Guidance 1 4 3

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2.16.1.3.3.2.1.4 Pilot A pilot is a controlled release solution usually with limited deployment, limited functionality, limited number of users, and/or allowed for a limited duration of time. 1.3.4.1 The stoma should be washed daily with water and dried thoroughly. 2003 1.3.4.2 To prevent blockages, flush the enteral feeding tube before and after feeding or administering medications using single-use syringes or single-patient-use (reusable) syringes according to the manufacturer's instructions. 4 Guidance on the compilation of safety data sheets Draft Public Version 4.0 April 2020 Replacement in chapters 4.2, 4.3 and 4.16 of the translated Hazards Class and Category Codes with the correct versions (i.e. English-based code text) as appear in Annex VI and VII of the CLP Regulation.

1 Guidance

1 Guidance

The following guidance is based on the best available evidence. The full guideline gives details of the methods and the evidence used to develop the guidance.

Terms used in this guidance

Aseptic technique An aseptic technique ensures that only uncontaminated equipment and fluids come into contact with susceptible body sites. It should be used during any clinical procedure that bypasses the body's natural defences. Using the principles of asepsis minimises the spread of organisms from one person to another.

Direct patient care 'Hands on' or face-to-face contact with patients. Any physical aspect of the healthcare of a patient, including treatments, self-care and administration of medication.

Hand decontamination The use of handrub or handwashing to reduce the number of bacteria on the hands. In this guideline this term is interchangeable with 'hand hygiene'.

Guideline 14 esc

Handrub A preparation applied to the hands to reduce the number of viable microorganisms. This guideline refers to handrubs compliant with British standards (BS EN1500; standard for efficacy of hygienic handrubs using a reference of 60% isopropyl alcohol).

Healthcare worker Any person employed by the health service, social services, a local authority or an agency to provide care for a sick, disabled or elderly person.

Healthcare waste In this guideline, healthcare waste refers to any waste produced by, and as a consequence of, healthcare activities.

Personal protective equipment Equipment that is intended to be worn or held by a person to protect them from risks to their health and safety while at work. Examples include gloves, aprons, and eye and face protection.

1.1 Standard principles

1.1.1 General advice

1.1.1.1 Everyone involved in providing care should be:

  • educated about the standard principles of infection prevention and control and

  • trained in hand decontamination, the use of personal protective equipment, and the safe use and disposal of sharps. [2012]

1.1.1.2 Wherever care is delivered, healthcare workers must[7] have available appropriate supplies of:

  • materials for hand decontamination

  • sharps containers

  • personal protective equipment. [new 2012]

1.1.1.3 Educate patients and carers about:

  • the benefits of effective hand decontamination

  • the correct techniques and timing of hand decontamination

  • when it is appropriate to use liquid soap and water or handrub

  • the availability of hand decontamination facilities

  • their role in maintaining standards of healthcare workers' hand decontamination. [new 2012]

1.1.2 Hand decontamination

1.1.2.1 Hands must be decontaminated in all of the following circumstances:

  • immediately before every episode of direct patient contact or care, including aseptic procedures

  • immediately after every episode of direct patient contact or care

  • immediately after any exposure to body fluids

  • immediately after any other activity or contact with a patient's surroundings that could potentially result in hands becoming contaminated

  • immediately after removal of gloves. [new 2012]

1.1.2.2 Decontaminate hands preferably with a handrub (conforming to current British standards[8]), except in the following circumstances, when liquid soap and water must be used:

  • when hands are visibly soiled or potentially contaminated with body fluids or

  • in clinical situations where there is potential for the spread of alcohol-resistant organisms (such as Clostridium difficile or other organisms that cause diarrhoeal illness). [new 2012]

1.1.2.3 Healthcare workers should ensure that their hands can be decontaminated throughout the duration of clinical work by:

  • being bare below the elbow[9] when delivering direct patient care

  • removing wrist and hand jewellery

  • making sure that fingernails are short, clean and free of nail polish

  • covering cuts and abrasions with waterproof dressings. [new 2012]

1.1.2.4 An effective handwashing technique involves three stages: preparation, washing and rinsing, and drying. Preparation requires wetting hands under tepid running water before applying liquid soap or an antimicrobial preparation. The handwash solution must come into contact with all of the surfaces of the hand. The hands must be rubbed together vigorously for a minimum of 10–15 seconds, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers. Hands should be rinsed thoroughly before drying with good quality paper towels. [2003]

1.1.2.5 When decontaminating hands using an alcohol handrub, hands should be free from dirt and organic material. The handrub solution must come into contact with all surfaces of the hand. The hands must be rubbed together vigorously, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers, until the solution has evaporated and the hands are dry. [2003]

1.1.2.6 An emollient hand cream should be applied regularly to protect skin from the drying effects of regular hand decontamination. If a particular soap, antimicrobial hand wash or alcohol product causes skin irritation an occupational health team should be consulted. [2003]

1.1.3 Use of personal protective equipment

1.1.3.1 Selection of protective equipment must[7] be based on an assessment of the risk of transmission of microorganisms to the patient, and the risk of contamination of the healthcare worker's clothing and skin by patients' blood, body fluids, secretions or excretions. [2003]

1.1.3.2 Gloves used for direct patient care:

  • must[7] conform to current EU legislation (CE marked as medical gloves for single use)[10]and

  • should be appropriate for the task. [new 2012]

1.1.3.3 Gloves must[7] be worn for invasive procedures, contact with sterile sites and non-intact skin or mucous membranes, and all activities that have been assessed as carrying a risk of exposure to blood, body fluids, secretions or excretions, or to sharp or contaminated instruments. [2003]

1.1.3.4 Gloves must[7] be worn as single-use items. They must be put on immediately before an episode of patient contact or treatment and removed as soon as the activity is completed. Gloves must be changed between caring for different patients, and between different care or treatment activities for the same patient. [2003]

1.1.3.5 Ensure that gloves used for direct patient care that have been exposed to body fluids are disposed of correctly, in accordance with current national legislation[11] or local policies (see section 1.1.5). [new 2012]

1.1.3.6 Alternatives to natural rubber latex gloves must[7] be available for patients, carers and healthcare workers who have a documented sensitivity to natural rubber latex. [2012]

1.1.3.7 Do not use polythene gloves for clinical interventions. [new 2012]

1.1.3.8 When delivering direct patient care:

  • wear a disposable plastic apron if there is a risk that clothing may be exposed to blood, body fluids, secretions or excretions or

  • wear a long-sleeved fluid-repellent gown if there is a risk of extensive splashing of blood, body fluids, secretions or excretions onto skin or clothing. [2012]

1.1.3.9 When using disposable plastic aprons or gowns:

  • use them as single-use items, for one procedure or one episode of direct patient care and

  • ensure they are disposed of correctly (see section 1.1.5). [2012]

1.1.3.10 Face masks and eye protection must[7] be worn where there is a risk of blood, body fluids, secretions or excretions splashing into the face and eyes. [2003]

1.1.3.11 Respiratory protective equipment, for example a particulate filter mask, must[7] be used when clinically indicated. [2003]

1.1.4 Safe use and disposal of sharps

1.1.4.1 Sharps should[12] not be passed directly from hand to hand, and handling should be kept to a minimum. [2003, amended 2012]

1.1.4.2 Used standard needles:

  • must not be bent[13] or broken before disposal

  • must not be recapped.
    In dentistry, if recapping or disassembly is unavoidable, a risk assessment must be undertaken and appropriate safety devices should be used[14]. [new 2012]

1.1.4.3 Used sharps must be discarded immediately by the person generating the sharps waste into a sharps container conforming to current standards[15]. [new 2012]

1.1.4.4 Sharps containers:

  • must[11] be located in a safe position that avoids spillage, is at a height that allows the safe disposal of sharps, is away from public access areas and is out of the reach of children

  • must not[11] be used for any other purpose than the disposal of sharps

  • must not[11] be filled above the fill line

  • must[11] be disposed of when the fill line is reached

  • should be temporarily closed when not in use

  • should be disposed of every 3 months even if not full, by the licensed route in accordance with local policy. [new 2012]

1.1.4.5 Use sharps safety devices if a risk assessment has indicated that they will provide safer systems of working for healthcare workers, carers and patients. [new 2012]

1.1.4.6 Train and assess all users in the correct use and disposal of sharps and sharps safety devices. [new 2012]

1.1.5 Waste disposal

1.1.5.1 Healthcare waste must be segregated immediately by the person generating the waste into appropriate colour-coded storage or waste disposal bags or containers defined as being compliant with current national legislation[11] and local policies. [new 2012]

1.1.5.2 Healthcare waste must be labelled, stored, transported and disposed of in accordance with current national legislation[11] and local policies. [new 2012]

1.1.5.3 Educate patients and carers about the correct handling, storage and disposal of healthcare waste. [new 2012]

1.2 Long-term urinary catheters

1.2.1 Education of patients, their carers and healthcare workers

1.2.1.1 Patients and carers should be educated about and trained in techniques of hand decontamination, insertion of intermittent catheters where applicable, and catheter management before discharge from hospital. [2003]

1.2.1.2 Community and primary healthcare workers must be trained in catheter insertion, including suprapubic catheter replacement and catheter maintenance. [2003]

1.2.1.3 Follow-up training and ongoing support of patients and carers should be available for the duration of long-term catheterisation. [2003]

1.2.2 Assessing the need for catheterisation

1.2.2.1 Indwelling urinary catheters should be used only after alternative methods of management have been considered. [2003]

1.2.2.2 The patient's clinical need for catheterisation should be reviewed regularly and the urinary catheter removed as soon as possible. [2003]

1.2.2.3 Catheter insertion, changes and care should be documented. [2003]

1.2.3 Catheter drainage options

1.2.3.1 Following assessment, the best approach to catheterisation that takes account of clinical need, anticipated duration of catheterisation, patient preference and risk of infection should be selected. [2003]

1.2.3.2 Intermittent catheterisation should be used in preference to an indwelling catheter if it is clinically appropriate and a practical option for the patient. [2003]

1.2.3.3 Offer a choice of either single-use hydrophilic or gel reservoir catheters for intermittent self-catheterisation. [new 2012]

1.2.3.4 Select the type and gauge of an indwelling urinary catheter based on an assessment of the patient's individual characteristics, including:

  • age

  • any allergy or sensitivity to catheter materials

  • gender

  • history of symptomatic urinary tract infection

  • patient preference and comfort

  • previous catheter history

  • reason for catheterisation. [new 2012] Disk doctor 4 2 trailer.

1.2.3.5 In general, the catheter balloon should be inflated with 10 ml of sterile water in adults and 3–5 ml in children. [2003]

1.2.3.6 In patients for whom it is appropriate, a catheter valve may be used as an alternative to a drainage bag. [2003]

1.2.4 Catheter insertion

1.2.4.1 All catheterisations carried out by healthcare workers should be aseptic procedures. After training, healthcare workers should be assessed for their competence to carry out these types of procedures. [2003]

1.2.4.2 Intermittent self-catheterisation is a clean procedure. A lubricant for single-patient use is required for non-lubricated catheters. [2003]

1.2.4.3 For urethral catheterisation, the meatus should be cleaned before insertion of the catheter, in accordance with local guidelines/policy. [2003]

1.2.4.4 An appropriate lubricant from a single-use container should be used during catheter insertion to minimise urethral trauma and infection. [2003]

1.2.5 Catheter maintenance

1.2.5.1 Indwelling catheters should be connected to a sterile closed urinary drainage system or catheter valve. [2003]

1.2.5.2 Healthcare workers should ensure that the connection between the catheter and the urinary drainage system is not broken except for good clinical reasons (for example changing the bag in line with the manufacturer's recommendations). [2003]

1.2.5.3 Healthcare workers must decontaminate their hands and wear a new pair of clean, non-sterile gloves before manipulating a patient's catheter, and must decontaminate their hands after removing gloves. [2003]

1.2.5.4 Patients managing their own catheters, and their carers, must be educated about the need for hand decontamination[16] before and after manipulation of the catheter, in accordance with the recommendations in the standard principles section (section 1.1). [2003, amended 2012]

1.2.5.5 Urine samples must be obtained from a sampling port using an aseptic technique. [2003]

1.2.5.6 Urinary drainage bags should be positioned below the level of the bladder, and should not be in contact with the floor. [2003]

1.2.5.7 A link system should be used to facilitate overnight drainage, to keep the original system intact. [2003]

1.2.5.8 The urinary drainage bag should be emptied frequently enough to maintain urine flow and prevent reflux, and should be changed when clinically indicated. [2003]

1.2.5.9 The meatus should be washed daily with soap and water. [2003]

1.2.5.10 To minimise the risk of blockages, encrustations and catheter-associated infections for patients with a long-term indwelling urinary catheter:

  • develop a patient-specific care regimen

  • consider approaches such as reviewing the frequency of planned catheter changes and increasing fluid intake

  • document catheter blockages. [new 2012]

1.2.5.11 Bladder instillations or washouts must not be used to prevent catheter-associated infections. [2003]

1.2.5.12 Catheters should be changed only when clinically necessary or according to the manufacturer's current recommendations. [2003]

1.2.5.13 When changing catheters in patients with a long-term indwelling urinary catheter:

  • do not offer antibiotic prophylaxis routinely

  • consider antibiotic prophylaxis[17] for patients who:

    • have a history of symptomatic urinary tract infection after catheter change or

    • experience trauma[18] during catheterisation. [new 2012]

1.3 Enteral feeding

1.3.1 Education of patients, their carers and healthcare workers

1.3.1.1 Patients and carers should be educated about and trained in the techniques of hand decontamination, enteral feeding and the management of the administration system before being discharged from hospital. [2003]

1.3.1.2 Healthcare workers should be trained in enteral feeding and management of the administration system. [2003]

1.3.1.3 Follow-up training and ongoing support of patients and carers should be available for the duration of home enteral tube feeding. [2003]

1.3.2 Preparation and storage of feeds

1.3.2.1 Wherever possible pre-packaged, ready-to-use feeds should be used in preference to feeds requiring decanting, reconstitution or dilution. [2003]

1.3.2.2 The system selected should require minimal handling to assemble, and be compatible with the patient's enteral feeding tube. [2003]

1.3.2.3 Effective hand decontamination must be carried out before starting feed preparation. [2003]

1.3.2.4 When decanting, reconstituting or diluting feeds, a clean working area should be prepared and equipment dedicated for enteral feed use only should be used. [2003]

1.3.2.5 Feeds should be mixed using cooled boiled water or freshly opened sterile water and a no-touch technique. [2003]

1.3.2.6 Feeds should be stored according to the manufacturer's instructions and, where applicable, food hygiene legislation. [2003]

1.3.2.7 Where ready-to-use feeds are not available, feeds may be prepared in advance, stored in a refrigerator, and used within 24 hours. [2003]

1.3.3 Administration of feeds

1.3.3.1 Use minimal handling and an aseptic technique to connect the administration system to the enteral feeding tube. [new 2012]

1.3.3.2 Ready-to-use feeds may be given for a whole administration session, up to a maximum of 24 hours. Reconstituted feeds should be administered over a maximum 4-hour period. [2003]

1.3.3.3 Administration sets and feed containers are for single use and must be discarded after each feeding session. [2003]

1.3.4 Care of insertion site and enteral feeding tube

1.3.4.1 The stoma should be washed daily with water and dried thoroughly. [2003]

1.3.4.2 To prevent blockages, flush the enteral feeding tube before and after feeding or administering medications using single-use syringes or single-patient-use (reusable) syringes according to the manufacturer's instructions. Use:

  • freshly drawn tap water for patients who are not immunosuppressed

  • either cooled freshly boiled water or sterile water from a freshly opened container for patients who are immunosuppressed. [new 2012]

1.4 Vascular access devices

1.4.1 Education of patients, their carers and healthcare workers

1.4.1.1 Before discharge from hospital, patients and their carers should be taught any techniques they may need to use to prevent infection and safely manage a vascular access device[19]. [2003, amended 2012]

1.4.1.2 Healthcare workers caring for a patient with a vascular access device[19] should be trained, and assessed as competent, in using and consistently adhering to the infection prevention practices described in this guideline. [2003, amended 2012]

1.4.1.3 Follow-up training and support should be available to patients with a vascular access device[19] and their carers. [2003, amended 2012]

1.4.2 General asepsis

1.4.2.1 Hands must be decontaminated (see section 1.1.2) before accessing or dressing a vascular access device. [new 2012]

1.4.2.2 An aseptic technique[20] Adobe prelude 2020 9 0. must be used for vascular access device catheter site care and when accessing the system. [new 2012]

1.4.3 Vascular access device site care

1.4.3.1 Decontaminate the skin at the insertion site with chlorhexidine gluconate[21] in 70% alcohol before inserting a peripheral vascular access device or a peripherally inserted central catheter. [new 2012]

1.4.3.2 Use a sterile transparent semipermeable membrane dressing to cover the vascular access device insertion site. [new 2012]

1.4.3.3 Consider a sterile gauze dressing covered with a sterile transparent semipermeable membrane dressing only if the patient has profuse perspiration, or if the vascular access device insertion site is bleeding or oozing. If a gauze dressing is used:

  • change it every 24 hours, or sooner if it is soiled and

  • replace it with a sterile transparent semipermeable membrane dressing as soon as possible. [new 2012]

1.4.3.4 Change the transparent semipermeable membrane dressing covering a central venous access device insertion site every 7 days, or sooner if the dressing is no longer intact or moisture collects under it. [2012]

1.4.3.5 Leave the transparent semipermeable membrane dressing applied to a peripheral cannula insertion site in situ for the life of the cannula, provided that the integrity of the dressing is retained. [new 2012]

1.4.3.6 Dressings used on tunnelled or implanted central venous catheter sites should be replaced every 7 days until the insertion site has healed, unless there is an indication to change them sooner. [2003]

1.4.3.7 Healthcare workers should ensure that catheter-site care is compatible with catheter materials (tubing, hubs, injection ports, luer connectors and extensions) and carefully check compatibility with the manufacturer's recommendations. [2003]

1.4.3.8 Decontaminate the central venous catheter insertion site and surrounding skin during dressing changes using chlorhexidine gluconate[21] in 70% alcohol, and allow to air dry. Consider using an aqueous solution of chlorhexidine gluconate if the manufacturer's recommendations prohibit the use of alcohol with their catheter. [2012]

1.4.3.9 Individual sachets of antiseptic solution or individual packages of antiseptic-impregnated swabs or wipes should be used to disinfect the dressing site. [2003]

1.4.4 General principles for management of vascular access devices

1.4.4.1 Decontaminate the injection port or vascular access device catheter hub before and after accessing the system using chlorhexidine gluconate[21] in 70% alcohol. Consider using an aqueous solution of chlorhexidine gluconate if the manufacturer's recommendations prohibit the use of alcohol with their catheter. [new 2012]

1.4.4.2 In-line filters should not be used routinely for infection prevention. [2003]

1.4.4.3 Antibiotic lock solutions should not be used routinely to prevent catheter-related bloodstream infections (CRBSI). [2003]

1.4.4.4 Systemic antimicrobial prophylaxis should not be used routinely to prevent catheter colonisation or CRBSI, either before insertion or during the use of a central venous catheter. [2003]

1.4.4.5 Preferably, a single lumen catheter should be used to administer parenteral nutrition. If a multilumen catheter is used, one port must be exclusively dedicated for total parenteral nutrition, and all lumens must be handled with the same meticulous attention to aseptic technique. [2003]

1.4.4.6 Preferably, a sterile 0.9 percent sodium chloride injection should be used to flush and lock catheter lumens. [2003]

1.4.4.7 When recommended by the manufacturer, implanted ports or opened-ended catheter lumens should be flushed and locked with heparin sodium flush solutions. [2003]

1.4.4.8 Systemic anticoagulants should not be used routinely to prevent CRBSI. [2003]

Guidance 14971

Handrub A preparation applied to the hands to reduce the number of viable microorganisms. This guideline refers to handrubs compliant with British standards (BS EN1500; standard for efficacy of hygienic handrubs using a reference of 60% isopropyl alcohol).

Healthcare worker Any person employed by the health service, social services, a local authority or an agency to provide care for a sick, disabled or elderly person.

Healthcare waste In this guideline, healthcare waste refers to any waste produced by, and as a consequence of, healthcare activities.

Personal protective equipment Equipment that is intended to be worn or held by a person to protect them from risks to their health and safety while at work. Examples include gloves, aprons, and eye and face protection.

1.1 Standard principles

1.1.1 General advice

1.1.1.1 Everyone involved in providing care should be:

  • educated about the standard principles of infection prevention and control and

  • trained in hand decontamination, the use of personal protective equipment, and the safe use and disposal of sharps. [2012]

1.1.1.2 Wherever care is delivered, healthcare workers must[7] have available appropriate supplies of:

  • materials for hand decontamination

  • sharps containers

  • personal protective equipment. [new 2012]

1.1.1.3 Educate patients and carers about:

  • the benefits of effective hand decontamination

  • the correct techniques and timing of hand decontamination

  • when it is appropriate to use liquid soap and water or handrub

  • the availability of hand decontamination facilities

  • their role in maintaining standards of healthcare workers' hand decontamination. [new 2012]

1.1.2 Hand decontamination

1.1.2.1 Hands must be decontaminated in all of the following circumstances:

  • immediately before every episode of direct patient contact or care, including aseptic procedures

  • immediately after every episode of direct patient contact or care

  • immediately after any exposure to body fluids

  • immediately after any other activity or contact with a patient's surroundings that could potentially result in hands becoming contaminated

  • immediately after removal of gloves. [new 2012]

1.1.2.2 Decontaminate hands preferably with a handrub (conforming to current British standards[8]), except in the following circumstances, when liquid soap and water must be used:

  • when hands are visibly soiled or potentially contaminated with body fluids or

  • in clinical situations where there is potential for the spread of alcohol-resistant organisms (such as Clostridium difficile or other organisms that cause diarrhoeal illness). [new 2012]

1.1.2.3 Healthcare workers should ensure that their hands can be decontaminated throughout the duration of clinical work by:

  • being bare below the elbow[9] when delivering direct patient care

  • removing wrist and hand jewellery

  • making sure that fingernails are short, clean and free of nail polish

  • covering cuts and abrasions with waterproof dressings. [new 2012]

1.1.2.4 An effective handwashing technique involves three stages: preparation, washing and rinsing, and drying. Preparation requires wetting hands under tepid running water before applying liquid soap or an antimicrobial preparation. The handwash solution must come into contact with all of the surfaces of the hand. The hands must be rubbed together vigorously for a minimum of 10–15 seconds, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers. Hands should be rinsed thoroughly before drying with good quality paper towels. [2003]

1.1.2.5 When decontaminating hands using an alcohol handrub, hands should be free from dirt and organic material. The handrub solution must come into contact with all surfaces of the hand. The hands must be rubbed together vigorously, paying particular attention to the tips of the fingers, the thumbs and the areas between the fingers, until the solution has evaporated and the hands are dry. [2003]

1.1.2.6 An emollient hand cream should be applied regularly to protect skin from the drying effects of regular hand decontamination. If a particular soap, antimicrobial hand wash or alcohol product causes skin irritation an occupational health team should be consulted. [2003]

1.1.3 Use of personal protective equipment

1.1.3.1 Selection of protective equipment must[7] be based on an assessment of the risk of transmission of microorganisms to the patient, and the risk of contamination of the healthcare worker's clothing and skin by patients' blood, body fluids, secretions or excretions. [2003]

1.1.3.2 Gloves used for direct patient care:

  • must[7] conform to current EU legislation (CE marked as medical gloves for single use)[10]and

  • should be appropriate for the task. [new 2012]

1.1.3.3 Gloves must[7] be worn for invasive procedures, contact with sterile sites and non-intact skin or mucous membranes, and all activities that have been assessed as carrying a risk of exposure to blood, body fluids, secretions or excretions, or to sharp or contaminated instruments. [2003]

1.1.3.4 Gloves must[7] be worn as single-use items. They must be put on immediately before an episode of patient contact or treatment and removed as soon as the activity is completed. Gloves must be changed between caring for different patients, and between different care or treatment activities for the same patient. [2003]

1.1.3.5 Ensure that gloves used for direct patient care that have been exposed to body fluids are disposed of correctly, in accordance with current national legislation[11] or local policies (see section 1.1.5). [new 2012]

1.1.3.6 Alternatives to natural rubber latex gloves must[7] be available for patients, carers and healthcare workers who have a documented sensitivity to natural rubber latex. [2012]

1.1.3.7 Do not use polythene gloves for clinical interventions. [new 2012]

1.1.3.8 When delivering direct patient care:

  • wear a disposable plastic apron if there is a risk that clothing may be exposed to blood, body fluids, secretions or excretions or

  • wear a long-sleeved fluid-repellent gown if there is a risk of extensive splashing of blood, body fluids, secretions or excretions onto skin or clothing. [2012]

1.1.3.9 When using disposable plastic aprons or gowns:

  • use them as single-use items, for one procedure or one episode of direct patient care and

  • ensure they are disposed of correctly (see section 1.1.5). [2012]

1.1.3.10 Face masks and eye protection must[7] be worn where there is a risk of blood, body fluids, secretions or excretions splashing into the face and eyes. [2003]

1.1.3.11 Respiratory protective equipment, for example a particulate filter mask, must[7] be used when clinically indicated. [2003]

1.1.4 Safe use and disposal of sharps

1.1.4.1 Sharps should[12] not be passed directly from hand to hand, and handling should be kept to a minimum. [2003, amended 2012]

1.1.4.2 Used standard needles:

  • must not be bent[13] or broken before disposal

  • must not be recapped.
    In dentistry, if recapping or disassembly is unavoidable, a risk assessment must be undertaken and appropriate safety devices should be used[14]. [new 2012]

1.1.4.3 Used sharps must be discarded immediately by the person generating the sharps waste into a sharps container conforming to current standards[15]. [new 2012]

1.1.4.4 Sharps containers:

  • must[11] be located in a safe position that avoids spillage, is at a height that allows the safe disposal of sharps, is away from public access areas and is out of the reach of children

  • must not[11] be used for any other purpose than the disposal of sharps

  • must not[11] be filled above the fill line

  • must[11] be disposed of when the fill line is reached

  • should be temporarily closed when not in use

  • should be disposed of every 3 months even if not full, by the licensed route in accordance with local policy. [new 2012]

1.1.4.5 Use sharps safety devices if a risk assessment has indicated that they will provide safer systems of working for healthcare workers, carers and patients. [new 2012]

1.1.4.6 Train and assess all users in the correct use and disposal of sharps and sharps safety devices. [new 2012]

1.1.5 Waste disposal

1.1.5.1 Healthcare waste must be segregated immediately by the person generating the waste into appropriate colour-coded storage or waste disposal bags or containers defined as being compliant with current national legislation[11] and local policies. [new 2012]

1.1.5.2 Healthcare waste must be labelled, stored, transported and disposed of in accordance with current national legislation[11] and local policies. [new 2012]

1.1.5.3 Educate patients and carers about the correct handling, storage and disposal of healthcare waste. [new 2012]

1.2 Long-term urinary catheters

1.2.1 Education of patients, their carers and healthcare workers

1.2.1.1 Patients and carers should be educated about and trained in techniques of hand decontamination, insertion of intermittent catheters where applicable, and catheter management before discharge from hospital. [2003]

1.2.1.2 Community and primary healthcare workers must be trained in catheter insertion, including suprapubic catheter replacement and catheter maintenance. [2003]

1.2.1.3 Follow-up training and ongoing support of patients and carers should be available for the duration of long-term catheterisation. [2003]

1.2.2 Assessing the need for catheterisation

1.2.2.1 Indwelling urinary catheters should be used only after alternative methods of management have been considered. [2003]

1.2.2.2 The patient's clinical need for catheterisation should be reviewed regularly and the urinary catheter removed as soon as possible. [2003]

1.2.2.3 Catheter insertion, changes and care should be documented. [2003]

1.2.3 Catheter drainage options

1.2.3.1 Following assessment, the best approach to catheterisation that takes account of clinical need, anticipated duration of catheterisation, patient preference and risk of infection should be selected. [2003]

1.2.3.2 Intermittent catheterisation should be used in preference to an indwelling catheter if it is clinically appropriate and a practical option for the patient. [2003]

1.2.3.3 Offer a choice of either single-use hydrophilic or gel reservoir catheters for intermittent self-catheterisation. [new 2012]

1.2.3.4 Select the type and gauge of an indwelling urinary catheter based on an assessment of the patient's individual characteristics, including:

  • age

  • any allergy or sensitivity to catheter materials

  • gender

  • history of symptomatic urinary tract infection

  • patient preference and comfort

  • previous catheter history

  • reason for catheterisation. [new 2012] Disk doctor 4 2 trailer.

1.2.3.5 In general, the catheter balloon should be inflated with 10 ml of sterile water in adults and 3–5 ml in children. [2003]

1.2.3.6 In patients for whom it is appropriate, a catheter valve may be used as an alternative to a drainage bag. [2003]

1.2.4 Catheter insertion

1.2.4.1 All catheterisations carried out by healthcare workers should be aseptic procedures. After training, healthcare workers should be assessed for their competence to carry out these types of procedures. [2003]

1.2.4.2 Intermittent self-catheterisation is a clean procedure. A lubricant for single-patient use is required for non-lubricated catheters. [2003]

1.2.4.3 For urethral catheterisation, the meatus should be cleaned before insertion of the catheter, in accordance with local guidelines/policy. [2003]

1.2.4.4 An appropriate lubricant from a single-use container should be used during catheter insertion to minimise urethral trauma and infection. [2003]

1.2.5 Catheter maintenance

1.2.5.1 Indwelling catheters should be connected to a sterile closed urinary drainage system or catheter valve. [2003]

1.2.5.2 Healthcare workers should ensure that the connection between the catheter and the urinary drainage system is not broken except for good clinical reasons (for example changing the bag in line with the manufacturer's recommendations). [2003]

1.2.5.3 Healthcare workers must decontaminate their hands and wear a new pair of clean, non-sterile gloves before manipulating a patient's catheter, and must decontaminate their hands after removing gloves. [2003]

1.2.5.4 Patients managing their own catheters, and their carers, must be educated about the need for hand decontamination[16] before and after manipulation of the catheter, in accordance with the recommendations in the standard principles section (section 1.1). [2003, amended 2012]

1.2.5.5 Urine samples must be obtained from a sampling port using an aseptic technique. [2003]

1.2.5.6 Urinary drainage bags should be positioned below the level of the bladder, and should not be in contact with the floor. [2003]

1.2.5.7 A link system should be used to facilitate overnight drainage, to keep the original system intact. [2003]

1.2.5.8 The urinary drainage bag should be emptied frequently enough to maintain urine flow and prevent reflux, and should be changed when clinically indicated. [2003]

1.2.5.9 The meatus should be washed daily with soap and water. [2003]

1.2.5.10 To minimise the risk of blockages, encrustations and catheter-associated infections for patients with a long-term indwelling urinary catheter:

  • develop a patient-specific care regimen

  • consider approaches such as reviewing the frequency of planned catheter changes and increasing fluid intake

  • document catheter blockages. [new 2012]

1.2.5.11 Bladder instillations or washouts must not be used to prevent catheter-associated infections. [2003]

1.2.5.12 Catheters should be changed only when clinically necessary or according to the manufacturer's current recommendations. [2003]

1.2.5.13 When changing catheters in patients with a long-term indwelling urinary catheter:

  • do not offer antibiotic prophylaxis routinely

  • consider antibiotic prophylaxis[17] for patients who:

    • have a history of symptomatic urinary tract infection after catheter change or

    • experience trauma[18] during catheterisation. [new 2012]

1.3 Enteral feeding

1.3.1 Education of patients, their carers and healthcare workers

1.3.1.1 Patients and carers should be educated about and trained in the techniques of hand decontamination, enteral feeding and the management of the administration system before being discharged from hospital. [2003]

1.3.1.2 Healthcare workers should be trained in enteral feeding and management of the administration system. [2003]

1.3.1.3 Follow-up training and ongoing support of patients and carers should be available for the duration of home enteral tube feeding. [2003]

1.3.2 Preparation and storage of feeds

1.3.2.1 Wherever possible pre-packaged, ready-to-use feeds should be used in preference to feeds requiring decanting, reconstitution or dilution. [2003]

1.3.2.2 The system selected should require minimal handling to assemble, and be compatible with the patient's enteral feeding tube. [2003]

1.3.2.3 Effective hand decontamination must be carried out before starting feed preparation. [2003]

1.3.2.4 When decanting, reconstituting or diluting feeds, a clean working area should be prepared and equipment dedicated for enteral feed use only should be used. [2003]

1.3.2.5 Feeds should be mixed using cooled boiled water or freshly opened sterile water and a no-touch technique. [2003]

1.3.2.6 Feeds should be stored according to the manufacturer's instructions and, where applicable, food hygiene legislation. [2003]

1.3.2.7 Where ready-to-use feeds are not available, feeds may be prepared in advance, stored in a refrigerator, and used within 24 hours. [2003]

1.3.3 Administration of feeds

1.3.3.1 Use minimal handling and an aseptic technique to connect the administration system to the enteral feeding tube. [new 2012]

1.3.3.2 Ready-to-use feeds may be given for a whole administration session, up to a maximum of 24 hours. Reconstituted feeds should be administered over a maximum 4-hour period. [2003]

1.3.3.3 Administration sets and feed containers are for single use and must be discarded after each feeding session. [2003]

1.3.4 Care of insertion site and enteral feeding tube

1.3.4.1 The stoma should be washed daily with water and dried thoroughly. [2003]

1.3.4.2 To prevent blockages, flush the enteral feeding tube before and after feeding or administering medications using single-use syringes or single-patient-use (reusable) syringes according to the manufacturer's instructions. Use:

  • freshly drawn tap water for patients who are not immunosuppressed

  • either cooled freshly boiled water or sterile water from a freshly opened container for patients who are immunosuppressed. [new 2012]

1.4 Vascular access devices

1.4.1 Education of patients, their carers and healthcare workers

1.4.1.1 Before discharge from hospital, patients and their carers should be taught any techniques they may need to use to prevent infection and safely manage a vascular access device[19]. [2003, amended 2012]

1.4.1.2 Healthcare workers caring for a patient with a vascular access device[19] should be trained, and assessed as competent, in using and consistently adhering to the infection prevention practices described in this guideline. [2003, amended 2012]

1.4.1.3 Follow-up training and support should be available to patients with a vascular access device[19] and their carers. [2003, amended 2012]

1.4.2 General asepsis

1.4.2.1 Hands must be decontaminated (see section 1.1.2) before accessing or dressing a vascular access device. [new 2012]

1.4.2.2 An aseptic technique[20] Adobe prelude 2020 9 0. must be used for vascular access device catheter site care and when accessing the system. [new 2012]

1.4.3 Vascular access device site care

1.4.3.1 Decontaminate the skin at the insertion site with chlorhexidine gluconate[21] in 70% alcohol before inserting a peripheral vascular access device or a peripherally inserted central catheter. [new 2012]

1.4.3.2 Use a sterile transparent semipermeable membrane dressing to cover the vascular access device insertion site. [new 2012]

1.4.3.3 Consider a sterile gauze dressing covered with a sterile transparent semipermeable membrane dressing only if the patient has profuse perspiration, or if the vascular access device insertion site is bleeding or oozing. If a gauze dressing is used:

  • change it every 24 hours, or sooner if it is soiled and

  • replace it with a sterile transparent semipermeable membrane dressing as soon as possible. [new 2012]

1.4.3.4 Change the transparent semipermeable membrane dressing covering a central venous access device insertion site every 7 days, or sooner if the dressing is no longer intact or moisture collects under it. [2012]

1.4.3.5 Leave the transparent semipermeable membrane dressing applied to a peripheral cannula insertion site in situ for the life of the cannula, provided that the integrity of the dressing is retained. [new 2012]

1.4.3.6 Dressings used on tunnelled or implanted central venous catheter sites should be replaced every 7 days until the insertion site has healed, unless there is an indication to change them sooner. [2003]

1.4.3.7 Healthcare workers should ensure that catheter-site care is compatible with catheter materials (tubing, hubs, injection ports, luer connectors and extensions) and carefully check compatibility with the manufacturer's recommendations. [2003]

1.4.3.8 Decontaminate the central venous catheter insertion site and surrounding skin during dressing changes using chlorhexidine gluconate[21] in 70% alcohol, and allow to air dry. Consider using an aqueous solution of chlorhexidine gluconate if the manufacturer's recommendations prohibit the use of alcohol with their catheter. [2012]

1.4.3.9 Individual sachets of antiseptic solution or individual packages of antiseptic-impregnated swabs or wipes should be used to disinfect the dressing site. [2003]

1.4.4 General principles for management of vascular access devices

1.4.4.1 Decontaminate the injection port or vascular access device catheter hub before and after accessing the system using chlorhexidine gluconate[21] in 70% alcohol. Consider using an aqueous solution of chlorhexidine gluconate if the manufacturer's recommendations prohibit the use of alcohol with their catheter. [new 2012]

1.4.4.2 In-line filters should not be used routinely for infection prevention. [2003]

1.4.4.3 Antibiotic lock solutions should not be used routinely to prevent catheter-related bloodstream infections (CRBSI). [2003]

1.4.4.4 Systemic antimicrobial prophylaxis should not be used routinely to prevent catheter colonisation or CRBSI, either before insertion or during the use of a central venous catheter. [2003]

1.4.4.5 Preferably, a single lumen catheter should be used to administer parenteral nutrition. If a multilumen catheter is used, one port must be exclusively dedicated for total parenteral nutrition, and all lumens must be handled with the same meticulous attention to aseptic technique. [2003]

1.4.4.6 Preferably, a sterile 0.9 percent sodium chloride injection should be used to flush and lock catheter lumens. [2003]

1.4.4.7 When recommended by the manufacturer, implanted ports or opened-ended catheter lumens should be flushed and locked with heparin sodium flush solutions. [2003]

1.4.4.8 Systemic anticoagulants should not be used routinely to prevent CRBSI. [2003]

1.4.4.9 If needleless devices are used, the manufacturer's recommendations for changing the needleless components should be followed. [2003]

1.4.4.10 When needleless devices are used, healthcare workers should ensure that all components of the system are compatible and secured, to minimise leaks and breaks in the system. [2003]

1.4.4.11 When needleless devices are used, the risk of contamination should be minimised by decontaminating the access port with either alcohol or an alcoholic solution of chlorhexidine gluconate[21] before and after using it to access the system. [2003]

1.4.4.12 In general, administration sets in continuous use need not be replaced more frequently than at 72-hour intervals unless they become disconnected or a catheter-related infection is suspected or documented. [2003]

1.4.4.13 Administration sets for blood and blood components should be changed every 12 hours, or according to the manufacturer's recommendations. [2003]

1.4.4.14 Administration sets used for total parenteral nutrition infusions should generally be changed every 24 hours. If the solution contains only glucose and amino acids, administration sets in continuous use do not need to be replaced more frequently than every 72 hours. [2003]

1.4.4.15 Avoid the use of multidose vials, in order to prevent the contamination of infusates. [new 2012]


[7] In accordance with current health and safety legislation (at the time of publication of the guideline [March 2012]): Health and Safety at Work Act 1974, Management of Health and Safety at Work Regulations 1999, Health and Safety Regulations 2002, Control of Substances Hazardous to Health Regulations 2002, Personal Protective Equipment Regulations 2002 and Health and Social Care Act 2008.

[9] For the purposes of this guideline, the GDG considered bare below the elbow to mean: not wearing false nails or nail polish; not wearing a wrist-watch or stoned rings; wearing short-sleeved garments or being able to roll or push up sleeves.

[10] At the time of publication of the guideline (March 2012): BS EN 455 Parts 1–4 Medical gloves for single use.

[11] For guidance see Management and disposal of healthcare waste (HTM 07-01).

[12] The updated recommendation contains 'should' rather than 'must' (which is in the 2003 guideline) because the GDG considered that this is not covered by legislation (in accordance with the NICE guidelines manual, 2009).

[13] It is acceptable to bend needles when they are part of an approved sharps safety device.

[14] See www.legislation.gov.uk/uksi/2013/645/contents/made.

[16] The text 'Patients managing their own catheters, and their carers, must be educated about the need for hand decontamination…' has replaced 'Carers and patients managing their own catheters must wash their hands…' in the 2003 guideline.

[17] At the time of publication of the guideline (March 2012), no antibiotics have a UK marketing authorisation for this indication. Informed consent should be obtained and documented.

[18] The GDG defined trauma as frank haematuria after catheterisation or two or more attempts of catheterisation.

[19] The updated recommendation contains 'vascular access device' rather than 'central venous catheter'. This change has been made because peripherally inserted catheters were included in the scope of the guideline update.

[20] The GDG considered that Aseptic Non Touch Technique (ANTT™) is an example of an aseptic technique for vascular access device maintenance, which is widely used in acute and community settings and represents a possible framework for establishing standardised guidance on aseptic technique.

[21] In 2012 a safety alert for chlorhexidine was issued related to the risk of adverse events.


SR 21-3 / CA 21-1 :

Supervisory Guidance on Board of Directors' Effectiveness

BOARD OF GOVERNORS
OF THE FEDERAL RESERVE SYSTEM
WASHINGTON, D.C. 20551

DIVISION OF
SUPERVISION AND REGULATION

DIVISION OF CONSUMER
AND COMMUNITY AFFAIRS

SR 21-3 / CA 21-1
February 26, 2021

TO THE OFFICER IN CHARGE OF SUPERVISION AT EACH FEDERAL RESERVE BANK AND TO LARGE FINANCIAL INSTITUTIONS

Supervisory Guidance on Board of Directors' Effectiveness

Applicability: This guidance applies to all domestic bank holding companies and savings and loan holding companies with total consolidated assets of $100 billion or more (excluding U.S. intermediate holding companies of foreign banking organizations established pursuant to the Federal Reserve's Regulation YY), and systemically important nonbank financial companies designated by the Financial Stability Oversight Council for supervision by the Federal Reserve.

Introduction

Guidance 1 4 3 4 Equals

The Federal Reserve expects the board of directors (board) of a large financial institution to be effective in its oversight of the firm because the board serves a critical role in maintaining the firm's safety and soundness and continued financial and operational resilience of its consolidated operations. The attached guidance describes the key attributes of effective boards at large domestic bank holding companies and savings and loan holding companies to: 1) set clear, aligned and consistent direction regarding the firm's strategy and risk appetite; 2) direct senior management regarding the board's information needs; 3) oversee and hold senior management accountable; 4) support the independence and stature of independent risk management and internal audit; and 5) maintain a capable board composition and governance structure. The guidance also includes illustrative examples of effective board practices.

Guidance 1 4 3 5 As A Fraction

Overview of Board of Directors Guidance

This guidance focuses on a board's performance of its core responsibilities in describing five key attributes of an effective board. The guidance notes that an effective board:

  1. Oversees the development of, reviews, approves, and periodically monitors the firm's strategy and risk appetite.
  2. Directs senior management to provide directors with information that is sufficient in scope, detail, and analysis to enable the board to make sound, well-informed decisions and consider potential risks.
  3. Oversees and holds senior management accountable for effectively implementing the firm's strategy, consistent with its risk appetite, while maintaining an effective risk management framework and system of internal controls.
  4. Through its risk and audit committees, assesses and supports the stature and independence of the firm's independent risk management and internal audit functions.
  5. Considers whether the board's composition, governance structure, and practices support the firm's safety and soundness and promotes compliance with laws and regulations, based on factors such as the firm's asset size, complexity, scope of operations, risk profile, and other changes that occur over time.

Implementation

Firms subject to the large financial institution rating system are assigned three component ratings: Capital Planning and Positions, Liquidity Risk Management and Positions, and Governance and Controls.1 The supervisory assessment of board effectiveness is one of the elements within the Governance and Controls component rating. As the board effectiveness guidance builds on the principles set forth in the large financial institution ratings framework, the Federal Reserve intends to use the board effectiveness guidance in informing its assessment of the governance and controls at all firms subject to the large financial institution rating system. Federal Reserve supervision staff will work closely with firms to help them understand the board effectiveness guidance. In assessing board effectiveness, the Federal Reserve supervisory staff will continue to review other sources of information, including but not limited to publicly available information, examinations from other regulators, and firm-provided materials.

Federal Reserve Banks are asked to distribute this letter to large financial institutions in their districts and to appropriate supervisory staff. In addition, supervised organizations may send questions via the Board's public website.2

signed by
Michael S. Gibson
Director
Division of
Supervision and Regulation

signed by
Eric Belsky
Director
Division of Consumer
and Community Affairs

  • SR Letter 19-3 / CA Letter 19-2, 'Large Financial Institution (LFI) Rating System'
Notes:
  1. See SR Letter 19-3 / CA Letter 19-2, 'Large Financial Institution (LFI) Rating System.' Return to text.
  2. See https://www.federalreserve.gov/apps/contactus/feedback.aspx. Return to text.
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