foreseen costs.

Sensitivity analysis in relation to the annual expenses Higher annual expenses 5.00% 20.00% 30.00% 40.00% 60.00%

VNAE 18,721,799 -966,227 -14,091,577 -

27,216,928 -

53,467,629

Page 107: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

107

RIRE 6.2663% 5.6453% 5.2304% 4.8148% 3.9814% B/C 2.17 2.16 2.14 2.15 2.14

It is noticeable that the investment is less sensitive to increases of

operating costs, without indicating, however, that such costs do not have to be optimised.

5.3.B. Building B

VAT 19%

lei/Euro = 4.6315 as at 11.12.2017

No.

Designation of expense category and subcategory

Value (VAT-exclusive) TVA Value (VAT-inclusive)

Lei Euro Lei Lei Euro

1 2 3 4 5 6 7 1ST CATEGORY - Expenses required to acquire and set up the land 1.1 Land acquisition 0 0 0 0 0 1.2 Land set-up. 560,000 120,911 106,400 666,400 143,884

1.3 Set-ups for environmental protection

122,500 26,449 23,275 145,775 31,475

1.4

Expenses required to relocate/protect utility services (deviations of utility networks within the premises)

185,000 39,944 35,150 220,150 47,533

TOTAL 1ST CATEGORY 867,500 187,304 164,825 1,032,325 222,892 2ND CATEGORY - Expenses required to secure the utilities necessary for the objective

2.1

Expenses required to secure the utilities necessary for the objective

75,000 16,193 14,250 89,250 19,270

TOTAL 2ND CATEGORY 75,000 16,193 14,250 89,250 19,270 3RD CATEGORY - Expenses for technical design and support 3.1 Land studies 34,000 7,341 6,460 40,460 8,736

3.2

Fees to obtain permits, permissions, authorisations

97,160 20,978 18,460 115,620 24,964

3.3 Design and engineering 13,163,983 2,842,272 2,501,157 15,665,139 3,382,304

3.4 Organisation of procurement procedures

264,214 57,047 50,201 314,414 67,886

3.5 Consultancy 3,510,395 757,939 666,975 4,177,371 901,948 3.6 Technical assistance 1,755,198 378,970 333,488 2,088,685 450,974

TOTAL 3RD CATEGORY 18,824,950 4,064,547 3,576,740 22,401,690 4,836,811

Page 108: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

108

4TH CATEGORY - Expenses for the main investment

4.1 Constructions and Installations 149,404,533 32,258,347 28,386,861 177,791,394 38,387,433

4.1.1 Demolition ofBuildings C4, C8 and C14

150,000 32,387 28,500 178,500 38,540

4.1.2 Multifunctional clinic 148,564,533 32,076,980 28,227,261 176,791,794 38,171,606

4.1.3 Extension of exterior networks 540,000 116,593 102,600 642,600 138,746

4.1.4

Vertical systematisation in the area of the new clinic

150,000 32,387 28,500 178,500 38,540

4.2 Installation-free technological machinery

24,115,951 5,206,942 4,582,031 28,697,982 6,196,261

4.2.1 Installation-free technological machinery

24,115,951 5,206,942 4,582,031 28,697,982 6,196,261

4.3

Machinery, technological and functional equipment plus installation

44,722,300 9,656,116 8,497,237 53,219,537 11,490,778

4.3.1 Technological machinery with installation

44,722,300 9,656,116 8,497,237 53,219,537 11,490,778

4.4 Installation-free machinery and transportation equipment

0 0 0 0 0

4.5 Facilities 43,879,943 9,474,240 8,337,189 52,217,132 11,274,346 4.5.1 Medical facilities 43,879,943 9,474,240 8,337,189 52,217,132 11,274,346 4.6 Intangible assets 0 0 0 0 0

TOTAL 4TH CATEGORY 262,122,727 56,595,644 49,803,318 311,926,045 67,348,817 5TH CATEGORY - Other expenses

5.1 Construction site organisation 1,148,596 247,997 218,233 1,366,829 295,116

5.1.1

Constructions and installations specific to construction site organisation

1,056,786 228,174 200,789 1,257,575 271,527

5.1.2 Expenses related to construction site organisation

91,810 19,823 17,444 109,254 23,589

5.2 Fees, legal costs, taxes, loan-related costs

0 0 0 0 0

5.3 Miscellaneous and unforeseen expenses

8,500,000 1,835,259 1,615,000 10,115,000 2,183,958

TOTAL 5TH CATEGORY 9,648,596 2,083,255 1,833,233 11,481,829 2,479,074

6TH CATEGORY – Expenses for technological trials and tests and delivery to the beneficiary

6.1 Operating staff training 0 0 0 0 0

6.2 Technological trials 0 0 0 0 0

Page 109: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

109

and tests

TOTAL 6TH CATEGORY 0 0 0 0 0 GENERAL TOTAL 291,538,772 62,946,944 55,392,367 346,931,139 74,906,864 Out of which C+ I (constr. + install.) 175,519,770 37,896,960 33,348,756 208,868,526 45,097,382

Operating costs

Electricity costs The status of electricity costs, in the no-project scenario, is the

following:

INVOICE NO. ISSUANCE DATE

INVOICE AMOUNT INVOICED PERIOD

1 17 F05572528 15.05.2017 100,249.99 01.04.2017-01.05.2017 2 17MF04370727 18.04.2017 114,553.87 01.03.2017-01.04.2017 3 17MF03172684 13.03.2017 122,153.56 01.02.2017-01.03.2017 4 17MF01615252 13.02.2017 133,278 01.01.2017-01.02.2017 5 17MF00789283 16.01.2017 185,348.91 01.12.2016-01.01.2017 6 6MF13510792 13.12.2016 158,947.98 01.11.2016-01.12.2016 7 6MF12678507 14.11.2016 142,135.08 01.10.2016-01.11.2016 8 6MF12288578 09.11.2016 45,279.22 08.09.2016-09.10.2016

10 6MF11095680 11.10.2016 50,561.61 01.10.2016-31.10.2016 11 6MF11093615 10.10.2016 83,061.29 02.08.2016-01.10.2016 12 6MF11506239 18.10.2016 9,608.54 01.10.2016-31.10.2016 13 6MF10316150 20.09.2017 93,312.96 01.04.2016-08.09.2016 14 6MF09905796 09.09.2016 50,561.61 01.09.2016-30.09.2016 15 6MF09901158 06.09.2016 5,645.03 01.08.2016-01.09.2019 16 6MF09002481 17.08.2016 6,858.04 12.07.2016-12.08.2016 17 6MF08617980 09.08.2016 50,561.61 01.08.2016-31.08.2016 18 6MF08236521 04.08.2016 139,203.30 01.07.2016-02.08.2016 19 6MF07843642 18.07.2016 50,561.61 01.07.2016-31.07.2016 20 6MF07446539 13.07.2016 6,705.44 12.06.2016-12.07.2016 21 6MF07431596 06.07.2016 225,227.98 01.06.2016-01.07.2016 22 6MF06662450 17.06.2016 52,875.96 01.06.2016-30.06.2016 23 6MF06594104 13.06.2016 6,965.97 12.05.2016-12.06.2017 24 6MF06249034 07.06.2016 58,418.85 01.05.2016-01.06.2016 25 6MF05476575 16.05.2016 9,186.93 01.04.2016-12.05.2016 26 6MF05077862 11.05.2016 52,875.96 01.05.2016-31.05.2016 27 6MF05071220 06.05.2016 53,145.86 01.04.2016-01.05.2016

TOTAL

2,007,285.16

In the scenario without a project, the monthly average electricity costs

amount to around 167,273 lei/monthVAT-exclusive.Following the project implementation, the estimates, based on the installed capacity and specific

Page 110: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

110

consumptions of the new facilities/equipment, are for an additional monthly electricity consumption of around 136,087 kWh. The kwh/hour cost is approximately 0.41lei/KWh, which provides an estimated monthly cost, for option 2, with a maximum investment, of 55.796 lei. According to the incremental principle, the increase of electricity-related costs shall be approximately 312,456 lei/year.

Water supply costs

The status of running water and sewer water costs, in the scenario without a project, is as follows:

INVOICE NO. ISSUANCE DATE

INVOICE VALUE VAT-

inclusive

INVOICED PERIOD M3/year

1 ANB170619542 14.06.2017 43.394 06.05.2017-06.06.2017 7.232 2 ANB170497041 15.05.2017 37.213 04.07.2017-05.05.2017 6.202 3 ANB170260622 14.03.2017 32.908 07.02.2017-06.03.2017 5.485 4 ANB170136431 14.02.2017 34.410 07.01.2016-06.02.2017 5.735 5 ANB170020817 18.01.2017 24.507 10.12.2016-06.01.2017 4.084 6 ANB160992111 16.12.2017 28.516 09.11.2016-09.12.2016 4.753 7 ANB160975577 13.12.2016 25.650 11.10.2016-08.11.2016 4.275 8 ANB160753479 18.10.2016 25.643 10.09.2016-10.10.2016 4.274 9 ANB160662323 26.09.2016 23.799 10.08.2016-09.09.2016 3.966

10 ANB160548492 17.08.2016 32.171 12.07.2016-09.08.2016 5.362 11 ANB160469545 15.07.2016 56.678 10.06.2016-11.07.2016 9.446 12 ANB160395618 16.06.2016 55.772 12.05.2016-09.06.2016 9.295

TOTAL/YEAR

420,659

70,110

In the scenario without a project, the monthly average costs for the supply of running and sewer water are around 35,055 lei/month (VAT-exclusive). Following increases in the number restrooms and the patient flow, the daily consumption is estimated to grow by approximately 110 mc, the equivalent of 3,300 m3/month. The price of a cubic meter of water is approximately 6Iei, resulting a cost of 19,800 lei/month. The incremental consumption of running water and sewer water amounts to 237,600lei/year. Telephone/internet subscription costs

Given the increasing number of medical personnel, it is estimated that updating the subscriptions to the local internet and telephony provider networks shall lead to an additional cost of approximately 3,450lei/month.

Page 111: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

111

According to the incremental principle, the telephone/internet subscription costs shall increase by around 41,400 lei/year.

Staff-related costs The staff-related costs may be found in chapter 5.3.A

Maintenance costs

Costs to purchase consumables Following the project implementation, there will be additional costs to

purchase consumables, given the increase of the number of patients and the new equipment provided in the project. We estimate an additional total annual cost of220,000 lei/year.

Sanitation services We estimate an incremental annual cost of24.000 lei/year. Repair costs The resulting annual cost for maintenance and repairs is 132,400

lei/year. Replacement costs We estimate the following replacement costs: The specialised furniture and the additional facilities have a lifespan

between 10 and 20 years. We estimate that these replacement costs shall be 0.2% during the 3rd year, 0.5% during the 7th year and 1% during the 11th year of operation, respectively, since not all the equipment items are likely to last until the end of the nominal term. Valueacc. to item 4.5 in the general cost estimate

Medical equipment, facilities and furniture

70,202,500 lei

Year 2 0.2 % 140,405 lei

Year 7 0.5 % 351,012 lei

Year 11 1 % 702,025 lei

Miscellaneous and unforeseen costs We estimate that the miscellaneous and unforeseen costs will

amount to 1% of the average figure of all annual recurring costs.

Page 112: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

112

Fiscal adjustments The investment cost is affected by several taxes/levies: VAT, permit-

related levies, levies to ISC and CSC. The investment valueforbuilding B,after applying the fiscal adjustment, is the following:

Adjustments of external factors These may have:

- negative influences, included in the analysis as economic costs; they occur both during construction and during the project lifespan;

- positive influences, included in the analysis as benefits; all these influences shall be divided according to their nature (environmental, economic, social).

5.4. B. Benefits attached to carrying out the investment 5.4.1.B Environmental benefits

Idem 5.4.1.A. The two buildings, A and B, shall abide by the “eco-friendly house” conceptand have a positive impact upon the environment.

5.4.2.B. Economic benefits According to the project, 380 beds are reserved for Building B. The

estimated average annual occupancy degree is estimated at 90%, resulting an annual number of hospitalised persons of approximately 124,830, out of which 70% are fit to work. Considering time savings of 4h/day/person, the annual benefit resulted is 24,282,306 lei.

Another benefit is the decrease of hospitalisation costs. With a price of 750 lei/dayand the estimation that 20% of the persons

admitted every year shallbear the costs of their own hospitalisation

Fiscal adjustment in lei

Indicator Investment Adjustment value

Investment value 346,931,139 VAT elimination -68,242,417

Tax elimination

-1,604,557 Adjustments sum -70,891,785 Adjusted value 276,039,354

Page 113: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

113

(excluding pensioners, insured individuals, pupils and students or surgical procedures which are, according to the law, tax-exempt), the resulting annual benefit is 18,724,500 lei, to which we can add healthcare subscriptions which physical persons or legal entities may conclude with “Dr. Calistrat Grozovici” Multifunctional Clinic, as well as amounts resulted from insurance contracts concluded by insurance companies with physical persons and/or legal entities.

The most important incomes shall be those provided bythe National Health Insurance House.

Based on the data from previous years, the cost of a five-day hospitalisation, settled by NHIH, is approximately 2,930 lei/bed.

Therefore, if 70% of the 380 bedsare 90% occupied by insured patients, the resulted estimated annual income from NHIH is around 51.2 million lei.

To this we can add healthcare subscriptions which physical persons or legal entities may conclude with “Dr. Calistrat Grozovici” Multifunctional Clinic, as well as amounts resulted from insurance contracts concluded by insurance companies with physical persons and/or legal entities.

Moreover, it is estimated that in the two buildings there will be approximately 9,000 day care medical services rendered on a monthly basis, with a monthly value of around 3 million lei. Therefore, the annual income resulted from the provision of these services amounts toapproximately 36 million lei.

5.4.3.B. Social benefits According to estimates, during the operating stage 191 new jobs will

be created, out of which: 35 upper-tier staff (physicians) and 156 medium-tier staff. The income to be gained from this avenue will amount to approximately 10,036.215 lei/year, benefits that could not be generated if the project were not implemented.

5.5.B. Sensitivity analysis The rates used for the shadow prices were the same as in the case

of building A (see 5.5.A) and the following indicators resulted from the economic analysis:

Internal rate of return

Indicator Obtained value Internal rate of return

13.29%

Net economic present value 140,934,600 Financial sustainability (Benefit-cost ratio) 2.96

Page 114: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

114

Specific costs of the investment in relation to the number of jobs and the gross area:

Beds

380

Exchange rate

4.6315 lei/Euro

Investment value (VAT-exclusive) Value lei/bed (VAT-exclusive)

Lei euro lei euro

Investment value = 291,538,772 62,946,944 767,207 165,650

din care Value C+I = 175,519,770 37,896,960 461,894 99,729

Machinery and

equipment = 44,722,300 9,656,116 117,690 25,411

Equipment, medical

facilities, furniture =

24,115,951 5,206,942 63,463 13,702

Other expenses= 45,028,539 9,722,237 118,496 25,585

(C+I) – construction and installation works Cost indicators concerning the cost/area ratio:

Area 23,685,60 sq m

exchange rate 4.6315 lei/Euro

Investment value (VAT-exclusive) Value lei/sq m (VAT-exclusive)

Lei euro lei euro

Investment value = 291,538,772 62,946,944 12,309 2,658

din care Value C+I

= 175,519,770 37,896,960 7,410 1,600

Machinery and

equipment =

44,722,300 9,656,116 1,888 408

Equipment, medical

facilities, furniture =

24,115,951 5,206,942 1,018 220

Other expenses 45,028,539 9,722,237 1,901 410

Page 115: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

115

=

Sensitivity analysis in relation tothe investment cost

Indicator change EIRR % NPV (lei)

Investment costs higher by 5% 12.71 136,222

Investment costs higher by 20% 10.14 97,401

Investment costs higher by 30% 8.74 71,521

Investment costs higher by 40% 7.53 45,640

Investment costs higher by 60% 5.51 -6,120

The evolution of investment costs does not significantly influence the

project yield, as it remains stable against major variations of costs.

Sensitivity analysis in relation to the annual costs Indicator change EIRR % NPV (lei)

Annual costs higher by 5% 13.70 148,857

Annual costs higher by 20% 13.63 147,940

Annual costs higher by 30% 13.58 147,328

Annual costs higher by 40% 13.53 146,717

Annual costs higher by 60% 13.43 145,494

As we can see in the table above, the values and benefit-cost ratio do

not suffer significant changes, the project thus being financially stable.

5.6. Risk analysis Risk management involves the following stages:

• risk identification; • risk analysis; • reaction to risk;

Risk identification -itis done by drawing up checklists. In order to identify risk, a risk assessment matrix shall be carried out. Risk analysis- ituses methods such as: determining the expected value, the Monte Carlo simulation anddecision trees. This stage is useful in establishing priorities when resources are allotted to control risks. During

Page 116: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

116

this stage it is essential to have a risk assessment matrix, depending on the occurrence probability and the impact caused. Reaction to risk-it comprises measures and actions intended to reduce, eliminate or share risk. Under risk we include the uncertainty associated to any result. Risk occurs when: - an event occurs with certainty, but its result is uncertain; - the effect of an event is known, but the occurrence of the event is uncertain; - boththe event and its effects are uncertain; The risk control techniques acknowledged by the literature in the field fall under the following categories: - risk avoidance entails changes in the management plan in order to eliminate risk occurrence; - risk transfer – sharing the negative impact of the risk with a third party (insurance contracts, guarantees); - risk reduction– techniqueslowering the likelihood and/ornegative impact of risk.

Risk type Risk elements Type of corrective action

Elimination method

Construction risk

The risk of occurrence of an event that might make it impossible to complete it in due time and within the estimated cost

Risk elimination

Signing a contract with a fixed completion deadline

Maintenance risk

The risk of occurrence of an event that generates additional maintenance costs due to the execution of the works;

Risk elimination

Signing a contract with extended guarantee clauses according to which such costs are covered by the contractor;

Acquiring funds

The risk that the beneficiary might not obtain funding;

Risk elimination

The beneficiaryand the Designer / consultant shall analyse in detail the documentation so that no situation of this kind should ever occur;

Technical solutions

The risk that technical solutions might not be compliant from a technological standpoint;

Risk elimination

The beneficiaryand the designer shallanalyse in detail the documentation so that the best technical solution should be selected.

Low activity degree of the project

The risk that the people might not enjoy the newly created space and, therefore, try to resort to the services of other units (state-owned or private);

Risk elimination

Conducting among the target groups an intense promotingcampaign in favour of the healthcare unit.

Page 117: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

117

Prices of materials

The risk that the prices of materials might increase and exceed the levels provided in the contract

Risk reduction

Signing a firm execution contract during project implementation and monitoring the implementation of the program as per the schedule.

As one may notice, the risks of failing to materialise the investment are fairly low and their force of impact does not affect the investment effectiveness or usefulness. The project costs shall be borne by the private partner and mainly consist in the following:

• the costs related to the construction works (project design and organisation, project management, land studies, the demolition of the 4 buildings and the actual construction and outfitting works benefitting buildings A and B);

• the costs related to the operation and maintenance activities, including operating costs, current maintenance, funding costs over the entire project duration, consisting in costs pertaining to the long-term loans granted, the costs related to the shareholders’ equity participation, bank fees, hedgingcosts in relation to the interest rate, etc. Construction costs do not exclusively cover the actual building, but

also other auxiliary works (demolitions, utilities, connections to utility services, etc.). According to the availability-based payment mechanism, regular payments are made to the private partner for the service provided. These payments are to be made as per the winning tender submitted as part of the bidding procedure. The principle is that the public partnerfull availability-based payments, for a certain period, only if the assets are fully available and adequate over the respective period, as defined in the contract (100% availability - 100% payment, 0 availability - 0 payment).

The annual availability-based payment can also be made in monthly instalments, as shall be subsequently agreed upon in the PPP contract. The availability-based payment set forth for each period as per the contractual rules is the main income source of the private partner, who needs to cover all of their costs (construction, maintenance, operation, funding, etc.) with such income. The amount of the current availability-based payment shall be adjusted and finalised following the construction and maintenance costs adjustment and the actual funding costs being set forth of at the time of the

Page 118: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

118

financial closure, in accordance tothe provisionsof the PPP contract, provided that it expressly stipulates this circumstance. The actual amount of the availability-based payment made by the public partner shall be reduced as opposed to the value adjusted and finalised as per the provisions above, as follows:

- the availability-based payment made by the public partnerto the private partner shall be reduced with the value of the latter’s receipts from the fees and prices charged; - the availability-based payment made by the public partner to the private partner shall be reduced by 60% of the latter’s receipts from the use of the secondary infrastructure; - the availability-based payment made by the public partner to the private partner shall be reduced when deductions are applied for failure to comply with performance standards / unavailability cases.

For“Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building B, the estimated execution costs were updated in 2016. In regard to updating the technical and economic indicators, the price index was taken into account. 5.7. Penalty system

The payment mechanism of the PPP contract contains provisions which entitle the public partner to benefit from deductions to the availability-based payments.

Three types of penalties that can be incurred are stipulated: first of all, deductions can apply if “Dr. Calistrat Grozovici” Multifunctional Clinic - Building A and Building Bis not fully functional; second, deductions can be applied when the private partner fails to fulfil their obligations stipulated in the contract (non-fulfilment of serviceability according to the contract provisions), and, finally, the public partner can apply penalties if the clinic is functional, but this entails considerable works which are yet to be completed. The penalty system is conceived in a manner that encourages the private partner to carry out the necessary maintenance works with as few patient flow disruptions as possible – the longer the disruption of end users, the higher the deductions from availability-based payments. The wider the partial closure of a ward/consulting room/operating room etc., the higher the deduction.

Here are some examples of the ways in which the private partner is encouraged to minimise the discomfort caused to of medicalservices:

• no deductions shall be incurred if the works are carried out outside the normal working hours;

• the performance of necessary works during the working hoursincreases the level of applicable deductions per hour by a

Page 119: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

119

multiple of 3, as compared with deductions applicable for nighttime works.

The private partner shall observe the requested level of the service,

both in relation to the end user (the patient) and the public partner, otherwise the latter is entitled to apply deductions to the availability-based payments. The service rendering obligations consist in the management, operation and maintenance of the investment objective based on the following two categories:

• non-compliances regarding the performance requirements, which affect the users’ safety;

• non-compliances regarding the performance requirements, which do not affect the users’ safety. In most cases, the private partner benefits from a time interval to

remedy the non-compliance case occurred, before being subject to “service points” applied for each day in which the respective non-compliance remains unsettled. The more serious the non-compliance, the higher the number of service points applied.

As part of a medical clinic management, operation and management activities, one may reasonably expect the occurrence of cases in which the private partner, for various reasons, is unable to fulfil, in full or in due time, all their obligations without causing the use of a very significant level of resources likely to lead to excessive costs being borne by the public partner, and such a conservative approach would not bring economic and financial benefits for the latter. Consequently, the principle employed is to allow the private partner to “accrue” a certain number of service points each month, up to the threshold beyond which financial penalties start being incurred, representing for them a “red flag” and an incentive to promptly rectify any non-compliances, otherwise ending up incurring the said penalties. At the same time, in order to deter any attempt the private partner might make to overlook the fulfilment of their obligations, once the respective threshold has been reached, the amount of deductions shall progressively increase, as the number of accrued points increases, as well.

The deduction point value was an element of the tender, proposed by each candidate preselected during the bidding procedure, all of them being provided with a range between 100 and 120 units.

The value quoted by the wining tenderer should be the maximum one, of 120 units, and should be included as such among the contract provisions. The deduction mechanism has to be conceived on grounds that, if a department/ward in the clinic is unavailable over a certain period of time, the deductions shall be calculated so as to eliminate any payments that would have been allotted for the respective department/ward over the

Page 120: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

120

relevant period of time (in other words, an extreme example would be that, if the entire clinicwere to be unavailable to patients, during the entire year, the private partner would not receive any annual availability-based payment for the respective year). Moreover, the PPP contract contains provisions according to which, in the case of long-lasting infringement-type events (a case equivalent to the accrual of a certain number of deduction points), the private partnermay initiate the contract termination procedure by fault of the private partner.

Moreover, one must consider, as the case may be, the penalty system stipulated in chapter 5.7.

The payment mechanism of the PPP contract contains provisions that entitle the public partner to apply deductions to the availability-based payments.

5.8. PPP contract cessation and payable compensations a) Termination by fault of the public partner If the PPP contract is terminated by fault of the public partner, they

shall pay a compensation to the private partner, and the amount payable as compensation shall allow the latter:

• to reimburse the amounts they owe at the time to financers as per the main financing contracts;

• to recover the amounts invested in the project by the private partner’s shareholders (minus any possible amounts already recovered);

• to pay any possible costs incurred with the termination of subcontracts by the private partner following the PPP contract cessation (for instance, the termination of the design and construction contract and/or the operation and maintenance contract);

• to ensure the rate of return for the amounts invested by the private partner at the time.

b) Cessation following the termination for convenience by the public partner

If the PPP contract comes to an end following the termination for convenience by the public partner, they shall pay the private partner a compensation equivalent to the amount payable in case of termination by fault of the public authority.

c) Cessation on grounds of force majeure

Page 121: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

121

If the PPP contract comes to an end following a force majeure event, the public partner shall pay a compensation to the private partner, and the amount payable as compensation shall allow the latter:

• to reimburse the amounts owed at the time by the private partner to financers as per the main financing contracts;

• to recover the amounts invested in the project by the private partner’s shareholders (minus any possible amounts already recovered);

• to pay any possible costs incurred with the termination of subcontracts by the private partner following the PPP contract cessation (for instance, the termination of the design and construction contract and/or the operation and maintenance contract). In comparison to the compensation payable when the PPP contract

comes to an end by fault of the public partner, the compensation payable if the contract is terminated due to a force majeure event shall not comprise the rate of return of the invested amounts, but only the actual unrecovered investment of the private partner, the grounds for cessation being outside the control of both parties and the cessation risk being thus split between the public partner and the private partner.

d) Termination by fault of the private partner According to the international practice in terms of PPP, the public

partner shall pay a compensation to the private partner if the contract is terminated by fault of the latter, as well, so as to avoid the undeserved enrichment of the public partner which receives, upon the contract cessation, a good with a significant value.

The principle of setting forth the compensation when the contract comes to an end by fault of the private partner is that of placing the compensation in relation to the value of the goods reserved for the public partner upon cessation / to the value of the project continued by the public partner / to the amounts advanced by the financers. The amounts set forth as compensation shall be due to the financers and shall be subject to the (total or partial) reimbursement of the amounts owed to them by the private partner at the time, according to the main financing contracts, the public partner and their shareholders being sanctioned for the failure to recover the investment made up to that point – its amount lying within the goods that are due to the contracting authority, whereas the subcontractors will receive no payment following the cessation of the design and construction contract/the operation and maintenance contract.

Page 122: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

122

6. Conclusions

The location of the two buildings, A and B, has been chosen so as to allow quick access to the two buildings on Grozovici str. and the proximity to Colentina hospital premises. During the entire execution process of “Dr. Grozovici” Multifunctional Clinic - Building A and Building B, “Prof.Dr.Matei Balș” National Institute of Infectious Diseases shall operate at a normal rate and the connection between the two structures shall be maintained in terms of networks. In terms of general volumetry, the architectural layout indicates a single, organic solution that immerses the structure in the existing style. The link between the two buildings, A and B, is physically achieved, by means of sweeping sections and the creation of leisure terraces fitted with vegetation. The architectural shapes are selected so as to provide a uniform and contemporaneous sight, with future references, designed to include all the medical sectors inside a single cohesive unit. The expression of shapes and materials, both vertically and horizontally, is in line with the modern conception of turning hospital architecture coldness into a welcoming human solution. Mention should be made that all the figures pertaining to the patient flow, the costs required to make investments and create facilities, as well as the achieved incomes, are estimated data, valid for 2016 – 2017 and calculated under normal operating conditions, indexed with the consumer price indices and the wage increase indices.

Page 123: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

123

Annex to the Substantiation Study

The “SMART” Clinic

Firstly, the implementation of a project of this nature requires the creation of aninfrastructure relying on the latest standards and technologies, leading us to the “intelligent clinic” or “smart clinic”phrase.

Healthcare facilities continuously evolve in order to better develop the needs of patients, physicians and the personnel, to comply with the new standards, to make way for efficient operation and to improve the medical care process. Therefore, hospitalshave to implement state-of-the-art technologies at all functional levels. Hospital administrators have to adapt and overcome the new challenges in the field, and to secure:

- a safe and secure environment, - network connectivity, - interconnected computer applications, - power supply network, - quick and modern means of communication, - interconnection of these systems.

Risk management

The first step in creating a safe and secure environment for patients, visitors and employees comprises the following:

- access control system, - smart lighting, - climate control/ventilation system, - communication system, - video surveillance, - anti breaking and entering systems (movement, pressure sensors,etc.), - fire detection system.

All these systems have to be managed by means of a centralised BMS-typesystem (Building Management System).

High-performance network

More than ever, a network relying on a high-performance structured cabling systemplays an essential role in the operation and management of a modern hospital. The lack of it makes it impossible to support the

Page 124: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

124

implementation of new technologies that allow the interconnection of all equipment (healthcare connected technology).

For: - network flexibility, - network topology, - cable type selection, - Wi-Fi.

1. Communication network 2. Ward 3. Registered nurses 4. Physicians 5. LAN 6. Wi-Fi 7. Servers 8. Medical equipment and devices

Medical facilities

WARD

- Smart bed o Weighing o Presence sensor (with integrated alerts) o Adjustment o Fall protection o Bed sore protection (smart mattress) o All the monitored data shall be transmitted to the electron

patient chart - Monitoring equipment and vital signs support (All the monitored

data shall be transmitted to the electron patient chart) - At least 17” touch screen - Smart lighting - Climate control/ventilation system - Access control - Smart restroom (self-cleaning and disinfection functions), sink with

sensors, shower with thermostat - Floor with shock sensor (self-activated and alert-triggering in case

of a fall) - Integrated computer system (information collection, transmission

and display)

Page 125: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

125

- Patient communication and control tablet (possibility to perform remote examinations)

- For VIP wards, tablet-controlled media system (menu pre-set, etc.) - Video monitoring with motion detection and, possibly, alert system - Barcode reader

NURSES’ OFFICE

- Patient management and monitoring system (nurse call, etc.) - Access control - Multifunctional screen (patient video surveillance, critical patient

vital sign display) - Storage spaces for medicines with automatic barcode scanning

and automatic inventory system - Smart carts fitted with tablets and barcode reader - Pneumatic tube post system (for the submission of laboratory

tests, etc.) – in-hospital robotics - Secured and fire protected storage space for medical documents - All-in-one (or Thin Clients, Zero Clients)Workstations, with smart

card authentication (ref.ID, etc.)

PHYSICIANS’ OFFICE

- Access control - Multifunctional screen(patient video surveillance, critical patient

vital sign display) - All-in-one (or Thin Clients, Zero Clients) Workstations, with smart

card authentication (ref. ID, etc.).

Page 126: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

126

TECHNICAL ROOM – IT INFRASTRUCTURE (SERVERS, NAS, NETWORK ASSETS)

Page 127: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

127

Page 128: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

128

Ward:

- Wireless. All the equipment and sensors that collect vital signs shall be collected via Wi-fior Bluetooth (wearable-type technology: thermometers, glycaemia monitoring, electrocardiogram,etc.). Where the use of wireless technologies is not possible, the equipment can be connected by way of a well-masked wired network. All these equipment items shall submit in real time the collected datato the server (the electronic patient chart) and display it on the patient monitoring screen.

Page 129: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

129

- A single touch screen, versatile for eachbed/patient, able to display information from several sources (server, patient evolution, vital signs, mirroring-type technologies for smartphones and tablets). This way, multiple screens and the cables pertaining to each monitoring device/equipment will be eliminated.

- The bed shall be added a smart urine collection recipient which, just as the other equipment items, shall transmit at pre-set intervals the amount + the possibility of a small assessment based on a real-time composition analysis.

- Ideally, the management of all the equipment in the ward shall beperformed both from a local console (tablet), as well as in a centralised manner, at a floor, hospital, etc. level.

The possibility of implementing IoT

Internet of Things (also abbreviatedIoT; the Internet of Objects) is a concept which entails using the Internet to connect various devices among them, automatic servicesand systems, thus a network of objects taking shape. This technology allows performing examination/monitoring activities remotely, providing basically a foundation for telemedicine (the physician can automatically receive from the interconnected equipment a report on their mobile phone, tablet, email, etc., automatically and at pre-set intervals).

Network (CAT 6a or 7 cable and Wi-Fi)

Network assets with centralised management, where all connections shall be grouped into a dedicated technical room, fitted with:

- A Wi-Fi Enterprise solution which would contain, in addition to assets (Aps, POE switches), a centralised management application.

- Equipment racks (building server). - Fire protection (inert gas). - Voltage drop protection (UPS). - Access control monitoring. - Video monitoring. - Humidity and temperature sensors. - Integrated alert-issuing solution (bySMS, phone, e-mail).

Page 130: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

130

The building shall be connected via FCwith the existing Data Centre.

Page 131: Substantiation study “DR. CALISTRAT GROZOVICI ... · general/sectoral/regional policies, current legislation, international agreements pursuant to which executing the investment

131

Registered nurses’/physicians’ office