2003 Legislative Compendium: Patient Safety/Quality Improvement

[ TSBME Reform | Medical Error Reporting | Office of Patient Protection ]

Early in the session, legislators addressed patient and physician concerns about patient safety and health care quality, by closely linking passage of medical error reporting and reform of the Texas State Board of Medical Examiners (TSBME) to tort reform. In fact, in January, when Gov. Rick Perry announced tort reform as emergency legislation, he included TSBME and patient safety legislation as part of his message, stating he favored legislation to improve the TSBME's "ability to police the medical profession" and additional legislation that "develops a process by which doctors and hospitals around the state can agree upon a clear set of procedures for reducing medical errors."

To demonstrate medicine's leadership and commitment to bettering patient care, TMA formed an ad hoc committee on patient safety in 2002 to develop the association's policy platform on health care quality improvement, including TSBME reform and medical error reporting. The ad hoc committee developed a multipoint plan for reshaping TSBME, including strengthening the peer review process and assuring more timely action when inferior physician care threatens patients. TMA opposed competency testing, a mechanism favored by the TSBME leadership. Competency testing was not included in the final bill. Senate Bill 104 also increases funding for the board, a top priority for the association. Monies will be used largely to enhance TSBME enforcement actions and to fund the new expert three-physician panel that will review standard of care cases.

TMA's leadership on these issues resulted in development of solid legislation that will bring about better patient care and restore credibility to the TSBME as a fair, but tough physician watchdog.

On the horizon …

TSBME will undergo sunset review beginning in August 2003. The Sunset Advisory Commission, which comprises four representatives, four senators, and two public members, will make recommendations to the 79th legislature for improving operations of the agency as well as changes to the Medical Practice Act. During the interim, TMA will actively monitor implementation of SB 104 as well as the sunset review process.

Impact of patient safety/quality legislation on physician practices: Improve public and physician confidence in the ability of TSBME to discipline bad doctors, thus improving the patient-physician relationship, and assuring a scientifically driven process for detecting and preventing medical errors within the health care delivery system.

TSBME REFORM

SB 104 by Sen. Jane Nelson (R-Flower Mound) and Rep. Ray Allen (R-Grand Prairie) strengthens TSBME to ensure that the health and safety of the public is protected from physicians who practice below the standard of care and provides appropriate due process. It provides the board these and other tools to deliver a fast, efficient, and fair ruling:

• Increased financial resources for enforcement, funded through a surcharge on physicians' license fees;
• Streamlined administrative simplification to focus on investigations;
• Expanded panel of experts to provide appropriate expertise needed for standard-of-care cases;
• New statutory authority to deny licenses or discipline physicians in certain offenses;
• New statutory authority to adopt a schedule of disciplinary sanctions commensurate with violation or conduct;
• New statutory requirement to discipline repeat offenders more harshly; and
• New statutory authority to restrict, not just suspend, a physician's license on an emergency basis without notice or hearing.

In addition, SB 104 contains these provisions:

• Provides more money for the board with a license renewal surcharge of $40 per year ($80 per two-year registration renewal). The money will go to a specific fund that the board can appropriate only for enforcement, specifically including the new "physician expert panel."
• Streamlines license renewal, which will result in administrative savings so that resources can be redirected to licensure and enforcement. License renewal will now be done on a two-year basis.
• Requires an expert physician panel to review standard-of-care cases. A panel of three physicians in the same or similar specialty as the defending physician will review the case; establish the standard of care; issue a report on how that standard was violated (if at all); and set out the clinical standards, peer-reviewed articles, and other sources they used to determine the standard. This will be shared with the physician prior to any hearing.
• Gives the board the ability to deny a physician a Texas license if the physician's license has been revoked in another state.
• Gives the board legislative direction to focus on certain types of cases, such as quality of care and repeat offenders.
• Gives the board the ability to better withstand a court challenge when temporarily suspending or restricting a physician's license.

MEDICAL ERROR REPORTING

House Bill 1614 by Rep. Vicki Truitt (R-Keller) requires hospitals, ambulatory surgical centers, and mental hospitals to report medical errors to the Texas Department of Health (TDH). TDH is required to develop a patient safety program that will serve as a clearinghouse for information about best practices and quality improvement strategies. It requires hospitals, ambulatory surgical centers, and mental hospitals, on renewing their annual license, to report the number of occurrences of certain adverse events. 

Hospitals are required to report nine events:

1. A medication error resulting in a patient's unanticipated death or major permanent loss of bodily function in circumstances unrelated to the natural course of the illness or underlying condition of the patient,
2. A perinatal death unrelated to a congenital condition in an infant with a birth weight greater than 2,500 grams,
3. The suicide of a patient in a setting in which the patient received care 24 hours a day,
4. The abduction of a newborn infant patient from the hospital or the discharge of a newborn infant patient from the hospital into the custody of an individual under circumstances in which the hospital knew, or in the exercise of ordinary care should have known, that the individual did not have legal custody of the infant,
5. The sexual assault of a patient during treatment or while the patient was on the premises of the hospital or facility,
6. A hemolytic transfusion reaction in a patient resulting from the administration of blood or blood products with major blood group incompatibilities,
7. A surgical procedure on the wrong patient or on the wrong body part of a patient,
8. A foreign object accidentally left in a patient during a procedure, and
9. A patient death or serious disability associated with the use or function of a device designed for patient care that is used for functions other than as intended.

Ambulatory surgical centers are required to report seven events:

1. A medication error resulting in a patient's unanticipated death or major permanent loss of bodily function in circumstances unrelated to the natural course of the illness or underlying condition of the patient,
2. The suicide of a patient,
3. The sexual assault of a patient during treatment or while the patient was on the premises of the center or facility,
4. A hemolytic transfusion reaction in a patient resulting from the administration of blood or blood products with major blood group incompatibilities,
5. A surgical procedure on the wrong patient or on the wrong body part of a patient,
6. A foreign object accidentally left in a patient during a procedure, and
7. A patient death or serious disability associated with the use or function of a device designed for patient care that is used or functions other than as intended.

Mental hospitals are required to report five events:

1. A medication error resulting in a patient's unanticipated death or major permanent loss of bodily function in circumstances unrelated to the natural course of the illness or underlying condition of the patient,
2. The suicide of a patient in a setting in which the patient received care 24 hours a day,
3. The sexual assault of a patient during treatment or while the patient was on the premises of the hospital or facility,
4. A hemolytic transfusion reaction in a patient resulting from the administration of blood or blood products with major blood group incompatibilities, and
5. A patient death or serious disability associated with the use or function of a device designed for patient care that is used or functions other than as intended.

In addition to reporting events, facilities are required to perform a root cause analysis and develop a corrective action plan within 45 days of the occurrence of any of the events. The root cause analysis should focus on system and process causes. The action plan should identify strategies that will reduce the risk of a similar event occurring in the future.  TDH has the authority to review, but may not take or copy, the root cause analysis or action plan during a survey, inspection, or investigation of a facility. 

Facilities have the option to report other best practices and safety measures that have been effective in improving patient safety.

Strong confidentiality and liability protections are granted for all information reported to TDH as well as analyses, plans, records and reports prepared by a facility under this chapter.

TDH has the responsibility to provide the public with access to statewide summaries of the reports. TDH is required to review the best practices reports it compiles and make public only those reports that the agency determines to be truly "best practices." The reports of aggregate errors and best practices can be grouped by these hospital size categories:

• Fewer than 50 beds,
• 50-99 beds,
• 100-199 beds,
• 200-399 beds, and
• More than 400 beds.

To protect patient confidentiality and prevent identification of a specific facility, the agency may combine two or more categories if the number of hospitals in any category is less than 40.

The commissioner of public health will evaluate the patient safety program in consultation with reporting health care facilities. TDH will report results of the evaluation and recommendations to the legislature not later than Dec. 1, 2006; unless continued in existence, this program expires Sept. 1, 2007.

TDH has until Jan. 1, 2004 to establish the patient safety program. However, because this act takes effect immediately, hospitals, ambulatory surgical centers, and mental hospitals should begin collection of data for the specified events, and within 45 days of the event, conduct a root cause analysis and action plan that identifies strategies to reduce the risk of a similar event occurring in the future.

Beginning July 1, 2004, hospitals, ambulatory surgical centers, and mental hospitals, upon renewal of their licenses, will submit annual reports to TDH listing the number of each of the specified events and description of best practices. TDH will determine the format of the reports and the process for integration of the patient safety program into current licensure operations through rulemaking.

(Summary of HB 1614 prepared by the Texas Hospital Association on behalf of the Texas Patient Safety Alliance)

OFFICE OF PATIENT PROTECTION

HB 2985 by Rep. Jaime Capelo (D-Corpus Christi) and Senator Nelson establishes the Office of Patient Protection (office) within the Health Professions Council (council). The office's mission is give the public assistance and information about the licensing agencies' health care complaint procedures and sanction processes. The office is:

• Required, in cooperation with the licensing agencies, to adopt a standard complaint form for members of the public to use when filing a complaint with a licensing agency;
• Prohibited from appealing an individual complainant's case before any agency;
• Entitled to access certain information; however, the confidentiality requirements that apply to the records of a licensing agency and the sanctions for disclosure of confidential information apply to the office and to information obtained by the office;
• Required to review and evaluate rules proposed for adoption by the licensing agencies and changes made to the statutes that govern the agencies' operation and the professions they regulate;
• Required to report to the legislature and recommend to licensing agencies changes in agency rules that, in the office's judgment, would positively affect the interests of consumers;
• Required to recommend these changes to the statutes to the Sunset Advisory Commission during the commission's review of the relevant licensing agency; and
• Funded by an initial licensing or registration fee charged by each licensing agency to increase by $5 and the renewal fee charged by each licensing agency to increase by $1 for each year for which the license or registration is renewed. 

The council is required to establish the office not later than Jan. 1, 2004.

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