Příloha č. 2

2010-2011 BCA project

FINAL REPORT

on

Registration and management of undesirable

events in providing health services in primary care

Bohumil Seifert

1st Faculty of Medicine, Charles University in Prague, Czech Republic

Coordinator:

Milena Kalvachova

Health Care Quality Department of the Ministry of Health of the Czech Republic

National professional Officer:

Alena Šteflová

National Professional Officer, EU_czh who Country Office, Czech Republic

2010-2011 BCA Project

Registration and management of undesirable events in providing health services in primary care

Name of the expected result(according to the BCA):

Strengthening the national capacities to improve the health care quality and the patients’ safety

Product name(according to the BCA):

Register and management of undesirable events in providing health services in primary care (elaboration of a methodology for data collection and evaluation) including creation of recommendations on a proper safe practice

Coordinator:

Mgr. Milena Kalvachová

Head of the Health Care Quality Department of the Ministry of Health of the Czech Republic

E-mail:

Solver:

Doc. MUDr. Bohumil Seifert, Ph.D.

Institute of General Medicine of the First Faculty of Medicine of Charles University in Prague

Albertov 7, 120 00 Prague 2

E-mail:

  1. Project background

In the times when quality and availibility of care is in many fields far ahead in developed countries, the questions of safety are arising. The same is evident in the Czech Republic, either for legal or for service reason and contentment of patients. In first case we lower the penalty risk, in second we avert to lose clients, because of loss of their safety feeling.

One learns most effectively from mistakes. And less painfully from mistakes of the others. We usualy meet the colleagues´ mistakes in medias black cronicle reports in our environment. Much better approach is to be seen in Germany, where an anonymous internet database for reporting mistakes works along with discussion and enlightening for others.

Supported by the Ministry of Health of the Czech Republic (MZ ČR), the Society of General Practice of the Czech Medical Association of J. E. Purkyně (ČLS JEP) implemented the project of Accreditation Standards for General Practices as a tool increasing the quality of care and the safety of patients in offices of general practitioners. The agenda of the registration, classification and management of undesirable events and medical errors was stated as a part of the good practice standard. However, this agenda has been currently neither executed nor generally perceived, and its significance is not appreciated by general practitioners.

  1. Objective of the project/planned activities in terms of the product:

The project objective is to create the conditions for creating an environment in which information on undesirable events, critical incidents and errors could be shared, could become a source of learning for the entire professional group of general practitioners, and could help to avoid situations that may be prevented and that could injure patients in their consequence. In order to achieve this objective it is necessary to execute the following part plans:

  1. To inform general practitioners and motivate them to regard positively the agenda of undesirable events and medical errors as a tool increasing the quality and safety of patients
  2. To create a system of registration and management of undesirable events and errors at the practical level
  3. To propose a method of data collection and management of undesirable events and medical errors
  4. To create recommendations for further development of the system
  1. Project form and schedule:

The project will be implemented in two stages:

Stage 1:

  • Preparing the classification of undesirable events for the project’s needs in accordance with the International Taxonomy of Medical Errors in Primary Care
  • Preparation of educational materials and literature for the project participants
  • Elaborating the methodology of organic integration of the undesirable events collecting into the quality evaluation systems
  • Identification and preparation of a group of health care facilities providing primary care for the collection of information on undesirable events

Stage 2:

  • Registration, classification and analysis of undesirable events and errors in selected health care facilities providing care in the branch of general medicine
  • Collection and central analysis of undesirable events and errors
  • Project evaluation and recommendations for further development of the system

Planned number of selected health care facilities: 15

Interconnection of the project/planned activities with the plans/strategic documents of the Ministry of Health of the Czech Republic:

-Action Plan of the Health Care Quality and Safety for 2010 – 2012 (PV No. 9 approved on 19 March 2010) Activities stated in this Action Plan are based on the EU Council Recommendation on patient safety, including the prevention and control of healthcare associated infections (approved on 9 June 2009 by the Ministers of Health of all EU Member States – 2009/C 151/01) and the WHO recommendations.

-Long-term programme of improvement of the health state of the Czech Republic population – Health for All in the 21st Century – Czech Republic Government Decree No. 1046 of 30 October 2002

Schedule of implementation of key activities:

Phase 1: until 30 September 2011

Phase 2: until 15 November 2011

CONTENTS OF KEY ACTIVITIES

  1. Preparing the classification of undesirable events for the project’s needs in accordance with the International Taxonomy of Medical Errors in Primary Care. The classification will be adopted from the International Taxonomy of Medical Errors in Primary Care.
  1. Preparation of educational materials and literature for the project participants

The educational materials will cover classification of medical errors, methodology of registration and analysis, errors registration sheet, and translation of relevant articles from specialized periodicals.

  1. Elaborating the methodology of organic integration of the undesirable events collecting into the quality evaluation systems

The agenda of undesirable events and errors will be integrated into the accreditation standards for general practices.

  1. Identification and preparation of a group of health care facilities providing primary care for the collection of information on undesirable events

A group of health care facilities providing care in the branch of general medicine, motivated to participate in the project, will be identified. Doctors and nurses will be provided with methodical preparation in the form of a workshop and written/electronic materials.

  1. Registration, classification and analysis of undesirable events and errors in selected health care facilities providing care in the branch of general medicine

Health care facilities will register, classify and analyse undesirable events and errors at a stated interval. They will also share the information on undesirable events and errors, as obtained from other facilities. The solver will obtain a feedback from them.

  1. Collection and central analysis of undesirable events and errors

Registered undesirable events and errors will be reported anonymously (in writing or electronically) and analysed centrally. Based on the experience obtained, a sustainable reporting system will be designed.

  1. Project evaluation and recommendations for further development of the system

The data obtained will be evaluated. The staff of the health care facilities will be consulted in order to obtain a feedback from them. The result will be recommendations for further development of the system. The outputs will be presented at a conference of general practitioners and in a relevant periodical.

Sources for possible translations from English to Czech:

  • Patients’ safety: Round table on Reporting systems in health care

September – 1 October 2010, Ljubljana, Slovenia

  • Elder N, Dovey M, Classification of medical errors and preventable adverse events in primary care: A synthesis of the literature. J Family Practice 2002;51:927-932
  • Bhasale AL, Miller GC, Reid S, Britt HC. Analysing potential harm in Australian general practice; an incident-monitoring study. Med J Aust 1998; 169: 73-6
  • Ely JW, Levinson W, Ekler NC, Mainous AG III, Vinson DC. Percieved causes of family physician’s errors. J Fam Pract 1995; 40: 40-6
  • Dovey SM, Meyers DS, Phillips RL jr, et al. A preliminary taxonomy of medical errors in family practice. Qual Saf health Care 2002; 11: 233-8
  • Britten N, Stevenson FA, Barry CA, Barber N, Bradleay CP. Misunderstanding in prescribing decisions in general practice: qualitative study. BMJ 2000; 320: 768-70
  • Holden J, O’Donnel S, Brindley J, Miles L. Anaalysis of 1263 deaths in four general practices. Br J Gen Pract 1998; 48: 125-33
  • The Linnaeus-PC Collaboration. International Taxonomy of Medical Errors in Primary Care – Version 2. Washington, DC: The Robert Graham Center, 2002
  • Sandars J, Esmail A, The frequency and nature of medical error in primary care: understanding the diversity across studies. Family Practice 2003; 20:231-236

Forms of study papers and materials for information and education

-Written or electronic materials

Material needed:

-Ordinary office supplies, hardware and software

Experts involved in the project:

Doc. MUDr. Bohumil Seifert, Ph.D., General Medicine Society of the Czech Medical Association of J. E. Purkyně (SVL ČLS JEP), First Faculty of Medicine of Charles University (1. LF UK)

MUDr. Mgr. Petr Struk, consultant, designated director of the Primary Care Accreditation Agency

Doc. MUDr. Svatopluk Býma, CSc., SVL ČLS JEP, Faculty of Medicine of Charles University in Hradec Králové (LF HK UK)

Description of the leading project solver’s work:

Project management

Content preparation and creation of information and methodical materials

Organization and guidance of the cooperating health care facilities

Arrangement of central data collection and analysis

Project evaluation and presentation

Project results

  1. The classification of undesirable events was adopted from the International Taxonomy of Medical Errors in Primary Care, version 2. Washington, DC: The Robert Graham Center, 2002.The taxonomy describes errors in several levels. The first level distuinguishes between “proces errors” and “errors in knowledge and skills”. The proces errors contains chapters “Administrative, Examination, Treatment, Communication, Payment and Staff”. Errors in knowledges and skills contains Performance of clinical tasks, wrong diagnosis and wrong treatment.
  1. Preparation of educational materials and literature for the project participants

The review of relevant literature was performed. The article by Sandards J et Esmail A, The frequency nad nature of medical error in primary care: understanfing the diversity across studies. Family Practice 2003; 20”231-236 has been translated. Another Czech article has been included. The introduction for medical professionals and staff working on a project has been developed. The conclusions from previous studies performed in primary care (PHARE 2000, Primary Care Quality Assessment 2002, National Standards for Accreditation in Primary Care, 2009) have been included in educational packet. A registration sheet for error and adverse event registration and classification has been prepared.

The educational packet for each participating practice was prepared, including the International Taxonomy of Medical Errors in Primary Care in Czech adapted version, methodology of registration and analysis of medical errosrs, errors registration sheet, relevant articleseither from Czech or international periodics.

  1. Elaborating the methodology of organic integration of the undesirable events collecting into the quality evaluation systems

Medical errors and adverse events in primary care in the Czech Republic are analysed and researched only in case of malpractice and complaints agenda. They are used seldom as a source of education in reports and presentations of forensic experts. The autonomy of GP surgeries provides barierrs for errors and adverse effects sharing and education. The reporting system of errors and adverse effects is not common except for adverse effects of medicines. In opposite there are some contries with voluntary reporting. In Switzerland, Germany and the Netherlands, only practices participating on external quality control systems report. Recently developed Accreditation standards for primary care included standard on voluntary reporting as a basic activity of each primary care surgery/centre, which corresponds with the new law on Health Care Services. An Order on Quality and Patient Safety Assessment accompanying the law indicates:

1.4. Standard: Errors and Adverse Events reporting

The aim: To implement a nonrepresive anonymous reporting system

1.4.1. Standard indicators: Standard is met when:

- a system of reporting and analysing medical errors and adverse events is implemented

- the reported errors and events are structured

- the errors and events analysis is performed

- the preventable measures are adopted

  1. Identification and preparation of a group of health care facilities providing primary care for the collection of information on undesirable events

15 health care facilities providing care in the branch of general medicine, motivated to participate in the project, were identified. Doctors and nurses were provided by methodological support at the introductory workshop and recieved written/electronic materials.

  1. Registration, classification and analysis of undesirable events and errors in selected health care facilities providing care in the branch of general practice

Health care facilities were instructed to register, classify and analyse undesirable events and

errors. A project of monitoring adverse events in primary care has been held from May to

September 2011. 14 practices took part in it. The physicians had to be facilitated several times

by phone calls to start register. Finaly 55 standardised forms have been recieved in total.

During data processing it has been observed that the International taxonomy is partly obsolete (missing classification of POCT mistakes) and some the events are not classifiable by this taxonomy.

Other difficulty was missclasiffication by an author. This was mainly in process mistakes assigned in chapter Communication instead of Administrative or Examination. For example the event of measuring CRP instead of INR was said to be failiure of doctor/nurse communication, but according to a result it is a mistake of examination. Regardles of some flaws the taxonomy has

been used especially because others previous studies has been already using it and therefore is

possible to compare the results.The participating practices were given possibility to share the others events and errors.

  1. Collection and central analysis of undesirable events and errors

Registered undesirable events and errors were reported anonymously (in writing or electronically) and analysed centrally. In the sample of 55 errors there was 19 Administrative errors addressing especially medical records, 10 errors of examination, 9 errors in treatment (e.g. prescription

without stamp, wrong dosing of the drug) and after an adjustment of the taxonomy 1 error in communication and 3 in payment were recorded in chapter Process errors. In chapter Errors in

knowledges and skills 2 events of performance of clinical tasks, 8 wrong diagnoses and 3 wrong

treatments were recorded. There was reported 77% of errors in Process and 23% in knowledges and skills in total. This corresponds even in this small sample with figures of foreign studies from Australia (79%:21%) and with studies from other countries (80%:20%) (1).

Severity of the errors was not evaluated purposely, because it depends on impact of the event.

These were not monitored in the project. The overview of reported errors at Table 1.

Event type according the taxonomy / počet událostí
Process errors / Office administration / 19
total / Investigations / 10
Treatments / 9
Communications / 1
Payment / 3
42
Knowledge and skills errors / execution of clinic task / 2
total / Mis-diagnosis / 8
Wrong treatment decision / 3
13
Events total / 55
  1. Project evaluation and recommendations for further development of the system

The gaps in International Taxonomy of Medical Errors in Primary Care were mentioned.

The registration sheet itself was accepted positively as a good instrument. Every record sheet contained free space for future preventive steps. These usualy and naturally

responded to particular errors, often with tendencies to suggest a system approach to prevent those mistakes. It is necessary to realize that a great number of system changes becomes sooner or later confusing, difficult and bonding method with uncertain results. The safety of patient (as shown in many cases) could be increased by strenghtening “safety culture”. This concept (2) is based on active search of weakpoints, training of staff for this task, sharing responsibilities, openness for new ideas, prediction and preparation for mistakes as an integral part of every activity and last but not least searching for root causes of adverse events instead of sweeping them under the carpet.

The project has shawn that general practitioners in the Czech Republic still have reservations to

open their practices, to break their autonomy and to share the weaknesses of their work. Even if

the concept of the project was friendly accepted a lot of effort from coordinator was needed to

activate the network and get at least few reports. At the end the feedback was positive from a

half of participating GPs.Based on this experience the coordinator strongly suggest further information campaigne on patient safety for general practitioners. The integration of this agenda, including registration and analysis of unexpected events and medical errors, in accreditation standards for primary care will give possibility to observe the trends within advanced practices. The Czech Society of General Practice will provide GPs with methodological support on patient safety measures.

An introduction of national system of anonymous reporting of unexpected events and medical errors seems to be currently unrealistic.

The outcomes of the project will be presented at a conference of general practitioners and in a relevant periodics.

1.MakehamMA,DoveySM,CountyM,KiddMR. An international taxonomy for errors in general practice: a pilot study. MedJAust.2002 Jul 15;177(2):68-72.

2. ParkerD

DETAILED PROJECT BUDGET

ITEMS / TOTAL COSTS / Ministry of health of the Czech Republic / who
CZK 133,300 / CZK 43,300 / CZK 90,000
Preparing the classification of undesirable events for the project’s needs in accordance with the International Taxonomy of Medical Errors in Primary Care
(20 hours of work per CZK 500) / CZK 10,000 / CZK 10,000
Preparation of educational materials and literature for the project participants
(14 hours per CZK 500; CZK 3,300 – material) / CZK 10,300 / CZK 10,300
Elaborating the methodology of organic integration of the undesirable events collecting into the quality evaluation systems
(34 hours of work per CZK 500) / CZK 17,000 / CZK 17,000
Identification and preparation of a group of health care facilities providing primary care for the collection of information on undesirable events
(12 hours of work per CZK 500) / CZK 6,000 / CZK 6,000
Registration, classification and analysis of undesirable events and errors in selected health care facilities providing care in the branch of general medicine / CZK 60,000 / CZK 60,000
Collection and central analysis of undesirable events and errors
(40 hours of work per CZK 500) / CZK 20,000 / CZK 20,000
Project evaluation and recommendations for further development of the system
(20 hours of work per CZK 500) / CZK 10,000 / CZK 10,000
TOTAL / CZK 133,300 / CZK 43,300 / CZK 90,000
Ministry of Health / WHO

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