Short title

This Act may be cited as the

Patient Safety Act of 2005

Findings

The Congress finds as follows: (1)The past decade has been a turbulent time for health care facilities and nurses. (2)Recent research published in the Journal of the American Medical Association has shown that registered nurse staffing levels have a significant impact on preventable deaths in hospitals, and that the odds of patient mortality increase 7 percent for every additional patient added to the average registered nurse’s workload. (3)Recent research supported by the Agency for Health Care Research and Quality, the Centers for Medicare & Medicaid Services, and the National Institute for Nursing Research shows that inadequate registered nurse staffing is directly related to serious complications such as pneumonia, upper gastrointestinal bleeding, and urinary tract infections, as well as failure to stop deaths caused by shock, cardiac arrest, sepsis, and deep vein thrombosis in hospitalized patients. (4)The Joint Commission on the Accreditation of Healthcare Organizations recently reported that inadequate nurse staffing contributes to nearly a quarter of all unexpected incidents that kill or injure hospitalized patients. (5)The Institute of Medicine has reported that both nursing-to-resident staffing levels and the ratio of professional nurses to other nursing personnel are important indicators of high quality of care, and that the participation of registered nurses in direct care giving and in the provision of hands-on guidance to nurse assistants is positively associated with quality of care in nursing facilities. (6)Recent research conducted by the Centers for Medicare & Medicaid Services found strong, objective proof that nurse staffing in nursing homes is directly related to quality measures such as sepsis, urinary tract infections, incidence of pressure sores, resisting care improvement, and weight loss. (7)As a payer for inpatient and outpatient hospital services for individuals entitled to benefits under the medicare and medicaid programs established under titles XVIII and XIX of the Social Security Act, the Federal Government has a compelling interest in promoting the safety of such individuals by requiring providers participating in such programs to provide these individuals with information regarding nurse staffing levels.

Public disclosure of staffing and outcomes data

(a)

Disclosure of staffing and outcomes

Any provider under the medicare program shall, as a condition of continued participation in such program, make publicly available information regarding nurse staffing and patient outcomes as specified by the Secretary. Such information shall include at least the following: (1)The number of registered nurses providing direct patient care. This information shall be expressed both in raw numbers, in terms of total hours of nursing care per patient (including adjustment for case mix and acuity), and as a percentage of nursing staff, and shall be broken down in terms of the total nursing staff, each unit, and each shift. (2)The number of licensed practical nurses or licensed vocational nurses providing direct care. This information shall be expressed both in raw numbers, in terms of total hours of nursing care per patient (including adjustment for case mix and acuity), and as a percentage of nursing staff, and shall be broken down in terms of the total nursing staff, each unit, and each shift. (3)Numbers of unlicensed personnel utilized to provide direct patient care. This information shall be expressed both in raw numbers and as a percentage of nursing staff and shall be broken down in terms of the total nursing staff, each unit, and each shift. (4)The average number of patients per registered nurse, licensed practical nurse, or unlicensed personnel providing direct patient care. This information shall be broken down in terms of the total nursing staff, each unit, and each shift. (5)Risk-adjusted patient mortality rate (in raw numbers and by diagnosis or diagnostic-related group). (6)Incidence of adverse patient care incidents, including as such incidents at least medication errors, patient injury, pressure ulcers, nosocomial infections, and nosocomial urinary tract infections. (7)Methods used for determining and adjusting staffing levels and patient care needs and the provider’s compliance with these methods. (b)

Disclosure of complaints

Data regarding complaints filed with the State agency, the Centers for Medicare & Medicaid Services, or an accrediting agency, compliance with the standards of which have been deemed to demonstrate compliance with conditions of participation under the medicare program, and data regarding investigations and findings as a result of those complaints and the findings of scheduled inspection visits, shall be made publicly available. (c)

Information on data

All data made publicly available under this section shall indicate the source and currency of the data provided. (d)

Waiver for small providers

The Secretary may reduce reporting requirements under this section in the case of a small provider (as defined by the Secretary) for whom the imposition of the requirements would be unduly burdensome. (e)

Reporting to Secretary

Providers shall submit to the Secretary in a uniform manner (as prescribed by the Secretary) the nursing staff information described in subsection (a) through electronic means not less frequently than quarterly. (f)

Secretarial responsibilities

The Secretary shall— (1)make the information submitted pursuant to subsection (a) publicly available, including by publication of such information on the Internet site of the Department of Health and Human Services; and (2)provide for the auditing of such information for accuracy as a part of the process of determining whether a provider is eligible for continued participation in the medicare program. (g)

Definitions

For purposes of this section: (1)

Licensed practical nurse or licensed vocational nurse

The term licensed practical nurse or licensed vocational nurse means an individual who is entitled under State law or regulation to practice as a licensed practical nurse or a licensed vocational nurse. (2)

Publicly available

The term publicly available means, with respect to information of a provider, information that is— (A)provided to the Secretary and to any State agency responsible for licensing or accrediting the provider; (B)provided to any State agency which approves or oversees health care services delivered by the provider directly or through an insuring entity or corporation; and (C)provided to any member of the public which requests such information directly from the provider. (3)

Medicare program

The term medicare program means the programs under title XVIII of the Social Security Act. (4)

Provider

The term provider means an entity that is— (A)a psychiatric hospital described in section 1861(f) of the Social Security Act (42 U.S.C. 1395x(f)); (B)a provider of services described in section 1861(u) of such Act (42 U.S.C. 1395x(u)), other than a skilled nursing facility, as defined in section 1819(a) of such Act (42 U.S.C. 1395i–3(a)); (C)a rural health clinic described in section 1861(aa)(2) of such Act (42 U.S.C. 1395x(aa)(2)); (D)an ambulatory surgical center described in section 1832(a)(2)(F)(i) of such Act (42 U.S.C. 1395k(a)(2)(F)(i)); or (E)a renal dialysis facility described in section 1881(b)(1)(A) of such Act (42 U.S.C. 1395rr(b)(1)(A)). (5)

Registered nurse

The term registered nurse means an individual who is entitled under State law or regulation to practice as a registered nurse. (6)

Secretary

The term Secretary means the Secretary of Health and Human Services.

Public disclosure of accurate data on nursing facility staffing

(a)

Medicare

Section 1819(b)(8) of the Social Security Act (42 U.S.C. 1395i–3(b)) is amended— (1)in subparagraph (A), by adding at the end the following new sentence: The information posted under this subparagraph shall include information regarding nurse staffing with respect to beds made available by reason of an agreement under section 1883.; and (2)by adding at the end the following new subparagraphs:

(C)

Submission and posting of data

(i)

In general

Beginning on January 1, 2006, a skilled nursing facility shall submit to the Secretary in a uniform manner (as prescribed by the Secretary) the nursing staff data described in section 3(a) of the Patient Safety Act of 2005 through electronic means not less frequently than quarterly and the Secretary shall make such data publicly available (as defined in section 3(g)(2) of such Act), including by posting such data on an Internet website. (ii)

Information on nurse aides

In addition to the nursing staff data described in clause (i), a skilled nursing facility shall submit to the Secretary the numbers of nurse aides (as defined in paragraph (5))(F)) utilized to provide direct patient care. This information shall be expressed both in raw numbers and as a percentage of nursing staff and shall be broken down in terms of the total nursing staff, each unit, and each shift. (D)

Audit of data

As part of each standard survey conducted under subsection (g)(2)(A), there shall be an audit of the nursing staff data reported under subparagraph (C) to ensure that such data are accurate.

(b)

Medicaid

Section 1919(b)(8) of the Social Security Act (42 U.S.C. 1395r(b)(8)) is amended— (1)in subparagraph (A), by adding at the end the following new sentence: The information posted under this subparagraph shall include information regarding nurse staffing with respect to beds made available by reason of an agreement under section 1883.; and (2)by adding at the end the following new subparagraphs:

(C)

Submission and posting of data

(i)

In general

Beginning on January 1, 2006, a nursing facility shall submit to the Secretary in a uniform manner (as prescribed by the Secretary) the nursing staff data described in section 3(a) of the Patient Safety Act of 2005 through electronic means not less frequently than quarterly and the Secretary shall make such data publicly available (as defined in section 3(g)(2) of such Act), including by posting such data on an Internet website. (ii)

Information on nurse aides

Audit of data

As part of each standard survey conducted under subsection (g)(2)(A), there shall be an audit of the nursing staff data reported under subparagraph (C) to ensure that such data are accurate.

Creating a staffing quality measure for consumers to compare nursing facilities

(a)

In general

Beginning no later than 90 days after the date of the enactment of this Act, and for as long as the Secretary of Health and Human Services publishes quality measures to help the public compare the quality of care that nursing facilities provide, these quality measures shall include a quality measure for nursing staff that— (1)reflects the average daily total nursing hours worked for the quarterly reporting period for which data are submitted under sections 1819(b)(8)(C) and 1919(b)(8)(C) of the Social Security Act (as added by subsections (a)(2) and (b)(2), respectively, of section 4), as well as, in the case of a skilled nursing facility, other information required to be reported under section 3(a); (2)is sensitive to case mix and quality outcomes; (3)indicates the percentile in which each nursing facility falls compared with other nursing facilities in the State; (4)indicates the rate of retention of registered nurses, licensed practical nurses, and certified nurse assistants; and (5)includes such other measures as the Secretary determines to be appropriate.

The Secretary shall not be required to comply with the requirements of paragraph (2) to the extent that the development of a methodology to comply with such requirement would delay the implementation of this section.

(b)

Form and manner

The nursing facility comparative staffing measure described in subsection (a) shall be displayed in the same form and manner as information that the Secretary displays to help the public compare the quality of care that nursing facilities provide.

Protection of certain activities by employees of Medicare providers

(a)

In general

Subject to subsection (c), no provider under the medicare program shall terminate or take other adverse employment action (including the failure to promote an individual or provide any employment-related benefit, an adverse evaluation or decision made in relation to accreditation, certification, credentialing or licensing of an individual, or other adverse personnel action) against any employee or group of employees for actions taken for the purpose of— (1)notifying the provider of conditions which the employee or group of employees identifies, in communications with the provider, as dangerous or potentially dangerous or injurious to— (A)patients who currently receive services from the provider; (B)individuals who are likely to receive services from the provider; or (C)employees of the provider; (2)notifying a Federal or State agency or an accreditation agency, compliance with the standards of which have been deemed to demonstrate compliance with conditions of participation under the medicare program, of such conditions as are identified in paragraph (1); (3)notifying other individuals of conditions which the employee or group of employees reasonably believe to be such as are described in paragraph (1); (4)discussing such conditions as are identified in paragraph (1) with other employees for the purposes of initiating action described in paragraph (1), (2), or (3); or (5)other related activities as specified in regulations promulgated by the Secretary of Health and Human Services. (b)

Sanction

A provider that takes an action in violation of subsection (a) is subject to a civil money penalty of not more than $20,000 for each such action. The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b)) shall apply to civil money penalties under this subsection in the same manner as they apply to a penalty or proceeding under section 1128A(a) of such Act. (c)

Exception

The provisions of subsection (a) shall not apply to the knowing or reckless provision of substantially false information by an employee or group of employees.

Report

Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to Congress a report on— (1)the manner in which the Secretary intends to implement reporting of additional nurse staffing variables such as unit worked, day of week (weekday and weekend), and type of care (direct or administrative) provided; and (2)the most effective mechanisms for auditing nurse staffing data under sections 1819(b)(8)(D) and 1919(b)(8)(D) of the Social Security Act (as added by subsections (a)(2) and (b)(2), respectively, of section 4) and for auditing nurse staffing date under section 3(f)(2).