H6140 CONGRESSIONAL RECORD — HOUSE September 19, 2012 

all the good work that is currently 

being done on pediatric diseases but 

that will also fill gaps that make it so 

hard for progress to be made. 

I urge full support for this bill, and I 

yield back the balance of my time. 

Mr. UPTON. Mr. Speaker, I yield 2 

minutes to the chairman of the Health 

Subcommittee, the gentleman from 

Pennsylvania, JOE PITTS, in support of 

the legislation. 

Mr. PITTS. Mr. Speaker, H.R. 6163, 

the National Pediatric Research Network Act, seeks to address important 

unmet needs in pediatric health. 

Pediatric research is so important to 

the health of our children, and it is essential to finding answers for unmet 

health needs. According to the National Institutes for Health, there are 

between 6,000 and 7,000 diseases considered rare that affect 25 to 30 million 

people. Most of the approximately 7,000 

rare diseases are pediatric diseases and 

often genetic. Unfortunately, the doctors do not have sufficient therapies to 

treat them. 

This bill seeks to alleviate that problem by establishing pediatric research 

networks and consortia. They will help 

by coordinating research efforts among 

participating institutions, concentrating that effort on the most pressing needs and enlisting the help of 

well-trained researchers. 

Through my association with Children’s Hospital of Philadelphia, I’m 

aware that there are too many diseases 

that children and their families face 

that do not have easy answers, and few 

adequate treatments. This bill will 

strengthen basic and clinical research 

and bring us closer to finding new 

treatments and cures. 

Mr. Speaker, this bill has strong bipartisan support. I urge my colleagues 

to support the bill. 

Mr. UPTON. Mr. Speaker, in closing, 

I know the hour is late. I would just 

urge my colleagues to support this bipartisan legislation. I, too, commend 

every Member that’s had a role here 

and truly appreciate the staff to get 

this bill prepared and ready for us to 

vote on tonight. 

I yield back the balance of my time. 

Mr. WAXMAN. Mr. Speaker, I am pleased to 

rise in support of H.R. 6163, the National Pediatric Research Network Act of 2012. 

H.R. 6163 represents a bi-partisan effort to 

allow the National Institutes of Health, NIH, to 

establish a national pediatric research network 

dedicated to finding treatments and cures for 

pediatric diseases and conditions—especially 

those that are rare. The network would be 

comprised of up to 20 research consortia or 

groups of collaborating research institutions 

such as universities and hospitals. These consortia would be investigator-initiated and would 

conduct basic, clinical, behavioral, and 

translational research on pediatric diseases 

and conditions. NIH funding would be used to 

create the infrastructure necessary to carry out 

this research. 

Within the network, the NIH Director is instructed to ensure that an appropriate number 

of awards go to those consortia that focus primarily on pediatric rare diseases such as spinal muscular atrophy—or SMA—or pediatric 

birth defects such as Down syndrome. These 

kinds of diseases and conditions are rare and 

some of the children who suffer from them are 

very fragile, making it difficult for them to travel great distances to participate in clinical trials 

or other research. This is often the case 

when—not infrequently—only one institution is 

conducting such research. The availability of 

consortia—by definition, multiple cooperating 

institutions—should make clinical research opportunities far more accessible to these kids 

and their families. In turn, we would hope they 

would help speed up the time and effort in 

finding treatments and cures for these devastating diseases and conditions. 

In addition to the research itself, the consortia are expected to serve as training 

grounds for future pediatric researchers. Traditionally, pediatric research has been underfunded. This has sometimes resulted in real 

challenges in recruiting the talent necessary to 

tackle diseases and conditions that affect 

kids—again, especially those that are rare. 

Thus, H.R. 6163 places a special emphasis on 

pediatric research techniques with the goal of 

helping to ‘‘prime the pump’’ for a greater 

number of leading edge pediatric researchers. 

Taken together, the components of H.R. 

6163 make for a package that would allow 

NIH to build on the strong body of pediatric research that it currently conducts and supports. 

I would encourage NIH to take full advantage 

of this opportunity. 

As we move forward with this legislation— 

here, and hopefully, in the Senate—I want to 

commend all those members of the Energy 

and Commerce Committee who have come together to make it happen. I especially want to 

the note the effort of Congresswoman CAPPS. 

She is the lead Democratic sponsor of the bill 

and has worked tirelessly to bring it before us 

today. 

I urge my colleagues to vote ‘‘yes’’ on H.R. 

6163. 

The SPEAKER pro tempore. The 

question is on the motion offered by 

the gentleman from Michigan (Mr. 

UPTON) that the House suspend the 

rules and pass the bill, H.R. 6163, as 

amended. 

The question was taken; and (twothirds being in the affirmative) the 

rules were suspended and the bill, as 

amended, was passed. 

A motion to reconsider was laid on 

the table. 

f 

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, 

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. 


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September 19, 2012 CONGRESSIONAL RECORD — HOUSE H6141 

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. 

b 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 inhouse. 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 socalled ‘‘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 

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 


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H6142 CONGRESSIONAL RECORD — HOUSE September 19, 2012 

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 (twothirds being in the affirmative) the 

rules were suspended and the bill was 

passed. 

A motion to reconsider was laid on 

the table. 

f 

VETERAN EMERGENCY MEDICAL 

TECHNICIAN SUPPORT ACT OF 2012 

Mr. PITTS. Mr. Speaker, I move to 

suspend the rules and pass the bill 

(H.R. 4124) to amend the Public Health 

Service Act to provide grants to States 

to streamline State requirements and 

procedures for veterans with military 

emergency medical training to become 

civilian emergency medical technicians, as amended. 

The Clerk read the title of the bill. 

The text of the bill is as follows: 

H.R. 4124 

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

Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Veteran 

Emergency Medical Technician Support Act 

of 2012’’. 

SEC. 2. ASSISTING VETERANS WITH MILITARY 

EMERGENCY MEDICAL TRAINING TO 

MEET REQUIREMENTS FOR BECOMING CIVILIAN EMERGENCY MEDICAL 

TECHNICIANS. 

(a) IN GENERAL.—Part B of title III of the 

Public Health Service Act (42 U.S.C. 243 et 

seq.) is amended by inserting after section 

314 the following: 

‘‘SEC. 315. ASSISTING VETERANS WITH MILITARY 

EMERGENCY MEDICAL TRAINING TO 

MEET REQUIREMENTS FOR BECOMING CIVILIAN EMERGENCY MEDICAL 

TECHNICIANS. 

‘‘(a) PROGRAM.—The Secretary shall establish a program consisting of awarding demonstration grants to States to streamline 

State requirements and procedures in order 

to assist veterans who completed military 

emergency medical technician training while 

serving in the Armed Forces of the United 

States to meet certification, licensure, and 

other requirements applicable to becoming 

an emergency medical technician in the 

State. 

‘‘(b) USE OF FUNDS.—Amounts received as a 

demonstration grant under this section shall 

be used to prepare and implement a plan to 

streamline State requirements and procedures as described in subsection (a), including by— 

‘‘(1) determining the extent to which the 

requirements for the education, training, 

and skill level of emergency medical technicians in the State are equivalent to requirements for the education, training, and skill 

level of military emergency medical technicians; and 

‘‘(2) identifying methods, such as waivers, 

for military emergency medical technicians 

to forego or meet any such equivalent State 

requirements. 

‘‘(c) ELIGIBILITY.—To be eligible for a grant 

under this section, a State shall demonstrate 

that the State has a shortage of emergency 

medical technicians. 

‘‘(d) REPORT.—The Secretary shall submit 

to the Congress an annual report on the program under this section. 

‘‘(e) FUNDING.—Of the amount authorized 

by section 751(j)(1) to be appropriated to 

carry out section 751 for fiscal year 2013, 

there is authorized to be appropriated to 

carry out this section $1,000,000 for the period 

of fiscal years 2013 through 2017.’’. 

(b) CONFORMING AMENDMENT.—Section 

751(j)(1) of the Public Health Service Act (42 

U.S.C. 294a(j)(1)) is amended by striking 

‘‘There is authorized to be appropriated’’ and 

inserting ‘‘Subject to section 315(e), there is 

authorized to be appropriated’’. 

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 Chair 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 in the 

RECORD on H.R. 4124. 

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 this evening in 

support of H.R. 4124, the Veteran Emergency Medical Technician Support Act 

of 2012. This act would take us forward 


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