PT reflects Management Competency (?)

One of my favorite airplane past-times is to read The Economist.  It is an eclectic magazine with a business slant and a huge variety of topics covered.  So it is not too surprising that I would find an article that pertains to quality and medical management.  For reference the edition is October 23-29, 2010.  The article on page 72 “How to save lives”.  It is also on the economist web-site (www.economist.com).

Two British investigators were interested in asking questions about hospital characteristics associated with  better outcomes (reduced deaths from heart attacks in the emergency department).  So they looked at 1200 facilities (US, UK, Canada, Europe) in a standardized fashion, and not too surprisingly they did find some characteristics with strong correlation.

Of interest the characteristics associated with better outcomes related to management.  Hospitals that perceived they were competing for patients had a better outcome.  Private facilities did better than Public.  Large institutions with lots of staff did better than intermediate sized and the intermediate did better than the small.  So far nothing surprising (well maybe the public versus private).
What caught my eye was the strong performers hired management who were clinically trained (doctors, nurses, technologists, pharmacists,  etc) to a greater degree than those that did not do as well.  In other words having management teams that have no training relationship to healthcare is a bad thing.

So what does this have to with medical laboratory quality?
In CMPT we look at microbiology laboratory performance using the measured outcome percent of annual achievable score met.  For example if a laboratory does 50 challenges their highest achievable score (in our program) would be 4 for each challenge for a total of 200 points.  If over the year they got 200 points, their percent achievable would be 100% .  If they got 180 points,  their percent achievable would be 90%. 

So as it turns out, like the hospitals referred to in the article, there is a strong correlation between size and complexity of the laboratory and performance.  Large laboratories do very well, intermediate less well, small again more less well, and very small even more so.   In a previous entry I showed a 10 year performance trend (see August 22. 2010: For Folks with an interest in Proficiency Testing).

The following depicts an additional year's performance.  While there was a substantial improvement last year in laboratory performance (Hooray!), the same relationship trend remains.

From surveys we have done we have suspected that the correlates with this were number of staff (that would fit with the above), and the progressively poorer access to continuing education,  microbiologist assistance and to newly trained technologists.  All of that makes sense. 

But we have never looked, or even considered if laboratory performance on proficiency testing correlates with other more clinical indicators in the hospital setting, and especially if it correlates with the training and knowledge and background and competency of management.

Now that would be really interesting. 

m

Canadian Standards Association Z252.

Most of you, I hope not all of you, have never heard of the Canadian Standards Association (CSA), unless it is in the context of electrical plugs or hockey helmets.  I will tell you that that is a shame because as standards development bodies go, CSA is about as excellent a Quality Partner as you can get. 

CSA does write nationally and internationally respected electrical standards and also standards for bicycle and hockey helmets. But in addition to these and many others, CSA has been actively involved in writing guidelines and standards for the broad scope of health care for many years (long before my time).  From the standards for HVAC and Anaesthetic Gas delivery through Infection Control and Sterilization and Chemical Fume Hoods to the specifics of ISO15189 and laboratory safety and on-and-on.  I have worked with them since 1998 and have had a hugely positive and successful relationship.   

They are also , importantly, the ongoing secretariat for ISO:9000.

They have sponsored and supported our group as we have written national standards, and an implementation guide for ISO 15189:2003 and a new guide for ISO15189:2007 (soon to be published).  They have  sponsored our technical committee’s participation in all working groups in ISO212. They  consistently promote active participation and engagement for our committee Z252 The National Committee for Medical Laboratory Quality Systems.

Over the next year we will be engaged in writing new documents to address standards for immunohistochemistry, for pre-examination procedures (requests-procurement-transport-transport-storage) and for laboratory safety.  Along the way we will be involved in the new pan Canadian initiative for units of measure standardization in preparation for Electronic Medical Records (EMRs) and projects for sharps containers, and likely fume hoods.  That will be a lot of work, but it likely all will happen, with the support and cooperation of CSA staff and liaisons.  

So congrats to us and to CSA for having and providing the opportunities to get really engaged as a medical laboratory Quality Partner.  

A busy and successful meeting today; an even busier (and hopefully as successful) one tomorrow.

If you are looking for a place to volunteer and participate in making Canada better and safer, finding time to become engaged in a CSA committee is pretty good activity to consider.

m

Quality and the Disclosure Dilemma

There is an interesting article that is getting a lot of discussion around the quality arena.   The Disclosure Dilemma – Large Scale Adverse Events by Dudzinski and others was published in the September 2, 2010 edition of the New England Journal of Medicine.  (N Engl J Med  363:10.  978-986.).  Dr. Dudzinski writes from the perspective of Bioethics and clearly has dovetails with the perspective of Quality.

The article raises the challenge associated with events where a "large"  number of patients may have adverse effects and poses the questions of the appropriateness of notification, whether to inform, who to inform, and how to inform.  The events that they write about include issues of potential infection exposure in a variety of situations, and also, relevant to this writing, issues that result from laboratory error.  Many of the laboratory issues cited we have previously raised, such as the immunohistochemistry problems in Newfoundland and New Brunswick.   From the perspective of laboratory quality, perhaps one of the largest large scale adverse events not included in the situations described was the examination problem reported by Quest Diagnostics with regard to Vitamin D testing where thousands of patients were affected.

What the authors conclude is pretty basic.  Many of the situations are not that easy to work through.  For some the impacts are huge and obvious, and for others they are minimal and the process of call-back and notification may cause more harm than good.  That being said, as much as decisions on call-backs and full scale notification are not simple, the process can be made much more straight forward if decisions are based on pre-existent policy and process.  Tools such as likelihood – outcome table can be very helpful for establishing an objective base for decision making (see September 25 – Medical Laboratory Quality and Risk).    

Many events that will occur will fall into the category of "unknown unknowns" and many details will be, by their nature event specific.  But the issues of if, when, who, and how for disclosure need to be principles driven. Rather than waiting for “the bad thing” to happen, having worked through the principles and having a plan in place will make the go-forward much easier.

Right out of the Quality Management and Risk Management playbooks. 

Congratulations to the authors and congratulations to the New England Journal of Medicine for profiling an issue so relevant to medical laboratory quality. 

WWW-Proficiency Testing

In the olden days, WWWWW was not a sign of a stuck "W" key, and was not an aberration of www.  It was the journalist code for :who, what, where, when, and why". 
Proficiency Testing (aka EQA) exists in two formats: Regulated - required and often from a required source, and Voluntary - selected for internal reasons.  In most countries PT/EQA is primarily voluntary, in large part because there is no regulation and equally important accreditation is spotty and infrequent. 
There is not only room for both formats,  at the individual laboratory level, the best solution is probably a combination of the two. 
We usually don't have a lot of influence or decision making over the Regulated structure, but we have tons of choice for the Voluntary.

I want to focus on www - who, what, and why, for Voluntary Accreditation - although maybe not in that order.

Why.
Voluntary PT provides a process for quality monitoring, competency testing, and continuing education.  Three very good reasons to be having PT in place in your laboratory. 
Quality monitoring and competency testing roll come together.  If an individual technologist is allowed to test the PT sample in a manner consistent with the laboratory's routine procedure, then performance on PT relates to competency.  If the PT procedure deviates from the routine, then we call that a "waste of time".

If a laboratory is performing around 1 PT sample for every 1000 clinical samples, PT has sufficient power to detect system error.  If the ratio is closer to 1:2500 then the utility of system error detection is near nil. 
For the smaller laboratory, PT reviews are often the only consistent and regular access to continuing education material.

Monitoring PT is a useful and easy quality indicator.  Is someone noticing and informing others when performance is on-target?  Is someone noticing and informing other AND following up when it is not? 

Of all the reasons for doing PT, probably the worst (at the individual level) is for "inter-laboratory comparison".  This is only useful for bureaucrats and statisticians.  Inter-laboratory comparison is probably the single greatest killer of laboratory quality that was every created.  All it does is promotes "gaming" (repeat testing, over-testing,  deceptive practices, like sending PT samples to reference laboratories). 
If you are performing the tests competently then does it matter if other laboratories are doing the same or not?  If you have opportunities for improvement, does it make it better if some other laboratories are having the same problems.  "I know our results are junk, but so are those of 5 other laboratories".

What.
PT samples should look like and more importantly act like true clinical samples.  This is especially true in microbiology and chemistry, and immunohistochemistry. 
Every time I give a presentation I get the same comment.  "You should disguise all your samples so that they have a patient name and medical insurance number.  That way we wouldn't know they come from CMPT.  Actually there were studies on enteric PT done in Japan in the '80s that looked at that.  At that time no significant differences in performance were detected.  But there is almost nothing that would prevent each laboratory to consider a disguising program.
In my experience, lyophilized samples rarely look like and more importantly act like true samples. 
But maybe I am biased.
To the extent possible, having a PT program for each type of sample and each test is desirable.  Usually it is not possible.


Who.
This is the beauty of volunteer PT.  You get to pick your provider. 
1- Do they provide you with the samples you need? 
For larger laboratories, you probably will need to work with 2 or 3 providers to get the volumes that you need.
2 - Will they provide you with extra samples so that you can do competency assessment for multiple technologists at the same time?
3 - Will they ensure their shipping dates, so that someone in the laboratory knows when to expect the samples?
4 - Are they an inspected group (certified or accredited) so that you can have confidence they are working at the same level of quality and competence as you are, or at least at the level that you would want to be?
5 - Is the quality of their continuing education material at the level that will be beneficial in your laboratory>
6 - Is their costing reasonable?

So, for me the right answer is, even if you are not an accredited laboratory, if laboratory quality is important to you, then  PT offers valuable quality monitoring and education.  If you work in a small or intermediate laboratory, you probably can get all the support that you need from one supplier.  If you are working in a larger laboratory, there are clear advantages to working with 2 or maybe 3 suppliers to get the samples and education information that you need.

If laboratory quality is not very important to you, then probably you are not visiting this site.

CMPT Annual General Meeting (Part 2)

Every October for the last 17 years, all the staff, volunteers, and accreditation bodies associated with the Clinical Microbiology Proficiency Testing program (CMPT) come together to discuss the year past, the year present and the year future, and to set both the goals and objectives for going forward and to do the pragmatic planning for the send-out challenges. Over the last 2 days we have enjoyed our 2010 meeting, which will guide us through to the end of the next programmatic year, which ends in May 2012. When we started our annual meetings it was a couple hours together in my living room. Now, with all the things that need discussion and action, the process takes two full days. By now this has become an annual tradition, a lot of work, a lot of decision making, and some socializing. It is clearly our most productive session of the year. It would be difficult to envision running CMPT without this meeting.
This year we had a chance to review some of the research projects that we are working with. The one most directly related to proficiency testing is that we have developed a transport material that will allow us to transport Campylobacter species in fresh simulated stool and have an assured transport survival for 14 days. Pretty good since the best that conventional transport media can do is 48-72 hours. In addition we have collaborated with others on a biofilm susceptibility project and on a number of opinion surveys.

We also talked about our most recent publication "“Progress and Improvement for Identification of Extended Spectrum Beta Lactamases (ESBLs) through External Quality Assessment". This document presents the progress and improvement in laboratory recognition of ESBLs through targeted samples, educational materials, newsletters, and meeting communications. What we cannot say is whether this progress would have occurred regardless of our having provided our proficiency testing samples, but we know now that medical laboratories that work with us can reliably distinguish between coliforms that are ESBL producers and those that are not, and can report them in a meaningful and interpretive fashion. That is a good thing. For those interested, the article is published in the September 2010 edition of EQA News, the journal of EQALM, the European Proficiency Testing interest group.

As with most Quality managed programs, our meeting provides a forum and opportunity to discuss our strengths, weaknesses, opportunities and threats (SWOT analysis) along with our Goals and Objectives. All this information is in our annual report (see http://www.cmpt.ca/).

CMPT is like many small organizations that participate in the community in a manner that is “way over our weight class”. While we are a small university based program, we provide education, outreach service, and research on a provincial, national, and international basis. Not to pat ourselves on the back too much (OK, maybe a little) we can do this for two reasons; first of all the University provides us the access and flexibility to do the good things that we can do, and second, and probably more important, we are very well organized. While we were bouncing along OK for the first 20 years, our real progress and achievement can be tied directly to our certification to first ISO9001:2000 (in 2002) and now to  ISO9001:2008. Our quality system has kept us sharply in the present, and at the same time focused on the future, and continual improvement, and has allowed us to detect our problems and challenges early, when they have done little damage.

Maybe we would have got to this point of structural success anyways. I doubt it.

For more on essentials of annual meetings, see yesterdays note on challenge selection.

The group assembles for the Annual Meeting.

Speakers at the Annual meeting included Michael Noble, Chair CMPT, Esther Kwok Coordinator CMPT, Michael Allard, Professor and Head Department of Pathology and Laboratory Medicine, UBC

Selecting PT Challenges

We are in CMPT Annual Meeting Challenge (more on this later) and one of the important tasks that needs to be accomplished is the selection of challenges for the next programmatic year.  Since our program year starts in May, the challenges we selected now go through to April 2012.
Selecting challenges for Clinical Microbiology Proficiency Testing is really interesting exercise that does not get easier with experience.  It gets harder.

Each year our group of committe participants, all knowledgeable and experienced, some laboratory physicians, some laboratory scientists, and some technologists meet with an empty slide.  By the time we finish we have 12 gram stains, two paper challenges, a variety of wound samples, blood culutres, CSF samples, urine samples, throat swabs, and enteric samples, all selected to address variety, complexity, cover the full laboratory tesing cycle, avoid repetition but allow for sequential testing, susceptibility testing, and try to increase the probability of having samples that will discriminate between strong and weak performers. And making sure that to the extent possible all will have gradable results.  And it needs to get done in under 4 hours, which includes the process of deciding on what the correct answer is going to be.  The fact that every year we get this done is no assurance that we will always be successful.

You would probably not be surprised to know that this is rarely a process that goes smoothly.  There is a lot of discussion, and lot of debate, and a lot of opinion and controversy.  But in the end we always come to a position of consensus, although rarely would it be total and absolute. Not everybody is happy, but at least everyone can live with and support the selection.  I can say that when we get up and leave the table every participant agrees that laboratories will be better having received and processed these samples, and worked through the critiques. 

But for those of you that are participators, and users of the information, I am sure you appreciate that selecting the menu is only the beginning.  Now we have to make sure we have the organisms, and ensure they will function as we expect them to.  We need to create the  mixtures of background flora to go with the challenge target, verify the growth patterns, validate the associated history, and then go through the process of quality control including all the transport issues.  All-in-all there is not a lot of time left over once we have worked through all these steps, so that we can ship them out on-time and go through the process of receiving and grading the results.

So why do we do all this.  First and foremost, laboratories and their accreditation bodies as well as the other quality partners expect that the samples are well thought out and will work to provide quality answers.  Second, if we don't produce quality samples, it becomes really hard to convince programs to continue to support us.  And third, it is actually a fun intellectual exercise that many would like to participate in, if ever they get the chance. 

For those of you that have the interest in promoting quality laboratory practice, working with your local PT program can be a positive and satisfying activity.

And for those in our neighbourhood, we will be doing this again next October. 

And then we go through the same exercise for our Mycology and Enteric Parasitology, and Water Bacteriology programs

m

The Canadian Sleeping Giant has awoken (maybe)

It is a recurring theme in MMLQR that laboratories have 7 Quality Partner groups (Standard Development, Accreditation, Proficiency Testing, Educators, Professional Organizations, and Equipment and reagent suppliers, and the Public), with the Public manifested by the media, the regulators and the legislators having the biggest impact because one they get turned on, things happen.  Not necessarily the most appropriate things, and not necessarily the best things, but things change.

It was therefore of interest that over the last two days there have been 2 big headlines directly associated with Canadian Laboratory Quality.  (see http://www.vancouversun.com/health/Clinical+errors+under+microscope+during+national+conference+surgical/3683674/story.html and http://www.montrealgazette.com/health/Pathologists+work+thin+edge+between+death+life/3680244/story.html

Both of these are “puff pieces” written for (or by) the Canadian Association of Pathologists (CAP) as they promote their particular interest in presenting guidelines for pathology.  This CAP (please note this is not the College of American Pathologists) is a professional organization and therefore in my classification also a Quality Partner.  I think they will ultimately succeed as the work with groups with broader based credibility in laboratory quality. 

But it is not so much our CAP that I am interested in, and more it is about the Vancouver Sun and the Montreal Gazette, both of which are credible newspapers.   Indeed it is my understanding is that these two articles appeared in a variety of newspapers across the country.  So it is really encouraging to see that these major newspapers have the internal structure and personnel that can actually understand why laboratories are important and why laboratory quality is important, and why medical laboratory poor quality can not be tolerated, or even worse, ignored.

What will be interesting to see is whether or not these articles are sufficient to move our legislators and regulators to support and endorse a real action plan to promote laboratory quality.

Canadian laboratories are similar to what you see in many places in the world.  When it comes to Quality they are very good at “talking the talk”.  A little Lean, and little Accreditation, and a little Proficiency Testing, but little to support the real substance of infrastructure and Quality Management. 

So we will see what happens… “talking the talk” or “walking the walk”.  

Fingers Crossed.

m

A Belated Happy Standards Day.

I receive a regular electronic issue from the Quality Digest (http://www.qualitydigest.com/). Usually some good stuff in it. The other day I received a “copy” with Again, lots of interesting stuff but what really caught my eye was an editorial written by Mike Richman who is the publisher. October 14th is World Standards Day (http://www.qualitydigest.com/inside/quality-insider-column/happy-world-standards-day.html)

Who knew?

Actually it seems that a lot of people knew and know. The first World Standards Day was celebrated in 1970. I am not sure how these things happen, but it seems that it was ISO that declared October 14th as World Standard Day. Either way this year marks 40 continuous years of international recognition, and so regardless of exactly how it got started, it certainly has been very successfully sustained.

Richman points some interesting things about October 14th. Like it is the anniversary date of the meeting when delegates came together in 1946 and formed the International Organization for Standardization. What is perhaps as interesting (for me personally, more interesting) is that October 14th is the anniversary of the birthday of W. Edwards Deming who was born in 1900. I’m more into coincidences that I am into the mystical, but the conjunction of these two events is pretty interesting.

In our classification for Quality, Standards Development Bodies are recognized as one of the seven essential Quality Partners, along with Accreditation Bodies, Proficiency Testing Providers, Educators, Professional Organizations, Equipment and Reagent Suppliers, and the Public. Without these groups, medical laboratories would never be able to progress and improve. 
I have worked with a few Standards Development Bodies including International Organization for Standardization, the Canadian Standards Association, the Canadian General Standards Board. Another organization including the Clinical and Laboratory Standards Institute would similarly qualify in the same group. Clearly all of them have characteristics in common. They work from basic principles, they work by broad consensus, they avoid, to the extent possible, both the presence and perception of conflict of interest. It is not a perfect process because there is always politics everywhere, but on clear balance, the world is better off because of the presence of international standards.

As ugly as this current recession has been, were it not for international standards, the opportunities for even more non-tariff barriers could have destroyed world trade and fully collapsed the world economy.
So congratulations to those interested in Quality and congratulations to ISO and all our standards development organizations. Keep up the good works.
And perhaps one day we will have a World Quality Partners Day to recognize all the quality partners.

Next year on Friday October 14, 2011 UBC Program Office for Laboratory Quality Management will host a special event.
m


PS: For those who care, October 14th is also the anniversary date of Earth Day.

Communicating Quality

Time was, not that long ago, that Quality in the Medical Laboratory was about doing quality control, doing some proficiency testing and calculating DBS units, and "trust me-trust me, we don't make mistakes".  And once in a while there would be an Accreditation walk through.
Over the last several years that has improved considerably, but it was still about as low-profile as a low-profile could get, and still be considered profile.
Then came 1999 and the creation of  To Err is Human, the book that changed the world.  All of a sudden the public started to understand how dangerous health care can be. 
A problem was that the laboratory was excluded from "Err..." but between a whole series of self-induced embarrassments, and the development of some significant international standards (ISO15189 for one) the laboratory figured out that it was time to get engaged.
A lot of individual activities have occurred.  Some accreditation bodies were borne (think OLA) and shot to the top of the heap in Canada.  Others (think DAP in BC) recognized the need and underwent major improvement.  And regions that never had accreditation have started to develop programs.  Good for them.
But it is in the area of communicating quality that we have seen the greatest and most significant change. 
Today, one is hard pressed to attend a laboratory meeting anywhere in Canada that does not have a Quality Session or Seminar.
Two weeks ago there were several Quality sessions at the BC Society for Medical Sciences (BCSLS) conference in Sydney.  Over the next short while we will have the Quality Confab (OK that's not in Canada), but in the first 6 months there will be a meeting in Montreal (AMMI-CACMID) a meeting in Winnipeg (3rd Quality Congress) and a major meeting in Vancouver in June (UBC Week-end Quality Confernce).
This is all good. 
Quality does poorly in isolation and grows with Culture and Culture grows in  direct relationship with the amount of Conversation present.
So I am all for promoting the conversation.

If you send me a notice of your Quality Conference I will publish it as a comment.

m

CMPT Annual Report 2009-2010

Some of you are interested in microbiology as a laboratory discipline, while others see microbiology as a critical part of the medical laboratory but not your particular interest.  Similarly, some of you see Proficiency Testing as the laboratory quality partner with the most frequent and constant exposure and influence on laboratory education and quality, while others don't.  That's one of the fascinations of medical laboratory as an area of interest.  By its very nature it is simultaneously both broad and narrow.

In either event, I think you mind find the CMPT Annual Report as an interesting document.

Our Annual Report highlights our own Quality Management through management review, internal audit, quality indicator, satisfaction survey, goals setting and monitoring.  For those with a primary interest in Quality Management, I think it is a good example of what the discipline of ISO9001:2008 can foster. 

It also gives a picture of medical laboratory performance across much of Canada, showing strengths, weaknesses, and trends. 

If you work with a PT provider that does not share this sort of information with you, it is a fair question to ask why not. 

Go to:  www.CMPT.ca and look under Annual Report.  The drop down menu on the left includes 2009-2010.
m

PS: Many of you are not CMPT subscribers.  This is likely the last year that this annual report will be available without being a CMPT subscriber or registrant.

Some easy and cheap things that you can do that will improve laboratory quality (Part 2)

I previously mentioned the Juran Quality Cost Model which points out that doing small things to improve prevention and assessment, have a big impact on to Quality spending, because they drive the costs of failure down by reducing the amount of failure.

I think that the model has merit.

The extension of the model is that inexpensive and easy to perform improvements can save TEEM (time, effort, energy and money).  As much as I am truly fatigued of the term, think about the “low hanging fruit” that will improve Quality. In part 1, I mentioned simplifying procedures, and improving procedure communicability, and introducing Quality discussion. 

So, continuing on the discussion: 

Create your own personal Quality Checklist.

There are a bunch of things that you know you should do on a regular basis, but for the most part they usually don’t get done until something official comes along.  Maybe its an upcoming accreditation, maybe it is a post-complaint investigation.  I know that we are all well meaning, but we can be busy or distracted.

So set yourself a check list (aka “to do” list or “personal audit” list).  Don’t wait for someone to make one for you (when it comes from your spouse, it becomes a “honey do” list).

A few things to put on your list:

1:         Have I checked the procedures that I am working on now in the last 3 months for changes?

2:         Have I checked to see if my personal short notes on the procedure are still consistent with the changes that have occurred?

3:         Did I update my own short notes?

4:         Did I check to see if there are short notes attached to my bench or analyzer, and have they been similarly kept current?

5:         Did I have one incident during the last month or three months that would quality as a learning opportunity or opportunity for improvement?  Did I make a personal notation in my own OFI book (more on this later.)

6:         Did I have at least one continuing education activity in the last 3 months, and did I record it.  That might include:

•         Read a book or article or website or see a video related to my work
•        Attend a seminar or meeting or interest group related to my work
•         Participate in a continuing education related course either in person or on-line

Keep the checklist in a private place, but check it at least once every 3 months.  It will take no longer than 2 minutes to check, and should generate no more than 10 minutes of activity.   But in a year you will have 4 checks of 6 points (that’s 24 check points) and in two years you will have 48.  

Do one internal audit a month.

We all know and understand that working in a laboratory is a lot like working in forestry.  Most of your time is spent jumping from one fire to another, and soon all you are doing is stomping out fires.  That is really important work, but some of those fires are self-induced because you never got back to check that the fire was actually put out.  That is what internal audits are for.

I find that so many of us like to think BIG.  That’s good for dreams, ambition, and goals.  For internal audits, thing SMALL.

An internal audit does not have to be much more that taking the personal checklist as above, and make it a little broader.  We need to be checking to make sure we are on track.  It’s just part of the Plan-Do-Check-Act thing, but make it really narrow and make it really specific.  And don’t take anymore than 30 minutes to get it done (45 minutes tops).  For example ...

1. Check the benches to confirm they are neat and clean at the end of the day?
2. Check the reagent kits to confirm that some one recorded the “open date” and the “expiry date”.
3. Check the equipment temperature recording charts to confirm they are being filled in.
4. Check the Proficiency Testing results to confirm that someone looked at them, and signed them off.
5. Check the SOPs to confirm that they have been reviewed on time.  (If you set that to happen with a few review times each month, then you don’t have the burden of doing them all year’s end).
6. Check to see if the preventive maintenance schedule is being followed on time.

Then write the results down and give a copy to someone in laboratory management.  That is all you need for an internal audit report.  You can draw up your own list, but keep it fewer than 12 (if the list gets too big, most will just drop it).  Once again, if you did each of these once every 6 months, at the end of one year you would have 12 completed internal audits and at the end of two years you would have 24.  If your list had 12 and you did them each twice a year, then at the end of a year you would have completed 24 internal audits.  That is huge!

The reality is that most of our colleagues would like to focus on doing better, and doing error free work, but we tend to make Quality tedious and excessive and overwhelming.  Too many rules and too many requirements.  And administration sees it as expensive.  So try this as something different.

More cheap and easy later.

m