- • Disclosure to Patient
As stated in the 2004 Annual Report to the General Assembly [p.37], the Advisory Committee working group members discussed the General Assembly's original concern that events were occurring without patients being informed. A proposal to require attestation by the organization that the patient was informed of the event in lieu of Freedom Of Information (FOI) disclosure of the adverse event report was raised, and the working group recommended that the adverse event form be modified to include a statement attesting to the fact that the patient has been informed of the adverse event. The General Assembly did not include any such feature in Public Acts No. 04-164 amendments to the “adverse event” reporting law, but the DPH has complied with the working group request. Beginning July 1, 2004, the DPH included in the Adverse Event Reporting Form a separate space for facilities to indicate 1) whether notification of patients and/or the authorized representative occurred, and 2) the date of notification. Since Public Act No. 02-125, §3(e) requires the Commissioner of the DPH to to codify an adverse event reporting form and system in regulations, these questions will ultimately reflect DPH regulations.
Although Connecticut does not mandated disclosure to patients of adverse events in statute, it is apparent that the Advisory Group and the DPH intend to bring focus to this issue. In fact, the October 2004 Annual Report to the General Assembly states that . . . Using the new reporting form, 82% of reports have a box checked to indicate that the patient or an authorized representative was informed of the adverse event. The other 18% indicate either that the patient was not informed, or have neither (Yes/No) box checked. Overall, there appears to be a high rate of notification." [PDF]
- • Public Disclosure
Connecticut status and intent regarding public disclosure is unclear based upon current statutes. Connecticut has changed its laws regarding what information is released to the public, based on its first year of experience with the 2002 version of the reporting program. In 2002 the passage of Public Act No. 02-125 called for the DPH to:
- 1. develop a format for a public quality performance measurement report, [§1(b)]
- 2. prepare a report, available to the public, that compares all licensed hospitals in the state based on the quality performance measures developed under the quality of care program, on or before April 1, 2004, [§1(g)]
- 3. release of adverse event information is delayed until 6-months after the date of submission of the adverse event report, albeit the information was not subject to subpoena or discovery or introduction into evidence in any judicial or administrative proceeding. [§3(g)]
An initial report of May 28, 2003 published in the Hartford Courant, reflecting experience with about 400 reported “adverse events” from October 2002 to January 2003, showed that 94 adverse events were reported at the state's 31 hospitals. One hospital reported 15 events, another reported only one. Some media and public response to the initial release of information was animated, and concerns regarding the validity of this information were raised by members of the Advisory Committee to the DPH, who questioned whether the uneven reporting might lead to misinterpretation of the data and create a muddled public perception of health care quality in Connecticut hospitals. There simultaneously was concern that under-reporting and an uneven reporting across facilities might reflect uncertainty regarding definitions and a reluctance on the part of some institutions to submit information that might be discoverable and released publicly according to provisions in the Freedom on Information Act.
As noted in the 2004 Annual Report to the General Assembly [PDF, p12], the investigation of adverse events were not protected from public disclosure, even though the 2002 law suggested that they should be.
"Investigations involving adverse events follow the same process as issues received through the public complaint process. Information is gathered through onsite inspection, review of medical records, interviews with institutional staff and vested parties as appropriate. This is a critical phase in the process since it can identify events that were due to medical error, and because the results of these investigations are available to the public, upon request, under the Freedom of Information Act. The patient or family is contacted during and after completing the investigation. If later contact by family or patient brings a new issue to light, the case may be reopened."
With the support of the Advisory Committee, the DPH lobbied for a radical change in the reporting law that would eliminate the ambiguity created by the definitions provided in 2002 and that would provide protection of the data from discovery by the FOI law. Without these changes, the Advisory Committee and the DPH felt that the reliability of reporting was suspect. The DPH and members of the Advisory Committee lobbied on behalf of HB 566, which passed the General Assembly on May 8, 2004 as Public Act No. 04-164, which dramatically changed prior law.
From the perspective of Public Disclosure, the new law provided the desired protections sought by the DPH for the adverse event reported data, shutting the door on disclosure, as provided in §1(e) stating:
"Information collected pursuant to this section shall not be disclosed pursuant to subsection (a) of section 1-210, as amended, at any time, and information collected pursuant to this section shall not be subject to subpoena or discovery or introduced into evidence in any judicial or administrative proceeding except as otherwise specifically provided by law. Nothing in this section shall be construed to limit access to or disclosure of investigative files, including any adverse event report contained in such files, maintained by the department as otherwise provided in section 19a-499."
Whereas Public Act No. 02-125 called for the release of a public report “that compares all licensed hospitals in the state based on the quality performance measures developed . .” in the reporting program, this same section of law specifically indicated that it would be available “. . on or before April 1, 2004.” [§1(g)] Subsequent changes in law created by Public Act No. 04-164 do not extend this date. There is, therefore, no statutory basis for reporting to the public after April 1, 2004. The only provision for reporting addresses the Commissioner of DPH report to the General Assembly, due annually on October 1. [Public Act No. 04-164, §1(d)]
Notwithstanding the lack of statutory authority, the Advisory Committee and the DPH repeatedly have indicated that accountability is one of the major themes of the reporting program. The likelihood is that provider-identified data will ultimately be released and that individual facilities will make independent contracts with Patient Safety Organizations that will dictate how ‘near-miss’ and less severe adverse events will be reported.
- • Provider Identification
Facility-specific report card type of information was initially intended as part of the initial 2002 legislation, but the 2004 law provides no provisions for release of provider-specfic data, let alone public release of any data.
The Adverse Event Reporting Form prepared by the DPH for facilities [PDF] requires the identification of both the facility and the physicians and other health professionals involved in each reportable event. Physician identification in the reporting process is transparent to the DPH and the licensure Boards, but this information is not released to the public unless malpractice is established. No specific information regarding an event is released to the public, but the physician is required to report his/her Profile Information as mandated by Public Act No. 99-284, Section 33(b). That information is available to the public at the Physician Profile website.
- • Content of Report
Reporting of data by category of event is quite likely, since the 2004 Annual Report released data by that method. However, the 2004 legislation addresses only a report by the Commission of the DPH to the General Assembly, and it fails to address public release of data, let alone provide instructions what information will be put into a report for public release. Furthermore, on page 36 in Appendix E of the 2004 Annual Legislative Report on Medical Errors to the General Assembly provides insights into the thinking of the Adverse Event Reporting Working Group of the DPH Quality in Health Care Advisory Committee. To see the fulltext, click here: (Show/Hide)