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Posts posted by bmsjbatt
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Oh how I wish I had version5, still stuck with clunky old version 4 for me
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Regulators in the UK expect clear competencies on ANYONE working in the bloodbank. If they are "in training" they MUST be supervised by someone with current competency in the tasks being completed.
This includes Locums, part-timers and students.
In fact they have reccommended that part-timers on shift are specifically rota'd onto days for a specific period of time in blood bank annually to ensure their competencies are still valid.
we also have to have a plan of reassessing competency on any staff member who has been out of the department on sickness / maternity leave etc for more than 3 months.
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I would recommend that as long as you state what is required in the competency assesor to enable them to carry out assessments. then you can allow for more than one assessor and they assess each other.
This seems to be the way the UK regulatory / accreditation agencies are wanting us to go.
We state what we consider to be our requirement and then stick to it.
e.g. must have qualification x, y and z and have carried out work as senior member of staff in discipline "a" for 4 years minimum and attended training course on "subject" etc
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Malcolm,
It appears to be equivalent to the IBMS Specialist / expert practice diplomas. Certainly post graduate level but below PhD. as many of the advertised courses can award credits to MSc degrees.
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All of our pipettes have been sent away for calibration and service for the first time this year .........
Why are you sending all of your pipettes away at the same time?? I would at suggest that you first send away half, leaving yourself with a suitable selection to continue with operating your systems, then 6 months later send the others off, that way you are never without any suitably calibrated, serviced pipettes.
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Try something using the following layout (understands is for the SOP / process)
[TABLE=width: 644]
[TR]
[TD] [/TD]
[TD]UNDERSTANDS[/TD]
[TD] [/TD]
[TD] [/TD]
[TD]SHOWN TASK[/TD]
[TD] [/TD]
[TD] [/TD]
[TD]COMPETENT[/TD]
[TD] [/TD]
[/TR]
[TR]
[TD] Basic theory given and understood[/TD]
[TD] [/TD]
[TD] [/TD]
[TD] Task demonstrated and explained[/TD]
[TD] [/TD]
[TD] [/TD]
[TD] [/TD]
[TD=colspan: 2]Agreed Competent[/TD]
[/TR]
[TR]
[TD]Date[/TD]
[TD]Trainee[/TD]
[TD]Trainer[/TD]
[TD]Date[/TD]
[TD]Trainee[/TD]
[TD]Trainer[/TD]
[TD]Date[/TD]
[TD]Trainee[/TD]
[TD]Trainer[/TD]
[/TR]
[/TABLE]
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Bump.
We have recently received notice regarding IT systems, and had to supply details of trust / IT technical agreement, mainly dealing with disater recovery and ability to access legacy systems / archives, but also with regard to IT failing to supply the department with change control notifications prior to carrying out a programme of hardware refresh.
Jo
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Hi Rashmi,
Recent Inspection, we were commended on the groups we have been using so far, but were also recommended to clearly separate the incidents identified internally and those identified external to the department.
our groups so far are.
CodeTrend analysis code 2010
A Personnel
B Reagent
C Equipment
D Training- lab staff
E Process/ Failure to follow Trust Guidelines
F Communication
G Concessionary Release / deviation
H DelayIRecall
J Wrong patient bled/ details written on
K Training- porters/ nurses/ drs/ drivers
L Traceability
M Hospital patient numbering problems
N SLA Hospital
O NBS errors
P Product
Q Winpath
R Complaints
S Cold Chain
T Inappropriate product issued/transfused
U None assigned/ not applicable
V Clerical Errors
Hope these help.
Jo
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Indeed, I sympathise with you on this, however do you not get any support from clinical director / Exec team, as they are ultimately responsible for MHRA failures and must answer to the DOH if things are not done properly? so maybe you need them to "order" your IT bods to do things properly and not in a half-arsed way.
Not saying this is the solution to all your problems, but if a sideways / bottom - up approach isn't working for you, maybe you need a top down approach.
best wishes
Jo
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Wow, this is great, Thanks for this I am now sitting highlighting the bits I want to watch.
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Are your PATH IT people Pathology staff with an IT interest? or IT people working in the PATH environment, if they are the latter start talking to them about ITIL best practice as much of the BSQR stuff relating to IT validation is based on ITIL service managment acceptance criteria. and they should be working to ITIL standards as it is an NHS preferred way of operating.
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Hi Rashmi,
What reference did they give to accompany the Non conf?? If they didn't give a reference I would argue the non conf. or ask them to reference the regulation they are using to support the N/C.
I would agree that the Format of the worksheet can be document controlled and be part of your usual document review cycle and link it's review to that of the SOP that it is mentioned in, but the worksheet itself cannot be controlled as it is a working document, provided that each action / entry can have an appropriate date and signature attached to it (could always use the track changes function in excel?)
For our QI worksheet I have shamelessly stolen and modified your spreadsheet and it was accepted as a suitable worksheet by our MHRA inspector when we sent it to him to close a post inspection N/C of us not having an overall monitoring tool.
Hope this clears things up a bit:)
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I'll be interested to see any results too, but I suspect that there is no easy answer and that this is just down to common sense.
the proof will be in an MHRA response I suspect.
regards
Jo
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Hi Rashmi,
For both of these areas (BTW our equipment stuff is mostly done on Q-Pulse), the only people with access are ; myself as QM, the BBM, SPOT and Senior in BB. but it is only accessed in a heirarchical manner, that is, the SPOT is responsible for anything ward based, the BBM for all lab based unless he is unavailable then the Senior acts as deputy with SPOT support, I just act as general dogsbody to monitor and tidy up occasionally.
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Indeed, and in my experience our hospital managers are taught to respond positively to evidence based changes of practice, so use tools like NPSA etc to give you some leverage.
We were encouraged to have stronger links with our Trust Risk and Safety Team by our last MHRA inspector, in part because he was unhappy with us not having ownership of all of the resolution procedures especially ones outside our department, but we now have an excellent relationship whereby our Trust reporting process has been modified to satisfy our requirements.
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Yes, that can be a bit of a problem. I gather that at some places the high number of incidents/ deviations being reported by the lab. is being taken by senior management as a negative indicator of practices rather than showing a positive, open reporting culture by the lab staff, who are willing to address issues rather than sweep these under the carpet...as has been done for many years.
As always these things are sent to try us!
Rashmi, To try and get these senior managers on-side you may try liaising with your risk & safety team. beacause they have evidence that shows that under reporting of incidents is seen as a negative thing and may influence the NHSLA grouping that the trust is awarded, and thereby a real financial cost pressure, we have been able to use this to persuade managers that adequate reporting of errors and incidents is critical as this is the only way we can improve, and save money!!!
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Hi Rashmi,
I have included a PPT that I have used to teach in the past if this helps you're welcome to use elements.
Jo
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An old RAF(UK) saying: - the 7 P's
"Proper Planning and Preparation Prevents P**s Poor Performance"
Change control anyone???along with KISS
and of course I love "lack of planning on your part does not constitute an emergency on my part."
and for you quality guys
"Errors are caused by faulty systems, processes and conditions, they are seldom caused by carelessness and lack of trying hard enough."
Its so easy to blame people and not the process, just because one person can carry out a procedure without error does not ensure that all people can do the same, KISS it and more people should be able to work without error. Thats my belief;)
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We also have question sheets for those procedures that require assessment but a handy tool that I used for tracking whether staff have read updates to documents was to send them via email and use the voting buttons to track them - we also used this for staff meeting minutes.
You attach a button for "read" and then use the emails tracking system. Of course this means you have to have all staff on email - but it does work well. And you get a nice printed sheet from the email to attach to your records for the auditors.
I got sick of sending around hard copies and then trying to hunt them down for weeks as they circumnavigated the lab (or more likely had sunk to the bottom of someone's desk).
What e-mail system do you use and how do you add the voting buttons?? I am Very interested in trying this it sounds fab!!
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"Quality" and "Fun" are the definition of antonyms and "Quality" and "Utter Boredom" are synonyms in my dictionary!!!!!!!!!!!!!!!!!!!!!!!
So Malcolm what does that make me then?? Cos I actually find quality stuff FUN
Admittedly some of the Quality stuff can be tedious, but I try my best to make it as painless as possible to many people. and even a little bit interesting too!! -
Rashmi, you are allowed to use the CPA quality policy, it is acceptable to MHRA, I have a separate quality manual for transfusion, to fulfil MHRA but, I refer to the pathologywide quality manual which has the pathology wide quality policy.
I think there may be some confusion about the quality Policy vs the Quality manual from some of our colleagues above, The Quality Policy should be short and sweet mission statements, no expansion necessary that comes in the quality manual.
So here it is, and we can just about get it to fit onto a single side of A4.
A3 Quality policy
A quality policy provides the basis for running a laboratory in a manner that will fulfil the needs and requirements of its users.
A 3.1 Laboratory management shall establish a quality policy [NOTE 1] that includes the following:
a) the scope of the service the laboratory intends to provide
a statement of the laboratory's intention with respect to the standard of services, including a commitment to meet the needs and requirements of users c) a statement of the purpose of the quality management system (A4) including a commitment to set quality objectives (A5) and to achieve continual quality improvement (H6)
d) a requirement that personnel are familiar with the contents of the quality manual and all procedures relevant to their work
e) a commitment to good professional practice
f) a commitment to the health, safety and welfare of all staff and visitors to the laboratory
g) a commitment to comply with relevant environmental legislation
h) a commitment to continuing compliance with CPA(UK)Ltd accreditation standards.
A 3.2 Laboratory management shall ensure that the quality policy is:
a) signed and issued by a person with appropriate authority
communicated, understood, available and implemented throughout the laboratory c) reviewed for suitability and effectiveness at the annual management review (A11).
NOTES
1 Where the laboratory is part of a larger organisation its quality policy should be consistent with other policies in the organisation.
CROSS REFERENCES
• ISO 15189:2007 4.2 Quality management system
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Hi Rashmi,
I have 3 seperate Quality manuals in play at the moment, the generic Pathology wide one for CPA, the BT specific one which encompasses haemovigilance etc, and a HTA hospital wide one as I have HTA responsibility too.
I came to the conclusion pretty rapidly that CPA would query the inclusion of things outside of the labs control if I merged them so there are 3 distinct Quality management systems in play too. but each one follows the format approved by CPA, and developed further to encompass all the other regs and requirements.
the dreaded C season doesn't start until after the school Carol concert, I cannot be dealing with it before then!!! and as a child it didn't start til 24th December as my sister's Birthday is 23rd December and she had to have her birthday first!!
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These are good practice standards set out in the UK primarily for hospital transfusion labs regarding staff qualifications, training and competency requirements, staffing levels and specific equipment use.
There is a hyperlink to the document supplied on this thread by Tonyd, but i can't seem to get this to open. If you do a google search 'UK transfusion laboratory collaborative '... you should be able to find this.
http://www3.interscience.wiley.com/cgi-bin/fulltext/122573960/PDFSTART is the correct link (the last bit of the one tonyd posted was incorrect
BTW i must agree with Jay jay about incident management, as the Quality manager for all of Pathology, I still co-ordinate and drive the RCA for all incidents including Haemovigilance episodes. this is done in conjunction with the BBM and TP, I try to take much of the pressure offas i can, but i am responsible for ensuring it is all followed up, particularly internally.
as for the query about how much time the quality manager should devote to the QMS in Transfusion, I had a rather long and heated discussion with MHRA inspector about my time split, I am 0.5WTE for all of Pathology, with responsibility for CPA in 4 disciplines, the MHRA stuff in BT and HTA stuff in the cell Path / mortuary, so this equates to less than 0.1 WTE for each thing, in reality, most of the CPA stuff is already well established and just requires me to facilitate and monitor certain elements, plus concentrating on the core common areas, this takes up approx 0.3 of my time allowing me to in reality alternate between giving 0.2 per week to BT and Mortuary. but the MHRA representative felt this to be a tall order!!, although he was not unsatisfied with what we had managed to acheive, so it is a case of being inventive and blunt, I am the hammer to crack the nut;)
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Hi Rashmi,
I prefer to keep them separate, it seems to help my audit team that way, it helps them differentiate between a good idea that has come out of an audit as opposed to a true N/C from an audit.
although the QI note can be used as part of a N?C corrective / preventative action
Admittedly some of the Quality stuff can be tedious, but I try my best to make it as painless as possible to many people. and even a little bit interesting too!!
ISO 15189 : 2012
in Quality
Posted
Sorry Rashmi, for late response been out of the loop for a while, dsicussions with colleagues who have been inspected is that the methodology is closer to an MHRA style inspection of show me, and following the rabbit down the hole approach, rather than the previous audit checklist approach.