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Sunday, September 9, 2012

Quality - the Consumer and Point-of-Care


One of the advantages of having worked in and around a field like healthcare for a long time, is that you have the opportunity to have seen what trends are sticking and which are flash faux-trends.   Training technologists was redundant because there was a glut of readily available personnel, and the laboratory was likely to disappear anyways.  Microbiology culture plates were going to be replaced by the monoclonal antibodies and/or microarrays.  Distributed laboratory services could be consolidated to a single facility.  All are good examples of faux-trends and bad ideas.
But there are some trends that have sustained over the long haul.  Every once in a while it is necessary to make sure that we are aligned to the trends, especially within the Quality Partner community. 

Some examples include:
In many countries people are living longer and healthier.
Healthcare facilities are more specialized and sophisticated.
Healthcare service delivery is being provided less often in hospitals.
Consumer healthcare (eye care, lifestyle management, cosmetic care, supportive care, pharmaceutical alternatives, point-of-care testing, etc) is becoming increasingly available and more mainstream.
Consumer is becoming more knowledgeable and assertive in care and management
Immigration patterns create diversity  to healthcare delivery

In health delivery some of these trends are having a monumental effect.   “Elder care” now accommodates a much broader level of health from the fit-and-trim, to the metabolic-syndrome sufferers and on to those with significant age-related mental and physical impairments.  The demand for knowledgeable and skilled geriatric specialists has put huge demands on the education providers for nurses, physicians, dentists, physiotherapists, nutrition therapists, and occupational therapists.  

For hospitals the transitions of the last 25 years may equal the impacts of change as they occurred in the 19th and most of the 20th centuries.  In the early years with the growth and development of modern surgery and obstetrics and antibiotics for infants and children, hospitals grew larger and larger, sometime creating as many problems as they solved.  Patients came into hospitals for weeks and months, sometimes to die due to hospital complications.  Today hospitals beds are getting fewer and fewer.  Nightingale wards are gone, soon to be followed by the elimination of 4-bed and 2-bed rooms, with only single rooms and special care units being available.  People come into hospital not for weeks, indeed often not for days; more often now only for hours.  Much of the residential or “hotelling” nature of hospitals is gone.  

So how do these trends impact on the laboratory?  

First and most obvious, is that as pressure on hospitals to reduce has increased, the cut-backs and consolidation to laboratories have compounded.  This has not had much effect on the care for the urban dweller, but has not been particularly beneficial for the rural community.  I have mentioned this before, and will again, later.

And immigration and age have created all sorts of challenges for the medical laboratory with impacts on reference ranges, on diagnostic requirements, and interpretations.  (Again, more on this later.)

But again I want to focus on a key interest of mine: the impacts of consumer power.  I have mentioned before that the demands and expectations for Quality have never been greater, and the impacts of poor quality explode in the media, and the courtroom and the halls of the regulators.  Laboratorians need more and better tools to ensure that they can demonstrate their quality systems are intact.  That creates pressure on the accreditation bodies, the proficiency testing bodies, the suppliers and the educators; making mistakes is a problem, failure to address mistakes is disastrous.   As the level of Risk and liability climbs, the option to opt out becomes more viable.  

But there is opportunity too.  Consumers don’t care if a test is done by point-of-care or in a reference facility; either way they expect to get a meaningful and interpretable result.  A wrong result that leads to a bad outcome is a problem regardless.  Point-of-care users have as many demands for Quality as do the laboratories.  There are lots of examples of the impact of poor point-of-care quality [see http://sanfrancisco.cbslocal.com/2012/03/05/sfpd-breathalyzer-error-puts-hundreds-of-dui-convictions-in-doubt/ ]   A recent article in Medical News Today points to the increasing issues medical error associated with poor point of care practices and the absence of sufficient guidelines see http://www.medicalnewstoday.com/articles/239960.php.   I argue that as point-of-care becomes more prevalent and more outside the traditional medical and laboratory settings, consumers expectations will become greater.  The pressures on storefronts and non-traditional clinics will increase, and the demands for standards and guidelines and challenge materials will increase.

As an addendum, I note with interest that the US Joint Commission is cutting back on its Quality requirements for tests waived by CLIA [see http://www.jcrinc.com/Joint-Commission-Requirements/Laboratories/#WT]  .  

Clearly their view is different from mine.  

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