Aseptic Processing Assessments

Transcription

1 Assessments Introduction This training can be used towards a number of accredited awards and in house training NVQ Pharmacy Services see competency mapping City and Guilds Process Technology Special processes unit You may also use the following assessment papers towards your in-house training: Candidate Evidence Record Primary Level Candidate Evidence Record Secondary Level Online Assessment Multiple Choice Questions (MCQs) You may test your knowledge through our online interactive programme, which can be accessed by clicking here or visiting A quiz is available with 20 multiple choice questions. A certificate of achievement can be printed on completion. Aseptic Processing Assessments 1

2 NHS TSET Aseptic Processing Training and Development Candidate Evidence Record (Primary Level) Candidate name:... Hospital: Mentor name:... Hospital: Satisfactory Completion:... Date Completed:... Instructions The questions provided in this section are intended to be used by the candidate or group of candidates, alongside the Aseptic Processing Programme or Workbooks, to gain sufficient knowledge on the subject. The text from training packages may be used as a reference for finding the answers and also to promote discussion. 1. Attempt each question when suggested by, either one at a time or several together. Refer to your work place mentor if you have any questions. 2. Try to refer to the pack as little as possible this is intended to show your understanding. 3. Your answers will be assessed by your mentor, with a formal feedback. 4. Your mentor will sign this booklet as evidence of satisfactory completion of all questions. This may also be used as evidence towards formal education programmes, such as NVQs or City and Guilds Process Technology. 5. It is expected that this booklet should be completed within a reasonable time, maximum 1 year. 2 Aseptic Processing Assessments

3 Assessments Good Manufacturing Practice Questions Q1 Sources of Contamination and Consequences What do we mean by contamination? Where does it come from? How can we control contamination in the cleanroom? Aseptic Processing Assessments 3

4 What happens if products become contaminated? Q2 Cleaning Solutions and Equipment What is the difference between cleaning, disinfection and sterilisation? Name some commonly used disinfectants? 4 Aseptic Processing Assessments

5 Assessments What are their advantages and disadvantages? What may make the disinfection process less effective? What would be the properties of an ideal disinfectant? Aseptic Processing Assessments 5

6 What type of equipment is used for cleaning and why is it used? Q3 Records for Cleaning Why do we need to keep records? What records do we need to keep? 6 Aseptic Processing Assessments

7 Assessments Q4 Cleaning of Aseptic Suites, LFC s, Isolators Why do we need to clean? How often do we need to clean: a. LFC s and Isolators b. Aseptic Suite What are we trying to achieve and how does this affect tour choice of disinfection? Aseptic Processing Assessments 7

8 Q5 Cleaning Methods How does the design of the cleanroom minimise contamination and assist the cleaning process? What is the sequence of cleaning and why is it done in this order? How is cleaning performed? 8 Aseptic Processing Assessments

9 Assessments Q6 Environmental Monitoring Why do we monitor? How do we monitor? Are there any problems in monitoring? Aseptic Processing Assessments 9

10 What do we do with the results? 10 Aseptic Processing Assessments

11 Assessments Primary Assembly Questions Q7 Questions Relating to Primary Assembly Why do we need documentation? How is the documentation generated? List the different types of documentation used in aseptic preparation and discuss their purpose? Aseptic Processing Assessments 11

12 What is primary assembly? What legislation is presently enforced in your place of work to protect you whilst you are carrying out your duties? Can you think of any chemicals you handle and use that have special handling requirements? 12 Aseptic Processing Assessments

13 Assessments Clean Room Questions Q8 Entry into the Clean Room, Rules and Regulations What rules should operators obey when entering an aseptic suite/dedicated isolator area? Why are there restrictions on entry into the aseptic facilities? Why should staff wash their hands when entering an aseptic facility? Aseptic Processing Assessments 13

14 Q9 Entry into a Cleanroom, Passing into Aseptic Areas Why should items be sprayed with a surface disinfectant prior to passing into the cleanroom/isolator? Why do we observe a lock-out time when passing in items? What effect do 2-way hatches and air locks have, and why should they not be compromised? 14 Aseptic Processing Assessments

15 Assessments How would you pass settle plates into the aseptic facility? Q10 Entry into Clean Room, Cleaning Clothing Why do we wear cleanroom clothing? What design features are seen with cleanroom clothing and with support area clothing? Aseptic Processing Assessments 15

16 What actions can staff take to minimise the risk of contamination to the facility and the product? Why do we segregate laundry before and after use? Q11 Actions Prior to Entry of Cleanroom What should be checked prior to entry into a cleanroom/isolator and why? 16 Aseptic Processing Assessments

17 Assessments Q12 Support and Preparation Areas, other than Cleanroom What is the purpose of a support area? Why should products be segregated when passing into an aseptic facility and how can this be done effectively? Aseptic Processing Assessments 17

18 Operational Queries Questions Q13 LFC s and Isolators What are 3 differences between LFC s and Isolators and how does each of these affect the way they are used? Q14 Open and Closed Systems What is the distinction between open and closed systems and why is this distinction so important? 18 Aseptic Processing Assessments

19 Assessments Q15 Process Monitoring Q16 Health and Safety What Health and Safety problems or situations can you think of? Aseptic Processing Assessments 19

20 Q17 In Process Checking How can checking be done? Identify problems and suggest how they can be addresses. Q18 Possible Errors List at least 6 different ways in which things can go wrong. For each of these, identify the most important ways of preventing or detecting these? 20 Aseptic Processing Assessments

21 Assessments Q19 Waste Didsposal and room Clearance In the Aseptic Suite, how would you dispose of: paper (eg syringe packaging), TPN outers, syringes, needles, ampoule tops, cytotoxic waste (eg aprons, gloves), cytotoxic needles? Q20 Product Segregation and Labelling Product should always be segregated, both prior to entry into the unit and upon exit. Why is this? Aseptic Processing Assessments 21

22 Q21 Checking and Release of Final Product What information would you expect to find on a label of a final product? Q22 Storage Facilities within Pharmacy and the Wards How do we ensure products are stored correctly and thus suitable for use? 22 Aseptic Processing Assessments

23 Assessments Q23 Distribution Methods What considerations should be taken into account when distributing products? Q24 Training of Staff A training policy should exist for all levels of staff in an aseptic unit. Why? Aseptic Processing Assessments 23

24 Q24 Reporting of Incidents and Accidents What do you consider an incident/accident to be? Why report an incident? Q25 End of Day Activities What end of day activities should be included? 24 Aseptic Processing Assessments

25 Assessments NHS TSET Aseptic Processing Training and Development Candidate Evidence Record (Secondary Level) Candidate name:... Hospital: Mentor name:... Hospital: Satisfactory Completion:... Date Completed:... Instructions 1. This is a formal assessment of some competencies in Aseptic Preparation. 2. The results should provide a formal evaluation of some theoretical competencies and identify any areas of serious deficiency. 3. The assessment is in the form of a written test, which should be completed within 1 hour. The significance of the answers is indicated by the marks awarded to each answer. 4. No reference material will be necessary. A calculator may be used where indicated. 5. Following the marking, a tutorial session is to be held with the trainee to discuss their performance and any remedial action needed. Aseptic Processing Assessments 25

26 Candidate Test (Secondary Level) (Example Questions) Extra marks may be awarded for additional relevant information. Q1 List 3 of the major publications which control the standards and activities performed in Aseptic Units and briefly comment on their significance. Marks: 2 marks for each book and up to 2 marks for each significance. Total: 12 marks Book Significance Marks Total Marks 26 Aseptic Processing Assessments

27 Assessments Q2 List 4 of the main differences between aseptic preparations under Section 10 exemption compared to specials manufacturing licence. Marks: 1 mark for each single, 3 marks for each pair. Total: 12 marks Section 10 Exemption Specials Manufacturing Licence Marks Total Marks Aseptic Processing Assessments 27

28 Q3 List at least 6 specific points describing the special interior design and finish within an Aseptic Unit Marks: 2 marks for each point Total: 12 marks Total Marks 28 Aseptic Processing Assessments

29 Assessments Q4 List at least 6 sources of potential contamination to a product and note briefly the preventative measures in place. Marks: 2 marks for each with satisfactory prevention. Total: 12 marks Source Prevention Marks Total Marks Aseptic Processing Assessments 29

30 Q5 Draw a simple flow chart showing all the steps in the processing of a new CIVAS request from a ward up to the point of collection by the porter. Marks: 1 for each step in the sequence, 0.5 marks for each step out of sequence. Total: 15 marks Total Marks 30 Aseptic Processing Assessments

31 Assessments Q6 List ALL generic items which COULD be included on a label of an aseptically prepared product. Marks: 0.5 marks for each item. Total: 12 marks Total Marks Aseptic Processing Assessments 31

32 Q7 List the reference sources you could use to evaluate a new request, then grade them for usefulness on a score of 1 = most useful, to 5 = least useful, with comments on their use. Marks: 1 mark each. Total: 13 marks Reference Score Comment Marks Total Marks 32 Aseptic Processing Assessments

33 Assessments Q8 What would you do if you were working in the cabinet room when the fire alarm sounded? Answer in some detail to identify specific actions sequentially. Include actions you would NOT take. Marks: 1 mark each. Total: 9 marks Step Action Taken / Not Taken Marks Total Marks Aseptic Processing Assessments 33

34 Q9 List the monitoring that is undertaken in the Aseptic Unit, with an indication of frequencies. Marks: 0.5 for each item monitored, 0.5 for its frequency. Total: 17 marks Item monitored Location Frequency Marks Total Marks 34 Aseptic Processing Assessments

35 Assessments Q10 Perform the following calculations. Marks: 0.5 marks for the correct method and 0.5 for the correct answer. Total marks: 12 a) Mr King is 71 Kg and needs a drug dose of 125 mcg/kg/hour. WITHOUT A CALCULATOR, which of the following is nearest to the amount of drug per hour? 9,000 mcg 8,880 mcg 7,000 mcg 8,800 mcg 8,875 mcg b) He then needs dopamine prescribed at 4 mcg/kg/min. The drug is usually prepared to 1 mg/ ml. At what rate should this be infused? 400 ml/hour 17 ml/hour 1.7 ml/hour 24 ml/hour 2.4 ml/hour c) Another drug is available as 15.4 mg/ml in 1 ml ampoules. If 20 ml syringe is to be used, what would be the best way to prepare the dilution and why? Use 20 mg of drug and make up to 20 ml Use 1.3 ml of drug with 18.7 ml diluent Use 1 amp and 14.4 ml diluent Add 1 amp to 20 ml diluent Use 1 amp and 19 ml diluent. Give reasons for your choice: Aseptic Processing Assessments 35

36 d) A baby needs Potassium supplement. For a weight of 2.5 kg and a dose of 3 mmoles/kg/day, how much Potassium should be added to an IV designed to last 12 hours? 7.5 mmoles 3.75 mmole mmole mmole 1.5 mmole e) A baby of 2.5 kg needs Glucose 5% at 40 ml/kg/day. At what rate should the infusion run? 83 ml/hour 8.3 ml/hour 4.2 ml/hour 42 ml/hour 17 ml/hour f) The baby s requirement increases to 90,l/kg/day. To what level should the pump be set? 220 ml/hour 22 ml/hour 94 ml/hour 9.4 ml/hour ml/hour Total marks Aseptic Processing Assessments