Best Practices Process

Best Practices Selection Criteria:
Compliance Function Involvement In Patient Safety & Medical Error Reduction
Summary
Patient safety is a critical aspect of health care delivery. Health care facilities have an obligation to provide a safe environment in accordance with their ethical commitment to quality patient care. The impetus to adopt systematic and pro-active approaches for improving patient safety and reducing medical errors is increasing. Government agencies, such as HHS OIG and CMS, and industry associations such as AHA, have raised the profile on the importance of implementing distinct processes to improve quality of care and patient safety. Accreditation bodies such as JCAHO are also making formal patient safety and medical error reduction programs a part of accreditation requirements.
Patient safety is not an issue that can be addressed in isolation. Effective initiatives to improve patient safety are organization wide and multi-disciplinary. Accordingly, the health care compliance function has an important contribution to make to an organization’s efforts to improve patient safety and reduce medical errors. This contribution is consistent with the compliance function’s commitment to enhance quality of care through system oriented efforts to foster organizational cultures which support ethical and legal conduct. These best practice criteria seek to recognize some of the innovative and diverse ways health care compliance can assist in the enhancement of patient safety and quality of care.
It is important to note that the establishment of formal patient safety programs in most health care organizations is a relatively new phenomenon. As such, the exact involvement of the compliance function in these initiatives is still evolving. It is anticipated that these current best practice criteria will change as the role of the compliance function in patient safety programs becomes more defined with time.
Definition
Effective efforts to improve patient safety and reduce medical errors depend on integrated, organization-wide initiatives that are strongly and visibly supported by leadership. The emphasis should be on developing a culture of safety where the focus is on improving systems rather than blaming individuals. Processes and internal control systems should be established to both prevent and detect medical errors. All areas and functions of the health care organization have a role to play in enhancing patient safety.
Achievement to Warrant Finding of Best Practice
The “Best Practice” criteria below describe the type of contribution a compliance officer could make to their organization’s efforts to improve patient safety. These criteria will be used for evaluation of nominations in this area.
Please note: These criteria are not intended to suggest that the compliance officer should have primary responsibility for overseeing the organization’s patient safety program or initiative. However, they do recognize that the expertise, skills and experiential knowledge developed while undertaking the compliance role are aligned to those required to establish an effective patient safety and medical error reduction program. Notably, effective compliance efforts and patient safety efforts share the following commonalities: (1) a strong system oriented approach; (2) mission driven and values-based; (3) promote and improve quality of care; (4) require strong, visible leadership support and appropriate governance structures; (5) need to be integrated within an organization and become part of the organizational culture; (6) should be supported by appropriate policies, procedures and mechanisms for reporting and disclosures of sensitive information, etc. These commonalities mean that the compliance officer is uniquely placed to make a useful contribution to their organization’s efforts to improve patient safety and reduce medical errors.
Compliance Officer Role. The compliance officer should:
  1. be a member of the organization’s patient safety committee. The committee should be multi-disciplinary and include representation from senior management, and key functional areas including compliance, quality, risk management, medical, nursing and maintenance;
  2. contribute to the development of the organization’s strategic plan to improve patient safety and reduce medical errors;
  3. provide guidance or assist in the development and implementation of appropriate systems and internal controls to prevent and detect medical errors and patient safety problems, including development of performance measures, analysis of outcomes and implementation of remedial actions;
  4. emphasize the links between patient safety efforts and the organization’s compliance efforts (e.g., emphasize the common goals to improve quality of care);
  5. promote patient safety and medical error reduction as a part of compliance-related education initiatives and compliance-related communications including newsletters, posters and web pages;
  6. assist in the development of an organizational reporting mechanism for patient safety concerns and medical errors. This should include guidance on related policies and procedures such as non-retaliation policies, reporting requirements (internal and external), disclosure of issues to patients and families, and handling of sensitive disclosures by medical staff (especially those which may impact on licensure or credentials), and investigations following reports. It may be appropriate to utilize some of the pre-existing compliance policies and procedures in this area, for example, a consistent non-retaliation policy that applies to use of all reporting mechanisms is preferable. In some cases the pre-existing compliance reporting mechanism (e.g., hotline) may also be used for patient safety reports, and in these cases, relevant policies and procedures should be amended accordingly;
  7. support leadership and governance efforts to promote the enhancement of patient safety;
  8. support and promote the sharing of information and beneficial practices related to patient safety and medical error reduction;
  9. provide oversight to assure compliance with applicable patient safety and medical error reduction regulations, laws and standards, including requirements of government agencies and accreditation bodies. The compliance officer should be prepared to provide oversight and correction in any case in which normal organizational processes (e.g., line of command or incident reporting processes) have failed;
  10. include patient safety and medical error reduction issues as part of routine compliance audits and compliance risk assessments;
  11. ensure that in teaching institutions the patient safety and medical error reduction program/initiative addresses activities of medical students;
  12. ensure that patient safety and quality of care issues (considered as part of medical appointment and re-appointments.)