Guidelines for the Implementation of a National Quality Improvement Programme in Histopathology Version 6.11 (2018)

Transcription

1 Guidelines for the Implementation of a National Quality Improvement Programme in Histopathology Version 6.11 (2018) 1

2 Developed by The Working Group on Histopathology National QI Programme, Faculty of Pathology, RCPI Dr Sine Phelan (Chair) Dr Niall Swan Dr Julie Mc Carthy Prof Conor O Keane Dr Ann Treacy Prof Kieran Sheahan Dr Stephen Crowther Consultant Histopathologist, University Hospital Galway Consultant Histopathologist, St Vincent s University Hospital Dublin Consultant Cytopathologist, Cork University Hospital Consultant Histopathologist, Mater Misericordiae University Hospital Dublin Consultant Histopathologist, Mater Private Hospital Dublin Consultant Histopathologist, St Vincent s University Hospital Dublin Consultant Histopathologist, AMNCH Tallaght Hospital Dublin Steering Committee, National Quality Improvement Programmes Prof Emer Shelley Dr Philip Crowley Dr Niall Swan Prof Conor O Keane Dr Peter Kavanagh Prof Max Ryan Prof Stephen Patchett Dr Chris Steele Mr Peter Clarke Mr Vincent Jordan Mr Brian Dunne TBC Ms Edel Costigan Ms Collette Tully Mr Sean Egan Ms Angela Fitzgerald Dr Ciaran Browne Dr Ann O Shaughnessy Chair HSE Quality Improvement Division Faculty of Pathology, RCPI, Working Group Chair Former Chair of Steering Committee, Faculty of Pathology. RCPI representative. Director of Quality and Clinical Care Faculty of Radiologists, RCSI, Working Group Chair Dean of Faculty of Radiologists, RCSI Consultant Gastroenterologist, Beaumont Hospital, Dublin, Working Group Chair Clinical Lead for the National Endoscopy Working Group, Consultant Gastroenterologist, Letterkenny General Hospital Patient advocate HSE Office of Chief Information Officer (OCIO) HSE OCIO, ICT Project Manager (Observer) Department of Health Private Hospitals Association of Ireland National Office of Clinical Audit, Royal College of Surgeons in Ireland Health Information and Quality Authority (Observer) HSE Acute Hospitals Division, Deputy National Director HSE Acute Hospitals Division Royal College of Physicians of Ireland There are no competing interests within the guideline development working or steering group members. 2

3 TABLE OF CONTENTS HISTOPATHOLOGY QI GUIDELINES 6.11 UPDATES SYNOPSIS 5 1. BACKGROUND Programme Development Clinical Audit Time and Resources 9 2. RECOMMENDED PROCEDURAL CODES Table 1: P Codes Summary Table 2: P Codes Expanded Explanation Table 3: Recommended Quality Activity Q Codes Table 4: Recommended Primary Organ/Site Q Codes GUIDELINES ON USING NQAIS-HISTOPATHOLOGY Sign off QI data in NQAIS Further review of QI reports QUALITY TARGETS, RECOMMENDATIONS AND ACTIVITIES Laboratory Histopathology Workload HISTOPATHOLOGY GUIDELINES (INCLUDING CYTOPATHOLOGY) Inter institutional Consultation Q001 Case referred externally for review Q002 - Case received internally for review Q003 Case referred externally for opinion Q064 - Cases received internally for expert opinion Q004 & Q005 Inter institutional agreement / disagreement Intradepartmental Consultation Q Correlation of frozen section diagnosis with final diagnosis Frozen section correlation Concordance Q Frozen section correlation Deferral Q Frozen section correlation Discordance Q Turnaround Times: 20 minutes Q061 >20 minutes Q

4 5.4. Cytopathology Quality Retrospective/Focused Real Time Review Report completeness Multidisciplinary Team Meetings Laboratory Based Non-Conformances Laboratory based External Quality Assessment (e.g. NEQAS) Turnaround Time Addendum Reports Corrected report Q Supplementary report Q Amended Report Q Reports communicated directly to clinician by pathologist - Q023 and Critical Diagnosis Reporting, Q Adult Autopsy Guidelines Intradepartmental Consultation Q Autopsy Case review Q Autopsy Turnaround time Autopsy Morbidity and Mortality Meetings Q Paediatric and Perinatal Autopsy Guidelines Extra Departmental Consultation Retrospective review Turnaround time SUMMARY TARGETS AND RECOMMENDATIONS TABLE 25 NATIONAL QI PROGRAMME IN HISTOPATHOLOGY 25 TARGETS 25 NATIONAL QI PROGRAMME IN HISTOPATHOLOGY 26 RECOMMENDATIONS REFERENCES APPENDIX 2 AUTOPSY CASE REVIEW APPENDIX 3 SCORING SYSTEM: PAEDIATRIC AUTOPSY RETROSPECTIVE REVIEW FOR SID/SUDI POST MORTEMS APPENDIX 4 - SCORING SYSTEM: PAEDIATRIC AUTOPSY RETROSPECTIVE REVIEW FOR SB AND NND POST MORTEMS APPENDIX 5 SCORING SYSTEM: GENERAL PAEDIATRIC POST MORTEM RETROSPECTIVE REVIEW 34 4

5 HISTOPATHOLOGY QI GUIDELINES 6.11 UPDATES SYNOPSIS 1. Updated Working Group and Steering Group members 2. Introduction of new Coroner and Non-Coroner P&P Post Mortem Procedure Codes Master Code P12 P13 P14 P15 P16 P17 P18 P19 P20 Expansion Coroner P&P Post Mortem SIDS/Metabolic Coroner P&P Post Mortem Perinatal/Neonatal/Stillborn Coroner P&P Post Mortem General Paediatric Coroner P&P Post Mortem foetus less than 500grams Non-Coroner P&P Post Mortem SIDS/Metabolic Non-Coroner P&P Post Mortem Perinatal /Neonatal/ Stillborn Non-Coroner P&P Post Mortem General Paediatric Non-Coroner P&P Post Mortem foetus less than 500grams No Autopsy performed 3. Introduction of new Quality codes and Primary Organ Site Quality codes National code Q063 Q064 QNCNS QNPNS QNMUS National Description NEW - Critical diagnosis value reporting NEW - Case Received for Expert opinion Central Nervous system Peripheral Nervous system Neurology Neuromuscular 4. Recommendation defined - recommendation refers to recommendations that should be implemented in each histopathology laboratory to fully support quality improvement activities. Where quality targets are absent, due to lack of sufficient evidence with which to base a standard upon, a recommendation will usually be made. These recommendations are wholly endorsed by the Steering Committee of the Specialty QI Programmes and the Faculty of Pathology. The view is that recommendations will be made targets, when sufficient evidence is available, in consultation with clinical users. 5. Name change NQAIS National Quality Assurance and Improvement System. 6. New Quality Codes Defined a. Q064 cases received internally for expert opinion - records cases that are received from other institutions/hospitals to the hospital for expert opinion. In the QI Report, it is located in the Quality Area Inter-institutional Consultation. 5

6 b. Cytopathology coding update - in prior QI Guidelines, cytology was viewed as a standalone diagnostic specialty. However the use of cytology / histology codes (Q011 & Q012) has been discontinued since August All cytological QI activities are monitored independent of histology cases using existing QI codes with suggested monitoring of intradepartmental review, MDT review and discrepancies, amended and corrected reports and cases communicated to clinicians. 7. All Targets and recommendations summary (new and already set): Key Quality Area Target & Key Indicators Notes Turnaround (TAT) ROUND 1/2 Time 1. Small biopsy 80% by day 5 2. GI biopsy 80% by day 5 3. Cancer resection 80% by day 7 4. Non-biopsy 80% by day 7 5. Cytology FNA 80% by day 5 6. Cytology exfoliative 80% by day5 Calculation is for working days Intradepartmental Consultation (IDC) ROUND 1/2 Frozen Section (FS) Diagnosis ROUND 1/2 7. Histology >3% minimum, >5% achievable 8. Cytology FNA - >7% minimum, >9% achievable 9. Cytology exfoliative >3% minimum, >5% achievable 10. Autopsy - >2% 11. FS Concordance rate 97% 12. FS Deferral rate 5% 13. FS Turnaround time - 85% within 20 minutes Deferral rate should be >1% Retrospective Time Review ROUND 3 Real Multidisciplinary Team (MDT) Meetings ROUND 3 Autopsy Retrospective Review ROUND % Agreement - Histology: 95% 15. % Agreement Cytology: 95% Disagreement is defined as when it is deemed necessary to issue an amended report. Programme guidance recommends locum / new consultants have a minimum 10% rate of review for 1 month but this is a local decision. 16. % MDT Agreement - 95% Disagreement is defined as when it is deemed necessary to issue an amended report. 17. % satisfactory >90% No. of cases reviewed to be decided locally. 6

7 Key Quality Area Target & Key Indicators Notes Autopsy Morbidity & Mortality (M&M) Conference ROUND >1% of cases presented per year at hospital M&M conference M&M conferences are typically presented at hospital Medical & Surgical Grand Rounds Key Quality Area Recommendations & Key Indicators Notes Multidisciplinary Team (MDT) Meetings ROUND 3 Addendum Reports ROUND 3 % cases discussed at MDT Meeting 1. Minimum 10% of all cases (cancer centre labs). 2. Minimum 5% of all cases (general labs) 3. Minimum 50%, achievable 90% of cancer resection specimens (all labs) % Amended Reports 4. Histology cases 1% 5. Cytology cases 1% % Corrected Reports 6. Histology cases 2% 7. Cytology cases 2% % Supplementary Reports 8. Histology cases 10% 9. Cytology cases 10% Cases listed for MDT are outside of pathologist direct control. Data needs to be collected with a view to setting the target in 2017 For general labs with low MDT meeting activity a combined peer review rate (with IDC) of >10% is recommended Classification of amended / corrected reports is to be further reviewed with a view to setting a target in 2017 Case mix can impact supplementary report rate and should be noted on NQAIS reports as applicable 7

8 1. Background The vision of the National QI Programme in Histopathology (HQI Programme) is to create a patient centred Quality Improvement framework within each pathology department, which facilitates their routine review of performance and drives improvement, in key quality areas against intelligent targets. The development of a National QI Programme in Histopathology was undertaken by the Faculty of Pathology, RCPI. This document provides guidance to pathologists on the implementation of a QI Programme. Local protocol will determine how these guidelines are adapted but it is recommended that systems are developed to collate the required data for each monitor outlined in this document. This quality improvement programme is merely a small component in maintaining a quality laboratory. A QI Lead Pathologist and Medical Scientists should be established within each histopathology laboratory to ensure routine review of quality data and to initiate improvements where required. The department should work within their local quality, patient safety and risk structures to collect, analyse report on and respond to quality improvement data. Improving Diagnosis in Healthcare National Academies Press/Institute of Medicine USA (2015) conservatively estimated 5% of adults seeking out patient care each year experience a diagnostic error. Furthermore, diagnostic error accounts for between 6% and 17% of hospital adverse events. The report did not identify an appropriate minimal error rate. There is a professional view that a zero error rates are achievable. The Faculty of Pathology, RCPI and the Histopathology QI Programme do not agree with this view and emphasise that there is a minimal error rate in diagnostic pathology. It is not possible to currently estimate an appropriate target. The Irish National Quality Improvement Programme is in a strong position to identify such a target value. This should be a major focus of the program which should also focus on identifying and acting to improve key quality areas. This document outlines: The key quality indicators by which individual histopathology laboratories will monitor their activities. Recommendations for the measurement of each key quality monitor. Existing national and international targets for each key monitor. Finally, the Faculty of Pathology accepts that this QI Programme is an evolving process and that this document will require regular reviews. It is intended that the guidelines will be reviewed on a suggested 2 to 3 yearly basis by the Working Group and approved by the Faculty of Pathology and the Steering Group Programme Development The HQI Programme was developed in response to cancer misdiagnoses in 2007 and With this programme, the Faculty of Pathology aimed to develop a quality improvement framework in every histopathology laboratory based upon data and international standards, to help assure the health service and the wider public that the histopathology service was and is meeting quality standards and was reacting appropriately to instances suboptimal practice. 8

9 This aim is in alignment with the aim stated in National Standards for Safer Better Healthcare (2012), issued by the Health information and Quality Authority and the HSE National Service Plan (2016). The Programme was initiated in 2009 and now includes 32 laboratories, both public and private, including the eight cancer centres. The programme has successfully rolled out an ICT system to collect and analyse data, for target setting, validation and comparison purposes. The aim of the programme is now to embed itself within the larger health service as a part of day-to-day activities Clinical Audit Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. This document recommends a number of clinical audit activities in which a Pathology Department should be engaged. For further information please reference RCPI Clinical Audit document Time and Resources The fundamental aim of the programme is to assure enhancement of patient care with timely, accurate and complete pathology diagnoses and reports. The Faculty of Pathology acknowledges that the quality improvement activities detailed in this programme will require time to perform and recommends that dedicated time be reserved for the QI Clinical Lead and Local Operational Manager for these. 9

10 2. Recommended Procedural Codes It is recommended to adopt the following list of P codes for coding QI Programme required data. It is anticipated that as the QI Programme evolves these categories as outlined in the table below may require further refinement Table 1: P Codes Summary Master Code P01 P02 P03 P04 P05 P06 P07 P09 P10 P11 P12 P13 P14 P15 P16 P17 P18 P19 P20 Expansion Small Biopsy GI Endoscopic Biopsy Non Biopsy Cancer Resection Non Biopsy Other (includes all external cases received) Cytology for Cerebrospinal Fluid Non Gynaecological cytology FNA Non Gynaecological cytology Exfoliative Gynaecological cytology Post mortem - Coroner Postmortem - Non Coroner/Consented/House Coroner P&P Post Mortem SIDS/Metabolic Coroner P&P Post Mortem Perinatal/Neonatal/Stillborn Coroner P&P Post Mortem General Paediatric Coroner P&P Post Mortem foetus less than 500grams Non-Coroner P&P Post Mortem SIDS/Metabolic Non-Coroner P&P Post Mortem Perinatal /Neonatal/ Stillborn Non-Coroner P&P Post Mortem General Paediatric Non-Coroner P&P Post Mortem foetus less than 500grams No Autopsy performed 2.2. Table 2: P Codes Expanded Explanation Code P01 Clarification Core, needle, punch, shave biopsies/shave excisions/skin small biopsies including but not limited to liver, bronchial, lung core, endometrial pipelle, skin punch, prostate, renal, lymph node core and targeted core biopsy for tumour P02 Endoscopic GI biopsies from oesophagus to anus P03 Cancer resections which includes (but is not limited to): specimens with no residual primary tumour (mastectomy, colectomy for malignant polyp, etc). 10

11 regional node dissections without primary resection (axillary, neck dissections) wide local excision for melanoma with or without sentinel node biopsy resection for pre-invasive / neoplastic disease (hysterectomy for hyperplasia, colectomy for polyposis. Orchidectomy for neoplasm Salivary gland / thyroid resections for neoplasm Note: For staging operative procedures prior to resection, specimens received can vary and coding depends on their nature (e.g. Lymph node biopsies, liver biopsies). Coding depends on nature of the specimen i.e. Liver biopsy = P01, lymph node excisional biopsy = P04. If the definitive cancer resection subsequently is performed the specimen is coded P03 P04 All other surgical specimens which are neither small biopsies nor cancer resections including TUR Bladder, TURP, lymph node biopsy, bone marrow trephine biopsy, colectomy for diverticular disease, skin ellipse, elliptical excisions, hysterectomy for fibroids, endometrial curetting, lymph nodes for lymphoma diagnosis, appendix, gallbladder, fallopian tubes, placenta, TAH for non malignancy, colon resections for non malignancy. External material received internally for review should be coded as P04. 11

12 2.3. Table 3: Recommended Quality Activity Q Codes National code Q001 Q002 Q003 Q004 Q005 Q006 Q007 Q008 Q009 Q010 Q011 Q012 Q013 Q014 Q015 Q016 Q017 Q018 Q019 Q020 Q021 Q022 Q023 Q024 Q025 Q026 Q027 Q028 Q029 Q030 Q031 Q032 Q033 Q034 Q035 Q036 Q037 Q038 National Description Case referred externally for review Case received internally for review Case referred externally for opinion Inter Institutional Agreement Inter Institutional Disagreement Case subject to Intradepartmental Consultation Frozen section correlation - Concordance Frozen section correlation - Deferral Frozen section correlation - Major discordance RETIRED - Cytology/histology correlation - Concordance RETIRED - Cytology/histology correlation - Discordance - False positive RETIRED - Cytology/histology correlation - Discordance - False negative Case subject to focused real time review Case subject to report completeness review Focused review - Agreement Focused review - Disagreement Case subject to MDT/M&M review MDT/M&M review - Agreement MDT/M&M review - Disagreement Supplementary Reports Amended Reports Corrected Reports Report Communicated Directly to clinician Cytology Interpretation error Histology Interpretation error Cytology sampling error Histology sampling error Agreement Disagreement Report Complete Report Incomplete Case subject to random review Random review - Agreement Random review - Disagreement Post mortem - Toxicology performed Post mortem - Histology performed Post mortem - Neuropathology performed Post mortem - Neither Toxicology nor Histo nor Neuro performed 12

13 Q039 Q040 Q041 Q042 Q043 Q044 Q045 Q046 Q047 Q048 Q049 Q050 Q051 Q052 Q053 Q054 Q055 Q056 Q057 Q058 Q059 Q060 Q061 Q062 Q063 Q064 Postmortem - Organ retained Perinatal & Paediatric Postmortem - SIDS/Metabolic Perinatal & Paediatric Postmortem - Non SIDS/Metabolic Autopsy case review satisfactory Autopsy case review unsatisfactory Perinatal & Paediatric autopsy satisfactory >= Min Accepted Score Perinatal & Paediatric autopsy unsatisfactory < Min Accepted Score Excellent Good Satisfactory Unacceptable Poor Frozen section correlation - Minor discordance Pre analytic high risk non conformance Pre analytic medium risk non conformance Pre analytic low risk non conformance Analytic high risk non conformance Analytic medium risk non conformance Analytic low risk non conformance Post analytic high risk non conformance Post analytic medium risk non conformance Post analytic low risk non conformance Frozen section turnaround time <= 20mins Frozen section turnaround time > 20mins NEW - Critical diagnosis value reporting NEW - Case Received for Expert opinion It is recommended to adopt the following list of Q codes for the classification of primary organ/site for each case Table 4: Recommended Primary Organ/Site Q Codes National code (POS) QADR QANAL QBIL QBLAD QBM QBR QCERV QCNS QCOL QCVS National Description Adrenal Anus Biliary tract (intra- and extra-hepatic) and Gallbladder Bladder Bone Marrow Breast Cervix Central Nervous system Colon (includes appendix) Cardiovascular (pericardium, cardiac, vascular) 13

14 QDUOD QFT QGAST QHEP QHN QKID QLN QLUNG QMED QMEL QOES QOTH QOV QPANC QPAT QPEN QPER QPL QPROS QRECT QSAL QSBO QSKEL QSKIO QSKIT QSOFT QSPL QTEST QTHY QURE QUT QVUL QNCNS QNPNS QNMUS Duodenum Fallopian tube Stomach Liver Upper aerodigestive tract, maxilla/mandible Kidney Lymph node (primary disease) Lung Mediastinium Melanoma Oesophagus Other (includes placenta, eye, scrotum, urethra) Ovary Pancreas Parathyroid Penis Peritoneum/Omentum Pleura (includes pleural fluid cytology) Prostate Rectum Salivary gland Small Bowel (jejunum and ileum) Skeletal system (bones/joints) Other Non-melanoma tumour Soft tissue Spleen Testis Thyroid Ureter Uterus Vulva/vagina Central Nervous system Peripheral Nervous system Neurology Neuromuscular 14

15 3. Guidelines on using NQAIS-Histopathology 3.1. Sign off QI data in NQAIS The QI Lead Histopathologist liaises with the QI Local Operational Manager monthly to ensure the data is uploaded to the NQAIS-Histopathology site. The data is examined at a local level to assess compliance with targets and comparison with other centres Further review of QI reports It is also recommended that the learning from QI activity in the Histology Laboratory be communicated to the Quality and Safety Committee in each hospital. The standardised, monthly QI reports could provide a straightforward method of delivering this information to the Committee. Opportunities for recognising high quality and making improvements should be identified and quality improvement initiatives developed and implemented accordingly. 4. Quality Targets, Recommendations and Activities The National Guidelines for Implementation of the QI programme in Histopathology set out a number of targets and specific recommendations for Histology Laboratories. Targets are developed by the QI Working group using international evidence, expert opinion, and analysis of data collected through the NQAIS-Histopathology tool in consultation with clinical users. For full details on this, please see our Target Setting Methodology Document on the Programme website. Target refers to the target associated with Quality Indicators Recommendation refers to recommendations that should be implemented in each histopathology laboratory to fully support quality improvement activities. Where quality targets are absent, due to lack of sufficient evidence with which to base a standard upon, a recommendation will usually be made. These recommendations are wholly endorsed by the Steering Committee of the Specialty QI Programmes and the Faculty of Pathology. The view is that recommendations will be made targets, when sufficient evidence is available, in consultation with clinical users Laboratory Histopathology Workload Each monthly and yearly report provides specific data for each laboratory with respect to total number of cases, specimens, blocks and stains (including special stains and immunohistochemistry). The workload can be tracked month to month and year to year to assess for trends and fluctuations in workload. 5. Histopathology Guidelines (including Cytopathology) 5.1. Inter institutional Consultation Q001 Case referred externally for review Inter institutional case review provides an additional mechanism for evaluating diagnostic accuracy at the original institution. It occurs when a patient s treatment is transferred to another institution triggering a review of original diagnosis. It can also occur when a clinician requests a review of original diagnosis by an external institution. 15

16 5.1.2 Q002 - Case received internally for review Cases received internally for review refers to when a patient s treatment is transferred internally triggering a review of patient diagnosis or where a clinician has requested a review of original diagnosis performed externally. All cases received internally for review should be coded as P Q003 Case referred externally for opinion Inter Institutional opinions, which relate to cases referred externally for opinion refers to where a Pathologist seeks opinion of an individual with perceived expert opinion at a separate institution due to diagnostic difficulty or lack of consensus opinion from intradepartmental consultation. In the QI Report, it is located in the Quality Area inter-institutional consultation Q064 - Cases received internally for expert opinion Records cases that are received in from other institutions/hospitals to the hospital for expert opinion. In the QI Report, it is located in the Quality Area Inter-institutional Consultation Q004 & Q005 Inter institutional agreement / disagreement Cases subject to inter institutional consultation are given an agreement (Q004) or disagreement (Q005) code on return of the case. This is also recorded on the external report. Where a report is received back after inter institutional consultation with a diagnosis that is discordant from the primary diagnosis made, it is recommended that the case be brought to an intradepartmental discrepancy case conference and an amended or corrected report be issued. Target Set: Recommendation: Not settable. Learning opportunity. Review of discordant cases at departmental discrepancy conference and issue of an amended / corrected report as appropriate. Ensure reports from external sites are returned Intradepartmental Consultation Q006 Intradepartmental consultation occurs when a consultant pathologist seeks a second opinion from another consultant pathologist within their department or within their regional hospital network on a particular case prior to authorisation of the final report. Pathologists should record the consultation in the QI system and where appropriate in the final report. Target Set: Histology cases 3% (minimum) -5% (achievable) Cytology exfoliative 3% (minimum)-5% (achievable) Cytology FNA 7% (minimum)-9% (achievable) 5.3. Correlation of frozen section diagnosis with final diagnosis Monitoring the correlation of frozen section diagnosis and permanent section diagnosis is an integral component of a histology QI program. It is recommended that permanent section slides should be analysed with the accompanying frozen section slides to establish if any discrepancy exists. It is recognised that certain frozen section activities have a high discordance rate and that errors may arise due to sampling or interpretative issues. Frozen section discordances should be reconciled in the final pathology report and reviewed and discussed at the departmental discrepancy conference Frozen section correlation Concordance Q007 Represents cases where frozen section and permanent section diagnosis are in agreement. 16

17 5.3.2 Frozen section correlation Deferral Q008 The number of cases where frozen section diagnosis was deferred until final diagnosis was reached on permanent section review Frozen section correlation Discordance Q009 Represents a discordance between the original frozen section diagnosis and the one rendered upon final diagnosis. Errors can be classed into interpretative or sampling errors. Please see coding tables Turnaround Times: 20 minutes Q061 >20 minutes Q062 The turnaround time for a frozen section is an important parameter due to the intraoperative nature of the consultation. College of American Pathologists (CAP) benchmarks for frozen sections turnarounds are included in the endnotes for information. Target: Frozen section concordance: 97% Deferral rate: 1-5% Turnaround time: 85% 20 minutes 5.4. Cytopathology Quality In prior QI Guidelines, cytology was viewed as a standalone diagnostic specialty. However, the use of cytology / histology codes (Q011 & Q012) has been discontinued since August All cytological QI activities are monitored independent of histology cases using existing QI codes with suggested monitoring of intradepartmental review, MDT review and discrepancies, amended and corrected reports and cases communicated to clinicians. Target: Please see sections 5.2, 5.5, 5.7 and 5.10 Recommendation: Review and monitoring of cytology cases using existing QI codes intradepartmental review, MDT review, MDT discrepancies, amended reports, corrected reports, reports communicated to clinicians Retrospective/Focused Real Time Review It is recommended that focused review of previous negative cases and specific, clinically relevant areas of practice identified locally is conducted. Examples of suggested areas suitable for the application of focused real time review include positive or negative prostate needle biopsies, cervical biopsies and melanocytic lesions. Local protocols and practices should determine which case type to review, frequency and number of cases to be considered. It is recommended that a minimum of one review is performed yearly and in a real time manner such that if a significant discrepancy that would affect patient care is found, the physician is notified as soon as possible. Cases with disagreements should be reviewed and discussed at departmental QI discrepancy conferences. Case subject to focused real time review Q013 Focused review agreement Q015 Focused review disagreement Q016 Target: Agreement 95% Recommendation: Review of 10% locum/new consultant cases for one month 17

18 5.6. Report completeness Measuring the completeness of pathology reporting is an important component of histopathology QI. Canadian Association of Pathology (CAP) reports that many studies have shown that standardized reporting forms, including synoptic reports or checklists, are highly effective in improving report adequacy, particularly for cancer reporting. ADASP, RCPath, CAP and ICCR Standards and Datasets for Histopathology on Cancers and Tissue Pathways have been written to help pathologists work towards a consistent approach for the reporting of the most cancers. It is recommended to conduct a minimum of one review yearly with particular emphasis on completeness of cancer reporting in accordance with these datasets. When reviewing a report for completeness, it is recommended that the report be evaluated for the presence of core items defined by guidelines from the bodies listed. If any one of these core items is omitted, the report is considered incomplete. If all core items are present, the report is considered complete. With the introduction of the new National laboratory information system (LIS) in 2017, standardised reporting of cancer cases will be integrated as part of the software and review of report completeness will become part of regular QI activities. Report complete Q030 Report incomplete Q031 Target: Recommendation: Not set Review of the report as part of the MDT review. Audit opportunity 5.7. Multidisciplinary Team Meetings Multidisciplinary Team (MDT) meetings form an essential part of the clinical care of patients with cancers, suspected cancer or other clinical conditions. Histopathologists are in a key position to participate fully in such meetings and play an important role in patient management. Organisation of MDT meetings and determining cases for review is the responsibility of the MDT coordinator or clinical teams within the hospital. The reviewing Pathologist should prepare the cases assigned for review at MDT, reconcile any discrepancies noted prior to MDT and attend the MDT meetings to present and discuss cases. After the MDT meeting records should be kept of the cases discussed, appropriate Q codes recorded for each case reviewed and any amended / corrected or supplementary reports issued as required. Cases which are discordant at MDT review should be reviewed at part of the departmental discrepancy case conference. If a case is reviewed more than once at MDT, each individual review should be coded although it should be noted NQAIS currently will only record one code (Q017) per case. Only disagreement at MDT due to pathological interpretation should be classified as disagreement at MDT. Disagreement which arises due to the provision of additional clinical information does not come under this category In the case where no in-house MDT's are held in a hospital and cases are referred externally for review at MDT, a case should only be recorded as reviewed at MDT if a pathologist from the institution which generated the case participates in person or remotely i.e. via video link. Otherwise the case should be recorded under inter-institutional case review (Q001) or under intradepartmental consultation (Q006) for cases sent out from smaller departments within their regional network. 18

19 MDT / M&M review Agreement Q017 MDT / M&M review Disagreement Q019 Target: Agreement 95% Recommendation: % cases discussed at MDT Meeting: 1. Minimum 10% of all cases (cancer centre labs) 2. Minimum 5% of all cases (general centre labs) 3. Minimum 50% of all cancer resection specimens (all labs) 4. Achievable Target 90% all cancer resection specimens (all labs) Comment: A high proportion of cancer resection cases (P03) should be discussed at MDT 5.8. Laboratory Based Non-Conformances A laboratory non-conformance is any event that has the potential to cause harm and should be classified according to the HSE risk assessment matrix. Reporting of laboratory based non-conformances is a requirement for laboratory accreditation. Each histopathology laboratory should have existing policies, processes and procedures in place for reporting non-conformances and determining corrective and preventative action. Since this is already embedded in the quality management systems of laboratories undergoing INAB / ISO accreditation it was decided recording of non-conformances in NQAIS QI data would duplicate work and coding of nonconformances for NQAIS is not currently recommended by the programme. Non-conformances should be reviewed within the laboratory. Target: Recommendation: Not set. Non-conformances should be reported as per existing laboratory policy and discussed at laboratory quality meetings Laboratory based External Quality Assessment (e.g. NEQAS) External Quality Assessment (EQA) schemes in histopathology form a key part of laboratory quality management. It is highly recommended that all histopathology laboratories participate in external quality assessment schemes that assess and score the quality of slide preparation and staining. Participation in EQA schemes is recorded under laboratory accreditation schemes. Since this is already in place recording of EQA scheme participation in QI data would duplicate work. Target: Not set. Recommendation: EQA scheme participation is recorded in existing laboratory accreditation policy Turnaround Time Turnaround time (TAT) is a key monitor of the overall function of the laboratory service and is considered a critical element of quality due to impact on clinical management of patients. Turnaround time is measured from the time the lab receives the specimen to the time the final report is authorised. Turnaround time is calculated based on working days and does not include weekends or bank holidays. 19

20 To ensure a meaningful representation of hospital case turnaround time, it is recommended to classify Biopsy TAT and Non Biopsy TAT separately. Non-Biopsy cases should be further classified into Cancer Resections (by organ/site) and into All Other cases. The National Cancer Control Programme (NCCP) and HIQA are developing national evidence-based clinical guidelines for the diagnosis, staging and treatment of common cancers. For turnaround time calculations the day of receipt of a specimen is considered day 0. The % of cases completed by day 1 includes samples completed on day 0 and day 1. Days are calculated in working days. Target: Code Type Completion P01 Small biopsy 80% day 5 P02 GI biopsy 80% day 5 P03 Cancer resection 80% day 7 P04 Non biopsy other 80% day 7 P06 Cytology - FNA 80% day 5 P07 Cytology - Exfoliative 80% day Addendum Reports An addendum report refers to any pathology report issued subsequent to original report and should be classified as corrected, supplementary or amended. Variable interpretations of the definitions of corrected, amended and supplementary reports are recognised. The National QI Programme definitions are listed below and there has been considerable debate with regard to their use and the possibility of consolidating them. Nonetheless the different codes continue to be used with targets and recommendations developed which will be monitored and revised as required. The term addendum report is synonymous with revised report Corrected report Q022 Report issued when transcription, patient identification, specimen site, or other related reporting errors occur. Corrected reports do not change original interpretive diagnosis Supplementary report Q020 Report issued when new information becomes available after the final report has been submitted. Newly obtained clinical information, findings on additional histological sections or review of archival material, the results of special studies such as immunohistochemistry or molecular diagnostics, and the results of consultations may be included in a supplementary report. When issued following a provisional report, the supplementary report acts as the final report. If the original report does not indicate further studies / opinions are being sought and the subsequent supplementary information changes the original diagnoses, the addendum report should be classified as amended Amended Report Q021 Report issued when the final report diagnosis changes due to an interpretive error or other important pathologic information becomes available that results in a major change in diagnosis and / or treatment. The reasons for the revision should be explained in the report and the clinician notified directly, because an amended report may significantly affect patient care. It is recommended that all amended reports/cases be reviewed at a QI discrepancy case conference. 20

21 Amended reports may be reportable as non-conformances and evaluated through the hospital management system to assess impact on patient care. Some centres may have higher rates of supplementary reports than target due to high volumes of cases requiring supplementary molecular or immunohistochemical analysis. Review of supplementary reports as an audit activity may locate incorrectly coded amended and corrected reports and would also be valuable in tracking the percentage of supplementary reports containing the final diagnosis Recommendation: Corrected report Q022: 2% Supplementary report Q020: 10% Amended report Q021: 1% Reports communicated directly to clinician by pathologist - Q023 and Critical Diagnosis Reporting, Q063 Communication between pathologists and clinicians is an important component of professional practice. Local policies and professional judgment of the pathologist often determine when to communicate directly with the clinician. Reasons for communication include urgent cases, unsuspected malignancies, medical emergencies and also in an effort to glean further clinical information. In many cases the communication relates to critical diagnoses. Q063 Records all cases communicated to clinicians that are regarded as a critical diagnosis. A list of critical diagnoses should be developed locally within each department / hospital with development of a local standard operating procedure (SOP) to determine the use of the code. A record of the communication is advised either on the report or within the reporting system (specimen notepad). Suggested examples include unsuspected malignancy, mycobacterial infection, life-threatening infection, fat in endometrial curetting, and amended reports (both codes should be used) Q023 should be used for cases communicated to clinicians that are not defined as critical diagnoses. Frozen section cases and on-site cytology evaluation would not be considered appropriate to include in this monitor. Target: Recommendation: Not set. Communication with clinicians is encouraged. Development of list of critical diagnoses within each department Adult Autopsy Guidelines Autopsy in the QI programme should include review of both Coroner and Non Coroner case types Intradepartmental Consultation Q006 Intradepartmental consultation occurs when a consultant pathologist seeks a second opinion from another consultant pathologist within their department or within their regional hospital network on a particular case. Generally, a pathologist should seek a second opinion if there is any doubt about the correct diagnosis, in particular information that might appear on the death certificate. Pathologists should record the consultation in the QI system and where appropriate in the final report. 21

22 Any review of an autopsy case that occurs prior to authorisation of the final report should be recorded as an intradepartmental consultation. Target: 2% cases Autopsy Case review Q032 Autopsy case review is auditing of the final report of randomly selected or focused cases. This review should take place every six months and within six months of the report being finalised. Obtaining an intradepartmental consultation on an element of an autopsy (e.g. histological sections of myocardium, wording of cause of death statement) does not qualify as a review of a case. An evaluation form for autopsy is provided in appendix 2 to facilitate autopsy case review. This form aims to interrogate the completeness, accuracy and scope of any given completed autopsy. Autopsy case review satisfactory Q042 Autopsy case review unsatisfactory Q043 Target: Recommendation: 90% satisfactory Number of cases reviewed to be decided locally Minimum number of cases reviewed is to be decided locally. ICU deaths and sudden cardiac deaths suggested types of cases Autopsy Turnaround time The Faculty recognises the potential benefit of provisional autopsy reporting to clinicians, pathologists and the coroner and recommends that provisional reporting be adopted as standard practice. For the purposes of this QI Programme, the turnaround time of the autopsy final report will be monitored. Final report turnaround time is measured from the date of autopsy to the date the final report is authorised Autopsy Morbidity and Mortality Meetings Q017 Morbidity and mortality meetings, ICU meetings or surgical grand rounds are carried out at most hospitals. Discussion of autopsy findings is encouraged at these meetings and represents a form of MDT review and discussion. Cases should be coded using the MDT codes for agreement (Q017) and disagreement (Q019). Target: 1% of autopsy cases per year Paediatric and Perinatal Autopsy Guidelines Paediatric autopsy refers to autopsies carried out on children aged up to the age of 16. Perinatal autopsy refers to autopsy carried out on stillbirths and infants dying within in the first week of life. Only perinatal autopsies > 500g should be included. P12 Coroner P&P PM SIDS/Metabolic A coroner s PM on a child where the clinical circumstances warrant a PM with additional test modalities. Obvious examples include sudden unexpected deaths where non accidental injury or inborn errors of metabolism are considerations and require investigations (e.g. skeletal survey, metabolic work-up) not routinely utilised in PM practice. P13 Coroner P&P PM Perinatal/Neonatal/Stillborn 22

23 A coroner s PM on a child stillborn, or dying in the first 28 days of life. This corresponds to the categorisation of infant deaths routinely used in maternity services and reflects PM s in which obstetrical history and placental examination are key considerations. P14 Coroner P&P PM General Paediatric All other coroner s PMs on children not covered by P12, P13 or P15 P15 Coroner P&P PM foetus less than 500gm A Coroner post mortem on a foetus under 500gm P16 Non-Coroner P&P PM SIDS/Metabolic A non-coroner s PM on a child where the clinical circumstances warrant a PM with additional test modalities. Obvious examples include deaths where inborn errors of metabolism are considerations and require investigations (e.g metabolic work-up) not routinely utilised in PM practice. P17 Non-Coroner P&P PM Perinatal/Neonatal Stillborn A non-coroner s PM on a child stillborn, or dying in the first 28 days of life. This corresponds to the categorisation of infant deaths routinely used in maternity services and reflects PM s in which obstetrical history and placental examination are key considerations. P18 Non-Coroner P&P PM General Paediatric All other non-coroner PM s on children not covered by P16, P17 or P19 P19 Non-Coroner P&P PM foetus less than 500gm A non-coroner post mortem on a foetus under 500gm P20 No autopsy performed P&P only A category requested by some of the maternity units to assist in data collection Q044 Paediatric and Perinatal autopsy satisfactory A PM where the modified Rushton score is above the designated minimum for the appropriate category of the PM Q045 Paediatric and Perinatal autopsy not satisfactory A PM where the modified Rushton score is below the designated minimum for the appropriate category of the PM Neonatal autopsy refers to autopsy carried out on infants dying within the first 28 completed days of life. The Paediatric and Perinatal Sub specialty group will develop specific guidelines once sufficient data has been collected Extra Departmental Consultation Paediatric autopsy extra departmental consultation occurs when cases are presented for review at multi-disciplinary Morbidity and Mortality (M&M) meetings Retrospective review Retrospective review is auditing of randomly selected or focused case types post reporting of final diagnosis. For autopsy retrospective review it is recommended that all metabolic/cot deaths, all 23

24 SIDS/SUDI and a minimum of 20 other paediatric autopsy (including stillbirths and neonatal deaths) cases are reviewed per year. It is recommended that retrospective review be carried out within 1 month of PM completion and no later than 3 months. Evaluation forms based on a modified version of the Rushton System to facilitate retrospective review of paediatric and perinatal post mortems PMs are provided in appendices 3, 4 and 5. These provide a scoring system which aims to interrogate the completeness and scope of completed autopsies. It should be noted that Evaluation of Overall Autopsy is an important quality measure for paediatric autopsy as in adult autopsy and will be included in future revisions of these QI Guidelines Turnaround time 1. Final report turnaround time is measured from the date of autopsy to the date the final report is authorised. The following indicators should be measured and reviewed annually for Paediatric Autopsy PM Final Report TAT. 24

25 6. Summary Targets and Recommendations Table NATIONAL QI PROGRAMME IN HISTOPATHOLOGY TARGETS Key Quality Area Target & Key Indicators Notes Turnaround Time (TAT) ROUND 1/2 Intradepartmental Consultation (IDC) ROUND 1/2 Frozen Section (FS) Diagnosis ROUND 1/2 1. Small biopsy 80% by day 5 2. GI biopsy 80% by day 5 3. Cancer resection 80% by day 7 4. Non-biopsy 80% by day 7 5. Cytology FNA 80% by day 5 6. Cytology exfoliative 80% by day5 7. Histology >3% minimum, >5% achievable 8. Cytology FNA - >7% minimum, >9% achievable 9. Cytology exfoliative >3% minimum, >5% achievable 10. Autopsy - >2% 11. FS Concordance rate 97% 12. FS Deferral rate 5% 13. FS Turnaround time - 85% within 20 minutes Calculation is for working days Deferral rate should be >1% Retrospective Real Time Review ROUND 3 Multidisciplinary Team (MDT) Meetings ROUND 3 Autopsy Retrospective Review ROUND 3 Autopsy Morbidity & Mortality (M&M) Conference ROUND % Agreement - Histology: 95% 15. % Agreement Cytology: 95% Disagreement is defined as when it is deemed necessary to issue an amended report. Programme guidance recommends locum / new consultants have a minimum 10% rate of review for 1 month but this is a local decision. 16. % MDT Agreement - 95% Disagreement is defined as when it is deemed necessary to issue an amended report. 17. % satisfactory >90% No. of cases reviewed to be decided locally. 18. >1% of cases presented per year at hospital M&M conference M&M conferences are typically presented at hospital Medical & Surgical Grand Rounds 25

26 NATIONAL QI PROGRAMME IN HISTOPATHOLOGY RECOMMENDATIONS Key Quality Area Recommendations & Key Indicators Notes Multidisciplinary Team (MDT) Meetings ROUND 3 % cases discussed at MDT Meeting 1. Minimum 10% of all cases (cancer centre labs). 2. Minimum 5% of all cases (general labs) 3. Minimum 50%, achievable 90% of cancer resection (P03) specimens (all labs) Cases listed for MDT are outside of pathologist direct control. Data needs to be collected with a view to setting the target in For general labs with low MDT meeting activity a combined peer review rate (with IDC) of >10% is recommended. Addendum Reports ROUND 3 % Amended Reports 4. Histology cases 1% 5. Cytology cases 1% % Corrected Reports 6. Histology cases 2% 7. Cytology cases 2% % Supplementary Reports 8. Histology cases 10% 9. Cytology cases 10% Classification of amended / corrected reports is to be further reviewed with a view to setting a target in Case mix can impact supplementary report rate and should be noted on NQAIS reports as applicable. 26

27 7. References ADASP Checklists ( Association of Directors of Anatomic and Surgical Pathology. Recommendations for Quality Assurance and Improvement in Surgical and Autopsy Pathology. Am J Clin Pathol. 2006;126: Association of Directors of Anatomic and Surgical Pathology. Recommendations for Quality Assurance and Improvement in Surgical and Autopsy Pathology 2006;126: Azam M, Nakhleh RE. CAP Laboratory Improvement Programs. Surgical Pathology Extra departmental Consultation Practices. A College of American Pathologists Q-Probes Study of 2746 Consultations From 180 Laboratories. Arch Pathol Lab Med. 2002;126: Building a Culture of Patient Safety - Report of the Commission on Patient Safety and Quality Assurance. Department of Health and Children. Dublin: CAP Cancer Protocol and Checklists - College of American Pathologists Clinical Pathology Accreditation (UK) Ltd. Standards for the Medical Laboratory. PD-LAB-Standards v2.01. Mar Link to website: Standards_v2.01_Mar_09.pdf Health Information and Quality Authority Investigation Report into the care received by Rebecca O Malley, Symptomatic Breast Disease Services at the Mid Western Regional Hospital Limerick and the Pathology Services at Cork University Hospital. Health Information and Quality Authority. Dublin: 2008 Health Information and Quality Authority Investigation Report into the Pathology Service and the Symptomatic Breast Disease Service at University Hospital Galway. Health Information and Quality Authority. Dublin: 2008 Guidelines for the Post Mortem Consent and retention of samples. February Faculty of Pathology. Royal College of Physicians of Ireland. Guidelines for Quality Management in Surgical Pathology Professional Practices. A Proposal for Laboratory Physicians in Ontario. A project of Path2Quality (a collaboration of the OMA Section on Laboratory Medicine and the Ontario March Guidelines for Safe and Effective Management and Use of Point of Care Testing. Approved by the Academy of Medical Laboratory Science, Association of Clinical Biochemists in Ireland, Irish Medicines Board and RCPI Faculty of Pathology November 28,