Cancer Care Ontario Colonoscopy Standards: Standards and evidentiary base

*See Appendix A Correspondence: Dr Linda Rabeneck (Chair), Odette Cancer Centre, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5. Telephone 416-480-4825, fax 416-480-5804, e-mail linda.rabeneck@sunnybrook.ca L Rabeneck, RB Rumble, J Axler, et al; for Cancer Care Ontario’s Colonoscopy Standards Expert Panel. Cancer Care Ontario Colonoscopy Standards: Standards and evidentiary base. Can J Gastroenterol 2007;21(Suppl D):5D-24D.


Les normes de coloscopie d'Action cancer Ontario : Fondées sur les normes et les preuves
Le cancer colorectal (CCR) est la principale cause de décès par cancer non relié au tabac chez les hommes et les femmes du Canada.En effet, il représente 10 % de tous les décès par cancer.On estime que 7 800 hommes et femmes recevront un diagnostic de CCR et que 3 250 en mourront en Ontario en 2007.Puisque l'incidence et le taux de mortalité du CCR en Ontario font partie des plus élevés dans le monde, le dépistage représenterait le meilleur moyen de réduire le fardeau de cette maladie.Le présent rapport décrit les observations et les recommandations du comité d'experts des normes de coloscopie d'Action cancer Ontario, convoqué en mars 2006 par le programme de soins fondé sur des preuves.Les recommandations formeront la base du programme d'assurance de la qualité des coloscopies effectuées en appui au programme ontarien de dépistage du CCR.
In June 2003, a one-year pilot study to evaluate implementation models for FOBT was funded by the Ministry of Health and Long-Term Care (MOHLTC) (9).In June 2005, CCO submitted a proposal for an FOBT-based CRC screening program to the MOHLTC.Funding for the program was announced by the MOHLTC in January 2007.In this program, colonoscopy will be used to investigate the 2% to 3% of screenees who have a positive FOBT.To support the program across the province, CCO will be responsible for quality assurance in the delivery of colonoscopies.
The present report describes the findings and recommendations of CCO's Colonoscopy Standards Expert Panel (Appendix A), which was convened in March 2006 by the Program in Evidence-Based Care.The recommendations will form the basis of the quality assurance program for colonoscopy delivered in support of Ontario's CRC screening program.

BACKGROUND
CRC is the third most commonly diagnosed cancer in men, following prostate and lung cancer, and in women, following breast and lung cancer (1).CRC is the second leading cause of cancer mortality in men, following lung cancer, and the third in women, following lung and breast cancer (1).
The primary treatment for CRC is surgery, which offers the best hope for long-term survival.However, offering surgery with curative intent depends on the cancer being detected at a resectable stage (10).For that reason, there is great interest in the early detection of CRC through screening.
Individuals with a positive FOBT or FS are advised to undergo colonoscopy, an examination of the rectum and entire colon using a colonoscope, a flexible fibre optic instrument.The tip of the colonoscope is equipped with a miniature video camera and a light that provide the endoscopist with a highresolution image of the bowel wall.The endoscopist can insufflate the colon with air and irrigate or suction the colon, perform biopsies, and snare and remove polyps.Colonoscopy requires complete bowel preparation to empty the colon of its contents.Although most patients are sedated for the procedure, colonoscopy can be performed as either an inpatient or an outpatient procedure.Colonoscopy is associated with a risk of complications such as bowel perforation and bleeding.FS is an examination of the rectum and lower colon using a flexible fibre optic instrument.
The purpose of the present report is to evaluate the existing evidence concerning the following three key aspects of colonoscopy: physician endoscopist standards, institutional standards and performance standards for the procedure.

Physician endoscopist standards
• What is the training required for physicians performing colonoscopy?

Institutional standards
What is needed for: • Patient assessment before the procedure?
• Monitoring during and after the administration of conscious sedation?

Performance standards
What is/are acceptable: • Colonoscopy-related perforation and bleeding rates?
• Use of sedation?
To address these questions related to colonoscopy practice, a systematic literature review and a comprehensive Internet search were undertaken.

Literature search strategy
The MEDLINE and EMBASE databases, the Cochrane Library database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects were systematically searched in March and June/July 2006 for evidence.Relevant papers were also solicited from the Expert Panel members.The searches were done in the following two stages; first, the initial MEDLINE and EMBASE searches in March 2006, and then, five additional searches in June/July 2006 to gather additional information.The literature searches were completed as follows: Inclusion criteria Eligible sources of information included: 1. Published full reports and abstract reports where any of the items of interest were reported for patients who underwent colonoscopy; 2. Randomized controlled trials (RCTs), retrospective study designs, prospective case series, educational interventions, mixed designs and other relevant designs; 3. Reports including physician endoscopists; and 4. Reports published in English.

Exclusion criteria
Ineligible sources of information included reports in which the results for colonoscopy could not be separated from the results for FS.

Internet search strategy
An Internet search was conducted to capture the relevant unindexed literature that would not be found in the formal literature review.The intent was to obtain both governmental and nongovernmental publications, policy statements, bulletins, health technology assessments and similar documents.
In addition, members of the Expert Panel were polled regarding unindexed publications about which they might be aware.The Internet search strategy was to review the first 50 hits, and if no compelling sources were flagged in the 10 hits before 50, the search would be considered complete.If relevant sources continued to be found, the search would continue until a series of 10 nonuseful hits had been reviewed.
In summary, a total of 1168 articles were found in the literature search, and the 157 considered possibly relevant were ordered for full publication review.Of these 157 articles, 49 met the full inclusion criteria and were retained .Additionally, two of the coauthors forwarded six articles (Regula et al [60], Levin et al [1], Rex et al [62,63], Bressler et al [64] and Barkun et al [65]), that were not found in the literature review.No relevant articles were found in the Cochrane Library Database of Systematic Reviews search.However, a protocol of an ongoing review that might be relevant was listed and, when made publicly available, will be included in a future update of this standards document (66).

Internet search results
An Internet search, using the Google search engine (www.google.ca), was performed on March 20 and 21, 2006, using the terms "colonoscopy guideline".A title review of the first 50 results yielded 10 sources that were deemed relevant; these were obtained for full review.Eight of these met the inclusion criteria and were retained (67)(68)(69)(70)(71)(72)(73)(74).
These eight sources (detailed below) informed such topics as what training is required to perform the procedure (67-70); institutional standards (69,70); monitoring during the use of conscious and deep sedation, as well as monitoring during resuscitation and recovery (71,72); perforation rates (73,74); cecal intubation rates (69,70,73,74); average colonoscopy withdrawal times (73,74); and adenoma detection rates (74).The report by the College of Physicians and Surgeons of Ontario (CPSO) (70) included standards that covered all endoscopy facilities, not just colonoscopy facilities.

67
Statement on colonoscopy privileging: American Academy of Family Physicians.

PHYSICIAN ENDOSCOPIST STANDARDS
Training required to perform colonoscopy -Literature search results A total of five papers were obtained that included data on the type of training involved in developing skill in colonoscopy (11)(12)(13)(14)(15). Three of the reports were retrospective chart reviews (11,12,14), and two were prospective case series (13,15).A summary of the findings appears in Table 1.
The findings were that intensive, supervised training programs are integral to acquiring colonoscopy skills.There is evidence that physician endoscopists who do not receive this type of training take much longer to acquire skills and raise them to an accepted level of competence (14).However, the evidence shows that, after proper training, family physicians and surgeons perform at the same level of skill as gastroenterologists (11)(12)(13).One study suggested that, in clinicians competent in FS, 50 supervised colonoscopies is the minimum number needed to ensure safety (11), while another concluded that there is no detectable threshold where competence can be assured (13).

Training required to perform colonoscopy -Internet search results
Four sources were obtained that provided data on the training required (67-70) (details provided below).Two sources stated that hospital governing boards should determine who can perform colonoscopies at their institutions (67,68).The American Society for Gastrointestinal Endoscopy (ASGE) guidelines (United States [US]) (68) recommend that adequate clinician training may consist of training and experience outside formal residency programs, following completion of an accredited program in general surgery, pediatric surgery, colorectal surgery or gastroenterology.The Joint Advisory Group (JAG) in the United Kingdom (UK) (69) recommends that trainees have received prior training in basic endoscopy skills, eg, upper gastrointestinal endoscopy or FS.The CPSO (70) recommends that physicians performing colonoscopy with polypectomy either be certified with the Royal College of Physicians and Surgeons of Canada or be family physicians with acceptable certification (or equivalent certification from a country other than Canada [CAN]).They should also have completed a residency program providing structured experience, with competency determined either by an instructor or the training program, or have equivalent postgraduate training and also have privileges at an accredited Ontario hospital to perform this procedure.

American Academy of Family Physicians (US) (67)
• Hospital governing boards must determine who should be granted colonoscopy privileges at their institutions with input from the medical staff.• Proctoring of applicants for privileges in gastrointestinal endoscopy by a qualified, unbiased staff endoscopist may be desirable when competency for a given procedure cannot be adequately verified by any submitted materials.
• Hospitals should have monitoring procedures in place for the ongoing renewal of privileges.
• Participation in continuing medical education related to endoscopy should be required as part of the renewal of endoscopic privileges.• For trainees in coloproctology, attendance at a UK-JAGcompliant basic skills or FS course to learn the basics of safe endoscopy would be an acceptable starting point.
• Trainees need to understand the techniques of patient preparation, the mechanics of the procedure and its indications, limitations and complications.
• Trainees should be able to perform 100 procedures within the course of a year, and will be considered to have achieved an acceptable level of expertise when the cecum is reached when possible.

Therapeutic
• Trainees should be competent in the techniques of hot biopsy, polypectomy and treatment of colonic bleeding.
• Trainees should be familiar with balloon dilation of strictures and techniques to stop bleeding and treat angiodysplastic lesions.
• Some trainees may wish to gain a higher degree of training in more advanced techniques, including dye spraying, tattooing, endoscopic mucosal resection, tumour debulking and stenting.

Training
• To facilitate the above standards, courses should be offered to trainees for basic skills in colonoscopy (JAG-compliant) and a more advanced course (also JAG-compliant).
The CPSO recommendations for independent health facilities (CAN) (70) Physicians • Physicians performing endoscopic procedures:  • To perform colonoscopy with polypectomy, credentials and qualifications specific to this procedure must be met and are defined as the following: • • Currently held privileges to perform the procedure in an accredited hospital in Ontario.
For physicians using conscious sedation • Physicians using conscious sedation should have an appropriate level of training in this field, acquired either during the training period, or separately in a structured experience, with the level of competency assessed by the instructor or preceptor.

Nurses using conscious sedation
• These nurses must have training in the pharmacology of agents commonly used during sedation/analgesia including: knowledge of opioids and benzodiazepines, dosages, titration, possible side effects, use of reversal agents, potentiation of sedative-induced respiratory depression by concomitantly administered opioids, knowledge of time intervals between doses of sedatives or analgesics resulting in cumulative overdose, familiarity of pharmacological antagonists for sedatives or analgesics, knowledge of complications associated with opioids and benzodiazepines, and the ability to recognize associated complications and be trained to perform basic life support skills (cardiopulmonary resuscitation, bag-valve-mask, ventilation); and • All nurses administering sedation and analgesia must be trained in the following: basic cardiopulmonary resuscitation, airway management and intravenous (IV) fluid administration.

Literature search results
No articles were obtained that provided any data on institutional standards.

Internet search results
Three papers obtained in the Internet search (70-72) provided information on institutional standards (see details below).The CPSO document (70) did not recommend a minimum number of procedures but did provide extensive information covering the use of conscious and unconscious sedation, the role of nurses, and the monitoring and resuscitation capability that must be present by facility type (either a Type I, II or III), as well as information on infection control.The Canadian Society of Gastroenterology Nurses and Associates document (71) provided information on monitoring during conscious sedation, as well as on resuscitation.The ASGE document (72) provided information on monitoring during conscious and deep sedation, as well as monitoring and procedures during resuscitation.

ASGE (US) (72)
When conscious or deep sedation is used • Patients undergoing procedures with conscious or deep sedation must have continuous monitoring before, during and after sedative administration.
• Standard monitoring includes recording heart rate, blood pressure, respiratory rate and oxygen saturation.
• Modern electronic monitoring equipment may facilitate assessment but cannot replace well-trained assistants.
• Continuous electrocardiogram monitoring is reasonable in high-risk patients.This subgroup of high-risk patients would include those who have a history of cardiac or pulmonary disease, the elderly, and those patients for whom a prolonged procedure is expected.

Monitoring during resuscitation
• Following the procedure, patients are to be monitored for adverse events from either the procedure or the sedation.
• The duration of monitoring depends on the perceived risk to the patient.
• Patients may be discharged from the endoscopy unit once vital signs are stable and an appropriate level of consciousness has been achieved.
• A competent companion must accompany the patient from the recovery area.
• Because the amnesia period that follows the administration of sedation is variable, written instructions should be given to the patient to take with him or her, including the procedures to follow if an emergency arises.
The CPSO (CAN) (70) • Along with the endoscopist, several other disciplines may be required (as needed), including anesthesiologists, registered nurses and endoscope reprocessing technicians.Adequately trained nurses may perform the tasks generally assumed by the endoscope reprocessing technician.
When conscious sedation is used • At least one physician certified and current in Advanced Cardiac Life Support or trained in general anesthesia should be on-site and available within 5 min.
• At least one Independent Health Facility person currently certified in Basic Cardiac Life Support must be present on-site during the procedure.
When deep sedation is used • A physician qualified to administer general anesthesia should be present.
• Assistance with the procedure is recommended for the following situations: • • If there is an increased risk of complications due to severe medical comorbidity; • • If there is an anticipated intolerance to standard sedatives, particularly if propofol is considered; or • • If there is an increased risk for airway obstruction due to variant anatomy.Note: If the physician performing the procedure does not have hospital admitting privileges, emergency transfer agreements with a nearby hospital must be prearranged.

Nurses assisting with endoscopy procedures
• Nurses assisting with endoscopy procedures must have current registration with the College of Nurses of Ontario.
• In addition to this, nurses should also have completed an electrocardiogram interpretation course and a health assessment course, and have training in electrocautery application and x-ray safety (as given by the Healing Arts Radiation Protection Act).For the institutional standards, the CPSO has delineated Type I, II and III facilities.Only the main points are listed below; for more complete listings, please refer to the original document.
Type I endoscopy facility: Topical/local anesthesia only • Proper environment for endoscopic procedures.
• Defibrillator and emergency resuscitation equipment.
Type II endoscopy facility: Topical anesthesia with sedation • Proper environment for endoscopic procedures.
• Patient monitoring equipment, including blood pressure apparatus, electrocardiogram and oximeter.This equipment must be tested on the day of and before endoscopy.
• Resuscitation equipment present, including defibrillator, endotracheal tubes, airways, laryngoscope, oxygen sources with positive pressure capabilities, emergency drugs and oxygen tanks.
• Access to a hospital for the transfer of emergency cases.
• An emergency power source.
Type III endoscopy facility: General or regional anesthesia • All of the above plus a Fellow of the Royal College of Physicians of Canada anesthesiologist present for all general and spinal anesthesia.

Infection control
• Gastrointestinal endoscopes come into contact with mucous membranes and are considered semicritical items.The minimum standard of practice for reprocessing is highlevel disinfection.
• Accessories (eg, reusable biopsy forceps) that penetrate mucosal barriers are classified as critical items and must be sterilized between each patient use.Accessories labelled as either single-use or disposable should not be reprocessed.
• Endoscopes have been implicated in the transmission of disease when appropriate cleaning, disinfection or sterilization procedures were not employed.Of particular significance is the need to thoroughly manually clean equipment before any manual or automatic disinfection or sterilization process.

Safety of personnel
Consistent practice must be maintained to prevent the spread of disease and to protect staff from the dangers of chemicals used in the cleaning and high-level disinfection of endoscopes.Practices that should be followed include: • All personnel performing or assisting with endoscopic procedures must follow universal precautions and wear appropriate equipment to protect themselves from fluid and body substances including but not limited to gowns, gloves, goggles and masks.
• Irritation can be minimized with covered containers and by using disinfectants in a well-ventilated area.
• Eye protection and moisture-resistant masks or face shields should be worn to prevent contact with splashes during the cleaning procedure and disinfection/sterilization process.
• Moisture-resistant gowns should be worn to prevent contamination of personnel due to splashes of blood or other body fluids or injury due to chemical disinfectant/sterilant contact.Gowns should be changed between patient procedures or when visibly soiled.
• Protective apparel should not be worn outside the procedure room and cleaning room.
• Nonsterile gloves must be worn for handling and cleaning dirty equipment, as well as for any potential contact with blood or body fluids.Gloves are recommended when handling disinfectant solutions to prevent caustic effects.
• All needles and sharps are to be appropriately disposed of in puncture-resistant containers at their point of use.Do not recap needles.
• Fingernails should be kept short to prevent puncturing of gloves.Jewellery should not be worn on the hands because it harbours micro-organisms, hinders hand washing and may puncture gloves.
• Meticulous hand washing with an appropriate antimicrobial solution must be done between patient contact, after glove removal, and when entering or leaving the endoscopy area.If hands or other skin surfaces are contaminated with blood or body fluids, wash immediately.
• All personnel performing or assisting with endoscopic procedures and personnel responsible for reprocessing the equipment must be knowledgeable about the infectious and chemical hazards associated with these procedures and equipment, including the relevant Workplace Hazardous Material Information System Guidelines.

Universal precautions
• According to the concept of 'universal precautions', all human blood and certain human body fluids are treated as if known to be infectious for HIV, hepatitis B virus and other bloodborne pathogens.
• Universal precautions must be observed in each facility to prevent contact with blood or other potentially infectious materials.All blood or other potentially infectious material will be considered infectious, regardless of the perceived status of the source individual.

Canadian Society of Gastroenterology Nurses and Associates (CAN) (71)
When conscious sedation is used • Minimal monitoring of all patients, including blood pressure, pulse, respiration, level of consciousness, temperature and dryness of skin, and pain tolerance at the initiation, during and at the completion of the procedure, is recommended.
• Depending on patient response, assessment may need to be more frequent.

Monitoring during resuscitation
• Minimal monitoring during resuscitation should include the following: • • Monitor oxygen saturation level and heart rate as determined by continuous pulse oximetry.• • Assess and document unexpected events and postprocedure complications as related to sedation and take interventions as required.
• • Assist and accompany patient to the bathroom, assessing the presence of orthostatic hypotension.
• • Remove IV access before discharge, assess site and document.
• Reinforce preprocedure teaching regarding driving, equipment operation, and making decisions requiring judgment.The teaching provided should be in written form and a copy given to the patient before discharge.

PERFORMANCE STANDARDS
Perforation rates -Literature search results Eight reports (12,(17)(18)(19)(20)(21)60,61) that provided data on perforation rates encompassed screening, diagnostic and therapeutic procedures in different patient populations.Four of the studies were retrospective designs (12,19,21,61) and four were prospective designs (17,18,20,60).The reported perforation rates ranged from a low of 0% (18) to a high of 0.33% (17).The highest rate (0.33%) was obtained in a series of patients undergoing therapeutic procedures (Table 2).An additional study by Garbay et al ( 16) not included in Table 2 was a retrospective survey covering the years 1981 to 1993 that reported on the complications associated with colonoscopy requiring surgery.The investigators found that perforations represented up to 93% of all complications that resulted in surgical interventions.In this study, which included 183 perforations, the diagnosis of perforation was immediate in 75 patients (42%) and delayed in 100 (58%), and delays ranged from 1 h to 42 days postprocedure.In the group of patients with delayed presentation of perforations, the observed mortality rate  was 12%.In 77 patients where perforation was detected 12 h postprocedure or sooner, the observed mortality rate was 0%.Two of the eight studies in Table 2 provided data on the risk factors associated with perforations (19,21).Gatto et al (19) detected associations between perforations and the following risk factors: age 75 years or greater (in this study, those 75 years of age or older had four times the risk of perforation compared with patients aged 65 to 69 years), increasing comorbidity, the presence of diverticulosis and the presence of colonic obstruction.Misra et al (21) reported associations between perforation and diverticulosis, previous abdominal surgery and poor bowel preparation.

Perforation rates -Internet search results
Two articles were obtained (73,74) that provided data on perforation rates (see details below).

ASGE (US) (73)
Perforation rates less than or equal to one in 500 (0.2%) overall or less than one in 1000 (0.1%) in screening patients are acceptable.
The US Multi-Society Task Force on Colorectal Cancer (US) (74) Incidence rates for perforation overall should be less than one per 1000 (less than 0.1%), and for screening examinations, less than one per 2000 (less than 0.05%).

Bleeding rates -Internet search results
No articles were obtained through the Internet search that provided data on bleeding rates.

Cecal intubation rates -Internet search results
Four articles (69,70,73,74) obtained in the Internet search provided data on cecal intubation rates (see details below).Three of the articles recommended that cecal intubation rates should exceed 90% for all cases (69,73,74), two articles recommended cecal intubation rates exceed 95% of all screening cases (73,74), and one article recommended cecal intubation rates exceed 95% in asymptomatic cases, both screening and surveillance (70).

JAG on gastrointestinal endoscopy (UK) (69)
Cecal intubation rates should exceed 90% in patients without stricturing or marked fecal contamination.
The CPSO recommendations for independent health facilities (CAN) (70) For colon cancer screening and surveillance, cecal intubation rates should approach 95% of otherwise asymptomatic patients.

ASGE (US) (73)
The cecum should be intubated in 90% or greater of all cases and in 95% or greater of all screening cases.
The US Multi-Society Task Force on Colorectal Cancer (US) (74) Cecal intubation rates in all cases (90% or greater) and in screening cases (95% or greater), with cecal intubation verified with photographic evidence that a visual landmark has been reached.

Average colonoscope withdrawal times -Literature search results
Five of the obtained studies reported data on average colonoscope withdrawal times (18,30,(32)(33)(34).Four were prospective case series (18,30,32,33), and one was a retrospective chart review (34).When calculating the average withdrawal time at 20.1 min, one study included patients who had polyps removed (18).For the four studies that did not include polyp removal time, the reported average withdrawal times ranged from less than 6 min (30) to a high of 10.1 min (32).The weighted mean withdrawal time for the three prospective studies that did not include polyp removal time (30,32,33) was 10.8 min.When the retrospective study (34) was included, the weighted mean was 7.2 min (Table 5).Additionally, the study by Simmons et al (34) examined the relationship between withdrawal times and the rate of polyp detection and found that, as withdrawal times increased, polyp detection rates also increased (P<0.0001), but this relationship was weaker for larger polyps, which are easier to detect.The authors of that study recommended a minimum withdrawal time of 7 min, which corresponds to a polyp detection rate above the median level of performance.

Rabeneck et al
Can J Gastroenterol Vol 21 Suppl D November 2007 14D

ASGE (US) (73)
Average withdrawal times should be 6 min or longer in colonoscopies with normal results performed in patients with intact colons.
The US Multi-Society Task Force on Colorectal Cancer (US) (74) Mean examination times (withdrawal phase) should average at least 6 min to 10 min.

Adenoma detection rates -Literature search results
Eight studies were obtained that reported on adenoma detection rates (11,15,32,35,39,40,60,62). The characteristics of the study populations varied across the reports.Six of these studies were prospective (15,32,39,40,60,62), and two were retrospective in design (11,35).In these studies, the adenoma detection rates ranged from a low of 12% (40) to a high of 62% (39).A weighted mean could not be calculated because some studies did not report the necessary data.One study (62) of same day back-to-back colonoscopies reported an overall miss rate for adenomas of 24%, and the risk of a missed adenoma increased with decrease in polyp size.
The study by Froehlich et al (32) found a positive relationship between the quality of bowel cleansing and the adenoma detection rates, with intermediate-quality and high-quality cleansings being associated with superior adenoma detection rates compared with low-quality cleansings (Table 6).

Adenoma detection rates -Internet search results
One article was obtained that reported on adenoma detection rates (74), with the target being greater than 25% in men older than 50 years and greater than 15% in women older than 50 years in persons undergoing first-time colonoscopies (see details below).
The US Multi-Society Task Force on Colorectal Cancer (US) (74) Adenoma prevalence rates detected during colonoscopy in persons undergoing first-time examinations, with the goal being 25% or greater in men older than 50 years and 15% or greater in women older than 50 years.

Cancer miss rates -Internet search results
No articles were obtained that reported cancer miss rates.
Several sedation regimens showed greater efficacy compared with other regimens in these trials.Midazolam was more efficacious than diazepam (42) or placebo (43).Propofol was more efficacious than midazolam with meperidine (47), remifentanil (48), and midazolam with fentanyl (50).Midazolam with meperidine showed greater efficacy than midazolam alone (49).Two RCTs showed a significant benefit  for patient-controlled sedation regimens over either continuous infusion or nurse-administered sedation (for patient satisfaction) (45) or over nurse-administered sedation alone (for better patient cooperation with the procedure, higher endoscopist satisfaction rates and higher patient satisfaction) (46).Another study did not detect a difference between patientadministered and nurse-administered sedation (51).

Use of sedation -Internet search results
No sources obtained in the Internet search reported on the use of sedation.

Bowel preparation -Literature search results
A position paper was obtained that was based on a literature review of bowel preparation conducted by the Canadian Association of Gastroenterology (65) that mainly assessed RCTs evaluating the efficacy and tolerability of four commonly used preparations: polyethylene glycol, sodium phosphate, magnesium citrate, and sodium picosulphate, citric acid and magnesium oxide-containing preparations.In that review, 43 RCTs were evaluated.The authors concluded that all four preparations provided effective bowel cleansing in the majority of patients, with varying tolerability, and stated that effective bowel preparations are critical to high-quality colonoscopy and to successful screening programs.In addition, Barkun et al (65) concluded that large volume preparations can be poorly tolerated and that adequate hydration was important in minimizing side effects, especially in those who received sodium phosphate solutions, and probably also sodium picosulphate, citric acid and magnesium oxide-containing preparations.
Three of these studies (11,18,32) reported on the relationship between bowel preparation and cecal intubation rates.Excellent preparation was associated with higher cecal intubation rates.
A retrospective study by Harewood et al (59) was obtained reporting on 93,004 colonoscopies.The authors found that after adjusting for age and sex, adequate bowel preparation (compared with inadequate preparation) was associated with greater colonic lesion detection (odds ratio [OR], 1.21; 95% CI 1.16 to 1.25; P<0.05), and adequate preparation was also associated with superior detection rates for small lesions (polyp 9 mm or less) compared with large lesions (mass lesion, polyp greater than 9 mm) (OR 1.23; 95% CI 1.19 to 1.28).

Bowel preparation -Internet search results
No sources obtained in the Internet search reported on bowel preparation.

RECOMMENDATIONS 1. Target audience
These recommendations apply to all physicians and institutions performing colonoscopy in support of Ontario's FOBTbased CRC screening program.

Physician endoscopist standards
Based on the consensus of opinion by members of the Expert Panel, informed by the evidentiary base, the following recommendations are made as standards for physician endoscopists: *Unless shown, the number of persons performing the procedure was not reported in the paper • • maintain in good standing with their hospital/college (CPSO); and • • have no identified practice problems.
B. Practicing gastroenterologists/general surgeons who maintain a regular colonoscopy service: These are physicians who have received formal or, in some cases, informal training and have maintained their competence in colonoscopy as defined by ongoing endoscopic practice for at least three of the previous five years.These physicians will have full colonoscopy privileges locally, granted by their hospital.These physicians can be presumed to be proficient for a period of two years provided that they: • • continue to practice, defined by no fewer than 200 colonoscopies annually; • • maintain in good standing with their hospital/college (CPSO); and

Institutional standards
Based on consensus of opinion by members of the Expert Panel, informed by the evidentiary base, the following recommendations are made as standards for institutions.

Patient assessment
• All patients should receive a preprocedure assessment, where information regarding the following items is obtained: • • informed patient consent; • • history of gastrointestinal bleeding; • • history of cardiac and respiratory disorders, including ischemic heart disease, hypertension and chronic obstructive pulmonary disease; • • history of coagulation disorders, such as hemophilia; • • history of communicable disease, such as hepatitis C, HIV or tuberculosis; • • list of current medications, including anticoagulants (such as warfarin), acetylsalicylic acid and clopidogrel (Plavix, sanofi-aventis Canada Inc); • • list of drug allergies; • • indication whether there is a family history of CRC; and • • list of operations, especially abdominal and gynecological surgery.
• All patients must receive follow-up care, which must include: • • reports to the family physician that include the following: type of procedure, date of procedure, sedation received, depth of colonoscope insertion, colonoscopic findings, histopathology report regarding any tissue that was removed, and recommendation regarding the need for follow-up colonoscopy and the time intervals, as required; and • • a follow-up appointment with the physician who performed the colonoscopy, if indicated.

Infection control
• The Expert Panel endorses the standards detailed by the CPSO concerning infection control (70).The CPSO standards and Expert Panel modifications are summarized below: • • Gastrointestinal endoscopes come into contact with mucous membranes and are considered semicritical items.The minimum standard of practice for reprocessing is high-level disinfection.
• • Accessories (eg, reusable biopsy forceps) that penetrate mucosal barriers are classified as critical items and must be sterilized between each patient use.Accessories labelled as either single use or disposable should not be reprocessed.
• • Endoscopes have been implicated in the transmission of disease when appropriate cleaning, disinfection or sterilization procedures were not employed.In contrast to the CPSO standards, the Expert Panel strongly recommends that automated machine cleaning, disinfection and sterilization processes be used following manual cleaning of the equipment to protect both patients and personnel.
• • Universal precautions must be observed in each facility to prevent contact with blood or other potentially infectious materials.All blood or other potentially infectious material will be considered infectious, regardless of the perceived status of the source individual.All personnel performing or assisting with endoscopic procedures should follow universal precautions and wear appropriate equipment to protect themselves from fluid and body substances.
• • Eye protection should be worn to prevent contact with splashes during the cleaning procedure and disinfection/sterilization process.• • Screening colonoscopy perforation rates no higher than one in 2000; and • • Overall colonoscopy perforation rates no higher than one in 1000.

Cecal intubation rates
• All colonoscopies should be performed using a video colonoscope.
• The equipment used to perform colonoscopies should have the capacity to create photographic records.
• The cecal intubation rate should be greater than 95% for screening colonoscopy provided bowel preparation is adequate and no structural abnormalities exist.

Use of sedation
• There is evidence that adequate sedation contributes to better patient outcomes in terms of greater patient cooperation, less patient memory of discomfort, reduction in reported pain and increase in patient tolerance of the procedure.All patients should be offered sedation unless the endoscopist judges this to be contraindicated.Patients need to be aware that they have the right to refuse sedation if they so desire.

Bowel preparation
• There is evidence that proper bowel preparation is associated with better cecal intubation rates and better adenoma detection rates.Appropriate bowel preparation is therefore recommended.

Pathology
• Tools and infrastructure are required to support the systematic collection of data associated with the colonoscopic and pathological findings.These include, but are not limited to: • • development and implementation of synoptic reports using uniform criteria and nomenclature; and   * A supplemental dose of 1.0 mg midazolam was delivered if the cecum was not reached within 30 min after introduction of the endoscope.After the procedure, patients received a dose of 0.1 mg flumazenil for each mg of midazolam administered for reversal of sedation; † But no more than 5.0 mg; ‡ but no more than 3.

TABLE 1
¶ Use of reversal agents with sedation, cardiorespiratory problems with sedation, bowel perforation, hospital admission, emergency department visits and bleeding requiring transfusion physicians with acceptable certification or have equivalent certification from a country other than Canada; and • • Must be licensed by the CPSO.

TABLE 2
*Unless shown, the number of persons performing the procedure was not reported in the paper.VA Veterans affairs

TABLE 3
Unless shown, the number of persons performing the procedure was not reported in the paper; † Bleeding rate for colonoscopy not reported; ‡ Gastrointestinal bleeding with hospitalization; § Gastrointestinal bleeding without hospitalization *

TABLE 5
*Unless shown, the number of persons performing the procedure was not reported in the paper; † Including polypectomy time.VA Veterans affairs

TABLE 4
(74)74) shown, the number of persons performing the procedure was not reported in the paper; † Unweighted 12-year mean.VA Veterans affairsAverage colonoscope withdrawal times -Internet search resultsTwo articles obtained in the Internet search reported on average withdrawal times(73,74)(see details below).Both the sources stated that withdrawal times should be at least 6 min(73,74), and one stated mean withdrawal times should be between 6 min and 10 min(74).

TABLE 6
*Unless shown, the number of persons performing the procedure was not reported in the paper

TABLE 8
program: These are physicians who wish to take up colonoscopy practice for the first time and who do not currently have full colonoscopy privileges locally, granted by their hospital.To be deemed proficient, they: • • will have to complete a Royal College of Physicians and Surgeons of Canada-accredited training; and

TABLE 9
Resuscitation capability• The Expert Panel endorses the standards detailed by the CPSO regarding resuscitation capability.These standards are summarized below.There are no modifications by the Panel.
• • appropriate information technology/information management infrastructure to collect these data and to enable integration with other relevant CCO initiatives.The Program in Evidence-Based Care (PEBC) is a provincial initiative of Cancer Care Ontario.It is supported by the Ontario Ministry of Health and Long-Term Care through Cancer Care Ontario.All work produced by the PEBC is editorially independent from its funding source.COPYRIGHT: This report is copyrighted by Cancer Care Ontario; the report and the illustrations herein may not be reproduced without the express written permission of Cancer Care Ontario.Cancer Care Ontario reserves the right at any time, and at its sole discretion, to change or revoke this authorization.DISCLAIMER: Care has been taken in the preparation of the information contained in this report.Nonetheless, any person seeking to apply or consult the report is expected to use independent medical judgment in the context of individual clinical circumstances or seek out the supervision of a qualified clinician.Cancer Care Ontario makes no representation or guarantees of any kind whatsoever regarding the report content or use or application and disclaims any responsibility for its application or use in any way.For information about the PEBC and the most current version of all reports, please visit the Cancer Care Ontario Web site at www.cancercare.on.ca/ or contact the PEBC office at: telephone 905-525-9140 ext 22055, fax 905-522-7681.