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    Temperature Monitoring in Clinic Rooms - Template SOP - June 2015

    Uploaded by

    Lakshman Kareti
    1) This document outlines procedures for monitoring temperature in clinic rooms where medicines are stored to ensure they remain within the required ranges. 2) Staff must check the minimum and maximum temperatures daily using a calibrated thermometer, record the readings on a monitoring chart, and reset the thermometer. More frequent checks are needed during extreme weather. 3) If temperatures go outside the required ranges of 15-25°C for ambient or 2-8°C for fridges, staff must take action to correct it and notify pharmacy staff. Completed monitoring records must be reviewed and signed off at the end of each month.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Temperature Monitoring in Clinic Rooms - Template SOP - June 2015

    Uploaded by

    Lakshman Kareti
    137 views5 pages
    1) This document outlines procedures for monitoring temperature in clinic rooms where medicines are stored to ensure they remain within the required ranges. 2) Staff must check the minimum and maximum temperatures daily using a calibrated thermometer, record the readings on a monitoring chart, and reset the thermometer. More frequent checks are needed during extreme weather. 3) If temperatures go outside the required ranges of 15-25°C for ambient or 2-8°C for fridges, staff must take action to correct it and notify pharmacy staff. Completed monitoring records must be reviewed and signed off at the end of each month.

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    Temperature Monitoring in clinic rooms - Template SOP_June 2015

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    1) This document outlines procedures for monitoring temperature in clinic rooms where medicines are stored to ensure they remain within the required ranges. 2) Staff must check the minimum and maximum temperatures daily using a calibrated thermometer, record the readings on a monitoring chart, and reset the thermometer. More frequent checks are needed during extreme weather. 3) If temperatures go outside the required ranges of 15-25°C for ambient or 2-8°C for fridges, staff must take action to correct it and notify pharmacy staff. Completed monitoring records must be reviewed and signed off at the end of each month.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    137 views5 pages

    Temperature Monitoring in Clinic Rooms - Template SOP - June 2015

    Uploaded by

    Lakshman Kareti
    1) This document outlines procedures for monitoring temperature in clinic rooms where medicines are stored to ensure they remain within the required ranges. 2) Staff must check the minimum and maximum temperatures daily using a calibrated thermometer, record the readings on a monitoring chart, and reset the thermometer. More frequent checks are needed during extreme weather. 3) If temperatures go outside the required ranges of 15-25°C for ambient or 2-8°C for fridges, staff must take action to correct it and notify pharmacy staff. Completed monitoring records must be reviewed and signed off at the end of each month.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    Medicines need to be stored within certain temperature ranges to maintain their quality and effectiveness. Temperatures outside these ranges can damage medicines.

    The aim is to describe the correct procedure for monitoring temperatures in clinic rooms where medicines are stored to ensure they remain within the required ranges.

    Action should be taken to try to ensure the room or fridge remains within the desired temperature range, such as opening/closing windows or using a fan/heater. The temperature record should also be updated and the thermometer reset to silence the alarm.

    SOP reference

    Temperature monitoring in clinic rooms where medicines are


    SOP Title
    stored.
    Version Number Version 1
    Date of issue/
    May 2015
    implementation
    Written by Orla Macdonald
    Name:
    Position:

    Date:
    Signature:

    On behalf of Pharmacy Department


    Approved by
    Name:
    Position:

    Date:
    Signature:

    On behalf of
    Date of review May 2017

    SOP: Temperature monitoring in clinic rooms


    1 Introduction
    Medicines must be stored under conditions which ensure that their quality is not
    adversely affected by the environment. Extreme hot and cold temperatures can
    damage medicines and therefore they must be stored according to manufacturers’
    recommendations i.e. within 15oC-25oC for ambient storage or within 2oC-8oC for
    fridge storage. In order to ensure the quality of medicines used within the trust, the
    temperature of all areas where medicines are stored must be monitored regularly.
    Monitoring records may be requested in the event of an inspection.

    2 Purpose
    The aim of this Standard Operating Procedure (SOP) is to describe the correct
    procedure for monitoring the temperature of any clinic room within the trust, when
    medicines are being stored there.

    3 Scope
    This SOP applies to all clinical staff working in areas where there is a clinic room on
    site that is used to store medicines.

    4 Roles and Responsibilities


    It is the responsibility of individuals carrying out this procedure to:

     Have read and understood this SOP and the instructions for the temperature
    monitor provided.

     Undertake the procedure as outlined below.

     Only use approved min/max temperature monitors which have a valid, up-to-
    date calibration certificate – for advice on suitable equipment speak to the
    pharmacy department.

     Store the temperature monitoring records where they can be retrieved for
    inspection.

     Inform pharmacy staff where appropriate

    5 Environmental Monitoring Procedure


    A calibrated max / min thermometer must be kept in all clinic rooms where
    medication is to be stored. This is used to monitor ambient room temperature.
    The thermometer must be kept next to the medication. If medication is also
    stored in a fridge there must be a separate fridge thermometer used to monitor
    that storage temperature.
    This procedure refers to a temperature recording chart found in the Appendix
    below. Staff may use this chart or an alternative chart, so long as it records the
    same information. If a digital temperature recording system is in place and
    working well, this can continue to be used instead of the procedure below,
    provided staff have written procedures for downloading and storing the
    temperature information and for responding to a temperature deviation.

    SOP: Temperature monitoring in clinic rooms


    5.1 Temperature monitoring
    1. At the beginning of each month start a new recording chart (see Appendix below
    for example). Write the month and year in the appropriate space.

    2. Check the temperature shown on the thermometer(s) daily and record max and
    min temperatures onto the chart. Sign in the appropriate space.

    3. Reset the thermometer according to the operational instructions.

    4. If daily recording isn’t possible, enter the details as frequently as possible.


    Min/max thermometers will keep a record of the minimum and maximum
    temperature reached until it is reset.

    5. During extreme (hot/cold) weather conditions the temperature should be


    monitored more frequently.

    6. At the end of each month the completed monitoring record form must be signed
    by a senior team member who must first check that no unreported deviation has
    occurred.

    7. All records must be kept in a folder along with the thermometers calibration
    certificate. These records will be requested during an inspection.

    5.2 Responding to an alarm or a temperature deviation:


    1. The alarms on the thermometer must be set to go off if the temperature reaches
    the boundaries of the desired range i.e. 15°C-25°C or 2 oC-8 oC.
    2. If the alarms go off, action must be taken to try to ensure that the room or fridge
    remains within the desired range – open / close windows, install portable fan /
    heater to cool / heat the room, close fridge door, contact engineer to service
    fridge.
    3. Once these measures have been taken, ensure that the temperature record has
    been recorded, then reset the thermometer to silence the alarm

    4. If the temperature has varied outside of the required range, inform a


    member of pharmacy staff or the medicines information department.
    They will need to know the temperature reached, an estimate of how long
    the temperature has been out of range and the details of any medication
    stored there.

    6 Definitions
    Ambient room temperature
    The minimum and maximum temperatures are within range of 15oC and 25oC
    Fridge temperature
    The minimum and maximum temperatures are within range of 2 oC and 8 oC
    SOP: Temperature monitoring in clinic rooms
    7 Revision History
    This is a new SOP that has not undergone any revisions since first approved

    8 Appendix
    Temperature Monitoring Record

    SOP: Temperature monitoring in clinic rooms


    Temperature Monitoring Record

    Month / Year:

    Ensure a MAX/MIN thermometer is used. Ensure the alarm is set to go off at the
    appropriate temperature boundaries (15oC and 25oC for ambient, 2oC and 8oC for fridge)
    Ensure the alarm is ON. Store the thermometer next to the medication. Record the
    temperatures shown then RESET the thermometer.

    Date Ambient room Fridge Monitor Signature


    reset
    Max Min Max Min (Tick)
    1
    2
    3
    4
    5
    6
    7
    8
    9
    10
    11
    12
    13
    14
    15
    16
    17
    18
    19
    20
    21
    22
    23
    24
    25
    26
    27
    28
    29
    30
    31

     To be completed daily, if possible, except when unit is unstaffed or when no drugs present.

    END OF MONTH REVIEW: (Signature) …..…………………………Role…………………

    SOP: Temperature monitoring in clinic rooms

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