Reducing medical errors through mandatory reporting systems and technology

Healthcare: Addressing the Issue of Medical Errors

Healthcare

Addressing the Issue of Medical Errors with Mandatory

Reporting Systems and Computer Technology

To combat the current crisis of deaths due to preventable medical errors the health care industry and lawmakers have taken two approaches. The first is the implementation of a system of mandatory reporting systems. The solution is to crate an atmosphere in hospitals that fosters less blame, not more, according to the IOM report. A blue-ribbon pane appointed by the IOM argues that the failure to acknowledge and analyze mistakes deprives hospitals of important information that could help prevent similar mistakes in the future. However, many in the healthcare industry argue that mandatory reporting of errors will foster an atmosphere of lawsuits and backlash by the public. The end results would be increased costs, higher insurance premiums, and an overall distrust of hospitals and other healthcare facilities. The Joint Commission states that it is fully supportive of creating an effective health and medical care error reporting system either voluntary or mandatory with characteristics expressed in events to be reported to the system be well defined. If the system is one that is Mandatory then the system should be limited to serious adverse events. . The fears of improper disclosure have been shown to be barrier or challenge as well as funding due to lack of federal funding for these programs however, due to the lack of legislation in this area these programs are vital for implementation to ensure patient safety in the future.

- Healthcare

Addressing the Issue of Medical Errors with Mandatory

Reporting Systems and Computer Technology

Table of Contents

Abstract

1

Introduction

3

Medical Errors Background Information

6

Stakeholders

10

Type of Errors

10

Mandatory Reporting Systems

13

Challenges

14

Legal Protection of Error Information

14

Public Disclosure of Errors

16

Legislation

18

Patient Involvement

25

Recommended Guidelines

27

Elements Impacting Mandatory Reporting Costs

30

The Mandatory System at Work: Florida & NY

31

Use and Analysis of Data: Florida

32

Use and Analysis of Data: New York

32

Cost Analysis of Reporting Programs

34

Summary and Conclusion

39

- Healthcare

Addressing the Issue of Medical Errors with Mandatory

Reporting Systems and Computer Technology

Introduction

Experts have known for some time the medical errors are widespread and have been for over a decade. However, the problem has not received a new dose of attention from the public and Congress following a recent report from the prestigious Institute of Medicine (IOM) giving confirmation to the extent of the phenomenon and urging reforms. In fact, more people die each year due to preventable medical mistakes in American hospitals than are killed in car crashes or by breast cancer or AIDS. To combat the current crisis of deaths due to preventable medical errors the health care industry and lawmakers have taken two approaches. The first is the implementation of a system of mandatory reporting systems.

The solution is to crate an atmosphere in hospitals that fosters less blame, not more, according to the IOM report. A blue-ribbon pane appointed by the IOM argues that the failure to acknowledge and analyze mistakes deprives hospitals of important information that could help prevent similar mistakes in the future. However, many in the healthcare industry argue that mandatory reporting of errors will foster an atmosphere of lawsuits and backlash by the public. The end results would be increased costs, higher insurance premiums, and an overall distrust of hospitals and other healthcare facilities.

On the other hand, current research evidence shows that when compared to paper-based systems, the optimal solutions for the prevention of medical errors are high-tech in nature. When implemented these solutions show marked reduction in all types of medical errors. The success of any rollout involving new hardware and software hinges on the collaborative and effort building between IT managers and the company employees. Possession of the high-end technology in itself alone without the willingness of the end-users to undergo proper training and then followed by a sincere effort to properly use the newly installed computer information systems. Likewise the IT management teams must access end-user needs as well as incorporating their suggestions into the finalized decision in the process. When these situations exist simultaneously with the end result being that of achievement.

Because we are in a computer/digital age coupled with the fact that healthcare organizations are trying to reduce or eliminate medical errors with alternative solutions, an in-depth discussion of high-techs options is highly relevant for hospital administrators and IT management to consider. This is specifically the case when uses of these systems reduce error rates dramatically; thereby positively affecting the health care patients receive. In addition, a net effect of reduction in heath care costs cannot be over looked. Today these pressing issues of are of an immense proportion to all American as the healthcare systems in the U.S. is poised to undergo significant changes in the near future." With the recent YIPA legislation, possible privatization of Medicare, new innovations including Wi-Fi Internet access, mobile computing, remote access and a never ending quest to eliminate costs, hospital IT management must always be cognizant of new technology as it materializes.

When making examination of the successful introduction and final adoption of high-tech solutions into the health care system, one must review the whole picture before and after implementation. By studying the overall characteristics of an organization, assumptions can then be made as to why certain applications are readily accepted while others are not. Also the same reasoning can be applied to the assessment of why particular departments within healthcare institutions welcome change while others resist at every step along the process of upgrading. Common areas of interests include the following:

Educational background of employees to be affected by the new computer system

Attitudes, perception, and biases toward computer technology

Educational background of employees to be affected by the computer systems.

Level of communications between different departments

Relationship between upper management, IT Personnel, and end users.

The extent of the problems leading to medical errors

Employee training and evaluations

The Technologies (hardware and software)

Medical Errors: Background information

Type of Errors

There are several types of medical errors and each of these may be inclusive in the category of "Diagnostic," "Treatment," "Preventative," or "Other."

Diagnostic

Error or delay in diagnosis

Failure to employ indicated tests

Use of outmoded tests or therapy

Failure to act on results of monitoring or testing

Treatment

Error in the performance of an operation, procedure, or test

Error in administering the treatment

Error in the dose or method of using a drug

Avoidable delay in treatment or in responding to an abnormal test

Inappropriate (not indicated) care

Preventative

Failure to provide prophylactic treatment

Inadequate monitoring or follow-up treatment

Preventative

Failure to provide prophylactic treatment

Inadequate monitoring or follow-up treatment

Other

Failure of communication

Equipment failure

Other system failure

The extremely complex issues associated with health care reporting systems demand critical examination before implementation of a system. Healthcare systems serve two main purposes, which are:

1.

Holding professionals accountable for their performance

2.

Improving Patient Safety

In a study conducted at Columbia University focused on the subject of medical errors the five search terms utilized as those of 'mistake', 'error', 'incorrect', 'inadvertent' and 'iatrogenic in the surveying of sets of multiple reports that are in the nature of a narration. The stated goals of the study are:

1) Measure the rate at which medical errors were documented in medical records; and

2) Characterize the types of errors that were identified.

Discovered were 222 medical errors in 286,000 discharge summaries from 1991-2000, 9 medical errors in 48,000 outpatient notes and 11 medical errors in 49.500 sign out notes. Keyword searches are stated to have "detected a broad range of errors, including medication, diagnosis, surgery, service, and administration error. The most common of the documented error were those that were 'therapeutic-related. The errors that were termed 'therapeutic errors were for the most part those which were of the nature of medication related errors. The errors were found throughout all four stages in the drug ordering and delivering system, which are:

Physician Ordering

Transcription and Verification

Pharmacy dispensing and delivery, and Nurse and Administration

Narrowing the category further, of those errors that were medication related the two main errors were those of:

Wrong dosage

Wrong Frequency

Wrong Drug Use

The breakdown of sections of discharge summaries revealed the following information in the chart below labeled Chart 2.0

Chart 2.0

Detected Medical Errors

Detected in the section "hospital course"(62.2%)

53

Detected in the section "history of present illness" (23.9%)

31

Detected elsewhere (14.0%)

67% of 'new' errors were reported in the "History Course"

75% percent of old errors are reported in the "History of Present Illness"

Implications of the study were that: "Voluntary reporting and mandatory reporting systems play a valuable role in error detection and are in widespread use." Nevertheless the systems reportedly, "miss most errors and adverse events, and usually have poor physician participation." Furthermore the reports have omitted details as well as the minimization of serious outcomes due to the errors. Stated to be barriers in the current environment and responsible for the reporting that is inadequate in relation to medical errors are:

Lack of a common understanding about errors among health care professionals

Physicians generally think of errors as individual that resulted from patient morbidity or mortality.

Physicians report errors in medical records that have in turn been ignored by researchers.

Interestingly errors in medication occur in almost 1 of every 5 doses provided to patients in hospitals. It was stated by Kaushal, et al., (2001) that "the rate of medication errors per 100 admission was 55 in pediatric inpatients. Using their figure, we estimated that the sensitivity of using a keyword search on explicit error reports to detect medication errors in inpatients is about 0.7%. They also reported the 37.4% of medication errors were caused by wrong dose or frequency, which is not far away from our result of 50.5%. (Hui, Colombia Univ. no date given) The Harvard Medical Practice Study reported that adverse events occurred in 3.7% of hospitalizations in New York in 1984, and 69% of these injuries were caused by errors" (Kuperman, et al. 1998 as cited by Hui, Colombia University no date given) There were found to be more than 250 laboratory results that contained errors although generally there were not serious consequences resulting from the errors. A few did however cause serious problems as exampled by the instance in which the "patient was started tuberculosis medication due to wrong report of positive AFB" (Hui, Colombia University nd) This error was harmful on a potential basis due to the fact that an incorrect diagnoses or mediations given to the patient could have been harmful if not fatal to that individual. The cause for wrong results or errors in lab work may be due to one of the following:

Pre-analytical: Samples from a patient in which there is a mixing up of the specimens with that of another individual.

Analytical: Map-operation of the devices; or Post-Analytical: The mixing up of patient data.

Stakeholders

Stakeholders are naturally concerned about patient safety as well as the development of strategies for identification and addressing threats to patient safety. The concern starts at the federal government and goes through the state and local governments and impacts public and private providers as well. State governments are able to "address the problem in a variety of roles, as purchasers, providers, and regulators, and others as well. Regulation of private health insurance, purchase significant amounts of health care as well as assuming responsibility for protecting the health and safety of the public.

A study published in 2000 by The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) summarizes the adverse events that are surgery linked over the past four years. There were 64 events that occurred in acute-care hospitals with 84% of the events resulting in the death of the patient and 16% resulted in the patient sustaining some type of serious injury. Ninety percent of these cases were of the nature of non-emergent type procedures. The majority of complications were found to have occurred during the 'post-operative period' with almost 25% during intra-operative procedures. The most frequent complications are inclusive of the following:

Naso-gastric feeding tube insertion into the trachea or a bronchus

Massive fluid overload from absorption of irrigation fluids

Acute respiratory failure during open orthopedic procedures

Endoscopic procedures with perforation of adjacent organs

Central venous catheter insertion into an artery

Liver laceration, peritonitis or respiratory arrest during imaging directed percutaneous biopsy or tube placement

Burns from electrocautery with a flammable prep solution

Eight 'root causes' for the problems were identified by the medical institutions. Incomplete communication was found to blame in nearly 2/3 of the cases as the 'root cause' with over 1/2 resulting from failure to adhere to procedures established in the hospitals. Other factors that were stated to be 'contributing factors' of:

1. Necessary personnel not available when needed incomplete pre-operative assessment inconsistent post-operative monitoring failure to question inappropriate orders inadequate supervision of house staff deficiencies in credentialing and privileging; and

2. Children and the elderly have been shown in the study to be much more vulnerable to medication errors than those of other age groups. An effective system to assist in the prevention of errors has been on the forefront of the minds of medical professionals since the release of the Institute of Medicine's 1999 report.

Each health care setting should have designated healthcare workers within its' institution that are in charge of the tasks of: 'Identifying and monitoring the occurrence of errors, and developing an understanding of their root causes, especially those that are preventable through,

1) Analyzing, interpreting, and disseminating data to clinicians and others in a position to effect changes within the organization;

2) Implementing error reduction strategies based on analysis and restructuring of health care systems; and

3) Seeking input as needed from experts with clinical, epidemiological, and management as well as, "

4) Training and experience for technical support and investigatory assistance; and finally evaluating the impact of these programs on patient safety.

There are several databases that are currently in use for the collection of information on specific errors. Examples of these are the Center for Disease Control and Prevention's hospital acquired infections reporting systems, The Food and Drug Administration's adverse drug and device event reporting system and the sentinel event system of JCAHO. Also included are the Veterans Health administration and facilities within some states. Under reporting of events has been a problem which renders the system ineffective in reductions of medical errors. Stated in the report is the fact that: Effective programs need to incorporate protection from legal discovery and liability, which cause errors to be concealed." (Goulding, 2003)

Solution One: Mandatory Reporting Systems

Benefits

Original envisioning of mandatory reporting systems have not culminated with the heretofore dreamed of success. The Mandatory reporting system, while it certain has its potential in the production of useful data, as well as compliance with requirements of reporting systems. However, released data shows that there has been an inconsistency in the reports from the mandatory system has been 'inconsistent' (Institute for Safe Medical Practices, 2000) Benefits of the Mandatory reporting system are in two main areas. First the improvement or enhancing of patient safety is a very important benefit of this type of reporting system and secondly the awareness that this brings to the mind of healthcare providers ensures that they will be responsible in their provision of healthcare rather than suffer the consequences, or it is at least hoped that this is so.

Challenges

Challenges in the Mandatory reporting system are quickly acknowledged by any individual giving consideration to the system for error reporting since there are many questions of privacy matters.

Legal Protection of Error Information

Adverse consequences for those reporting errors exist creating a demand for systems that "incorporate incentives and safeguards" which are "likely to receive more and better data if the system is perceived as trustworthy and safe (OAHHS, 2000) Offering "confidentiality and some level of evidentiary protection for the information submitted" to these systems is suggested as being significant in terms of incentives. (OAHHS, 2000) Patient safety data would not be subject to any of the following:

A civil or administrative subpoena;

Discovery in connection with a civil or administrative proceeding;

Disclosure pursuant to a Freedom of Information Act request; or Admission as evidence or disclosure in any civil or administrative proceeding. (House Report 108-031, Part I: Patient Safety Improvement Act of 2003)

There is no proposal for the establishment of a national voluntary system of reporting medical errors in the IOM report. The Center for Patient Safety is a proposed center that has been "charged with oversight of this process." (OAHHS, 2000)

There are several options are available for voluntary system general design, recommends for ISMP as well as establishing or enhancing mini-systems targeted toward selected health areas stated to be "surgical events, anesthesia events, medication events, and pediatric events." Framework for the 'mini-systems' should be national in scope and voluntary in nature, as well as being confidential. The framework should be non-punitive towards those who report such errors and in relation to regulatory or accreditation entities the system should be independent of these. The framework of the 'mini-systems should be objective in terms of findings as well as using objectivity in recommendations in order to be embraced and receive support of the full healthcare community. The framework should be of a nature that is effective and credible in analysis and utilization of the information and should be timely and cover a large area through communications about errors and the prevention of errors. The framework should be of the nature that encourages "unrestricted practitioner reporting and should be able to receive reports of events that are either serious or fatal and caused by error, "near misses" as well as hazardous error-potential situations. The framework should last of all "encourage universal acknowledgment, adoption, and implementation of proven safety practices; and offer a level of evidentiary protection for the error information reported to it." (OAHHS)

Public Disclosure of Errors and Provider Accountability

As pointed out in the Institute of Medicine report, "healthcare providers have a moral and ethical obligation to disclose medical errors honestly and promptly" however this is not always the case. If disclosure were handled in a prompt manner then the financial risk taken on by organizations such as hospitals and clinics would be greatly reduced. The report states that:

"Providers and other participants in the healthcare process should be held accountable for the successful implementation of selected safety strategies that grow out of expert analysis of reported adverse events and scientific research. Reporting systems should not have the power to mandate implementation of recommendations that arise from analysis of adverse events." (OAHHS, 2000)

According to the Joint Commission on Accreditation of Healthcare Organizations, "meaningful improvement in patient safety will eventually be reflected by a significant reduction in the number of medical/health care errors that result in harm to patients. Achieving this significant reduction is dependent upon:

1) Identification of the errors that occur;

2) Analysis of each error to determine the underlying factors-- the "root causes" --that, if eliminated, could reduce the risk of similar errors in the future;

3) Compilation of data about error frequency and type and the root causes of these errors;

4) Dissemination of information about these errors and their root causes to permit health care organizations, where appropriate, to redesign their systems and processes to reduce the risk of future errors; and

5) Periodic Assessment of the effectiveness of the efforts taken to reduce the risk of errors.

Further stated is that the aggregation of data from many healthcare organizations about their medical/healthcare errors and the root causes of these errors is necessary in order to set priorities for error reduction activities; to identify priorities for system/process redesign in health care organizations; and to assess the effectiveness of the efforts to reduce errors over time.

The Joint Commission states that it is fully supportive of creating an effective health and medical care error reporting system either voluntary or mandatory with characteristics expressed in events to be reported to the system be well defined. If the system is one that is Mandatory then the system should be limited to serious adverse events. Serious events must be inclusive of that found to be the root cause in analysis of the event. Legal protection from disclosure must be in place concerning all information reported to the system. This includes protection from subpoena, discovery, and introduction of evidence, testimony, and any other such of disclosure in relation to a civil or administrative federal or state law or proceeding and under the Freedom of Information Act.

The Commission in as well as other healthcare oversight bodies have a "need to know" which is considered legitimate therefore granting them full and timely data access privileges in the reporting system, and on a healthcare organization basis specifically. Included are adverse event data, root cause analyses and the actions taken to minimize damage both in short- and long-term aspects in reducing future risk. There must not be a waiver of the protection of disclosure of the state or federally provided information when disclosure to health oversight bodies and the like. The Joint Commission is required to play a central role in evaluating 'root cause analyses' for the accredited organization and as well in the dissemination of pertinent information that facilitates learning in the health care field in the implementation of actions in the improvement of the safety of patients.

Legislation

As of 2002 there exited no provision of law addressing Patient Safety Improvement. However, the Patient Safety Improvement act amended Title XI of the Social Security Act with the addition of "Part D" which is inclusive of six newly created sections 1181-1186. In relation to the reporting systems that are mandatory in nature the report states that those systems have failed to achieve the success that was hoped for. Although the system that is mandatory does have the potential to, "produce useful data, compliance with reporting requirements has been inconsistent, as evidenced by significant variation in the volume of reports and amount of useful information received by most of the mandatory systems. Such underreporting, despite any mandate, is stated to be understandable when you consider that disclosure has typically exposed such organizations and individual practitioners to financial penalties, punitive actions concerning professional and organizational licenses, and legal and public scrutiny." (OAHHS, 2000)

At the core of the mandatory reporting system is punishment of healthcare providers as well as organizations. The report states that this type of system of bound for failure both in terms of "gaining new knowledge about errors and in holding providers accountable for the safety of patients. Further stated in the report is that "while punishment may be warranted in rare instances for illegal or malicious behavior, mandatory reporting in today's health systems typically results in punitive measures against health care professionals and organizations involved in medical error, whether punishment is warranted or not." (OAHHS, 2000) The Institute of Medicine report relates that the perception of the mandatory type reporting systems is one of a lack of credibility but this is because they "tend to assign blame rather than identify and correct the system-based errors." (IOM, 2000) Another important fact that that the mandatory systems produce reports that are not inclusive of crucial information used in the identification of errors that are system-based as well as not having included the 'error reduction strategies that can offer the greatest chance for success." (OAHHS, 2000)

According to Daulerio (1999) the Institute of Medicine's 1999 report in relation to errors in medical records have hospitals "scrambling to upgrade patient safety initiatives." Also stated is that the push for stricter safety standards will "reduce their exposure and force health care workers to practice more due diligence." Daulerio (1999) In Daulerio (1999) Legal News stated is are the following facts by experts in or linked to the field of healthcare provision:

John Hinton: Acting Chief Medical Officer, Catholic Healthcare Partners in Cincinnati, Ohio

"Any time you make information like that available there is that potential [for a lawsuit],." "I think there is always a sense of nervousness when a more public approach to adverse outcomes is made. The challenge is to temper the approach so that the intent on improving the outcome is the main goal."

"In particular, experts say hospitals are vulnerable when they reveal mistakes under disclosure guidelines that do not differentiate between major medical errors and minor gaffes. "Many times there are medical errors that are true injuries and have fatal outcomes, and then there may be medical errors that are near misses. I don't think any of us have any idea what the near misses are."

Dr. Berry Hieb: Research Director for Gartner Group, Technological Research

"If this material [reporting of medical errors] is required, it is likely that through a variety of mechanisms it would become discoverable in various legal proceedings," he says. "One can well imagine that this could then be used to initiate a variety of lawsuits based on 'mining' these reports for medical errors."

Daulerio (2001) relates the following facts in the Legal News Report (2001) writing that: "Officials are reportedly more concerned about the "complex web of laws and regulations hastily enacted in the wake of the IOM report, which concluded about 98, 000 deaths in the United States are attributable to provider's mistakes. Lawyer say this could be an even larger population for hospitals and hospital systems than increased lawsuits.at the end of the 2000 legislative session, more than 30 new medical error bills were introduced. This year, 21 states have introduced new medical-error legislation, including bills on mandatory reporting, public disclosure, and voluntary reporting systems. On the regulatory front there is, first, the Joint Commission on Accreditation of Health Care Organizations' patient safety standards, which went into effect July 1. JCAHO requires hospitals to inform patients, patient's families, to the outcomes of care, including unanticipated outcomes."

Patient Safety Improvement Act of 2003

Prior to the Patient Safety Improvement Act of 2003 there were no statutory provisions for reporting of medical errors, or in fact for guiding patient safety. Recommendations were for a nationwide mandatory reporting system as well as for a voluntary reporting system. The provision would in effect establish in Social Security Act Title XI a new Part D that encourages the voluntary reporting system for data of patient safety. Patient safety data refers to any "data, reports, records, memoranda, analyses, deliberative work, statements, or root cause analyses that are collected or developed to improve patient safety or health care quality. That would include patient safety data collected or developed by a provider to report to a patient safety organization on a timely basis, as well as data collected or developed by a patient safety organization or by or on behalf of the Center for Quality Improvement and Patient Safety, regardless of whether the data are transmitted back to the health care provider that supplied the information originally." (House Report 108-031, Part I: Patient Safety Improvement Act of 2003)

Recommended as well was the creation of a Patient Safety Organization (PSO) which would be a private or public organization for the conduction of activities for improvement of patient safety and healthcare quality through assisting health care organizations who in turn report to the PSO. The PSO activities would include:

The collection and analysis of patient safety data that are voluntarily reported by more than one provider on a local, state, regional, or national basis;

The development of and dissemination to providers and other patient safety organizations information such as recommendations, protocols, and best practice data; and The utilization of patient safety data to help providers minimize patient risk. Patient safety organizations would be required to ensure the confidentiality of individually identifiable health information, submit non-identifiable information to the Center for Quality Improvement and Patient Safety, if applicable, in a format established by the Secretary, and maintain appropriate data security measures. (House Report 108-031, Part I: Patient Safety Improvement Act of 2003)

The Patient Safety Organization (PSO) would be required as well to be:

1.

To be managed, controlled (i.e., the provider is able to significantly influence or direct its actions or policies), and operated independently from providers that report data to it;

2.

To collect data from providers in a standardized manner to facilitate comparisons of similar cases across similar providers; and

3.

To meet other requirements specified by the Secretary. An entity that no longer qualified as a patient safety organization would be required to destroy its patient safety data, return (if practicable) the data to the reporting providers, or transfer data to another patient safety organization with the approval of the provider and that organization. (House Report 108-031, Part I: Patient Safety Improvement Act of 2003)

According to one report, entitled "Patient Safety/Medical Errors" (Premiere Inc., 2004) "the 1999 Institute of Medicine report on medical errors ignited a firestorm of unprecedented media attention and sustained public, legislative and regulatory scrutiny.... The IOM [Institute of Medicine] sequel, released March 2, 2001, found the American healthcare system seriously lacking in its ability to deliver consistent quality care -- of which patient safety is a critical facet." (Premier Inc. Report, 2004) The IOM has two reports dated November, 1999 and March 2001 and both of which focuses on improvement in the quality of healthcare provided specifically on medical errors, the safety of patients and the consistency of healthcare delivery.

Premier is a group of individuals and groups that stakeholders in the healthcare issues such as the IOM, Medicare Payment Advisory Commission (MedPAC), Leapfrog Group, and Center for Medicare and Medicare Services (formerly HCFA)." (Premiere, 2004) Premiere states that its opinion is expressed by the fact that "Premier supports The Medication Errors Reduction Act (S. 824), which establishes a ten-year $1 billion grant program to facilitate qualified providers' acquisition and implementation of emerging patient safety and information technologies." According to the report entitled, Taking on Mistakes published in a November 2003 HealthLeaders Factfile, "Results from patient safety organizational assessment survey of 24 hospitals show that hospitals have taken consideration action to implement patient-safety practices within their organization." The report states that experts give the following suggestion for improving the safety mechanisms in hospitals and clinics:

Design around precarious events

Standardize

Automate where possible

Make information visible to patients and staff

Plan for Obsolesce of facilities, equipment and technology

Review design for human factors

Reduce or eliminate noise

Involve patients and families with care regimen

Make the facility adaptive, scalable, flexible and accessible

Minimize staff fatigue

Focus design on organizational processes, not just departmental processes

Stated is the need for addressing the areas of:

Strategic/Structural

Incorporation of standards of patient safety into the mission statement and operational meetings.

Cultural

Learn from mistakes, reward staff for making improvements and raise the levels of awareness at all levels of the organization.

Technical

Implementation of programs for safety training, use of information systems related to safety. Medication Administration: Monitoring patients that are taking hazardous medications as well as using bar coding to for detection of adverse drug adverse reactions. Also bar coding should be used in other provisions of care and in administration for avoiding administration point of care errors.

Patient Involvement

Education of patients and their families on safety issues regarding their care, aftercare and about medication safety once discharged.

This survey was one of inquiry focusing on the action that was being taken or put into place in relation to review of the strategic, cultural, technical, medication and patient involvement factors or best practices that are deemed effective in the initiative of improving quality in hospitals. This is a 'baseline analysis' is a method that is uniform in the benchmarking of the performance of the hospital against goals that are stated or mandated quality standards issued by the government. Of the 24 hospitals surveyed 65% had addressed the issues overall with 70% having addressed the strategic best practices, 80% having addressed the structural issues in their organization and 60% of the hospitals having addressed the cultural factors. While only 50% had addressed technical issues in their organization 80% had addressed issues and practices related to medication. Finally as to patient involvement over 62% of the hospitals had addressed this issue.

Chart 1.0

Source: HealthLeaders November 2004 Factfile

Recommended Guidelines Designed to Improve Patient Safety

Automated systems may prove effective in error reduction. Stated in the Health Policy Monitor is that "Electronic medical records and interactive decision-support tools have the potential to allow health care providers timely knowledge of a patient's history and improve clinical care. Electronic Access to a patient's charts removes uncertainties regarding the patient's health history and can give physicians, nurses and other providers essential access to the most current results of consultations, laboratory tests, x-rays, and other studies, and to previous test results." (Sewell, 2001) Stated in the article is that automated systems are "more rigorous than non-automated systems for management of fraud." (Sewell, 2001) It has been found that with both pharmacy and medical records that are automated systems that the incidence of fraud, misuse and of security breaches is much lower than the same with use of paper records.

A Massachusetts bill that requires all state agencies that contract health services to guarantee that their partners are abiding by all major 'patient safety initiatives' such as the one SB 567 or computerized medication order entry. Another healthcare technology that has been proposed in Massachusetts if SB 552 that would provide loans with zero interest to community hospitals as well as neighborhood health centers for funding to institute these type systems. (Sewell, 2001)

Voluntary Reporting Systems

Voluntary reporting systems are said to have been more successful than those of a mandatory nature due to the facts as follows:

§ The wealth of information contained within a representative sampling of errors reported to voluntary programs;

§ The recognition that error reduction efforts should not wait until a numerical threshold has been exceeded; and § Its focus on enhancing systems to improve practitioner performance.

The Institute of Medicine (IOM) report makes suggestion that the reporting systems purposes be holding providers accountable for patient safety as well as for the information gains that is conducive to patient safety improvement are not incompatible on a conceptual basis but that the satisfaction of both simultaneously may be difficult. (OAHHS, 2000) The report states that the reporting systems that are voluntary [both internal and external] "are more useful and effective in learning about adverse events and improving patient safety." And states further that, "both mandatory and voluntary reporting systems are recommended to meet the goals for learning about errors and holding providers accountable for enhancing patient safety." (OAHHS, 2000) Other recommendations made by the Institute of Medicine are the following:

§ Regulators and accreditors should require healthcare organizations to implement meaningful patient safety programs with defined executive responsibility;

§ Public and private purchasers of healthcare services should provide incentives for healthcare organizations to demonstrate continuous improvement in patient safety;

§ Professional societies should recognize patient safety considerations in practice guidelines and in standards related to the introduction and diffusion of new technologies, therapies, and drugs;

§ Educational bodies, professional societies, and group purchasers should define standards of practice, inform members about patient safety, and call attention to the issues among the general public;

§ Competency testing of professionals should encompass error-prone activities; Accrediting bodies and group purchasers should recognize and reward healthcare organizations that participate in voluntary reporting systems;

§ Healthcare organizations should incorporate well-understood safety principles; and Healthcare organizations should implement proven medication safety practices. {Institute of Medicine, 2000)

According to the work of Rosenthal et al. (2001) entitled "Cost Implications of State Medical Error Reporting Programs: A Briefing Paper" there are more deaths each year that occur in medical settings than there are deaths due to automobile accidents or breast cancer. (Rosenthal, et al., 2001) The Institute of Medicine report states that most errors are the result of multiple contributing factors as opposed to events or bad people." Costs incurred to purchase both hardware and software as well as in establishing a network, creation of websites, and installation of database programming and data security systems to support the collecting, storing and analyzing of received data through implementation of Mandatory Reporting Systems. Costs may also be realized if reports are submitted through either a secure Internet site or via fax. Costs may also be realized for "activities related to review and investigation of reported incidents beyond the initial screening and follow-up telephone calls to the reporting entity ....[which may include] collection and review of additional information, charge reviews, staff interviews, on-site investigations, and the use of agency or outside experts to assist in the review of an incident." (Rosenthal, 2001)

The report further states that there are varying costs incurred depending on the percentage of reports triggering an on-site investigation performed by the reporting program. Validation of reports may also trigger costs in making determinations as to whether facilities are within compliance. The education of individuals and the collective facilities in relation to requirements in reporting and production as well as sharing "hospital-specific and aggregate reports" both internally and externally. Training is another area in which costs may be expected to incur during the implementation process of a reporting system. Administrative costs which are inclusive of the total scope of management and enforcement staff of the mandatory reporting programs which are separate from other components of the program. Summarizing the report states that costs are incurred for activities related to synthesizing and trending information collected from reportable incidents for internal use by program administrators."

Elements Impacting Mandatory Reporting Costs

Stated in the work Cost Implications of State Medical Error Reporting Programs, Rosenthal (2001) is that the costs for a mandatory reporting program are influenced by the goals of the program as well as the ability to leverage that program. Furthermore, investments that are paid 'up-front' in mandatory reporting systems should be considered separate from the costs of maintaining the system. (Rosenthal, et al. 2001)

The Mandatory Reporting System at Work: Florida and New York

Florida and New York were selected for participation in a 'detailed cost analysis' because the programs in their state are "mature programs representing substantial experience as well as clearly delineated components." It is noted that Florida and New York take completely different methods of approach in the constructing of a program for this type reporting. The analysis shows a vital aspect in the process, which is the fact that "Florida and New York offer useful contracts with respect tot the relationship of the Mandatory reporting program to pre-existing operation within the same respective state. (National academy for State Health Policy Report 2001 May) It was in actuality a crisis in the business environment due to lack of availability in procuring medical malpractice insurance. The following chart, labeled Chart 3.0 represents the 'Key Elements" of Florida and New York's reporting programs.