propedeutica complementar erros laboratoriais ii

Clin Chem Lab Med 2009;47(2):143–153 � 2009 by Walter de Gruyter • Berlin • New York. DOI 10.1515/CCLM.2009.045 2009/361Article in press - uncorrected proof

Review

Causes, consequences, detection, and prevention of

identification errors in laboratory diagnostics

Giuseppe Lippi1–3,*, Norbert Blanckaert2,4,

Pierangelo Bonini2,3,5, Sol Green2,6,

Steve Kitchen2,7, Vladimir Palicka2,8,

Anne J. Vassault2,9, Camilla Mattiuzzi10

and Mario Plebani3,11

1 Clinical Chemistry Laboratory, University ofVerona, Verona, Italy2 EPSC – European Preanalytical ScientificCommittee (www.specimencare.com)3 International Federation of Clinical ChemistryWorking Group on Patient’s Safety4 Laboratory Medicine, University Hospital Leuven,Leuven, Belgium5 Clinical Biochemistry, School of Medicine,University Vita-Salute San Raffaele, Milano, Italy6 BD Diagnostics – Preanalytical Systems, NewJersey, USA7 Sheffield Hemophilia and Thrombosis Center,Royal Hallamshire Hospital, Sheffield, UK8 Institute of Clinical Biochemistry and Diagnostics,Charles University, Medical Faculty and UniversityHospital, Hradec Kralove, Czech Republic9 Laboratoire de Biochimie B, Hopital Necker EnfantsMalades, APHP, Paris, France10 Direzione Medica, Azienda Ospedaliera di Verona,Verona, Italy11 Department of Laboratory Medicine, University ofPadova, Padova, Italy

Abstract

Laboratory diagnostics, a pivotal part of clinical deci-sion making, is no safer than other areas of health-care, with most errors occurring in the manuallyintensive preanalytical process. Patient misidentifica-tion errors are potentially associated with the worstclinical outcome due to the potential for misdiagnosisand inappropriate therapy. While it is misleadinglyassumed that identification errors occur at a low fre-quency in clinical laboratories, misidentification ofgeneral laboratory specimens is around 1% and canproduce serious harm to patients, when not promptlydetected. This article focuses on this challengingissue, providing an overview on the prevalence and

*Corresponding author: Prof. Giuseppe Lippi, MD, Sezionedi Chimica e Microscopia Clinica, Dipartimento di ScienzeMorfologico-Biomediche, Universita degli Studi di Verona,Ospedale Policlinico G.B. Rossi, Piazzale Scuro, 10,37134 Verona, ItalyPhone: q39-045-8124308, Fax: q39-045-8201889,E-mail: [email protected], [email protected] July 16, 2008; accepted November 25, 2009;previously published online December 22, 2008

leading causes of identification errors, analyzing thepotential adverse consequences, and providing tent-ative guidelines for detection and prevention basedon direct-positive identification, the use of informa-tion technology for data entry, automated systems forpatient identification and specimen labeling, two ormore identifiers during sample collection and deltacheck technology to identify significant variance ofresults from historical values. Once misidentificationis detected, rejection and recollection is the most suit-able approach to manage the specimen.Clin Chem Lab Med 2009;47:143–53.

Keywords: errors; laboratory medicine; misidentifi-cation; patient identification; patient safety.

Introduction

Recent evidence attests that healthcare is no saferplace than it has traditionally been assumed to be.Today, an estimated 98,000 Americans die each yearas a result of medical error, and a nearly equalnumber succumbs to infections they acquire in hos-pitals (1). While those numbers have been revised byestimating the patient prognosis and probability thatdeath could have been prevented by optimal care (2),the more closely we examine patient care, the moreerror we find. These error rates mirror a disappointingsituation worldwide which is objectionable at thebeginning of the new millennium. In fact, despitemany efforts and recommendations to improvepatient safety, we still lack concrete evidence thatsafety and quality of healthcare have reached theirpinnacle. The National Coordinating Council for Med-ication Error Reporting and Prevention defines a med-ication error as ‘‘«any preventable event that maycause or lead to inappropriate medication use orpatient harm while the medication is in the control ofthe health care professional, patient, or consumer’’(3). By definition, medical errors can occur at anystage in professional practice, including prescribing,order communication, product labeling, packaging,compounding, dispensing, distribution, and adminis-tration. Although there is a common perception thatmost medical errors arise from inappropriate ordelayed clinical management, mistakes associatedwith diagnosis, either delayed or missed, may stilloccur with frequency. In the renowned publication ofthe IOM report on medical errors (To Err is Human)(1), the term ‘‘medication errors’’ is cited 70 times,while ‘‘diagnostic errors’’ appears only twice. This isinteresting, since diagnostic errors comprised 17% of

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the adverse events in the Harvard Medical PracticeStudy (from which 44,000–98,000 deaths numbers ofthe IOM were drawn), and account for twice as manymalpractice suits as medication errors (4). From lit-erature searches of English language studies identi-fied in the National Patient Safety Foundationbibliography database, Medline and EMBASE, diag-nostic errors vary from 26% to 78% of identified med-ical errors in a primary care setting (5). Overall, theerror rate in laboratory medicine ranges from lessthan 0.05% up to 10%, depending on the wide varietyof definitions, the methods for identifying error fre-quency and nature and the type of healthcare facility(6, 7). The great majority of these errors, however,occur for individual or system design defects in extra-analytical phases of the total testing process, espe-cially in the preanalytical setting, which is incidentallyone of the most labor-intensive activities and it islargely performed in the wards, outside the control ofthe clinical laboratory (8). Most errors arise from inad-equate procedures for collection of the specimen,including inappropriate quality (hemolysis, clotting,and contamination), insufficient volume to performthe analysis, inappropriate containers and, last butnot least, misidentification (7).

Despite the existence of an internationally acceptedrecommendation for the area of Laboratory Medicine(9), the practical application of the concept of ‘‘Direct(positive) identification’’ is limited. It must be empha-sized that this term indicates a situation where theidentity of the patient is unequivocally linked to thesample, and the link is maintained throughout thetotal testing process. A procedure for the correct iden-tification of patient and related objects in any medicalprocedure is also recommended by CEN – EuropeanCommittee for Standardization TC 251-Health Infor-matics (10). Therefore, through their work on the web-site specimencare.com and their cooperation with theInternational Federation of Clinical Chemistry andLaboratory Medicine (IFCC) Working Group on PatientSafety, the European Preanalytical Scientific Commit-tee realized that there was a need for a further reviewof patient misidentification, which is a concerningsource of errors in laboratory diagnostics.

Prevalence of patient misidentification

Proper patient identification is the mainstay of patientsafety in any healthcare organization, being a neces-sary component for providing safe (effective) clinicaland diagnostic services. Misidentification occurs notonly in consulting rooms, wards, and operating the-atres, but also in laboratories and imaging suites,often resulting in someone receiving inappropriatetreatment or getting the wrong test results. There is,however, an objective difficulty in providing a reliableestimate of this concerning phenomenon, since mis-identification errors are frequently not easily detect-able or, as in the case of front-line healthcare staff, noharm comes to the patient so it is not deemed to beworth the time to fill out an incident report. There also

may be the inhibition caused by fear of blame (11), orperhaps high levels of embarrassment since theerrors seem so simple to be prevented.

Misidentification is a major risk not only in the areaof laboratory medicine but in many other criticalissues concerning the patient treatment, such as pre-scription/administration of drugs; a proper identifica-tion of a patient should be carried out before anymedical procedure, possibly in an automatic way (12).A major area of risk involves blood transfusions. Asof March 2008, the Joint Commission (JC), formerlyJoint Commission on Accreditation of HealthcareOrganization, sentinel event database included 114cases of transfusion errors (Sentinel Event Alert �10)from January 1995 to March 2008 (13). Patient mis-identification was also cited in more than 100 individ-ual root cause analyses by the United StatesDepartment of Veterans Affairs (VA) National Centerfor Patient Safety from January 2000 to March 2003(14). Over the 12-month period of February 2006 toJanuary 2007, the United Kingdom National PatientSafety Agency received 24,382 reports of patientsbeing mismatched to their care (15). Retrospectiveand prospective data collected in an AcademicMedical Center showed that registration-associatedpatient misidentification errors occurred from 7 to 15times per month (16). A particularly common class oferrors results from patient misidentification in Neo-natal Intensive Care Units (NICU). Simpson et al.reported that 25% of the serious medication errorsthat were seen during a 6-month study period in aBritish NICU were caused by patient misidentification(17). Similarly, Suresh et al. reported that 11% and10% of errors, submitted to a voluntary, anonymous,internet-based reporting system for medical errorsover almost 2 years at the University of Vermont Col-lege of Medicine NICU, involved patient misidentifi-cation and mislabeling of samples, respectively (18).

Comprehensive statistics on identification errorsare available from the field of transfusion medicine,where the prevalence is reportedly heterogeneous,but the overall chance that a patient might receive ablood product intended for another patient is ratherhigh, approximately 1 in 20,000 (19, 20). A study usinghemolytic transfusion reactions as a case-findingmethod reported a specimen identification error rateof 19 per million specimens (21). A further study,based on historical ABO typing to determine whetheran incoming specimen was improperly identified,estimated a ‘‘wrong blood in tube’’ rate of 337 permillion specimens (22). Data from New York Statealso indicate that approximately 1 of every 33,000 redcell units transfused is ABO-incompatible with therecipient. National application of these data suggeststhat as many as 360 ABO-incompatible whole bloodand red cell transfusions might occur annually in theUnited States (12). Based on reports of the SeriousHazards of Transfusion (SHOT scheme) between 1996and 2003, the risk of an error occurring during trans-fusion of a blood component is estimated at 1:16,500and of receiving an ABO-incompatible transfusion at1:100,000 (23). Phlebotomy and blood bank laboratory



Lippi et al.: Patient misidentification and laboratory medicine 145


Table 1 Prevailing causes of misidentification in laboratorydiagnostics.

1. Physician ordering laboratory tests on the wrongpatient

2. Incorrect or incomplete entry of patient’s data inthe Laboratory Information System

3. Collection of specimens from the wrong patient4. Inappropriate labeling of the specimens5. Lost identification (label) on the specimens6. Incorrect entry of patient’s results in the database

of the Laboratory Information System

errors cause some of these ABO-incompatible trans-fusions, but the greatest number result either partiallyor solely from the failure of transfusionists to properlyidentify either the patient or the blood component thepatient receives.

With the exception of blood transfusion practice,the prevalence of patient misidentification in otherhealthcare settings, such as clinical laboratories, hasbeen less extensively investigated. Unfortunately,misidentification often has complex causal pathways,takes time to be revealed and may not harm for hours(missed acute pulmonary embolism), days (misseddeep vein thrombosis), or even years (missed cancer).Therefore, it does not produce the same visceralwallop as misadministration of drugs or wrong-sitesurgery. Moreover, diagnostic errors are difficult todetect objectively, particularly through retrospectivechart review. However, although patient identificationerrors in transfusion medicine occur in 0.05% of spec-imens, the rate is much higher for general laboratoryspecimens, around 1% (24). In 1995, a prior Q-Probesstudy observed a misidentification error rate of 7.4%,with individual hospital rates generally related to hos-pital size, smaller hospitals having a higher error rate(25). A subsequent Q-Tracks inter-laboratory qualityimprovement program showed a reduction of the ini-tial error rate of 7.4% to 3.1% following continuousmonitoring and educational initiatives (26). A study of14 Australian laboratories, where errors transcribinga patient’s name from pathology requisitions to com-puter systems were reviewed, the median institutionmade transcription errors involving patient identity in1% of cases, whereas the worst performer made iden-tification errors in 9% of cases (27). In the College ofAmerican Pathologists (CAP) Q-Probe study, per-formed in 660 institutions, a total of 5514 of 114,934outpatient requisitions (4.8%) were associated with atleast one type of order entry error, including one ormore discrepancies in the identity of patients or phy-sicians (28). Reviewing more recent studies on thistopic, laboratory errors due to misidentificationranged from 1% to 2% for inpatients and from 0.2%to 6% for outpatients (29). More recently, Carraro andPlebani reported that the frequency of misidentifica-tion in a stat laboratory might be as high as 8.8% (30).An additional CAP Q-Probes study of patient andspecimen identification errors at 120 institutions iden-tified an overall rate of patient identification errors of55 per 1,000,000 billable tests. More than 50% of iden-tification errors were reported to result from primaryspecimen labeling errors, and 22% were attributed tocomputer registration errors or order entry errors. Inthis study, 5731 identification errors were detectedbefore test results were released, and 974 were foundafter results had been verified. Thus, 85% of reportedidentification errors were detected within the labora-tory before result verification (31).

Causes of patient misidentification

Many factors may contribute to misidentification,including malpractice, issues related to workflow,materials used in the identification process, or the

approach taken by the staff to confirm the identity ofindividual patients (Table 1). Pragmatically, all thesecauses arise throughout the preanalytical step of thetotal testing process and can be clustered into fivemajor categories: incorrect collection of patient’s dataon admission, collection of specimens from thewrong patient, problems with labels on the speci-mens, problems emerging during specimen process-ing, and incorrect entry of patient’s results in theLaboratory Information System (LIS) database.

A common charting error involves a physicianordering laboratory tests on the wrong patient, eitherbecause the patient gives someone else’s identity orbecause the physician makes mistakes while com-pleting the order. Patients with identical names pres-ent a unique challenge to acute healthcare settings, asituation particularly relevant in communities wheremost individual’s names are not unique (32). If apatient is misidentified during admission, incorrectdata are entered in the patient’s profile and an incor-rect armband might be generated and placed on thepatient’s wrist. Apparently, simple data, such as anindividual’s name or date of birth, might be muchmore complex than they first appear and may poseproblems for the use of informatics tools. Mistakesmight also occur as a result of language or commu-nication barriers: names of patients coming from for-eign countries might be unfamiliar to the localhealthcare personnel and potentially misspelled ormisinterpreted, especially when handwritten. As forpublic demand, a doctor’s handwriting has been fod-der for jokes for decades. Accordingly, handwrittenentries, small font size, and poor visibility of thepatient’s name and number on paper order copies(often via an addressograph imprint), compounded bylook-alike last names, can also result in enteringorders into the incorrect profile. If the patient is un-able to speak, the problem remains. Misidentificationmay also occur for data duplication (patient name andmedical record number, MRN) in the healthcare sys-tem, when patients might be attributed with identicalidentification codes. Collection of specimens from thewrong patient is a common cause of misidentifica-tion. Under some circumstances, either intentionallyor accidentally, the patients’ armbands might havebeen removed and studies have indicated that manypatient-identification errors occur when patients arewithout identification armbands. Less frequently,errors might arise as patients are wearing more thanone wristband (33). The risk of sample misidentifica-





tion is likely to be higher when there is a spatial and/or temporal interval between patient identification,sample labeling, and blood drawing. Other causes arebiological samples with lost identity (label), labeledwith incorrect accession numbers, multiple phlebot-omists using one printer, resulting in mixing one ano-ther’s printed labels, specimens batched in areas withpre-printed labels from different patients, handwrittenlabels being applied to specimen containers, tissuecassettes, and slides, all frequently leading to mis-identification (33).

Incorrect entry of patient results in the LIS databasecan occur, especially when a query-host systembetween instrument and LIS is unavailable or mal-functioning. The laboratory personnel are henceforced to enter data manually by using initials or partsof the name, digits of the National Healthcare Systemor laboratory code. Many facilities always encounterpatients with the same name or similar identificationnumbers and, to our knowledge, no system of alertshas been developed when such data duplicationoccurs in a health system.

The NICU environment and patient population pres-ent additional challenges since the complex nature ofthis ward and the vulnerability of the population plac-es young patients at extremely high risk of misiden-tification and so to adverse events related to theseerrors. Unlike many pediatric or adult wards, NICUpatients are not able to participate actively in the iden-tification process and many of the commonly usedmethods to identify individuals in everyday life, suchas physical appearance (size, age, hair color, and gen-der), are not immediately apparent or distinguishablewithin this population. As such, NICU clinicians mustrely on standardized patient wristbands for identific-ation purposes (34). Unfortunately, however, wrist-bands might not be regarded as a panacea, in thatreports from general hospital and NICU populationsdemonstrate that errors in wristband content or usemight also be frequent, thus underlining the impor-tance of quality and information contained in thewristband itself. A survey from the CAP identified45,197 errors out of 1,757,730 (2.6%) wristbands dur-ing 2 years monitoring (1999–2000) in 217 institu-tions, which were attributed to missing wristbands(72%), missing ID information (9%), illegible wrist-band (8%), erroneous ID information (7%), conflictingwristband (4%), and incorrect wristband (1%) (26).Recent reviews of experience within the 34 NICUs ofthe Vermont Oxford NICQ 2002 Quality ImprovementCollaborative found that standard identification bandsare not present on 20%–80% of NICU patients (34).Conversely, identification bands are often affixed to apatient’s bedside or chart. In part, this practice is relat-ed to concerns regarding the fragility of a prematureinfant’s skin that can lead to skin lacerations and ero-sions when standard plastic-coated identificationbands are placed around arms or legs. In addition, theneed to rotate intravenous lines frequently betweenlimited sites often requires identification bands to beremoved. Even when identification bands are presentand contain the correct identifying information, these

identifiers may not be recognizably unique to busyNICU clinicians. The sequential nature by whichMRNs are assigned in many hospitals means thatpatients who are admitted to the NICU within a rela-tively short timeframe are at highest risk of sharingsimilar medication administration records, a problemexacerbated by multiple births (34).

Potential consequences of patient misidentification

Although harmful incidents from patient misidentifi-cation are frequently reported, there are many differ-ences in degree and definition across the availablestudies, which make it rather difficult to draw defini-tive conclusions. Reports of fatal hemolytic transfu-sion reactions due to misidentification of laboratoryspecimens have appeared in mass media and peer-reviewed literature for decades (20, 35), accountingfor the largest proportion of all adverse events. Basedon reports of the Serious Hazards of Transfusion(SHOT scheme) between 1996 and 2003, the risk ofdeath as a result of an incorrect blood componenttransfused is around 1:1,500,000 (23). The hemovigi-lance program in Quebec identified mistransfusion asthe most common major adverse event occurring ata rate of 1 in 12,000 transfusions (36), and similar find-ings have been reported from the hemovigilance pro-gram in France (37).

It is often difficult to establish a strict causal linkbetween laboratory errors and patient outcomes,especially outside the transfusion medicine setting.There is, however, clear evidence that laboratoryerrors, in general, might impact on patient care pro-ducing serious harm, with a risk of inappropriate careand adverse events ranging from 6.4% to 12% of totalerrors (6). Nutting et al. reported that 27% of labora-tory problems discovered in their survey were judgedby the physician to have an effect on patient care (38).In a study monitoring laboratory mistakes in statexams from four different departments, Plebani andCarraro concluded that most of the laboratory mis-takes (74%) did not affect patient outcomes (39). How-ever, in 19% of the patients they were associated withfurther inappropriate investigations and unjustifiableincreases in costs, whereas in 6.4% of the patientsthey were associated with inappropriate care or inap-propriate modification of therapy (2.2% inappropriatetransfusion, 2.2% inappropriate modification of hep-arin infusion, 1.0% inappropriate infusion of electro-lyte solution, and 1.0% inappropriate modification ofdigoxin therapy) (39). Hofgartner and Tait also report-ed the average level of actual harm resulting fromerrors during clinical genetic testing; moderate orhigh levels of harm occurred in only 0.008% of totalcases (40). When relating patient harm to the specificproblem of misidentification, the CAP Q-Probes studyreported that approximately 1 in 18 identificationerrors resulted in an adverse event. More than 70%of the adverse events resulted in significant patientinconvenience with no known change in treatment oroutcome. Extrapolating the adverse event rateobserved in this study to all United States hospital-based laboratories suggests that more than 160,000





adverse events per year result from misidentificationof patients’ laboratory specimens (31). In February2006, a project completed at the VA New York HarborHealthcare System identified several adverse conse-quences associated with misidentification of patientsamples, including unnecessary prostatectomies,delay in treatment of tumors or infections, medicaltreatment for the incorrect patients, unnecessarydiagnostic procedures, and unnecessary hospitaliza-tions (33). Suresh et al. also highlighted that identifi-cation errors in the NICU might produce serious harmin 2% of the cases, and minor harm in 25% of thecases, respectively (18). These events are particularlyconcerning, as a significant number could be easilyprevented by an obsessive attention to clerical details(41).

Detection and prevention of patient

misidentification

Patient identification has represented for a long timea dogma for many operating within the healthcaresystem. Despite some progress, however, correctpatient identification is still a goal that must beachieved to obtain the best possible standard of care.As such, improving the accuracy of patient identifi-cation has been the most important among the JCNational Patient Safety Goals from 2003 throughout2008, which includes the specific issue ‘‘Improve theaccuracy of patient identification’’ in the ‘‘AmbulatoryCare Program’’ (42). Awareness of a problem does notmean, however, that there is always an easy solutionand the many efforts placed to overcome this chal-lenge have been somehow less productive thanexpected. According to Leape and Berwick, the needto reduce medical errors is obvious and the mandateis clear (43). Nevertheless, there are no ‘‘quick fixes’’,nor are there ready-to-use universal solutions and sothe necessary changes are implemented as a varietyof cultural and technical changes. First and foremost,like any industrial process, a system that measuresquality and safety must be created and implementedwithin the daily practice. Regardless of the specifictarget, two approaches for improving quality inhealthcare are commonly suggested. The first, called‘‘quality by inspection’’, is a system based on thebelief that quality is best achieved by removing ‘‘badapples.’’ The second, based on the theory of contin-uous improvement, calls for understanding and revi-sion of the production process rather than placingblame on the individual (44). While the problem ofmedical error is not fundamental due to lack of knowl-edge (45), laboratory errors represent a distinctiveentity, since ‘‘malpractice’’ can result from education-al drawbacks other than environmental or attitudinalpitfalls. Typically, healthcare workers, similar toemployees in many other industries, tend to workaround problems when these are encountered, meet-ing patients’ immediate needs but not resolving theroot causes of the problems, so that they are facedwith the same problems every day for years. These

persistent difficulties manifest themselves as regularinefficiencies within the system, and they occasion-ally lead to catastrophic mistakes. Basically, thechance of misidentification may develop at any stagein the total testing process and increases exponen-tially with the number of steps through which it mustpass. As originally depicted by ‘‘Reason using the tra-ditional Swiss cheese model’’, an error (misidentifi-cation) is the consequence of an accident trajectory(unpredictable event) penetrating the defensive layersof a particular process (laboratory diagnostics). Eachdefensive layer (slice of cheese) has a number ofvulnerabilities (holes) that are continually opening,shutting, and shifting their location, leaving theopportunity for a trajectory of accident opportunitythat may irreversibly penetrate the barrier (46). There-fore, the most suitable solution for such a concerningvulnerability is to re-examine processes and redesignall the steps to make them less vulnerable to humanor technical errors, i.e., ‘‘Root Cause Analysis’’ (RCA).RCA is designed as a process to describe in chrono-logical and precise detail what happened during aclose call or an adverse event, identify the root causesof that event and, most importantly, recommend cor-rective actions. To successfully prevent laboratoryerrors, a process and risk analysis, i.e., the detectionof the most critical and at risk steps in the laboratoryprocess, is very important. In this respect, the use ofthe ISO risk curve, representing the most critical pro-cesses as a result of the cognitive analysis, hazardand operability study and absolute probability judg-ment can be very helpful (47, 48). Although it is the-oretically possible to find all identification errors (e.g.,by performing molecular identity testing on everyspecimen) (31), this is impractical to achieve in prac-tice and several, alternative ‘‘defensive layers’’ shouldbe set (Figure 1).

Monitor identification errors

Although RCA is prerogative of total quality systemsin both industry and healthcare, it needs to be linkedto a reliable error monitoring system to work properly(29). Laboratory service errors are detected in manyways, including caregiver complaints, incident reportsfrom inside or outside the laboratory, error checkingprotocols within the laboratory, and a variety of labo-ratory management reports. Basically, the number oferrors found at a particular institution depends tosome degree on how methodically laboratory staffand clinical caregivers look for errors. This fact some-times produces a paradox, in that facilities that aremore focused on detecting and correcting errors mayappear to have error rates higher than rates at insti-tutions that do not pay as much attention to dis-covering errors (31). Nevertheless, a continuousmonitoring process based on reliable performanceindicators adapted to the local environment wouldhelp detect vulnerabilities, allowing redesign or reor-ganization of processes according to a safer model,possibly with decreased complexity and hence lesserror-prone activities. The opportunity to relate iden-tification errors to economical and clinical outcomes





Figure 1 Prevention of identification errors throughout the total testing process.

would also provide the ideal basis for an efficientaudit and feedback with clinical departments anddecentralized ambulatory facilities, improving theentire healthcare process. Powerfully supported byinnovative information technology, this approachwould not entail extraordinary expenditures, which isan important consideration for healthcare managers(29). Preliminary experiences demonstrate that ongo-ing monitoring is worthwhile, as it is associated witha lower rate of misidentification (31). Obviously, thissystem will only work if preventive and correctiveactions are taken to eliminate the root cause of adetected non-conformity.

Accurate data entry

As most identification errors arise during order entryor patient admission, handwritten entries and smallfont sizes should be avoided. Moreover, patient datashould be carefully checked for potential duplication(patient name and codes). If feasible, computerizedphysician order entry should be preferred and systemof alerts should be made available to warn about

potential duplication of data (patient name and/orcodes).

Appropriate patient identification during sample

collection – direct (positive) identification

For a fail-safe patient sample identification system, asmentioned above, the identity of the patient must beunequivocally linked to the sample container at thesample collection phase, this link being maintainedthroughout the total testing process. To concretizethis recommendation, a patient sample identificationsystem is needed, where safety does not depend onthe good will of operators, but on necessary require-ments in all relevant operations. This means that ifany step of the procedure is not correctly followed,the system should stop operations automatically. Ifsuch a procedure is not technically feasible, anacceptable level of safety must be an integral com-ponent of the system in which it is always possible tocheck if all the operations have been correctly per-formed. This means that, at any point in the link tothe patient, sample collection, sample processing and





result reporting, or other service where identificationis at risk, the system should ensure its integral secu-rity. Security at the collection phase would also implylabels to be automatically generated as a result of arequest, printed by a device located near the patient,just before venipuncture, obligatorily activated by anidentification worn by the patient (e.g., a wrist-brace-let with patient data) or strictly linked to the patient’sbody. Alternatively, if labeled blood collection tubesare prepared in advance, patient identification report-ed on patient sample containers should be automati-cally matched, at the time of venipuncture, withpatient data reported on a wrist-bracelet or otherdevice attached to the patient’s body. This transactionmust be automatically recorded (9). The JC NationalPatient Safety Goal 1A clearly mandates to ‘‘use atleast two patient identifiers (neither to be the patientroom number) when providing care, treatment orservices, including taking blood samples and otherspecimens for clinical testing’’ (42). Therefore, patientverification using two identifiers should be requiredfor all critical processes, especially medication useand diagnostic/monitoring activities. Of course, hos-pitals would have to make it a priority to ensure thattwo identifiers (e.g., name, birth date, identificationnumber) are readily available and clearly legible tostaff for verification. Moreover, standardization ofphlebotomy around a new process (‘‘single pieceflow’’) in which only one patient with one set ofpatient labels is handled at a time, and a secondpatient is not phlebotomized until the first patient’sspecimens are submitted to the laboratory is recom-mended (49).

Automated systems for patient identification

Positive patient identification provides the foundationfor error prevention and improvements in numerouspatient-care applications. The pressure to use bar-codes, especially for improving medication adminis-tration safety, has come from many organizations,including professional societies, hospital networks,industry consortiums, and patient safety groups. TheJC also suggests considering, where feasible, imple-mentation of automated systems (e.g., electronicorder entry, barcoding, radiofrequency identification,biometrics) to decrease the potential for identificationerrors (50). Barcode data entry can be used for record-ing patient’s data on admission, for safe collectionand labeling of the specimens and for entering resultsin the LIS. Since their invention in the 20th century,barcodes – especially the Universal Product Code(UPC) – have become an essential part of modern civ-ilization. Their use is widespread, and the technologybehind barcodes is constantly improving. Originally,barcodes stored data in the widths and spacing ofprinted parallel lines, but now they also come inpatterns of dots, concentric circles, and text codeshidden within images. Barcodes can be read by opti-cal scanners called barcode readers or scanned froman image by special software. Barcodes are widelyused to implement Automatic Identification and DataCapture (AIDC) systems that automatically identify

objects, collect data about them, and enter that datadirectly into computer systems. Technologies typical-ly considered as part of AIDC include barcodes, radiofrequency identification (RFID), biometrics, magneticstripes, optical character recognition, smart cards,and voice recognition (35). In a valuable effort towardstandardization of the design of patient wristbands,information on them and processes used to produceand check them in the healthcare setting, from 18 July2008 all national healthcare system (NHS) organiza-tions in England and Wales that use patient wrist-bands should: 1) only use patient wristbands thatmeet the National Patient Safety Agency’s designrequirements; 2) only include core patient identifiers(last name, first name, date of birth, NHS number,first line of address); 3) develop clear and consistentprocesses, specifying which staff can produce, apply,and check patient wristbands; and 4) only use a whitewristband with black text (15). It is important to men-tion, however, that a patient can have multiple med-ical record numbers, each issued by the organizationthat provided them care, and such numbers uniquelyidentify the patient only within the issuing organiza-tion. A patient identifier that is unique only within oneorganization or enterprise does not address the issuesof matching patients and their data among differenthealthcare organizations. Therefore, the Food andDrug Administration (FDA) is currently exploringimplementation of a unique device identifier for med-ical devices, which will unequivocally contribute tofurther improve patient safety, reduce medical errors,facilitate device recalls, improve device adverse eventreporting and, last but not least, easing patient accessthroughout a variety of healthcare services.

Barcoding and RFID solutions are at the heart ofmany patient safety initiatives in healthcare facilities.The obvious advantage of these technologies is thatthey enable nurses, pharmacists, laboratory techni-cians, therapists, and other healthcare professionalsto record and verify information more quickly andaccurately than by handwriting or keyboard dataentry. Similarly, RFID systems, which do not requireline-of-sight access to patient identification bands(digital data encoded in an RFID tag or ‘‘smart label’’captured by a reader using radio waves), may provevaluable and even more practical. On admission,patient data are encoded in a barcode or RFID tag inthe wristband when it is printed (strict standardsshould be adopted to record comprehensive patientinformation, including first name, last name, middleinitials, date of birth, gender, healthcare code, medi-cal record number). Data are read and recorded byscanning with a barcode or RFID reader, instead ofmanually reading the wristband to verify the patient’sidentity. Readers are integrated with a computer thatlooks up the scan data in a database and displays thepatient information for the nurse or other caregiver.A barcoded wristband can provide two forms of iden-tification in one easy-to-access place by encoding thepatient name and identification number. Includingtwo forms of patient ID on the wristband aids HealthInsurance Portability and Accountability Act (HIPAA)





compliance, because information encoded in a bar-code instead of being expressed in text satisfies pri-vacy requirements. Before taking a biological sample,phlebotomists or nurses scan the patient’s barcodedwristband and check a mobile computer to verify thecorrect patient, the specifications of the order, andthat the sample has not already been taken. While thesample is being drawn, a mobile printer automaticallyproduces a barcoded label to accurately identify thesample. The staff member then immediately appliesthe label to the sample container. In the laboratory,incorporating barcode labels on test tubes, slides, andsample containers enable technicians to track speci-mens throughout the testing process all the waythrough the reporting of results. The required testscan even be encoded on the sample label in a two-dimensional (2-D) barcode or RFID tag to eliminateany chance of confusion as to what tests should beperformed. At the same time, this barcoding aids testresult recording and improves patient record accura-cy, it provides measurable process improvementsand time savings for laboratory staff. Finally, whenmanual entry of test results into the LIS is required,the laboratory technician can double check the patientcode by reading the barcode on the specimen andcompare it to that on the database of the LIS. Last butnot least, wristbands can be incorporated into physi-cal security systems. RFID chips can be embeddedwithin barcoded wristbands to provide an invisible,unobtrusive form of protection that can be readthrough bed linen, so patients do not have to be dis-turbed when sleeping. They can be used with fixedreaders in doorways and corridors, to help staff keeptrack of ambulatory patients. The chip on the wrist-band can also be read when the patient attempts toleave the ward, which may sound an alarm, trigger anotification at the nurses’ station, or even lock thedoor. In healthcare settings, RFID wristbands are typ-ically used to protect infants, Alzheimer’s patients,and others deemed a high risk. Despite the potentialbenefits of these auto-identification technologies, cli-nicians must ensure that such technologies are testedadequately in the unique environment of the health-care system and that they are implemented in a man-ner that avoids disruption of workflow. Nevertheless,automatic identification systems would end at least50% of preventable medical errors, according to theUS FDA (51). Accordingly, Killeen et al. reported thatthe introduction of barcodes in an emergency depart-ment reduced identification error rates from 2.56 to0.49 per 1000 specimens (52), a remarkable improve-ment which was also confirmed in separate studiesby Murphy and Kay (53), Nichols et al. (54) and Aske-land et al. (55). As in the adult wards, a barcode-basedelectronic positive patient and specimen identificationsystem was effective in reducing identification errorsin a pediatric hospital’s clinical laboratory (56). Theautomatic identification of samples is also recom-mended; each supply or disposable item used forpatients should be automatically identified by thesame procedure using new strategies of informationsystem management (57).

Appropriate labeling of the specimens

Phlebotomists and nurses should be educated regard-ing the proper policy and procedure for blood collec-tion. Whoever draws the blood must label the tube atthe patient’s bedside without taking the tube awayfrom the patient’s bedside. As already mentioned,automated labeling is preferable (the application ofhandwritten labels should be limited to exceptionalcases) and relabeling should be minimized (33). Newflexible polymer tubes containing lab-on-a-chip inte-grated with physical and biochemical sensor modulesmounted on a flexible spiral structure for measuringphysiological (temperature/flow rate) and metabolicdata (glucose concentration) in a catheter applicationhave recently been designed and fabricated (58).Expansion of this technology with RFID chips, con-taining a variety of patient data embedded in the pri-mary tubes (the only data contained in barcode labelsis a serial number) and equipped with signal com-munication modules, would be helpful not only forensuring high quality specimens but also for trackinglaboratory specimens more efficiently than usingother technologies, such as barcodes. The use ofRFID-based test tube systems would finally decreasethe chance of read errors, improving retrieval, man-agement, and security (both reading and writing ofdata to/from the RFID chip is more accurate and mightbe secured via a keycode) of high-value samples out-side and within the laboratory environment. It isimportant to mention, however, that the potential forharmful electromagnetic interference (EMI) by elec-tronic antitheft surveillance systems and RFID onimplantable pacemakers and defibrillators hasalready been recognized (59), and it has also beenrecently reported that RFID technology is capable ofinducing potentially hazardous incidents in medicaldevices, primarily due to malfunctioning of infusion/syringe pumps, external pacemakers, mechanicalventilators, and dialysis devices (60). Therefore,implementation of RFID in the intensive care unit andother similar healthcare environments should requireon-site EMI tests in addition to updated internationalstandards.

Adequate environment

An adequate environment is mandatory to preventany type of error in daily laboratory practice. Thework area should follow human factor principles forlaboratory personnel who apply accession numbersto incoming specimens and should be re-engineeredaccordingly. Afterwards, automation of both the pre-analytical and analytical processes should be pro-moted whenever possible by (i) introduction ofpreanalytical processors that eliminate a variety ofmanual steps (lower chance of mislabeling of aliquotsand losing labels from the tube), (ii) implementationof front-end automation and analyzers with directsampling from the primary tube (lower chance oferroneous patient’s data entry when manually pro-gramming the instrument), and (iii) consolidatingtests on less analytical platforms (smaller number of





tubes and lower chance of errors while performingaliquots from the primary sample). While workspacearound isolettes is often insufficient in the NICU, hos-pitals should use whatever means possible to dis-cretely separate the work areas available for eachinfant to prevent mix-ups with medication administra-tion records, flow sheets, medications, specimens,and equipment.

Result reporting

Delta check technology is an automated comparisonof the patient’s current and previous laboratory testvalue, which is designed to draw attention to labora-tory results at significant variance from historicalvalues. If the values are significantly different fromhistorical values, the result is flagged and considera-tion might be given to the possibility that the speci-men may have been obtained from a different patient.Delta checking procedures vary but usually involverepeating the test and investigating for misidentifica-tion. There is little doubt that this approach would besuitable, as confirmed by Oosterhuis et al. whoreported that an expert system that validated testresults on the basis of a multianalyte delta checkdetected 78% of intentionally altered test results (61).A system of alerts should also be made available inthe LIS to warn about data duplication (patient nameand codes) in the same health system.

Conclusions

In recent times, medical errors have been the focusof attention in the patient safety field, the healthcarefacility being held accountable for creating safer sys-tems by implementing incident reporting systems,patient safety officers, RCA, teamwork training, andmore. However, healthcare systems are increasinglydependent on reliable clinical laboratory services,which, as part of the overall healthcare system, areprone to errors. But if diagnostic errors are seen as aminor (rare) phenomenon, the healthcare facility isunlikely to contribute to their solution, or even focusmuch attention to them. However, we have clear evi-dence that diagnostic errors occur with frequency,and that some of them can be caused by misidentifi-cation. Sometimes patients end up with someoneelse’s diagnosis, incorrect medications and surgery,or having their blood collected with the next doorneighbor’s tubes or infants are discharged to theincorrect families (16). As quality and safety move-ments gallop along, the need to fix misidentificationerrors grows more pressing. First and foremost, anysafety and quality practice put into practice to preventthis unfavorable event should prove effective and,preferably, affordable before promoting or mandatingwidespread implementation. There is, in fact, a seri-ous concern in vigorously promoting or mandatingsafety practices with weak evidence, due to the inher-ent risk that squandering scarce resources divertsthem from better strategies, and subjects the safetyfield to the whims of opinions and biases. Definitely,

rigorous studies are needed to look at what works andwhat does not work towards increasing patient safety.However, we have to start somewhere. As currentlyrecommended by the JC, positive identification is thefoundation of patient safety, and the use of at leasttwo patient identifiers when providing care, treatmentor services (including two identifiers to label samplecollection containers in the presence of the patient)are recommended to maintain sample identitythroughout the total testing process. Process-sup-porting information technology has also been herald-ed as an important building block in attempts toimprove the quality and safety of healthcare. Twoareas in particular have drawn both attention andfunding. The first is clinical decision support, i.e.,information systems designed to improve clinicians’decision making. The second involves automaticpatient identification and computerized physicianorder entry (62, 63). Such technologies, combinedwith web-based electronic medical records and wire-less computing, offer significant opportunities toreduce diagnostic and drug administration errors,which represented more than one-third of all medicalerrors and are easily preventable (64). Informationtechnology, however, is not a safety critical object byitself, but it must be included in the generic processof safety (35). Despite the improvements, error rateswith automatic identification systems, especially bar-codes, still did not achieve zero errors. As with anynew technology, protection against mistakes is notperfect, and new problems (resistance to change, con-fusion regarding the best technology, uncertaintyregarding the return-on-investment) (65) and types oferrors (missing or the incorrect data on the wristband,system malfunctioning, use of manual data entrywhen the barcode scan is unsuccessful or unavail-able) may be introduced (66). However, remarkableimprovement due to ongoing training and educationhas decreased the rate of wristband error from 5.5%in 1993 (25) to 0.1–1% in 2005 (67).

It is currently being emphasized that optimizingdecisions on corrective actions and moving from asubjective individual criterion to systematic and com-parative management for strategic and support pro-cesses in laboratory medicine is necessary to improvequality of laboratory services (68). While strict adher-ence to available guidelines and recommendationsfor specimen collection, the use of information tech-nology for data entry, automated systems for patientidentification and specimen labeling, two or moreidentifiers during sample collection and delta checktechnology might be effective in preventing and iden-tifying identification errors, rejection and recollectionis the most suitable approach to manage the speci-men once misidentification has been ascertained.

Acknowledgements

The authors acknowledge Dr. Emmanuel J. Favaloro for thevaluable contribution in drafting this article.





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