Trust but Verify in Healthcare

I am NOT the first person who has thought about this.  I am NOT the first person who has experienced this.  This is NOT my first time to struggle with the dilemma of tests performed inside the medical system but outside the laboratory.  But it has reached a level that needs attention.

So about 7 months ago, my family doc thought that that it would be a good idea for me at my age to have a screening occult blood test done to rule out a silent bowel cancer.  Unfortunately the test did not rule out bowel cancer, but understand the test is VERY specific, which means it is detects blood, but VERY non-specific in that there are a bazillion reasons that one can have a positive blood test, and NOT have bowel cancer.  In fact the highest probability was that I do not and did not have any good reason to  suspect I have cancer.  But in the modern era, if there is even the tiniest suspicion one has to do a follow-up test, a bowel scoping (colonoscopy).

So a scoping is arranged and 6 months (!!) later, I  get an appointment and after going through all the preparations I have my test, which I am told indicates no cancer.  No surprise, but YAY, none the less. 

But for a guy who spends his time thinking about Quality and performance, this was a really unsatisfying experience because, what if the test result was wrong.  As we all know, it can happen.  

One thing is always certain… errors occur.  Maybe the doc doing the test is incompetent, or maybe he was distracted or maybe is under a lot of stress, too much work and not enough time.  Maybe the scope was defective.  Maybe the biopsy that was taken was taken incorrectly from the wrong place.  The reality is that our system makes the assumption that the scope doc is competent, but we have NOTHING but faith to back that up. 

In the laboratory we perform Quality Control regularly to ensure that our equipment works, our reagents work.  We can, to the extent possible, ensure that samples were collected properly and transported properly.  We can maintain quality indicators to monitor for incorrect reports, and we can most certainly monitor for complaints.   Further we have External Quality Assessment (Proficiency Testing) to monitor that our staff are proficient/competent.  And we have regular Quality Indicators that can measure and record all sorts of parameters to give us early detection of problems arising.  It is part of our norm, part of our routine.   It is called verification and validation of the process.

In clinical care we don’t have that or do that.   We have Trust me… Trust ME!  I didn’t see any evidence of cancer… Trust me.   I didn’t see anything that looked like a polyp… Trust me.  Or, I saw a polyp and took a biopsy correctly… Trust me.   Of course I know what I am looking at with my scope.  I am a good doctor… I was trained at the best place by the best people.  I always am careful… I never make mistakes… TRUST ME.

Let me argue, the days of trust are getting pretty thin, and I can see a time in the not-do-distant future that “Trust, but verify”  does not only apply to nuclear physics and bomb site laboratories.  There are many many organizations where Quality processes are the norm (maybe not in physician or lawyer offices or teachers and certainly not politicians) where regular audit, and re-certification is the routine.  Think about restaurants, and food chain, and medical equipment suppliers, and medical laboratories where audits to ISO international standards are routine in most countries around the world.  (Even politicians have a form of validation and verification  every 4 years!).  In the United States, if a medical laboratory does poorly on its proficiency testing, the facility can lose its ability to bill for federal funds.  In Canada, a laboratory can be closed until the quality requirements are addressed.

In the olden days, one could make the argument “Yes we agree, but there is no way one can make an assessment, and measurement, a determination.  That is no longer the case.  In the medical laboratory we can make samples that closely simulate typical laboratory sample proficiency testing is can be a real-to-life experience.  In the medical training arena there are dolls that look like and act like real patients.  Some of these can be and are used in examination and training settings.  We no longer rely solely on actors playing patients. 

What we need to do as individuals, as interested parties, as professionals start the movement.  Verification by demand. 

It won’t stop all errors, but it will provide documentation of meeting requirements and help professionals become aware of potential weaknesses, and provide our customers, our patients and their families with the confidence that we take Quality Monitoring and Quality Improvement seriously.

TRUST ME!!!

Quality and Error and Standardization of Laboratory Reports

Over the last while I have been reading about and hearing presentations on Electronic Health Records.  The concept is that EHRs while expensive, and difficult to establish, once established will revolutionize care.  Dependence on having access to every clinician’s records will become a non-issue.  Test results will be readily and rapidly available side-by-side by date, rather than being in a separate record for each laboratory.  Repeat testing will become a thing of the past.  

Well it turns out that maybe by taking it very slow, we have done the right thing.  It may be that EHRs are going to be our Ford Edsel.  A whole slew of challenges have appeared.  Getting agreement on common EHR language is slow and painful.  And even if we have common language, many laboratory results are highly analyzer specific and not comparable across platforms.  And now some economic cracks are appearing [see: http://www.darkdaily.com/healthcare-observers-disagree-on-cost-effectiveness-of-electronic-health-record-systems-1116#axzz2CnmDcvnZ ]. 

So time will tell us soon enough whether EHRs are actually going to happen.  

But in the meantime, we still have a big problem that needs to be solved, one way or another.   

Several years back, I was in conversation with a group of pathologists all with particular interest in one particular anatomic target.  The group saw great opportunity to band together to create an on-call network so that there would always be pathology support for surgeons but at the same time they would also be free to work on their own research activities on a set schedule.  Because they were working as a team, they collectively agreed that if a doc called, he would get the on-call pathologist rather than a specific one.  Since they all basically had similar knowledge in the specific target, they could say that everyone was receiving a standardized level of care.  All that made infinite sense.  

Unfortunately the system started to break down after barely a few months.  The problem was that when it came to writing reports, each had their own style.  Some would construct separate sections within the report, while others preferred a narrative style.  Some were brief and precise, others were more verbose.  Some were heavily jargon enriched while others preferred to use both the accepted jargon, but also explanatory comments.  When we tried to establish a code to standardize reporting, the push-back was huge.  “No one is going to tell me how I can or will practice my craft.”  End stop.

It’s interesting that we also see this same mind-set in medical microbiology.  As much as we have much commonality to microbiology test methods, there is no requirement that these “standard” test methods actually get used.  There is no requirement that all microbiology laboratories use uniform microbial nomenclature.  There is no requirement that all microbiology laboratories use a common set of interpretive or cautionary notes; where common concepts get reported, they are as often as not crafted with personalized verbiage.  

We microbiologists are a highly individualized and ornery group.  “My laboratory … My way”.  It’s not that we are resistant to change [for a read on Luddites see: http://www.medicallaboratoryquality.com/2011/11/innovation-and-medical-laboratory-part.html ], it’s more that we sometimes get more locked into our own subtleties than in adopting general principles.   

Example 1:

At CMPT, our proficiency testing program, we promote common concepts, such as requiring the reporting of “Methicillin Resistant Staphylococcus aureus (MRSA)” rather than “ Staphylococcus aureus ; R-Oxacillin”.  

Clinicians understand that MRSA is a signal that Infection Control needs to be contacted.  Laboratories that choose to not use that terminology put patients at risk.

Example 2:

I understand that the problem is not necessarily an ego issue.  Sometimes it is our technology.  A number of years back at CMPT we sent out a simulated urine culture with a heavy and pure coliform, suggestive and supportive of a urinary tract infection.  [see: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3327405/ ]  Unfortunately because of the limitations of the LIS systems available at the time the results came back in 14 different styles of units, and rarely with a confirmation comment (consistent with urinary tract infection).  When we send out reports as either 1X10^5 bacteria/mL or 1000X10^5 bacteria/L or 1X10^8 bacteria/L, we can not be particularly surprised when confusion sets in (Note:  all these values are the SAME!). 

What concerns me is that for us, microbiology is what we do and understand.  That is not the case for clinicians.  When we refuse to adopt even simple rules for standardizing the text of reports, then we increase the risk of people misinterpreting our reports, and open the gates to error.    And now that many patients can receive reports directly, without any health care intermediary, our level of hazard and risk grows substantially.  

So here’s the bottom line.  Waiting for EHRs to solve our reporting standardization problems is a time killer and potentially a patient killer.  Simple low tech solutions are available, and we avoid them at our peril.