Reconciliation, Inspection and Checks

Transcription

1 Chapter 15 Reconciliation, Inspection and Checks By the end of this chapter, you will be able to: l Explain the terms reconciliation, inspection, checks l Understand the importance of safe checking systems l List the information that should be present on the worksheet at assembly stage l Give examples of what to look for when performing a visual check on finished products l List the checks carried out by an appropriately trained person Introduction Reconciliation, inspection and checks must happen throughout the whole preparation process. This is all part of quality assurance. But what do we mean by each of the terms reconciliation, inspection and checks? Reconciliation This is when quantities, e.g. of containers, labels are checked against the worksheet at critical points throughout the process. Everything should be able to be accounted for. Inspection This is a vital and important part of all aseptic preparation. It occurs at various stages in the process. Initially we inspect the starting materials visually for any faults such as discolouration, particles, leaks, or label defects. When making a product, inspection at various stages is essential to check for: l Good mixing l Accurate volumes l Degradation l Discolouration l Precipitation and other particles At the end of the process the finished product is again inspected to ensure that it is fit for use on a patient. Chapter 15: Reconciliation, Inspection and Checks 1

2 Aseptic Processing Checks This includes checks for the appropriate signatures and technical information on the worksheet and label prior to preparation. Calculations and formulae must also be checked before preparation starts. Other checks are carried out in-process, e.g. volume checks, as well as final checking of the finished product. (Assembly checks can be carried out by a suitably trained and accredited person who is not necessarily a pharmacist.) All errors or unusual events throughout the process should be reported. You should check your local SOPs and see co.uk or National Patient Safety Agency (NPSA) Safe Checking Systems There should be an agreed approach to accuracy checking in every unit, which is documented within a Standard Operating Procedure (SOP). Some good practice tips are as follows: l Always check systematically in the same order in accordance with SOP l In the order as appears on worksheet l Follow your local checklist l Follow the mnemonic e.g. HELP (see below) l Be independent and accurate, never assume that it will be ok You may want to try this method; use the RPSGB HELP acronym: How many Expiry date Label Product Check calculations on worksheet Expiry date of product Label patient name, product name, strength, route, etc Product correct drug, strength, final volume, diluent Always perform a three-way check: l Product against Worksheet against Label l If interrupted always restart the checking process from the beginning l Do not rush Any individual performing a checking process e.g. Pre-process assembly Worksheet, Labels, Calculations In-process Reconciliation, volumes Final Product Checking Reconciliation of product and labels should be trained and signed off as competent. Do not perform checks beyond your competency level, even if encouraged or pressured to do so. Training may be through an in-house training programme using nationally developed checking frameworks such as: l In-Process and Pre-Process Checking (IPPC) l Final Accuracy Checking (FAC) See 2 Chapter 15: Reconciliation, Inspection and Checks

3 Chapter 15 Reconciliation, Inspection and Checks Underpinning knowledge programmes are also available either: l Local IPPC/FAC Accreditation l Accredited Accuracy Checking Programmes l Accredited Medication Safety Programmes These may be delivered in-house or via a training provider such as a regional training unit a college or a university. Worksheet Validation All worksheets must be authorised by an appropriately trained person. This involves ensuring formulations and calculations are correct and all necessary data is present, including signatures, batch numbers, label specimens, etc. Remember! The Worksheet is a critical document in reconciliation and checking. The worksheets are the main audit trail and record for every preparation. They accompany the product through assembly, transfer to work zone, preparation, transfer from work zone and through to labelling, final checking and release. Here is and example of a worksheet for a CIVAS product The previous image highlights some of the checks required on the worksheet l Patient and prescription request details l Materials required: manufacturer, batch number, expiry, quantity. l Dilution (in this example) l Labels Information: Refer to Chapter 8 Quality Systems for Operators for more details on the information that should be present on worksheets. Assembly and Production Checks Here is a reminder of some of the checks that take place at the assembly stage: Quantities: The quantities of each starting material must be checked for against the worksheet. Components: The correct number of components should be present. Labels: The correct number of labels should have been issued, according to the worksheet. This needs to be properly checked by actual counting of what has been issued by a suitably trained person. Chapter 15: Reconciliation, Inspection and Checks 3

4 Aseptic Processing Worksheet: The worksheet should be validated as above. Information on the worksheet should be legible especially as it is usually sent into the clean room in a plastic sleeve or bag. It should be easy to read, with clear instructions. Batch numbers and expiry dates also need to be recorded. Components: Make sure the component selected during assembly is appropriate for the product being prepared, e.g. syringe sizes and quantities, needle sizes, filters. Also check the starting materials are correct by checking the name and strength of the drug against the worksheet. Signatures: All the necessary signatures should be present. It is important that these are added to the worksheet at the time the activity is completed Here is a reminder of some of the checks that take place during the preparation stage: Numbers: The calculation should be correct. A formal, properly done, independent check should be performed and the result checked against what has been provided as ingredients. It is not always possible to perform complex calculations. Try to do a common sense check. An example would be a vial contains 500mg and if the dose it 250mg then you would expect to use half the solution from the vial. Tray: Check that the assembled tray contains everything needed to complete preparation from start to finish. Stoppages in workflow and interruptions can cause errors and lack of concentration. Information: Refer to Chapter 11 Assembly, to reinforce your learning. In-process Checks In-process checks must be made to ensure the product is made correctly including checks of additions, volumes and starting materials. Check involve: l The vials/ampoules that have been used as starting materials contain the correct drug at the correct strength or concentration (for liquids) and are in date. l The volume of drug to be added is correct l For infusion bags-the correct infusion bag and volume has been selected and is in date 4 Chapter 15: Reconciliation, Inspection and Checks

5 Chapter 15 Reconciliation, Inspection and Checks l For infusion bags-the volume of diluent removed from the infusion bag, if applicable, is correct. l Diluents and diluent volumes are correct Once all in-process checks have been made the worksheet must be signed in the relevant place, by the person checking. Reconciliation Checks Note: In some instances some starting materials i.e. vials, are not passed out, but are held back for use in other preparations later the same day. If this happens the person passing out the material should indicate what is remaining. Visual Inspection of products Prior to labelling, all sterile products should undergo a thorough visual inspection for the presence of: l Particulate matter l Leaks/cracks/punctures l Closure seal properly applied l Other visual abnormalities e.g. contamination Wherever possible all remnants of starting materials, containers, labels, or components need to be passed out of the clean area together with the finished products so that careful reconciliation can be made. Note: In many units cytotoxic empties are not passed out for reconciliation. Be careful not to throw away any materials with the paper rubbish until after a final or reconciliation check has been completed. All containers whether empty or part full must be checked by an appropriate person (unless it is deemed unsafe to do this). The final product must be checked against the worksheet (and prescription if applicable). If the person carrying out the visual check normally wears glasses for reading or other close work, then they should be worn for the inspection To show up particulate matter, the bag or syringe should be gently agitated. Chapter 15: Reconciliation, Inspection and Checks 5

6 Aseptic Processing Labelling Label reconciliation is an important part of both the assembly check and final check/ release of the product. Air bubbles normally rise and do not behave like particulate matter which normally sinks. Items should be held at about 25 cm (10 inches) from your eyes* Infusion bags and syringes should be viewed against both a white and a dark background for about 10 seconds each. Eye drops should be viewed using a magnifying viewer with both normal and polarised light. Any product that shows signs of particulate contamination or any visual abnormality should be rejected, such as colour changes or evidence of poor mixing. Abnormal products are segregated at the time of rejection so that they are not labelled. Rejected products should be clearly marked and disposed of appropriately, after appropriate records have been made on the worksheet. They could also be used for sterility testing. * This is the best distance for acute vision and for spotting small particles in solution. Only one product should be assembly checked or released at a time and line clearance should be observed to ensure that products and labels from different processes do not become mixed up. Label reconciliation at the assembly stage is to ensure the correct numbers of labels have been printed for the product. Usually this is one for the worksheet, one for each product and one for the secondary packaging. The one for the worksheet is usually attached at this point. If there are insufficient labels at this stage additional labels should be printed. Reconciliation at the final accuracy check and release of the product is to ensure that all the labels are still present and correct and have been attached to the finished product and secondary packaging as appropriate. If there are additional labels present the product, worksheet and packaging must be double checked to ensure that all labels have been attached correctly. Once this is complete they should be accounted for as part of the reconciliation as destroyed and the number annotated and signed for. 6 Chapter 15: Reconciliation, Inspection and Checks

7 Chapter 15 Reconciliation, Inspection and Checks If at the point of reconciliation there are labels missing they must be found and accounted for. This involves checking that two have not been attached to the worksheet, product or packaging. That they have not been left in the bag with the worksheet, that they have not dropped on the floor or been swept up in packaging and put in the waste bin. If the missing label cannot be found it should be annotated on the worksheet that additional labels were printed and this should be accounted for as a separate reconciliation check. Chapter 15: Reconciliation, Inspection and Checks 7

8 Aseptic Processing Visual Inspection Labelling section Accuracy check Clinical Check Final Release Worksheets Lets have a look at some of the checks on this worksheet example: Below is an example of a worksheet for a CIVAS product The Accuracy Check Section contains the following entries requiring signatures: l Preparation details (signatures for Prepared by: Process checked by:) l Reconciliation of materials and components l Visual Inspection of product section l Labelling section including space for an actual sample label to be attached l Accuracy check Completed by: Reconciliation Preparation details The Clinical Check section Certain staff have the responsibility of performing a clinical check on the worksheet before preparation begins. Check your SOP s. The Final Release Section see section below Product Release The product is checked by an appropriately trained person depending on whether it s a licensed or unlicensed unit to ensure that it complies with the details recorded on the batch processing record. Checking of the product involves: l Ensuring the right starting materials have been selected l Ensuring the right volume has been used l Packaging is sealed properly with no leaks and signs of damage. l Labelled with the right patient name and medicine details l The correct batch number and expiry date has been assigned to it. l The product is free of all visible particles and should be clear with no signs of precipitation or other chemical interactions. (See previous section on inspection). Final accuracy checks can be carried out by an accredited technician. (See Checking Frameworks and best practice Guide to Checking in the Library.) The release of medicines made under Section 10 products must be done by the pharmacist. The release of medicines made under a specials licence must be by Quality Control. (Medicines made under a full product licence (Marketing Authorisation) must be released by a Qualified Person (Q.P.). 8 Chapter 15: Reconciliation, Inspection and Checks

9 Chapter 15 Reconciliation, Inspection and Checks Before release, the pharmacist has to complete a number of checks: l Visual inspection of the product l Ensure that the product complies with the prescription and appropriate specification including the label l Ensure that the product has been produced in accordance with approved validated operating procedure and be aware of any quality exceptions reports l Be aware of any recent microbiological and environmental results for the facilities l Ensure that the daily monitoring records for the unit are satisfactory e.g. pressure differentials and cleaning l Be aware of the recent retrospective test results for the products l Ensure that the reconciliation of empty and part used containers of components and starting materials has been carried out. Expiry and storage To ensure stability all medicines must be kept under the correct conditions, such as temperature or light, during and after preparation l Storage Information is given on the worksheet l Expiry date and time is given on the worksheet l Reference to stability data should be given on the worksheet In some instances the expiry date is given based on routine storage in a fridge plus 24 hours at in use temperature. If an item requires refrigeration, this should take place as soon after preparation as possible. If this item has yet to be checked or released it should be quarantined in the fridge, i.e. clearly labelled so it is not used before the release processes have been completed. If a refrigerated item exceeds 8o c for any length of time a risk assessment will be necessary to determine if it is safe for use. Errors All errors should be documented, including near misses. Further Reading on errors Check your local SOPs for guidance Visit National Reporting and Learning System (NPSA) at Information: Refer to Chapter 8 Quality Systems for Operators for more information on error monitoring. Chapter 15: Reconciliation, Inspection and Checks 9

10 Aseptic Processing Test Yourself Where would you get expiry and storage information from? Test Yourself Can you remember what you would be looking for during a visual inspection of a product? 10 Chapter 15: Reconciliation, Inspection and Checks

11 Chapter 15 Reconciliation, Inspection and Checks Activity The importance of the worksheet Using the information above on worksheets, information from Chapter 8 Quality Systems for Operators, and your local SOPs and worksheets: l List 10 important pieces of information that a worksheet might contain. l How many checks can you find on a worksheet? l What types of checks are there on a worksheet? Chapter 15: Reconciliation, Inspection and Checks 11

12 Aseptic Processing Questions Q1 Define each of the following terms. Term Reconciliation Definition Inspection Checks 12 Chapter 15: Reconciliation, Inspection and Checks

13 Chapter 15 Reconciliation, Inspection and Checks 1. Q2 List 5 checks carried out during the assembly stage Chapter 15: Reconciliation, Inspection and Checks 13

14 Aseptic Processing 1. Q3 List 3 checks carried out during the preparation stage Chapter 15: Reconciliation, Inspection and Checks

15 Chapter 15 Reconciliation, Inspection and Checks Q4 What is checked prior to labelling? (4) Q5 What must happen if a product shows signs of particulate contamination or any visual abnormality? (2) Chapter 15: Reconciliation, Inspection and Checks 15

16 Aseptic Processing Q6 What checks are carried out before product release? (7) 16 Chapter 15: Reconciliation, Inspection and Checks