Patient Safety Achieving a New Standard for Care (2004) / Chapter Skim
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Appendix C: Examples of Federal, State, and Private Sector Reporting Systems
Appendix C: Examples of Federal, State, and Private Sector Reporting Systems
Pages 341-426
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From page 341... ...
This appendix summarizes a sample of reporting systems. For each sector the following areas are described: • Type of system -- reporting or surveillance • History of reporting/surveillance system • Voluntary or mandatory • Reportable events • Classification system and severity index • Reporting time frame • Data collected -- format and summary • Method of reporting • Who reports • Root-cause analysis trigger • Follow-up, including root cause • Other information collected • Confidentiality issues • Relationship with other reporting systems • Relationship with JCAHO 341
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were examined. Most of these systems were initiated by the federal agencies that manage them; however, one was mandated in legislation -- the Vaccine Adverse Event Reporting System (VAERS)
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, while others focus solely on adverse events.1 However, a few general statements can be made about them. The CDC- and FDA-managed systems tend to focus on specific types of adverse events, based on patient outcome or what caused the event -- nosocomial infections; infections resulting from hemodialysis; vaccine events; and medical device, biologic and blood product, drug product, and special nutritionals events.
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. The MHS PSP and NCPS do not use a standardized format for initially collecting data -- they allow facilities to use locally accepted methods for reporting -- but then report the data to their central agencies in a standardized manner.
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Table C–1a includes the two CDC-managed systems and the joint FDA- and CDCmanaged VAERS. Table C–1b includes the FDA-managed MedWatch system, CMS's MPSMS, and the MHS PSP.
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The system is used to describe the surveillance epidemiology of nosocomial infections and antimicrobial resistance system trends. Voluntary or Voluntary.
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It was initiated by CDC in of certain adverse events following August 1999. vaccination to help ensure the safety of vaccines distributed in the United States.
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Each pathogen requires data for different antimicrobial agents. The pathogens are Staphylococcus aureus, coagulase-negative staphylococci, Enterococcus species, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Enterobacter species, and Pseudomonas aeruginosa.
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APPENDIX C 349 CDC Joint FDA/CDC Dialysis Surveillance Networkb Vaccine Adverse Event Report Systemc • Any sequela (including death) of above events • Events described in manufacturer's package insert as contraindications to additional doses of vaccine Vaccine/toxoid = Pertussis in any combination • Anaphylaxis or anaphylactic shock • Encephalopathy (or encephalitis)
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350 PATIENT SAFETY TABLE C–1a Continued Federal Agency CDC Name of System National Nosocomial Infections Surveillance Systema Classification All infections are categorized into major and specific infection sites, system and/or using standard CDC definitions that include laboratory and clinical severity index criteria. Surgical site infection roles are stratified by a risk index based on wound classification, duration of operation, and the American Society of Anesthiologists severity assessment score.
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Events are classified initially according to Reported adverse events that are listed on outcome: hospitalization or in-unit IV the Reportable Events Table are antimicrobial start. categorized by type of vaccine, to the They are further classified according to the extent possible.
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To participate, a hospital must have 100 or more "set up and staffed" acute care beds to meet minimum requirements for infection control staffing.
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Standard format -- information collected for Standard format: Data collected include: hospitalizations: that patients have been description of adverse event; relevant hospitalized; the problem or diagnoses diagnostic tests and/or laboratory data; prompting hospital admission, especially information about the vaccines whether the patient had signs and administered (e.g., type, manufacturer, symptoms of access infection; and the lot number, date administered) ; and results of blood cultures done in the patient information, including relevant hospital soon after admission.
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. Confidentiality The CDC Division of Healthcare Quality Improvement (formerly Division issues of Hospital Infections)
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None. Health professionals and consumers may report any clinically significant adverse event occurring after the administration of any vaccine licensed in the United States.
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reporting systems Relationships NNIS central line–associated bloodstream infection rate and device with Joint utilization measures are being pilot tested as JCAHO core measures. Commission on Accreditation of Healthcare Organizations (JCAHO)
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APPENDIX C 357 CDC Joint FDA/CDC Dialysis Surveillance Networkb Vaccine Adverse Event Report Systemc None.
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handles biologic and blood product events, and the Center for Drug Evaluation and Research (CDER) handles drug product events.
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The CMS Clinical Data and implemented a pilot patient safety Abstraction Centers will provide data reporting system from October 2000 to collection support. The MPSMS is being April 2001; in August 2001, DOD developed to measure and track over Instruction Number 6025.17 "Military time adverse events and their associated Health System Patient Safety Program" patient risk factors among the Medicare was signed.
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Reportable Serious adverse events and product problems are reported to the FDA events/events directly or via the manufacturer. These include: monitored • Death: Report if patient's death is suspected as being a direct outcome of the adverse event.
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Voluntary. Adverse events are defined as unintended, Close calls: Defined by DOD Instruction measurable harms made more likely by Number 6025.17 as events or situations the processes of health care delivery.
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Classification Adverse events or product problems are classified according to system and/or whether they are attributed to medical device, biologic and/or blood severity index product, drug product, or special nutritional product. No severity index -- only serious adverse events or product problems are required to be reported.
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occurrences involving death or serious • The adverse event category measures physical or psychological injury or risk may include adverse events themselves, thereof (as defined by JCAHO)
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therapeutic failures must be periodically monitored, and any significant increase must be reported within 15 days. Mandatory reporting regarding devices (as outlined by the Safe Medical Devices Act of 1990)
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Events with scores of SAC 3 are put into one of two groups: adverse event or sentinel event. Events with scores of SAC 1 are also put into two groups: no harm and harm.
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Data collected: Standard format: Data collected include description of event or Format and problem, relevant tests and/or patient history, suspect product summary information, and reporter name and contact information.
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, or sentinel event (SAC continuously entitled to Part A of 3)
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. Who reports Consumers, health professionals, and user facilities.
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In addition, to increase the efficiency of identifying medical records likely to include relevant exposures and associated adverse events, claims-based algorithms are used to target medical records for abstraction. As a component of the beta test, cognitive interviews are being conducted with an interdisciplinary group of professionals, including clinicians and hospital epidemiologists, to validate the exposure and event case definitions as well as the associations between the exposures and adverse events.
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Other Health professionals may report any adverse event that they judge to information be clinically significant, whether it is considered serious by the FDA collected definition or not. through the system dMAUDE is the Manufacturer and User Data Experience database, which serves as the reporting system for events involving medical devices.
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a list of "triage" or "memory jogger" questions. The team then completes an RCA form (a set of Microsoft Word templates that include the RCA and the proposed action plan)
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Medication Errors Reporting (MER) Program and USP's reporting MedMARx system.
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All sentinel events meeting the JCAHO definition of reviewable sentinel event are to be reported to JCAHO. The completed RCA and action plan also should be made available to JCAHO consistent with JCAHO's policy and time limits.
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complementary external The PSI included a Sentinel system to the internal NCPS Event Reporting System, Reporting System. For the VA, whose purpose was to prevent the NCPS is a "safety valve" for adverse events through an incidents that otherwise may understanding of systems-level go unreported to the internal causes and then following up NCPS system.
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Reportable Close calls: Defined as events or Adverse events and close calls events/events situations that could have (as defined by NCPS) and monitored resulted in an accident, injury, lessons learned or safety ideas.
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Additional categorization of reports began in late 2002 using an NCPS-developed Primary Analysis and Categorization (PAC) methodology, which includes key attributes of the event such as the location of occurrence within the VA Medical Center, the activity or process under way at the time, and other aspects of the adverse events or close calls.
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Once an event/close call is entered into the Patient Safety Information System AND if an RCA is required, the facility has 45 days to complete the RCA. Data collected: Initial report is not in a standard Standard paper form that is Format and format; each VA facility has its mailed to NASA directly by the summary own locally accepted method individual reporting the of reporting an adverse event incident.
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• Any other close calls with a potential SAC score of 3 receive a full RCA. • At the discretion of the PSM and the facility director, any event or close call can undergo an RCA.
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a cognitive aid called the receipt may be used to "Triage Questions for Root- contact the reporter for Cause Analysis." clarifications if necessary. Then, based on the results of the PSRS is designed to identify RCA for an event/close call, vulnerabilities but does not corrective actions are proposed provide detailed solutions, by the RCA team.
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None. information collected through the system Confidentiality RCAs of adverse events and close PSRS reports are considered issues calls are protected from confidential and privileged disclosure under 38 U.S.C.
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If an event is reported to JCAHO, then the results of the RCA are also reported to JCAHO. VHA policy requiring disclosure to patients who have been injured by adverse events is consistent with JCAHO requirements that hospitalized patients and their families be told of "unanticipated outcomes" of care.
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The survey found that 15 states required mandatory reporting from acute and general hospitals of adverse events. Twenty-one states now require reporting (Rosenthal, 2003)
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represent the most serious occurrences and require notification to the New York State Patient Safety Center within 24 hours or one business day from occurrence of the event using the short form (see Table C–2b) and an RCA carried out by the hospital (see Analysis of More Serious Events below)
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As noted earlier, in New York State the most serious offenses (i.e., codes 108–110, 911–913, 915–923, 938, and 961–963 in Table C–2a) require notification to the New York State Patient Safety Center within 24 hours or one business day from occurrence of the event and an RCA carried out by the hospital.
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• Table C–2d: Extra data for all New York State reportable medication errors. • Table C–2e: Florida State reportable events.
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mandatory Reportable events/ For the purpose of NYPORTS reporting, an occurrence is an events monitored unintended adverse and undesirable development in an individual patient's condition occurring in a hospital. aInformation on the Florida State reporting system has been obtained from Florida Health and Human Services, Agency for Health Care Administration (2003)
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Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given informed consent; or g. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient's condition prior to the adverse incident; Continued
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Less serious occurrences (codes 201–854) : adverse events with less serious patient outcomes, such as complications of surgery, burns, and falls.
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Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or 4. Was a procedure to remove unplanned foreign objects remaining from a surgical procedure.
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data can be released. Relationship with Within hospitals/freestanding clinics, there are other relevant other reporting New York State reporting systems -- cardiac adverse events, systems perinatal adverse events, and hemolytic transfusion reactions and other types of blood- and tissue-related adverse events.
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As indicated above, a Code 15 report includes some description of the cause of the event and corrective or proactive actions taken. AHCA may require further documentation from the facility about the incident and its corrective action plan (or RCA)
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The contract is based on information sharing of the overall process, which includes complaint and incident investigations and a range of other surveillance activities. Additionally, there is direct overlap between the JCAHO sentinel events and NYPORTS serious events, with the exception of hemolytic transfusion reactions, which are captured in another unit within DOH.
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APPENDIX C 393 Floridaa The Florida Agency for Health Care Administration deems JCAHO accreditation as meeting its biennial licensure requirements. The agency performs validation surveys on approximately 5 percent of JCAHO-accredited facilities each year as directed by CMS.
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109. A medication error occurred that resulted in a near-death event (e.g., cardiac or respiratory arrest requiring Basic Life Support (BLS)
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RCA required 911. Wrong patient, wrong site -- surgical procedure.
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396 PATIENT SAFETY TABLE C–2a Continued Broad Category Codes RCA 901. Serious occurrence warranting DOH notification, not covered by NOT required 911–963.
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APPENDIX C 397 TABLE C–2b NYPORTS Short Form The short form collects a limited amount of data items, including the following: • Occurrence date • Occurrence code (three-digit code above) • ICD–9–CM code corresponding to the diagnosis for which patient was admitted • ICD–9 procedure code most closely associated with occurrence • Hospital medical record number • Location in hospital where incident occurred • SPARCS number -- the Statewide Planning and Research Cooperative System is a comprehensive patient data system • The service for which the patient was originally admitted • Date of birth • Sex • Admission date • Readmission date • Do you believe that this occurrence will likely lead to (check all that apply)
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Other elements required in the RCA form are: • Literature search • Executive summary • List of participant titles TABLE C–2d NYPORTS Medication Supplement For codes 108–110 the following extra information is collected: • Type of occurrence (e.g., wrong patient, wrong drug, wrong dose, wrong route, wrong frequency, wrong time, omission, administration after order discontinued/expired, wrong dilutent/concentration/dosage form, monitoring error, other) • Where in the process (e.g., prescribing, transcription, dispensing, administration, documentation on medical administration record)
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: All the above, plus the following: • Permanent disfigurement • Fracture or dislocation of bones or joints • A resulting limitation of neurological, physical, or sensory function that continues after discharge from the facility • Any condition that requires specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given informed consent • Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient's condition prior to the adverse incident
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• License numbers of personnel (or social security numbers of unlicensed personnel) directly involved in incident and relationship to facility • A description of all malpractice claims filed against the facility, including the nature of the incident, license numbers of persons involved in the claim, and the status or disposition of each claim • Total number of new claims • Total number of claims pending • Total number of claims closed during the reporting year • Copy of the facility's policies and procedures to reduce risk of patient injuries and adverse incidents • Copy of each regular summary to the facility governing board from the risk manager for the calendar year
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• Resulting injury (using ICD–9 Codes 800–999.9) • List any equipment directly involved in incident • Outcome (e.g., death, fetal death, brain damage, spinal damage, surgical procedure performed on the wrong patient, surgical procedure performed on the wrong site, wrong surgical procedure performed, surgical procedure unrelated to patient's diagnosis, surgical procedure to remove foreign objects remaining from a surgical procedure, surgical repair of injuries from a planned surgical procedure)
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In addition, all of these are essentially voluntary nonpunitive systems, with the possible exception of the JCAHO Sentinel Event Policy. JCAHOaccredited organizations are "encouraged, but not required" to report events meeting its criteria for reviewable sentinel events (see the "Reportable events" row of Table C–3b for more detail)
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Any type of event meeting JCAHO's Sentinel Event definition (which may be interpreted slightly differently by each accredited organization) can be reported to JCAHO; however, the only events that must be reported are those meeting JCAHO's list of reviewable sentinel events (see the "Reportable events" row of Table C–3b for more detail)
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The Joint Commission does make a form available for organizations to use in self-reporting sentinel events but does not require use of the form. In addition, JCAHO allows RCAs and action plans to be conducted according to each organization's locally accepted method; however, these RCAs and action plans are required to be thorough and credible before they will be accepted by JCAHO.
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Table C–3a includes MERS-TM, the MER Program, and MedMARx. Table C–3b includes JCAHO's Sentinel Event Policy.
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and National Coordinating Council for Medication Error Reporting and Prevention (1998)
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In 1991, USP began coordinating the MER In 1998, USP spearheaded the formation of Program with the Institute for Safe the National Coordinating Council for Medication Practices; in 1994, USP Medication Error Reporting and purchased the MER Program from ISMP. Prevention (NCC MERP)
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. Reportable events/ The system monitors all events (error, incident, deviation, variance, events monitored discovery, occurrence, or adverse or sentinel event)
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An error occurred that reached the patient but did not cause patient harm. patient but did not cause patient harm.
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time frame Data collected: Event Discovery Report (standard format) : Format and Section A: Data collected include date and time of discovery, summary where the event was discovered, information about who dHarm is defined as impairment of the physical, emotional, or psychological function or structure of the body and/or resulting pain.
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An error occurred that may have contributed to or resulted in permanent contributed to or resulted in permanent patient harm. patient harm.
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Sentinel Event Policy has been obtained from the following sources: Joint Commission on Accreditation of Healthcare Organizations (2002a, c) , and Schyve (2002)
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Standardized pick lists are used for nearly all of the data entries; however, reporters are not limited to these lists. These pick lists are constructed based on the NCC MERP Taxonomy of Medication Errors.
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Modeling the types of events and recovery steps that occur in the transfusion process allows for the identification of factors or system elements that have the potential to cause future errors. Monitoring the existing areas of concern to determine whether the incidence of near misses and accidents is changing and to evaluate the impact of corrective actions.
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They can track and analyze trends in medication errors through a standardized format that can be inculcated into the hospital's internal quality improvement Continued
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systems Relationships with For JCAHO-accredited organizations: All sentinel events meeting the JCAHO/Medicare JCAHO definition of a reviewable sentinel event can be reported certification to JCAHO (this is determined at the local level)
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All sentinel events meeting the JCAHO definition of reviewable sentinel event can be downloaded into a JCAHO template located in MedMARx.
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. If the Joint Commission becomes aware of a reviewable sentinel event that occurred at an accredited organization, whether self-reported or not, that organization must prepare and submit an RCA and action plan to JCAHO or otherwise provide evidence of having completed a thorough and credible RCA and action plan (see "Method of reporting" below for available alternatives)
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At a minimum, an organization's definition must include those events defined as reviewable sentinel events by JCAHO; however, they have latitude in setting more specific parameters to define "unexpected," "serious," and "the risk thereof." Reporting If the Joint Commission becomes aware (through voluntary selftime frame reporting or otherwise) of a reviewable sentinel event that occurred at an accredited organization, that organization must prepare and submit an RCA and action plan to JCAHO within 45 calendar days of the event or of becoming aware of the event.
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The JCAHO Sentinel Event Database has certain required data elements that are abstracted from RCAs, action plans, and follow-up activities. The three major categories of data elements included are sentinel event data, root-cause data, and risk reduction data.
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RCA trigger All events defined by the accredited organization as sentinel events, which will, at a minimum, include JCAHO reviewable sentinel events, require an RCA. Follow-up Each organization can conduct RCAs and develop action plans (including RCA)
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An action plan will be considered acceptable if it: • Identifies changes that can be implemented to reduce risk or formulates a rationale for not undertaking such changes; and • Where improvement actions are planned, identifies who is responsible for implementation, when the action will be implemented, and how the effectiveness of the actions will be evaluated. After the RCA and action plan are accepted by JCAHO, an Official Accreditation Decision Report is issued.
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collected through the system Confidentiality Handling of any submitted RCA and action plan is restricted to issues specially trained staff in accordance with procedures designed to protect the confidentiality of the documents. Upon completing the review of any submitted RCA and action plan and abstracting the required data elements for the Joint Commission's Sentinel Event Database: • The original RCA documents will be returned to the organization and any copies will be shredded.
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2001a. Near Miss/Adverse Events/Sentinel Event Reporting Form (unpublished)
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1999. Vaccine Adverse Event Reporting System: Table of Reportable Events Following Vaccination.
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Joint Commission on Accreditation of Healthcare Organizations. Conference call regarding JCAHO Sentinel Event Policy.
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