Appendix 1 Key responsibilities of QMP Clinical Leads

Appendix 1 Key responsibilities of QMP Clinical Leads The following table provides an overview of the key responsibilities for each of the designated QMP Clinical Lead roles. Role QMP Provincial Lead QMP Regional Lead QMP Facility Lead Key Responsibilities 1. Chair (or co-chair) QMP provincial committee (composed of QMP regional leads and other program and organization representatives) that reviews and updates the quality reports and definitions based on evidence and best practice 2. Foster good relationships with other program leads 3. Lead the province in defining quality based on evidence and best practices 4. Lead the review of quality reports at all levels (physician, facility, regional/system), and support leads in addressing potential issues 5. Foster innovation and best practice 6. Lead identification of appropriate quality improvement opportunities for identified issues 7. Provide support to regional and facility leads 1. Participate in QMP provincial committee that reviews and updates the quality definitions based on evidence and best practice 2. Participate in the review of quality reports at all levels and ensure that deficiencies in practice quality are improved 3. Support and work with facility leads to review data, address physician and facility quality issues, and recommend improvement opportunities when quality indicators are not meeting standards. 4. Foster innovation and best practices across the region 5. Monitor regional clinical performance and support quality improvement 6. Work with Cancer Care Ontario Regional Cancer Programs, LHINs and other program leads to meet the needs of the regions with respect to the Dimensions of Quality (e.g., access, equity, etc.) 7. Collaborate with other leads to facilitate knowledge transfer and ensure consistent quality across the province 8. Support facility leads in review and follow-up of physician and facility reports and act as a liaison between provincial and facility leads 1. Ensure required data are gathered and submitted to CCO in a timely way 2. Review their facility reports and associated peer comparisons and initiate quality improvement initiatives (e.g., process improvement) as appropriate 3. Review individual physician-level quality reports and initiate quality assurance/improvement initiatives as appropriate. 4. Ensure policies and procedures are in place and utilized when identifying and taking i

Role Key Responsibilities action on adverse events 5. Receive and respond to facility and equipment quality concerns revealed by quality assurance processes 6. Foster innovation and best practices to improve quality at the facility level ii

Appendix 2 for Quality Defined and Quality Assurance recommendations Appendix 2.1 Colonoscopy The table below provides a selection of the draft recommendations for colonoscopy standards, guidelines and quality assurance including the rationale for these recommendations. Recommendations All facilities must adhere to a common set of standards based on the CPSO s Out of Hospital Premises Inspection Program. All personnel that regularly reprocess endoscopy equipment must participate in a formalized training program (beyond the training provided by manufacturers). All facilities must participate in a common quality assurance program that includes regular inspections and assessments. All facilities must use the Global Rating Scale (GRS) as a quality assurance/quality improvement tool. Implementation of this tool will be carefully planned to ensure appropriate support is provided. The Out-of-Hospital Premises Inspection Program (OHPIP) is a comprehensive program which may serve as the basis for developing future standards in hospitals recognizing that some variations will apply. Future work is required to optimize the Ontario standards in in all settings where colonoscopies are provided. CPSO OHPIP Standards: http://www.cpso.on.ca/cpso/media/documents/cpgs/other/ohp- Standards-Dec19_13.pdf Participation in a formalized training program will provide knowledge on training of scope handling, mechanics, infection control, reprocessing, etc. It would also contribute to consistent infection control for colonoscopy procedures. It is noted that the CPSO, through the OHPIP, will require formalized training for scope technicians, beginning in 2015. For consistency, this should be required of all scope technicians, regardless of the type of facility where colonoscopies are performed. It is also recognized that reprocessing and scope equipment is expensive and costly to repair and replace. Formalized training may lead to a reduction in equipment costs. Periodic assessments ensure that facilities meet appropriate standards and are fit to operate. Ontarians should receive the same quality of care, no matter which facility is providing the colonoscopy. Quality can only be measured across various types of facilities if standards are applied (and compared) consistently. The GRS is a tool that captures clinical indicators of quality and patient experience dimensions and is already adopted by other provinces and some hospitals in Ontario. Facilities can choose their own foci for quality improvement pathways and review peer comparison data from across the country. iii

Recommendations A centralized, electronic repository should be developed to include past procedural reports and relevant pathology findings, as well as images and/or video related to the procedure. All facilities should adopt both electronic and synoptic reporting. Implementation will be carefully planned to ensure appropriate support is provided. System users often go years between colonoscopies, and often are not able to recall the results or details of a prior procedure. In addition, users may have a different endoscopist in subsequent procedures and that provider may not be aware of a patient s medical, symptomatic or screening history. A centralized repository would allow physicians to review the reports, pathology and images related to prior procedures. Standardization of electronic reports, including mandatory reporting elements, permits standardization of data capture that can inform quality assurance and quality improvement activities. According to the 2012 Canadian Journal of Gastroenterology consensus guidelines on safety and quality indicators in colonoscopy (see reference below), deficits in endoscopy reporting include variability in the definitions of inflammation in ulcerative colitis, differences in the level of completion of different report elements (such as lesion identification and removal), sedation, demographic data and quality of procedure. Reference: Canadian Association of Gastroenterology consensus guidelines on safety and quality indicators in endoscopy, Armstrong et al, Can J Gastroenterol, 2012; 26(1):17-31 Appendix 2.2 Mammography The table below provides a selection of the draft recommendations for mammography standards, guidelines and quality assurance including the rationale for these recommendations. Recommendation Optimizing care All women who choose to undergo screening mammography and meet the criteria must be screened in the Ontario Breast Screening Program (OBSP). Mammography reports must be standardized. The OBSP provides high quality screening to Ontario women, but it does not currently incorporate screening for all eligible women at all sites. Accordingly, an important early opportunity in mammography will be to expand OBSP to all women who meet the program criteria. The interpretation of the mammogram and the clarity of the mammography report are essential to high quality care and ensure that referring health professionals understand the radiologists assessments and acts on their recommendations. The radiologist/facility must provide the referring health professional with either a normal or an abnormal breast imaging report (i.e., incorporating mammography, breast ultrasound, breast MRI and if done image-guided biopsy) in a timely manner, ideally in a structured, standardized format. Standardization will be enhanced through the use of information technology, ideally common and or a single platform software solution in use across all facilities, to track and report on all breast imaging. iv

Recommendation Quality Equipment and Technology All mammography must be digital. All breast images and reports must be integrated into a provincial repository to allow imaging and report sharing. Clinically, digital mammography and film screen are both acceptable for mammography. 1 However, digital mammography has significant advantages over film screen, including quicker image acquisition, more efficient image archiving, better image portability, improved integration with other imaging modalities (ultrasound and MRI) and elimination of hazardous chemicals used in developing films. In addition, film screen imaging is becoming obsolete as manufacturers abandon production of necessary supplies and equipment. For all these reasons, mammography must be digital. MRTs and radiologists need access to prior mammograms and reports when reporting a current mammogram in order to decide if a finding has changed in the intervening period. Barriers to obtaining prior mammograms and reports include poor portability of film (especially if films are shipped or carried by the patient and later returned). Digital images often require costly CD shipping or inconvenient pick-up by the patient, and can be unreadable or poorly presented on different picture archiving and communication systems (PACS).All breast imaging and reports must be integrated into a provincial repository that allows image and report sharing between facilities and referring physicians across the province. Quality Assurance Processes Equipment Regular quality control must be performed on all mammography units. All mammography units and viewing chain must be regularly inspected by a qualified medical physicist with training in mammographic systems. Quality control detects, identifies and corrects equipment-related problems before they affect clinical images, and must be carried out regularly at frequencies ranging from daily to semi-annually. The OBSP s Digital Mammography Quality Control for the Mammographic Technologist describes the required quality control procedures. Medical physicists conduct regular inspections to assure proper functioning of the units and the associated viewing chain (e.g. PACS, monitors). Physicists also conduct inspections when equipment is new, when problems are suspected and after servicing or maintenance of the equipment. The OBSP s Digital Mammography Quality Control for the Mammographic Physicist describes the required testing protocols. Quality Assurance Processes Facilities All facilities must maintain Canadian Association of Radiologists Mammography Accreditation Program (CAR-MAP) accreditation. CAR-MAP accreditation assures that mammography units produce clinically acceptable images, and also confirms that MRTs and radiologists are properly licensed for mammography. All facilities must ensure that each mammography unit is currently CAR-MAP accredited and that each MRT and each radiologist at their facility is currently CAR- MAP accredited. 1 Chiarelli AM, Edwards ST, Prummel MV et al. Digital compared with screen-film mammography: performance measures in concurrent cohorts within an organized breast screening program. Radiology. 2013 Sep;268(3):684-93. doi: 10.1148/radiol.13122567 v

Recommendation All facilities must participate in regular inspections and assessments to ensure they meet appropriate standards. All mammography facilities must receive regular reports on their quality outcomes and follow-up to improve if required. Periodic assessment ensures that facilities meet appropriate standards. All IHFs must be regularly assessed by the CPSO. An analogous assessment program should be developed for hospitals. These assessment programs must be value added and non-duplicative (i.e. they must not assess aspects of quality that are assessed through other processes). Facility outcomes are reported to allow facilities to gauge how well they meet standards of care for service users and to compare their outcomes with their peers. Outcome reporting on wait times and follow-up activities currently exist for facilities that participate in the OBSP; these must be expanded to all mammography facilities. It is expected that more indicators for facility outcomes will be developed over time. Quality Assurance Processes MRTs All medical radiation technologists (MRTs) performing mammography must have regular image reviews. MRTs are responsible for correctly positioning the breast to produce a high quality mammogram that will reduce recalls for technical problems and maximize cancer detection. Image reviews assess MRT s positioning technique and identify where they are performing well and where they may need to improve. The OBSP conducts regular image reviews for MRTs who work in OBSP and mandates follow-up for MRTs who require assistance to achieve excellent positioning. These image reviews must be expanded to all MRTs performing mammography. Quality Assurance Processes Radiologists All reading radiologists must receive regular reports on their screening mammography outcomes and follow-up to improve if required. Retrospective peer review of interval cancers should occur for all reading radiologists. A prospective peer review (second reads) system should ideally be developed for screening Radiologist outcomes are reported to allow radiologists to compare their outcomes with their peers as well as to provincial and national standards and targets. This helps radiologists identify where they are performing well and where they may need to improve. Organized review and follow-up by appropriate clinical leads allows decisions to be made on acceptable methods of dealing with radiologists who are not performing to standards. Outcome reporting and follow-up activities currently exist for radiologists who read screening mammograms within the OBSP; these must be expanded to all reading radiologists for reads inside and outside the OBSP. It is expected that indicators for all screening and for diagnostic mammography will be developed over time. Retrospective peer review is a QA process that provides valuable learning opportunities for reading radiologists. During interval cancer reviews, all cancers that occur between screenings are reviewed by peers; reading radiologists must be able to review the cases in which there was a finding related to the cancer. OBSP conducts regular interval cancer reviews; these must be expanded to all reading radiologists. Prospective peer review is a promising regional and/or provincial QA process that may improve overall quality and provide educational opportunities for screening radiologists. Health Quality Ontario is currently developing peer review for other aspects of diagnostic vi

Recommendation mammography. CPSO peer assessments must be utilized for radiologists in Ontario. imaging. The mammography peer review processes will be complementary and align with this broader diagnostic imaging initiative. Peer assessments for radiologists are a useful non-punitive tool that can be leveraged for quality assurance purposes. Peer assessments provide supportive education to improve the quality of care and ensure patient safety. CPSO is developing peer assessments for radiology. These assessment programs must be value added and non-duplicative (i.e. they must not assess aspects of quality that are assessed through other processes). Appendix 2.3 Pathology The table below provides a selection of the draft recommendations for pathology standards, guidelines and quality assurance including the rationale for these recommendations. Recommendations Foundational Elements All laboratories in Ontario must have a Pathology Professional Quality Management Committee (PPQMC). All laboratories in Ontario must have a Pathology Professional Quality Management Plan. All laboratories in Ontario must have a guideline for classification of report defects/discrepancies/ discordances/errors. All laboratories in Ontario must have a guideline outlining the responsibilities of a pathologist requesting an external consultation, if applicable. A pathology professional quality management committee is important for local facilities to have a venue to discuss and monitor quality issues and to implement quality improvement processes and projects in order to ensure safe, effective and reliable pathology services for all patients. A pathology professional quality management plan allows local facilities to focus on key quality deliverables on a regular basis. A guideline for classification of defects/ discrepancies/discordances/errors is important for patient safety to ensure that consistent terminology and definitions are used in a facility. External consultants are experts in a particular area of subspecialty. Since they are external to the institution of origin of the case, they would not necessarily have access to important clinical information as well as other data which is needed to allow proper interpretation of the case. Providing consistent and relevant information to an external consultant is important for them to provide an accurate opinion in a timely fashion. Intra-Departmental Consultation (Prospective Peer Review) outlines the procedure for consultation with intra-departmental colleagues, including the Intradepartmental consultation is a form of prospective peer review. A second pathologist reviews a case prior to reporting in order to ensure vii

Recommendations documentation of those consults. Each laboratory must have a policy that outlines which sorts of cases require mandatory intra-departmental consultation and which are discretionary for the professional group. All laboratories must collect and review data on intra-departmental consultations, for the professional group. accuracy of the diagnosis or other findings. This may involve either a direct request from one pathologist to another or a consultation in the course of a case conference or similar. Intradepartmental consultation leads to improved decision making, uniformity in the use of diagnostic terminology, grading systems and criteria and should increase compliance with quality assurance processes. Due to the variability of caseload, each facility should develop its own policy about which cases are considered mandatory for intradepartmental consultation. Groups that report a wide variety of cases may consider having a policy for review of all first time diagnoses which could lead to a significant clinical intervention. Subspecialty practice groups may choose to focus on cases which result in significant clinical action or prone to diagnostic variability. Monitoring intradepartmental consultations demonstrates the extent to which prospective peer review is occurring. External Consultation (Prospective Peer Review) outlines the procedure for requesting external consultation, including the review and documentation of the resulting consultation opinion, if applicable. The policy must provide guidance as to the types of cases that are appropriate for external consult. All laboratories must collect and review data on external consultations, for the professional group, if applicable. This occurs when a pathologist seeks and opinion from a pathologist external to their group. This may occur when they have uncertainty about a case, if they lack resources for ancillary investigations at their site or if there are divergent opinions. External consultation occurs before a final diagnosis is rendered and therefore is a form of prospective second review. Data on external consults is a measure of secondary prospective review activity and provides confidence to clinicians and patients that the diagnosis and information contained in the report is accurate. Intra-Operative Consultation outlines the processes for, and the documentation of, the comparison of intraoperative consultation results with final diagnoses. Intraoperative consultations provide rapid information to surgeons during an operation in order to make appropriate intra-operative clinical decisions. Monitoring intraoperative consultation results with the findings on permanent sections prior to final release of a cases s is necessary to resolve discrepancies between the two different techniques. viii

Recommendations All laboratories must collect and review data on the appropriateness and accuracy of intraoperative consults and deferral rates, for the professional group. Monitoring data on intraoperative consultation provides confidence to clinicians and patients that the process is reliable, accurate and appropriate. Previous/ Concurrent Laboratory Reports (Retrospective Peer Review) outlines the procedure for correlation of current surgical pathology cases with pertinent previous/ concurrent laboratory cases from the index patient. Review of pertinent previous/concurrent laboratory cases from a current surgical pathology case ensures consistency and may help determine the most appropriate diagnosis for the current case. External Review (Retrospective Peer Review) outlines the processes for handling requests for review of cases by an external pathologist including the documentation and review of those results. All laboratories must collect and review facility level data on report defect and discordances revealed by external reviews, for the professional group. External reviews occur when there is a request by a pathologist, clinician, institution or patient to have a case reviewed by a laboratory or pathologist external to the one in which the case was originally reported. These are a form of secondary review and may be requested to clarify information for patient treatment, as a pro forma requirement of an institution. Monitoring of diagnostic discrepancies from external review can reassure patients, pathologists, clinicians and institutions that diagnoses are accurate and can identify areas for quality improvement. Corrected Reports outlines the following: The criteria for revising or correcting reports, including those in which diagnoses are revised or corrected. This policy should include definitions of the terms employed by the group for such reports, criteria for their use, the procedures and documentation required to issue them, and related follow-up quality assurance actions. When to directly inform the responsible clinician of the revision or correction (e.g., by verbal communication) and how to document that communication Procedure for notification of the Laboratory Director (or depending on a group s policies, the Chair of the PPQMC), and through the Laboratory Reports may be corrected for a number of reasons demographic information, provider information, diagnostic information, etc. Ensuring a low level of corrected reports is desirable and ensuring notification of the responsible healthcare provider of corrections is important for patient care and safety ix

Recommendations Director (or Chair, PPQMC) initiation of critical incident and similar reporting where appropriate. When revised or corrected reports have to be documented for risk management, root cause analysis and quality improvement purposes via that organization s processes. All laboratories must collect and review data on corrected reports and the reasons for the corrections, for the professional group. Monitoring of corrected reports helps to identify quality improvement opportunities in order to decrease corrected report rates as necessary. Critical Diagnosis/Results outlines the types of diagnoses/ findings which are considered critical in the practice/s of physicians served by a surgical pathology group. There should be a defined procedure for timely communication of these diagnoses/ findings to the physician most responsible for the care of the patient involved. The communication of these results should be documented. Critical diagnoses or significant unexpected findings must be communicated to the appropriate healthcare provider to ensure timely management of important medical conditions in order to prevent morbidity and mortality. Turnaround Times outlines the processes for monitoring turnaround times on a regular basis. All laboratories must collect and review facility data on turnaround times, for the professional group. Diagnostic reports must be provided in a timely manner in order to ensure patients receive appropriate care in a timely manner. Timely reports also decrease patient anxiety. Turn Around Times (TATs) are dependent on and reflect system issues. Monitoring of TATs can identify system problems for correction and quality improvement initiatives. Pathology Proposed Best Practice Guideline Recommendations For Individual Pathologists (only) on intra-departmental consultations, for each pathologist. on external consultations, for each pathologist. Refer to for Standards #5 and #6 Refer to for Standards #7 and #8 x

Recommendations All laboratories should collect and review on the appropriateness and accuracy of intraoperative consults and deferral rates, for each pathologist. on report defect and discordances revealed by external reviews, for each pathologist. on corrected reports and the reasons for the corrections, for each pathologist. on turnaround times, for each pathologist. Refer to for Standards #9 and #10 Refer to for Standards #12 and #13 Refer to for Standards #14 and #15 Refer to for Standards #17 and #18 For Professional Group and each Pathologist on report defect and discordances revealed by review of previous/ concurrent laboratory cases, for the facility and for each pathologist. on report defects and discordances revealed by retrospective reviews, for the facility and for each pathologist. on reporting of critical diagnoses, results and alert values, for the facility and for each pathologist. on service satisfaction, for the professional group and for each pathologist. Refer to for Standard #11 Retrospective reviews occur after cases have been signed out and finalized. They are a form of secondary review to determine whether there is diagnostic agreement between two separate pathologists interpreting the same sample, and hence, data on report defects and discordances revealed by retrospective reviews in an important measure of diagnostic accuracy within an institution. Refer to for Standard #16 Feedback from those who use pathology services helps provide knowledge of user needs, expectations and experience with a particular pathology laboratory. As such, it is an important marker of quality of care from the user s perspective. Policy All laboratories in Ontario should have a process in place to ensure that the professional group is aware of Patient Safety Checklists for Surgical Pathology as a reference standard to ensure day to day The use of Patient Safety Checklists minimizes reliance on user memory in the face of complex multi-step processes and procedures. They may also decrease the issues of variable input and inconsistency, and in doing so, increase workflow xi

Recommendations practice meets best practice. All laboratories should have a policy that outlines the various types of retrospective reviews and follow-up that should be performed, and their documentation and reporting for quality management purposes. efficiency and, ultimately, minimize error and increase diagnostic accuracy. A benefit of retrospective focused reviews is that evaluation of case sets may identify previously unrecognized areas of deficiency or discrepancy. Evaluation of reports and/ or slides or other materials as part of a retrospective review may also generate educational feedback about the original cases. The quality assurance draft recommendations for Phase 2 are focused on the on interpretive phase of pathology. To develop the recommendations, a comprehensive current state analysis of pathology was conducted to identify existing quality assurance programs and processes and determine where gaps and opportunities exist. Throughout this process, quality assurance programs at the provider level (i.e., pathologists) and the facility level (i.e., academic, community and private laboratories) were considered. Based on the current state analysis, the following draft recommendations have been identified. Pathology Proposed Quality Assurance Programs and Processes Recommendations Standards and guidelines (for internal quality assurance) should be maintained and monitored by an identified organization External Quality Assurance (EQA) should be a component of a provincial quality management program The QMP Provincial Pathology Committee will determine how an EQA program will be integrated into a quality management program for pathology. Standards2Quality (S2Q) is a set of recommended quality assurance processes and guidelines from which standards and indicators were derived by the Expert Advisory Panel for endorsement by the Partnership. The Provincial Pathology Quality Committee will be responsible for determining who will maintain and monitor S2Q to ensure standards are being met. EQA refers to slide schemes and challenges that are designed and administered by an entity outside the laboratory. EQA is of value to a provincial quality management program for pathology; however, more work is needed to determine how best to integrate this assessment into the program. The QMP Provincial Pathology Committee will establish a working group to determine the following: Evidence to support EQAs Ownership and responsibility for EQAs Identify the type of EQA that would be most valuable to patient care determine The specifics of how it should be designed and structured xii

Appendix 3 Pathology Implementation of Standards Indicators The table below outlines the indicators that will be collected and reported to evaluate the implementation of the standards identified in Section 1 of the Consultation document. S2Q Category Foundational Elements Intra-Departmental Consultation External Consultation Intra-operative Consultation Previous Concurrent Laboratory Reports External Review Indicator (Y/N) Does your facility have a Pathology Professional Quality Management Committee? Does your facility have a Pathology Professional Quality Management Plan? Does your facility have a guideline for classification of report defects/discrepancies/ discordances/errors? Does your facility have a guideline outlining the responsibilities of a pathologist requesting an external consultation, if applicable? Does your facility have a policy that outlines the procedure for consultation with intra-departmental colleagues, including the documentation of those consults? Does your facility have a policy that outlines which sorts of cases require mandatory intra-departmental consultation and which are discretionary for the professional group? Does your facility collect and review data on intra-departmental consultations, for the professional group? Does your facility have a policy that outlines the procedure for requesting external consultation, including the review and documentation of the resulting consultation opinion; if applicable (the policy shall provide guidance as to the types of cases that are appropriate for external consult)? Does your facility collect and review data on external consultations, for the professional group, if applicable? Does your facility have a policy that outlines the processes for, and the documentation of, the comparison of intra-operative consultation results with final diagnoses? Does your facility collect and review data on the appropriateness and accuracy of intra-operative consults and deferral rates, for the professional group? Does your facility have a policy that outlines the procedure for correlation of current surgical pathology cases with pertinent previous/ concurrent laboratory cases from the index patient? Does your facility have a policy that outlines the processes for handling requests for review of cases by an external pathologist including the xiii

S2Q Category Corrected Reports Critical Diagnoses/ Results Turnaround Times Indicator (Y/N) documentation and review of those results? Does your facility collect and review facility level data on report defect and discordances revealed by external reviews, for the professional group? Does your facility have a policy that outlines the criteria for revising or correcting reports, including those in which diagnoses are revised or corrected (this policy should include definitions of the terms employed by the group for such reports, criteria for their use, the procedures and documentation required to issue them, and related follow-up quality assurance actions)? Does your facility have a policy that outlines when to directly inform the responsible clinician of the revision or correction (e.g. by verbal communication) and how to document that communication? Does your facility have a policy that outlines procedure for notification of the Laboratory Director (or depending on a group s policies, the Chair of the PPQMC), and through the Laboratory Director (or Chair, PPQMC) initiation of critical incident and similar reporting where appropriate? Does your facility have a policy that outlines when revised or corrected reports have to be documented for risk management, root cause analysis and quality improvement purposes via that organization s processes? Does your facility collect and review data on corrected reports and the reasons for the corrections, for the professional group? Does your facility have a policy that outlines the types of diagnoses/ findings which are considered critical in the practice/s of physicians served by a surgical pathology group? Does your facility have a defined procedure for timely communication of these diagnoses/ findings to the physician most responsible for the care of the patient involved? Does your facility document the communication of these results? Does your facility have a policy that outlines the processes for monitoring turnaround times on a regular basis? Does your facility collect and review facility data on turnaround times, for the professional group? xiv