[Congressional Record Volume 156, Number 105 (Thursday, July 15, 2010)]
[Senate]
[Pages S5968-S5969]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. HAGAN:
  S. 3596. A bill to establish the Culture of Safety Hospital 
Accountability Study and Demonstration Program; to the Committee on 
Finance.
  Mrs. HAGAN. Mr. President, today I am proud to introduce the Culture 
of Safety Hospital Accountability Act. This bill will test alternatives 
to the current, inflexible system to ensure that hospitals are meeting 
the highest health and safety standards for their patients.
  Under the current system, the Centers for Medicare and Medicaid, or 
CMS, requires hospitals participating in Medicare and Medicaid to 
comply with Conditions of Participation--health and safety standards 
established by CMS for the protection of Medicare and Medicaid 
beneficiaries. CMS contracts with State agencies to perform inspections 
of hospitals, nursing homes, and other health care facilities to ensure 
compliance.
  However, there are significant deficiencies in the current system. A 
major concern among hospitals is CMS' assignment of Immediate Jeopardy, 
which puts hospitals on a 23-day fast-track to losing their Medicare 
and Medicaid funding. Right now, the only remedy that CMS has when a 
hospital receives a citation is termination. There is no flexibility to 
consider the incident on a case-by-case basis--or even to consider 
whether the hospital self-reported and immediately corrected the 
incident. Moreover, current procedures fail to consider the substantial 
resources and efforts that hospitals are already investing in quality 
improvement and patient safety.
  Take, for example, a hospital in my State, which last year got a 23-
day termination notice after they self-reported that one of their 
nurses had H1N1. The hospital immediately sent the nurse home and, as I 
mentioned, immediately reported the incident to CMS. Nevertheless, the 
hospital was required to undergo an inspection and submit the requisite 
plan of correction to CMS. The agency was not able to process the 
paperwork until day 22 of the 23-day notice, causing undue stress for 
the community as they wondered whether the hospital was going to be 
forced to close its doors.
  In addition to the uncertainty for the hospital, the human resources 
required and costs incurred to implement this inflexible system are 
enormous. Once a hospital is cited as out of compliance with their 
Condition of Participation, the State CMS inspectors are required to 
survey the entire hospital and any other hospitals under the same CMS 
provider number. In the case of the hospital I just mentioned, it took 
State inspectors an entire week with 17 staff to survey their hospital 
system.
  To address this inflexibility in the current system, I am introducing 
the Culture of Safety Hospital Accountability Act. This bill would do 
three things:
  First, it would require the Secretary of Health and Human Services to 
study

[[Page S5969]]

existing quality assurance and patient safety activities within 
hospitals and identify best practices that should be replicated.
  Second, it would create a demonstration program among hospitals, 
State health care agencies, and HHS to promote and implement best 
practices for improving patient safety and quality of care. HHS would 
identify up to 6 States and not more than 24 hospitals to participate 
in a 3-year demonstration program.
  Finally, the bill would authorize the Secretary of HHS to promulgate 
regulations modifying termination agreements regarding health and 
safety requirements with hospitals and critical access hospitals to 
better ensure compliance, prevent recurrence of violations, and improve 
internal structures and processes that address patient quality and 
safety.
  Patient safety must be first and foremost, and it is not the intent 
of the demonstration project to keep CMS or State inspectors out of 
hospitals, nor to impair the remedies CMS needs to address quality 
issues. Instead, the bill will help to explore how CMS, State 
regulatory authorities, and hospitals can work collaboratively to 
address quality and safety issues in ways that will ensure the best 
quality of care for patients.
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