This filing was published in the 03/15/2007, issue, Vol. 2007, No. 6, of the Utah State Bulletin.
Patient Safety Sentinel Event Reporting
NOTICE OF PROPOSED RULE
DAR File No.: 29538
Filed: 02/22/2007, 08:45
Received by: NL
Purpose of the rule or reason for the change:
After five years of implementation, an intrafacility users group has recommended that the Sentinel event rule be expanded in order to be compliant with national standards for the surveillance and monitoring of "never events". These reference standards include the Center for Medicare/Medicaid Services (CMS), Joint Commission Accreditation of Healthcare Association (JCAHO), and National Quality Forum (NQF). This rule allows the state to oversee what is happening specifically in the state of Utah. The ability for the state to monitor this activity at the local level provides the opportunity to design locally implemented solutions. It was additionally recommended that the reporting format be more quantitative in order to conduct better surveillance analysis. Current feedback has indicated that there is confusion regarding the differences between the state requirements and national standards. Additionally, because of the differences, differing surveillance systems have needed to be in place. Examples of where the differences between JCAHO standards and the state in terms of reporting include bed sores, environmental related events, and emergency room events resulting in death or permanent major loss or harm JCAHO accredited facilities may already be collecting this information but has not to date notified the state. Non-accredited facilities may now need to pay attention to these types of events and report them to the state. The goal is to design state-based solutions. One such example is with the correct site surgery initiative. As data began to collect, wrong site surgeries were happening everywhere. Rather than simply adopting the national standard, the user's group conducted a survey to compare policies. It was determined that almost every facility had a policy in place, but implemented it differently resulting in 12 differing methods for markings some of which were directly opposed to each other. As surgeons, nurses, operating room technicians, and anesthesiologists move from facility to facility, system noise, and confusion abounded. The users group decided on a single standard and that was promoted throughout the state regardless of accreditation status. This type of cooperative and collaborative activity brings the quality of care up across the board for every Utah citizen regardless of where they may be receiving their care. This should be especially true in what are determined to be never events - events that NO ONE should have to experience at the hands of the healthcare system.
Summary of the rule or change:
The recommended rule changes add more specificity to the types of events reported, expand the list to be compliant with national standards, and integrate three separate reporting standards into one reporting mechanism. The rule also formalizes an interdisciplinary advisory group (users group) to continue advising the department on the direction of this surveillance and monitoring function. This rule was crafted by industry representatives and has their support.
State statutory or constitutional authorization for this rule:
Subsections 26-1-30(2)(a), (b), (e), and (g), and Section 26-3-8
This rule or change incorporates by reference the following material:
JCAHO - "Root Cause Analysis Matrix, Minimum Scope of Root Cause Analysis for Specific Types of Sentinel Events - October 2005" http://www.jointcommission.org/NR/rdonlyres/3CB064AC-2CEB-4CBF-85B8-CFC9E7837323/0/se_root_cause_analysis_matrix.pdf, last viewed on February 22, 2007
Anticipated cost or savings to:
the state budget:
Anticipated one-time costs of $7,500 to $10,000 will be incurred from existing budget resources for the development of a WEB reporting tool. This will allow facility reporters to submit their report on line, allowing them to track their reports, and allowing the Department of Health staff to conduct data analysis.
If a local government owns a healthcare facility, this may have an indirect impact on the subsidy it is providing to that facility. Currently, there are only a few that fall in this category and are rural. The incidence of these types of events in rural facilities tends to be low, due to the low number of hospital days. The impact will be negligible especially after the WEB reporting system is put into place and the process has been streamlined.
There will be a limited financial impact. Using a best case scenario in which reporting would go from an average of 40 a year to what is estimated to be 400 a year, aggregate costs for reporting at 30 minutes per event would result in about 200 hours per year spread across approximately 50 hospitals. Depending on size of hospital and numbers of hospitalizations, the actual costs will vary. The additional 200 hours at $50 per hour would result in $10,000 per year for reporting. As events are better identified and root causes revealed and corrected, overall costs to the consumer and facilities should improve with improved process for prevention of hospital errors. This rule has been reviewed by the Utah Hospital Association and it has determined that there will be minimal impact on existing accredited facilities. With the expansion of the rule into the emergency room and intensive care units, non-accredited facilities may have some impact but they tend to be rural where there is also limited number of hospitalizations. Non-accredited facilities make up a small proportion of the overall industry patient hospital days in Utah. It is estimated that costs accrued to this sector would result in about one-fourth of the total costs or about $2,500 per year.
Compliance costs for affected persons:
A facility that is JCAHO accredited already provides essentially the same reports to JCAHO, so the additional cost to provide the information is approximately $25 per event. Hospitals in Utah that are not JCAHO accredited are rural hospitals. Rural Utah hospitals owned by major corporations already gather this information. There are only six rural Utah hospitals that are not owned by major corporations. For those six hospitals, the estimated cost under this rule is $150 per event, but because there are so few reportable incidents for all non-accredited hospitals, it is not possible to estimate the total cost for any one non-accredited facility.
Comments by the department head on the fiscal impact the rule may have on businesses:
Improvements in patient care justify the very small fiscal impact this rule will have on business. David N. Sundwall MD, Executive Director
The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:Health
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY UT 84116-3231
Direct questions regarding this rule to:
Iona Thraen at the above address, by phone at 801-538-6471, by FAX at 801-538-7053, or by Internet E-mail at firstname.lastname@example.org
Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:
This rule may become effective on:
David N. Sundwall, Executive Director
R380. Health, Administration.
R380-200. Patient Safety Sentinel Event Reporting.
"Facility" means a general acute hospital, critical access
hospital, ambulatory surgical center, psychiatric hospital, orthopedic
hospital, rehabilitation hospital, chemical dependency/substance abuse hospital
chronic disease] hospital as those terms
are defined in Title 26, Chapter 21.
"Incident facility" means a facility where the patient safety sentinel event occurred.
safety sentinel event" means [
an event that must be reported under
section 3 of this rule].
"Root cause analysis" means a process for identifying the basic or causal factor(s) that underlie variation in performance, resulting in the occurrence or possible occurrence of a patient safety sentinel event.
R380-200-3. Reporting of Patient Safety Sentinel Events.
(1) Each facility shall report to the Department all patient safety sentinel events.
(2) Patient safety sentinel events include:
all deaths that occur at the facility
and that are directly related to any clinical service or process provided to a
patient for which the patient at the time of death: (i) was not
subject to a "do not resuscitate" order; (ii) was not in a
critical care unit, except where the patient is transferred to a critical care
unit as a consequence of a patient safety sentinel event that occurs elsewhere
in the facility ; (iii) was not in
the emergency room or operating room having presented in the last 24 hours with
a Glasgow score of 9 or lower; (b) events that
occur in the facility and that are directly related to any clinical service or
process provided to a patient and which result in: (i) surgery on
the wrong patient or wrong body part; (ii) suicide of a
patient; or (iii) major loss
of physical or mental function not related to the natural course of the
patient's illness or underlying condition; and (c) events that
occur in the facility and that are not directly related to clinical services
provided to a patient and which result in an alleged: (i) patient
abduction; (ii) discharge of
an infant to the wrong family; (iii) rape of a
patient; (iv) intentional
injury to a patient, whether by staff or others; or (v) suicide of a
(3) The incident facility shall report the
patient safety sentinel event to the Department within seventy-two hours of the
facility's determination, but in no event later than four hours prior to
convening a formal root cause analysis.
] (4) The report shall be submitted in a Department-approved paper or electronic format and shall include at a minimum:
the specific unit within the facility
where the patient safety sentinel event occurred; (b) the patient's
age and gender; (c) the patient's
admitting diagnosis; (d) each of the
patient's current or discharge diagnoses; (e) a short
narrative description of the patient safety sentinel event; and (f) the name and
phone number of the facility lead individual who will lead the facility's root
cause analysis for the reported event]
R380-200-4. Root Cause Analysis.
(1) The incident facility shall establish a root cause analysis process and designate a responsible individual to be the facility lead for each patient safety sentinel event.
(2) The Department representative may participate in the facility's root cause analysis in a consultative role with the facility lead to enhance the credibility and thoroughness of the root cause analysis. The Department shall notify the facility lead within 72 hours of receiving the report of the patient safety sentinel event if it intends to participate in the facility's root cause analysis. The Department representative shall not be present at the facility's internal root cause analysis meetings unless invited by the facility lead.
(3) Participation in the facility's root cause analysis by the Department representative shall not be construed to imply Department endorsement of the facility's final findings or action plan.
(4) The incident facility and the Department shall each make reasonable accommodations when necessary to allow for the Department representative's participation in the root cause analysis.
(5) If, during the review process, the Department representative discovers problems with the facility's processes that limit either the thoroughness or credibility of the findings or recommendations, the representative shall report these to the designated responsible individual orally within 24 hours of discovery and in writing within 72 hours.
(6) The facility shall conduct a root cause
analysis which is thorough and credible to determine whether [
]reasonable system change would likely prevent a patient safety
sentinel event in similar circumstances.
(7) The root cause analysis shall:
(a) focus primarily on systems and processes, not individual performance;
(b) progress from specific, direct causes in clinical processes to contributing causes in organizational processes;
(c) seek to determine related and underlying causes for identified causes; and
(d) identify changes which could be made in systems and processes, either through redesign or development of new systems or processes, that would reduce the risk of such events occurring in the future.
(8) The Department shall determine the root cause analysis to be thorough if it:
(a) involves a complete review of the patient safety sentinel event including interviews with all readily identifiable witnesses and participants and a review of all related documentation;
(b) identifies the human and other factors in the chain of events leading to the final patient safety sentinel event, and the process and system limitations related to their occurrence;
(c) searches readily retrievable records to analyze the underlying systems and processes to determine where redesign might reduce risk;
(d) inquires into all areas appropriate to the
specific type of event as described in the Joint Commission for the
Accreditation of Healthcare Organizations' "Minimum Scope of Root Cause Analysis for Specific Types of Sentinel Events" found at [
last viewed on June 1, 2001], which is incorporated by reference.
(e) makes reasonable attempts to identify and analyze trends of similar events which have occurred at the facility in the past;
ying] risk points
and their potential contributions to this type of event; and
(g) determines potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or determining, after analysis, that no such improvement opportunities exist.
(9) The Department shall determine the root cause analysis to be credible if it:
(a) is led by someone with training in root cause analysis processes and who was not involved in the patient safety sentinel event;
(b) involves, if necessary, consultation with either internal or external experts in the processes in question who were not involved in the patient safety sentinel event;
(c) includes participation by the leadership of the organization and by the individuals most closely involved in the processes and systems under review;
(d) is internally consistent, i.e., not contradicting itself or leaving obvious questions unanswered;
(e) provides an explanation for all findings of "not applicable" or "no problem;" and
(f) includes consideration of relevant, available literature.
R380-200-5. Reports and Action Plan.
(1) Within [
45] days of
determination of the patient safety sentinel event, the incident facility shall
[ develop] an action plan that:
(a) identifies changes that can be implemented to reduce risk, or formulates a rationale for not implementing changes; and
(b) where improvement actions are planned, identifies who is responsible for implementation, when the action will be implemented (including any pilot testing), and how the effectiveness of the actions will be evaluated.
Within 14 days of the development of the
action plan, t]he incident facility shall provide a final report to
the facility's administration and the Department in a Department-approved paper
or electronic format that includes:
a one sentence description of the
patient safety sentinel event; (b) a brief
summary of each of the findings of the root cause analysis; and (c) a brief
summary of each of the action plan steps.]
4]) If the Department representative identifies
problems with the processes that limit the thoroughness or credibility of the
findings and recommendations and that have not been corrected after reporting
them to the designated responsible individual, the representative may submit a
separate written dissenting report to the administrator of the incident
facility, and the Department.
5]) The incident facility may seek review of the
dissenting report by filing a request for agency as allowed by the Utah
Administrative Procedures Act and Department rule. If a dissenting report is not challenged or is upheld on review:
(a) the facility shall include it in the facility's records of the root cause analysis; and
(b) the Department may forward it, together with the facility's report, to the appropriate state agencies responsible for licensing the facility.
As required by Section 63-46a-3(5): An entity that violates any provision of this rule may be assessed a civil money penalty not to exceed the sum of $5,000 or be punished for violation of a class B misdemeanor for the first violation and for any subsequent similar violation within two years for violation of a class A misdemeanor as provided in Section 26-23-6.
KEY: hospital, [
injury prevention], quality improvement, patient safety
Date of Enactment or Last
Substantive Amendment: [
Notice of Continuation: October 10, 2006
Authorizing, and Implemented or Interpreted Law: 26-1-30(2)(a); 26-1-30(2)(b); 26-1-30(2)(d); 26-1-30(2)(e); 26-1-30(2)(g); 26-3-8
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For questions regarding the content or application of this rule, please contact Iona Thraen at the above address, by phone at 801-538-6471, by FAX at 801-538-7053, or by Internet E-mail at email@example.com
For questions about the rulemaking process, please contact the Division of Administrative Rules (801-538-3764). Please Note: The Division of Administrative Rules is NOT able to answer questions about the content or application of these administrative rules.
Last modified: 03/13/2007 2:20 PM