INFECTION PREVENTION AND CONTROL POLICY , HOSPITAL CANSELOR TUANKU MUHRIZ

Policies and Procedures on Infection Prevention and Control HCTM

(h) Storage.
1. Hang the endoscope vertically with the distal tip hanging freely in a clean, well-ventilated, dust-

freestorage cupboard.
2. Ensure the valves are dry and lubricate if necessary and store separately.
3. All High Level Disinfectant should keep at dedicated cabinet.
Automated endoscope reprocessors (AERs).
1. Manual cleaning is the essential step in cleaning and disinfection of flexible endoscope before using

the automated reprocessor. The AER is useful as it can standardize the endoscope reprocessing
process and reduce personnel exposure to the chemical used for disinfection.
2. When using the AER, the staff must ensure that all manufacturers’ instructions are adhered to.
3. A copy of work instruction on how to use the AER must be available for reference in the endoscopy
unit. All staff involved in using the reprocessor must have easy access of the work instructions.
4. Drying and storage are the same as described in manual disinfection.
5. They must be cleaned and maintained on a daily basis.
6. They must have regular maintenance and regular microbiological surveillance at least once a month.

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CHAPTER 6.0 : MORTUARY

Introduction
The mortuary is a source of potential hazards and risks, not only to mortuary staffs but also to mortuary
visitors and those handling the body in the mortuary. Infections from dead bodies in the mortuary maybe
acquired by one or more of the following routes:

A. Inhalation

B. Inoculation

C. Ingestion

D. Entry through the conjunctiva or pre-existing wounds.

For safety and infection control in the mortuary, the following Hazard Group definitions should be applied:

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Safety and infection control in a mortuary must consider all procedures related to body handling, transfer
and storage, autopsy procedures, autopsy specimen handling, clinical waste management and preparation
of dead bodies for release.

General Precautions
1. All dead bodies are potentially infectious and ‘Standard Precautions’ should be implemented for
every cases including hand hygiene after interaction with the bodies.
2. Avoid direct contact with the dead bodies, blood or body fluid discharge from the dead bodies.
3. All healthcare workers (HCWs) who are likely to come into contact with dead bodies should
received immunization against Hepatitis B.
4. Healthcare workers should be trained in the prevention of infections.

Transfer Of Bodies From Wards And A&E To The Mortuary
1. The ward staffs shall have the responsibility of notifying the mortuary of any suspected, probable or

confirmed high-risk biohazard cases.
2. Any open wounds on the dead bodies must be properly covered by the ward staffs during completing

the last office. All tubes, drains and catheters should be removed.
3. HCWs involve in the transferring of dead bodies must wear appropriate PPE (Surgical Mask, Gloves

and Disposable Apron).
4. HCWs shall not smoke, eat or drink while handling the bodies and they should avoid touching their

mouth, eyes or nose.
5. For suspected, probable or confirmed high-risk syndromic biohazard cases and Hazard Group 4 cases,

the following additional requirements shall apply:
a) Preparation of body in the ward:
▪ First layer – wrap body with white linen
▪ Second layer – place wrapped body in a body bag
▪ Third layer – place the body bag in a second body bag.
b) PPE for HCWs involve in transferring the body shall comprise of gloves, long-sleeved
disposable gown, protective apron and N95 mask.
c) The body shall remain in the body bag until they are released from the mortuary
d) Trolleys that have been used to transport these bodies shall be disinfected using
appropriate disinfectant.

Bid Cases Received Directly From The Police At The Mortuary

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Sealed body bags that are received from the police should not be opened in the mortuary until further
instructions from the Forensic Pathologists or Medical Officers or Forensic Officers. The precautions
mentioned in Transfer Of Bodies From Wards And A&E To The Mortuary apply.

Body Storage
1. It is desirable for all biohazard cases to be stored in the dedicated body refrigerators as soon as they

are received at the mortuary. Exceptions can be made if no autopsy is required and the body can be
released to the claimant within the stipulated time as per SOP upon receipt of the body at the mortuary.
2. All stored suspected or confirmed biohazard cases must have the biohazard tags attached to the
refrigerator doors.

Autopsy Procedures
Prior to the autopsy, the Forensic Pathologist, based on the circumstances of death, shall undertake a pre-
autopsy risk assessment to decide whether a case needs to be approached as a high-risk autopsy requiring
additional safety precautions and suitable mortuary facilities. The forensic pathologist shall decide on the
need to transfer the body to a more suitable mortuary for high-risk autopsy.

1. Compliance with proper PPE, suitable autopsy equipment, practising safe dissection techniques and
good common sense are the foundations for a safe autopsy.

2. Although rapid pre-autopsy screening for blood-borne viruses (Hepatitis B, C and HIV) is useful for
pre-autopsy risk assessment, non-reactive results should not lead to a downgrading of PPE or safety
precautions if the circumstances of death suggest otherwise.

3. Minimum PPE for non-high-risk biohazard cases:
▪ Scrub suits.
▪ Plastic apron.
▪ Surgical mask and cap.
▪ Waterproof boots.
▪ Double gloves.
▪ Cut-resistant glove on non-dominant hand.

4. PPE for high-risk biohazard cases such as Hepatitis C, HIV and tuberculosis:
▪ Scrub suits.
▪ Long sleeved disposable apron.
▪ N95 mask and cap.
▪ Eye-visor/goggles/face shield.
▪ Waterproof boots.
▪ Double gloves.
▪ Cut-resistant glove on non-dominant hand.

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5. The autopsy of high-risk syndromic outbreak cases such as SARS, should only be performed at BSL-
3 mortuaries in accordance with the established BSL-3 Work Procedure Manual of the relevant
centres.

6. Every effort must be made during autopsy to minimize liquid dispersion splashing and production of
aerosol.

7. All members of an autopsy team must be trained and familiar with the proper handling of autopsy
instruments to avoid sharp injuries.

8. Hypodermic needles should never be handled by hands during autopsy. Only forceps should be used
when attaching or removing needles from syringes.

9. The use of PM40 pointed blades should be avoided during autopsy; only PM40 blunt tipped blade
should be used.

10. Open the chest wall by cutting along costal cartilage to avoid sharp ends. If ribs are cut instead of
costal cartilage, it is strongly recommended that an oscillating saw with bone dust extractor be used
instead of rib shear.

11. It is strongly recommended that an oscillating saw with vacuum attachment be used for opening of the
skull.

12. Upon the conclusion of the autopsy, all used PPEs are disposed off accordingly and hand hygiene
procedures are strictly complied with.

Specimen Handling
1. All biological specimens acquired during an autopsy are biohazard materials and should be treated

accordingly.
2. Group 3 agents such as mycobacterium, Hepatitis C and HIV are inactivated in formalin-fixed tissue

specimens that have been acquired for histology.
3. Autopsy tissues/body fluid specimens that are intended for other pathological and toxicological

analyses shall be collected in the prescribed containers and shall be handled as biohazard material.

Preparation For Body Release
1. The release of bodies to the claimant should only be undertaken in the body preparation room and not

directly from body storage area.
2. Body release of any HIV suspected, probable or confirmed high-risk syndromic biohazard and Hazard

Group 4 cases shall be carried out under strict precautionary measures and shall be supervised by an
Assistant Environmental Health Officer.
3. For suspected, probable or confirmed high-risk syndromic biohazard and Hazard Group 4 cases;

a. Bathing and kafan of a Muslim body maybe done in the autopsy/body preparation room
by the trained personnel with strict adherence to PPE requirements.

b. Embalming should be avoided.

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c. The body shall be placed in body bag(s) and shall be coffined (sealed coffin) under the
supervision of an Assistant Environmental Health Officer.

d. The next of kin is prohibited from opening the coffin.
e. It is advocated that the body is buried together with the coffin or cremated.

Clinical Waste
Clinical waste must be handled and disposed of properly according to legal requirements.
1. Human tissues, body fluids and disposable items such as paper shrouds, swabs, dressings, protective

clothing and gloves must be discarded into Yellow Bin or yellow plastic biohazard bags for incineration.
2. Discarded syringes, needles and other disposable sharps must be placed in a Sharps Bin

immediately after use.
3. Chemical waste to be collected for disposal by appointed concession Company

Visitors
Next of kin should not be allowed to enter the dirty areas of the mortuary.

Exposure To Sharps Injuries
In case of percutaneous injury or mucocutaneous exposure to blood or body fluids of the dead body, the
injured or exposed areas should be washed with copious amount of water and according to the hospital
procedures for sharps injuries. All incidents should be reported to Incident Officer immediately.

CHAPTER 7.0 : NEPHROLOGY AND HEMODIALYSIS

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Nephrology And Hemodialysis Unit
A. Haemodialysis

Haemodialysis unit water supply and air conditioning

1. The water used for haemodialysis should comply with the requirement of the Association of the

Advancement Medical Instrumentation (AAMI) 2015/ISO 23500:2014 Standards. The water supply to
the dialysis machines must be supplied separately, and include standard filtration and reverse osmosis
units (RO) to minimize the risk of exposure to pyrogens and endotoxins.

2. For haemodialfitration (HDF) treatment ultrapure water should be used.
3. The water treatment system should be designed to allow routine disinfection of the entire system,

including the distribution system and the connections to the dialysis machine. The entire system should
be disinfected as per recommendation by the National Haemodialysis Quality Standards 2018.

4. Microbial testing of the water samples (bacterial colony count and endotoxin level) should be carried

out once a month. The water samples should be taken before the reverse osmosis unit (RO),
immediately after the RO and at the first, middle and final distribution point.

5. Chemical contaminants such as chlorine, chloramine and water hardness should be tested daily.

Whereas chemical analysis of water should be tested 6 monthly in an accredited laboratory. Site of
testing as per guideline (National Haemodialysis Quality Standards 2018)

6. Taps and sinks specification must be adjusted to avoid excessive splashing.

The health of healthcare workers

1. All staff working in the unit should have immunisation to hepatitis B if not already immune.
2. Any staff that develops viral hepatitis must avoid direct patient care until serological markers and liver

function tests indicate that they are no longer infectious.

3. All staff must practice standard precautions to minimize percutaneous and mucous membrane

exposure to the inoculation-risk viruses (Standard Precautions)

Hand hygiene
(Refer to Policies and Procedures on Infection Prevention and Control HCTM ; Section B: Chapter 2.1 :
Hand Hygiene)

Inoculation risks and body fluids

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1. All staff must be aware of the infection risk from body fluids, blood, needles and sharps and must
ensure that others are not exposed to these hazards.

2. Discard sharps only into sharps bins.
3. Never fill sharps bins more than three-quarters full.
4. Do not leave needles and sharps lying around for somebody else to clear up.
5. Needles should not be re-sheathed.
6. Blood spillages must be cleared up at once.
7. Wear non-sterile disposable latex gloves and a plastic apron.
8. Spillage should be disinfected following HCTM infectious control guideline. (Refer to Policies and

Procedures on Infection Prevention and Control HCTM ; Section B: Chapter 2.4 : Management
Of Body Fluids and Spillage)
9. Discard gloves, apron and paper towels into a yellow bag for incineration.
10. Splashes of blood or any other body fluid on to the skin should be washed off at once with soap and
water.
11. Gloves should be worn for any procedure involving blood and body fluids or contact with broken skin
or mucous membranes.
12. Staff with broken skin on their hands should wear a waterproof bandaid/bandage before wearing
gloves for handling any body fluid.
13. If an accident occurs, the protocol for dealing with sharps injuries and mucosal exposure must be
followed immediately. (Refer to Policies and Procedures on Infection Prevention and Control
HCTM ; Section B: Chapter 2.6 : Injection Safety and Sharp Management)
14. Annual screening for blood borne viruses shall be performed for dialysis staffs and Hep B vaccination
may be required to ensure their HepBAb level is > 10 IU/ml.

Screening of patients for blood borne viruses (Hep B/C and HIV)

1. All patients will be routinely screened for HIV, Hep B and C before being accepted to the Hemodialysis
programme and three monthly thereafter.

2. Until the HIV, Hep B and C status of a dialysis patient is known; all patients must be treated as
potentially infective.

3. Known positive patients should be dialysed in the unit using a dedicated haemodialysis machine in a
dedicated area or room.

4. HepBAb titre should be checked minimum 6 monthly.
5. In newly infected Hep B patients, subsequent serological testing such as HepB eAg, HepBeAb and

HepB DNA titre should be discussed with the gastroenterology team to determine disease
management and clinical outcome.
6. Confirmed positive Hep C or HIV patients may not require repeat Hep C or HIV serological testing
respectively.

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Hepatitis B immunization
1. All patients should be vaccinated against HepB as early as possible in the course of their disease.
2. It should be noted that the antibody response rate in these patients is lower than in the general

population and hence the vaccination dose and schedule should follow those recommended for
haemodialysis patients.
3. Patients who are HepBsAg negative and have HepBsAb titre less than 10 IU/L shall be vaccinated

Disinfection and disposal at the end of haemodialysis
1. Staff must take care to avoid accidents with sharp instruments.
2. Gloves and an apron must be worn.
3. On completion of the haemodialysis treatment, all used dialysers and blood lines should be placed in

leak proof containers/bags when transporting them from the dialysis station to the disposal area.
4. All machines should be cleaned with the standard disinfectant solution (hospital grade). The

maintenance of the dialysis machine following the manufacturers requirement.
5. Normal cleaning is adequate for patients' table and chair unless contaminated by blood or other body

fluids in which case the spillage procedure is followed.
6. Heavily blood-soaked linen or linen contaminated with blood from HepB, Hep C, HIV positive patients

should be placed in a red plastic bag before placed into a red-coloured linen bag

Infection Control Precautions for all Patients
1. Disposable gloves MUST be worn whenever caring for the patient or when touching the patient’s

equipment (including the haemodialysis machine) at the haemodialysis station. The disposable gloves
MUST be removed and hands MUST be washed between patients or dialysis stations.
2. Items taken into a dialysis station should be disposed of, dedicated for a single patient or cleaned and
disinfected before using on other patients.
3. Dialysis chairs, tables, haemodialysis machines etc MUST be cleaned and disinfected between
patients.
4. Clean area should be clearly designated for handling and storage of medications, unused disposables,
equipments and machines.
5. Venous and arterial pressure transducers filter/protector should be used in each patient and should
not be reused.
6. Common cart should not be used to deliver medications to patients.

Management of Hepatitis B positive patients
1. Requires the same infection control precautions recommended for all haemodialysis patients.

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2. HepBsAg positive patients should be dialysed in separate room using separate machines, equipment
and supplies.

3. Staff caring for HepBsAg positive patients MUST not care for non- Hep B patients at the same time
4. Eye protector/ glasses or visors are advised to protect against the spray of blood that may occur when

inserting needles into the patient.

Management of Hepatitis C positive patients
1. Requires the same infection control precautions recommended for all haemodialysis patients
2. Hep C positive patients should be dialysed in a separate room using separate machines, equipment

and supplies.
3. Staff caring for Hep C positive patients MUST not care for Hep C negative patients at the same time
4. Hep C positive patients who acquired sustained response after antiviral treatment should continue to

be dialysed with machines at dialysis stations dedicated for Hep C positive patients. However, it is
preferred that these patients are dialysed during the first shift.
5. Eye protector/ glasses or visors are advised to protect against the spray of blood that may occur when
inserting needles into the patient.

Management of Hepatitis B and C positive patients
1. Patients with Hep B and C co-infection should be dialysed on a separate machine with separate

equipment and supplies. When it is not possible, the patient shall be dialysed in a Hep B isolation
facility during the last shift.
2. For patients with Hep B and C co-infection, single use of dialyser is mandatory.
3. Eye protector/ glasses or visors are advised to protect against the spray of blood that may occur when
inserting needles into the patient.

Management of HIV positive patients
1. It is necessary to have a dedicated machine for HIV-positive patients but all venous pressure

transducers must be changed between patients.
2. Disposable dialysers should be used.
3. Eye protector/ glasses or visors are advised to protect against the spray of blood that may occur when

inserting needles into the patient.

Other infection control procedures
1. Standard ‘no-touch’ dressing changes and care of intravascular catheters should be performed

according to the nursing procedures. (Refer to Policies and Procedures on Infection Prevention

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and Control HCTM ; Section B: Chapter 5.1 : Aseptic Technique and Chapter 6.5 : Central
Venous Catheter Related Infection)
2. Patients with temporary or cuffed-tunneled dialysis catheters should be monitored for evidence of exit
site or tunneled infection.

B. Continuous Ambulatory Peritoneal Dialysis (PD)

Screening
1. All patients will be routinely screened for HIV, Hep B and C before being accepted to the PD

programme and six monthly thereafter.
2. Patients who are HepBsAg negative and have HepBsAb titre less than 10 IU/l shall be vaccinated.
PD Catheter insertion
1. Patients should be screened for staphylococcus aureus before surgical insertion of the catheter
2. Carriers of Staph aureus (MRSA) should be decolonized with nasal mupirocin and topical antiseptics

in order to clear staphylococcal carriage before the catheter is inserted.
3. On the day of catheter insertion, the patient should shower using 4% aqueous chlorhexidine/

equivalent applied to their whole body to reduce skin flora.
4. Prophylactic antibiotics pre catheter insertion is IV Cephazolin 1g stat (follow hospital/surgical

prophylaxis antibiotic guideline)
5. The intra-abdominal catheter must be inserted with full aseptic precautions.

Care of the PD system
1. The patient must receive adequate instruction on how to change the dialysis bags and how to maintain

the exit with aseptic precautions at all times. (refer patient’s training leaflet/guide available in the PD
unit)
2. An infection control team shall be notified to activate, regulate, monitor and report infection control
activities including staff training, case detection, documentation and audit activities.
3. Strict adherence to the guidelines for universal precautions by the staff shall be practiced at all times.
4. The PD unit should provide a clean area clearly designated for preparation of patients for an exchange;
this area shall be disinfected in between patients.

Management of PD effluent in Hepatitis B/ C/ HIV patients
1. Dispose of PD effluent fluid in the toilet bowl and disinfect with 1:100 chlorine solution before flushing

the toilet. Any spillage is to be cleaned with a spillage kit.

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2. Disposal of effluent bag:. All the effluent bags for the day are placed in 2 layers of biohazard garbage
bags. The bags are tied up and disposed of.

CHAPTER 8.0 : LABORATORY
General Principles

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A. Classification of infective microorganism
The relative dangers of infective microorganisms by risk group are according to topic WHO Risk
Groups 1, 2, 3, and 4. This risk group classification should only be utilised in the laboratory. The risk
groups are listed in Table 1.1.

Table 1.1: Classification of infective microorganisms by risk group

B. Laboratory Facilities according to appropriate risk assessment

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Laboratory facilities are designated as Biosafety Level 1 (basic), Biosafety Level 2 (basic), Biosafety Level
3 (containment), and Biosafety Level 4 (maximum containment).
Biosafety level designations are based on design elements, construction, containment facilities,
equipment, practices, and operating procedures required when working with agents from distinct risk
groups.
A risk assessment must be used to provide a biosafety level to an agent for laboratory work. In determining
the proper biosafety level, such an assessment will evaluate the risk category and other considerations.

Table 1.2: Summary of biosafety level requirements

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As a result, the organism (pathogenic agent) utilised, the facilities available, and the equipment techniques
and procedures required to conduct work safely in the laboratory are all considered when assigning a
biosafety level.
Table 1.3 compares risk groups to the biosafety level of laboratories built to work with organisms in each
risk group, although it does not "equalise" them.

Table 1.3: Relation of risk groups to biosafety levels, practices, and equipment

Guidance and recommendations
Diagnostic laboratories must meet Biosafety Level 2 or higher requirements. Laboratory personnel may be
exposed to organisms from the "high-risk group" since no laboratory has total control over the specimens
it receives. As a result, standard measures should be taken and followed and promote acceptable GMT.
Code of practice
This code contains a collection of the most critical laboratory practices and procedures for GMT. Each
laboratory should include a safety or operating manual that lists known and potential dangers and policies
and processes for removing or minimizing them. The most crucial ideas are presented below.

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A. Access

1. The international biohazard warning symbol and sign must be posted on the doors of rooms
where microorganisms from Risk Group 2 or higher risk groups are handled (Table 1.1).

2. Only authorized individuals should access the laboratory's operating areas.
3. Keep the laboratory doors closed.
4. Children should not be allowed or authorized to enter working areas in laboratories.

B. Personal protection

1. Coveralls, gowns, or uniforms must be worn in the laboratory. Before leaving the laboratory,
remove your coat/gown and place it in the designated spot.

2. For all procedures that may entail direct or accidental contact with blood, body fluids, or other
potentially infectious materials, appropriate gloves must be used. Gloves should be removed
aseptically after usage, and hands should be cleaned.

3. After handling contagious materials and leaving the laboratory, personnel must wash their
hands.

4. Eye and facial protection from splashes, hitting objects, and sources of artificial UV radiation
should be worn whenever possible.

5. Before beginning work, any cuts, abrasions, or other skin lesions must be adequately covered
to prevent contamination.

6. In the laboratory, eating, drinking, smoking, applying cosmetics, and handling contact lenses
are all banned.

7. Keeping human food or drinks in laboratory working facilities is forbidden.

C. Procedures

1. No materials should be put in the mouth.
2. Any technical processes should be carried out to minimize the creation of aerosols and

droplets.
3. Hypodermic needles and syringes should be used sparingly. They should not be used in place

of pipetting equipment.
4. The laboratory supervisor must be notified of any spills, accidents, or overt or possible

infectious material exposures. Such accidents and incidents should be documented in writing.
5. All spills must be cleaned up according to a defined method that must be followed.
6. Before being discharged to the sanitary sewer, contaminating liquids must be decontaminated

(chemically or physically). Depending on the risk assessment for the agent(s) being handled,
an effluent treatment system may be necessary.

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7. Written documents that are expected to be removed from the laboratory need to be protected
from contamination while in the laboratory.

8. Written papers withdrawn from the laboratory should be secured from contamination while in
the lab.

D. Laboratory working areas
1. The laboratory should be kept nice, clean, and free of non-work-related materials.
2. After any spill of potentially hazardous material, work surfaces must be decontaminated. All
working surfaces must be decontaminated at the end of the day.
3. Before disposal, all contaminated objects, specimens, and cultures must be decontaminated.
Any items that can be reused must be decontaminated.
4. National and international regulations must be followed when packing and transporting.

E. Biosafety management

1. The laboratory director is responsible for developing and adapting a biosafety management
strategy and a safety or operations handbook.

2. The laboratory supervisor should guarantee that laboratory safety training is delivered
regularly.

3. Special hazards should be communicated to employees, who should be expected to read the
safety or operating manual and adhere to established practices and procedures. The
laboratory supervisor should make sure that everyone in the lab knows these rules. The
laboratory should have a copy of the safety or operations manual.

4. An arthropod and rodent control program should be implemented.
5. In a medical emergency, appropriate medical examinations, monitoring, and treatment should

be provided to all staff, and adequate medical records should be kept.

Laboratory design and facilities

Particular attention should be paid to conditions identified as posing a safety risk. These include:

• Aerosol formation
• Working with large volumes and high concentrations of microorganism
• Overcrowding and excessive equipment
• Rodents and arthropods infestation
• Unauthorized access

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• Workflow: usage of specific samples and chemicals

A. Design features

1. Enough space must be provided for safe laboratory work, cleaning, and upkeep.
2. The laboratory walls, ceilings, and floors should be smooth, easy to clean, impervious to

liquids, and resistant to chemicals and disinfectants. Slippery floors should be avoided.
3. Bench tops should be resistant to disinfectants, acids, alkalis, organic solvents, moderate

heat, and be impervious to water.
4. All activities should have adequate lighting. Reflections and glare should be avoided at all

costs.
5. Sturdy laboratory furniture is required. Cleaning should be possible in the open spaces

between and under benches, cabinets, and equipment.
6. There must be enough storage space to retain materials for immediate use, preventing clutter

on benchtops and aisles. Additional long-term storage space should also be provided, easily
positioned outside the laboratory working spaces.
7. Safe handling and storage of solvents, radioactive materials, compressed and liquefied
gasses should be supplied with space and facilities.
8. Outside of the laboratory working areas, facilities for storing outerwear and personal goods
should be provided.
9. Outside of the laboratory working spaces, eating, drinking, and resting facilities should be
provided.
10. Hand-washing facilities, ideally near the exit door, should be provided in each laboratory
room, preferably with running water.
11. Doors should have view panels, a good fire rating, and be self-closing if possible.
12. An autoclave or other means of decontamination should be accessible near the laboratory at
Biosafety Level 2.
13. Fire, electrical emergencies, emergency showers, and eyewash facilities should all be
covered by safety mechanisms.
14. There should be first-aid spaces or rooms that are well-equipped and easily accessible.
15. When designing new facilities, mechanical ventilation systems that offer an inward flow of air
without recirculation should be considered. Windows should be able to be opened if there is
no mechanical ventilation.
16. A separate air conditioning system should be installed to reduce the heat gain from equipment
with high heat outputs, such as refrigerators and incubators. A sealed type of unit that
recirculates chilled air into the room is desirable.
17. It is critical to have a consistent supply of high-quality water. Cross-connections between
laboratory and drinking water supplies should be avoided. To protect the public water system,
an anti-backflow device should be installed.

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18. To allow for a safe evacuation, there should be a stable and enough energy supply and
emergency lights. A standby generator helps support critical equipment, including incubators,
biological safety cabinets, and freezers, among other things. 19. Gas should be available on
a consistent and sufficient basis. The installation must be kept in good working order.

Laboratory equipment

Technically, using safety equipment in conjunction with proper procedures and practices will help to limit
risks while dealing with biosafety threats. The laboratory director should make sure that appropriate
equipment is available and correctly utilized. Specific broad criteria namely should choose equipment:

i. Designed to keep the operator from coming into contact with the infectious material.
ii. Materials impervious to liquids, corrosion-resistant, and meet structural criteria.
iii. Free of burrs, sharp edges, and moving parts that aren't protected.
iv. Designed, constructed, and installed to allow easy maintenance, cleaning, decontamination, and

certification testing; glassware and other breakable items should be avoided if possible.

Essential biosafety equipment

1. Class II biological safety cabinets should be utilized whenever:

i. All infectious materials are handled; these can be centrifuged in the open laboratory if sealed
centrifuge safety cups are utilized. The materials are loaded and unloaded in a biological safety
cabinet.

ii. There is a higher chance of illness spreading through the air.

iii. Procedures that have a high risk of creating aerosols are used, such as centrifugation, grinding,
blending, violent shaking or mixing, sonic disruption, and opening infectious materials containers.

2. To limit aerosol formation, electric transfer loop incinerators could be employed inside the biological
safety cabinet.

3. Tubes and bottles with screw-on caps.
4. Decontamination of pathogenic items using autoclaves or other acceptable methods.
5. To transport and store Petri dishes, they must be arranged on racks or baskets.
6. Whenever possible, use plastic disposable Pasteur pipettes to avoid using glass.
7. Before being used, equipment such as autoclaves and biological safety cabinets must be validated

using acceptable methods.
8. Recertification should take place at regular intervals, according to the manufacturer’s instructions.

Health and medical surveillance

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The employing authority is responsible for ensuring that laboratory personnel's health is monitored
correctly through the laboratory director. This type of monitoring aims to keep an eye out for diseases that
are acquired on the job.

i. Providing active or passive immunization where indicated is an appropriate activity to achieve
these aims.
ii. Making it easier to detect laboratory-acquired infections early.
iii. Preventing very vulnerable persons (such as pregnant women or those with impaired immune
systems) from participating in potentially dangerous laboratory work.
iv. Adequate personal protective equipment and procedures are provided.

Waste disposal and decontamination

Infectious materials and containers should be identified and separated using identification and separation
procedures. The following categories should be included:

i. Non-infectious (non-contaminated) wastes can be reused, recycled, or disposed of as "domestic"
waste.

ii. Hypodermic needles, scalpels, knives, and shattered glass are examples of contaminated
(infectious) "sharps." These should always be collected and treated as contagious in puncture-proof
containers with coverings.

iii. Contaminated material to be autoclaved for decontamination, then washed and reused or recycled.
Contaminated material for autoclaving and disposal.

Disposal of sharps

Needles must not be re-sheathed to avoid needle stick injuries. Hand-bending or breaking of needles
using hands is not permitted. Sharps must be disposed of as soon as possible after use in a sharps
container. The individual who used the sharp is responsible for its safe disposal after being used. This
needs to be done at the point of use. The sharps container should be easily accessible. Sharps
containers must be stiff, impermeable, and disposed of when they are 2/3 full or after 1 week of usage
(whichever comes first).

Chemical, fire, electrical, radiation, and equipment safety

Chemical, fire, electrical, or radiation catastrophes can result in a pathogenic organism containment
collapse. In any microbiological laboratory, maintaining high safety standards in these sectors is
particularly critical.

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Transport of infectious substances
National and international regulations govern the transportation of contagious and possibly infectious
products. The proper use of packaging materials, as well as other shipping criteria, are described in these
standards.
Infectious substances must be transported in accordance with applicable transportation standards by
healthcare personnel. The following will occur if the rules are followed:

i. Reduce the chances of packages being broken and leaking, and hence
ii. Reduce the number of exposures leading to probable infections.
iii. Increase package delivery efficiency.

The basic triple packaging system:
I. There are three layers to this packaging system: the primary receptacle, secondary packaging,
and outer packaging.
II. The primary container for the specimen must be watertight, leak-proof, and clearly labeled with
the contents. In the event of a break or leak, the primary receptacle is covered in adequate
absorbent materials to absorb all liquids.

III. To enclose and protect the primary receptacle, a second watertight, leak-proof packing is
used. A single secondary packing can hold several wrapped primary receptacles. Certain
regulatory documents include volume and/or weight limits for packaged infectious drugs.

IV. The third layer prevents the secondary packaging from harm during shipment. Specimen data
forms, letters, and other types of information that identify or characterize the specimen, as well
as the shipper and receiver, must be provided, as well as any additional documents required.

Figure 1.1: Triple layer packaging

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Please refer to JPMD guidelines for managing the delivery of specimens to external laboratories.

Handling and processing infectious substances

1. Any procedure that has the potential to produce fine-particulate aerosols (for example, vortex or
sonication of specimens in an open tube) should be carried out in Class II Biological Safety Cabinet
(BSC). For centrifugation, appropriate physical containment devices should be utilized.
i. Seal the tubes with parafilm first, then place them in centrifuge cups and tightly seal them before
placing them in the centrifuge. Before opening the centrifuge, wait 15 minutes.
ii. Rotors and buckets should be loaded and unloaded in a BSC as much as possible. Perform any
procedures outside of a BSC in a way that reduces the potential of an unintentional sample
release.

2. Decontaminate work surfaces, equipment, and the transportation box with appropriate disinfectants
once the specimens have been processed. Use any hospital disinfectant that the Environmental
Protection Agency has approved. Follow the manufacturer's instructions, including dilution, contact
time, and handling precautions.

3. Place all disposable garbage in an appropriate biohazard bag and seal it before autoclaving or
incineration. All trash must be stored in a designated area until it can be disposed of. To avoid waste
overload, the garbage must be disposed of at regular intervals based on the volume of samples.

5. The following activities involving manipulation of potentially infected specimens should be performed
in a Class II BSC:
i. Aliquot and diluting specimen
ii. Inoculating bacterial or mycological culture media (Sample processing)
iii. Performing diagnostic tests that do not involve propagation of viral agents in vitro or in vivo
iv. Nucleic acid extraction procedures involving potentially infected specimens
v. Preparation of chemical- or heat-fixing smears for microscopic analysis. i.e., AFB Smear

6. Virus Isolation

Virus isolation in cell culture and initial characterisation of viral agents recovered in cultures of
SARS-CoV-2 specimens should only be conducted in a BSL-3 laboratory using BSL-3 practices.
Site-specific and activity-specific biosafety risk assessments should be performed to determine if
additional biosafety precautions are warranted based on situational needs.

Vaccinations

Vaccinations are required for all staff/students who have contact with clients and those working in
laboratories and departments of forensic medicine/ morgues who may contact blood, body substances, or
infectious materials. All the vaccination policies use our national Vaccination guidelines.

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(Refer to Policies and Procedures on Infection Prevention and Control HCTM ; Section E: Chapter
4.0 : Immunization For Healthcare Worker)

Staff are expected to maintain their screening and vaccination records and have them available for
inspection. The incident officer’s responsibility and care must ensure that all staff have received the
required vaccinations depending on the work to be undertaken. Staff must not be permitted to work with
clients or perform tasks that may involve contact with blood, body substances, or infectious materials until
they have provided appropriate vaccination records.

Microbiology accident emergency plan:

1. Notify the incident officer.

2. Accident and spills:

i. “Dry” spills (overturned or broken culture plate) with no significant aerosol formation.

• Evacuation of the room probably not indicated.
• Flood area with a tuberculocidal disinfectant, such as 10% bleach.
• Soak up disinfectant and contaminated material with an absorbent material (sand,

paper towels), place in a Biohazard container, and seal the container.
• The spill area is thoroughly washed down with a tuberculocidal disinfectant after

removing the contaminated material.
• Biohazard bag is to be placed into another bag for removal to the incinerator.

ii. Liquid spills on bench or floor:

• If significant aerosols were formed, the area is to be evacuated and not re-entered
for at least one hour.

• Cover the spill with absorbent material (as above). When absorption is complete,
the porous and contaminated material should be placed in a Biohazard bag for
disposal, as noted above.

• The entire spill area should be thoroughly washed down with a tuberculocidal
disinfectant (as above) after removing the contaminated material.

iii. Centrifuge spills:
• Shut off the instrument. Do NOT open the centrifuge for at least one hour. In
addition to gloves, the person responsible for the clean-up of the area is to wear
adequate personal protective equipment.

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• If liquids are present, absorbent materials should be used, as noted above. After
removing contaminated material, the instrument is to be thoroughly cleaned with
a tuberculocidal disinfectant before resuming work.

iv. Spills in incubators or other closed areas:
• The absorbent material is to be used as above if liquids are present. The organic
material must be removed as thoroughly as possible before disinfection or
sterilization.
• The spill area must be thoroughly washed after the contaminated material has
been removed.

Training program
A continuous safety training program is essential to maintain safety awareness among laboratory and
support staff. With the assistance of the biosafety officer and other resource persons, Laboratory
supervisors play a crucial role in staff training. Safety and health training effectiveness depend on
management commitment, motivational factors, adequate initial job training, good communications, and
ultimately the organization’s goals and objectives.

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CHAPTER 9.0 : FOOD SERVICES

Introduction

Hospital food service in HCTM is out-sourced to private company and supervised by Jabatan
Perkhidmatan Dietetik & Sajian Makanan (JPDSM).

Hospital food service management involve planning, procurement of food items, storage, food preparation
and serving of food to patients.
Hospital patients are particularly vulnerable to food poisoning. Thus, every quality control effort should be
implemented to ensure foods served to patients are free from contamination.

Continuous monitoring, process control and audit are part of food service activities to ensure quality and
safety. All involved in food service from preparation to serving of food should adhere to good hygiene
standards.

Food quality and hygiene standards as in Hazard Analysis and Critical Control Point (HACCP) and HALAL
certification should be considered in management policies to identify, evaluate and control food safety
related hazards.

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Facilities and Equipment Requirements

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Operation System Requirements

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Other Food Services Requirements

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CHAPTER 10 : INFECTION CONTROL IN PHARMACY

Sterile pharmaceutical preparation

Sterile pharmaceutical preparations involve the aseptic compounding of various sterile products including
cytotoxic drugs, parenteral nutrition, radiopharmaceuticals, IV admixtures, ophthalmology preparations
and other sterile formulations. These preparations are classified as high-risk category products due to high
risk for microbiological contamination and increased risk for causing systemic infections if manufactured in
uncontrolled environments. Therefore, these preparations require a controlled environment with well-
established quality assurance-driven procedures and facilities to be produced.

Sterile pharmaceutical preparation facilities

1. Compounded sterile preparations (CSP) can be classified according to risk categories based on final
product beyond use rate (BUD) and aseptic technique shall be strictly adhered for all risk categories.

2. Compounded preparations in anticipation of prescription drug orders, shall be allowable on the basis
of routine, regularly observed prescribing patterns and must not exceed BUD as stipulated in
international pharmacopoeia such as United States Pharmacopeia (USP) Pharmaceutical
Compounding – Nonsterile Preparations Chapter <795> and Pharmaceutical Compounding – Sterile
Preparations Chapter <797>.

3. All sterile pharmaceutical preparations should be manufactured in clean room facilities designed and
built in accordance to Good Preparation Practice (GPP) requirements and based on the latest ISO
primary engineering control requirements. The facilities which do not meet these requirements should
work towards it.

4. The design, layout and specifications of the clean room facilities should follow the current guidelines
approved by National Pharmaceutical Regulatory Agency.

5. A dedicated air handling unit consist of Heating, Ventilation and Air-conditioning (HVAC) System to
the cleanroom facility should comply the requirement statement as in the table below:

Clean areas for the preparation of sterile compounded preparations are classified in 4 grades (A, B, C and
D) based on the required characteristics of the environment (Table 1). The level of room classification
should be specified according to the activities performed and the compounded preparation. Accordingly,
for each clean area or suite of clean areas “in operation” conditions (installation is functioning in the defined
operating mode with the specified number of personnel working) and “at rest” conditions (complete
installation with production equipment but without personnel, i.e. unmanned) should be specified.
Appropriate air filtration (terminal HEPA filters for grades A, B and C) and sufficient number of air changes
(Table 1) should be defined in order to reach the specified conditions.

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Table 1: Clean room classification for compounded sterile preparations (CSP)

Note: HLF: Horizontal Laminar Flow; NA: not available; ND: not detected; VLF: Vertical Laminar Flow
Location and use of sinks should be carefully considered in view of their potential to cause microbiological
contamination. Sinks or hand-washing facilities should not be available in preparation rooms or the final
stage of the changing rooms. If present in adjacent areas, they should be regularly monitored and
disinfected.

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Activities in Cleanrooms
• Handling and filling of aseptically prepared compounded preparations (open and closed
procedures) should be performed in a grade A environment in a laminar flow cabinet (LFC). The
room should have a positive pressure (ideally 10 – 15 Pascals) and air flow relative to the
surrounding areas of a lower grade in order to protect the compounded preparations from
contamination.
• Preparation of solutions which are to be sterile filtered should be done in a grade C environment;
while for the none filtered solutions, the preparation of materials and compounded preparations
should be done in a grade A environment.
• After washing, components should be handled in at least a grade D environment. Handling of
sterile starting materials and components, should be done in a grade A environment.
• Preparation under negative pressure, protecting the operator and the environment from
contamination should only be used for the preparation of hazardous pharmaceuticals (e.g.
cytotoxic drugs), together with appropriate precautions against contamination of the medicinal
product (e.g. appropriate background room air quality, positive pressure airlock systems).
• Biohazard safety cabinets (BSCs) should be used with a vertical downward air flow exhausting
vertically from the cabinet and not towards the operator.
• For aseptic compounded preparations the microbiological environment in which they are prepared
is of the utmost importance. Therefore, the environment should be controlled and only authorized
people should be allowed to have access. The background environment for LFCs and BSCs
should meet grade B requirements, with grade D required for pharmaceutical isolators.

Table 2 gives examples of operations for aseptic preparations to be carried out in the various grades.
Table 2: Operations for aseptic preparations according to cleanroom grades

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Storage, receiving, distributing and transport of CSPs
1. All storage areas shall be designed to ensure good storage conditions e.g. clean, dry and maintained.
2. If special storage conditions are required (e.g. temperature and humidity) these shall be provided,

checked and monitored regularly using appropriate devices.
3. Storage of Finished Products

• CSPs should be refrigerated at 2-8°C when the preparation is not immediately dispensed or
administered, unless the chemical and physical stability of the CSPs are adversely affected by the
refrigerated temperature.

• Storage areas should be monitored daily to ensure that such spaces are not subject to prolonged
temperature fluctuations.

• If a CSP has been exposed to temperatures that exceed storage temperature limits, the CSP
should be evaluated to determine if the CSP is still suitable for use.

• All CSPs should only be stored for as long as the intended BUD according to its content and
preparation method.

4. Transport of Finished Product
• For finished products to be transported out of pharmacy, the type of packaging used, handling
method, storage and transport processes should be appropriate so as to maintain the physical
integrity, sterility, and stability of the products.
• The instructions on storage of the CSP should be clearly labeled on the outer packaging.
• Appropriate safeguards such as sealed plastic bags and leak-proof containers with cautionary
labels should be used for transporting hazardous CSPs.
• There should be adequate training for delivery personnel responsible for the handling, transport
and storage of CSPs released out of the pharmacy. Training should include spills management
and handling of hazardous substances.

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Limits for clean room control parameters
i. Microbial contamination limit

Frequency of monitoring is dependent on facility risk assessmen
ii. Temperature, humidity and air pressure differential limit

Note: RH: Relative Humidity

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Cleaning procedure for clean room & equipment
1. Clean areas should be regularly cleaned according to a documented and approved procedure. Any

staff performing cleaning duties should have received documented training, including the relevant
elements of GMP and should have been assessed as competent before being allowed to work alone.
2. Cleaning and sanitization of facilities and equipment within the cleanroom and anteroom should be
duly performed with an appropriate disinfectant at its recommended frequency.
3. Cleaning and disinfecting agents should be free from viable microorganisms and those used in Grade
A and B areas should be sterile and spore free. Periodic use of sporicidal cleaning agents should be
considered to reduce contamination from spore forming microorganisms.
4. The effectiveness of cleaning should be routinely demonstrated, by microbiological surface sampling
e.g. contact plates or swabs.
5. If there is evidence of resistant strains, a different type of disinfectant should be used.
6. Cleaning activity should be carried out during a time when no aseptic preparation is taking place.
7. There should be designated cleaning tools for cleanroom. Tools (e.g. sponges and mops) used to
clean the cleanroom should be non-shedding. There should also be a separate set of cleaning tools
for areas involved in the preparation of hazardous products.
8. There should be a responsible person assigned for all matters regarding cleaning of the clean room.
The staff shall provide training to the cleaning personnel (pharmacy personnel and/or any hospital
personnel) to enable the personnel to perform cleaning duties.
9. Appropriate PPE should be worn by staff/ health care worker upon entering and working in cleanroom.
10. All the raw materials required for CSP shall be wiped with appropriate disinfectant (alcohol 70%) before
being placed into the clean room. The disinfected materials and equipment shall be brought into the
clean room through a pass box.
11. All cleaning procedures shall be documented upon completion.
12. Facilities should be designed and equipped to afford maximum protection against the entry of pests or
other animals.

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The table below shows the cleaning frequency for related area and equipment
Table 3: Recommended Cleaning Frequency for related area

Maintenance procedure for clean rooms & equipment
1. Procedure for Monitoring

Physical Monitoring for temperature, humidity and air pressure differential should be recorded daily
before the procedure. Records need to be checked, analyzed and verified.
2. Planned Preventive Maintenance (PPM) shall be done for equipment at least once a year according
to the scheduled agreement. This maintenance can be carried out either by in-house engineering
department or by appointed and accredited Third Party Testing Agent. A copy of all the reports shall
be made available to the user.

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Personnel
i. The personnel should have relevant knowledge and current practical and theoretical experience in the

preparation of sterile compounded products.
ii. Before undertaking sterile work, all staff should be appropriately trained and have their competence

assessed. The training will provide them with:
• an appropriate knowledge of Good Manufacturing Practice or Good Preparation Practice
• knowledge of local practices, including health and safety
• competence in the necessary sterile skills
• knowledge of pharmaceutical microbiology
• working knowledge of the department, compounded preparations, and services provided

iii. Regular reassessment of the competency of each member of staff to undertake sterile manipulations
should be undertaken, and revision or retraining provided where necessary.

Quality control
Every compounding process should have a quality control system to ensure that compounding
preparations are prepared in accordance to the established specifications.
The sterile preparation of TPN by Pharmacy Department shall undergo quality control monitoring.
Sampling is done as below:
a) Samples taken for microbiological analysis shall be representative of the material being tested.
b) Samples shall be taken from the final container of the preparation prior to sealing of infusion port.
c) Sample is taken from every patient TPN bag that is compounded on the day. The amount of TPN

sample should be at least 3-5 mls.
d) Any growth from this sample should be informed immediately to the ward and pharmacist.

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CHAPTER 11: HAEMATOLOGY ONCOLOGY

Introduction
Despite treatment advances and the availability of targeted therapy for haematology and oncology,
infection remains one of the leading causes of morbidity and mortality among these patients. There is an
interplay between patient/host, disease, treatment, and environmental factors that contribute to infection
occurrence. Therefore, infection control strategies are required to minimize the risk of infection. Guidelines
for infection control and prevention (ICP) in patients with hematologic or oncologic malignancies are based
on recommendations for hematopoietic stem cell transplant (HSCT) recipients. The basic management
principles include hand hygiene, air quality, barrier isolation, endogenous flora suppression by prophylactic
antibiotics, and the prevention of device‐related infections.

Common pathogens and sites of infection
1. An equally relevant aspect of ICP for patients with cancer is the recognition of higher rates of

colonization and infections by multidrug-resistant organisms (MDROs), such as vancomycin-resistant
Enterococcus (VRE), methicillin-resistant Staphylococcus aureus (MRSA), and multidrug-resistant
Gram-negative bacilli (MDR-GNB), and Clostridium difficile compared with the general patient
population.
2. Risk factors associated with the transmission of these MDROs include hematologic malignancy,
neutropenia; frequent contact with the healthcare environment; multiple and/or prolonged
hospitalizations; devices, including urinary catheters and central lines, and changes in the microbiome
driven by the use of antimicrobial agents and chemotherapy.
3. The common pathogens include bacterial commensals from the gastrointestinal tract or skin and fungi
including Candida, Aspergillus and other species.
4. Opportunistic infections include Toxoplasma, Cryptococcus, Pneumocystis and Cryptosporidium, and
infection or reactivation of viruses.

Healthcare personnel
Healthcare personnel should adhere to guidelines established by the hospital Policy & Procedure on
Infection Prevention and Control

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1. Healthcare personnel must adhere to guidelines (refer SECTION B Fundamental Principles of
Infection Prevention)

a) Standard Precautions
i. Hand hygiene will be performed in accordance with the Infection Prevention and Control
Policy: (Refer to Policies and Procedures on Infection Prevention and Control HCTM
; Section B: Chapter 2.1 Hand Hygiene and Chapter 5.1 Aseptic technique)
ii. Healthcare personnel must adhere to the Infection Prevention and Control Policy: (Refer
to Policies and Procedures on Infection Prevention and Control HCTM ; Section B:
Chapter 2.2 Personal Protective Equipment)

b) Respiratory Hygiene and Cough Etiquette
• Healthcare personnel must adhere to the Infection Prevention and Control
Policy: (Refer to Policies and Procedures on Infection Prevention and
Control HCTM ; Section B: Chapter 2.9 Respiratory Hygiene and Cough
Etiquette)
• Additional precautions (Refer to Policies and Procedures on Infection
Prevention and Control HCTM ; Section B: Chapter 3 : Transmission
Based Precautions) can be found in Section B.
• All healthcare personnel are aware of facility sick leave policies, including staff
who are not directly employed by the facility but provide essential daily
services
• Masks are required in all areas of the Hematology/ Oncology Unit, regardless
of vaccination status.
• Healthcare personnel with a respiratory infection avoid direct patient contact;
if this is not possible, then a N95 facemask should be worn while providing
patient care and frequent hand hygiene should be reinforced
• Healthcare personnel are up-to-date with all recommended vaccinations
• Healthcare personnel must adhere to the Infection Prevention and
Control Policy:
▪ The decision to isolate patient should be based on the infection risk,
symptoms and risk of transmission.

c) In ambulatory settings, place patients requiring contact precautions in an exam room or cubicle
as soon as possible.
i. Donning an appropriate PPE upon room entry to patients and properly
discarding before exiting the clean area.

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ii. Use disposable or dedicated patient-care equipment (e.g., blood pressure
cuffs). If common use of equipment for multiple patients is unavoidable, clean
and disinfect such equipment before use on another patient.

iii. Prioritize cleaning and disinfection of the rooms of patients on contact
precautions ensuring rooms are frequently cleaned and disinfected focusing
on frequently-touched surfaces and equipment in the immediate vicinity of the
patient.

IV. Staff should:
• Provide affected service users and visitors with an explanation of their
infection, isolation procedures and treatment.
• Ensure that areas used for isolation purposes have dedicated hand
hygiene
• Clear signage must be displayed on the door or wall to alert staff and
visitors to infection control precautions.

2. Healthcare Personnel must adhere to the Infection Prevention and Control Policy: (Refer to Policies
and Procedures on Infection Prevention and Control HCTM ; Section B: Chapter 2.4:
Management of Blood and Body Fluid Spillage)

3. Healthcare Personnel must be familiar with and follow the guidelines in the Infection Prevention and
Control Policy: (refer SECTION B Exposure Control Plan for Bloodborne Pathoqens and the
Tuberculosis Control Plan)

4. Healthcare Personnel must adhere to the Infection Prevention and Control Policy: (Refer to Policies
and Procedures on Infection Prevention and Control HCTM ; Section C: Chapter 1:
Environmental Cleaning)

5. Caregiver / Visitor

1. Written policies for visitors should be documented and made available.
2. Visitors with respiratory symptoms should not enter the Hematology Ward.
3. Restriction to visitor numbers to two per patient at any one time is recommended.
4. All visitors must be able to follow appropriate hand hygiene and isolation precautions.
5. Vendors / contractors / students should report to ward manager at any time prior to entry or while

onsite of facility
6. Adult outpatient and clinic areas will allow one adult companion per patient, but we continue to

encourage individuals who are able to come alone to do so in order to support physical distancing
efforts.

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7. Hematology / Oncology patients may not have any caregiver / visitor, unless compassionate care is
approved.

8. Fresh or dried flowers, potted plants are not permitted in the Hematology ward and fresh fruit must be
peeled off. (refer to ward orientation leaflet)

Patient

1. Patients with infections are routinely encountered in outpatient settings, to prevent the transmission of
respiratory infections in the facility, the following infection prevention measures are implemented for
all potentially infected persons at the point of entry and continuing throughout the duration of the visit.
This applies to any person (e.g., patients and accompanying family members, caregivers, and visitors)
with signs and symptoms of respiratory illness, including cough, congestion, rhinorrhea, or increased
production of respiratory secretions.

I. Upon entry to the facility, all patients and visitors MUST wear masks for the entire visit
II. Masking and Separation of Persons with Respiratory Symptoms

III. If patient calls ahead:
▪ Have patients with symptoms of a respiratory infection come at a time when the
facility is less crowded or through a separate entrance, if available
▪ If the purpose of the visit is non-urgent, patients are encouraged to reschedule
the appointment until symptoms have resolved
▪ Alert registration staff ahead of time to place the patient in an designated area for
isolation with a closed door/curtain upon arrival

If identified after arrival:
▪ Ensure all persons wear the facemask properly (including persons accompanying
patients) who are coughing and have symptoms of a respiratory infection
▪ Place the patient with respiratory infection in a designated area for isolation and
a closed door/curtain as soon as possible if airborne pathogen is suspected (refer
to Section B : Transmission based precaustions - Airborne Precautions)
▪ Accompanying persons who have symptoms of a respiratory infection should not
enter patient-care areas and are encouraged to wait outside the facility.

2. Patient Hygiene
I. Patients are advised to take daily chlorhexidine bathing / mild soap with attention to perineal
hygiene. If a patient is unable to use the bath or shower, the body wash should still be used
for daily personal hygiene using a disposable or fresh cloth.

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II. Patient are advised to practice good oral hygiene
• use of chlorhexidine 0.12% oral care, or to rinse orally 4-6x/day with sterile water,
normal saline or sodium bicarbonate.
• to brush their teeth at least twice a day with a soft-bristled toothbrush
• Removable dentures and space retainers should not be worn unless while eating
and should be cleaned at least twice daily with soft brush and soaked in proper
soaking solution.

III. Patient / caregiver/ visitor are advised to practice good Hand Hygiene
IV. All patients should be used with individual bowls, towels and other items required for their

personal hygiene needs.
V. Avoid the use of rectal thermometers, enemas, suppositories or rectal examinations especially

during episodes of neutropenia.
VI. Dental clearance should be performed 10-14 days before induction of bone marrow transplant.
VII. Skin sites, especially portal sites should be inspected daily. Care of central venous access

should follow the guideline.
VIII. Inpatients must wear masks during the following

• Physical examination
• ward round
• care of patient
• transport to another unit

3. Dietary Principles - High risk neutropenic diet

4. Antibiotic and Antifungal Prophylaxis

I. Prophylactic antimicrobial and antifungal therapy is used mostly in certain patients with high‐
risk cancer, such as patients with hematologic malignancies undergoing induction
chemotherapy and high‐risk transplant recipients, to decrease the incidence
of Candida and Aspergillus spp. Infections. Refer to the Chemo Protocol, Cell Therapy Centre,
UKMMC (2013).

II. Refer to PPUKM Anti-Infective Guidelines 2012 / Antimicrobial stewardship

5. Isolation Room for Immunosuppressed Patients
I. A single room with ensuite bathroom is prioritize for:
• neutropenic patients with a neutrophil count of < 0.5 x 10° /L or
expected to fall below 0,5 x 10°/L

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• autologous stem cell transplant recipients up to 3 months post-
transplant

• allogeneic stem cell transplants up to 6 months post-transplant
• acute graft versus host disease
• chronic graft versus host disease

II. Patients with acute myeloid leukaemia (AML) and those who have undergone
allogenic bone marrow transplant is to be nursed in a HEPA-filtered room until
neutrophil recovery
• If HEPA filtered rooms are available on site they are to be used for
these patients.
• If a HEPA filtered room is not available allocate a single room with
ensuite bathroom, initiate Standard Precautions plus Transmission
Based Precautions as appropriate

III. Where isolation has been deemed appropriate, the door to the room should remain
closed to prevent aerosolization to adjacent clinical areas, especially during bed
making and room cleaning.

6. Management of Febrile Neutropenia Patients

Definitions, Risk Stratification and use of Growth Colony Stimulating Factors (G-CSF) refer to the
Ministry of Health Systemic Therapy Protocol 3rd Edition (2016) and Chemo Protocol, Cell Therapy
Centre, UKMMC (2013).

7. Central Venous Access Devices (CVADs) Care & Maintenance

I. The procedures outlined below pertain to the access and maintenance of long-term
central venous catheters. These include:
• peripherally inserted central catheters (PICC),
• tunneled catheters (e.g., Broviac®. Hickman®, Groshong®)
• apheresis catheters
• implanted ports.

II. Healthcare personnel are to follow manufacturers' instructions and labeled use for
specific care and maintenance.

III. Only healthcare personnel who have attained and maintained competency should
perform these procedures.

IV. Refer to Central Vascular related infection for general maintenance and access
procedures.

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SECTION E : SPECIFIC MICROORGANISM IN INFECTION CONTROL

CHAPTER 1 : GRAM POSITIVE MDRO - METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS
(MRSA)

Introduction

Methicillin-Resistant Staphylococcus Aureus (MRSA) have been a major cause of health care-associated
infections (HCAI) worldwide. Detection of MRSA within hospitals and long term care facilities has increased
dramatically and a great deal has been written regarding its management and control.

Concern about MRSA is related to the potential for health care and community transmission and the limited
number of antibiotics available to treat infections caused by this organism.

Epidemiology

In Malaysia, the rate of MRSA isolate was 0.5% per 100 admissions in 2005 and 0.3% 2007. The
epidemiology of MRSA has changed with the apparent emergence of MRSA in the community with clinical,
epidemiologic and bacteriologic characteristics distinct from health care-associated MRSA.

Methicillin-Resistant Staphylococcus Aureus

• Staphylococcus aureus is a facultative anaerobe, non-motile, catalase and coagulase-positive,
gram-positive cocci in clusters.

• It is the most important human pathogen among the staphylococci.
• S. aureus that is resistant to the synthetic penicillins (methicillin, oxacillin, nafcillin) is referred to as

MRSA.
• MRSA colonises the skin, particularly the anterior nares, skin folds, hairline, axillae, perineum and

umbilicus. They may also colonise chronic wounds, for example in eczema, varicose and decubitus
ulcer.
• MRSA is transmitted primarily through direct person-to-person contact, commonly through the
hands of health care workers. However, It can also be transmitted through contact with inanimate
objects such as linen, clothing and dust, although these do not represent significant sources for
transmission.
• Nasal carriage of MRSA is very common and due to hand to nose transmission.
• A nasal carrier often contaminates his/her own hands by hand to nose contact, then transmits the
organism in the course of routine activities.

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• Since skin to skin contact is the most significant mode of transmission, hand hygiene is of primary
importance in preventing its spread.

• Because of its resistance to antibiotics, management of MRSA infections requires more toxic and
expensive treatment.

• MRSA colonization and infections have a significant impact on patients and institutions.
• Many patients with MRSA remain colonized indefinitely, and the majority of hospital and nursing

homes that have endemic MRSA never eradicates MRSA from the institution.

Clinical Manifestation

• Infections caused by MRSA are wound infections, bacteremia, ventilator-associated pneumonia
and less commonly endocarditis and osteomyelitis

• It also produces toxins which can cause necrotising entero-colitis among newborns.

Laboratory Diagnosis

• Screening for MRSA colonization can be detected by culture of the nares or wound swabs
• Clinical infection caused by MRSA can be identified by cultures of blood, bronchoalveolar lavage,

sputum, urine or surgically obtained specimens.
• Oxacillin susceptibility testing by the Kirby Bauer technique is the preferred method of identifying

MRSA. Methicillin-resistant staphylococci are resistant to all currently available beta-lactam
antimicrobial agents ie, penicillins, beta-lactam combination agents, cephems (with the exception
of ceftaroline), and carbapenems.
• Methicillin resistance in MRSA is conferred by the mecA gene, which encodes an altered penicillin
binding protein (PBP2a).

Treatment

Treatment of MRSA falls into two areas, one is the antimicrobial treatment of clinical invasive infection and
the other is topical to eradicate skin and nasopharyngeal colonization.

Eradication of colonized patients is recommended as these patients provide a reservoir for subsequent
spread of MRSA.

(i) Hygiene
● Body and hair wash daily for 5 days with an antiseptic body wash such as 4%
chlorhexidine gluconate scrub or 2% triclosan
● Leave the antiseptic body wash for 3 minutes before rinsing with clean water.

(ii) Nasal carrier

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The usual treatment for nasal carriage is mupirocin nasal, which is an effective topical
agent
● Apply mupirocin nasal ointment three times per day for a period of five days. A

'match head' size of ointment should be applied to the inner side of the nostril.
● After the five-day treatment course, cease eradication therapy for two days and

repeat the swabs.
● If after two courses of mupirocin treatment the nasal carriage is not eradicated, the

mupirocin should be stopped because of the risk of resistance.
(iii) Wound treatment

Colonisation or infection caused by MRSA may delay wound healing. These general
principles can be applied:
● Clean wound with sterile water.
● Use povidone-iodine or silver sulphadiazine preparations where possible.
● Cover wound with an appropriate dressing.
● DO NOT USE TOPICAL ANTIBIOTICS FOR LOCALISED WOUND INFECTION
(iv) Systemic infection
● The glycopeptides agent vancomycin is the treatment of choice for infections cause

by MRSA.
● Vancomycin can have serious side effects, include ototoxicity, nephrotoxicity, 'red

man syndrome' and allergic reactions
● Alternative antibiotics to treat MRSA include linezolid, rifampicin, fucidic acid, and

teicoplanin.
● Avoid using rifampicin or fucidic acid as single agent because of rapid

development of resistance.

Infection Control and Prevention

• The preventive measures of infection control for MRSA follows the contact-based precautions
which includes hand hygiene, isolation, gloving, linen handling and environmental cleaning.

• Hand hygiene is the single most important factor in preventing the spread of MRSA, therefore the
5 moments shall be adhered to at all times.

• Gloves should be worn for any contact with blood/body fluids, secretions and excretions wounds,
invasive site, or mucous membrane of a patient

• Gowns may be worn if splashing or extensive soiling is likely.
• Masks and eye protection are indicated if exposure to aerosols generated by coughing patient is

likely or when irrigating wounds.
• Daily routine cleaning of fomites must be done with a disinfectant (70% alcohol) and performed in

a sanitary manner as is done in all rooms regardless of the presence of MRSA. Terminal cleaning
shall be performed upon patient discharge. Equipment should be routinely cleaned, disinfected or
sterilized per institution policy.

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• The MRSA colonized or infected patient should be isolated in single room if available or cohort
with other known MRSA patient.

• Contact based precaution should be strictly adhered to at all times, irrespectively of isolation.
• Ensure OT table be cleaned with 70% alcohol after MRSA case done.
• Visitors shall obtain permission and instruction from the duty nurse before any contact with

patients and practice hand hygiene after contact.

Recommended Practices

A. High risk areas of a hospital where MRSA is endemic eg ICU, NICU:
● Admission screening
● Use antiseptic for bathing affected patient
● Isolate /cohort carriers

Environmental screening shall be done only during an outbreak

B. Transfer of colonized / infected patients
● Within the hospital
o Bathe & wash hair with antiseptic detergent 4% chlorhexidine gluconate
scrub or 2% triclosan
o Clean new clothing

● Out- patients or specialist clinics eg radiology department
o Keep at the end of working session
o Make prior arrangements

● Another hospitals
o Arrangement by primary team Doctor and acknowledgement to infection
control team.

● Discharge of patients
o MRSA status included in discharge summary
o Educate patient

● Deceased patients
o Plastic body bags not necessary

C. Transport of colonized / infected patients
● Lesions should be occluded WITH impermeable dressing.
● Attendants should wear appropriate PPE i.e. gloves if handling patient.
● Trolley / wheelchairs should be cleaned with 70% alcohol.
● Staff should wash hands with antiseptic after the procedure.

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CHAPTER 2: GRAM POSITIVE MDRO - VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE)

Introduction
Enterococci are the second most common cause of HCAI in the United States. The emergence of
vancomycin-resistant enterococci (VRE) as an important nosocomial pathogen in susceptible populations
represents a significant challenge to infection control personnel. In Malaysia, the prevalence rate of VRE is
0.8% in 2007
Enterococcus
Enterococci are gram-positive cocci usually arranged in short chain, which forms part of the normal flora of
the gastrointestinal in 95% of individuals. It is a non-pathogenic organism, which may colonise the flora in
the female genital tract, oral cavity, perineal area, hepatobiliary tract, and upper respiratory tract.
The two most common species causing human infection are Enterococcus faecalis, which causes 80% to
90% of all enterococcal infections, and Enterococcus faecium, which causes 5% to 15%. Virtually all VRE
are E. faecium. Mechanism of resistance in VRE is due to the presence of van gene (van A,B,C,D,E,G).
CIinicaI Manifestation

● Enterococci are relatively poor pathogens, usually causing colonization rather than infection.
● Most enterococcal infections are endogenous, but cross-infection between hospitalized

patients does occur mainly on hands contaminated by contact with colonised or infected
patients, contaminated surfaces or fomites.
● They can also cause urinary tract infections, bacteraemia, meningitis and wound infections. In
most patients, colonisation with VRE precedes infection.
● These organisms were traditionally susceptible to ampicillin, vancomycin, aminoglycosides
and quinolones.

Epidemiology of VRE
Populations found to be at increased risk for VRE include:

● Those who have received vancomycin or cephalosporins and/or multi-antimicrobial therapy;
● Those with severe underlying disease or immunosuppression;
● Those who have had intra-abdominal or cardiothoracic surgical procedures;
● Those who have an indwelling urinary catheter or central venous catheter.
● Patients who have undergone sigmoidoscopy or colonoscopy.
● Patients in ICU/renal /oncology/haematology units.
● Patients in long stay institutions

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Treatment
● Antibiotics used include linezolid and teicoplanin.

General Recommendations for the Control of VRE Transmission
A. Patient Screening
● Faeces is the most useful screening specimen. Where a faeces sample is unobtainable a
rectal swab may be taken.
● Screening to identify colonised patients is recommended during outbreaks.
● Other colonised patients may be identified by screening other sites e.g. wounds and vascular
catheter sites.

B. Patient Placement
● Place VRE infected or colonised patients in a single room with own toilet facilities or cohort
with other affected patients.
● STRICT ADHERENCE TO CONTACT BASED PRECAUTION MUST BE PRACTICE AT ALL
TIMES.
● Patients with diarrhoea or incontinence due to or suspected of VRE pose a high risk of
transmission to other patients and MUST be isolated.
Isolation may be discontinued when the patient is well and diarrhoea-free and capable
of self-caring and good hygiene.

C. Treatment
● As colonisation with VRE is more frequent than infection patients must be assessed before
commencing treatment.
● Attempts at clearance by oral therapy are usually unsuccessful and not recommended.

D. Hand Hygiene
● Thorough hand washing by staff before and after patient contact, after handling incontinence
material or faeces.
● Wash hands after glove removal.
● Alcoholic hand rub are effective if hands are physically clean.
● Patients with VRE should be educated to wash their hands after using the toilet.

E. Gloves/Aprons
● When carrying out-patient procedures wear disposable gloves. Wash hands after removal.
● Wear an apron when entering the room of a patient infected or colonised with VRE:

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o If substantial contact with patient or with environmental surfaces in the patient's room
is anticipated.

o If the patient is incontinent.
o If the patient has had an ileostomy or colostomy, has diarrhoea, or has a wound

drainage not contained by a dressing.
o Remove gloves and apron BEFORE leaving the patients room and immediately wash

hands or use alcohol hand gel.
o Dedicated thermometers, blood pressure cuffs, stethoscopes, should be kept in the

patient’s room. After discharge they should be cleaned and disinfected appropriately.

F. Transfer Of Infected Or Colonized Patients
● Patients that are colonised with VRE must not be transferred without prior knowledge of the
receiving hospital or department.
● VRE positive patients may attend other hospital departments such as radiology, with prior
arrangement with the receiving department.

G. Waste Disposal
● Dispose of aprons/ gloves and incontinence wear in clinical waste bin.

H. Linen
● Soiled linen must be placed in a red alginate bag prior to placement in red outerbag.

I. Cleaning Policy
● Separate equipment must be kept for isolation areas.
● Thorough cleaning of all surfaces including bed rails, call bells, bedside tables, commodes,
bathroom and toilets must be done on at least a daily basis.
● On the advice of the Infection Control Nurse, hypochlorite 1: 1000 maybe recommended after
cleaning.
● On discharge of the patient all areas/surfaces of the room or ward must be thoroughly cleaned
with hypochlorite.

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CHAPTER 3.0 : MULTI RESISTANT GRAM NEGATIVE MDRO -

3.1 : Carbapenem-resistant Enterobacterales (CRE)

1. CRE is a group of gram-negative bacteria that confer resistance to the carbapenem group of antibiotics.
Common organisms include Klebsiella pneumoniae, E.coli and Enterobacter spp.

2. The resistance occurs due to production of carbapenamase enzymes such as Klebsiella pneumoniae
carbapenemase (KPC), New-Delhi Metallo-beta-lactamase (NDM) and Verona Integron-Mediated
Metallo-beta-lactamase (VIM). Many of the genes encoding for these enzymes are found on mobile
genetic elements that can be transmitted from one bacterium to another, enabling the rapid spread of
resistance. These CRE are also called carbapenem-producing Enterobacterales (CPE).

3. Carbapenem-resistance may also be due to non-carbapenemase production mechanisms such as the
combination of chromosomal mutations and acquired non-carbapenemase resistance mechanisms (for
example, a porin gene mutation that limits the ability of carbapenems to enter the bacteria combined
with acquisition or upregulation of a beta-lactamase). These CRE are called non-carbapenemase-
producing CRE.

4. The emergence of Mobilized Colistin Resistance (mcr-1) gene among CRE in several parts of the world
has caused resistance to colistin, a last-resort antibiotic to treat multidrug-resistant infections.

3.2 : Extended spectrum beta-lactamase (ESBL)-producing Enterobacterales

ESBL-producing Enterobacterales are resistant to the second and third generation cephalosporin groups of
antibiotics. Many of the genes encoding this enzyme are found on transferrable plasmids. Common
organisms include Klebsiella pneumoniae, E.coli, Enterobacter spp. and Proteus spp.

3.3 : Acinetobacter spp.
1. Acinetobacter spp. is gram-negative bacteria frequently associated with healthcare-associated

infection.

2. Multiple combinations of resistance mechanisms have been found to be responsible in multidrug-
resistant strains.

3. They can survive for long periods on both dry and moist surfaces in the hospital environment.

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