Assessment Protocol for Premises Standards€¦ · e) Benzodiazepine IV (at least one of:...

Assessment Protocol for Premises Standards

OHPIP STANDARD 2.2 MEDICAL DIRECTOR RESPONSIBILITIES Indicator Meets Meets with

Recommendations Does not Meet Not Applicable (please provide comments)

a) The Medical Director is responsible for all dutiesoutlined in the OHP Standards.

b) In situations where a Medical Director is not present,an “Acting Medical Director” must be appointed.

OHPIP STANDARD 2.2.6 OHP POLICIES AND PROCEDURES The Medical Director/Acting Medical Director is responsible for ensuring all CPSO policies and procedures, as well as applicable laws including Ontario Regulations enacted pursuant to Statute, are adhered to in the operation of the premises. Policies and Procedures Common to all OHPs Indicator Meets Meets with


a) The premises’ policy and procedure manual iscurrent, complete and available for personnel signedby Medical Director/Acting Medical Director:• Administrative• General Response to Emergencies• Urgent Transfer of Patients• Job Descriptions• Procedures• Forms Used• Inventories/Lists of equipment to be maintained• External (non-OHP) policies

b) The Medical Director /Acting Medical Director shallensure that all staff:• Read P&P manual upon being hired and confirm

action with signature and date• Review P&P manual annually, and confirm action

with signature and date• Read their individual job descriptions of duties

and responsibilities, and sign and date, indicatingthey have been read and understood

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OHPIP STANDARD 4.1 GENERAL PHYSICAL STANDARDS

Indicator Meets Meets with Recommendations

Does not Meet Not Applicable (please provide comments)

a) The premises is neat, comfortable and clean andfacilitates patient care and safety

b) The site complies with all applicable building codes,including fire safety requirements

c) Access for disabled persons complies with provinciallegislation (Ontarians with Disabilities Act) and/ormunicipal by-law

d) The following areas are functionally separate, whereappropriate, allowing adequate space to ensurepatient safety, privacy, confidentiality, emergencyprotocols and infection control standards:• administration and patient-waiting area• procedure room and/or operating room• recovery area• clean utility area• dirty-utility room• reprocessing room• endoscope cabinet• staff change room and staff room

e) The size of the OHP is adequate for all procedures tobe performed safely

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OHPIP STANDARDS 4.1.2 Electrical



a) All electrical devices are certified by CSA or licensedfor use in Canada.

b) Emergency power supply can provide for safelycompleting the procedure and recovering thepatient.

OHPIP STANDARDS 4.1.6 Physical Emergency Measures



a) Hallways, stairways and elevators are sufficientlywide to allow emergency evacuation of a patient byemergency personnel and their equipment.

b) Provisions are in place to ensure the safe evacuationof patients and staff in case of an emergency, i.e.,stretchers, wheelchairs, or other adequate methodsof transport are available.

c) Provisions are in place to ensure there is appropriateaccess to the patient for an ambulance to transferthe patient to a hospital.

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OHP PHYSICAL STANDARDS Physical Standards for Procedure Rooms – Physical requirements*

OHPIP STANDARDS 4.2.1 Physical Requirements



****All levels a) All OHPs provide the following physical

requirements: • adequate lighting for the procedures performed • floors and walls can be cleaned to meet infection

control requirements (e.g. surfaces are smooth and washable)

• immediate access to hand-washing facilities and proper towel disposal

OHPIP STANDARDS 4.2.2 Ventilation



****All levels a) Ventilation must ensure patient and staff comfort;

and fulfill occupational health and safety requirements.

b) Where applicable, ventilation and air circulation should be augmented to meet manufacturer’s standards and address procedure-related air-quality issues; e.g., cautery smoke, endoscopy, disinfecting agents (e.g., Glutacide venting is separate from the other internal ventilation).

c) Where gas sterilization is used, a positive pressure outbound system is used, vented directly to the outside.

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Physical Standards for Procedure Rooms – Physical requirements*

OHPIP STANDARDS 4.2.3 Equipment

**** All levels Indicator Meets Meets with


a) The following documentation for equipment isavailable:• equipment operating manuals• equipment maintenance contracts• log for maintenance of all medical devices (e.g.

suction machines)

b) A biomedical technician annually inspects allequipment and reports in writing that the equipmentis safe and operating according to themanufacturer’s specifications

c) The following equipment is provided in all OHPs:• cleaning equipment as required for the specific

procedures• accessible anesthetic material and equipment• blood pressure and oxygen saturation

monitoring equipment****Levels 2&3

d) Levels’ 2&3 meet the above requirements and mustcomply with the following:

• sterile supplies and instruments• table/chair that permits patient restraints and

Trendelenberg positioning• table/chair/stretcher that accommodates

procedures performed and provides for adequaterange of movement for anesthetic procedures

• Equipment necessary for emergency situations (i.e.Defibrillators, oxygen supply, suction) should beinspected on a weekly basis and documented.

• suction equipment and backup suction, foranesthesia provider's exclusive use.

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4.2.4 Anesthetic and Ancillary Equipment Indicator Meets Meets with


**** Level 1- N/A **** Level 2 Both a) anesthetic and ancillary equipment (selection, installation, maintenance) and b) medical compressed gases and pipelines must comply with:

• Canadian Standards Association (CSA) or licensed for use in Canada, and

• Specific applicable recommendations arising from provincial legislation or as identified in other CPSO requirements

c) A second supply of (full cylinder) oxygen capable of delivering a regulated flow must be present.

**** Level 3 Level 3 OHP provides: a) anesthetic machine b) anesthetic equipment/drug cart.

OHP PHYSICAL STANDARDS 4.3 Physical Standards for Recovery-Area Indicator Meets Meets with


****All Levels OHPIP STANDARDS 4.3.1 Physical Requirements

a) A sink for hand washing is accessible ****Levels 2&3 only OHPIP STANDARDS 4.3.2 Size and Layout

a) The size of the recovery area depends on planned use: it must accommodate the volume of patients expected for a minimum of two hours operating room time, i.e.,

• 1 hour procedure = 2 patients • 0.5 hour procedure = 4 patients.

b) The recovery area allows for transfer of patients to/from a stretcher and performance of emergency procedures

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4.3 Physical Standards for Recovery-Area OHPIP STANDARDS 4.3.3 Equipment Indicator Meets Meets with


a) Monitoring, suction, oxygen, and bag-valve maskdevices, intravenous and other medical supplies areimmediately available.

MEDICATION STANDARDS



OHPIP STANDARDS 4.4 General Medication Standards

a) A general medication inventory recordb) periodically inspect all medications for viability• drug name• drug dosage• expiration date• D.I.N.c) Medications are labeled in accordance with the Food

and Drug Act (FDA) and the Controlled Drugs andSubstances Act (CDSA) and its regulations

d) Medications are stored according to themanufacturer’s recommendations (e.g., refrigerationif required, fridge is at correct temperature andchecked daily, refrigerator is not used for foodstorage)

e) Medications are stored in a manner suitable forsecurity and restocking:

f) organized for easy access in appropriately labeledbins/cupboards

g) Medications administered are documented in thepatient record

h) Appropriate verbal and written post-dischargeinstructions are given to the patient and/or theaccompanying adult.

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MEDICATION STANDARDS

OHPIP STANDARDS 4.5 Controlled Substances Standards



a) Controlled substances are handled and administered in accordance with Food and Drug Act (FDA) and the Controlled Drugs and Substances Act (CDSA) and its regulations

b) There is one qualified designated staff (e.g. RN, RPN with medication skills, physician) assigned to managing controlled substances

c) Controlled substances are stored in a designated fixed locked cabinet.

d) Controlled substances are accounted for in a “Log of Controlled Substances”

e) For each controlled substance, the following information is specified: • name • quantity • date received • expiry date • loss (damaged, expired, spilled) date and • quantity and stock balance

****All levels f) For patient administration, the following information

is collected: • patient name • drug name • amount removed from inventory date and time • quantity used and waste • name of staff administering the medication

g) An end-of-day balance of the inventory of controlled substances is calculated by physical count and verified by the signatures of qualified (regulated) staff

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The following drugs for resuscitation are required to be available on the premises:

OHPIP STANDARD 4.6 Drugs for Resuscitation Yes No N/A ****All levels

a) Diphenhydramine b) Epinephrine for injection c) Oxygen d) Salbutomol e) Intralipid if Bupivicaine/Ropivicaine is used

****Levels 2 and 3 only a) Amiodarone IV b) Antihypertensive IV (at least one of Labetalol, Hydralazine) c) ASA 81mg po d) Atropine IV e) Benzodiazepine IV (at least one of: Midazolam, Diazepam, Lorazepam) f) BETA Blocker IV (at least one of Metoprolol, Propranolol, Esmolol) g) Calcium IV (chloride or gluconate) h) Dextrose 50% IV i) Diphenhydramine IV j) Flumazenil IV k) Hydrocortisone IV 100mg or 500mg l) IV agent for SVT (at least one of Adenosine, Esmolol, Verapamil) m) MHAUS treatments if triggering agents present, following MHAUS guidelines n) Naloxone IV (if narcotics are stocked) o) Neuromuscular blocking agents, if qualified staff available p) Nitroglycerine spray q) Pressor IV (at least two of: Epinephrine, Ephedrine, Vasopressin, Phenylephrine) r) Sodium bicarbonate IV

****Level 3 only a) Antihypertensive IV (at least two of Labetalol, Hydralazine or Nitroglycerine) b) IV agent for SVT (at least three of Adenosine, Esmolol, Verapamil, Metoprolol c) Lasix IV d) Lidocaine 2% (pre-filled syringe) e) Magnesium Sulfate IV

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OHPIP STANDARD 4.7 Monitoring and Resuscitation Requirements Yes No N/A ****Level 1 only

a) AED ****All levels

b) IV setup c) Adequate equipment to manage local anesthetic toxicity d) Appropriately sized equipment for infants and children, if required.

****Levels 2 and 3 only e) Assortment of disposable syringes, needles, and alcohol wipes f) Cardiopulmonary resuscitation equipment with current ACLS/PALS-compatible defibrillator g) ECG monitor h) Intubation tray with a variety of appropriately sized blades, endotracheal tubes, and oral airways i) Laryngeal mask airways j) Means of giving manual positive pressure ventilation (e.g., manual self-inflating resuscitation device) k) Means to verify end-tidal CO2 l) Oxygen source m) Pulse oximeter n) Suction with rigid suction catheter o) Torso backboard

QUALITY ASSURANCE STANDARDS



****All levels OHPIP STANDARD 8 Quality Assurance

a) Quality Assurance meetings must be comprised with representation of all staff providing patient care for every type of anesthetic and surgical procedure

b) The Medical Director must attend and chair, at a minimum, two QA Committee meetings at each OHP site, per year

c) Quality Assurance Meetings must address the following topics:

• Reports on Quality of Care for each service • Infection Control • Adverse Events • Staffing Credentials

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QUALITY ASSURANCE STANDARDS



****All levels OHPIP STANDARD 8.1 Monitoring Quality of Care

a) The OHP has a documented process in place to regularly monitor the quality of care provided to patients. These activities include, but are not limited to a review of: 1) Non-medical staff performance

2) Review of individual physician care to assess: • patient and procedure selection are

appropriate • patient outcomes are appropriate • adverse events (see 8.2)

3) Review a selection of individual patient records to assess completeness and accuracy of entries by all staff

4) Review of activity related to cleaning, sterilization, maintenance, and storage of equipment

5) Documentation of the numbers of procedures performed: any significant increase/decrease (>50% of the last reported assessment).

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QUALITY ASSURANCE STANDARDS Indicator Meets Meets with


OHPIP STANDARDS 8.2 Monitoring and Reporting Adverse Events a) All OHP staff must monitor adverse events.

Indicators of adverse events generally includecomplications related to the use ofsedation/anesthesia or to the procedure.

b) Every member who performs a procedure in an OHPshall report the following events to the Collegewithin 24 hours of learning of the event. Theseevents are termed ‘Tier 1 Events’ to denote thepotential serious nature of the event and the need toprevent a recurrence.

Tier 1 events are: • Death within the premises;• Death within ten (10) days of a procedure

performed at the premises;• Any procedure performed on the wrong patient,

site or side; or,Transfer of a patient from the premises directly to a

hospital for care. c) Members performing procedures in an OHP are

required to document other quality assuranceincidents (Tier 2) which are deemed less critical forimmediate action. The premises’ QA Committee andthe Medical Director/Acting Medical Director willsubmit Tier 2 events to the College after review (onan annual basis).

Tier 2 events include, but are not limited to: • Unscheduled treatment of a patient in a hospital

within ten(10) days of a procedure performed at apremises

• Complications such as infection, bleeding or injuryto other body structures

• Cardiac or respiratory problems during thepatient’s stay at the OHP

• Allergic reactionsMedication-related adverse events

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OHPIP STANDARDS 8.2 Monitoring and Reporting Adverse Events d) All OHP staff should report adverse events as

follows: • The member must report Tier 1 adverse events

(see above) to the Medical Director/Acting Medical Director and to the College in writing within 24 hours of learning of the event using the form provided on the College website

• Death occurring within the OHP should also be reported to the coroner.

• The member should report in writing any Tier 2 adverse event (see above) to the Medical Director/Acting Medical Director within 24 hours of the event.

The written report should include the following: • name, age, and sex of the person(s) involved in

the incident; includes staff and patients • name of witness(es) to the event (if applicable) • time, date, and location of event • description of the incident and treatment

rendered • date and type of procedure (if applicable) • analysis of reasons for the incident

outcome.



OHPIP STANDARD 8.3 Review of Adverse Events and other QA Monitoring Activities a) The Medical Director/Acting Medical Director

should: 1. Review all adverse events reports and QA

monitoring findings occurring over a 12-month period

2. Document the review and any relevant corrective actions and quality improvement initiatives taken

3. Provide feedback to all staff regarding identified adverse events.

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ADDITIONAL QUALITY STANDARDS – ENDOSCOPY/COLONOSCOPY OHPs/IHFs



Equipment a) All equipment used for a colonoscopy and/or GI

endoscopy procedure (e.g. cleaners andreprocessors) must be:I. Tracked and maintained with a log to ensure full

equipment functionality and safety.

II. Subject to compliance testing and certificationwhere required by the Canadian StandardsAssociation (CSA) or licensed for use in Canada.

III. Subject to a regular quality control program thatis documented and the equipment required forthe performance of a particular procedure isreadily accessible in the form of a log book.

IV. Replaced where necessary to maintain an up-to- date and high standard of service.

b) All Clinics must:I. Have standard equipment to remove polyps

and manage complications; including but notlimited to: thermal devices, vasoconstrictingagents, clipping devices and tattooingequipment.

II. Use automatic endoscopic reprocessors (AERs)for all procedures.

III. Have enough AER capacity to ensure that allscopes are cleaned and ready for use beforethe next scheduled appointment.

IV. Have an automatic irrigator available for everyappointment.

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V. Demonstrate that they have technology to capture, store and review clinically relevant landmarks or pathology during endoscopy procedures.

c) All colonoscopy procedures must be performed using a video colonoscope that must be maintained within manufacturer specifications.



Policies and Procedures 1. Clinics must have a documented process for the storage

and retrieval of endoscopic images that identifies how each image is linked with a patient.

2. Clinics must have a policy for: • Following up on pathology as outlined in the CPSO

test results policy: http://www.cpso.on.ca/policies- publications/policy/test-results-management.

• Documented identification of a care path to follow

up on findings where subsequent therapy or surgery is required.

http://www.cpso.on.ca/policies-

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3. Clinics must manage the continuum of care for theirpatients and have processes or procedures in place topromote quality patient care, including:

• Referral criteria that are readily available to referringphysicians and the public to ensure that theappropriate patients have their procedures in theappropriate setting.

• An internal process to review referrals to ensure theappropriateness of the:

a. Indication/reason for the endoscopy.b. Timing of the endoscopy.c. Procedure to be completed in an out-of-

hospital facility.

• A policy that guides the criteria and conditions‘direct to procedure' (i.e. open access) referrals tothe clinic, as opposed to consultation prior to theprocedure. A policy in place to ensure that postendoscopy, any findings and recommendations arecommunicated to the referring and other physicians.

• Recommendations regarding the timing for the nextcolonoscopy.



Quality Improvement 1. Clinics must prescribe and document individual quality

improvement processes to address any identified qualityissues (i.e. from quality assurance and other).

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Observational Assessment Protocol

This observational component is comprised of observations/ review of policies and procedures/documentation within the patient record.

Observational Component

PROCEDURAL STANDARDS Observational Component Indicator Meets Meets with

Recommendations Does not Meet

Not Applicable (please provide comments)

****All levels Patient Admission requirements

a) The patient is admitted by an appropriatelyqualified provider

b) The following information is obtained anddocumented by a health care provider under thesupervision of a physician:

• Pulse oximetry• Vital signs• Allergies• NPO status• Height, weight• Medication taken on morning of surgeryc) An appropriately qualified provider assisting in

the procedure room/OR:• Completes an operative record with appropriate

and accurate documentation regarding theprocedure (e.g. pre-procedure assessment,consent form)

d) A preoperative checklist is utilized

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Observational Component Indicator Meets Meets with



OHPIP STANDARD 6.5 First Verification

a) The first verification takes place in the pre- procedure area.

b) The patient is awake and aware c) The nurse preparing the patient for the

procedure • Confirms the patient identity, procedure, site

and/or side with the patient/substitute decision- maker/legal guardian

• Documents the first verification on the “Surgical Safety Checklist”

OHPIP STANDARD 6.6 Second Verification

a) The second verification must be conducted during the time-out in the location where the procedure takes place, immediately before starting the procedure

b) The entire procedure team confirms the patient identity, procedure, site and/or side and acknowledges their agreement: nurse(s), attending physician, attending anesthesiologist [if applicable], and physician-assistant [if applicable]

OHPIP STANDARD 6.7 Site Marking

a) The marks are made by the physician performing the procedure and must be:

• Placed using a permanent marker at or near the incision/insertion site

• Visible at time of patient preparation and visible at time of incision

• Explicit (e.g. initials) to indicate the intended site of incision or insertion

b) If site marking meets exemption criteria as outlined in 6.7.5 of the OHP standards, this is documented in the patient’s record

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OHPIP STANDARD 6.8 Intra-operative Patient Care

a) If the physician administering the sedation orregional anesthesia is also performing theprocedure, the patient must be attended by asecond individual (physician, RT, RN or AA) 1)who is NOT assisting in the procedure and 2) whois trained to monitor patients undergoingsedation or regional anesthesia.

b) If assistance is required during the procedure, athird HCP must be available. The personmonitoring the anesthetic shall remain with thepatient at all times throughout the duration ofanesthetic care until the patient is transferred tothe care of a recovery-area staff in the recoveryarea.

c) Patients shall be attended for the duration of theanesthetic care as follows:• O2 saturation must be continuously

monitored and documented at frequentintervals. In addition, if the trachea isintubated or an LMA is used, end-tidal carbondioxide concentration must be continuouslymonitored and documented at frequentintervals. Capnography must be available atthe premises for use, where appropriate, onpatients receiving deep sedation.

• Patient monitoring e.g., pulse, blood pressureand electrocardiography must be incontinuous use during the duration ofanesthetic care.

• Audible and visual alarms are activated

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OHPIP STANDARD 6.9 Post-Procedure Patient Care

***** OHP levels 2 and 3: a) Staffing requirements for the recovery area meet

the premises standardsb) If written orders are not provided, there is a

verbal report provided to appropriate recovery- area staff

c) Registered nurse trained in recovery roomprocedures remain in continuous attendance tothe patient




OHPIP STANDARD 6.10 Patient Discharge

***** OHP levels 2 and 3: a) An anesthesiologist or physician is responsible for

writing the discharge order. However, the actualdecision for discharge from the recovery areamust be based on discharge criteria using anobjective scoring system; the decision can bedelegated to recovery-area staff.

b) All patients should be accompanied by an adultwhen leaving the OHP. Patients having receivedsedation or general anesthesia must beaccompanied by a responsible adult.

c) Appropriate verbal and written post-dischargeinstructions are given to the patient and theaccompanying adult.

d) The patient and accompanying adult areinstructed to notify the OHP of any unexpectedadmission to a hospital within 10 days of theprocedure.

Assessment Protocol for Premises Standards€¦ · e) Benzodiazepine IV (at least one of:...

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