Aseptic intro Flashcards

1
Q

What year was the Medicines Act established?

A

1968

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2
Q

What does The Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 require?

A

Employers to use safer sharps which incorporate protection mechanisms to prevent or minimise the risk of accidental injury.

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3
Q

What are the purposes of patient safety alerts?
Give examples.

A

To seek to understand and address errors w/injectable medicines.
- Breckenridge report (1976); CIVA services
- Farwell report (1995); Aseptic preparation

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4
Q

What are the COSHH regulations (2002)?

A

Control of Substances Hazardous to Health Regulations (2002). This concerns:
- Chemicals, biological agents but NOT radioactive substances.

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5
Q

What regulations other than COSHH govern the safe handling of chemicals/biologicals etc?

A
  • Health and Safety at Work Act (1974)
  • Management of Health and Safety Work Regulations (1999)
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6
Q

How must chemotherapy be supplied from the manufacturer?

A

Chemo containers must be:
- Securely sent
- Sealed
- Clearly labelled
- Spill-proof

Cytotoxic bag (clear) with product double wrapped, transported in person or within secure transport box.

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7
Q

What is defined as product waste, and how is it disposed?

A
  • Empty vials
  • Consumables
  • Contaminated administration equipment

> Disposed of in designated sharps bins w/purple lids

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8
Q

Where should spill kits be located?

A

These should be stored in any place that Chemo is stored, manipulated, administered or disposed.

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9
Q

What is a Laminar Air Flow Cabinet (LAFC), and what does it protect?

A

This is a continuous, unidirectional flow of sterile air. It protects the product, but not the worker.

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10
Q

What does The Yellow Guide entail, and what regulation does it include?

A
  • Provides guidance on GMP for aseptic dispensing e.g. procedures, competencies, responsibilities, control of materials, provision/maintenance/monitoring of facilities and equipment
  • EL(97)52 Regulation/Farwell report; guidance on aseptic dispensing contained within The Yellow Guide.
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11
Q

What did the Farwell report (1995)

A

Farwell; set out requirements for aseptic dispensing in NHS patients.

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12
Q

Why are hands rubbed during hand washing?

A

This will create friction and in turn allow the mechanical removal of microorganisms

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13
Q

Definition of microbial contamination

A

Microbiological contamination refers to the unintended or accidental introduction of infectious material like bacteria, yeast, mould, fungi, virus, prions, Protozoa, or their toxins and by products.

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14
Q

What is the role of an Accountable pharmacist?

A

The pharmacist responsible for all aspects of the services within an aseptic preparation unit. The duties of the Accountable Pharmacist include the approval of all systems of work and documentation used in the unit. This person is also an Authorised Pharmacist.

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15
Q

Define what a clean room is

A

A clean room is a room in which the number and concentration of viable and non-viable airborne particles is controlled. The room is constructed and used in a manner that minimises the introductions, generation, and retention of particles inside the room, and other relevant parameters e.g., temperature and humidity are controlled as necessary.

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16
Q

Who is am internal audit undertaken by and what is an internal unit

A

An internal audit is undertaken by staff who are part of the management organizational structure of the department. This is sometimes termed self-inspection.