Patient Safety Organization Laws and Regulations

Patient Safety and Quality Improvement Act of 2005 (PSQIA).

Notice of proposed rule making, February 12, 2008.

Final Patient Safety Organization (PSO) rule, November 21, 2008.

Excerpt from final rule: confidentiality and privilege provisions.

The Common Formats for data collection in the Network of Patient Safety Databases.

Two Provisions from the Patient Protection and Affordable Care Act (PPACA) Address Patient Safety Organization (PSO) Participation

1. Health insurance exchanges. Participating health plans may only contract with hospitals with greater than 50 beds when the hospital is working with a PSO. State-based health insurance exchanges are to be in place by January 1, 2014, and the compliance date for hospital contracts is January 1, 2015.
2. Hospital readmissions. HHS will, by 2012, develop a program for high-readmission rate hospitals to improve their readmission rates through the use of PSOs.

PPACA full text. (2.22MB file)

Note that the “patient safety evaluation system” referred to below is from 42USC299b-21(6): The term “patient safety evaluation system” means the collection, management, or analysis of information for reporting to or by a patient safety organization.

Section 1311. Affordable Choices of Health Benefit Plans. [Establishing state-based health insurance exchanges]

(h) QUALITY IMPROVEMENT.—

(1) ENHANCING PATIENT SAFETY.—Beginning on January 1, 2015, a qualified health plan may contract with—

(A) a hospital with greater than 50 beds only if such hospital—

(i) utilizes a patient safety evaluation system as described in part C of title IX of the Public Health Service Act; and

(ii) implements a mechanism to ensure that each patient receives a comprehensive program for hospital discharge that includes patient-centered education and counseling, comprehensive discharge planning, and post discharge reinforcement by an appropriate health care professional; or

(B) a health care provider only if such provider implements such mechanisms to improve health care quality as the Secretary may by regulation require.

(2) EXCEPTIONS.—The Secretary may establish reasonable exceptions to the requirements described in paragraph (1).

(3) ADJUSTMENT.—The Secretary may by regulation adjust the number of beds described in paragraph (1)(A).

Section 3025. Hospital Readmissions Reduction Program.

(b) QUALITY IMPROVEMENT.—Part S of title III of the Public Health Service Act, as amended by section 3015, is further amended by adding at the end the following:

“SEC. 399KK. QUALITY IMPROVEMENT PROGRAM FOR HOSPITALS WITH A HIGH SEVERITY ADJUSTED READMISSION RATE.

“(a) ESTABLISHMENT.—

“(1) IN GENERAL.—Not later than 2 years after the date of enactment of this section, the Secretary shall make available a program for eligible hospitals to improve their readmission rates through the use of patient safety organizations (as defined in section 921(4)).

“(2) ELIGIBLE HOSPITAL DEFINED.—In this subsection, the term ‘eligible hospital’ means a hospital that the Secretary determines has a high rate of risk adjusted readmissions for the conditions described in section 1886(q)(8)(A) of the Social Security Act and has not taken appropriate steps to reduce such readmissions and improve patient safety as evidenced through historically high rates of readmissions, as determined by the Secretary.

“(3) RISK ADJUSTMENT.—The Secretary shall utilize appropriate risk adjustment measures to determine eligible hospitals.

“(b) REPORT TO THE SECRETARY.—As determined appropriate by the Secretary, eligible hospitals and patient safety organizations working with those hospitals shall report to the Secretary on the processes employed by the hospital to improve readmission rates and the impact of such processes on readmission rates.”.

Rationale for Patient Safety and Quality Improvement Act of 2005 (PSQIA)

An excerpt from Sen. Edward Kennedy’s Senate Floor speech of July 21, 2005:

For even one American to die from an avoidable medical error is a tragedy. When thousands die every year from such errors, it is a national tragedy, and it is also a national disgrace, and an urgent call to action.

Five years ago, the Institute of Medicine reported that medical errors cause 98,000 deaths every year. That is an average of 268 deaths a day, every day. If errors in aviation killed 200 passengers a day in plane crashes, we would do more than simply encourage voluntary reporting. If errors at factories caused the deaths of 200 workers a day, we would demand more than corporate reports. We would require real changes.

Unfortunately, the culture of medicine has an expectation of infallibility in health professionals, and this unrealistic assumption has been reinforced by generations of medical training and medical practice.

When confronted with a mistake in health care, doctors and patients and citizens often ask, “How can there be errors without negligence?” Obviously, the fear of legal liability or embarrassment among peers and in the press leads to strong pressure to cover up mistakes.

In many cases, however, the inadequate design and implementation of health systems are responsible for the problem, including excessive work schedules and unreasonable time pressures.

We can do better. We can encourage the development of a safer health care system. We can learn important lessons from other dangerous fields, such as the aviation industry and the military, which are skillful in designing ways to provide maximum feasible safety.

The Institute of Medicine has called for strong action, and our proposal is responding to that call. The Institute’s series of reports on health care quality contain numerous recommendations for improving patient safety, and if we work together, we can make more of them a reality.

The Institute recommended that health care professionals should be encouraged to report medical errors, without fearing that their reports will be used against them. Our legislation implements this sensible recommendation by establishing patient safety organizations to analyze medical errors and recommend ways to avoid them in the future. The legislation also creates a legal privilege for information reported to the safety organizations, but still guaranteeing that original records, such as patients’ charts will remain accessible to patients.

Drawing the boundaries of this privilege requires a careful balance, and I believe the legislation has found that balance. The bill is intended to make medical professionals feel secure in reporting errors without fear of punishment, and it is right to do so. But the bill tries to do so carefully, so that it does not accidentally shield persons who have negligently or intentionally caused harm to patients. The legislation also upholds existing state laws on reporting patient safety information.