Umeå University Medical Dissertations, New Series, No 1637

Improving venous blood specimen collection practices Method development and evaluation of an

educational intervention program

Karin Bölenius

Department of Nursing

Department of Medical Biosciences, Clinical Chemistry

Umeå University 2014

Cover: Hans Karlsson

Cover photo, front page: Karin Bölenius

Cover photo, last page: Västerbotten county council

Key authors mail: karin.bolenius@umu.se

Responsible publisher under Swedish law: the Dean of the Medical Faculty

This work is protected by the Swedish Copyright Legislation (Act 1960:729).

ISBN: 978-91-7601-023-5

ISSN: 0346-6612

Electronic version avaliable at http://umu.diva-portal.org/

Printed by: Print & media, Umeå University, Umeå, Sweden, 2014

“You have no idea what you’re capable of until you try”

Unknown

Table of Contents

Abstract i Abbreviations iii Original Articles iv Svensk sammanfattning v Preface vii Introduction 1 Background 2

Theoretical framework 2 Patient safety and prevention of errors 4 Laboratory services and analysis 7 Preanalytical venous blood specimen collection procedures and error rates 10 Monitoring venous blood specimen collection practices 14

Rationale 16 Aims 17

Specific aims 17 Methods 18

Research context and population 18 Research design 18 The educational intervention program 19 Studies I and II 20 Study III 23 Study IV 25 Ethical consideration 26

Results 27 A validated venous blood sampling questionnaire 27 Adherence to venous blood specimen collection guidelines 27 Blood specimen quality 30 Experiences of venous blood specimen collection practices 31

Discussion 33 Opportunities for preventing venous blood specimen collection errors 33 Implications for the future 39

Methodological discussion 43 Strenghts 43 Limitations 44

Conclusions 46 Clinical implications 47 Acknowledgements 48 References 51 Appendix

i

Abstract

Background: About 60%–80% of decisions regarding diagnosis and

treatment are based on laboratory test results. Low adherence to venous

blood specimen collection (VBSC) guidelines may lead to erroneous or

delayed test results, causing patient harm and high healthcare costs.

Educational intervention programs (EIPs) to update, improve and sustain

VBSC practices are seldom evaluated. After testing a self-reported venous

blood sampling questionnaire, the overall aim of this thesis was to evaluate

the impact of a large-scale EIP on healthcare personnel’s VBSC practices.

Methods: The study settings were primary healthcare centres (PHCs) in

northern Sweden. Participants were VBSC personnel. Data consisted of a

VBSC questionnaire of self-reported practices, records of low-level

haemolysis index in serum samples (specimen quality indicator), and

interviews reflecting VBSC practices. First, experts on questionnaires and

VBSC were consulted, and test-retest statistics were used when testing the

VBSC questionnaire for validity and reliability. Thereafter, we evaluated the

impact of a short, large-scale EIP with a before-after approach comparing

self-reported VBSC questionnaire of two county councils. The personnel of

the county councils (n = 61 PHCs) were divided into an intervention group (n

= 84) and a corresponding control group (n = 79). In order to test changes in

blood specimen quality we monitored haemolysis in serum samples (2008, n

= 6652 samples and 2010, n = 6121 samples) from 11 PHCs. Finally, 30 VBSC

personnel from 10 PHCs reported their experiences. The interview questions

were open-ended with reflective elements and the interviews were analysed

by qualitative content analysis.

Results: The VBSC questionnaire was found to be valid and could be used

to identify risk of errors (near misses) and evaluate the impact of an EIP

emphasising VBSC guideline adherence. The intervention group

demonstrated several significant improvements in self-reported practices

after the EIP, such as information search, patient rest, test request

management, patient identification, release of venous stasis, and test tube

labelling. The control group showed no significant improvements. In total,

PHCs showed minor differences in blood specimen quality. Interviews

summarized VBSC personnel experiences in the overall theme: education

opened up opportunities for reflection about safety.

Conclusion: This thesis is, to our knowledge, the first to evaluate the

impacts of a large-scale EIP on VBSC practices. The VBSC questionnaire and

monitoring for low-level haemolysis reflected VBSC practices. The frequently

ii

occurring near-miss markers made it possible to compare and benchmark

VBSC practices down to the healthcare unit and hospital ward. The short,

general EIP opened up opportunities for reflection about safety and

improved VBSC practices in PHCs with larger deviations from guidelines.

EIPs that provide time for reflection and discussion could improve VBSC

further. Directed EIPs focused on specific VBSC flaws might be more

effective for some near misses in VBSC practices, while some near misses

must be changed at a different level in the system.

Clinical relevance: Our results indicate that monitoring and counteracting

the near misses in VBSC practices is a well-functioning preventive action. We

propose that the VBSC monitoring instruments (VBSC questionnaire &

haemolysis index) we used and the EIP strategy proposed should be tested in

additional countries with different healthcare settings. It is suggested that a

national program intended to identify near misses and prevent VBSC errors

be developed in the healthcare system. General e-learning programs may be

cheaper than, and as effective as, the EIP program and may be performed

everywhere and any time. Systematic planning, useful for reflection and with

focus on the specific elements in a skill, together with VBSC guidelines, could

probably increase improvements. Our studies have led to deeper and

extended knowledge of the impact of an EIP on VBSC practices. Our results

can be used when considering future VBSC practice interventions. Using a

model for practical skills in nursing to describe VBSC in a more holistic and

less technical way might highlight VBSC as a practical nursing skill.

Keywords: Education, Experiences, Guideline adherence, Haemolysis,

Intervention, Patient safety, Phlebotomy, Practical skills, Preanalytical

errors, Primary healthcare, Questionnaires, Reliability and validity, Venous

blood specimen collection

iii

Abbreviations

CG Control group

CI Confidence interval

EIP Educational intervention program

ES Effect size

Hb Haemoglobin

HI Haemolysis index

IG Intervention group

LID Laboratory identification

LVN Västernorrlands county council

Md Median

OR Odds ratio

PHC Primary healthcare centre VBS Venous blood sampling VBSC Venous blood specimen collection VBSQ Venous blood sampling questionnaire

VLL Västerbottens county council

iv

Original Articles

This thesis is based on four studies; they will be referred by their Roman

numerals in the text.

I. Bölenius K, Brulin C, Grankvist K, Lindkvist M & Söderberg J: A

content validated questionnaire for self-reported venous blood

sampling practices. BMC Research Notes 5:39 (2012).

II. Bölenius K, Lindkvist M, Brulin C, Grankvist K, Nilsson K & Söderberg

J. Impact of a large-scale educational intervention program on venous

blood specimen collection practices. BMC Health Services Research

13:463 (2013).

III. Bölenius K, Söderberg J, Hultdin, Lindkvist M, Brulin C & Grankvist K:

Minor improvement of venous blood specimen collection practices in

primary healthcare after a large-scale educational intervention. Clinical

Chemistry and Laboratory Medicine 51:303–10 (2013).

IV. Bölenius K, Brulin C & Graneheim U. Personnel’s experiences of

venous blood specimen collection practices after participating in an

educational intervention program. Submitted in March 2014.

Articles were reprinted with the permission of the publishers: BioMed

Central (Studies I & II) and De Gruyter (Study III).

v

Svensk sammanfattning

Bakgrund: Av kliniska beslut angående diagnostik och behandling baseras

60%–80% på laboratorieresultat. Därför är det helt nödvändigt att

laboratorieresultat är tillförlitliga. Låg följsamhet till provtagnings

anvisningar kan leda till felaktiga och fördröjda analysresultat, förorsaka

skada och lidande för patienter och utgöra en stor kostnad för hälso- och

sjukvården. Felaktiga provsvar beror till stor del på felaktig provtagning och

provhantering och går oftast att undvika. Interventioner som avser att

uppdatera och säkra korrekt venprovtagning kan leda till förbättringar men

genomförda interventioner har sällan utvärderats. Efter att en enkät för

självrapporterad venprovtagning testats för validitet och reliabilitet

genomfördes ett omfattande interventionsprogram som utvärderades med

hjälp av den testade enkäten och andra utvärderingsmått. Det övergripande

syftet var att utvärdera i vilken utsträckning interventionsprogrammet

påverkade provtagande personals praktiska utförande av venprovtagning.

Metoder: Studierna i denna avhandling omfattade provtagande personal

vid hälsocentraler i norra Sverige. För datainsamling användes en enkät som

mäter självrapporterad venprovtagning, förekomst av låggradig hemolys

(indikator på blodprovets kvalitet) och intervjuer. Initialt testades enkätens

förmåga att mäta vad som avsetts (validitet) och testades enkätens förmåga

att vid upprepade mätningar vara tillräckligt stabil (reliabilitet) för att

användas i interventionsstudier. Därefter utvärderades ett kort men

storskaligt interventionsprogram i preanalys inkluderande venprovtagning

med före och efter mätningar. Vi jämförde provtagande personal från två

landsting vid 61 hälsocentraler. Landstingens personal delades upp i en

interventionsgrupp (n=84) och en motsvarande kontrollgrupp (n = 79). För

att mäta kvaliteten av blodproverna extraherades uppgifter om hemolys i

serumprover (2008, n = 6652 blodprov) och (2010, n = 6121 blodprov) från

elva hälsocentraler i ett landsting. Slutligen, intervjuades 30 provtagande

personal från 10 hälsocentraler efter att de deltagit i

interventionsprogrammet. Intervjuerna var öppna och genererade korta

berättelser och analyserades med innehållsanalys.

Resultat: Venprovtagningsenkäten befanns vara valid och kan användas för

att utvärdera personalens följsamhet till provtagningsanvisningar i

venprovtagning och identifiera riskhändelser. Interventionsgruppen visade

flera signifikanta förbättringar i självrapporterat utförande av

venprovtagning såsom förbättrad informationssökning, vila inför

provtagning, remissförfarande, kontroll av patientidentitet, användning av

stas och etikettering av provrör. Kontrollgrupen visade inga signifikanta

vi

förbättringar. Blodprovskvaliteten visade små skillnader. Provtagande

personals erfarenheter från intervjuerna sammanfattades i ett övergripande

tema; utbildningsinsatsen öppnade upp möjligheter för reflektion om

säkerhet.

Slutsats: Avhandlingen är så vitt vi vet den första att utvärdera effekten av

ett storskaligt interventionsprogram med hjälp av självrapporterat utförande

av venprovtagning och blodprovers kvalitet (låggradig hemolys). Med dessa

metoder ökar andelen riskhändelser så att jämförelser kunde göras även på

enhetsnivå och avdelningsnivå. Utbildningsprogrammet öppnade upp för

reflektioner om säkerhet och förbättrade utförande av venprovtagning vid

enheter med större brister. Utbildningsprogram som öppnar upp för

reflektion och diskussion kan leda till ökad patientsäkerhet i hälso- och

sjukvården. Trots utfallet av resultaten, är riktade utbildningsinsatser för

sjukvårdsenheter som uppvisar specifika brister troligtvis mer effektiva än

breda utbildningsinsatser.

Klinisk betydelse: Interventionsprogram avseende preanalys och venös

provtagning förbättrade personalens praktiska utförande. Monitorering av

och åtgärder för att minska riskhändelser är väl fungerande preventiva

åtgärder. Instrumenten (självrapporterande enkät och hemolys) bör också

testas i andra kontexter inom hälso- och sjukvården. Ett externt nationellt

program för att identifiera och förebygga riskhändelser bör utvecklas i hälso-

och sjukvården. Interventioner i form av e-lärande kan då vara ett alternativ

som är billigt och effektivt. Dessutom kan systematisk planering och

genomförande med fokus på reflektion av specifika delar i en färdighet vara

effektivt för att uppnå förbättringar. Våra studier har bidragit till en djupare

och utökad kunskap om effekten av ett interventionsprogram på utförande

av venprovtagning. Resultaten kan användas vid framtida planering av

utbildningsinsatser. Modeller för praktiskt färdighetsutövande inom

omvårdnad kan beskriva venprovtagning ur ett helhetsperspektiv och

synliggöra venprovtagning som en viktig praktisk färdighet inom

omvårdnad.

vii

Preface

My entry into the doctoral studies was via the project on correct venous

blood specimen collection practice for increased patient safety. The project

identified low adherence to venous blood specimen collection practices in

2007. With the intention to improve VBSC practices, Västerbotten county

council developed and performed an educational intervention program in

2009, which will be briefly described later. The research team were

interested to know whether the intervention program had an impact on

VBSC practices. This is where I became involved in the project.

This thesis is based on interdisciplinary research between the Department of

Nursing and the Department of Medical Biosciences, Clinical Chemistry,

Umeå University.

viii

1

Introduction

Laboratory services influence clinical decision making (1, 2). Almost 60%–

80% of the most important decisions in diagnosis, administration, and

medication are based on laboratory test results (1, 3). Error rates in

laboratories range between 0.05% and 10% (4, 5). In Västerbotten county

council (VLL) around 6 million clinical chemistry analyses are performed

each year (6), and this means that 3000–600,000 of those may be

erroneous. Deficiencies in venous blood specimen collection (VBSC)

practices may lead to a repeated collection procedure, and delay in diagnosis

and treatment. Jeopardised test results also mean additional patient

suffering and high costs for the society as well as for the individual patient (7

–10). VBSC is strictly regulated by international (11, 12) or existing practice

guidelines and regulations (13, 14). VBSC personnel, unfortunately, largely

deviate from those guidelines (15–19) which increases the risk for an error to

occur. Errors in VBSC usually depend on human mistakes in relation to the

system (20–22), indicating that they could be prevented. To be able to

evaluate such prevention programs, it is necessary to use well-functioning

outcome measures tested for validity and reliability. Thus, to further

improve future intervention programs increased knowledge about VBSC

practices has to be gained.

2

Background

Initially, the background presents the theoretical framework, followed by a

literature review of international as well as national research. The theoretical

framework in this thesis is based on practical skill performance in nursing.

Theoretical framework

In nursing research there exists a lack of evidence-based knowledge focused

on hands-on performance in clinical settings. However, this focus is as

important as taking care of the mind and emotions (23). Attention should be

given to physical and practical aspects of how nurses develop and perform

practical skills (24). VBSC is a nursing skill that demands theoretical

knowledge as well as good practical skills (23, 25). A theorisation based on a

model of practical skill performance in nursing (26) might contribute to a

more holistic approach to VBSC.

Nursing practical skills

In the nursing literature different opinions about the focus in nursing have

been discussed during the last decades (27). De Tornyay argued that

practical skills are less important than communication, leadership, and

decision-making (28), while Quinn pointed out that practical skills are the

main purpose in nursing education (29). During Florence Nightingale’s era,

as well, good routines, accuracy, and caring were described as important in

practical skills, and practical skills were considered the foundation of

nursing (30). Nurses and technology are linked (24, 27). One hundred years

ago, fever persons were treated with a bath, whereas today a bath is a

complement to medical treatment. Following such changes, the impact of

technology has increased in the nurses’ role (27). Patients feel more safe and

comfortable if nurses work with safe techniques (31).

Nursing practical skills are historically understood as an art or as a

psychomotor skill. Nursing as an art was in focus during the first half of the

20th century and was described as the refinement of practical skills towards

the art of taking care of the patient. In 1950–1970, practical skills were

defined more narrowly with the term motor skill, but after 1970 replaced

with psychomotor skill (23). However, high-quality nursing performance

demands psychomotor skills and affective skills as well as nurses’ critical

creative and reflective thinking abilities (32, 33). Both ethical reasoning and

3

communication skill and theoretical knowledge are needed to know what to

do in different kinds of actions and situations (25, 33). In 1999 a broader

understanding of nursing practical skills was defined, constituting three

dimensions: performance, intention, and understanding of nursing

discipline (23). It is important to update and sustain knowledge about, for

example, guidelines in clinical practice to avoid having work become

obsolete, routine traditions (33, 34).

Bjørk and Kirkevold developed a model of practical skill performance in

nursing as a part of an observation study (26). Their analysis resulted in six

non-hierarchy categories: substance, sequences, accuracy, fluency,

interaction, and caring comportment (Figure 1). These categories together

are considered to reflect the good performance of a practical skill. The model

has been successfully used in nursing research, nursing education, and

nursing practices (35, 36). The focus in my thesis is to evaluate adherence to

guidelines and blood specimen quality, and to describe participants’

experiences of VBSC after participating in an EIP. In comparison with the

model, this thesis mainly focuses on substance, sequences, and accuracy

(Studies I, II, and III). Study IV also highlights the categories fluency,

integration and caring comportment.

Figure 1. The model of practical skill performance, © Ida Torunn Bjørk 1999.

4

Substance is described as including relevant content in skill performance,

instructions, and information. It means, for example, that nursing and

medical knowledge is needed and that guidelines should be followed when

performing a practical skill such as VBSC. Instruction and information

should be relevant to the skills in focus. Sequences involves performing the

components of a practical skill, and giving instruction and information in a

logical order following guidelines and local routines and in accordance with

the regulations. Accuracy refers to an exactness in each step during the

practice and correctness in instruction and information, for example, always

checking that the name on a referral is correct, that precise instruction is

given regarding preparation procedures, and that correct information is

given about, for example, pain relief. Fluency means performing a practical

skill without interruption and giving an impression of ease and smoothness.

Being well prepared, having all materials available, and working in a suitable

environment increases fluency. Integration means adapting the practical

skill to the patient and the situation by harmonising parallel aspects of the

skill, such as performance, physical support, and verbal interaction, that is,

being attentive to the total needs of the patient. Caring comportment means

creating an atmosphere that is respectful, accepting and encouraging. It also

includes personnel taking the patient’s feelings into account, as well as the

patient’s reaction to the instrumental steps of the practice (26, 36, 37).

Nurses perform and are responsible on a daily basis for practical skills and

their quality of healthcare (25, 31). Errors due to nurses lacking practical

skills may cause harm to patients (31, 38). Errors cannot be separated into

nursing or medical errors, because nurses work in an intermediary space

between general healthcare workers and the patient. In the healthcare

system, nurses are in a frontline position to recognise and prevent potential

errors (34, 38).

Patient safety and prevention of errors

Two international descriptions of patient safety are “the reduction of risk of

unnecessary harm associated with healthcare to an acceptable minimum”

(39) and “prevention of errors and adverse effects to patients associated with

health care” (40). A Swedish definition is “protection from healthcare related

injury” (41). Since the late 20th century, intensive efforts to identify avoidable

injuries in healthcare have been made both internationally and nationally (2,

19–21, 40, 42–46). Still, after all these efforts with the purpose to improve

healthcare, no major changes has been seen globally (20, 47–49). About

27%–70% of all medical injuries are preventable, as measured in different

healthcare settings (20, 21, 45). In Sweden, approximately 100,000 patients

5

suffer from avoidable injuries each year due to errors in the healthcare (42).

Similar figures have been shown in other countries (20, 21, 45).

In Sweden and internationally, similarly risks for errors have been reported

(42, 50–54). Errors that may lead to adverse events are most often caused by

human mistakes in relation to the system (2, 4, 42, 51–53, 55), and less often

by technical failures (52–54). Human mistakes may arise due to

forgetfulness, poor motivation, carelessness (50), stress, work environment

(55), incorrect knowledge or usage of guidelines (51), and lack of

attentiveness or inappropriate judgement (38). Human mistakes may be

active or latent. Active mistakes are unsafe acts attributable to and caused by

personnel in the frontline in direct connection with the patient. They are

often recognised at the moment they occur, while latent mistakes are

weaknesses within the system, often distant and unrecognised for a long

time (50). Mistakes can lead to a single adverse event or to minor but more

frequent events that may go undetected (45). However, to a large extent,

latent mistakes can be identified before an adverse event occur (50, 54).

Prevention of complications is an important goal of good nursing care (38,

56). A general way to eliminate errors has been to report adverse events and

thereafter try to learn from them (10, 34, 57, 58). Underreported adverse

events range between 50% and 96% annually (21, 58–61). Therefore,

assessment of near misses that can lead to adverse events and occur more

often than adverse events may add noticeably more value to healthcare

improvement than sole focus on adverse events (59, 62). Intervening

healthcare personnel acting as the last line of defence may be able to prevent

injuries (45, 63–65). Errors performed by frontline personnel could

eventually be avoided by improved knowledge and awareness of the risk of

error in a given situation (64). Who is responsible when an error occurs does

not matter for patients. What matters is whether the error is detected before

it causes any delay in diagnosis, or causes outright patient harm (66).

Designing for standardisation, understanding errors, and finding different

solutions of adaption to situations are vital considerations for improving

patient safety (9, 67–69).

Improving healthcare by use of guidelines

To reduce errors and thus increase patient safety, several methods have been

used (70, 71). One important method is to use clinical guidelines, which

reduce errors in healthcare if they are followed (72, 73). Guidelines are

described as syntheses of best available evidence that support decision-

making, standardise practices, and attempt to speed translation of evidence-

6

based practices (70, 74–77). There are concerns about guidelines and their

effectiveness (75, 77). Users of standards can apply the recommendations

unthinkingly and standards are not always adapted to clinical practice (77).

A review concluded that lack of agreement, limited familiarity, and lack of

awareness are main barriers to adoption of guidelines (74). However,

improved adherence to, and use of, guidelines has been shown (72, 73, 78–

80). For example, guidelines have reduced blood-stream infections and also

decreased costs for the healthcare system (72, 79). Compliance with

guidelines is strongly related to the way the guidelines are developed and

implemented (71, 75, 81). Short guidelines that are easy to understand have a

better chance of being followed than more complex ones (70, 71). Checklists

are also experienced as helpful when working in a constant hurry (56, 61,

72). However, local adjustments of international or national guidelines may

be necessary so that recommendations are suited to different contexts (75,

76).

There are few official international recommendations or guidelines on VBSC,

such as the H3-A6 VBSC guideline issued by the Clinical and Laboratory

Standards Institute (11) or the guidelines on drawing blood, published by the

World Health Organization (12). The existing guidelines are quite short with

point-by-point guidance. A study showed that strict compliance with a VBSC

guideline can improve quality of care (80). VBSC is performed in different

contexts and by different professionals and should be strictly performed

according to guidelines to ensure reliable test results (60, 76). As methods

for VBSC change over time, guidelines should be updated followed by

intervention programs (17).

Improving healthcare through interventions

To effectively optimise adherence to guidelines, intervention programs could

be used. “Interventions refer to treatments, therapies, procedures, or actions

implemented by health professionals to and with clients, in a particular

situation, to move the clients’ condition toward desired health outcomes that

are beneficial to the clients” (82). Several different interventions occur in

clinical practice and focus on individual professionals, patients, groups,

teams or specific aspects of the organisation of care. A review pointed out

that interventions with mostly effective outcomes are education with a

combination of strategies, such as interactive small group meetings and

reminders. However, in general, no approaches to transferring best available

evidence to practice have been appropriate for all changes in all situations

(71).

7

In this thesis we evaluate a large-scale educational intervention program

(EIP) initiated, developed, and performed by the VLL in 2009. Large-scale

programs may be planned actions, such as education performed by a

healthcare provider to prevent errors and thereby improve the quality in

healthcare. Programs often vary in conditions and start and finish at

different times (77, 83). Large-scale intervention programs are difficult to

standardise and need to be tailored to suit the target. A problem with large-

scale intervention programs is that there are many criteria for success of a

program, which should include short- as well as long-term follow-up

outcomes (83). Outcome, then, should be assessed from different

perspectives. A negative factor in large-scale intervention programs is that

each program and situation is unique, and generalisations are difficult to

make. However, the description of the program and the context allows others

to decide the relevance of the program for their own contexts. Little evidence

of the effectiveness of large-scale interventions has been presented (83), so

further research may identify factors needed for successful implementation

(84).

Quality assurance of laboratory services

In contrast to large-scale intervention programs that are difficult to

standardise (83), laboratory services have internal as well as external quality

control systems. An example of internal control is laboratories’ practice of

continuously calculating a median value for all patients’ sample analyses to

see if these values are stable over time. External quality control includes

specimen comparisons with other national laboratories, and also

comparisons between countries (85, 86), primarily to determine whether the

concentration of the measured analyte is correct. The Swedish organisation

EQUALIS is an example of such a national organisation aiming to ensure

analytical quality and thereby patient safety by providing external quality

control programs (87). Accredited laboratories show higher quality than

laboratories without accreditation programs (69).

Laboratory services and analysis

Laboratory services provide testing of patient samples, usually of blood but

also of other specimens such as tissues, urine, and faeces. A venous blood

test can, for example, identify release of plasma proteins troponin I & T

which are of diagnostic value for myocardial injury (85). A total of 6000

unacceptable blood samples per million were identified in an international

study including 10 nations, of which Sweden was one (88). A wide variety of

8

definitions and methods are used to identify laboratory errors (3, 4, 7).

Errors among laboratories are heterogeneous worldwide, while the

likelihood of detecting a laboratory error is small, and the real frequencies of

errors are not known. One example is incorrect ordering of analyses, where

probably only the care provider has a chance to detect the error (3, 7, 66).

Most errors occur because of lack of, or low, adherence to standardised

protocols (4, 53, 68, 89). Of laboratory errors, 25%–30%, have been

estimated to have some effect on patient care, while 6%–10% may translate

into adverse events (90). Presumably, identified errors are the tip of an

iceberg, and near misses (39) are of most importance to identify and reduce

(91) to ensure patient safety (41).

Venous blood specimen collection practices

This thesis focuses on VBSC and refers to venous blood samples drawn by

needle from peripheral veins (85, 92). VBSC is the most common way of

obtaining blood for laboratory testing (85, 92). Blood or serum tests assess

the concentration of several substances, such as plasma proteins and

electrolytes in the extracellular fluid. For example, potassium moves across

cell membranes and may shift, depending on health conditions. Increased or

decreased potassium levels may result in cardiac arrhythmias (85, 92).

VBSC can be viewed as a dependent practical skill, meaning that different

kinds of professionals perform and encompass the totality of VBSC practices

(82). Worldwide, different professionals perform VBSC, but venipuncture

should be performed by educated and competent personnel (14, 92) because

VBSC practices demand theoretical knowledge as well as good practical skills

(25, 26, 36, 92). In Finland, trained laboratory technicians collect most of

the blood samples in primary healthcare centres (PHCs) (93). Physicians,

registered nurses, enrolled nurses and biomedical technicians are often

mentioned as phlebotomists (18, 68, 93). In Swedish PHCs, VBSC is almost

always performed by trained enrolled nurses, registered nurses, or a few

biomedical technicians (18).

Patient’s perspectives of VBSC practices

Phobia about VBSC is common and estimated to occur in up to 3.5%–4% of

all collections (92). Phobia is anxiety caused by a previous bad experience in

a specific situation, often leading to avoidance behaviour (25). VBSC is

considered as something VBSC personnel just do, and patients are not

always asked for consent (94). Patient consent is essential for all healthcare

9

procedures, including VBSC. Asking for consent and giving information

about the procedure, or analysis should be done and can reduce patient

anxiety (25). Nurses should never underestimate the impact on the patient

undergoing VBSC. Correct VBSC practices reduce anxiety and pain for

patients undergoing VBSC and also lead to reliable test results (92).

The total testing process including VBSC

The total testing process starts with the ordering of a laboratory test and

ends with its interpretation. Thus, the total testing process consists of several

interrelated processes and each of them involve a serial of steps (Figure 2)

that all can result in errors (7, 95).

Figure 2. The total testing process, inspired by Lundberg (1981) and Plebani (2006).

The total testing process is usually divided into three phases; preanalytical,

analytical, and postanalytical (Figure 2) (2, 7, 89, 96), while some authors

have added also a pre-preanalytical phase and a post-postanalytical phase

(97, 98). The majority of published articles includes pre-pre in the

preanalytical phase and post-post in the postanalytical phase (7, 96). The

focus of this thesis is the preanalytical phase (excluding the pre-pre phase)

Patient

Preanalytical

Specimen ordering Preparation Identification Venipuncture Specimen handling Information

Analytical

Specimen analysis in laboratory

Postanalytical

Reporting Interpretation Delivery of test results

10

encompassing the VBSC steps before the blood specimen is analysed in a

laboratory (3, 5), which is the most error-prone phase (46%–77%) (5, 99,

100) in the total testing process. In Spain, 7.4% of the samples were found to

contain errors in the preanalytical phase (101). The analytical phase,

occurring in the controlled laboratory environment with more technical

equipment, is less error prone (10%–15%) (5, 8, 53, 100) and has contributed

to reducing the frequencies of errors in the analysis process because of

extensive efforts to improve safety over a long time (89). Also the

postanalytical phase, including delivery of test results and so on (Figure 2)

(3, 5, 7, 66), is less exposed to errors (8%–23%) (8, 53) compared to the

preanalytical phase. Common consequences of errors in the total testing

process are delay in care (24%), time or financial costs (22%), suffering or

harm (11%), and no consequences (26%) (91). In the total testing process,

73% of detected errors are classified as preventable (5).

Preanalytical venous blood specimen collection procedures and error rates

Preanalytical VBSC practices comprise several overlapping steps. Below,

each part will be described in a logical order.

Patient preparation procedures

Patients need to be correctly prepared before VBSC for certain requisitioned

analyses. For example fasting (11, 102) and patient rest (13, 102) are common

preparation procedures. Only 6% of VBSC personnel in PHCs reported that

they always allowed the patient to rest (17) at least 15 minutes in a sitting

position before VBSC, compared to 18% of hospital VBSC personnel (103).

That the patient should rest in a sitting position for 15 minutes prior to

sampling is recommended (13, 102), because changes of body position affect

the plasma volume. Changes in plasma volume might influence the test

results for some analyses, for example, albumin, aldosterone, LDL, and HDL

cholesterol, which increase by 5%–15% (102, 104). Test results are compared

with previous results or reference intervals. So, sampling following the same

procedures is important to ensure reliable and comparable test results (88,

104). Reliable test results lead to less repeated sampling and minimises

patient suffering.

11

Identification procedures

In this thesis, identification procedures include patient identification

procedures, labelling of test tubes, and test request management. During a 6-

month period, 352 samples per million were found to have identification

errors in an Italian hospital (68). They constituted approximately 27% of all

preanalytical errors and included failure to check the patient’s identity and

failure to include the patient’s name in the request. Similar figures are

reported in other studies (5, 7, 16). All identification errors have similar

consequences, as the errors may result in delayed or missed diagnosis, mix-

up of patients, wrong treatment, or even death (22, 43, 105–107). An adverse

event is estimated to occur in 1 of every 18 identification errors (108).

Identification procedures have been improved in recent years due to

computerised systems. Computer systems have reduced errors in name,

identification number, and care unit on the test request, but have not

eliminated the risk of mismatching patients during VBSC (5). An

international recommendation is to have two identifiers when collecting

blood samples for clinical testing (105).

Patient identification procedure. Söderberg pointed out that only 54% of

VBSC personnel from PHCs reported that they always asked patients to state

their name and identification number, and only 5% reported that they always

identified patients by photo ID (17). Patient misidentification constitutes

around 27% of all preanalytical errors (22). Patient identification should be

performed by healthcare personnel with competence in the procedure, and

identification should be made by means of an identification wristband or

identification paper. If this is not possible, VBSC personnel should ask

patients for their full names and identification numbers. In some cases

relatives can certify a patient’s identity (14). Appropriate patient

identification procedures are of outmost importance to optimise patient

safety which is a prioritised goal in nursing and health care (7, 47, 109, 110).

Labelling of test tubes. Mislabelling is common (111), and accounts for about

50%–65% of all identification problems (68, 108). One study estimated

mislabelling of test tubes at 1 error in every 165 specimens (88). In Sweden

in 2009, the National Board of Health and Welfare reported 40 adverse

events during blood transfusion; 20 of these adverse events were due to

incorrect labelling of test tubes (112). In PHCs, 86% of VBSC personnel

reported labelling the test tubes themselves, and only 12% of them reported

labelling the test tubes prior to sampling (18). In hospitals, 22% of VBSC

personnel reported labelling the test tube at a later occasion away from the

patient (16). Labelling errors may be latent, as there is no direct interaction

between the patient and the healthcare professionals who interpret and

12

report the test results (88, 105). In Sweden, test tubes should always be

labelled prior to blood collection (14, 113), but guidelines (11, 13) are

contradictory, and some recommend labelling in close proximity to the

patient. Other suggestions to decrease labelling errors are barcoded

wristbands and new handheld computer resources for both patient and

sample (114).

Test request management. Test request errors have been found in several

studies (16, 18, 65, 91), and are estimated to range between 4% and 8% of all

errors in the total testing process (91, 108). As many as 10%–25% of VBSC

personnel have reported not always signing the test request (16, 18, 106). As

well, paper-based test requests are an important source of errors in the

preanalytical phase. The information on test requests should be compared

and rechecked with the patient’s full name and identification number to

ensure patient safety (14, 99).

Venipuncture

Problems in the preanalytical phase are often associated with venipuncture

(phlebotomy), for example, empty filled tubes, wrong type of collection tube

(22, 99, 115), and incorrect use of venous stasis (116). Venous stasis is used to

make the veins more visible and easier to localise and puncture (11). Only

12% of VBSC personnel in PHCs removed stasis as soon as possible (17) in

line with recommendations (11, 13). Around 60% stated that they removed

stasis after collection (15). Research points out that prolonged stasis may

influence test results, by, for example, increasing the level of albumin and

potassium concentration (116–119). Recommendations are to release the

venous stasis as soon as possible when receiving blood or within a maximum

of one minute (11, 13). An incorrect applied tourniquet might become

uncomfortable and create pain for the patient (92) as well as causing harm as

a result of resampling (111).

Venous blood specimen handling

Multiple factors are associated with incorrect handling of blood specimens.

Collection tube centrifugation delays, missing tubes, clotting, incorrect

inversion, and incorrect storage of samples occur (111). In Italy, 871 clotted

samples were identified per million samples (68). In PHCs 71% stored test

tubes vertically after specimen collection (17), and in hospitals 90% stored

test tubes lying horizontally (15). Test tubes should stand up vertically

according to the guidelines (11, 13). In PHCs 66% of personnel stated they

13

always invert test tubes after sampling (17) compared to 62% in hospitals

(15). The recommendation is to invert test tubes 5–10 times (13) for mixing

the additives with the collected blood (11). Too many inversions will increase

haemolysis in samples and no inversion will increase the risk for clotting of

specimens, factors that may influence the test result or lead to repeated

sampling (120, 121). However, research and evidence is disputed in this area

(122, 123).

Haemolysis

Breakdown of red blood cells accompanied by release of haemoglobin and

other intracellular components into the surrounding plasma is called

haemolysis (124, 125). Haemolysis may occur in vivo or in vitro. In vivo

haemolysis (the premature destruction of red blood cells within the

circulation) may occur due to genetic, ethnic or diseases factors. It is rare

and constitutes up to 3.2% of all haemolysed samples (125–127). This thesis

will focus on in vitro haemolysis due to preanalytical handling of the venous

blood specimen (124, 127, 128).

In vitro haemolysis is the main cause of sample rejection by the clinical

chemistry laboratory. As many as 60%–65% of all rejected samples may be

due to haemolysis (65, 99, 126). In one study 13% of tests were rejected due

to high level of haemolysis (129). In VLL 0.8% of 8849 samples from PHCs

had a haemolysis index (HI) level ≥50 (0.5 g/L free haemoglobin (Hb)),

which is the rejection level for potassium and iron in serum samples (128). A

single haemolysed sample may cause the absence of 20 or more test results

(3).

Several factors that cause in vitro haemolysis have been reported to depend

on the way the blood specimen is drawn (124, 126, 128, 130–135), for

example, location of venipuncture (121, 124, 130–132), poor knowledge or

skill (124), prolonged tourniquet (124), large tubes (115), thin needles >22

gauge (124, 127), inappropriate mixing of tubes (121, 124, 126, 135),

unsuitable transport, and long delay before tube centrifugation (124, 135).

Blood samples from the emergency department are more often haemolysed

than samples from other units (128, 132–134, 136). One reason for this is a

large proportion of sampling from peripheral venous catheter in the

emergency department (121, 129, 131, 132, 136, 137). Haemolysed samples

may lead to delay of diagnosis and need of repeated sampling (128, 138). So,

nurses who works with a proper technique increases patient safety and

increase patients’ experience of safety which means that quality of VBSC

practices improve (31).

14

Information search procedures

Problems in the preanalytical phase may occur due to incorrect information

search procedures, since updated, correct information is crucial in order to

draw samples according to VBSC guidelines (9, 120). Online guidelines were

implemented in northern Sweden before 2007, but only 18%–60% of VBSC

personnel reported using them, and only 20%–45% pointed out that they

never asked a colleague about VBSC information (16, 18). Such behaviour

increases the risk for unreliable information. Online manuals can provide

correct, updated information that is available also for personnel out in the

field. Improved information search techniques might motivate VBSC

personnel to search updated guidelines on-line (139, 140).

Monitoring venous blood specimen collection practices

Generally, the aim of monitoring programs is to decrease the risk of adverse

events. To develop such programs, it is essential to identify potential risks

and methods aimed to identify risks. Monitoring programs should be tested

for validity and reliability in a representative population (3, 86). Few errors

during VBSC practices are actually reported (141). However, even a low

incidence of laboratory errors among billions of tests worldwide has an

impact on public health and patient safety, given the large number amount

of analyses performed (66). In addition, several steps are involved in the

testing procedure that could cause damage and suffering for the patient.

Thus, it is important to develop valid and reliable instruments aimed at

identifying VBSC risks. Below, methods such as a questionnaire, assessment

of sample quality, interviews, and observations suitable for monitoring VBSC

practices are described.

Questionnaires. Generally, questionnaire surveys are cost effective and easy

to coordinate, and not very time consuming. A large geographical area can be

covered and questionnaires offer a great possibility to ensure confidentiality

(142–144). Self-reported questionnaires could be valuable in order to

identify near misses (15). However, postal distributing of questionnaires

increase the risk of drop outs and repeated reminders are often necessary to

get an acceptable response rate (142). Self-reported answers may also

produce overestimating or underestimating in the source of data. In

addition, invalid questionnaires might also lead to unreliable results (145),

why it is nessasary to test questionnaries in respect to validity and relability.

Blood sample quality. The determination of HI in automated analysers is an

efficient method for detecting haemolysis. Assessment of frequent occurring

15

mildly haemolysed specimens has been suggested as a suitable marker for

pre-analytical blood sample quality (128) instead of assessment of the

relatively infrequent number of analytically rejected samples. Thus, it is

possible to evaluate interventions intending to improve VBSC practices at

ward/PHC level.

Observations. Observations can be successfully used to collect information

on people’s behaviour, nonverbal communication, activities and

environmental conditions (144). Direct observation of the underlying

mechanisms and causes of VBSC errors in the preanalytical phase can yield

information on what to improve in clinical practices (5, 68, 146). Carraro and

co-authors observed VBSC performance in direct action for one week at

three wards in an Italian hospital. In addition, they identified all

noncompliance events in VBSC procedures during a 6-month study period.

Interviews. Personal interviews are useful to describe structure and practice

in healthcare (147, 148). Interviews may provide a deeper understanding of

the preanalytical phase (149) and provide additional information in relation

to other quantitative data in order to understand phenomena and situations

(142, 144, 150, 151). Lundberg performed semistructured interviews to reveal

constraints affecting accident investigation practices that lead the

investigation forward (150). Unlike a questionnaire, an interview allows

rephrasing of questions and explanations. Open-ended questions in an

interview allow for longer answers compared to closed questions in a

questionnaire (142). However, both interviews and observations are costly in

both time and money (144).

16

Rationale

Patient safety is considered a priority in modern healthcare and is essential

in nursing. Avoiding patient injury and providing the best possible care is a

continuous struggle. Laboratory results following VBSC constitute a major

cornerstone in the diagnosis and treatment of patients. VBSC errors may

cause delay in diagnosis, repeated sampling, and erroneous treatment. These

errors jeopardise patients’ health and safety.

The general practice of VBSC is described in local and national guidelines

that should be followed by healthcare personnel. The literature review and

our earlier studies show that low adherence to VBSC guideline practices is

common and can cause serious errors such as incorrect identification

procedures, incorrect specimen collection practices, and incorrect handling

of specimens. In addition, there is a lack of implementation advice in VBSC

guidelines, as well as a lack of continuous personnel education aiming to

update and sustain proper VBSC practices. In general, large-scale EIPs are

common, but their effectiveness has been explored in a rudimentary way at

best. It is therefore important to evaluate the impact of large-scale EIPs on

VBSC practices. To achieve trustworthiness in results, it is important to test

outcomes in respect to validity as well as reliability such as stability.

No study, has, as far as I know, investigated the implementation of an EIP

for VBSC practices by monitoring specimen haemolysis or by using a

validated venous blood sampling questionnaire (VBSQ). The instruments

(sample haemolysis and a self-reported questionnaire) have hitherto not

been used in an evaluation process. Research focusing on the personnel’s

own experiences of VBSC is also lacking. VBSC personnel’s experiences of

VBSC are crucial when developing VBSC education programs. In the future,

such knowledge will be of outmost importance in optimising EIPs aimed at

reducing errors in VBSC.

17

Aims

After testing a self-reported venous blood sampling questionnaire, the overall aim of this thesis was to evaluate the impact of a large-scale educational intervention program on healthcare personnel’s VBSC practices.

Specific aims

Study I: To test a recently developed questionnaire on self-reported venous blood sampling practices for validity and reliability.

Study II: To evaluate the impact of a large-scale educational intervention program on primary healthcare phlebotomists’ adherence to venous blood specimen collection guidelines.

Study III: To monitor the percentage of haemolysed venous blood specimens of eleven PHCs before and after a large-scale intervention to assess possible improvements of venous blood specimen collection practices.

Study IV: To describe primary healthcare personnel’s experiences of venous blood specimen collection practices after participating in an educational intervention program.

18

Methods

Research context and population

There are approximately 1100 PHCs in Sweden and about one third of them

are privately owned. In 2009, there were about 40 million visits to PHCs and

those visits accounted for about 17% (€3.7 billion) of the total healthcare

costs. In northern Sweden, PHCs are mainly publicly owned, with several

professional employees who have responsibility for population health within

a geographical area (152). Swedish PHCs have similar organisations,

personnel set-up, personnel education, and organisation of healthcare (153).

This thesis includes VBSC personnel working in PHCs, except Study I which

also includes a few participants from the university hospital. The PHCs are

located in rural as well as urban areas in three counties, VLL, Västernorrland

(LVN), and Jämtland, all in northern Sweden. The counties have about

614,000 inhabitants. In this thesis, PHCs (Study III) were divided according

to distance to the laboratory in the same manner as in Söderberg et al.’s

study (128). The urban area refers to PHCs within 1–17 km from a laboratory

and rural PHCs refers to PHCs more than 17 km from the nearest laboratory.

The distribution of VBSC personnel in PHCs is typical of Sweden. The term

VBSC personnel will be used henceforth and includes biomedical

technicians, enrolled nurses and registered nurses.

Research design

This thesis has its base in Wallin’s and Söderberg’s theses (154, 155). Their

results showed low adherence to VBSC guidelines, which motivated VLL to

develop and implement a mandatory large-scale EIP focused on improving

adherence to VBSC guidelines. The four studies included in my thesis reflect

interconnected quantitative and qualitative components. Therefore, we used

both quantitative and qualitative methods. In 2010, the validity process was

described and a test-retest was added (Study I) to examine whether the

VBSQ used was stable enough to use for evaluations. It is essential to use a

comparative before-after design to produce strong evidence when evaluating

educational programs. This approach increases trustworthiness, and changes

can be explained by the program itself (83). Thus, using a follow-up design,

we systematically evaluated the EIP’s impact on VBSC practices (Studies II

and III). In study II, we compared self-reported questionnaire answers

within an intervention group (IG) and within a control group (CG);

comparisons between the two groups were also carried out. In Study III, a

follow-up study comparing blood specimen quality before and after the EIP

19

within a single group of PHCs was used. We also performed face-to-face

interviews to describe VBSC personnel’s experiences of VBSC after

participating in the EIP (Study IV). Figure 3 presents an overview of the

research plan and study design.

Figure 3. An overview of the research plan and the data collected and analysed in this thesis. The black dots represent the studies in my dissertation; the grey dot shows the EIP, and the light grey dots show the basic data collected by Johan Söderberg and Olof Wallin.

The educational intervention program

The VLL executive board gave permission for a large-scale EIP (Figure 3),

provided it would be cheap and cause minimal interference with daily

healthcare work. Following these restricted premises, laboratory instructors

with experience of teaching developed and performed a 2-hour EIP

regarding pre-analytical practices, including a specific lecture on VBSC

guideline practices. Almost all hospital, laboratory, and PHC VBSC

personnel (n = 2171) in VLL, northern of Sweden, participated in the

education (in this thesis only PHCs are included). Participation ranged from

8 to 89 VBSC personnel in each lecture session. One third of the IG (n = 27)

in Study II participated through live Internet link. Educational substance

2007

Baseline

VBSQ survey

Results showed low adherence to VBSC guidelines, VLL & LVN

2008

Baseline

Monitoring of HI

Results showed varied blood samples quality, VLL

2009-2010

EIP in VLL

1. Participants' reading of national guideline

2. Listening to an oral presentation on local shortages and review of guidelines

3. Knowledge test

4. Competence certificate

2010

Studies I & III

1. Continued development and testing of the VBSQ, VLL

3. Follow-up on blood samples quality, VLL

2010-2011

Studies II & IV

2. VBSQ follow-up on VBSC guideline adherence, VLL & LVN

4. Face-to-face interviews, VLL

20

(Table 1) was based on the guideline the National Handbook for Healthcare

(13) and local directives (113), both almost identical to the CLSI H3-A6

guideline (11). The EIP was mandatory and included three parts: 1)

Participating VBSC personnel had to read the national VBSC guideline (13)

as a part of the EIP and signify that they had read the guidelines before the

education. 2) Attendance at two oral lectures as compulsory. The first

included VBSC practices concerning information regarding local non-

adherence to preanalytical practices (154, 155), and emphasis was also put on

how to avoid haemolysis (121, 128, 134–136) and the importance of several

preanalytical practices (Table 1). The second lecture focused on collection of

microbiological specimens. 3) Participants who responded adequately to six

written examination questions regarding VBSC received a competency

certificate valid for four years. An example of a question was: “When should

the stasis be released?” More examples are described in Study II.

Table 1. Overview of VBSC procedures that were in focus during the EIPs as well as the studies reporting the results at follow-up

Preanalytical VBSC procedures

Educational content Study

Preparation procedures

Fasting status II, IV Need of rest prior to sampling II, III, IV Need of relaxation of muscles and body III, IV Recommended needle size III

Identification procedures

Correct patient identification procedure II, IV Labelling procedures II, IV Checking of data against referral and labels II, IV

Venipuncture

Recommended order of test tubes IV Correct use of stasis II, III, IV Syringe use III, IV

Handling of specimens

Inversion of test tubes 5–10 times II, III, IV Use of automatic test tube inversion II, III, IV Storing of test tubes II, IV

Information search

Information search via internal network II, IV

Other factors taught but not evaluated

Filling of the tube, intravenous cannula, clotting of samples, influence of medication, hygiene routines, date & time, diurnal variation

Studies I and II

Participants

To achieve face validity (Study I), a focus group consisting of seven enrolled

nurses with experience of practical VBSC was consulted. For content validity,

nurses and senior researchers from the Department of Nursing as well as

21

physicians and senior researchers from the Department of Medical

Biosciences, were consulted as well as laboratory instructors. In our test-

retest (Study I), a total of 28 VBSC personnel participated. In Study II, a

total of 213 VBSC personnel were invited and 163 (77%) from 61 PHCs

participated (Study II, Figure 1). Those from VLL constituted the IG and

those from LVN the CG. Background characteristics of the participants are

shown in Table 2. Comparing the background characteristics, we found that

enrolled nurses were over represented in the IG (Table 2).

Table 2. Background characteristics of the participants

Background data IG (n=84) CG (n=79) p-value

Sex

Female n 79 79 0.059

Male n 5 0

VBSC personnel’s professional status

Registered nurses n 26 50 <0.001

Enrolled nurses n 56 28

Biomedical technicians n 2 1

Age (Years)

Age Md (Q1; Q3) 55 (49; 60) 56 (49; 62) 0.604

Range 28–65 38–70

Numbers of years employed at the job site

Md (Q1; Q3) 11 (7; 27) 11 (5; 20) 0.045

Range 0–37 0–38

How often personnel performed VBSC

Every day n 61 44 0.028

Every week n 19 33

Every month or less n 4 2

IG = Intervention group, CG = Control group, p = significant test to detect differences at baseline between groups

The venous blood sampling questionnaire

The VBSQ (Supplement 1) was initially developed to assess self-reported

VBSC performance (15) in accordance with the national guideline (13). An

instruction containing information on how to complete the questionnaire

was located on the first page. It was pointed out that the respondents should

state how they usually performed VBSC practices and not how they knew it

should be performed. The VBSQ included questions on background

characteristics (6 questions), patient identification and collection of

specimens (4 questions, 10 items), sample storage and information seeking

(2 questions, 7 items), test request management and test-tube labelling (4

questions, 12 items), and frequency of error reporting and suggestions (3

22

questions, 8 items). The majority of questions were answered using a four-

point ordinal scale; Never, Seldom, Often, and Always, and one question was

answered yes/no. Four “by other means” items are retained in the VBSQ, but

were excluded from Study I because of a high rate of missing internal data.

Data collection

All VBSQs were given a code to enable sending of new questionnaires to non-

responders. The questionnaires were delivered by postal mail to the PHCs,

and a person at each PHC assisted in the distribution and collection of the

VBSQs. An information letter was distributed together with the

questionnaire, describing the purpose of the survey and explaining that

participation was voluntary. Participants were asked to put the completed

VBSQ in an anonymous reply envelope, seal the envelope, and send it back to

the investigators. In Study II, a reminder questionnaire was sent to the non-

responders after two weeks and after four weeks. In Study I, we collected

data at two occasions from focus group members. The focus group members

provided comments on the VBSQ’s substance, length, and clarity. From the

dialogues with professionals, data on the questionnaires and different

aspects of VBSC were obtained. For stability, a test-retest was performed

with 3–4 weeks between the test and retest. In Study II, the IG VBSQs from

2007 were paired with completed questionnaires from 2010–2011, 6 months

after the EIP. The CG completed the follow-up questionnaire in April 2010,

and data were investigated undergoing the same procedure, except for the

EIP.

Analysis

In Study I, face validity was achieved through focus group meetings with

discussions. During the development process, extensive efforts were made to

ensure that each item was easy to understand, was clearly outlined, and

could not be misinterpreted. Discussions within the focus group were

followed and transcribed by members of the research group. To achieve

content validity, dialogues with professionals, including senior researchers

(with experience of questionnaire design), nurses, and physicians were

performed. Laboratory instructors from the local laboratory and the experts

rewrote the content in some questions and ensured that the questions were

reasonable and in accordance with the guidelines. To examine the stability,

Spearman’s rank correlation was used to measure the association; Kappa

coefficient (K) and percentage agreement (%A) were used to measure the

agreement for questions and items in the test-retest. VBSQ items were

23

accepted as stable if answers passed at least one of two set criteria. Criterion

two complemented criterion one. In those cases, combinations of the

measures used were judged to be acceptable.

Criterion one: K ≥ 0.61 = good or rs ≥ 0.7 or %A ≥ 90%.

Criterion two: K ≥ 0.51 = moderate and rs ≥ 0.6 or K ≥ 0.51 = moderate

and %A ≥ 80%.

In Study II, the paired VBSQs were compared within groups by Wilcoxon

signed rank test for continuous data and by McNemar test for dichotomised

data. VBSQs between the IG and CG were analysed by Mann-Whitney U-test

for continuous data and Chi-square for independence for dichotomised data.

Questions and items with missing answers were excluded from the study. In

Studies I and II, SPSS® version 18, (IBM, New York, USA), was used for all

statistical analyses, except for non-symmetrical K values, (Study I), and

effect size (ES) values, (Study II), which were manually calculated by the

author. ES is a way to quantify the size of the differences between two groups

(156). The statistical significance level was defined as p < 0.01, Study II.

Study III

Subjects

Serum blood samples were monitored for HI in the IG, before (year 2008, n

= 6652) and after (year 2010, n = 6121) the EIP. In 2008, we collected

samples from both rural (n = 2039) and urban (n = 4613) PHCs. In 2010 the

numbers of samples were 1902 for rural and 4219 for urban PHCs.

Information about age and sex of the patients (Study III, Table 3) was

available from the laboratory information system.

Haemolysis

It has been suggested that monitoring the HI from blood specimens provides

a suitable marker for preanalytical quality (91, 128). The samples

investigated were intended for routine clinical chemistry analyses on Vitros

5,1 automated analysers (Ortho-Clinical Diagnostics, Inc., Rochester, NY,

USA). Blood specimens were considered haemolysed at an HI ≥15,

corresponding to ≥150 mg/L free Hb, which was the detection limit for the

Vitros 5,1. The analysers automatically determine the HI in all blood

samples. HI determination for the Vitros 5,1 was authenticated by serial

dilution of a purified haemolysate into two serum specimens with a low

24

degree of haemolysis. The amount of free Hb in these specimens was

measured using a spectrophotometric assay (157). The HI and the amount of

free Hb had a linear relationship (R2 = 0.9865) (158), and 1000 mg/L of free

Hb corresponded to an HI of 99. Data from the laboratory information

system were merged by using the corresponding laboratory identification

(LID) number for each analysis. Specimens with duplicate LID numbers

(specimens where more than one analysis was requested) were excluded.

Cases with missing HI values due to machine error, and a few cases with

invalid sex and age data, were also excluded.

Data collection

The HI in blood samples from eleven PHCs was investigated during a 3-

month period before and after the EIP. VBSC personnel collected blood

using needles, and not intravenous catheters, with recommended gauge

between 19 and 23 gauge (20) in plastic 3.5 mL evacuated serum separator

test tubes with an inert polymer gel barrier and a clot activator (cat. no

367957, Becton Dickinson, Franklin Lakes, NJ, USA). After allowing for

clotting 30 min, the specimens were centrifuged locally or in the laboratory

for nearby PHCs. Test tubes were transported in cooled insulated boxes

(512°C), twice a day from the urban, and once a day from the rural PHCs.

The total file information contained the name of the ordering PHC, specimen

HI, and age and sex of the patients.

Analysis

In Study III, the data were analysed using Chi-square for independence and

Mann-Whitney U-tests, where appropriate. The PHCs were divided

according to distance to the laboratory; the urban group included six PHCs

and the rural group included five PHCs. We used multiple logistic regression

analysis mainly to explore the association between haemolysis (HI ≥ 15) and

year (before/after intervention), with consideration for sex, age, and PHC.

Odds ratios (OR), confidence intervals, and p-values (p) are reported. The

statistical significance level was defined as p < 0.01.

25

Study IV

Participants

VBSC personnel (n = 35) who had completed a VBSQ in 2007, completed the

EIP in 2009–2010, and answered the same questionnaire between

September 2010 and June 2011 were asked to participate. A total of 30 VBSC

personnel from 10 PHCs accepted participation. Of those, three were men.

Participants worked at PHCs in urban or rural areas and varied in respect to

age, working years, and profession. VBSC personnel consisted of enrolled

nurses (n = 18), registered nurses (n = 11) and a biomedical technician (n =

1). The median age was 57 years (range 32–65) and median length of time

working in PHCs was 20 years (range 1–37).

Interviews

VBSC personnel were informed about the study by a postal letter, and

thereafter asked for participation by follow-up phone call. Face-to-face

interviews were performed by the first author (KB) at the participant’s work

place during working hours. All interviews were conducted using open-

ended questions with reflective elements and were informal in nature. The

interview guide addressed experiences of VBSC after participating in an EIP.

The first question was, “Could you please tell me about your experiences of

VBSC after participating in the VBSC EIP?” The answers were followed by

questions such as “Tell me more about it” and “Please could you give me an

example of that?” Each interview lasted 17–44 min (Md = 22 min). The

interviews were tape-recorded and transcribed verbatim.

Analysis

In Study IV, we analysed the text using qualitative content analysis (159)

with an inductive approach (160). The interviews were read through to gain a

sense of the content. Thus, text that did not respond to the aim was

excluded, such as descriptions on capillary or bacterial specimens. We

analysed manifest as well as latent content. The text was divided into

meaning units and thereafter condensed and marked with codes. The codes

were compared for similarities and differences and sorted into eight

categories. The categories were abstracted and three subthemes were

formulated. Finally, a consensus was reached and a theme was formulated

after several discussions with co-authors. In addition, relevant quotations

along with our findings are presented.

26

Ethical consideration

The research plan, including Studies I and II (Dnr 06-104M) and Studies III

and IV (Dnr 2010-355-32M additions to Dnr 06-104M) were approved by

the Regional Ethical Review Board in Umeå. The EIP was mandatory, and

the heads of the PHCs gave final permission to participate in the EIP. In

Studies I, II and IV the participants were assured of confidentiality in the

information letter and also informed that they could withdraw from the

survey or stop the interview at any time without declaring any reason.

Participants gave their informed consent to participate and were also

informed that data would only be presented at group level. In Study IV

participants also received verbal information on the study and were able to

choose the time and place of the interview. The participants were informed

that all information would be handled confidentially; for example, the

questionnaires and transcript interviews were decoded and kept confidential

in a locked space. Only the researcher had access to the codes and the

corresponding names. The possible risks of the project were seen as low.

Risks such as transferring feelings and shame were considered to be

outweighed by the benefits of improved VBSC practices.

27

Results

The presentation of results is based on the main findings of each study.

A validated venous blood sampling questionnaire

In Study I, we tested a recently developed questionnaire on self-reported VBSC practices for validity and reliability.

The VBSQ (Appendix 1) was found to have acceptable validity and reliability.

It included 19 questions of which 9 had in total 34 underlying items (Study 1,

Table 1). The VBSQ was found to have face and content validity. The test-

retest analysis demonstrated that all questions and items had acceptable

stability; a total of 82% fulfilled the reliability acceptance criteria. Criterion

one was fulfilled by 71% and criterion two by 68% of all questions and items.

Items 7c, 8b, 8c, 10a, 16a, 18e, and 18f did not fulfil the acceptance criteria

(Study 1, Table 1). Items 7c, 18e, and 18f were removed from the

questionnaire, while items 8b, 8c, 10a, and 16a were not stable, but were

retained because the items were interrelated with other underlying items.

The process of establishing validity resulted in modifications. Answer

alternatives were reduced from five to four (the alternative “sometimes” was

removed), and some questions were modified to suit the PHC’s setting.

Focus group meetings resulted in further modification of some questions and

also the removal of a question about order of test tube collection and

centrifugation. Questions and items were considered clearly outlined and

easy to understand. It was judged that the number of questions included

could be completed in a reasonable amount of time. Thereafter, the VBSQ

was judged by experts in VBSC and questionnaire design to have acceptable

content validity, and face validity was established by the focus group with

vast experience.

Adherence to venous blood specimen collection guidelines

In Study II, we evaluated the impact of a large-scale EIP on primary

healthcare personnel’s adherence to VBSC guidelines.

When evaluating the EIP, we found that self-reported adherence to

guidelines had significantly improved in several items (10 out of 32) in the

IG (Study II, Table 3 and 4), while the CG showed no significant

28

improvements at all. In order to get another understanding of the results we

present percentage of self-reported VBSQ responses (Table 3).

Table 3. Percentage of self-reported VBSC practices in the IG and CG

Questions IG (n = 75 – 83) CG (n = 71 – 79) 2007

(%) 2010– 2011 (%)

2007 (%)

2010–2011 (%)

7d Always/often identify by checking photo-ID

5 23 35 44

8c Never release stasis when specimen collection is finished

41 59 42 38

9 Always allow the patient to rest >15 minutes prior to VBSC

21 37 30 23

11a Never use the old paper-based laboratory manual

41 70 71 65

11b Always/often use updated online laboratory manual

77 95 100 96

11d Never/seldom ask a colleague for VBSC information

35 54 60 63

11f Never/seldom phone the laboratory for VBSC information

78 92 89 90

15f Always check that the test request and test tube (barcode) number match

54 70 82 84

16b Always/often label the test tube prior to sampling

31 53 7 16

19a Reported to have enough knowledge for daily work with VBSC

49 76 44 54

Information search and preparation procedures. IG participants reported

more often searching for information using the Internet and internal

networks. They more seldom used printed papers, and seldom asked

colleagues for information (ES = 0.23–0.33, p < 0.001–0.003), (Study II,

Table 3). Participants also reported that they more often allowed the patients

to rest for the recommended time before venipuncture (ES = 0.27,

p = 0.004), (Study II, Table 4). All improvements in the text above regarding

information search procedures were significantly different from those of the

CG.

Identification procedures. After the EIP, IG participants stated that they

more often checked that the test request and test tube identification number

matched (ES = 0.23, p = 0.003), and more often labelled test tubes at the

patient’s side before specimen collection (ES = 0.49, p = <0.001), (Study II,

Table 3) in accordance with guidelines. They also significantly improved

control of patient’s photo identification (ES = 0.34, p = <0.001), (Study II,

Table 3). All findings above regarding identification procedures were

significantly improved for the IG, but no differences were found in the

between-group comparisons with the CG.

29

Venipuncture. The IG participants reported shorter venous stasis time (ES =

0.22, p = 0.006) after the EIP compared to before the EIP (Study II, Table

3).

Venous blood specimen handling. No changes were noted for test tube

inversion or test tube storage within or between the groups.

Table 4. Percentage of self-reported VBSC practices in the IG and CG

Questions IG (n = 74–82) CG (n= 70–79) 2007

(%) 2010–2011 (%)

2007 (%)

2010–2011 (%)

7a Always/often ask for name and identification number

89 93 94 96

7b Never identify by previous knowledge of the patient

44 50 39 42

8a Always/often release stasis before first sample is drawn

52 56 49 52

8b Always/often release stasis during sampling 66 60 74 55 8d Never/seldom keep stasis as long as necessary

41 56 40 39

10a Always invert the test tube immediately 55 79 53 81 10b Always/often use automated reverser 78 78 72 77 12a Never store test tubes lying on work-bench 67 72 76 91 12b Never store test tubes in the pocket 100 96 99 100 12c Always store test tubes in a test tube stand 84 81 86 90 13 Never let someone else mark the sampling time

74 80 67 73

14 Insert sampling time 0-30 minutes after sampling

45 51 51 62

15a Always compare identification number with test request

75 80 81 90

15c Always sign the test request 92 86 90 99 15d Always check the information on the test request, if somebody else has completed it

72 83 81 87

15e Always adjust sampling time, if the marked time differ with more than 30 minutes from the actual sampling time

49 60 55 58

16a Always/often label test tubes before approaching the patient

5 9 3 0

16c Always/often label test tubes after VBSC 75 67 97 92 16d Never label test tubes at a later occasion 87 94 96 90 16e Never let somebody else label the test tube in advance

84 89 96 92

16f Never let somebody else label the test tube after VBSC

95 88 90 90

19b Proper collection and handling is considered a priority at my PHC

48 60 58 54

30

Blood specimen quality

In Study III, we monitored the percentage of haemolysed venous blood

specimens from 11 PHCs before and after a large-scale intervention (the

EIP), to assess possible improvements of VBSC practices.

The total percentage of specimens with HI ≥ 15 during July to September

2010 was 11.8% compared to 10.5% in 2008 (p = 0.022), showing a

degradation of blood specimen quality. Rural PHCs had a higher percentage

of haemolysed specimens before the intervention and higher reduction of

haemolysis in the univariate analyses (Table 5); therefore, it was essential to

compare rural with urban PHCs. Divided into groups, rural PHCs (Nos 4, 5,

9–11) demonstrated a significant (p < 0.001) reduction in haemolysis

(OR = 0.74, CI = 0.651–0.851) after intervention, whereas the urban PHCs

demonstrated a significant (p < 0.001) increase (OR = 1.45, CI = 1.912–

1.765) in haemolysis (Study III, Table 3). Of the urban PHCs, Nos 6 and 7

had a significantly higher percentage of haemolysed specimens in 2010

compared with 2008, whereas the others were unaffected.

Table 5. Percentage of haemolysed specimens (HI ≥ 15, free Hb ≥ approx. 150 mg/L) and HI 95th percentile in 11 PHCs before (July–September 2008) and after (July–September 2010) the EIP PHCs 2008

n1 HI ≥ 15 (%)

HI 95th

PHCs 2010

n1 HI ≥ 15 (%)

HI 95th

P

PHCs all 6652 10.5 19 PHCs all

6121 11.8 22 0.022

Rural 2039 15.8 23 Rural 1902 12.8 22 0.007** Urban

4613

8.2

18

Urban

4219

11.4

22

<0.001*

1 472 6.4 16 1 559 5.9 16 0.864 2 713 7.2 16 2 628 8.3 19 0.502 3 1223 7.6 17 3 989 9.7 21 0.063 4 477 9.0 18 4 396 9.6 19 0.834 5 307 17.6 24 5 363 12.0 22 0.059 6 609 7.9 18 6 606 16.5 27 <0.001* 7 1138 8.3 18 7 1089 13.3 23 <0.001* 8 458 13.7 24 8 348 16.1 24 0.409 9 362 13.8 21 9 364 12.1 21 0.561 10 649 14.9 21 10 541 10.9 21 0.049 11 244 32.0 34 11 238 24.4 31 0.080 Rural = PHCs 4, 5, 9–11: Urban = PHCs 1–3, 6–8 n1 = number of specimens, P = chi square for independence *significantly increased percentage of haemolysed specimens, **significantly decreased percentage of haemolysed specimens

31

Experiences of venous blood specimen collection practices

In Study IV, the aim was to describe primary healthcare VBSC personnel’s

experiences of VBSC practices after participating in the EIP.

In the participants; experience, the education opened up opportunities for

reflections on safety. They became aware of risks, achieved improvements in

clinical practice and felt strengthened in working as usual. Reflections on

safety revealed during the analysis could be identified in almost all

subthemes and in relation to the EIP. Table 6 presents an overview of

categories, subthemes and theme.

Table 6. Overview of categories, subthemes, and theme revealed during the

analysis

Categories Subthemes Theme Identification procedure Environmental disturbances Lack of knowledge Transfer of information

Becoming aware of risks

Education opens up opportunities for reflection on safety

Standardised ways of working Accuracy in clinical practice

Achieving improvements in clinical practice

Doing as usual in a correct way Doing as usual in an incorrect way

Feeling strengthened in working as usual

Becoming aware of risks

The participants experienced having become aware of risks. Participants

related that low accuracy and communication problems could be risky when

performing identification procedures. Participants reflected on

environmental disturbances and pointed those out as a risk for VBSC errors.

They described the physical environment as varying from arranged to

completely unfamiliar places. They also reported that they sometimes

worked in a stressful and noisy atmosphere and also worked according to a

deficient work plan that they not always could affect by themselves. The

participants reflected on lack of knowledge among VBSC personnel. Not

knowing the content in the VBSC guidelines was experienced as risky. Before

the EIP several of the participants did not know how to label test tubes and

to perform VBSC with the correct sequence and the correct order of tubes.

After education, the participants increased their understanding of several

VBSC practices. Transfer of information was described as a risk for

misunderstanding and sample delay. The participants described that

patients and/or the professionals sometimes received wrong or no

information at all, which was experienced as a safety risk. In other cases,

32

information and referral might reach the patient but not the PHC’s

personnel. It occurred that wrong orders were entered into the computer.

Achieving improvements in clinical practice

Participants reflected on safety and reported that they had achieved

improvements in clinical practice. To ensure quality, having standardised

ways of working was described as important. Participants described how

they improved in following guidelines, such as using stasis for a shorter

period of time and inverting test tubes more in line with the national

guidelines. One PHC had bought bags especially for sampling, with space for

all materials and a carrier to store the tubes standing as instructed. The

participants described better routines, such as performing one thing at a

time, and reflected on improvements in planning, being well prepared,

making systematic checks, and having all the materials available.

Standardised ways of working contribute to increased accuracy in clinical

practice. The participants described being more careful after the education

and having learned about the importance of comparing the identity with the

test request. They were also more accurate in labelling test tubes. The EIP

motivated and reminded them of the consequences that could appear if they

were careless.

Feeling strengthened in working as usual

Some participants reported that they did not learn anything new during the

EIP. However, some of these felt recognised and confirmed that they were

already working as instructed; they went on doing as usual in a correct way.

The VBSC education motivated and reminded them of consequences that

could appear in daily VBSC practices. Participants experienced the EIP as

positive and pointed out that VBSC was made visible due to the education.

However, there were participants that went on doing as usual in an

incorrect way. They experienced having learned new things during the EIP,

but still did not work according to the new instructions. They just did not

want to change their routines.

33

Discussion

After testing a self-reported VBSQ, the overall aim of this thesis was to

evaluate the impact of a large-scale EIP on healthcare personnel’s VBSC

practices. Our main findings showed that the VBSQ was valid. Thus, it could

be used to monitor VBSC practices, identify near misses and evaluate the

impact of an EIP emphasising VBSC guideline adherence. Secondly,

following the large-scale EIP, several specific VBSC practices were

significantly improved, indicating that the EIP had an impact on the

adherence to guideline practices. Thirdly, the percentage of haemolysed

specimens was significantly reduced in rural PHCs but significantly

increased in urban PHCs after the EIP. Finally, using methods to describe

experiences, it was obvious that the large-scale EIP opened up opportunities

for reflections about safety.

To understand the results in this thesis, findings will be discussed in relation

to the system perspective (64, 161). Organisations working with a system

perspective allow improvements on several levels in the system (64), which

can create opportunities for VBSC personnel to perform their skills correctly

(66, 110). The reason that some VBSC personnel did not improve in

guideline adherence can also be discussed in relation to the system

perspective. Specific findings will also be interpreted in relation to the model

of practical skill performance (26). Further, the model of practical skill

performance in nursing makes it possible to describe VBSC in a broader

perspective. As a tentative suggestion, a monitoring program intended to

identify and eliminate VBSC errors and provide implementation advice for

VBSC educational programs will be discussed.

Opportunities for preventing venous blood specimen collection errors

To understand the extent to which the environment influences various

events in the organisation, the system can be divided into four different

parts: the people working on the frontline, local work environment (PHCs),

local organisational structures, and national or international structures.

Each part should effectively protect against errors: if one barrier fails, the

next barrier should ensure patient safety (161). Barriers may act

preventively, but as long as many errors are latent and undetected, it is

difficult to develop effective barriers (62, 74). Errors in VBSC often occur in

the preanalytical phase (16, 18, 100), are related to human mistakes, and are

often undetected (53). These errors can be prevented by using the model of

34

practical skill performance in nursing as a basis to ensure that every part in

the process of VBSC will be achieved. The model describes practical skills in

nursing as complex and points out that a good practical skill in nursing is

performed when all six categories are integrated (26). The modified model

below reflects VBSC practical skills in nursing and could be a support in

VBSC education (Figure 4).

Figure 4. A model of VBSC practices in nursing, modified from Figure 1, Bjørk 1999.

To be prepared is crucial when performing VBSC

Staying up to date with relevant content in skill performance, instruction,

and information is referred to as substance in the model of practical skills in

nursing (26). Increased patient health has been associated with the use of

35

retrieved information (162). Therefore, having updated content on VBSC

procedures is important, since VBSC guidelines and laboratory methods

change over time (139). Thus, it is particularly important that healthcare

personnel are aware of how to search and have access to correct information

in the internal network. This thesis showed increased use of information via

internal networks after, compared to before, the large-scale EIP. From a

system perspective, the VBSC EIP was a good initiative to ensure that

personnel have the qualifications to work safely, which indicates that the EIP

is considered as good for implementing information search procedures.

Information that is needed and readily available (38, 162), as well as

interventions that concern use of computerised information, often

constitutes effective interventions (71).

Errors may also occur due to deficient transfer of information between

healthcare units (Study IV). Participants described situations where patients

and/or professionals received incorrect or no information. This could

correspond to the category integration in the practical skill model pointing

out that personnel’s verbal interactions with patients and colleagues are

important nursing skills (26). System errors in nursing and primary care due

to deficient transfer of information are common (38, 51, 163, 164), and its

consequences may lead to increased visits to the healthcare service and

delayed diagnostics and treatment (164). However, such deficiencies cannot

be improved by a short large-scale EIP, but are considered more as a local

organisational structure problem (51, 161). Thus, information routines

within and between professionals, units, and organisations must be

considered in future interventions and research.

Another preanalytical preparation procedure is patient rest, which could

correspond to the category substance in the practical skill model. After the

EIP, still only 37% reported following guidelines (Study II) regarding patient

rest prior to sampling. However, participants described changes in the

routines and now allowed patients to rest in the waiting room before VBSC

(Study IV), which also can be related to the category sequence. Using a

reflective tool as a complement to a general education may accelerate

improvements and increase personnel’s knowledge (36). On a system level,

to improve safety, routines regarding rest prior to sampling could easily be

standardised (38). This is important and could be improved by

implementing routines but should not be prioritised in an education directed

to the personnel, where the identification procedure should be prioritised as

number one (17, 103).

36

Accurate identification procedures ensure patient safety

Since patient misidentification is not easily detectable (165) and reporting of

identification errors may cause blame for the personnel (110), assessment of

near misses and development of successful interventions are of most

importance. An opinion paper from 2012 stated that improving patient

identification is an ongoing challenge in all types of blood collection

procedures (166), and also a critical issue in other healthcare areas (165).

Using the VBSQ, the IG (Study II) significantly improved patient

identification by photo ID. They also more often checked that the test

request matched the test tube identification, indicating increased

identification accuracy. The results in Study IV showed that low accuracy

was a risk for deterioration of the patient identification procedure. Accuracy

due to the model in nursing means exactness in each step during the VBSC

practices (26). Patient identification procedures performed with accuracy

include several steps, such as identifying the patient and confirming that the

patient’s name and identification number are correct in comparison to

referrals and labels (14). Those steps are typically important safety barriers

in the frontline personnel’s routines and are intended to prevent patient

identity mix-up at the last defence. Nurses have an important role in

minimising nursing errors (110, 111). Other patient identification procedures

and test request management procedures had not improved (Study II) after

the EIP. From a system perspective it may partly be due to the organisational

structure. Participants in Study IV working at the VLL were actually

responsible for the municipality VBSC personnel’s registering and signing of

referrals. In accordance with the regulation, personnel are by themselves

responsible for signing test requests (167). In these cases it was not possible.

The VLL personnel had to register and sign, whereas the municipality

personnel collected the venous sample. The VLL personnel described how

not taking responsibility for the co-workers’ tasks could lead to suffering for

the patients. Thus, clinical reasoning and good judgement are fundamental

skills in VBSC nursing practices (110).

Study II showed that most participants labelled the test tubes before or after

VBSC but alongside the patient, which could correspond to as the categories

sequence and accuracy in the practical skill model. Some authors have

suggested that labelling specimens immediately after collection alongside the

patient should be considered as acceptable practice (105). Still, despite the

EIP, participants sometimes labelled the test tube at a later occasion away

from the patient, which is unacceptable. This kind of informal routine

involving low accuracy has in other areas caused patient deaths, when the

nurse did not follow guidelines (38). Understanding when and why things go

wrong is fundamental for patient safety in nursing. From a system

37

perspective, attempts have been made to decrease human mistakes. Use of

barcoded wristbands (117) is an attempt from an organisational level, while

double-checking the patient’s identity (105) is a routine created for VBSC

personnel at the last line of defence (67). In Sweden, there is also a

regulation that states that test tubes should be labelled prior to specimen

collection (14). However, there are VBSC guidelines (11, 13) that recommend

labelling test tubes alongside the patient before leaving the side of the

patient, before or after specimen collection. The wide variation in responses

(Study II) indicates that unclear recommendations can makes it difficult for

personnel to know whether they should adhere to the regulations or the

guidelines (74, 111). In addition, VBSC instructors or other healthcare

teachers may become less credible when what they teach is unclear (74).

Regarding regulations and national guidelines, the organisation at a national

level has a large responsibility to preserve and ensure patient safety (74,

168). When a barrier aimed to ensure safety fails, such as contradictory

guidelines and regulations, errors may occur in the lower levels of the

organisation (4, 67, 110, 111, 169). Thus, it may be necessary to standardise

and clarify guidelines so they cannot be interpreted as contradictory.

Our findings indicate that some participants improved their patient

identification procedure without increased risk awareness, but rather due to

other colleagues’ opinions. Decisions on how to perform a nursing skill are

influenced by collaboration with colleagues: nurses seek to adhere to other

nursing personnel and often put their own opinions aside (170). Education

that stimulates reflection and discussion and increases awareness may then

maximise improvements in identification procedures to ensure patient

safety. Some participants (Study IV) did not change their behaviour at all, as

they thought that the changes were not important for patient safety. From a

system perspective, unit-based nurses with a leadership role are noted as a

key factor for improvements in the local work environment if they support

personnel during the change process (61, 163, 171). Management and leaders

also have a large responsibility to support and motivate their personnel to

make improvements (169, 172). Personnel who feel valued and supported by

the management have a better possibility to change routines (63, 148, 172–

174). Positive personnel attitudes towards research (175) and motivation are

an important factor in influencing personnel behaviour (163).

Venipuncture and specimen handling culture

Releasing venous stasis (Study II) and also using shorter venous stasis

(Study IV) after having undergone the EIP led to more reliable test results.

Incorrect use of venous stasis may be explained by incorrect sequences of

38

performance (26, 36). Use of stasis before cleaning the patients’ skin means

that venous stasis time probably will be longer than one minute and thereby

influence the test results (80). A proposal from that study was to clean the

venipuncture site and let it dry before stasis. This is also suggested in the

Swedish national guideline (13). From a system perspective this problem can

be identified as an error on the frontline. By using the model as a reflective

tool when discussing VBSC performance against the guidelines in education

and clinical practice, a problem like this can probably be identified

beforehand.

In vitro haemolysis is a consequence of incorrect venipuncture or blood

specimen handling. Söderberg concluded that variation in HI among PHCs

reflects varying preanalytical conditions (128). We concluded that

monitoring HI could be used to identify near misses. We evaluated whether

blood specimen quality had improved after the EIP (Study III). The rural

PHCs had significantly lower numbers of haemolysed blood specimens after

the EIP, while the urban PHCs showed a significant increase of haemolysed

samples after the EIP. However, rural PHCs had a higher percentage of

haemolysed samples at baseline, which indicates that the EIP might be

effective in PHCs demonstrating VBSC practices with larger deviation from

guidelines. VBSC practices were also quite stable within each PHC between

years 2008 and 2010 which might be attributed to preserved cultures in the

local work environment. From a system perspective, organisational

structures can be described in which VBSC practice takes place, while the

culture of a PHC may be multifaceted and include the VBSC personnel’s

beliefs and assumptions. Thus, there is a need to consider the VBSC

personnel’s resources for achieving successful changes (174). Pronovost

described culture as the way healthcare personnel do things around each

unit. He also pointed out that there is a lack of interventions that have been

shown to improve the work culture. Improving work culture must focus on

the people at the frontline, because culture is local. Results from

interventions should be reported to the personnel involved in the

intervention. If the culture is not responsive to the intervention, there is no

point in measuring it (176).

Caring comportment and complex work environment.

To create an accepting and respectful atmosphere during VBSC practices are

essential in nursing care and refer to caring comportment in the practical

skill model (26, 36) and may decrease patient anxiety (92). Caring

comportment includes to taking the patient’s feelings and reactions into

account. In Study IV, the participants described how conflicting emotions

39

arose when they needed to hold a patient during VBSC. Nurses’ ethical

practice is a complex process of reasoning and decision-making that also is

influenced by personal and work environments (170). Ethical decisions are

often based on medical and nursing knowledge, and individual values and

experiences (170, 177, 178). The participants described lack of knowledge as

a risk that might influence their actions and decision-making in different

situations (Study IV).

An adaption of practical skill performance is needed when working in

varying environments; this is referred to as integration (26). Environmental

disturbances were experienced as risks that could lead to mistakes (Study IV)

and jeopardise patient safety. Physical obstacles in the work environment

can make it difficult to use safe nursing practices, that is, caring

comportment (148, 179). For example, having several VBSC sites in the same

room (Study IV) was experienced as a source of decreased integrity for the

patient, if the patients were sampled simultaneously. Decreased integrity

may cause stress and anxiety for the patient (180). From a system

perspective, the physical environment may be difficult for personnel to

influence (180) because rebuilding and changing the physical work

environment occur at an organisational level (50). Environmental

disturbances in Study IV take high workload into consideration, as it could

contribute to low guideline adherence (169). A calm and silent physical space

is important to ensure a work environment with fewer distractions (180).

VBSC practices without interruption correspond to fluency, which is crucial

for good performance and give an impression of ease and smoothness (26,

36). From a system perspective, fluency ia also related to the local work

environment, as to be well prepared with proper routines and available

materials may increase fluency and create a sense of security for the patient.

Fluency may be improved by repeated experimental learning followed by

reflections and discussions (178, 181). Observation studies to further identify

not only fluency but also accuracy, integration, and caring comportment in

VBSC practices could be valuable in future research to improve VBSC

education.

Implications for the future

Implication in nursing

VBSC is a common procedure in nursing care. A fundamental responsibility

for nurses is to alleviate suffering (25, 177). Repeated VBSC due to

deficiencies in the organisation or suboptimal VBSC practices can be

prevented. Training in work technique is important for safety and well-being

40

of patients (31, 182). Good practical skills in nursing that combine technical,

theoretical, psychosocial and physical elements are therefore needed.

Therefore, practical skills within nursing research must be worthy of interest

(24). Using a model for practical skills in nursing to describe VBSC in a more

holistic and less technical way might highlight VBSC as a practical nursing

skill. Therefore, patient safety programs that minimise risk of harm to

patients and providers through system effectiveness as well as individual

practice are needed (34, 47, 56, 182).

Implementation strategies to plan and develop educations

Adoption of practice guidelines is affected by several issues, among them the

way they are implemented (169, 173). High evidence that the context is

accessible to change, as well as positive cultures (174), appropriate

monitoring and feedback mechanisms (71), and available time for personnel

to read and discuss research (163, 173) are mentioned as improving adoption

of guidelines. The evidence level supporting the EIP evaluated in this thesis

varied, as did the context and culture in the PHCs (128, 183). In light of this

finding it is a challenge to implement changes in VBSC in healthcare to

improve patient safety. Studies point out that use of implementation theories

may identify implementation barriers beforehand (163, 184). In respect to

our findings and also the challenge to change practical routines in healthcare

we suggest the use of an implementation theory when implementing

guidelines for VBSC practices. For a successful implementation of routines

for adherence to VBSC guidelines, it is also important to take into

consideration cognitive theories monitoring performance and providing

feedback (73, 185, 186). It is important to study the implementation process

as a whole in order to improve future interventions.

More specifically, for a successful implementation, conditions influencing

improvements must be taken into account in order to speed up

improvements in health care (186, 187). Also, it is necessary to create a

culture in which the existence of risks is acknowledged (3, 41, 55, 57, 187)

and to accept that most human mistakes are performed in relation to the

system (51). Furthermore, it is essential to maintain a successful

implementation, and maintenance of patient safety is a creative process. The

use of multidisciplinary teams is one way to maintain an implementation

procedure (9, 61) and is essential to enhance patient safety.

41

Monitoring of VBSC errors

To prevent diseases, screening programs are used, aimed at detecting early

signs of the disease or condition (188). In comparison, monitoring high

frequencies of near misses (Studies II and III), aimed at identifying potential

errors, would improve the quality of VBSC practices more than merely

focusing on assessment of underreported incidents or registered rare adverse

errors. Monitoring for near misses makes it possible to prevent VBSC errors

such as mismatching of patients (5, 51, 182). Before implementing a

monitoring strategy it is important to determine whether the benefits

outweigh the harms (152, 188). In this thesis, several benefits for the patient,

such as less repeated sampling, correct treatment, and a decrease in

diagnosis delay have already been described.

A tentative suggestion (Figure 5) for a national VBSC error-monitoring

program is divided into three levels. Monitoring is performed simultaneously

in all Swedish healthcare units. The validated VBSQ is used in a survey

among VBSC personnel and laboratory records estimate the frequency of

low-level haemolysis. The results of the VBSQ and the frequency of low-level

haemolysed specimens lead to a decision as to which action to take, such as

education or a directed intervention or both. Eventually, interviews could be

used to identify deficiencies in the higher level of the system.

Figure 5. A tentative suggestion of a monitoring program for preanalytical VBSC errors.

Continuous general large-scale VBSC education

According to the system perspective, the management should ensure that

routines assure that the competence among healthcare personnel is

maintained (9, 41). The EIP in this study was performed by laboratory

instructors. Education was given at different times and mostly at the

university hospital, which offered low flexibility for when to take part in the

program. Despite difficulties in performing the EIP, conditions

improvements were found. To develop an effective education, curriculum

designers and instructors must be aware of appropriate pedagogical

strategies (71). To ensure that every VBSC personnel member has the

Monitoring VBSC practices with HI and VBSQ

Detection of units with high level of near misses

Confirm the problems

Implementation of an EIP or other action

VBSC practices improvements

42

opportunity to take part in the EIP, e-learning is a successful way to teach

and has been shown to be as effective as a general educational program (189-

191). Thus, a VBSC e-learning program could be appropriate for large

organisations, and accessible to personnel in rural areas. E-learning gives

flexible opportunities for the organisation as well as for the personnel; it is a

cheap and a growing educational tool (189). The large-scale EIP could be

transferred into an e-learning program and revised to include interactive

meetings, reminders, discussions and exercises. Education via e-learning

provides as good and possibly better, results among users as traditional

education, including oral presentation (189).

Directed VBSC education when needed

In this thesis we evaluated a general EIP in the area of VBSC. However, a

directed intervention probably would have improved sample quality even

more. Another study showed that directed intervention involving individual

phlebotomists succeeded in improving venous stasis use (192) by

implementing CLSI H-03-A6 (11). If the aim of the EIP is to reduce repeated

sampling due to sample rejection caused by haemolysis, directed

interventions should focus on changes with high evidence. Thus, it is

essential to perform VBSC by venepuncture, instead of using intravenous

catheters (136, 138, 193), and drawing blood from antecubital fossa, instead

of more distal sites (193). On the other hand, one must also consider that

recommendations with less evidence should be implemented, such as using

needles with large bore gauge >22 (124), and fully filling test tubes (124,

134), and that recommendations of a short time between sampling and

analyses (134), conservative use of tourniquet (116, 124, 138), no delay in

separation of blood from plasma (113), and assurance of muscle relaxation

during sampling (13) should be included in the EIP. However, in developing

direct interventions, it is important to decide where to put the cut-off for

steps included in the EIP.

A general as well as a directed intervention can also include hands-on

practice with subsequent reflection (194). That kind of directed education

might decrease the frequency of haemolysed specimens and lead to less

repeated sampling and more reliable test results further. The model of

practical performance in nursing (26, 36, 194) might be a valuable reflection

tool in interventions. To develop education that motivates reflection is

considered as important in education. Reflection in relation to earlier

experiences may lead to deeper learning in contrast to superficially

memorising of facts (181).

43

Methodological discussion

Using triangulation to achieve trustworthiness in research provides a basis

for convergence of the truth (144). We used triangulation in design,

participants and subjects, data collection, and analytical techniques.

Strenghts

A strength of this thesis was that the research was clinic-based and the EIP

was developed out of the needs of the VBSC personnel.

In this thesis, we described the context, so that other researchers or nurses

can decide whether they can apply our results in their contexts or carry out a

similar study (159, 160). Our studies were performed in all PHCs in two

county councils. Recruiting participants from two county councils,

constituting the IG and the CG, respectively, reduced the risk of spillover

effect (Study II).

We used the VBSQ, the HI, and interviews evaluating the large-scale EIP

focusing on VBSC practices to answer the research aim. Those methods

enable a broad range of preanalytical VBSC practices to be cross-checked

(144, 147). Thus, we could study adherence to VBSC guidelines from

different perspectives (147, 151). Studies II and III had a comparative before

and after design. Comparing a group who had undergone an EIP with a CG

who did not take part in the EIP produced good evidence based on the

results (83).

The EIP comprised almost all VBSC personnel of VLL and thus included

VBSC personnel in both hospital wards and primary healthcare. We limited

our evaluation to the PHCs. However, the study population was clinically

relevant, as the distribution of the participants’ professional status is typical

of Swedish PHCs. Informants and blood specimens from PHCs in VLL and

LVN were included. We also interviewed 30 VBSC personnel from ten PHCs,

which provided a variety of the participants’ experiences.

When testing the VBSQ for validity and reliability the period between test

and retest was three to four weeks. It was judged to be close enough that

collection procedures and guidelines had not changed and long enough so

the participants’ did not remembered how they answered at the first test

(142). Further, the self-reported VBSQ demonstrated results similar to those

in other observational studies (68, 146). That strengthened our VBSQ.

44

Monitoring low-level haemolysis is valuable in order to identifying poor

VBSC practices. Monitoring HI also allowed a big sample as well as short-

and long-term follow-ups. A perfect intervention should lead to short as well

as long-term improvements (82). In Study III there were no differences

between the short- or the long-term measurements (results not shown). The

linear relationship between HI and free Hb (R2 = 0.986) (158) showed

validity for HI as a measurement. Thus, results (Study III) can be

generalisable to other laboratories, if using the same test tube manufacturers

and laboratory analysis instruments. Furthermore, all the interviews were

conducted by the first author at the participants’ workplaces and with the

same open-ended guide.

Teams of multiple individuals analysed and interpreted the data in all

studies. Different statistics were used in the analytical process to achieve a

strength in the analyses. In the interviews, two authors analysed five

interviews independently, and all authors discussed and compared

interpretations in an open dialogue continuously.

Limitations

Professions, qualifications, and work environment in the PHCs vary. As well,

the counties within this thesis are affected daily by different influences which

were difficult for us, as researchers, to control and may affect our results.

However, the reason for the increased number of haemolysed specimens

(Study III) is not known; the working conditions before and after the

intervention were similar, and the result could not be explained by low

participation. In PHC number 6, 100%, and in PHC number 7, 95%, of VBSC

personnel took part in the educational intervention. Findings (Studies II and

III) might also be affected by the previous questionnaire survey in 2007.

PHCs with high frequencies of correct answers or high specimen quality at

baseline had little room for positive change. An intervention improvement is

expected when the starting point adherence to guidelines or blood specimen

quality is low and vice versa.

There are some limitations in using self-reported questionnaires; one of

them is the ability to remember (Study I); others are changes in knowledge

and behaviour over time (Studies I and II) (142, 145).

Other circumstances that could have affected the outcome are personnel

turnover, which was rather high after the intervention; the sample size; a

small variation between the answers; and recall bias. There was also an

imbalance between professional groups in the IG (Study II, Table 2) at

45

baseline, and more enrolled nurses were employed in the CG whereas more

registered nurses were employed in the IG. No significant differences in self-

reported answers regarding adherence to guidelines were found between

those two professional groups.

The national guideline (13) as well as the EIP included information

concerning other important topics that indirectly affect the sampling, which

might have caused the reader to miss information in instructions. Guidelines

and information in educational programs should be short and easy to

understand (70). A weakness with the short EIP is that it contained no

practical training or opportunities for deeper discussions. One third of the IG

(Study II) performed the EIP through live Internet link, while the others had

traditional lectures. However, no significant differences were found between

those two groups in seven randomly selected items.

46

Conclusions

This thesis, as far as we know, is the first to evaluate the impact of a large-

scale, preanalytical EIP aimed at improving VBSC practices. Self-reported

VBSQs and monitoring of low-level haemolysis reflected VBSC practices and

could be used to evaluate the EIP’s impact on VBSC practices. The high

frequency of near-miss markers in contrast to low frequencies of reported

adverse events makes it possible to compare and benchmark healthcare units

and hospital wards. It was obvious that the EIP opened up opportunities for

reflection on safety. The general EIP had an impact on several VBSC

practices, while some VBSC practices remained unchanged. There are still

several areas in VBSC practices that need improvement through further and

continuous interventions, with the understanding that changes take time. In

addition, EIPs providing time for reflection and discussion based on specific

VBSC flaws may be effective. Findings could also be explained in large part

from a system perspective, which indicates that some elements such as

deficiencies in transfer of information, environmental disturbances, rest

prior to sampling, and unclear guidelines must be changed on a level in the

system other than an educational program for VBSC personnel on the

frontline. Further research is needed to explore different PHC cultures and

how different cultures influence VBSC practices.

47

Clinical implications

Our results demonstrate that an EIP improved VBSC practices indicating

that monitoring and counteracting the near misses in VBSC is a well-

functioning preventive action. The VBSQ can be used as a valuable

instrument to develop the quality in healthcare worldwide. Also, employing

low-level haemolysis to evaluate or benchmark VBSC practices in this

systematic way can be recommended to other laboratories or healthcare

units. Self-reported questionnaire surveys can also be compared with the

haemolysis level of the corresponding healthcare unit. A VBSC educational

intervention can update and sustain VBSC practices in healthcare. The

general EIP can improve VBSC practices in PHCs with larger deviations from

guidelines, while a directed educational program with increased focus on

specific topics and including reflection and discussions is probably more

effective than a general EIP when specific flaws are identified. Our studies

have led to deeper and extended knowledge of the impact of an EIP on VBSC

practices. Participants experienced that the EIP opened up opportunities for

reflections on safety and described several additional risks during VBSC

practices, such as transfer of information between occupations and units,

and environmental disturbances. Our results can be used when considering

future VBSC practice interventions. Using a model for practical skills in

nursing to describe VBSC in a more holistic and less technical way might

highlight VBSC as a practical nursing skill.

48

Acknowledgements

I wish to thank all who have supported me and helped me in various ways

during the process of my doctoral studies and writing of this thesis. In

particular, I would like to thank –

All the participants who answered the VBSQ, and all who shared their

experiences with me during the interviews. Your participation was essential

for the development of this thesis.

The Faculty of Medicine, Umeå University, Umeå, Sweden; the Swedish

National Board of Health and Welfare, Sweden; and Västerbotten County

Council in Sweden for research funding.

My supervisors, Christine Brulin, Kjell Grankvist, and Johan Söderberg, for

giving me the opportunity to work within this research project, and for your

engagement and interested discussions. All three of you have believed in me;

supported me; asked me tricky, uncomfortable questions; and guided me

through the research jungle. You have taught me the importance of writing

skills: less is more; emphasise the take-home message is what counts. You

have encouraged me to discuss and present our research worldwide, and

much more. I’m impressed that you always have time for me – even when

you don’t. I have often left Christine’s office with new thoughts and an Aha!

experience, and Kjell’s office with new strength, because you listen to my

good and bad ideas, and share your interest in discussing articles and power

points from courses and conferences. I will always remember to think a little

more “squarely”. Johan has inspired me to be more systematic, to use the

correct words, and to follow the red thread.

My co-authors, whose support and engagement have been invaluable: Ulla H

Graneheim, for guidance in qualitative content analysis. Marie Lindkvist, for

guidance in different aspects of biostatistics. Johan Hultdin, for great advice

and for sharing your pedagogical skills. Karin Nilsson, for valuable

comments.

The laboratory instructors: Susanna Hermansson, Marie Lundgren, Marie

Backlund, and particularly, AnnBritt Lindström, for your time, engagement,

and discussions. It has been inspiring to work with you.

My friend Maria Lindström, who listens and discusses work as well as

private issues. We have shared great and small things during our hundred

trips to and from work.

49

All colleagues at the heart centre throughout the years, including for giving

me time off for studies.

Everyone at the Department of Nursing and the Department of Medical

Biosciences, for creating a friendly atmosphere and for chitchat in the

corridors as well as in the break room. Particularly, Ingagreta Nilsson,

Majken Hjalmarsson, Terry Persson, Malin Degerman, and Karin Nilsson,

for always being helpful and making my administrative work easier. Majken!

For being my toastmaster (this is not the first time and probably not the last

time). Birgitta Olofsson, for your engagement and constructive criticism, and

for our long talks on bikes between Åsele and Saxnäs. Kristina Lämås, for

support and interesting talks about practical skills during flights and

meetings. Åsa Hörnsten, Mitzie Nordh, Magnus Engström, and Lisbeth

Lundström, for support during my first year as a teacher. And, especially,

Ulrika Öberg, for being a good friend and creating a positive atmosphere.

All previous and present doctoral colleagues who shared this journey with

me: Britt-Marie, Ulrika F, Anders, Kerstin, Anita, Sabine, Anna-Klara,

Helena L, Chatarina, Johan, Sofia, Åsa, Pia, Maria, and Lenita. Especially

Karin H, who shared my fear of flying, for good breakfasts and discussions

during the conference in Montreal and during my whole time as a student.

Senada, Jonas, and Lina, my neighbours in the office, who shared

discussions, creativity, energy, and happiness. Karin S, for support,

discussions, and shared interest in questionnaire development, but

especially for lending me your hiking boots. Elisabeth and Karin N, for your

company in Graze and for giving constructive feedback on my presentation.

Eva, Lena J, Anders, Sussi, and Helena A, for sharing lunches and

supporting me, especially in the last weeks.

All members in RiNS (Research in Nursing Skills), especially Ida Torunn

Björk, who kindly invited me to RiNS and shared her knowledge of practical

skills in nursing.

All friends at the European Academy of Nursing Science School, for several

lovely weeks with a friendly atmosphere, in Leaven and Nijmegen, and

especially Floor, Margarita, Cäcelia, and Tiina for your great teamwork.

My family: Krister, my companion for many years, for your unending

patience and for sharing my ups and downs. Without your support and back

rubs, this would not have been possible. Jonna, Jakob, and Albin, I am very

grateful that you are such a large part of my life. Love you all!

50

My parents, for always believing in me, and constantly supporting me in my

decisions and inspiring me to take chances in life. Your home has always

been open to me, my family, and my friends. Big hug!

My parents-in-law, for taking care of the children, when needed, and

spoiling the whole family with the most delicious food.

My siblings, Britt-Marie and Anders, and your families, for lovely

“relaxation” time associated with diving and hiking adventures. You support

me and are my best friends always. Peder, for your involvement with our

kids and for your always funny jokes. Anni, for always welcoming us to your

Bruntbo and home in Nacka.

All my friends, especially Anna-Karin, Linda, Malin, Karin Bj, Åsa, Karin M,

Lena, Agneta, and Reneé. We have had lots of fun times together, and

hopefully we will be planning our next party, adventure, or pentathlon soon.

All neighbours and friends, for making ours a friendly community, especially

Johanna and Fredrik, for your friendship and your helpfulness around the

kids. And to Annika and Per for nice dinners, treats, and a wonderful stay at

your island.

51

References

1. Forsman R. Why is the laboratory an afterthought for managed care organizations? Clin Chem. 1996;42(5):813-6.

2. Kalra J. Medical errors: impact on clinical laboratories and other critical areas. Clin Biochem. 2004;37(12):1052-62.

3. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem. 2002;48(5):691-8.

4. Lippi G, Guidi GC. Risk management in the preanalytical phase of laboratory testing. Clin Chem Lab Med. 2007;45(6):720-7.

5. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem. 2007;53(7):1338-42.

6. Grankvist K. Personal communication. 2013. 7. Plebani M. Errors in clinical laboratories or errors in laboratory

medicine? Clin Chem Lab Med. 2006;44(6):750-9. 8. Plebani M. Exploring the iceberg of errors in laboratory medicine.

Clin Chim Acta 2009;404(1):16-23. 9. Hammerling JA. A review of medical errors in laboratory diagnostics

and where we are today. Lab Med. 2012;43(2):41-4. 10. Astion ML, Shojania KG, Hamill TR, Kim S, Ns VL. Classifying

laboratory incident reports to identify problems that jeopardize patient safety. Am J Clin Pathol. 2003;120(1):18-26.

11. Clinical and Laboratory Standards Institute. Procedures for the collection of diagnostic blood specimens by venipunture. 6 ed. Wayne: CLSI; 2007, CLSI document H3-A6.

12. World Health Organization. WHO guidelines on drawing blood: best practices in phlebotomy. Geneva: WHO Document Production Services; 2010, NLM classification WB 381.

13. The Handbook for Healthcare. Blodprov, venös provtagning (In Swedish). Available at: http://www.vardhandboken.se/In-English/ [Accessed: 2014-03-04 ].

14. SOSFS 2009:29. Socialstyrelsens föreskrifter om transfusion av blodkomponenter (In Swedish). Stockholm: Socialstyrelsen.

15. Wallin O, Soderberg J, Van Guelpen B, Brulin C, Grankvist K. Patient-centred care - preanalytical factors demand attention: A questionnaire study of venous blood sampling and specimen handling. Scand J Clin Lab Invest. 2007;67(8):836-47.

16. Wallin O, Soderberg J, Van Guelpen B, Stenlund H, Grankvist K, Brulin C. Preanalytical venous blood sampling practices demand improvement - A survey of test-request management, test-tube labelling and information search procedures. Clin Chim Acta 2008;391(1-2):91-7.

17. Söderberg J, Wallin O, Grankvist K, Brulin C. Is the test result correct? A questionnaire study of blood collection practices in primary health care. J Eval Clin Pract. 2010;16(4):707-11.

18. Söderberg J, Brulin C, Grankvist K, Wallin O. Preanalytical errors in primary healthcare: a questionnaire study of information search

52

procedures, test request management and test tube labelling. Clin Chem Lab Med. 2009;47(2):195-201.

19. Simundic A-M, Lippi G. Preanalytical phase–a continuous challenge for laboratory professionals. Biochem Med. 2012;22(2):145-9.

20. Johnstone M. Patient safety ethics and human error management in ED contexts. Part I: development of the global patient safety movement. Aust Emerg Nurs J. 2007;10(1):13-20.

21. Kohn L, Corrigan J, Donaldson M. To err is human: building a safer health system. Washington, D.C: The National Academies Press; 2000.

22. Wiwanitkit V. Types and frequency of preanalytical mistakes in the first Thai ISO 9002: 1994 certified clinical laboratory, a 6–month monitoring. BMC Clin Pathol. 2001;1:5.

23. Bjørk IT. What constitutes a nursing practical skill? West J Nurs Res. 1999;21(1):51-63.

24. Bjørk IT. Neglected conflicts in the discipline of nursing: perceptions of the importance and value of practical skill. J Adv Nurs. 1995;22(1):6-12.

25. Lavery I, Ingram P. Venepuncture: best practice. Nurs Stand. 2005;19(49):55-65.

26. Bjørk IT, Kirkevold M. From simplicity to complexity: developing a model of practical skill performance in nursing. J Clin Nurs. 2000;9(4):620-31.

27. Sandelowski M. Venous envy: The post-World War II debate over IV nursing. JAVA. 2010;15(2):75-81.

28. De Tornyay R, Thompson MA. Strategies for teaching nursing. 3 ed. New York: Wiley; 1987.

29. Quinn F, Hughes S. Quinn's principles and practice of nurse education. ed, editor. Cheltenham: Nelson Thornes; 2007.

30. Nightingale F. Notes on nursing: What it is and what it is not. London: Harrison and Sons; 1860.

31. Kjellberg K, Lagerström M, Hagberg M. Patient safety and comfort during transfers in relation to nurses’ work technique. J Adv Nurs. 2004;47(3):251-9.

32. Fitzpatrick JM, While AE, Roberts JD. The role of the nurse in high‐quality patient care: a review of the literature. J Adv Nurs. 1992;17(10):1210-9.

33. Benner P. The roles of embodiment, emotion and lifeworld for rationality and agency in nursing practice. Nurs Philos. 2000;1(1):5-19.

34. Idvall E, Rooke L, Hamrin E. Quality indicators in clinical nursing: a review of the literature. J Adv Nurs. 1997;25(1):6-17.

35. Bjørk IT, Lomborg K, Nielsen CM, Brynildsen G, Frederiksen AMS, Larsen K, Reierson IÅ, Sommer I, Stenholt B. From theoretical model to practical use: an example of knowledge translation. J Adv Nurs. 2013;69(10):2336-47.

36. Nielsen C, Sommer I, Larsen K, Bjørk IT. Model of practical skill performance as an instrument for supervision and formative assessment. Nurse Educ Pract. 2012;13(3):176-80.

53

37. Bjørk IT, Kirkevold M. Issues in nurses' practical skill development in the clinical setting. J Nurs Care Qua. 1999;14(1):72-84.

38. Benner P, Sheets V, Uris P, Malloch K, Schwed K, Jamison D. Individual, practice, and system causes of errors in nursing: a taxonomy. J Nurs Adm. 2002;32(10):509-23.

39. Runciman W, Hibbert P, Thomson R, Van Der Schaaf T, Sherman H, Lewalle P. Towards an international classification for patient safety: key concepts and terms. Int J Qual Health Care 2009;21(1):18-26.

40. World Health Organization. Patient Safety. Available at: http://www.euro.who.int/en/health-topics/Health-systems/patient-safety/patient-safety [Accessed 2014-03-04].

41. SOSFS 2010:659. Patientsäkerhetslag (In Swedish) Stockholm: Socialstyrelsen.

42. The National Board of Health and Welfare. Vårdskador inom somatisk slutenvård 2008 (In Swedish). Available at: http://www.socialstyrelsen.se/publikationer2008/2008-109-16 [Accessed 2014-03-04].

43. Howanitz P. Errors in laboratory medicine: Practical lessons to improve patient safety. Arch Pathol Lab Med. 2005;129(10):1252-61.

44. Lippi G, Simundic AM, Mattiuzzi C. Overview on patient safety in health care and laboratory diagnostics. Biochem Med. 2010;20(2):131-43.

45. Vincent C, Neale G, Woloshynowych M. Adverse events in British hospitals: preliminary retrospective record review. Brit Med J. 2001;322(5):517-9.

46. Mangione-Smith R, DeCristofaro AH, Setodji CM, Keesey J, Klein DJ, Adams JL, Schuster MA, McGlynn EA. The quality of ambulatory care delivered to children in the United States. N Engl J Med. 2007;357(15):1515-23.

47. Thornlow DK, McGuinn K. A necessary sea change for nurse faculty development: spotlight on quality and safety. J Prof Nurs. 2010;26(2):71-81.

48. Vincent C, Aylin P, Franklin BD, Holmes A, Iskander S, Jacklin A, Moorthy K. Is health care getting safer? Brit Med J. 2008;337:a2426.

49. Baines RJ, Langelaan M, de Bruijne MC, Asscheman H, Spreeuwenberg P, van de Steeg L, Siemerink KM, van Rosse F, Broekens M, Wagner C. Changes in adverse event rates in hospitals over time: a longitudinal retrospective patient record review study. BMJ Qual Saf. 2013;22(4):290-8.

50. Reason J. Human error: models and management. Brit Med J. 2000;320(7237):768-70.

51. Chang A, Schyve PM, Croteau RJ, O’Leary DS, Loeb JM. The JCAHO patient safety event taxonomy: a standardized terminology and classification schema for near misses and adverse events. Int J Qual Health Care 2005;17(2):95-105.

52. Reiman T, Rollenhagen C. Human and organizational biases affecting the management of safety. Reliab Eng Syst Safe. 2011;96(10):1263-74.

54

53. Szecsi PB, Odum L. Error tracking in a clinical biochemistry laboratory. Clin Chem Lab Med. 2009;47(10):1253-7.

54. Manuele FA. Severe injury potential. Prof Saf. 2003;48(2):26-31. 55. Rollenhagen C, Westerlund J, Lundberg J, Hollnagel E. The context

and habits of accident investigation practices: A study of 108 Swedish investigators. Safety Sci. 2010;48(7):859-67.

56. Alfredsdottir H, Bjornsdottir K. Nursing and patient safety in the operating room. J Adv Nurs. 2008;61(1):29-37.

57. Leape L. Errors in medicine. Clin Chim Acta 2009;404(1):2-5. 58. Ohrn A, Elfstrom J, Liedgren C, Rutberg H. Reporting of sentinel

events in Swedish hospitals: a comparison of severe adverse events reported by patients and providers. J Qual Patient Saf. 2011;37(11):495-501.

59. Barach P, Small SD. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems. Br Med J. 2000;320(7237):759-63.

60. Lippi G, Chance JJ, Church S, Dazzi P, Fontana R, Giavarina D, Grankvist K, Huisman W, Kouri T, Palicka V, Plebani M, Puro V, Salvagno GL, Sandberg S, Sikaris K, Watson I, Stankovic AK, Simundic AM. Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med. 2011;49(7):1113-26.

61. Richardson A, Storr J. Patient safety: a literative review on the impact of nursing empowerment, leadership and collaboration. Int Nurs Rev. 2010;57(1):12-21.

62. Amalberti R, Benhamou D, Auroy Y, Degos L. Adverse events in medicine: Easy to count, complicated to understand, and complex to prevent. J Biomed Inform. 2011;44(3):390-4.

63. Boakes E. Using foresight in safe nursing care. J Nurs Manag. 2009;17(2):212-7.

64. Reason J. Beyond the organisational accident: the need for “error wisdom” on the frontline. Qual Saf Health Care. 2004;13(2):28-33.

65. Simundic AM, Nikolac N, Vukasovic I, Vrkic N. The prevalence of preanalytical errors in a Croatian ISO 15189 accredited laboratory. Clin Chem Lab Med. 2010;48(7):1009-14.

66. Boone DJ. How can we make laboratory testing safer? Clin Chem Lab Med. 2007;45(6):708-11.

67. Norris B. Human factors and safe patient care. J Nurs Manag. 2009;17(2):203-11.

68. Carraro P, Zago T, Plebani M. Exploring the initial steps of the testing process: frequency and nature of pre-preanalytic errors. Clin Chem. 2012;58(3):638-42.

69. Simundic AM, Bilic-Zulle L, Nikolac N, Supak-Smolcic V, Honovic L, Avram S, Beregovaja E, Dobreanu M, Guimaraes JT, Kovacs GL, Singh NM, Sierra-Amor RI, Sypniewska G, Zima T. The quality of the extra-analytical phase of laboratory practice in some developing European countries and Mexico–a multicentric study. Clin Chem Lab Med. 2011;49(2):215-28.

55

70. Gagliardi AR, Brouwers MC, Palda VA, Lemieux-Charles L, Grimshaw JM. How can we improve guideline use? A conceptual framework of implementability. Implement Sci. 2011;6:26.

71. Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients' care. Lancet 2003;362(9391):1225-30.

72. Berenholtz SM, Pronovost PJ, Lipsett PA, Hobson D, Earsing K, Farley JE, Milanovich S, Garrett-Mayer E, Winters BD, Rubin HR, Dorman T, Perl TM. Eliminating catheter-related bloodstream infections in the intensive care unit*. Crit Care Med. 2004;32(10):2014-20.

73. Allegranzi B, Gayet-Ageron A, Damani N, Bengaly L, McLaws ML, Moro ML, Memish Z, Urroz O, Richet H, Storr J, Donaldson L, Pittet D. Global implementation of WHO's multimodal strategy for improvement of hand hygiene: a quasi-experimental study. Lancet Infect Dis. 2013;13(10):843-51.

74. Francke AL, Smit MC, de Veer AJ, Mistiaen P. Factors influencing the implementation of clinical guidelines for health care professionals: a systematic meta-review. BMC Med Inform Decis Mak. 2008;8:38.

75. Browman GP. Clinical practice guidelines and healthcare decisions: credibility gaps and unfulfilled promises? Nat Clin Pract Oncol. 2005;2(10):480-1.

76. Oosterhuis WP, Bruns DE, Watine J, Sandberg S, Horvath AR. Evidence-based guidelines in laboratory medicine: principles and methods. Clin Chem. 2004;50(5):806-18.

77. Grol R, Wensing M, Eccles M. Improving Patient Care The Implementation of Change in Clinical Practice. Philadelphia: Elsevier Limited; 2005.

78. Zwerver F, Schellart AJ, Knol DL, Anema JR, van der Beek AJ. An implementation strategy to improve the guideline adherence of insurance physicians: an experiment in a controlled setting. Implement Sci. 2011;6(1):131.

79. Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006;355(26):2725-32.

80. Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Picheth G, Guidi GC. Impact of the phlebotomy training based on CLSI/NCCLS H03-A6-procedures for the collection of diagnostic blood specimens by venipuncture. Biochem Med. 2012;22(3):342-51.

81. Turner T, Misso M, Harris C, Green S. Development of evidence-based clinical practice guidelines (CPGs): comparing approaches. Implement Sci. 2008;3(1):45.

82. Sidani S, Braden CJ. Design, evaluation, and translation of nursing interventions. Chichester: John Wiley & Sons, Ltd; 2011.

83. Ovretveit J, Gustafson D. Using research to inform quality programmes. Brit Med J. 2003;326(7392):759-61.

56

84. Ovretveit J, Gustafson D. Evaluation of quality improvement programmes. Qual Saf Health Care 2002;11(3):270-5.

85. Nilsson-Ehle P, Berggren Söderlund M, Theodorsson E. Laurells klinisk kemi i praktisk medicin. 9 ed. Lund: Studentlitteratur AB; 2012.

86. Sciacovelli L, Plebani M. The IFCC Working Group on laboratory errors and patient safety. Clin Chim Acta 2009;404(1):79-85.

87. EQUALIS. External quality assessment for clinical laboratory investigations. Available at: http://www.equalis.se/en/start.aspx [Accessed 2014-03-04]

88. Dzik WH, Murphy MF, Andreu G, Heddle N, Hogman C, Kekomaki R, Murphy S, Shimizu M, Smit-Sibinga CT. An international study of the performance of sample collection from patients. Vox Sang. 2003;85(1):40-7.

89. Lippi G, Guidi Gian C, Mattiuzzi C, Plebani M. Preanalytical variability: the dark side of the moon in laboratory testing. Clin Chem Lab Med. 2006;44(4):358-65.

90. Plebani M, Piva E. Medical errors: pre-analytical issue in patient safety. J Med Biochem. 2010;29(4):310-4.

91. Kirchner MJA, Funes VA, Adzet CB, Clar MVD, Escuer MI, Girona JM, Barellas RM, Alsina CP, Aquilá CR, Isern GT, Navarro CV. Quality indicators and specifications for key processes in clinical laboratories: a preliminary experience. Clin Chem Lab Med. 2007;45(5):672-7.

92. Phillips S, Collins M, Dougherty L. Venepuncture and cannulation. Chichester: Wiley-Blackwell; 2011.

93. Kouri T, Siloaho M, Pohjavaara S, Koskinen P, Malminiemi O, Pohja-Nylander P, Puukka R. Pre‐analytical factors and measurement uncertainty. Scand J Clin Lab Invest. 2005;65(6):463-76.

94. Pfeffer N, Laws S. ‘It's only a blood test’: what people know and think about venepuncture and blood. Soc Sci Med. 2006;62(12):3011-23.

95. Lundberg GD. Acting on significant laboratory results. JAMA. 1981;245(17):1762-3.

96. Plebani M, Laposata M, Lundberg GD. The brain-to-brain loop concept for laboratory testing 40 years after its introduction. Am J Clin Pathol. 2011;136(6):829-33.

97. Goldschmidt HM. A review of autovalidation software in laboratory medicine. Accredit Quality Assur. 2002;7(11):431-40.

98. Stroobants A, Goldschmidt H, Plebani M. Error budget calculations in laboratory medicine: linking the concepts of biological variation and allowable medical errors. Clin Chim Acta 2003;333(2):169-76.

99. Goswami B, Singh B, Chawla R, Mallika V. Evaluation of errors in a clinical laboratory: a one-year experience. Clin Chem Lab Med. 2010;48(1):63-6.

100. Plebani M. The CCLM contribution to improvements in quality and patient safety. Clin Chem Lab Med. 2013;51(1):39-46.

57

101. Romero A, Cobos A, López-León A, Ortega G, Muñoz M. Preanalytical mistakes in samples from primary care patients. Clin Chem Lab Med. 2009;47(12):1549-52.

102. Irjala KM, Grönroos PE. Preanalytical and analytical factors affecting laboratory results. Ann Med. 1998;30(3):267-72.

103. Wallin O, Soderberg J, Van Guelpen B, Stenlund H, Grankvist K, Brulin C. Blood sample collection and patient identification demand improvement: a questionnaire study of preanalytical practices in hospital wards and laboratories. Scand J Caring Sci. 2010;24(3):581-91.

104. Maw G, Mackenzie I, Taylor N. Redistribution of body fluids during postural manipulations. Acta Physiol Scand. 1995;155(2):157-63.

105. Lippi G, Sonntag O, Plebani M. Appropriate labelling of blood collection tubes: a step ahead towards patient’s safety. Clin Chem Lab Med. 2011;49(12):1921-3.

106. Murphy M, Stearn B, Dzik W. Current performance of patient sample collection in the UK. Transfus Med. 2004;14(2):113-21.

107. Meier FA, Jones B. Patient safety and sources of error in point-of-care testing. J Lab Med. 2010;34(3):141-7.

108. Valenstein PN, Raab SS, Walsh MK. Identification errors involving clinical laboratories: a college of American pathologists q-probes study of patient and specimen identification errors at 120 institutions. Arch Pathol Lab Med. 2006;130(8):1106-13.

109. The Joint Commission. 2014 National patient safety goal. Available at: http://www.jointcommission.org/standards_information/npsgs.aspx [Accessed 2014-03-04]

110. DeBourgh GA, Prion SK. Patient safety manifesto: A professional imperative for prelicensure nursing education. J Prof Nurs. 2012;28(2):110-8.

111. Mäkitalo O, Liikanen E. Improving quality at the preanalytical phase of blood sampling: literature review. IJBLS. 2013;2(1):7-16.

112. The National Board of Health and Welfare. Allvarliga händelser och biverkningar inom blodverksamheten rapporterade till Socialstyrelsen för 2009 (In Swedish). Stockholm: Socialstyrelsen

113. Västerbottens Läns Landsting. Provtagningsanvisningar Laboratoriemedicin (In Swedish). Available at: https://webappl.vll.se/provtagningsanvisningar [Accessed 2014-03-04]

114. Lippi G, Salvagno GL, Montagnana M, Franchini M, Guidi GC. Phlebotomy issues and quality improvement in results of laboratory testing. Clin Lab. 2006;52(5-6):217-30.

115. Cox SR, Dages JH, Jarjoura D, Hazelett S. Blood samples drawn from IV catheters have less hemolysis when 5-mL (vs 10-mL) collection tubes are used. J Emerg Nurs. 2004;30(6):529-33.

116. Lippi G, Salvagno GL, Montagnana M, Brocco G, Guidi GC. Influence of short-term venous stasis on clinical chemistry testing. Clin Chem Lab Med. 2005;43(8):869-75.

58

117. Lippi G, Salvagno G, Montagnana M, Franchini M, Guidi G. Venous stasis and routine hematologic testing. Clin Lab Haematol. 2006;28(5):332-7.

118. Lippi G, Salvagno GL, Montagnana M, Guidi GC. Short-term venous stasis influences routine coagulation testing. Blood Coagul Fibrin. 2005;16(6):453-8.

119. Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Manguera CL, Sumita NM, Picheth G, Guidi GC, Scartezini M. New ways to deal with known preanalytical issues: use of transilluminator instead of tourniquet for easing vein access and eliminating stasis on clinical biochemistry. Biochem Med. 2011;21(2):152-9.

120. Becan-McBride K. Laboratory sampling: does the process affect the outcome? J Intraven Nurs. 1999;22(3):137-42.

121. Fang L, Fang SH, Chung YH, Chien ST. Collecting factors related to the haemolysis of blood specimens. J Clin Nurs. 2008;17(17):2343-51.

122. Lippi G, Salvagno GL, Montagnana M, Banfi G, Guidi GC. Evaluation of different mixing procedures for K2 EDTA primary samples on hematological testing. Lab Med. 2007;38(12):723-5.

123. Lima-Oliveira G, Lippi G, Salvagno GL, Montagnana M, Gelati M, Volanski W, Boritiza KC, Picheth G, Guidi GC. Effects of vigorous mixing of blood vacuum tubes on laboratory test results. Clin Biochem. 2012;46(3):250-4.

124. Lippi G, Plebani M, Di Somma S, Cervellin G. Hemolyzed specimens: a major challenge for emergency departments and clinical laboratories. Crit Rev Clin Lab Sci. 2011;48(3):143-53.

125. Guder W, da Fonseca-Wollheim F, Heil W, Schmitt Y, Töpfer G, Wisser H, Zawta B. The haemolytic, icteric and lipemic sample recommendations regarding their recognition and prevention of clinically relevant interferences. Recommendations of the working group on preanalytical variables of the German society for clinical chemistry and the German society for laboratory medicine. J Lab Med. 2000;24(8):357-64.

126. Carraro P, Servidio G, Plebani M. Hemolyzed specimens: a reason for rejection or a clinical challenge? Clin Chem. 2000;46(2):306-7.

127. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, Vassault AJ, Plebani M. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med. 2008;46(6):764-72.

128. Söderberg J, Jonsson PA, Wallin O, Grankvist K, Hultdin J. Haemolysis index - an estimate of preanalytical quality in primary health care. Clin Chem Lab Med. 2009;47(8):940-4.

129. Grant MS. The effect of blood drawing techniques and equipment on the hemolysis of ED laboratory blood samples. J Emerg Nurs. 2003;29(2):116-21.

130. Dugan L, Leech L, Speroni KG, Corriher J. Factors affecting hemolysis rates in blood samples drawn from newly placed IV sites in the emergency department. J Emerg Nurs. 2005;31(4):338-45.

59

131. Tanabe P, Kyriacou DN, Garland F. Factors affecting the risk of blood bank specimen hemolysis. Acad Emerg Med. 2003;10(8):897-900.

132. Burns ER, Yoshikawa N. Hemolysis in serum samples drawn by emergency department personnel versus laboratory phlebotomists. Lab Med. 2002;33(5):378-80.

133. Laga A, Cheves T, Maroto S, Coutts M, Sweeney J. The suitability of hemolyzed specimens for compatibility testing using automated technology. Transfusion 2008;48(8):1713-20.

134. Ong ME, Chan YH, Lim CS. Reducing blood sample hemolysis at a tertiary hospital emergency department. Am J Med. 2009;122(11):1054-56.

135. Thomas L. Haemolysis as influence and interference factor. Biochim Clin. 2002;26(2):95-8.

136. Munnix IC, Schellart M, Gorissen C, Kleinveld HA. Factors reducing hemolysis rates in blood samples from the emergency department. Clin Chem Lab Med. 2011;49(1):157-8.

137. Ong M, Chan YH, Lim CS. Observational study to determine factors associated with blood sample haemolysis in the emergency department. Ann Acad Med Singapore 2008;37(9):745-8.

138. Lippi G, Salvagno GL, Montagnana M, Brocco G, Guidi GC. Influence of hemolysis on routine clinical chemistry testing. Clin Chem Lab Med. 2006;44(3):311-6.

139. Bennett ST, Kern DA. Automated production of an on-line laboratory reference manual from a laboratory information system. J Med Syst. 2002;26(2):145-9.

140. Blechner M, Kish J, Chadaga V, Dighe AS. Analysis of search in an online clinical laboratory manual. Am J Clin Pathol. 2006;126(2):208-14.

141. Söderberg J, Grankvist K, Brulin C, Wallin O. Incident reporting practices in the preanalytical phase: Low reported frequencies in the primary health care setting. Scand J Clin Lab Invest. 2009;69(7):731-5.

142. Streiner D, Norman G. Health measurement scales: a practical guide to their development and use. 4 ed. Oxford: Oxford university press; 2008.

143. Chung KC, Pillsbury MS, Walters MR, Hayward RA. Reliability and validity testing of the Michigan hand outcomes questionnaire. J Hand Surg Am. 1998;23(4):575-87.

144. Polit DF, Beck CT. Nursing research generating and assessing evidence for nursing practice. 9 ed. Philadelphia: Lippincott Williams & Wilkins; 2012.

145. Schwarz N. Self-reports: how the questions shape the answers. Am Psychol. 1999;54(2):93.

146. Schlueter K, Nauck M, Petersmann A, Church S. Using BD Laboratory Consulting Services™ to understand the impact of the preanalytical phase on sample quality and safety, a multi country perspective. Biochem Med. 2013;23(2):224.

60

147. Connelly LM. Mixed methods studies. Medsurg Nurs. 2009;18(1):31-2.

148. Skoglind-Öhman I, Kjellberg K. Factors that influence the use of safe patient transfer technique in home care service. Int J Occup Saf Ergo. 2011;17(4):433.

149. Lippi G, Plebani M. The importance of incident reporting in laboratory diagnostics. Scand J Clin Lab Invest. 2009;69(8):811-4.

150. Lundberg J, Rollenhagen C, Hollnagel E. What you find is not always what you fix—How other aspects than causes of accidents decide recommendations for remedial actions. Accid Anal Prev. 2010;42(6):2132-9.

151. Östlund U, Kidd L, Wengström Y, Rowa-Dewar N. Combining qualitative and quantitative research within mixed method research designs: a methodological review. Int J Nurs Stud. 2011;48(3):369-83.

152. Anell A, Glenngard AH, Merkur SM. Sweden health system review. Health Syst Transit. 2012;14(5):1-159.

153. Glenngård AH, Anell A, Beckman A. Choice of primary care provider: Results from a population survey in three Swedish counties. Health Policy 2011;103(1):31-7.

154. Söderberg J. Sources of preanalytical error in primary health care -implications for patient safety [dissertation]. Umeå: Umeå University; 2009.

155. Wallin O. Preanalytical errors in hospitals - implications for quality improvement of blood sample collection [dissertation]. Umeå: Umeå University; 2008.

156. Coe R. It's the effect size, stupid: What effect size is and why it is important. Available at: http://www.leeds.ac.uk/educol/documents/00002182.htm [Accessed 2014-03-04].

157. Kahn S, Watkins B, Bermes E. An evaluation of a spectrophotometric scanning technique for measurement of plasma hemoglobin. Ann Clin Lab Sci. 1981;11(2):126-31.

158. Knabbe C, Ratge D, Christen K, Sonntag O. Evaluation of sample integrity measurement with VITROS® 5,1 FS chemistry system. J Lab Med. 2009;33(1):33-8.

159. Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today 2004;24(2):105-12.

160. Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nurs. 2008;62(1):107-15.

161. Reason J, Hollnagel E, Paries J. Revisiting the «swiss cheese» model of accidents. J Clin Eng. 2006;27:110-5.

162. Pluye P, Grad R, Repchinsky C, Jovaisas B, Johnson‐Lafleur J, Carrier ME, Granikov V, Farrell B, Rodriguez C, Bartlett G, Loiselle C, Légaré F. Four levels of outcomes of information‐seeking: A mixed methods study in primary health care. J Am Soc Inf Sci Tec. 2013;64(1):108-25.

61

163. Ploeg J, Davies B, Edwards N, Gifford W, Miller PE. Factors influencing best-practice guideline implementation: lessons learned from administrators, nursing staff, and project leaders. Worldv Evid-Based Nu. 2007;4(4):210-9.

164. Amalberti R, Brami J. ‘Tempos’ management in primary care: a key factor for classifying adverse events, and improving quality and safety. BMJ Qual Saf. 2012;21(9):729-36.

165. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, Vassault AJ, Mattiuzzi C, Plebani M. Causes, consequences, detection, and prevention of identification errors in laboratory diagnostics. Clin Chem Lab Med. 2009;47(2):143-53.

166. Lippi G, Becan-McBride K, Behúlová D, Bowen RA, Church S, Delanghe J, Grankvist, Kitchen S, Nybo M, Nauck M, Nikolac N, Palicka V, Plebani M, Sandberg S, Simundic AM. Preanalytical quality improvement: in quality we trust. Clin Chem Lab Med. 2013;51(1):229-41.

167. SOSFS 2008:14. Socialstyrelsens föreskrifter om informationshantering och journalföring i hälso- och sjukvården (In Swedish). Stockholm: Socialstyrelsen.

168. SOSFS 2011:9. Socialstyrelsens föreskrifter och allmänna råd om ledningssystem för systematiskt kvalitetsarbete (In Swedish). Stockholm: Socialstyrelsen.

169. Sandström B, Borglin G, Nilsson R, Willman A. Promoting the implementation of evidence-based practice: a literature review focusing on the role of nursing leadership. Worldv Evid-Based Nu. 2011;8(4):212-23.

170. Goethals S, Gastmans C, de Casterlé BD. Nurses’ ethical reasoning and behaviour: A literature review. Int J Nurs Stud. 2010;47(5):635-50.

171. Flodgren G, Parmelli E, Doumit G, Gattellari M, O’Brien MA, Grimshaw J, Eccles MP. Local opinion leaders: effects on professional practice and health care outcomes (Review). The Cochrane Collaboration. Chichester: Wiley & Sons, Ltd; 2011, Review.

172. Gunningberg L, Brudin L, Idvall E. Nurse managers’ prerequisite for nursing development: a survey on pressure ulcers and contextual factors in hospital organizations. J Nurs Manag. 2010;18(6):757-66.

173. Fink R, Thompson CJ, Bonnes D. Overcoming barriers and promoting the use of research in practice. J Nurs Adm. 2005;35(3):121-9.

174. McCormack B, Kitson A, Harvey G, Rycroft‐Malone J, Titchen A, Seers K. Getting evidence into practice: the meaning of 'context'. J Adv Nurs. 2002;38(1):94-104.

175. Squires JE, Estabrooks CA, Gustavsson P, Wallin L. Individual determinants of research utilization by nurses: a systematic review update. Implement Sci. 2011;6:1.

176. Pronovost P, Sexton B. Assessing safety culture: guidelines and recommendations. Qual Saf Health Care 2005;14(4):231-3.

62

177. ICN - International Council of Nurses. The ICN Code of Ethics for Nurses. Geneva: ICN - International Council of Nurses; 2012.

178. Benner P. Using the Dreyfus model of skill acquisition to describe and interpret skill acquisition and clinical judgment in nursing practice and education. B Sci Technol Soc. 2004;24(3):188-99.

179. Mahmood A, Chaudhury H, Gaumont A, Rust T. Long-term care physical environments–effect on medication errors. Int J Health Care Qual Assur. 2012;25(5):431-41.

180. Meriläinen M, Kyngäs H, Ala-Kokko T. 24-hour intensive care: an observational study of an environment and events. Intensive Crit Care Nurs. 2010;26(5):246-53.

181. Bek A. Undervisning och reflektion: Om undervisning och förutsättningar för studenters reflektion mot bakgrund av teorier om erfarenhetslärande [dissertation]. Umeå: Umeå University; 2012.

182. Lillo R, Salinas M, López Garrigós M, Naranjo Santana Y, Gutiérrez M, Marín MD, Miralles M, Uris J. Reducing preanalytical laboratory sample errors through educational and technological interventions. Clin Lab. 2012;58(9-10):911-7.

183. Nilsson K, Grankvist K, Juthberg C, Brulin C, Soderberg J. Deviations from venous blood specimen collection guideline adherence among senior nursing students. Nurse Educ Today 2014;34(2):237-42.

184. Davies P, Walker AE, Grimshaw JM. A systematic review of the use of theory in the design of guideline dissemination and implementation strategies and interpretation of the results of rigorous evaluations. Implement Sci. 2010;5:14.

185. Grol RP, Bosch MC, Hulscher ME, Eccles MP, Wensing M. Planning and studying improvement in patient care: the use of theoretical perspectives. Milbank Q. 2007;85(1):93-138.

186. Foy R, Ovretveit J, Shekelle PG, Pronovost PJ, Taylor SL, Dy S, et al. The role of theory in research to develop and evaluate the implementation of patient safety practices. BMJ Qual Saf. 2011;20(5):453-9.

187. Ovretveit J. Understanding the conditions for improvement: research to discover which context influences affect improvement success. BMJ Qual Saf. 2011;20(1):18-23.

188. Eddy E, M,. Common Screening Tests. Philadelphia: American College of Physicians; 1991.

189. Means B, Toyama Y, Murphy R, Bakia M, Jones K. Evaluation of evidence-based practices in online learning: A meta-analysis and review of online learning studies. Washington, D.C: U.S Department of Education; 2010.

190. Chang WY, Hsiao Sheen ST, Chang PC, Lee PH. Developing an E-learning education programme for staff nurses: processes and outcomes. Nurse Educ Today. 2008;28(7):822-8.

191. Lain D, Aston J. Literature review of evidence on e-learning in the workplace. Brighton: Institute for employment studies; 2005.

192. Lima-Oliveira G, Lippi G, Luca Salvagno G, Montagnana M, Picheth G, Cesare Guidi G. The effective reduction of tourniquet application

63

time after minor modification of the CLSI H03-A6 blood collection procedure. Biochem Med. 2013;23(3):308-15.

193. Heyer NJ, Derzon JH, Winges L, Shaw C, Mass D, Snyder SR, Epner P, Nichols JH, Gayken JA, Ernst D, Liebow EB. Effectiveness of practices to reduce blood sample hemolysis in EDs: A laboratory medicine best practices systematic review and meta-analysis. Clin Biochem. 2012;45(13-14):1012-32.

194. Reierson IÅ, Hvidsten A, Wighus M, Brungot S, Bjørk IT. Key issues and challenges in developing a pedagogical intervention in the simulation skills center–an action research study. NEP. 2013;13(4):294-300.

Appendix

Questionnaire regarding blood-sampling practices at primary health care centres (PHCs)

(Please read the attached information letter before proceeding below)

Instructions for completing the questionnaire This questionnaire contains questions concerning venous blood sampling for clinical chemistry analysis. You will be asked to complete a few yes/no questions. You will also be asked if you Never, Seldom, Often or Always carry out a task in a specific manner. It is important that you select the most suitable alternative from the choices given. This means that you should not mark an answer between two alternatives. In the final question we will ask for your opinion and suggestions.

Mark your answers by placing a cross in the box beside the most suitable alternative

If you wish to change an answer, fill in the incorrectly marked box completely █

We are interested in how you carry out your daily work. If you are unsure of how to answer a question – answer how you usually do. In questions like in the example below, it is IMPORTANT that you mark one alternative for EACH row. Example of a correct answer:

Ⓐ Which utensil do you use for eating soup?

Never Seldom Often Always

a) Fork □□ □□ □□

b) Spoon □□ □□ □□

c) Knife □□ □□ □□

Place the completed questionnaire in the enclosed envelope, seal it and give the envelope to the head of your PHC. We will collect the envelopes at the end of the survey period.

It is crucial that you answer the questions as honestly and carefully as possible. This means that you should answer how you usually perform a given task, not how you know that it is supposed to be done.

The following section contain questions regarding year of birth, education and routines

1 In which year were you born?

19 __ __

2 For how long have you been employed at this PHC?

_ _ year _ _ month

3 How often do you carry out venous blood sampling?

Every workday □□ Every week □□

Every month □□ More seldom □□

Never □□

4 Which year did you receive your most recent education in venous blood sampling?

_ _ _ _

5 Which year did you before that, receive education for venous blood sampling?

_ _ _ _

6 Do you want education in venous blood sampling?

No □□ Yes □□

The following questions concern patient identification and collection of specimen

It is important for you to mark ONE alternative for EACH row in the following section.

7 How and how often do you check the identity of a patient when collecting venous blood samples?

Never Seldom Often Always

a) I ask the patient to state his/her name and social security number □□ □□ □□ □□

b) I already know the patient and don’t have to check this □□ □□ □□ □□ c) I ask the patients relatives □□ □□ □□ □□ dd)) II cchheecckk tthhee ppaattiieenntt’’ss pphhoottoo--IIDD □□ □□ □□ □□ ee)) BByy ootthheerr mmeeaannss::................................................................................................................................ □□ □□ □□ □□ 8 If you use stasis when performing venous blood sampling, when do you remove it?

Never Seldom Often Always

a) Before the first sample is drawn □□ □□ □□ □□ b) During sampling □□ □□ □□ □□ c) When the sampling is finished □□ □□ □□ □□ d) If there is difficulty collecting the sample, I keep the stasis as long as necessary □□ □□ □□ □□

9 How long do you usually allow your patient to rest (supine or sitting) prior to venous blood sampling?

Not at all

0-5 min 6-10 min 11-15 min More then 15 min I don’t check this

□□ □□ □□ □□ □□ □□

10 How often do you carry out the following tasks? Never Seldom Often Always a) If the test tube has an additive, invert the test tube several times immediately before the next one is filled? □□ □□ □□ □□

b) Use an automatic test tube inverter □□ □□ □□ □□

The following questions concern sample storage and seeking information

It is important for you to mark ONE alternative for EACH row in the following section.

11 What do you do when you are not sure of how a sample should be collected? Never Seldom Often Always a) I check printed sampling instructions (available at the PHC) issued by the lab □□ □□ □□ □□ b) I check sampling instructions on the lab homepage/on the internal network

□□ □□ □□ □□

c) I ask a college □□ □□ □□ □□ dd)) II ccaallll tthhee llaabb □□ □□ □□ □□ ee)) BByy ootthheerr wwaayy::.......................................................................................................................................... □□ □□ □□ □□

12 How do you store the test tubes immediately after sampling? Never Seldom Often Always

a) Lying on a workbench or other similar location □□ □□ □□ □□ b) In the pocket of my work wear □□ □□ □□ □□ c) In a test tube stand □□ □□ □□ □□ d) By other mean:………………………………………………. □□ □□ □□ □□

The following questions ONLY concern sampling with paper based test requests

It is important for you to mark ONE alternative for EACH row in the following section.

13 How often does someone else mark the sampling time on the test request?

Every day Every week Every month More seldom Never

□□ □□ □□ □□ □□

14 When do you mark the sampling time on the test request, if you do it yourself?

I never mark sampling time

More than 30 min before sampling

0-30 min before sampling

0-30 min after sampling

More than 30 min after sampling

□□ □□ □□ □□ □□ 15 How often do you perform the following tasks? Never Seldom Often Always a) Compare the patient’s name and social security number with the information on the test request □□ □□ □□ □□

b) Use test requests that somebody else has filled in □□ □□ □□ □□ c) Sign the test request □□ □□ □□ □□ d) Check the information on the test request, if somebody else has completed it □□ □□ □□ □□ e) Adjust sampling time on the test request, if the marked time differ with more than 30 min from the actual sampling time? □□ □□ □□ □□ f) Check that the test request and test tube identification (barcode) numbers match, before delivery to the laboratory

□□ □□ □□ □□

16 When do you label the test tube? Never Seldom Often Always

a) Before I approach the patient □□ □□ □□ □□ b) Alongside the patient before sampling □□ □□ □□ □□ c) Alongside the patient after sampling □□ □□ □□ □□ d) At a later occasion □□ □□ □□ □□ e) Somebody else has labelled the test tube in advance □□ □□ □□ □□ f) Somebody else labels the test tube after sampling □□ □□ □□ □□

These final questions concern error reporting, ranking and suggestions

It is important that you to mark ONE alternative for EACH row in the following section

17 Approximately, how many error reports have you written after observing or making an error in venous blood sampling?

Number of times Haven’t written any

_ _ times □ 18 If you have refrained from writing a error report: What was/were the reason/reasons?

(Please complete the questions below even if you have never written any report.)

Never Seldom Often Always

a) I don’t have enough time □□ □□ □□ □□ b) It wouldn’t make any difference □□ □□ □□ □□ c) Nobody else does □□ □□ □□ □□ d) It is too complicated □□ □□ □□ □□ e) The head of the PHC writes the error reports □□ □□ □□ □□ f) I am concerned about possible consequences (specify below) □□ □□ □□ □□ ………………………………………………………………………………………………………………………

g) By other reason:……………………………………………… □□ □□ □□ □□ 19 To what extent do you agree in the following statements?

Do not

agree at all Agree to

some extent Totally agree

a) I have enough knowledge for my daily work with respect to venous blood sampling and specimen handling □□ □□ □□ b) Proper collection and handling of venous blood samples is considered a priority at my PHC □□ □□ □□

Thank you for completing the questionnaire!

Please make sure that you have completed all questions, then place the questionnaire in the enclosed anonymous returning envelope, seal it, and give the envelope to the head of your PHC.