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Regulation of Private Healthcare Facilities

Regulation of Private Healthcare Facilities

Regulatory Actions Against Non-Compliances

Under Cap. 633, the Director of Health is empowered to issue a code of practice (“CoP”) and the licensee of a private healthcare facility (“PHF”) shall ensure the PHF comply with the licence conditions and the CoP.

Regulatory actions are considered when there is a breach of conditions of licence or CoPs. “Non-compliance” refers to unsatisfactory fulfilment or failure to meet the conditions of licence or requirements under the CoPs.

A risk-based approach to regulatory actions is adopted. The risk level of non-compliance is assessed by how likely it would impact on patient safety (Table 1) and the seriousness of consequence in terms of patient harm that the non-compliance could cause (Table 2). The likelihood of impact on patient safety and consequence level are cross-matched against the risk matrix (Table 3) to guide the decision-making process on the regulatory actions to be undertaken.

Depending on the risk level involved, regulatory actions against non-compliances may include (a) advice, (b) requirement notice, (c) warning notice, (d) enforcement order, (e) amendment of condition of licence, (f) suspension of facility service or licence, and (g) cancellation of licence. Records on regulatory actions may be published on the website of the Office for Regulation of Private Healthcare Facilities for public reference. Details of the regulatory actions according to the risk level of contravention are set out in Figure 1 & Figure 2.

PHFs are expected to take immediate actions to rectify non-compliances to mitigate risks to patient safety. If a PHF does not rectify the non-compliance within the timeframe imposed or the rectification is unsatisfactory, regulatory actions may be escalated in accordance with the risk level.

On the other hand, stronger regulatory actions could also be imposed in accordance with the level of risk which the PHF had involved, without going through a staged approach as mentioned above. For instance, if it is considered that continual operation of a PHF would pose immediate and high risk to patient safety, the PHF concerned would be requested to suspend the facility service with no prior warning required.

Table 1: Likelihood of Impact on Patient Safety
Likelihood of impact on patient safety Description
Possible Consequence for patient safety may arise, if no appropriate actions were taken by the PHF
Likely Consequence for patient safety will probably happen, if no appropriate actions were taken by the PHF
Very likely Consequence for patient safety is expected to arise, if no appropriate actions were taken by the PHF
Table 2: Consequence Level of Non-compliance
Level Patient harm
Low Negligible or minor patient harm
Moderate There was patient harm as defined by the following conditions:
  • Readmission (for the same condition or a complication from the original episode of care)
  • Unplanned return to operating room
  • Unplanned patient transfer (e.g. from general ward to high dependency unit or ICU, from ambulatory setting to hospital setting)
An event which impacts on more than one but less than five patients
High There was patient harm as defined by the following conditions:
  • Incident leading to death
  • Permanent loss of function1
An event which impacts on five or more patients
1 Defined as sensory, motor, physiologic, or intellectual impairment not present on admission requiring continues treatment or lifestyle change. When “permanent loss of function” cannot be immediately determined, applicability of the policy is not established until either the patient is discharged from the hospital with continued major loss of function, or two weeks have elapsed with persistent major loss of function, whichever occurs first. (Reference: The Joint Commission. Comprehensive Accreditation Manual Hospital (CAMH). United States; 2013 January.)
Table 3: Risk Matrix and Regulatory Actions
Consequence level of non-compliance
Likelihood of impact on patient safety Low Moderate High
Possible Advice Requirement Notice Enforcement Order
±Amend / Suspend*
Likely Requirement Notice Warning Notice Enforcement Order
±Amend / Suspend*
Very likely Enforcement Order
±Amend / Suspend*
Enforcement Order
±Amend / Suspend*
Enforcement Order
±Amend / Suspend*
* Refers to amendment of conditions of licence, or suspension of facility services.
Figure 1: Type of Regulatory Actions
Figure 2: Regulatory Actions according to Risk Levels
* Pursuant to section 37(1), 29 and 28(b) of the Private Healthcare Facilities Ordinance, the Director of Health may amend the condition of a licence for, suspend a facility service in, or by order suspend or cancel a licence a private healthcare facility on a ground specified in section 38.

  • Directions by Notice may be given when immediate direction is required on remedial action(s) to be taken by PHF.

Escalation of regulatory action take place when:

  • Non-compliance not rectified within the time frame imposed or rectification is unsatisfactory; OR
  • No satisfactory remedial action after two pieces of Advice or Requirement Notices issued within the past 12 months (related or unrelated non-compliances)