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Patient safety reporting requirements

By Anna Bamonte Torrance, Esq.

The new Pennsylvania Medical Care Availability and Reduction of Error Act (MCARE Act), signed into law on March 20, 2002 by Governor Schweiker, contains, in addition to CAT Fund and tort law reforms, patient safety provisions that impose new reporting and notification requirements on medical facilities and physicians. The reporting requirements are intended to help reduce and eliminate medical errors by identifying problems and implementing solutions to improve patient safety. The MCARE Act requires health care facilities to report serious events and incidents to a newly established Patient Safety Authority. Physicians are also required to report complaints, disciplinary actions and criminal offenses to the Professional Licensure Board. The following is an outline of the patient safety provisions and specifically, the reporting and notification requirements for health facilities and physicians mandated by the MCARE Act.

In an effort to reduce medical errors and improve patient safety, the MCARE Act establishes a Patient Safety Authority, an 11 member panel appointed by the Governor and legislature and chaired by the Pennsylvania Physician General. The majority of the panel is to be composed of health care workers, including a physician, pharmacist, nurse and administrative worker. The Authority will contract with for-profit or registered non-profit entities to collect, analyze and evaluate data regarding reports of serious events and incidents, transmit to the Authority recommendations for changes in health care practices and procedures and advise reporting medical facilities of immediate changes that could be instituted to reduce serious events and incidents. The Patient Safety Authority evaluates the recommendations made by these entities and reports on those recommendations to the Department of Health and, thereafter, issues recommendations to the medical facilities regarding changes, trends and improvements in health care practices and procedures. The Authority will also report annually to the Pennsylvania General Assembly.

Medical facilities, including ambulatory surgical facilities, birth centers and hospitals, are required to develop and implement an internal patient safety plan. The plan is to be developed in consultation with the licensees providing health care services in the medical facility. The plan must designate a patient safety officer, a patient safety committee and establish a system for health care workers of the facility to report serious events and incidents. The plan shall also prohibit any retaliatory action against the health care worker for reporting and provide for written notification to patients (which is discussed below). Medical facilities will need to address the reporting and notification obligations required under the Act in personnel policies as well as medical staff by-laws.

The documents, materials and other information prepared or created pursuant to the responsibilities of the patient safety committee are confidential and will not, therefore, be discoverable or admissible as evidence in any civil or administrative action or proceeding. Likewise, those individuals who are responsible for, or who participate in, the patient safety committee meetings will not be required to testify as to any matters within the knowledge gained as a result of the person’s responsibilities or participation on the patient safety committee.

A medical facility is to submit its patient safety plan to the Department of Health for approval no later than July 18, 2002. Upon approval of the patient safety plan, the medical facility is required to notify all health care workers and medical staff of the patient safety plan.

Who Reports and What is Reported

Provisions relating to written notice of serious events, designation of a patient safety officer and establishment of a patient safety committee became effective May 9, 2002, while physician reporting requirements took effect March 20, 2002.

Health care workers who reasonably believe that a “serious event or incident” has occurred shall report the serious event or incident in accordance with the Patient Safety Plan. A “health care worker” is defined in the MCARE Act as an employee, independent contractor, licensee or other individual authorized to provide services in a medical facility. An “incident” is defined as 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 “serious event,” which is distinct from an “incident,” is defined as “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.”

A patient affected by a serious event must be notified of the event in writing by the medical facility through a designated individual at the facility. Notification to the patient, or to an adult family member, must be made within seven days of the occurrence or discovery of the occurrence of the serious event. The notification requirements are not deemed to be confidential and any documentation in the medical record is potentially discoverable or admissible in a civil or administrative action or proceeding. The Act further states that patient notification shall not constitute an acknowledgment or admission of liability. There is no requirement that patients be notified of an “incident.”

Once a report of a serious event or incident is received, a medical facility’s patient safety officer would then insure that an investigation take place. Following investigation, the patient safety officer will make a report to the medical facility’s patient safety committee. The medical facility is then required to report to the Department of Health and the Patient Safety Authority all serious event reports (within 24 hours of confirmation of the occurrence), incident reports (without patient or other identifiable individual information) and infrastructure failure reports. “Infrastructure failure” is defined as an undesirable or unintended situation involving the physical plant and service delivery systems of the medical facility or the disruption/discontinuation of a service which could seriously compromise patient safety.

Health care workers may file an anonymous report regarding a serious event with the Patient Safety Authority. The Authority will then notify the medical facility that a report was filed. The Authority can then commence its own investigation of the serious event unless the medical facility has already done so. If the Authority is dissatisfied with the medical facility’s investigation, it can perform its own review. The Authority can also notify the Department of Health of any failure by a facility or licensee to make a report.

If a medical facility fails to report a serious event or an infrastructure failure, or fails to develop and comply with a patient safety plan, it shall be in violation of the Healthcare Facilities Act and may be liable for any penalties imposed under the Healthcare Facilities Act. A medical facility can also be subject to an administrative penalty of $1,000 per day imposed by the Department of Health. If a medical facility discovers that a licensee providing health care services in a medical facility during a serious event failed to report the event, the medical facility is required to notify the licensee’s licensing board of the failure to report. The Act also allows the medical facility to take appropriate corrective action against a licensee for making false reports or failing to report a serious event.

Physicians Required to Report to State Medical Boards

Physicians are required to report either to the State Board of Medicine or State Board of Osteopathetic Medicine (Board), as appropriate, the following events:

• Medical professional liability actions filed against the physician.

• Disciplinary actions by a health care licensing authority of another state.

• Convictions for offenses above summary offenses.

• Arrests for a felony (criminal homicide, aggravated assault, sexual offenses) or an offense under the Controlled Substance, Drug, Devise and Cosmetic Act.

Reporting the filing of a medical malpractice action is a new requirement under the MCARE Act. Physicians must report the filing of an action within 60 days of receiving notice of the action and must provide the Board the docket number of the case, where the case is filed and a summary of the allegations in the complaint. Only malpractice actions initiated after March 20, 2002 must be reported. Upon notice of a medical malpractice complaint, the Board is required to commence an investigation within four years of the notice of the complaint unless an investigation has already been initiated. If, after an investigation and a hearing before the Board, the Board determines that a physician has practiced negligently, the Board may impose disciplinary sanctions or corrective measures.

Under the Act, any documents or information used by the Board exclusively for an investigation are confidential and privileged. No person who has access to the confidential information can be required to testify in any judicial or administrative proceeding without the written consent of the Board. This does not, however, limit or preclude introduction of this information or the testimony of related witnesses in a hearing before the Board. Letters from the Board informing a physician of the final outcome of the investigation, hearing or orders/sanctions issued by the Board are not privileged. The Act requires the Board to take action against a physician within four years of notice of disciplinary or criminal action. In addition to any other civil remedy or criminal penalty provided for under this Act, the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, the Board may levy a civil penalty of up to $10,000 on any licensee.

Licensure Board Reporting

Each licensure board is required to report annually to the Consumer Protection and Professional Licensure Committee of the Pennsylvania Senate and to the Professional Licensure Committee of the House of Representatives. The report will include the number of complaint files that were opened and closed and the number of disciplinary sanctions imposed in the proceeding five calendar years, as well as the number of revocations, suspensions and other licensure actions taken over the same period. This report will be posted on each licensure board’s publicly accessible website.

Anna B. Torrance, Esq., is an attorney with the Pittsburgh law firm of Houston Harbaugh, P.C. and concentrates her practice in the area of health law.

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