399 / Safe use of tumor markers

SPAIN
Classification of the PSP
Type of Patient Safety Practice Safe
 
Clinical Practice (CP)
Related practices from PaSQ database
"Best fit" category of the reported practice
Diagnostics
Other There is no specified text here
Topic of the reported practice
Clinical guidelines or pathways
Aim and the benefit of the Patient Safety Practice
 
Background: The WHO Patient Safety strategies refer to carrying out procedures in a correct manner.
The European Group on Tumor Markers (EGTM) has stated that the use of these should be limited to follow-up of the disease and monitoring of treatments. However, incorrect usage of these is frequent. The use of these tests for screening purposes results in other investigations that are invasive for the patient and affect his safety.

Objective: To measure the impact of the application of a protocol for the determination of tumor markers on the biopsies carried out.

Relevance. The suspicion of cancer causes much anxiety in the patient and an inappropriate use of tumor markers can lead to unnecessary and injurious tests being carried out on the patient, and at the same time to overloading the rest of the hospital services and increasing the cost.
Description of the Patient Safety Practice
 
Methods: Period of study: 2010 and 2011. Requests for all the most frequent tumor markers were analyzed: CEA, CA 15.3, CA 19.9 and CA 125, from 2010 and 2011. The Oncology Service was excluded given that it treats confirmed tumors, but biopsies that were requested later were studied. In 2011, clinical services were informed of the application of a new protocol for determining tumor markers according to EGTM instructions. All requests for tumor markers that did not provide the necessary information requested in the protocol were rejected. To check the impact of such a measure the biopsies carried out on patients according to the protocol were analyzed, as well as the biopsies requested from those patients in which the request for tumor markers had been rejected. Validation. During the two years of the study 7080 requests were made for the analysis of tumor markers. Those from the Oncology Service were discarded. The positive results and the biopsies generated were studied as follows Results: In the year 2010, 5316 tumor markers were requested. 42% of the requests were diagnostic. Pathological results were only found in 14.3% of cases. In the biopsies generated only 21% gave a result of neoplasia. The introduction of the protocol in 2011 caused a decrease of 58% in the number of requests for tumor markers. The percentage of requests for diagnostic tests remained at 42%. Only 7.45%of the samples analyzed reached a pathological level. 35% of the biopsies carried out later were positive for neoplasia. The rejected requests rose to 40%. The clinician only decided to request a biopsy in 10% of cases. 63% of the biopsies carried out on these patients were positive for neoplasia. Conclusions: The safe use of tumor markers, according to EGTM, means a decrease in the number of requests. It reduces the number of negative biopsies carried out at the same time as increasing their usefulness. It is confirmed that tumor markers should not be used as screening tests. This translates into an improvement in patient safety, as it avoids invasive tests which are not properly justified. NOTE: This study got an award by Division of Management Sciences and Patient Safety - AACC. Annual Meeting 2012 LA, CA. And this study is being applied in the Hospital of Padova in collaboration with the Prof. Plebani.

http://www.seguridaddelpaciente.es/index.php/lang-es/informacion/eventos/con ferencias-internacionales-sp/vi-conferencia/presentaciones.html Other references: Merida F, Moreno E. Fundamentos de Seguridad del Paciente. Análisis y estrategias aplicadas al laboratorio clínico. Ed. Panamericana. Madrid 2011. ISBN 9748-84-3835-431-7
Attachment of relevant written information and/or photos, as appropriate
There is no specified text here
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Effectiveness of the Patient Safety Practice
 
Degree of implementation of reported practice
Yes, fully
Level of implementation of reported practice
Institution level
Specific and measurable outcome for the reported practice were defined
Yes
A baseline measurement before implementation of the reported practice was obtained
Yes
A measurement after full implementation of the reported practice was obtained
Yes
Evaluation of a "positive" effect of the reported practice on Patient Safety
The evaluation showed improvements in Patient Safety outcomes
Type of before-and after evaluation
Quantitative
Enclosure of a reference or attachment in case of published evaluation's results
1.-F. J. Merida, S. Palacios, E. Moreno, N. Bel, M. Perez.Increase in positive biopsies and the safe use of tumor markers. CLINICAL CHEMISTRY, Vol. 58, No. 10, Supplement, 2012

2.- Uso seguro de los marcadores tumorales. Francisco Javier Mérida. Presidente del grupo de trabajo sobre Seguridad del Paciente. Sociedad Espanola de Bioquímica Clínica y Patología Molecular.
http://www.seguridaddelpaciente.es/recursos/documentos/VI_Conferencia/01merida.pdf
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Health care context where the Patient Safety Practices was implemented
 
Primary care
Community care facility
Hospital
Transferability
 
Successful implementation of this Patient Safety Practice in other health care settings than above stated
No
Specification of implementation in another health care setting(s)
Primary care
Successful implementation's level  of this Patient Safety Practice across settings
There is no specified text here
Involved health care staff
 
Physicians
Patient Involvement
 
Direct service user's involvement as integral part of this Patient Safety Practice
Yes
Specification of the service users or their representatives' involvement in the implementation of this Patient Safety Practice
Patient(s)
Patient representative(s)
Point of time in which service user or their reprasentatives' involvement takes place
During the development of the Patient Safety Practices
Active seeking of service users' opinion, feedback, experience, etc. as integral part of this Patient Safety Practice
Not known
Short description of the service users' level of involvement
Not known
Public accessibility of information regarding this Patient Safety Practice to patients and citizens/service users
No
List of sources where public information is accessible
There is no specified text here
Implementation of the Patient Safety Practice
 
Existing collaboration with other countries or international organisations related to implementation of this Patient Safety Practice
No
Problems encountering in the implememntation course of this Patient Safety Practice like lack of motivation, no management support, etc.
Yes
List of the most prevelent difficulties encuntered during implementation of this Patient Safety Practice
Lack of knowledge on implementation strategies
Lack of sharing of progress information among involved staff
No motivation among staff
Other
List of the most prevalent drivers for a successful implemetation of this Patient Safety Practice
There is no specified text here
Use of any specific incentives to enhance motivation while implementing this Patient Safety Practice
No
Description of used incentives, if any.
There is no specified text here
Existence of support or approval by the clinical or hospital management or any other hihg level authority in the implementation process of this Patient Safety Practice
Yes
Costs of the Patient Safety Practices
 
Completion of cost calculation related to this Patient Safety Practice
Yes
Total number of person days required to implement this Patient Safety Practice
Clinical staff: 10
External consultants: 0
Support staff: 0
Managerial staff: 2
Others: 1
Not relevant: 0
Total number of person days required for training as preparation for implementation of this Patient Safety Practice
Clinical staff: 2
External consultants: 0
Support staff: 0
Managerial staff: 1
Others: 2
Not relevant: 0
Total cost in Euro of specific equipment (machines, software, communications supplies, etc.) needed to support implementation of this Patient Safety Practice
0
Associated cost with a work reduction or foregoing in order to deliver this Patient Safety Practice
0
Contact information
 
Name: Francisco Merida
Country: SPAIN
Organisation: Hospital Serranía, Andalusia
E-mail: franciscoj.merida.sspa@juntadeandalucia.es
Phone: +34697956698
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