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Instructions for Completing
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| General Instructions Please review and complete all sections of the major incident report. It is strongly encouraged that the report be typed. There are specific areas on the reporting form that state if more space is needed, additional pages may be submitted. That direction applies to the entire reporting form: any time you need to supply additional information and the form does not provide enough space, you may attach additional pages. When using additional pages, indicate the applicable section you are addressing. If you have questions about completing the reporting form, call the Board’s PCA Division at (617) 654-9800 Section I. Report Identification Indicate whether you are submitting an initial or a follow-up major incident report. The same form is used for both. If you are completing a follow-up report, be sure to indicate the date on which you submitted the initial report. Reports of major incidents must be submitted to the Board on a quarterly basis, i.e., you must submit an initial major incident report no later than 30 days following the quarter in which the incident occurred. The Board is aware that some facilities will not have completed their internal investigations of the incident or taken all appropriate corrective measures within this time frame. If this is the case and a report is due, you should submit an initial major incident report without waiting until the investigation is completed. In submitting the initial report, you should indicate, in Section VIII, that the investigation is still open and provide the date on which you believe the investigation will be completed. When the investigation has been completed, you must submit a follow-up report and provide any information that was not available at the time of the initial report. You may submit as many follow-up reports as needed. However, please do not wait to submit a follow-up report until the Board contacts you and requests it: you are responsible for submitting a follow-up report as soon as the investigation has been completed. If you take additional corrective measures after submitting the first follow-up report, or you need to update the Board on any other information pertaining to the incident, submit another follow-up report. Section II. Reporting Health Care Facility It is the responsibility of the facility’s PCA Coordinator to ensure that the major incident report is complete and submitted in a timely fashion. If the PCA Coordinator does not have a clinical background, sections VII (Nature of Incident); VIII (Internal Investigation); and IX (Corrective Measures) must be completed by someone who does. If a committee serves as the PCA Coordinator, the person completing the form should be a member of that committee and have a clinical background. More than one health care facility may be responsible for submitting a major incident report about the same event. Under some circumstances, a facility is responsible for reporting an incident that may not have occurred on the premises but nonetheless originated at the institution. If, for example, a patient underwent an ambulatory procedure at your facility, was discharged, and died later at home or at another facility, the Board expects that your quality assurance program would (or should) learn of the event, investigate the care your facility delivered to the patient and report the case as a major incident. The same would apply, for example, to a delivery that took place at your facility after which the mother died at another institution from a cause related to the delivery. In such cases, it is often through the patient’s attending physician that a facility becomes aware of the unexpected outcome. Attending physicians should be aware of their responsibility to inform the PCA Coordinator of these events. You are not obligated to obtain and review medical records or other confidential documents from outside sources. However, the Board expects that you will review your own records in order to assess the quality of care delivered at your facility. Section III. Date and Location of Incident Location code information is found in Table I (attached). Select the appropriate two-digit code for the place where the incident occurred. Section IV. Patient(s) Involved in the Incident In most cases, you will be providing the patient’s date of admission. Health care facilities that normally do not "admit" patients (e.g., clinics) should indicate the patient’s date of presentation. Presentation date should also be used by facilities in cases where the patient was not admitted but was seen by staff. These cases often involve the emergency room, e.g., a patient death that occurs in the emergency room; a transfer of a patient from the emergency room to another facility; or an incident occurring at a patient’s home or en route to or from the hospital after s/he was "discharged" from the emergency room. Ordinarily, you should submit a separate report for each patient involved in a major incident. However, you may submit one report for two patients if they were both involved in the same incident; for example, if a delivery results in the death of or serious injury to both mother and infant. Section V. Facility Staff Involved in Incident Physicians’ names and license numbers are optional. If you do provide names or license numbers, you may still be asked for certain information that is not maintained by the Board, such as data on physicians’ complication rates. If you do not provide names and license numbers, the Board may ask for additional information about a physician’s background and experience. This type of physician-specific information is not used for disciplinary purposes but to ensure that your PCA program is working properly. The PCA Division keeps its information about major incidents and physicians strictly confidential and does not share it with the Enforcement Division. The Board may request information about the background and experience of a non-physician involved in a major incident as well. Relationship code information is found in Table II (attached). Select the two-digit code that best describes a practitioner’s relationship to the patient. Section VI. Type of Incident On the reporting form, mark the space for the appropriate "type" of major incident that took place. If the event is either a Type 3 or Type 4 major incident, indicate whether the patient died, suffered a temporary disability, or suffered a permanent disability. We define disability as an inability to function normally, either physically or mentally. If none of these three choices apply, indicate "other" and provide a brief explanation. You should base your selection on what you know about the patient’s condition at the time you are completing the report. The definition of a Type 4 event is similar to, and replaces, the former definition of a Category II major incident. VII. Nature of Incident Basis codes can be found at Table III (attached). Select the basis code(s) that best describe(s) the nature of the incident. Choose as many as apply, but no more than ten. When describing a major incident, keep in mind that the report will be reviewed by physician Board members and others at the Board with a medical or nursing background. In addition, certain cases involving a specialized area of medicine may be reviewed by one expert or a panel of experts in that field. While knowledgeable in a range of clinical issues, none of these reviewers knows anything (at least initially) about the patient or the events leading up to the incident other than what you include in the narrative description. You therefore need to describe the incident as fully and completely as possible, answering the basic question of "what happened?" Other information to provide, if applicable, includes the patient’s condition prior to medical intervention or treatment, a description of the intervention or treatment, and the patient’s subsequent condition. While the Board’s review of the incident is directed more to your facility’s response to the event than to the event itself, it is difficult to evaluate the response without understanding what happened to the patient. It is usually better to err on providing too much information rather than too little. You may attach as many pages or supplementary materials as you wish. Section VIII. Internal Investigation If the internal investigation is still open at the time of the initial report, please provide the date (even if it is only approximate) on which the investigation is scheduled to be completed. Once it is completed, be sure to submit the results of the investigation in a follow-up major incident report. A primary focus of the Board’s review of a major incident report is to evaluate the thoroughness and completeness of the facility’s internal investigation. This section should summarize the investigatory process and provide a complete description of the results of the investigation. Information should be included on who was involved in the review of the event (titles of individuals or names of committees), the areas or issues that were examined (including medical care, nursing care, systemic processes, and quality assurance/risk management factors) and, if possible, determinations made about the ultimate cause of the patient’s death or injury. Ultimate conclusions regarding the quality of care delivered to the patient and whether the event could have been prevented should be provided. Section IX. Corrective Measures If the facility took no corrective measures, so indicate in Part A of this section and provide an explanation. For example, if, after investigating the incident, the facility found that while the event was not ordinarily expected, there was no way that it could have been prevented and nothing can be done to prevent a similar incident in the future, explain that here. If the facility took corrective measures prior to the completion of its investigation, indicate what those measures were in Part B. Corrective measures taken following the investigation should be described in Part C. The facility may need to submit one or more follow-up reports to complete this section in order to provide information on all corrective measures taken or to include updated information on the corrective action. If policies, procedures or protocols were changed as a result of the incident, these materials should be included as an attachment to the report. It is helpful to know how new policies or procedures differ from those that were in place at the time of the incident: either explain how the revised procedures differ from the old or submit copies of the old and new, highlighting the changes. |
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