Checklist for Endoscopy in Clinical Office Practice · Checklist for Endoscopy in Clinical Office...

Checklist for Endoscopy in Clinical Office Practice | 1

Checklist for Endoscopy in Clinical Office Practice

When to use this document: This checklist was developed as a tool to assist public health units and others during

IPAC lapse investigations and can be used to conduct inspections, audits and reviews of IPAC programs.

Disclaimer: Public Health Ontario (PHO) has developed this Checklist for Endoscopy in Clinical Office Practice and its content,

based on the Provincial Infectious Disease Advisory Committee’s (PIDAC’s) Infection Prevention and Control for Clinical Office

Practice, June 2013. This document is intended to support a review or audit of public health practices and does not replace best

clinical practices or legislative requirements. PHO is not responsible for any losses or damages arising from the use of this

document or its contents, including for any purposes to inform any decision or determination, clinical or otherwise, regarding

inspections, findings, outcomes or recommendations.

Location name:

Location address:

Date of visit:

Reason for inspection:

Name of inspector:

Location contact (name, title and phone number):

Leg. Req. = Legislated

Requirement:

Must be compliant with the relevant Act or regulation (e.g. Occupational Health and Safety Act).

High Risk:

Immediate health hazard exists. Stop practice and correct immediately. The act or failure to act

immediately may lead to the transmission of infection or risk of illness or injury. Practices that

cannot be corrected immediately must be stopped until the health hazard is observed to have

been eliminated. An Order may be warranted/issued.

Medium Risk: Signifies practices that must be corrected. Timelines for compliance or agreement on alternate

process determined during inspection.

Inform and Educate (I/E): Provide information regarding best practices, mandatory legislated practice requirements etc.

This may also include just-in-time education.

NOTE: These categorizations represent the minimum risk level. Based on good judgement and circumstance, public health units may increase

the risk category.

http://www.publichealthontario.ca/en/eRepository/IPAC_Clinical_Office_Practice_2013.pdf


Legend:

NOTE: This section highlights areas to review as outlined in the PIDAC’s Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices (May 2013)

Leg Req: Legislated Requirement

C: Compliant NC: Not Compliant

N/A: Not Applicable


For the purpose of this checklist component, endoscopes will be considered to be two types:

Critical Endoscope – Endoscopes used in the examination of critical spaces, such as joints and sterile cavities. Many of

these endoscopes are rigid with no lumen. Examples of critical endoscopes are arthroscopes and laparoscopes. Critical

endoscopes shall be sterilized prior to use.

Semicritical Endoscope – Fibreoptic or video endoscopes used in the examination of the hollow viscera. These

endoscopes generally invade only semicritical spaces, although some of their components might enter tissues or other

critical spaces. Examples of semicritical endoscopes are laryngoscopes, nasopharyngeal endoscopes, transesophageal

probes, colonoscopes, gastroscopes, duodenoscopes, sigmoidoscopes and enteroscopes. Semicritical endoscopes

require a minimum of high-level disinfection prior to use.

NOTE: Opinions differ regarding the reprocessing requirements for flexible bronchoscopes and cystoscopes. Since

they are entering a sterile cavity, it is preferred that bronchoscopes and cystoscopes be sterilized; however, if the

cystoscope or bronchoscope is not compatible with sterilization, high-level disinfection is the minimum requirement.

Unless otherwise indicated, the reference used for the development of this checklist is PIDAC’s Best Practices for

Cleaning, Disinfection and Sterilization of Medical Equipment/Devices (May 2013). This document is referred to as

PIDAC CDS throughout this checklist. Specific sections are cited as to where the information may be found within the

document.

1 Policies and Procedures Leg. Req.

Risk C NC N/A Notes/Resources Inspection Notes (to be completed by individuals conducting visits/inspection)

1.1 The purchase of endoscopes that cannot be cleaned and reprocessed according to recommended standards is prohibited. There is a written policy to support this.

High Refer to: PIDAC CDS – See section on Purchasing and Assessing Medical Equipment/Devices and/or Products for Disinfection or Sterilization Processes

1.2 There are written, detailed device-specific procedures for the handling (including disassembly and reassembly), cleaning and disinfection/ sterilization of each type of endoscope and accessories that follow the manufacturer’s instructions.

Med. Refer to: PIDAC CDS – Section on Reprocessing Endoscopy Equipment/Devices

1.3 There are written procedures and manufacturer’s instructions for the use of automated endoscope reprocessors (AERs), sterilizers or other equipment used in reprocessing.

Med. CSA Group. CSA Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014.

http://www.publichealthontario.ca/en/eRepository/PIDAC_Cleaning_Disinfection_and_Sterilization_2013.pdf










Legend:




N/A: Not Applicable


2 Education and Training Leg. Req.


2.1 Staff assigned to reprocess endoscopes must receive device-specific reprocessing instructions to ensure proper cleaning and high-level disinfection or sterilization. Education should include theoretical and practical components.

High The health care setting has access to infection prevention and control expertise related to reprocessing of endoscopes.

This could be affiliated hospital, the local PHU or the local RICN.

All aspects of reprocessing shall be supervised and shall be performed by knowledgeable, trained personnel.

Refer to: PIDAC CDS – See section on Reprocessing Endoscopy Equipment/Devices;

CSA Group. CSA Z314.0-13: Medical device reprocessing – general requirements. Toronto, ON: CSA Group; 2013.

Also: CSA Group. CSA Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014.

2.2 Competency testing of personnel reprocessing endoscopes is performed at least annually and documented.

I/E Staff assigned to reprocess endoscopes receive device-specific reprocessing instructions to ensure proper cleaning and high-level disinfection or sterilization.

Staff shall not be allowed to reprocess endoscopes until competency has been established.

Refer to: PIDAC CDS – See section on Education and Training

See also: CSA Group. CSA Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014.






Legend:




N/A: Not Applicable


2 Education and Training Leg. Req.


2.3 There is additional training with documented competency when new endoscope or AER models are introduced.

High Staff should not be allowed to reprocess endoscopes until competency has been established.

Refer to: PIDAC CDS – See section on Education and Training

3 Physical Space Leg. Req.


3.1 There is a one-way work flow from dirty to clean to prevent cross-contamination.

High For items 3.1 to 3.4 – Refer to: PIDAC CDS – See Appendix C: Recommendations for Physical Space for Reprocessing

Decontamination work areas should be physically separated from clean and other work areas by walls or partitions to control traffic flow and to contain contaminants generated during the stages of decontamination.

Work surfaces shall be flat, cut-resistant, seamless and composed of a non-porous material so they can be cleaned, disinfected and dried; stainless steel surfaces are recommended.

3.2 There is adequate space for the storage and holding of soiled materials that is separate from other activities and controlled to prohibit public contact.

Med.

3.3 Processing/decontamination room(s) is/are provided with utility sink(s) appropriate to the size and type of endoscope used, the volume of work and method of decontamination used.

Med.







Legend:




N/A: Not Applicable


3 Physical Space Leg. Req.


3.4 Processing/decontamination room(s) has a dedicated hand washing sink with hands-free controls.

Med.

3.5 The reprocessing area has engineering controls to ensure good air quality, specifically:

a.) air-exchange equipment (e.g., ventilation system, exhaust hoods) is in place to minimize the exposure of all persons to potentially toxic vapours

b.) there is documented, regular maintenance of the air-exchange equipment

c.) chemical products are maintained in closed, covered, labelled containers at all times

Med. The vapour concentration of the chemical disinfectant used shall not exceed allowable limits (e.g., 0.05 ppm for glutaraldehyde). Air-exchange equipment (e.g., ventilation system, exhaust hoods) should be used to minimize the exposure of all persons to potentially toxic vapours.

Ventilation shall be such as to remove toxic vapours generated by, or emitted from, cleaning or disinfecting agents.

Refer to: PIDAC CDS – See section on Reprocessing Endoscopy Equipment/Devices – Physical Space; also,

CSA Group. CSA Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014.

CSA Group. CSA Z317.2-15. Special requirements for heating, ventilation, and air-conditioning (HVAC) systems in health care facilities. Toronto, ON: CSA Group; 2015.

4 Cleaning Procedures Leg. Req.


4.1 The endoscopy suite is cleaned at least once daily and additionally as required.

Med. Refer to: PIDAC CDS – Appendix C: Recommendations for Physical Space for Reprocessing









Legend:




N/A: Not Applicable




4.2 The treatment area is cleaned between patients.

Med. Refer to: PIDAC’s Best Practices for Environmental Cleaning for Prevention and Control of Infections (May, 2012)

See section on Principles of Cleaning and Disinfecting Environmental Surfaces in a Health Care Environment

4.3 Chemical products containing a disinfectant have a drug identification number (DIN) from Health Canada.

High Refer to: PIDAC CDS – See section on Methods of Disinfection for Semicritical Medical Equipment/ Devices

4.4 Point-of-Care: Immediately following completion of the endoscopy procedure:

For item 4.4 a) to e) – Refer to: PIDAC CDS – See section on Cleaning Procedures

a.) all endoscope channels are flushed with enzymatic detergent or water, according to manufacturer’s instructions

High

b.) the exterior is wiped with damp cloth

High

c.) the endoscope and accessories should be kept moist during transport and until manual cleaning occurs

Med. CSA Group. CSA Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014.

d.) the endoscope and accessories are placed in a covered, leak proof container and transported to the designated decontamination area

High

e.) transportation to decontamination area should be completed and full manual or automated endoscope reprocessor (AER) cleaning started within one hour of bedside pre-cleaning

High If transport is greater than one hour, automated AER cleaning is not valid as biofilm will begin to develop. If manual cleaning delayed by greater than three hours, secretions will have dried making cleaning more difficult. CSA Group. CSA Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014.

http://www.publichealthontario.ca/en/eRepository/Best_Practices_Environmental_Cleaning_2012.pdf














Legend:




N/A: Not Applicable




4.5 Decontamination Area: Following completion of the endoscopy procedure:

a.) the manufacturer’s instructions for cleaning and cleaning products are followed

High Consider irrigation adaptors or manifolds that may be recommended by the manufacturer to facilitate cleaning.

Refer to: PIDAC CDS – See section on Endoscope Disinfection And Sterilization

b.) a leak test is performed after each use, prior to cleaning, according to the manufacturer’s instructions

High Items 4.5 b) to o) Refer to: PIDAC CDS – See section on Cleaning Procedures

c.) an endoscope that fails the dry leak test does not undergo the immersion leak test and is sent for repair

High There should be a documented process in place for transporting the contaminated endoscope back to the manufacturer.

d.) all immersible endoscope components are soaked and manually cleaned with water and a recommended cleaning agent prior to automated or further manual disinfection or sterilization

High

e.) endoscope components (e.g., air/water and suction valves) are disconnected and disassembled as far as possible and completely immersed in enzymatic cleaner

High

f.) external surfaces of the endoscope and accessories are cleaned using a soft, lint-free cloth or sponge

High

g.) all channels and lumens of the endoscope are flushed and brushed (where appropriate) while submerged to remove debris and minimize aerosols

High

h.) brushes used for cleaning lumens are of an appropriate size, inspected before and after use, and discarded or cleaned and high level disinfected and dried following use

High






Legend:




N/A: Not Applicable




i.) the endoscope and all components are thoroughly rinsed with clean, fresh tap water prior to disinfection/sterilization and excess rinse water is removed from the channels by purging with forced air

High

j.) damaged endoscopes/accessories are identified and immediately removed from service

High

k.) enzymatic cleaner is discarded after each use and sink is cleaned

High

l.) non-disposable cleaning items are discarded if worn or damaged

Med

m.) disposable cleaning items are discarded

High

n.) non-disposable cleaning items are thoroughly cleaned and high-level disinfected/sterilized between uses

Med.

o.) Single-use endoscopic accessories are discarded after each use

High

p.) Reusable semicritical endoscopic accessories are cleaned (e.g., in an ultrasonic washer), then receive high-level disinfection (HLD) according to manufacturer’s instructions

High Refer to: PIDAC CDS – See section on Biopsy Forceps and Brushes



Legend:




N/A: Not Applicable




q.) Reusable critical endoscopic accessories (e.g., biopsy forceps, cytology brushes, papillatomes) are cleaned, then sterilized according to the manufacturer’s instructions

High

Because of the difficulty in cleaning biopsy forceps/brushes, it is strongly recommended that endoscopic accessories (e.g., biopsy forceps) that enter sterile tissue or the vascular system be disposable. If endoscopic accessories that break the mucosal barrier are to be reused, they must be sterilized after each use.

Refer to: PIDAC CDS – See section on Biopsy Forceps and Brushes American Society for Gastrointestinal Endoscopy. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. Gastrointest Endosc. 2003; 58(1):1-8.

r.) Fully cleaned and rinsed endoscopes should not sit longer than 30 min. prior to proceeding to the HLD process

High CSA Group. CSA Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014.

5 High-Level Disinfection Leg. Req.


5.1 Semicritical endoscopes receive, at minimum, high-level disinfection

High Refer to: PIDAC CDS: See section on Endoscope Disinfection and Sterilization

5.2 The following steps are included in the disinfection/sterilization procedure:

For item 5.2 a) to i) - Refer to: PIDAC CDS – See section on Endoscope Disinfection and Sterilization

a.) the disinfectant/chemical sterilant is compatible with the endoscope

High









Legend:




N/A: Not Applicable




b.) if a high-level disinfectant is used, the minimum effective concentration of the disinfectant is monitored before each use with test strips available from the disinfectant product manufacturer

High

c.) high-level disinfectant test strip bottles are dated when opened and discarded as per the manufacturer’s instructions

High

d.) a written log of high-level disinfectant concentration monitoring is maintained

High

e.) when high-level disinfectants are opened, the container is dated and the disinfectant is not used past the expiry date or date indicated by the manufacturer

High

f.) the manufacturer’s directions are followed regarding the disinfectant’s ambient temperature and duration of contact

High

g.) the endoscope/endoscope components are completely immersed in the disinfectant/chemical sterilant and all channels are perfused

High During manual disinfection, the endoscope is completely submerged and lumens are flushed with disinfectant for the appropriate time, according to the manufacturer’s instructions.

h.) Following high level disinfection:

rinse the endoscope and flush the channels (filtered or sterile water preferred)

Depending on the intended use of the device, tap water followed by a 70-90% alcohol rinse may be acceptable

High High-level disinfection of cystoscopes should be followed by a sterile water rinse.

Rinse water must be discarded after each use/cycle.

Legend:




N/A: Not Applicable




i.) Steps in the final drying of semicritical endoscopes include:

initial flushing of all channels with medical or filtered air

flushing all channels with 70% isopropyl alcohol to aid in the drying process

second flushing of the channels with medical or filtered air or drying in a HEPA-filtered drying cabinet

High The alcohol and final air purging steps may not be necessary if storing in a channel purge storage cabinet.

5.3 The water bottle and its connecting tube, used for cleaning the endoscope lens and irrigation during the procedure, is sterilized at least daily.

High Items 5.3 and 5.4 – Refer to: PIDAC CDS – See section on Equipment Used For Cleaning

5.4 The water bottle is filled with sterile water.

High

5.5 If manual disinfection is performed, the disinfectant container is kept covered during use and washed, rinsed and dried when the solution is changed.

High

6 Automated Endoscope Reprocessors (AER)

Leg. Req.


6.1 The sterilizer/AER is licensed in Canada.

High This is a CPSO requirement

6.2 The AER is compatible with all endoscopes to be reprocessed in the AER.

High Items 6.2 to 6.7 – Refer to: PIDAC CDS – See section on Automated Endoscope Reprocessor (AER)

6.3 There is a process to routinely review alerts, and advisories for reports of AER deficiencies.

Med.





Legend:




N/A: Not Applicable


6 Automated Endoscope Reprocessors (AER)

Leg. Req.


6.4 AER process indicators are monitored for each run and results are recorded in a logbook that includes identification of endoscopic equipment processed (see Record-Keeping below).

High Biological indicators are only used in Steris System 1 (Steris claims to sterilize at point of use and therefore require biological monitoring) and not required in other AER's.

6.5 Once started the AER is not opened or stopped for any reason; if a cycle is stopped, the entire process is repeated.

High If an AER cycle is interrupted, high-level disinfection cannot be assured.

6.6 There is a documented preventive maintenance program(s) for the AER(s).

Med.

6.7 If an AER with a drying cycle is used, consult the AER manufacturer to determine whether the rinse with 70% isopropyl alcohol and forced air drying is required.

High

7 Storage of Endoscope Leg. Req.


7.1 All endoscopes are dried before being placed in storage.

High Refer to: PIDAC CDS – See section on Drying and Storage of Endoscopes

7.2 Storage procedures include the following:

For all items in 7.2

Refer to: PIDAC CDS – Section on Drying and Storage of Endoscopes

a.) reprocessing date identified for each endoscope

High

b.) caps, valves, and other detachable components are removed during storage and reassembled just before use

High

c.) detachable components are stored close to the endoscope in a manner that minimizes contamination

High

Legend:




N/A: Not Applicable


7 Storage of Endoscope Leg. Req.


d.) after HLD, endoscopes are stored by hanging vertically in a well-ventilated area in a manner that minimizes contamination or damage

High Semicritical endoscopes are stored hanging vertically in a dedicated, closed, ventilated cabinet outside of the decontamination area and procedure room. Endoscopes are not coiled, allowed to touch the floor or bottom of the cabinet while hanging, or stored in their cases.

e.) endoscopes are prevented from coiling or touching the floor or bottom of the cabinet while hanging

High

f.) endoscope storage cabinets are constructed of non-porous, cleanable material

High

g.) endoscope storage cabinets are cleaned at least weekly

High

h.) colonoscopes are reprocessed if not used within seven days

High Over time, bacteria and fungi might reproduce inside the endoscope channel especially if moisture is present in any lumens or channels.

8 Endoscope Transport Leg. Req.


8.1 Endoscopes are transported in a lidded, leak proof container that protects the endoscope from damage.

Med. Refer to: PIDAC Infection Prevention and Control for Clinical Office Practice – See Appendix L: Reprocessing Endoscopy Equipment

8.2 Transport containers used to carry contaminated endoscopes are cleaned and disinfected after each use.

Med.

8.3 There is a system in place to differentiate transport containers used for clean and contaminated endoscopes (e.g., colour-coding).

Med.




Legend:




N/A: Not Applicable


9 Record Keeping Leg. Req.


9.1 For each procedure, the following are documented:

For item 9.1 – Refer to: PIDAC CDS – See section on Record Keeping

a.) patient’s name and record number

High

b.) date and time of the procedure

High

c.) type of procedure High

d.) name of endoscopist High

e.) serial number or other identifier of both the endoscope and the AER

High

9.2 A record is kept of each sterilization/HLD cycle, including:

For item 9.2 – Refer to: CSA Group. Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014.

a.) the load control label which includes the sterilizer/AER number, load number and date of HLD

High

b.) recording chart or printout of the physical parameters of the sterilization/HLD cycle

High

c.) load contents High

d.) person responsible for the sterilization/HLD cycle

High

9.3 A log is kept of chemical indicator monitoring results.

High

9.4 A log is kept of all maintenance and interventions associated with a positive chemical indicator.

High

9.5 The endoscope serial number is recorded in the client/patient record.

High

9.6 Records are retained according to the policy of the health care facility.

High

Legend:




N/A: Not Applicable


10 Occupational Health and Safety

Leg. Req.


10.1 Setting reviews all protocols for reprocessing medical equipment/devices to verify that worker safety measures and procedures to eliminate or minimize the risk of exposure are followed and are in compliance with the Occupational Health and Safety Act, R.S.O. 1990, c.O.1 and its Regulation including the Health Care and Residential Facilities.

Leg. High

Refer to: PIDAC CDS – See section on Occupational Health and Safety for Reprocessing Also see: CSA Group. CSA Z314.8-14: Decontamination of reusable medical devices. Toronto, ON: CSA Group; 2014; and Health Care and Residential Facilities, O. Reg. 67/93, as am by O. Reg. 631/05. Available from: https://www.ontario.ca/laws/regulation/930067

10.2 All staff working in reprocessing are offered Hepatitis B immunization unless they have documented immunity to Hepatitis B.

Med. Staff have received education in the prevention of transmission of blood-borne pathogens (e.g., hepatitis B) and the management of body fluid exposures.

Refer to: PIDAC CDS – See section on Occupational Health and Safety for Reprocessing

CSA Group. CSA-Z314.0-13: Medical device reprocessing - general requirements. Toronto, ON: CSA Group; 2013.

10.3 Appropriate personal protective equipment (PPE) is worn for all reprocessing activities.

High CSA Group. CSA-Z314.0-13: Medical device reprocessing - general requirements. Toronto, ON: CSA Group; 2013.

Refer to: PIDAC CDS – See section on Personal Protective Equipment (PPE)

10.4 There is a policy that prohibits eating/drinking, storage of food, smoking, application of cosmetics or lip balm and handling contact lenses in the reprocessing area.

Leg. High Health Care and Residential Facilities, O. Reg. 67/93, s. 32. Available from: https://www.ontario.ca/laws/regulation/930067



https://www.ontario.ca/laws/regulation/930067









Legend:




N/A: Not Applicable


Please print and sign.

Owner/Operator (Print name):

Signature:

Date:

Person conducting visit (print name):

Signature:

Date:

Public Health Ontario acknowledges the financial support of the Ontario Government.

Checklist for Endoscopy in Clinical Office Practice · Checklist for Endoscopy in Clinical Office...

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