Duty to report clinical incidents – an update for day procedure centres in Hong Kong

Patient Safety Incident Reporting and Learning System (PSI System)

The Private Healthcare Facilities Ordinance (Cap 633) (PHFO) was passed in 2018 to enhance protection of patients’ safety and rights. The Director of Health (DoH) has issued the Code of Practice for Day Procedure Centres (CoP), which sets out the regulatory standards for all day procedure centres (DPCs) licensed under PHFO.

To further enhance patient safety through identification and reduction of risks, the CoP has been revised to include details of the reporting requirements of PSI system for DPCs. With effect from 1 July 2023, all DPCs are required to report events specified in the updated version of CoP (February 2023 version).

Reportable events

Three types of reportable events are defined under the CoP (see paragraphs 1.3.8.2 and 1.3.8.3 of the CoP), which captures not only medical procedures at DPCs, but also dental procedures if dental practice is in place.

Sentinel events (SEs)

• “Surgery/interventional procedure involving a wrong patient or body part” - This includes any surgery or interventional procedure inconsistent with the patient’s informed consent. Reportable events include those detected at any time after the start of the surgery or interventional procedure. Operating on or performing interventional radiology on unintended site or extraction of wrong tooth could be captured under this type of event.
• “Retained instruments or other material after surgery/interventional procedure” - This targets unintended retention of instruments or materials, such as foreign objects inserted into a patient’s body but not removed as planned, regardless of their size or whether they are to be removed after discovery. The circumstances could include retention of a surgical item during laparoscopic surgery, intraoperative loss of a suture needle tip, a tourniquet left at surgical site or a gauze left inside a patient’s body. Swallowed dental instruments such as broken Gracey curette tip or extracted tooth could also be considered unintentionally retained foreign objects. Leaving a throat pack in a patient’s mouth after the procedure could also be considered reportable.
• “Medication error resulting in major permanent loss of function or death” - This includes prescribing, dispensing or administering medicine in a wrong manner and/or to the wrong patient. In particular, erroneous use of medication, including anaesthetic, in patients with known drug allergy history resulting in allergic reaction of patients is reportable.
• “Intravascular gas embolism resulting in death or neurological damage” - This is reportable where an intravascular air embolism has been introduced during intravascular infusion or bolus administration or through a haemodialysis circuit, resulting in death or neurological damage (causing major permanent loss of function).
• “Other adverse events resulting in permanent loss of function or death (excluding complications)” - Reportable events include those involving any injury related to medical management and resulting in permanent loss of function or death. Medical management includes all aspects of care such as diagnosis and treatment of patients, and use of systems and equipment to deliver care.

Serious untoward events (SUEs)

• “Medication error which could have led to death or permanent harm or carries a significant public health risk” - This includes unintended administration of high alert medications, such as concentrated electrolytes, chemotherapeutic agents, drug associated with known drug allergies, and other adverse events related to medications requiring intervention or extension of monitoring.
• “Patient misidentification which could have led to death or permanent harm” – Misidentification includes situations where a prescription is given to a patient not requiring medication and patients’ specimens are mixed up, resulting in possible harm to or need for intervention to one patient while delaying necessary management for the other.

Other reportable events (OEs)

• “Unplanned transfer of a patient to a hospital directly from a day procedure centre during or after a planned procedure, which emergency management was required at the hospital” - This happens where complications arise, including patients having a cardiac arrest during haemodialysis, suffering from perforation during an endoscopy procedure or developing anaphylaxis during chemotherapy procedure at DPCs, requiring transfer to a hospital for emergency management.
• “Other events of public health significance” – These events include “radiation health incidents, or serious incidents, such as cessation of water or electricity supply, resulting in harm to patients who are receiving care in the facility”. However, incidents which did not affect patient care or cause harm to a patient during the interruption are excluded.

Notification of an event

Who - Either the chief medical executive (CME), staff member(s) of DPCs or anyone as appropriate and appointed by the licensee of DPCs can report patient safety incidents. The CME is a medical practitioner, or a dentist if the facility provides dental practice only and is held accountable for the management and governance of DPCs.

When - DPCs must report SEs and SUEs to DoH within 24 hours upon identification. They are also required to report OEs upon identification.

How – A notification form (PHF 213) which includes details of the reportable event, patient’s condition and outcome, and remedial measures taken is to be submitted through email or fax to DoH. Where immediate attention of DoH is required, the notification should first be made by telephone, followed by email. A notice in the prescribed form (PHF215) will be issued to the patients concerned and/or their relatives in relation to an investigation of a medical incident conducted by the DoH.

Investigation under the PSI system

In addition to notification of reportable events, DPCs also have a duty to investigate. Within four weeks of the notification to the DoH, the designated personnel of the DPCs involved should investigate the reported event and prepare an investigation report in the prescribed form (PHF 214). The investigation report should set out all the required information, including a summary and chronology of the event and possible contributing factors and causes of the event in different aspects concerning the operation of DPCs. The latter includes management, policies and guidelines, staff, communication, work environment, equipment and the patient’s medical history and underlying condition. Submission of relevant protocols, guidelines, and training records may be required. It is recommended that the staff involved in the reported event should not participate in the investigation in order to maintain impartiality.

The DoH may direct inspection of the site for further investigation of the reported event and DPCs might be asked to submit supplementary information. Once the investigation is concluded, the DoH will require DPCs to report on the progress of implementation of the risk reduction action plan and submit documents to prove that action has been taken. Cases involving criminal issue or professional misconduct should be referred to relevant authorities as necessary.

DPCs should also communicate the investigation result to the staff, patient or patient’s relatives, public or media where appropriate. If the reported SE involves an unanticipated death or serious morbidity, DPCs should have their communication plan ready and assign designated person(s) to respond to media enquiries. The reported events will be published on the website of the Office for Regulation of Private Healthcare Facilities of the Department of Health periodically, and a public announcement will be made if there is a significant public health impact or ongoing public health risk, or if the incident is preventable by immediate action.

Legal implications

Compliance with the CoP is a condition for issuance and renewal of licences. Non-compliance, including unsatisfactory fulfilment or failure to meet the conditions of a licence or requirements under the CoP could result in regulatory actions. With the introduction of more detailed requirements, medical and dental practitioners in charge of DPCs are reminded to be familiarised with the reporting criteria in order to ensure good compliance with relevant regulatory requirements. As some events might be subject to further investigation by different authorities and/or media exposure, it is prudent for DPCs to ascertain the purpose of different enquiries and their rights and obligations before they provide information to different parties.