Pressures on Blood bank staff

[RR1]

I have recently come into information that some Transfusion Lab Managers within the UK are being held accountable for clearing all major MHRA non-conformances regardless of the problems that have been noted with staffing levels, workload, maturity of the quality system etc. There have been noted 'suggestions' of these folk being taken down the 'capability route' .

It may be useful for us to know to what level this is occurring. I would like folk to vote as honestly as possible on this poll so we get an accurate indication of any serious problems.

Edited November 30, 2009 by RR1

[RR1]

Please also indicate an appropriate response if the Quality Manager/ Officer is also under any of these constraints.

Thanks!

[Bill]

Lost my manager position because of this--even when inspector was wrong about the issue.

[RR1]

Sorry to hear of that Bill.

In the UK it's not that our regulators are wrong about issues, in my experience our MHRA inspectors have been quite consistent in their citations and have always been incredibly helpful.

The issue concerned is more of how some hospital senior management don't understand that to create and then maintain a robust quality system requires adequate resourcing at all times not just for a short while to deal with the non-conformances given at inspections, otherwise these will not be cleared.

The fact that some staff are being informed that they personally will be fired from posts if they receive any major non-conformances at re-inspections,without management making any reasonable attempt at helping to progress things is unacceptable. Improvements in labs will certainly not be achieved by demoralising, demotivating, and frightening folk trying to achieve this.

[adiescast]

I have recently come into information that some Transfusion Lab Managers within the UK are being held accountable for clearing all major MHRA non-conformances regardless of the problems that have been noted with staffing levels, workload, maturity of the quality system etc. There have been noted 'suggestions' of these folk being taken down the 'capability route' .

It may be useful for us to know to what level this is occurring. I would like folk to vote as honestly as possible on this poll so we get an accurate indication of any serious problems.

Sorry Rashmi, I voted on this before I realized you were looking for UK answers. I picked the third choice "struggled to obtain help" so you can eliminate that if you need to...

[RR1]

Sorry Rashmi, I voted on this before I realized you were looking for UK answers. I picked the third choice "struggled to obtain help" so you can eliminate that if you need to...

Not a problem adiescast....interesting that we are all experiencing similar problems with trying to improve our labs, regardless of which part of the world we are in.

[Eoin]

I have for some time been looking for a formula for assessing staffing needs as proof to supply our managers. This is a very serious issue and will lead to worsening of standards, not improvement. In ISO15189, Clause 4.1.5 states that the Laboratory Manager is responsible to ensure that resources are in place to meet the demands (Both staffing and Equipment etc). This surely must be communicated to Hopsital Managers.

Does the BBTS need to lobby the appropriate hospital and Trust managers in the NHS. Timing of this is bad, given the economic downturn.

Regards,

Edited December 2, 2009 by Eoin

[Malcolm Needs ☆]

Sorry to hear of that Bill.

In the UK it's not that our regulators are wrong about issues, in my experience our MHRA inspectors have been quite consistent in their citations and have always been incredibly helpful.

The issue concerned is more of how some hospital senior management don't understand that to create and then maintain a robust quality system requires adequate resourcing at all times not just for a short while to deal with the non-conformances given at inspections, otherwise these will not be cleared.

The fact that some staff are being informed that they personally will be fired from posts if they receive any major non-conformances at re-inspections,without management making any reasonable attempt at helping to progress things is unacceptable. Improvements in labs will certainly not be achieved by demoralising, demotivating, and frightening folk trying to achieve this.

I agree with everything else you say Rashmi, but in my experience, there have been times when they have been wrong, and they are far, far too arrogant to admit it. This has left Blood Bankers trying to "improve" by doing something they know is wrong.

:angered::angered:

[Malcolm Needs ☆]

I have for some time been looking for a formula for assessing staffing needs as proof to supply our managers. This is a very serious issue and will lead to worsening of standards, not improvement. In ISO15189, Clause 4.1.5 states that the Laboratory Manager is responsible to ensure that resources are in place to meet the demands (Both staffing and Equipment etc). This surely must be communicated to Hopsital Managers.

Does the BBTS need to lobby the appropriate hospital and Trust managers in the NHS. Timing of this is bad, given the economic downturn.

Regards,

I'm not sure, but this may be more of a role for the IBMS (and, possibly, the RCPath) than BBTS.

Certainly though, it should be a role for the Chief Scientific Officer.

I'll have a think about this one.

:confused::confused:

[RR1]

I have for some time been looking for a formula for assessing staffing needs as proof to supply our managers. This is a very serious issue and will lead to worsening of standards, not improvement. In ISO15189, Clause 4.1.5 states that the Laboratory Manager is responsible to ensure that resources are in place to meet the demands (Both staffing and Equipment etc). This surely must be communicated to Hopsital Managers.

Does the BBTS need to lobby the appropriate hospital and Trust managers in the NHS. Timing of this is bad, given the economic downturn.

Regards,

I think we need to produce a list of weekly tasks with the hours assigned to complete each one to the appropriate level to begin with .We could then work out individually how many hours of staff time are available , and average these out for our own labs.

At my lab the staffing on paper looks quite good until you actually work out that all staff on the shift system are really only in the lab during core hours (09:00 to 17:30) for 65% of the time. There is no slack during any of the 'shift' periods to perform any significant amount of routine tasks other than group,screening and crossmatching.

The BSQR is improving practises and patient safety in the short term, but the loss of highly trained people from the profession will happen because nobody will really want to take on the responsibility anymore of trying to achieve and maintain compliance in an under resourced lab with ridiculous and unrealistic pressures put on them. This will contribute to an increase in serious incidents in the coming years.

Edited December 2, 2009 by RR1

[RR1]

I was informed today of even more UK folk having these problems at work. If there is anyone out there that needs any help, support, or a shoulder to cry on feel free to contact me. I think we now need to urgently assess these issues and until people are honest about what is happening in their places (off forum would be best), we may not get the necessary help.

You can contact me: fullname(no spaces)@hotmaildotcom.

[hutch]

"I agree with everything else you say Rashmi, but in my experience, there have been times when they have been wrong, and they are far, far too arrogant to admit it. This has left Blood Bankers trying to "improve" by doing something they know is wrong"

I agree that they are not always correct.

Example: I must assign an "in use expiry date" to all antisera even although the manufacturer has confirmed that they are suitable for use up to the expiry date (provided stored correctly) that they have assigned.

[Malcolm Needs ☆]

"I agree with everything else you say Rashmi, but in my experience, there have been times when they have been wrong, and they are far, far too arrogant to admit it. This has left Blood Bankers trying to "improve" by doing something they know is wrong"

I agree that they are not always correct.

Example: I must assign an "in use expiry date" to all antisera even although the manufacturer has confirmed that they are suitable for use up to the expiry date (provided stored correctly) that they have assigned.

HEAR, HEAR!!!!

An excellent post. I'm glad it's not just me!

:D:D:D:D

[RR1]

"I agree with everything else you say Rashmi, but in my experience, there have been times when they have been wrong, and they are far, far too arrogant to admit it. This has left Blood Bankers trying to "improve" by doing something they know is wrong"

I agree that they are not always correct.

Example: I must assign an "in use expiry date" to all antisera even although the manufacturer has confirmed that they are suitable for use up to the expiry date (provided stored correctly) that they have assigned.

Even though this isn't the correct thread for this topic, I would say that there is nothing wrong with that comment. Some reagents ( e.g screening cells) may deteriorate faster even though you are storing at the correct temperature. If you repeatedly movie these from room temp to the fridge you could 'stress' the cells and affect the more fragile antigens.

We have seen this with reagent storage on our analysers. Once a bottle is in use -you should justify the time period you are going to use it for. If you decide this is as stated for expiry of the reagent, state this in the sop, and respond accordingly to the inspectors.

[RR1]

HEAR, HEAR!!!!

An excellent post. I'm glad it's not just me!

:D:D:D:D

Malcolm, i'm sure throughout the world there are 'diificult' inspectors, but there are also many really good ones whose purpose is to help us reach acceptable standards- and this does affect patient safety.

The first few inspection years were always going to be difficult for some labs with non-existent quality systems.

[Malcolm Needs ☆]

Malcolm, i'm sure throughout the world there are 'diificult' inspectors, but there are also many really good ones whose purpose is to help us reach acceptable standards- and this does affect patient safety.

The first few inspection years were always going to be difficult for some labs with non-existent quality systems.

NHSBT has been inspected for many years by the MHRA - and they still seem to delight in making it as difficult as they can.

[Eoin]

I try to look on reg audits as a positive experience and leads to increased patient safety - but it is very hard sometines to join up those dots !!!!! (Sorry just had a Reg audit two weeks ago n still feeling battered n bruised).

Cheers Eoin

[RR1]

Hi Eoin,

I know what you mean, definitely need a few drinks after one, but if folk are being pressurised even further by their management having unrealistic expectations........they probably feel battered and bruised permanently. It's not good or safe to work in an environment like that.

[hutch]

Even though this isn't the correct thread for this topic, I would say that there is nothing wrong with that comment. Some reagents ( e.g screening cells) may deteriorate faster even though you are storing at the correct temperature. If you repeatedly movie these from room temp to the fridge you could 'stress' the cells and affect the more fragile antigens.

We have seen this with reagent storage on our analysers. Once a bottle is in use -you should justify the time period you are going to use it for. If you decide this is as stated for expiry of the reagent, state this in the sop, and respond accordingly to the inspectors.

I would not dispute that that would be the case for cells, what I was referring to was reagent antisera which is a different ball game all together. If a reagent comes from the manufacturer with a 2 year expiry and we have to put a 3 month expiry on it at point of receipt (ie when batch acceptance tesing is performed) then that can be extremely wasteful especially with antisera not used on a regular basis.

I also would agree that MHRA does serve a very useful purpose and can help to raise standards, I, on the whole have had a positive experience. However, to re-iterate Malcom's point, they do not always get it right and they do not always want to listen.

[RR1]

Hi Hutch,

I would say the same principle needs to be applied to your antisera.

As TimOz nicely put this in a thread (EQUIPMENT- pipette verification tips on BBT) when he was discussing control reagents:

"I have had a bit to do with designing controls and many blood bankers really do not understand their test performance, so they do not understand using controls in red cell serology. Here is a classic example: Someting as robust and simple as a vial of monoclonal Anti-A can be damaged by a whole range of things like bacterial and reagent contamination, poor transport and poor storage. What do we QC it with? an A2 cell (or an A2B cell if we are diligent). The reality is that a

good brand of Anti-A can loose 95 to 97% of its activity and still give a score 4 with an A2 cells but fail to detect an A3 cell. This is not really controlling the test at all."

Your reagents will be under a lot more stress in the lab than the testing performed by the manufactuer. If you decide to carry on using these reagents up to the 2-year expiry, then state this to the MHRA with reasons and evidence of acceptable controls. Get additional clarification from the manufacturer and submit this too. Personally I wouldn't use my most critical, open vial reagents (ABO/D typing) for more than a couple of weeks on analysers.

The use of rare antisera for longer periods would need to be justified.

I am sure that sometimes the MHRA want you to comment on why you are doing/ not doing something and state this formally in your procedures, it doesn't always require a change of practice. How was your citation worded for this event?

Edited February 8, 2010 by RR1