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Investigation into workplace culture for medication error reporting in pharmacy

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Title:
Investigation into workplace culture for medication error reporting in pharmacy
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English
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Gulley, Tamala Lavelle
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University of South Florida
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Subjects / Keywords:
Medicine
Pharmacists
Corporate
Ethics
Survey
Dissertations, Academic -- Industrial Engineering -- Doctoral -- USF   ( lcsh )
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bibliography   ( marcgt )
theses   ( marcgt )
non-fiction   ( marcgt )

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Summary:
ABSTRACT: This study determined impacts on reported medication errors in pharmacy by analyzing the culture in an undisclosed pharmacy in Florida. SPSS Statistical Software was used to determine the relationship between medication errors and workplace culture. Workplace culture was analyzed by distributing a 43-question culture survey to the pharmacists. There were two treatment groups, Control and Intervention, and the culture survey was two-fold, pre-survey and post-survey, utilizing identical questions to note the difference in a comparative analysis. During the pre-survey, the pharmacists in the Intervention Group received an informational sheet which contained information on a non-punitive culture as well as information about the National Practitioner Databank.The data were collected, compiled into an Excel spreadsheet, and statistically analyzed using SPSS to test the effect due to time (pre versus post intervention), treatment group (control versus intervention) and the interaction between time and treatment group. Of primary interest was knowing if the change from pre to post was significantly different for the two treatment groups using a statistical significance of 0.05. There was a 26.7% increase in the total number of medication errors reported from pre to post survey as compared to the number of reported medication errors for the prior year. It was determined that organizational culture plays a role in the moral make-up of its individuals. Additionally, it was determined that a multi-culture approach was needed to develop a non-punitive culture. Developing a non-punitive culture in pharmacies across the United States is essential to accurate reporting of medication errors.This study will showcase a few attributes - survey development, culture assessment, and culture development - held by Industrial Engineers. Although this study focuses primarily on pharmacy services, very few healthcare facilities employee industrial engineers. Hopefully, this study will be a gateway for industrial engineers to enter into the healthcare industry.
Thesis:
Dissertation (Ph.D.)--University of South Florida, 2007.
Bibliography:
Includes bibliographical references.
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Mode of access: World Wide Web.
Statement of Responsibility:
by Tamala Lavelle Gulley.
General Note:
Title from PDF of title page.
General Note:
Document formatted into pages; contains 185 pages.
General Note:
Includes vita.

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oclc - 189747225
usfldc doi - E14-SFE0002118
usfldc handle - e14.2118
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ABSTRACT: This study determined impacts on reported medication errors in pharmacy by analyzing the culture in an undisclosed pharmacy in Florida. SPSS Statistical Software was used to determine the relationship between medication errors and workplace culture. Workplace culture was analyzed by distributing a 43-question culture survey to the pharmacists. There were two treatment groups, Control and Intervention, and the culture survey was two-fold, pre-survey and post-survey, utilizing identical questions to note the difference in a comparative analysis. During the pre-survey, the pharmacists in the Intervention Group received an informational sheet which contained information on a non-punitive culture as well as information about the National Practitioner Databank.The data were collected, compiled into an Excel spreadsheet, and statistically analyzed using SPSS to test the effect due to time (pre versus post intervention), treatment group (control versus intervention) and the interaction between time and treatment group. Of primary interest was knowing if the change from pre to post was significantly different for the two treatment groups using a statistical significance of 0.05. There was a 26.7% increase in the total number of medication errors reported from pre to post survey as compared to the number of reported medication errors for the prior year. It was determined that organizational culture plays a role in the moral make-up of its individuals. Additionally, it was determined that a multi-culture approach was needed to develop a non-punitive culture. Developing a non-punitive culture in pharmacies across the United States is essential to accurate reporting of medication errors.This study will showcase a few attributes survey development, culture assessment, and culture development held by Industrial Engineers. Although this study focuses primarily on pharmacy services, very few healthcare facilities employee industrial engineers. Hopefully, this study will be a gateway for industrial engineers to enter into the healthcare industry.
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Investigation into Workplace Culture for Medication Error Reporting in Pharmacy by Tamala Lavelle Gulley A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy Department of Industrial and Ma nagement Systems College of Engineering University of South Florida C o Major Professor: Michael Weng Ph.D. Co Major Professor: Paul McCright, Ph.D. William Lee, Ph.D. Michael Fountain, Ph.D. Kingsley Reeves Ph.D. Date of Approval: June 8 200 7 Keywo rds: medicine, pharmacists, corporate ethics, survey Copyright 200 7 Tamala Lavelle Gulley

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Note to Reader Note to Reader: The research included in this dissertation was conducted at an undisclosed facility in Florida.

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Dedication I can do all thin gs through Christ, who strengthens me. This doctorate is dedicated to my grandm other, the late Ruth Evelyn Hill Bailey. I loved her more than I loved myself. She always said, No matter what you do, get an education. God bless her soul because those a re the words that fueled my fire. Thank you, Grandm other This is also dedicated to my husband, Troy Gulley and my children, Ytrenda, Brenda, and Troy Jr. I thank God for humbling me in so many ways and blessing me abundantly.

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Acknowledgments I wou ld like to acknowledge those individuals who inspired me to pursue this doctorate. Foremost, I thank God for giving me the strength to complete this dissertation. Thank you Dr. Anita Callahan for your direction and supportI miss you. Thank you Dr. McCr ight for EVERYTHING! Without you, there would be no me completing this doctorate. Thank you for your unwavering support and direction. Thank you from every breath in my body! Dr. Weng, thank you for stepping in as my Committee Chair. I send a heart felt thank you to you. Dr. Reeves, Dr. Lee, and Dr. Fountain, thank you for your participation on this dissertation. Your comments were welcomed and appreciated. They helped to strengthen this dissertation. A very special thank you to the Institute on Black Life and Mrs. Clara Cobb. The support and encouragement that I received from your department fed my mind, body, and soul. I thank you for filling me up. To Jeanette Williams mommy, I thank you for listening when I really needed it. Thanks for a lways being there for me. A sincere thank you to Gloria Hanshaw Latter for always keeping me on pointI love you to pieces. Thank you and God bless you. For those who have blessed me financially, I send a sincere thank you: Dorothy Schnabel, Paul and An n Givens, Florida Georgia Louis Stokes Alliance for Minority Participation program and Institute on Black Life. God bless you all.

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i Table of Contents List of Tables ................................ ................................ ................................ ........ i v L ist of Figures ................................ ................................ ................................ ....... v i A bstract ................................ ................................ ................................ ............... v ii C hapter 1 Introduction ................................ ................................ .......................... 1 1. 1 Introduction ................................ ................................ .......................... 1 1 .2 Proble m Setup/Definition ................................ ................................ ..... 4 1.3 Summary of Objectives ................................ ................................ ........ 7 1.4 Chapter Summ ary: Organization of this Work ................................ ...... 7 C hapter 2 L iterature Review ................................ ................................ ............... 10 2.1 Introduction ................................ ................................ ........................ 10 2.2 Opinion ................................ ................................ .............................. 11 2.2 .1 Public ................................ ................................ ................... 12 2.2 .2 Healthcare ................................ ................................ ............ 13 2. 3 Reporting Errors ................................ ................................ ................. 15 2.4 Ethics ................................ ................................ ................................ 17 2.5 Eliminating E rror ................................ ................................ ................ 20 2. 6 Le gal Issues ................................ ................................ ....................... 22 2. 7 Making it Worth Disclosing ................................ ................................ 25 2.8 Understanding Culture ................................ ................................ ....... 27 2. 8 .1 Organizational Culture ................................ ......................... 28 2.8 .2 Culture Change ................................ ................................ .... 30 2.8 .3 Strong Culture ................................ ................................ ...... 32 2.8 .4 Importance of Culture ................................ ........................... 35 2. 9 Industry Leaders ................................ ................................ ................ 37 2. 10 Chapter Summary ................................ ................................ ............ 39 C hapter 3 Theoretical Development ................................ ................................ ... 42 3 1 Introd uction ................................ ................................ ............................. 42 3 .2 Defining Error and Its Classifications ................................ ...................... 44 3 3 Thought Process Mode ................................ ................................ ........... 46 3 .4 Beginning of an Error ................................ ................................ .............. 49 3 5 Pharmacist and the Pharmacy ................................ ................................ 50 3 .5 .1 Errors in Pharmacy ................................ .............................. 52

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ii 3 .5 2 Causes to Medication Erro rs ................................ ................ 52 3 .5 3 System Practi ce in Pharmacy ................................ .............. 54 3 .6 Development of Hypotheses ................................ ................................ ... 55 3 6 .1 O rganizational Characteristics ................................ ............. 56 3 .6 .2 Error and Environment ................................ ......................... 60 3 .7 The Problem ................................ ................................ ............................ 62 3 .8 The Reality ................................ ................................ .............................. 63 3 8 .1 Report or Remain Silent ................................ ....................... 66 3 9 Theory Summary ................................ ................................ ..................... 66 Chapter 4 M et hodology ................................ ................................ ...................... 68 4 1 Introduc tion ................................ ................................ ............................. 68 4 .2 Survey De velopment ................................ ................................ ............... 68 4 .2 .1 Integrity/Humanistic Culture ................................ ................. 70 4 .2 .2 Effici ency/Quality Oriented Culture ................................ ...... 74 4 .2 .3 Innovative Culture ................................ ................................ 75 4 .2 .4 Del iberative/Traditional Culture ................................ ............ 77 4 .2 .5 Established/Stable Culture ................................ ................... 79 4 .2 .6 Urg ent/Seat of the Pa nts Culture ................................ ......... 80 4 .3 Sc ale Development ................................ ................................ ................. 81 4 .4 Pilot Test ................................ ................................ ................................ 82 4 .5 Sample Size Justification ................................ ................................ ........ 82 4 .6 Statistical Methods ................................ ................................ .................. 85 4 .7 Procedure ................................ ................................ ................................ 86 4 .8 Surve y Distribution and Collection ................................ .......................... 87 4 .9 Method Summary ................................ ................................ .................... 87 C hapter 5 Data Analysis ................................ ................................ ..................... 89 5 1 I ntroduction ................................ ................................ ............................. 89 5 1 .1 Variations to Statistic al Methods ................................ .......... 90 5 .1 .2 Derivation of Scale Scores ................................ ................... 92 5 2 Hypothesis 1 Data Analysis ................................ ................................ ..... 96 5 .3 Hypothesis 2 Data Analysis ................................ ................................ ... 106 5 .4 Hypothesis 3 Data Analysis ................................ ................................ ... 108 5 .5 Exploratory Data Analysis ................................ ................................ ..... 114 5 .6 Data Summary ................................ ................................ ...................... 116 C hapter 6 Discussion of Results, C onclusions and R e commendations ................................ ................................ ...... 11 8 6 .1 Discussion of Work ................................ ................................ ............... 118 6 .2 Conclusions ................................ ................................ ........................... 119 6 .3 Technological Insight Into the Advancement of Medicine ..................... 129 6 4 Rec ommendations ................................ ................................ ................ 1 31 6 4 .1 Re sponsibility ................................ ................................ ..... 133 6 4 .2 Further Research ................................ ............................... 1 34

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iii R eference s ................................ ................................ ................................ .... 136 Bibliography ................................ ................................ ................................ ...... 149 A ppendices ................................ ................................ ................................ .... 159 Append ix A: Historical Perspective ................................ ............................ 1 60 Appendix B : Summary of Congressio nal Response to IOM Report ................................ ................................ ..................... 166 Appendix C : Wh ats Your Corporate Culture? ................................ ............. 1 68 Appendi x D: Data Assessmen t Measures ................................ ................... 172 Appendix E : Final Revision of Survey ................................ ......................... 176 Appendix F: Non Punitive Culture Information ................................ ............ 1 80 Appendix G: National Practitioner Data Bank NPDB Information ................................ ................................ .............. 1 82 Appendix H: Tests of Within Subjects Effects ................................ ............. 1 84 A bout the Author ................................ ................................ ...................... End Page

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iv List of Tables Table 1 1 Shame Culture ................................ ................................ ..................... 3 Table 3.1 Hypotheses ................................ ................................ ......................... 5 9 Table 4 .1 Culture Characteristics ................................ ................................ ....... 71 Table 4 .2 Cultures Studied and Corresponding Question Numbers ................... 72 Table 4 .3 List of Mea sures ................................ ................................ ................. 82 Table 5 .1 Group Distribution ................................ ................................ ............... 91 Tab le 5 .2 Pre an d Post Sur vey Data for Scales ................................ ................. 93 Table 5 .3 Tests of W ithin Subjects Effect Scale 1 ................................ .............. 96 Table 5 .4 Tests of Between Subject Effect Scale 1 ................................ ............ 97 Table 5 .5 Average Scale Score for Treatment Groups ................................ ....... 97 Table 5 .6 Variation in Average Scale 1 Score Over Time ................................ .. 98 Table 5 .7 Group Variation in Average Scale 1 Score Over Time ....................... 99 Table 5 .8 Tests of Between Subjects Effects ................................ ................... 102 Table 5 .9 Average Score for Treatment Groups ................................ ............... 103 Table 5 .10 Average Scale Score Over Time ................................ .................... 104 Table 5 .1 1 Group Variation in Average Scale Score Over Time ...................... 105 Table 5 .12 Reported Medication Errors ................................ ............................ 107 Table 5 .13 Post Survey Reported Medication Errors ................................ ........ 107 Table 5 .1 4 Question 1 Scale Data ................................ ................................ .... 110

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v Table 5 .15 Equality of Means ................................ ................................ ........... 111 Table 5 .16 Pearsons Correlati on Coefficient for a ll Sca les .............................. 115 Table 6.1 Pre to Post Grou p Change ................................ ............................... 124 Table 6 .2 Non Punitive Cultur e Characteristics and Origin .............................. 129 Tabl e A. 1 Historical Perspective ................................ ................................ ....... 160 Table A. 2 Test s of Within Subjects Effects ................................ ....................... 184

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vi List of Figures Figure 3 1 Theoretical Model ................................ ................................ .............. 4 3 Figure 5 1 Pre_Scale 2 Frequency Histogram ................................ .................... 94 Figure 5 .2 Pre_Scale 6 Frequency Histogram ................................ .................... 94 Figure 5 .3 Pos t_Scale 2 Frequency Histogram ................................ .................. 95 Figure 5 .4 Pos t_Scale 6 Frequency Histogram ................................ .................. 95 Figure 5 .5 Group Va riation Average Scale 1 Score ................................ ............ 98 Figure 5 .6 Variation Av erage Scale 1 Sc or e Over Time ................................ ..... 99 Figure 5 .7 Group Variation Av erage Scale 1 Score Over Time ........................ 100 Figure 5 .8 Post Surv e y Reported Medication Errors ................................ ........ 108 Figure 5 .9 Distribution of S cale 1 Scores for Question 1 ................................ .. 112 Figure 5 .10 Distribution of Scal e 4 Scores for Question 1 ................................ 114 Figure 5 .11 Scatter P l ot of Scale 4 versus Scale 5 ................................ ........... 116 Figure 6 .1 Pat hway to Non Punitive Culture ................................ ..................... 128

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vii Investigation into Workplace Culture for Medication Error Reporting in Pharmacy Tamala Lavelle Gulley ABSTRACT This study determined i mpacts on reported medication errors in pharmacy by analyzing the culture in an undisclosed pharmacy in Florida. SPSS Statistical Software was used to determine the relationship between medication errors and workplace culture. Workplace culture was analy zed by distributing a 43 question culture survey to the pharmacists. There were two treatment groups, Control and Intervention, and the culture survey was two fold, pre survey and post survey, utilizing identical questions to note the difference in a comp arative analysis. During the pre survey, the pharmacists in the Intervention Group received an informational sheet which contained information on a non punitive culture as well as information about the National Practitioner Databank. The data were collec ted, compiled into an Excel spreadsheet, and statistically analyzed using SPSS to test the effect due to time pre versus post intervention, treatment group control versus intervention and the interaction between time and treatment group. Of primary in terest was knowing if the change from pre to post was significantly different for the two treatment groups using a statistical significance of 0.05.

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viii There was a 26.7% increase in the total number of medication errors reported from pre to post survey as compared to the number of reported medication errors for the prior year. It was determined that organizational culture plays a role in the moral make up of its individuals. Additionally, it was determined that a multi culture approach was needed to devel op a non punitive culture. Developing a non punitive culture in pharmacies across the United States is essential to accurate reporting of medication errors This study will showcase a few attributes survey development, culture assessment, and culture development held by Industrial Engineers Although this study focuses primarily on pharmacy services, very few healthcare facilities employee industrial engineers. Hopefully, this study will be a gateway for industrial engineers to enter into the healt hcare industry.

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1 Chapter 1 Introduction In the shame/blame environment, where errors are seen as a form of personal moral failure that shatters the culture of infallibility inculcated in physicians since the first day of professi onal training, the physicians ultimate fear losing face in front of ones peers. A Wu, Medical Error: The Second Victim. British Medical Journal 320 : p726 727, 2000 1.1 Introduction Medication errors are commonplace in pharmacies in the commercial, military, and community sector. In the past, the rep orting of medicatio n errors was limited to the facility in which the error occurred. There were no governing boards to verify the credentials of the pharmacists nor were there any reporting agencies to report the medication errors, and no mandatory reporting laws. However, as medication errors began to get the media attention, agencies that governed patient safety began to emerge. It was not until 1997 when medication errors were specifically addressed when Representative William Coyne Democrat, Pennsylvania introduced the Safe Medications Act of 1997 See Appendix A. This was the first bill that addressed the reporting of medication errors, although it only pertained to the occurrence of death. As an

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2 incentive for reporting the death related medication error, 1 the healthcare facility avoided a $15,000 fine for each unreported death, and 2 the healthcare facility would continue to receive Medicare and state healthcare payments. Until recently, the majority of the research focused on the individual that made the error and not the organization. According to a comment made by a pharmacist, pharmacists were considered incompetent and dismissed from employment if the pharmacist had made three medication errors. In other words, if the pharmacist want ed to keep the jo b, then some action need ed to be taken so the employer w ould not find out. The reluctance to reveal the medical error stems from various motives: loyalty to ones peers, the shame associated with making and admitting a mistake, and fear of reprisal Hadda d, 2001. The fear of retaliation, loyalty and shame are only part of the reluctance to reveal a medical error. The 2004 Institute of Medicine report notes that nurses are educated to believe that clinical perfection is an attainable goal, and that "good" nurses do not make errors. These same beliefs are echoed throughout the entire medical community. Phy sicians, pharmacists, optometrists, and all other healthcare profession al s are educated to believe that infallible job performance is optional and if the y work hard enough, they can achieve it. The 2004 Institute of Medicine report suggests that this fallacy is perpetuated by litigation practices and licensing boards which have unjustly disciplined healthcare professionals who were involved in an error, b ut found blameless by a number of independent

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3 authoritative bodies ISMP, February 2005 These actions are typical in a culture where punishment is the solution to a medical error. Ruth Benedict created a model of the shame culture See Table 1. 1 Th is model provides some insight into the primary aspect of a punitive system, punishment. A punitive culture is one that supports finger pointing and eventually leads to a punishment. In Benedicts model, punishment is the result of a person believing he/ she did something wrong as well as others believing that the person did something wrong. In short, Benedicts model points out the way an individual feels towards something he/she did or did not do, is based solely on the perception of others. This impli es the work environment / culture has some bearing on whether or not to admit to wrong doing. Benedict states t he downside is the license it appears to give to engage in secret wrong doing Atherton, 1976. Because of this, numerous medica l errors go unre ported. Further, the researcher believe s if a culture could exist in the healthcare industry where pharmacists were not blamed for the occurrence of a medication error, the pharmacist would be more prone to disclose the medication error. Table 1. 1 Shame Culture Shame Culture Other People Believe I believe I didn't do it I did it I didn't do it No problem I am ashamed and dishonored by their belief I did it No one knows, so I am not ashamed I am guilty and punished

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4 1. 2 Problem Setup/Definition Only a few researchers have addressed the issue of medical errors. According to the U nited S tates Institute of Medicine 1999 a medical error is defined in the following context: safety is defined as freedom from accidental injury" and "error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim". Medical error awareness dates back to 197 6 when the U nited S tates House of Representatives Subcommittee on Oversight and Investigation of the Commi ttee on Interstate and Foreign Commerce issued its report, Cost and Quality in Health Care: Unnecessary Surgery. The House Subcommittee on Oversight and Investigations as cited in Null, G., Dean, C., Feldman, M., Rasio, D., Smith, D., 2004 estimated that, on a nationwide basis, there were 2.4 million unnecessary surgeries performed annually, resulting in 11,900 deaths Since then, researchers from the medical industry have written about medical errors and the one thing that is in agreement is that m edical errors do occur. On November 29, 1999 the Institute of Medicine IOM issued a report, To Err is Human: Building A Safer Health System, stat ing that medical errors are the 8 th leading cause of death in the United States, with as many as 98,000 people dying per year In all the literature, there appears to be a few gaps in the research of medical errors, which are the driving force behind the direction of this dissertation. The gaps in the research are as follow:

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5 1 The majority of the research fo cus es on reporting or lack there of. The IOM report recommended the establishment of a nationwide, mandatory public reporting system. 2 The majority of data presented in the literature describes only the issue of medical errors and not why or how they occ ur. 3 There has been little research into why a clinician opts to hide a medical error. Also, there has been little analysis as to whether the organizational and individual characteristics contribute to the decision to disclose that a medical error occurred or to keep quiet. Of the total number of deaths reported as stated in the I nstitution of Medicine report, over 7,000 deaths per year are attributed to medication related errors. As defined by the National Coordinating Council for Medication Error Report ing and Prevention NCC MERP, a medication error is defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; mon itoring; and use. Because of the questions raised by the gaps in the present literature, this research is designed to investigate the following questions: 1 Can intervention improve company culture?

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6 2 Are low company culture scores associated with a low numbe r of reported errors? A low company culture score means a low representation of that particular culture within the organization. A company could have a high score on one scale as it relates to a particular culture and low score on another scale as it rel ates to another type of culture. In this dissertation, the individual score is compared to the aggregate response from the survey group. A company having a high score on one scale and a low score on another scale would imply that the culture of that orga nization resembles that of the highest scale score. 3 Will individuals with greater fear of reporting errors have lower company culture scores on average than individuals with less fear? The overwhelming number of deaths per year and the gaps in the existi ng research defines my focus for this dissertation topic. More narrowly put, the purpose of this research is to increase the reporting of medication errors and create a blueprint for an improved workplace culture. Through the use of pharmacists comments on practice in pharmacy and a detailed survey that asks pertinent questions related to organizational culture and individual moral make up within that culture, a picture of the pharmacists work ethics and work culture will be revealed. Both survey and c omments will be analyzed to determine if organizational culture and individual moral make up can contribute to a greater understanding of why a pharmacist opts to hide a medication error.

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7 1. 3 Summary of Objectives The initial motivating factor of this research was to increase medication error reporting. Key milestones to reaching this goal included: 1 determining the current obstacles to increased reporting, 2 developing a survey tool to analyze the pharmacists workplace culture, 3 recruiting p harmacists to participate in the survey, and 4 comparing reported medication errors pre and post survey with the prior year reported medication errors. The second objective of this research was to determine what entities in a pharmacy system could pos sibly have an impact on medication safety. Goals in meeting this objective included analyzing all facets of a pharmacy and what role each aspect played. The results of identified pharmacy related entities are then used to formulate a warning system as to when potential error is on the horizon. The last objective of this research was to develop a template for the creation of a culture that supports medication error reporting. The following milestones were reached in accomplishing this objective: 1 dev elop ment of a theoretical model of error, and 2 develop ment of a triple check system that includes the ordering physician, patient, and pharmacy. 1. 4 Chapter Summary: Organization of this Work This chapter gives a brief discussion on medical errors and how medical errors became the primary focus in the realm of patient safety. This chapter also defines the term, medical error. The current problem under investigation is explained in detail. Further, this chapter identifies the gaps in the research of medical errors and explains the goals of this research.

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8 In Chapter 2, a comprehensive review of literature as it relates to medical errors is unfolded. Public opinion and that of pharmacists are noted on the issue of medication errors. The essence of r eporting errors and the ethics associated with disclosure including a legal perspective are discussed. Also in Chapter 2, a thorough analysis of culture to include a formal definition, main characteristics, and its effect on people in the organization is presented. In Chapter 3, a theoretical model of error in an organization is proposed and discussed. Various types of errors are identified, defined, and discussed. The thought process mode in relation to human task performance is discussed. The discus sion of the pharmacy and the pharmacists highlight the working environment and job design. In this chapter, medication errors and causes are identified. Further, the development of the three hypotheses are discussed and outlined. Chapter 4 presents the methodology behind the creation of the comprehensive survey used in this research to assess pharmacists in an organization. Also, Chapter 4 identifies the six types of cultures and their associated characteristics are discussed. The scale development an d sample size justification are presented in this chapter. The statistical methods used to analyze the data is identified and discussed. A detailed data analysis in relation to the three hypotheses is presented and discussed in Chapter 5. Variations to the statistical methods mentioned in Chapter 4 are identified and discussed. How the survey scale scores were derived is also presented in Chapter 5.

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9 Lastly, Chapter 6 provides a summary of work and conclusions based on the results of Chapter 5. A pat hway to a non punitive culture is identified, presented and discussed. Further, technological insights, recommendations, and further research in the realm of medication errors are discussed.

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10 Chapter 2 Literature Review 2. 1 Introduction The iss ue of medical errors is not new, but in the past, the problem has not received its deserved attention. Awareness of this issue dates back to 1976 See Historical Perspective, Appendix A Research began to emerge quite rapidly and in great abundance on t he topic of medical errors in the early 1990s with accomplished research by Lucian Leape, M.D., and David Bates, M.D., and supported by the Agency for Health Care Policy and Research, now the Agency for Healthcare Research and Quality. Most of the researc h on t he issue of medical errors is an offspring of the November 29, 1999 Institute of Medicine report, To Err is Human: Building A Safer Health System. The report states that medical errors are the 8 th leading cause of death in the United States, with as many as 98,000 people dying per year and the estimated medical errors cost the n ation, roughly, $ 37.6 billion each year. Of the 98,000 deaths per year, 7,000 are a result of medi c ation errors. The report called for mandatory and voluntary medical error reporting See Summary of Congressional Response, Appendix B Reporting provides a way to obtain needed information about medical errors Reporting is essential to holding healthcare systems accountable for delivering quality care and educating

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11 t he public about the safety of their healthcare system. Most importantly, r eporting is crucial to identifying existing patterns and discovering ways to prevent recurring medical errors whether through surgery or prescription filling. 2. 2 Opinion Since the Institute of Medicines 1999 report, patient safety has since become a popular topic for journalists, healthcare leaders, medical professionals Congress and patients Providing healthcare is a difficult task in itself Now, add the varying medical profe ssionals that must interact in order to accomplish an overall task of patient wellness. The interaction among varying medical professionals makes providing healthcare not only difficult but complex. Some believe that improvement in medicine and medicatio n safety go hand in hand. According to Robert Wachter an expert on patient safety, medicine and medication safety go in opposite directions. Wachter states that unless there is an investment in safety with the same vigor as investment in medicinal prog ress, the situation will actually get worse rather than better Olsen, 2004 However, significant improvements have been made in some healthcare facilities since the Institute of Medicine released the 1999 landmark report. A ccording to a study in The Jo urnal of the American Medical Association the rate of change has been painstakingly slow, and the death rate has not changed much In 2003, as cited in Leape & Berwick, 2005 Joint Commission for Accreditation of Hospital Organization began requiring ho spitals to implement 11 safety practices, including improving patient identification, communication, and "surgical site verification" marking a body part to ensure surgery is performed on the correct

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12 part. Additionally, new residency training hour limit ations were reduced to aid in the reduction of errors contributed to fatigue. 2. 2 .1 Public As the Institute of Medicine released its 1999 report, as cited in AHRQ, February 2000 51% of Americans followed it closely, according to a survey by the Kaiser Family Foundation. A national poll conducted by the National Patient Safety Foundation found that Americans have a very real fear of medical errors. In this survey, as cited in AHRQ, February 2000 Americans rated the healthcare system as moderately safe 4.9 on a 1 to 7 scale, where 1 is not safe at all and 7 is very safe. The American Society of Health System Pharmacists 1999 conducted a survey and asked respondents whom they would trust most to explain their medication and it found that:1 5 6% of r espondents said the doctor; 2 32% said the pharmacist; and 3 10% said a nurse. This is evident that doctors, pharmacists, and nurses need to form an alliance for the overall health and we l lness of the patient. Most people believe that medical errors ar e the result of the failures of individual providers. Likewise, in pharmacy, a medication error is viewed by most people, as the result of the failure of the individual pharmacist. When asked in a survey about possible solutions to medical errors, as ci ted in AHRQ, February 2000 75% of the respondents thought it would be most effective to keep health professionals with bad track records from providing care and 69% thought the problem could be solved through better training of healthcare profe ssionals Accord i ng to the I nstitute for S afe M edication P ractice 2001

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13 survey on perceptions of a non punitive culture, it is suggested that work is needed on all fronts to fully adopt a non punitive culture Institute for Safe Medication Practice, September 2001. ISMP FAQ defines a non punitive environment as a co nfidential reporting system where everyone understands that errors will not be linked to an individuals performance. ISMP FAQ states in this type of practice environment, it should be easy to report err ors, reward error reporting and provide timely feedback to show what is being done to address problems. In the ISMP 2001 survey, it found that 1 approximately 15% believed that a nonpunitive culture excuses poor performance and absolves staff of personal responsibility; 2 twenty one percent believed that such a culture might increase carelessness as individuals learn they will not be punished for mistakes. 2. 2 .2 Healthcare Despite a growing awareness of the system based causes of errors, many in healt hcare are still struggling to come to terms with the role of individual accountability in a non punitive culture. The researchers blame the complexity of health care systems, a lack of leadership, the reluctance of doctors to admit errors and an insuranc e reimbursement system that rewards errors hospitals can bill for additional services needed when patients are injured by mistakes but often will not pay for practices that reduce those errors Weise, 2005 In the event of medication error, pharmaci sts in conjunction with the Quality Systems team usually conduct the root cause analysis. To effectively use th e root cause analysis approach to medication error, all focus must be taken off the pharmacist involved with the error and placed on the system based

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14 causes of error. The Institute of Medicine 1999 report emphasized that most of the medical errors are system errors. Research has shown that system maintenance and enhancements can improve quality of care as well as reduce the rate of error. Hospit als in the Department of Veterans Affairs use hand held, wireless computer technol ogy and bar coding, which has cut overall hospital medication error rates. A 1999 study published in the Journal of the American Medical Association as cited in AHRQ, Febru ary 2000 indicated that i ncluding a pharmacist on medical rounds reduced the error s related to medication ordering by 66% It is apparent that systematic approaches to improving patient care are essential to eliminate frequent errors in medication. Prete nding that they do not exist is to put the clinicians interests above those of the patients who have entrusted their lives to the medical staff Pietro et.al, March 2000 In 2001 ISMP asked pharmacist s to comment on the new government proposal which wo uld require a bar code on packages of all human drug and biological products beginning in 2003 M ost responded, Its long overdue ISMP, March 2002. Even so, some expressed concern about the increased risk of errors with internal repackaging of medica tions, especially if manufacturers continue their downward trend of unit dose packaging ISMP, March 2002. In May 2002, over 600 pharmacists responded to an ISMP survey on pharmacy interventions to tell about their experiences with: 1 factors that imped e or facilitate pharmacy interventions; 2 the types of interventions currently performed; and 3 how the information is received by physicians, documented and used. When barriers to optimizing a medication safety strategy interfere with

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15 the pharmacist's ability to perform interventions, serious errors may reach the patient ISMP, June 2002 Lack of technology support, inadequate staffing, and inefficient documentation process were cited in the survey results as the most frequent barriers to pharmacy int ervention Before new technology is introduced in a system, the manpower required to operate it as well a s a technology support team should be identified. 2. 3 Reporting Errors The I nstitute of Medicine report recommends the establishment of a nationwide, mandatory public reporting system. The implementation planned would begin in hospitals and then venture out to encompass all locations where patient care is practiced To achieve a successful reduction in errors, information on best practices and effect ive solutions needs to be shared throughout the medical community One of the reasons that information is not always available is that the current healthcare system has disincentives for sharing information Eisenberg, 1999 It is thought of as airing d irty laundry and sh u n ned in the medical industry. Eisenberg 1999 believed that t he work of the Clinton Administration could help change the culture of secrecy surrounding medical errors into a culture of education and improvement. The purpose of creati ng a reporting infrastructure is to help identify where gaps in safety or certain patterns might exist in the health care system Eisenberg, 2002. Reports would be made to state health departments, applicable national accrediting organizations, and Medic are peer review organizations. Aggregate statistics, without identifiers, would be submitted to the

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16 federal government, and confidentiality and privacy protections would be applied to encourage reporting of errors United States Congress, 2000. Provider s would be called upon to voluntarily report a range of patient safety data, including the events that led to a patients undesirable outcome or potential undesirable outcome as a direct association with the medical care the patient received. Critical to the success of any national medical error reporting system is language that protects reported data from subpoena or legal discovery A merican Hospital Association and J oint C ommission on A ccreditation of H ospital O rganizations 2001. A s it stands now, hospitals are supposed to voluntarily notify the J oint C ommission on Accreditation of Healthcare O rganizations of sentinel events and then complete a root cause analysis of preceding system failures. Sentinel events are patient care errors or accidents tha t lead to patient death or major injury Moore Jr, 1998. Allowing voluntary reporting in a shame blame environment leads to a low number of reported medical errors In order for a medical error reporting system to work, legislation is needed that pro tects confidentiality of all parties involved in the error including the patient. Patients should have readily available access to information about preventable medical error s that cause serious injury or death, and providers should have protections to en courage reporting which will aid in a speedy elimination of that type of medical error. As cited in Shalgian 2001, r eporting systems s hould facilitate the sharing of patient safety information among healthcare organizations and foster confidential colla boration with other healthcare reporting systems Confidentiality protections for patients, healthcare

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17 professionals, and healthcare organizations as well as a non punitive environment that encourages identification of errors Voelker, 2001 are essential to the ability of any reporting system to learn about errors and effect their reduction National Coordinating Council for Medication Error Reporting and Prevention 2003 The correct response is to redesign systems so that errors are acknowledged, dete cted, intercepted, and mitigated Pietro et.al., March 2000 2. 4 Ethics Ethics are rules for behavior, base d on beliefs about how things should be. Ethical systems concern the shoulds and should nots of life, the principles and values on which hum an relations are based Mott, 200 1 In some situations, a behavior is considered ethical, whereas in what appears to be an identical situation, that particular behavior is considered unethical. Ethical judgment is defined by its community members in exp ressing moral approval or disapproval. Meriam Webster Online defines moral as 1 of or relating to principles of right or wrong in behavior; and 2 sanctioned by or operative on one's conscience or ethical judgment A successful doctor patient, doctor ph armacist, a nd pharmacist patient relationship should be built upon the already successful relationship between the doctor pharmacist. The development of these relationships should be built upon what is ethical and morally right, and most importantly, hone sty Ethics, professional policy and the law suggest that timely and candid disclosure should be standard practice Hebert, Levin, Robertson, CMAJ 2001.

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18 Candor about error may lessen, rather than increase, the medicolegal liability of the health ca re professionals and may help to alleviate the patients concerns Kraman and Hamm 1999. It has been suggested by many that guidelines exist for disclosure of a medical error to patients and their families. Revealing medical errors to the public can be a positive experience for the medical community and can promote public confidence in medicine Pietro, Shyavitz, Smith, Auerbach, 2000. Disclosure of error, by contrast, is consistent with recent ethical advances in medicine toward more openness w ith patients and the involvement of patients in their care Hebert, Levin, Robertson, 2001 The majority of patients and surrogates expect, respect, and reward honesty on the physicians part I n other words, evidence that patients who feel they have be en communicated with candidly are more likely to trust than sue the physician Kraman and Hamm 1999. Patients are due information about medical errors out of respect for them as human beings as well as out of, what should be paramount, common courtesy Furthermore, by the principle of justice and/ or fairness, when patients are injured they should be able to seek appropriate restitution. This ethical rationale for disclosure, based on a strong notion of autonomy, goes beyond what the law might require one to do Hebert, Levin, Robertson, 2001. When a medical error is not disclosed, those who witness the error must determine whether they should remain silent or reveal the error Rajendran, 2001. Although the immediate temptation may be to cover up the fact that an error has taken place Kapp, 2001, indulging that temptation may bring about an

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19 unfavorable outcome in the long run. The reluctance to reveal the medical error stems from various motives: loyalty to ones peers, the shame associated w ith making and admitting a mistake, and fear of reprisal Haddad, 2001. The need to cover up a medical error is strong, especially when it is believed that the consequences o f reporting the error will be detrimental Weighing the benefits and harm from this perspective, one might conclude that withholding the truth about the error is justified Haddad, 2001. Failing to disclose errors to patients undermines public trust in medicine because it potentially involves deception Bok, 1979. This fai lure can be seen as an infringement of professional ethics. In this case, there is a lapse in the c ommitment to act exclusively in the best interest of the patient. Ultimately patients may be caused preventable harm if they are injured further by the fa ilure to disclose. At its core, concealing a medication error is one of the worst acts that violate a doctor patient or pharmacist patient relationship on an ethical level. There is no legal duty to disclose negligence when the disclosure would not impro ve the likelihood of a good outcome from drug therapy Pharmacy Law and Management Conference 2002. Respect to others i s demonstrated by being honest, even when it is difficult to do. It shows a sign of integrity and moral behavior even if it is perc eived that a g reater good would come from ignoring the error. T here are some who interpret the principle of truth telling to require complete honesty in every case. It is important to note that withholding the truth is a form of deception, hence a lie H addad, 2001.

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20 To change the balance of good and harm that result from reporting medical errors, healthcare professionals need to recognize that government entities like Agency for Healthcare Research and Quality or internal review bodies can bring p ositive outcomes Haddad, 2001. Agency for Healthcare Research and Qualitys mission is to improve the quality, safety, efficiency, and effectiveness of healthcare for all Americans. Further, healthcare professionals need to trust that the good that com es from reporting an error outweighs the negative effects on group loyalty and trust between co workers that make it possible to provide comprehensive healthcare Haddad, 2001. 2. 5 Eliminating Error Throughout the pharmacy system, fail safes should be ins talled to prevent a medication error from occurring. These fail safes are sometimes referred to as forcing functions. "Forcing functions" should be integrated t o make it impossible to act without meeting a precondition Leape, 1994 Twelve suggestions have been proposed to assist in the elimination and eradication of medication errors. 1 A utomat e functions 2 Im prove engineering of equipment, tools, inst r uctions, pr o cedures, the work environment the organizational structure 3 Improve the monitoring of operati ons to eliminate some of the consequences of errors, even if the errors cannot be reduced 4 Improve feedback of information about errors and their cons e quences to increase sensitivity to error generating work habits 5 Improve interface design for pharmacists a nd machines 6 Increase and/or improve training to assist in awareness of contributory factors of medication errors 7 Standardization of medications a Medication dosage unit dose system b Times medications are administered c All packaging and labeling

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21 d Storage eac h unit should be organized similarly to assist nurses who float between units e Predetermined dosing schedules for specific drugs f Preprinted orders g Equipment i.e. IV administration equipment 8 Share responsibility in the medicinal treatment plan 9 L imit number o f hours worked in a day and in a week 10 M andate breaks 11 M andate light therapy for pharmacists working in non daylight hours 12 Mandate continuing education training about medication errors Items 2 through 4 above were suggested by Altman as cited in DeGreene, 1970. Item 7, sta ndardization of medications was suggested by Medical Mutual. S tandard ization is needed to ensure that any prescribing clinician can electronically send a prescription to any pharmacy thereby eliminating the risk of misinterpreting what is heard over the phone or what is handwritten on a prescription. I n many states, verified electronic signatures are not acceptable, thus prescribers must ph ysically sign each prescription ISMP, March 2001 which introduces a potential pathway to error A reduction in medication errors can be obtained if the pharmacy standardizes its processes. Likewise the pharmaceutical industry must take a stance on medication errors. We as cited in ISMP, April 2001 have learned much from practitioner reports, i ncluding evidence that a large percentage of medication errors are attributable, at least in part, to commercial labeling, packaging, and nomenclature issues. The stance of the pharmaceutical companies should be one of a take charge approach where they co llaborate with the medical community and participate in the standardiz ation of drug package s w hich are imprinted with a unique barcode.

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22 Another recommendation for medication error reduction is continuous quality improvement When utilizing continuous qu ality improvement techniques, a systems approach is used to solve problems. Plan Do Check Act are the steps used within continuous quality improvement systems Value Based Management.net, 2003 These steps require people to think before they act and to meticulously monitor the results. In conjunction with advanced technology in the form of bar coding and automation, Plan Do Check Act can reduce the amount of medication errors significantly. Separately, Plan Do Check Act, if used attentively and appropr iately, can work just as well as being coupled with advanced technology. 2. 6 Legal Issues One of the largest impediments to a vigorous frontal assault on the medical errors issue is the fact that many physicians and other healthcare professionals persist in equating the admission of errors with legal suicide Kapp, 1997. Error reporting is tied to significant malpractice reforms. Fear of litigation has hindered efforts to identify medical errors as well as a clinicians admittance to involvement in a m edical error. The culture of blame as cited in Cutler and Bocchino, 2000 pervades every aspect of medicine, from affecting patient safety to increasing medical costs by encouraging the practice of defensive medicine. Cutler and Bocchino 2000 stated t hat we need to enact malpractice reforms applicable to healthcare claims in order to promote a more positive environment for identifying and reporting medical errors. According to Wachter as cited in Olsen, 2004 m alpractice becomes an easy excuse for wh y clinicians don't talk to

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23 one another about medical errors. Some medical professionals say that if the malpractice issue could be fixed, the approach to medical errors would be fundamentally different. In order to achieve the open and honest forum neces sary for learning from and correcting our mistakes, we may need further protection in law for this process, in the overriding interest of good health Smeltzer, 1989. In 2003, President Bush was disappointed with the Senates failure to pass the Medical Liability Bill. The medical liability crisis is driving good doctors out of medicine, and leaving patients in many communities without access to both basic and specialty medical services Bush, 2003. Anxieties about adverse legal consequences, in the for m of malpractice lawsuits and, especially in the long term care arena, of regulatory punishments, generally pervade contemporary healthcare environments Kapp, 2001. Thus, as a general rule, an error by an employee pharmacist leads to liability of the c orporate pharmacy employer and an error by a non pharmacist clerk working under the supervision of a pharmacist leads to liability of the pharmacist Pharmacy Law and Managemen t Conf erence 200 2 Pharmacists and providers are taught the language to use i n writing the patient record in order to avoid litigation Olsen, 2004. Pharmacists have to make certain that patient recordings in patient record s can be interpreted in only one way. Pharmacists are taught to avoid words which are vague or have various meanings. As cited in Phillips, Dovey, Hickner, Graham, Johnson n.d. t he absence of federal protection for submitted information to patient safety reporting systems discourages the use of such systems, which reduces the opportunity to identify

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24 patterns and implement corrective measures. I nformation developed in connection with reporting systems should be privileged for purposes of federal and state judicial proceedings, including with respect to discovery, subpoenas, testimony, or any other form of disc losure Phillips et. al., n.d. From both a legal and ethical perspective, the physician/patient relationship in the United States at this time is best characterized as fiduciary in nature, built and dependent on the trust that the patient is able to pla ce in the physician Journal of the American Geriatrics Society, October 2001. This trust is predicated on the patients assumption that the physician must be guided in practice by the ethical principles of nonmaleficence avoiding causing harm, or primu m non nocere, beneficence affirmatively doing well, and fidelity honesty and loyalty Kapp, 2001. The main event which triggers malpractice litigation is patient injury Pharmacy Law and Management Conference 2002. Many lawsuits begin because a h ealthcare professional expresses that the end result of another healthcare professionals designated patient therapy was negligent. When seeking compensation for medical errors, l itigants primarily state that they hope to prevent further untoward incident s A significant external barrier that impedes full implementation of a non punitive culture is an external legal and regulatory environment that perpetuates an ongoing punitive focus on individuals who make errors ISMP, February 2005 In the investiga tion of airline accidents it is not just the pilots that are in vestigated but the entire crew and all the passengers. The aircraft, the weather, and air traffic systems are also investigated to determine if they played

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25 a role in the accident. Likewise, i n healthcare, the entire health delivery system should be investigated. Long lasting and essential changes can be witnessed when the entire process of the health delivery system is analyzed just as in the airline industry 2. 7 Making it Worth Disclosing H ow a facility deals with a health care error can either exacerbate an already painful incident or, through disclosure, promote openness, healing, learning and prevention College of Nurses Ontario, 2004 No specific error can be rectified after it has oc curred, other than to be open and honest with the patient and seek whatever remedial measures are necessary to treat problems caused by the error Pharmacy Law and Management Conference, 200 2 Colorado's largest malpractice insurer, COPIC, for example, h as enrolled 1,800 physicians in a disclosure program under which they immediately express remorse to patients when medical care goes wrong and describe in detail what happened Kowalczyk, 2005 According to College of Nursing August 2004 the I nsti tute for Safe Medication Practice Canada lists 13 steps involved in best practices in disclosing a healthcare error. The best practice steps are as follow: 1 Have open disclosure policies and procedures in place. 2 Have a key contact person or team ready and avail able to help staff deal with adverse events. 3 Disclose as soon as possible to the client as soon as she/he is physically and emotionally stable. 4 Choose an appropriate setting that is private and comfortable. 5 Acknowledge that a mistake has been made. 6 Describ e the course of events, using lay terms. 7 State the nature of the mistake, the consequences, and the corrective action taken. 8 Express regret and apologize.

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26 9 Elicit questions or concerns and commit to addressing them. 10 Provide follow up to the client and let h im/her know when to expect further information. 11 Provide support and guidance to staff. No one sets out to make medical mistake. 12 Learn what happened with the human machine interaction in the system of duty performance. 13 Communicate the incident. Sharing a medical mistake with other facilities is a powerful step in the direction of error prevention. It is of utmost importance that patients get involved in their therapy. It is important for patients to understand, comprehensively, what their treatment plan is as dictated by the doctor and what medications are a part of the treatment plan. According to AHRQ July 2003, t he United States Department of Health and Human Services in conjunction with the American Hospital Association and the American Medical Asso ciation developed Five Steps to Safer Health Care, for patients to follow. Those five steps are as follow: 1 Ask questions if you have doubts or concerns. 2 Keep and bring a list of ALL the medicines you take. 3 Get the results of any test or procedure. 4 Talk to your doctor about which hospital is best for your health needs. 5 Make sure you understand what will happen if you need surgery. Another Patient Fact Sheet, 20 Tips to Help Prevent Medical Errors, was developed by the Agency for Healthcare Research and Quality. These tips range from a patient taking part in every decision about his/her healthcare to asking the doctor i f the proposed treatment is based upon the latest scientific evidence. Uninvolved and uninformed patients are less likely to accept the doctor's choice of treatment and less likely to do what they need to do to make the treatment work AHRQ Publication No. AHRQ 00 P038 Feb ruary 2000.

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27 2. 8 Understanding Culture The word, culture is derived from the Latin verb colere, which means to cul tivate, and draws some of its meaning from this association from the act of tilling soil for harvesting a rich produce Renard, 2006. Merriam Websters dictionary defines culture generally as the integrated pattern of human knowledge, belief, and behavio r that depends upon mans capacity for learning and transmitting know ledge to succeeding generations. Schermerhorn s definition of c ulture is the shared set of beliefs, values, and patterns of behavior common to a group of people Schermerhorn Jr., 1996. Morasco define s culture as a set of characteristics that sets one group of people apart from another Morasco, 2002. Although there are many definitions of the word, culture, there are similarities in the meaning. Culture consists of explicit and implicit patterns of behavior acquired, created and transmitted Renard, 2006. How a set of abstract principles is translated into day to day behavior is defined by its culture Morasco, 2002. Culture is learned; it is not genetic, just as a persons de sire for a cream cheese bagel and orange juice in the morning is not genetic, but a learned cultural response to morning hunger Renard, 2006 On the contrary, Morasco believes that people ha ve a set of nearly instinctive default behaviors, programmed in to each person from infancy, which represent s accepted norms and modes within each persons local environment Morasco, 2002. Whether learned or instinctive, a persons behavior is driven by three forces: 1 human nature; 2

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28 culture and; 3 personality Morasco, 2002. Further, c ulture is powerful but not immutable template of behavior The Wharton School, 2004. 2. 8 .1 Organizational Culture Just as culture transcends from one person to another in society, it transcends within an organization ; hence t he term organizational culture, sometimes referred to as corporate culture or company culture. Cultures in organizations are the same as in societies Nitschke, n.d. however, in an organization there a r e two levels of culture, the observable culture and the core culture Schermerhorn Jr. 1996 Observable culture is what one sees and hears and the core culture is the underlying beliefs that influence behavior and actually give rise to the aspects of observable culture. There are several definitions o f organizational culture in which all have fundamental similarities. Organizational culture as defined by Edgar Schein i s a pattern of basic assumption invented, discovered, or developed by a given group as it learns to cope with its problems of external adaptation and internal integration that has worked well enough to be considered valid and, therefore, to be taught to new members as the correct way to perceive, think, and feel in relation to those problems Schein, 1990. Organizational culture is th e environment in which people work Hodgetts, 1999. O rganizational culture has been defined as a collection of values and norms that are shared by people in an organization and that control the way they interact with each other and with stakeho lders outs ide the organization. Organizational culture is a seri es of values, standard interpre t at ions, insights and ways of thinking that are s hared by

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29 members of an organization and are passed on to new members of the organization Daft, 2002. Company culture is a system of shared values, beliefs, behaviors and goals widely accepted by the membership and translated into the way a company treats its employees and internal and external customers Culture or Reputation, n.d.. Company culture is based on shared values and workplace norms Rao, 2003. The shared beliefs, from top to bottom, are what the company is doing, what it is offering or providing or what it is manufacturing is of the highest quality Culture or Reputation, n.d.. Because culture is shared it can remain influential long after its creator has been forgotten Deering, Dilts & Russell, 2003. Culture creates vast inertial guidance in all that is done leading one to repeat readily what has gone before with little concern for why The Wharton School, 2004. Thus a key aspect of a culture is its ability to pass on knowledge and competence to its members Deering, Dilts & Russell, 2003. Corporate culture is that intangible something that influences the environments in which we work every da y Pegasus Communication, 2004 It is the perceived personality of an organization that is determined by the people who form or make up an organization and partly from the reputation it has from the quality of goods or services that it offers Culture or Reputation, n.d.. Corporate culture thus refers to the emotional climate or personality of the organization Renard, 2006 An organizations culture refers to unspoken beliefs, values and traditions translated into statements of vision and mi ssion, co mmon to the work force that are expressed in silence and powerful rules, which control and

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30 reinforce the behavior that is encouraged or discouraged in the workplace Renard, 2006. Corporate culture not only forms the foundation of any business but also s hould be reflected in the company s mission statement and re enforced through internal objectives Culture or Reputation, n.d.. Culture comprises values, norms, and conventions that people both absorb and recreate as part of the community of people, wh ether a company, work group, or religious organization The Wharton School, 2004. Every company and every organization has a culture of sorts and it can be a force for good or for bad depending on its values, the way the corporate leaders determine strat egy and d irection and how they train their staff to interpret those values Culture or Reputation, n.d. C ulture has the potential to mold behavior, strengthen common beliefs, and promote members to apply their efforts to accomplish organizational object ives that are viewed as impo rtant. Well crafted, it can effectively align thousands of people and decisions; poorly designed, it can misalign an entire organization The Wharton School, 2004. The challenge of identifying and analyzing company culture li es in its invisibility Renard, 2006. 2.8.2 Culture Change Cultures that are developed over the course of years and years of evolution are not changed in the short term nor does change come easily Nitschke, n.d.. Change happens and most people cannot tell how or when things changed, they just did Nitschke, n.d.. While changing a companys culture overnight is downright impossible, workplace experts say the first step is to take a close look at the existing culture, define it, and then ask if it has the r ight

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31 qualities to back up the business goals Leung, 1997. Cultures can be changed, but it takes recognition, perseverance, time and leadership Nitschke, n.d.. The truth is that more than 70% of large scale system implementation change efforts fail an d of these failures more than 70% are due to culture related issues: employee resistance to change and unsupportive management behavior Witt, 2006. Sometimes there are valid reasons for employee skepticism, and that is probably due to ill conceived plan s for change that failed in the past Nitschke, n.d.. Cultures are capable of making or breaking an organization if left to their own evolution Nitschke, n.d.. When leadership is fragmented or inconsistent, when departments degenerate into factions, wh en gaps emerge between a companys stated purpose and its actual mode of operation, toxic cultures are born Sea Change, 2003. It is vital that a new hire fits the co r porate philosophy, or he stand s little chance of long term success Rodgers, 2006. Fr om the CEO to the lowest level member of the organization, the hiring process sho u ld focus on what the organization needs and whether or not the candidates fully understand that they are there to move the organization forward, not just for their own self i nterest Nitschke, n.d.. Reducing turnover starts with commitment from the top, so management philosophy should not only match the corporate climate but should invite others to join in with their best foot forward Rodgers, 2006. Dysfunctional cultures are simply tough to fix Witt, 2006. Cultural mismatch is a major reason for employee employer relationship failure Rodger s 2006 Studies show that up to 50% of the typical employees job satisfaction is

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32 determined by the quality of his relationship with his direct manager Rodgers, 2006. If there is a high quality relationship between the employee and his direct manager, the employees job satisfaction will be high and vice versa. 2.8.3 Strong Culture Cultures develop and evolve over time through the ac tions of past leaders, events and circumstances Nitschke, n.d.. Most cultures evolve unnoticed and untouched by management for two main reasons: 1 organizational leadership is focused on the short term results of the company, usually quarter over quart er results ; and 2 leadership usually comes and goes on a frequent bas i s Nitschke, n.d.. The strength of the culture depends on two factors : 1 the degree to which the values of the culture are codified and effectively transmitted to all ; and 2 the deg ree of pain people suffer for straying outside the cultural norms Morasco, 2002. Strong cultures are believed to exist where members respond to stimulus beca u se of their alignment with the organizational values CEOs fail to see that employees actions are often prompted by fear fear of losing status, fear of losing control, fear of losing their jobs Sea Change, 2003. It is only when the culture is recognized and understood that managers, at all levels, can proceed with running the business through recruitment and training programs Culture or Reputation, n.d.. New employees should be trained in the company culture. Also, decisions on hiring need to be made carefully since people in an organization are the key reasons cultures either are strengt hened and reinforced, or, alternatively, weakened and diminished Rao, 2003. T he corporate culture, and the

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33 reputation, is maintained through the recruitment process and thus it is not easy to change strategy, direction or corporate culture over night si mply because of intertwining of beliefs and ideals. Culture or Reputation, n.d.. Morasco believes that t he strongest cultures are those in which all members clearly know and understand the code, and also recognize that the penalties for violation are h arsh Morasco, 2002. The unofficial source of information in a company is called the grapevine. Contrary to Morascos belief, Seaman suggests as stated in Sea Change, 2003 in a healthy culture, senior management can actually learn a lot about whats going on by listening in to the grapevine inviting people to come forward and talk about what is going on, without fear of censure or retribution. There is genuine conversation leaders listen to what people say Deering, Dilts & Russell, 2003. I ts a way of identifying significant issues before they get out of hand and c ause major employee discontent Sea Change, 2003. People at all levels are encouraged and supported to speak openly and honestly about what they think Deering, Dilts & Russell, 2003. As a result, leaders pick up signals that give clues or coming opportunities and hints about emerging threats Deering, Dilts & Russell, 2003. When you care about people, they are going to be happier and more efficient at their jobs Leung, 19 97. If people at the top are open, honest, communicative, and responsive and are aware of moral, social and ethical values then it is more likely the company will have those same qualities Culture or Reputation, n.d.. That is because the very qualiti es

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34 demanded of leaders are the same qualities that go to make up corporate culture Culture or Reputation, n.d.. A strong culture can be developed at a company even if employees do not spend their evenings after work together socializing Rao, 2003. T he key to developing a strong culture is to make it relevant to the companys business and to assure that it reinforce s the qualities necessary for the company to succeed Rao, 2003. Those qualities include accountability, teamwork, training, responsibil ity, integrity, focus, understanding, growth, and ethics Culture or Reputation, n.d.. A companys culture thrives when there is stable leadership and when senior management and employees share common values and patterns of behavior Sea Change, 2003 This begins by developing the shared values for the company with the team, not simply issuing them top down and gaining consensus and agreement on what these core principles should be Rao, 2003 T he team must recognize that they are addressing a comm on goal, and they must be willing and able to work collaboratively together to achieve it Witt, 2006. A successful company culture requires the existence of a well defined, structured environment with no ambiguous organ ization charts Renard, 2006. Ve ry clear job descriptions and unmistakable lines of reporting provide clarity and maintain the companys stability and continuity Renard, 2006. Strong cultures are built where there is true alignment between actions that are desired and actions that are rewarded Rao, 2003. The organizations actions and plans are determined by the desire and efforts of people at all levels of the organization, and the credit for success is spread to many contributors Deering, Dilts &

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35 Russell, 2003. T he only way a c ompany can build a strong corporate culture is by weaving it into the fibers of the company Rao, 2003 Thus, bu ilding a high performance culture requires extended and consistent investment over several years, but once achieved, the built in inertial mom entum can help sustain high performance for years ahead The Wharton School, 2004. 2. 8 .4 Importance of Culture The 1999 I nstitute of Medicine report emphasizes of utmost importance, when a medical error occurs, to not place individual blame. Additiona lly, the report emphasized a dire need for leadership by executive leaders and clinicians as well as holding the board of trustees accountable for patient safety. Prevention and correction of system based errors should be the only focus of a no n punitive culture, not pointing fingers and placing blame. The first task is the creation of a blame free, protected environment that encourages reporting of all medical errors. Fear of reprisals, public castigation, and loss of business will continue to im pede the reporting of serious errors unless incentives for making mistakes known to accountable oversight bodies are provided JCAHO, February 2000 The blame for mislabeling a prescription and the punishment for doing so, outweigh a pharmacists intent of doing what is right and reportable medication errors are continually driven underground. For a typical caregiver involved in a medical error that leads to a serious adverse event, the incentives to report are all negative p otential job loss, humiliat ion, and shunning JCAHO, February 2000 Some positive reinforcement and a

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36 supportive environment that encourages the reporting of a medical error and full disclosure to the patient are warranted in all realms of the medical industry Presiden t Clinton wanted to replace what some call a culture of silence with a culture of safety, an environment that encourages others to talk about medical errors, what caused them and how to prevent them. According to the United States Department of Veterans A ffairs, Frequently Asked Questions, c reating a culture of safety means moving beyond a culture of blame to one of "safety mindfulness". Traditionally, the dominant psychological environment of medicine has been a simplistic one of shaming and blaming, and then punishing, individual actors who have been singled out for making mistakes, rather than an environment in which errors are recognized as a complex systemic phenomenon requiring broader solutions Reinertsen, 2000. In the shame/blame environment, wh ere errors are seen as a form of personal moral failure that shatters the culture of infallibility inculcated in physicians since the first day of professional training, the physicians ultimate fear is losing face in front of ones peers Wu, 2000. The existing culture of blame and punishment, which suppresses information about errors, must be transformed into a culture of safety that encourages information sharing A merican M edical A ssociation 2000. Hoping to foster organization cultures tha t promote error reduction efforts, the Joint Commission has designed its policies not to penalize the accreditation status of an organization that surfaces an error and performs the appropriate due diligence required under the policy. The resulting atmosp here provides incentives that

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3 7 favor the surfacing of information about errors which contributes to error reduction strategies that can be used by other organizations JCAHO, February 2000. 2. 9 Industry Leaders When it comes to medical error reporting the federal government has been leading by example. The Department of Veterans Affairs and Department of Defense have been frontiers in the use of automated and other systems to reduce medical errors According to t he United States Department of Vetera ns Affairs National Center for Patient Safety n.d., t he Veterans Health Administration has two systems internal and external in place for reporting medical errors. According to the V eterans A dministration both system s are confidential and non puniti ve However, the external system is voluntary and the internal system is mandatory for death and serious injuries Using the expertise of the National Aeronautics and Space Administration, the Veterans Administration develop ed an internal reporting sys tem, the Patient Safety Information System, called SPOT U.S. Veterans Affairs National Center for Patient Safety FAQ This system identifies weaknesses in the system of providing care rather than attempting to define how many errors occur in a given amou nt of time. SPOT has been pilot tested in Veterans Administrations Veterans Integrated Services Network 8 which encompasses the state of Florida and the most southern part of Georgia. The external system is called the Patient Safety Reporting System. This system was developed by a collaborated effort between Veterans Health Administration and the National Aeronautics and

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38 Space Administration. According to U.S. Veterans Affairs National Center for Patient Safety FAQ n.d., o nly National Aeronautics an d Space Administration personnel assigned to the reporting system can review data until the de identification process is complete The V eterans A dministration completed implementation of an automated order entry system in all its health care facilities, along with a bar coding system for medication administration in 2000. Because people on the frontline are usually in the best position to identify issues and solutions, Root Cause Analysis teams at each of the V eteran A dministration h ealthcare facilities formulate solutions, test, implement, and measure outcomes in order to improve patient safety. Findings from the teams are shared nation wide as cited by the United States Department of Veterans Administration in Culture Change: Prevention, Not Punishmen t As a result of such findings, V eterans A dministration increased patient safety training for staff from 15 to 20 hours a year. In spring 2000, all 500 D epartment of Defense hospitals and clinics implemented a mandatory reporting system Clinton Gore Administration, 2000 D epartment of Defense implemented a new computerized medical record that makes pertinent clinical information on a patient available when and where it is needed. Further, the D epartment of Defense launched an integ rated pharm acy system for over 8 million of their beneficiaries. This new system allow s D epartment of D efenses physicians to precisely track prescriptions as they are filled in public and private pharmacies worldwide thereby, alleviating drug drug interactions and/o r adverse event s

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39 There have been others that contributed to the foothold on medication errors. In private industry and non punitive medication error reporting, the Oklahoma State Board of Health leads the way. In 2001, Oklahoma became the first state t o grant legal protection to the United States Pharmacopeia 2001 Institute for Safe Medication Practices USP ISMP. Oklahoma regards submitted reports as privileged communications and bans their use in legal proceedings. The ability to report medicat ion errors without fear of retribution should help healthcare providers identify trends and implement system wide safety measures to prevent future errors Cohen, 2001. 2. 10 Chapter Summary A major effect of the 1999 Institute of Medicine report was t hat it helped to enlist a diversified variety of stake holders to advance the patient safety cause In 2001, Congress responded to the Institute of Medicine recommendations by a ppropriating $50 million annually for patient safety research to the Agency fo r Healthcare Research and Quality in order to further understand when, how, and under what circumstances errors occur; identify the causes of errors; develop tools, data, and research needed to foster a national strategy to improve patient safety; and wor k with public and private partners to apply evidence based approaches to the improvement of patient safety T he lead federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, improve patient safety, a ddress medical errors, and broaden access to essential services United States Congress Subcommittee on Health of the Committee on Energy and Commerce House of Representatives, 2002 The

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40 most important stake holders are the physicians, nurses, therapists and pharmacists who have become much more alert to safety hazards and who are committed to making improvements on the front lines Leape and Berwick, 2005. In 1999 the Institute of Medicine committee asked the Food and Drug Administration to: 1 devel op and enforce standards for the design of drug packaging and labeling to maximize safety; 2 require pharmaceutical testing of proposed drug names; and 3 establish an appropriate response to problems identified through post marketing surveillance, especi ally those that are perceived to require immediate response to protect the safety of patients. The Institute for Safe Medication Practice March, 2002 conducted a survey on drug companies providing fewer unit dos e packaged medications. It is clear from the survey that, despite some initial worry about costs, many hospitals are ready to do their part to move patient medication technology forward. The survey results indicated that almost two thirds of respondents would be less likely to purchase a product if it were not available in unit dose packaging ISMP, March 2002 The pharmaceutical industry must now join the battle of medication error preventi on and produce all products in unit dose packages with a uniform bar code. As of 200 4 there has not bee n any new labeling or packaging guidance documents; pharmaceutical companies are not required to test proposed drug names and packaging; a standard process for this testing has not been established; and at times, FDA response to problems uncovered through reporting programs is slow or non existent ISMP, November 2004.

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41 While t he 1999 Institute of Medicine report, To Err Is Human €, has not yet succeeded in creating comprehensive, nationwide how to steps for improvements in patient safety, it has made a pr ofound impact on individual and organizational attitudes. The 1999 Institute of Medicine report has changed the way healthcare professionals think and talk about medical errors. A central concept of the report that bad systems and not bad people lead to most errors has since become a mantra in healthcare Leape and Berwick 2005 A 2004 Institute of Medicine report, Keeping Patients Safe: Transforming the Work Environment of Nurses , suggests that a persistent professional culture that fosters unreali stic expectations of clinical perfection is an external barrier that seriously impedes full implementation of a non punitive, just culture of safety ISMP, February 2005

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42 Chapter 3 Theoretical Development 3 1 Introduction As was stated in the literature review of medical errors, the theory proposed and tested by this research will primarily reflect the relationship between the culture and the pharmacists decision to hide or come forth in the discovery of a medication error. The model will pro pose an intervention process that attempts to explain some of the difference in human behavior in an organization by cultural characteristics and individual moral make up. The purpose of this research is not to identify the process, but to identify the t y pes of culture in conjunction with ones moral values that may account for the difference in decision making. Because complete disclosure of a medication error does not occur most of the time, the research will be of necessity, an assessment of organizat ional culture and individual moral make up. This model is designed to explain why some pharmacists choose to reveal report that a medication error did occur while other s in what appears to be the same situation choose to remain silent not report. A theoretical model of error in the organization is proposed in Figure 3 1 An incident is an occurrence of an action or situation that is a separate unit

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43 Figure 3 1 Theoretical Model Person Responsibles Incidents Error Discover y Non Punitive Punitive Report No Yes Job Design

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44 of exper ience occur ring in the organization. The incident may be as simple as a phone ringing or a colleague interrupting to ask a question. However, the incident is a direct reflection on job design. The incident, if not handled in accordance with job design results in an error. This compromise on job design could be as complicated as giving Jane Doe 2 years of age a medication that was meant for Jane Doe 82 years of age. In the military, for example, personnel error can be defined as any deviation from established procedure. This may imply punitive measures and assumes all error would be eliminated by following the checklist or following procedures DeGreene, 1970. In these type thinking organizations, there is a persons responsible as dictated in a punitive environment. In these instances, the event is the discovery of an error rather than the discovery of a flaw in the system. It now becomes the individuals decision to report or not report the error. 3 2 Defining Error and Its Classificatio ns Error is defined as an unintentional mistake MSN Encarta, 2006 To be considered an error, an aspect of human behavior must potentially have a degradative effect on system performance Degreene, 1970. In general, all errors can be termed either ac tive or latent. An active error is one whose effect is immediate. For instance, jumping out of an airplane without a parachute has an immediate effect. Either you splash into the water or you hit the ground. Active failures have an underlying history that extends back in time and up through the levels of the system. Latent errors are those errors whose effects are delayed the proverbial "accident waiting to happen" Reason, 1990. In the parachute

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45 example, perhaps the sky diver strapped his look a like knapsack on his back thinking it was his parachute sack. As a result, every time the sky diver needs to make a jump the potential for disaster is high. Latent errors arise from decisions made by designers, builders, policy makers, procedure writers, and top level management. For example, top level management says that one pharmacist can only be on the clock during an eight hour shift, otherwise the pharmacist that works beyond eight hours in one day will be written up. A medication error becomes more l ikely as the pharmacist is approaching the e nd of his/her eight hour shift as work is sped up to complete necessary prescriptions before the shift ends. James Reason developed the Swiss cheese model of how defenses, barriers, and safeguards may be penetra ted by an accident trajectory. The holes in the Swiss cheese model are analogous to the holes in the defenses, barriers, and safeguards of a system The holes arise for two reasons: active failures and latent conditions. Latent conditions have two kinds of adverse effects: error provoking conditions time pressure, understaffing, fatigue, etc. and long lasting holes untrustworthy alarms and indicators, unworkable procedures, etc. in the defenses Reason, 2000. Latent conditions can be identified and remedied well in advance of the occurrence of an adverse event. Knowing and understanding that remedial action aids in the prevention of error can lead to proactive risk management. Once errors are understood, steps to prevent them can be developed.

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46 A number of classification schemes have been developed to categorize human errors. For example, Kirwan 1994 identifies four types of errors, including 1 errors of commission, in which incorrect actions were taken, 2 errors of omission, in which requir ed actions were not taken, 3 extraneous acts, in which an action that was not required was taken, and 4 error recovery opportunities, comprised of actions which can recover previous errors. E rrors have been classified into categories such as failure t o follow procedures, incorrect diagnosis, using poor judgment, misinterpretation of communications, and insufficient attention or caution DeGreene, 1970. Other schemes divide errors into motor and cognitive categories while some divide errors into techn ical or intellectual errors PharmCon, n.d. In pharmacies, a technical error is one that generally occurs as a result of a pharmacist having performed a function incorrectly ; for example, the dispensing of a drug in the wrong strength. In an article pub lished by Pharm C on, Inc, Medication Error Reduction Perspectives From Two States With Legal Case Analysis , a n intellectual error is one that usually occurs as a result of a pharmacist having failed to recognize, and acted to prevent, a problem with drug therapy; for example, the failure to warn or to detect duplicative therapy or failing to properly counsel 3 3 Thought Process Mode Cognitive psychology is the study of higher mental processes such as attention, language use, memory, perception, problem s olving, and thinking

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47 American Psychological Association, 2002 Simply put, cognitive psychology is the study of how people think. Cognitive scientists have attempted to understand and model cognitive abilities such as perception, learning, language, me mory, and problem solving. Cognitive psychologists and human factors specialists have been studying how and why people make errors for many years Cognitive psychologist s determined that human beings operate in an automatic mode and problem solving mode In automatic mode, human beings perform processes that do not require attention and can often be performed along with other tasks without interference. For example, i n automatic mode, human beings can hold a conversation while tying a shoe. In this mo de, the actions are unconscious and effortless and once we have a task "down," it becomes a part of automatic mode thinking Leape, 1994 The mind switches to problem solving mode when a problem surfaces The problem solving mode involves thinking that is directed toward solving specific problems and that moves from an initial state to a goal state by means of a set of mental operations APA, 2002 Errors that occur in the problem solving mode might occur when the wrong rule is chosen, either because t he situation was mis calculated or the rule was misapplied. Factors that a ffect the functioning in problem solving mode are pattern matching, biased memory, the availability heuristic, confirmation bias, and overconfidence, filling in the gaps of knowledge Leape, 1994 An example of pattern matching is when a pharmacist has to fill a prescription for 0.1 milligrams of levothyroxine for Patient A and a prescription for 1.0 milligrams of levothyroxine for Patient B The pharmacist relies on previous

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48 thoug ht out solutions from filling Patient As prescription as the pharmacist fills Patient Bs prescription An example of bias memory is when a pharmacist fills 10 prescriptions of 0.1 milligrams of levothyroxine on a daily basis and one day he is to fill a prescription for 1.0 milligrams of levothyroxine. Because of the familiarity of filling the prescription for 0.1 milligrams of levothyroxine, the pharmacist over generalizes when he fills the prescription for 1.0 milligrams of levothyroxine. An example o f availability heuristic is, if the pharmacist filled the 1.0 milligrams of levothyroxine with 0.1 milligrams of levothyroxine because that was the first information to come to mind. An example of confirmation bias is when a pharmacist receives current do cumented evidence that 0.1 milligrams of levothyroxine has no therapeutic value and continues to prescribe the 0.1 milligrams of levothyro xi ne because of a decade old, supported hypothesis that 0.1 milligrams of levothyroxine has been shown to increase the functioning of the thyroid in 95% of the s ubjects tested. Further, an example of over confidence is when the pharmacist believes that his/her actions to continually prescribe 0.1 milligrams of levothyroxine are justified and the pharmacist is in favor of all evidence that supports his/her course of action. While operating in the problem solving mode, t he result i s a delay in the algorithm for problem solving processes. Like the cognitive psychologists, human factor s specialists are concerned with unders tanding the interactions between human beings and systems. According to the Human Factors and Ergonomic s Society 2005, t he human factors profession applies theory, principles, data, and other methods to design

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49 systems that will optimize human well being and overall system performance. Human Factors and Ergonomics at San Jose State University, defines the specialty of h uman factor s specialists to include improving the operability, maintainability, usability, comfort, safety and health characteristics of systems to improve the human and system effectiveness and to reduce the potential of injury and error 3 4 Beginning of an Error Human errors begin during the design stage, extending beyond process and workplace design into construction and continuing in to the design of management systems for operations and maintenance Process Improvement Institute, 2005 These systems include management and training policies and procedural development and standard operating procedure development. Faulty procedures may be the actual cause of an error that initially appears to be the result of inattention Pharmacy Law and Management Conference, 200 2 There is seldom a single reason that an error occurs. A large number of factors, broad in range, can be attributed to a single error. Usually, a chain of events that has gone undetected and unnoticed by a system leads to a recurring safety problem Most pharmacy errors result from problems created by today's complex healthcare system It is impossible to practice any pr ofession without occasionally making a mistake Pharmacy Law and Management Conference, 200 2 T he right conditions, at the right time, can lead to a mistake by anyone Typically,

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50 mistakes become a concern only when a person is injured. To prevent the m istake from occurring again, punishment is usually the preferred solution 3 5 Pharmacists and the Pharmacy The practice of pharmacy is a vital part of total health care. The basic value of medicinal treatment to patients in the United States is eviden ced by the increased therapeutic use of prescriptions. In 2004, there was an average number of 63,500 prescriptions dispensed annually per co mmunity pharmacy PR Newswire Association LLC., 2006 With a total of 24,500 c ommunity pharmacies, community pha rmacists dispense approximately 1.6 billion prescriptions annually PR Newswire Association LLC., 2006 Annually, a total of 1.3 million Americans experience a medication mixup CNN, 2005. Pharmacists dispense medications prescribed by physicians, dent ists, and other authorized medical practitioners. According to Florida Health Careers, m ost pharmacists work about 43 hours per week. Earnings are high, but some pharmacists work long hours, nights, weekends, and holidays Bureau of Labor and Statistics, 2006 Long working hours and overtime contribute to increased worker fatigue and safety problems Dawson et al 2004 The long hours and nights could potentially give rise to fatigue and result in a medication error. The role of the pharmacist has radi cally changed over time According to an article by Academy of Managed Care Pharmacy: Pharmacists Cognitive Services, i t has shifted from one of product dispenser to one of medication thera py expert on a healthcare team. According to American Phar macists Association Foundation n.d. p harmacists are trained to understand the

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51 composition of drugs, including their chemical, biological, and physical properties. By understanding the composition of drugs and how they work in the body, pharmacists can identify medication interactions. Pharmacists must understand the use, clinical effects, and composition of drugs, including their chemical, biological, and physical properties Bureau of Labor Statistics, 2006 In McKee vs. American Home Products, Corp: A review of case law from reported judicial opinions discloses that the trend is toward recognition of responsibilities by pharmacists to both accurately process prescription orders and also competently monitor drug therapy Pharmacy Law and Management Co nference, 200 2 Pharmacists must exercise skill and care in the realm of duty performance so as to prev ent undesirable effects from dispensed medications. Skill refers to the ability to produce good results, and care refers to the effort one expends in producing good results Leape, 1994. For the pharmacist, job design is an intricate part of his/her job. Pharmacy is usually practiced in a very public area with many distractions and interferences having the potential to divert attention from the task of processing prescriptions and providing pharmaceutical care services for patients Pharmacy Law and Management Conference, 200 2 The challenges facing those who design pharmacy systems that take into account the interaction of man and machine, are many varied, and complex Quantitative information about human performance, including error performance, is necessary for realistic system planning, functions allocation, equipment design, selection, training, and

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52 evaluation Degreene, 1970. If done correc tly and integrated with properly designed equipment and ideal facility layout, errors will be few and far between. 3 5 .1 Errors in Pharmacy Medication errors tend to fall into three categories: prescribing, dispensing and administering medicines Cousins, 2005. A prescribing error involves incorrectly entering the prescription. Examples of prescribing errors are wrong dose, wrong drug, illegible hand writing on a written prescription, and incorrect use of a prescribed drug. A dispensing error involves wrong drug, wrong patient, mislabeling of prescription, and wrong dose An administering error involves drug omission, wrong drug given to patient, and incorrect route of entry. T here are four types of events that are associated with each category of med ication errors: 1 adverse event unintended incidents in care that may result in undesirable outcomes and may require additional care; 2 near miss events in which unwanted consequences were prevented; 3 sentinel event event in which death or seriou s harm to a patient has occurred; and 4 no harm event an event that has actually occurred no recovery action was taken but where no actual harm has come to the patient or the organization. The causes of these medication errors are complex in nature b eing that it is seldom a single error that causes the mistake Often, there are some underlying systemic issues that compromise the quality of the healthcare delivery system 3.5.2 Causes of Medication Error s Lucian Leape M.D., identified a number of proxima l causes to medication error. Proximal causes are defined as the apparent 'reason' the error

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53 was made Leape et. al. 1995. Sometimes there is more than one proximal cause associated with a medication error. Proximal causes are expansive categories wh ere the underlying system problems that result in medication errors may be found. Proximal causes as identified by Leape et. al. 1995 include the following: lack of knowledge of the drug, lack of information about the patient, violations of rules, slips and memory lapses, transcription errors, faulty identity checking, faulty interaction with other services, faulty dose checking, infusion pump and parenteral delivery problems, inadequate monitoring, drug stocking and delivery problems, preparation e rrors lack of standardization The Institut e for Safe Medication Practices March 2001 identifies the main cause to medication error as failed communication. Other causes as identified by ISMP March 2001 include the following: 1 Failed Communication: this category includes the six broad categories: a Handwriting and oral communications, especially over the telephone b Drugs with similar names c Missing or misplaced zeroes and decimal points d Confusion between metric and apothecary systems of measure e Use of no n standard abbreviations f Ambiguous or incomplete orders 2 Poor Drug Distribution Practices 3 Complex or poorly designed technology 4 Access to drugs by non pharmacy personnel 5 Workplace environmental problems that lead to increased job stress 6 Dose Miscal culations 7 Problems Related to Drugs and Drug Devices 8 Labeling and packaging problems 9 Drug delivery device design flaws 10 Incorrect Drug Administration 11 Lack of Patient Information 12 Lack of information on the patients disease state or condition 13 L ack of information on changes in a patients therapy

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54 Because causes of medication error are an intricate part of this dissertation, all causes of medication errors as defined by Institute on Safe Medication Practices have been included in the above list. Two major categories of factors that influence error are physiological and psychological Leape 1994 Physiological factors include fatigue, sleep deprivation, drugs, alcohol, and sickness. Psychological factors include distraction due to other activi ty, as well as emotional states such as boredom, anger, fear, and anxiety. Psychological factors can be triggered by external factors such as overwork, interpersonal relations, and other forms of stress Leape, 1994 In the airline industry as analogou s to the medical industry, fatigue is noted as the primary adverse physiological facto r that is associated with the occurrence of a irline accident s 3 5 .3 System Practice in Pharmacy It is important that with any activity in which safety matters, that ac tivity should be done purposefully, according to a system, in which each specific action is understood to cause a specific result, and changes can be made in the system to improve results Pharmacy Law and Management Conference, 2002 A system can be def ined as "an interdependent group of items, people, or processes with a common purpose" Langley, Nolan K, Nolan T, 1992. Most pharmacists develop a system of their own for processing prescription orders, and it is important that this individual system be compatible with the system developed by the employer Pharmacy Law and Management Conference, 200 2 Systems that rely on error free performance are doomed to failure

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55 Leape, 1994 An eff ective and efficient system can avert p harmacy errors and create a fail safe system environment that absorbs error in pharmacy When an error occurs, the most common reaction is to find someone to blame. In reality, most medication errors are due in larg e part to multiple contributing factors that cut across numerous lines of responsibility, technical procedural, and managerial, all which are inclusive of a system. Medicati on use systems are complex and the dispensing of one prescription, or the adminis tration of even one dose of a medication, involves from 10 to 15 steps, of which each step offers a potential pathway to error. According to Academy of Managed Care Pharmacy: Frequently Asked Questions, e ach system involved in each of the 10 to 15 steps, such as computer systems, dispensing devices or drug delivery devices, are potential sources of error Preventing errors and improving safety for patients require system modification s to rid the system of factors that contribute to medication errors. Saf e medication practice is about minimizing the risk of patient safety incidents involving medicines Cousins, 2005, not blaming individuals. There exists no recorded data that validates medical errors being r educed as a result of blaming an individual 3 6 Development of Hypotheses A set of three hypotheses regarding the nature of organizational characteristics and individuality have been developed and are presented in Table 3 1 The first and second hypotheses are concerned with the characteristics of the organization while the third hypothesis investigates the relationship between the individual and the organizational culture.

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56 3 6 .1 Organizational Characteristics Organizational culture is the shared set of beliefs, values, and patterns of behavior common to a group of people Schermerhorn Jr., 1996. The term corporate culture and workplace culture are often used synonymously with organizational culture. Simply put, organizational culture is the environment in which people work. In an organizatio n the likelihood to shape attitudes and behavior exists and m embers are encouraged to apply their efforts to accomplish important organizational goals. It is very important to mention that there are two levels of culture, the observable culture and the c ore culture. Observable culture is what the workplace environment looks like and what it sounds like. The core culture consists of the fundamental beliefs that manipulate behavior and give rise to the aspects of observable culture. Hypothesis 1 states that intervention will improve company culture. Intervention can come in many forms. Intervention can be a new process for filling prescriptions, a new piece of equipment, an alarm installed as a fail safe, an external audit of the pharmacy, a workflow a nalysis, distribution of a pharmacy related information sheet or a survey of the organizational culture For example, a new process for filling a prescription could be a triple check on prescription verification. A new piece of equipment could be an auto mated pharmaceutical dispenser. An alarm could be installed within the electronic prescription verification system to notify the pharmacist of a mix match. External audit of the pharmacy could be performed by a non affiliated entity outside of the organi zation. A workflow analysis could be performed to assess the functionality

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57 of the workflow. The distribution of an information worksheet could serve as an eye opener for pharmacy related issues. A survey could serve as an assessment of issues related to pharmacy and serve as an opportunity to gain members perspective on dealings associated with pharmacy. In short, these interventions are all considered as a type of defense that can be interjected into the organization at anytime. Defenses, barriers, a nd safeguards occupy a key position in the system approach Reason, 2000. Some technological systems have varying layers of defenses built into their organization. The installation of these interventions can be accomplished by an industrial engineer as well as a human factors specialist. In a nutshell, i ndustrial engineers deal with work design and productivity. Industrial engineers are capable of designing work and creating policies and procedures that are conducive to a safe work environment and hea lthy culture while maximizing productivity. Like industrial engineers, h uman factors specialists deal with the applied science of workplace equipment design with the intent to maximize productivity by reducing operator fatigue and discomfort which can cau se errors. As stated previously, it is important that with any activity in which safety matters, that activity should be done purposefully, according to a system, in which each specific action is understood to cause a specific result, and changes can be ma de in the system to improve results Pharmacy Law and Management Conference, 200 2 Further, if we acknowledge the potential cau s al role of culture in the success or failure of organization change, then it makes sense to develop strategies for examining a nd redesigning cultural systems as an

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58 integrated aspect of change management Dooley, n.d. Therefore, it seems plausible that intervention may improve organizational culture. Change is eminent for every type of culture as the world advances, technologi cally. The chosen intervention applied to this research is a cultural assessment survey as well as pharmacy related information al sheet s These tools served the purpose of an organizational development comprehensive intervention. Organizational Developme nt comprehensive interventions are used to directly create change throughout an entire organization Gale, 2006. The reasoning behind the use of a survey for the chosen intervention was to assess pharmacy related issues and to gain the members perspecti ve of their work environment The pharmacy related issues were in reference to medication errors, reporting medication errors, patient safety, job task performance, relationships within the work place, customer concerns, and management within pharmacy He nce, a n evaluation of the culture is the only way to know if the culture is having an impact on medication errors. The use of the Non Punitive Information sheet was to serve as an eye opener to the pharmacists. It was intended to serve as information and inform the pharmacists that such a culture does exist. Further, it was intended to serve as a stimulation tool for pharmacist s to begin to report all medication errors regardless of the severity. The National Practitioner Data Bank sheet was to serv e as a source of truthful information in relation to the functioning of the National Practitioner Data Bank A n anonymous pharmacist said, the National Practioner Data Bank

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59 serves as a lynching mob for any medical personnel that makes an error T he res earcher thought that that attitude may have an impact on reporting medication error s Thus, an information sheet with specific information about the National Practitioner Data Bank was included as part of the intervention. A comprehensive and systemati c data collection strategy was used to identify organizational attitudes and individual moral make up. The data was then analyzed for results Chapter 5 and a plan of constructive action was made Chapter 6 Table 3 1 Hypothes e s Hypothesis Number Hyp othesis 1 Intervention will improve company culture. 2 Low company culture scores are associated with a low number of reported errors. 3 Individuals with a greater fear of reporting errors versus the average score will have low er company culture scores on average than individuals with less fear.

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60 3 6 .2 Error and Environment The problem of error induced by work environment is admittedly a complicated task Error itself is a complicated issue when looking at the bigger picture, inclusive of the envir onment. The workplace environment, commonly referred to as organizational culture, produces behavior amongst its employees that govern the employees actions to certain situations that arise in the workplace. The National Coordinating Council for Medicat ion Error Reporting and Prevention Council has taken the position that differences in culture and in defining a medication error may give rise to the varying number of medication errors reported. Hypothesis 2 states that low company culture scores will be associated with a low number of reported errors. As discussed in Chapter 1, a low company culture score means a low representation of that particular culture within the organization. A company could have a high score on one scale as it relates to a p articular culture and low score on another scale as it relates to another type of culture. In this dissertation, the individual score is compared to the aggregate response from the survey group. A company having a high score on one scale and a low score on another scale would imply that the culture of that organization resembles that culture associated with the highest scale score. On the contrary, a company having a low score would less likely resemble that particular culture. Historically, measurement efforts have focused on practitioner reporting of medication errors, which, at best, uncovers just a fraction of the errors, most of them harmless ISMP, March 2006 It is estimated that incident reports identify

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61 only 2% to 5% of reportable adverse drug events AMCP, n.d. Therefore, it seems plausible that a low company culture score will be associated with a low number of reported errors. If a pharmacist does not believe that the company will support him/her in reporting a medication error, it is li kely that the pharmacist does not believe in the company culture and will exhibit a low company culture score in relation to the culture in which he/she works. Without a detailed analysis of mishaps, incidents, near misses, and "free lessons," we have no way of uncovering recurrent error traps or of knowing where the "edge" is until we fall off the cliff Reason, 2000 It is imperative that healthcare organizations encourage all medication error reporting. Gross and Ayres a nalyses of accident data acr oss industries as cited in Barnes, 2000 show that human error plays a causal or contributing role in 50 80% of significant accidents. Human error is widely acknowledged as the major cause of quality, production, and safety risks in many industries Proc ess Improvement Institute, 2005 The most commonly designated cause of accidents is human error DeGreene, 1970. Based on human nature, human error is certain and will surface in every part of the process life cycle. Although it is unlikely that huma n error will ever be completely prevented, there is growing recognition that many human performance problems stem from a failure within organizations to develop an effective policy for managing human reliability Process Improvement Institute, 2005 Huma n reliability identifies the likelihood and consequences of human error. As defined by Meister as cited in De G reene, 1970 human reliability is the probability that a task will be successfully

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62 performed at any required stage of system operation within a criterion time period. As long as fail safes are installed within a system, human reliability will always be high In the system approach, according to Reason as cited in Wholey, Moscovice, Hietpas, Holtzman, 2003 errors are seen as consequences rat her than causes, having their origins not so much in the perversity of human nature as in "upstream" systemic factors S ystemic factors include frequent and reappearing e rror traps in the workplace and the organizational processes that transport them throu gh the system Processes are generally not well protected from human errors since many safeguards are focused on equipment failure Primatech, 2006 3 7 The Problem Professionals are trained to believe that perfect performance is not only expected, it is also achievable Leape, 1994 Often in the public eye, physicians are expected to perform their tasks flawlessly as infallible performers, and any error that occurs is often seen as a failure of character more than anything else Felciano, 1995 Me dical professionals are trained to become experts in their field. As defined by Websters Ninth New Collegiate Dictionary, an expert is one with the special skill or knowledge representing mastery of a particular subject. That definition does not mention infallible. Psychologists would call this a false belief because the reality is that regardless of how skilled, and careful, human beings will make errors.

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63 There ha ve been numerous causes linked to errors in the pharmacy. Some of the causes are as follo w: shortage of pharmacist and pharmacy technicians; unrealistic workloads; lack of a double check system; and high frequency of replacement of brand name with many different generic name drugs. In a survey conducted by Pharmacy Today as cited in Parker a nd Waichman, 2005 pharmacist s were asked, "What could cause dispensing errors?" Of 187 responses from 171 pharmacists and 16 pharmacy paraprofessionals, insufficient filling time and too many distractions were identified as two of the major areas of conce rn Parker and Waichman, 2005 In a study of 500 pharmacist malpractice claims conducted by Pharmacists Mutual Insurance Company, the following types of errors were identified: wrong drug dispensed 52%, wrong strength dispensed 27%, wrong directions g iven 7.4%, for a total of 86.4% of errors that could have been prevented Parker and Waichman, 2005 3 8 The Reality When an error is discovered, most often through a complaint, there are three options that a healthcare facility can exercise in respon se to the medication error: admit it, deny it or ignore it. Generally, if the healthcare facility admits that an error occurred, the complaint is resolved quickly and at the least possible cost. Colorado's largest malpractice insurer, COPIC, has enrolle d 1,800 physicians in a disclosure program in which they immediately express remorse to patients when medical care goes wrong and describe in detail what happened. Since 2000, COPIC has reimbursed more than 400 patients an average of

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64 $5,300 each for bad m edical outcomes, or a total of about $2 million Kowalczyk, 2005. If the complaint is denied, it could potentially cost the healthcare facility a great deal of money. As stated by Jerome Buckley as cited in Kowalczyk, 2005 th e cost of settling the doc tors claims has dropped by 23%. If the complaint is ignored and the healthcare facility is found liable, the cost to the healthcare facility could be astronomical. Another example as stated by Richard Boothman as cited in Kowalczyk, 2005 states that t he University of Michigan Health System ha s cut claims in half and reduced settlements to $1.25 million from $3 million a year since developing a disclosure policy in 2002. There are several reasons that many believe the error rate to be higher than act ually reported in the United States. Due to the punitive nature of most health care systems, effective reporting is stifled. Because of the extreme sensitivity to legal impact of error, physicians are often unwilling to openly discuss slips or mistakes th ey make in an effort to analyze what systemic influences may have brought on these errors Felciano, 2005 Exposure to liability for order processing errors is of great concern to pharmacists because error correction is typically punishment in the form o f malpractice tort litigation Felciano, 2005 As Troyen Brennan, author of Practice Guidelines and Malpractice Litigation: Collision or Cohesion? noted, one of the reasons that the error rate is high is because promoting safety is primitive, based on the myth that the way to eliminate errors is to perform perfectly, but human beings are incapable of sustained perfect performance. Brennan concluded that fear of punishment for performance errors inhibits error reporting. Although it is

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65 reasonable to ex pect an employer to take seriously every pharmacy error, and to seek means of improvement to prevent future errors, it is unreasonable to expect an employer to discharge a pharmacist from employment simply for having made an error Pharmacy Law and Managem ent Conference, 200 2 Pharmacists are all human and all humans make mistakes. Hypothesis 3 states that individuals with greater fear of reporting errors will have lower company culture scores on average than individuals with less fear. The current syste m of error prevention focuses on blame and accountability. The public seeks out someone to blame; the legal system seeks out someone to pay, usually the one with the deepest pockets. Pharmacist malpractice falls into the same category as medical malpracti ce, in the respect that if pharmacists and pharmacy technicians fail to treat the patient with a reasonable degree of skill and care, they are guilty of medical malpractice just the same as a doctor, nurse or other health care provider Reich and Binstock, n.d. The culture of blame that exists in many healthcare systems creates strong pressure on individuals to cover up mistakes rather than admit them AMCP FAQ n.d. The threat of malpractice litigation provides an additional incentive to keep silent. Considering the problem of medical errors as the responsibility of individuals who are in separable parts of systems has a better potential for focusing on accountability without blame and on consequences without necessitating that they "suffer" the conse quences McKereghan, 2003. Therefore, it seems plausible that individuals with greater fear of reporting errors

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66 versus the average score will have lower company culture scores on average than individuals with less fear. 3 8 .1 Report or Remain Silent Whe n an error occurs, it may be discovered immediately or it could possibly have a latent effect. Upon discovery of the error, comes the decision to report or not report the error. The nature of the situation does indeed have some bearing on the behavior of the participants Callahan, 1989. After all, behavior patterns, beliefs, moral values, laws and traditions are the defining features of a culture. Sometimes the self serving nature of the situation plays an important role in an individuals decision to speak up or to remain silent. Before the decision to reveal that one was involved in a medication error, an event or series of events must take place in order to trigger the decision making process Callahan, 1989. These series of events are related to the culture as well as the individual moral make up. The se events determine if a person is going to report the medication error or remain silent. 3 9 Theory Summary Although a punitive response may be appropriate in some cases, it is not an effective way to prevent errors from recurring as well as promoting error reporting within the organization. Healthcare systems must establish a non punitive environment and system for reporting errors within their organization. Trust is an essential piece of a repor ting culture. Pharmacists must t rust that the y will not be fired They must trust that the y will not be blamed They must t rust that the organization really wants the pharmacist to reveal the medication

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67 error They must trust that the organization stan ds completely and supportively behind the pharmacist They must trust that the safest procedures are protocol in the pharmacists duties. Engineering a just culture is an essential early step in creating a safe culture Reason, 2000. Although normative in nature, healthcare organizations should provide or be provided resources to encourage error reporting and to implement methods to alleviate errors. H ealthcare facilities should have procedures to identify and improve vulnerable parts of a system prior to an error reaching the patient. Developing a system to mitigate medication errors in pharmacy is a priority in itself. The priority is a life saving event. In order to develop a system to alleviate the number of medication errors, this study will a scertain the validity of the following h ypotheses: 1 Intervention will improve company culture ; 2 Low company culture scores are associated with a low number of reported errors; and 3 Individuals with a greater fear of reporting errors versus the averag e score will have low er company culture scores on average than individuals with less fear.

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68 Chapter 4 Methodology 4 1 Introduction In order to study the phenomenon of medication errors in pharmacy, a prospective multi method approach has been impl emented. Because of the inaccurate total of medication errors in the United States, it would be ideal to study a pharmacist at work. None the less, this approach was not conducive to a safe work environment as an observer becomes an added distraction in the already busy work environment of a pharmacist As stated in Chapter 4, T heoretical Development, distractions were a primary cause of medication error. The phenomenon of medication errors is complex in nature, therefore this research chose a multi ana lysis survey approach to analyze the pharmacists perceived workplace culture and moral make up. This survey was developed in an attempt to address some of the shortcomings of being an actual observer of pharmacists at work. 4 .2 Survey Development The s urvey for this study was developed using the Corporate Culture survey Corporate Survey, n.d. developed by Connect2 Corporation See Appendix C as a foundation. The first step in building upon the existing culture survey was to determine if there were additional characteristics of a workplace

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69 culture that influence behavior at work, in this instance, pharmacists behavior at work. Having the privilege to attend pharmacy meetings the researcher noted that some of the pharmacists had innovative ideas as to the structure of work and how it should be performed Others expressed operating more efficiently while maintaining quality with specific regard to pharmacy layout and order processing O thers spoke of integrity and doing what is right. Based upon the pharmacists comments additional cultures, as listed, emerged: 1 I ntegrity/Humanistic ; 2 Efficiency/Quality ; and 3 Innovative These were cultures other than those cultures outlined in the Corporate Culture survey. The following cultures were outl ined in the Corporate Culture survey: 1 Deliberative/Traditional; 2 Established/Stable; and 3 Urgent/Seat of the Pants. The additional cultures as well as mor al implications associated with the members of the culture emerged The factors/characteristi cs that formed the bases for each culture are outlined in Table 4 1 In many situations, culture has a powerful influence on the moral order of an organization. Generally, p eople from the same type of culture have more or less identical realities and way s of thinking Maiese, 2003 These identical realities and mindsets are what contribute to the attributes of the moral make up of a person belonging to a certain type of organizational culture. The individual moral make up in the cultures studied is ded uced from the trait characteristics that make up the culture See Appendix E. Table 4 2 lists the cultures studied and the corresponding question numbers from the culture assessment survey.

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70 4 .2 .1 Integrity/Humanistic Culture Organizational Integrity is a complex of virtues working together to form a coherent character: a hopeful, identifiable, and purposeful community where trust abounds Ethics and Policy Integration Centre, 2003 Merriam Webster Online Dictionary describes integrity as a firm adhere nce to a code of especially moral or artistic values. Integrity often refers to a refusal to engage in lying, blaming, or other behavior generally seeming to evade accountability which aims at the discovery of some truth. Integrity is synonymous with hon esty hence the measured paradigm. Critics argue that honesty tests measure many things unrelated to honesty: fearfulness, traditionalism, street wiseness, admission of human frailty Strategic Dimensions, n.d. Although the issue of medication error is one that is fearful in itself, particularly to a pharmacist, the issue of integrity must be addressed. At the end of the work day, do we ask the pharmacist to have a seat and strap him/her to a lie detector and ask questions? As the questions are being a sked, do we inject the pharmacist and monitor his eye movement and body language to detect truth telling? The inaccurate low number of medication errors reported suggests that there is an integrity issue at stake in pharmacy hence the interest in integri ty testing. There are ways to objectively and effectively measure integrity. The key step is to identify integrity based behavior in pharmacy. Behavior indicative of integrity in pharmacy could be a pharmacist telling a patient that he/she has been wro ngly filling a prescription for a period of time or a pharmacist openly sharing a

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71 Table 4 1 Culture Characteristics CULTURE CHARACTERISTICS Integrity/Humanistic € This culture tends to be an honest entity € People in this type of organization consider integ rity to be at the top of the list € The organization likely encourages a nurturing environment € Upper level management communicates clearly and frequently to employees Efficiency/Quality oriented Culture € This culture tends to be quality oriented € People in t his type of organization tend to be hard workers € The organization likely has many informal systems that allow the employee to do what he/she needs to do to get the job done € Upper level management communicates priorities frequently to employees Innovative Culture € This culture tends to be innovative € People in this type of organization often consider issues carefully prior to making suggestions and/or solutions € The organization likely has many formal systems that allow the employee to feel empowered and to co mmunicate ideas € This cultural type regularly hires groups of new employees that are thinkers and doers € Upper level management communicates frequently to employees € Employees communicate frequently Deliberative Culture € This culture tends to be intellectual and thoughtful € People in this type of organization often consider issues carefully prior to making a change € The organization likely has many formal systems, yet flexibly forms and reforms teams in accordance with immediate client needs € This cultural type regularly hires groups of new employees, generating a valuable flow of diverse talent with fresh perspectives € Senior management communicates frequently to employees Established/Stable Culture € This organization has most likely been around for a long time a nd/or is a family business. These organizations tend to have solid institutional memories, so they are likely not to waste resources by repeatedly "reinventing the wheel" € This type of company has processes in place to address most situations € Organizations of this type tend to cultivate employees by encouraging development through mentoring programs and/or formal training opportunities € This culture type is known for compensating its people relatively well

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72 Table 4 1 Continued Urgent/Seat of the Pants Cult ure € This culture type features a positive work environment, with tight bonds among employees € It is likely that an aspect of this organization's mission includes responding to crisis. People care deeply about the firm's mission and work hard to achieve the organization's goals € Employees who frequently hurry to beat the clock can create great results in a short time, provided that quality is a strong value in the organization € These organizations tend to have a flat structure that fosters communication and co llaboration among employees and speeds the decision making process Table 4 2 Cultures Studied and Corresponding Question Numbers Culture Studied Corresponding Question Numbers Integrity 2 13 Efficiency/Quality 14 19 Innovative 20 25 Deliberati ve/Traditional 26 30 Established/Stable 31 35 Urgent/Seat of the Pants 36 43 medication error with his/her colleagues. Integrity means that it is not what is said, but what is done. Likewise, e thics is not about what we say or what we intend, its about what we do Scribblers Ink, 2005 Remember the old adage, actions speak louder than words. Integrity encompasses ethical behavior truthfulness moral values, trustworthiness, and compassion as a

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73 measure of ones general character. Integ rity is the purposeful, knowledgeable, trusting exercise of authority in service to a broader community Ethics and Policy Integration Centre, 2003 The purpose of o rganizational e thics is to guide the design and d evelopment of structures and systems to evolve toward organizational integrity Ethics and Policy Integration Centre, 2003 A n organization with organizational integrity is a community that has many of the characteristics of a tribe Ethics and Policy Integration Centre, 2003 Integrity is the strength, unity, clarity and purpose that upholds and sustains all of the activities of the enterprise Bracher, n.d. The characteristics of an organization exhibiting integrity according to Ethics and Policy Integration Center are as follow: 1 cor e beliefs; 2 inward motivation towards growth; 3 stability in leadership; 4 intense sense of loyalty and devotion in support of the core beliefs According to Bracher, there are eight attributes of an integrity centered company: 1 character; 2 honest y; 3 openness; 4 authority; 5 partnership; 6 performance; 7 charity; and 8 graciousness Character is demonstrated by the organization following through on statements made in the organization. Honesty is demonstrated through truthful communication. Openness is demonstrated through sharing appropriate information. Authority is demonstrated through employee empowerment. Partnership is demonstrated through organizational commitment to fulfill obligations. Performance is demonstrated through account ability throughout the entire organization from the ground floor up. Charity is demonstrated through generous public service throughout the

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74 community. Graciousness is demonstrated when the organization respects both the employee and the customer. The gi st of an integrity based organization is one that is honest, nurturing, and communicates openly, clearly, and frequently to its employees. Employees tend to get self satisfaction from performing their job. They are very knowledgeable in their field l ove every aspect of the ir job and get a high sense of honor when asked to explain a job related function. The culture assessment survey questions that pertain to an integrity/humanistic culture are Questions 2 through 13. Through the use of deductive reaso ning based upon the previous paragraphs in this section, the following statements a re applicable to t he moral implications of individuals in this culture 1 Individuals are people with a strong sense of honesty ; 2 These individuals are aware of the gove rning boards for their profession ; 3 These individuals believe in doing what is right and supports full disclosure of the medical errors ; and 4 These individuals believe in telling the truth regardless of how difficult it may be 4 2 .2 Efficiency/Quali ty Oriented Culture Efficiencies are defined as reforms that 1 reduce resources eg, people or assets, while maintaining the same level of service provision; 2 result in additional outputs, such as enhanced quality or quantity of service, for the same r esources; 3 remodel service provision to enable better outcomes IDeA, n.d. Quality Culture Changer uses the knowledge of mistake attributes and human behavior to create cultural changes essential in promoting error proofing. Easy to learn and use, th ese principles help organization leaders recognize why most

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75 quality initiatives are destined to fail before they begin. Identifying and avoiding actions that reward or punish mistakes removes key barriers to error proofing. According to Woods 1996 au thor of The Six Values of a Quality Culture, there are six values intrinsic to a quality culture. Those six values are: 1 Were all in this together company; 2 No subordinates or superiors allowed; 3 Open, honest communication is vital; 4 Everyone has access to all the information they need; 5 Focus on processes; 6 There are no successes or failures, just learning experiences. These six values work together to form an efficient culture. The culture assessment survey questions that pertain to the ef ficiency/quality oriented culture are Questions 14 through 19. The following statements about individual moral make up characteristics were derived through deductive reasoning by use of the above information : 1 These individuals want to produce a high q uality product in the form of wellness for the patient ; 2 These individuals in this culture want fast results without compromising quality ; 3 These individuals create an efficient way of doing business ; 4 These individuals will be truthful because they do not want to compromise quality Any untruthfulness will make their sy stem unbalanced and quality will be compromised. 4 2 .3 Innovative Culture Organizations with innovative cultures establish excellent working relationships at every level of the organ ization. Employees tend to feel happy, motivated, and fulfilled. Channels of communication are established among employees, middle management and senior management IES Consulting, n.d. The employees welcome, share, and appreciate each other s ideas.

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76 Communication channels are open, upward and downward Corporate Survey, n.d. Employees tend to be loyal, productive, and have excellent rapport with the customers. These organizations have a crystal clear vision that is shared by every member of the or ganization. Members fathom how their role plays a part in the organizations ability to accomplish its goals. This is crucial to its success. K ey elements of an innovative culture include: 1 a fear free workplace to tryout new ideas and take risks; 2 o pen communication; 3 resources in the form of time, money and people; 4 mutual support from colleagues and management; 5 praise for success and failure. In a culture of openness, intelligent risk taking is encouraged and intelligent failure is perceive d as an opportunity for learning IES Consulting, n.d. Mistakes are dealt with constructively and good work/behavior is effectively rewarded Corporate Survey, n.d. Happy accidents good things happening by accident and unexpected surprises are en couraged through creativity. Creativity necessarily involves the destruction of old and sometimes comfortable and perfectly good ways of doing business Schuler, 2002 In an innovative culture, c reativity and quality exceeds quantity in terms of val ue It appears that fostering innovation requires the proper mix of structure and flexibility Runyon, 2005 More flexibility and less structure aids in the creation of an environment that is conducive to fostering an innovative culture. The strength and success of these organizations can be attributed to: 1 open and candid dialogue between employees and management; 2 win win based

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77 solutions for all stakeholders and 3 employee employer desire to want the other to succeed. The culture assessment surv ey questions that pertain to the innovative culture are Questions 20 through 25. The following statements about individual moral make up characteristics were derived through deductive reasoning by use of the above information : 1 The moral implications o f individuals in this culture are caring, sharing, and confiden t ; 2 These individuals care about patient safety ; 3 They are confident and do not feel ashamed about reporting /sharing a medication error ; and 4 These individuals are creative which is a ch aracteristic of innovative, and they are ca pable of tell ing the truth in many ways without fully disclosing the whole truth. 4 2 .4 Deliberative/Traditional Culture According to www.webster.com tradition is define d as an inherited, established, or customary pattern of thought, action, or behavior as a social custom. Further, it states that tradition is the handing down of information, beliefs, and customs by word of mouth or by example from one generation to anoth er without written instruction. An organization that has a traditional culture has a top down style of bureaucratic management. The organization seldom rewards achievement, but often reprimands for errors. This negative reward system leads members to shi ft responsibility to others to avoid being blamed Corporate Survey, n.d. Organizations that have a traditional culture have some cult like characteristics. Members feel like they should be in accord with,

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78 gain the approval of, and be liked by others. Members are expected to conform, follow the rules, and make a good impression Corporate Survey, n.d. According to the authors of What Is Your Corporate Culture?, a workplace that has a traditional culture tends to be intellectual and thoughtful Mc Ginty and Moss, 2001 The employees in the traditional culture think about issues carefully before reaching a decision hence the word deliberate. The Business Edge n.d. states that a deliberate culture begins with an overall mission that defines the firms central focus and a vision of what the company wants to become. In a deliberative/traditional culture, the actions are intentional, purposeful, and deliberate. The rules are made to be followe d and any disregard for the rules implies negligence an d disrespect for the organization. The culture assessment survey questions that pertain to the deliberat ive /traditional culture are Questions 26 through 30. The following statements about individual moral make up characteristics were derived through deduc tive reasoning by use of the above information : 1 Individuals in this culture care about their jobs and understand how each task in doing his/her job is purposeful in producing a desired outcome ; 2 These individuals are detail oriented knowledgeable, an d well rounded as they socialize with people of diverse professi onal backgrounds ; and 3 T hese individuals will tell the truth as long as it is in the best interest of the company O therwise, silence may be the chosen alternative.

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79 4 2 .5 Established/Sta ble Culture In the past, the behavior, beliefs, and environment of a stable culture were equally supportive. The beliefs support the behaviors, the behaviors fit comfortably into the environment, and this in turn helps to reinforce the beliefs Gilman, 199 7 Merriam Webster Online defines stable as firmly established and designed so as to develop forces that restore the original condition when disturbed from a condition of equilibrium or steady motion. The latter part of this definition develop forces that restore the original condition is what prompted a change in the direction of two of the questions Question 31 and 34 asked in the survey as opposed to the questions Question 6 and 9 asked in the What is Your Corporate Culture ? s urvey. In a st able culture, the response to employees not getting along and customer concerns are pre scripted and timely. In other words, when employees are not getting along, the supervisor checks the company protocol and that is what is delegated to the employees. Likewise, when customers have concerns, the company follows protocol in a speedy resolution to the problem. These stable cultures want their organization to be undisturbed and have installed pre scripted measures to address issues that cause a fluctuation in their system of doing things. These cultures are established and have an attitude of if it aint broke, dont fix it. An organization with a stable culture resists change. If the level of stress in this culture grows to a noticeable level that im balances the stability of the organizational culture, it is difficult for the organization to return to the stableness

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80 The culture assessment survey questions that pertain to the established/stable culture are Questions 31 through 35. The following state ments about individual moral make up characteristics were derived through deductive reasoning by use of the above information: 1 The individuals maintain a balanced work life and are content in the work environment ; 2 These individuals do not like change or conflict and a s a result, t hese individuals follow protocol on every issue that arises ; 3 They find peace in a stable environment. 4 They are likely to bend the truth so as to not upset the balance of the workplace. They will adjust the truth so th at it fits nicely into one of the if this happens, then do this procedures ; and 5 They feel comfortable knowing that a protocol exists for every issue. 4 2 .6 Urgent/Seat of the Pants Culture Gandhi as quoted in the 2005, August article published in Ex ecutive Coaching and Change Management Whats Important Isnt Necessarily Urgent says i f you want the world to be filled with hyper efficient robots, obsessively focused on getting their own tasks done at the expense of others' progress, never veerin g off to look at a friend's new project, or to answer a colleague's question, then by all means, please be that sort of person. The article also states that t he term urgency suggests a ruthlessly businesslike approach to time management This approach t o time management is considered flying by the seat of the pants. According to Edge/Schneider Consulting Group, p eople began "flying by the seat of their pants" about 100 years ago If quality is deeply instilled within the workplace culture, employees

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81 wh o rush to beat the deadline can obtain great results. For time management task s the quality of the output will often relate to the a mount of input into the project. The culture assessment survey questions that pertain to the urgent/seat of the pants cul ture are Questions 36 through 43. The following statements about individual moral make up characteristics were derived through deductive reasoning by use of the above information: 1 The se individuals feel competent at performing their duties ; 2 They are often driven by money. However, if the price is right, they will stay with the employer for a long time ; and 3 T hese individuals are more than likely to not tell the truth. These individuals are in a hurry and will undoubtedly say what is needed in ord er to complete a task. 4 3 Scale Development Scales were developed for this study using the Corporate Culture survey, developed by Connect2 Corporation, as a foundation. Using the factors discussed in each culture type from Section 4 2 .1 through 4 2 .6 above, a list of measures for which scales were developed is listed in Table 4 3 Item pools for each scale were developed to fit a pharmaceutical work environment as suggested by several pharmacists. A high score would represent a high level of the para digm as a low score would be representative of a low level of the paradigm. As with every culture, there are advantages and disadvantages commonly referred to as pitfalls, which formed the basis for the data assessment measures Appendix D. The data ass essment measures for the

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82 Deliberative/Traditional, Established/Stable, and Urgent/Seat of the Pants culture s were developed by Connect2 Corporation Table 4 3 List of Measures SCALE NUMBER MEASURE PARADIGM SURVEY QUESTION NUMBER 1 Integrity Personal hone sty/morals 2 13 2 Efficiency/quality Personally rewarding 14 19 3 Innovativeness Idea driven; win/win 20 € 25 4 Traditional Company honesty 26 € 30 5 Stableness If it ainˆt broke donˆt fix it 31 35 6 Urgency Itˆs due yesterday 36 43 4 4 Pilo t Test The initial items were piloted on 10 pharmacists The subjects were given a brief introduction to the study and asked to complete and critique the questionnaire. All surveys were administered on an individual basis. In all cases, the time needed to complete the battery was less than 15 minutes. After the data were collected, an item analys i s was conducted and the items were revised See Appendix E. The subjects for this study are pharmacis ts at an undisclosed facility in Florida. Subject part icipation in this study is completely voluntary. 4 5 Sample Size Justification The sample size and power calculations a re carried out using the PASS 2002 software PASS 2002 Release: May 2, 2002, NCSS Statistical Software,

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83 Kaysville, Utah. The sample size was chosen based on the detection of a statistically significant difference in the primary outcome measures of the primary aim of the study. These measures are the six subscales from the company culture questionnaire: 1 Integrity/Humanistic Culture; 2 Efficiency/Quality Oriented Culture; 3 Innovative Culture, 4 Deliberative/Traditional Culture 5 Established/Stable Culture, and 6 Urgent/Seat of the Pants Culture. These sub scales are described in detail including the advantages as well as pitfall s of each culture in Appendix D. This research involves two treatment groups, a control group and an intervention group Each group w as measure d independently and co dependently. R epeated measures analysis of variance w as used to test the effect due to t ime pre versus post intervention, treatment group control versus intervention, and the interaction between time and treatment group. Of primary interest is knowing if the change from pre to post is different for the two treatment groups as well as the interaction effect No preliminary data exist to suggest what the averag e baseline value will be for any of the scales, t herefore the sample size justification is based upon effect size. Effect size is a measure of how big a difference in response there is between the two treatment groups. Effect size as defined by the Institute of Educational Sciences, refers to the standardized magnitude of the effect or the departure from the null hypothesis. The e ffect size is calculated as a difference between two population means divided by the appropriate standard deviations

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84 Institute of Educational Sciences U.S. Department of Education n.d. as follow: 1 the standard deviation of the treatment group means for the main effect due to treatment ; 2 the standard deviation of the interaction effect group m eans for the interaction effect ; and 3 the standard deviation of the time means for the time effect. It was anticipated that 60 subjects c ould be recruited for this study. Thus, it was anticipate d that approxi mately 30 subjects w ould be in the control group and approximately 30 subjects w ould be in the intervention group. Each subject w as measured twice as represented in a pre and post survey. Assuming no change in the company culture score from pre to post i ntervention in the control group and a 70% increase which is based upon the result of the sample size of 30 in the intervention group, the between subject standard deviation is 0.71 calculated as the standard deviation of the treatment group means and the within subject standard deviation is 1.00. This design achieves 94% power when an F test is used to test the g roups control and intervention f actor at a 5% significance level and the actual standard deviation among the appropriate means is 0.33 this is the standard deviation of the two group means when averaged over both time points separately for each group which represents an effect size of 0.47. The design achieves 95% power when an F test is used to test the t imes pre and post f actor at a 5% si gnificance level and the actual standard deviation among the appropriate means is 0.33 and represents an effect size of 0.33. The design achieves 81% power when an F test is used to test the group by time interaction at a 5% significance level and the act ual

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85 standard deviation among the appropriate means is 0.26 and represents an effect size of 0.26. Thus, a sample size of 60 is justifiable for this study. 4 6 Statistical Methods All statistical analyses will be performed using SPSS for Windows SPSS 12. 0, SPSS Inc., Chicago, IL. The study sample will be described using measures of central tendency mean and median and dispersion standard deviation and range for continuous/ord i nal scaled variables and frequency and percent for categorical scaled varia bles. All of the analyses w as two sided with a 5% alpha level unless specified otherwise. For the primary aim of the study, hypothesis 1, the intervention will improve the company culture scores, r epeated measures analysis of variance will be used to test the effect on the company culture scales due to the interaction between time and treatment group. The total variability in the response variable may be attributable to subjects, time, treatment group and interaction between treatment group and time. The r epeated measures analysis of variance allows test ing of whether time, group and interaction between time and group are statistically significant factors in explaining the total variation in the dependent variable. For the secondary aim of the primary out come measures repeated measures analysis of variance w as used to test the effect on the company culture scales due to the main effects of time and treatment group. For hypothesis 2, adverse company culture scores i.e. low scores are associated with a low number of reported errors, scatter plots and Pearson correlation coefficients are used to measure the linear association between each

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86 of the baseline company culture scales and the number of errors reported at baseline. For hypothesis 3, individuals with greater fear of reporting errors are expected to have more adverse i.e. lower company culture scores on average th an individuals with less fear, one way analysis of variance is used to compare the distribution of baseline company culture scales betw een the various categories of Question 1 of the questionnaire, which is a surrogate measure of the subjects level of fear toward reporting errors. If the analysis of variance is found to be statis tically significant, post hoc Bonferroni adjusted two sampl e t tests can be used to determine which groups are different from which. For exploratory purposes scatterplots and Pearson correlation statistics are used to evaluate the associations among all six company culture scores. Where necessary, either n on par ametric techniques or transform ation of variables w as implemented in order to achieve normal distributions. 4 7 Procedure Taking a blind stab at a random number table designate d the starting point for stacking the surveys. The random number table w as re ad from top to bottom. The odd numbers represent ed a control group survey and the even numbers represent ed an intervention group survey. The intervention group survey had literature attached to the end of the survey. The literature w as a n on p unitive i n formation s heet Appendix F and a National Practitioner Data Bank information sheet Appendix G Making a guest appearance at a weekly pharmacy meeting, a brief introduction to the survey w as given The surveys w ere stacked

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87 according to a random number table to allow randomization in the study. The potential subjects w ere asked to take a survey if they wish to participate in the study and to return it to the slot in the locked box located inside the pharmacy. The data was retrieved on a weekly basis o ver a two week period. Three months later, the subjects w ere re surveyed in an identical format as the initial survey. 4 8 Survey Distribution and Collection Eighty five pharmacists at an undisclosed location in Florida were surveyed as part of this rese arch. Fifty two pharmacists completed and returned the survey resulting in a response rate of 61 percent. Of those fifty two responses, 11 were deemed to be unusable because they had not completed either the initial or the follow up survey. Therefore, a total of 48 percent of the target population were included in the analysis. Due to the sensitivity of this research in respect to the potential for retaliation for admitting to a medication error, the informed consent was waived. The low response rate c ould possibly be contributed to the sampling procedure or fear of reprisal or the lack of time available for a n already overworked pharmacist to complete 4 9 Method Summary Of the six organizational cultures discussed above, it was determined that the culture representative of the organization studied in this research had an integrity/humanistic workplace culture. This is discussed in greater detail in Chapter 6 Although it was anticipated that sixty pharmacists would participate in this study, only forty one were recruited. However, t he statistical mea sures remained the same but, the effect size had to be recalculated based up on the

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88 group control and intervention distribution. Chapter 5 explains in detail the chan ges in the effect size to account for a lower number of participants.

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89 Chapter 5 Data Analysis 5. 1 Introduction The data was collected on a weekly basis during the pre and post timeframe, sorted according to group control or intervention, and coded a false response repr esented a value of 0 and a true response represented a value of 1. The coded data was put into an Excel spreadsheet and then analyzed using SPSS for Windows. While some surveys were missing data the researcher chose to replace the missing values with the average for all non missing questions within a given scale, by a study participant. SPSS supports the replacement of missing values with the series mean SPSS, 1997. None of the surveys required more than 3 missing values to be replaced. Both descri ptive and inferential statistical methods were employed. All testing was based on determining statistical significance at a two sided alpha level of 0.05. As stated in Chapter 4 t he study sample was described using measures of central tendency mean and median and dispersion standard deviation and range for continuous variables and frequency and percentage for categorical variables. Repeated measures analysis of variance was used to test the effect due to time pre versus post intervention, treatmen t group control versus intervention, and the interaction between time and treatment group.

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90 5 1 .1 Variations to Statistical Methods Although an attempt was made to recruit 60 possible participants, only 52 responded, 41 of which had usable data. There w ere a total of 41 valid surveys which corresponded to the N value used for statistical analyses of the data. The group distribution control and experimental for the 41 participants is located in Table 5 1 The control group had a total of 16 particip ants and the intervention group had a total of 25 participants. To accommodate the lower number of participants than expected and to validate the data, a repeated measures design with one between factor, treatment group Control versus Intervention, and one within factor, t ime Pre versus Post was used to analyze the data. This design uses t he Geisser Greenhouse correction as referred to in SPSS. It is a correction factor that is computed which corrects the degrees of freedom more than other F tests Ke ppel, n.d. This design achieves 44% power to test the treatment factor using a Geisser Greenhouse Corrected F Test with a 5% significance level when the actual standard deviation is 0.04 which represents an effect size of 0.29 It achieves 88% power to test the time factor using a Geisser Greenhouse Corrected F Test with a 5% significance level when the actual standard deviation is 0.04 which represents an effect size of 0.50. The design achieves 88% power to test the interaction between treatment and t ime using a Geisser Greenhouse Corrected F Test with a 5% significance level when the actual standard deviation is 0.04 an d represents an effect size of 0.50

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91 Table 5 1 Group Distribution Group Frequency Percent Control 16 39 Interventi on 25 61 Valid Total 41 100 It was stated in Chapter 4 that H ypothesis 2, adver se company culture scores i.e. low scores will be associated with a low number of reported errors, would be analyzed using scatter plots and Pearson correlation coefficients in o rder to measure the linear association between each of the baseline company culture scales and the number of errors r eported at baseline The Pearson correlation coefficient measures the strength and direction of a linear relationship between the X and Y variables Lethen, 1996. The data collected for Hypothesis 2 was comprehensive of the entire pharmacy instead of on an individual basis. Therefore, a quantitative and qualitative approach was taken to answer Hypothesis 2. Although in Chapter 4 it was stated that f or H ypothesis 3, individuals with greater fear of reporting errors will have more adverse i.e. lower company culture scores on average than individuals with less fear, a one way analysis of variance will be used The one way analysis of va riance was to compare the distribution of baseline company culture scales between the various categories of Question 1 of the survey The various scales represented a surrogate measure of the subjects level of fear toward reporting errors Because of th e responses received for Question 1, a different test statistic was employed Two sample t

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92 tests were used to compare the average company culture scores for Question 1 of the survey, between those who said they would report errors immediately versus thos e who did not say they would report the error immediately. Pearsons correlation coefficient was used to measure the linear association between the company culture scores. 5 1 .2 Derivation of Scale Scores Scale scores were derived according to the instr uctions provided by Connect Two. The number of true responses were counted and the subscale which had the most true responses, percentage wise, was indicative of that type of culture in the organization studied. If there were the same number of true resp onses in more than one section, the culture match is assigned to this combination of types www.ConnectTwo.com Table 5 2 summarizes the data for pre and post survey for each scale. M inimum refers to the lowest scale score that was marked by a t least one participant for one of the scale categories. Pre_Scale 6 as well as Post_Scale 6 had the lowest minimum percentage of 0.13 which indicates that the culture present was less likely to be that of urgent/seat of t he pants type of culture. Maximum refers to the highest scale score that was marked by a participant f or one of the scale categories in which a score of 1 indicated that at least one participant marked each item as true in a particular category. Pre_Scal es 1, 3, 4, and 5 as well as Post_Scales 1, 3, 4, and 5 all had a maximum score of 1. Not one participant agreed with all the attributes of Pre_Scale s 2 and 6 as well as Post_Scale s 2 and 6. Figures 5 1 5 .2 5 3 and 5 4 depict this graphically in a fre quency histogram. Scale 2 refers to an

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93 efficiency/quality oriented culture while Scale 6 refers to an urgent/seat of the pants culture. Figure 5.2 represents Pre Scale 6 data and Figure 5.4 represents the Post Scale 6 data. Both figures seem to be of a bi modal nature. Individually, t he histograms seem to illustrate two values or data ranges that appear most often. This could reflect the presence of two different processes being mixed. For instance, t his could be a result of pharmacists operating on t wo different shifts. Overall, w hat Figures 5 1 5 2 5 3 and 5 4 illustrate is that there was not at least one pharmacist in the pre and post survey that agreed true response to all questions relative to the efficiency/quality oriented culture Questio ns 14 19 nor the urgent/seat of the pants culture Questions 36 43. Table 5 2 Pre and Post Survey Data for Scales Statistics N Scale Valid Mean Median Standard Deviation Minimum Maximum Pre_Scale1 41 0.77 0.80 0.13 0.44 1 Pre_Scale2 41 0.51 0 .50 0.17 0.17 0.83 Pre_Scale3 41 0.63 0.67 0.17 0.33 1 Pre_Scale4 41 0.74 0.80 0.23 0.25 1 Pre_Scale5 41 0.74 0.80 0.21 0.40 1 Pre_Scale6 41 0.50 0.50 0.17 0.13 0.75 Post_Scale1 41 0.78 0.80 0.12 0.50 1 Post_Scale2 41 0.53 0.50 0.14 0.17 0.83 Post_S cale3 41 0.67 0.67 0.18 0.17 1 Post_Scale4 41 0.74 0.80 0.21 0.20 1 Post_Scale5 41 0.76 0.80 0.19 0.40 1 Post_Scale6 41 0.53 0.63 0.17 0.13 0.75

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94 Scale Score Figure 5 1 Pre_Scale 2 Frequency Histogram Note: All v alues are in generic units Scale Score Figure 5 2 Pre_Scale 6 Frequenc y Histogram Note: All v alues are in generic units Frequency Frequency

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95 Scale Score Figure 5 3 Post_Scale 2 Frequency Histogram Note: All Values are in generic units Scale Score Figure 5 4 Post_Scale 6 Frequency Histogram Note: All Values are in generic units Frequency Frequency

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96 5 2 Hypothesis 1 Data Analysis F or Hypothesis 1, intervention will improve the company culture scores repeated measures analysis of variance was used to test the effect on the company culture scales due to the interaction between time and treatment group. Table 5 3 shows that the main effect for time was not statistically significant P=0.827. Additionally, Table 5 3 shows that the interaction effect between time and treatment group was not statistically significant P=0.084. In other words, the National Practitioner Data Bank infor mation and the Non Punitive Culture information sheet had no significant effect from pre to post survey on the improvement of company culture scores. Table 5 3 Tests of Within Subjects Effect Scale 1 Source Type III Sum of Squares df Mean Square F P Sphericity Assumed 0 1 0 0.049 0.827 Greenhouse Geisser 0 1 0 0.049 0.827 Huynh Feldt 0 1 0 0.049 0.827 Time Lower bound 0 1 0 0.049 0.827 Sphericity Assumed 0.016 1 0.016 3.155 0.084 Greenhouse Geisser 0.016 1 0.016 3.155 0.084 Huy nh Feldt 0.016 1 0.016 3.155 0.084 time group Lower bound 0.016 1 0.016 3.155 0.084 Table 5 4 shows that the main effect of treatment group was not statistically significant P=0.099. Table 5 5 and Figure 5 5 show how the average score differed between the cont rol and intervention groups. The contr ol

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97 group had an average Scale 1 score of 0.803 while the intervention groups average Scale 1 score was 0.743. The average scale score shows how likely the group studied is of that particular culture. It is expected that the pre and post scale scores would be minimally different. Table 5 6 and Figure 5 6 show the pattern of variation in the average Scale 1 over time. The average Scale 1 score was 0.78 versus 0.77 for pre and post respectively. This implies that w hen the pharmacists were asked questions relative to an integrity type culture Questions 2 13, the pharmacists were quite consistent in the survey responses from pre to post. Table 5 4 Test of Between Subject Effect Scale 1 Source Type III Sum of Squa res df Mean Square F P 2 tailed Group 0.069 1 0.069 2.849 0.099 Table 5 5 Average Scale 1 Score for Treatment Groups 95% Confidence Interval Group Mean Std. Error Lower Bound Upper Bound Control 0.803 0.027 0.747 0.858 Intervention 0.743 0.022 0.699 0.788

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98 Control Intervention Figure 5 5 Group Variation Average Scale 1 Score Note: All Values are in generic units Table 5. 7 and Figure 5. 7 show how the pattern of variation in the average score over time differed for the control and intervention groups. The average Scale 1 score decreased for the control group from pre 0.819 to post 0.786 while the intervention group increased from pre 0.731 to post 0.756. Table 5 6 Variation in Average Scale 1 Score Over Time 95% Confidence Interval Time Mean Std. Error Lower Bound Upper Bound Pre 0.775 0.02 0.734 0.815 Post 0.771 0.019 0.733 0.809 Average Scale 1 Score

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99 Pre Post Figure 5 6 Variation Average Scale 1 Score Over Time Note: All Values are in generic units Table 5 7 Group Variation in Average Scale 1 Score Over Time 95% Confidence Interval Group time Mean Std. Error Lower Bound Upper Bound Pre 0.819 0.031 0.756 0.882 Control Post 0.786 0.029 0.727 0.846 Pre 0.731 0.025 0.68 0.781 Intervention Post 0.756 0.023 0.709 0.803 Average Scale 1 Score

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100 Pre Post Figure 5 7 Group Variation Average Scale 1 Score Over Time Note: All Values are in generic units Repeated measures of analysis of variance was used to test the main effects and the interaction effect for each of the six scales. The data for Scale 1 was presented above. After analyzing the data for Scales 2 through Scale 6 it was found that the main effect for time, the interaction effect between time and treatment group, a s well as the main effect of treatment group were not statistically significant. In other words, pre to post had no bearing on the Scale 2 through Scale 6 nor did the interaction of pre and post in relation to the control group and the intervention group. Further, the control group and the intervention group had no effect on the cultures studied from Scale 2 through Scale 6. A comprehensive table for tests of within subjects effects for all six scales was produced and included in Appendix H. The p valu e for all within subjects Average Scale 1 Score

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101 effect was greater than 0.05. This implies that the within subjects, pre versus post, had no bearing on this study. The data for Scale 1 through Scale 6 is summarized in Tables 5 8 through 5 .1 1 The range of P values in Table 5 8 goes from 0.099 Scale 1 to 0.831 Scale 5. Note that all P values are greater than 0.05 which indicates that the between subjects effect is not significant. Table 5 9 shows that the control groups Scale 1 score had the greatest mean of 0.803 and t he intervention groups Scale 6 score had the lowest mean of 0.493. This implies that the culture studied is more like Scale 1 Integrity for the control group and less like Scale 6 Urgency for the intervention group. In Table 5 10 Scale 1 pre survey had the greatest mean score of 0.775 and standard error of 0.02 while Scale 6 pre survey had the lowest mean score of 0.507 and a standard error of 0.027. Again, this implies that the pre survey culture was more like Scale 1 Integrity and less like Sca le 6 Urgency. In fact, the organization studied had relatively similar scores for Scale 1 Integrity = 0.775, Scale 3 0.634, Scale 4 0.743 and Scale 5 0.742. Since Scale 1 Integrity was the highest the evaluations of the study is based on that scale. Table 5 .1 1 summarizes the average scale score from the treatment groups over time pre and post. Although the tables and graphs provide useful information, none of the results validated Hypothesis 1. Therefore, it is concluded that intervention in the form s presented in this research survey development and informational sheets will not improve company culture scores. On another note, had the research been setup with a P value less than 0.1 as significant the between subject effect

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102 would have been marginally significant for Scale 1 P=.099. This would have indicated that the observed difference is too large to be explained by chance alone. In other words, we would have failed to reject the hypothesis that intervention will improve the compa ny culture scores Table 5 8 Tests of Between Subjects Effects Scale Source Type III Sum of Squares df Mean Square F P Scale 1 Group 0.069 1 0.069 2.849 0.099 Scale 2 Group 0.011 1 0.011 0.309 0.581 Scale 3 Group 0.064 1 0.064 1.473 0.232 Scale 4 Gro up 0.015 1 0.015 0.201 0.656 Scale 5 Group 0.003 1 0.003 0.046 0.831 Scale 6 Group 0.068 1 0.068 1.661 0.205

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103 Table 5 9 Average Score for Treatment Groups 95% Confidence Interval Scale Group Mean Std. Error Lower Bound Upper Bound Control 0.803 0.027 0.747 0.858 Scale 1 Intervention 0.743 0.022 0.699 0.788 Control 0.506 0.033 0.439 0.574 Scale 2 Intervention 0.53 0.027 0.476 0.584 Control 0.689 0.037 0.614 0.764 Scale 3 Intervention 0.632 0.03 0.572 0.691 Control 0.755 0 .048 0.657 0.852 Scale 4 Intervention 0.727 0.039 0.649 0.805 Control 0.747 0.044 0.658 0.836 Scale 5 Intervention 0.759 0.035 0.688 0.83 Control 0.552 0.036 0.48 0.625 Scale 6 Intervention 0.493 0.029 0.435 0.551

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104 Table 5 10 Average Scale Score O ver Time 95% Confidence Interval Scale Time Mean Std. Error Lower Bound Upper Bound Pre 0.775 0.02 0.734 0.815 Scale 1 Post 0.771 0.019 0.733 0.809 Pre 0.511 0.028 0.455 0.567 Scale 2 Post 0.525 0.022 0.48 0.571 Pre 0.634 0.028 0.579 0. 69 Scale 3 Post 0.686 0.028 0.629 0.744 Pre 0.743 0.037 0.668 0.818 Scale 4 Post 0.739 0.035 0.669 0.809 Pre 0.742 0.035 0.671 0.812 Scale 5 Post 0.764 0.031 0.702 0.826 Pre 0.507 0.027 0.453 0.562 Scale 6 Post 0.538 0.027 0.483 0.594

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105 Table 5 .1 1 G roup Variation in Average Scale Score Over Time 95% Confidence Interval Scale Group Time Mean Std. Error Lower Bound Upper Bound Pre 0.819 0.031 0.756 0.882 Control Post 0.786 0.029 0.727 0.846 Pre 0.731 0.025 0.68 0.781 Scale 1 Intervention Post 0.756 0.023 0.709 0.803 Pre 0.502 0.043 0.415 0.589 Control Post 0.51 0.035 0.44 0.581 Pre 0.52 0.035 0.45 0.59 Scale 2 Intervention Post 0.54 0.028 0.483 0.597 Pre 0.639 0.043 0.552 0.725 Control Post 0.74 0.044 0.65 0.829 Pre 0.63 0.034 0.56 0.7 Scale 3 Int ervention Post 0.633 0.035 0.562 0.705 Pre 0.772 0.058 0.654 0.889 Control Post 0.738 0.054 0.628 0.847 Pre 0.714 0.046 0.62 0.808 Scale 4 Intervention Post 0.74 0.043 0.653 0.827 Pre 0.731 0.054 0.622 0 .841 Control Post 0.763 0.048 0.666 0.859 Pre 0.752 0.043 0.664 0.84 Scale 5 Intervention Post 0.766 0.038 0.689 0.843 Pre 0.527 0.042 0.442 0.612 Control Post 0.578 0.043 0.492 0.664 Pre 0.488 0.034 0.42 0.556 Scale 6 Intervention Post 0.499 0.034 0.43 0 .568

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106 5 .3 Hypothesis 2 Data Analysis The number of reported medication errors that occurred in pharmacy during the pre and post survey as well as the prior year pre and post survey timeframe are included in Table 5 .1 2 Although there is a difference 1 00% increase from pre 3 medication errors to post 6 medication errors, this can lead one to believe the lowest company culture score was during the pre survey and the highest company culture score was during the post survey. Looking at Table 5 10 loc ated in Section 5 2 the lowest average mean score in relation to time for the pre survey was Scale 6 Urgency and the highest post survey scale score was Scale 1 Integrity It was important to obtain the number of reported medication errors during th e prior year timeframe for both pre and post survey in order to determine if there was pattern. The idea was to get a snapshot of the past reporting history and compare it to the recently reported medication errors to determine if there was increased repo rting Taking it a step further, the researcher decided to determine if there would be a continued effort to report medication errors once the post survey was completed. So, the researcher decided to track the number of reported medication errors for an a dditional three months after the post survey In order to determine if there were any changes, the researcher decided that the prior year data for the additional three months tested was just as important. The researcher thought that after partaking in th e survey, pharmacists would be prone to report medication errors immediately. Hence, it was anticipated that there would be an increase in the number of reported medication errors after the

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107 post survey. The data is presented in Table 5 .1 3 Figure 5 8 re presents the data graphically. Table 5 .1 3 and Figure 5 8 show that over a 3 month post survey period, 30 medication errors were reported as compared to 22 medication errors reported during the same timeframe in the prior year. That equates to a 26.7% in crease in the number of medication errors reported. Thus, Hypothesis 2, l ow company culture scores are associated with a low number of reported errors, was not rejected. Table 5 .1 2 Reported Medication Errors Timeframe Number of Reported Medication Erro rs Pre Survey 3 Post Survey 6 Prior Year Pre Survey 0 Prior Year Post Survey 0 Table 5 .1 3 Post Survey Reported Medication Errors Timeframe April May June 2005 10 8 12 2004 6 10 6

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108 0 2 4 6 8 10 12 14 April May June Month Reported Medication Errors 2005 2004 Figure 5 8 Post Survey Reported Medication Errors Note: A ll Values are in generic units 5 4 Hypothesis 3 Data Analysis Question 1 of the survey was independently analyzed to address Hypothesis 3 that individuals with greater fear of reporting errors will have more adverse i.e. lower company culture scores o n average than individuals with less fear Three subjects were missing data for Question 1. Of the remaining 38 subjects, 31 82% said that they would report an error immediately. One 3% subject said that he or she would report the error only if som eone saw them or knew that it could have only been them. One 3% said that he or she would report the error if it were a minor error no patient harm. Five 13% said they would report the error if it were a major error serious patient harm. The l ast three groups were too small to analyze statistically so they were combined into one group and labeled, not immediately.

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109 Now, the analysis compared two groups, those who said, immediately n=31 versus those who did not say, immediately n=7. Since there were only two groups to be compared, the two sample t test was used instead of analysis of variance. Table 5 .1 4 presents scale data for all six scales for Question 1. Table 5.1 4 shows that those who said, immediately had the highest mean sc ale score 0.78 for Scale 1 Integrity and the lowest mean scale score 0.51 for Scale 6 Urgency. For those who said, not immediately the highest mean scale score 0.66 for Scale 1 and the lowest mean scale score 0.45 for Scale 2 Efficiency. This implies that those who said, immediately as well as not immediately both align with Scale 1 Integrity. Those that said immediately would less likely align with Scale 6 Urgency and those that said not immediately would less likely align with Scale 2 Efficiency. Table 5. 15 presents the equality of means for all six scales in relation to Question 1. After studying Table 5.1 5 and analyzing Figure 5. 9 it was found that there is some evidence to suggest that those who would not report err ors immediately tend to have a lower Scale 1 score than those who did say immediately . Table 5.1 4 and 5.1 5 show that the group that did not say immediately had a statistically significantly smaller average Scale 1 score than the group that did say immediately. The average standard deviation for Scale 1 score for the group that did say immediately was 0.78 versus 0.66 for the group that did and did not say immediately. The P value for the equality of means of Scale 1 scores was 0.036. This su ggests that we accept the hypothesis that individuals with greater fear of reporting errors will

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110 have more adverse i.e. lower company culture scores on average than individuals with less fear for Scale 1 Integrity. Table 5 .1 4 Question 1 Scale Data N Sc ale Question1 Valid Missing Mean Median Std. Deviation Minimum Maximum Immediately 31 0 0.7801 0.8 0.1274 0.44 1 Scale1 Not Immediately 7 0 0.6646 0.7 0.12211 0.5 0.82 Immediately 31 0 0.5226 0.5 0.17393 0.17 0.83 Scale 2 Not Immediately 7 0 0.4524 0.5 0.18545 0.17 0.67 Immediately 31 0 0.629 0.6667 0.1692 0.33 0.83 Scale 3 Not Immediately 7 0 0.5905 0.6667 0.15482 0.33 0.8 Immediately 31 0 0.779 0.8 0.22127 0.4 1 Scale 4 Not Immediately 7 0 0.6 0.6 0.1633 0.4 0.8 Immediately 31 0 0.7774 0.8 0.2089 0.4 1 Scale 5 Not Immediately 7 0 0.6571 0.6 0.22254 0.4 1 Immediately 31 0 0.5121 0.5 0.16034 0.25 0.75 Scale 6 Not Immediately 7 0 0.5 0.5 0.17678 0.25 0.75

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111 Table 5 .1 5 Equality of Means t test for Equality of Means Scale t df P Value 2 tailed Scale1 2.182 36 0.036* Scale 2 0.954 36 0.347 Scale 3 0.552 36 0.584 Scale 4 2.011 36 0.052 Scale 5 1.361 36 0.182 Scale 6 0.177 36 0.86 indicates P< 0.05

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112 immediately not immediately Figure 5 9 Distribution of Scale 1 Scores for Question 1 Note: All Values are in generic units F urther analysis of Tables 5 .1 4 and 5 .1 5 showed t h at there is little evidence to suggest a difference between those who said immediately versus those who did not say immediately for Scales 2, 3, 5, and 6. The P value for those scales were all greater than 0.05. After analyzing Figure 5 10 which is Scale 1 Score

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113 e xclusively Scale 4 data, there is some evidence to suggest a difference between the two groups immediately and not immediately. However, Tables 5 .1 4 and 5 .1 5 show that there was not a statistically significant difference in the average Scale 4 score between the two groups. The average standard deviation Scale 4 score was 0.78 versus 0.60 for the group that did and did not say immediately, respectively P=0.052. Had the P value tested been set to less than 0.1, Tables 5 .1 4 and 5 .1 5 would have shown a statistically significant difference for Scale 4 Traditional Culture between the two groups immediately and not immediately. This would have indicated that the observed difference is too large to be explained by chance alone. In other words, it is probably true that individuals with greater fear of reporting errors had lower company culture scores on average than individuals with less fear for Scale 4 Traditional.

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114 immed iately not immediately Figure 5 10 Distribution of Scale 4 Scores for Question 1 Note: All Values are in generic units 5 5 Exploratory Data Analysis For exploratory purposes, scatter plots and Pearsons correlatio n statistics were used to compare each company culture score with each other. Table 5 .1 6 summarizes the data for the Pearsons correlation statistics for each of the company culture scales. Of all the comparisons between the six company culture scales, o nly Scale 4 Traditional and Scale 5 Stableness were statistically significantly correlated. Although Figure 5 .1 1 shows little evidence of a linear association, Table 5 .1 6 shows that there was a statistically significant, Scale 4 Score

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115 moderately strong positive a ss ociation between Scale 4 and Scale 5, r=0.48 with a corresponding P value of 0.002. T his made the exploratory a nalysis well worth the additional investigation. It has been shown, yet again, that if the statistically significance level had been set to a P value less than 0.1, Scale 4 Traditional and Scale 2 Efficiency as well as Scale 5 Stableness and Scale 6 Urgencywould have been statistically significantly correlated with P values of 0.097 and 0.087, respectively. Table 5 .1 6 Pearsons Corr elation Coefficient for a ll Scales Sc ale Scale1 Scale2 Scale3 Scale4 Scale5 Scale6 Pearson Correlation 1 0.089 0.009 0.258 0.051 0.235 P value 0.579 0.957 0.103 0.754 0.139 Scale1 N 41 41 41 41 41 41 Pearson Correlation 0.089 1 0.071 0.26 3 0.156 0.207 P value 0.579 0.66 0.097 0.33 0.193 Scale2 N 41 41 41 41 41 41 Pearson Correlation 0.009 0.071 1 0.161 0.139 0.101 P value 0.957 0.66 0.314 0.385 0.528 Scale3 N 41 41 41 41 41 41 Pearson Correlation 0.258 0.263 0.161 1 .478** 0.25 P value 0.103 0.097 0.314 0.002 0.115 Scale4 N 41 41 41 41 41 41 Pearson Correlation 0.051 0.156 0.139 .478** 1 0.27 P value 0.754 0.33 0.385 0.002 0.087 Scale5 N 41 41 41 41 41 41 Pearson Correlation 0.235 0.207 0.101 0.25 0.27 1 P v alue 0.139 0.193 0.528 0.115 0.087 Scale6 N 41 41 41 41 41 41 ** Correlation is significant at the 0.01 level 2 tailed.

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116 Scale 4 Score Figure 5 .1 1 Scatter Plot of Scale 4 versus Scale 5 Note: All V alues are in generic units 5 6 Data Summary It was quite interesting to see the data bring true meaning to this dissertation. Although Hypothesis 1 was rejected and variations had to be made for the analysis of Hypothesis 2 and Hypothesis 3, the tables and graphs revealed a clear picture of what the data meant. It was determined for S cale 1 Scale 5 Score

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117 Integrity that Hypothesis 3, individuals with greater fear of reporting errors will have more adverse i.e. lower company culture scores on average than individua ls with less fear was not rejected. It was determined that the group that would not report errors immediately had a statistically significantly smaller average Scale 1 I ntegrity score than those who said they would report errors immediately. In th e exploratory section of this dissertation, Section 5 5 it was discovered that Scale 4 and Scale 5 were statistically significantly correlated. In summary, Hypothesis 1, Intervention will improve company culture was rejected. Hypothesis 2, Low company culture scores are associated with a low number of reported errors, was not rejected. Hypothesis 3, Individual s with a greater fear of reporting errors versus the average score will have low er company culture scores on average than individuals with less fear was not rejected. Further detail is provided in Chapter 6.

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118 Chapter 6 Discussion of Results, Conclusions and Recommendations 6. 1 Discussion of Work The 1999 Institute of Medicine report, To Err Is Human sparked a worldwide debate over medical errors. It shed light on the exacerbated problem of medical errors that aggregately went unnoticed and undetected for many years. The report however, united organizations to form commitments to better understand how to deliver high quality care Many organizations form ed partnerships and began the development of workshops geared toward s the s haring of information on medical errors The persons approach was and still is dominant in the healthcare industry. The view shared by those that util ize the persons approach is that someone caused the medical error. The systemic way of analyzing a medical error plays no role in the persons approach. It was not until recently that the medical industry realized the role that the system played in medi cal errors. Yet, some prefer the persons approach to error while others in growing numbers, cho o se a systems approach. Three hypotheses were developed and tested in this dissertation. It was hypothesized that 1 intervention would improve company cu lture; 2 low company culture scores would be associated with a low number of reported errors; and 3 individuals with a greater fear of reporting errors will have low er

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119 company culture scores on average than individuals with less fear. These hypotheses w ere tested on pharmacists at an undisclosed facility in Florida. 6 2 Conclusion s I ntervention w as expected to improve company culture scores. The intervention was in the form of information National Practitioner Data Bank information s heet and Non P unitive Culture information s heet. The reason behind the use of the National Practitioner Data Bank information s heet as part of the intervention tool was that an anonymous source said, Why would I report a medication error or encourage others to do so, when the National Practitioner Data Bank serves as a lynching mob for those who make errors ? The researcher believed that if one pharmacist felt this way, there were many others that shared this identical thought of the National Practi tioner Data Bank. Another comment made by a pharmacist regarding the National Practitioner Data Bank is that T he National Practitioner Databank is a public arena for displaying a history of medical errors committed by a clinician. Upon research of the National Practition er Databank, it was discovered that the d atabank serves as a clearing house for clinicians that were involved in a medical error that resulted in any form of payment to an individual and only authorized healthcare personnel offices can gain access to the d atabank. Credentialing is required every two years for clinicians in the United States and the National Practitioner Data Bank serves this purpose. It was expected that there would be an increase in the number of reported medication errors from pre to p ost survey in the intervention group. In fact, there

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120 was a 100% increase in the reported medication errors from pre to post. It is possible that the post survey reported medication errors were errors made by the same pharmacists that reported the error in the pre survey. It is also possible that a new generation of pharmacists emerged after partaking in this study and decided to do what is right and report the medication errors It is also possible that a stronger set of interventions might have resul ted in a more significant difference. As expected, individuals with greater fear of reporting errors had lower company culture scores on average than individuals with less fear. Those who said that they would not report an error immediately had lower sco re averages than those who said they would report the error immediately. This proved true for Scale 1 integri ty/humanistic culture When the data were collected, coded, and then tallied for the number of true responses, it was determined that the organi zation studied as part of this dissertation possessed an integrity/humanistic workplace culture. In this type of culture, pharmacists tend to be honest and they consider integrity to be at the top of the list. The pharmacy encourages a nurturing environm ent and upper level management communicates clearly as well as frequently to employees. As with every type of culture, there are advantages as well as disadvantages. Although honesty is an excellent policy, too much information can be damaging. The phar macists in the company studied are loyal to what is right, not to the organization. A highlighted pitfall characteristic of the integrity/humanistic culture is that the organization studied should be aware of the cultural implications of fostering

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121 a God like environment that may bring religion into play when making work related decisions. The term, God like is explained i n the King James version of the Holy Bible, Deuteronomy 32:4 states, He is the Rock, his work is perfect: for all his ways are judgme nt: a God of truth and without iniquity, just and right is he. This implies that God is perfect, righteous, and just. God is perfect, meaning that he makes no mistakes God is righteous, meaning that He will not pass over wrongdoing God is just, mean ing that He is fair. These attributes are what could potentially be used in the decision making of work related issues. Thus, being God like in the realm of practicing pharmacy could lead to error For instance, a pharmacist acting in a God like capacit y could potentially convince himself that he knows the best medicinal therapy for a patient regardless of what research exists to dispute his claim Just like God, the pharmacist is omniscient. This event could potentially lead to error in pharmacy. The researcher thought it would be interesting to see the actual group average score changes from pre to post survey for all six scales. Th e group average score change s are located in Table 6 1 The smallest percentage change 0.30 occurred in the interven tion group on Scale 3 while the largest change 10.10 occurred in the control group on Scale 3. Please note that Scale 3 refers to an innovative culture. This is a quite interesting revelation that the intervention group was 99.7% consistent with their responses from pre to post survey while the control group was 89.9% consistent with their responses from pre to post. This may lend itself to further investigation in a future study.

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122 Overall, I conclude that we can reduce medication errors and improve s ystems, to make better choices. By installing fail safes in all aspects of the pharmacy system and educating patients on their medicinal therapy, collaboration is promoted amongst key players including pharmaceutical companies, pharmacy managers, and legi slators. Safer healthcare is the driving factor in effecting change within the entire delivery system of pharmaceuticals. The benefit to the world is literally life saving. An educated patient is the best defense against a potential medication error. I n addition, educated patients are intimately familiar with all aspects of medicinal therapy necessary for the sustainment of good health. Through implementation of a non punitive culture, medication error reporting will increase initially, and subsequentl y decrease over a reasonable period of time. Based upon the above conclusions, a road to having a non punitive culture in pharmacy for medication errors was built Figure 6 1 Utilizing Lewins three phases Unfreezing, Changing, Refreezing of plan ned change Schermerhorn Jr., 1996 the development of a non punitive culture was structured Steps a through e in Figure 6 1 are representative of Lewins Phase I, Unfreezing. In Phase I, the goal is to create a felt need and preparation for change. St eps f through h is representative of Lewins Phase II, Changing. Changing people, changing tasks, changing structure, and changing technology are instrumental in the success of Phase II. Training, group discussions, sharing of knowledge are essential to bring about change. Also motivation, exchange of ideas, and quality awareness forums are extremely critical to institutionali z e the

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123 change. Steps i through k are representative of Lewins Phase III, Refreezing. In this phase, outcomes are reinforced, re sults are evaluated, and constructive modifications are made. Evaluation is a final key component in the refreezing phase. It gives the organization an opportunity to evaluate the successes and the failures of the implemented changes as well as an opport unity to institute a contingency plan to make constructive modifications. If the importance of the change is thoroughly understood at the ground l evel, then success will be achieved. Although one culture type is not a fix all for every type of organiza tion, development of a non punitive culture requires a combination of culture characteristics. Collaboratively, the mixed culture characteristics form an ideal workplace environment for the development of the non punitive culture. Often times, a workplac e culture is represented by more than one culture type. In fact, it was a combination of the six cultures that produced the characteristics of the non punitive culture. The characteristics of a non punitive culture and their culture of origin are outline d in Table 6.2. These characteristics were based upon at least an 80% favorable response rate yes to each survey question as it paralleled the description of the non punitive culture described on the Non Punitive Culture Information sheet See Appendix F. The yes was in response to the described conditions of the pharmacists work environment. There was over 80% response of no to Question 43, Salary is more important to me than professional growth. This no response was included because it dem onstrates that salary is not the governing factor in the pharmacists career. The described

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124 Table 6 1 Pre to Post Group Change Scale Group Pre Post Change % Change Control 0.819 0.786 0.03 3.30 Scale 1 Intervention 0.731 0.756 0.03 2.50 Control 0.502 0.51 0.01 0.80 Scale 2 Intervention 0.52 0.54 0.02 2.00 Control 0.639 0.74 0.10 10.10 Scale 3 Intervention 0.63 0.633 0.00 0.30 Control 0.772 0.738 0.03 3.40 Scale 4 Intervention 0.714 0.74 0.03 2.60 Control 0. 731 0.763 0.03 3.20 Scale 5 Intervention 0.752 0.766 0.01 1.40 Control 0.527 0.578 0.05 5.10 Scale 6 Intervention 0.488 0.499 0.01 1.10

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125 conditions covered the attributes of the six cultures evaluated in this dissertation. It was interest ing to see that the yes response rate and the one no response rate w ere in line with the Non Punitive Culture Information sheet Over 80% of the pharmacists surveyed responded favorably to Questions 6 10, 13, 15, 17, 20, 22, 26, 28, 32, 34, 35, 38, 42 and 43 See Appendix E. A synopsis of the favorable response is stated in the following sentences. The environment and the organization in which they work supports full disclosure of medical errors. The pharmacists believed the patients should be mad e aware that a medical error has occurred. The reporting of medical errors to a federal agency will allow other clinicians to develop safety precautions in their system of work as well as reduce the number of medical errors overall. The pharmacists belie ve that a non punitive culture will actually increase reporting of medical errors. In fact, the pharmacists feel comfortable in reporting a medical error to his/her supervisor. The pharmacists and the supervisors are most interested in quality care for th e patient and patients concerns are addressed in a timely manner. In fact, the supervisors encourage new ideas about increasing patient safety. The pharmacists understand how their duties contribute to the success or failure of the organization. They se em to have a genuine interest because they expect to work at the organization for their whole careers. W hen there is a conflict, they believe in working out differences before going to the supervisor. The job meets the professional expectations of the ph armacists and personal growth is more important than salary. The pharmacists associate with people from a wide variety of professional and personal backgrounds.

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126 One of the main characteristics of the non punitive culture is truthfulness which leads to o penness and disclosure of a medication error. According to Partnership for Health and Accountability July 2004, a major goal in a non punitive culture is to create a culture where people come forward when errors occur According to Optimum Motivation C oaching n.d., w hen staff feel secure and nurtured in their work environment they perform better. Further, when people feel they are treated fairly they remain loyal to the company and motivated by their work. Likewise, in pharmacy, w hen pharmacists are nurtured in their work environment they are more apt to develop a deep sense of care about the organizations mission and work hard to achieve the organizational goals. Just as clinicians have to make recordings in the patient record that can only be in terpreted in one way Pharmacy Law and Management Conference, 2002 upper level management has to communicate clearly and effectively to the pharmacists. Once a hospital has assessed its culture of patient safe t y the leadership can decide which dimensio ns provide the best opportunity for interventions within that organization Partners for Health and Accountability, July 2004. The non punitive culture wants to avoid disruption, although not completely possible, so processes are put in place to address m ost situations. Although the pharmacists are empowered to make decisions when they do encounter situations not addressed in the policy manual, they consider the issues carefully as well as communicate them effectively to management. Pharmacists are hard workers and are paid relatively well as a sign of compensation for doing an invaluable humanistic type job. Salary.com, Inc. n.d. lists t he median salary

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127 for a typical pharmacist in the United States as $100,720 Over the course of employment, pharmaci sts are encouraged to attend formal training to stay abreast of new technology and to share information about medication errors without the fear of punishment. Most states require the pharmacist complete approximately 15 hours of continuing education each year http://www.pharmacist.com/articles/l_t_0001.cfm The non punitive culture was built out of respect for pharmacists, patients, and other clinicians with the intent to increase the qual ity of work life for pharmacists and other clinicians. Additionally, i t was developed with the intent for the patient to realize his/her role in the quest for wellness so that the patient can maintain or improve his/her quality of life Pharmacist s do no t set out to make a medication error, it is simply the system way of doing things that allows a medication error to happen. A systems approach was utilized in the development of the non punitive culture. Until the systems approach has been globally acc epted by all pharmacists, pharmacy managers, pharmacy governing boards, pharmaceutical companies, and other clinicians, unfortunately, the reported medication error rate will continue to be low and inaccurate. Changing structure, tasks, or technology of any organization will change the behavior and/or satisfaction of its members Reitz, 1987. An organizational culture change to a non punitive culture is instrumental in ridding our nation of preventable medication errors. Wachter stated that, while th ere are many potential solutions to the problem of medical errors, I think the cultural change

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128 Figure 6 1 Pathway to Non Punitive Culture Set the Goal: Achievement of a Non Punitive Culture in Order to Facilitate a Safe Work Environment for Clinicians and to Promote Patient Safety Weed Out Weaknesses/Threats Effectively Communicate the Goal Throughout the Organization Conduct a Culture Assessment Institute the Cultural Changes Provide T imely Feedback of All Concerns from the Employees Provide Timely Feedback of the Results of the Culture Assessment Track Results and Communicate to the Employees Train Employees on New System Mission Accomplished Maintain Non Punitive Culture Yes N o a b c d e f g j k i h

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129 will turn out to be the best and most lasting investment that can be made Olsen, 2004 Establishing a culture that supports the reporting of errors without fear and/or shame is crucial to creating an effective reporting system. Table 6 2 Non Punitive Culture Characteris tics and Origin Characteristics Culture of Origination 1 Honest entity 2 Integrity at top of the list 3 Encourages a nurturing environment 4 Upper level management communicates clearly and frequently to employees Integrity/Humanistic 5 Quality oriented 6 Hard worker s Efficiency/Quality oriented 7 Many formal systems that allow the employee to feel empowered to communicate ideas Innovative 8 Intellectual and thoughtful 9 Considers issues carefully Deliberative 10 Company has processes in place to address most situations 11 Cul tivate employees by encouraging development through mentoring programs and/or formal training opportunities 12 Compensates employees relatively well Established/Stable 13 People care deeply about the firms mission and work hard to achieve the organizations go als Urgent/Seat of the Pants 6.3 Technological Insight into the Advancement of Medicine Since the 1999 Institute of Medicine report, some have said that the healthcare industry has been slow to make technological advancements in the realm of patient safety in order to reduce the number of medical errors. Yet, research shows Bates DW et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA 1998;280:1311 16 that over half of all medi cation errors can be prevented through computerization of physician order entry ISMP, March 2001 Technology exists today that will allow for a much safer healthcare industry

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130 Either no one has thought of how to combine todays technology to solve a mu lti fold pharmacy/pharmaceutical problem or technological advancements in healthcare are painstakingly slow. Although some of the proposed technology is in operation today, collectively, as a unit, the meeting of all facets of the technology proposed has not occurred. What i s being proposed is the collaboration of existing technolog y to produce an error free medication system. The day will come when insurance agencies will deli ver a prescription card that serves as a gateway to better quality health care. This prescription card will be universal in its acceptance at any pharmacy. This prescription card will be the product of collaboration between pharmaceutical companies prescribing clinicians and pharmacists. The pharmaceutical companies will wor k hand in hand with pharmacies and those clinicians with prescribing rights. The pharmaceutical companies will develop a database of all drugs to include a photo routes, dosage, and indication When a patient goes to the doctors office and the doctor prescribes a drug t he doctor will retrieve the name of the medication out of the database select the route, dosage, and select/ record the indication. The doctor will then scan the patients prescription card so that the patients card will contain the full name of the medication, a colored picture of the drug, dosage, route, and indication. The patient goes to the pharmacy to pick up his/her prescription. The pharmacy technician scans the prescription card and this is where the automated double check system begins. Independent double checks serve two purposes: to hopefully, though not dependably, detect a serious error before it reaches a

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131 patient; and just as important, to bring attention to the systems that allow the introduction of human error ISMP FAQ, n.d. The prescription is then filled. During the filling process, by use of an automated machine, a picture of the drug being filled is taken and compared to both the database drug photo and the drug photo from the scanned prescription card. Thi s creates a three way automated system check on the prescribed drug. The prescribed drug, inclusive of the full name of the medication, purpose of the medication, dose, and route is then delivered to the patient. Legislation should require that the medic ations purpose and full instructions be written on each new prescription so that pharmacists can educate patients properly and prevent errors if the purpose and prescribed drug do not match ISMP, March 2001 As it stands in 2006, there are no laws gov erning p rescription labeling that mandates the purpose and/or full instructions on the label. Until there is public outcry, there is no foreseen voluntary change in the medical community to produce beneficial information on prescription labels. 6. 4 R ecommendations The recomme ndations are from a systemic point of view for all aspects of the medication delivery system. When the term system is used most seem to think that the reference is specific to equipment. However, t he pharmacy system is inclusiv e of the following: 1 pharmaceutical companies that process and package the drugs unit dose processing and packaging 2 delivery of the drugs to the pharmacy box labeling and receiving procedures

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132 3 the storage of the drugs clearly labeled and organized so a s to accommodate a floating pharmacist 4 operating procedures of the pharmacy clear and comprehended by all pharmacy staff 5 pharmaceutical governing boards communicates changes, provide training/workshops 6 top level management at the pharmacy communicate s clearly and provides timely feedback 7 workplace policies and procedures fathomed by all pharmacists 8 interaction with the varied professionals as related to patient wellness positive group dynamics 9 equipment that is used in pharmacy pharmacist s are i ntimately familiar with the operation of all equipment used in pharmacy 10 prescribing clinician s electronically order prescription 11 pharmacists knowledgeable, skilled, and trained 12 pharmacy technicians knowledgeable, skilled, and trained 13 delivery of pres criptions prescription card check 14 workplace culture non punitive environment 15 interaction with patients open and honest 16 pharmacy layout maximize productivity, increase efficiency, maintain quality 17 pharmacy job design intimately familiar with all a spects of how to do the job 18 patient involved in his/her care Together, these components work together to produce a high performance system. Successful collaboration requires building trust and using consensus building processes, actively engaging key p layers and all stakeholders, staying focused on the shared goal of improving patient safety, and learning from others active in the field AHRQ, June 2001 According to the United States Department of Veterans Affairs: Culture Change Prevention, Not Pu nishment i t can only happen as a result of effort on everyone's part to take a different approach to the way we look at things I f any one of the 18 components of a pharmacy system is compromised, the end result could potentially lead to a medication er ror. Media reports of failures of quality, state board pharmacy

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133 activities that punish pharmacists who err, and sizable jury verdicts against pharmacy chains for easily preventable errors, have created a demand for systematic approaches to increase qualit y and reduced exposure to liability Pharmacy Law and Management Conference, 200 2 Adherents of the system approach strive for a comprehensive management program aimed at several different targets: the person, the team, the task, the workplace, and the institution as a whole Reason, 2000 A n emphasis on prevention via a systems approach in its entirety, is what is needed to attain significant improvements in patient safety throughout the United States, as a direct result of increased reporting of medi cation errors in a non punitive culture. 6. 4 .1 Responsibility There needs to be more responsibility in the prescribing, dispensing, and administering of drugs. This responsibility should be three fold to include the doctor, the patient, and the pharmaci st. In the event of an incapacitated patient, a designated proxy will act on his/her behalf. T he relationship between the doctor and the patient should be one where the doctor communicates the treatment plan for the patient to the patient The part of t he treatment plan that requires medication should be explicit and address all the patients concerns. The doctor should tell the patient what he/she is prescribing and what each medication is for. A dditionally, the doctor should provide a color copy of t he drug from the database mentioned in Section 6 3 to include the purpos e for the drug. The patient should then be responsible for validating exactly what the doctor

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134 ordered. Then the patient goes to the pharmacy to get the prescription filled. Sectio n 6 3 expl ains the dispensing of drugs. To take it a step further, when the prescription is ready for pick up, the patient should have to validate that the 3 way comparison photo scanned prescription card photo/database photo/actual photo is correct. T o handle the responsibility of administering drugs, patient counseling should be required for all new prescriptions. The counseling should be validated by the patient prior to the patient accepting the prescription An educated patient or caregiver can be a crucial last check on the safety of any medication ISMP, March 2001 H aving the patient validate what the doctor prescribed, what the pharmacist dispensed, and how the drug should be administered may reduce or eliminate liability for both doctor an d pharmacist. Now, a misdiagnosis by the doctor is a completely different set of circumstances which was not covered in this research. 6.4.2 Further Research While this study provided many insights into the workplace culture and moral make up of pharmacists in an organization, this study has some limitations as well. Only one facility was investigated. Not every available pharmacist participated in this study. Ano ther area that might lend itself to further investigation would be determining the workplace cul ture of similar facilities to determine if similar results are obtained. As well, determining the workplace culture of those individuals/entities pharmaceutical companies, other prescribing clinicians, pharmacy governing boards, nursing staff of which pharmacists interact would be interesting. Further research might include

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135 following a medication error via the route of the workplace culture as part of the root cause analysis Root cause analysis typically involves individuals involved in the error an d does not address the issue of the workplace environment nor the complete system. T his study addressed the pharmacists moral make up as it pertained to the workpla ce culture in regards to truthfulness other factors outside of the workplace could shed a dditional light on the pharmacists limitations of truthfulness Although pharmacists are human the public seems to think pharmacists should be infallible at work. A 2004 Hillsborough County, Florida general election ballot listed a constitutional amen dment that would give patients the right to review, upon request, records of health care facilities or providers adverse medical incidents On the same ballot, there was a proposed constitutional amendment that would prohibit medical doctors who have be en found to have committed three or more incidents of medical malpractice from being licensed to practice medicine in Florida. Further research might include obtaining the publics opinion on disclosure of all workplace errors, whether a pharmacist, docto r, lawyer, beautician, cashier, politician, clergyman, chef, etc. As technology advances, the ability for a system to produce an error will lessen. Further research might include obtaining the publics view on the use of biotechnology to obtain prescri ptions. Instead of using a prescription card to obtain prescriptions the use of a scanned fingerprint and/or eye scan could directly identify the person for whom the prescription is intended. Only time will tell how receptive the public is to these view s.

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136 References Academy of Managed Care Pharmacy. n.d.. FAQ's about Managed Care Pharmacy Retrieved from http://www.amcp.org/amcp.ark?c=pc&sc=xB5DA8F59D093CD77E 98958B 4D248016D Academy of Managed Care Pharmacy. n.d.. Pharmaci s t s Ÿ Cognitive Services. Retrieved from http://www.amcp.org/data/legislative/concep ts/Pharmacists%20Cognitive %20Services%2Epdf Agency for Healthcare Research and Quality. 2000, February. Medical Errors: The Scope of the Problem Fact sheet, Publication No. AHRQ 00 P037. Maryland: Agency for Healthcare Research and Quality. Retrieve d from http://www.ahrq.gov/qual/errback.htm Agency for Healthcare Research and Quality 2000, February. 20 Tips to Help Prevent Medical Errors. Fact sheet, Publication No. AHRQ 00 P038. MD: Agency for Healthcare Research and Quality. Retrieved from http://www.ahrq.gov/consumer/20tips.htm Agency for Healthcare Research and Quality. 2001, June. Beyond State Reporting: Medical Errors and Pa tient Safety Issues Retrieved from http://www.ahcpr.gov/news/ulp/ptsafety/ptsafety.htm Agency for Healthcare Research and Quality. July 2003. Five Steps to Safer Health Care. Fac t sheet, Publication No. AHRQ Publication No 03 M007. Maryland: Agency for Healthcare Research and Quality. Retrieved from http://www.ahcpr.gov/consumer/5steps.htm American Hospital Association & J oint C ommission on A ccreditation for H ospital O rganizations 2001, August 13. JCAHO Database Worries AHA. Modern Healthcare v31, pp. 4 American Medical Ass ociation. 2000. AMA Specifications for a National Health System Error Prevention, Resear ch, and Patient Safety Initiative. A merican Medical Association

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139 D ooley, J. n.d.. Cultural Aspects of Systemic Change Management Retrieved from http://www.well.com/user/dooley/culture.pdf EDGE/Schneider Consulting Group, LLC. n.d.. Building High Perform ance Cultures Retrieved from http://www.workwithedge.com/otherassesstools.html Eisenberg, J., 1999, December 13. Statement on Medical Errors. Agency for Healthcare Research and Quali ty, before the Senate Appropriations Subcommittee on Labor, Health, and Human Services, and Education. MD : AHRQ Retrieved from http://www.ahrq.gov/news/stat1213.htm Eisenberg, J. 2002 January. AH RQ Partnerships Promote Patient Safety U.S. Medicine Retrieved from http://www.usmedicine.com/column.cfm?columnID=80&issueID=34 Ethics and Policy Integration Centre. 2003. Organizational Integrity Retrieved from http://www.ethicaledge.com/quest_1.html Felciano, R. 1995, February Human Error: Designing for Error in Medical Information Systems Stanford Univers ity. Retrieved from http://www smi.stanford.edu/people/felciano/research/humanerror/humanerrortalk.htm l Florida Health Careers. n.d.. Pharmacy Retriev ed from http://www.flahec.org/hlthcareers/PHARM.HTM Gale, T. 2006. Thomson Corporation. 2006. Organizational Development. Thomas Corporation. Retrieved from http://www.referenceforbusiness.com/encyclopedia/Oli Per/Organizational Development.html Gilman, R. 1997. Stages Of Change Context Institute Retrieved from http://www.context.org/ICLIB/IC09/Gilman1.htm Haddad, A 2001. Senators Set To Offer Medical Errors Bill Congress Daily, United States Congress. Ethics in Action. RN v64i9: p25 Hebert P ., Levin, A., Robertson, G. 2001 Bioethics for C linicians: 23 Disclosure of Medical Error. Canadian Medical Association Journal: 1644 pp 509 13 Hodgetts, R. 1999. Modern Human Relations at Work 7 th Edition Texas: Harcourt Brace College Publishers

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156 Reason, J. 2000, March 18. Human E rror: M odels and M anagement. British Medical Journal 320, pp. 768 770 Retrieved from http://bmj.bmjjournals.com/cgi/content/full/320/7237/768#B3#B3 Reid, R. 1998. Characteristics of High Performing Teams Retrieved on September 25, 2000 from http://www.impr ove.org/team1.html Remarks by the President on Medical Errors 2000 Dwight D. Eisenhower Executive Office building, White House Roberts, H. and Sergesketter, B. 1993 Quality Is Personal: A Foundation for Total Quality Management New York: The Free Press The Roots of Sound and Rational Thinking n.d.. Retrieved March 30, 2004 from http://www.plusroot.com/term.html?term_id=295 Schermerhorn, J., Hunt, J. and Osborn, R. 1994. M anaging Organizational Behavior 5 th Edition New York: John Wiley and Sons, Inc. Shaha, S., Brodsky, L., Leonard, M., Cimino, M., McDougal, S., Pilliod, J., Martin, K. n.d.. Establishing a Culture of Patient Safety Through a Low tech Approach to Redu cing Medication Errors Retrieved f rom http://www.ahrq.gov/downloads/pub/advances/vol3/Shaha.pdf Shields, T. 2000, February. Major Healthcare Gaps Begin Medical Error Preventio n Programs. Healthcare Purchasing News Retrieved f rom http://www.findarticles.com Spiegel, M, Schiller, M., Srinivasan, R. 2000. SchaumŸs Outline of Probability and Statistics 2nd Edition McGraw Hill Comp anies Spector, P. 1997. Job Satisfaction: Application, Assessment, Causes, and Consequences New York: John Wiley & Sons Spector, P. 1999. Industrial and Organizational Psychology New York: John Wiley & Sons SPSS 1997. SPSS Missing Value An alysis 7.5. Chicago: SPSS Inc. Stammer, L. 2000, October. Seeking Safety. Healthcare Informatics Stewart, D. n.d.. Growing the Corporate Culture Retrieved from http://www.wachovia.com/small_biz/page/0,,447_972_1695_1946_1966,0 0.html

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157 Sweeney, R. 2000, March 1. ISMP Leads Congressional Briefing on Medication Errors. American Family Physician Taylor, F. 1947. The Principles of Scientific Management Ne w York: W.W. Norton & Company, Inc. Think Win Win n.d. Retrieved March 20, 2004 from http://www.bemerson.com/seven/Think%20Win Win.htm Thomas, M. 2001, October 1. Medication Error Reports to FDA Show a Mixed Bag. Drug Topics Retrieved f rom http://www.findarticles.com Treacy, M., & Wiersema, F. 1995. The Discipline of Market Leaders Massachusetts: Perseus Books Ukens, Carol. 19 97, November 17. California Pharmacists Association to Receive United States Pharmacopeia Help With Error Reporting. Drug Topics U.S. News. 1998, February 28. Report: Deaths from Medication Errors on Increase Retrieved f rom http://www.cnn.com/us/9802/28/briefs/medication.deaths/index.html Vecchione, A. October 18, 1999. Hospitals Focusing More Attention on Medication Error Reporting Efforts. Drug Topics 14320 p51 Weingart, S. 2000, March 18. Epidemiology of Medical Error. British Medical Journal v320 pp 774 777. Retrieved from http://www.findarticles.com Wojcieszak, D. 2005, May/June. Standards, Audits and Saying Im Sorry: An Engineers Family Proposes Solutions. Patient Safety & Quality Healthcare Retrieved on August 26, 2005 Retrieved from http://www.psqh.com/mayjun05/consumers.html 2000, April. Reducing Errors in Health Care. Translating Research Into Practice AHRQ Publication No. 00 PO58. Maryland: AHRQ 2000, August 26. Medical Errors: Reporting and Punishment. The Lancet v3569231 p 773 2000, December 11. FDA Incr eases Medication Error Focus Retrieved f rom http://www.findarticles.com 2000, June. Confidentially. Nursing Library Retrieved from http://www.findarticles.com

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158 2000, November 1. How Many Deaths Are Due to Medical Errors? JAMA Letters. JAMA v28417 2000, October 3 6. Process Industry Incidents Investigation Protocols, Case Histories, Lessons Learned Center for Chemical Process Safety. Performance, S afety and Health Associates, Inc 200 1 The Holy Bible: King James Version Barbour Publishing, Inc O hio 2001, April 25. Margin of Error: The Ethics of Mistakes in the Practice of Medicine. JAMA, 28516

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159 Appendices

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160 Appendix A: Historical Persp ective Table A.1 Historical Perspective DATE INDIVIDUALS/ ORGANIZATIONS ACTIONS OUTCOMES 1976 U.S. House of Representatives Subcommittee on Oversight and Investigation of the Committee on Interstate and Foreign Commerce Issued its report, Cost and Quality in Health Care: Unnecessary Surgery. Estimated that there were some 2.4 million unnecessary operations every year, with as many as 11,900 deaths attributed to these unneeded operation 1984 The Harvard Medical Practice Study Looked at over 3 0,000 hospitalizations in New York State Approximately 27,000 individuals die each year in New York hospitals alone as a result of preventable medical errors. 1997 Representative William Coyne D, Pennsylvania Introduced the Safe Medications Act of 1997 Required that health facilities report deaths from drug errors. The bill would impose a fine of $15,000 for each unreported death and exclude those facilities convicted of failing to report a death from receiving Medicare and state health care payments 1997 President Clinton and Vice President and the Office of Personnel Management Established the Advisory Commission on Consumer Protection and Quality in the Health Care Industry Quality Commission and launched the National Forum for Health Care Quali ty Measurement and Reporting. Developed standard quality measurement tools to help purchasers, providers, and consumers better evaluate and ensure the delivery of health care services.

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161 Appendix A : Continued Table A.1 Continued 1998 President Clinto ns Advisory Commission on Release the final report on Consumer Protection and Quality in the Health Care Industry Identified medical errors as one of the four major challenges facing the Nation in improving health care quality March 1998 President Clin ton Established the Quality Interagency Coordination Task Force QuIC Respond to the IOM report with recommendations on improving health care quality and protecting patient 1999 Institute of Medicine Issued a report, To Err is Human: Building a Safer H ealth System Medical errors are the 8 th leading cause of death in America. An estimated 44,000 to 98,000 deaths occur each year in the U.S. as a result of medical errors. December 1999 President Clinton Directed the Health Care Quality Task Force to anal yze the Institute of Medicine study Concur with IOM recommendations 1999 James Jeffords, VT Mike Enzi, WY Bill Frist, TN Introduced a bill to amend the Public Health Service Act to reduce medical mistakes and medication related errors and referred to the Senate Labor, Health, Education and Pensions Committee Amended current law to reduce medical mistakes and medication related errors by creating a Center for Quality Improvement and Patient Safety to track medical mistakes and best practices.

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162 Appen dix A : Continued Table A.1 Continued 1999 Edward Kennedy, MA Patty Murray, WA Christopher Dodd, CT Introduced Voluntary Error Reduction and Improvement in Patient Safety Act and referred to the Senate Labor, Health, Education and Pensions Committee Amended current law to develop the Center for Quality Improvement for Patient Safety to direct a national voluntary reporting system, research and dissemination of critical information. 2000 QuIC Response Endorsed virtually every IOM recommendation proposed President called for a mandatory reporting system in the 500 military hospitals and clinics serving over 8 million patients; and a phased in nationwide state based system of mandatory and voluntary error reporting Feb. 23, 2000 Connie Morella, M D Brian Baird, WA Donald Manzullo, IL Ron Paul, TX Thomas Tancredo, CO Phil English, PA Dennis Moore, KS Joseph Pitts, PA Tom Udall, CO Introduced Medication Error Prevention Act of 2000 and referred to the House Committee on Commerce Subcommittee on Heal th and Environment Amended current law to reduce medication related medical errors by providing for voluntary reporting by health care providers of medication error information in order to assist appropriate public and nonprofit private entities in develo ping and disseminating recommendations and information.

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163 Appendix A : Continued Table A.1 Continued Feb. 28, 2000. Arlen Specter, PA Tom Harkin, IA Daniel Inouye, HI Introduced Medical Error Reduction Act of 2000 and referred to the Senate Com mittee on Health, Education, Labor, and Pensions Amended current law to reduce accidental injury and death resulting from medical errors including establishing 15 demo projects in an effort to develop a model for medical error reduction and reporting. A pril 6, 2000 Charles Grassley, IA Richard Byran, NV Joseph Lieberman,CT Robert Kerrey, NE Introduced Stop All Frequent Errors in Medicare and Medicaid Act of 2000 and referred to the Senate Committee on Finance Amended the Social Security Act to im prove the safety of Medicare and Medicaid. March 2001 Michael R.Cohen, MS, RPh President of ISMP Presented before Congress. Medicare Reform: Laying the Groundwork for a Prescription Drug Benefit Underutilized technology. Recommended incentives for faci lities that adopt technology known to reduce medication errors. July 2001 Joint Commission on Accreditation of Healthcare Organizations JCAHO Adopted new standards Safety programs must include systems for responding to medical errors and for internal a nd external reporting. July 2001 JCAHO Revised its patients rights standard Required to inform patients and families about the outcomes of care, including adverse events August 2002 President Bush Called for medical liability reform See July 2003 Ou tcome Comments

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164 Appendix A : Continued Table A.1 Continued 2002 JCAHO JCAHO reviews Emergency Care Documentation System and pronounced EmpowER a success story and role model In Accreditation Issues for Emergency Departments Discharge instructions are now available in six languages in addition to English, and automatically print out in the patient's native language 2002 Food and Drug Administration Introduced Performance Plan: Reduce Adverse Events Related to Medical Products Goal is to develop and en hance surveillance of FDA regulated products to identify harm resulting from use, understand harm through expert analysis, and prevent harm to other patients by taking action January 2003 President Bush Bush urged Congress to protect America's patients, d octors, and hospitals from the staggering costs of out of control lawsuits by passing important medical liability reforms See July 2003 Outcome Comments April 29, 2003 President Bush Proposals for Health Security in the World's Best Health Care System fo r Patients Bill of Rights Strongly supports the passage of a Patients' Bill of Rights that leaves medical decisions in the hands of physicians, instead of insurance companies July 9, 2003 President Bush Senates Response to Medical Liability Reform Pres ident disappointed with Senates failure to pass Medical Liability Bill December 2003 Food and Drug Administration Sought bar code system in bid to cut down on medical errors Goal is to use bar coding technology on drugs to reduce hospital medical errors and deaths

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165 A ppendix A : Continued Table A.1 Continued June 2004 President Bush Discussed use of wireless and broadband technology in healthcare Goal is to streamline the use of technology in providing faster, accurate and better care. January 27, 200 5 President Bush Bush participates in an event on health care information technology at the Cleveland Clinic in Cleveland, Ohio Bush pushes the use of computerized medical records June 29, 2005 Mr. Enzi and Mr. Baucus 109 th Congress Fair and Reliable Me dical Justice Act introduced in Senate To restore fairness and reliability to the medical justice system and promote patient safety by fostering alternatives to current medical tort litigation, and for other purposes July 29, 2005 President Bush Bush sign s law to create medical errors database A national database on medical errors, designate individual reports as confidential and shield participating providers from liability

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166 Appendix B: Summary of Congressional Response to IOM Report The response to the IOM report by Congress was heard in a Joint Hearing of the Committee on Health, Education, Labor, and Pensions HELP and the Subcommittee on Labor, Health and Human Services, and Education. President Clinton released a plan for a nationwide, state based system of reporting medical errors to be phased in over time. The plan included mandatory reporting of preventable medical errors that cause death or serious injury, and voluntary reporting of other medical mistakes and "near misses," or "close calls." T he Clinton Gore Administration 2000 worked with the National Quality Forum, a private public group of health care experts, to develop a set of patient safety measurements that would lay the foundation for a uniform system of reporting errors. Information will be aggregated and made public without identifying patients or individual health care professionals to educate the public about the safety of their health systems. President Clinton described these efforts as a balanced, common sense approach based on prevention, not punishment; on problem solving, not blame placing. As put by Senator Christopher Dodd, the IOM study revealed a major health crisis not a deadly new virus or another tear in the safety net but a crisis of human error. Further, he stat ed that most Americans feel confident that the health care they receive will make them better or at the very least, not make them feel worse. And in the vast majority of circumstances, that confidence is deserved.

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167 Appendix B: Continued Senator Edward Kennedy stated that any legislation put forward will not effectively reduce medical errors unless it holds institutions accountable for implementing practices and standards that improve patient safety. The public deserves meaningful information about how well individual health care institutions perform on patient safety measures, so that patients can make informed choices. Senator James Jeffords, Chairman of Committee on Health, Education, Labor, and Pensions stated that the ideal reporting system must b e non punitive, voluntary, confidential, and de identified. It is the view of Senator Arlen Specter that there should be a professional responsibility by doctors and hospitals to tell people when they have been injured. It may be that in the long run, tha t the disclosure of errors can lead to a way to deal with this problem which would be different from the current tort system of medical malpractice, and perhaps those who are injured could be compensated in some other way, like perhaps workmens compensati on without respect to fault.

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168 Appendix C: What Is Your Corporate Culture? Quiz: What Is Your Corporate Culture? Corporate culture is a complex subject. Yet analyzing your company's culture can help you create a plan to improve it. This 15 question surve y has been developed to serve as a starting point for your analysis. by Debra Woog McGinty and Nicole C. Moss Corporate culture is a complex subject. Yet analyzing your company's culture can help you create a plan to improve it. This 15 question surv ey has been developed to serve as a starting point for your analysis. Answer each true/false question according to what is true most of the time. And answer based on how your organization actually acts -not how you would like it to be. True/False Q uestions 1 I know how my projects contribute to the success or failure of our organization. 2 Management here makes lots of announcements to employees. 3 I have colleagues from a wide variety of professional and personal backgrounds. 4 In this organiz ation, people who are not ready to be promoted after a certain length of time at their level are generally encouraged to leave. 5 Departments or teams compete with each other for our organization's resources. 6 When people are not getting along here, it' s a long time before we directly address the issue. 7 When it's time for me to learn a new skill, training is readily available at no cost to me. 8 When the boss tells us to "jump!" we ask "how high?" 9 It takes a long time for this organization to addr ess customer concerns. 10 Many employees expect to work at this organization for their whole careers. 11 Senior management says the door is always open -and they mean it. 12 It is fun to work here. 13 We have three or fewer layers of management. 14 We have performance reviews less than once a year. 15 Compensation and benefits are relatively low here. Count your "True" responses in each third of the quiz questions 1 5, 6 10, 11 15. The section in which you have answered "True" the most times corr esponds to the culture type your organization most closely matches. If you have the same

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169 Appendix C: Continued number of "True" responses in more than one section, your culture matches this combination of types. On the next page, you'll find a list of primary advantages and potential pitfalls of each one. For questions 1 5: If you had the most "True" responses in this set of questions, your company has a Deliberative/Traditional culture Advantages: 1 This culture tends to be intellectual and tho ughtful. 2 People in this type of organization often consider issues carefully prior to making a change. 3 The organization likely has many formal systems, yet flexibly forms and reforms teams in accordance with immediate client needs. 4 Senior mana gement communicates frequently to employees. Pitfalls: 1 Although plenty of communication usually flows from the top of this organizational type, management often does not indicate interest in feedback from all levels. Beyond making announcements from m anagement, ask for regular feedback so you don't miss critical information and/or valuable innovations from your staff. 2 Be careful that your organization doesn't discuss change for so long that you miss important opportunities to change for the better 3 This cultural type regularly hires groups of new employees, generating a valuable flow of diverse talent with fresh perspectives. 4 Be aware of the cultural implications of fostering competition within a company. Internal competition may create r esentment that drives costly turnover. For questions 6 10: If you had the most "True" responses in this set of questions, your company has an Established/Stable culture Advantages: 1 This organization has most likely been around for a long time and /or is a family business. These organizations tend to have solid institutional memories, so they are likely not to waste resources by repeatedly "reinventing the wheel". 2 This type of company has processes in place to address most situations. 3 Organ izations of this type tend to cultivate employees by encouraging development through mentoring programs and/or formal training opportunities. 4 This culture type is known for compensating its people relatively well.

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170 Appendix C: Continued Pitfalls: 1 Typically this type of organization struggles to handle conflict well, often becoming either conflict avoidant or "command and control." If your organization tends to be conflict avoidant, it may be time to address those problems that are out of hand, or that have been out of hand in the past. 2 "Command and control" style leadership may yield feelings of disconnectedness among employees. Consider assessing employee morale immediately. 3 Overall, this culture type tends to be wary of turnover, so ta ke a careful look at your organization and consider whether it's holding on to people who might best be let go. 4 While established systems can be a positive sign of organizational health, make sure your processes are focused toward addressing customer n eeds in a timely matter. If your processes impede rapid resolution of customer problems, rework them right away. For questions 11 15: If you had the most "True" responses in this set of questions, your company has an Urgent/Seat of the Pants culture A dvantages: 1 This culture type features a positive work environment, with tight bonds among employees. 2 It is likely that an aspect of your organization's mission includes responding to crisis. People care deeply about the firm's mission and work ha rd to achieve the organization's goals. 3 Employees who frequently hurry to beat the clock can create great results in a short time, provided that quality is a strong value in your organization. 4 These organizations tend to have a flat structure that fosters communication and collaboration among employees and speeds the decision making process. P itfalls: 1 Caution: minimum rewards both tangible and intangible and minimum feedback are common to this culture type. Rewards and recognition are impor tant not only to generate loyalty but also to foster collaboration. 2 The constant rush to get things done quickly can lead to burnout and increase the ever present danger of losing talent. 3 Although this type of culture generally features frequent upward communication and grassroots change, top down communication tends to be inadequate. Beyond staying accessible, take time to share important messages and expectations with your entire staff to keep them motivated and moving in the right direction.

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171 Appendix C: Continued 4 Making decisions under intense time pressure may lead to a reduction in the quality of your products or services. Is your culture type consistent with your expectations? If so, you probably have a g ood handle on how your compa ny behaves, its primary cultural drivers, and how to make improvements where necessary. Is your type different from what you thought it would be? If so, you might have an unrealistic perception of your company's character and values. Take a closer loo k at your answers above, and use the questions themselves as a guide to shifting your organization's behaviors toward becoming the type of culture you would like to see. About the authors: Debra Woog McGinty, principal of connect2 Corporation, coaches leaders to be expert managers. She welcomes your comments at inc@connecttwo.com Nicole Moss provides emerging companies with recruiting consulting services through her company Blueprint. She welcomes your com ments at nicole@blueprintonsite.com Copyright 2001 -Connect2 Corporation and Blueprint -All Rights Reserved

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172 Appendix D: Data Assessment Measures Count your "True" responses in each section of the survey questions 2 13, 14 19, 20 25, 26 30, 31 35, 36 43. The section in which you have answered "True" the most times corresponds to the culture type your organization most closely matches. If you have the same percentage of "True" responses in more th an one section, your culture matches this combination of types. For questions 2 13: If you had the most "True" responses in this set of questions, your company has an Integrity/Humanistic culture Advantages: This culture tends to be an honest entity. 1 People in this type of organization consider integrity to be at the top of the list. 2 The organization likely encourages a nurturing environment. 3 Upper level management communicates clearly and frequently to employees. Pitfalls: 1 Although honesty is an excellent policy, too much information can be damaging. 2 People in this type of organization are loyal to what is right, not to the organization. 3 Be aware of the cultural implications of fostering a God like environment that may bring religion into play when making work related decisions. For questions 14 19: If you had the most "True" responses in this set of questions, your company has an Efficiency/Quality Oriented culture Advantages: 1 This culture tends to be quality oriente d. 2 People in this type of organization tend be hard workers. 3 The organization likely has many informal systems that allows the employee to do what he/she needs to do to get the job done.

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173 Appendix D : Continued 4 Upper level management commun icates priorities frequently to employees. Pitfalls: 1 Although quality should be at the top of the list, if the organization moves efficiency to the bottom of the list, negative return on investment will occur. 2 Be careful that your organizations informal systems may be used against the organization in lieu of an error. 3 Be aware that communication should flow in both directions. It is important to listen to your employees. A hire turnover can exist if employees are not listened to. 4 Be awa re that communication should flow in both directions. It is important to listen to your employees. A hire turnover can exist if employees are not listened to. For questions 20 25: I f you had the most "True" responses in this set of questions, your compan y has a n Innovative culture Advantages: 1 This culture tends to be innovative. 2 People in this type of organization often view issues as creative challenges. 3 The organization likely has many formal systems that allows the employee to feel empo wered and to communicate ideas. 4 This cultural type regularly hires new employees that are thinkers and doers. 5 Upper level management communicates frequently to employees. 6 Employees communicate frequently to upper level management. Pitfalls: 1 Although innovation is good, too many thinkers may begin to compete with each other and lose track of what is important. 2 Be careful that your organization doesn't discuss change for so long that you miss important opportunities to change for the bett er. 3 Be aware of the cultural implications of fostering competition within a company. Internal competition may create resentment that drives costly turnover. For questions 26 30: If you had the most "True" responses in this set of questions, your compa ny has a Deliberative/Traditional culture

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174 Appendix D : Continued Advantages: 1 This culture tends to be intellectual and thoughtful. 2 People in this type of organization often consider issues carefully prior to making a change. 3 The organiza tion likely has many formal systems, yet flexibly forms and reforms teams in accordance with immediate client needs. 4 This cultural type regularly hires groups of new employees, generating a valuable flow of diverse talent with fresh perspectives. 5 Senior management communicates frequently to employees. Pitfalls: 1 Although plenty of communication usually flows from the top of this organizational type, management often does not indicate interest in feedback from all levels. Beyond making announce ments from management, ask for regular feedback so you don't miss critical information and/or valuable innovations from your staff. 2 Be careful that your organization doesn't discuss change for so long that you miss important opportunities to change fo r the better. 3 Be aware of the cultural implications of fostering competition within a company. Internal competition may create resentment that drives costly turnover. For questions 31 35: If you had the most "True" responses in this set of questions your company has an Established/Stable culture Advantages: 1 This organization has most likely been around for a long time and/or is a family business. These organizations tend to have solid institutional memories, so they are likely not to waste resources by repeatedly "reinventing the wheel". 2 This type of company has processes in place to address most situations. 3 Organizations of this type tend to cultivate employees by encouraging development through mentoring programs and/or formal tra ining opportunities. 4 This culture type is known for compensating its people relatively well. Pitfalls: 1 Typically this type of organization struggles to handle conflict well, often becoming either conflict avoidant or "command and control." If you r organization tends to be conflict avoidant, it may be time to address those problems that are out of hand, or that have been out of hand in the past. 2 "Command and control" style leadership may yield feelings of disconnectedness among employees. Cons ider assessing employee morale immediately.

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175 Appendix D : Continued 3 Overall, this culture type tends to be wary of turnover, so take a careful look at your organization and consider whether it's holding on to people who might best be let go. 4 Whil e established systems can be a positive sign of organizational health, make sure your processes are focused toward addressing customer needs in a timely matter. If your processes impede rapid resolution of customer problems, rework them right away. For qu estions 36 43: If you had the most "True" responses in this set of questions, your company has an Urgent/Seat of the Pants culture Advantages: 1 This culture type features a positive work environment, with tight bonds among employees. 2 It is li kely that an aspect of your organization's mi ssion includes responding to cri sis. People care deeply about the firm's mission and work hard to achieve the organization's goals. 3 Employees who frequently hurry to beat the clock can create great results in a short time, provided that quality is a strong value in your organization. 4 These organizations tend to have a flat structure that fosters communication and collaboration among employees and speeds the decision making process. Pitfalls: 1 Cautio n: minimum rewards both tangible and intangible and minimum feedback are common to this culture type. Rewards and recognition are important not only to generate loyalty but also to foster collaboration. 2 The constant rush to get things done quickly c an lead to burnout and increase the ever present danger of losing talent. 3 Although this type of culture generally features frequent upward communication and grassroots change, top down communication tends to be inadequate. Beyond staying accessible, t ake time to share important messages and expectations with your entire staff to keep them motivated and moving in the right direction. 4 Making decisions under intense time pressure may lead to a reduction in the quality of your products or services.

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176 A ppendix E: Final Revision of Survey Building A Non Punitive Culture in Pharmacy for Medical Error Reporting Questionnaire Fill In 1 Answer for Each Question 1 of 3 1. If I made a medical error, I would report it O Immediately O Only if someone saw m e or knew that it could have only been me O Only if it were a minor error no patient harm O Only if it were a major error serious harm to patient O Never 2. I would only feel comfortable reporting a medical error if I knew that there would not be any rep ercussions against me. O true O false 3. I have personally reported a medical error. O true O false 4. If Question 3 applies, I would report it again. O true O false 5. If Question 3 applies, the medical error I reported was associated with this organiza tion. O true O false 6. The environment/section that I work in supports full disclosure of medical errors. O true O false 7. I believe that this organization as a whole supports full disclosure of medical errors. O true O false 8. Patients sho uld be made aware that a medical error has occurred. O true O false 9. Reporting medical errors to a federal agency would allow other clinicians to develop safety precautions in their system of work O true O false Please Provide the Last 5 Digits of Home Phone _____________

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177 Appendix E : Continued 10 Reporting medical errors reduces the number of medical errors overall. O true O false 11. I have heard of the National Practitioner Data Bank NPDB. O true O false 12. If Question 11 applies, I have a positive impression of the NPDB. O true O false 13. A non punit ive culture will actually increase reporting of medical errors. O true O false Building A Non Punitive Culture for Medical Error Reporting Questionnaire Fill In 1 Answer for Each Question 2 of 3 14. My supervisor is most interest in getting the job done as fast as I can. O true O false 15. My supervisor is most interested in quality care for the patients. O true O false 16. I am most interested in getting the job done as fast as I can. O true O false 17. I am most interested in quality car e for the patients. O true O false 18. The safety protocols that I have to follow slow down my job. O true O false 19. The safety protocols that I follow add more efficiency to my job. O true O false 20. My supervisor encourages new ideas about i ncreasing patient safety. O true O false 21. I have ideas that could increase patient safety. O true O false 22. I feel comfortable reporting a medical error to my supervisor. O true O false

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178 Appendix E : Continued 23 I would be embarrassed if my colleagues found out that I made a medical error. O true O false 24. It is people who make medical errors not the system. O true O false 25. It is the system that fails that allows medical errors to occur. O true O false 26. I understand how m y duties contribute to the success or failure of our organization. O true O false 27. Management effectively communicates in a way that meets the need of the staff. O true O false 28. I have colleagues from a wide variety of professional and personal backgrounds. O true O false Building A Non Punitive Culture for Medical Error Reporting Questionnaire Fill In 1 Answer for Each Question 3 of 3 29. Opportunity for advancement is based on performance rather than length of employment. O true O fa lse 30. Departments or teams compete with each other for our organizations resources. O true O false 31. When people are not getting along here, my supervisor addresses the issue in a timely manner. O true O false 32. It is important for indivi duals to work out their differences before going to the supervisor. O true O false

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179 Appendix E : Continued 33. When it is time for me to learn a new skill, training is readily available at no cost to me. O true O false 34. Customer concerns are addressed in a timely manner. O true O false 35. Many employees expect to work at this organization for their whole careers. O true O false 36. When I have a problem and my supervisor cant solve it, Chief/Assistant Chief say the door is always ope n and they mean it. O true O false 37. It is fun to work here. O true O false 38. My job meets my professional expectations. O true O false 39. We have too many layers of management. O true O false 40. The Service needs more supervisi on. O true O false 41. Performance reviews are comprehensive and adequately access my performance. O true O false 42. Salary and benefits are relatively low here compared to others in my profession. O true O false 43. Salary is more importan t to me than professional growth. O true O false

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180 Appendix F: Non Punitive Culture Information The Institute for Safe Medication Practices defines a non punitive environment as a confidential reporting system where everyone understands that errors wi ll not be linked to an individuals performance. Furthermore, in a non punitive reporting system no criminal action and no disciplinary measures will be undertaken against the reporter on the basis of information contained in submitted reports. The intent of a non punitive culture for medication error reporting is to encourage staff to report medication errors whether it is a near miss or death. In a non punitive environment, medication errors are classified as system based errors. These system based err ors can be defined as a flaw in the system of medicine, i.e. reading the wrong prescription on a script, administering the wrong medication because the bottles looked alike or the names sound alike, dispensing medication to the wrong patient, etc. System based errors exist in all healthcare facilities. In the proposed non punitive culture, system based medication errors are reported and the reporter has the option of either complete anonymity does not identify the facility nor the staff members involv ed or disclosure of his/her identity which would not be available outside of the facility. The purpose of disclosure would be to derive facts in the investigation process for further clarification. What is of utmost importance is how the error occurred and what measures need to be instituted to eliminate the system based error from repeated occurrence. It is important that system based errors be reported as they occur in order to prevent future harm to patients.

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181 Appendix F: Continued Imagine a cultur e where you were not reprimanded for coming forth with an error that involved you. Imagine a culture where you could offer suggestions as to how to get a task done that would eliminate any possible harm to the patient. Imagine a culture where management listens to your problems and respect your proposed solutions. Imagine a culture where pharmacists from across the world could share system based error information with one another and remain anonymous. Imagine a system that provided timely feedback to sh ow how the reported errors saved lives. Imagine a system where there would be no more blame and shame but, honor and praise. Imagine a system where patients were informed in a timely manner less than 24 hours of a medication error and management and th e facility director supported you 100 percent. Just imagine a culture of unstressed truth. There is such a culture that exists, the non punitive culture. It can be yours. A non punitive culture offers a nurturing environment that is open to innovation, c reativity, and change because fear of failing is not a limiting factor http://www.mers tm.net/training

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182 Appendix G: National Practitioner Data Bank NPDB Information The Health Care Quality Improvement Act of 1986 authorized the Department of Health and Human Services to establish a National Practitioner Databank to collect and release certain information relating to inept, incompetent or unprofessional physicians, dentists, pharmacists and other health care practitioners. The intent is to improve the quality of health care by encouraging State licensing boards, hospitals and other health care entities, and professional societies to identify and discipline those who engage in unprofessional behavior; and to restrict the ability of incompetent physicians, dentists, and other health care practitioners to move from State to State without disclosure or discovery of previous medical malpractice payment and adverse action history. Adverse actions can involve lic ensure, clinical privileges, professional society membership, and exclusions from Medicare and Medicaid. The NPDB is primarily an alert or flagging system intended to facilitate a comprehensive review of health care practitioners' professional credentials. The information contained in the NPDB is intended to direct discrete inquiry into, and scrutiny of, specific areas of a practitioner's licensure, professional society memberships, medical malpractice payment history, and record of clinical privileges. The information contained in the NPDB should be considered together with other relevant data in evaluating a practitioner's credentials; it is intended to augment, not replace, traditional forms of credentials review.

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183 Appendix G: Continued Access to Info rmation Access to information in the NPDB is available to entities that meet the eligibility requirements as defined in the provisions of the NPDB regulations. In order to access information, entities must first register with the Data Bank. NPDB informati on is not available to the general public. However, information in a form that does not identify any particular entity or practitioner is available. Confidentiality Information reported to the NPDB is considered confidential and shall not be disclosed exc ept as specified in the NPDB regulations. The Privacy Act of 1974, protects the contents of Federal systems of records such as those contained in the NPDB from disclosure, unless the disclosure is for a routine use of the system of records as published ann ually in the Federal Register. The published routine uses of NPDB information do not allow for disclosure of information to the general public. T he Office of Inspector General OIG, Health and Human Services HHS, has the authority to impose civil money penalties on those who violate the confidentiality provisions of Title IV. Persons, organizations, or entities that receive information either directly or indirectly are subject to the confidentiality provisions and the imposition of a civil money penalty of up to $11,000 for each offense if they violate those provisions. For additional information log onto www.npdb hipdb.com

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184 Appendix H: Tests of Within Subjects Effects Table A. 2 Tests of Within Subjects Effects Scale Source Type III Sum of Squares df Mean Square F P Sphericity Assumed 0 1 0 0.049 0.827 Greenhouse Geisser 0 1 0 0.049 0.827 Huynh Feldt 0 1 0 0.049 0.827 time Lower bound 0 1 0 0.049 0.827 Sphericity Assumed 0.016 1 0.016 3.155 0.084 Greenhouse Geisser 0.016 1 0.016 3.155 0.084 Huynh Feldt 0.016 1 0.016 3.155 0.084 Scale 1 Time Group Lower bound 0.016 1 0.016 3.155 0.084 Sphericity Assumed 0.004 1 0.004 0.283 0.598 Greenhouse Geisser 0.004 1 0.004 0.283 0.598 Huynh Feldt 0.004 1 0.004 0.283 0.598 time Lower bound 0.004 1 0.004 0.283 0.598 Sphericity Assumed 0.001 1 0.001 0.048 0.828 Greenhouse Geisser 0.001 1 0.001 0.048 0.828 Huynh Feldt 0.001 1 0.001 0.048 0.828 Scale 2 Time Group Lower bound 0.001 1 0. 001 0.048 0.828 Sphericity Assumed 0.053 1 0.053 3.093 0.086 Greenhouse Geisser 0.053 1 0.053 3.093 0.086 Huynh Feldt 0.053 1 0.053 3.093 0.086 time Lower bound 0.053 1 0.053 3.093 0.086 Sphericity Assumed 0.047 1 0.047 2.7 1 0.108 Greenhouse Geisser 0.047 1 0.047 2.71 0.108 Huynh Feldt 0.047 1 0.047 2.71 0.108 Scale 3 Time Group Lower bound 0.047 1 0.047 2.71 0.108

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185 Appendix H : Continued Table A. 2 Continued Scale Source Type III Sum of Squares df Mean Square F P Sphericity Assumed 0 1 0 0.013 0.91 Greenhouse Geisser 0 1 0 0.013 0.91 Huynh Feldt 0 1 0 0.013 0.91 time Lower bound 0 1 0 0.013 0.91 Sphericity Assumed 0.018 1 0.018 0.677 0.416 Greenhouse Geisser 0.018 1 0.018 0.677 0.416 Huynh Feldt 0.018 1 0.018 0.677 0.416 Scale 4 Time Group Lower bound 0.018 1 0.018 0.677 0.416 Sphericity Assumed 0.01 1 0.01 0.456 0.503 Greenhouse Geisser 0.01 1 0.01 0.456 0.503 Huynh Feldt 0.01 1 0.01 0.456 0.503 time Lower bound 0.01 1 0.01 0.456 0.503 Sphericity Assumed 0.001 1 0.001 0.066 0.798 Greenhouse Geisser 0.001 1 0.001 0.066 0.798 Huynh Feldt 0.001 1 0.001 0.066 0.798 Scale 5 Time Group Lower bound 0.001 1 0.001 0.066 0.798 Sphericity Assumed 0.019 1 0.019 1.159 0.288 Greenh ouse Geisser 0.019 1 0.019 1.159 0.288 Huynh Feldt 0.019 1 0.019 1.159 0.288 time Lower bound 0.019 1 0.019 1.159 0.288 Sphericity Assumed 0.008 1 0.008 0.497 0.485 Greenhouse Geisser 0.008 1 0.008 0.497 0.485 Huynh Feldt 0.008 1 0.00 8 0.497 0.485 Scale 6 Time Group Lower bound 0.008 1 0.008 0.497 0.485

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About the Author Tamala Gulley received a Bachelors Degree in Nuclear Engineering Science from University of Florida in 1994 and a M. E in Civil Engineering from University of South Florida in 1996. Prior to and during the Ph.D. program, Mrs. Gully taught several math courses College Algebra, Trigonometry, Calculus, Engineering Statistics as an adjunct professor. She entered the Ph.D. program at the University of South Florida in Fall of 2000. While in the Ph.D. program at the University of South Florida, Mrs. Gulley acquired some life changing knowledge through courses taken within the Industrial Systems and Engineering Management Department. Mrs. Gulley believes that life is not abou t herself, but what she can give to others. She has been a mentor since 1999 and actively involved in the community since.