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SOP for daily temperature checks


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Hello everyone.  I was asked by the laboratory manager to write an SOP for the daily temperature checks.  It sounds easy enough.  The problem is I've never written an SOP and have no idea where to even start.  If anyone is willing to share the SOP they use at their facility, I would really appreciate it.  I want to get an idea on what to write.   Thanks in advance for your help.

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I have been there. There is probably a template that your laboratory uses. Look at your current P/P book in your area or in other areas of the lab and see if there is a pattern to all the P/P. Some regulatory agencies require specific things in all the procedures so you don't want to have to rewrite it.

 

You want to write it so that a person could follow along and be able to do what is required but you don't want it to be so specific that you get dinged because the techs don't follow the steps as written. Do what you say, say what you do. Slightly vague, slightly specific. I tend to be specific and I have to pull myself back.

 

We are CAP inspected. I look at the standards and find anything that may relate to the P/P I am writing and try to include the points to hit. Don't forget about Commons and General standards.

 

Write it, then put it aside for a few days. when you come back to it, it may sound totally dumb. Give it to the people in your department and have them critique it. Can they follow the steps as written?

 

I copied and pasted my procedure for checking the blood storage temps. Hope this helps. Cutting and pasting caused it to lose it's format but you will get the gist of it.

 

PRINCIPLE AND CLINICAL SIGNIFICANCE:

All Temperature Dependent Equipment (TDE) in the Blood Bank are continually monitored to ensure that blood products are maintained within proper temperature ranges.

 

POLICY:

  1. The Blood Bank equipment in which blood products are stored must maintain temperatures in the following ranges:

 

                        Blood Bank Refrigerator        2-6° C                         

FFP Freezer                             -18° C or colder

                        Platelet Incubator                    20-24° C                                 

 

  1. If the continuous automated monitoring chart system is not operational, temperatures must be taken and documented every 4 hours to ensure that products are maintaining the correct temperatures.

 

 

  1. Equipment and Materials: 
    1. Refrigerator, freezer or platelet incubator to be checked
    2. Refrigerator, freezer or platelet incubator temperature chart.

 

 

  1. Safety Precautions

All blood products should be treated as potentially infectious. Use universal precautions.

 

 

  1. PROCEDURE:

Daily Checking of Continuous Monitored Chart System:

  1. Temperatures of TDE are documented daily at about the same general time of day.
  2. Document the temperature of each TDE on Blood Bank Temperature Check form.
  3. Assess that the chart is turning properly, is within the temperature guidelines, and is currently at the appropriate day and time on the chart.
  4. The person taking the daily temps should initial the chart each day when it is checked.  This verifies the proper day/time setting was checked

 

Weekly Chart Change

  1. Temperature charts are changed weekly at about the same general time.  Information listed on the back of each chart should include the equipment identification number and the date, time the chart is placed on the equipment and initials of the person replacing the chart.
  2. Completed charts should have the date and time removed and should be initialed.
  3. Weekly charts are paper-clipped together and placed in the file for review.

 

  1. Procedure for Abnormal Results:

Audible Alarm Sounds – The audible alarm for the refrigerators and platelet incubator is set to sound before the upper and lower temperature range is reached.  If refrigerator or freezer temperature reaches unacceptable limits at any time, an alarm sounds in the blood bank and the power plant. When this situation occurs, the following steps should be taken:

  1. Compare Chart and Thermometer Readings- If these are within range, the probable cause is prolonged door opening. Limit entrance into the refrigerator or freezer and monitor the temperature which should begin to return to normal range shortly. The tech noting the alarm and deviation of temperature should initial and make a note on paper chart to reflect the cause of the alarm.
  2. Temperature of Equipment Does Not Return to Normal Range- Carefully monitor temperature of equipment so that products will remain within acceptable range. Call Maintenance Department for STAT assessment of equipment. If equipment temperature stays the same or continues to increase, blood products must be removed to prevent loss. It is not necessary to seek Lead Technologist approval before removing blood products to safer conditions.  RBC units and reagents should be moved to another monitored refrigerator in the Blood Bank. The blood center should be called to provide insulated boxes and dry ice for frozen products before the freezer temperature reaches unacceptable temperatures. Frozen products should be placed in blood center insulated boxes with dry ice placed on top of the units. Platelets may be placed in RT platelet shipping boxes for up to 24 hours without agitation.    

 

Remove products when temperatures of equipment approach the following sustained temperatures:

            Refrigerator    ≥6.0° C            FFP                 above -18° C         

            Platelets           ≥24° C             Surgery           above -65° C

           

  1. Actions if System is Inoperable

            Power Failure- In the event of a power failure, make sure that auxiliary power is functioning.  If this cannot be ascertained, call Maintenance.  In the event of a complete power equipment failure, our current blood supplier or other area hospital facilities may be called to provide help with red cells.  With an area power failure, red cells would be maintained in boxes with bags of wet ice placed on top.  FFP would be maintained in boxes with dry ice placed on top of units.  Platelets can be maintained in platelet shipping boxes for up to 24 hours without agitation. Reagents should be placed in insulated boxes with bags of wet ice placed on top.

 

Refrigerator/Freezer/Platelet Alarm Inoperable – If blood products must be stored under unmonitored conditions, the temperature will be checked every four hours and documented on Manual Temperature Recording Log form. This will document that proper storage temperature has been maintained.

 

            If the Ultra-low Freezer in Surgery is Not Functional- The Surgery department is responsible for maintaining the temperature of the tissues stored in the ultra-low freezer. Blood Bank may help by obtaining insulated blood boxes from the local blood supplier and Surgery may obtain dry ice to pack around the tissues. Space may be available in the laboratory ultra-low that is located in Chemistry, however, this freezer generally does not have free space.  

 

  1. When the Refrigerator /Freezer/Incubator is Back in Service- Before blood products and/or reagents are placed back into the TDE once it is repaired, the equipment must be temperature stable for at least 4 to 24 hours. Temperature and alarm checks on the TDE must be satisfactorily performed and recorded. Reagents and antisera should be inspected for quality concerns and must pass QC before patient testing is performed. Reagents and/or antisera that does not pass quality inspection must be discarded.

 

 

SOURCES:

AABB Technical Manual, Current Edition

 

RELATED DOCUMENTS:

Blood Bank Temperature Check form (QC002)

Manual Temperature Recording Log (QC005)

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Ditto to all the excellent advice from DebbieL. I would bet your lab has a template with a standardized header, format etc. If not, you get to make one. If you are CAP inspected, make sure your procedure complies with the All Common checklist as well as the Transfusion Medicine. And check out the AABB Standards if you are AABB. A few other thoughts re the art of writing P&P: 

 

1. These are directions for performing tasks. Make it easy for the staff to find what they need. For Debbie's procedure, in the Table of Contents under the procedure name, list A.  Daily Checking of Continuous Monitored Chart System: with a page number, B. Weekly Chart Change – etc.

2. You can crossreference to other procedures. Too much of this, however, gets annoying, because you end up skipping all over the manual.

3. Staff needs to review and sign off.

4. Yearly competency is a good place to review P+P. Ask questions that they might not know the answer to off the top of their heads. Besides being a refresher for them, and an opportunity to address your  pet peeves, it serves as a good critique for the P+P.  If they can't find the answer readily you need to make it easier to do so.

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Believe it or not we actually had an "SOP for SOPs".  When we were initially reviewing it I suggested that they increase the font size from 10 to at least 14 or 15 to accommodate the aging laboratory staff.  The Pathologist initially thought my suggestion was funny until I explained that I was quite serious and had been doing it for years, much to the appreciation of my staff.  He was then quite upset that anyone found any fault in his beautiful masterpiece.  As you can guess the font stayed 10.  :crazy:

 

The SOP was quite helpful in both standardizing the corporate lab SOPs, which was the primary goal, and making reviewing and accepting them a fairly painless operation.  Hopefully your facility has something similar to help guide you through the process.   

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Believe it or not we actually had an "SOP for SOPs".  When we were initially reviewing it I suggested that they increase the font size from 10 to at least 14 or 15 to accommodate the aging laboratory staff.  The Pathologist initially thought my suggestion was funny until I explained that I was quite serious and had been doing it for years, much to the appreciation of my staff.  He was then quite upset that anyone found any fault in his beautiful masterpiece.  As you can guess the font stayed 10.  :crazy:

 

The SOP was quite helpful in both standardizing the corporate lab SOPs, which was the primary goal, and making reviewing and accepting them a fairly painless operation.  Hopefully your facility has something similar to help guide you through the process.   

 

We also have a policy regarding the 'development of a quality document,' i.e. policy/procedure. We don't have a corporate template (yet?) for which I am grateful. We also run into the font size issue but we've met in the middleground at 12pt font.

 

On the subject of fonts, did you know there's an entire school of thought based on them? I had never heard of it until a childhood friend who's going back to school for design enlightened me, typology. Kind of fascinating in a nerdy way that something so taken for granted has a rich history and researched/intentionally-crafted design.

Edited by goodchild
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We also have a SOP SOP. We have a template but it's more structural in nature (header boxes to fill in with title, date etc). If you vary the font size or style it's OK (for now). I use a 12 on my P&P, probably because that's what I can see with my reading glasses! And this makes me realize I'm just as centric as those young bastards who write things with a 10 font that I think are too small.

 

I'm convinced we got a CAP specimen wrong once because an aging tech analyzed the wrong one because she couldn't read the apparent 2 font CAP uses on the vial and mixed up a 6 and 8.

Edited by Dr. Pepper
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  • 2 weeks later...

Ours...

 

We also have charts for recording them

 

 

 

Area of Application: Blood sciences, Transfusion  

 

Document Title:                 

Blood Bank Alarms , Fridge Cleaning/Temperature Chart Checking

 

 

 

 

 

Author :   ZZZZZZZZZZZZZZZZZZZ

           

Responsible for document upkeep and review process:   See Q-pulse owner

 

Number of paper copies (if relevant):                                       2

 

Persons authorised to carry out this procedure following suitable instruction, training, supervision and competence assessment:  (delete this bracket and edit list below as required)           

 

 

·         Lead Biomedical Scientist (Operational Manager)

·         Biomedical Scientist, Advanced

·         Biomedical Scientist, Specialist

·         Biomedical Scientist, Trainee

·         Healthcare Assistant (Medical Laboratory Assistant)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contents  (CTRL & Click on heading to go to relevant section)

 

1)          Environmental and safety controls

 

2)          Purpose of examination

 

3)          Principle and method of the procedure used for examinations

 

4)          Performance characteristics

 

5)          Type of sample

 

6)          Patient preparation

 

7)          Type of container and additives

 

8)          Required equipment and reagents

 

9)          Calibration procedures (metrological traceability)

 

10)       Procedural steps

 

11)       Quality control measures

 

12)       Interferences

 

13)       Principle of procedure for calculating results including where relevant, the           measurement of uncertainty of the measured quantity values

 

14)       Biological reference intervals or clinical decision values

 

15)       Reportable interval of examination results

 

16)       Instructions for determining quantitative results when a result is not within the     measurement interval.

 

17)       Alert / critical values, where appropriate

 

18)       Laboratory clinical interpretation

 

19)       Potential sources of variation

 

20)       References

 

 

1          Environmental and safety controls

 

1.1 Risk Assessment

 

Insert section heading or sub-heading number in ‘Step’ column

Step

Severity

Likelihood

Score

Risk Rating

Controls

 

Minor

Unlikley

4

Electrical hazard

When cleaning fridge avoid liquid around electrical components

 

Minor

Unlikley

4

Biological hazard

Contains Blood and blood products

Use gloves if required

 

Minor

Unlikley

4

Biological hazard

Disinfectant used to clean fridges

Use gloves if required

 

All equipment is checked annually by balfour Beatty for elextrical safety and by Estates at BGH

All the reagents and blood within the fridges are sourced from donors tested to be negative for high risk infective agents

 

 

 

1.2  Risk assessment score matrix

 

Severity (S)

Likelihood (L)

Risk rating = S x L

1 = Insignificant

1 = Rare

1 - 3

Insignificant

2 = Minor

2 = Unlikely

4 - 9

Minor

3 = Moderate

3 = Possible

10-15

Moderate

4 = Severe

4 = Likely

16-20

Major

5 = Catastrophic

5 = Almost certain

25

Catastrophic

 

1.3  Manual handling assessment

 

Manual Handling assessment

Yes

No

Further clarification

Full assessment required

 

P

 

Weight guidelines exceeded

 

P

 

Arc or distance of move excessive

 

P

 

Twisting actions required

 

P

 

 

1.4  COSHH assessment

 

All COSHH assessment information is available via the Properties section of the Q-Pulse record for this document.

 

 

 

 

 

2          Purpose of examination

 

Monitor Blood Bank/Freezer Temperatures. Change chart each weeks on the fridges and freezers. Clean monthly. Change pens as required. Act on any problems encountered.

 

 

 

3          Principle and method of the procedure used for examinations

     N/A

 

 

4          Performance characteristics

    Blood fridges, freezers and incubators must be within stated temperature range.

 

 

5          Type of sample

 

           N/A

6          Patient preparation

 

           N/A

7          Type of container and additives

 

           N/A

8          Required equipment and reagents

 

           Charts, pens, cleaning equipment.

           ThermoFisher Blood Fridges 1 and 2 (RBH)

 

 

             Lorne/fiochetti Issue fridge outside of Lab.                    BGH

            ThermoFisher Blood Fridge: Stock fridge in lab.

Labcold plasma freezers (BGH and RBH)

Lorne platelet incubator (RBH)

Labcold platelet incubator (BGH)

  

Cleaned monthly as per blood fridge protocol.

 

 

 

 

9          Calibration procedures (metrological traceability)

           Blood fridges, freezer and incubators are calibrated, maintained and temperature   mapped yearly by Deva medical. Records and certificates are held in Q-pulse.

 

 

10      Procedural steps

 

Checking the Alarms on the XXX Site

 

         The blood banks, at XXX have their alarms connected to XXX Workplace’s Help desk (Phone XXX) and Security (Phone XXX) at XXX.

 

The two blood banks and plasma freezer at XXX can be heard on site if the alarms are triggered as well as at XXX Workplace Help Desk (09.00 – 17:00) and Security (24 hrs) at RBH.

The blood banks all now register the type of alarm, whether it is a high or low alarm or power failure, on a VDU at XXX Workplace and Security, along with the location. The staff at XXX Workplace and Security also have protocols on local procedures.

The two blood banks and 1 plasma freezer conform to British Standard (BS) 4376 part I Type 2 cabinet conforms to BS 4376 part II and type A. Both blood banks and the plasma freezer have a temperature recording chart which runs for exactly seven days when the full one is replaced with a new chart.  These are checked for any abnormality and stored in date order for future reference.

 

At the same time that the temperature recording charts are replaced, the audible alarms are intentionally triggered and checked and confirmed by Security (XXX Workplace also have a screen). This is normally carried out once a week.

 

The temperature recording devices in the blood banks are fed by a battery in the back of the recorder. Batteries are changed at least every six months (Set up as a scheduled audit)

 

 

Check of Platelet incubator at XXX

 

The alarm for the platelet incubator is located on the underside of the top panel (it’s a black wire with a probe at the end). To test the upper alarm temperature (24oC) take the probe between two fingers and allow the probe to rise to above 24oC. The alarm will sound once this temperature has been passed.

To test the low alarm (set at 20oC), place a cool pack up to the probe and allow the probe to cool. The incubator will alarm once the low end temperature (20oC) is passed.

 

Check of Plasma freezer

The chart on the front of the freezer is changed weekly, checked and stored in the correct            file. To check the alarm, press and hold the telephone icon on the digital display on the front of    the freezer. This will sound the alarm on the unit.

The temperature range is -32oC to -45oC and the alarm will sound if the temperature goes outside this range. To mute the alarm press and hold the thermometer icon on the digital display until it stops. The temperature should return to within range.

   To change the chart open the cover with the key supplied and replace the chart with a new one.

 

Fridge/freezer failures at Royal XXX.

 

In the event of a fridge failure, transfer the stock within the faulty fridge to a working fridge.  Try to ascertain the problem and report the fault to XXX Workplace’s Help Desk (42020) ASAP.  In the case of a failure with the plasma freezer, transfer stock to suitable frozen storage. FFP needs to be stored at <-30oC. (Biochemistry’s -800C freezer would be suitable).  Again, inform XXX Workplace of fault. Once Fridge / Freezer are in working operation, transfer stock back to original location.

 

            Out of hours contact XXX Workplace on 42020 (this gets transferred through to security, 43030). The engineer then assesses the need to call out the refrigeration people.  It is essential for the safety of the blood and blood products, that engineers are made aware of the priority of the fault, particularly temperature wise, and for staff to move the blood to another blood bank if the fridge is out of order.

 

Procedure for Security on alerting BMS of an Alarm

 

Security will only notify dept. regarding an active alarm after 17:00 hrs.  The alarm is allowed to sound for 2 minutes, then the security person on duty will contact the on-call BMS via:

 

1) Tel numbers 85149 or 81083 or 84529

2) Pager 019

3) or via switchboard.

 

NOTE:  Please check the alarms at XXXafter each generator test. This is to enable XXX Workplace to check that the “Black Boxes” (systems operators) have been re-booted. This will enable the alarms to be visible on security’s alarm panel.

 

 

Procedure for Checking Alarms on the YYY Site.

 

This procedure should be done each week to ensure that the blood fridge alarm is working correctly and that the alarm sounds in the lab. At present the alarms are not connected up to switchboard and will only sound in the laboratory. Any problems with the fridge or the alarms must initially be reported to maintenance on ext. 14777 (or shift engineer out of hours). If the hospital maintenance staff cannot fix the problem they will report it to Sweetmores who will come in and fix the problem.

Transfer stock to another fridge if the fridge is not working correctly.

 

Procedure for the Lorne fridges

A test button for each high and low alarm is fitted. Press the appropriate button to activate. The alarm is situated in the lab at YYY on the roof above the specimen reception bench. It will sound a siren if the fridge alarm goes off.

 

High temperature alarm button ( top )

Push in the HIGH temperature alarm test button.

The temperature display will rise above the set upper temperature level.

The alarm will sound at the fridge and in the lab and the red ALARM light will come on.

Release the button to cancel the alarm.

Check the temperature returns to display the current value.

 

Low temperature alarm button ( bottom )

Push in the LOW temperature alarm test button.

The temperature display will drop below 1.9oC.

The alarm will sound at the fridge and in the lab and the red ALARM light will come on.

Release the button to cancel the alarm.

Check that the temperature returns to display the current value.

 

These alarms are simulated for test purposes – the temperature inside does not change.

 

Procedure for the Thermo fridge

 

During normal operation pressing the ‘res’ button on the temp display will provide a 3 second display, buzzer and LED test. The probe inside the fridge that is in the bottle of water can be placed in warm water and then iced water to check that the chart responds and the temperature goes up and down.

 

The alarms can be tested by leaving the doors open until the temperature rises but this must only be done when there is no blood in the fridges.

 

 

Procedure for the FFP freezers

 

The chart on the front of the freezer is changed weekly, checked and stored in the correct file. To check the alarm, press and hold the telephone icon on the digital display on the front of the freezer. This will sound the alarm on the unit.

The temperature range is -32oC to -45oC  and the alarm will sound if the temperature goes outside this range. To mute the alarm press and hold the thermometer icon on the digital display until it stops. The temperature should return to within range.

To change the chart open the cover with the key supplied and replace the chart with a new one.

 

 

It is recommended that the alarm systems be checked once a week. The functional test should be verified in the laboratory. The date checked sheet should then be filled in by the person checking the alarms who adds their initials and the date.

 

Procedure for the labcold platelet incubator at YYY

 

Press and hold the telephone icon on the display unit on the front of the platelet incubator to activate the alarm. This will sound at the unit. Labcold recommend using this technique to check the alarm.

 

To check the probe inside, hold something warm and then cold against it until temperature goes up or down.

 

To check door alarm, leave the door open for 3 minutes and the alarm should sound.

 

 

 

 

External Private Hospital Fridge

 

Private Hospital's (GPH) alarm sounds only at GPH and they arrange their own electrical/refrigeration engineer in the event of failure and they arrange their own servicing. Should ZZZ blood bank fail and it cannot be restored quickly within 30 minutes, all packs of blood contained within that blood bank must be returned to YYY or XXX immediately for correct storage at 4oC in a recognised blood bank. When GPH’s blood bank is functioning normally again, crossmatched blood can be returned for storage at 4oC. Transport of blood between ZZZ and YYY/XXX should be in the blood transfusion red transportation boxes only.

 

Blood Fridge Cleaning

 

Cleaning

 

The blood fridges should be cleaned every month to maintain a good standard of cleanliness. If there has been a spillage the fridge will need to be cleaned straight away.

The reagent fridge in biochem at YYY needs to be cleaned monthly as well.

 

Use Trigene disinfectant (or other suitable disinfectant) diluted 1 in 100 to wipe down the interior and exterior of each fridge. A spray bottle of the disinfectant and paper towels can be used to wipe the fridges.  Dry the surfaces thoroughly after cleaning.

 

Take care when cleaning that the fridge door is not kept open for too long and the blood bags are not sprayed with disinfectant. It may be necessary to remove the blood before cleaning.

          Fill in the fridge cleaning log as directed.

 

Fridge Charts

 

            Temperature charts on the fridges are replaced every week (Friday on both sites)

with new charts. Charts can be found in the drawer labelled “Thermo Fridge Charts: New Charts” (by the tracesoft bench at XXX and next to the booking in bench at YYY).

 

To change the charts get the appropriate labelled keys from the box above the centrifuge at XXX and from the drawer in blood bank at YYY.

Open the cover and unscrew the screw in the middle of the chart holding the chart in place. Replace with a new one setting the day and time to the correct position with the pen recorder. Replace the middle screw and make sure the chart is held in place firmly.

 

The old charts are:

1.    inspected to make sure they are running at the correct temperature (2-6oC),

2.    then signed for against the “Cleaning / Temp Chart” log,

3.    Then are filed away in a file named “Fridge Logs and Charts”.      

 

          Make sure the pen is working and there is ink in the pen giving a bold line on the chart. If the ink is showing a faint trace on the chart this may fade with storage and affect the ability to read the temperature after storage. A Q-pulse audit is set up to change the chart pens every 3 months. If the pen needs changing for any reason in between these times the pens are kept with the charts and just slide onto the pen holder on the chart recorder. The pen holder is hinged and will allow the arm to move out away from the chart to allow the pen to be slipped into the holder on this arm. Make sure that the pen arm is placed back on the chart surface.

 

 

If the temperature is not running within the specified range i.e. 2-6oC, inform a senior member of staff.  Or contact XXX Workplace on 42020 and follow the SOP for Fridge Failure.

At YYY contact maintenance helpdesk on 14777.

 

Thermo Fridge LCD display.

 

The LCD panel displays the low and high settings and also the current temperature of the unit.  Sometimes this display gets corrupted and displays a mishmash of characters. This can be rectified by resetting the display. This can be done as follows:

1.    Stand in front of the fridge to orientate yourself. The switch to reset the alarm is located at the left hand side of the fridge and at the back.

2.    The switch (silver paddle switch) is located on a small black box.

3.    Flip the switch off and back on again. Doing this will result in a high pitch squeal from the alarm panel, this indicating that is has been reactivated.

4.    The characters should be displayed as normal. If not, inform a senior, or ring Balfour Beatty Workplace.

 

 

 

11      Quality control measures

 

Charts are checked 3 times each week and changed one a week. Any problems with   temperature recording must be reported to a senior member of staff in the transfusion department.

Fridges under maintenance contracts.

Yearly calibration are performed by Deva.

Temperature mapping is done on a yearly basis.

 

 

12      Interferences

           N/A

 

13      Principle of procedure for calculating results including where relevant,      the measurement of uncertainty of the measured quantity values

          N/A

 

14      Biological reference intervals or clinical decision values

          N/A

 

15      Reportable interval of examination results

           Chart changed weekly

           Cleaning done monthly

 

16      Instructions for determining quantitative results when a result is not           within the measurement interval

            N/A

 

17      Alert / critical values, where appropriate

           Fridges normally run at 4oC to 5oC.

Low and high temperature alarm settings are 2oC and 6oC.

Plasma freezers run at -32oC to -45oC

Platelet incubators run at 20oC to 23oC

 

 

 

18      Laboratory clinical interpretation

 

           N/A

19      Potential sources of variation

           N/A

 

20      References

          Blood fridge manuals are held in the transfusion departmentArea of Application: Blood sciences, Transfusion  

 

 

BLOOD FRIDGE CLEANING/TEMPERATURE LOG

 

FRIDGE 1      (XXX)                                     MONTH/YEAR:                             

 

 

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range 2-6 oC

Did it sound at Security/switch?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

 

 

 

 

Week 2

 

 

 

 

 

Week 3

 

 

 

 

 

Week 4

 

 

 

 

 

Week 5

 

 

 

 

 

Monthly

Clean

To be done on the first Thursday of every Month

Sign in column

 

 

 

 

FRIDGE 2      (XXX)                                     MONTH/YEAR:                             

 

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range 2-6 oC

Did it sound at Security/switch?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

 

 

 

 

Week 2

 

 

 

 

 

Week 3

 

 

 

 

 

Week 4

 

 

 

 

 

Week 5

 

 

 

 

 

Monthly

Clean

To be done on the first Thursday of every Month

Sign in column

 

 

 

Platelet Incubator   (XXX)                                                 MONTH/YEAR:                    

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range 20-23oC

Did it sound at Security/switch?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

 

 

 

 

Week 2

 

 

 

 

 

Week 3

 

 

 

 

 

Week 4

 

 

 

 

 

Week 5

 

 

 

 

 

Monthly

Clean

To be done on the first Thursday of every Month

Sign in column

 

 

 

 

Plasma Freezer       (XXX)             MONTH/YEAR:                             

 

 

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range -32 to -45 oC

Did it sound at Security/switch?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

Labcold

Chest freezer

 

 

 

Week 2

 

 

 

 

 

 

Week 3

 

 

 

 

 

 

Week 4

 

 

 

 

 

 

Week 5

 

 

 

 

 

 

Monthly

Clean

To be done on the first Thursday of every Month

Sign in column

 

 

 

 

YYY Logs

 

FRIDGE 1      blood bank   (YYY)                         MONTH/YEAR:                             

 

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range 2-6 oC

Did it sound in the lab?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

 

 

 

 

Week 2

 

 

 

 

 

Week 3

 

 

 

 

 

Week 4

 

 

 

 

 

Week 5

 

 

 

 

 

Monthly

Clean

To be done on the first Friday of every Month

Sign in column

 

 

 

 

FRIDGE 2      Issue Fridge (YYY)                                    MONTH/YEAR:          

 

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range 2-6 oC

Did it sound in the lab?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

 

 

 

 

Week 2

 

 

 

 

 

Week 3

 

 

 

 

 

Week 4

 

 

 

 

 

Week 5

 

 

 

 

 

Monthly

Clean

To be done on the first Friday of every Month

Sign in column

 

 

 

 

 

Platelet Incubator   (YYY)             MONTH/YEAR:                             

 

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range 20-22oC

Did it sound in the lab?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

 

 

 

 

Week 2

 

 

 

 

 

Week 3

 

 

 

 

 

Week 4

 

 

 

 

 

Week 5

 

 

 

 

 

Monthly

Clean

To be done on the first Friday of every Month

Sign in column

 

 

 

Plasma Freezer 1    (YYY)             MONTH/YEAR:                             

 

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range -32 to -45 oC

Did it sound in the lab?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

 

 

 

 

Week 2

 

 

 

 

 

Week 3

 

 

 

 

 

Week 4

 

 

 

 

 

Week 5

 

 

 

 

 

Monthly

Clean

To be done on the first Friday of every Month

Sign in column

 

 

 

 

 

 

 

Plasma Freezer 2    (YYY)             MONTH/YEAR:                             

 

Month

Visual Inspection

Write date in box below

Temperature Chart Check

Alarm Test

Sign

 

Note Predominant Temp

Inform Senior if out of range -32 to -45oC

Did it sound in the lab?

(write initials)

Sign name in box below

 

Chart pens changed every 3 month

As per Q-pulse audit schedule

 

Week 1

 

 

 

 

 

Week 2

 

 

 

 

 

Week 3

 

 

 

 

 

Week 4

 

 

 

 

 

Week 5

 

 

 

 

 

Monthly

Clean

To be done on the first Friday of every Month

Sign in column

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fridge Down Time/problems

 

Date

Description of Fault

Initial

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reagents Fridge                  Clean on the first Friday of every month   

 

 

 

DATE

 

CLEANED AND INSPECTED BY (SIGN)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Then we have this for continuous temperature monitoring

 

(there are pretty pictures in it too)

 

Area of Application: Blood sciences, Transfusion  

 

Document Title:     

Comark – Wireless temperature Monitoring  

 

 

 

 

Author :   ZZZZZZZZZZZZZZZZZZZZZZZZZ

           

Responsible for document upkeep and review process:   See Q-pulse owner

 

Number of paper copies (if relevant):                                       1

 

Persons authorised to carry out this procedure following suitable instruction, training, supervision and competence assessment:

 

 

·         Lead Biomedical Scientist (Operational Manager)

·         Biomedical Scientist, Advanced

·         Biomedical Scientist, Specialist

·         Biomedical Scientist, Trainee

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contents  (CTRL & Click on heading to go to relevant section)

 

1)          Environmental and safety controls

 

2)          Purpose of examination

 

3)          Principle and method of the procedure used for examinations

 

4)          Performance characteristics

 

5)          Type of sample

 

6)          Patient preparation

 

7)          Type of container and additives

 

8)          Required equipment and reagents

 

9)          Calibration procedures (metrological traceability)

 

10)       Procedural steps

 

11)       Quality control measures

 

12)       Interferences

 

13)       Principle of procedure for calculating results including where relevant, the           measurement of uncertainty of the measured quantity values

 

14)       Biological reference intervals or clinical decision values

 

15)       Reportable interval of examination results

 

16)       Instructions for determining quantitative results when a result is not within the     measurement interval.

 

17)       Alert / critical values, where appropriate

 

18)       Laboratory clinical interpretation

 

19)       Potential sources of variation

 

20)       References

 

 

 

1          Environmental and safety controls

 

1.1 Risk Assessment

 

Insert section heading or sub-heading number in ‘Step’ column

Step

Severity

Likelihood

Score

Risk Rating

Controls

Skin contamination

Insignificant

Rare

 

 

 

Eye contact

Insignificant

Rare

 

 

 

Inhalation

Insignificant

Rare

 

 

 

Ingestion

Insignificant

Rare

 

 

 

Electrical

Minor

 

Possible

6

Electrical

Equipment checked annually by independent contractors.

 

All equipment is checked annually by Cofley for electrical safety and by Estates at BGH.

Routine 6 monthly pms are carried out by OCD qualified engineers.

 

1.2  Risk assessment score matrix

 

Severity (S)

Likelihood (L)

Risk rating = S x L

1 = Insignificant

1 = Rare

1 - 3

Insignificant

2 = Minor

2 = Unlikely

4 - 9

Minor

3 = Moderate

3 = Possible

10-15

Moderate

4 = Severe

4 = Likely

16-20

Major

5 = Catastrophic

5 = Almost certain

25

Catastrophic

 

1.3  Manual handling assessment

 

Manual Handling assessment

Yes

No

Further clarification

Full assessment required

 

P

 

Weight guidelines exceeded

 

P

 

Arc or distance of move excessive

 

P

 

Twisting actions required

 

P

 

 

1.4  COSHH assessment

All COSHH assessment information is available via the Properties section of the Q-Pulse record for this document.

 

 

 

 

2          Purpose of examination

Comark provides: wireless, real time temperature monitoring of various areas within Pathology.

 

3          Principle and method of the procedure used for examinations

Comark's RF500 wireless temperature and humidity monitoring system is controlled by Gateway units, providing an economic and flexible solution to your measurement applications.

 

With self-healing network properties, data encryption and automatic retrieval ensures high data integrity and elimination of data loss.

 

The RF512 transmitter is for use with the RF500 wireless monitoring systems. Complete with an integral temperature sensor, connectors for an additional two temperature sensor are also built-in, and another for an external door sensor.

 

4          Performance characteristics

RF500A Gateway

Number of Channels          Up to 256

Number of Transmitters      Up to 64

Storage Capacity     Up to 10 years’ storage

RF Frequency          2.4 GHz using IEEE 802.15.4

Battery Life 1 hour

Operating Conditions

Temperature 0°C to +40°C / +32°F to + 104°F

Humidity        10-90% RH non-condensing

Clock Accuracy 4ppm (2 minutes per year)

 

Temperature Measurement Range

Internal Thermistor Sensor – RF512, RF516 -30°C to +70°C/-22°F to +158°F

Humidity Measurement Range     10 to 90% RH

System Accuracy with Standard Sensors

 Temperature

 External Thermistor -20°C to +70°C ±0.5°C/ ±0.9°F

 External Thermistor – full range ±1°C/ ±2°F

 Internal Thermistor -20°C to +70°C ±0.5°/ ±1.0°F

 Pt100 – full range ±0.05°C/ ±0.1°F plus probe

 Humidity

 10-90% RH  ±3%

 Storage Temperature -40°C to +85°C / -40°F to +185°F

 Radio Range* Typically 50 metres indoors

Clock Accuracy** 20ppm (1 minute/month)

at 25°C/ 77°F

Logging Memory 32000 records

Logging Frequency Programmable between

1 minute and 60 minutes

Monitoring Frequency 1 minute

LEDs Red – Warning

Green – External Power

 

5          Type of sample

           Not applicable

 

6          Patient preparation

           Not applicable

 

7          Type of container and additives

           Not applicable

 

8          Required equipment and reagents

            PC connected to internet

            RF500 Gateway

            RF512 temperature monitoring transmitter

 

9          Calibration procedures (metrological traceability)

Not applicable

 

10         Procedural steps

1.    Log in to Comark program on the designated PCs. BSC temperature icon on desktop.

2.    The following screen is displayed:

 

 

3.    Enter user name, click “ENTER”, then a password prompt will appear.

4.    Enter password, click “ENTER”.

5.    The home screen will then be displayed.

 

 

 

6.    On this home screen: messages will be displayed on the top, in red. These can be assessed by “clicking” on them. The link will then take you into the probe that is in alarm.

7.    By clicking on each individual temperature monitors, the following screen will be displayed (hover the mouse over the graph and “click”).

 

8.    This display will show you the “tracking temperature” for the times (x-axis) indicated.

9.    Turning the alarm limits to “on” (hover mouse over “off” and click to turn “on”), the following screen will be displayed

 

10. This presents a visual display of whether the alarm is within/outside the set alarm limits.

11. To get back to main screen click on “Home” button”.

12. An active alarm is display as a message across the top of the home screen ( as mentioned above) but is also highlighted as seen below.

 

 

 

 

13.  Repeat point 7 to access the individual alarm.

14.  The alarm can be acknowlegde or put into snooze mode, depending on the circumstances presented. You may want to monitor the alarm over a period of time, hence snooze. Or acknowledge an alarm as already action and this will close out the current alarm condition.

15. Depending on the alarm condition it might be nessecary to access whether to:

1.    Leave contents in location as it was only a temporary shift in temperature conditions.

2.    Relocate the material in the unit due to equipment fault.

3.    Escalate the issue to a more senior member of staff.

16. For more detailed use of the Comark Sytem, refer to document:

1.    Comark System manual BS/DT 70

2.    Comark Web view help BS/DT 71 (IFU).

 

 

11      Quality control measures

The Comark probes are subject to annual calibration by a UKAS calibrated probe, supplied by Comark.

 

12      Interferences.

Possible interference of signal between monitors and gateway.

Network issues.

 

13      Principle of procedure for calculating results including where relevant,      the measurement of uncertainty of the measured quantity values

                Not applicable

 

14      Biological reference intervals or clinical decision values

Not applicable

 

15      Reportable interval of examination results

The individual probes have temperature limits set, in accordance to what materials are stored in that location.

 

16      Instructions for determining quantitative results when a result is not           within the measurement interval

Not applicable

          

17     Alert / critical values, where appropriate.

Laboratory clinical interpretation.

Not applicable

 

18     Potential sources of variation.

Not applicable         

 

19.    References.

            BS/DT 70

            BS/DT 71

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