The Out-of-Hospital Premises Inspection Program (OHPIP) supports continuous quality improvement through developing and maintaining standards for the provision of procedures in Ontario out-of-hospital premises (OHPs) and by inspecting premises for safety and quality of care. The OHP Standards are intended to articulate the core requirements for the performance of procedures in certain settings/premises outside a hospital as defined in Ontario Regulation 114/94 under the Medicine Act, 1991 .

The OHP Standards are used for the inspection of premises and are applicable to all physicians who work in such premises. The OHP Standards include information applicable to the range of procedures performed in OHPs.

The OHPIP is overseen by CPSO’s Premises Inspection Committee. Decisions made by the Premises Inspection Committee will be based on the information within these Standards as well as any additional relevant guidelines, protocols, standards and legislation (e.g., the Canadian Anesthesiologists’ Society Guidelines to the Practice of Anesthesia, the Food and Drugs Act, etc.), including requirements set out by other regulatory bodies and provincial guidelines.

What is the purpose of the Regulation?

The Regulation creates the framework for the regulation of OHPs in Ontario and sets out which procedures are captured by the OHPIP, along with CPSO’s powers and responsibilities in relation to inspection of OHPs.

The Regulation sets out specific criteria regarding the procedures that are captured by the OHPIP. How do I determine which procedures are captured by the OHPIP, and therefore can only be performed in an OHP that meets the requirements set out in the OHP Standards?

Any procedure performed under general or regional anesthesia or parenteral sedation is captured by the program and is therefore subject to the requirements set out in the OHP Standards, including approval of and inspection by CPSO.

Some procedures that are performed using local anesthesia are also captured by the Program. This includes any procedure performed with local anesthetic that is:

• A tumescent procedure involving the administration of dilute, local anesthetic
• A nerve block for chronic pain
• A cosmetic procedure involving the surgical alteration or removal of lesions or tissue; or
• A cosmetic procedure involving the injection or insertion of any permanent filler, autologous tissue (i.e., tissue from the patient’s own body), synthetic device, materials or substances.

There are some procedures performed with local anesthetic that are not captured by the Program, including:

• A minor dermatological procedure such as the removal of skin tags, benign moles and cysts
• A procedure involving the alteration or removal of tissue where done for clinical and not cosmetic reasons
• Procedures using only an external topical anesthetic (e.g., Lasik eye surgery).

Minor cosmetic procedures that are not captured by the Program include temporary and semi-permanent fillers (e.g., hyaluronic acid fillers), botulinum toxin injections, platelet rich plasma injections, laser skin resurfacing, and sclerotherapy.

Ultimately CPSO makes the final determination over which procedures are captured by the OHP Program, and whether specific procedures can be performed in an OHP.

What are the OHP Levels and how are they determined?

The OHP level has two determinants - anesthesia and procedure - and the level is decided by the higher ranking of the two. For example, if the patient is receiving a minor nerve block (level 1) for limited invasive procedure (level 2), the OHP is considered level 2.

OHP Level	Anesthesia	Procedure
Level 1	Local anesthesia Minor nerve block e.g., occipital Tumescent anesthesia <500cc of infiltrate solution	Minimally Invasive: No surgical wound is created Procedure does not interfere with target organ function or general physiological function. e.g., permanent fillers
Level 2	IV Sedation Regional anesthesia e.g., major nerve blocks, spinal, epidural, or caudal Tumescent anesthesia >500cc of infiltrate solution	Limited Invasiveness: Surgical wound is created, but not for the purpose of penetration of a body cavity or viscus Procedure has minimal impact on target organ or general physiological response Liposuction 1 to 1000cc of aspirate A small subcutaneous implant is inserted e.g., facelift, surgical abortion, endoscopy, cataract extraction, lip or chin implant
Level 3	General anesthesia	Significantly Invasive: Surgical wound allows access to a body cavity or viscus A significant amount of liposuction aspirate is removed (1000 - 5000 cc.) A large prosthesis is inserted e.g., augmentation mammoplasty, arthroscopy

How are the different types of anesthesia defined?¹

Local Anesthesia refers to the application, either topically, intradermally or subcutaneously, of agents that directly interfere with nerve conduction at the site of the procedure.

Sedation is an altered or depressed state of awareness or perception of pain brought about by pharmacologic agents and which is accompanied by varying degrees of depression of respiration and protective reflexes.

Minimal Sedation (“Anxiolysis”) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.²

Moderate Sedation (“Conscious Sedation”) is a drug-induced depression of consciousness during which patients respond purposefully³ to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

Deep Sedation is a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. Note: Due to the potential for rapid and profound changes in sedative/anesthetic depth and the lack of antagonist medications, patients that receive potent intravenous induction agents (including, but not limited to Propofol, Ketamine, Etomidate, and Methohexital) must receive care that is consistent with deep sedation even if moderate sedation is intended. These medications must be administered by a physician qualified to provide deep sedation.

Regional anesthesia: Major nerve blocks include, but are not limited to, spinal, epidural, caudal, retrobulbar, stellate, paravertebral, brachial plexus, transcapular, intravenous regional analgesia, celiac, pudendal, hypogastric, sciatic, femoral, obturator, posterior tibial nerve and cranial nerve block.

General anesthesia is regarded as a continuum of depressed central nervous system function from pharmacologic agents resulting in loss of consciousness, recall, and suppression of somatic and autonomic reflexes.

What are CPSO’s responsibilities in relation to regulating OHPs?

CPSO’s responsibilities include but are not limited to:

1. Developing and maintaining the OHP Standards
2. Approving any new premises
3. Approving OHP Medical Directors
4. Approving new OHP procedures
5. Conducting inspection of the premises and in some cases observing procedures to ensure that services for patients are provided according to the standard of the profession
6. Determining the outcome of inspections
7. Maintaining a current public record of inspection outcomes on CPSO’s website
8. Issuing notices for payment of OHP fees.

What does the inspection process involve?

New premises or relocating premises will be inspected within 180 days of notification. All OHPs are inspected every 5 years, or more often if CPSO deems it necessary or advisable.

The inspection may involve but is not limited to:

1. completion of the on-line notification form
2. completion of a pre-visit questionnaire
3. a site visit by a nurse inspector appointed by CPSO that includes:
   • a review of records and other documentation
   • review of the OHP's compliance with accepted standards
   • review of any other material deemed relevant to the inspection
4. enquiries or observation of procedures, where relevant.

CPSO provides a copy of the inspection report to the Medical Director.

As outlined in the Regulation, the Premises Inspection Committee determines the inspection outcome and an OHP will be given either a “Pass”, “Pass with Conditions”, or “Fail” outcome.

What does a “Pass” outcome mean?

A “Pass” outcome means the OHP Standards are met for the specific procedures identified by the OHP at the time of the inspection and that no deficiencies were identified.

What does a “Pass with Conditions” outcome mean?

A “Pass with Conditions” outcome means that deficiencies have been identified in the OHP. If an OHP receives this outcome they may:

1. be restricted to specific procedures
2. be required to make submissions in writing to CPSO within 14 days of receiving the report
3. be subject to a follow-up inspection at CPSO’s discretion within 60 days of receiving the OHP’s written submission
4. receive a “Pass” outcome when deficiencies have been corrected to CPSO’s

What does a “Fail” outcome mean?

A “Fail” outcome means that significant deficiencies have been identified in the OHP. Where a “Fail” outcome is given:

1. All OHP procedures must cease in the OHP;
2. The OHP may make submissions in writing to CPSO within 14 days of receiving the report; and
3. A follow-up inspection may be conducted at CPSO’s discretion within 60 days of receiving the OHP’s written.

The Medical Director is responsible for ensuring compliance with the OHP Standards and providing any information necessary in relation to the premises. Failure to provide the information may result in an outcome of Fail by the Premises Inspection Committee, in accordance with the Co-operation with the Out-of-Hospital Premises Inspection Program Standard and may result in the removal of the Medical Director and direction to appoint a new Medical Director.

Endnotes

^1. The definitions of anesthesia have been adapted from the “Continuum of Depth of Sedation” and “Statement on Safe Use of Propofol” by the American Society of Anesthesiologists.

^2. For the purpose of the OHP Standards, sole or minimal use of oral anxiolysis for the purpose of pre-medication is not considered sedation.

^3. Reflex withdrawal from painful stimulus is NOT considered a purposeful response.