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10.07.06.00.htm 10.07.06.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 07 HOSPITALS Chapter 06 Hospital Patient Safety Program Authority: Health-General Article, ยง19-308 and 19-319, Annotated Code of Maryland
10.07.06.01.htm 10.07.06.01. 01 Purpose.. The purpose of this chapter is to provide a safe environment for patients by requiring hospitals to:. A. Identify adverse events;. B. Encourage reporting of near-misses;. C. Assess and prioritize near-misses and adverse events based on level of disability or potential disability to patients;D. Determine the appropriate hospital response based on level of disability or potential disability;. E. Conduct a root cause analysis of:. 1) All level 1 events;.
10.07.06.02.htm 10.07.06.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Action plan" means a written document that includes:. a) Specific measures to correct problems or areas of concerns;. b) Specific measures to address areas of system improvement;. c) Time frames for implementation of any specific measures; and. d) Title of responsible individual to monitor implementation and effectiveness.. 2) "Adverse event" means an unexpected occurrence
10.07.06.03.htm 10.07.06.03. 03 Patient Safety Program.. A. General. On or before March 15, 2004, a hospital shall have in effect a patient safety program that meets the requirements of this chapter.B. Duties of the Hospital.. 1) The hospital shall identify an individual as patient safety coordinator who shall:. a) Coordinate patient safety activities;. b) Facilitate assessment and determination of the appropriate response to reported near-misses and adverse events related to patient care;
10.07.06.04.htm 10.07.06.04. 04 Near-Miss and Adverse Event Reporting and Determination of Appropriate Response.. A. The hospital shall develop and encourage a supportive environment that permits spontaneous identification, open discussion, and timely and accurate reporting of near-misses and adverse events.B. The hospital shall establish a clear and well-defined near-miss and adverse event identification and reporting process tha1) Encourage reporting of near-misses and require reporting of adverse events;.
10.07.06.05.htm 10.07.06.05. 05 Procedures for Level 1 and 2 Adverse Events and Certain Near-Misses.. A. When a level 1 or 2 adverse event, or a near-miss that warrants a root cause analysis occurs, the hospital shall:1) Provide immediate care to the patient;. 2) Identify any immediate corrective action to prevent reoccurrence;. 3) Identify and report the event in accordance with the hospital's reporting process;. 4) Complete a root cause analysis within 60 days of the time that the hospi
10.07.06.06.htm 10.07.06.06. 06 Root Cause Analysis.. A. The hospital shall appoint an interdisciplinary root cause analysis team that shall include:. 1) Individuals who have knowledge of the event or near-miss;. 2) Representatives of hospital leadership; and. 3) Individuals with expertise in the subject matter of the event.. B. The root cause analysis team shall interview and permit participation of individuals who were directly involved in the event or near-miss and allow the individual to partic
10.07.06.07.htm 10.07.06.07. 07 Procedures for Level 3 Adverse Events and Certain Near-Misses.. A. If the event is not a level 1 or 2 event or a near-miss that warrants a root cause analysis, the hospital shall conduct an evaluation of the event to determine any problem area and corrective action.B. All events shall be aggregated by type and level to determine any patterns or trends.. C. The hospital is encouraged to evaluate and trend all near-misses to determine any system problems.
10.07.06.08.htm 10.07.06.08. 08 Information Sharing.. The patient safety program shall require that the quality assurance and other medical review committees share information and take any appropriate action concerning near-misses and adverse events.
10.07.06.09.htm 10.07.06.09. 09 Reports to the Department.. A. A hospital shall report any level 1 adverse event to the Department within 5 days of the hospital's knowledge that the event occurred.B. A hospital shall submit the root cause analysis and action plan for the level 1 adverse event to the Department within 60 days of the hospital's knowledge of the occurrence.C. Any root cause analysis and any other medical review committee information submitted to the Department and the identity of
10.07.06.10.htm 10.07.06.10. 10 Documentation.. Actions taken by the quality assurance and medical staff credentialing and peer review committees shall be documented in committee minutes.
10.07.06.11.htm 10.07.06.11. 11 Patient Complaint Program.. A. In accordance with this regulation, the patient safety program shall include a formal written program for addressing patient complaints.B. The hospital shall provide patients with information regarding the hospital's patient complaint program including:1) The name of the hospital's representative that the patient may contact if the patient wishes to make a complaint; and2) The hospital representative's phone number or address..
10.07.06.12.htm 10.07.06.12. 12 Interhospital Notification Of Level 1 or Level 2 Adverse Events.. A. A hospital that admits a patient with a condition resulting from a level 1 or level 2 adverse event that the hospital perceives may be related to care that was provided at another Maryland hospital and that appears to be unknown to the other hospital at the time of discharge shall notify and provide any necessary information to the appropriate medical review committee at the hospital where the
10.07.06.13.htm 10.07.06.13. 13 Records.. The hospital shall maintain records that document the operation of its patient safety program..
10.07.06.14.htm 10.07.06.14. 14 Documentation.. A. On or before March 15, 2004, the hospital shall send to the Secretary a written description of its patient safety program that includes:1) The name of the patient safety coordinator;. 2) The board policy statement relevant to patient safety activities including the process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program;
10.07.06.15.htm 10.07.06.15. 15 Plan of Correction.. A. If the Department notifies a hospital that the patient safety program of the hospital does not meet the requirements of this chapter, the hospital shall submit a plan indicating the steps the hospital shall take to meet the requirements of this chapter.B. The plan shall be sent to the Secretary within 30 days after the Department notifies the hospital that the hospital does not meet the requirements of this chapter.
10.07.06.16.htm 10.07.06.16. 16 Penalties.. If a hospital fails to have in effect a patient safety program in accordance with this chapter, then the Secretary may impose on the hospital the following penalties:A. Revocation of the hospital's license; or. B. A fine of $500 for each day that the hospital is in violation of this chapter..
10.07.06.9999.htm 10.07.06.9999. Administrative History Effective date: March 15, 2004 (31:5 Md. R. 448).
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