Preventing Preanalytical Errors in Laboratory Testing in Viet Nam: Patient Identification, Specimen Integrity and Diagnostic Reliability

Preventing Preanalytical Errors in Laboratory Testing in Viet Nam: Patient Identification, Specimen Integrity and Diagnostic Reliability

A laboratory result can appear entirely reliable while providing misleading information about a patient. The analyzer may have performed correctly, internal quality control results may be acceptable, and the reported measurement may meet the analytical method's performance requirements. Yet the specimen may have been collected from the wrong person, labeled incorrectly, contaminated during collection, or exposed to conditions that altered its composition before testing.

These problems are particularly concerning because analytical quality controls cannot reliably detect every error that occurred before testing. A blood specimen assigned to the wrong patient's record may produce technically accurate measurements. Similarly, a hemolyzed sample may generate numerical results even though certain measured substances have been affected by damage to red blood cells.

The consequences extend beyond the laboratory. Clinicians may act on information that does not accurately represent the patient's condition, potentially leading to unnecessary investigations, inappropriate treatment, or delayed recognition of disease. In other circumstances, the laboratory may identify an unsuitable specimen and prevent an unreliable result from being released, but recollection and additional processing may still delay care.

Diagnostic reliability therefore begins before analysis. Correct patient identification, appropriate specimen collection, and preservation of specimen integrity are essential to the clinical usefulness of laboratory results.

International standards provide an established foundation for addressing these risks. ISO 15189:2022 establishes requirements for quality and competence in medical laboratories, while ISO 20658:2023 and relevant Clinical and Laboratory Standards Institute (CLSI) documents address specimen identification, collection, handling, and transport. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has also updated its recommendations for measuring quality across the total testing process.

For healthcare organizations in Viet Nam, the challenge is to translate these principles into dependable everyday practice. Laboratory professionals cannot manage every preanalytical risk independently. Physicians, nurses, phlebotomists, transport personnel, information technology teams, and healthcare leaders all influence whether the specimen reaching the laboratory can support a reliable result.

The objective is not simply to reduce rejected specimens or improve laboratory efficiency. It is to ensure that biological material is reliably associated with the correct patient, remains suitable for the intended examination, and provides information that supports safe clinical decisions.

Why Laboratory Quality Begins Before Analysis

Laboratory testing is commonly described as a process involving preanalytical, analytical, and postanalytical activities.

The preanalytical phase encompasses activities occurring before examination of the specimen begins. Depending on the framework used, these include examination requests, patient preparation, identification, specimen collection, labeling, handling, transport, receipt, and preparation for analysis.

Some professional literature distinguishes activities occurring outside the laboratory as pre-preanalytical processes. This distinction can help identify responsibilities, particularly in hospitals where specimens are collected in clinical departments rather than by laboratory personnel. Regardless of terminology, a failure occurring before analysis may compromise the reliability of the result.

A physician may request an examination, a nurse may collect the specimen, a courier may transport it, and a laboratory professional may receive and prepare it for testing. Each person completes a different part of the process, but the final measurement depends on the reliability of the entire sequence.

Analytical quality controls remain essential. Laboratories need appropriately maintained equipment, verified or validated methods, competent personnel, and suitable internal quality control and external quality assessment arrangements. However, these safeguards cannot necessarily establish whether a specimen was collected from the intended patient or maintained under appropriate conditions before analysis.

Consider a blood specimen collected from one patient but labeled with another patient's identifiers. The sample may be suitable for measurement, and the instrument may accurately determine the concentrations of substances in that material. The problem is that the results are attributed to the wrong individual.

The same principle applies when collection or handling changes a specimen's characteristics. An analytical method may accurately measure the altered sample without being able to determine whether the result still represents the patient's condition at the time of collection.

Preanalytical quality therefore concerns more than technical specimen handling. It determines whether the material entering the analytical process can reliably answer the intended clinical question.

Patient Identification: Connecting the Right Patient, Request, and Specimen

Patient identification is one of the most consequential safeguards in laboratory medicine.

Identification failures may originate during registration, examination ordering, specimen collection, labeling, accessioning, or transfer of information between systems. These events are related, but their causes and consequences are not necessarily identical.

A patient identification error concerns incorrect identification of the person receiving care. A specimen identification error involves an incorrect or uncertain association between the collected material and the person from whom it originated. An examination request identification error involves incorrect or inconsistent patient information associated with the requested test.

A particularly serious situation occurs when a specimen is collected from one patient but labeled with another patient's identifiers. In blood testing, this may be described as a wrong-blood-in-tube event.

The danger is that the resulting laboratory values may appear entirely plausible. Routine analytical quality control may not reveal that the sample belongs to another patient.

CLSI PRE01:2024, Patient and Laboratory Specimen Identification Processes, provides an important international standard addressing identification throughout laboratory workflows. Its scope includes examination ordering, registration, patient and specimen identification, labeling, handling, and the use of electronic identification systems.

A reliable collection process should establish the patient's identity using appropriate independent identifiers and reconcile that information with the examination request and specimen label.

Common identifiers include the patient's full name, date of birth, and a unique medical record or encounter identifier. Healthcare organizations should specify which identifiers are appropriate for their services and how they are verified.

Room number, bed location, or physical appearance should not be used as substitutes for reliable patient identification.

Where possible, patients should participate actively in confirming their identity. However, the process must also account for people who cannot provide reliable information, including unconscious patients, young children, and individuals with communication difficulties. These circumstances require approved alternative identification arrangements rather than assumptions based on location or familiarity.

Specimen labeling at the point of collection is another essential safeguard. The association between the patient, examination request, and collected material should be verified during the collection encounter, following procedures that minimize opportunities for specimen mix-ups.

Electronic labels and barcode systems can improve traceability and reduce certain transcription errors. However, their effectiveness depends on the quality of the information entered into the system and the way the technology is used.

A barcode generated from an incorrect patient record can preserve and propagate the original error. Similarly, scanning the wrong identifier may create a specimen that appears fully traceable while remaining incorrectly associated with the patient.

Organizations should therefore examine how personnel verify identities, select electronic records, generate labels, and respond when identification information does not agree. Particular attention may be needed for patients with similar names, temporary identifiers, duplicate records, or changes in registration details.

When specimen identity is uncertain, the problem should not be resolved through an undocumented assumption about which patient probably provided the material.

The laboratory needs an established procedure for containing the risk, investigating the discrepancy, and communicating with the responsible clinical team. Recollection may be necessary when reliable identification cannot be established.

Irreplaceable or difficult-to-recollect specimens create additional challenges. Any exceptional decision concerning such material requires an appropriately authorized assessment of clinical necessity, the available evidence, and the limitations affecting specimen identity. An exception must not be used to conceal unresolved uncertainty or present inadequately identified material as reliably associated with a particular patient.

Identification failures can affect more than one person. If one patient's specimen is attributed to another individual, the person receiving the incorrect report may be exposed to inappropriate decisions, while the original patient may remain without the intended diagnostic information.

This potential for serious harm makes identification a priority even when the recorded frequency of errors is low.

Specimen Integrity: When the Sample No Longer Represents the Patient

Correct identification is necessary, but it does not guarantee specimen suitability.

A sample may belong to the right patient and still become unreliable because of problems during collection, handling, processing, or transport. The consequences depend on the specimen type, substances being measured, analytical method, and nature of the problem.

Hemolysis is a familiar example. When red blood cells are damaged, intracellular constituents may be released into serum or plasma. Depending on the analyte and method, this can alter measured concentrations or interfere with the analytical process.

The effects are not uniform across laboratory examinations. Some measurements are particularly susceptible to hemolysis, while others may remain sufficiently reliable under the same conditions.

Laboratories therefore need evidence-based, method-appropriate criteria for identifying interference and determining whether individual results can be reported.

A hemolyzed specimen should not automatically be rejected for every examination. Equally, a specimen that appears visually acceptable should not be assumed free from analytically significant interference.

Other important preanalytical problems include insufficient specimen volume, incorrect collection containers, inappropriate additives, clotting in specimens intended to remain anticoagulated, contamination, and failure to maintain suitable handling conditions.

An underfilled collection tube may be particularly problematic when an examination requires a defined relationship between specimen volume and an additive. The sample may appear adequate while being unsuitable for the intended analytical method.

Collection through vascular access devices introduces additional considerations. Depending on the circumstances, contamination or dilution by infused substances may affect laboratory measurements. These risks should be addressed through procedures appropriate to the collection method, intended examination, and clinical setting.

Specimen integrity is not exclusively a blood-testing concern.

Urine specimens may be affected by contamination, inappropriate containers, or delayed processing. Microbiological examinations require collection and transport conditions appropriate to the organisms or substances being investigated. Other specimens may have particular requirements for timing, preservation, or handling.

Conditions appropriate for one examination may be unsuitable for another. Refrigeration, for example, is not a universal solution to specimen deterioration. Acceptable temperatures and transport intervals depend on the material and the requirements of the intended examination.

CLSI PRE04:2023, Handling, Transport, Processing, and Storage of Blood Specimens for Routine Laboratory Examinations, provides guidance relevant to the integrity of whole blood, serum, and plasma used for routine testing.

Its scope does not extend to every blood examination. Blood gases, coagulation specimens, blood cultures, point-of-care testing, and molecular diagnostics may require additional or different professional guidance.

The essential principle is that specimen suitability must be evaluated against the specific examination being performed.

Once biological material has been altered in a way that affects the intended measurement, even a highly accurate analytical method may be unable to recover the original information.

Patient Preparation and Collection Conditions

Preanalytical reliability begins before the specimen is collected.

For certain examinations, the patient's preparation, collection time, medication exposure, physiological state, or other circumstances can influence the result.

Some measurements require attention to fasting status, medication timing, or expected biological variation. Others may be affected by posture, recent physical activity, or the circumstances of specimen collection.

These considerations should not be reduced to a universal instruction that every patient must fast or follow identical preparation procedures. Requirements vary substantially between examinations, and unnecessary restrictions may create inconvenience or, in certain circumstances, clinical risk.

The responsible clinical and laboratory teams should establish examination-specific instructions that reflect the intended investigation, relevant evidence, and the methods used by the laboratory.

When important preparation conditions have not been met, the information should be recorded and considered. Whether testing should proceed, be postponed, or be reported with an appropriate qualification depends on the examination and clinical circumstances.

Collection procedures also require appropriately trained personnel with demonstrated competence.

A written standard operating procedure is important, but its existence does not establish that staff consistently perform the process correctly.

Working conditions differ between inpatient wards, outpatient collection rooms, emergency services, and remote collection locations. High workload, interruptions, inadequate supplies, poorly organized collection areas, and unclear electronic interfaces can increase the likelihood of error.

Competence assessment should therefore consider performance under realistic working conditions rather than theoretical knowledge alone.

CLSI PRE02:2025, Collection of Diagnostic Venous Blood Specimens, provides current professional guidance for venous blood collection. It includes considerations for collection through vascular access devices, blood culture collection, isolation environments, emergency circumstances, and pediatric or otherwise challenging patients.

The joint EFLM-COLABIOCLI recommendation on venous blood sampling provides another evidence-informed reference, particularly for collection using closed blood collection systems.

However, this recommendation has a defined scope. It should not automatically be applied to catheter-based collection, pediatric collection, or other circumstances outside its stated coverage.

The appropriate approach is to use professional guidance relevant to the procedure being performed, alongside applicable local requirements and validated institutional procedures.

Maintaining Specimen Integrity During Transport

A correctly collected specimen can become unsuitable before reaching the analytical department.

Delays between collection and processing, temperature exposure, packaging problems, and inappropriate transport conditions may affect specimen integrity. These risks are particularly important when samples travel from outpatient clinics, collection centers, or smaller healthcare facilities to centralized laboratories.

A specimen may pass through several individuals or services before arriving at the laboratory. If responsibilities are unclear, the organization may be unable to establish where a delay occurred or whether required conditions were maintained.

A dependable transport process should preserve specimen identity and traceability while maintaining the conditions appropriate to the intended examination.

Relevant information may include the specimen type, collection time, origin, transport conditions, receipt time, and deviations that could affect suitability. The extent of documentation and monitoring should reflect the characteristics of the material and the clinical consequences of failure.

For time-sensitive or temperature-sensitive examinations, defined transport requirements and appropriate monitoring arrangements may be necessary. A specimen should not automatically be considered acceptable simply because it arrived within the courier's scheduled delivery period.

ISO 20658:2023, Requirements for the Collection and Transport of Samples for Medical Laboratory Examinations, provides an international framework for these activities.

The standard applies to medical laboratories and relevant service providers involved in pre-examination processes, including examination requests, patient preparation, identification, specimen collection, and transport.

Its scope does not include blood and blood components intended for transfusion, such as red blood cells, platelets, or fresh frozen plasma. However, it may apply to the collection and transport of donor samples intended for laboratory testing.

This distinction matters because different specimen and product categories may be subject to additional specialized requirements.

Where external specimen transport providers are involved, the laboratory and healthcare organization should establish clear responsibilities and service expectations. These arrangements may address packaging, identification, transport conditions, traceability, communication of delays, and management of incidents affecting specimen quality.

Transport personnel may not interpret laboratory results, but their work can directly influence whether the laboratory receives material suitable for reliable examination.

Laboratory quality management therefore cannot stop at the physical boundaries of the laboratory.

Specimen Acceptance and Rejection as Patient Safety Decisions

The laboratory's responsibility when receiving a specimen extends beyond confirming that a container has arrived.

The receiving process should establish whether the material is correctly identified, consistent with the examination request, and suitable for the intended analysis.

A specimen that does not meet established requirements may need clarification, further assessment, rejection, or recollection, depending on the nature and clinical significance of the problem.

These decisions involve competing risks. Accepting unsuitable material may allow misleading results to enter the clinical record. Rejecting a specimen may delay diagnosis, require another collection, or create particular difficulties when the material cannot readily be replaced.

Laboratories therefore need documented acceptance and rejection criteria appropriate to their examinations and specimen types.

Not every nonconformity carries the same level of risk. A minor documentation discrepancy may be resolved through an authorized verification process, while an unresolved specimen identification problem may undermine the fundamental reliability of the material.

Hemolysis similarly requires examination-specific assessment. A sample may be unsuitable for one measurement while remaining acceptable for another.

Decisions should be based on the degree of interference, analytical method, validated or otherwise established criteria, and available evidence rather than a blanket rule applied to every hemolyzed sample.

Certain specimens may be difficult or impossible to recollect. In these circumstances, an exceptional decision concerning examination of nonconforming material may be considered under appropriately authorized procedures.

Such a decision should account for clinical need, specimen limitations, and the consequences of reporting potentially unreliable information. Where a known problem materially affects interpretation, any result released should communicate the relevant limitations appropriately.

The clinical team also needs to know when requested information remains unavailable because a specimen was rejected. A rejected sample should not simply disappear from the workflow without appropriate notification, particularly when the examination is time-sensitive.

Importantly, specimen rejection is not automatically a diagnostic error.

Rejecting unsuitable material may prevent unreliable results from reaching clinicians. Nevertheless, repeated rejection can delay care, increase costs, and expose patients to unnecessary recollection.

An unusually low rejection rate does not necessarily demonstrate excellent practice either. It may reflect reliable specimen collection, but it could also result from inadequate detection or documentation of nonconforming samples.

The value of specimen acceptance procedures lies in the reliability of the decisions made, not simply the number of specimens accepted.

Responding When a Preanalytical Problem Is Discovered

Some preanalytical problems are identified before analysis. Others may become apparent only after testing has been completed or results have been released.

A specimen identification discrepancy may emerge during a review of patient records. A laboratory value may appear unexpectedly inconsistent with earlier measurements, or new information may indicate that a sample was collected or transported under unsuitable conditions.

The response should be proportionate to the potential clinical consequences. The first consideration is whether the problem may have affected a result that has already been released or used in patient management.

The laboratory should examine the relevant information, determine which specimens or results may be unreliable, and communicate clinically important concerns to the responsible clinical team.

Depending on the circumstances, further action may include withholding unreleased results, arranging verification or recollection, issuing a corrected or appropriately qualified report, or reviewing whether patient management has been affected.

A confirmed identification failure requires a different investigation from an isolated hemolysis event. A transport deviation involving a time-sensitive examination may require assessment of how the delay affected the particular measurement.

These situations should also be described accurately during incident review.

A preanalytical nonconformity is a failure to meet an applicable requirement. A near miss is an event that could have caused harm but was detected or interrupted before that harm occurred. An incorrect laboratory result is a reported finding that is inaccurate or incorrectly attributed, while a confirmed diagnostic error requires an appropriately supported determination that the diagnostic process or conclusion was incorrect.

These concepts may overlap, but they are not interchangeable.

A specimen problem does not automatically establish that an incorrect result was issued, that a diagnostic error occurred, or that a patient suffered harm. Likewise, identifying an error during internal quality review does not, by itself, constitute a legal determination of professional or technical error, negligence, or liability.

An effective incident record should establish what happened, when the problem was identified, which specimens or reports were affected, and what actions were taken.

The purpose of incident review is to contain risk, support appropriate patient care, and identify opportunities to improve the system.

Shared Responsibility Across the Specimen Pathway

Preanalytical quality cannot be managed effectively by laboratory personnel alone.

Specimens may be collected in clinical departments, transported by separate services, and registered through information systems maintained by other teams. Every transfer of material or information creates an opportunity for identification, traceability, or specimen integrity to be compromised.

Laboratory leadership should establish specimen requirements, acceptance criteria, quality indicators, and procedures for communicating nonconformities.

Clinical departments should ensure that personnel involved in preparation and collection understand and follow the applicable procedures. Transport services need clearly defined responsibilities concerning specimen identification, handling conditions, and traceability.

Healthcare organization leadership should provide oversight, appropriate resources, and coordination when recurring problems involve several departments.

Consider a clinical department that repeatedly submits hemolyzed samples. Rejecting unsuitable specimens may prevent unreliable results, but rejection alone will not necessarily solve the underlying problem.

The laboratory and collection team may need to examine collection methods, equipment, patient-related factors, transport arrangements, and actual working conditions.

Similarly, repeated specimen identification problems may originate in registration or electronic ordering rather than the physical labeling process. Retraining collection personnel may have limited effect if the underlying weakness is an unreliable electronic workflow.

A systems-based approach examines these interactions rather than assuming that the individual who handled the specimen last necessarily caused the error.

Professional accountability remains important, but it should be supported by procedures that make correct performance feasible and encourage early identification of problems.

Measuring Preanalytical Quality With IFCC Indicators

Quality indicators allow laboratories to identify recurring problems, monitor processes, and determine whether improvement efforts are producing meaningful results.

In November 2025, the IFCC Working Group on Laboratory Errors and Patient Safety published recommendations for an essential quality-indicator panel intended for broad international adoption. The paper appeared in the 2026 volume of Clinical Chemistry and Laboratory Medicine.

The panel identifies six essential quality-indicator groups covering the total testing process. Three directly address preanalytical risks: misidentification, specimen rejection, and hemolysis.

The first group concerns misidentified examination requests and specimens.

Pre-MisR measures the number of misidentified requests relative to the total number of requests. Pre-MisS measures misidentified specimens relative to the total number of specimens.

Distinguishing these indicators is important because errors in examination requesting and specimen identification may originate in different parts of the workflow and require different improvement strategies.

The second group concerns specimen rejection.

Pre-RejS measures the number of rejected specimens relative to the total number of specimens. This indicator can capture problems involving specimen identification, unsuitable containers, insufficient volume, clotting, contamination, and other reasons for rejection.

Its usefulness depends on consistent rejection criteria, reliable documentation, and appropriate interpretation of the findings.

The third group concerns hemolysis.

Pre-HemI and Pre-HemV measure hemolysis detected through an automated hemolysis index or visual inspection, respectively.

The IFCC recommendation defines this essential indicator using the proportion of specimens with free hemoglobin greater than 0.50 g/L among specimens assessed for hemolysis.

This threshold is intended to support standardized quality measurement. It should not be interpreted as a universal rejection threshold for every laboratory examination.

Whether hemolysis invalidates an individual result depends on the analyte, method, and degree of interference. Laboratories require method-appropriate criteria when deciding whether results can be reported.

Automated hemolysis indices and visual inspection should also not be assumed to offer equivalent sensitivity or directly interchangeable results.

The other three essential IFCC indicator groups concern unacceptable performance in external quality assessment or proficiency testing, cardiac troponin turnaround time at the 90th percentile for emergency care, and laboratory reports corrected after release.

The cardiac troponin indicators distinguish turnaround time from specimen receipt in the laboratory to result release from clinical turnaround time measured from blood sampling to result release.

This distinction recognizes that delays before a specimen reaches the laboratory can affect the timeliness of diagnostic information. However, these turnaround-time indicators should not be classified simply as measures of specimen integrity before analysis.

The IFCC recommendations provide a standardized starting point for quality monitoring. They do not automatically establish universal numerical targets or mandatory reporting obligations for every laboratory in Viet Nam.

Their practical value depends on consistent definitions, accurate data collection, and careful interpretation.

Understanding What Quality Indicators Actually Show

A quality indicator can reveal that something is changing without fully explaining why.

A high specimen rejection rate may suggest problems with collection or handling. It may also reflect a laboratory that consistently identifies and documents unsuitable specimens.

A low rejection rate may represent reliable processes, but it could also result from inadequate detection or incomplete reporting.

The indicator alone cannot distinguish these explanations.

Hemolysis rates may vary according to collection location, specimen type, patient population, collection method, and the technology used to identify hemolysis.

Results from an emergency department, for example, may not be directly comparable with those from a routine outpatient collection center without considering differences in case mix and working conditions.

Comparisons between laboratories also require attention to specimen acceptance policies and measurement methods.

Patterns within an organization may be more useful than an overall percentage.

A laboratory may report a stable rejection rate while experiencing persistent problems at one collection site. Another may identify increasing hemolysis after changes to collection equipment or transport arrangements.

Examining indicators by location, specimen type, and reason for nonconformity can help identify where improvement is needed.

Near misses also deserve attention. An identification mismatch discovered before analysis may not result in an incorrect report, but it reveals a weakness that could have more serious consequences under different circumstances.

Because serious identification failures may be infrequent, reviewing individual events and their potential consequences is important even when aggregate rates appear low.

Supplementary measures may also be useful, including recollection frequency, delays caused by unsuitable specimens, and the timeliness of communication when another sample is needed.

These additional indicators should be selected for a defined purpose. A larger dashboard does not necessarily provide better understanding.

The objective is to identify a manageable set of measures that reveal important risks and help determine whether the specimen pathway is becoming more reliable.

Turning Recurring Errors Into Effective Improvement

Repeated errors should prompt examination of the process rather than an automatic reminder for personnel to be more careful.

Consider a collection area where specimen labeling errors continue despite repeated training.

A closer review may reveal that labels for several patients are printed together, collection stations are frequently interrupted, or the registration system does not adequately support identification at the point of collection.

Under these circumstances, additional education alone may have limited effect.

Improvement may require redesigning label generation, changing how labels are stored, reducing opportunities for specimen mix-ups, or making patient verification easier to perform consistently.

The same principle applies to hemolysis.

Repeatedly notifying a clinical department that its specimens are unsuitable may not reduce the problem unless the laboratory and collection team investigate the possible causes.

Depending on the findings, appropriate interventions may involve reviewing collection methods, equipment, transport conditions, personnel competence, or workflow design.

Corrective action should be guided by evidence rather than assumptions about individual behavior.

A constructive reporting culture also matters.

Many preanalytical weaknesses become visible because personnel report nonconformities or near misses. If reporting automatically leads to blame, valuable information about system vulnerabilities may remain hidden.

Healthcare organizations should encourage appropriate reporting and learning while maintaining professional accountability and addressing unsafe practices.

After an intervention, the relevant indicators should be reassessed.

Introducing a new barcode system, revising a standard operating procedure, or conducting another training session does not, by itself, demonstrate that the problem has been resolved.

The meaningful question is whether the change has reduced the targeted risk without introducing new problems or unnecessary workload.

A reliable improvement program connects measurement, investigation, corrective action, and reassessment.

Using Digital Identification and Traceability Responsibly

Digital technology can improve preanalytical reliability when it is integrated into suitable clinical workflows.

Barcode systems may help connect patient identifiers, examination requests, and specimens. Laboratory information systems can improve traceability, reduce manual transcription, and support documentation of specimen receipt, transport conditions, and nonconformities.

Electronic information may also help identify recurring collection problems across departments or facilities.

However, technology cannot compensate for incorrect information entered at the beginning of the process.

A barcode attached to the wrong specimen can still be scanned successfully throughout the laboratory. The system may record every subsequent movement accurately while preserving the original identification error.

Organizations should therefore evaluate how personnel interact with digital systems, not only whether the technology functions correctly.

If scanners frequently fail, staff may resort to manual entry. If labels are printed far from collection areas, personnel may develop practices that increase the likelihood of specimen mix-ups. If electronic workflows are difficult to use, informal shortcuts may undermine the intended safeguards.

These circumstances should be examined as potential design and workflow problems rather than treated solely as failures of individual compliance.

Digital identification systems should be evaluated under realistic operating conditions, including interruptions, temporary identifiers, equipment downtime, and communication between different electronic platforms.

The objective is not maximum automation. It is a dependable process in which the relationship between the patient, examination request, and specimen remains accurate and traceable.

Preanalytical Quality Within Viet Nam's Regulatory Framework

Preanalytical quality in Viet Nam should be considered within the applicable legal framework and the practical organization of medical laboratory services.

The Law on Medical Examination and Treatment No. 15/2023/QH15, as amended and reflected in Consolidated Document No. 26/VBHN-VPQH dated February 26, 2026, provides the broader legal framework for medical examination, treatment, and related professional responsibilities.

More specifically, Circular No. 01/2013/TT-BYT, issued by the Ministry of Health on January 11, 2013, establishes requirements and guidance concerning laboratory quality management at medical examination and treatment facilities.

The circular addresses quality management responsibilities, documented procedures, and relevant activities throughout the laboratory testing pathway, including pre-examination processes.

As of October 2026, Circular No. 01/2013/TT-BYT remains in effect, subject to the amendment introduced by Circular No. 25/2026/TT-BYT, issued on June 30, 2026.

Article 1 of Circular No. 25/2026/TT-BYT amends Clause 5 of Article 5 of Circular No. 01/2013/TT-BYT concerning participation in external quality assessment programs.

The amended provision encourages healthcare facilities to participate in relevant specialty-based external quality assessment programs, consistent with the Ministry of Health's arrangements for professional laboratory quality oversight, as well as recognized international external quality assessment programs.

This amendment took effect on August 15, 2026.

The distinction between encouragement and a mandatory obligation is important when interpreting the amended provision. It should also be considered separately from other applicable quality management responsibilities and requirements established under different legal or accreditation arrangements.

Other provisions of Circular No. 01/2013/TT-BYT are particularly relevant to preanalytical risk management.

Clause 6 of Article 5 requires laboratories to establish quality indicators appropriate to the conditions of the laboratory and healthcare facility and to review or adjust those indicators at least annually.

This provides a direct regulatory basis for institutional quality measurement. However, it does not mean that the specific IFCC essential indicators automatically constitute the mandatory indicator set for every laboratory in Viet Nam.

Article 10 addresses the responsibilities of clinical departments in laboratory quality management, including specimen collection, preservation, transport, and receipt of laboratory results.

It assigns relevant responsibilities to clinical department leadership and nursing management and provides for designated personnel to undertake specimen-related activities.

This provision is especially important because it recognizes that laboratory quality is not solely the responsibility of personnel working inside the laboratory.

The Ministry of Health's Decision No. 2429/QD-BYT, dated June 12, 2017, established criteria for assessing the quality levels of medical laboratories.

These criteria remain a relevant reference in Viet Nam's laboratory quality assessment and improvement framework. Their application should be understood according to the applicable assessment arrangements rather than presented as equivalent to international laboratory accreditation.

International standards provide additional technical and management guidance.

ISO 15189:2022 establishes requirements for the quality and competence of medical laboratories, including relevant aspects of personnel competence, pre-examination processes, nonconforming work, risk management, and continual improvement.

Viet Nam's national standard, TCVN ISO 15189:2025, is identical to ISO 15189:2022 and replaces TCVN ISO 15189:2014.

ISO 20658:2023 complements this framework by addressing the collection and transport of specimens intended for medical laboratory examinations.

CLSI PRE01:2024, PRE02:2025, and PRE04:2023 provide further professional standards or guidance relevant to identification, venous blood collection, and the handling of routine blood specimens.

These documents should be applied according to their stated scope and the specific characteristics of the laboratory's activities.

Specialized examinations may require additional safeguards. Requirements developed for routine serum or plasma testing should not automatically be applied to microbiology, molecular testing, coagulation, transfusion-related activities, or other specialized services.

International standards and IFCC recommendations should also be distinguished from obligations established under Vietnamese law, licensing conditions, or specific accreditation requirements.

Using an international standard as a reference for quality improvement does not automatically make every provision independently mandatory for every healthcare facility.

Protecting patient information is another relevant responsibility.

Viet Nam's Law on Personal Data Protection No. 91/2025/QH15 and its implementing Decree No. 356/2025/ND-CP took effect on January 1, 2026.

Specimen labels, examination requests, laboratory information systems, and incident records may contain identifiable health information and other personal data.

Healthcare organizations should assess the applicable requirements concerning lawful processing, confidentiality, access control, information security, and the disclosure or transfer of data.

Consent requirements, applicable exceptions, and other relevant legal conditions must be considered according to the nature and purpose of the processing activity.

Where specimens are collected at one facility and examined at another, arrangements should preserve both specimen traceability and appropriate protection of the associated patient information.

A reliable laboratory quality system must therefore address the biological integrity of the specimen as well as the accuracy, confidentiality, and authorized handling of the information connected to it.

Building a Practical Improvement Program

Improving preanalytical reliability does not require every healthcare organization to redesign its entire laboratory testing pathway at once.

A practical starting point is to identify the most consequential or frequently observed problems within the local service.

For one facility, specimen misidentification may represent the greatest concern. For another, repeated hemolysis, a high rejection rate, or transport delays may require attention.

A laboratory receiving samples from several collection locations may find that responsibilities and communication between facilities deserve particular priority.

The starting point should be determined by local evidence rather than assumptions about which errors are most common elsewhere.

An improvement initiative can focus on a clearly defined specimen pathway, identify the professionals involved, and examine how the existing safeguards work in practice.

The organization should establish baseline performance using appropriate indicators, investigate recurring patterns, and develop corrective actions with the services responsible for the affected processes.

Personnel who perform the work should participate in designing improvements where appropriate. Collection staff, nurses, transport personnel, and laboratory professionals may identify practical difficulties that are not apparent from written procedures or aggregate data.

Regular feedback can also help connect specimen quality with its clinical consequences.

An incorrectly labeled tube is not simply a documentation problem. A rejected specimen is not merely an operational inconvenience. These events may affect the reliability or timeliness of diagnostic information and, in some circumstances, expose patients to unnecessary recollection or inappropriate decisions.

At the same time, organizations should recognize that not every specimen problem is preventable and not every rejected sample reflects poor collection practice.

The objective is to reduce avoidable risk, identify unsuitable material consistently, and manage unavoidable limitations transparently.

After implementing changes, the organization should reassess performance and determine whether the intervention has produced a meaningful improvement.

A sustainable program connects measurement, investigation, corrective action, and reassessment rather than treating each error as an isolated event.

From Specimen Integrity to Diagnostic Reliability

Medical laboratory testing depends on transforming biological material into information that clinicians can use with confidence.

That confidence begins before analysis.

The specimen must belong to the correct patient, be collected under appropriate conditions, and retain the characteristics necessary for the intended examination. When these requirements are not met, even excellent analytical technology may produce results that are misleading, difficult to interpret, or clinically unusable.

The IFCC's updated quality-indicator recommendations, together with ISO and CLSI standards, provide a strong foundation for recognizing and measuring these risks. Viet Nam's laboratory quality management framework offers an important basis for adapting these principles to local practice.

For healthcare organizations, the most meaningful improvement is to recognize preanalytical quality as a shared responsibility across the specimen pathway.

Reliable patient identification cannot depend solely on the person attaching a label. Specimen integrity cannot depend solely on the laboratory receiving the sample. Both require coordinated procedures, clearly assigned responsibilities, competent personnel, and meaningful measurement.

A laboratory that identifies unsuitable specimens and prevents unreliable results from reaching clinicians performs an important patient safety function. A healthcare organization that investigates and addresses the causes of those specimen problems takes a further step toward more dependable diagnostic care.

Diagnostic reliability depends not only on how accurately a laboratory measures a specimen, but also on whether the correct specimen, from the correct patient, reaches the examination process in a condition that can support a trustworthy result.

Selected References and Regulatory Sources

De Guire V, Galoro CAO, Ibarz M, et al. Recommendations from the IFCC Working Group on Laboratory Errors and Patient Safety for the Global Adoption of an Essential Quality Indicators Panel in Laboratory Medicine. Clinical Chemistry and Laboratory Medicine. Published online November 20, 2025; 2026;64(4):806–812. DOI: 10.1515/cclm-2025-1462.

International Federation of Clinical Chemistry and Laboratory Medicine. Working Group on Laboratory Errors and Patient Safety: Model of Quality Indicators.

International Organization for Standardization. ISO 15189:2022 — Medical Laboratories: Requirements for Quality and Competence.

International Organization for Standardization. ISO 20658:2023 — Requirements for the Collection and Transport of Samples for Medical Laboratory Examinations.

Clinical and Laboratory Standards Institute. Patient and Laboratory Specimen Identification Processes. CLSI Standard PRE01. First Edition. 2024.

Clinical and Laboratory Standards Institute. Collection of Diagnostic Venous Blood Specimens. CLSI Standard PRE02. Eighth Edition. 2025.

Clinical and Laboratory Standards Institute. Handling, Transport, Processing, and Storage of Blood Specimens for Routine Laboratory Examinations. CLSI Guideline PRE04. First Edition. 2023.

Simundic AM, Bölenius K, Cadamuro J, et al. Joint EFLM-COLABIOCLI Recommendation for Venous Blood Sampling. Clinical Chemistry and Laboratory Medicine. 2018;56(12):2015–2038. DOI: 10.1515/cclm-2018-0602.

Viet Nam National Standard. TCVN ISO 15189:2025 — Medical Laboratories: Requirements for Quality and Competence. Identical to ISO 15189:2022 and replacing TCVN ISO 15189:2014.

Ministry of Health of Viet Nam. Circular No. 01/2013/TT-BYT, Guiding the Implementation of Laboratory Quality Management at Medical Examination and Treatment Facilities. Issued January 11, 2013, as subsequently amended.

Ministry of Health of Viet Nam. Circular No. 25/2026/TT-BYT, Amending and Supplementing Certain Provisions of Circular No. 01/2013/TT-BYT and Other Ministry of Health Circulars. Issued June 30, 2026. Article 1 effective August 15, 2026.

Ministry of Health of Viet Nam. Decision No. 2429/QD-BYT, Promulgating Criteria for Assessing the Quality Levels of Medical Laboratories. June 12, 2017.

National Assembly of Viet Nam. Law on Medical Examination and Treatment No. 15/2023/QH15, as amended and reflected in Consolidated Document No. 26/VBHN-VPQH dated February 26, 2026.

National Assembly of Viet Nam. Law on Personal Data Protection No. 91/2025/QH15. Effective January 1, 2026.

Government of Viet Nam. Decree No. 356/2025/ND-CP, detailing certain provisions and implementation measures of the Law on Personal Data Protection. Effective January 1, 2026.

Professional Scope and Disclaimer

This article is published by Diagnostic Excellence Vietnam (DxEx.vn), a professional initiative dedicated to advancing diagnostic quality, safety, and reliability in Viet Nam through evidence-informed knowledge sharing, risk management, measurement, and quality improvement.

The content is intended for general professional education and discussion. It does not constitute patient-specific medical advice, laboratory testing instructions for an individual patient, a clinical diagnosis, an individualized recommendation concerning specimen collection or result interpretation, a determination of professional or technical error, or legal advice. References to international standards and professional recommendations do not imply that they are automatically mandatory under Vietnamese law unless such requirements are independently applicable.

Patient identification, specimen collection, handling, acceptance, testing, reporting, and clinical interpretation must be undertaken by appropriately qualified and authorized healthcare professionals in accordance with applicable Vietnamese law, relevant professional standards, validated laboratory procedures, and the patient's clinical circumstances.

Diagnostic Excellence Vietnam does not provide clinical diagnosis or treatment services.