- • 2000 DOH Rules Start Event Reporting
Tennessee's mandatory medical error reporting program was developed when Tennessee Rule 1200-8-1-.11 was filed by the Department of Health on March 18, 2000.
- • Creation of Public/Private Task Force (TIPS)
Subsequent to the release in November 1999 of the IOM's To Err is Human: Building a Safer Health System, the Tennessee Department of Health convened a task force that addressed definitions and guidelines for error reporting, and it recruited a Tennessee Improving Patient Safety (TIPS) committee and coalition of volunteer stakeholders. Activity for the TIPS groups officially began in August 2001.
The combined private-public collaboration recommended revisions in the existing reporting program. Upon the recommendations from TIPS, the legislature passed the “Health Data Reporting Act of 2002,” creating new statute-based definitions for “unusual events” and defining a reporting program designed to create public accountability for medical facilities, while respective of confidentiality. The law was signed by the Governor in March 2002 and promulgated into amendments to existing rules and creation of new rules for all facilities licensed within the Department of Health, including Hospitals (Tennessee Rule 1200-8-1-.11).
June 2003 marked the beginning of mandatory reporting of over 30 “unusual events.” Simultaneously in 2002 with legislative deliberations, an electronic extranet report system, the Unusual Event Reporting System (UIRS ) was developed within the Department of Health and was implemented before passage of the law.
- • Features of the Reporting Program
Public release of reported “unusual event” data does not identify individual medical facilities nor any individual licensed health professionals involved in these reportable events. The reporting program is designed to provide confidentiality without compromising public accountability. Reporting of aggregate data (without identification of individual facilities) has been provided for 2002 (released May 7, 2003) [PDF] and for 2003 (released in early 2004). In addition, aggregate data is available on a quarterly and annual basis by facility type after 2003.
The initial experience reveals that the performances of facilities within the state are characterized by under-reporting of “unusual events,” inadequate compliance, and generally inadequate quality of Corrective Action Plans (CAPs) that were developed and submitted to the Department of Health as mandated by statute. While the Department of Health has seen evidence of improvement from 2002 to 2003, some non-compliance has been evident. Whereas a non-punitive posture was adopted in 2002, sanctions against facilities for non-reporting and for late reporting were issued in 2003.
Tennessee has developed an ambitious medical error reporting program with a technically-sophisticated reporting system. Collaboration between public and private contributors has developed a well-thought reporting program with an extensive number of reportable “unusual events” under the regulatory control of the Department of Health.
Extensive education and training has characterized an ambitious state-of-the-art effort for translating definitions into reportable information, and the Department of Health has provided resources to evaluate the action plans with an intent to share lessons learned with all facilities. This latter element of the program has yet to be realized due to previously mentioned probelms, incomplete reporting to the UIRS, and logistical problems in the system that remain to be worked out.
A more detailed history of Tennessee's reporting program is available.
Prior to the issuance of the Institute of Medicine's report, To Err is Human: Building a Safer Health System, in November 1999, Tennessee facilities reported unusual events, and they were reviewed, investigated when necessary, then placed in a file by the Department of Health. The Department did not tabulate any monthly or annual totals.
Following the release of the IOM report in November 1999, Tennessee perused recommendations from private organizations and national accrediting organizations such as The Joint Commission on Accreditation of Healthcare Organizations and the National Quality Forum. In an effort to improve the program and respond to the challenges of the IOM report, the DOH convened a task force of concerned individuals to define terms, identify issues, and develop guidelines. Representatives from facilities, surveyors, nurses, administrators, and attorneys served on this task force, which worked on defining ‘unusual event.’ Its work extended into 2001, coalescing with the formation of the TIPS committee in August 2001.
While Tennessee began tracking unusual events in the year 2000, the work of the task force extended overr several months of exhaustive meetings. This group laid the foundation for legislative action and provided groundwork for the realization that the state needed a better system to improve the quality of health care in Tennessee, and it led to the passage of the Health Data Reporting Act of 2002 that modified the reporting program, including the definitions of unusual events.
Statutes and Administrative Rules
- • General Information
- ◊ Tennessee Rules and Regulations (TRR)
The entire list of administrative rules and regulations for the state of Tennessee is available at the Tennessee Department of State website. The rules are maintained in Chapters, numbered from 0020-##-## through 1730-##-## with designations for each department, agency, or other state entity. The chapters in the 1200-##-## group includes 31 groups of chapters 1200-1-## through 1200-31-##, which are the combined rules for both the Department of Health and the Department of Environment & Conservation. A breakdown of chapter groupings within 1200 by department and bureau/division/entity rules is available. An individual chapter, therefore, is a concatenation of three numbers, divided by hyphens, e.g., 1200-8-1. Tennessee provides its rules only in PDF format, with a separate file for each of these individual chapters, rendering Tennessee's Rules and Regulations searchable by keywords only one chapter at a time.
Proper citation of Tenness Rules and Regulations, (where Comp. = Compilation) is a concatenation of Tenn Comp. R. & Regs. + [Chapter ##-##-##] + . + [section#]. For example, section 1 (Definitions) of Chapter 1200-8-1 (Standards for Hospitals) is cited as Tenn Comp. R. &Regs. 1200-8-1.1, which is designated on this website as TRR §1200-8-1.1.
- ◊ Tennessee Laws and Statutes
Tennessee's laws addressing patient safety and quality are provided in 2 categories of laws. Session Laws | Public Acts are general laws that are enacted by the Legislature and signed by the Governor. The legislative sessions are available on the web from 1997 through the present. Tennessee Code Annotated (TCA) is the codified compilation of all permanent laws now in force, and they are published by the West Group Publishing Company for public use.
Tenness Code is arranged in 71 Titles, each title addressing a sector of Tenness code, including:
- Title 33 – Mental Health and Developmental Disabilities
- Title 63 – Professions of the Healing Arts
- Title 68 – Health, Safety, and the Environmental Protection
- Title 71 – Welfare
On this website, Tennessee Code is cited as annotated code: TCA § [Title]-[Chapter]-[Section]. For example, law addressing ‘Health Data Reporting’ for hospitals is found in section 211 of Part 2 (Regulation) of Chapter 11 (Health Facilities and Resources) within Title 68, designated as TCA §68-11-211.
- ◊ Tennessee Rules and Regulations (TRR)
- • Laws and Regulations Governing Tennessee Programs
The public policy affecting “unusual event” reporting was created by the legislature by the passage of the “Health Data Reporting Act of 2002” (Title 68, Chapter 11, Part 2, Section 211). Many of the features of this law were developed with feedback from the Department of Health and the Tennessee Improving Patient Safety (TIPS) Committee and Coalition.
In 1998, the legislature passed the Health Care Consumer Right-to-Know Act of 1998 (T.C.A. § 63-51-101 through § 63-51-119), which requires designated licensed health professionals to furnish certain information to the Tennessee Department of Health. This legislation grew out of efforts to provide information on health providers to all Tennessee consumers, while also providing monitoring of medical malpractice claims on health professionals. In addition, Public Acts, 2004, c. 902 (HB 3252) [PDF] amended the Health Care Consumer Right-to-Know Act, mandating reporting of medical malpractice claims by Insurance carriers. The Tennessee Consumer, as a result of this law, has Internet access to this information on health professionals as part of the licensure process.
Within the Tennessee Department of Health, the Board for Licensing Health Care Facilities – Division of Health Care Facilities has created rules addressing “unusual event” [PDF] reporting requirements that reflect the statutory language of T.C.A. 68-11-211. Regulations reflecting the “Health Data Reporting Act of 2002” have been created and approved for multiple types of medical facilities, including hospitals [TRR §1200-8-1.11]
HMOs, practitioner offices (of all types – physicians, chiropracters, dentists, etc.), medical clinics, and others not included in this list of facility types are not included in the mandate for reporting of “unusual events.”
TENNESSEE LAWS / STATUTES SECTION DESCRIPTION Title 63 – Professions of the Healing Arts Chapter 6 - Medicine and Surgery, General Provisions –Legislative policy declaration - Medical review committees - Immunity of members - Confidentiality of records - Short title. Chapter 51 - Health Care Consumer Right-to-Know Act of 1998 –All Sections of Act Title 68 – Health, Safety, and Environmental Protection Chapter 11 – Health Facilities and Resources – Part2, Regulation –Health Data Reporting TENNESSEE RULES & REGULATIONS TRR §1200-8-1 – Standards for Hospitals –Records and Reports
According to the Health Data Reporting Act of 2002, an “unusual event” is the central event that is mandated for reporting. In T.C.A. §68-11-211(c)(7), an
“unusual event is an unexpected occurrence or accident resulting in death or life-threatening or serious injury to a patient that is not related to a natural course of the patient's illness or underlying condition. An unusual event also includes an incident resulting in the abuse of a patient.”
Although not included in statute, the Department of Health task force in 2002 provided further interpretive guidelines [PDF, p6] by defining “serious injury” or “life-threatening” for guidance in determining what needs to be reported:
“Serious injury” or “life-threatening” requires the patient to undergo significant additional diagnostic or treatment measures.
The Department of Health task force was the key group in providing guidelines to the legislature for what reported events should appear in the statute. Compared to other states with adverse event reporting programs, Tennessee stipulates the longest list of reportable events, i.e. “unusual events” [T.C.A. §68-11-211(d)(2)]. (New York actually reports a greater number, but they are not defined in law.)
It would appear that many of the JCAHO reviewable sentinel events” and the NQF's 27 ‘Serious Reportable Events in Health Care’ are included in the Tennessee list. However, the list extends beyond the JCAHO and NQF list of reportable events. Furthermore, there are some definition differences among Tennessee, JCAHO, and NQF defined events, as can be seen by comparing definitions across programs.
In T.C.A. §68-11-211(d)(2)(I) are listed 22 distinct events that occur following procedures, some of which may or may not be related to procedures (e.g. elopement, rape, etc.) and some of which (e.g., hemorrhage and wound infection) reflect events that are known to occur even in the context of excellent health care and outside the context of ‘adverse events.’, (according to the IOM definition – “events that occur as a result of medical management’). In this context, it is apparent that some reported “unusual events” that reflect procedure-specific performance measures, as opposed to medical errors, are also monitored in Tennessee. It is noteworthy that New York's NYPORTS also acknowledges monitoring of adverse events in the 1999, Executive Summary.
Tennessee's reporting events are very similar to those in New York. Similar to New York's NYPORTS system, Tennessee has gone to great lengths to provide definitions that are clear and concise by use of ‘Occurrence Codes’ and ‘Includes/Excludes’ lists. Tennessee extends the definitions and ties those definitions to mutually understandable expectations for the Department of Health and for all health care facilities.
As part of the implementation and validation process, Tennessee developed and provides the “Interpretive Guidelines for Reporting Unusual Events” [PDF]. This impressive reference provides interpretive guidelines based on work performed by the Department of Health task force, which was instrumental in designating ‘Occurrence Codes’ and developing the ‘Includes/Excludes’ lists (similar to those used in NYPORTS) for use by surveyors and health care facilities.
For example, codes that automatically trigger a visit from the Department of health include any unusual event associated with a complaint and all deaths of reportable unusual events. These and other codes are utilized to develop guidelines for Department of Health investigations and visitations, as provided by the Department of Health table. It is apparent that Tennessee's electronic reporting program required a lot of development time and education in order to translate statute-defined definitions into results that are readily evaluated and interpretable. The reporting system, while designed to simplify and clarify reporting by each definition, is technically-sophisticated and likely requires on-going training for new personnel and for smaller facilties that report very infrequently. It represents an ambitious state-of-the-art effort for translating definitions into reportable information.
Medical Facility Participation
According to statute, mandatory reporting is required for “any facility licensed under this part,” i.e., all facilities licensed under the Department of Health.
As described in the Division of Health Care Facilities (HCF), and as supported by 20 separate set of department regulations for licensed facilities, it is apparent that Tennesse has extended the mandate for reporting to include most facilities. Hospitals, Ambulatory Surgical Treatment Centers, and Nursing Homes are the three primary targeted facilities.
HMOs, offices of practitioners (i.e., MDs, osteopaths, chiropracters, dentists, etc.), medical clinics, and healthcare facilities that require certification only but not licensure, (Comprehensive Outpatient Rehabilitation Facilities, Intermediate Care Facilities for Mentally Retarded, Occupational Therapists in Independent Practice, Physical Therapists in Independent Practice, Portable X-ray Units, Rehabilitation Centers,* Rural Health Clinics), are not included in the mandate for reporting of “unusual events.”
* It should be noted, however, that Tennessee hospitals are defined in administrative rules to include licensed rehabilitation hospitals, which obviously are not the same as unlicensed rehabilitation centers.
Patient Safety Coalition
- • Tennessee Improving Patient Safety Coalition (TIPS)
The Tennessee Improving Patient Safety (TIPS) Coalition is a voluntary group of concerned health care stakeholders established in August 2001 that is administered within the Tennessee Department of Health. The broad-based coalition is represented by more than 30 different groups, including health care providers, professionals, industry associations, consumers, regulatory and accrediting organizations and purchasers committed to improving patient safety in Tennessee [PDF].
The coalition provides leadership and strategic planning for Tennessee's patient safety activities. Its members represent the major interests and stakeholders in health care and patient safety. As stated in the “2002 Unusual Events Summary Report” [PDF, p7]:
“This group was asked to assist the Department with the goal of improving patient safety in health care facilities in Tennessee and reducing costs, both in terms of human suffering and the economic costs associated with medical errors. This group of individuals has the potential to facilitate learning and collaboration, in addition to providing a forum for leaders to share successful patient safety strategies. The coalition promotes open dialogue about patient safety issues and advocates for an improved culture for reporting and accountability.”
The coalition has been instrumental in developing ‘Best-Practice Guidelines’, reviewing and recommending changes in reporting guidelines, providing recommendations for legislative changes to address confidentiality and civil liability, plus other contributions noted in the Annual Summary Reports and on the TIPS website.
The activity of the committee and coalition, as described on the TIPS webpages suggests that all of the activity of the coalition is directed via the Department of Health. The coalition membership [PDF] includes the Commissioner of Health and the Assistant Commissioner of Health and 11 other employees of the Department of Health, including representatives of key professional boards. It would appear that the leadership and the agenda lies entirely within the Department of Health. In this regard, the coalition is not an independent entity like coalitions that have developed in several other states.
- • Creation of Public/Private Task Force (TIPS)