User guidance

1. User guidance • This presentation can be used to train record screeners and medical reviewers for both retrospective record review and record review of current in-patients (slides can either be projected with a beamer or distributed in hard-copy) • Deliver this training approximately one week before the record review but start preparing early (rehearsing, preparing training materials, etc.) • Record screeners and medical reviewers should attend the same training session • The slides can be used to train screeners and reviewers who have not received any training and have no experience with record reviews (at least one day for the former and one to two days for the latter) or for a refresher course for trained and experienced screeners and reviewers (half a day): the content is the same but the pace of work varies • Adapt the slides in line with local requirements as appropriate • Distribute a “record review of current in-patients protocol” or a “retrospective record review protocol” (depending on training objective) and a copy of the RF2 form to each participant at the beginning of the training session • Provide further training if necessary

2. Training of record screeners and medical reviewers <insert your name, title and affiliation>

3. What and how will you learn? • What: • Unsafe care and WHO’s response • Key concepts of patient safety • The objectives and process of record review • Your role and responsibilities as a record screener or medical reviewer • How to excel in your role: do's and dont‘s • How: • Facilitator-led presentation • Questions and discussion • Quiz • Hands-on exercise

4. What is patient safety? • Freedom from accidental injuries during medical care • Activities to avoid, prevent or correct any adverse outcomes which may result from the delivery of health care

5. Why is patient safety important? • Every year tens of millions of patients suffer disabling injuries or death due to unsafe medical care • In developed countries 1 in 10 patients is harmed while receiving hospital care • We know little for developing countries but evidence suggests that they are even more affected by patient harm • The consequences are millions of devastated lives and billions of dollars unnecessarily spent on prolonged hospitalization, loss of income, disability and litigation

6. The initiative of the World Health Organization • Against this backdrop, the World Health Organization called into life the World Alliance for Patient Safety in 2004 • The Alliance pays particular attention to patient harm in developing and transitional countries • Since fact-based knowledge is often rare in such contexts, the Alliance has developed simple methods to help local practitioners and researchers assess and tackle patient harm in data-poor environments • You can contribute to successfully conducting one of these methods by acting as a nominal group meeting facilitator

7. What is a record review? Record review is the process of analysing medical records for evidence of HIs based on a set of criteria The objective of record review is to… • identify areas with care problems • gain data on which to base interventions/solutions • raise awareness of patient safety

8. Key concepts Harmful incident (HI) Preventability • Unintended injury or complication • Prolonged admission, disability at discharge or death • Caused by health-care management rather than the disease process • May or may not be preventable or caused by negligence (e.g. post-operation wound infection) • Harm would not have arisen if standard levels of care had been used • or • Event is preventable if reasonable steps to prevent this occurrence can be identified

9. Key concepts In-patient Contributing factor • Patient admitted to a health-care facility for treatment that requires at least one overnight stay • A factor in an event, effect, result or outcome which is similar to a cause and can relate to the • Patient (e.g. co-morbidities) • Task (e.g. lack of guidelines/protocols or their use) • Individual (e.g. lack of knowledge) • Team (e.g. poor team-work) • Environment (e.g. defective or unavailable equipment) • Organisation (e.g. poor co-ordination of overall services)

10. Key concepts Prevalence of HIs Incidence of HIs • the ratio on the day of data collection of the number of cases with HIs to the total number of cases: • number of HIs x 100 • number of screened records • the ratio for the year of data collection of the number of cases with HIs to the total number of cases: • number of HIs x 100 • number of screened records

11. Record review of current in-patients vs. retrospective record review

12. The record review process Record screening Record review Phase • Why: to select cases with high likelihood of HIs and reduce the number of records that need to be reviewed by the medical reviewer • Who: trained nurse • What: screen records and gather information from staff (the latter only for record review of current in-patients) • How: based on detection criteria (see method protocol, p. x) • How long: x hours for x records • Why: to review records of ‘high-risk’ cases for evidence of HIs, preventability, contributing factors and nature of HIs, among others • Who: trained physician with clinical experience in the ward he/she is assessing • What: review positively screened records and gather information from staff (the latter only for record review of current in-patients) • How: based on a comprehensive questionnaire (RF2) • How long: x hours for x records Specifi- cations

13. Zoom in on a record review of current in-patients: IBEAS study • Scope: 11,426 patients from 58 hospitals in Mexico, Costa Rica, Peru, Colombia and Argentina • Design: observational cross-sectional study • Subjects of study: all patients hospitalized at the time of the study (“a day” in 2007) • Case definition: Active HIs on the day of data collection • Results: • 10.5% prevalence of active HIs, that is 1,191 of the 11,426 patients suffered an active HI (almost 60% were preventable) • HIs related to health-care-associated infections (37.13%), procedures (28.5%), care (13.4%), medication (8.23%) and diagnosis (6.15%), or were not specified (6.52%)

14. Zoom in on a retrospective record review: EMRO/AFRO study • Scope: records of 18,146 randomly selected patients from 26 hospitals in Egypt, Jordan, Kenya, Morocco, Tunisia, Sudan, South Africa and Yemen • Design: a two-phase retrospective audit of randomly selected medical records of hospitals. • Subjects of study: all patients hospitalized in the selected hospitals in 2005 • Case definition: an HI that occurred in 2005. • Results: • incidence rate of 8.2%, that is HIs were found in 1,277 of the 18,146 examined records (83% were preventable) • Most frequent HIs related to therapeutic errors (34.2%), diagnostic errors (19.1%) or were surgical HIs (18.4%), obstetric HIs (8.6%) or neonatal HIs (7.5%)

15. The role of record screeners* • Principal investigator only: study method protocol, present the objective of initiative to facility managers/stakeholders, receive their approval, check whether record quality is sufficient for record review (otherwise select another method) and select and train screener/reviewer • Team: prepare to explain and conduct the record review and arrange meeting room and materials • Team: explain the objective and procedure of the record review upon arrival at health facility • Select and gather relevant records (instructions given in method protocol), write list of names and note missing records • Screen records for specific criteria (see RF1) and consult local staff for additional information (for record review of current in-patients only) • Return negatively screened records to local staff and hand positively screened records (presence of at least one criteria) to medical reviewer • Assist medical reviewer in estimating the incidence/prevalence of HIs and comparing results to those of previous assessments (for monitoring and improvement only) • Return all records, explain next steps, thank staff and help with presenting results to facility managers * more comprehensive guidance is provided in the method protocol

16. The role of record reviewers* • Principal investigator only: study method protocol, present the objective of initiative to facility managers/stakeholders, receive their approval, check whether record quality is sufficient for record review (otherwise select another method) and select and train screener/reviewer • Team: prepare to explain and conduct the record review and arrange meeting room and materials • Explain the objective and procedure of the record review upon arrival at the health facility • Gather relevant records (instructions given in method protocol), write list of names and note missing records • Complete a copy of the RF2 form for each positively screened record and consult local staff for additional information (for record review of current in-patients only) • Ensure that forms are completed as fully as possible and destroy list of names and first pages of RF2 forms • Calculate the rates of HIs and compare results to those of previous assessments (for monitoring and improvement only) • Return all records, explain next steps, thank involved staff and present results to facility managers * more comprehensive guidance is provided in the method protocol

17. How to excel in your role: do… • study the method protocol • prepare your role thoroughly and well in advance • clarify potential questions with the principal investigator • conduct the record review in a calm environment and avoid interruptions • read the HI detection criteria (screener) or the RF2 form (reviewer) carefully during the review and do not improvise • screener: ask the reviewer if you are unsure about the presence of an HI • ensure nurse/doctor is aware that the objective is to examine patient cases not to test him/her (RR of current in-patients only) • allow time to build a relationship of trust with nurse/doctor (record review of current in-patients only) • ensure full confidentiality during and after the record review

18. How to excel in your role: do not… • proceed with a retrospective record review if record quality is insufficient (inform principal investigator who will select another method) • hesitate to request further explanation or information from the doctor/nurse in charge if needed • blame staff for bad record quality but rather explain how to improve

19. Questions? Comments?

20. Quiz Instructions • This is not a pass/fail test but an opportunity to identify areas requiring further discussion or training. • Participants discuss each question in small groups (you can use your method protocol), followed by each group presenting their answers and by a facilitator-led general discussion. Questions • Can you explain the concepts of patient safety, HIs, preventability and contributing factors in your own words and give examples for each? • Can you summarize the objective and processes of the form of record review you will be conducting (record review of current in-patients or retrospective record review)? • Can you describe, step-by-step, the tasks you will be performing as a record screener or medical reviewer? • Can you explain how to best ensure that the do‘s and don’ts are respected?

21. Hands-on exercise • Participants split into small groups of record screeners and medical reviewers. • Record screeners receive sample records from the trainer and determine for each case whether an HI is present or not (based on the screening criteria in the method protocol). • Similarly, medical reviewers receive sample records and confirm/reject for each case whether HIs are present and, if so, determine their preventability and contributing factors (based on RF2 form). • At the end of the exercise, each group explains the problems they have faced and the lessons they have learned. The trainer clarifies potential questions.

22. Further information • For further information, questions or comments contact <insert your name and telephone number or email> • Visit the Patient Safety Programme (Research) website at: http://www.who.int/patientsafety/research/en/