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Patient Safety in Pennsylvania

        Pennsylvania requires older adult living centers to establish policies and procedures for reporting unusual incidents and cases of abuse or suspected abuse.1 Employees and administrators of various residential, home, and long-term care facilities must immediately report suspected instances of abuse, neglect, sexual abuse, and serious bodily injury to, depending on the circumstances, a protective services agency, department of public welfare and/or law enforcement officials.2 Information contained in these abuse reports is confidential, but may be disclosed in limited circumstances (e.g. investigation, court order).3 This confidentiality protection extends to information maintained by certain home or nursing service providers regarding the abuse or neglect of persons over the age of 60.4 Local providers of protective services must transmit reports to the department of aging that regard occurrences of sexual abuse, serious bodily injury, and suspicious deaths in certain home and nursing care facilities.5

        Within 24 hours of a serious event or incident, health care workers submit a report in compliance with their facility’s patient safety plan. The facility must subsequently notify an affected patient within 7 days of the discovery of an event or occurrence.6 Medical facilities must report serious events and incidents to the department of health and patient safety authority.7

        Information obtained and generated by a health care facility’s patient safety committee or governing board that relates to patient safety is confidential. However, the department of health may access serious event reports for licensing and corrective action purposes.8

        Pennsylvania requires hospital pharmacies to maintain records regarding adverse drug reactions and sensitivities for a minimum or two years9 while ambulatory surgical facilities must record patients’ adverse drug reactions and sensitivities in their medical record.10 Additionally, hospitals performing open heart11 surgeries and cardiac catheterizations12 must keep, and submit to the department of health, data regarding mortality/morbidity, infections, complications, and risk factors. Health care facilities and providers must submit data regarding patient morbidity, patient severity, and unusual occurrences on a quarterly basis to the Health Care Cost Containment Council.13 The Health Care Cost Containment Council will use the information to generate provider quality reports that include comparisons on mortality rates, infection rates, and complication rates.14

 

Footnotes

  • 1. 6 Pa. Code § 11.16 (2012)
  • 2. 35 Pa. Stat. Ann. § 10210.501 (West 2012)
  • 3. 35 Pa. Stat. Ann. §10210.505 (West 2012)
  • 4. 35 Pa. Stat. Ann. §10225.306 (West 2012); 35 Pa. Stat. Ann. § 10225.705 (West 2012)
  • 5. 35 Pa. Stat. Ann. § 10225.702 (West 2012)
  • 6. 40 Pa. Stat. Ann. § 1303.308 (West 2012)
  • 7. 40 Pa. Stat. Ann. § 1303.313 (West 2012)
  • 8. 40 Pa. Stat. Ann. § 1303.311 (West 2012)
  • 9. 28 Pa. Code § 113.23 (2012)
  • 10. 28 Pa. Code § 561.22 (2012)
  • 11. 28 Pa. Code § 136.21 (2012)
  • 12. 28 Pa. Code § 138.20 (2012)
  • 13. 28 Pa. Code Chapter 912; 35 Pa. Stat. Ann. § 449.6 (West 2010)
  • 14. 35 Pa. Stat. Ann. § 449.7 (West 2008)

 

Patient Safety in Pennsylvania

Subtopic Statute/Regulation Description
Patient Safety Annual audited financial statements - 28 Pa. Code § 912.61 Hospitals and ambulatory service facilities must annually file audited and certified financial statements within 120 days after the close of the...
Confidentiality and compliance - 40 Pa. Stat. Ann. § 1303.311 Any documents, materials or information prepared by or received by the patient safety committee or governing board of a medical facility related to...
Confidentiality of and access to confidential reports - 35 Pa. Stat. Ann. § 10225.705 Reports made about abuse of an adult over age 60 who receives services in or from any of the following facilities are confidential:   ...
Confidentiality of and access to confidential reports - 35 Pa. Stat. Ann. §10210.505 Information contained in reports of abuse that are made to local protective service agencies, the department of public welfare and law enforcement...
Confidentiality of records - 35 Pa. Stat. Ann. §10225.306 Information contained in reports, records of investigation, client assessment and service plans relating to abuse or neglect of service recipients...
Data dissemination and publication - 35 Pa. Stat. Ann. § 449.7 The health care cost containment council will utilize data submitted by providers and other records and information available to it to prepare...
Data submission and collection - 35 Pa. Stat. Ann. § 449.6 The health care cost containment council is authorized to collect and providers must submit all data required under this section. The council may...
Medical facility reports and notifications - 40 Pa. Stat. Ann. § 1303.313 Medical facilities must report to the department of health and the patient safety authority an occurrence of a serious event involving the clinical...
Medicare cost reports and Medical Assistance Form 336 - 28 Pa. Code § 912.63 Hospitals and ambulatory care facilities must quarterly report summary utilization and financial reports to the council. 28 Pa. Code Chapter 912,...
Quality management and improvement - 28 Pa. Code § 136.21 Hospitals performing open heart surgery must maintain patient data on the following:         Mortality/...
Quality management and improvement - 28 Pa. Code § 138.20 Hospitals performing cardiac catheterization services must maintain patient data on the following:        ...
Records - 28 Pa. Code § 113.23 Hospital pharmacies must maintain the following:         A record of all drug transactions, correlated with...
Records - 28 Pa. Code § 561.22 Ambulatory surgical facilities must provide pharmaceutical services; drug transactions of such services must be recorded, and those records must be...
Reporting and notification - 40 Pa. Stat. Ann. § 1303.308 Any health care worker who reasonably believes that a serious event or incident has occurred must report the event according to the patient safety...
Reporting by employees - 35 Pa. Stat. Ann. § 10210.501 Employees and administrator of the following facilities are subject to reporting requirements: An assisted living residence; A domiciliary...
Reporting Incidents of Professional Misconduct - 35 Pa. Stat. Ann. § 448.806a All health care facilities and hospitals must report to the applicable state board within 60 days of the occurrence of any of the following events...
Reporting of unusual incidents - 6 Pa. Code § 11.16 Older adult daily living centers must establish written policies and procedures on the recording, reporting and management of unusual incidents which...
Reports to department and coroner - 35 Pa. Stat. Ann. § 10225.702 The local provider of protective services must transmit to the department of aging written reports involving sexual abuse, serious physical injury,...
Required data elements - 28 Pa. Code § 912.21 Health care facilities must quarterly submit the following data elements:1         Those contained in health...