[Congressional Record (Bound Edition), Volume 158 (2012), Part 10]
[House]
[Pages 14381-14383]
[From the U.S. Government Publishing Office, www.gpo.gov]




             TAKING ESSENTIAL STEPS FOR TESTING ACT OF 2012

  Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill 
(H.R. 6118) to amend section 353 of the Public Health Service Act with 
respect to suspension, revocation, and limitation of laboratory 
certification.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 6118

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

[[Page 14382]]



     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Taking Essential Steps for 
     Testing Act of 2012''.

     SEC. 2. SUSPENSION, REVOCATION, AND LIMITATION OF LABORATORY 
                   CERTIFICATION.

       Section 353 of the Public Health Service Act (42 U.S.C. 
     263a) is amended--
       (1) in subsection (d)(1)(E), by inserting ``, except that 
     no proficiency testing sample shall be referred to another 
     laboratory for analysis as prohibited under subsection 
     (i)(4)'' before the period at the end; and
       (2) in subsection (i)--
       (A) in paragraph (3), by inserting before the period at the 
     end of the first sentence the following: ``, except that if 
     the revocation occurs pursuant to paragraph (4) the Secretary 
     may substitute intermediate sanctions under subsection (h) 
     instead of the 2-year prohibition against ownership or 
     operation which would otherwise apply under this paragraph''; 
     and
       (B) in paragraph (4), by striking ``shall'' the first place 
     it appears and inserting ``may''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Pennsylvania (Mr. Pitts) and the gentlewoman from California (Mrs. 
Capps) each will control 20 minutes.
  The recognizes the gentleman from Pennsylvania.


                             General Leave

  Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials into the Record on H.R. 6118.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Pennsylvania?
  There was no objection.
  Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today to support H.R. 6118, the Taking Essential 
Steps for Testing Act of 2012.
  H.R. 6118 would give the Centers for Medicare and Medicaid Services 
much needed regulatory flexibility to enforce prohibitions against 
improper referrals of proficiency testing under the clinical laboratory 
improvement amendments.
  In order to operate as a business, laboratories must adhere to CMS 
procedures for processing samples, must share testing results with CMS 
periodically and are prohibited from intentionally referring testing 
samples to any other lab.
  Currently the Centers for Medicare and Medicaid Services is required 
under statute to revoke the CLIA certificate of any laboratory that 
intentionally refers its proficiency testing samples to another 
laboratory for testing for a period of 1 year.
  In addition, the statute requires that a person who has owned or 
operated a laboratory which has had its CLIA certification revoked, 
including those owning multiple labs, may not own or operate a 
laboratory for a period of 2 years following such revocation.
  However, there have been instances where a hospital or independent 
laboratory has accidently referred a PT sample to another lab due to 
mistakes by employees or through automated systems. In such instances 
CMS is not allowed by law to consider the circumstances under which the 
test was accidently referred or if the lab acted in good faith to 
report and address the incident.
  H.R. 6118 would address these issues by amending section 353 of the 
Public Health Service Act to allow the Secretary discretion to 
determine whether the 1-year ban on laboratories should be applied and 
the flexibility to levy immediate sanctions instead of the 2-year 
prohibition against ownership or operation of the lab.
  The legislation enjoys bipartisan support among this body as well as 
numerous organizations, including the American Clinical Laboratory 
Association, the American Hospital Association, the College of American 
Pathologists, and the Clinical Laboratory Management Association, among 
others.
  I would like to thank Congressman Grimm and Congressman Roskam for 
their work on this legislation, and I urge Members to support the bill.
  I reserve the balance of my time.

                              {time}  2110

  Mrs. CAPPS. Mr. Speaker, I yield myself 5 minutes.
  Mr. Speaker, the Taking Essential Steps for Testing Act is a 
bipartisan, sensible bill which will provide the Centers for Medicare 
and Medicaid Services the flexibility it needs in imposing penalties on 
clinical laboratories that violate certain recertification procedures. 
While not commonly discussed, the Clinical Laboratory Improvement 
Amendments of 1988, or CLIA, is an important law that ensures all labs 
operating in the United States can be trusted. Under CLIA, all labs 
must be certified to prove they are qualified to perform clinical tests 
while meeting quality and safety standards. We can all agree this is a 
good thing.
  Labs are periodically retested to keep their CLIA certification. To 
do this, labs are required to perform proficiency tests which measure 
the quality and competency of a lab's work. Unlike some tests that come 
to a lab that can be sent out to other labs, proficiency tests must be 
performed in-house. Currently, if a lab is found to have referred a 
proficiency test to another lab, the Secretary of HHS must revoke that 
lab's certificate for at least 1 year. This prevents it from 
participating in Medicare or Medicaid for that period. In addition, the 
operator of any lab that has had its certificate revoked is barred from 
owning or operating any certified labs for 2 years.
  However, current law does not allow the Secretary any flexibility in 
imposing these penalties for labs that improperly refer proficiency 
tests--even when it's an unintentional referral. This has led to labs 
that are being shut down across the country, potentially affecting 
patient care and access, even when their actions are not worthy of such 
a sanction. This is especially pronounced when the sanction occurs on 
just one lab that is part of a larger health care system, as the 
penalties apply to the entire system, even if all the other labs happen 
to be in compliance.
  So this legislation would help address these problems by allowing CMS 
the flexibility to institute lesser sanctions to really address the 
problem instead of penalizing an entire system for unintentional 
proficiency test referrals. The bill does so without changing the 
accountability within the law or making our labs less reliable. And CMS 
still will be required and able to hold so-called ``bad actors'' 
accountable.
  This bill is a very commonsense reform to CLIA, and I'm pleased to 
support it. I urge my colleagues to do so as well.
  I reserve the balance of my time.
  Mr. PITTS. Mr. Speaker, at this time I yield 4 minutes to the 
gentleman from New York (Mr. Grimm).
  Mr. GRIMM. Thank you for yielding me time.
  Today, I rise in strong support of this legislation, H.R. 6118, the 
Taking Essential Steps for Testing Act. I would like to thank Chairman 
Upton for his leadership, Ranking Member Waxman, as well as the Health 
Subcommittee and their entire staff for their support and dedication to 
this important bill.
  The TEST Act is a bipartisan and bicameral solution to an issue that 
threatens Americans' access to health care. Under the Clinical 
Laboratory Improvement Amendments, CLIA, any lab that conducts human 
specimen testing must have a CLIA certificate and comply with the law's 
proficient testing, or PT, requirements. CLIA requires labs to treat PT 
samples as it would a patient sample. However, the law explicitly 
prohibits a lab from referring a PT sample to another laboratory, 
although this may be normal for patient procedures. The purpose of this 
prohibition is to ensure labs submit their own results for PT samples. 
I believe that this does clearly promote continued patient safety, 
accurate results, and that a lab is not getting reimbursed for tests it 
does not or cannot perform.
  The concern is that labs which have accidentally referred a PT sample 
to another lab and self-reported this mistake are being told by CMS 
that CLIA does not provide any flexibility and therefore their 
certificates must be revoked. As a result, labs that make a mistake and 
proactively try to correct it are treated identically to labs that 
knowingly and in bad faith violate the law.
  Without a CLIA certificate, as we have heard, labs are unable to 
conduct

[[Page 14383]]

any human specimen testing. For hospitals, this could mean choosing 
between shutting down essentially all services such as the ER and the 
operating room or paying millions of dollars to bring in an outside lab 
for 2 years. Both of these options result in reduced access to health 
care and other related services for patients.
  The TEST Act gives CMS discretion to not revoke a CLIA certificate 
for a PT referral if it is determined that the lab was acting in good 
faith. And for labs which are bad actors, the TEST Act does nothing to 
alter CMS's ability to punish those labs and revoke their certificate. 
H.R. 6118 also gives CMS the discretion to not apply the revocation to 
an entire hospital network or other owner-operators based on the facts 
of a particular case.
  In determining whether or not to revoke a CLIA certificate, I urge 
CMS to consider factors such as the nature of the violation, the lab's 
history of compliance and past PT experience, whether or not the lab 
voluntarily reported the referral, any remedial actions taken by the 
lab, and any recommendations made by the State or applicable 
accrediting organization.
  I would like to end by saying thank you to all of my colleagues that 
helped support this legislation and urge all my colleagues to vote in 
favor of H.R. 6118. It's commonsense legislation that ultimately puts 
patients first.
  Mrs. CAPPS. May I ask the chairman if he has any other speakers?
  Mr. PITTS. We have no further speakers.
  Mrs. CAPPS. Mr. Speaker, in closing, the Taking Essential Steps for 
Testing Act is a straightforward bill with bipartisan support. It will 
give CMS tools to effectively deal with labs that unintentionally refer 
out their proficiency tests, maintain sanctions for labs that 
intentionally flaunt the law, and ensure that certified clinical labs 
are there for us when we need them.
  I urge support for this bill, and I yield back the balance of my 
time.
  Mr. PITTS. Mr. Speaker, I urge support for this commonsense, 
bipartisan bill, H.R. 6118, and I yield back the balance of my time.
  Mr. WAXMAN. Mr. Speaker, I am pleased that we are taking up H.R. 
6118, a bipartisan, non-controversial bill that will provide the 
Centers for Medicare & Medicaid Services (CMS) with additional 
flexibility in imposing and enforcing penalties on clinical 
laboratories under the Public Health Service Act.
  The Committee on Energy and Commerce has a long history of being 
vigilant with respect to quality and safety standards for clinical 
laboratories. In fact, the Public Health Service Act standards for labs 
originated in this Committee when John Dingell, Ed Madigan, Ron Wyden 
and I sponsored the legislation in the 1980's.
  All laboratories in the United States must be certified and meet 
certain quality and safety standards. To maintain certification, 
laboratories must periodically perform proficiency tests, which measure 
the quality of a lab's work. These proficiency tests must be performed 
in-house--as the test is intended to measure that specific lab's 
quality and competency.
  If a lab is found to have intentionally referred a proficiency 
testing sample to another laboratory, the Secretary of HHS must revoke 
that lab's CLIA certificate for at least 1 year (thereby preventing it 
from billing Medicare or Medicaid for that period). In addition, the 
owner or operator of any lab that has had its CLIA certificate revoked 
is barred from owning or operating any CLIA-certified laboratory for 2 
years.
  Current law does not allow the Secretary any flexibility in imposing 
these penalties for labs that improperly refer proficiency tests--even 
for an unintentional referral.
  Equally importantly, there have been a number of changes in the 
organization and delivery of health care since these penalties 
provisions were enacted. In particular--the growth of health systems 
that have many providers joining together to operate under the same 
umbrella. In the case of laboratories, one hospital system may own and 
operate a number of labs. If one lab is found to have a proficiency 
testing violation, all of the labs under the hospital's system would be 
barred from Medicare--even if those labs had no quality or proficiency 
testing issues.
  This is not a sensible result. This legislation would address that 
problem.
  First, H.R. 6118 ensures the statute is clear on the point that no 
proficiency testing sample may be referred to another laboratory even 
if such referral would be part of the testing lab's standard procedure 
for patient specimens (a point of existing law on which some providers 
have been confused).
  Second, it grants the Secretary discretion in determining whether to 
revoke a lab's CLIA certificate for improper referrals of PT testing 
samples--to account for the case of unintentional error.
  Finally, the bill would grant the Secretary discretion to apply 
alternate sanctions in lieu of the 2-year owner/operator ban if a CLIA 
certificate has been revoked due to an improper proficiency testing 
referral, correcting the problem of having to ban all labs in a health 
system, even if the others had no known problems.
  The Taking Essential Steps for Testing Act would address that issue, 
striking a balance to ensure quality protections remain, yet giving the 
Secretary the flexibility to more appropriately tailor penalties for 
violations of the law. I'm pleased to support this bill today.
  Mr. UPTON. Mr. Speaker, H.R. 6118, the Taking Essential Steps for 
Testing (TEST) Act of 2012, is an important measure that grants CMS the 
necessary flexibility to enforce its rules without unnecessarily 
punishing employers for unintentional acts.
  Under current law, laboratories must adhere to CMS procedures for 
processing testing samples in order to do business under the Clinical 
Laboratory Improvement Amendments (CLIA) law. In addition, they are 
prohibited from intentionally referring testing samples to other labs.
  Unfortunately, CMS is not allowed to look at the circumstances under 
which labs refer samples, and must levy the same penalties for those 
operating in good faith as those knowingly and willfully breaking the 
law. These penalties include the loss of a lab's certification for a 
year and a prohibition against the owner operating any lab for a period 
of two years.
  In instances where a hospital or independent laboratory has 
accidentally referred a sample due to mistakes by employees or through 
automated systems, these penalties can be needlessly harsh and threaten 
the livelihood of American workers. H.R. 6118 would address these 
issues by allowing the Secretary discretion when determining penalties.
  The legislation has received bipartisan support among this body as 
well as numerous organizations. I would like to commend Congressmen 
Grimm and Roskam for their work and urge Members to support its 
passage.
  Mr. ROSKAM. Mr. Speaker, I rise today to express my support for H.R. 
6118, the ``Taking Essential Steps for Testing Act of 2012'' or TEST 
Act. This legislation will give the Centers for Medicare and Medicaid 
(CMS) greater leeway when dealing with hospitals and laboratories 
across the nation.
  Last year I was contacted by a hospital in my Congressional District 
who informed me that they had unintentionally referred a proficiency 
test to an outside lab because the lab technician was following patient 
procedure. They informed me that because of this error they would be 
forced to potentially close the lab and essentially fire the lab 
director. Upon further investigation, I was troubled to learn that the 
same problem was occurring across the country because CMS lacked the 
authority to handle these cases in any other fashion.
  This is why I was happy to work with my good friend from New York, 
Mr. Grimm, and Mr. Ross from Arkansas, as well as Senators Boozman, 
Klobuchar, and Shaheen, to come up with a simple, commonsense solution 
to the problem. While working with CMS and our friends across the 
aisle, we were able to demonstrate that this institution is still 
capable of recognizing problems and pursuing solutions for the people 
we represent back home.
  It is my hope that the Senate will quickly take up this legislation 
and send it to the President for signature so we can help provide 
regulatory relief to our nation's hospitals and labs.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Pennsylvania (Mr. Pitts) that the House suspend the 
rules and pass the bill, H.R. 6118.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

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