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Medical Errors and Patient Safety


The Commonwealth of Pennsylvania has mandated reporting of three types of events, as defined in 40 PA CS §1303.302.

  • Serious event” – An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident.
  • Incident” – An event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The term does not include a serious event.
  • Infrastructure Failure” – An undesirable or unintended event, occurrence or situation involving the infrastructure of a medical facility or the discontinuation or significant disruption of a service which could seriously compromise patient safety.

Pennsylvania's “Incident” is synonymous with a ‘near-miss’. The Patient Safety Authority is instructed to “Collect, analyze and evaluate data regarding reports of serious events and incidents, including the identification of PERFORMANCE INDICATORS AND PATTERNS in frequency or severity at certain medical facilities or in certain regions of this Commonwealth.” [40 PA CS §1303.304(a)(5)]. This mandate for ‘near-miss’ events is distinctly different from other states that usually mandate reporting of only serious events.

Infrastructure Failure” events are reported only to the Department of Health.

Editorial Note: Maryland began voluntary reporting of near-miss events to the Maryland Patient Safety Center (MPSC) in late 2005, and Washington begins mandatory reporting of near-misses in 2007, once the Internet reporting system is functional.

Pennsylvania Health and Safety regulations provide instructions for interpretation of that statute. [28 PA Code §51.3(g)]. The code states that facilities must report "events which seriously compromise quality assurance or patient safety include, but are not limited to, the following:"

(1)Deaths due to injuries, suicide or unusual circumstances.
(2)Deaths due to malnutrition, dehydration or sepsis.
(3)Deaths or serious injuries due to a medication error.
(5)Transfers to a hospital as a result of injuries or accidents.
(6)Complaints of patient abuse, whether or not confirmed by the facility.
(8)Surgery performed on the wrong patient or on the wrong body part.
(9)Hemolytic transfusion reaction.
(10)Infant abduction or infant discharged to the wrong family.
(11)Significant disruption of services due to disaster such as fire, storm, flood or other occurrence.
(12)Notification of termination of any services vital to the continued safe operation of the facility or the health and safety of its patients and personnel, including, but not limited to, the anticipated or actual termination of electric, gas, steam heat, water, sewer and local exchange telephone service.
(13)Unlicensed practice of a regulated profession.
(14)Receipt of a strike notice.

(15)* Transfers to hospitals as a result of injuries or accidents.
(16)* Admissions to hospitals as a result of injuries or accidents.

* "In addition to the notification requirements in § 51.3, long-term care nursing facilities shall report these two requirements in writing to the appropriate division of nursing care facilities field office . ." [28 PA Code §201.14(d)]

Editorial Note: It will be noted that that the 16 listed criteria above translate to 21 discrete adverse events. These events incompletely map to 7 of the 27 'Never-events' defined by the [NQF]. There is also incomplete mapping of Pennsylvania criteria to JCAHO definitions of seven (7) 'Reviewable sentinel events.'

Furthermore, nursing homes are NOT mandatory reporting participants facilities in the PSA program in 2006, so that these latter two reporting requirements are not included in the annual PSA reports.

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