Operational Features and Processes
- • Facility Processes
- ◊ Mandatory Reporting – Since July 1, 2003, a ‘limited implementation’ of mandatory reporting by hospitals was managed by the MHA, and on December 6, 2004, the ‘full implementation’, managed by the MDH, has been in place for both hospitals and ambulatory surgery centers.
- ◊ Timing
- → Each facility must advise the MDH “as soon as is reasonably and practically possible, but no later than 15 working days . . ” after discovery of the event [§144.7065.1],
- ◊ Submission of report
- ◊ Reporting of Near-miss Events – NO PROVISION
- ◊ Root Cause Analysis (RCA)
- ◊ Action Plan
- → Timing: Findings of RCA and copy of corrective action plan must be filed with the commissioner within 60 days of the event [§144.7065.8(2)].
- → Discretionary Action Plan
- -- Facilities must report to the commissioner any reasons for not taking corrective action [§144.7065.8(2)].
- -- Facilities may submit RCA and Action Plan to MDH with the initial reporting of the event but otherwise must submit it within 60 days of the event [§144.7065.8(2)].
- -- Facilities must implement action plan, if one is submitted
- → Agency approval of plan: None – The MDH has a duty to analyze submitted reports and communicate findings, including potential sharing of findings with other facilities. No formalized process for ‘approval’ exists [§144.7067.2].
- ◊ No new hospital committees required
- → No patient safety committees are created. Facilities responsible for devloping reporting program.
- ◊ Other features:
- → Each facility must comply with requirements of Vulnerable Adult Act [§144.7065.10(a)],
- → Each facility shall receive from the Commissioner adverse event notifications from licensing boards§144.7068,
- → Each facility shall receive and respond as directed to communications, potential sanctions, and expectations from Commissioner [§144.7067.2]
- • State Agency Processes
- ◊ Timing
- → No time-limitations on investigation stipulated,
- ◊ Mandatory Response
- → The MDH has a duty to analyze submitted reports and communicate findings, including potential sharing of findings with other facilities [§144.7067.2].
- → Disclosure of report findings – Except for reported data appearing in the annual report, all adverse event reports are non-public data [MN Statute §144.7065.10(e)].
- ◊ % Investigated: All RCAs and Action Plans are reviewed, but approval of the plan is not formally addressed and investigation beyond facility submission of these reports has not been reported by the MDH.
- ◊ Annual Report Beginning in January 2005 [PDF], annual reports are released to the legislature and public [§144.7067.2(4)].
- ◊ Provide feedback to Facilities
- → Registry Advisory Council – In 2004 while managing the reporting system, the MHA created the MHA formed a Registry Advisory Council, made up of patient safety professionals from member hospitals, to review the information being reported. It was the role of the Registry Advisory Council to look for trends, identify needs for safety alerts and develop recommendations for acting on data and sharing what has been learned.
- → Safety Alerts – Timely releases of Safety Alerts for lessons learned
- → MAPS Best Practices Subcommittee – MAPS Best Practices Subcommittee to research and promote best practices around prevention and treatment of reportable events,
- → Safest in America – Safest in America, a collaboration of 10 hospital systems in the Twin Cities and Rochester that are committed to working together to improve their combined patient care service areas, has begun using the data to refine its surgical guidelines.
- ◊ Board of Medical Practice
"Within 30 days of making a determination under paragraph (a) that an event qualifies as an adverse health care event, the Board of Medical Practice shall forward to the commissioner of health a report of the event, including the facility involved, the date of the event, and information known to the board regarding the event. The report shall not include any identifying information for any of the health care professionals, facility employees, or patients involved." [§147.155(b)]
(Similar 30-day datelines apply to reporting by other boards to the Commissioner, including Pharmacy, Podiatry, Physician Assistants, etc.)
- ◊ Timing
- • Confidentiality of Information
According to Laws 2003, c99, §7(b), in reference to data shared between the MHA and th MDH,
“ . . data reported to or retrieved by the commissioner under this section, and data created or obtained by the commissioner in reviewing or investigating reports under this section, are nonpublic data and confidential data on individuals as defined in MN Statute, § 13.02, except as necessary for the commissioner to communicate with facilities and publish the annual report as required by MN Statute, § 144.7067.2.”
Confidentiallity is also confirmed to all information, data, reports, and documents in the adverse events reporting programs MN Statute, § 144.7065.10(e) and peer review activities MN Statute, §145.64, which may share the same committees or processes in hospitals.
- • Education
The educational mandates for facilities are few, although mandates are placed upon the Commissioner of Health to “work with organizations and experts familiar with patient safety when developing the format for reporting . . . categories in MN Statute, §144.7065.1 ” . . . . . . and “make necessary Clarifications and develop educational materials.” [Laws 2003, c99, §7(a2)]