18
1 MMP1: Temperature Monitoring in Clinic Rooms Procedure Description This procedure describes the process to be followed for temperature monitoring in all clinical areas where medicines are stored. Which policy does the procedure link to Trust Policy reference MM01: Medicines Management Policy Version Number Version 6 Date of issue/ implementation July 2019 Written by Orla Macdonald (Clinical Lead Pharmacist for Research & Development) Amended by Joanne Galloway (Clinical Trials Pharmacist) Richard Hunponu-Wusu (Clinical Lead Pharmacist) Approved by Name: Michael Marven Position: Deputy Chair, DTG Date: 31 st July 2019 Signature: On behalf of Drug & Therapeutics Group Name: Michael Marven Position: Chief Pharmacist Date: 31 st July 2019 Signature: Chief Pharmacist Date of review July 2021

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Page 1: MMP1: Temperature Monitoring in Clinic Rooms

1

MMP1: Temperature Monitoring in Clinic Rooms

Procedure Description

This procedure describes the process to be followed for temperature monitoring in all clinical

areas where medicines are stored.

Which policy does the procedure link to

Trust Policy

reference MM01: Medicines Management Policy

Version Number Version 6

Date of issue/

implementation July 2019

Written by Orla Macdonald (Clinical Lead Pharmacist for Research &

Development)

Amended by Joanne Galloway (Clinical Trials Pharmacist)

Richard Hunponu-Wusu (Clinical Lead Pharmacist)

Approved by

Name: Michael Marven

Position: Deputy Chair, DTG

Date: 31st July 2019

Signature:

On behalf of Drug & Therapeutics Group

Name: Michael Marven

Position: Chief Pharmacist

Date: 31st July 2019

Signature:

Chief Pharmacist

Date of review July 2021

Page 2: MMP1: Temperature Monitoring in Clinic Rooms

2

Responsibilities

Ward/Unit Managers, Nurses and Pharmacy Staff (see section 4 of the procedure for further

details.

Procedure 1. Introduction

Medicines should 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 should be stored according to manufacturers’ recommendations, which

unless otherwise stated will be 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 (see point

5 for exceptions). Monitoring records may be requested in the event of an inspection. The

Trust accepts that there will occasionally be situations where the temperature deviates from

the recommended range. This SOP documents action to take in that circumstance and what

to do to mitigate risks associated with temperature excursions.

2. Purpose

The aim of this Standard Operating Procedure (SOP) is to describe the correct procedure for

monitoring the temperatures within areas of the trust where medicines are being stored.

3. Scope

This SOP applies to all appropriate staff working in areas where medicines are stored or

handled.

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

monitoring equipment provided.

• Undertake the procedure as outlined below.

• Only use approved equipment – Infogrid System, EasyLog Data Loggers or Min/Max

temperature monitors – for advice on suitable equipment speak to the pharmacy

department.

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

Page 3: MMP1: Temperature Monitoring in Clinic Rooms

3

In the event of a temperature excursion, see section entitled “Responding to an

alarm or temperature deviation”

5. Environmental Monitoring Procedure

Temperature recording equipment must be kept in all areas where medication is to be

stored. Exceptions to this include, but may not be exclusive to, emergency medicines

and patient own drugs. All exceptions will be documented on the Risk Register.

The Trust temperature monitoring equipment of choice is the Infogrid System platform.

This consists of temperature sensors which send readings via radio waves to a connector

device which uploads the information to the Cloud and can be viewed on the Infogrid

System website.

Other equipment is available and may be used if a need is identified after discussion with

your pharmacy lead. Any decision and reasoning for not using Infogrid System should be

documented.

EasyLog temperature data loggers record the environmental temperature on a

continuous basis; they are usually set to take a temperature reading every 10 minutes.

This data can then be downloaded onto a computer and presented as a graph showing

the recorded temperatures over a period of time. Recommended temperature data

loggers have an audible and visual alarm, indicating any temperature deviations outside

of the required boundaries. Temperature data loggers allow us to accurately see the

duration of any temperature deviations. When data loggers are used staff do not need

to use the temperature recording chart/s described below.

Min/max thermometers should have an audible alarm which alerts staff to temperature

deviations. When using min/max thermometers, staff must record the environmental

temperature on a recording chart on a daily basis (see Appendices A & B below for an

example). Staff should only use the approved OHFT chart to record temperatures.

6. Temperature monitoring

Using the Infogrid System sensors, connectors and website – you will need access to

the Infogrid System website via an individual password. Speak to your pharmacy team

if you do not have necessary access to the website.

An invitation will be sent to register on the website and create a password. Ensure that you

have actioned this email invitation.

The Infogrid System equipment will continuously record the temperature in the area they are

sited.

Page 4: MMP1: Temperature Monitoring in Clinic Rooms

4

If the temperature deviates from the set range, an email will be sent to all nominated staff to

inform them that the deviation has occurred.

Log on to the Infogrid System website and select the site or ward that you want to view.

You will see what all the sensors attached to that area are recording, you can click into

individual sensors to be able to see a graph of the temperature over the time period that you

require.

The sensor that have recorded the deviation will be highlighted in the “Alerts” column.

See Appendix E for further How to Guide to Using the Infogrid System.

Using data loggers – you will need the Easy Log USB application installed on your

computer and a cable to connect the logger via USB to access the information on the

Data Logger (see Appendix C)

a) Ensure you have the EasyLog USB application on your computer and the connection

lead

b) Read the How to Guide for using the temperature data loggers (see Appendix C).

c) At the end of each month, print out a graph showing the temperatures logged during

that period.

d) At the end of each month the printed graph must be reviewed by a senior member of

the team to check if there have been any deviations, readings on the graph above or

below the set temperatures, once happy that all deviations have been reported and

actioned they MUST sign and date the graph.

e) File this graph in the Temperature Monitoring section of the Medicines Management

Folder, which should be kept in the clinic room, along with the calibration certificates

or the manual showing the accuracy specifications for the devices being used. These

records may be requested during an inspection.

f) Ensure that the data logger is set to continue monitoring by following the user guide

– see appendix C and replace in the required location.

Using Min/Max Temperature Monitors

a. Ensure that the maximum and minimum temperatures are set on the thermometer

(Fridge min 2°C / max 8°C and ambient min 15°C / max 25°C) to enable the alarm to

sound if a temperature is logged out of the range set

b. Using the OHFT Temperature Monitoring Form, at the beginning of each month start

a new recording chart (see Appendices A & B below for example). Write the month

and year in the appropriate space and circle the readings from the thermometer(s)

Page 5: MMP1: Temperature Monitoring in Clinic Rooms

5

for that day, please note there are two temperature monitoring forms, one for ambient

and one for fridge.

c. Each day thereafter, check the temperature shown on the thermometer(s) and circle

max and min temperatures onto the chart. Sign in the appropriate space.

d. After recording the temperatures on the chart, reset the thermometer by pressing the

‘memory clear’ button on the front of the device – see appendix D.

e. 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.

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

more frequently.

g. At the end of each month the completed monitoring record form must reviewed by a

senior member of the team ward / unit to check if there have been any deviations,

once happy that all deviations have been reported and actioned they MUST sign and

date the form.

h. All records must be kept in a folder labelled ‘Medicines Management Folder’ along

with the thermometers calibration certificate. These records will be requested during

an inspection.

Responding to an Alarm or a Temperature Deviation:

a) The alarms or notifications on the temperature monitoring equipment are set to go off if

the temperature reaches the boundaries of the desired range i.e. Ambient 15°C - 25°C or

Fridge 2oC -8oC.

b) If the alarms go off or you are notified of a deviation via an email or telephone alert, action

must be taken to try to ensure that the room or fridge remains within the desired range –

open / close windows (ensure the windows are closed when leaving the clinic room), close

fridge door, contact Estates to service fridge.

c) Once these measures have been taken, record the temperatures that have been reached

and for how long the excursion lasted. For min/max thermometers this can be recorded

on the record sheet.

d) Refer to the Temperature Excursion Response Matrix in the first instance to decide what

action to take. Follow the instructions on the Matrix and be sure to document all your

actions on the event log on the Infogrid System so that an audit trail is maintained for

review by inspectors. If using min/max the actions should be documented on the

record sheets

Page 6: MMP1: Temperature Monitoring in Clinic Rooms

6

e) If there is a need to inform a member of pharmacy staff or the medicines information

department, they will need to know the temperature reached and an estimate of how

long the temperature has been out of range. They will also need to know the details of all

medication stored there.

f) Any decision to reduce the expiry date of the medicines or destroy any medicines due to

temperature excursions MUST be approved by the pharmacy clinical lead for your

directorate. Stock can be quarantined but CANNOT be altered or destroyed without

appropriate permission. Even after a temperature excursion medicines may still be safe to

use and this decision lies with the pharmacy team.

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

Temperature deviations

Pharmacy staff, or Medicines Information, will utilise the following calculations to base their

advice regarding medicines that have been subjected to temperature deviations1;

• Q10 calculations

• Mean Kinetic Temperature

These calculations allow pharmacy to provide advice on the suitability of a medicine for

administration after temperature deviation or the need to reduce the expiry (shelf-life) of a

medicine.

Revision History

• April 2019 - This SOP has been revised to include details about using the Infogrid

System Software. The sections to do with data loggers has also been removed from

the SOP.

• December 2018 - This SOP has been revised to include details about using the DT

Solutions equipment. data loggers as well as min/max thermometers.

• May 2018 -This SOP has been reviewed to include an updated temperature

monitoring form as well as adding details of getting the Easy log software for

individual users, also a ‘how to guide’ on how to set up and download the data from

the temperature data loggers.

Page 7: MMP1: Temperature Monitoring in Clinic Rooms

7

References

1NHS Pharmaceutical QA Committee (1st Edition) Risk Management of Medicines Stored in Clinical Areas: Temperature Control

Appendices

A. Fridge Temperature Monitoring Record (min / max thermometers)

B. Ambient Temperature Monitoring Record (min / max thermometers)

C. How to guide for using Data Loggers.

D. How to use the Maximum/Minimum Temperature Monitor

E. How to guide to Infogrid System Software.

F. Temperature Excursion Response Matrix

Page 8: MMP1: Temperature Monitoring in Clinic Rooms

8

Appendix A: Fridge Monitoring Form

Actu

alCh

ecke

d by

Ther

mom

eter

Acti

ons

take

n if

ala

rm s

ound

s

°Cin

itia

lsRe

set (

tick

)or

tem

pera

ture

out

of r

ange

1-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

2-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

3-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

4-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

5-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

6-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

7-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

8-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

9-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

10-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

11-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

12-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

13-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

14-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

15-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

16-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

17-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

18-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

19-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

20-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

21-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

22-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

23-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

24-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

25-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

26-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

27-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

28-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

29-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

30-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

31-1

01

23

45

67

89

1011

-10

12

34

56

78

910

11

Any

devi

atio

ns

(Ple

ase

Circ

le)

All d

evia

tion

s ha

ve b

een

acti

oned

acc

ordi

ng

to th

e Te

mpe

ratu

re M

onit

orin

g SO

PYe

s /

NO

or

N/A

Chec

ked

&

sign

ed

Report to Team Leader & seek advice from Medicines Management/Pharmacy

Report to Team Leader & seek advice from Medicines Management/Pharmacy

Report to Team Leader & seek advice from Medicines Management/Pharmacy

Report to Team Leader & seek advice from Medicines Management/Pharmacy

MA

X

Dat

eYE

S /

NO

DA

ILY

MED

ICIN

ES R

EFRI

GER

ATO

R M

ON

ITO

RIN

G F

ORM

MU

ST R

EPO

RT &

ACT

ION

IF T

EMPE

RATU

RE IS

LO

WER

TH

AN 2

°C O

R H

IGH

ER T

HAN

8°C

OR

ALAR

M S

OU

ND

S

Tem

pera

ture

°C (c

ircl

e as

app

ropr

iate

)

ACT

ION

ACT

ION

ACT

ION

MO

NTH

:

YEAR

:

ACT

ION

MIN

Tim

eD

ate

Page 9: MMP1: Temperature Monitoring in Clinic Rooms

9

Appendix B: Ambient Monitoring Form

Ac

tual

Checked

Actio

ns taken if

ala

rm s

ounds

°Cby

(initia

ls)

or te

mpera

ture

out o

f ra

nge

113

1415

1617

1819

2021

2223

2425

2627

2813

1415

1617

1819

2021

2223

2425

2627

28

213

1415

1617

1819

2021

2223

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2627

2813

1415

1617

1819

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2223

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2627

28

313

1415

1617

1819

2021

2223

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2627

2813

1415

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1819

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2223

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28

413

1415

1617

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2021

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613

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713

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813

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913

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1013

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1413

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1513

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1813

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2013

1415

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2113

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3013

1415

1617

1819

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3113

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28

Reset

(tic

k)

Report to Team Leader & seek advice from Medicines Management / Pharmacy

MA

XM

IN

ACT

ION

ACT

ION

All d

evia

tion

s ha

ve b

een

acti

oned

acc

ordi

ng to

the

Tem

pera

ture

Mon

itor

ing

SOP

DA

ILY

MED

ICIN

ES A

MBI

ENT

ROO

M T

EMPE

RATU

RE M

ON

ITO

RIN

G F

ORM

MU

ST R

EPO

RT &

ACT

ION

IF T

EMPE

RATU

RE IS

LO

WER

TH

AN 1

5°C

OR

HIG

HER

TH

AN 2

5°C

OR

ALAR

M S

OU

ND

S

Chec

ked

& s

igne

d

byD

ate

Any

devi

atio

ns

(Ple

ase

Circ

le)

Tem

pera

ture

°C (c

ircl

e as

app

ropr

iate

)

ACT

ION

ACT

ION

MO

NTH

:

YEAR

:

Report to Team Leader & seek advice from Medicines Management / Pharmacy

Report to Team Leader & seek advice from Medicines Management / Pharmacy

Tim

eD

ate

YES

/ N

OYe

s /

NO

or

N/A

Page 10: MMP1: Temperature Monitoring in Clinic Rooms

10

Appendix C: How to guide for using Data Loggers

Downloading the software

In order to use your temperature data logger, you will need to download the EasyLog

software onto your computer. You should ensure that several members of your team have

access to this software so that the data logger can be used at all times (please note: the

software is only accessible to an individual user log in) follow the instructions below to order

the EasyLog software onto your lap/desk top computer from IT

• Intranet home page ->

• Departments ->

• IT ->

• Getting it Done ->

• Order things ->

• Log in with desktop log in /user name ->

• Software ->

• Business Applications ->

• EasyLog USB ->

• Enter computer name i.e (OXHFT – four-digit number from home page of your

desktop / laptop) If you have a problem with this click on the magnifying glass icon

this should bring the computer name up ->

• Click ‘order now’ on the right-hand side of the page

• Ensure you inform your Manager that you have ordered this for them to approve

• Once approved IT will put it on your computer / laptop – please note that this will be

for your personal log in only

Once the software is installed you will see the icon below on your

screen: if IT have said they have installed this and you can’t see it on

your device, contact IT for advice

Page 11: MMP1: Temperature Monitoring in Clinic Rooms

11

Installing / setting the data logger to record

• Using the USB cable that is supplied with the temperature data logger, attach the

logger to your computer/laptop

• Open the application the following screen will appear:

The screen below will appear - Follow steps 1 to 4

Easy Log

Temperature

Data Logger

USB Cable to

attach the

temperature

logger to your

desk/lap top

Click on ‘Set

up and start

the USB data

logger’

1, Enter the Ward /

Unit Name & indicate

if fridge or ambient

(i.e. Bluebell Fridge)

2. Ensure the

Temperature scale is

set to °C

3. Set the frequency of log to

10 mins / 2 years

4. Click ‘Next’

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The screen below will then appear: Follow the steps

Setting the Temperature

Ambient temperature the max (high alarm) is 25°C and the min (low alarm) is 15°C.

Fridge monitoring the max (high alarm) is 8°C and the min (low alarm) is 2°C.

Follow the instructions below:

1. Select ‘LCD & backlight on for a short period after

button pressed’

2. Ensure this

box is NOT

ticked – as we

don’t want the

logger to stop

recording 3. Click

‘Next’

1. Tick BOTH ‘high alarm’

& ‘low Alarm’

2. Enter the high &

low temperature

range for either ambient or fridge

3. Tick BOTH ‘hold’

boxes

4. Click ‘Next’

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Setting the Alarm on the logger

Setting the logger to Start

On the final page you can choose when you want the logger to start logging. This is useful if

you are programming it in a separate location to where it will be used, and you therefore

wish to delay the start – select the option you would like

• The screen on the temperature logger will light up once set.

• The following screen will be displayed on your computer

1. Enter ‘1’

2. Ensure that the

‘Disable all LEDs’ &

‘Disable sounder’ are

NOT ticked

3. Click ‘Next’

1. Select when you

want the

temperature data

logger to start

recording the

temperature

2. Click ‘Finish’

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Once programmed you can remove the USB connection (store in a safe place) and place the

data logger in the desired location – ensuring you put them in the temperature that the data

logger is set for

Maintenance of the temperature data logger

Once the Temperature data logger is in place, by pressing the button on the RIGHT you can

• Check what the current temperature is in the room / fridge by pressing the button on

the right

• Check that the batteries in the log aren’t running low

To view the temperature,

press the button on the

Right, this will also show if

the batteries are running low

Click ‘OK’

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Appendix D: How to use the Maximum/Minimum Temperature

Monitor

• Set up the thermometer

as per the manufacturer’s

instructions

• Every day -take the max /

min temp

• Record on the

appropriate monitoring

sheet

• Press the ‘memory clear’

button to reset the

monitor

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Appendix E: How to Guide Infogrid System Software

• Note: The Infogrid system only works on Google Chrome web browser.

Google Chrome can be requested from IT using the link below;

https://oxfordhealth.service-now.com/oxford_health_ess/business_applications.do

• Access the Infogrid webpage https://app.infogrid.io

• If you do not have a password to access the system, please speak to your pharmacy

team.

• Enter your email and password where indicated.

• The sites or wards allocated to you will be listed.

• Click onto an individual ward or unit to view the information about that site.

• On the individual site page, you can see a list of sensors for the ward / unit and the

temperature that they have most recently recorded.

• To review a particular area (e.g. fridge) where perhaps there has been a deviation,

click on the relevant sensor name to see the information and a graph. The “Historical

data” tabs will allow you to view the last hour, last day, last week or last month. You

may also customise the data range you wish to view.

• If there has been a temperature deviation this will create an alert. The un-actioned

alerts will be highlighted in red on this page.

• Click on “View event log” to see details of the deviation(s).

• Refer back to the relevant period on the historical graph to ascertain the extent and

duration of the deviation.

• Use the information on the Temperature Excursion Response Matrix to aid a decision

on your actions following the excursion.

• To acknowledge single or multiple alert(s):

o Single alert – Click on View Event Log and click the green acknowledge button

and add any text to reflect your actions regarding this temperature excursion.

o Multiple alerts – Click on Acknowledge all and add any text to reflect your

actions regarding these temperature excursions.

• On the Event Log you can use the message tab at the bottom to enter any relevant

text as a separate line from acknowledgements.

• All temperature graphs and logs can be downloaded to save or print

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Appendix F: Temperature Excursion Response Matrix

All medicines in the fridge should be stored between 2 and 8˚C

All other medicines should be stored between 15 and 25˚C

Temp/Time Anything up to 30

minutes

BRIEF

Up to 1 hour

MODERATE

1-4 hours

EXTENDED

4 hours plus

Fridge out of

temperature

range (below 2˚C

or above 8˚C)

All fridge deviations that exceed 30 minutes should be communicated to the pharmacy team as soon as possible but no later than the next day.

If there is no response within 24 hours, contact pharmacy (01865 904888) or Medicines Information for advice (01865 904365).

Ambient Storage

has been recorded

up to 29˚C

No Action needed Document excursion on the on the

Infogrid event log

Follow guidance on SOP. Email your

pharmacist or MMT (see overleaf). Document

action on the Infogrid event log. A response

should be expected by the end of the next

working day.

Follow guidance on SOP. Email your pharmacist

or MMT (see overleaf). Document action on the

Infogrid event log. A response should be

expected by the end of the next working day.

Ambient storage

recorded as

between 29-35˚C

Document

excursion on the on

the Infogrid event

log

Document excursion on the Infogrid

Event Log. No further action needed if

temperature has returned to normal

range.

Follow guidance on SOP. Email your

pharmacist or MMT (see overleaf). Document

action on the Infogrid event log. A response

should be expected by the end of the next

working day.

Contact your pharmacist or MMT as a matter of

urgency. If no response is received by the

following day, contact pharmacy or medicines

information. Document action on temperature

excursion form/ event log.

Ambient storage

recorded as over

35˚C

Document

excursion on the on

the Infogrid event

log

Follow guidance on SOP. Email your

pharmacist or MMT (see overleaf).

Document action on the Infogrid event

log. A response should be expected by

the end of the next working day.

Follow guidance on SOP. Email ward

pharmacist or MMT (see overleaf). Document

action on the Infogrid event log. A response

should be expected by the end of the next

working day.

Contact your pharmacist or MMT as a matter of

urgency. If no response is received by the

following day, contact pharmacy or medicines

information. Document action on temperature

excursion form/ event log.

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Information to gather before calling medicines information, pharmacy or ward pharmacist/MMT:

• What is the highest/lowest temperature reached during the time it has been out of range?

• How long has the temperature been outside of the recommended range?

• What action has already been taken?

• Do you have any medicines stored in your department with special storage requirements?

Contacts:

Ward/Unit Pharmacist:

Tel/Email:

Ward/Unit Medicines Management Technician:

Tel/Email:

CPSU Pharmacy: 01865 904888 / [email protected]

Weston Pharmacy: 01865 903843 / [email protected]

Medicines Information: 01865 904365 / [email protected]

Suggested email template to be sent following temperature excursion:

Dear

The temperature on ***** ward/unit has deviated from the recommended storage range. The fridge/ambient temperature has been recorded as … for … hours.

Please respond with any necessary action.