with the publication of  to err is human : building a safer health care system  and an estimate of up to 98.000 death per year due to treatment errors , the institute of medicine in 1999 not only highlighted substantial deficiencies in patient care but also raised public awareness for the meaning of patient safety for quality in medicine . during the following years this report triggered various international projects at the world health organization ( who  world alliance on patient safety ) , the organization for economic cooperation and development ( oecd  health care quality indicator project ) , and the european union ( european commission on public health  simpatie : safety improvement for patients in europe ) , with the common objective to improve patient safety .
in line with a core postulation of the iom report , safety culture is included as an integral part into the scope of these initiatives .
the most recent international project , the european network for patient safety ( eunetpas ) , a collaboration of all 27 eu - countries also mentions  promoting a culture of patient safety  as one of 5 focus areas and puts it first on its list of priorities .
taken together , it is well recognized that safety culture is pivotal for quality in medicine and that  patient safety encompasses 
the attributes of organizations that help guard against harm and enable rapid recovery when risk escalates  .
generally spoken , the term  safety culture  refers to an  organizational culture focused on safety objectives  . even though  safety culture  is a widely and frequently used term , so far no common definition of it exists .
 researchers tend to use safety culture , safety climate and perhaps safety management interchangeably , as the terms are not so clear cut  . according to the 
safety culture is defined as follows :  culture of safety : an integrated pattern of individual and organizational behavior , based upon shared beliefs and values , that continuously seeks to minimize patient harm which may result from the processes of care delivery  . in german , it is common practice to also use the word  error culture 
analogue to safety culture . taking the definition provided by the  physicians centre for quality in medicine  as a basis ,  error culture
 represents a revised management of error away from a superficial reactive culture of blame towards a system oriented proactive safety culture . along this line ,
advisory council for the concerted action in health care  demands systematic and prospective error management to become an attribute for quality in medicine ( new error culture ) which can overcome the notion of physician 's infallibility , and the tendency to search for a single guilty individual .  
donald berwick indicated already in 1989 that a  theory of bad apples  is improper to address issues in quality and to support continuous improvement in health care .
instead , the phenomenon of  human error  in medicine does require a far more sophisticated view which , based on the work by j. reason , needs to differentiate between active failures of individuals and latent conditions hidden within the organization .
his concept of safety culture is based on attitudes , values , and beliefs of people supported by appropriate infrastructure to manage data and system information .
provide further evidence that  the culture of the future must be a culture of safety and of quality ; a culture of openness and of accountability ;  a culture in which collaborative teamwork is prized  .  
all together , the acceptance for applying human factor theory and system thinking to quality management in medicine has dramatically increased over the last decade , a fact that is reflected in the following statement of the insitute of medicine :  more commonly , errors are caused by faulty systems , processes and conditions that lead people to make mistakes or fail to prevent them   
this is also in line with schrappe , who demands the integration of safety culture into the self - image of hospitals . an organization s safety culture can be evaluated by using specific questionnaires .
in addition , the presence of incident reporting systems , specific measures like crew resource management or high reliability trainings adopted from high reliability theory and other activities in conjunction with risk or error management can be used as implicit ( indirect ) indicators for the existence of a culture of safety , , . mearns et al .
are referring to indirect indicators as a source of information about safety culture and argue :  the extent to which these factors are found to be in tune with each other may determine whether or not an organization has a positive safety culture  .   from a regulatory point of view , the german health care reform 2000 already included comprehensive measures for quality assurance in hospitals .
the following  fallpauschalengesetz ( drg law )  in 2002 obligates all accredited hospitals to publish biannual quality reports ( initially in 2005 for the prior year 2004 ) based on common standards .
objectives and metrics used in these quality reports were determined by the federal joint committee in 2004 and documented in the  declaration according to  137 abs . 1 satz 3 nr . 1 sgb v on the basic requirements for a quality management for hospitals accredited in compliance with  108 sgb v  .
the aim of the quality reports is to provide patients , sick funds , and referring physicians with orientation regarding health services offered and their corresponding quality .
furthermore , quality reports are expected to promote comparability between individual hospitals in relation to major quality dimensions .
while not demanding pre specified activities for risk and error management , both are mentioned explicitly in the outline for the quality reports issued by the  gemeinsamer bundesausschuss  .
given that safety culture has been identified and widely accepted as a major contributor to quality in medicine , one would expect documentation on this matter within hospital quality reports .
however , as of today there is no knowledge to what extent these reports provide insights into the status quo of safety culture in germany .
the aim of the research at hand therefore is to analyze the 2006 hospital quality reports with respect to their informative value about the extent to which safety culture did find its way into routine quality management efforts .
based on that , first and of course preliminary conclusions on the awareness for the importance of safety culture as a key component of quality management in german hospitals are drawn .
an initial assessment of the quality reports was performed by using safety culture , error culture and error management as search items in order to gain an understanding for the prevalence of explicit mentioning of safety culture and related concepts within the quality reports .
mortality and morbidity conferences , while not named specificly in the context of safety culture , were also included in the initial assessment , acknowledging their long tradition in assessing outcomes and treatment related adverse events including potential error . in a second step a literature research
was conducted in order to identify indicators which either allow for directly measuring safety culture ( direct indicators ) , or which qualify as implicit measures ( indirect indicators ) for safety culture , .   as a result of this ,
the following methods for the direct assessment of safety culture were identified ( e.g. ): ormag  operating room management attitudes questionnairesaq  safety attitudes questionnairesloaps  strategies for leadership : an organizational approach to patient safetypscho 
veterans administration patient safety culture questionnairehsops  hospital survey on patient safetycss  culture of safety surveyscs 
veterans administration patient safety culture questionnaire hsops  hospital survey on patient safety css  culture of safety survey scs 
 hospital transfusion service safety culture survey hspsc  hospital survey on patient safety culture mapsaf  manchester patient safety framework indirect indicators for safety culture can be divided into tools for organizational development / teamwork and more technical tools for capturing or analyzing data related to incidents .
for the first category the literature search yielded to the following findings ( e.g. , ): crm  crew resource managementacrm 
high reliability teams technical tools to collect safety relevant data are : cirs  critical incident reporting system icusrs 
icu safety reporting system cirs medical  reporting system aezq ( http://www.cirsmedical.de/)pasis  patient safety information system pasos 
 icu safety reporting system   cirs medical  reporting system aezq ( http://www.cirsmedical.de/ ) pasis  patient safety information system   pasos  patient safety optimization system ( https://www.pasos-ains.de/indexssl.php ) cirs dgch  http://www.dgch.de/de/cirs/index.html complementary to these data management applications used for incident reporting , a number of risk and error analysis tools exist which can also serve as indirect indicators for the existence of safety culture . in the literature ,
hazard analysis and critical control points hva  hazard vulnerability analysis ( joint commission on accreditation of healthcare organizations 2002 , http://www.jointcommission.org/ ) fmea  failure mode and efficiency analysis   fta  fault tree analysis   rca  root cause analysis   era  error and risk analysis   hra  human reliability analysis   hazop  hazard and operability study   sherpa  systematic human error reduction and prediction approach   pha  proactive hazard analysis   hfmea  healthcare failure mode and effect analysis   haccp  hazard analysis and critical control points   hva  hazard vulnerability analysis ( joint commission on accreditation of healthcare organizations 2002 , http://www.jointcommission.org/ ) the direct as well as the indirect indicators for safety culture served as a basis for the analysis - matrix that was compiled to evaluate the quality reports with respect to the appearance of indicators for safety culture . in order to identify chapters relevant for  safety culture  the standard structure of the reports was reviewed .
the reports themselves are divided into 4 subsections . whilst chapter a and b are concentrated on structural and procedural data ( e.g. number and type of wards , number of beds , number of specific interventions  ) , chapter c ( measures and projects on quality assurance in the hospital ) and d ( internal quality management , e.g. systematic strategies and measures to support continuous improvement ) are explicitly focused on the documentation of the implementation of quality management in hospitals . consequently only chapters c and d of the quality reports were analyzed in terms of their reference to direct and indirect indicators of safety culture .
1 ) summarizes the signal steps of the methodological procedure . to minimize any potential for selection bias due to disease specialization only quality reports of hospitals providing maximum medical care ( n=96 , source : ims 2007 ) were considered .
since the presented data are based on an analysis of published quality reports and not on information collected specificly on safety culture in the hospitals themselves , conclusions on the current distribution of safety culture within the present paper remain preliminary and have do be interpreted with precaution .
figure 2 ( fig . 2 ) shows the results of the initial search within the quality reports using the key words  safety culture  ,  error culture  ,  error management  and  morbidity / mortality conferences  .  
2 ) , only seven ( 7% ) of all hospitals explicitly mentioned  safety culture  as an integral part of their quality assurance . both other search terms ,  error culture 
most commonly mentioned terms were  morbidity / mortality conferences  with a frequency of 44% ( 42 hospitals ) .
31 hospitals or 32% of the sample did not refer to any of these search items .
the distribution of direct and indirect indicators according to the analysis matrix is shown in figure 3 ( fig .
3 ) , evaluation of safety culture as a direct measure based on specific questionnaires was not mentioned in any of the quality reports . among the indirect indicators incident reporting systems turned out as the most prominent tool and were listed in 47 hospitals or 49% of the quality management reports as part of the quality assurance efforts .
only two hospitals ( 2% ) are naming specific risk management tools in their reports .
none of the investigated quality reports did refer to teamtraining activities identified as indirect indicators for safety culture .
more than half of the reviewed reports ( 49 or 51% ) did not make reference to any of the listed indicators for safety culture .
matching the mentioning of cirs against the explicit reference to safety culture within the quality reports lead to the following result : amongst hospitals which use reporting systems a significant proportion ( 66% ) did not explicitly adress  safety culture  or  error culture  in their quality report ( figure 4 ( fig .
along with the drg legislation 2002 went the decision to introduce standardized quality reports for german hospitals . with respect to structural data and simple quantifiable parameters , such as an outline of the overall organization , number of beds , number of patients , frequency of specific interventions ,
the documentation instructions issued by the  federal joint committee  in 2004 are characterized by a high degree of clarity and specifity .
contrary to this , the requirements for the quality management relevant chapters c ( quality assurance ) and in particular d ( quality management ) are less explicit in terms of information mandatory to be included . as a consequence ,
the content of these chapters , in particular chapter d , comprises much more of individual initiatives by hospitals than of documentation standards which would allow for benchmarking implemented measures with prespecified reference values .  
our analysis revealed an incidence of 7% for the term  safety culture  , or a total incidence of 20% when considering the synonym  error culture  within the quality reports of the investigated sample .
compared to the combined frequency of occurrence of 20% for the search terms safety / error culture , the appearance of the more general term 
error management  was higher with 33% indicating an overall awareness for the need to adress error in at least one third of the hospitals .
most frequently the latter term was mentioned in association with incident reporting systems and/or the use of mortality and morbidity conferences .
none of the other indirect indicators for safety culture turned out to play a significant role in this sample . from the authors ' point of view , this finding may imply that the information value of the reports with respect to the issue of safety culture is not sufficient . at the same time , it seems plausible to conclude that the basic requirements from the iom report did not evoque an unsolicited or sustainable response in the sense of documented activities related to safety culture for the majority of investigated hospitals .
one could argue that the frequent mentioning of incident reporting proofs the latter hypothesis wrong , in particular since available evidence on the use of critical incident reporting systems ( cirs ) suggests that  high reporting rates may be indicators of a positive safety culture  .
however , even in the category of hospitals mentioning cirs or any other reporting system 31 out of 47 ( 66% ) neither refer to safety culture nor to error culture in their quality reports . as a consequence ,
it remains unclear whether or not the introduction of cirs was accompanied by an awareness for the meaning of safety culture or not .
this is of special importance since available evidence indicates that incident reporting systems tend to remain ineffective when implemented as an isolated measure , , .
state that  management attitudes and institutional climate can greatly influence the success or failure of reporting efforts  . aside from the predominantely missing reference to safety culture , any referral to compliance with the incident reporting systems or information on the frequency of incidents being documented was lacking . without that information
, there is no reliable foundation for using the acceptance of documenting incidents as a sign for safety culture or for benchmarking the implementation across different hospitals based on the quality reports .  
the frequent mentioning of morbidity and mortality conferences as a more traditional approach for assessing performance and outcomes can also not reduce the impression of a limited awareness for the concept of safety culture .
while these conferences can be seen as an ambition to investigate causes of error , it needs to be taken into consideration that they do suffer from some potential limitations .
in particular , a narrow focus on individual performance rather than system thinking as well as hindsight bias and search for error instead of focusing on error promoting conditions are to be mentioned as weaknesses of that tool .
further constraints are caused by the high variance in the understanding of how to adequately perform morbidity and mortality conferences .
there is wide variation in how morbidity and mortality conferences are conducted across departments and little conformity to known models for analyzing medical incidents  .   a possible explanation for the poor consideration of safety culture and its direct and indirect indicators within quality reports may be that the prevailing understanding of quality is still based on a perception of error as an event happening at the sharp end , while latent or system - based issues remain in the background .
this interpretation is supported by the fact that none of the investigated hospitals reported specific measures on teamtraining within the context of safety and risk management .
similarly , any mentioning of questionnaires for a systematic evaluation of safety culture is missing .
. opportunities for improvement above and beyond the focus on numerical metrics was already expressed in a study bei geraedts et al . who were looking at patient and physician opinion of the reported quality indicators . in line with that
, reason highlights that  the corollary in healthcare institutions is a singular focus on critical numerical indices .
culture as a soft factor for performance is less tangible and carries an element of uncertainty which people may want to escape through hiding themselves behind numerical metrics .
all in all , the findings from the analysis at hand are comparable to the results of the  krankenhausbarometer 2008  . according to that survey , about 31% of all hospitals in germany do use at least to some extent some sort of risk management systems .
that number fits well with the identified 33% of hospitals referring to error management in their quality reports in the present study .   however ,
the  krankenhausbarometer  does not mention  safety culture  at all . apart from that
, according to the  krankenhausbarometer 2008  , the most frequently reported tool mentioned within the context of risk management was complaints management ( 90.9% of all hospitals with risk management ) .
this high reliance on complaints management is thought - provoking , since previous research suggests that the reliability of patient information on medical error is rather limited , an issue which is raised by tanne with reference to study findings :  more than half the incidents reported by patients were problems with the service rather than medical error  . in light of this , complaints management rather qualifies as an indicator for efforts regarding patient satisfaction than efforts for patient safety . the preceding analysis leads us to the notion that despite all efforts , the matter of safety culture has not reached a level of awareness which automatically would translate into explicit reference and/or corresponding strategies / tactics in standard quality reports in germany . in view of the high relevance of the human factor for safety in health care , it seems to be critically important to substantially improve the content of the quality reports through specifying requirements on risk and error management and in particular to offer a framework for establishing safety culture . a concrete example for that is provided by  the joint commission for accreditation of healthcare organizations ( jcaho )  in the us , who integrated an annual assessment of safety culture in 2007 in their objectives on patient safety .
further guidance could also be taken from the nhs in the uk based on the work of the national patient safety agency ( npsa ) . building a safety culture
seven steps to patient safety  and corresponding tools for implementation are available online ( http://www.nrls.npsa.nhs.uk/resources/collections/seven-steps-to-patient-safety/?entryid45=59787 ) .   in line with the final report from the sympatie project the authors of the present paper conclude that it can be considerd indisputable that 
patient safety management is a clear distinguishable , but inseperable part of our quality management system , that should be part of our normal management and leadership system , both professional and managerial  . this in mind only the combination of technical skills with an appropriate safety culture acknowledging human failability and favouring patient safety will translate into error elasticity   as a concept for preventing harm to patients .   in light of this ,
a revision of the current requirements for the quality reports issued by german hospitals might be worth to be considered . as stated by the institute of medicine :  setting and enforcing explicit standards for safety through regulatory and related mechanisms , such as licensing , certification , and accreditation , can define minimum performance levels for health care organizations and professionals  .
 in 1999 the institute of medicine ( iom ) published the landmark report  to err is human : building a safer healthcare system  highlighting critical deficiencies within the area of patient safety . 
 as a consequence , safety culture evolved as a core component of quality management in medicine . 
 purpose of the investigation at hand was to find out to what extent this is reflected in standard quality reports issued by german hospitals providing maximum medical care . 
 reports issued for the year 2006 were analysed with respect to the appearance of indicators for the presence of a safety culture . 
 results suggest that despite the huge awareness for patient safety caused by the iom report , the topic of safety culture does not get the anticipated attention within the quality reports . 
 this may indicate that the current requirements for the quality reports do not facilitate transparency when it comes to the human factor of patient safety . 
Introduction
Background
Methodology
Results
Discussion
Notes
Conflicts of interest