DAR File No. 29538

Health, Administration

R380-200

Patient Safety Sentinel Event Reporting

NOTICE OF PROPOSED RULE

DAR File No.: 29538
Filed: 02/22/2007, 08:45
Received by: NL

RULE ANALYSIS

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.

local governments:

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.

other persons:

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
Administration
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 ithraen@utah.gov

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:

04/16/2007

This rule may become effective on:

04/23/2007

Authorized by:

David N. Sundwall, Executive Director

R380. Health, Administration.

R380-200. Patient Safety Sentinel Event Reporting.

R380-200-2. Definitions.

"Contaminated" means contamination that can be seen with the naked eye, or with use of detection mechanisms in general use, as they become reported or known to the health care facility.

"Facility" means a general acute hospital, critical access hospital, ambulatory surgical center, psychiatric hospital, orthopedic hospital, rehabilitation hospital, chemical dependency/substance abuse hospital or [chronic disease]long-term acute care hospital as those terms are defined in Title 26, Chapter 21.

"Incident facility" means a facility where the patient safety sentinel event occurred.

"Medication Error" means medication administration:

(a) of a drug other than as prescribed or indicated;

(b) of a dose other than as prescribed or indicated;

(c) to a patient who was not prescribed the drug;

(d) at a time other than prescribed or indicated;

(e) at a rate other than as prescribed or indicated;

(f) of a improperly prepared drug;

(g) by a means other than as prescribed or indicated; and

(h) administration of a medication to which the patient has a known allergy or drug interaction to the prescribed medication.

"Major permanent loss of function" means sensory, motor, physiologic, or intellectual impairment not present on admission requiring continued treatment or life-style change. When major loss of function cannot be immediately determined, applicability of the policy is not established until either the patient is discharged with continued major loss of function, or two weeks have elapsed with persistent major loss of function, whichever occurs first.

"Patient safety sentinel event" means [an event that must be reported under section 3 of this rule]an event which has resulted in an unanticipated death or major permanent loss of function, not related to the natural course of the patient's illness or underlying condition or is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response.

"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 within seventy-two hours of the facility's determination that a patient safety event may have occurred, but in no event later than four hours prior to convening a formal root cause analysis.

(2) Patient safety sentinel events include:

(a) [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 patient.]Surgical Events:

(i) Surgery performed on the wrong body part;

(ii) Surgery performed on the wrong patient;

(iii) Incorrect surgical procedure performed on a patient;

(iv) Retention of a foreign object in a patient after surgery or other procedure, except for:

(A) objects intentionally implanted as a part of a planned intervention;

(B) objects present prior to surgery that were intentionally left in place, and

(C) broken microneedles; and

(v) Intraoperative or immediately post-operative death of a patient who the facility classified prior to surgery as Anesthesia Surgical Assessment Class I. "Intraoperative" means literally during surgery. "Immediately post-operative" means within 24 hours after surgery, or other invasive procedure was completed, or after induction of anesthesia if surgery not completed.

(b) Product or Device Events.

(i) Patient death or disability arising from the use of contaminated drugs, devices, or biologics provided by the facility.

(ii) Patient death or disability associated with the use or function of a device in patient care in which the device is used for an off-label use, except where the off-label use is pursuant to informed consent.

(iii) Patient death or disability associated with intravascular air embolism that occurs while being cared for in the facility, except for intravascular air emboli associated with neurosurgical procedures.

(c) Patient Protection Events.

(i) Infant discharged to the wrong person;

(ii) Patient death or disability arising from a patient elopement or the disappearance of other than competent adults;

(iii) Patient suicide while in the facility or within 72 hours of discharge.

(d) Care management Events.

(i) Patient death or major permanent loss of function arising from a medication error;

(ii) Patient death or major permanent loss of function arising from a hemolytic reaction due to the administration of ABO/HLA incompatible blood or blood products;

(iii) Maternal death or major permanent loss of function in a low-risk pregnancy arising from labor or delivery while being cared for in a facility, except deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy or cardiomyopathy. "Low Risk Pregnancy" refers to a woman aged 18-39, with no previous diagnosis of essential hypertension, renal disease, collagen-vascular disease, liver disease, cardiovascular disease, placenta previa, multiple gestation, intrauterine growth retardation, smoking, pregnancy-induced hypertension, premature rupture of membranes, or other previously documented condition that poses a high risk of poor pregnancy outcome.

(iv) Unanticipated death of a full-term newborn;

(v) Patient death or major permanent loss of function arising from hypoglycemia, the onset of hypoglycemia which occurs while the patient is being cared for in the facility;

(vi) Kernicterus associated with failure to identify and treat hyperbilirubinemia, bilirubin greater than 30 milligrams per deciliter, in neonates.

(vii) Stage 3 or 4 pressure ulcers acquired after admission to the facility, except for pressure ulcers that progress from stage 2 to stage 3, if the stage 2 ulcer was documented upon admission.

(viii) Patient death or major permanent loss of function due to spinal manipulative therapy; and

(ix) Prolonged fluoroscopy with cumulative dose greater than 1500 rads to a single field;

(x) Radiotherapy to the wrong body region;

(xi) Radiotherapy greater than 25% above the prescribed radiotheraphy dose; and

(xii) Death or major permanent loss of function related to a health care acquired infection.

(e) Environmental Events.

(i) Patient death or major permanent loss of function arising from an electric shock while being cared for at a health care facility, excluding emergency defibrillation in ventricular fibrillation and electroconvulsive therapies;

(ii) Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by a toxic substance;

(iii) Patient death or major permanent loss of function arising from a burn incurred from any source while being cared for in a facility;

(iv) Patient death or major permanent loss of function associated with the use of restraints or bedrails while being cared for in a facility; and

(v) Patient death or major permanent loss of function arising from a fall while being cared for in a health care facility, including fractures and intracranial hemorrhage.

(f) Criminal Events.

(i) Any care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed or certified health care provider;

(ii) Abduction of a patient of any age;

(iii) Non-consensual sexual contact on a patient, staff member, or visitor by another patient, staff member or unknown perpetrator while on the premises of the facility; or

(iv) Patient death or major permanent loss of function resulting from a criminal assault or battery that occurs on the premises of the health care facility.

(3) If a facility suspects that a patient safety sentinel event may have occurred to a patient who was transferred from another facility, the receiving facility shall report the suspected patient safety sentinel event to the facility that initiated the transfer.

[ (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:

(a) [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]facility information;

(b) patient information;

(c) event information

(d) type of occurrence;

(e) analysis;

(f) corrective action.

 

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 timely, thorough and credible to determine whether [a ]reasonable system changes 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' "Root Cause Analysis Matrix, Minimum Scope of Root Cause Analysis for Specific Types of Sentinel Events - October 2005" found at [http://www.jcaho.org/sentinel/rcamatrx.html, last viewed on June 1, 2001]http://www.jointcommission.org/NR/rdonlyres/3CB064AC-2CEB-4CBF-85B8-CFC9E7837323/0/se_root_cause_analysis_matrix.pdf, last viewed on February 22, 2007, 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;

(f) identif[ying]ies 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]60 calendar days of determination of the patient safety sentinel event, the incident facility shall [develop]submit a final report with 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.

(2) [Within 14 days of the development of the action plan, t]The 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) [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.]type of harm;

(b) contributing factors;

(c) actions taken.

([4]3) 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]4) 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.

 

R380-280-8. Advisory Panel.

The department shall establish a multi-disciplinary advisory panel to assist it in carrying out its responsibilities under this rule. Representatives from facilitites that are required to report under this rule shall be included as members of the advisory panel.

 

R380-200-[8]9. Penalties.

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]sentinel event, quality improvement, patient safety

Date of Enactment or Last Substantive Amendment: [October 15, 2001]2007

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