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Characteristics of State Adverse Event Reporting Systems

California

Reportable event

Occurrences such as epidemic outbreaks, poisonings, fires, major accidents, death from unnatural causes, or other catastrophes and unusual occurrences that threaten the welfare, safety, or health of patients, personnel, or visitors. Other occurrences include, but are not limited to, prevalence of communicable disease; infestation by parasites or vectors; disappearance or loss of a patient or inmate-patient; sexual acts involving patients who are minors; nonconsenting adults, or persons incapable of consent; physical assaults on inmate-patients, employees, or visitors; and all suspected criminal activity involving inmate-patients, employees, or visitors.

Who submits reports

General acute care hospitals, acute psychiatric hospitals, skilled nursing facilities, immediate care facilities, home health agencies, pri-



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D Characteristics of State Adverse Event Reporting Systems CALIFORNIA Reportable event Occurrences such as epidemic outbreaks, poi- sonings, fires, major accidents, death from unnatural causes, or other catastrophes and unusual occurrences that threaten the wel- fare, safety, or health of patients, personnel, or visitors. Other occurrences include, but are not limited to, prevalence of communi- cable disease; infestation by parasites or vec- tors; disappearance or loss of a patient or inmate-patient; sexual acts involving pa- tients who are minors; nonconsenting adults, or persons incapable of consent; physical assaults on inmate-patients, em- ployees, or visitors; and all suspected crimi- nal activity involving inmate-patients, em- ployees, or visitors. Who submits reports General acute care hospitals, acute psychiatric hospitals, skilled nursing facilities, immedi- ate care facilities, home health agencies, pri- 254

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255 APPENDIX D mary care clinics, psychology clinics, psychi- atric health facilities, adult day health cen- ters, chemical dependency recovery hospi- tals, and correctional treatment centers. Number of reports 4,337 (1998) Year initiated 1972 (approximately) Mandatory or voluntary Mandatory; must be submitted within 24 hours of the incident. Access to information Reports that do not contain confidential infor- mation are accessible to the public. Reports that do contain confidential information can be obtained only by subpoena. The local li- censing and certification office handles all requests for copies of reports. Use of information The state reviews the reported event and de- termines if an onsite visit is warranted. If violations of the regulations are suspected an onsite visit is conducted. If deficiencies are noted the facility must submit an accept- able plan of correction. Violation of regula- tions can also result in state or federal cita- tions. Civil penalties of up to $50 per day or enforcement actions can be imposed. COLORADO Reportable event All deaths arising from unexplained causes or under suspicious circumstances. Brain and spinal cord injuries. Life-threatening com- plications of anesthesia. Life-threatening transfusion errors or reactions. Burns; miss- ing persons; physical, sexual, and verbal abuse; neglect, misappropriation of prop- erty; diverted drugs; malfunction or misuse of equipment. Who submits reports All state-licensed health care facilities. Number of reports 1,233 (1998) Year initiated 1989

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256 TO ERR IS HUMAN Mandatory or voluntary Mandatory under Colorado State Statute 25- 1-124(2). Access to information The name of the facility is disclosed. Patient and personnel information is kept confiden- tial. Report summaries are posted on the Internet once the facility investigation is complete. Use of information An advisory committee meets monthly to iden- tify patterns and issues. Summaries of the reviewed reports are sent out to the facili- ties and they have seven days to comment. The state will issue deficiencies if deemed necessary. All information is entered into a computer program for tracking. Surveyors and investigators review the information in the institution-specific database prior to conducting the regular survey and com- plaint investigations. CONNECTICUT Reportable event All accidents or incidents that resulted in seri- ous injury, death, or disruption of facility services. Who submits reports Nursing homes and hospitals. Number of reports 14,783 (1996)—approximately 14,000 from nursing homes. Year initiated 1987 Mandatory or voluntary Mandatory for nursing homes; voluntary for hospitals. Access to information Reports disclose the name of the facility, but no information on patients or personnel. To obtain a report, one must fill out a Freedom of Information Act form and submit the re- quest to the health department. Use of information Information is reviewed by a nurse consultant who determines if there needs to be an in- vestigation by the health department.

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257 APPENDIX D FLORIDA Reportable event Urgent issue: life-threatening situation, epi- demic outbreak. Code 15: serious adverse event (i.e., wrongful death, brain injury, wrong limb removal, incorrect surgery). Who submits reports Hospitals and ambulatory surgical centers. Number of reports Approximately 5,000 a year; 4,000 are urgent issue and 1,000 are Code 15. Year initiated 1985 Mandatory or voluntary Mandatory Access to information A summary of the aggregate data collected from reports is issued once a year. All other information is confidential and cannot be released without a subpoena. Use of information Urgent-issue situations are considered to be outside the facility’s control; and thus no fa- cility follow-up is required. When report- ing a Code 15, an analysis of the injury and a plan of correction must be submitted by the facility within 15 days. The state’s risk management program tracks trends in the reporting. KANSAS Reportable event An act by a health care provider that (1) is or may be below the applicable standard of care and has a reasonable probability of causing injury to a patient or (2) may be grounds for disciplinary action by the ap- propriate licensing agency. Who submits reports All licensed medical care facilities. Number of reports 488 (1997) Year initiated 1986 Mandatory or voluntary Mandatory Access to information All reports are confidential. All peer review in- formation and standard of care determina- tions are protected under the risk manage- ment statutes. Only the facts of the case

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258 TO ERR IS HUMAN have been subpoenaed. The name of the re- porter is protected. Use of information Each facility must establish a written plan for risk management and patient care quality assessment on a facility-wide basis. This ini- tial plan must be submitted to the health department at least 60 days prior to the li- censure date. The plan will be reviewed and the facility will be notified in writing con- cerning plan approval. The facility’s govern- ing board must review and approve the risk management plan on an annual basis. All changes must be approved by the depart- ment. Following an incident, the depart- ment will review the facility’s plan to ensure that it is adequate. Depending on the sever- ity of the incident, the department will then possibly conduct an investigation. MASSACHUSETTS Reportable event Injury that is life-threatening, results in death, or requires a patient to undergo significant additional diagnostic or treatment mea- sures. Medication errors. Major biomedical device or other equipment failure resulting in serious injury or having potential for seri- ous injury. Surgical errors involving the wrong patient, the wrong side of the body, the wrong organ, or the retention of a for- eign object. Blood transfusion errors. Any maternal death within 90 days of delivery or termination of a pregnancy. Death of a pa- tient by suicide. Who submits reports All licensed health care facilities. Number of reports 10,500 (1997); 390 were from hospitals Year initiated 1986 Mandatory or voluntary Mandatory

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259 APPENDIX D Access to information Copies of reports submitted by facilities are available to the public after official action has been taken by the health department. The identity of the patient is removed. Re- ports relating to abuse, neglect, or misap- propriation are confidential and are not re- leased. Use of information All reports are entered into a Massachusetts Health Department database and are re- viewed. This database is used to retain in- formation on the individual case and look for general patterns across cases. Depend- ing on the incident, the department can de- cide to contact the facility for more infor- mation or conduct a site visit. Deficiencies are cited if the facility is found to have not reported all relevant information. MISSISSIPPI Reportable event Suicide or attempted suicide, wrongful death, unexplained injuries, abuse, and interrup- tions of service at the facility. Who submits reports All licensed health care facilities. Number of reports Not provided Year initiated 1993 Mandatory or voluntary Mandatory Access to information Actual reports are not accessible to the public; however statements of deficiencies and plans of correction are available by request. The health department does spend a great deal of time in litigation with malpractice attorneys who are attempting to subpoena its records. Use of information Attempts are made to identify trends in the data received, and the department’s findings are discussed with the facility.

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260 TO ERR IS HUMAN NEW JERSEY Reportable event Any incident that endangers the health and safety of a patient or employee and any death or injury associated with anesthetics. Who submits reports All state licensed health certificates. Number of reports Not provided Year initiated 1986 Mandatory or voluntary Mandatory Access to information Information is disclosed only in the event that the facility receives a citation from the state. Penalty letters revealing the name of the fa- cility and describing the incident that led to the citation are posted on the Internet. Pa- tient and personnel information is kept con- fidential. Use of information If deemed necessary, a state inspection team is sent to investigate the facility. The team’s findings are shared with the facility, which must comply with the report’s recommen- dations or be cited with deficiencies. Then the facility must submit a plan of correction for each deficiency. The health department can impose fines, curtail admissions, ap- point a temporary manager, issue a provi- sional license, suspend a facility’s license, or close the facility. NEW YORK Reportable event An unintended adverse and undesirable devel- opment in an individual patient’s condition occurring in a hospital. A list of 47 occur- rences is included on a specification of re- portable events. Who submits reports Hospitals Number of reports 15,000–20,000 reports each year Year initiated 1986 Mandatory or voluntary Mandatory

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261 APPENDIX D Access to information Narrative reports on incidents and the investi- gations conducted are protected by law, but the state can release aggregate data by hos- pital, including the number of reports sub- mitted. State actions against a facility are posted on the Internet (whether the source was the reporting system, patient complaint, or other). Use of information The state may investigate specific incidents. If the hospital has taken action acceptable to the department, the case is closed. If the vio- lation persists, the state may issue deficien- cies or fines. The state also intends to de- velop regional error rates for benchmarking and dissemination to regional councils that are being formed. OHIO Reportable event Death or injury resulting from equipment mal- function or treatment of the wrong subject or wrong modality. Who submits reports Free-standing therapy, imaging, and chemo- therapy centers Number of reports Not provided Year initiated 1997 Mandatory or voluntary Mandatory Access to information Governed under Ohio’s public record law. This law prohibits the collection of patient- specific information. The state will only be releasing aggregate data on the incidents re- ported. Facilities will have access only to their own information. The state plans to compile an annual report on incidents that will be available to the public. Use of information A database is being developed to track the number of reports received and provide an indicator of which facilities should be inves-

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262 TO ERR IS HUMAN tigated. The goal is to identify noticeable trends in types of errors. The director of health monitors compliance and can inspect any health care provider. Health care pro- viders may be required to regularly issue re- ports and undergo independent audits. PENNSYLVANIA Reportable event An event that seriously compromises quality assurance or patient safety, including: deaths due to injuries, suicide, or unusual circumstances; deaths due to medication er- ror; deaths due to malnutrition, dehydra- tion, or sepsis; elopements; patient abuse; rape; surgery on the wrong patient or mo- dality; hemolytic transfusion reaction; infant abduction or discharge to wrong family; fire or structural damage; unlicensed practice of a regulated profession. Who submits reports Hospitals, nursing homes, home health agen- cies, ambulatory surgical facilities, interme- diate care facilities for persons with devel- opmental disabilities. Number of reports Not provided Year initiated 1990 Mandatory or voluntary Mandatory Access to information All collected information is confidential. Re- ports are often shared only with another state agency. They are not considered pub- lic material and were not intended to pro- vide information to the public. The depart- ment usually requests that courts overrule subpoenas, and in the majority of cases its request is granted. Use of information On some occasions, the department will re- quest more information from a facility and conduct investigations. This is usually done when there is a recurrence of incidents or

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263 APPENDIX D drug misappropriation. Very few cases have resulted in a fine to a facility following an adverse event. RHODE ISLAND Reportable event Any incident causing or involving the follow- ing: brain injury; mental impairment; para- plegia; quadriplegia; paralysis; loss of use of limb or organ; birth injury; impairment of sight or hearing; surgery on the wrong pa- tient; subjecting a patient to any procedure that was not ordered or intended by the physician. Who submits reports Hospitals Number of reports 134 (1998) from 15 facilities Year initiated 1994 Mandatory or voluntary Mandatory Access to information The names of personnel and patients are not disclosed in submitted reports. All reports are confidential and are protected by law. The hospital involved is contacted when- ever the health department receives a sub- poena from an attorney. The hospital may initiate proceedings to quash the subpoena. However, if the state takes action against the facility—for example, following a site inves- tigation—then this information may be dis- closed to the public. Use of information Reports are reviewed by department staff and filed. If deemed warranted, an investigation of the incident will be conducted. After sub- mitting a report the hospital must conduct a peer review process to determine whether the incident falls within the normal range of outcomes, given the patient’s condition. If the hospital’s findings conclude that the in-

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264 TO ERR IS HUMAN cident was outside the normal range, the hospital must provide the health depart- ment with the following information: an ex- planation of the circumstances surrounding the incident; an updated assessment of the effect of the incident on the patient; a sum- mary of current patient status including fol- low-up care provided and post-incident di- agnosis; and a summary of all actions taken to correct the problems identified to pre- vent recurrence and/or improve overall pa- tient care. Incidents that are determined to have fallen within a normal range of out- comes by the hospital are reviewed by the health department. In the event that the health department disagrees with the hospital’s findings, a separate investigation is conducted and peer review documents are examined. SOUTH DAKOTA Reportable event Unnatural deaths; missing patients or resi- dents; incidents of abuse, neglect, or misap- propriation. Who submits reports All licensed health care facilities. Number of reports The health department has not kept track of the exact number of reports received. The majority are submitted by nursing homes. Year initiated 1994 Mandatory or voluntary Mandatory Access to information Reports are completely confidential, unless a deficient practice is identified at the facility. A summary of the cited deficiency is releas- able information. As required by state law, a judicial court order must be issued before the health department will release any other information.

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265 APPENDIX D Use of information Each incident report is analyzed to assess whether the facility did everything possible to avert the incident. If it did not, the facil- ity will be cited and then they must develop a plan of correction. SOURCE: Information for this table was collected from each state health department by telephone between February 24 and May 5, 1999. Each respondent was given the oppor- tunity to review the draft and correct any errors.