[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
CLINICAL LAB QUALITY: OVERSIGHT WEAKNESSES UNDERMINE FEDERAL STANDARDS
=======================================================================
HEARING
before the
SUBCOMMITTEE ON CRIMINAL JUSTICE,
DRUG POLICY, AND HUMAN RESOURCES
of the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
JUNE 27, 2006
__________
Serial No. 109-221
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
http://www.house.gov/reform
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee DIANE E. WATSON, California
CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California LINDA T. SANCHEZ, California
JON C. PORTER, Nevada C.A. DUTCH RUPPERSBERGER, Maryland
KENNY MARCHANT, Texas BRIAN HIGGINS, New York
LYNN A. WESTMORELAND, Georgia ELEANOR HOLMES NORTON, District of
PATRICK T. McHENRY, North Carolina Columbia
CHARLES W. DENT, Pennsylvania ------
VIRGINIA FOXX, North Carolina BERNARD SANDERS, Vermont
JEAN SCHMIDT, Ohio (Independent)
------ ------
David Marin, Staff Director
Lawrence Halloran, Deputy Staff Director
Teresa Austin, Chief Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
MARK E. SOUDER, Indiana, Chairman
PATRICK T. McHenry, North Carolina ELIJAH E. CUMMINGS, Maryland
DAN BURTON, Indiana BERNARD SANDERS, Vermont
JOHN L. MICA, Florida DANNY K. DAVIS, Illinois
GIL GUTKNECHT, Minnesota DIANE E. WATSON, California
STEVEN C. LaTOURETTE, Ohio LINDA T. SANCHEZ, California
CHRIS CANNON, Utah C.A. DUTCH RUPPERSBERGER, Maryland
CANDICE S. MILLER, Michigan MAJOR R. OWENS, New York
VIRGINIA FOXX, North Carolina ELEANOR HOLMES NORTON, District of
JEAN SCHMIDT, Ohio Columbia
Ex Officio
TOM DAVIS, Virginia HENRY A. WAXMAN, California
J. Marc Wheat, Staff Director
Michelle Gress, Counsel
Malia Holst, Clerk
Tony Haywood, Minority Counsel
C O N T E N T S
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Page
Hearing held on June 27, 2006.................................... 1
Statement of:
Aronovitz, Leslie G., Director, Health Care, GAO............. 14
Hamilton, Thomas, Director, Survey & Certification Group,
Centers for Medicare and Medicaid Services, U.S. Department
of Health and Human Services............................... 49
O'Leary, Dennis S., M.D., president, Joint Commission on
Accreditation of Healthcare Organizations; Thomas Sodeman,
M.D., president, College of American Pathologists; and Doug
Beigel, chief executive officer, COLA...................... 80
Beigel, Doug............................................. 96
O'Leary, Dennis S........................................ 80
Sodeman, Thomas.......................................... 90
Letters, statements, etc., submitted for the record by:
Aronovitz, Leslie G., Director, Health Care, GAO, prepared
statement of............................................... 16
Beigel, Doug, chief executive officer, COLA, prepared
statement of............................................... 98
Cummings, Hon. Elijah E., a Representative in Congress from
the State of Maryland, prepared statement of............... 9
Hamilton, Thomas, Director, Survey & Certification Group,
Centers for Medicare and Medicaid Services, U.S. Department
of Health and Human Services, prepared statement of........ 52
O'Leary, Dennis S., M.D., president, Joint Commission on
Accreditation of Healthcare Organizations, prepared
statement of............................................... 83
Sodeman, Thomas, M.D., president, College of American
Pathologists, prepared statement of........................ 92
Souder, Hon. Mark E., a Representative in Congress from the
State of Indiana, prepared statement of.................... 4
CLINICAL LAB QUALITY: OVERSIGHT WEAKNESSES UNDERMINE FEDERAL STANDARDS
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TUESDAY, JUNE 27, 2006
House of Representatives,
Subcommittee on Criminal Justice, Drug Policy, and
Human Resources,
Committee on Government Reform,
Washington, DC.
The subcommittee met, pursuant to notice, at 2:06 p.m., in
room 2247, Rayburn House Office Building, Hon. Mark E. Souder
(chairman of the subcommittee) presiding.
Present: Representatives Souder, Schmidt, Cummings, Davis,
Watson and Norton.
Staff present: Michelle Gress, counsel; Malia Holst, clerk;
Tony Haywood, minority counsel; and Teresa Coufal, minority
assistant clerk.
Mr. Souder. The subcommittee will come to order.
Good afternoon. I thank all of you for being here.
We're here today to discuss the findings and
recommendations of a GAO report requested by Mr. Cummings, the
ranking member of this subcommittee, Senator Grassley and
myself.
We asked the GAO to investigate oversight of clinical labs
and implementation of quality requirements imposed through the
CLIA, the Clinical Lab Improvement Amendments of 1988. In
particular, we requested that GAO assess quality of lab testing
and the adequacy of CLIA oversight.
Lab testing is a vital link in our Nation's healthcare
system. Lab tests affect an estimated 70 percent of medical
decisions and are one of the most frequently billed Medicare
procedures. Accurate results are necessary for determining
proper treatment of patients, while erroneous results can lead
to the wrong treatment decisions with potentially detrimental
effects for the patients, and quite possibly unnecessary mental
anguish.
The resulting report by the GAO, ``Clinical Lab Quality:
CMS and Survey Organization Oversight Should Be Strengthened,''
is a sobering evaluation of the current state of clinical lab
oversight and the quality assessment deficiencies that exist
across the country for monitoring the Nation's 193,000 labs.
Our request of the GAO was prompted by problems at the
Maryland General Hospital that came to light in 2004. Maryland
General Hospital's lab issued more than 450 questionable HIV
and hepatitis test results. The College of American
Pathologists [CAP], inspected and accredited Maryland General
Hospital during the 14-month period that the lab was issuing
the questionable results. CAP's inspections failed to identify
the ongoing deficiencies in lab testing at the Maryland General
facility.
Maryland General's situation was compounded by numerous
problems and deficiencies in reporting and evaluation of the
lab, prompting this subcommittee, at the request of Mr.
Cummings, to hold two hearings to investigate the issues that
led to the deficiencies at Maryland General Hospital and how
these problems went undetected and unaddressed for such a long
period of time. The subcommittee was concerned then, as it is
now, that a similar situation might repeat itself at other
hospitals or labs in other parts of the country.
Today's release of the GAO report demonstrates that there
are several areas where clinical lab quality oversight by the
Centers for Medicare and Medicaid Service is deficient. The
problems flagged by the GAO show quite clearly that despite
CMS's responsibility for overseeing the quality of our Nation's
labs, there is insufficient data for measuring the seriousness
or extent of the problems.
While the responsibility for ensuring lab quality
ultimately lies with CMS, lab survey and accreditation is
handled largely by independent national accrediting
organizations. Ninety-seven percent of all accredited labs are
surveyed by three accrediting organizations, each of which has
three representatives here today to testify, the College of
American Pathologists [CAP]; COLA, formerly known as the
Commission on Office Laboratory Accreditation; and the Joint
Commission on Accreditation of Healthcare Organizations
[JCAHO]. Two States, New York and Washington, are CLIA-exempt,
but have State survey programs.
Each of the survey organizations measure labs using
standards that CMS has determined are at least equivalent to
CLIA standards. And the survey organizations are required to
conduct complaint investigations and monitor proficiency test
results. In theory, this arrangement should ensure that
accredited labs have been inspected on a reasonable periodic
basis and found to meet CLIA standards. Nonetheless, GAO found
that in contemporary practice, it is impossible to get a true
picture of lab quality standards.
Among the problems flagged by the GAO and which we will
explore today are: Survey organization standards are not
standardized with CLIA requirements, making it impossible to
measure lab quality nationwide in a standardized manner; lab
quality deficiencies may not be reported due to accrediting
agencies' emphasis on education or enforcement; whistleblower
protections don't exist for all survey organizations, including
COLA, which does not have a formal whistleblower policy. Lab
sanctions are rarely imposed; in fact, out of more than 9,000
labs that had sanctions imposed, only 501 labs were actually
sanctioned by CMS from 1998 to 2004.
Despite the fact that there is a solid framework for what I
believe should be a workable system to ensure lab quality, GAO
has found that in current practice the oversight by CMS is
deficient, making it impossible to accurately measure the
effectiveness of independent survey organizations.
Today's hearing will explore the GAO's findings and
recommendations and give CMS and survey organizations an
opportunity to present ways to improve the current situation so
that what happened at Maryland General Hospital does not repeat
itself anywhere else in the country.
Our first witness is Leslie Aronovitz, Director of the
Health Division, U.S. Government Accountability Office [GAO].
We will then hear from Mr. Thomas Hamilton, Director of the
Survey and Certification Group at the Centers for Medicare and
Medicaid Services.
Our last panel will include Dennis O'Leary, M.D., president
of the Joint Commission of Accreditation of Healthcare
Organizations; Doug Beigel, chief executive officer of COLA;
and Thomas Soderman, M.D., president of the College of American
Pathologists.
Thank you all for being here today, and we look forward to
your testimony and insights.
[The prepared statement of Hon. Mark E. Souder follows:]
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Mr. Souder. I now yield to Ranking Member Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman. And I
thank you for holding today's hearing to examine findings and
recommendations set forth in the GAO report entitled ``Clinical
Lab Quality: CMS and Survey Organization Oversight Should Be
Strengthened.''
I want to thank Senator Grassley and you, Mr. Chairman, for
joining me in asking GAO to conduct the investigation that led
to this eye-opening report.
As you know, Mr. Chairman, the GAO report that we are
releasing today cites numerous weaknesses in the operation and
oversight of the Federal program for ensuring quality medical
testing and labs that seek Medicare reimbursement for
performing medical testing.
Enacted in 1988, the Clinical Laboratory Improvements Act
established within the Centers for Medicare and Medicaid
Services the program for implementing, enforcing and overseeing
stringent Federal regulations governing the operation of these
labs.
The CLIA statute reflects Congress' recognition of the
fundamental role of medical testing and the delivery of medical
care and treatment. Plainly, physicians and patients must have
accurate medical test results in order to make appropriate
medical decisions.
On March 11, 2004, an article in the Baltimore Sun broke
the story of a lawsuit filed by Christine Turner, a young lab
technician at Maryland General Hospital who 1 year earlier
contracted HIV and hepatitis C when the machine used to test
blood samples malfunctioned, spraying Ms. Turner with infected
blood. After being terminated from employment in December 2003,
Ms. Turner reported the matter to State health officials,
triggering an investigation by the State health department in
January 2004, and followup inspections involving the State
health department, CMS and the Joint Commission on
Accreditation of Healthcare Organizations.
The College of American Pathologists, a private accrediting
organization responsible for accrediting the Maryland General
lab under the CLIA program, was not informed of the complaints
by the other parties, and conducted a separate investigation
after learning of the lab's problems by way of news reports.
CAP's inspection resulted in the revocation of the lab's
accreditation in two key testing areas. Ultimately the
investigations established that between June 2002 and August
2003, more than 2,000 patients were issued invalid HIV and
hepatitis C test results by Maryland General Hospital. The
investigative report cited numerous deficiencies, indicating
the lab had not been in compliance with CLIA standards for a
prolonged period of time.
In May and July 2004, this subcommittee held hearings aimed
at determining how the serious deficiencies at Maryland General
Hospital could have gone undetected for so long despite the
safeguards established by CLIA, the CLIA process, to ensure
that patients receive accurate and reliable test results. CAP,
after all, had conducted an accreditation survey while the
deficiencies were ongoing, but having failed to identify the
problems during their survey, CAP awarded Maryland General Lab
its Accredited with Distinction certificate, certifying the lab
as being in compliance with CLIA standards and additional
requirements established by CAP.
In addition, the Maryland Health Department had conducted
an investigation in response to a July 2002 whistleblower
complaint. Later, then-Health Secretary Nelson Sabatini stated
that the complaint was too vague to lead inspectors to uncover
the problems found during the inspections that followed Ms.
Turner's complaint.
During our hearings, witnesses cited the following factors
as contributing to the failure of the CLIA process to detect
serious deficiencies in Maryland General Hospital laboratory:
One, fear of retaliation among lab workers for reporting
problems; two, advance notice of accreditation surveys allowing
labs to hide deficiencies; three, an emphasis on collegiality
and education over aggressive investigation during
accreditation surveys; and four, failure to communicate
complaint information between the State and the private
accreditation organization.
Witnesses from CMS and the College of American Pathologists
testified that they had not seen such an extreme case before,
and that they believe that the Maryland General Hospital
situation was an aberration. They felt this in part because of
the lengths to which the lab had gone to purposely cover up
problems, efforts that included falsifying quality control
readings from a device used to test blood samples for HIV and
hepatitis C.
But CMS and CAP could not say with any degree of certainty
that what occurred at Maryland General Hospital could not occur
elsewhere. At best, Maryland General demonstrated that the CLIA
problem was not completely foolproof. Possibly it indicated
weaknesses in the program's overall operation and oversight.
In order to understand the extent to which labs across the
country were experiencing serious quality problems, Chairman
Souder and I asked the GAO to do the following examination. We
wanted them to examine the quality of lab testing under CLIA.
We wanted them to examine the effectiveness of accreditation
surveys, complaint investigations and enforcement actions in
detecting and addressing lab problems. And we also wanted them
to examine the adequacy of CMS's CLIA oversight.
Disturbingly, the GAO report to Congress concludes that
insufficient data exists to identify the extent of serious
quality problems at labs. Effective oversight and
accountability of any Federal program requires useful and
reliable data. The lack of critical data found by GAO is
distressing because it undermines the fundamental purpose of
the CLIA problem. This is plainly unacceptable and must be
remedied.
In addition, GAO found numerous weaknesses in the exercise
of oversight by CMS and State and private survey organizations
that accredit labs under the CLIA program. According to the
report, these shortcomings render CLIA oversight, ``inadequate
to ensure that labs are meeting CLIA requirements.''
In particular, the report underscores three prominent
concerns expressed by whistleblowers during the subcommittee's
2004 hearing, namely--and I'm about to close, just a little bit
longer, I just want to get all this in--fear of retaliation
among lab workers is an obstacle to the reporting of serious
lab deficiencies by employees. The strong emphasis of
accreditation organizations on education tends to make the
masking of deficiencies easier, and the imposition of sanctions
for deficiencies that are found less likely. And finally, the
composition of CAP survey teams may undermine their
objectivity.
The report also notes that inconsistencies in the
imposition of CMS sanctions make it unclear how effective CMS
enforcement is at compelling labs to comply with the CLIA
requirements, and that CMS is failing to ensure in a timely
manner that updated standards by accreditation organizations
meet requirements for equivalency with CLIA standards.
To correct these shortcomings GAO reported that CMS take a
number of actions including the following: standardizing the
reporting of survey deficiencies to permit meaningful
comparisons across survey organizations; working with survey
organizations to ensure that educating lab workers does not
preclude appropriate regulation, such as identifying and
reporting deficiencies that affect lab-testing quality; and
allowing the CLIA program to fully use revenues generated by
the program to hire sufficient staff to fulfill its statutory
responsibilities.
My own proposals for congressional action are set forth in
legislation that I introduced back in October 2004, and that I
reintroduced, along with Congressman Ruppersberger, in the
109th Congress. The Clinical Laboratory Compliance Improvement
Act, H.R. 686, will establish whistleblower protections for
employees of clinical labs; require labs to post signage to
facilitate reporting of lab problems to CLIA entities; require
survey organizations to report complaints of deficiencies to
the Secretary of HHS; and require lab accreditation surveys to
be unannounced. I believe the GAO report underscores the need
for enactment of this legislation.
And so, Mr. Chairman, I'm looking forward to hearing from
our witnesses today. I think that without a doubt this is a
very important subject for all of us. I cannot think of
anything that is more significant when you consider that all of
us, everybody sitting in this room, everybody sitting in this
room has had some kind of test that determined what their
status, health status, may have been and were treated or not
treated according to those test results. And we in this country
simply cannot afford to have anything but the very best in
testing.
And again, Mr. Chairman, I thank you for your working with
me on this. And we will continue the fight to make sure that
all Americans are protected. And with that, I yield back.
[The prepared statement of Hon. Elijah E. Cummings
follows:]
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Mr. Souder. Ms. Schmidt, do you have questions?
Ms. Schmidt. No.
Mr. Souder. Ms. Norton.
Ms. Norton. Mr. Chairman, I just want to thank you and Mr.
Cummings for working together on this issue, which I can only
call frightening.
I think this may be the third hearing we've had on this
issue. I certainly hope it leads to action.
I know we've been waiting for the GAO report. You know,
when you first hear of the Maryland incident--we heard about it
perhaps closer than some others because, of course, Baltimore
is so close, but what bothered me was knowing Maryland to be a
high-quality health State, I couldn't believe that this was an
isolated incident. And we talk about life and death, that's a
cliche when it comes to lab results.
It does seem to me, Mr. Chairman, that we want Federal
standards that were enforceable for the same reason that this
committee has been pressing--not this committee, excuse me, Mr.
Chairman, that one of the subcommittees has been pressing for,
computerized medical records, is because this is no longer a
matter of your local hospital. If you get, I don't know, tests
done at Washington Hospital Center, they may be used at Johns
Hopkins, especially in an emergency.
So this is a real threshold issue, and yet there's been
much more focus in the United States on mistakes made in
hospitals. Yeah, I want to know about mistakes made in
hospitals, but we may never know that the mistake originated in
the hospital if we don't have a way of finding out whether the
tests themselves, which we assumed, we all assume, have been
correct and valid, were not part of the problem.
I was very troubled by what I learned about the GAO report,
but perhaps it was to be expected, and that is, you know, we
can't even compare; we don't have any data that allows us to
compare, much less Federal standards.
Mr. Chairman, what is frightening about this is the only
way this came to attention was newspaper reports--thank you,
Baltimore Sun--and a catastrophic accident. That's liability.
So essentially, despite all the accreditation
paraphernalia--that's what it turned out to be--they were
outside institutions, the courts and the newspapers, that
alerted us to what we were told would be uncovered by various
organizations that deal with the State and with local agencies.
So I would think, Mr. Chairman, that at a minimum we would want
to begin with the Cummings bill to respond to this situation.
We may need more.
I'm impressed--and Mr. Cummings deals in his bill with the
whistleblowing notion. It does seem to me that's the one thing
everybody in Congress agrees upon. Somebody ought to be able to
step forth and tell it without fearing that he would lose his
or her position. But it does seem to me that, given the top
rating that the Maryland lab received, we have a serious
problem with regulation, and we need to attend to it as soon as
we can.
Thank you very much for doing the work, it seems to me,
that can lead to that kind of action and enforcement
improvement.
Mr. Souder. Thank you.
I ask unanimous consent that all Members have 5 legislative
days to submit written statements and questions for the hearing
record, and any answers to written questions provided by the
witnesses also be included in the record. Without objection,
it's so ordered.
I also ask unanimous consent that all exhibits, documents
and other materials referred to by the Members and witnesses
may be included in the hearing record, and that all Members be
permitted to revise and extend their remarks. And without
objection, so ordered.
First panel is Leslie Aronovitz. And so if you will stand
and raise your right hand. It's the practice of this committee
to swear in each of our witnesses.
[Witness sworn].
Mr. Souder. Let the record show that the witness responded
in the affirmative.
Thank you for joining us and your work on this study, and
we're looking forward to hearing your conclusions.
STATEMENT OF LESLIE G. ARONOVITZ, DIRECTOR, HEALTH CARE, GAO
Ms. Aronovitz. Thank you, Mr. Chairman and members of the
committee. I'm pleased to be here today as you discuss
oversight of clinical labs by CMS and survey organizations.
My remarks are based on a report that was released today
that focused on the 36,000 labs that perform moderate or high-
complexity testing. Survey organizations are responsible for
conducting biennial lab inspections and for investigating
complaints, and CMS's role is to ensure the thoroughness and
consistency of such inspections, and to impose sanctions when
it identifies poor lab performance.
Because of inadequate CMS oversight and limited comparable
data, too little is known about the quality of lab testing. In
2004, CMS modified historical State survey agency findings on
lab quality and did not maintain a backup file. Moreover, based
on interviews with 10 State survey agencies, we found that some
surveyors refrained from citing serious deficiencies if a lab
worker is new or a lab has a good compliance history.
Due to inconsistent surveys, the percentage of labs with
serious deficiencies varied considerably across States in 2004,
ranging from none in 6 States, to as much as 25 percent in 1
State.
Additionally, the lack of a straightforward method to link
similar requirements across survey organizations makes it
virtually impossible to assess lab quality in a standardized
manner. Proficiency testing, which measures a lab's ability to
consistently produce accurate test results, is the only data
set that can be used uniformly to compare lab quality
nationwide. Despite the importance of proficiency testing data,
CMS requires proficiency testing for labs three times a year,
as opposed to the statutory requirement for quarterly testing.
We also found that educating lab workers sometimes
precludes appropriate regulation. On more than one occasion,
CMS has provided labs with a significant educational period of
from 2 to 4 years before enforcing new requirements. We found
this long educational period to be particularly troubling for
the regulation of Pap smear testing for cervical cancer. CMS is
letting poor performers off the hook for 2 years, even though
labs have anticipated the new regulations for more than 13
years.
CMS also rarely uses sanctions to help deter noncompliance.
For example, only 30 of the 274 labs with serious repeat
deficiencies on consecutive surveys from 1998 to 2004 had
sanctions imposed. We also found that there are relatively few
complaints about lab quality problems. This may be due to
insufficient publicity on how to file a complaint, and privacy
complaints resulting from limited whistleblower protections for
lab workers.
Some survey organizations have operated without proper
authority and have utilized requirements that were less
stringent than CLIA because CMS has been an average of over 3
years late in determining whether their inspection requirements
are at least equivalent to CLIA's. Nor does CMS always review
interim changes prior to implementation. Although officials of
CMS attributed these delays to having too few staff, the CLIA
program is funded by lab fees and currently has a $70 million
surplus.
Finally, validation reviews. One of CMS's most important
oversight tools does not provide an independent assessment of
the extent to which surveys identify all serious deficiencies
because many are performed simultaneously with such surveys.
Moreover, CMS has not required that validations occur in
each State. From 1999 through 2003, 11 States had no validation
reviews in multiple years. And this is particularly troubling
to us because it is the State survey agencies that are
responsible for conducting validation reviews of accrediting
organization surveys.
Mr. Chairman, this concludes my oral statement, and I'm
happy to answer any questions you or other members of the
subcommittee may have.
[The prepared statement of Ms. Aronovitz follows:]
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Mr. Souder. Before I start my questioning, I wanted to--
because these hearing records are a kind of a permanent record
for people to go back through, and I have no prepared
questions, I have no agenda with this, it's more of a generic
question. And I know that you could provide more specific data
if we want later, but I just wanted a general idea. When you do
a study like this--you head the Health Division at GAO?
Ms. Aronovitz. I'm one of six Directors that work with the
Director of our Health Division.
Mr. Souder. And then do you have--then when you decided to
go ahead with this study, did you have some people on staff,
and then you contracted with others? Could you kind of walk
through a little bit what you do to prepare a survey like that?
Ms. Aronovitz. Sure. We sometimes do use contractors or
other experts when we do a study of this enormity, but we
actually did this study in house. We used experts to consult
with to make sure we understood the meaning of different terms
and terminologies, but because we were looking at oversight
mechanisms and different administrative and other types of
logistical and regulatory requirements, which is more within
our bailiwick, and not scientific or clinical requirements, we
did not need, in our minds, to go with specific medical or
clinical experts. In other words, we did not independently
assess the quality of any labs. That would have been well
beyond our expertise. What we did is try to see who is
responsible for overseeing the quality of labs and what types
of activities they were involved in.
Mr. Souder. So in the process here you would have talked
with each of the individual groups?
Ms. Aronovitz. Absolutely. We spent quite a bit of time
working with CMS, the two exempt State CLIA program
representatives, and the accrediting organization
representatives.
Mr. Souder. And with CMS themselves?
Ms. Aronovitz. Absolutely, extensively with CMS.
Mr. Souder. And you referred to--did you say you had 10
States respond in a survey?
Ms. Aronovitz. What we did is, in addition to working with
CMS, we also separately, independently interviewed 10 State
survey agencies to get their perspective.
Mr. Souder. Did you see anything as glaring as what we saw
in the Maryland General Hospital or cases like that?
Ms. Aronovitz. No. I think a lot of what we saw really has
to do with the regulatory structure and also the potential for
problems to occur. But we saw no specific cases that were
quite--that came to us.
Mr. Souder. When we look at the national CLIA requirements,
do you think there is an efficient and effective way to have
some sort of a national standard that would give us a clearer
picture and at the same time allow these different
organizations to have additive standards? One of the problems
we have in housing in all sorts of flood standards and
everything else is the Federal standards become the minimum--I
should say they become the maximum and drive everybody to one
standard which is not necessarily as high as some. Do you see
how to reconcile that question?
Ms. Aronovitz. It's a difficult one to reconcile. We think
the fact that the CLIA requirements give the accrediting
organizations the opportunity to have requirements that are
equivalent or even more stringent really goes far to really
push labs to try to have high quality. We're impressed with how
hard the accrediting organizations work, and the State exempt
programs, to develop standards that they feel, based on their
own clinical knowledge, are needed and required to do a good
job in a lab.
The problem we have is not with the types of requirements
that accrediting organizations develop, but the fact that when
they develop their own set of requirements, it becomes very
difficult for CMS to translate their findings and State
findings into one common language, and therefore it becomes
very difficult to look at the quality of labs across different
types of survey organizations. We think there has to be a
solution of some way that all the different organizations that
are serving labs could come to some type of language where they
could communicate to CMS what the serious deficiencies they're
finding are and how they translate.
For example, we actually asked the accrediting
organizations to supply us with a crosswalk to say if you find
serious deficiencies based on your requirements, how does that
translate to CLIA requirements? And COLA and CAP spent an
enormous amount of effort to try to provide us with a
crosswalk, which ended up really not being a good enough common
language. And JCAHO tried very hard to do that, but it would
have had to go through each individual case file to come up
with that information, which we thought was not fair to that
organization to have to do that. So right now it really leaves
CMS in a position where it cannot look at lab quality in terms
of the findings of these different survey organizations across
organizations.
Mr. Souder. One other question I wanted to raise. When I
was first elected to Congress and served on one of the
oversight committees, we were spending a lot of time with OSHA.
And one of the concerns in OSHA was how much they played
gotcha, put fines on, versus how much they spent educating and
working with different companies.
Here we have kind of the reverse question going on, and
it's a struggle of how we do this in government, because, in
fact, the oversight process, if it's not an egregious risk, I
think the way we worked through it in OSHA is now more than
half the funding they're to be given time to work through
something and educate through the process unless there is an
imminent health and life question.
Could something be worked through here? Because, in fact, a
lot of the oversight should be an education process, not a
gotcha process, because, in fact, often that drives more
complaints underground, less whistleblower because of fear of
retribution as opposed to cooperation; yet at the same time if
it's all just talk and nobody--there is never a sanction, it
doesn't leave much leverage either.
Do you have, as we work through this, a refined suggestion
of how we might balance this education and penalty sanction
question? And maybe it's pointed to by your just previous
answer, which is if it's egregious, it's one thing; if it's not
egregious, it's another; if we can agree on what's egregious.
Ms. Aronovitz. I think that's true, if we could agree on
what is egregious. The languages that different organizations
use really look at serious deficiencies, but their definition
of serious doesn't also translate to a CLIA definition of a
serious deficiency, so from that standpoint we still need a
common language.
But we've been wrestling a lot with this whole issue of
education versus regulation, and we in no way discount the
importance of having an educational component. What we worry
about is that an educational component, if it precludes a
regulatory one, and there is a slippery slope, there would come
to a point where you would never really know what the state of
lab quality is, and that's what really concerned us.
Specifically in certain cases where there were deficiencies in
consecutive surveys and the lab wasn't sanctioned, or in a case
where the quality control standards that CMS applied in 2003
that became effective in 2004, the labs had 2 years before a
deficiency would be noted, and now that has been extended 2
more years.
So what we worry about is by giving the labs every benefit
of the doubt and to try to train them and to try to make sure
that lab workers understand the requirements, we might be
leaning over so far to give them every educational opportunity
that we're really losing track of what the quality of labs are
so that we could react when there are serious deficiencies
noted.
Mr. Souder. Thank you.
Mr. Cummings.
Mr. Cummings. Yes. First of all, I want to thank you very
much for a very thorough report. And we truly appreciate the
role that GAO plays in providing us with the information we
need to do our jobs.
I want to just kind of go back just a moment. I know that
was not your focus, necessarily, the Maryland General case, but
it had some elements in it that I would just like for you to
comment on.
The chairman and I mentioned--and I think it was Ms.
Norton, too--the whole idea of the whistleblower and the
significance of the whistleblower. In your findings there was
some findings, if I recall--as I recall that there was an issue
of whether there was an open environment for people to feel
comfortable telling about what they see in these labs. And I
just want you to comment, if you can, on the significance of
the whistleblower and how that might--having a kind of closed
environment might hurt our efforts to make sure that our labs
are doing what they're posed to do.
Ms. Aronovitz. Yes. We did talk to several surveyors and
some lab workers, and also the 10 survey agencies at the State
level, and we heard that it was not that uncommon for two
things to happen, for lab workers not to be aware of how to
file a complaint, and also, when they were aware, that they
were worried about retaliation to the extent that the law or
the legal structure didn't really protect them or their
privacy.
It became very clear to us that a lab worker who would file
a complaint would probably have the best information and the
most specific information for an oversight entity to decide
whether this was a serious complaint and whether it warranted
further investigation. On the other hand, lab workers felt that
if they gave very specific information, they could easily be
associated with the labor, the type of equipment or the
department where the complaint came from, and therefore,
without very strong protections, and a really good
understanding of how to file a complaint, they were very
reluctant to do so, at least among the people we talked with.
When we went to the State survey agencies, we found that
some States possibly have whistleblower protections that would
protect lab workers, but many States said that they did not
have, even at the State level, the kind of protections that lab
workers would need. Obviously you know that at the Federal
level, there is no Federal statute, whistleblower statute, that
protects lab workers that are covered under CLIA, and not all
accrediting organizations have that either.
Mr. Cummings. And I would take it that, when you have a
situation where--when you answered Mr. Souder's questions about
how to--this fact that we have insufficient information to
accomplish what we need to accomplish here, I would take it
that the whistleblower, under those circumstances, becomes even
more significant, although we don't know, once they blow the
whistle, exactly what standards they might be using; is that a
fair statement?
Ms. Aronovitz. Right. I think once they would have to--once
they would file a complaint, it would have to be investigated
immediately--well, actually there would be a consideration as
to whether the complaint warranted an investigation, and then
it would have to be investigated, and the standards or the CLIA
requirements that would apply would then be looked at very,
very closely.
Mr. Cummings. Going back to the Maryland General case, one
of the problems was that there was a lack of sharing of
information. You could have one organization come in and say,
we've got problems; you could have a whistleblower out there
saying there are problems; then you have another organization
that comes in and says, my, you're doing a great job.
Can you comment on the sharing of information? Because I
think that's a very significant thing that has not been
happening, but I'm sure we'll hear from some of our
representatives on things they may be doing now.
Ms. Aronovitz. Yeah, I think you will. I think--this is--
excuse me, this is one of the areas that--another area that's a
very, very critical one, and one we're just beginning to see
some progress.
CMS has mentioned that it is establishing something called
performance reviews both with State agencies, but also with the
accrediting organizations. And with the accrediting
organizations, one of the most important performance areas will
be the extent to which accrediting organizations are able to
communicate with CMS and within its organization to make sure
that it understands what types of complaints and results of
proficiency testing have occurred, and to make sure that CMS is
aware of that also. So communication among entities is
critical, and it's one of the areas that CMS is going to be
focused on.
Mr. Cummings. Now, under these circumstances, going back to
the--one of the things that you have said in your report is
that even when CMS has the information, that they are not
necessarily effectively using the information that they have;
is that correct? Is that what you said?
Ms. Aronovitz. That is correct.
Mr. Cummings. Do you want to get some water?
Ms. Aronovitz. No, I'm fine. Thanks.
Mr. Cummings. All right. Can you explain that for us,
please? I mean, so they get the information, they get
information--maybe not all the information that they should
have, but they get it. But then the information that they do
have is not used effectively and efficiently.
Ms. Aronovitz. Well, this information is in several
different areas. One of the areas has to do with proficiency
testing. First of all, CMS requires proficiency testing for
every lab three times a year. We think the statute really
requires four times a year. So they're getting less information
than they should. And CMS justifies this and feels very
strongly that they have followed the law. And I could elaborate
on that if you'd like. I don't want to get into too much detail
if it's not relevant here.
But also on sanctions, for instance, as the chairman was
saying, there should be an ability for labs to be able to take
corrective action. There is a grace period for a lot of labs to
fix the problems that are noted in surveys; however, CMS has
sometimes bent over backward to give labs an opportunity to fix
problems where they just crop up again at the next survey, and
nothing more than that has happened.
So in some cases where there have been serious
deficiencies, there have not been sanctions, and it's because
the labs have been given an opportunity to correct the problem
without it really being noted.
Mr. Cummings. Speaking of correcting problems, I heard just
an incredible argument when we held hearings before with regard
to why unannounced visits would be a problem; it was almost
shocking to the conscience.
What we were told was that if there were unannounced
visits, they would be so disruptive to the lab that it would
just--the benefit just far outweighs the disruption. Did you
hear any of that as you talked to folks?
Ms. Aronovitz. We actually did hear that. We feel very
strongly that, to the extent possible, surveys should be
unannounced. Now, we do note that in small physician labs where
patients are coming in and seeing the doctor and getting lab
tests during those visits, it could be somewhat disruptive if
you have a team come in and pretty much take over the lab. So
we do understand that. We would expect some smaller labs to, in
fact, need an announced survey. However, the hospital labs
where there's people, there is many people that could work with
the surveyors, and there's always people onsite, it would be
much less necessary. And, in fact, some of the accrediting
organizations are beginning to do unannounced surveys.
The big issue that we have really has to do with the amount
of time that accrediting organizations or different survey
organizations are giving in terms of notifying labs ahead of
time. CMS's policy, when State survey organizations notify
labs, their policy is to give labs 2 weeks' notice. They feel
that's the right amount of time for a lab not to be able to go
back and react and change everything or fix everything, but, at
the same time, make sure that the proper people are there and
that it won't be too disruptive. On the other hand, there are
some survey organizations that give up to 12 weeks' notice. We
think this is excessive, and we think it's unnecessary.
So if, in fact, it's necessary to give labs some notice, we
think a 2-week unannounced--a 2-week notice period in
conformance with CMS's guidelines would be much more
appropriate.
Mr. Cummings. I'm just going to ask you a few more
questions because I know we've got to move on. But I want to
just go to the College of American Pathologists and some of the
things that they're trying to do. And the more I look at some
of the things that they're trying to do, the more I'm convinced
that maybe they--first of all, I believe they've apparently
seen the light, and the light is shining brightly, and that
perhaps it can shed some role modeling, at least so far, for
some of the other survey organizations. But I just want to get
your comments on some of the things that they're doing and how
what they are doing there fits into what you all found and what
you all are recommending, OK?
One of the things that they have moved to are these
unannounced visit surveys, so I take it that's something that
you think is very good?
Ms. Aronovitz. Yes. I'm wondering if I could just make a
comment before we do.
Mr. Cummings. Please, please.
Ms. Aronovitz. We worked extensively with the accrediting
organizations, and we are absolutely convinced that they are
doing a lot to try to improve the quality of lab testing. We
think that each of the accrediting organizations have a lot of
strengths and areas of improvement. So while we do applaud CAP
for some of the things it's doing, we also note that there are
other areas where it really is working to improve and maybe is
even as up to speed as some of the other accrediting
organizations.
So we're very proud of how all of the organizations are
moving forward, but we think all of them have their strengths
and weaknesses. I just wanted to say that because I think that
we all can learn from each other from that standpoint.
The unannounced surveys we think are very much a definite
positive step, and I believe JCAHO is also going toward
unannounced surveys.
Mr. Cummings. And I just to want go through a few things--
--
Mr. Souder. Can I ask something? By unannounced, do you
mean 2 weeks, or just completely unannounced?
Ms. Aronovitz. In some cases completely unannounced, maybe
a day or two, or just enough in terms of logistics, but at a
maximum we're hoping it will be 2 weeks.
Mr. Cummings. And I'm not just highlighting CAP, it's just
that I'm more familiar with what they're doing than other
organizations. I'm sure you're going to tell us about them, but
we won't hear from you, they're going to come up, and I just
want to get your comments, that's all.
Ms. Aronovitz. Absolutely.
Mr. Cummings. And if there are things that really impress
you about some of the things that they're doing, please let us
know.
Ms. Aronovitz. OK.
Mr. Cummings. One of the things I know CAP is doing or
moving to do is having an organization--the group of
pathologists who actually do the examination of the lab present
their findings, and then another group, totally independent
group, then does the accreditation issue, deals with that. What
do you think of that? I mean, is that significant?
Ms. Aronovitz. Sure. Any time you have a separate
independent group overseeing the work of a different group,
you're getting another set of expertise, and we think that's
very positive.
Mr. Cummings. OK. And with regard to whistleblowers, the
fact that they're having these signs put up in the lab to
encourage people to call in to our hotline number, and it
sounds like they are maintaining some kind of high level of
confidentiality so that we don't have a situation where the
whistleblower feels as if they are going to get in trouble with
their employers, because that was a big deal at the Maryland
General Hospital case. In that case, as a matter of fact, there
were two whistleblowers, both of whom--one of whom I had met in
my office, and literally she just broke down in tears because
she was so fearful. And sadly, a lot of the things that she
feared came to be true. So how is--you go ahead.
Ms. Aronovitz. No, I'm sorry.
Mr. Cummings. No, you go ahead.
Ms. Aronovitz. I think any effort to try to educate lab
workers on how to file complaints is very, very positive. CAP,
when it started requiring posters to be placed in labs to
explain just that, found that it had, instead of about an
average of 11 complaints a month, had about 22 complaints per
month for the 3 months after it started putting up posters.
Now, JCAHO, in responding to our report, thought that while
that might be a good idea for us being so proscriptive, it
could limit what other ideas accrediting organizations had to
maybe encourage lab workers to report complaints.
We think what CAP did was an excellent effort, and we think
that it really paid off. If accrediting organizations have
different approaches, as long as the principle of making sure
that lab workers feel like they know where to go and also they
feel protected, that's really all we care about.
Mr. Cummings. And finally, the collegiality issue. You
know, a lot of people were concerned--are concerned that when
people are in the same region or they know each other, it's--
you know, you scratch my back, I scratch yours. Maybe we were
just playing golf last week, and I'm going to run in and take a
look at your lab. And I think a lot of what we deal with here
is not only the actual validity of a testing process, but even
the appearance of the fairness and impartiality of the testing
process. And so I understand that CAP is moving toward more of
a regional kind of a situation, and I'm just wondering, trying
to get it so that we neighbors are not looking at each other's
labs.
Ms. Aronovitz. Yeah, I think that is an area that we have
been talking to CAP about. It pointed out that about 42
percent--and I might have that number wrong, but it's about
half of the surveys that it actually does is someone has to go
on an airplane, so there wouldn't be people who were at the
next lab.
But the other half really do look at labs that are in the
community, if not right next door. We worry a little bit about
that. We think that any type of structure you could put in
place where there would be not just a perception, but a real
sense, of independence is very, very important.
Along that line, we've been talking to CAP about the
construction of their--or the structure of their survey teams.
Right now they have a volunteer program where lab workers and
supervisors in one lab would actually look at a different lab.
And the structure of those teams usually include the supervisor
and the team that work in a particular lab because they work
well together, and they could accomplish a lot together.
The thing we do worry about in that structure is if you're
my boss in my real job, and you're telling me that we should
downgrade or we should, in fact, not write up a deficiency, and
I have a different judgment, and I think it's serious enough to
write up, we do have a question. And we don't have any evidence
that this has happened, but we do have a strong perception that
this could be a real dilemma for a lab surveyor. So we're
working with CAP to try to figure out how they could construct
their teams, but write their conflict of interests and
independent standards so that lab workers feel like they do
have a way out or they have a place to go if they don't agree
with their supervisor in a particular situation.
Mr. Cummings. A little bit earlier at a press conference we
were talking about this, and Mr. Souder and I answered a
question with regard to legislation, and this is the reason why
I spent so much time on this part. So often it's hard to get
the legislation that we want through here on the Hill, but you
said something that was very interesting. You said that you
were very encouraged and very impressed with the efforts that
the agencies have been making. And I've mentioned a few things.
Are there other things that you see that you would like to see
continue? In other words, there is more than one way to skin a
cat sometimes, so we're trying to figure out how do we make
sure that we get to the result that we want, because we don't
like the way it is right now.
Ms. Aronovitz. Right. I should, unfortunately, qualify what
I said just a little bit. We've had great discussions with CMS
and two exempt--CLIA-exempt States, and also the accrediting
organizations, they all do seem to be very anxious to move
forward, but that's just the first step. We have 13
recommendations, and that doesn't even include your
legislation, which we think is important, and we would like to
see how CMS responds to our recommendations.
We have a provision in GAO where we followup on open
recommendations, and it's on our Web site, where anyone in the
public could see what recommendations--what the agency has done
to take action on our recommendations. So while I'm very
encouraged in terms of our conversations, there have been quite
a few disagreements with some of the things we've said along
the way. We're hoping that we'll be able to negotiate or come
to terms on some of these. But ultimately it's the actions that
CMS takes that will really tell whether we're going to have
improvements in this area.
Mr. Cummings. Do you feel comfortable whether a person in
Mr. Souder's district, a rural district, going into a hospital
lab today can feel comfortable that they are getting accurate
results with regard to tests that might be lifesaving,
determine what kind of treatment they get? I mean, do you feel
comfortable based upon what you've seen?
Ms. Aronovitz. I think that the CLIA amendments have been
one of the most important positive approaches to getting us
closer to ultimately where we want to be, and I'd rather be
getting a lab test now than maybe even 5 years ago. However,
until it's airtight, until it will be 100 percent, I would not
feel comfortable if it were someone in my family.
So, no, I think we all need to keep working very, very hard
to get even better. We're not there yet.
Mr. Cummings. Thank you very much.
Mr. Souder. Ms. Watson, do you have any questions?
Ms. Watson. I really want to thank the Chair for this
hearing, and I believe you probably have responded to my query.
I do know mistakes and inaccuracies happen--it's a whole
movie I just saw recently starring Queen Latifah that
illustrates that; and I think what you're doing is right.
You know, I think all inspections ought to be unannounced.
We ought to say the year of 2007 is a year that we might happen
into your laboratory, because as I read the summary of what
happened at the Maryland General Hospital, most everybody
involved was fired. So we don't know if the problem rests with
the personnel, we don't know if it's cronyism, we don't really
know. So I would think that you would want to pick a period of
time and see if you can get to the factors and offer dissenting
reports so we can pin down what happens in these laboratories.
Are the pathologists moonlighting? Are they doing other things,
they're not really focusing? And what is the background
experience of the lab technicians and so on?
I think this is a serious problem. It affects all humanity,
particularly here in this country, and I think that maybe you
want to do a study in a given year to find out where the
problems really are. That's a comment, and you can respond.
Ms. Aronovitz. Yeah, I think that's a really important
comment. And I think you hit on some of the very essence of
what a survey really involves. It really looks at the quality
of the personnel, and the qualifications of the personnel, and
the quality assurance system, and the quality control systems
that are in labs, and how a lab monitors itself, and how it
makes sure that it fixes some of the problems that are
identified.
Right now I think that the structure, the framework, exists
for us to go into a lab--not us personally, but accrediting
organizations and other survey organizations--to go into a lab
and identify problems. It's what happens when those data are
then communicated or not communicated in the aggregate to other
oversight organizations where things could break down.
Mr. Watson. Let me just probe that a bit. Let me just probe
that a bit. After you go in, and you get--and you do a report,
is there another step that could be taken, you know, it's like
getting multiple opinions. Is there another step that could be
taken to be assured of the accuracy?
Ms. Aronovitz. When lab surveys are finished, the survey
organizations do discuss and make sure that they were done
properly, but in addition to that CMS has a very important
tool. It's called a validation survey, and the validation
survey really goes in behind the survey organization to make
sure that those surveyors did a good job and reported all
condition level deficiencies. Now, we do have some concerns
about the way validation surveys happen because we think too
many of them happen simultaneously instead of independently.
But the validation survey I think is the quality step that you
are referring to.
Ms. Watson. Thank you so much, and I yield back the rest of
my time.
Mr. Souder. I wanted to ask you briefly a clarification
question. My impression is that, how the labs--who owns the
labs and how they're managed is not uniform. Could you kind of
just give me a brief snapshot, are most of these labs owned by
a private entity, are they owned by the hospital? Are they
owned by a group of doctors? And I have a followup question to
that.
Ms. Aronovitz. I don't know exactly what the breakdown is.
I do know that there are hospital labs that do millions of
tests a year and then there are also on the other end labs that
get CLIA certificates that are physician labs that also do
2,000 tests in a year that would be owned by the physicians
themselves. We could get you a breakdown, which would be much
more appropriate than for me to try to estimate.
Mr. Souder. I'd appreciate at least some kind of a rough--
because in any kind of review strategy, if the primary reviewer
isn't going to be a uniform--single, uniform organization, and
I myself would like to see how to make a flexible system work,
but one thing in limiting conflict of interest is it's
important to know who the ownership groups are. In other words,
part of this, if you're not going to say, you have to be so far
away to be a reviewer, that you have to get on an airplane, I
think that was one standard that you put forth that 40 percent
had to fly in or something in that order, 40 percent didn't,
would be to say that certainly you don't want a doctor who's a
partner, who may have another lab at another unit be the
reviewer. You don't want a hospital who has a hospital system
be a reviewer of their own hospital system and that would be a
start, would it not, for some sort of conflict of interest?
Does that exist currently?
Ms. Aronovitz. I'm not sure. I don't know, and I think we
could find out for you and supply you with a breakdown and more
of a rationale.
Mr. Souder. Because nobody who I would think at minimum
reviewers, nobody that has a financial stake that overlaps with
the person they're reviewing should be doing the reviewing.
Ms. Aronovitz. I know that each survey organization does
have certain conflict of interest requirements and standards,
but to the extent that they would cover or be sufficient, we
would have some questions.
Mr. Souder. Thank you.
Mr. Cummings. I have just one question. You know, I'm just
curious, you made throughout your testimony, you have talked
about how you interacted with all--interacted with the various
agencies and whatever. And I'm just wondering, have you seen--
is there--can you see a difference that has been made as a
result of the Maryland General case? Are you following what I'm
saying?
Ms. Aronovitz. Yes.
Mr. Cummings. In your discussions with folks, in this case,
is this a major incident that happened? And if so, if it's a
major incident, how has it affected, from what you could see,
other labs and enforcement of the CLIA policies or what have
you?
Ms. Aronovitz. Yeah. I think we believe that the Maryland
General situation did have a traumatic effect on making labs
and survey organizations understand again how important it was
to do the kinds of things we're talking about today and to
assure lab quality. Given that, though, I personally was
surprised at how much still needs to go to happen, that we
found some of the things we did that the communication lines
aren't as strong as they should be, that the sanctions aren't
used as much as they could be, that proficiency testing
failures occur without a whole--often without a lot of
sanctions or followup occurring. We were surprised that CMS
still doesn't have a way to understand across survey
organizations the extent to which condition-level deficiencies
occur in the aggregate. We think it's so important because then
you could look at trend data and you could look and you could
answer the question that you're asking, not what kind of
impression I have, but with real hard data, and that's where we
think we need to be, and we're surprised that we're not there.
Mr. Cummings. Do you believe from what you have seen that
Maryland General is an aberration?
Ms. Aronovitz. I can't answer that. I don't know, but I do
know that it's important that labs have the potential for
having problems if they're not well overseen, and we think that
there are still gaps in the oversight process. So we worry
about the potential. We don't know whether there's a lab out
there right now that's on the verge.
Mr. Cummings. Right. Thank you. Thank you very much.
Mr. Souder. I thank you for your testimony and appreciate
your report, and we'll be looking forward to additional
followups.
Ms. Aronovitz. Thanks very much.
Mr. Souder. Our next panel is Mr. Thomas Hamilton. If you
will come forward and remain standing, I will give you the
oath. Mr. Hamilton is the Director of Survey & Certification
Group, the Centers for Medicare and Medicaid Services, U.S.
Department of Health and Human Services. Raise your right hand.
[Witness sworn.]
Mr. Souder. Thank you. Let the record show that the witness
responded positively. I thank you for coming today and we look
forward to your testimony.
STATEMENT OF THOMAS HAMILTON, DIRECTOR, SURVEY & CERTIFICATION
GROUP, CENTERS FOR MEDICARE AND MEDICAID SERVICES, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Mr. Hamilton. Thank you. Chairman Souder, Representative
Cummings, Representative Watson, distinguished members of the
subcommittee who may appear yet, thank you for the opportunity
to discuss CMS's efforts to assure quality testing in all
laboratories in the United States as required under the
clinical laboratory improvement amendments. Thank you.
CLIA established nationally uniform quality standards for
all clinical laboratory testing to ensure the accuracy,
reliability and timeliness of patient test results regardless
of the setting in which the test was performed. Under CLIA,
three categories of laboratory tests have been established,
waived tests, tests of moderate complexity, including the
subcategory of provider-performed microscopy, and tests of high
complexity. CLIA specified detailed quality standards for the
latter two categories.
For laboratories that perform moderate or high-complexity
tests, those laboratories must be surveyed biannually to
maintain certification. They may choose whether they wish to be
surveyed by CMS or by a private CMS-approved accrediting
organization. Laboratories that conduct only waived tests are
subject to surveys if a complaint is alleged.
The CMS survey process focuses on outcomes. That is, we
focus on the test results in the actual or the potential harm
that may be caused to patients due to inaccurate testing.
Education and enforcement are both used and both are important.
An educational approach permits a surveyor to provide resources
and an explanation of the applicable requirements to the
laboratory. This facilitates the laboratory's ability to
correct deficiencies prior to the imposition of enforcement
actions.
However, if the laboratory cannot or will not correct the
problems within a reasonable and specified amount of time,
sanctions are imposed that are commensurate with the history,
seriousness, and pervasiveness of the deficiencies.
Fulfillment and enforcement of CLIA standards is CMS's
primary focus. When CMS finds problems during a survey, the lab
is generally provided an opportunity to correct those problems
prior to enforcement actions unless there is actual or
potential harm to patient safety or there are recurring
deficiencies. Over the past 5 years CMS has initiated
enforcement action in more than 5,000 cases. These proposed
sanctions carry a clear communication, problems must be fixed
promptly and effectively. I am pleased to say that in
approximately less than 10 percent of the time have we needed
to implement the sanctions because of laboratory failure to
take effective and timely remedial action.
In a moment I will discuss the challenges that we face, and
Ms. Aronovitz did an excellent job describing the findings of
the GAO and some of those challenges. But first I wish to
emphasize that the Clinical Laboratory Improvement Amendment
enacted by Congress and faithfully implemented by CMS has
substantially improved the reliability and accuracy of
laboratory testing in this country. The first onsite surveys of
laboratories conducted right after CLIA implementation in 1992,
for example, revealed that up to 35 percent of laboratories had
significant quality control and quality assurance problems.
Currently less than 7 percent of the laboratories surveyed by
CMS each year evidence such quality control problems. More
recently, the percentage of laboratories that meet our
proficiency testing standard has increased from about 88
percent in 1998 to about 93 percent in 2003.
CMS continues to improve our survey and certification
system. For example, in 2003 we strengthened quality control
standards through new regulations. In 2004, we established
performance standards for State organizations. Also in 2004, we
initiated national meetings with all accrediting organizations
to strengthen the national system and enter into better
information sharing agreements, as Representative Cummings has
so eloquently described is needed.
In 2005, we implemented national annual cytology
proficiency testing for all people who examine pap smears. For
the first time, more than 12,000 people took individual exams
to test and demonstrate their ability to make accurate readings
of pap smears.
In 2006, we implemented a national electronic tracking
system for all complaints and all complaint investigations
received by CMS and State survey agencies. These advances,
however, do not mean that further improvements are not possible
or desired. They are. To such an end, we appreciate the
subcommittee action to make resources of the Government
Accountability Office available to study what we are doing and
make a number of very useful recommendations.
The GAO made 13 recommendations. We committed ourselves to
21 action steps in response to those 13 recommendations from
GAO, and we are putting in place the plans necessary to do even
more. For example, the GAO recommended that CMS standardize
criteria used by accrediting organizations. Recognizing that
the law permits accrediting organizations to have standards
that are different than CMS's standards so long as they are
equivalent, we will improve the crosswalks of our different
standards to make them more comparable. But in addition, we
will work with the accrediting organizations to create a
taxonomy of deficiency findings to promote consistent
enforcement of standards on the back end.
We've also convened a work group of accrediting
organizations and CMS representatives to develop data-driven
performance indicators similar to those used to monitor State
survey agencies' performance, as Ms. Aronovitz described. These
performance measures will complement the validation surveys
that we now conduct to check on the accuracy of accrediting
organization surveys. The GAO also recommended that we ensure
that lab workers know how to submit a complaint to the proper
entity. We will do so. Complaints from lab workers represent an
important source of information about potential problems. We
are working with surveying entities to increase awareness of
the ways of lab workers and others may submit complaints,
including how to get their complaints to the right place
confidentially.
In addition, in March 2006 we implemented a new, more
sophisticated data system to receive and track such complaints.
This tracking system will enable all surveying entities
eventually to submit access information that is collected on
any lab. The GAO also recommended that CMS establish an
enforcement data base to monitor actions taken by State survey
agencies. We will definitely do so. We have developed such a
data base for nursing homes and other providers, and it has
been extremely useful. I have directed that the timetable for
inclusion of clinical laboratories in this data base and
electronic system be moved up as soon as possible.
In conclusion, we in CMS are dedicated to ensuring the
accuracy of test results from our Nation's laboratories. I
thank the subcommittee for your interest in improving clinical
laboratory testing in the United States. There is no substitute
for objective, trained personnel examining the quality of
health care. That is the purpose of CMS's survey and
certification system, and that is the function served by GAO in
examining CMS's oversight.
We are putting the results of the GAO study to good and
prompt use, and I thank you for directing their energies toward
our common purpose of improving the quality of health care in
the United States. I look forward to answering any questions
you may have about our efforts.
[The prepared statement of Mr. Hamilton follows:]
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Mr. Souder. On the GAO recommendation No. 9, that you
utilize your revenues generated by the program to hire
sufficient staff to fulfill its statutory responsibilities,
your response was CMS is fulfilling its statutory
responsibilities. My understanding was--is that the fees
collected, that you've had a reduction in staff from 29 to 22
and you have carryover balances of $70 million. What happens to
that $70 million? Does that go to other agencies to use as a
cash-flow? Why would you have reduced your staff from 29 to 22?
Have the number of labs reduced? What would be the reason?
Mr. Hamilton. CMS has been very careful to ensure that the
burden placed on laboratories through the user fees are managed
very conservatively. Those lab fees are set in advance and only
infrequently adjusted, and what happens in the early years is
that there is a surplus and then over time expenditures exceed
the revenues that are generated and that surplus is diminished
to the point where the fees then need to be raised again. We
are over the tipping point, so at the current point the
expenditures for the Centers for Disease Control, for the
States, for CMS and the FDA, who all work in combination to
achieve the results of CLIA, the expenditures at this point in
time are just beginning to exceed the incoming revenue. So that
$70 million is going down.
What has happened overall in CMS in terms of the staffing
is that as the agency diminished staffing somewhat, the CLIA
staff had been subjected to that diminishment as well. And we
have had a request in to re-examine that practice, and that
examination has been completed, and I am pleased to say that we
are in the process of separating out the CLIA staffing into its
own set of controls where the staffing will be governed not so
much by what's happening in the rest of the agency but what's
happening precisely in the way of the CLIA workload and the
user fees.
Mr. Souder. Yeah. Because you're different than the rest of
the agency. In a sense, you have a fee that's collected to do
the enforcement. Is that correct?
Mr. Hamilton. That is correct.
Mr. Souder. How is the $70 million counted in the budget?
Do you automatically--are you automatically guaranteed what is
at a maintenance level? I mean, it's like a postage stamp. In
other words, we always have more income at the beginning of the
postage stamp than we do at the end and then you raise the
fees. That's basically what you describe there, but you are not
a frozen agency. In other words, HHS, is this fund subject to
the general HHS appropriations?
Mr. Hamilton. It is. Your analogy is perfect in terms of
postage stamps. Those funds that are received from the user
fees are held in trust and used exclusively for the Clinical
Laboratory Improvement Act amendments.
Mr. Souder. Wouldn't you have been able then to hire, not
reduce, staff if you had the funding and in fact if you had 29
and you said we wanted to keep 29 because it's necessary for
our mission, that would have meant you would have raised the
fees?
Mr. Hamilton. That is the way it could work in the future.
In the past, the overall personnel controls in terms of the
number of people that could be devoted to this function have
been treated separately without regard to budget. Now we're
separating those out.
Mr. Souder. In the sanctions question, in one of your
responses you said that in fact a lab--part of the reason you
didn't agree that if you had multiple failures that they would
automatically be sanctioned was--is that it could be in
different subsections of the same lab for a different task.
That implies that you believe the reasons for failure are
specific as opposed to generic. In other words, that a lab is
lax in their processes, therefore if they have a failure in one
area, then they have a failure in another area. It isn't a
failure of the management or the general commitment. It's a
failure of whatever happened in that particular area. Am I
correct in articulating that and why would such an assumption
be made? And let me make one other followup with that. In the
sanctions process, I mentioned in the first panel about
egregiousness. I kind of look at this as a little bit like
restaurant violations. In other words, it's one thing if you
don't have the ketchup bottle top on. It's another if you have
salmonella in your meat. Do you have some sort of a standard
here that dependent on the egregiousness there's an immediate
automatic sanction? Do you have tiered levels in that--how are
you dealing with this? Because one type might just be a lax
management that's why you would have repeated areas of
different departments or more staff turnover than would be
normal so staffers weren't as highly educated, therefore
they're more likely to make an error, which is once again a
management question, to some degree a pay question, to some
degree whatever other management questions there is, and some
are just like making an error, some which we've heard in
Maryland General are just catastrophic, putting pressure on the
process where somebody gets AIDS and is fired, and then you
have others that they couldn't for a fairly long period of time
even tell us whether they had misidentified whether somebody
had AIDS or not. So you have a whole bunch of people hanging in
balance as to whether they have AIDS or not or whether the
surveys are accurate. That seems to be fairly egregious, that
kind of--how do you work through that sanctions standard?
Mr. Hamilton. The problems in Maryland General were indeed
egregious, and in that kind of situation we need very prompt
sanctions and very effective remedy. We need also the ability
to distinguish that kind of situation from minor problems, and
our point in our reply was simply to say if we found, for
example, a problem in proficiency testing in general, then we
need to look beneath the surface to discern whether or not this
is a systemic problem of the overall management or is isolated.
We have found situations, for example, where the problem
was concentrated in a neonatal testing area of the laboratory
and not generalized to other parts of the laboratory. In that
case we really need to focus on what's happening in the
neonatal testing area. Now, if we looked back and saw that the
previous year that the proficiency--the lab had a proficiency
testing problem, but that it was in a completely different area
and there seemed to be no common systemic problems, then we
need the ability to make appropriate judgments with regard to
the strength of the sanctioning and enforcement action.
So that was the only point we were trying to make there. We
may need to make refinements in our data system to be able to
pick up on some of these nuances because when we run the
reports we might just find that the data indicate the frequency
of problems in the overall deficiency area rather than getting
beneath the surface. So for us to do effective monitoring of
our States and accrediting organizations, we may need to adjust
the data base to be able to do so.
Mr. Souder. I have one more question, and I ask this
somewhat with fear and trembling that in the--because in
listening to the doctors of our areas and Medicare-Medicaid
reimbursement questions all the time, when we charge a fee for
these labs, for the oversight, if that goes up, how is that
factored in in reimbursement questions in Medicare and
Medicaid? Is it irrelevant? Do they just have to absorb it?
Mr. Hamilton. The fees range from a low of $150 for say a
physician office lab that's doing a few tests to on the other
extreme $8,000 for a lab that may do a million or more tests a
year.
Mr. Souder. So if it went from $150 to $170, it's not going
to have a huge impact?
Mr. Hamilton. [Yes indicated.]
Mr. Souder. OK. Thank you. Mr. Cummings.
Mr. Cummings. The GAO found that CMS is not meeting its
requirements to determine in a timely manner the--continue the
equivalency of accrediting organization and exempts States
inspection requirements between periodic equivalency
determinations before it reviews the proposed changes. And I
was wondering, what was your opinion on that? Because
apparently there's a time when you all are trying to figure out
whether the surveyors' standards meet CLIA standards, and one
of the complaints has been--and you heard it, you heard it a
few minutes ago--that there sometimes has been a kind of long
delay. What is that about? Is that a personnel issue?
Mr. Hamilton. It has been primarily a personnel issue and a
prioritization issue. But let me first clarify the
circumstance. Let us take, for example, the situation where an
accrediting organization changes its standards. The accrediting
organization is obliged to notify us of the changes. What
hasn't been happening in a timely manner is our formal response
back to the accrediting organization. That's not to say we
don't take a look at the change. We do take a look at the
change as it comes in and make a triage decision as to whether
or not this seems to be a significant change, serious change,
or it could be an accrediting organization adopting something
that is more stringent than the minimum requirements that are
specified in law and regulation.
So we make that initial review. What we haven't been doing
is making the formal determination, sending the letter back to
the accrediting organization, saying this is a problem or not a
problem because generally we haven't found that those changes
have been problems. The priority decision has been--as we look
at all of the work that we've had to do, some things are much
more important than others, and frankly, during the past year
one of the most important things we have done, I think,
believe, is to implement the cytology proficiency testing
requirement. And that has been a major accomplishment, and we
devote considerable energies to that effort and to responding
to the concerns from the field that we have had about that
testing.
So in light of that kind of priority comparison, we have
elected in the past to simply take a look at the accrediting
organization changes to their standards, but not immediately
issue a response back. We're going to respond in a more timely
manner in the future, but we will always need to take a look at
our workload and make determinations with regard to priorities,
some things being more important than others.
Mr. Cummings. Going back to the Maryland General situation,
how has that affected your agency? I mean, I know it's affected
the people who are sitting right behind you, but I'm wondering
how has that affected you all because basically while they are
the folks who do the surveys, you are the folks who kind of
oversee them. So what if any--effect has it had?
Mr. Hamilton. I would say for CMS its effect was similar to
the effect of Hurricane Katrina. I think only Rip Van Winkle
could have slept through the wake-up call that was presented by
the Maryland General situation.
Mr. Cummings. So this is major stuff, huh?
Mr. Hamilton. It was of significant concern to us not only
in terms of the immediate events and findings but also of great
concern to us in terms of how long it took the hospital system
to accept the problems that it had and engender systemic
corrections, and so there were two aspects to that problem, and
I think, as Representative Watson pointed out, there were
significant personnel changes subsequent to that, and I think
those personnel changes had more to do with the slowness of the
response and not just the immediate problems that they faced.
Mr. Cummings. Now, the recommendations that were made by
the GAO, you talked about things that you felt pretty good
about. I was just reviewing some of your, you know, responses
and what have you. What did you disagree with?
Mr. Hamilton. We appreciate the caution that GAO
communicated with regard to ensuring that we have a balanced
approach between education and enforcement, and we appreciated
their worry because we worry about it in terms of constant
vigilance. However, the two instances that they cite we very
much disagree with. Consider, for example, the cytology
proficiency testing. This was a new requirement. While the law
had been passed by Congress some time ago, the conditions
requiring laboratories to ensure that all of their affected
workers were individually tested did not apply until 2005. That
was a new requirement for the laboratories. We told the
laboratories that if they failed to enroll all of their
affected workers in the testing, we would provide sanctions. We
told them that if they failed to ensure that their workers were
retested should they fail, we would apply sanctions. The only
thing that we said that we wouldn't do is to levy sanctions if
a laboratory had failed to ensure that 100 percent of its
workers in that year achieved a passing score. So we think that
we did a very responsible job.
On the other hand, I appreciate the GAO concern because on
one hand while they're saying that we've been too lenient, I
have stacks of correspondence from professional societies and
others saying that we were too stringent and that we ought to
slow things down.
So we think that we have crafted and implemented the
perfect Goldie Locks solution, something neither too lenient
nor too stringent but one that got the job done, and the end
result is that 100 percent of the pertinent labs participated
in the proficiency testing and ensured that their workers were
tested. So the American public has a much greater assurance
today that the people who are reading pap smears are doing so
accurately and reliably.
Mr. Cummings. Did you listen to--I'm sure you did--to the
previous witness and particularly the last question that may
have been next to the last question that I asked her, whether
she would feel comfortable with labs, and did you hear what she
said?
Mr. Hamilton. I believe she didn't give you a direct reply
but expressed her concern. I thought it was a very good answer.
We likewise are concerned about any lapse in the accuracy,
reliability or timeliness of testing, and we would like to see
continuous improvement in all laboratories in such testing. To
that end, we dedicate ourselves and will use the GAO report as
effectively as possible to make those improvements.
Mr. Cummings. You said a little bit earlier that you all
were working on trying to bring all these standards together so
you have--everybody's pretty much reading from the same page in
the same handbook. Is that pretty much accurate?
Mr. Hamilton. That is correct.
Mr. Cummings. What is your timetable with regard to that?
Mr. Hamilton. We will accomplish that in the next calendar
year. I asked before coming here for one of our staff to bring
me the latest set of standards and correspondence back and
forth between one of the accrediting organizations, and they
wheeled in a very large cart, and I can tell you that when
we've got not just one accrediting organization but multiple
accrediting organizations, each of which has a different
process instead of criteria, it's a substantial undertaking,
but it is high on our agenda, and we are regularly meeting now
with all of the accrediting organizations to figure out ways in
which we can improve our information sharing, our red alerts,
our communications and our compatibility in our processes. But
I would point out that GAO recommendation pertained to the
front end; that is, are the standards comparable? We are
perhaps even more concerned with making further improvements on
the back end, which is after the survey is done, are we able to
agree on what the most serious findings are and ensure that
there is appropriate followup action and correction for any
problems that are identified. To that purpose, we would like to
construct with the accrediting organizations a taxonomy of
deficiency findings so that we can have greater comparability
and followup to ensure that remedial action is promptly and
effectively made when such action is called for.
Mr. Cummings. Now, see, you are taking me back to my days
as a lawyer. Did you answer my question?
Mr. Hamilton. I don't know if that was a compliment or not.
Mr. Cummings. Sounded nice, but I mean it----
Mr. Hamilton. I was--your question had to do----
Mr. Cummings. With timetable. I said----
Mr. Hamilton. In the next year, yes.
Mr. Cummings. Is it next year?
Mr. Hamilton. Yes.
Mr. Cummings. Oh, OK, next year.
Mr. Hamilton. Perhaps I said it under my breath.
Mr. Cummings. I missed it. Did you actually say that?
Mr. Souder. Yeah, he said it. He explained why it was going
to take him a year.
Mr. Cummings. OK. Just one other question, Mr. Chairman. I
want to go back to some questions that the chairman asked about
the $70 million. And I'm trying to figure out, if you have a
Maryland General situation, and let's say you had--you felt
that the problem was just there were probably maybe a lot of
Maryland Generals out there, and you said, wait a minute, we've
really got to do something different here. In other words, had
you had a true emergency, what happens then? And you know you
need more personnel, you know it. You just can't get around it,
and it would be almost negligent if you failed to take money
that you have to deal with the emergency and then figure out
how to collect more dues in the future or whatever. I mean,
what happens under that circumstance?
Mr. Hamilton. Under a circumstance such as the one that you
described, we would mobilize national resources to make them
available and we would deal with the fiscal consequences later,
whether or not that meant that we needed to increase the
table--timetable or speed up the timetable for fees or
whatever.
Mr. Cummings. All right. I don't have anything else.
Mr. Souder. Ms. Watson.
Ms. Watson. Thank you.
Mr. Souder. Let me briefly followup because my
understanding to your first answer when we compared to postage
stamp revenue and the latter part you draw down, now my
understanding was, as you said, HHS will no longer put you
under an arbitrary uniform shared cost reduction if budgets are
squeezed, which they are everywhere in personnel because of our
increases, aren't meeting the increased cost of living demands
is the bottom line. Do you have control over--does your
subagency have control over your revenue that comes in
independently or is that decided by OMB or HHS headquarters?
Mr. Hamilton. The fees are established through the
publication and the Federal Register process pursuant to the
regulations that have been previously established. So we go
through a process of publishing any change in the fees.
Mr. Souder. So that generates the revenue. Who controls the
expense side?
Mr. Hamilton. The expense side, CMS controls. From the user
fees then we work out a budget for the Centers for Disease
Control, one of our partners in this effort, and the budget for
the Food and Drug Administration, and then ourselves.
Mr. Souder. So do you have an internal--like for the
postage stamp, would you have projections and say when we
increase it to 39 cents we will have this much revenue at the
beginning, making these assumptions, and then it will draw down
by X year? Do you have an internal budget like that?
Mr. Hamilton. Yes. We have internal budget controls and as
we look at the personnel needs here, we are going through our
own process of examining the workload and then ensuring that
any position that we have is fully justified in terms of the
priority and the workload.
Mr. Souder. Would you have the flexibility if you felt an
increased workload to accelerate that plan and kick in an
increase earlier? Would that be something your department
would--would you have automatic flexibility? Would you have to
run that up through the Secretary and then through OMB?
Mr. Hamilton. Definitely. We would go through the Federal
Register process with Health and Human Services and OMB.
Mr. Souder. So it's not a dedicated fund per se like the
gas tax or the inland waterway, airport tax where those
agencies would have control over their budget; they would still
have to have it reviewed. You, while you have a dedicated fee,
in fact have to go through traditional budgeting inside the----
Mr. Hamilton. Inside the agency and within the executive
branch. That is correct, and through the Federal Register
process. But it is a dedicated fund in the sense that it cannot
be used for any purpose other than CLIA.
Mr. Souder. Well, thank you very much for your testimony,
and we're looking forward to hearing how the followup goes over
the next year and the implemented standards. Thank you for
coming today.
Mr. Hamilton. Thank you very much, and thank you for all
the time that you have put into this issue.
Mr. Souder. Our third panel could come forward and remain
standing for the oath.
Dr. Dennis O'Leary, president of the Joint Commission on
Accreditation of Healthcare Organizations; Dr. Thomas Sodeman
president, College of American Pathologists; and Mr. Beigel,
chief executive officer of COLA.
It is the practice of this committee to swear in all
witnesses.
[Witnesses sworn.]
Mr. Souder. Let the record show that all the witnesses
responded in the affirmative. We thank you for participating in
the hearing today. And we'll start with Dr. O'Leary.
STATEMENTS OF DENNIS S. O'LEARY, M.D., PRESIDENT, JOINT
COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS; THOMAS
SODEMAN, M.D., PRESIDENT, COLLEGE OF AMERICAN PATHOLOGISTS; AND
DOUG BEIGEL, CHIEF EXECUTIVE OFFICER, COLA
STATEMENT OF DENNIS S. O'LEARY, M.D.
Dr. O'Leary. Thank you. Good afternoon. I'm Dr. Dennis
O'Leary, president of the Joint Commission on Accreditation of
Healthcare Organizations. We thank the subcommittee for taking
a leadership role and urging improvements on laboratory
services in this country. We would also like to commend the GAO
for its detailed review of the quality of testing in our
Nation's clinical laboratories.
The Joint Commission accredits more than 3,000 laboratories
that hold varying numbers of CLIA certificates. Some of these
laboratories are hospital based while others are independent.
Assuring that accredited laboratories are providing safe, high-
quality services is one of the Joint Commission's highest
priorities. Joint Commission laboratory surveys are conducted
by experienced medical technologists and pathologists who have
passed a rigorous certification examination and participate in
training exercises on an ongoing basis.
Recognizing the critical importance of laboratory services,
the Joint Commission has designated the laboratory as an
essential hospital service. This designation has elevated the
importance of the laboratory's compliance with established
requirements in determining the overall accreditation status of
the hospital that it serves. This policy underscores the
patient care implications of laboratory quality and the need
for hospital leaders to pay particular attention to laboratory
performance.
The Joint Commission's close working relationship with CMS
on laboratory issues demonstrates the value of public-private
sector partnerships in improving health care and to serve
laboratories and Medicare beneficiaries well. The Joint
Commission makes a special effort to assure open communications
and coordination of efforts with the State and Federal agencies
and other private accrediting bodies responsible for the
quality oversight of laboratory services.
The Joint Commission welcomes the GAO report on the
oversight of quality in laboratories. We emphasize, however,
the need to strike a balance between timely identification and
resolution of performance issues and laboratories and the
education and improvement objectives inherent in the
accreditation process. Simply pointing out deficiencies in
laboratory performance does not automatically translate to
effective resolution of those identified problems.
While the Joint Commission generally concurs with the GAO
findings and conclusions in this report, we wish to highlight
several areas of concern with respect to its recommendations.
First, while the GAO recommendation that CMS standardize the
categorization reporting of survey findings may simplify
administrative oversight of the laboratory program, it may also
stifle innovation in evaluation approaches and thereby
ultimately compromise the safety of patient care. This
recommendation assumes that CLIA requirements and
categorizations are a gold standard rather than a set of basic
expectations for laboratories and that more advanced
performance standards do not exist. In fact, the rationale for
relying on private sector accreditation is that this makes
possible the timely setting of higher standards on an ongoing
basis. This GAO recommendation basically fails to acknowledge
that the Joint Commission and others use different contemporary
approaches to assessing laboratory performance. We suggested
the recommendation to standardize a categorization and
reporting a survey findings be set aside in the favor of
directing CMS to develop a common taxonomy that could be used
by all laboratory quality oversight bodies that would track
serious deficiencies.
Second, the Joint Commission believes that GAO has
misinterpreted its validation of survey data. Based on this
analysis, the GAO concludes that independent surveys are more
effective than simultaneous surveys in identifying condition
level deficiencies that were missed by accrediting bodies.
However, the data presented in the report do not support this
assertion. In fact, the proportion of condition level findings
was generally equivalent in both types of surveys. Further,
there are significant benefits to simultaneous surveys because
they allow dialog between CMS and Joint Commission evaluators
and staff that leads to enhanced understanding of how each
entity conducts its evaluation process.
Finally, while GAO's detailed review addresses a number of
laboratory quality issues, it does not address a long-
acknowledged shortcoming of CLIA requirements, the
qualifications of laboratory personnel. We believe that the
personnel standards currently required by CLIA are insufficient
to adequately protect patients in the public health. Today the
problems underlying failures in laboratory performance are the
growing shortage of laboratory technologists and the inadequacy
of their training. These shortcomings become especially glaring
in the face of the expanding array and increasing complexity of
laboratory tests in hospitals today.
In conclusion, the longstanding positive working
relationships among CMS, the Joint Commission and its colleague
accrediting bodies has benefited the public through assuring
continuous access to and application of state-of-the-art
methods for evaluating quality and safety in laboratories. The
Joint Commission remains firmly committed to working with all
of its partners in both the public and private sectors to
ensure continuous improvement of laboratory services.
Thank you.
[The prepared statement of Dr. O'Leary follows:]
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Mr. Souder. Thank you for your testimony. Dr.--is it
Sodeman?
STATEMENT OF THOMAS SODEMAN, M.D.
Dr. Sodeman. Sodeman, yes.
The College of American Pathologists is pleased to appear
before the subcommittee for this hearing of issues related to
the GAO report on clinical laboratory quality. I am Dr. Thomas
Sodeman, president of the CAP, a medical specialty society of
nearly 16,000 board certified pathologists who practice
clinical and anatomical pathology.
The CAP inspects and accredits more than 6,000 laboratories
worldwide under its laboratory accreditation program. I am here
today to provide our perspective on the GAO report and to
update the committee on CAP's recent initiatives to improve its
laboratory accreditation program. We are pleased to work with
the GAO on this report and appreciated the opportunity to
provide comments and testify before this subcommittee.
As an organization dedicated to improving laboratory
medicine and patient care, we take seriously the findings and
recommendations of the GAO. The CAP will analyze the report to
assess if there are additional steps that CAP needs to take to
address the issues identified as areas of concern regarding our
accreditation program.
Beginning in 2004, the CAP initiated its own evaluation of
its laboratory accreditation program. The testimony we
presented to this committee on May 18th and July 7, 2004
included information on changes that we implemented. Since
those hearings, the CAP has announced and implemented
additional initiatives designed to strengthen our program. In
its report the GAO acknowledges many of the new initiatives,
including moving to unannounced inspections by July 3rd, nearly
100 percent of all CAP inspections will be unannounced.
We enhanced and require training for all CAP inspectors.
This training will supplement the inspectors' years of
professional experience with specific guidance on inspection
techniques.
We implemented mandatory signage to facilitate the
reporting of quality complaints. The CAP policy also includes
whistleblower protections that shield the reporting laboratory
worker from employee retaliation.
We strengthen conflict of interest policies by making the
policies more comprehensive and explicit.
We are spending $9 million on the development of integrated
data systems to better assess laboratory quality that will
provide early detection of potential problems in our accredited
laboratories.
The GAO report provides valuable insight for the College to
consider as it strives to continuously improve its program.
There are also portions of the report that we have a different
perspective. The CAP believes that the GAO underestimates the
value of utilizing laboratory professionals in the inspection
process. We believe the combination of current professional
experience in the laboratory and training in advanced
inspection technique make the CAP inspectors uniquely qualified
to ensure compliance with the CLIA standards. Proficiency
testing data indicates that the CAP system is comparable to
other models. We also have to keep in mind that CAP accredited
laboratories voluntarily choose CAP accreditation, which
includes requirements that are more stringent than CLIA. We
believe this dedication to enhanced quality by laboratory
professionals demonstrates a commitment to the quality of
patient care that goes beyond that is required by CLIA.
With respect to the regulatory and educational functions of
CLIA, the CAP believes that these dual objectives are not
mutually exclusive and that education is an inherent and
important outcome to the inspection process of identifying and
correcting deficiencies. The CAP believes that the dual
objectives should be complementary. However, we recognize the
primary purpose of the CLIA statutes are to ensure minimum
standards.
The GAO also was charged with examining the quality of
laboratory testing and was unable to make a determination about
this issue. Proficiency testing is one of the areas for which
there is a dated measure of quality. Laboratory quality as
measured by the CMS aggregate PT data for all enrolled
laboratories showed mark improvement in performance since 1996.
Much of the report is devoted to examining Federal oversight of
CLIA. In general, we believe that CLIA provides appropriate
Federal oversight for ensuring accuracy of laboratory testing
and promoting ongoing quality improvement.
We are pleased with the CMS partner initiative, which
provides a forum for sharing information among all accrediting
entities and provides a forum for discussion of best practices
in the laboratory inspection and accreditation. We believe this
enhanced CMS initiative is a strong indication of the
commitment of the agency and all of the accrediting and
oversight entities to improve our communication and strengthens
the collaboration necessary to ensure laboratory quality.
CAP thanks the subcommittee for its interest in assuring
the highest quality laboratory testing and is firmly committed
to working with Congress, CMS and other oversight entities and
accreditation organizations on a way to ensure laboratory
quality.
Thank you, sir.
[The prepared statement of Dr. Sodeman follows:]
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Mr. Souder. Thank you. We finish with--is it Beigel,
correct?
Mr. Beigel. Yes, sir.
Mr. Souder. Mr. Doug Beigel, the chief executive officer of
COLA.
STATEMENT OF DOUG BEIGEL
Mr. Beigel. Mr. Chairman, members of the committee, I am
Douglas Beigel, chief executive officer of a nonprofit
organization whose purpose is to promote excellence in
laboratory medicine and patient care through a program of
voluntary education, consultation and accreditation. COLA
appreciates the opportunity to speak to you today about the
findings and recommendations contained in the GAO report.
The COLA accreditation standards and methodologies were
developed by internists, family physicians and pathologists to
be practical and meaningful to the laboratory. The requirements
have a positive and immediate impact on patient care. We are in
the quality improvement business, and we expect our clients and
ourselves to commit to continuous quality improvement. However,
we must be vigilant to ensure that we do not disrupt patient
care and that we maintain access to critical laboratory
services that are convenient and important.
During the course of this study we responded to numerous
written and verbal inquiries from the GAO and performed several
in-depth data analyses. I'm pleased to share with you that we
agree with the number of the GAO findings and recommendations,
and I look forward to discussing those with you now. I will
also touch on a few areas of the report that we found
troubling.
We wholeheartedly agree that education to improve lab
quality should not preclude identification and reporting of
deficiencies that affect lab testing quality. We also believe
that phase-in requirements are absolutely appropriate.
Education is a critical component to the reasonable and
appropriate implementation and enforcement of laboratory
performance requirements. COLA takes its enforcement
responsibilities very seriously, and we are proud of our
consistent track record and the appropriate enforcement of
CLIA.
We agree that laboratories should provide lab workers with
instructions on how to follow anonymous complaints. And as an
approved survey organization, we expect laboratories to act
accordingly. We take complaints very seriously, and actively
investigate all complaints. We require laboratories to post
instructions to lab workers on how to file anonymous
complaints. We agree that unannounced inspections in a smaller
laboratory are destructive and unworkable.
The GAO is correct in concluding that unannounced
inspections for the smaller laboratory will not be appropriate
because these laboratories are so small, and because the
medical and laboratory directors are often wearing many hats,
and arriving unannounced causes disruption to the laboratory
work, which, in turn, reduces the quality of patient care. We
agree that CMS should be appropriately resourced and organized
so that they can review and approve survey organization
programs in a timely manner.
We have long appreciated the dedication and commitment with
the CMS staff with whom we have worked so closely over the
years. We agree that where possible, CMS should make whatever
structural change is necessary to ensure that survey
organization programs and requirements are approved
expeditiously and prior to the expiration date of the current
approval.
And most importantly, we agree with the assertion that
survey organizations, including CMS, should employ trained
surveyors and assessors who perform consistent surveys. The
report specifically mentions surveyor training and consistency
assessments as key factors to a strengthened laboratory
oversight system.
COLA is proud of its significant and extensive surveyor
training program and our high level of consistency between
surveyors. This means that COLA effects the same survey,
whether the lab is located in Alaska, Maryland or Indiana. We
utilize results of validation surveys to see if citations given
by our survey match those of another. We look for patterns of
validations that may indicate weaknesses in a particular area.
We are proud that the GAO recognized these items already
implemented by COLA as best practices for the industry.
We disagree, however, with the GAO's assertion that
laboratory quality may not have been improved. COLA now
accredits more laboratories than it has in the past 10 years.
Data that COLA provided to GAO but was not used in the draft
report shows that, in general, condition level deficiencies
declined in laboratories that have been surveyed over multiple
years.
Also, the percentage of COLA laboratories that fail
proficiency testing has decreased. COLA is proud of the fact
that our program is having a positive impact on laboratories
and patient care.
We disagree with the GAO's assertion that education and
enforcement are mutually exclusive. While COLA laboratory
inspections are highly educational, we enforce 100 percent of
our CMS approved accreditation requirements.
We disagree with the GAO's assertion that allowing a
laboratory to prepare for a survey masks the discovery of
laboratory problems. We know of no research that would support
such a conclusion.
While much of the laboratory's evidence of compliance is
documented, there is little of this evidence that can be
fabricated in a short period of time. More importantly,
however, the vast majority of laboratory professionals are
dedicated to providing the highest quality of patient care
possible, and therefore generally would not falsify records.
A qualitative interactive assessment of a laboratory,
coupled with the ongoing participation in proficiency testing
provides COLA with a more accurate picture of the overall
quality of a laboratory. We have seen improvement and are proud
of the strides we have made, but that doesn't mean we don't
look ahead and raise the bar. Our paramount concern is
provision or excellent patient care through meaningful
standards and quality improvements. Thank you for inviting me
to share my insights with you today.
[The prepared statement of Mr. Beigel follows:]
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Mr. Souder. Dr. O'Leary, in his statement, said that one
thing he believed that GAO overlooked was the pressures on kind
of the increasing sophistication of what is needed in lab
technicians and the supply of well-trained people. Do you--Dr.
Soderman and Mr. Beigel, do you agree with that?
Dr. Soderman. There is a shortage of medical technologists,
and there has been a decreasing number of training programs in
medical technology for a number of years that, in fact, is
resulting in a decreasing pool.
I would certainly agree with Dr. O'Leary in terms of the
complexity of laboratory testing is certainly increasing and
requires additional skills; however, built into the CLIA laws
are very extensive competency testing requirements that through
the accreditation program, we assure that those laboratories
are completing that competency testing on individuals. And we
think that supports the fact that the work force out there is a
good work force, they know what they're doing, and they are
getting the proper oversight to assure that they are performing
appropriately.
Mr. Souder. Mr. Beigel.
Mr. Beigel. Yes. I agree with Dr. Soderman. Essentially, 80
percent of the laboratories, maybe a little bit more than 80
percent of our laboratories that we accredit are smaller
laboratories, more in the physician office laboratory
environment, one or two, three physician offices service that
office. They are allowed, under CLIA, to have individuals that
may not be medical technologists, depending upon the complexity
of the testing conducted. So far, we have not seen a direct
impact on the quality of laboratory testing, but this is a
significant shortage. And we are projecting that shortage will
have a significant impact in the years to come.
Mr. Souder. Is part of the shortage--I assume you haven't
seen increases in Medicaid and Medicare reimbursement. Could
you discuss what kind of--in these labs, what percentage of
this is paid for by the government, and how does the tightness
of and the pressures from private sector and insurance
companies as well as the Federal Government on the cost
pressures intersect with what you just described as the
potential shortage or declining number of people at the entry
level to the testing system?
Dr. O'Leary.
Dr. O'Leary. Well, this is primarily a pipeline problem.
You know, you have seen large numbers of 4-year med tech
schools close. And so you have an aging work force of people,
and now that gap is filled with 2-year tech trainees. And the
CLIA requirements are not very stringent. In fact, if you want
to perform waived testing, you just need to be a high school
graduate or less. And I think that is where we have pipeline
problems on the one hand, and now the inability to get the
people, the temptation is going to be to get anybody who you
can. And I think all of us, the fact is we are dealing with
more complex testing generally in a wider array of tests. And
if you match that against people of, you know, lesser training
and, you know, competency, I think that is probably a disaster
waiting to happen.
I'll just comment that when I went to the IQLM meeting
about, I guess, 2 years ago, I raised a concern because we, for
the first time, were seeing laboratories conditionally
accredited or losing their accreditation or bringing their
hospitals down, I had never seen that before. And in the past 2
years, we have had nine hospitals go down because their
laboratories lost their accreditation. And we have this 42
laboratories and hospitals conditionally accredited, we have
never seen that before.
When I raised that question, all the people I talked to
traced that to the quality of personnel issue. There wasn't
even anything in second place. I think we've got a problem.
Mr. Souder. I don't want to jump to a conclusion, but
probably not a lot of these were suburban hospitals?
Dr. O'Leary. They were all kinds.
Mr. Souder. So this pressure wouldn't be just urban or
rural, it is everywhere?
Dr. O'Leary. It is everywhere.
Mr. Souder. Because one of the things that keeps many
hospitals floating are private pay patients where they can be
charged more. And to the degree you have HMOs, to the degree
you have insurance plans and to the degree you have Medicaid
and Medicare, I am trying to sort out how much of this is a
reimbursement question.
Dr. O'Leary. I don't think it is.
Mr. Souder. Why would the pipeline then be declining if
there was adequate pay incentive for people to enter into the
field? Has there been some kind of a shift?
Dr. O'Leary. I don't know why this has become a less
attractive profession. There are a lot of other dynamics going
on in our society that people that didn't used to go into
healthcare that go on to other walks of life today, and I think
that is very real. So I cannot explain why we have seen this
shrinkage in the medical technology field, but we do observe
that it exists.
Mr. Souder. Because almost every medical group that comes
into my office will tell me that they are looking at a decline
in their field because of----
Dr. O'Leary. Right, I understand that.
Mr. Souder [continuing]. Because the declining rate of
income is what the general argument is.
Now, the nursing profession is slightly different because
there is also shifting of opportunities for women, for example,
historically that haven't been there in addition to the cost
pressures and the other types of pressures on the system, and I
was trying to sort out where the technicians are here.
Part of this whole decision here--I always think of the--
Bill Cosby did a routine years ago--in fact, it was on an LP,
which shows you how long ago it was that I heard this--about
that he is in an operation and the doctor goes woops. And he
goes, wait a minute; I know what it means when I say woops,
what does it mean when the doctor says woops? And this is
ultimately so critical in your area. We can't have really woops
in a diagnosis of whether you have HIV, whether you have
cancer, whether you have any one of any number of diseases,
whether you are diabetic, oh, nope, you're not. Oh yeah, you
are, that we can't have this kind of--this is the fundamental
entry point of really everything else in medicine.
Dr. O'Leary. I totally agree.
Mr. Souder. And the question is, if a fundamental problem
here is the quality of service and trying to measure the
quality of service, then in looking at the quality of service,
we have kind of egregious errors and kind of second tier
errors. And as I used the example earlier of restaurants, it's
one thing if you don't have the ketchup bottle top on and it's
another if you have meat that's been exposed and you get
poisoning from it.
In the pipeline that you're talking about, if there is a
shortage of people and you start bringing in people, which type
of errors are you getting? Both. Is there a way for us to--and
this gets to the education question, because if you are
accelerating people coming into the system and you don't have a
sufficient supply, the education component almost becomes on
the oversight function, which isn't necessarily where you want
it to be. And at the very least, we would hope that the
oversight function would be kind of the ketchup-bottle type
questions, not on whether you have turned the labeled around or
whether you have mishandled the labels or got kind of
fundamental errors in diagnosis or exposure of what was a lab
test.
And in trying to sort through, that's kind of what was
behind my question of starting out with the supply question,
because how we deal at the end of the day with the bigger
questions here of how much is education, how much is
enforcement, how common can you have the standards, how do we
determine what's egregious is really an underlying assumption
of your work force.
Dr. O'Leary. Let me just comment. First of all, I would be
surprised if this is strictly a salary issue. I will tell you,
in the nursing arena, if you don't fix that working
environment, you are not going to have any nurses. And that has
been studied----
Mr. Souder. Mandatory overtime.
Dr. O'Leary. Right, mandatory overtime is a great case in
point. So I think we need to get underneath this problem and
figure out exactly what is going on. In the data base that we
maintain, there are clear correlations between numbers of staff
and competency of staff and the frequency of adverse events.
There's no question about that. We don't have a lot of
laboratory events in our data base, but just across the general
hospital, if you don't have enough people and they are not
properly trained, you get bad accidents.
Dr. Soderman. The problem that exists, Mr. Chairman, is the
problem between regulatory and individuals to do the testing.
If we tighten the regulations very high, we drive individuals
out of the process. If we implement very strict licensing
requirements within the States and control of how those
individuals are used, we reduce the manpower that's the work.
We have to utilize the tools that we have.
Yes, we need more medical technology schools, we need a
greater investment by the Federal Government in those schools
to allow that to develop to give us the personnel. In that
interim, filling that pipeline is going to take years because
it's taken years to close it, it's going to take years to open
it. We have to find tools that we can use the individuals that
are already in our laboratories to successfully do the testing
and assure the competency that they have. I am not sure that
can be--needs to be regulated more than it is regulated under
the CLIA rules already.
Mr. Souder. Mr. Beigel, do you have any comments?
Mr. Beigel. I will speak maybe to the smaller laboratory
environment.
I think that it's a real different situation that's being
posed in the small laboratories. And it may affect patient care
in some degree. Certainly, laboratory manufacturers have
recognized the fact that labor shortages are going to come down
the pike. I think the issue that they have done, then, is
created a lot more instrumentation that will go under the waive
category, so the laboratory test that you may see now at your
point of care sight at your doctor's office, you may need to go
to a reference lab to get your test done. So I think it will
eventually have that kind of effect. We are seeing that now.
Certainly in the CLIA data, you will see that a percentage of
waived testing has significantly increased over the last 10
years, and I believe that is going to--that trend is going to
continue, primarily driven by the fact there won't be qualified
personnel in the physician office to be able to conduct the
test appropriately.
Mr. Souder. Mr. Cummings.
Mr. Cummings. Dr. Soderman, initially I think CAP expressed
some concerns about the unannounced visits. And apparently it
sounds like there may have been a change of heart here. Can you
explain to me, and I may be inaccurate, but what is your--how
did you come to the conclusion that unannounced visits might
not be a bad idea?
Dr. Soderman. Our reservations were mostly how we were
going to implement the process. It is not easy to take the
number of labs that we accredit and assign teams to do that and
turn it into an unannounced process. And I think our initial
concerns were, how are we going to do this? Over this last
year, we have worked at developing the policies in our
accreditation program that will allow us to do that. With the
implementation--final implementation in July, almost 100
percent of the laboratories will be unannounced.
Now, if you think about what it takes, it means that an
accreditation team has to be put together, they have to be
moved to that community. So you have to have hotels, motels,
you have to let that team know what the expectations are at
that site, and you have to assure that nobody on that team
makes any contact whatsoever with the site that they are being
inspected.
Our unannounced process does not allow a 2-week notice, it
does not allow a 1-hour notice, we walk in unannounced. And it
is the orchestration of that process that has taken us this
last year to try to get implemented. We believe we have it in
place now. We've been doing some pilot unannounced
accreditation inspections over this last year to test this out,
and we are ready to march ahead.
Mr. Cummings. The whole issue of whistleblowers, Mr.
O'Leary, do you think whistleblowers are very important in your
industry?
Dr. O'Leary. They sure are. We actually have a
whistleblower protection provision in our requirements.
Mr. Cummings. And how does that work?
Dr. O'Leary. Well, if there is any evidence of--this is
what we call a condition of participating in the accreditation
process. So it's as bad as falsifying information. So if
somebody blows the whistle and there is evidence of
retaliation, they can lose their accreditation just flat out on
that basis.
Mr. Cummings. And what about you, Dr. Soderman?
Dr. Soderman. The college has the same policy, in fact. If
there is any retaliation against a whistleblower, their
accreditation is immediately pulled.
We do believe in the whistleblower. We have developed
posters, we have developed a route in which only two
individuals at the college know the individual that calls in to
assure that there is confidentiality maintained on this
process.
Mr. Cummings. So since you established--what about you, Mr.
Beigel?
Mr. Beigel. We take whistleblowers very seriously, always
have. We consider it a complaint against the laboratory. Some
of the complaints come in anonymously, and obviously we don't
know who that individual is, it could be a patient, it could be
an employee of the laboratory, it could be a current employee,
it could be a past employee, don't know. If the complainant
does give us their name, it's held in strict confidence, it's
not shared with anyone at the lab, it's not shared when we
report the complaint to CMS who the complainant is. We consider
it exceptionally serious.
Mr. Cummings. Dr. Soderman, you found that there's been an
increase in complaints; is that right, since you did this
signage thing?
Dr. Soderman. Yes. Our complaint rate has doubled. And I
suspect it's going to even go up and above that as we've made
available to the laboratory technologists and technicians and
pathologists and to the inspection teams themselves the ability
to call in and express their concern about the accreditation
process or a process that's taking place within the laboratory.
Mr. Cummings. Because we are running out of time, I'm just
going to ask one other thing.
You know, CMS makes a big deal of this standardized--some
kind of standard--I'm sorry, GAO--by which they can--all the
labs are being held to--I know we've got the CLIA standard, but
apparently they feel clearly that there is more needed to be
done. How do you all feel about that, how do you see
accomplishing that? Dr. O'Leary.
Dr. O'Leary. Well, as I said in my testimony, we don't
think it is practically accomplishable the way the GAO has
framed it. We need a common terminology and understanding as to
what a serious deficiency is, and that is the development of a
taxonomy. Mr. Hamilton spoke to that, we are very supportive of
that. We think it is doable, we think it answers the need.
Mr. Cummings. You, Dr. Soderman?
Dr. Soderman. I would agree with Dr. O'Leary. If we can get
down the same terminology. As he expressed in his discussions
early on, there are differences between how we approach
inspection of laboratories, and it's important that differences
be allowed. At least the base standards have to be similar. So
we ought to be able to communicate when those base standards
are failed.
Mr. Cummings. Let me just--Mr. Beigel.
Mr. Beigel. I absolutely agree.
Mr. Cummings. One of the things that was very interesting
in the Maryland General case is there was an issue as to
machinery not working properly, and that the--and the
allegations were that key people knew the machinery wasn't
working properly and were not disclosing the information, not
correcting the machine. And it seems to me that is the kind of
thing that no matter how you look at it should send all kinds
of red lights flashing, no matter how you all do what you do.
Is that accurate? Would that be an accurate statement? In other
words, if you knew that there was a machine not properly doing
what it is supposed to do, knowing that--not knowing, but
strong allegations that it probably was giving false readings,
and that people who knew this were holding back information, I
mean, would that kind of thing cause you all to say wait a
minute, this is--if this is true, you've got a major problem?
Dr. O'Leary. Maryland General's situation is a horrible
situation. There were so many things wrong with that picture
and so many lessons to be learned out of it. I mean, we have an
unusual situation in this situation because we accredited the
hospital in which the laboratory existed. So in that case, for
us it was a failure in--it was a failure in communication. Now,
we can blame people for not communicating with us, but we had
an obligation to create the mechanisms to assure that
communication happened. And we now have that in place, and we
would not have had that in place without Maryland General.
So I hope that we will harvest some important lessons out
of the Maryland General situation because it was--you know, the
communication problems were really horrible, probably the
worst--I think the worst part of that whole situation.
Dr. Soderman. One of the interesting aspects of the college
program is that we send in, as part of the team, medical
technologists and pathologists that are actively working in the
laboratory. Our hope is that these individuals will interact
and appeal to peer relationship and hopefully uncover problems
like this. The real key in the inspection process is to get the
inspector in front of and at the work bench, and not have their
nose constantly in paperwork that may reflect past experiences
or results of the test, but an active dialog with the
individuals in that laboratory. Because there is a greater
chance of in that dialog, they will share information that is
critical to give us some idea of what the real performance is
within that lab.
So one of the keys that we have learned from Maryland
General is you not only have to go in there and inspect the
paperwork, but we recognize that there are hundreds of
thousands of pieces of paper at any time you inspect a lab, we
can't inspect every one. It is that personal one-to-one
relationship that is the real key in successfully inspecting.
Mr. Cummings. I have some followup questions. Thank you,
Mr. Chairman. I will send them to you in writing.
Mr. Souder. Thank you. And one of the challenges, just like
we went through this machine question and the company then said
the whole succession of employees didn't know how to operate
the machine, given what you said about what is likely to be
happening in the workplace, the bottom line is if you have a
whole group of employees who say they can't work the machine,
it's real irrelevant whether it's the machine or the employees
because we are headed into that type of determination.
Thank you for your testimony today. We look forward to
continuing to work with you. And please stay in touch with us
as any legislation may evolve and the regulations may evolve.
With that, the subcommittee stands adjourned.
[Whereupon, at 4:26 p.m., the subcommittee was adjourned.]