You asked a number of questions concerning medical error reporting in the state, specifically whether: (1) Connecticut hospitals follow a common protocol in reporting medical errors, (2) hospitals include in their error reporting a provision that patients be notified of the error, (3) state law on adverse event reporting requires patient notification, and (4) any states require patient notification of medical errors.

SUMMARY

Connecticut law requires both hospitals and outpatient surgical facilities to report adverse events within seven days. An “adverse event” is any event that is identified on the National Quality Forum's (NQF) “List of Serious Reportable Events” or on a list compiled by the commissioner of the Department of Public Health (DPH). The law also directs the commissioner to review the list periodically and annually determine whether any changes are needed.

DPH has developed an adverse event reporting form (known as “AE #1”) that all hospitals and outpatient facilities must use when reporting adverse events.

The law does not require health care facilities to notify patients of medical errors. But the adverse event reporting form does include a section on “Notification” asking whether the facility has notified the patient or his authorized representative of the adverse event (a box is checked “yes or “no”). According to DPH, every adverse event form filed over the last year indicates that the patient or representative has been notified.

At least four states have reporting systems that require patient notification after an adverse event. Pennsylvania was the first to adopt such a measure.

CONNECTICUT LAW

Adverse Event Reporting

PA 04-164, An Act Concerning the Quality of Health Care, made significant changes to a then two-year-old law on health care quality that was 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 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 (CGS § 19a-127n) replaced the adverse event classification reporting system with a list of reportable events identified by the NQF or DPH. The NQF “Serious Reportable Events” list includes 27 serious events in six major categories that may occur in hospitals and outpatient facilities. (More detail on the law can be found in OLR Report 2004-R-0532. )

But based on its experience with PA 02-125, DPH determined that it needed certain information on additional events in order to improve the safety of patients in Connecticut. DPH has added six Connecticut-specific events to the NQF list. The Connecticut-specific events are:

1. perforations during open laparoscopic and/or endoscopic procedures resulting in death or serious disability;

2. falls resulting in serious disability while being cared for in a health care facility;

3. obstetrical events resulting in death or serious disability to the neonate;

4. significant medication reactions resulting in death or serious disability;

5. laboratory or radiologic test results not reported to the treating practitioner or reported incorrectly resulting in death or serious disability due to incorrect or missed diagnosis in the emergency department; and

6. nosocomial infections defined as reportable sentinel events by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

The 2004 law also restricts disclosure of adverse event information. Previously, the information collected on adverse events did not have to be disclosed for a six-month period from the date the required report was submitted. PA 04-164 instead provides that the information need never be disclosed and as under existing law, is not subject to subpoena, discovery, or introduction into evidence in any judicial or administrative procedure except as specifically provided by law.

In 2006, the General Assembly passed PA 06-142 creating an 11-member Committee on Healthcare Associated Infections to develop, operate, and monitor a mandatory reporting system for health care associated infections. DPH must implement the committee's recommendations.

According to DPH's October 2006 Adverse Event Report to the General Assembly (the law requires an annual report), the most common adverse events reported involve two of the Connecticut-specific categories — (1) falls resulting in serious disabilities and (2) perforations during open, laparoscopic and/or endoscopic procedures. The two leading types of events from the NQF list are (1) retention of a foreign object in a patient after surgery and (2) stage 3-4 pressure ulcer acquired after admission to a facility. (The DPH report is attached. )

Adverse Event Reporting Form

Under the law, the hospital or outpatient surgical facility must submit a written report of an adverse event to DPH on a specific department form (Form AE #1; copy attached) within seven days after the event occurred. Separate reports must be submitted for each adverse event that affects a patient while in the facility.

The reporting form asks for:

1. facility information (type of hospital , i. e. general, children's, chronic disease, mentally ill hospice, maternity);

2. patient information, including the date and time of the adverse event and when it was first known;

3. location of the event (e. g. emergency room, operating room, outpatient setting, surgical unit, neonatal intensive care);

4. notifications (to patient, other state agencies, local/state police, others);

5. description of the adverse event (event facts and status of the patient's condition, immediate plan of action taken to reduce the risk of a similar event); and

6. a corrective action plan (a plan must be filed for each adverse event within 30 days after its occurrence).

Patient Notification

The law does not require that the facility notify the patient or his authorized representative of the adverse event. As noted above, the DPH reporting form does include a “Notification” section that asks whether the patient or his authorized representative was notified of the event (see page 2 of AE#1). Over the past year, patients were notified in every case of the over 400 adverse events reported to DPH, according to the department's review of submitted AE #1 forms. (More information should be available in the annual adverse events report due in October 2007. )

STATES REQUIRING PATIENT NOTIFICATION OF MEDICAL ERRORS

At least four states have systems requiring patient notification after an adverse event — Florida, Nevada, New Jersey, and Pennsylvania.

Pennsylvania

In 2002, Pennsylvania became the first state to pass legislation establishing mandatory reporting requirements in relation to both adverse events and “near miss” incidents. Under the Pennsylvania “Medical Care Availability and Reduction of Error Act” (MCARE), health care workers are required to report “serious events” or 'incidents” within 24 hours to the medical facility. Facilities are in turn required to report these occurrences to the Patient Safety Authority, an independent state agency. Non-regulatory and non-punitive in nature, the authority evaluates reports and recommends solutions to facilities for improving health care practices and procedures. Serious events must also be reported to the Department of Health, which is responsible for investigating these events and approving the authority's recommendations (40 Pa. Stats. §§ 1303. 301 et seq. ).

The medical facility, through an appropriate designee, must also provide written notification to a patient affected by a serious event or to a family member or designee within seven days of the event's occurrence or discovery. The law specifies that such notification does not constitute an acknowledgment or admission of liability (Section 308 of MCARE; 40 Pa. Stats. § 1303. 308).

The law defines “serious event” as an event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an “incident. ” Incident is separately defined as an event (other than a serious event), occurrence, or situation involving the clinical care of a patient in a medical facility that could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient (§ 1303. 302).

Florida

Florida law requires an appropriately trained person designated by each licensed health care facility to inform each patient, or an individual identified pursuant to law, in person about adverse incidents that result in serious harm to the patient. Notification of outcomes of care that result in harm to the patient do not constitute an acknowledgment or admission of liability, nor can it be introduced as evidence (Fla. Stats. Title 29, § 395. 1051).

Nevada

Nevada law requires each medical facility to designate a representative to notify patients who have been involved in sentinel events at that facility. The designated representative must , within seven days after discovering or becoming aware of a sentinel event that occurred at the facility, provide notice to each patient who was involved in the event (Nev. Stats. Title 40, § 439. 855).

New Jersey

Under New Jersey law, a health care facility must assure that a patient affected by a serious preventable adverse event or an adverse event specifically related to an allergic reaction is informed of the event no later than the end of the episode of care or, if discovery occurs after the end of care, in a timely fashion as established by regulation. The time, date, participants, and content of the notification must be documented in the patient's medical record (New Jersey Stats. § 26: 2H-12. 25).

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