Medical Error Reporting Law

You asked for information on the state’s medical error reporting law, particularly changes made in the 2004 session. You are interested in the differing positions of the Connecticut Hospital Association and the Hartford Courant on this recent legislation.

Public Act 04-164, An Act Concerning the Quality of Health Care, made significant changes to a two-year-old law on health care quality that is generally referred to as the “medical error” or “adverse event” reporting law. The original legislation (PA 02-125) required hospitals and outpatient surgical facilities to report adverse events to the Department of Public Health (DPH). Generally, adverse events were injuries caused by or associated with medical management that resulted in death or measurable disability. The act classified adverse events as A through D, with Class A being the most serious. Adverse event reports generally became public information under the 2002 law six months after their filing with DPH.

PA 04-164 amends the 2002 law by replacing the adverse event classification reporting system with a list of reportable events identified by the National Quality Forum (NQF) or DPH. This act also restricts disclosure of adverse event reports.

The Connecticut Hospital Association and others supported this legislation. As best as we can determine, there was no testimony against the bill. An article and editorial published in late May 2004 in the Hartford Courant criticizes the 2004 changes primarily because of (1) the switch to the NQF list of reportable events, which the newspaper believes weakens the reporting requirements and (2) the restrictions on information provided to the public.

The state’s medical error reporting law was initially enacted in 2002 (PA 02-125, “An Act Creating a Program for Quality in Health Care”). This act required DPH to establish a quality of care program for health care facilities. It required DPH to develop a health care quality performance measurement and reporting system applicable to the state’s hospitals. (Other health care facilities come under the quality program in later years as it develops. ) An advisory committee, chaired by the DPH commissioner, advises the program. An important component of this quality program was the reporting of “adverse events” by hospitals and outpatient surgical facilities.

This act required hospitals and outpatient surgical facilities to report adverse events to DPH. An “adverse event” was defined as an injury caused by or associated with medical management that results in death or measurable disability. The law created four categories of adverse events:

1. Class A—an adverse event resulting in or associated with a patient’s death or immediate danger of death;

2. Class B—an adverse event resulting in or associated with a patient’s serious injury or disability or immediate danger of such;

3. Class C—an adverse event resulting in or associated with a patient’s physical or sexual abuse;

4. Class D—an adverse event not reported under 1 through 3 above.

Beginning October 1, 2002, the act required hospitals and outpatient surgical facilities to report Class A, B and C adverse events as follows:

1. a verbal report within 24 hours of the event,

2. a written report within 72 hours of occurrence, and

3. a corrective action plan within seven days of occurrence.

Class D adverse events had to be reported quarterly to DPH and the facilities had to include corrective action plans to reduce the risk of future events.

PA 02-125 specified that information collected on adverse events did not have to be disclosed for a six-month period from the date the required written report was submitted (72 hours after the adverse event). This information, under the act, was not subject to subpoena, discovery, or introduction into evidence in any judicial or administrative proceeding except as otherwise specifically provided by law.

It also required DPH to report annually to the Public Health Committee, by March 1, on adverse event reporting

1. replacing the adverse event classification reporting system with a list of reportable events identified by the National Quality Forum or DPH;

2. changing the timing for reporting to DPH and requiring immediate emergent reports to DPH;

3. restricting disclosure of adverse event reports; and

4. allowing DPH to use practitioners with clinical expertise of the type involved in an adverse event in investigating reports.

The act also allows DPH to designate as a “patient safety organization” a public or private organization whose primary mission involves patient safety improvement activities. The act requires hospitals and outpatient surgical facilities to seek to work and contract with such organizations as they become available. These organizations must disseminate to health care providers and others, as appropriate, information on best practices.

PA 04-164 eliminates the Class A through D adverse event reports and instead requires reports of any event identified on NQF’s “List of Serious Reportable Events” or a list compiled by the DPH commissioner and adopted in regulations. The act requires the commissioner to review the list at least annually to determine if any changes are necessary. NQF is a not-for-profit membership organization created to develop and implement a national strategy for health care quality management and reporting. (For more information on the National Quality Forum and its list of reportable events, see OLR report 2004-R-0240; attached. )

As noted above, PA 02-125 required hospitals and outpatient surgical facilities to report adverse events according to certain time frames. The 2004 act instead requires them to (1) submit to DPH a written report and the status of any corrective steps taken within seven days after an adverse event as identified on the NQF or DPH list occurs and (2) a corrective action plan not later than 30 days after the event. They must make emergent reports, which DPH must define in regulation, immediately to DPH.

NQF basically identifies 27 adverse events in six major categories: (1) surgical, (2) product or device, (3) patient protection, (4) care management, (5) environmental, and (6) criminal.

As noted above, under the 2002 law, information on adverse events did not have to be disclosed for a six-month period from the date the required report was submitted. But the 2004 act specifies that the information never need be disclosed and, as under existing law, is not subject to subpoena, discovery, or introduction into evidence in any judicial or administrative proceeding, except as specifically provided by law.

PA 04-164 also specifies that it should not be construed as limiting access to or disclosure of investigative files maintained by DPH, including adverse event reports. Existing law provides that information DPH receives through filed reports must not be disclosed publicly in a way that identifies any patient or institution, except in limited circumstances. By law, all records DPH obtains in connection with any investigation must not be disclosed to the public (1) for six months from the date of petition or other event initiating the investigation or (2) until the investigation is terminated pursuant to a withdrawal or other informal disposition or a hearing is convened, whichever is earlier.

The act requires DPH to report annually to the Public Health Committee by October 1, instead of March 1, on the adverse events reported to it.

Following is a summary of some of the key testimony on Senate Bill 566, which became PA 04-164. The public hearing on the bill was held on March 11, 2004. (As best as we can determine, there was no testimony against the bill. )

DPH basically supported the bill and offered some information and observations. Concerning the bill’s proposed replacement of the current categories of adverse events with the NQF’s list of reportable events, the department commented that it “believes this will lead to more clarity and uniformity regarding the events that need to be reported” (Testimony of Wendy Furniss, Chief of DPH’s Bureau of Healthcare Systems).

The CHA supported the changes to the adverse event reporting law included in SB 566. It noted, “in part due to the General Assembly’s enactment of PA 02-125…Connecticut has become a national leader in hospital quality performance reporting. Connecticut hospitals actively participated in developing the comparative report on hospital quality that will be released by the Connecticut …DPH next month and have worked closely with DPH on other initiatives created by the Act . ” (Testimony of CHA President and Chief Executive Officer Jennifer Jackson. ) Jackson continued:

“Connecticut’s hospital quality performance reporting system successfully promotes the dual goals of quality improvement and public accountability. Although the adverse event reporting system is designed to achieve the same two goals, the current system is not able to achieve either one, because it lacks the necessary foundation of standardized, accurate, and useful information. SB 566 would provide the necessary foundation to enable the adverse event reporting system to effectively promote both these goals by adopting the…NQF list of serious reportable events as the events reported to the Department of Public Health. The current A, B, C and D adverse event classifications are not specific enough to facilitate comparative analysis of reported events and, although hospitals have been reporting events for almost 18 months, no information that could be used to improve patient safety has been provided to hospitals. Adoption of the NQF list will allow for evaluation of reported events, identification of trends, and development of concrete strategies to improve patient safety in Connecticut. Use of the NQF list will also allow Connecticut to compare results and share strategies with several other states who have adopted or are evaluating adoption of the NQF list…

The NQF list is focused on events that are usually preventable, as opposed to the current adverse event reporting system, which requires hospitals to report events that may have no relationship to the quality of care provided by that hospital. The current system’s combination of errors and unpreventable adverse events makes public disclosure of the number of reported events misleading and unreliable as a basis for consumer information. ”

On the issue of making information available to the public, the CHA’s Jackson stated “SB 566… will facilitate accurate public reporting by making available to the public the DPH’s regulatory findings after investigation of adverse events but maintaining the confidentiality of adverse events as they are filed. ”

Qualidigm, in Middletown, Connecticut, is a not-for-profit health care quality improvement organization. It works statewide with hospitals, physicians, nursing homes, home health agencies, and other providers in Connecticut on a variety of projects aimed at improving the quality of care delivered to patients. In its testimony, Qualidigm stated that it “strongly supports SB 566… which contains several provisions that were specifically recommended by the Quality in Health Care Advisory Committee to improve Connecticut’s adverse event reporting system. SB 566 would align Connecticut’s adverse event reporting requirements with national standards by adopting the list of events recommended by the National Quality Forum for states’ use in developing mandatory reporting systems. ” (Testimony of Maxine Goldsmith for Qualidigm. )

Qualidigm also supported the legislation because it would “facilitate the provision of accurate and meaningful information to the public by making DPH’s adverse event investigation findings public while preserving the confidentiality of adverse events as they are filed. ” (Goldsmith testimony. )

CMS testified that it “concurs with the Connecticut Hospital Association that the changes to the system recommended through this legislation should be supported. This legislation will conform the definition of adverse events in Connecticut statutes with national standards established by the National Quality Forum, a change that will provide for more consistency among reported events. The legislation also amends reporting time frames to establish more appropriate and attainable periods, while not compromising the process. ”

After the passage of PA 04-164, the Hartford Courant published an article on the new law (May 23, 2004) and an editorial on May 27, 2004. It wrote in its editorial, “Without fanfare, Connecticut lawmakers have passed a bill that will help hospitals hide mistakes. The legislation will limit the mandatory disclosure of medical errors and reduce public access to reports…. On both the national and state level, doctors and hospitals have fought attempts to require greater disclosure of medical errors, estimated to kill tens of thousands of people yearly. Two years ago, Connecticut adopted a law requiring hospitals to report to the state all medical mistakes that result in ‘death or measurable disability.

The editorial continues, “The new law kills that provision and inserts, instead, a standard list of reportable mistakes, such as operating on the wrong patient, discharging an infant to the wrong person or leaving a surgical instrument inside a patient. As disclosed by Courant reporter Jack Dolan, this list leaves out some serious mistakes…the weakened law gives the Department of Public Health commissioner authority to add categories to the list of what must be reported. Listing specific categories is fine, but why delete the original language, which clearly states that all serious mistakes must be disclosed?”

On the public information issue, the editorial states, “Currently, error reports become public information six months after they are filed with the state Department of Public health. This provision, too, was amended to bar disclosure unless the DPH investigates a case—thus keeping the public in the dark about some errors. ”


July 2, 2004		2004-R-0532
MEDICAL ERROR REPORTING LAW

By: John Kasprak, Senior Attorney