Recommendations on Basic Requirements for Intensive Care Units

ELECTRONIC SUPPLEMENTARY MATERIAL

Recommendations on basic requirements for Intensive Care Units: Structural and Organisational Aspects

Andreas Valentin, Patrick Ferdinande on behalf of the European Society of Intensive Care (ESICM) working group on Quality Improvement

Content

Paragraph 1: Conceptual Framework for the planning of an ICU 2-4

Paragraph 2: Quality criteria 5

Paragraph 3: Handling of durable equipment 6

Paragraph 4: Services in patient areas 7-8

Paragraph 5: Storage 9

Paragraph 6: Fire safety – Floor plan 10

Paragraph 7: Central Services 11-12

Paragraph 8: Communication 13

Paragraph 9: Calculation of physician manpower 14

Paragraph 10: Glossary 15 2

Paragraph 1

Conceptual Framework for the planning of an ICU

This list provides an systematic approach to important issues that need to be considered when planning an ICU. It needs to be completed according to local needs.

Part I :Operational Guidelines

Definition and objectives of an Intensive Care Unit Functional Criteria Location Size Medical Staffing Director of the Intensive Care Unit Medical staff member Medical trainees Continuity of medical activity Nursing Staff Organisation and responsibilities Head Nurse Nurses Nurses in training Allied health care personnel Physiotherapists Technicians Radiology technician Dietician Speech and language therapist Psychologist Occupational therapist Pharmacist Administrative personnel Cleaning personnel Activity Criteria General remarks Definition of intensive care patients Definition of Levels of Care (LOCS) Required number of intensive care beds Quality control Management of equipment Consumables Durable equipment Selection Purchasing Storage Servicing Sterilisation Replacement 3

Part II : Design Requirements

Planning Team Floorplan + Connections Accomodation Patient area Management functions in the patient area Visual observation of the patient Services in patient areas Bedside layout Electricity Vacuum Oxygen Compressed air Water supply Radio and TV sockets Monitoring and computer equipment in patient area Monitoring Computer systems at bedside integrated in the hospital information system Central nursing station Storage Storage for consumables (5m2/bed) Storages for durable equipment (5 m2/bed) Separate storage for emergency and transport equipment Utility Nurse’s office Medical office Secretariat Staff lounge Physician on call bedroom(s) Laboratory Workshop Kitchen Reception area and relative’s rooms Receptionist’s office Special procedures/therapy room/admission room Seminar room – conference room Cleaners’ room Interview room Corridors Floor coverings Wall decoration and ceiling Fire safety General Floor plan Smoke and toxic gases Means of escape Related issues Central services Electricity Vacuum Oxygen 4

Compressed air Other medical gases Ventilation Water supply and plumbing Heating Lighting Communications Telephone Intercom Alarm calls Local communication Nurse and allied health care professional call system Personal on-call system 5

Paragraph 2

Quality criteria

A. Items for the evaluation of performance and for the benchmark with peers

- Basic quality control measures (quality indicators) - Safety and Risk management including measurement of safety culture and errors (critical incident reporting) - Protocols, checklists, and guidelines: in order to standardize medical activities most processes in the ICU should preferentially have a written protocol and defined daily goals of treatment. Examples include: Admission and discharge criteria, infection control and management of infections, management of mechanical ventilation including weaning procedures, cardiac and circulatory therapies and resuscitation, nutritional support, pain and sedation strategies, management of restraints of patients, management of specific patient subpopulations, documentation of decisions regarding treatment limitation or – withdrawal - Regular staff meetings with meeting report - Mortality and morbidity conferences - Participation in a multicenter database for benchmarking - Infection monitoring

B. Objective quality criteria for the evaluation of the activity and the quality of care in an ICU:

- Minimal clinical data: indicating type of pathology, diagnosis, demographic data, occupancy rate, mean length of stay, mortality and predicted mortality - Minimal nursing data: indicating the level of nursing activity (e.g., TISS, or similar scoring systems) - Severity of illness scores and outcome prediction models (e.g. SAPS, APACHE) - Organ system failure scores - Complications during ICU stay, nosocomial infections, readmissions [1-6], [1-6]costs generated by the ICU stay [7] - Overview of technical procedures (percentage number of patients on artificial ventilation, hemodialysis, mechanical cardiac support, etc. …)

References:

1. Rosenberg AL, Watts C, (2000) Patients readmitted to ICUs : a systematic review of risk factors and outcomes. Chest 118: 492-502 2. Cohn WE, Sellke FW, Sirois C, Lisbon A, Johnson RG, (1999) Surgical ICU recidivism after cardiac operations. Chest 116: 688-692 3. Metnitz PG, Fieux F, Jordan B, Lang T, Moreno R, Le Gall JR, (2003) Critically ill patients readmitted to intensive care units--lessons to learn? Intensive Care Med 29: 241-248 4. Rosenberg AL, Hofer TP, Hayward RA, Strachan C, Watts CM, (2001) Who bounces back? Physiologic and other predictors of intensive care unit readmission. Crit Care Med 29: 511-518 5. Russell S, (1999) Reducing readmissions to the intensive care unit. Heart Lung 28: 365-372 6. Chen LM, Martin CM, Keenan SP, Sibbald WJ, (1998) Patients readmitted to the intensive care unit during the same hospitalization: clinical features and outcomes. Crit Care Med 26: 1834-1841 7. Csomos A, Varga S, Bertolini G, Hibbert C, Sandor J, Capuzzo M, Guidet BR, (2010) Intensive care reimbursement practices: results from the ICUFUND survey. Intensive Care Med 36: 1759-1764 6

Paragraph 3

Handling of durable equipment

A. Selection Continuously up-dated selection policy is recommended. Selection criteria will be:

- Cost - Availability of space - Maintenance cost - Cost of necessary disposables (specific infusion apparatus etc.) - Compatibility with existing material - Technical advice from instrument engineers - Methods of sterilization differing from hospital facilities - Maintenance and repair services.

B. Purchasing A complete order should be made also containing:

- Recommended space needed - Copies of instruction books - Stock of eventual disposables - Report on electrical safety - Installation work required - Acceptance procedure - Delivery date - Training arrangements for the ICU staff

C. Storage (see also paragraph 5 of the EMS) A separate storage room for durable material is needed in the ICU. Lockable storage facilities may be useful for small but valuable items. Only durable serviced material ready for use is stored in this room.

D. Servicing On the basis of economic and complexity considerations, maintenance can be carried out by:

- The user - In house-servicing - The manufacturer

An equipment log or fault card with dates should be kept for all major items to record faults or modifications.

E. Sterilization Satisfactory methods for sterilizing all non-disposable parts must be described, possibly with the manufacturers’ assurance on suitable techniques. Sterilization will be done in the central sterilization unit in the hospital after initial decontamination, with the exception of endoscopic material, if it can be sterilized in the ICU under trustworthy conditions. 7

F. Replacement Most well selected items have a lifespan of 10 years or become obsolete after this period of time. A realistic policy of replacement should be formulated on the basis of a continuing review of available equipment. Decisions on replacements should be planned well in advance to avoid ill-considered last minute selections. 8

Paragraph 4

Services in patient areas

Electricity 16-20 grounded sockets divided over three isolated transformers are required per bed. Sockets on the same transformer have identical color codes. One socket for mobile radiology equipment per patient area. Sockets serving vital equipment should be on a no-break circuit and back up generators. For illumination see paragraph 7 of the EMS .

Vacuum Three outlets per bed, low vacuum type with keyed plug-in connections.

Oxygen Four outlets per bed with 4 flowmeters, two on each side of the bed. Manual resuscitation system (Ambu, Laerdal type)

Compressed air Three outlets per bed (driving ventilators, gas mixing device) 1 flowmeter.

Water supply Minimum of one, and probably optimally two, hand-basins, deep and wide enough to prevent splashing and equipped with hand-free operated taps, must be available for every patient care area to minimize the transfer of infection. Self-sterilizing heated traps are recommended. Hand drying facility in the form of disposable paper towels. Standard towels must be forbidden. Hand disinfection facilities with alcoholic solutions are provided in every patient room and anteroom on inviting and visible locations (entry, head of the bed, etc.….).

Radio and TV sockets

Monitoring and computer equipment in patient area

1. Monitoring Each bed is equipped with a patient monitoring system adapted to the needs of the unit and integrated in a health information network. Modular systems are preferred to maintain necessary flexibility and to cope with future evolution. Standardization of equipment with other areas (operating theatre, Emergency department) is recommended. Physiological monitoring provides continuous or intermittent display of:

- Arterial pressure

- Central venous pressure

- Multi-purpose pressure channel (ICP, Swan-Ganz)

- Temperature (central and/or cutaneous) 9

- Pulse oximetry

- Continuous monitoring of patient ventilation (minute volume, FIO2, capnography)

- Pressure control in cuff of endotracheal tubes

- Portable non-invasive arterial pressure monitoring

- Cardiac output monitor/computer and hemodynamic-derived values on bedside monitors

- Alarm recording and hard copy, allowing documentation of all monitored parameters

The ability to establish trends of directly measured physiological parameters and the availability of hard copy for all data is recommended.

In addition the following monitoring may be considered

- Oximetry of inspired gases

- Pulmonary function

- Mixed venous saturation measurement

- Arrhythmia detection

- ST-T analysis

- Patient weighing system (combined with a patient lifting and mobilization equipment to facilitate manual handling).

The primary variables (ECG, blood pressure, pulse oximetry) have high-low visible and acoustic alarms, with selectable communication in optional networks with other patient areas and interfacing facilities for all basic parameters. The monitors must be placed in a fashion that permits unobstructed comfortable viewing. Moreover, serum electrolyte, lactate, glucose, hemoglobin, hematocrit and blood gas analysis should be readily available on a 24-h basis, preferably in the ICU (point of care testing) or in its near vicinity, with quality assurance in cooperation with the central laboratory.

2. Computer systems at bedside integrated with the hospital information system

Such a system should include the following functions:

- Trend analysis of all on-line measured physiological parameters

- Calculation of derived values from on-line, measured physiological parameters (hemodynamic, pulmonary shunt calculation, renal function, ventilation)

- Hard copy of visual display and trends

- Automatic reports of all directly measured, calculated and validated data on 24-h basis 10

- Communication with laboratory and diagnostic departments

- Computerized Physician Order Entry (with incorporated decision support such as dosage schemes, information for adverse effects, real-time alerts for drug-drug interactions and information regarding the correct administration of drugs)

- Management of stock of drugs, disposables etc.

- Charging of therapeutic acts and printing of labels for laboratory samples

- Analysis and report of patient acuity data

- Essential patient information like diagnosis, known allergic reactions, history etc.

Displays with functions listed above may be repeated in the central nursing station. 11

Paragraph 5

Storage

It consists of:

1. Storage for consumables (5m²/bed) - Satellite pharmacy - Intravenous and dialysis fluids - Enteral nutrition - Sterile and non-sterile nursing material (linen, disposables) - Refrigerator for pharmaceuticals - Refrigerator for blood and plasma products

2. Storage for durable equipment (5m²/bed) - Ventilators - Dialysis machines - Infusion pumps - Back-up monitoring apparatus - Drip stands - Blood warmers - Trolleys - Suction units - Mobile radiology and surgical equipment - Endoscopic equipment - Sonographic equipment/echography - Equipment for use by allied health care professionals

Only serviced equipment ready for use is stored in this space. This storage room should have a bench, electrical sockets medical gas outlets, sinks and a wall rail.

3. Separate storage for emergency and transport equipment

- Case with emergency drugs and equipment during transport of critically ill patients (1 for 6 beds)

- Transport monitor (ECG, invasive, non-invasive blood pressure monitoring, pulse oximetry, respiration monitoring)

- Transport ventilator and mobile suction unit arranged on a transport trolley attachable to the bed

- Defibrillator on rechargeable battery, adult and pediatric paddles, display and recorder

- Pacemakers - Emergency trolley with extended drug and resuscitation equipment (1 for 8 beds) - One anesthetic trolley with scavenging system should be considered according to local needs 12

Paragraph 6

Fire safety – Floor plan

A floor plan (with scale 1 : 100) should be displayed in a highly visible place showing the following:

- The unit with its compartments and sub-compartments

- Fire exits, entrances to each sub-compartment

- Fire hoses and chemical extinguishers

- Control panels of medical gases

- Electrical mains

- Vacuum and compressed air sources

- Specific hazard areas

- Protected escape routes and fire-resistant doors. 13

Paragraph 7

Central Services

1. Electricity There should be a 220-240 V single-phase electrical supply with a single common earth and with all the outlets in the patient areas on the same phase. The patient areas and central computers should be served by a maintained stand-by power source, which is activated after a maximum of 5 s interruption of the normal electrical current. A separate circuit is required for emergency lighting, computers, ventilators and other sensitive equipment. For computers and other sensitive equipment, a back-up current source with separate protected, battery power is provided. A circuit for non-vital purposes X-Ray does not need to be supplied by a stand-up supply source.

2. Vacuum A central medical vacuum source capable of generating a sub atmospheric pressure of 500 mmHg (66, 6 kPa) and maintaining 40 l/min of air flow at each outlet when all outlets are in use.

3. Oxygen Medical oxygen 100 % should be available at a pressure of 5 Bar (500 kPa). This pressure should remain constant when the flow is 20 l/min at each outlet when all are in use.

4. Compressed air A supply of breathable medical air (free from particles, oil and droplets) should be available at a pressure of 5 Bar (500 kPa). The pressure should be stable when the flow is 20 l/min at each outlet when all are in use. A stand-by compression pump should be provided on a high priority instant switching stand-by supply. All artificial ventilators should be equipped with a microfilter.

5. Other medical gases Pipelines for other medical gases may be needed. The will operate the same pressure regime to avoid cross mixing. Note: all plug-in connections should be specific for each medical gas. Vacuum, oxygen and compressed air pressures are centrally monitored with visual and audible alarm systems. Wall connections should not be at head level to avoid facial injury when plugs are incompletely inserted. 14

6. Ventilation All air should be 99 % filtered to a particle diameter of 5 micron. All rooms should have air- conditioning with ambient adjustable temperature, relative humidity between 40 and 60 % and a choice of positive and negative pressure relative to the open area. Air-conditioning is also mandatory in:

- Rooms with heat-generating equipment (laboratory, computers, …)

- Staff rooms, conference room

Air changes should be six per hour in isolation rooms, other patient areas and staff rooms. Active ventilation must be provided in sanitary rooms, teaching rooms, laboratory and reception rooms.

7. Water supply and plumbing Should conform to the recommendations of the US Centers of Disease Control [1]. At least one sink per patient area is provided. Warm and cold water at equal pressure with mixing tap activated by foot or elbow are recommended. These sinks are located in the anteroom of the isolation rooms or at the entry of the room in other patient areas. One self-sealing trapped dialysis outlet may be provided per patient area and per maximum of two beds. Sinks in the drug preparation area. Laboratory and dialysis may have specific needs for deionized or specific water for dialysis. Restrooms for staff and visitors are separate.

8. Heating Ambient temperature should be adjustable in

- Patient areas 18-27 °C

- Staff rooms and open areas 18-24 °C

- Dirty utility 16-21 °C

- Storage rooms and cleaners’ room 16-21 °C

9. Lighting Natural daylight with a view is essential for both patient rooms and staff offices. The quality of artificial lighting should approach daylight characteristics. Too much solar light can be a hindrance and solar tinted glass may be needed. The artificial lighting consists of:

- General illumination with dimming possibility (>300 lux)

- Indirect night illumination not interfering with the rest of the patients and permitting observation (>100 lux)

- Reading lamp at each bed

- Mobile operating theatre illumination

- Instantaneously acting emergency lighting powered by a stand-by generator 15

References

1. Sehulster L.M. CRYW, Arduino M.J., Carpenter J., Donlan R., Ashford D., Besser R., Fields B., McNeil M.M., Withney C., Wong S., Juranek D., Cleveland J., (2004) Guidelines for environmental infection control in health care facilities. Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Chicago IL; American Society for Healthcare Engineering / American Hospital Association. www.cdc.gov/ncidod/hip/enviro/guide.htm 16

Paragraph 8

Communication

Telephone At least two external lines per 8 beds located in the nursing station in the patient area are mandatory. Each individual patient area has an in-hospital telephone line unless a wireless phone system is in place. In each architectural entity (offices, staff room, laboratory, etc. …) an internal telephone line is mandatory. The secretariat needs at least one external telephone and two internal telephone lines. An emergency phone bypassing the hospital switch-board is desirable.

Internet Connection Internet and intranet connection for communication via e-mail and the use of online services (e.g. certifications, library, citation and information services, guideline platforms, SOP exchanges, advanced education platforms).

Intercom This system connects all rooms (apart from sanitary and cleaners’ room) in the unit and also such key department as blood bank, laboratory and pharmacy.

Alarm calls A code alarm button or an alternative system must be provided per bed. Activation of the alarm must alert the central station, staff lounge, conference room and physician’s bedroom. The attending staff must also be summoned by the staff location system or a wireless phone system.

Local communications In isolation rooms a separate communication between the room and the corridor and/or nursing station may be useful.

Nurse and allied health care professional call system One call system per bed operated by the patient.

Personal on-call system All members of the medical staff, head nurses, physiotherapists and technicians should have a personal on-call system with alarm function for staff location and can be combined with a portable phone function. 17

Paragraph 9

Calculation of physician manpower

Example:

The example refers to a 6-8 bed ICU carrying mainly for patients requiring a level of care II.

(1) Needed manpower time per day (hrs) :

24 hrs coverage +1,5 hrs as handover time +8 hrs for extra-intensivist during morning session = total of 33.5 hrs per day

Needed manpower time per year = 33.5 hrs x 365 = 12227.5 hrs

(2) Net working time (hrs) per FTE per year :

Total working time = hours per week (eg 40 hrs x 52 weeks) = 2080 hrs) Holiday leaves (eg 30 days x 8 hrs) = -240 hrs) Study leave (eg 10 days x 8 hrs) = -80 hrs) Sick leave (eg 5 days x 8 hrs) = -40 hrs) Net remaining working time/FTE/year = 1720 hrs)

Medical manpower calculation in this example= 12227.5 hrs /1720 hrs = 7.1 FTEs 18

Paragraph 10

Glossary (Text + EMS)

AHCP Allied Health Care Professional db decibel

ECMO Extracorporeal Membrane Oxygenation

ECG Electrocardiogram

ESICM European Society of Intensive Care Medicine

ESM Electronic supplementary material

FiO2 Fraction of Inspired Oxygen

FTE Full Time Equivalent

HDU High Dependency Unit

Hrs Hours

ICP Intracranial Pressure

ICU Intensive Care Unit iv intravenous kPa kilopascal

LOC(S) Level(s) of Care l/min liter per minute

M and F Male and female

SARS Severe Acute Respiratory Syndrome

WQI Working Group of Quality Improvement (ESICM)