Comment on Proposed Sentinel Event Reporting Rules October 2009 2

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Maine Hospital Association     October 20, 2009     Anne Flanagan, Assistant Director Maine Department of Health and Human Services Division of Licensing and Regulatory Services 11 State House Station 41 Anthony Avenue Augusta, Maine 04333-0011   Dear Anne:   On behalf of our entire membership, the Maine Hospital Association (MHA) appreciates the opportunity to provide these preliminary comments on the proposed sentinel event reporting rules. The MHA is an Augusta-based non-profit membership organization representing all 39 community hospitals in our state. Our comments are presented by section for easy reference.   Overall   As the National Quality Forum’s endorsement ist he applicable national standard of care, we appreciate that the Division has proposed adopting many of the standards and definitions from the National Quality Forum’sS erious Reportable Events in Healthcare 2006 Update. Consistency of language and application is critical to quality improvement efforts and learning from the national data provided by other organizations, such as the newly emerging Patient Safety Organizations. To assure complete consistency, we recommend incorporating the entire National Quality Forum’s publication by reference, as may be updated from time to time. This approach would replace the relevant portions of the proposed rule, and allow all relevant definitions, additional specifications and implementation guidance to apply to Maine’s reporting system. It would also permit the most recent update to be incorporated without returning to the rulemaking process. This is also the approach we agreed to take during the legislative session negotiations around the amendments to the sentinel event reporting statute.   Notably, the National Quality Forum’s consensus stnadards have legal status as described herein:   Originally conceptualized by the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, the National Quality Forum was established as a nonprofit, public benefit corporation and a unique public-private collaborative venture in 1999. It became operational in February 2000. The NQF's mission is to improve American health care through the endorsement of consensus-based national standards for the measurement and public reporting of health ___________________________________________________________________________           33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   1

care performance data that provide meaningful information about whether care is safe, timely, beneficial, patient-centered, equitable, and efficient. The NQF is a voluntary consensus standards-setting organization as defined by the National Technology Transfer and Advancement Act of 1995 (NTTAA) and Office of Management and Budget (OMB) Circular A-119. It has a formal process by which it achieves consensus and endorses standards. This process meets the requirements of the NTTAA, and, therefore, the NQF- endorsed consensus standards enjoy a consequent legal status. In particular, the NTTAA specifies that when a Federal Government agency establishes standards in an area it is obligated to “use voluntary consensus standards in lieu of gov 1 ernment unique standards except where inconsistent with law or otherwise impractical.”   Section 1. Definitions   Section 1.4  We recommend that the definition of “discovery” in Section 1.4 be amended as follows:   Discovered. For the purposes of these rules, “discovered” means the point at which one detects becomes aware of an occurrence sentinel event that triggers an action under these  rules.    These clarifications are necessary because:   •  “Sentinel event” is a definde term, but “occurrence” is not; •   The mandatory actions under these rules are triggered by the detection of a sentinel event; and •   “Becomes aware of” is a vague phrase taht is not synonymous with discovery. Discovery is assessing or detecting whether a set of facts does or does not meet the applicable statutory definitions.   Section 1.5  We recommend that the definition of “Division” in Section 1.5 be amended as follows because “sentinel event team” is separately defined in Section 1.23:   Division. “Division” means the Department of Health and Human Services (DHHS), Division of Licensing and Regulatory Services (DLRS). The Sentinel Events Team is a unit of DLRS.   Section 1.7  We recommend that the definition of “finala gency action” be amended as follows to correct a typographical error and incorporate the relevant definition of “persons”:                                                     1  http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=aps.section.7695. ________________________________________________________________________________________________________             33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   2

Final Agency Action. “Final Agency Action” mean as decision by DHHS which affects the legal rights, duties or privileges of specific persons which is dispositive of all issues, legal and factual, and for which no further recourse, appeal or review is as provided  within DHHS, 5 M.R.S.A. §8002 (4).    Section 1.13  We appreciate the Division’s use of federla and/or nationally accepted definitions of terms whenever appropriate for consistency and availability of additional guidance. Accordingly, just as Section 1.3’s definition o f“disability” incorporates the federal term used in the Americans with Disabilities Act (ADA), we recommend amending the definition of “major life activiites” to repeat and reference the ADA definition as follows:   Major Life Activities. For the purposes of these rules, “major life activities” means activities that an average person can perform with little or no difficulty. Examples include walking, seeing, hearing, speaking, breathing, learning, performing manual tasks, caring for oneself, working. These are examples only. Other activities such as sitting, standing, lifting, or reading are also major life activities (see Americans with Disabilities Act). functions, including but not limited to, caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, working and the operation of a major bodily function. For the purposes of these rules, operation of a major bodily function includes but is not limited to functions of the immune system, normal cell growth, digestive, bowel, bladder, neurological, brain, respiratory, circulatory, endocrine, and reproductive functions.   Section 1.15  For consistency, we recommend aligning the definition of “near miss” with the Joint Commission of “near miss” as follows:   Near miss event.  "Near miss" means a act of commission or omission that could have  harmed the patient, but did not as a result of chance, prevention or mitigation. any process variation that did not affect an outcome but for which a recurrence carries a significant chance of a serious adverse outcome.   Section 1.22.2  In alignment with the relevant statutory definition, we recommend that the definition of a sentinel event clearly requires that the major permanent loss of function be one that was not present at the time of admission but developed during the hospitalization and is present at the time of discharge.    We also recommend deleting the last sentence from this definition of a sentinel event because it is not part of the definition of a sentinel event, but a component of the reporting process that is repeated in 3.3.2.1.1. _______________________________________________________________________________________________________   _           33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   3

  A major permanent loss of function unrelated to the natural course of the patient's illness or underlying condition or proper treatment of that illness or underlying condition in a health care facility that was not present at the time of admission but is present at the time  of the discharge of the patient. If within 2 weeks of discharge from the facility, evidence is discovered that the major loss of function was not permanent, the health care facility is not required to submit a report pursuant to 22 MRSA § 8753 (2);   Section 1.22.4  As noted at the beginning of these comments, we recommend completely deleting this section and replacing it with an incorporation by reference of the National Quality Forum’sS erious Reportable Events in Healthcare 2006 Update, as may be updated from time to time. Consistency of language and application is critical, and this approach would allow all of the National Quality Forum’sr elevant definitions, additional specifications and implementation guidance to apply to Maine’s reporting system.   If this approach is impossible, we recommend the following amendments to Section 1.22.4 to maximize clarity and consistency:   1. 22.4 Other serious and preventable events identified by a nationally recognized quality forum and listed that are referenced here pursuant to 22 MRSA § 8752 (4-A) (D), and  include the applicable definitions, additional specifications and implementation guidance:   1. 22.4.1.2 Wrong surgical procedure performed on a patient, excludes emergent  situations that occur in the course of surgery and/or whose exigency precludes obtaining informed consent.    1. 22.4.1.3 Unintended rRetention of a foreign object in a patient after surgery or other  procedure.   1. 22.4.1.4 Intra-operative or immediately post-operative death in an normal healthy  patient ASA Class I patient. 1.22.4.2.3 Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a healthcare facility, excludes death or serious disability associated with neurosurgical procedures known to present a high risk of intravascular air embolism. 1. 22.4.3.2 Patient death or serious disability associated with patient elopement (disappearance) for more than four hours, excluding events involving competent adults.       ________________________________________________________________________________________________________             33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   4

            1. 22.4.4.2 Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products (transfusion of the wrong blood type).    1. 22.4.4.3 Maternal death or serious disability associated with labor or delivery in a low- risk pregnancy while being cared for in a health care facility, excludes deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy or cardiomyopathy.      1. 22.4.4.5 Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia jaundice in neonates in the first 28 days of life newborns.    1. 22.4.4.6 Stage 3 or 4 pressure ulcers acquired after admission to a health care facility, excludes progression from Stage 2 to Stage 3, if Stage 2 was recognized upon admission.    1. 22.4.5.1 Patient death or serious disability associated with an unintended electric shock  while being cared for in a health care facility.    Section 1.23  Consistent with the confidentiality provisions of the statute, we recommend the following amendment to the definition of the “sentinel event team”:   Sentinel Events Team. The Sentinel Events Team (SET), is a segregated unit of the  Division of Licensing and Regulatory Services (DLRS) that maintains separate and confidential communications and records to assure that all notifications and reports of sentinel events filed pursuant to this chapter and all information collected or developed as a result of the filing and proceedings pertaining to the filing, regardless of format, are confidential and not disclosed, except as permitted under Section 7.4. The SET is assigned the responsibility to implement these rules.     Section 1.25   We recommend deleting the definition of “seirous adverse event” because it conflicts with the already separately defined “seirous” and “adverse” and “event” within this proposed rule.    Serious Adverse Event. “Serious adverse event” means an event, occurrence or situation involving the clinical care of the patient in a healthcare facility that results in unanticipated injury or compromises patient safety.    Section 1.26    We recommend deleting this definition of “serious disability” which simply repeats the  ADA definition of “disability” in proposed Section 1.3.   _______________________________________________________________________________________________________   _           33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   5

 Serious Disability. “Serious disability” means an impirament that substantially limits one or more major life activities.    Section 1.27    Consistent with Maine law (17-A M.R.S.A. § 251) and to avoid characterizing medically necessary health care (e.g. a rectal exam) with sexual assault, we recommend the following amendment to Section 1.27:    Sexual Assault. “Sexual assault” as a reportbale event means unconsented sexual contact for the purpose of arousing or gratifying sexual desire or for the purpose of causing bodily injury involving a patient and another patient, staff member, or other perpetrator while being treated or on the premises of the health care facility, including oral, vaginal or anal penetration or fondling of the patient’s sex organ(s) by another individual’s hand, sxe organ or object.   Section 1.29    We recommend adoption of the National Quality Forum definition of “surgery” as  follows:     Surgery.  “Surgery” means an invasive operativ eprocedure in which skin or mucous  membranes and connective tissue is incised or an instrument is introduced through a natural body orifice.     Section 2. Facility Responsibilities   Section 2.1    We recommend deleting Section 2.1 as it partially, but not completely, repeats Section 3.1. Repetition is unnecessary, and partial repetition is confusing.    Notification Required. A healthcare facility must notify the SET when a sentinel event occurs.   Section 2.2  The Medicare Conditions of Participation assigns the hospital governing board the responsibility for ensuring that: “The hospital must develop,i mplement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program” (§482.21 Condition of Participation: Quality Assessment and Performance Improvement Program). The federal regulations at §482.21(a)(2) also require that: “The hospitla must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations.” This requirement is emphasized at §482.21(c)(2): “Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that _______________________________________________________________________________________________________   _           33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   6

include feedback and learning throughout the hospital.” The federal regulations also mandate that appropriate action be taken and tracked to ensure that necessary improvements are sustained: “The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained” (§482.21(c)(3)).   As CMS stated when it published the final Quality Assessment and Performance Improvement (QAPI) final rule (Federal Register, Vol. 68, No. 16, p. 3435). “In addition, the QAPI entails all activities required for measuring quality of care and maintaining it at acceptable levels.” CMS explicitly stated that sentinele vents are considered adverse events: (p. 3438):   Comment: Many commenters stated the proposed QAPI requirements will substitute high-level hospital-wide QI processes for more effective, focused, department-level performance improvement. These commenters suggested strengthening the language by adding sentinel events to the minimum performance elements. Response: We agree that hospitals should consider adverse events in the development of its QAPI strategy. We expect hospitals to implement an internal error reduction system. Adverse event tracking and analysis of underlying causes are an effective way to determine issues involving medical errors. We emphasize the need for hospitals to assess processes and systems that affect patient care and quality. Section 482.21(c) requires the hospital(s) to establish priorities, and identify areas of risk that affect patient safety. We believe that the identification of adverse events and analyses of events must be an integral part of the hospital’s QAPI program, as the analyses will lead to better protections for patients.   CMS also requires that: (p. 3449) A hospital’s performance improvement activties should track adverse patient events, analyze their causes, and implement preventive actions and mechanisms of feedback and learning throughout the hospital. This must include incidents of medical errors and adverse patient events. Finally, hospitals are required to take actions that result in performance improvements. After implementing actions, the hospital must measure its success and track its performance to assure that improvements are sustained.   Therefore, consistent with Maine’s deeming sattute, we recommend deleting Section 2.2 in its entirety and explicitly referencing the Medicare regulations regarding adverse patient events within the definition of sentinel event as follows:   Section 1.22 Sentinel Event. A “sentinel event” is an adverse event within the meaning of the Centers for Medicare and Medicaid Services Conditions of Participation  and means:        _______________________________________________________________________________________________________   _           33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   7

Section 2.3 Staff education, both generally and specifically around sentinel events, is ongoing and the design of educational programming around adverse events is the responsibility of the hospital according to CMS: (p.3437)   After monitoring, tracking, and assessing performance in all areas of hospital service and operations, the hospital has the flexibility to design a program to address its specific needs. We also believe giving the hospital flexibility to design its own program provides the hospital with the flexibility to adopt its own best practices in specific areas, (for example, hospital staff education, record reviews, and information technology).   Therefore, we recommend deleting Section 2.3.    2.3 Staff Education. Maintain documentation of education during new employee orientation and annually to staff, and individuals with privileges, at all levels regarding:    2.3.1 The facility’s Sentinel Event Notification and Reporting System .   2.3.2 Maine rules regarding mandatory reporting of sentinel events, the voluntary  reporting of near miss events, and the standardized procedures for notification and reporting.    2.3.3 Facility internal processes for notifying leadership.    2.3.4 Facility responsibility to implement action plans.    2.3.5 Facility responsibility to annually attest that all sentinel events were reported to  the SET.    Section 2.5  Section 2.5 proposes that each health care facility must submit annual written statement to the state that they complied with the sentinel event reporting requirements of Maine law. Requiring such attestation is not authorized by the enabling statute, and if it were, such a requirement is unprecedented and unnecessary. Hospitals are required to comply with countless state and federal laws. Annual certification of compliance with any single one would be a superfluous waste of private and public resources. Accordingly, we recommend that Section 2.5 be deleted.    2.5 2.7 Annual Attestation notification. By January 30 TH   of each year, on a department-approved form approved by the SET, each healthcare facility must send the SET a written attestation notice that contains an affirmative statement that it reported, in accordance with Section 2.2, all sentinel events that occurred in the prior calendar year.     _______________________________________________________________________________________________________   _           33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   8

Section 3. Standardized Procedures   Section 3.2.1  The definition of a sentinel event is complex. Sometimes it is immediately obvious that an event meets the definitions, e.g. surgery on the wrong patient. Other circumstances are not as clear and may require some inquiry or investigation before ascertaining whether it is or is not a sentinel event under this proposed rule. Therefore, the notification requirement outlined in Section 3.1 is appropriate: “The health care facility must notify the SET of a sentinel event (Section 1.22) by the next business day after the event occurred or the next business day after the facility discovers that the event occurred.” However, Section 3.2.1 must be amended as follows to allow necessary inquiry, if any, to take place:   3.2.1 Notification of the discovery of a sentinel event must not be delayed beyond  the next business day after the event occurred or the next business day after the facility discovers that the event occurred secondary to internal deliberations or pending autopsy or medical examiner results. Section 3.2.3  Section 3.2.3 requires that the facility only notify the SET of a sentinel event by fax, but call the same day to confirm that the SET received the fax and possibly schedule an on-site SET visit. Mandating notification of a sentinel event occurrence by fax as outlined in Section 3.2.2 is acceptable. However, the SET should review the notification form and call the facility for any necessary follow-up. The notification from the hospital may arrive to the SET office fax machine when the team is away on another site visit, during week-ends, holidays, state shut- down days or off-hours or other days/times when the SET is unavailable. Therefore, this proposed language imposes a legal requirement that hospitals cannot always comply with due to circumstances beyond their control. Accordingly, we recommend deleting Section 3.2.3.   3.2.3 The day the notification facsimile is sent to the SET, the facility must telephone  the SET to confirm its receipt of the notification facsimile and, at the discretion of the SET, schedule an on-site SET visit.   Section 3.3  It is not clear who has the reporting obligation around inter-facility transfer that involves a sentinel event. As discussed during the legislative deliberations, the sending facility that was the scene of the sentinel event has the legal obligation for reporting, so we recommend the following amendments:   3.3.1 Inter-facility Transfer Notification.  A sending facility is required to submit  to the SET notification regarding a sentinel event when the transfer to another  facility is unrelated to the natural course of the patient’s illness or underlying  condition; or unrelated to the proper treatment of that illness or underlying condition in their a health care facility.    _______________________________________________________________________________________________________   _           33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   9

Section 3.3.2. At the recent licensing update, state staff reviewed the new 14 day window of determining whether a major loss of function was permanent. As we recall, a physician attestation that full recovery was expected would suffice as evidence that a major loss of function was not permanent. For example, patients recovering from a bone fracture repair would be discharged with a cast and major loss of function that would be expected to extend beyond 14 days, but not be permanent. Whether or not a major permanent loss of function is permanent determines if an event meets the definition in Section 1.14. Therefore, we recommend deleting Sections 3.3.2.1 and 3.3.2.1.1 and amending Section 1.14 as follows:   3.3.2.1 A facility is required to submit to the SET notification regarding a  sentinel event involving a patient with a major permanent loss of function that is present at the time of discharge.   3.3.2.1.1 Within 14 days of discharge from a health care facility, if evidence  is discovered that the major loss of function was not permanent, the facility must submit the department-approved Functional Evidence form with supporting documentation to the SET, and a RCA of the event is not required.   1.14 Major Permanent Loss of Function.  “Major permanent loss of function” means sensory, motor, physiological or intellectual impairment that was not present at the time of admission but is present at the time of discharge unless there is a signed physician attestation that full recovery is expected and  1.4.1    requires continued treatment or   1.4.2     imposes persistent major restrictions in activities of daily living.   1.4.3. within 14 days of discharge from a health care facility, if it is discovered that the major loss of function was not permanent, the facility must submit a signed physician attestation that full recovery is expected and then a RCA of the reported sentinel event is not required.         Section 3.3.3  Section 3.3.3 is part of the definition of a reportable sexual assault and so should be incorporated in Section 1.22.4.6.3 as follows:   3.3.3 Sexual Assault Notification. If one or more of the following criteria is met, the facility is required to submit notification regarding a sexual assault (Section 1.22.4.6.3):   3.3.3.1 Any staff-witnessed sexual assault.   _______________________________________________________________________________________________________   _           33 Fuller Road, Augusta, Maine 04330 Phone: [phone]; Fax: [phone]; web site: www.themha.org   01