In response to comments from Donna Kinney dated 17 Apr 1995:

        (1) When I suggested that we should all agree to approach the
issues raised by CLIA 88 from the perspective of the patient, DK replied
that "patients don't want to make extra trips to reference labs and
return visits to doctors to discuss test results.  They would prefer
`one-stop shopping.'"  Undoubtedly this is true, but the issue must be
to distinguish what is truly _best for_ the patient from what is
_convenient_ for the patient.  We must not sacrifice medicine for public
relations.
        (2) When I said that "it should be clear that the patient would
be ill-served if we were to jettison quality control in the name of
turn-around-time," DK responded that "there was NO evidence of a quality
problem in physician office labs."  It seems to me that DK's implication
is that physicians are above error by virtue of the fact that they are
MDs.  The argument that there should be no QC in a POL because an MD is
in charge is a non-starter.  Human and technical errors occur within
clinical labs and POLs, but DK wants to exempt POLs from the QC which
can detect these errors.
        (3) As I said, "you might be able to make a case for [exempting
wet mounts from the rigors of CLIA 88], but in that case you are arguing
for a single test, and CLIA is about controlling quality in all testing."
DK responded "and that is part of the problem.  There is no reason for a
physician to need a CLIA certificate before he can perform a pregnancy
test which is available to patients in drug stores."  I accept her logic,
but she seems to have failed to notice that she has undermined her initial
premise, which was that physicians should be TOTALLY exempted from CLIA 88.
DK makes a good argument for eliminating regulation on very simple tests,
but then she wants us to believe that by eliminating regulation on ALL
testing that patient care will somehow magically be improved.  She offers
no convincing or even supporting evidence in favor of this remarkable
extrapolation.
        (4) Sadly, I must quote extensively from DK:  "The original wording
of the implementing regulations would have virtually required all physicians
to hire MTs if they wished to do any testing."  [Why aren't the physicians
capable of living up to the QC and PT standards that MTs accept as reason-
able _without_ hiring MTs?]  "This in spite of the fact that MTs are not even
trained in some of the specialized microscopic exams that certain specialists
perform."  [I don't deny that specialized testing occurs; I have not seen any
regulation which requires physicians to hire MTs, however.]  "As it is, MTs
are hired in large numbers by the government and by other organizations to
inspect physician offices to make sure that all their documentation and
paperwork meet CLIA standards."  [I am not competent to argue one way or the
other on this point; I do wonder, however, whom DK would prefer to perform
inspections instead of those who maintain the highest level of expertise in
clinical laboratory testing.]  "Furthermore, the closing of POLs has caused
increased business for clinical labs.  As a consequence of CLIA 88, everyone
is profiting EXCEPT patients and their physicians.  There is nothing
accidental about this.  The groups who are profiting are the groups who
lobbied hardest for this legislation."  [I would like to see some references
to the claim that clinical lab workload has increased as a direct consequence
of POLs closing.  Such references may exist, but I have not seen them, and I
am skeptical of this argument.  I certainly see no reason to believe that
patients have suffered because physicians must perform QC testing:  on its
surface, this claim seems far-fetched at best, and DK has provided no evidence
to support it.  I do believe that POLs that either would not or could not
comply with QC standards see less profit under CLIA 88, but that does not
translate to diminished patient care.
        (5) DK declined to address my main point raised on 15 April 1995.
What is inherently wrong about having a universal, minimal standard of QC
and PT testing for anyone performing clinical laboratory testing?  It seems
obvious to me that a uniform standard would be in the absolute best interest
of the patient, and I would like to hear DK defend how a double standard will
help the patient.  CLIA 88 is imperfect, both for the POL and for the clincal
laboratory.  But how can you justify exempting the POL but not the clinical
lab from QC and PT testing?
        (6) I'll close with a few comments recently forwarded to me from an
MT much better versed in the history of laboratory regulation than I:  "In
1967 the first CLIA affected all labs with 10,000 or more reported tests per
year.  The personnel standards required that you have at least 90 hours of
post secondary education to report a value in these settings without a
supervisor review.  This affected all hospitals and most large reference
labs.  The CLIA 88 attempted to bring all testing personnel under a CLIA
ruling [that covered] POLs, mall cholesterol testing, etc, etc.  The new
personnel standards stated that high school graduates could report results,
but by 1997 everyone would have to have at least an associates degree.
This increased qualification [standards] for some, but is actually decreasing
the requirements for hospitals.  The AMA and AHA are trying desperately to
have CLIA 88 repealed.  Should this happen, there will be no personnel
standards.  The AHA would love to replace anyone they can for a less
expensive person.  The fact of the matter is then 45% of all decision on care
and treatment of patients will come from people with no qualifications.  In
other words, the person that is qualified to do DNA testing in the OJ
Simpson trial will have the same credentials as the person pouring Slurpees
at the Circle K. . . .These people just don't seem to realize that lab tests
are currently performed by people who essentially have majors in chemistry,
biology, and medical technology.  When you drop from 95% proficiency to
60% proficiency, perhaps someone will notice."
==============================================================================
Bob R. Bogle, MT(ASCP),CLS(NCA)         Voice:   (520) 694-6107

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<advance apologies for large deletions due to length>  

:       (2) When I said that "it should be clear that the patient would
: be ill-served if we were to jettison quality control in the name of
: turn-around-time," DK responded that "there was NO evidence of a quality
: problem in physician office labs."  It seems to me that DK's implication
: is that physicians are above error by virtue of the fact that they are
: MDs.  

That is certainly not what I intended to imply.  Quality control is
important, but there is no reason to regulate it by adding mounds of
paperwork and government inspections, etc.  Physicians have plenty of
incentive to see that they diagnose and treat their patients correctly.  
If you have any doubt of that, you might want to have a conversation with
a malpractice attorney.

:       (4) Sadly, I must quote extensively from DK:  "The original wording
: of the implementing regulations would have virtually required all physicians
: to hire MTs if they wished to do any testing."  [Why aren't the physicians
: capable of living up to the QC and PT standards that MTs accept as reason-
: able _without_ hiring MTs?]  

They are certainly capable.  The original draft of the CLIA requirements
contained personnel standards would not have qualified physicians to
perform essential roles in their own office labs.

"This in spite of the fact that MTs are not even
: trained in some of the specialized microscopic exams that certain specialists
: perform."  [I don't deny that specialized testing occurs; I have not seen any
: regulation which requires physicians to hire MTs, however.]

Re-read the personnel qualifications section of the original regs.

  "As it is, MTs
: are hired in large numbers by the government and by other organizations to
: inspect physician offices to make sure that all their documentation and
: paperwork meet CLIA standards."  [I am not competent to argue one way or the
: other on this point; I do wonder, however, whom DK would prefer to perform
: inspections instead of those who maintain the highest level of expertise in
: clinical laboratory testing.]

There is no demonstrated need for ANYONE to inspect physician office
labs.  The current regulations have created a ludicrous situation where
MTs are inspecting the labs of physicians WHO WROTE THE BOOKS that the
MTs were taught from.

I am certainly not opposed to QC.  But QC does NOT necessitate government
intervention.  QC happens all the time, in all industries, without
government supervision or regulation.  In this case we have implemented
extremely costly and intrusive government regulation, in the absence of
any evidence of a detectable problem.    

As to the issue of personnel qualifications, I do not understand why the
government should need to regulate this.  Certainly they do not set
hiring criteria for other employers.  Employers hire the people with the
expertise to do a given job.  If they need an engineer, it is not
necessary to write government regulations to prevent them from hiring
illiterate people to fill that job.  Perhaps you can explain why you
think that government intervention is necessary in the job market for MTs.

The reference labs did (still do?) have a detectable problem, at least
with Pap smear testing.  Furthermore, the CLIA regulations are written in
such a way that they generally co-incide with safe practice IN
HIGH-VOLUME TESTING ENVIRONMENTS.  The effort to apply those same
standards to physicians offices is a clear attempt on the part of the
laboratory industry to shut down physician office labs, as an effort to
eliminate the competition.  That effort has been successful and a
majority of physicians have either closed their labs or reduced their
test menus.  

There is absolutely no reason to assume that quality does not occur in
the absence of federal regulation.  The government should only intervene
to protect patients when there is a proven failure, and after other
efforts have failed.  Then it should use the minimum necessary
intervention.  By these criteria, the CLIA regulation of physician office
labs fails on all counts.

Thank you for your comments and the opportunity to debate this issue.  I
have cross-posted to talk.politics.medicine.
--
Donna Kinney                    | My views are mine, alone.  It's unlikely

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