Pathology Quality Management Program Standards Implementation Guide

Transcription

1 Pathology Quality Management Program Standards Implementation Guide Version 2 Version 2 Issued June 6, 2017 Originally Issued: Summer 2016

2 Introduction This document has been developed to assist pathologists and laboratory medicine professionals to implement a quality management program for pathology that will support the provision of consistent, high-quality care across all facilities providing surgical pathology in Ontario. This document was first created and distributed in 2016; it was updated in June 2017 with new templates, policies and reference articles. The Quality Management Partnership (the Partnership) is implementing quality management programs (QMPs) in colonoscopy, mammography and pathology. The Partnership is looking to further advance the quality agenda in this area by building on the great foundational work that has been done by pathologists and laboratory medicine professionals in Ontario, who have been leaders in quality for more than 75 years. The QMPs for each health service area are based on a common framework that includes standards and guidelines, quality reporting, a clinical leadership structure and quality improvement and resource opportunities. The focus of the pathology QMP has been on the interpretative phase of pathology, specifically surgical pathology; however, it is recognized the pre-interpretative (or pre-analytic) and post-interpretative (post-analytic) phases as well as an integrated and well-designed system are equally important in the provision of high-quality pathology. In 2013, the Path2Quality group (a collaboration of the Ontario Medical Association Laboratory Section and the Ontario Association of Pathologists) released an updated guideline document outlining foundational elements in addition to policies and procedures related to the interpretative phase of pathology. The pathology QMP used this document (Standards2Quality Guidelines for Quality Management in Pathology Professional Practices - Version 2 1 ; Standards2Quality) as a basis for the standards and proposed indicators included in the pathology QMP. For more information, please see Provincial Quality Management Programs for Colonoscopy, Mammography and Pathology in Ontario. It should be emphasized that Standards2Quality were developed as voluntary guidelines, predicated on the assumption that appropriate resources are in place to successfully implement some or all of the Standards2Quality guidelines. This toolkit outlines the prioritized standards for 2017/18 (refer to the appendix for a list of prioritized QMP standards) and contains resources to facilitate their implementation. Standards were prioritized based on stakeholder feedback and availability of external resources. Additional standards will be phased in over time based on feedback from the Pathology Provincial Quality Committee. The toolkit largely provides information directly from Standards2Quality. It also includes a sampling of templates, policies and plans that have been contributed by Ontario hospitals, laboratories and private laboratories that have already adopted these standards. Information and resources provided in the toolkit are organized by standard and include a clear description and summary about the resource s intended use. The resources and information provided will continue to be revised as implementation progresses as this is intended to be a living document. In recognition that resource strategies necessary to support quality at the facility level may take some time to develop, the Partnership s early approach to minimize the impact to laboratories is to proceed with a gradual, phased implementation and to leverage processes already in place in many laboratories.

3 It is also recognized that policies may need to be tailored to meet the unique needs of each facility and that some standards may be challenging to implement for smaller laboratory facilities. The Partnership is in the process of establishing the Pathology Quality Management Model to support the implementation of standards within facilities. The Partnership wishes to acknowledge the contributions of the following organizations and thank them for sharing their resources to support the development of this toolkit: Brant Community Healthcare System, Grand River Hospital, LifeLabs, London Health Sciences Centre, Niagara Health System, Path2Quality, Trillium Health Partners and the University Health Network. The templates provided have been anonymized for legal and privacy purposes. Sample content has not been altered and may contain current and outdated acronyms (e.g. QMPLS) and references to documents that are specific to the contributing organization and are not applicable to or included in this toolkit. Disclaimer: We encourage you to use and benefit from this document. However, please be aware that the information in this toolkit has been gathered from a number of sources and is intended for informational purposes only. None of the organizations that have contributed to this document, including CCO and the College of Physicians and Surgeons of Ontario (individually or as the Quality Management Partnership), is responsible in any way for anyone s use of any of the information in this toolkit. Anyone using this information should exercise his or her own professional skill and judgment. For more information about the content or how to use this toolkit, please contact info@qmpontario.ca.

4 Table of Contents Pathology Professional Quality Management Committee and Pathology Professional Quality Management Plan... 6 Standard: Laboratories must have a Pathology Professional Quality Management Committee... 6 Standard: Laboratories must have a Pathology Professional Quality Management Plan Pathology Professional Quality Management Committee and Pathology Professional Quality Management Plan: Additional Resources Classification of Report Defects, Discrepancies, Discordances and Errors Standard: Laboratories must have a documented guideline for classification of report defects, discrepancies, discordances and errors, and a policy for their investigation and resolution Classification of Report Defects, Discrepancies, Discordances and Errors: Additional Resources.. 38 Review of Cases by an External Pathologist Standard: Laboratories must have a policy that outlines the processes for handling requests for review of cases by an external pathologist, including the documentation and review of those results...39 Review of Cases by an External Pathologist: Additional Resources Turnaround Times Standard: Laboratories must have a policy that outlines the processes for monitoring turnaround times on a regular basis Standard: Laboratories must collect and review data on turnaround times, for the professional group Turnaround Times: Additional Resources... 53

5 Intra-operative Consultation Standard: Laboratories must have a policy that outlines the processes for, and the documentation of, the comparison of intra-operative consultation results with final diagnoses, if applicable Standard: Laboratories must collect and review data on intra-operative consultation cases with defects or diagnostic discordances, for the professional group, if applicable Standard: Laboratories must collect and review data on deferral rates of intra-operative consults, for the professional group, if applicable Intra-operative Consultation: Additional Resources Additional QA/ QI Resources. 72 Appendix..74 Pathology QMP Standards..74 Pathology QMP Indicators...76 Reference. 76

6 Pathology Professional Quality Management Committee and Pathology Professional Quality Management Plan Standard: Laboratories must have a Pathology Professional Quality Management Committee Standard Index: 1. Rationale 2. QMP Guidance Comments 3. Standards2Quality (excerpt p ) 4. Tool: Terms of Reference (5 samples) Describes the purpose and structure of the committee, the scope of the committee s responsibilities and the responsibility of each committee member 5. Tool: Sample Agenda (2 samples) Supports meeting planning and structure 6. Pathology Professional Quality Management Committee: Additional Resources 1. Rationale It is important for local facilities to have a Pathology Professional Quality Management Committee 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. 2. QMP Guidance Comments It is recognized that it may be a challenge for small facilities to establish a Pathology Professional Quality Management Committee as outlined in Standards2Quality. The Partnership will work with small facilities through their facility and regional leads as needed to assist them to meet this requirement. Please note the title of the quality committee is at the discretion of the facility; samples provided in this section may not apply consistent terminology. 3. Standards2Quality Pathology Professional Quality Management Plan Overview To provide leadership in and support for quality assurance and improvement, pathologists should establish a Pathology Professional Quality Management Committee (PPQMC) Membership and Roles: A senior pathologist should serve as the Chair of the PPQMC and this individual should be chosen to reflect the organization of the professional group. Most often the Chair will be the Laboratory Director but may, in large professional groups, be a delegated responsibility. The committee should be comprised of pathologists and be supplemented by others as appropriate and as required to perform its work. 6

7 The committee should be separate from the committees and quality management programs for the technical work processes whenever possible. Integration of the professional and technical quality programs will be determined by the host institution s organizational structure. Responsibilities: The PPQMC will: Develop terms of reference that include appropriate governance elements including (in conjunction with the host institution) articulation of the responsible body to which it will report. Establish sub-committees or working groups as required; for instance, with larger professional groups, it may be appropriate to define sub-committees or working groups to oversee the execution of the quality assurance plan for surgical pathology separate from that for cytopathology, and cytopathology separate from hematopathology, and so on. Meet on a regularly scheduled basis. Oversee the preparation of an annual pathology professional quality improvement plan and associated objectives. Establish plans to meet those objectives. Monitor, evaluate, improve upon, and report the performance with respect to the pathology professional quality improvement plan at least annually. Establish performance standards and benchmarks for the professional group. Ensure critical incident reporting meets local and provincial requirements and standards. Make recommendations to the responsible body regarding quality improvement initiatives and policies related to pathology. Advise on professional education to support continuous quality improvement. Ensure that best practice information supported by available scientific evidence is provided to pathologists in the group. Carry out any other responsibilities provided for in regulation, or as determined by the responsible body. Operate in a non-punitive and non-coercive way, encouraging a culture of open and constructive communication. Reporting Structure: The PPQMC will: Provide regular reports to the Laboratory Director and Chief of Staff (for hospitals). Provide other regular reports to the responsible body as described in its terms of reference these will vary professional group to professional group according to their institutional situations. 7

8 4. Tool: Terms of Reference Sample 1 Sample verbatim as received Title: Laboratory Services - Terms of Reference Pathology Professional Quality Committee Manual: Laboratory Services Section: Quality Management Document Number: Issuing Authority: Laboratory Medical Director Date Issued: Date Revised: POLICY STATEMENT: The Pathology Professional Quality Committee will monitor, evaluate and provide recommendations for quality improvement related to the provision of pathology services at the hospital. MEMBERSHIP: Chair: Chief of Laboratory Services. (If the Chief is not a pathologist, they will appoint an individual from the group of pathologists to serve as the chair) Members: All permanent pathologists at the hospital. Team Lead for Pathology and Laboratory Quality Management Ad hoc: Group Lead, Laboratory Services Laboratory Information Specialist AUTHORITY: This committee shall report to the Laboratory Services Leadership Team and Laboratory Quality Management Committee as necessary. TERMS OF OFFICE: All members are permanent members of the committee VOTING: Decisions will be made by consensus whenever possible. If consensus is not reached then a quorum of 50% of the members are required. MINUTES: Minutes shall be available prior to or at the next meeting FREQUENCY OF MEETINGS: The team shall meet a minimum of nine (9) times per year or at the call of the chair RESPONSIBILITIES: 1. Monitor quality processes and indicators, prioritizing actions for quality improvement when specific targets are not met or where emerging trends have been identified. 8

9 Sample verbatim as received Page 2 of 2 2. Monitor professional pathology resources and make appropriate recommendations to Chief of Medical Staff and Senior Leadership when resource issues impact quality. 3. Ensures the alignment with laboratory quality management initiatives. 4. Develop, monitor and recommend annual quality improvement activities. 5. Communicate and provide advise to Medical Advisory Committee, through the Laboratory Services Team, on related matters related to pathology professional quality. 9

10 4. Tool: Terms of Reference Sample 2 Sample verbatim as received Pathology Professional Interpretation Quality Management Committee Terms of Reference Membership Chair of PIQM and Pathology QA committee Chief of PaLM/Laboratory Director Program Heads of Surgical Pathology, Cytology, Autopsy and Molecular Diagnostics and section heads Members of the Department and CCO lead Resident (rotational) Purpose The goal of the PIQM committee is to provide oversight with regards to quality assurance and quality improvement in professional interpretation. This is to be performed in a transparent fashion, with an emphasis on education, and not on blame. A culture of open and constructive communication is encouraged. The PIQM committee will be responsible for setting internal processes and expectations related to quality management of professional interpretive practices in pathology. These processes will be evaluated by the committee. Meetings Quarterly As needed when issues arise Reporting Structure The Committee will report to the Chief of Laboratory Director and as necessary through them to the and Hospital Quality of Care committee. Responsibilities Examine the way in which we currently document and manage quality management processes related to professional interpretation Assess overlap of functions with current department QA committee Review QA practices related to professional interpretation in the literature Standardize and document internal QA processes 10

11 Sample verbatim as received Assess and document data quarterly Respond to external QA programs such as QMPLS and S2Q as needed Specific Tasks 1. Audit of quality indicators a. FS discrepancy rates i. Aim to identify specific problem areas requiring education or discussion ii. iii. Teams to present on problem areas to department All significant discrepancies (QAF 1-3) require documentation using diagnostic discrepancy review form b. Review of supplementary and corrected reports i. Review of major discrepancies (QAC or QAS 1-3) ii. Documentation using diagnostic discrepancy review form c. Review of cases at outside request, with documentation of number of cases with minor or major diagnostic discrepancies d. Monitoring of external consults e. TAT i. Biannual (data for QA Committee, to be discussed by PIQM as necessary) ii. Per pathologist (quarterly) f. Internal consult rates (biannual, per pathologist, with comparison to peer group) g. Discrepant case reviews h. Physician initiated review (documentation, number of cases, number requiring supplementary or corrected reports) i. Case conference documentation j. Alert values development of general and team specific guidelines k. Cytology l. Autopsy 11

12 Sample verbatim as received m. Immunopathology n. CCO data 2. Help teams in developing strategies for QA/QI a. Develop list of cases where internal consultation may be prudent b. Develop list of alert values c. Perform periodic targeted reviews (eg on clinically important and problem prone cases) 3. Develop a yearly QI plan 12

13 4. Tool: Terms of Reference Sample 3 Sample verbatim as received TITLE: Terms of Reference Pathology Quality Management (PQM) Committee POLICY SECTION: SUBSECTION: APPROVED BY: PAGE 1 OF 2 EFFECTIVE DATE: (DD/ MM/YY) REVISION DATE: (DD/MM/YY) Purpose The goal of the PQM Committee is to provide oversight with regards to quality assurance and quality improvement in professional interpretation. This is to be performed in a transparent fashion, with an emphasis on enhancing quality and education, and not on blame. A culture of open and constructive communication is encouraged. The PQM Committee will be responsible for setting internal processes and expectations related to quality management of professional interpretive practices in pathology. These processes will be evaluated by the Committee. Membership Chair of PQM Committee Regional Director of Laboratory Medicine Site Laboratory Directors Members of the Department AD HOC basis Frequency of Meetings Quarterly As needed when issues arise Reporting Structure The Committee will report to the Chief of the Department and as necessary to the Hospital Quality Council Committee. Responsibilities Examine the way in which we currently document and manage quality management processes related to professional interpretation. Assess overlap of functions with current department QA Committee. Review QA practices related to professional interpretation in the literature. Standardize and document internal QA processes. Assess and document data quarterly. Respond to external QA programs such as QMPLS and S2Q as needed. Specific Tasks The following tasks will be developed over a period of time based on resources and priorities. 1. Audit of quality indicators: a. FS discrepancy rates i. Aim to identify specific problem areas requiring education or discussion. ii. All significant discrepancies (QAF 1 3) require documentation using QA Request for Internal Review / Diagnostic Discrepancy Review form. b. Review of addendum and corrected reports i. Review of major discrepancies (QAC or QAA 1 3) ii. Documentation using QA Request for Internal Review / Diagnostic Discrepancy Review form c. Review of cases at outside request, with documentation of number of cases with minor or major diagnostic discrepancies. 13

14 TITLE: Terms of Reference Pathology Quality Management (PQM) Committee Sample verbatim as received EFFECTIVE DATE: (DD/ MM/YY) REVISION DATE: (DD/MM/YY) PAGE 2 OF 2 d. Monitoring of external consults. e. TAT i. Bi-annual (data for QA Committee, to be discussed by PQM as necessary) ii. Per pathologist (for annual review by Chief of Department only) f. Internal consult rates (bi-annual, per pathologist, with comparison to peer group) g. Discrepant case reviews h. Physician initiated internal review (documentation, number of cases, number requiring addendum or corrected reports) i. Case conference documentation j. Alert values development of general and departmental specific guidelines k. Cytology l. Autopsy m. Immunohistochemistry 2. Assist Committees in developing strategies for QA/QI programs a. Develop list of cases where internal consultation may be prudent. b. Develop list of alert values. c. Perform periodic targeted reviews (ie. on clinically important and problem prone cases) 3. Develop a yearly QI plan References Standards2Quality 2011 Section 1, page

15 4. Tool: Terms of Reference Sample 4 Author: Lab Admin Supervisor AUTHOR Version #, Status: 2.0 DRAFT Document Id #: Pathology Professional Quality Management, Terms of Reference Folder: Interpretive Pathology ALL SITES Effective Date: Authorized by: Sample verbatim as received GOAL To provide leadership in and support for quality assurance and improvement. PURPOSE To promote and drive continuous quality improvement as a clear and visible priority. Guide the development of a quality assurance plan that is aligned with the Laboratory Quality Management System and the facility s strategic plan. OBJECTIVES Oversee the preparation of an annual quality improvement plan and associated objectives Monitor, evaluate, improve upon and report performance with respect to the improvement plan at least annually Establish performance standards and benchmarks for the professional group Establish and maintain interpretive pathology policies, processes and procedures Monitor organizational and regulatory requirements of pathologists Establish and monitor quality indicators Advise on education to support continuous quality improvement Ensure best practice information supported by available scientific evidence is available to the pathologist group Examine opportunities to streamline operations and processes to improve quality of service, leverage resources and maximize efficiency Identify and prioritize improvement needs or opportunities and make recommendations Charter teams or sub-committees for identified projects and monitor their progress Generate effective, team-based decision making to practice systematic process improvement Recognize team efforts Ensure critical incident reporting meets local, provincial requirements and standards Communicate to the pathologist group, laboratory staff and leadership regarding committee activities Operate in a non-punitive and non-coercive way, encouraging a culture of open and constructive communication Carry out any other responsibilities provided for in regulation, or as determined by the responsible body Print Status: Page 1 of 2 15

16 Sample verbatim as received Author: Lab Admin Supervisor AUTHOR Version #, Status: 2.0 DRAFT Document Id #: Pathology Professional Quality Management, Terms of Reference Folder: Interpretive Pathology ALL SITES Effective Date: Authorized by: ACCOUNTABILITY The committee, through its chairperson is accountable to the Chief, Laboratory Medicine & Genetics Program. MEMBERSHIP Chair a Senior Pathologist or facility lead for QMP program Pathologists Division lead for anatomic pathology or chief/medical director for LMP and genetics program Pathology Manager Quality manager Lab Director Others as required CHAIR TERM To be determined. MEETINGS Meetings are regularly scheduled and held monthly or at the call of the Chair A minimum of 4 meetings per year will be held Meeting agendas, minutes and related material is distributed at least 2 days prior to the meeting Agenda items should be forwarded no later than 3 days prior to the meeting Minutes are recorded, action-oriented and distributed within two weeks after the meeting Lab Administrative assistant will reserve meeting rooms and maintain the distribution list MEETING MINUTES Recorder: Lab Admin Assistant Distribution: via to members and Program Director. OTHER Terms of reference are reviewed annually. Print Status: Page 2 of 2 16

17 4. Tool: Terms of Reference Sample 5 Sample verbatim as received Department of Laboratory Medicine Document#: Draft Page 1 of 4 Section: Date of Issue: Draft Manual: Pathologist Manual Revision Date: Revision #: 0 Document Title: Terms of Reference Laboratory Professional Quality Management Committee (Path2Quality) Prepared by: Quality Manager Approved by: Medical Director of Laboratory Medicine A Quality Management Program (Path2Quality) in anatomic pathology covers surgical pathology and cytopathology. A Path2Quality plan is intended to measure, assess and improve the quality of services we provide, in order to fulfill our vision to deliver best laboratory services and be recognized as centre of excellence. 1.0 MISSION STATEMENT: To provide leadership and support for quality assurance activities that lead to improvement for the professional component of pathology in combination with the technical component of the pathology department. 2.0 PROBLEM STATEMENT: A Quality Management Program for laboratory physicians (Path2Quality) is new for the industry and also at the laboratory. A Path2Quality program will be developed through a committee to implement and oversee the program and to ensure that the objectives of the program are met. The processes, procedures, systems, and issues to be covered by the committee include all aspects of the Laboratory Professional Quality Management Program including the Path2Quality Plan, OLA and CAP. 3.0 BOUNDARIES: This section, describes where the process/system/issue to be studied begins and ends. Also include a statement of the team s authority to recommend and/or implement change; and any powers given or delegated to them. It is here that mention needs to be made of the systems, policies, procedures, legislation, etc., that are outside the scope of consideration by the team. Avoid unnecessary duplication of resources and effort with OLA requirements. Modify current SOPs to include Path2Quality guidelines. Qpulse to serve as the sole source of documentation. 4.0 SPECIFIC ISSUES TO BE ADDRESSED: Oversee the maintenance and ongoing improvement of the Laboratory Professional Quality Program. Oversee the preparation of the annual Laboratory Professional Quality Improvement Plan and associated objectives. Establish action plans to meet those objectives. Monitor, evaluate, approve, and report performance with respect to the Laboratory Professional Quality Improvement Plan annually. Establish performance standards and benchmarks for the professional group. 17

18 Sample verbatim as received Department of Laboratory Medicine Document#: Draft Page 2 of 4 Section: Date of Issue: Draft Manual: Pathologist Manual Revision Date: Revision #: 0 Document Title: Terms of Reference Laboratory Professional Quality Management Committee (Path2Quality) Prepared by: Quality Manager Approved by: Medical Director of Laboratory Medicine Ensure critical incident reporting meets hospital and provincial requirements and standards. Make recommendations regarding quality improvement initiatives and policies related to surgical pathology. Advise on professional education to support continuous quality improvement. Ensure that best practice information is supported by scientific evidence and is provided to surgical pathologists within the group. Ensure quality assurance indicators, reviews, and audits are performed and reviewed at schedule intervals (eg. quarterly, semi-annually or annually). Operate in a non-punitive manner, encouraging a culture of open and constructive communication without blame or shame tactics. 5.0 DESIRED OUTCOMES/OUTPUTS: Recommendations for improvements or changes to the Laboratory Professional Quality Program to improve overall practice as well quality of service. Quality assurance reports including performance of quality indicators, reviews, audits, and client satisfaction surveys Documentation of action taken to correct any deficiencies detected by the committee is maintained along with the quality improvement reports and monitors. Follow-up review is carried out to ensure that deficiencies, once detected are corrected and changes are effective. Results of the follow-up review are maintained with those of the original studies. 6.0 Committee PROCESSES AND STRUCTURE: Timeframes The Laboratory Professional Quality Management Committee will be in effect indefinitely to ensure the development, implementation and maintenance of the Laboratory Professional Quality Management Program (Path2Quality). The committee will prepare a report quarterly for the Integrated Operational and Quality Committees (IOC and IQC) and annually for the Hospital s Senior Quality Team on the status of the Laboratory Professional Quality Management Program Membership 18

19 Sample verbatim as received Department of Laboratory Medicine Document#: Draft Page 3 of 4 Section: Date of Issue: Draft Manual: Pathologist Manual Revision Date: Revision #: 0 Document Title: Terms of Reference Laboratory Professional Quality Management Committee (Path2Quality) Prepared by: Quality Manager Approved by: Medical Director of Laboratory Medicine Laboratory Medical Director Chair Laboratory Administrative Director Laboratory Manager, Pathology and Cytology Pathologists Senior Technologists, pathology and cytology Quality Manager Hospital Quality Team Members Ad Hoc: Pathologist Assistants Cytotechnologists LIS coordinator Laboratory Physicians Clerical/Medical/Surgical Staff Meetings Meetings will be held monthly or at the call of the Chair. Once a year, the Laboratory Professional Quality Management Committee (Path2Quality) will review the prior year s Path2Quality Plan and structure the program for the following year. Meetings and rooms will be booked by the Lab secretary using Outlook calendars of the committee members. Minutes will be recorded by the Lab secretary using the integrated meeting minute s template and will be posted and distributed to committee members for approval online in Qpulse within 2 weeks of the meeting. Resources Team members will be trained using a variety of tools such as the Quality Management Program/Quality Manual, quality assurance reports and indicators by the Laboratory Director or designate or the Senior Technologist/LIS coordinator. The CoPath pathology computer system will be able to track data required to monitor the Quality Management Program (path2quality). The laboratory clerical staff and secretary will be available for any clerical support. The Lab technical staff will be available for technical resource support. The Laboratory Manager, Pathology and Cytology Senior Technologist, LIS Coordinator are available resources for data mining, report generation, SOPs and modifications to the LIS to support the Quality Management Program. The Laboratory Manager and Laboratory Directors will coordinate staffing resources and workload assignments as needed to enable team members to carry out the 19

20 Sample verbatim as received Department of Laboratory Medicine Document#: Draft Page 4 of 4 Section: Date of Issue: Draft Manual: Pathologist Manual Revision Date: Revision #: 0 Document Title: Terms of Reference Laboratory Professional Quality Management Committee (Path2Quality) Prepared by: Quality Manager Approved by: Medical Director of Laboratory Medicine tasks of the committee without neglecting the requirements of their existing operational and patient care responsibilities. Reporting Guidelines The Laboratory Professional Quality Management Committee will report quarterly to the Laboratory Quality and Operation Committees (IQC and IOC) and through them to Hospital s Senior Quality Team as well as to the Chief of Staff annually. Reports will include quality indicators, reviews, audits, turnaround times and results of any client satisfaction surveys consistent with the Laboratory Professional Quality Improvement Plan (Path2Quality Plan). Any significant issues of quality or sentinal events will be reported promptly to Risk Management and Chief of Staff Office through the Medical Director or designate. 20

21 5. Tool: Sample Agenda 1 Sample verbatim as received Pathology Quality Management Meeting A G E N D A Meeting Date: Time: Site / Conference Room: Members Present (P) Absent (X) Regrets (R) Vacation (V) Teleconference (T) Approval of Minutes AGENDA ITEM TIME ALLOTTED FOLLOW-UP Business Arising Standing Agenda Items Data Review Summary Reports for QA Code Tracking / External Review Correlation Discrete Synoptic Report Comparison TAT > All Cancer Sites Pathology Quality Issues Tracking Record New Business Next Meeting <Date> at <Time> hours in the <Meeting Location> 21

22 5. Tool Sample Agenda 2 Sample verbatim as received Department of Laboratory Medicine Document #: Section: LABORATORY ADMINISTRATION Manual: Document Title: Prepared by: Laboratory Administrative Secretary Controlled copy is in Q-Pulse or embossed in manuals; hard copy for documentation and reference purposes only Date of Issue: Draft Revision Date: Revision # 0 Approved by: Medical Direct Attendees: Absent/Regrets: Recorder: Chair: Agenda Item Discussion Follow-up/Action Item/ Responsibility Goals Attachment 22

23 6. Pathology Professional Quality Management Committee: Additional Resources Please refer to Pathology Professional Quality Management Committee and Pathology Professional Quality Management Plan: Additional Resources 23

24 Standard: Laboratories must have a Pathology Professional Quality Management Plan Standard Index: 1. Rationale 2. QMP Guidance Comments 3. Standards2Quality (excerpt p ) 4. Tool: Pathology Professional Quality Management Plan Provides a sample policy outlining the approach to quality assurance and improvement 5. Tool: Quality Improvement Plan Provides an example of an anatomic pathology quality improvement plan 6. Pathology Professional Quality Management Committee and Pathology Professional Quality Management Plan: Additional Resources 1. Rationale A Pathology Professional Quality Management Plan enables local facilities to focus on key quality deliverables on a regular basis and provides overarching vision and scope for quality management at each facility. 2. QMP Guidance Comments Although small facilities may face challenges in establishing a Pathology Professional Quality Management Committee, they should consider development of a Pathology Professional Quality Management Plan in order to monitor processes and identify quality improvement opportunities as applicable for the unique needs of the facility. At a minimum, a Pathology Professional Quality Management Plan should include the pathology QMP prioritized standards. 3. Standards2Quality To provide leadership in and support for quality assurance and improvement, pathologists should: develop a Pathology Professional Quality Management Plan. The plan will articulate: A purpose statement which includes goals that: o Support continuous quality improvement. o Encourage timely, accurate and complete pathology reports. o Help to minimize error and enhance patient safety. o Are fair and objective as well as focused on improvement and education o Protect professional and patient privacy. o Meet regulatory requirements and standards for good medical practice. Policies and procedures that encompass the entire pathology workflow process(es), as well as procedures for monitoring related outcomes. How all processes are regularly measured, monitored, and improved as necessary. 24

25 The plan will also: Consider the complexity, structure, responsibilities, and needs of each professional group s circumstances and organization. Interface with other quality management programs such as Ontario Laboratory Accreditation, the institution s quality of care program, when appropriate. Establish quality objectives and priorities based on criteria such as problematic and high risk work processes. Assign responsibilities and timelines for action items. When possible, incorporate the input of clients and stakeholders that deal with patient outcomes. Communicate changes to policies and procedures, and the outcome of any monitoring activities in an open and transparent manner. Be regularly reviewed for its effectiveness, and modified and improved as required. 25

26 4.Tool: Pathology Professional Quality Management Plan Author: Lab Admin Supervisor AUTHOR Version #, Status: 1.0 DRAFT Document Id #: Pathology Professional Quality Management Plan Folder: Interpretive Pathology ALL SITES Effective Date: Authorized by: Sample verbatim as received Scope: This policy is applicable at all sites. Overview: this policy outlines the Interpretive Pathology approach to providing quality assurance and quality improvement. The approach will include the regular review and implementation of best professional practices from provincial, national and international sources. Quality benchmarks and other indicators of best practices will be utilized to continually monitor improvement. Purpose: the purpose of this policy to ensure high quality patient care and safety, enhance the effectiveness and responsiveness of pathology services and ensure compliance with regulatory and organizational requirements. Responsibility: Pathology is committed to providing quality service within the scope of the MOHLTC Laboratory License and is accountable to the public. Principles: 1. The pathology professional quality management process is aligned to the organization s strategic plan. 2. Quality assurance (QA) methods will be informed by the best available scientific evidence and will support high quality patient care and safety. Internal auditing will be used to benchmark against best practice outcomes. These benchmarks will be monitored along with patient safety risks to provide the basis for improvement plans. 3. Based on provincial, national and international recommendations, a quality system will be developed that will support efficient, effective, high quality and appropriate surgical pathology services with a focus for patient safety. QA and quality improvement (QI) plans will be key components of this system. 4. The QI process will be performed in a collaborative, transparent manner as areas for improvement are identified and best practice guidelines and goals are developed. Policy: to provide leadership in and support for QA and QI, pathologists will: 1.0 Establish a Pathology Professional Quality Management Committee Membership and Roles Chaired by a senior pathologist who reflects the organization of the corporation Includes appropriate representation from the pathology group Includes lab staff (e.g. Pathology Manager, Lab Quality Manager) 26

27 Sample verbatim as received Author: Lab Admin Supervisor AUTHOR Version #, Status: 1.0 DRAFT Document Id #: Pathology Professional Quality Management Plan Folder: Interpretive Pathology ALL SITES Effective Date: Authorized by: Responsibilities Develop Terms of Reference, including governance elements Meet monthly Oversee preparation of an annual QI plan Establish plans and recommends appropriate resources to meet those objectives Evaluate, monitor and report on the performance with respect to the QA/QI plan at least annually Consider and make recommendations to the responsible body regarding QI initiatives and policies within any organization or institution Advise on education to support continuous QI Ensure that best practice information supported by available scientific evidence is translated into materials that are distributed to medical staff and employees providing service in the program or organization Carry out any other responsibilities provided for in the regulations 2.0 Develop a QA and QI Plan Plan Development Overview: Articulates a purpose statement which includes goals that: - Minimize error - Enhance patient safety - Ensure timely, accurate and complete surgical pathology reports - Meets the needs of patients and personnel responsible for patient care - Meets regulatory requirements and standards for good medical practice - Supports continuous QI Considers complexity, structure, responsibilities, and needs of specific pathology department circumstances and institution Considers the complete pathology workflow process and interfaces with other quality processes such as Ontario Laboratory Accreditation when appropriate Establishes quality objectives and priorities based on criteria such as problem an high risk areas Assigns responsibilities and timelines for action items When possible, incorporates the input of clients and stakeholders that deal with patient outcomes Includes policies and procedures and communicates findings and changes to all appropriate personnel in an open and transparent process Monitoring: 27

28 Sample verbatim as received Author: Lab Admin Supervisor AUTHOR Version #, Status: 1.0 DRAFT Document Id #: Pathology Professional Quality Management Plan Folder: Interpretive Pathology ALL SITES Effective Date: Authorized by: The monitoring process is based on approved policies and procedures related to the following areas: Intraoperative consults Previous/Concurrent lab results Intradepartmental consultation/reviews External consults Additional testing decisions and utilization External reviews Retrospective reviews and audits Corrected reports Turnaround times Critical and significant unexpected diagnosis Completion of reports Service satisfaction Other areas of oversight and monitoring include: Status of preventive, corrective and improvement actions Reports and assessments from management and external/regulatory bodies Quality indicators that monitor the laboratory s contribution to patient care Major changes in organization and management resource (including staffing) or process follow up of previous management reviews Indicators: Establishes, documents, monitors, audits, acts upon, re-evaluates and reports quality indicators The quality indicators will be developed for the interpretive phases of the pathology workflow The quality indicator review process will: - Be performed on a regular, planned basis - Be conducted and reported against agreed criteria, with mandatory baseline goals identified on an annual basis. Additional, optional criteria may also be reviewed, based on the annual quality plan - Be appropriate for the practice environment scope of care, resources, volume and scope of sample material - Incorporate the use of recent best practice benchmarking data - Determine corrective and preventive actions with appropriate timelines Accountability: There is an expectation that each member of the professional medical team will understand commit to the QA and QA plan. This may be demonstrated by: Participating in the QI plan and patient/client/caregiver service satisfaction surveys and initiatives Supporting the accomplishments of their work groups through the quality, timeliness and professionalism of their work attitudes 28

29 Sample verbatim as received Author: Lab Admin Supervisor AUTHOR Version #, Status: 1.0 DRAFT Document Id #: Pathology Professional Quality Management Plan Folder: Interpretive Pathology ALL SITES Effective Date: Authorized by: Supplying accurate and timely data as required for performance tracking and reporting Applying resources in a manner which maximizes their efficiency and effectiveness in assuring achievement of quality Maintaining a work environment which will contribute to the assurance of quality Adhering to regulations, establishing procedures, performing selfchecking, utilizing surgical pathology patient safety checklists and paying attention to detail in the performance of their work Notifying the Director/management in a timely manner of any critical incident, quality deficiencies or problems with procedural compliance using established administrative processes Making recommendations to improve the quality and efficiency of their work Definition of Terms: See Glossary Section of Laboratory Medicine & Genetics Quality Manual (link below): [Para-Link] Related Documents: Corporate Quality of Care POL INT Medical Quality of Care Initiatives for Members of the Professional Staff P&P INT References: 1. IQMH. Ontario Laboratory Accreditation Requirements, Version 6.0 December, Ontario Regulation 156/10 made under the Public Hospitals Act. May 3, Bill 46 (Chapter 4 Statues of Ontario, 2010) An Act Respecting the Care Provided by Healthcare Organizations. June 8, Appendix: N/A 29

30 5. Tool: Quality Improvement Plan Sample verbatim as received PATHOLOGY PIQM COMMITTEE QI PLAN Standardize our policies and procedures to align them with S2Q report 2. Begin documenting cases sent out by pathologists for external consultation 3. Ensure pathologists are using new departmental forms on all appropriate cases (diagnostic discrepancy review, physician initiated review etc) 4. Encourage teams to develop team specific guidelines for internal consultation and alert values 30

31 6. Pathology Professional Quality Management Committee and Pathology Professional Quality Management Plan: Additional Resources Online Resources Quality Compass, Health Quality Ontario. Available from: Excellent care for all act; Bill 46, an act respecting the care provided by health care organizations. Available from: Journal and Print Resources Designing a quality improvement plan. In: Nakhleh, RE, Fitzgibbons PL, editors. Quality Management In Anatomic Pathology, Promoting Patient Safety through systems improvement and error reduction. Illinois: College of American Pathologists; 2005, p Association of Directors of Anatomic and Surgical Pathology, Nakhleh R, Coffin C, Cooper K. Recommendations for quality assurance and improvement in surgical and autopsy pathology. Am J Clin Pathol Sep; 126(3): Institute for Quality Management in Healthcare. IQMH Accreditation Requirements and Guidance Information, Version 6.1. Toronto: Institute for Quality Management in Healthcare; Section II. Nakhleh RE. What is quality in surgical pathology? J Clin Pathol Jul; 59(7): Quality Management in Laboratory Medicine. In: Wagar EA, Horowitz RE, Siegal GP, editors. Laboratory Administration for Pathologists. Illinois: College of American Pathologists; 2011, p Public Hospitals Act. Ontario Regulation 156/10; filed May 3, Long-Mira E, Washetine K, Hofman P. Sense and nonsense in the process of accreditation of a pathology laboratory. Virchows Archiv Jan 1;468(1):43-9. Henricks WH, Wilkerson ML, Castellani WJ, Whitsitt MS, Sinard JH. Pathologists as stewards of laboratory information. Archives of Pathology and Laboratory Medicine Mar;139(3): Smith ML, Raab SS. Quality assurance and regulations for anatomic pathology. In: Essentials of Anatomic Pathology 2016 (pp ). Springer International Publishing. Nakhleh RE. Has diagnostic (analytic) accuracy improved in anatomic pathology? Are we better today than we were 20 years ago?. Archives of Pathology and Laboratory Medicine Jun;139(6): Lewandrowski K. Utilization management in anatomic pathology. In: Utilization Management in the Clinical Laboratory and Other Ancillary Services 2017 (pp ). Springer International Publishing. Andiric LR, Massambu CG. Laboratory quality improvement in Tanzania. American journal of clinical pathology Apr 1;143(4):

32 Duggan MA, Trotter T. Alberta Health Services: Anatomical Pathology Quality Assurance Plan. Canadian Journal of Pathology. 2016;8(3):

33 Classification of Report Defects, Discrepancies, Discordances and Errors Standard: Laboratories must have a guideline for classification of report defects, discrepancies, discordances and errors, and a policy for their investigation and resolution Standard Index: 1. Rationale 2. QMP Guidance Comments 3. Standards2Quality (verbatim excerpt p ) 4. Tool: Quality Assurance Code Tracking Record A sample tracking record to document report defects, discrepancies, discordances and errors 5. Tool: Diagnostic Discrepancy Follow-up Form A template for quality assurance review of cases with major diagnostic discrepancies 6. Classification of Report Defects, Discrepancies, Discordances and Errors: Additional Resources 1. Rationale A guideline for classification of defects, discrepancies, discordances and errors is important for patient safety to ensure that consistent terminology and definitions are used in a facility. 2. QMP Guidance Comments Diagnostic disagreements or discordances can arise in a number of settings; for example in the process of external review, intradepartmental consultation, frozen sections or review of previous pathology results. As there is currently no standard agreed upon classification scheme for the province, facilities should decide internally the most effective way to classify discrepancies and discordances for their professional group. 3. Standards2Quality Guidelines for Classification of Report Defects/Discrepancies/Discordances/Errors There is not yet agreement in the literature about how best to classify report defects/discrepancies/ discordances/errors. One method that may be familiar to many is that described by the Association of Directors of Anatomic and Surgical Pathology (Recommendations on Quality Control and Quality Assurance in Anatomic Pathology. Am J Surg Pathol. 1991;15: ). Depending on the type of review undertaken, discordances may be described in that scheme as minor or major, depending on clinical, or potential, clinical impact. Others have provided more complex and sophisticated classification schemes. Meier et al (Meier, FA et al, Amended Reports - Development of a Taxonomy of Defects. Am J Clin Pathol. 2008;130: ), for instance, suggest a classification of report defects into those related to misinterpretations (falsepositives and false-negatives, each with sub-classifications as primary and secondary; misclassifications; and others), misidentifications, specimen defects, report defects, and other. 33

34 In developing schemes for classification of report defects/ discrepancies/ discordances/ errors, professional groups should consider whether it is, or is not, advisable and advantageous to attempt to assign some measure of clinical impact. There are arguments for both approaches; many groups may find it less cumbersome to use schemes independent of the consideration of clinical impact for the purposes of pathology defect/ discrepancy/ discordance/ error analysis and classification. If that route is taken, the host institution s program for reporting incidents with clear, or likely, adverse clinical outcome may be used, as a parallel and complementary system by which to register those cases. Each professional group should explore the various classification schemes available in the literature, and choose one appropriate to its needs and the needs of the larger quality system in which they report. There has not yet been developed a classification system that will allow standardized report defect/discrepancy/discordance/error reporting to the provincial level, i.e., no system that will allow the performance of one professional group to be compared with another. 34

35 4. Tool: Quality Assurance Code Tracking Record Sample verbatim as received Frozen Sections/Intra-op Consults (QAF) Corrected Reports (QAC) Addendum Reports (QAA) External Consults Intradepartmental Consults Date Path Report# QA Code Date Path Report# QA Code Date Path Report# QA Code Date Path Report# Date Path Report# Uncontrolled Document For Information Only 0 No change in diagnosis 4 Change within the same category of interpretation 7 Misidentification (patient, specimen site or type) 1 Change in categorical interpretation 5 Change in threshold 8 Diagnosis deferred 2 Change in margin status 3 Change in lymph node status 6 Change I information unrelated to diagnosis 9 Other 35

36 5. Tool: Diagnostic Discrepancy Follow-Up Form Sample verbatim as received Quality Assurance Review of Cases with Major Diagnostic Discrepancies * Current Case Number: Patient Name: Tissue Type/ Site: Current Diagnosis: Previous Case Number: Tissue Type/ Site: Previous Diagnosis: Reviewer Comments Date Completed Current Case Pathologist Original Pathologist 36

37 Sample verbatim as received page 2 of 2 Case # Reason for Discrepancy: Sampling / Interpretation / Other: Follow up: No further action required Results discussed with Dr. Corrected report issued QA code used: Could anything have been done to prevent this occurrence? Does this occurrence provide teaching points? Reviewed by, Division Head, Surgical Pathology / Cytology 37

38 6. Classification of Report Defects, Discrepancies, Discordances and Errors: Additional Resources Journal and Print Resources Nakhleh RE, Nosé V, Colasacco C, Fatheree LA, Lillemoe TJ, McCrory DC, et al., Interpretive Diagnostic Error Reduction in Surgical Pathology and Cytology: Guideline From the College of American Pathologists Pathology and Laboratory Quality Center and the Association of Directors of Anatomic and Surgical Pathology. Arch Pathol Lab Med Jan; 140(1): Huck A, Nosé V. Knowledge, Training, and Experience. In: Nakhleh RE, editor. Error Reduction and Prevention in Surgical Pathology. New York: Springer Press; 2015, p Error Reduction in the Preanalytical Process. In: Nakhleh, RE, Fitzgibbons PL, editors. Quality Management In Anatomic Pathology, Promoting Patient Safety through systems improvement and error reduction. Illinois: College of American Pathologists; 2005, p Shah RB, Leandro G, Romerocaces G, Bentley J, Yoon J, Mendrinos S, Tadros Y, Tian W, Lash R. Improvement of diagnostic agreement among pathologists in resolving an atypical glands suspicious for cancer diagnosis in prostate biopsies using a novel Disease-Focused Diagnostic Review quality improvement process. Human Pathology Oct 31;56:

39 Review of Cases by an External Pathologist Standard: Laboratories must have a policy that outlines the processes for handling requests for review of cases by an external pathologist, including the documentation and review of those results Standard Index: 1. Rationale 2. QMP Guidance Comments 3. Standards2Quality (verbatim excerpt p ) 4. Tool: Quality Assurance Guideline External Review Outlines recommendations for developing a policy for handling requests for review of cases by an external pathologist. This guideline also identifies responsibilities of the case pathologist and monitoring considerations. 5. Tool: External Review Correlation Record A template external review correlation record for review by the Pathology Professional Quality Management Committee 6. Tool: External Review Policy Sample policy outlining the external review process, including the responsibilities of the case pathologist and monitoring considerations 7. Review of Cases by an External Source: Additional Resources 1. Rationale 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 or 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. 2. QMP Guidance Comments All facilities should have a process for handling cases requested by an external source including the documentation of the review and communication of the results. A facility agreed-upon classification scheme for discordant or discrepant results should be in place (see above) with a process to resolve and document discordant findings. The classification scheme should indicate the severity of the discordance or discrepancy and should include an indication of the degree of patient harm. For further information, please refer to the Canadian Medical Protection Agency s guide: Learning from adverse events: Fostering a just culture of safety in Canadian hospitals and health care institutions. 39

40 3. Standards2Quality Guidelines for Dealing with Report Defects/Discrepancies/Discordances/Errors If report defects/discrepancies/discordances/errors are revealed by any of the forms of review the professional group employs, there should be in place a policy and predetermined processes for their investigation and resolution, and for the documentation of same. At a minimum, the pathologist who becomes aware of a report defect/discrepancy/discordance/error should: Discuss the report defect/discrepancy/discordance/error with the pathologist responsible for the report in question, to determine if there is agreement that the report contains a report defect/ discrepancy/ discordance/ error; o o If they agree that there is a report defect/discrepancy/discordance/error, they will attempt to determine why the report defect/discrepancy/discordance/error arose, the clinical import of the report defect/discrepancy/discordance/error, and the appropriate action; If they disagree that there is a report defect/discrepancy/discordance/error, resolution may be sought by various means, for instance: o o o consultation with others in the professional group; consultation with the Laboratory Director; external consultation. This discussion and follow-up should be documented. At a minimum, when a report defect/discrepancy/discordance/error is determined to be present, the pathologist responsible for the report in question should: Directly communicate with the clinician for those patients whose treatment or clinical management may need to be modified; If appropriate, document the above in an addendum to the original report; If an addendum report is issued, ensure that any originally issued reports are clearly marked in such a way as to ensure that they are not confused or misinterpreted as the final report for the case. At a minimum, the policy and processes the professional group should have in place should predefine for cases of potential report defect/discrepancy/discordance/error: Processes for the various pathologists involved to follow, including mechanisms for dispute resolution; Criteria to determine when notification of clinicians should take place; Criteria to determine when addendum reports should be issued; Criteria to determine if the Laboratory Director should be notified; 40

41 Criteria to determine if critical incident reporting, including notification of the Chief of Staff, or equivalent, is required; How the pathologist responsible for the report in question will be notified, when that pathologist is not immediately available; Documentation and tracking of report defects/discrepancies/discordances/errors, including those that are not considered to warrant communication with the clinician, addendum report, etc.; How professional group improvement plans will be based on the above. 4. Tool: Quality Assurance Guideline External Review Source: Standards2Quality (verbatim excerpt p ) Quality Assurance Guideline External Review Trigger: Previously finalized cases are reviewed externally in a variety of circumstances. Principle /Purpose External reviews occur when there is a request by a pathologist, clinician, institution (e. g. cancer clinic), or patient to have a case reviewed by a laboratory or pathologist/s external to the one in which the case was originally reported. External reviews may be required to clarify information for patient treatment or may be a pro forma requirement of an institution. They may also be requested by a clinician or patient as a second opinion. External review is distinguished from external consultation (see QA Guideline External Consultation) which occurs in a variety of circumstances; external consultation occurs before a final case report is issued, while external review occurs after a final diagnosis is rendered and a final case report issued. Policy As part of the Pathology Professional Quality Management Plan, there should be a policy that outlines the processes for handling requests for review of cases by an external pathologist including the documentation and review of those results. When the results of an external review are received the original report should be reviewed and compared with it. The external review may be documented in the report of the case in question if so, most often this will require an addendum report. After an external review the case pathologist determines whether new clinically relevant information is available as a result, and determines if an addendum report is required. The professional group should have tracking and audit processes, to ensure that external reviews are sent, and that the related review reports are received, documented, and retained. Monitoring for outstanding 41

42 cases should occur on a regular basis. Exceptions Practice Type Considerations Responsibilities of Case Pathologist For quality assurance purposes, the external review should be forwarded to the case pathologist for review, whether or not the original pathologist finalizes the report. None This guideline applies to all types of practice. When a request for an external review is received, the case pathologist should review the original material and determine the appropriate slides and/ or blocks and/ or other material to be sent for external review. When the external review is returned, the case pathologist should review the consultant s opinion and document that review. In most cases this will require an addendum report. Monitors When report defects or discordances are revealed, the case pathologist should participate in their investigation and resolution, according to the policies and processes the professional group usually employs. The Pathology Professional Quality Management Committee should collect and review data on report defect and discordances revealed by external reviews, for the professional group and for each pathologist. As data is collected, it should be compared to established benchmarks and trended over time. Minimum Requirements: Number of cases where external review revealed report defects or diagnostic discordances, compared with number of all cases in same time period, for professional group overall Indicator Example: o % of cases with report defects or diagnostic discordances, for professional group overall Optional: Number of cases where external review revealed report defects or diagnostic discordances, compared with number of all cases in same time period, by individual pathologist Further analysis of the above by specific anatomic site or disease type Indicator Example: o % of cases with report defects or diagnostic discordances, by individual pathologist Frequency: Quarterly (or as appropriate for the group) 42

43 5. Tool: External Review Correlation Record Sample verbatim as received Reports to be printed on a quarterly basis and reviewed by PQM Committee Date Sent Path Surg Path/Cyto # Requested by Originating Dx Date Returned External Dx Agree Minor - no affect DISAGREEMENT Minor - some affect Major Uncontrolled Document For Information Only Signature Date 43

44 6.Tool: External Review Policy Author: Version #, Status: 1.05 DRAFT Document Id #: Sample verbatim as received External Review Policy Folder: Interpretive Pathology - INTEGRATED Effective Date: Authorized by: Scope: This policy is applicable at all site(s). Purpose: This policy defines the guidelines surrounding the external review process of finalized cases that are reviewed by an external laboratory physician/pathologist at the request of a pathologist, clinician, institution, patient, external agency/insurance company, centralized biomarker (Oncotype Dx). Policy: When a request is made for an external review, the case pathologist determines the material to be sent for review (see responsibilities below). When the result of the external review is received, the consultant report is compared to the original report. The results of the external review are recorded in the appropriate LIS field with respect to the degree of concordance between the original report and the external reviewers report according to the department s policy Guidelines for Classification of Defects/Discrepancies/Discordances/Errors The result of the external review is documented in the report of the case in a manner that best suits the nature of the information received in the review. If clinically significant changes require an addendum or corrected report, appropriate clinician(s) should be notified. Responsibility: Case Pathologist: 1. When a request for an external review is received, the case pathologist should review the original material and determine the appropriate slides and/or blocks or other material to be sent for external review. 2. When the external review is returned, the case pathologist should review the consultant s report and determine if there are report defects or discordances that should be investigated and resolved according to the policies and processes of the professional group. 3. When the external review is returned, the case pathologist determines whether new clinically relevant information is available as a result, and determines if an addendum or corrected report is required. Definition of Terms: External Review: review requested by a pathologist, clinician, institution (e.g. cancer center) or patient to have a finalized case (signed out) reviewed by a laboratory physician/pathologist external to the one in which the case was originally reported. This includes requests for second opinion and automatic review of new patient referrals to an institution. 44

45 External Review Policy Sample verbatim as received Author: Version #, Status: 1.05 DRAFT Document Id #: Folder: Interpretive Pathology - INTEGRATED Effective Date: Authorized by: Monitors: Collect and review data on report defect and discordances revealed by external reviews: 1. Number of cases where external review revealed report defects/discrepancies/discordances/errors, compared to the number of all cases requiring external review in the same time period, for the professional group (expressed as %). Optional: Same data as above analyzed for : - individual pathologists - Anatomic site - Disease type (i.e. cancer cases) Related Documents: Standards to Quality: Guidelines for Quality Management in Pathology Professional Practices. 45

46 7. Review of Cases by an External Pathologist: Additional Resources Online Resources The Working Group on Histopathology QA Guidelines, Faculty of Pathology, RCPI. Guidelines for the Implementation of a National Quality Assurance Programme in Histopathology. Version 5.0. Royal College of Physicians of Ireland Available from: Learning from adverse events: Fostering a just culture of safety in Canadian hospitals and health care institutions [Internet]. Ottawa, Ontario: Canadian Medical Protective Association p.Available from: Journal and Print Resources Raab SS, Grzybicki DM. Secondary case review methods and anatomic pathology culture. Am J Clin Pathol Jun; 133(6): Raab SS, Grzybicki DM, Mahood LK, Parwani AV, Kuan SF, Rao UN. Effectiveness of random and focused review in detecting surgical pathology error. Am J Clin Pathol Dec; 130(6): Renshaw AA, Gould EW. Measuring the value of review of pathology material by a second pathologist. Am J Clin Pathol May; 125(5): Association of Directors of Anatomic and Surgical Pathology. Recommendations on quality control and quality assurance in anatomic pathology. Am J Surg Pathol Oct; 15(10): Raab SS, Nakhleh RE, Ruby SG. Patient safety in anatomic pathology: measuring discrepancy frequencies and causes. Arch Pathol Lab Med Apr; 129(4):

47 Turnaround Times Standard: Laboratories must have a policy that outlines the processes for monitoring of turnaround times on a regular basis Standard: Laboratories must collect and review data on turnaround times, for the professional group Standard Index: 1. Rationale 2. QMP Guidance Comments 3. Tool: Quality Assurance Guideline Turnaround Times Outlines recommendations for a policy for surgical pathology turnaround times and practice considerations 4. Tool: Turnaround Time Policy (2 samples) Provides a sample histopathology turnaround time policy 5. Turnaround Times: Additional Resources 1. Rationale 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. Turnaround times are dependent on and reflect system issues. Monitoring of turnaround times can identify system problems for correction and quality improvement initiatives. 2. QMP Guidance Comments Turnaround times are a reflection of system factors including transportation, human resources (technologists, lab assistants, pathologist s assistants as well as pathologists) and infrastructure supports (for example, access to timely immunohistochemistry or molecular studies). As implementation proceeds the pathology Provincial Quality Committee will be working toward scoping a turnaround time indicator including standard definitions; however, at this early stage, it is suggested that facilities monitor turnaround times, which can help to drive system quality improvements in their respective institutions. 47

48 3. Tool: Quality Assurance Guideline Turnaround Times Source: Standards2Quality (verbatim excerpt p ) Quality Assurance Guideline Turnaround Times Trigger: Turnaround times are monitored. Principle/ Purpose Turnaround times are key indicators of surgical pathology work processes, as they reflect the efficiency of the surgical pathology service, and the professional group s and individual pathologist s ability to report cases in a timely fashion. Policy Exceptions As part of the Pathology Professional Quality Management Plan, there should be a policy that outlines the processes for monitoring turnaround times on a regular basis. Overall surgical pathology turnaround times should be measured from the time the laboratory receives the specimen to the time the final report is issued; those turnaround times may be analyzed further, according to constituent work processes, e.g., those portions which are the responsibility of technical and other support staff and those that are the direct responsibility of the surgical pathologists involved. It should be specified whether turnaround times are measured in calendar or working hours or days. Cases such as those sent for external consultation and cases that, as part of a group s standard protocols, may not follow standard work processes may be excluded from analysis by the professional group. Practice Type Considerations Turnaround times may vary due to a number of factors such as: case volume and type, concurrent urgent and routine requests, number of laboratory staff and pathologists, subspecialty expertise, availability of intradepartmental tests and expertise, the available information technology, geographical location, and the need for resident training. Depending upon the complexity of an individual case, additional time may be allowed for adequate acquisition of clinical information, reviewing previous reports and materials, ensuring adequate fixation, employing special techniques or testing, or obtaining external consultation. The professional group may choose to monitor specific types of cases depending on clinical needs and perceived issues/ changes in their practice. Responsibilities of Case Pathologist Monitors Delays that may impact patient care should be communicated to the clinician, and that communication documented in the report. The Pathology Professional Quality Management Committee should collect and review data on turnaround times, for the professional group and for each pathologist. As data is collected, it should be compared to established benchmarks and trended over time. 48

49 Minimum Requirements: Times from specimen receipt to case sign-out, for professional group overall. Cumulative number of cases signed out by professional group, by day after specimen receipt. Separate reporting for distinct specimen or report types. Indicator Examples: Mean turnaround time, for professional group overall. Cumulative percent of cases signed out by professional group, by day after specimen receipt. Optional: Times from specimen receipt to case sign-out, by individual pathologist. Cumulative number of cases signed out by individual pathologist, by day after specimen receipt. Times from when cases available to pathologists to case sign-out, for professional group overall. Times from when cases available to pathologist to case sign-out, by individual pathologist. Indicator Examples: Mean turnaround times, for professional group overall. Mean turnaround times, by individual pathologist. Cumulative percent of cases signed out by individual pathologist, by day after specimen receipt. Further analysis of the above by specific anatomic site or disease type or by other attributes. Frequency: Quarterly (or as appropriate for the group. 49

50 4. Tool: Turnaround Time Policy Sample 1 Sample verbatim as received Title: Turn Around Time in Pathology Manual: Anatomic Pathology Section: General Document Number: Issuing Authority: Medical Director, Laboratory Services Date Issued: Date Revised: Purpose Turnaround times (TAT) for anatomic pathology specimens and frozen sections are key indicators for the overall function of the pathology laboratory. TAT within recognized as a key component of quality practice with direct correlation to effective and efficient management of patients. Scope This policy applies to Histology Laboratory staff within the hospital. Policy The division of Pathology looks to the needs of the physicians (clients) with regards to an acceptable TAT deliverable. The division of Pathology will have the final surgical report to the physician(s) office within 4-5 business days to facilitate the follow-up visit between the patient and the physician/surgeon. Uncomplicated specimens have a turnaround time of 2-4 days. These times are calculated based on the time of specimen receipt within the Pathology Department. Turnaround times exclude weekends and holidays. The Division of Pathology meets the CAP-Q probe benchmark that 90% of intra-operative consultations are completed within 20 minutes. (Complicated cases of multiple simultaneous frozen sections are excluded from this benchmark). Tissue specimens requiring specialized analysis (decalcification) and/or external consultation are excluded from TAT studies. Turnaround times for these indicators are monitored monthly by the Tech Specialist and Corrective Action Logs completed. TAT is one of the quality indicators that have been selected for the division of Pathology. Reference Quality Improvement Manual in Anatomic Pathology, 2 nd Edition, CAP, 2002 Revision History Revision # Nature of Revision Date 1 TAT update 50

51 4. Tool: Turnaround Time Policy Sample 2 Sample verbatim as received Author: QIP Committee Version #, Status: 1.1 CURRENT Document Id #: Interpretive Pathology Turnaround Time Policy Folder: Effective Date: Authorized by: Scope: This policy is applicable at all sites. Purpose: This policy defines the interpretive pathology group s intent with respect to case turnaround time (TAT). Turnaround time is a key indicator of work processes, as it reflects the efficiency of the service, the pathologist group and individual pathologist ability to report cases in an appropriate timeframe. Policy: Target turnaround time* is clearly defined and readily available to clinicians for all categories of specimens. (See Appendix). Delay in reporting a case that may impact patient care, is communicated to the clinician, by the case pathologist, and that communication is documented in the report. Turnaround time data is: - generated by Laboratory LIS, - collected for the pathologist group and for each pathologist, - reviewed quarterly by the QIP Committee, - is compared to benchmarks and trended over time, - excluded for those cases sent for external consultation and cases that, as part of a group s standard of practice, may not follow standard processes. Responsibility: the QIP committee, in consultation with clinicians and the Pathology Manager, is responsible for establishing expected turnaround times. The QIP Committee is also responsible for establishing and monitoring appropriate turnaround time for the portion of the process that is the direct responsibility of the pathologists. Monitoring: - times from specimen receipt to case sign-out, for professional group overall and by individual pathologist - separate reporting for distinct specimen or report types Definition of Terms: *Expected TAT is measured from the time the lab receives the specimen to the time the final report is issued. Related Documents: N/A References: Standards 2 Quality. Guidelines for Quality Management in Pathology Professional Practices Version 2. September 3,

52 Author: QIP Committee Version #, Status: 1.1 CURRENT Document Id #: Sample verbatim as received Interpretive Pathology Turnaround Time Policy Folder: Effective Date: Authorized by: Appendix: TAT - Pathology Cases Targets (>90% cases) Specimen Type Days = Mon-Fri Rush biopsy 3 days Small biopsy** 5 days Large resection, cancer 10 days Large and small resection, non-cancer 10 days Cytology, non-gyne 5 days Cytology, gyne 10 days Autopsy 3 months Bone marrow biopsy + aspirate 7 days **specialized biopsy (e.g. kidney, muscle, nerve, skin) may require longer TAT 52

53 5. Turnaround Times: Additional Resources Online Resources The Working Group on Histopathology QA Guidelines, Faculty of Pathology, RCPI. Guidelines for the Implementation of a National Quality Assurance Programme in Histopathology. Version 5.0. Royal College of Physicians of Ireland Available from: Alshieban S, Al-Surimi K. Reducing turnaround time of surgical pathology reports in pathology and laboratory medicine departments. BMJ Qual Improv Rep [Internet] Nov 24;4(1): [about 3pp.]. Available from: Journal and Print Resources Volmar KE, Idowu MO, Souers RJ, Karcher DS, Nakhleh RE. Turnaround time for large or complex specimens in surgical pathology: a College of American Pathologists Q-Probes study of 56 institutions. Arch Pathol Lab Med Feb;139(2): Institute for Quality Management in Healthcare. IQMH Accreditation Requirements and Guidance Information, Version 6.1. Toronto: Institute for Quality Management in Healthcare; Sections II and VIII. Association of Directors of Anatomic and Surgical Pathology, Nakhleh R, Coffin C, Cooper K. Recommendations for quality assurance and improvement in surgical and autopsy pathology. Am J Clin Pathol Sep;126(3): Inal TC, Goruroglu Ozturk O, Kibar F, Cetiner S, Matyar S, Daglioglu G, Yaman A. Lean six sigma methodologies improve clinical laboratory efficiency and reduce turnaround times. Journal of Clinical Laboratory Analysis Feb 1. Byrd L. Pathway of a Positive Breast Biopsy: Reducing Testing to Treatment Times. Journal of Oncology Navigation & Survivorship Oct 2;7. Azam AS, Belasco M, Awasthi R. Analysis of Turnaround Times for Histological Reporting of Placenta. The Journal of Pathology Mar 1;238:15. Leeftink AG, Boucherie RJ, Hans EW, Verdaasdonk MA, Vliegen IM, van Diest PJ. Predicting turnaround time reductions of the diagnostic track in the histopathology laboratory using mathematical modelling. Journal of clinical pathology Jan 21:jclinpath

54 Intra-operative Consultation Standard: Laboratories must have a policy that outlines the processes for, and the documentation of, the comparison of intra-operative consultation results with final diagnoses, if applicable Standard: Laboratories must collect and review data on intra-operative consultation cases with defects or diagnostic discordances, for the professional group, if applicable Standard: Laboratories must collect and review data on deferral rates of intra-operative consults, for the professional group, if applicable Standard Index: 1. Rationale 2. QMP Guidance Comments 3. Tool: Quality Assurance Guideline - Intra-operative Consultation Outlines recommendations for developing an intra-operative consultation policy, including practice and monitoring considerations 4. Tool: Intra-operative Consultation Policy//Procedures (3 samples) Provides sample intra-operative consultation policy /procedures 5. Tool: Intra-Operative Consultation Patient Safety Checklist Provides a reference standard that surgical pathologists can use to ensure that their day-to-day practice meets best practice, on a case by case basis 6. Tool: Frozen Sections Process Flow Diagram Provides a sample process flow for an intra-operative consultation 7. Intra-operative Consultation: Additional Resources 1. Rationale Intra-operative consultations provide rapid information to surgeons during an operation in order to make appropriate intra-operative clinical decisions. Monitoring intra-operative consultation results with the findings on permanent sections prior to final release of cases is necessary to resolve discrepancies between the two different techniques. Monitoring data on intra-operative consultation provides confidence to clinicians and patients that the process is reliable, accurate and appropriate. 2. QMP Guidance Comments This standard is not applicable to facilities that do not perform intraoperative consultation. 54

55 3. Tool: Quality Assurance Guideline - Intra-operative Consultation Source: Standards2Quality (verbatim excerpt p ) Quality Assurance Guideline - Intra-operative Consultation Trigger: Review and correlate intra-operative consults with current case. Principle/ Purpose Intra-operative consultations include rapid interpretations with gross and, in many cases, microscopic (frozen section) examinations. Other techniques (including cytology) may be employed, depending on specimen type. The correlation of intra-operative consultation materials with more permanent preparations and their associated final diagnoses is necessary to resolve discrepancies between the different techniques. Review of discordances aids in the measure of intra-operative consultation performance and improves recognition of morphologic alterations related to the various techniques employed. Rates of deferred diagnoses should also be reviewed as the rates vary depending upon expertise, types of specimens and resections encountered by a professional group. Policy As part of the Pathology Professional Quality Management Plan, there should be a policy that outlines the processes for, and the documentation of, the comparison of intra-operative consultation results with final diagnoses. The review should include an analysis of the turnaround times required for intraoperative consultations. The review should include an analysis of those diagnoses deferred, and the appropriateness of that deferral. See also Guidelines for Review of Previously Reported Cases, Guidelines for Dealing with Report Defects/Discrepancies/ Discordances/Errors, and Guidelines on Classification of Report Defects/Discrepancies/Discordances/Errors. Exceptions Certain specialized studies or cases, such as Moh frozen sections, may be exempt from the process. Deferred diagnoses should not be considered discordant results. Practice Type Considerations Responsibilities of Intra-operative Consult Pathologist This guideline applies to all types of practice. Refer to Intra-operative Consultation Patient Safety Checklist prior to providing a report to the clinician. When report defects or discordances are revealed, the case pathologist should participate in their investigation and resolution, according to the policies and processes the professional group usually employs. 55

56 Responsibilities of Case Pathologist When practical (this may depend on the size of the professional group), it is preferable that the case pathologist be another pathologist (and not the same individual as the intra-operative consult pathologist). The case pathologist should compare both the intra-operative consult report and materials with the permanent material. This review and comparison should be documented in the final case report and should include comment on any inconsistencies or discordances. Monitors The Pathology Professional Quality Management Committee should collect and review data on the appropriateness and accuracy of intra-operative consults and deferral rates, for the professional group and for each pathologist. As data is collected, it should be compared to established benchmarks and trended over time. Minimum Requirements: Number of cases where review of the intra-operative consultation revealed report defects or diagnostic discordances of various kinds, compared with number of all cases in same time period, for professional group overall Number of cases where intra-operative consultation diagnosis deferred (sub-classified as appropriate or inappropriate), compared with number of all cases in same time period, for professional group overall Times from specimen receipt to intra-operative consult report (may be defined by the group as verbal or written report to the clinician), for professional group overall Indicator Examples: o % of cases with report defects or diagnostic discordances of various kinds, for professional group overall o o % of cases with deferred diagnosis (sub-classified as appropriate or inappropriate), for professional group overall Mean turnaround time, for professional group overall Optional: Number of cases where review of the intra-operative consultation revealed report defects or diagnostic discordances of various kinds, compared with number of all cases in same time period, by individual pathologist Number of cases where intra-operative consultation diagnosis deferred (sub-classified as appropriate or inappropriate), compared with number of all cases in same time period, for individual pathologist 56

57 Times from specimen receipt to intra-operative consult report (may be defined by the group as verbal or written report to the clinician), by individual pathologist Times from when intra-operative material available to pathologists to intraoperative consult report, for professional group overall Times from when intra-operative material available to pathologists to intraoperative consult report, by individual pathologist Further analysis of the above by specific anatomic site or disease type, or for other attributes Indicator Examples: o % of cases with report defects or diagnostic discordances of various kinds, by individual pathologist o o % of cases with deferred diagnosis (sub-classified as appropriate or inappropriate), by individual pathologist Mean turnaround time, by individual pathologist Frequency: Monthly (or as appropriate for the group) 57

58 4. Tool: Intra-operative Consultation Policy/ Procedure Sample 1 Sample verbatim as received Intraoperative Consultation Policy Author: QIP Committee Version #, Status: 1.1 CURRENT Document Id #: Folder: Effective Date: Authorized by: Scope: This policy is applicable at all sites. Purpose: This policy defines intraoperative consultation (IOC) service at the facility. Policy: 1. The intraoperative diagnosis should be communicated with the responsible clinician either directly or by phone. If the information is given by phone the IOC pathologist should ascertain who they are talking to, and that the person receiving the message clearly understands which patient the diagnosis pertains to. The read back diagnosis should be considered. 2. IOC pathologist should enter their diagnosis in the appropriate field of LIS with the name of clinician/delegate who received the diagnosis and time of the verbal report. 3. All IOC diagnoses should be correlated with the final diagnosis. Agreement and disagreement between intraoperative diagnosis and final diagnosis should be documented in the IS system by the pathologist who is responsible for the final case. Please see appendix for the codes of correlation. If determination of the code category remains questionable, the case should be discussed with the chief of the department and/or the appropriate clinician. 4. If there is a major disagreement (category C), the case must be brought to attention of the responsible clinician as soon as possible to mitigate any further risk. The case should be discussed with the original IOC pathologist. 5. In the cases of Codes A, B, D, the case should be discussed with IOC pathologist. If there are issues with correlation, the case should be brought to attention of the chief of the department for final resolution. 6. A comment about discrepancy could be considered to be included in the final report. 7. Discrepant and/or difficult cases could be considered to be reviewed at the departmental quality rounds. Responsibility: 1. The IOC pathologist is responsible for oversight of the entire IOC process. The pathologist scheduled to be on IOC on a given day is responsible for the entire IOC process. This includes reviewing the requisition, grossing, allocating tissue for frozen sections, special techniques, microscopic examination, and delivery of the diagnosis to the responsible clinician. 58

59 Sample verbatim as received Intraoperative Consultation Policy Author: QIP Committee Version #, Status: 1.1 CURRENT Document Id #: Folder: Effective Date: Authorized by: 2. The IOC pathologist has to make every effort to be available for the OR in a timely manner. Pathologist must carry a mobile device by which they may be promptly contacted by technical staff and hospital locating. Monitors 1. Number of deferred cases compared with the number of all IOC cases in the same period of time for the entire professional group 2. Number of cases (single block/specimen) with delayed (0ver 20 minutes) response of IOC diagnosis compared with the number of all IOC cases 3. Number of cases with code C compared with the number of all IOC cases Related Documents: N/A References: 1. Standards2Quality Version 2 (2013) 2. Professional Quality Assurance Policy and Procedure Manual, Sunnybrook Health Sciences Centre Department of Anatomical Pathology (2012) Appendix: Codes for correlation of IOC with final surgical pathology FS-A/B/C/D/E A minor disagreement no impact on patient B disagreement - minor impact on patient C major disagreement major impact on patient D diagnosis deferred E no disagreement 59

60 4. Tool: Intra-operative Consultation Policy/ Procedure Sample 2 Sample verbatim as received ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation Policy and Procedure Prepared by: Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine INTRAOPERATIVE CONSULTATION POLICY AND PROCEDURE Policy: An intraoperative consultation (IOC) may be performed for a patient in a hospital operating room, ward, radiology department or outpatient clinic and includes: Frozen section examination Cytological examination of a fine needle aspirate or touch preparation of a lesion obtained during an operative procedure Gross only examination of a specimen without a frozen section A pathologist going into the operating room, at the request of the surgeon, to view a specimen in-situ or excised for an opinion and/or orientation Indication for Frozen Section Examination: A frozen section may be requested for the following reasons: To establish a diagnosis that may alter the planned operative procedure To determine that sufficient or appropriate tissue has been sampled in order to make a diagnosis or specimen triage decision (eg culture, electron microscopy, genetic testing, flow cytometry, immunophenotyping, research etc.) To confirm adequacy of resection margins The immediate urgency of the frozen section (FS) examination focuses considerable attention and resources on the proper performance of this technique. A correct diagnosis depends as much upon the clinical setting and the question(s) posed by the surgeon/physician as it does on the skill of the pathologist. As such, the pathologist reserves the right to decline performing a FS if it is felt to be an inappropriate request for the specimen or the tissue is limited and the ultimate evaluation may be compromised by performing this technique. This decision should be made in consultation with the surgeon. Contraindication for Frozen Section: A frozen section should be declined in the following situations: When the sample of tissue or lesion is so small that performing a frozen section would not leave enough tissue for permanent sectioning via routine histological processing When the gross only examination provides adequate diagnostic information When there is a high risk of exposure to an infectious agent (eg. TB) If one of the above reasons are not met 60

61 Sample verbatim as received Department of Laboratory Medicine Document #: Page: 2 of 7 ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation Policy and Procedure Prepared by: Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine INTRAOPERATIVE CONSULTATION POLICY AND PROCEDURE CONT D: Policy Cont d: Safety Requirements: The frozen section/gross dissection area should be constructed to protect the pathologist, technologist and clerical staff from biohazards; be free of all but essential instruments; well ventilated; easily disinfected; clean; of suitable size; and where possible used for no other purpose. The appropriate safety attire must be used when handling fresh tissue: Gloves Gore gown/lab coat/disposable apron Face shield (where appropriate ie no protective shield or the shield is raised above eye level on the biological safety cabinet or downdraft/hepa filtered grossing bench and the risk of splashing is high) Surgical greens, head cover and booties (if required for entry into the operating room suite) Specimen and Requisition Labeling Requirements: Specimen container(s) and requisition(s) should contain the following information: Patient s full name MRN (Medical record number) Date of birth Specimen source Submitting physician Date/time of specimen collection (optional required if specimen arrives before the pathologist is available) 61

62 Sample verbatim as received Department of Laboratory Medicine Document #: Page: 3 of 7 ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation Policy and Procedure Prepared by: Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine INTRAOPERATIVE CONSULTATION POLICY AND PROCEDURE CONT D: Policy Cont d: Pathologist Responsibilities: The pathologist is required to document on the back of the surgical requisition: the gross description of the entire specimen, including all appropriate measurements, description of the area submitted for the frozen section procedure frozen section diagnosis the date and time of reporting the initials of the pathologist performing the frozen section/gross only procedure The pathologist is also responsible for submitting tissue for appropriate special studies (as required/requested). These studies include: Culture Electron microscopy Flow Cytometry Genetic studies The pathologist is also responsible for completing the IOC log in excel which will be used: to capture turnaround times for each activity in the process; to capture frozen section/gross only case numbers and diagnoses; to document issues with the frozen section process (technical and diagnostic); to document the appropriateness of the frozen section request. 62

63 Department of Laboratory Medicine Document #: Page: 4 of 7 ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation Policy and Procedure Prepared by: Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine INTRAOPERATIVE CONSULTATION POLICY AND PROCEDURE CONT D: Policy Cont d: Pathologist Responsibilities Cont d: Difficult Diagnostic Cases: An intradepartmental consultation should be obtained in difficult diagnostic cases. Where there is only one pathologist available, a diagnosis should be rendered only when the pathologist is sure about the interpretation. If there is significant diagnostic uncertainty, the diagnosis should be deferred to permanent sections. NOTE: A consultation pathologist is readily available at one facility but not at the other. Availability of technologies such as digital pathology is required for intradepartmental consultations to occur as there is only one pathologist at the site. Capital requests have been submitted for this technology however, is still currently unavailable. Reporting of Frozen Section/Gross Only Diagnoses/Observations: Communication with the surgeon may occur via direct communication in the operating room (OR) or OR lab, or via phone/intercom as applicable. The surgeon is required to repeat the diagnosis in the case of a verbal report to ensure the information received is correct. (Hard copy reporting is a future direction for reporting of frozen section/gross only diagnoses.) NOTE: Care should be taken to ensure a verbal diagnosis is not given in the presence of a patient who is awake, without the expressed permission of the surgeon. Turnaround Time Expectation: There is no realistic way to specify the length of time that the ideal frozen section examination should take. However, 20 minutes from the time of receipt of the frozen section specimen to communication of the diagnosis is the target turnaround time (TAT), (additional time is required for multi-block cases). The time for each step in the process is to be documented in the IOC log spreadsheet for TAT data collection. This information will be audited and reported to the Pathologist QA Committee and Integrated Operations Committee as part of the QA process. 63

64 Sample verbatim as received Department of Laboratory Medicine Document #: Page: 5 of 7 ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation Policy and Procedure Prepared by: Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine INTRAOPERATIVE CONSULTATION POLICY AND PROCEDURE CONT D: Procedure: Notification of Intraoperative Consultations: 1. Intraoperative consultations may be booked through the laboratory offices or through the administrative secretary. 2. Non-booked intraoperative consults are directed to the Histology laboratory or laboratory office. Staff in these areas notify the frozen section pathologist at each site of the arrival of the specimen. 3. Each specimen for a frozen section must be received in an appropriately labeled container or wrapped in an OR towel with a patient identification label attached. In addition, an appropriately labeled requisition must accompany the specimen for proper accessioning into the pathology computer system (CoPath) to occur. The requisition must also contain appropriate clinical information, list of special procedures to be performed (ie flow cytometry etc), and potential infectious nature of the specimen, and specimen site. Gross Examination: Specimens are usually delivered to the OR lab or Histology lab. On the occasion that a pathologist must enter the OR suite, don the appropriate safety attire as required to enter the OR suite (ie head cover, gown, booties etc.) 1. Confirm the patient identification and specimen source indicated on the specimen container and requisition match. 2. Review the clinical information provided. Consultation with the surgeon may be required to ensure the appropriate area of the specimen is reviewed to obtain the appropriate diagnosis/information for patient care. 3. Measure and describe the specimen as indicated by the specimen source and grossing protocols. Ink the specimen as required before taking a section for frozen sectioning. 4. Record the gross description and measurements along with the time of gross dissection on the back of the surgical requisition. 5. Dissect the specimen and provide the tissue for frozen sectioning to the histotechnologist for freezing. Ensure the appropriate specimen identification is provided with each piece submitted. (Eg A1, B1, B2 etc.) Touch preps may also be prepared if required/appropriate. NOTE: The number of sections prepared will vary from case to case at the discretion of the pathologist and/or as per established protocols for the specimen type. 64

65 Sample verbatim as received Department of Laboratory Medicine Document #: Page:6 of 7 ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation Policy and Procedure Prepared by: Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine INTRAOPERATIVE CONSULTATION POLICY AND PROCEDURE CONT D: Procedure Cont d: Gross Examination Cont d: 6. Determine if material is required for special studies such as culture, EM, flow, molecular etc. Inform the Histology technologist and request the appropriate solution (MEM, glutaraldehyde or sterile container) for the testing required. (Obtained from the Histology laboratory.) Frozen Section Interpretation and Reporting: 1. While the frozen section is being cut, log on to the computer and open the password protected IOC log spreadsheet by double clicking on the short cut located on the desktop of the computer and entering the password xxx when prompted. 2. Select the appropriate month tab (located at the bottom of the spreadsheet) and enter the following information on the next available line (one line per case and part): date, patient name, surgical case number (if available) specimen source, new case (or gross only if applicable) select your initials from the list of pathologists (first 2 characters of last name + first 3 characters of first name) time of receipt of the specimen (in military time/24 hour clock) (if known) time of gross dissection (in military time/24 hour clock) (if known) NOTE: The Histology technologist may assist by entering this information for the pathologist 3. Review the first stained slide (when available). Request additional sections as required. 4. Review additional slides/recuts as applicable to obtain the frozen section diagnosis. 5. Contact the surgeon as soon as possible and provide the frozen section/gross only diagnosis. Ensure the surgeon repeats the diagnosis to ensure the information received is correct. NOTE: Care should be taken to ensure a diagnosis is not given in the presence of a patient who is awake, without the expressed permission of the surgeon. 6. Document the time of notification to the surgeon in the IOC log spreadsheet (military time/24 hour clock). 65

66 Sample verbatim as received Department of Laboratory Medicine Document #: Page: 7 of 7 ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation Policy and Procedure Prepared by: Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine INTRAOPERATIVE CONSULTATION POLICY AND PROCEDURE CONT D: Procedure Cont d: Frozen Section Interpretation and Reporting Cont d: 7. Document the frozen section diagnosis on the back of the requisition for typing into the Intraoperative Consultation section of the report. This information must also be typed into the IOC log spreadsheet. Include your initials/name, date and time of reporting. 8. Document the appropriateness of the intraoperative consultation in the IOC log spreadsheet. 9. Document any issues that occurred during the procedure (ie technical difficulties, delays in reporting due to intradepartmental consultation requirements etc.) in the IOC log spreadsheet. 10. Inform the Histotechnologist that the frozen section procedure is complete and the blocks may be transferred to formalin. Place the remaining tissue in formalin or ask for assistance to complete the handling of the fresh tissue. 11. Clean the grossing area and utensils used or ask for assistance to complete this task (if available). Safety Equipment: 1. Surgical gore gown 2. Gloves 3. Surgical or N95 mask (N95 masks identified during fit testing must be used for all lung cases and known or suspected infectious cases.) 4. Downdraft and hepa filtered hood/biological safety cabinet 5. Hospital approved disinfectant solution (ie Virex) Related Documents: 1. Frozen Section Pathologist s Duties PATHOLOGY.MAN Frozen Section Procedures PAT.HIS.B Intraoperative Consultation QA Policy and Procedure PATHOLOGY.MAN.008 Reference Material: 1. CAP Turnaround Time Guidelines 2. Path2Quality Documents 66

67 4. Tool: Intra-operative Consultation Policy/ Procedure Sample 3 Sample verbatim as received Department of Laboratory Medicine Document #: Page: 1 of 2 ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation QA Procedure Prepared by: Manager Histology/Cytology and Medical Director of Laboratory Medicine Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine INTRAOPERATIVE CONSULTATION QA PROCEDURE Policy: Evaluation of frozen section reports must be included as part of the laboratories quality improvement program. The review should include evaluation of the following parameters: Procedure: Turnaround time (TAT) of frozen section diagnosis (including technical and professional steps) Discrepancy between frozen and final diagnosis Appropriateness of frozen section examination request Turnaround Time Audits: 1. Audits of turnaround times are to be performed quarterly by the Pathology Manager and Core Lab Manager. Cases over 20 minutes should be investigated to determine the reason for the delay in order to identify areas for improvement. 2. The audit will be reviewed with the Pathologist s QA Committee and Integrated Operations Committee to determine if the TAT is appropriate for patient care and meets the needs of the surgeon s. 3. Corrective actions and outcomes will be monitored by the respective managers and QA committees. Diagnostic Discrepancies: 1. A discrepancy between the frozen section and final diagnosis is documented as follows: a) The final report sign out pathologist should make a statement in the comment field that the frozen section diagnosis does not correlate with the permanent diagnosis b) The sign out pathologist determines if the permanent section includes lesional tissue not identified in the frozen section due to trimming further into the block or if lesional tissue was missed in the frozen section slide. c) The sign out pathologist discusses any diagnostic discrepancy with the original frozen section pathologist and Medical Director of Laboratory Medicine. (Document this discussion in the comment field of the final report.) d) The sign out pathologist enters the QA activity in the QA module of CoPath under QA Diagnosis Review (See embedded document for step by step instructions 2. Identify the category of discrepancy based on the effect upon patient care. Discrepancies are classified as follows: 67

68 Sample verbatim as received Department of Laboratory Medicine Document #: Page: 2 of 2 ANATOMICAL PATHOLOGY Manual: Pathologist s Manual Document Title: Intraoperative Consultation QA Procedure Prepared by: Manager Histology/Cytology and Medical Director of Laboratory Medicine Date of Issue: Revision Date: Revision #: 00 Approved by: Medical Director of Laboratory Medicine a) Category A Minor disagreement with no effect upon patient care b) Category B Disagreement with some, but not significant, consequences to patient care c) Category C Major disagreement with impact on patient care 3. Select the appropriate Resolution(s) from the drop down menu in the QA module of CoPath. In absence of appropriate drop down choice, pathologist can select comment and free text resolution comment in the QA module. 4. Select the appropriate reason(s) for the disagreement from the drop down menu in the QA module of CoPath as follows: a) Failure to identify lesion grossly b) Inappropriate selection of material for FS c) Sectioning/technical problems d) Staining problems e) Interpretation problem f) Failure to communicate with surgeon g) Sampling problem h) Labeling problem i) Other 4. Enter additional information in the free text field to the right of the reason. 5. Immediately communicate/disclose major Category C discrepancies to the surgeon and include documentation in Riskpro along with the appropriate QA in CoPath. 6. An audit of the information will be performed bi-annually by the Pathology Manager to include the % of total discrepancies; % of major discrepancies; and % of deferred cases (by group and individual pathologist if available). A report identifying appropriate vs inappropriate deferrals will be developed if possible. This report will be provided for both QA committees. NOTE: The acceptable threshold for major disagreements in frozen section diagnosis is 3% and for deferred (inappropriate deferrals) cases is 10%. Related Documents: 1. Frozen Section Pathologist s Duties PATHOLOGY.MAN Frozen Section Procedures PAT.HIS.B Intraoperative Consultation Policy and Procedure PATHOLOGY.MAN.009 Reference Material: 1. CAP Turnaround Time Guidelines 2. Path2Quality Documents 3. Association of Directors of Anatomic and Surgical Pathology (ADSAP) 68

69 5. Tool: Intra-Operative Consultation Patient Safety Checklist Source: Standards2Quality (verbatim excerpt p. 26) 2.0 INTRA-OPERATIVE CONSULTATION PATIENT SAFETY CHECKLIST 2.1 Pertinent previous clinical history, diagnostic imaging and laboratory reports are available for review. 2.2 The referring physician or appropriate other personnel is contacted for additional information, if required. 2.3 Specimens from concurrent consultations are kept separate. 2.4 Tissue for frozen section or other rapid analysis is selected taking into account the possible need for fixed tissue or subsequent studies. 2.5 Each frozen section slide or other preparation created is labeled with two unique patient identifiers. 2.6 Frozen section slides or other preparations are of sufficient quality for intra-operative diagnosis. 2.7 If a verbal report is given, the referring physician or delegate is contacted directly by the pathologist. 2.8 The patient's identification is checked before delivery of any verbal report. 2.9 Results provided verbally are read-back by the referring physician, or delegate, and checked for accuracy by the pathologist The performance of an intra-operative consultation, its results, any verbal communication to the referring physician, and the date and time of any communication are permanently documented in the report for the specimen Following the intra-operative consultation, tissue is submitted for further studies as required. If any checklist element does not meet quality expectations, appropriate corrective actions are taken and documented. 69

70 6. Tool: Frozen Sections Process Flow Diagram Sample verbatim as received Inability to accession in order to give an electronic frozen section report needs to be accessioned Discrepancy resolution process needs to be written and clarified, development of a decision tree Frozen Sections Review OR List for any pre-booked or potential casesreview printed list OR list is given day before On day of surg-lab gets phone call. techs / clerical notify pathologist and Pathologist goes to where the specimen is. Review identification review gross and label Contact surgeon or go into OR Consultation with surgeon Could be cancelled Could be gross only -passed on to surgeon Specimen is given to tech to be frozen and to have a slide made Slide is given to pathologist for review If they can t make diagnoses then consult with another pathologist Once they have diagnoses they contact the surgeon either by phone call or by going right in to the OR Document the frozen and diagnose Needs to be documented on frozen section logs- Write: -Surgical # -Name PT -Part Types -Diagnosis -Same info captured at both sites End of frozen section process Process not standardized using excel spreadsheet keep additional information: -Time of receipt -Time gross section ready -Time slide given to pathologist -Time report given to physician Accession if not already done by clerical -Transfer frozen section diagnosis to report Gross dissection happens transfer any gross description to the report Photo copy frozen section req and give to frozen section pathologist to correct any errors Processed to create slides Frozen section slides are combined with permanent section slides and delivered to case pathologist or super market Case pathologist reviews all slides including frozen section. Review frozen section diagnosis for typos, transcription errors, diagnostic errors and diagnosis If discrepancy in final diagnosis vs. frozen Documentation for discrepancies in diagnosis between frozen and final define indicator to measure Correct transcription errorsreview from req review with the frozen section pathologist looking for documentation and follow-up Case is signed out by case pathologist My not have to proceed with technical frozen Consistent -Frozen Section diagnosis -Time -Reporting -Written on Req paper -Initials need electronic data, ability to measure turnaround times 70

71 7. Intra-operative Consultation: Additional Resources Online Resource The Working Group on Histopathology QA Guidelines, Faculty of Pathology, RCPI. Guidelines for the Implementation of a National Quality Assurance Programme in Histopathology. Version 5.0. Royal College of Physicians of Ireland Available from: Journal and Print Resources Mahe E, Ara S, Bishara M, Kurian A, Tauqir S, Ursani N, et al. Intraoperative pathology consultation: error, cause and impact. Can J Surg Jun; 56(3):E13-8. Özdamar SO, Bahadir B, Ekem TE, Kertiş G, Gün BD, Numanoğlu G, et al. Frozen section experience with emphasis on reasons for discordance. Turkish J Cancer. 2006; 36(4): Zarbo RJ, Jones BA, Friedberg RC, Valenstein PN, Renner WS, Schifman RB, et al. Q-Tracks: a College of American Pathologists program of continuous laboratory monitoring and longitudinal tracking. Arch Pathol Lab Med Sept; 126: Raab SS, Tworek JA, Souers R, Zarbo RJ. The value of monitoring frozen section-permanent section correlation data over time. Arch Pathol Lab Med Mar; 130(30): Coffin CM, Spilker K, Zhou H, Lowichik A, Pysher TJ. Frozen section diagnosis in pediatric surgical pathology: a decade s experience in a children s hospital. Arch Pathol Lab Med Dec; 129(12): Association of Directors of Anatomic and Surgical Pathology, Nakhleh R, Coffin C, Cooper K. Recommendations for quality assurance and improvement in surgical and autopsy pathology. Am J Clin Pathol Sep; 126(3): Nakhleh RE. What is quality in surgical pathology? J Clin Pathol Jul; 59(7): Novis DA, Zarbo RJ. Interinstitutional comparison of frozen section turnaround time. A College of American Pathologists Q-Probes study of frozen sections in 700 hospitals. Arch Pathol Lab Med Jun; 121(6): Gephardt GN, Zarbo RJ. Interinstitutional comparison of frozen section consultations. A College of American Pathologists Q-Probes study of 90,538 cases in 461 institutions. Arch Pathol Lab Med Sep; 120(9): Khalifa MA, Salama S, Vogel RI, Klein ME, Richter J, Pulver T, Mullany SA, Winterhoff B. Assessment of the Intraoperative Consultation Service Rendered by General Pathologists in a Scenario Where a Well-Defined Decision Algorithm Is Followed. American journal of clinical pathology Mar 1;147(3):322. Sams SB, Wisell JA. Discordance Between Intraoperative Consultation by Frozen Section and Final Diagnosis: A Classification Model to Guide Quality Improvement. International Journal of Surgical Pathology Feb;25(1):

72 Additional QA/ QI Resources 1. Additional QA/ QI Resources: Structured/Synoptic Reporting Journal and Print Resources Aumann K, Niermann K, Asberger J, Wellner U, Bronsert P, Erbes T, Hauschke D, Stickeler E, Gitsch G, Kayser G, Werner M. Structured reporting ensures complete content and quick detection of essential data in pathology reports of oncological breast resection specimens. Breast cancer research and treatment Apr 1;156(3): Ellis DW, Srigley J. Does standardised structured reporting contribute to quality in diagnostic pathology? The importance of evidence-based datasets. Virchows Archiv Jan 1;468(1):51-9. King S, Dimech M, Johnstone S. Structured pathology reporting improves the macroscopic assessment of rectal tumour resection specimens. Pathology Jun 1;48(4): Renshaw AA, Gould EW. Comparison of accuracy and speed of information identification by nonpathologists in synoptic reports with different formats. Archives of pathology & laboratory medicine Jan 5;141(3): Renshaw MA, Renshaw SA, Mena-Allauca M, Carrion PP, Mei X, Narciandi A, Gould EW, Renshaw AA. Performance of a web-based method for generating synoptic reports. Journal of Pathology Informatics. 2017;8. 2. Additional QA/ QI Resources: Other Rakha EA, Bennett RL, Coleman D, Pinder SE, Ellis IO. Review of the national external quality assessment (EQA) scheme for breast pathology in the UK. Journal of Clinical Pathology Jan 1;70(1):51-7. Romano RC, Novotny PJ, Sloan JA, Comfere NI. Measures of Completeness and Accuracy of Clinical Information in Skin Biopsy Requisition Forms. American Journal of Clinical Pathology Dec 16:aqw186. Lewandrowski K, Baron J, Dighe A. Utilization Management in the Clinical Laboratory: An Introduction and Overview. In: Utilization Management in the Clinical Laboratory and Other Ancillary Services 2017 (pp. 7-29). Springer International Publishing. Cheng CL, Tan PH. Digital pathology in the diagnostic setting: beyond technology into best practice and service management. Journal of Clinical Pathology Jan 6:jclinpath Canadian Partnership Against Cancer. On behalf of the Quality Initiative in Interpretive Pathology Thought Leaders Group. Pan-Canadian Quality Assurance Recommendations for Interpretive Pathology Nov. Becerra AZ, Aquina CT, Berho M, Boscoe FP, Schymura MJ, Noyes K, Monson JR, Fleming FJ. Surgeon-, pathologist-, and hospital-level variation in suboptimal lymph node examination after colectomy: Compartmentalizing quality improvement strategies. Surgery Jan 11. Blackstock S, Irvine R, Ejiofor F, Popa S, Tarma J, Furetta A, Cleugh F. G593 Team pod: a quality improvemensprint to improve pathology services. Archives of Disease in Childhood Apr 1;100(Suppl 3):A274-.t 72

73 Burks FN, Hu JC, Telang D, Liu A, Hawken S, Montgomery Z, Linsell S, Montie JE, Miller DC, Ghani KR, Collaborative MU. Repeat Prostate Biopsy Practice Patterns In A Statewide Quality Improvement Collaborative. The Journal of Urology Feb 28. Dabbs DJ, Stoos CT, Mallon A. Quality assurance and patient safety protocols for breast and gynecologic pathology in an Academic Women s Hospital. Applied Cancer Research Nov 21;36(1):3. Kalra J, Kopargaonkar A. Quality improvement in clinical laboratories: a six sigma concept. Pathol Lab Med Open J. 2016;1(1): Krasowski MD, Schriever A, Mathur G, Blau JL, Stauffer SL, Ford BA. Use of a data warehouse at an academic medical center for clinical pathology quality improvement, education, and research. Journal of pathology informatics. 2015;6. Lisovsky M, Schutz SN, Drage MG, Liu X, Suriawinata AA, Srivastava A. Number of Lymph Nodes in Primary Nodal Basin and a Second Look Protocol as Quality Indicators for Optimal Nodal Staging of Colon Cancer. Archives of Pathology & Laboratory Medicine Sep 28;141(1): Martin BS, Arbore M. Measurement, Standards, and Peer Benchmarking: One Hospital's Journey. Pediatric clinics of North America Apr 30;63(2): McCall SJ, Souers RJ, Blond B, Massie L. Physician Satisfaction With Clinical Laboratory Services: A College of American Pathologists Q-Probes Study of 81 Institutions. Archives of Pathology & Laboratory Medicine Oct;140(10): Priebe MT. Study of Quality Assurance Programs in Anatomic Pathology that Drive Improved Proficiency, Reduce Cost and Enhance Positive Patient Outcomes. J Mol Biomark Diagn. 2016;7(297):2. Sapatnekar S, Figueroa P, Colbert C. A Quality Improvement Curriculum for Pathology Residents. American Journal of Clinical Pathology Oct 1;144(suppl 2):A104-. Sciacovelli L, Aita A, Padoan A, Pelloso M, Antonelli G, Piva E, Chiozza ML, Plebani M. Performance criteria and quality indicators for the post-analytical phase. Clinical Chemistry and Laboratory Medicine (CCLM) Jul 1;54(7): Path2Quality. Work2Quality: Guidelines for workload measurement in pathology professional practices. Version 1.2 Toronto: OMA Section on Laboratory Medicine and Ontario Association of Pathologists; Barnes, Ian. NHS England. Pathology Quality Assurance Review Jan. BC Patient Safety & Quality Council. Culture Change Toolbox Oct. 73

74 Appendix Pathology QMP Standards: Shading indicates the standard has been prioritized for 2017/18 1. Laboratories must have a Pathology Professional Quality Management Committee. 2. Laboratories must have a Pathology Professional Quality Management Plan. 3. Laboratories must have a documented guideline for classification of report defects, discrepancies, discordances and errors, and a policy for their investigation and resolution. 4. Laboratories must have a policy that outlines the processes for handling requests for review of cases by an external pathologist, including the documentation and review of those results. 5. Laboratories must have a policy that outlines the processes for monitoring of turnaround times on a regular basis. 6. Laboratories must collect and review data on turnaround times, for the professional group. 7. Laboratories must have a policy that outlines the processes for, and the documentation of, the comparison of intra-operative consultation results with final diagnoses, if applicable. 8. Laboratories must collect and review data on intra-operative consultation cases with defects or diagnostic discordances, for the professional group, if applicable. 9. Laboratories must collect and review data on deferral rates of intra-operative consults, for the professional group, if applicable. 10. Standards and best practice guidelines for internal quality assurance must be maintained and monitored. 11. Laboratories must have a policy that outlines the procedure for requesting external consultation, including the review and documentation of the resulting consultation opinion. The policy must provide guidance as to the types of cases that are appropriate for external consult. 12. Laboratories must have a guideline outlining the responsibilities of a pathologist requesting an external consultation to ensure data and important clinical information are sent to the external consultant to allow for proper interpretation of the case in a timely manner. 13. Laboratories must collect and review data on external consultations, for the professional group. 14. Laboratories must have a policy that outlines the types of diagnoses/findings that are considered critical in the practices of physicians served by a surgical pathology group. 15. Laboratories must have a defined procedure for timely communication of critical diagnoses/significant unexpected findings to the physician most responsible for the care of the patient involved. The communication of these results must be documented. 74

75 16. Laboratories must have a policy that outlines the procedure for consultation with intradepartmental colleagues, including the documentation of those consults. Each laboratory must have a policy that outlines which cases require mandatory intra-departmental consultation and which are discretionary for the professional group. 17. Laboratories must collect and review data on intradepartmental consultations, for the professional group. 18. Laboratories must 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. When to directly inform the responsible clinician of the revision or correction (e.g., by verbal communication) and how to document that communication. The procedure for notification of the Laboratory Director (or, depending on a group s policies, the Chair of the Pathology Professional Quality Management Committee), and through the Laboratory Director (or Chair of the Pathology Professional Quality Management Committee) 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 the organization s processes. 19. Laboratories must collect and review data on corrected reports and the reasons for the corrections, for the professional group. 20. Laboratories must have a policy that outlines the procedure for correlation of current surgical pathology cases with pertinent previous/concurrent laboratory reports and, if required, related slides and other material. 21. Laboratories must collect and review facility-level data on report defect and discordances revealed by external reviews, for the professional group. definition of corrected to be determined 75