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Skip Navigation LinksPennsylvania Department of Health > Healthcare Facilities > Laws and Regulations > Outpatient Facilities > Department of Health Status of Fulfillment of Duties Under Act 13

Department of Health Status of Fulfillment of Duties 
Under Act 13

Duty:

The Department is required to review and approve patient safety plans submitted by medical facilities (hospitals, ASFs and birth centers).  The patient safety plans must:

designate a patient safety officer, establish a patient safety committee, establish a system for the health care workers of a medical facility to report serious events and incidents which shall be accessible 24/7, prohibit any retaliatory action against a health care worker for reporting a serious event or incident, provide for written notification to patients.

Fulfillment:

All medical facilities were required to submit patient safety plans to the Department on or before May 19, 2002.  The Department reviewed all plans to ensure they contained the elements required in the Act. The Department provided feedback to the facilities on deficiencies in their plans and assisted them in filing acceptable plans.  As new facilities are licensed, the Department reviews their patient safety plans for compliance with the Act.  As part of the regular licensure survey process, the Department reviews patient safety plans and ensures they have been updated to reflect any changes in the facility and that the plans are being implemented appropriately.

Duty:

The Department is to receive reports of serious events and infrastructure failures within 24 hours of the occurrence or discovery of a serious event or infrastructure failure.  The Department is also required to investigate serious events and infrastructure failures.

Fulfillment:

In conjunction with the Patient Safety Authority, the Department has worked with EDS to create a one-stop electronic reporting system through which medical facilities can provide the required information.  The result is PA-PSRS ( Pennsylvania Patient Safety Reporting System) which consists of a password protected Internet reporting system. The appropriate personnel at each medical facility complete a questionnaire which assists in categorizing the matters reported as: serious events, incidents or infrastructure failures.  When the questionnaire is transmitted electronically to EDS the following occurs: serious events are sent to both the Patient Safety Authority and the Department, incidents are sent to the Patient Safety Authority only and infrastructure failures are sent to the Department only.

Every surveyor in the Division of Acute and Ambulatory Care (DAAC) has access to the PA-PSRS system to check the reports filed by the facilities which they survey.  The surveyors review these reports daily and take appropriate action depending on the substance of the report and the steps the facility has taken to correct any problems.  This can range from contacting the facility by phone or an onsite visit.  The chief focus is to ensure that patients are in a safe environment and that the facility has policies and procedures in place to respond to the event and prevent its reoccurrence.

Mandated reporting through PA-PSRS was phased in across the Commonwealth in June 2004 with all facilities required to report by July 1, 2004.  Prior to the commencement of mandatory reporting, the Department and the Patient Safety Authority conducted 19 sessions in various locations in the Commonwealth to train the medical facilities in the PA-PSRS system.

Duty:

The Department is required to meet with the Patient Safety Authority to implement the patient safety requirements of Act 13.

Fulfillment:

The Department has been meeting on a regular basis with the chairperson, executive director and support staff of the Patient Safety Authority to discuss implementation of PA-PSRS and to ensure that the Department will receive the information it needs to carry out its responsibilities.  These meetings continue as further refinements are discussed. 

Duty:

Medical facilities are required to provide patients or their designees who have been affected by a serious event with written notification within seven days of the occurrence or discovery of a serious event.

Fulfillment:

During the survey process, the Department is checking patient records to ensure that appropriate notification has occurred within the seven day time frame.  This requirement went into effect in May 2002—the Department has been enforcing this provision since that time and has issued deficiencies to several facilities for failure to provide patient notification.

Duty:

Starting July 1, 2002, the Department is to assess an annual surcharge to each medical facility.  The total assessment shall not exceed $5 million in the first year, and $5 million plus Consumer Price Index increase in every year thereafter.   If a facility does not pay the surcharge within 30 days of receiving notice, the Department may assess an administrative penalty of $1,000 per day.   All funds are to be deposited in the Patient Safety Trust Fund to be administered by the Patient Safety Authority.

Fulfillment:

The Department is basing the assessment on the total number of beds (hospitals) or procedure rooms (ASFs and birthing centers) operated by all medical facilities.  This total was divided into $5 million for the first year’s assessment.  The Department published notice in the Pennsylvania Bulletin, sent out individual notices to all medical facilities and transmitted all payments to the Patient Safety Trust Fund.  The Department pursued collection of payment from facilities that did not respond to the assessment.  After direction by the Patient Safety Authority, the Department assessed a surcharge of $2.5 million in the second year.  Similar processes were followed regarding notice and collection.  The Patient Safety Authority has directed that the Department assess a surcharge of $2.5 million in the current year.  Those notices will be mailed shortly.