ISO 15189:2022 Implementation Training

Opens with how a doctor can know a result is right and belongs to the right patient. Sets out the course: twenty-six modules in three parts, seven steps for each requirement, practice, written exercises and a final exam. Covers the scope and purpose of the standard, why a laboratory is accredited and not certified, the three main changes from the 2012 edition, and the benefits of accreditation. A mislabelled tube from a ward shows that errors can begin before the examination.

What you will be able to do

• Explain what ISO 15189:2022 covers and why it exists
• Say why a medical laboratory is accredited, not certified
• Name the main changes from the 2012 edition

Why it matters

In a medical laboratory, patient safety is the business case: it protects patients first and the laboratory's standing with the doctors who rely on it.

Practice: Practice: Welcome: quality in the medical laboratory · 3 questions

Begins with a new clinical chemistry kit at XYZ Hospital, where confusion between verify and validate delays an examination. Covers clause 2 and clause 3, the pre-examination, examination and post-examination phases, laboratory user and patient, primary sample and sample, point-of-care testing, bias, trueness and measurement uncertainty. Then reference interval against clinical decision limit, quality control terms, turnaround time and complaint, with a glucose meter exercise.

What you will be able to do

• Name the three phases of the laboratory's work
• Choose between verification and validation for an examination
• Use reference interval and decision limit, not normal range

Why it matters

An assessor will ask what each word means, so one short glossary built on the standard's terms keeps procedures, forms and reports consistent.

Practice: Practice: The language of the medical laboratory · 3 questions

Begins with XYZ Hospital's laboratory choosing between rewriting procedures and first comparing practice with every requirement. Covers the eight clauses and three annexes, the three questions that group them, the alignment with ISO/IEC 17025:2017 and the path of a sample through clause 7. Then clause 8.1.1 and clause 8.1.2, the stages of the route to accreditation, a five-step gap assessment, and the range of laboratory activities in clause 5.3.1.

What you will be able to do

• Describe the structure of the standard and its annexes
• Carry out a five-step gap assessment with priorities and owners
• List the range of laboratory activities, including every site

Why it matters

Laboratories that find out where they stand first fix the gaps that threaten patients early, and this training course then builds only what is needed.

Practice: Practice: How the standard is built · 3 questions

Opens with a diagnostic laboratory in Dubai that pays referring doctors a fee for every sample. Covers the five parts of clause 4.1, the sources of threat named in its note, a five-step way to put impartiality in place and a threat register for XYZ Hospital. Then clause 4.2: managing patient information through legally enforceable agreements, release required by law, and the confidentiality duty of everyone with access, including contractors.

What you will be able to do

• Identify and record threats to impartiality, then eliminate or minimise them
• Set up a release route for patient information
• Apply the confidentiality duty to staff, committee members and contractors

Why it matters

Nothing but the patient's sample should shape the result, and a register that changes over time shows an assessor that you monitor.

Practice: Practice: Impartiality and confidentiality · 3 questions

Begins with a hospital laboratory in Hong Kong that sends out a report with another patient's result and the choice of whether to tell the patient. Groups the nine processes into five themes: information, the right examinations, openness, respect and continuity. Covers a yearly review of the examinations offered, disclosure of near misses, informed consent, care without discrimination and retained samples if a laboratory closes, with XYZ Hospital and a blood bank.

What you will be able to do

• Establish and implement the nine patient processes of clause 4.3
• Disclose incidents and near misses, and record the actions taken
• Plan for retained samples and records if the laboratory closes or merges

Why it matters

A patients' rights poster with no process behind it changes nothing, while openness about an error can leave the patient trusting the laboratory more.

Practice: Practice: Requirements regarding patients · 3 questions

Opens with a Singapore laboratory whose reports pile up when the director goes on leave without a written delegation. Covers clause 5.1 on the legal entity, clause 5.2 on director competence, responsibility and documented delegation, clause 5.3 on the range of activities and advice to users, and clause 5.4 on structure and the five quality duties. XYZ Hospital, a blood bank and a POCT clinic show different shapes.

What you will be able to do

• Document the director's duties and any delegation of them
• Set up arrangements for advice and interpretation for users
• Define structure, authority and the five quality duties of clause 5.4.2

Why it matters

Clear roles keep patients moving: delegate the task, never the responsibility, and a director's absence will not stop the reports.

Practice: Practice: The laboratory director and structure · 3 questions

Begins with XYZ Hospital's objective of excellent service, which nobody counts, and what counting rejected samples revealed. Covers clause 5.5: objectives and policies, measurable objectives, protecting the management system during change, and the four types of quality indicator. Then clause 5.6: identifying risks of harm to patients and opportunities, an outpatient collection risk list, examples from Singapore and London, and the director checking effectiveness.

What you will be able to do

• Write measurable objectives with an owner and a date
• Set quality indicators for pre-examination, examination and post-examination
• Identify risks of harm to patients and the actions to address them

Why it matters

What you measure, you can improve, and an indicator with no action and owner is just a number on a monthly chart.

Practice: Practice: Objectives, indicators and risk management · 3 questions

Opens with a night-shift locum at XYZ Hospital who releases a result her laboratory's own rules say needs a blood film. Covers resources in general, access to competent persons, acting impartially and ethically, and the induction programme. Then specifying competence for each function, the assessment methods in the note to clause 6.2.2, a competence record, the difference between competent and authorised, an authorisation matrix, continuing education and the five record items of clause 6.2.5.

What you will be able to do

• Specify competence for each function and assess it at a set frequency
• Authorise named people for specific tasks, each with their own login
• Keep the procedures and records clause 6.2.5 lists

Why it matters

Experience counts but is not authorisation, and a result traced to a competent, authorised person is one you can defend.

Practice: Practice: Resources and personnel · 3 questions

Opens with a reagent cold room at XYZ Hospital where weekend temperatures are filled in from memory. Covers clause 6.3.1: conditions specified, monitored and recorded at every site, including POCT. Then the five facility controls of clause 6.3.2 with safety devices, separation in a molecular laboratory in Manila, storage in clause 6.3.3, personnel facilities, and the sample collection areas of clause 6.3.5, with a Dubai centre.

What you will be able to do

• Specify, monitor and record the conditions that affect results
• Apply the five facility controls, including safety devices
• Plan collection areas for privacy, access and first aid

Why it matters

The room is part of the result, so a monitored and alarmed condition catches a fault the same night, not a month of doubtful reagent lots later.

Practice: Practice: Facilities and environment · 3 questions

Begins with a repaired analyser at XYZ Hospital put back into service at night with no acceptance check. Covers clause 6.4: what counts as equipment, including software and a pneumatic tube system, the register, acceptance against criteria set in advance, safeguards in use, maintenance, and taking faulty equipment out of service. Then incident reporting, manufacturer recalls, and the eleven record items of clause 6.4.7, with a POCT clinic and a blood bank.

What you will be able to do

• Keep a register of every item that can influence results
• Accept equipment against criteria written before testing, including after repair
• Take faulty equipment out of service and review results already produced

Why it matters

Seems fine is not the same as shown to be fine: the laboratory decides when equipment returns to service, and keeps the record.

Practice: Practice: Medical laboratory equipment · 3 questions

Begins with a new reagent lot at XYZ Hospital loaded late on a Friday without a comparison, which shifted patient results. Covers clause 6.5: calibration requirements, procedures, the documented unbroken chain of calibrations and the options when traceability is not possible. Then clause 6.6: receipt and storage, acceptance testing of each lot using patient samples, quarantine inventory, adverse incidents and recalls, and the record items for each reagent.

What you will be able to do

• Set calibration procedures and document the traceability chain
• Accept each new reagent lot with patient samples before use
• Keep accepted stock apart from unchecked stock and record each lot

Why it matters

A new lot can move results without anyone touching the analyser, so comparing lots the way patients will see them protects patient results.

Practice: Practice: Calibration, traceability and reagents · 3 questions

Opens with a critical result phoned to a referral laboratory's general number at night. Covers clause 6.7.1 on reviewing agreements with users and telling them of changes, clause 6.7.2 on agreements with point-of-care testing areas, and clause 6.8 on externally provided products and services. Includes requirements for referral laboratories and consultants, the list kept, and the five procedures of clause 6.8.3, with XYZ Hospital, a courier in Manila and a blood bank in Sydney.

What you will be able to do

• Review agreements with users and record significant changes
• Specify critical result handling with each referral laboratory
• Choose and re-evaluate external providers on set criteria

Why it matters

What you send out still carries your name, so a clear agreement gets a critical result to the right doctor on the right night.

Practice: Practice: Agreements and external providers · 3 questions

Opens with a paper request carrying only a name at XYZ Hospital's outpatient clinic, and a result filed to the wrong record. Covers clause 7.1: risks to patient care, residual risk and one example risk for each phase. Then clause 7.2.1 and clause 7.2.2 on pre-examination procedures and information for users, and clause 7.2.3 on requests as agreements, unclear requests and oral requests with written confirmation. Examples include a blood bank in New York.

What you will be able to do

• Identify, mitigate and monitor risks to patient care in all three phases
• Publish the information users need before they send a request
• Accept a request, including an oral one, only with identifiers and confirmation

Why it matters

The request is where traceability begins, and a missing identifier queried at the desk stops a mix-up before it reaches a record.

Practice: Practice: Process requirements and requests · 3 questions

Begins with samples waiting for hours in a warm courier box at a diagnostic laboratory in Dubai. Covers clause 7.2.4 to clause 7.2.7: the collection procedure and review of volumes and containers, information before collection, informed consent, eight collection instructions with identity checks, transport instructions, the seven elements of sample receipt, compromised samples, and stability and add-on time limits, using XYZ Hospital.

What you will be able to do

• Write collection instructions that verify identity and label samples at once
• Set written acceptance and rejection criteria for samples
• Handle a compromised sample by recording the risk and stating the problem on the report

Why it matters

The sample decides the result before the analyser does, and a perfect analyser examining the wrong patient's blood still produces a worthless result.

Practice: Practice: Primary samples: collection to storage · 3 questions

Opens with a diagnostic laboratory in Toronto that switches to a cheaper reagent never tested on its analyser. Defines verification and validation, then covers clause 7.3.1: methods validated for their intended use. Clause 7.3.2 on verification is shown with a clinical chemistry analyser and ward glucose meters at XYZ Hospital. Clause 7.3.3 on validation of developed, stretched or modified methods follows, with the specifications that may be included and the records.

What you will be able to do

• Decide whether a method needs verification or validation, and record why
• Plan a verification with criteria approved before any data
• Finish a validation with a signed statement of fitness for the intended use

Why it matters

Verify the claim and validate the new use: a new use needs new evidence, and a quick check on a few samples can cost more than the savings.

Practice: Practice: Verification and validation of methods · 3 questions

Begins with a Manila diagnostic laboratory that printed the maker's reference interval without checking the population behind it. Defines measurement uncertainty and covers clause 7.3.4: evaluating it, comparing it with performance specifications, qualitative examinations and answering a physician's question. Then clause 7.3.5 on reference intervals and clinical decision limits with a recorded basis, and clause 7.3.6 on documenting examination procedures and bench summaries, using XYZ Hospital.

What you will be able to do

• Evaluate measurement uncertainty and compare it with performance specifications
• Define reference intervals for the patients you serve and record the basis
• Keep bench summaries matched to the full documented procedure

Why it matters

An interval borrowed from the wrong population flags healthy patients and teaches clinics to ignore flags, so an interval must describe your patients.

Practice: Practice: Uncertainty, intervals and procedures · 3 questions

Opens with a hospital laboratory in Singapore at night where a failed control is rerun until it fits and the queue is released. Defines internal quality control and external quality assessment, then covers clause 7.3.7: monitoring with charts, fit control material, frequency set by risk, what to do when a control fails, scheme choice and alternatives, and comparability across methods and sites. XYZ Hospital plans one examination, with a clinic in Toronto.

What you will be able to do

• Plan internal quality control with material, frequency and an acceptance rule
• Handle a failed control by holding results and evaluating earlier ones
• Treat external samples as routine and compare results across methods and sites

Why it matters

A failed control is a signal, not a nuisance: stopping, fixing and looking back keeps every result that leaves the laboratory right.

Practice: Practice: Ensuring the validity of examination results · 3 questions

Begins with an unanswered ward phone in Hong Kong and a critical result that reaches the doctor hours late. Covers clause 7.4.1 in its eight parts: general reporting and delay notification, review before release, critical result calls with escalation, special considerations, automated release, the thirteen report items, extra information and amendments. Then clause 7.4.2 on how long samples are kept, using XYZ Hospital's report layout and retention plan.

What you will be able to do

• Review and authorise results before release
• Call and log critical results, verify accuracy and escalate when needed
• Issue amended reports that show the reason and trace to the original

Why it matters

A result helps the patient only when it arrives, so a logged call with read-back shows the right person heard it in time.

Practice: Practice: Reporting of results and samples afterwards · 3 questions

Opens with a warm reagent fridge at a diagnostic laboratory in Sydney where nobody knows who decides whether to stop. Covers clause 7.5: named authority, halting examinations and withholding reports, evaluating clinical significance and results already released, revision, authorised restart and corrective action, with an incubator record from XYZ Hospital. Then clause 7.6: information systems, interface validation, calculation checks, downtime plans and off-site providers.

What you will be able to do

• Specify who may halt work, evaluate it and authorise restart
• Look back at results released before a problem was found
• Validate information systems and practise a downtime plan

Why it matters

Stop first, then decide: a named authority and a look back at released results keep a fault from quietly guiding treatment.

Practice: Practice: Nonconforming work and information · 3 questions

Begins with a clinic in Manila whose complaint about a result is judged by the scientist who ran it. Defines a complaint, then covers clause 7.7: receipt, substantiation, investigation, publicly available description, resolution by people not involved, and a log at XYZ Hospital. Then clause 7.8: identifying emergency risks, the four duties, a continuity plan for power, analyser and staff failures, and testing it with a desk exercise.

What you will be able to do

• Log, investigate and resolve complaints through people not involved
• Publish a description of the complaints process
• Build and test a continuity plan from identified risks

Why it matters

A complaint handled well builds trust, and a continuity plan that has been tried is more than a hope on the worst day.

Practice: Practice: Complaints and continuity planning · 3 questions

Opens with a laminated bench card at XYZ Hospital that kept an old dilution step on the night shift. Covers clause 8.1.1 and its eight minimum parts, the option of an existing quality management system in clause 8.1.2, and staff awareness. Then documentation in clause 8.2, the nine document controls of clause 8.3.2 with a master list, and records in clause 8.4: made at the time, traceable amendments and retention times.

What you will be able to do

• Describe the eight minimum parts of the management system
• Control internal and external documents, including bench cards
• Make, amend and retain records so every change stays traceable

Why it matters

Documents say what to do and records show what was done, so the right version at every point of use protects results on every shift.

Practice: Practice: Management system, documents and records · 3 questions

Begins with mislabelled ward samples at XYZ Hospital that returned after a retraining action nobody checked. Covers clause 8.5: identifying and prioritising risks and opportunities, actions in proportion to impact, and a register. Then clause 8.6: improvement plans, sources of opportunity and feedback from patients, users and personnel. Clause 8.7 follows with the steps of corrective action, a muted blood fridge alarm in Dubai, and records.

What you will be able to do

• Prioritise risks and opportunities and record decisions and actions
• Collect feedback from patients, users and personnel and act on it
• Find the cause of a nonconformity and check the corrective action worked

Why it matters

A problem fixed only on the surface returns in front of a patient or an assessor, so closing an action only after a check keeps it fixed.

Practice: Practice: Risks, improvement and corrective action · 3 questions

Opens with a rising rejected-sample chart for the emergency department at XYZ Hospital that goes to every meeting and prompts no decision. Covers clause 8.8.1 on evaluations, the plan for each quality indicator under clause 8.8.2, and internal audits under clause 8.8.3 with a risk-based programme and the question of independence. Then clause 8.9: the ten recorded inputs of management review, including point-of-care testing, and outputs with an owner and a date.

What you will be able to do

• Plan a quality indicator with objective, method, limit and action plan
• Build an audit programme that gives priority to risk to patients
• Record management review outputs with owners and dates

Why it matters

Monitoring matters only when it leads to action, and a review that ends in dated decisions shows an assessor how you know the laboratory works.

Practice: Practice: Indicators, audits and management reviews · 3 questions

Begins with ward glucose meters at XYZ Hospital in Mumbai, where strips are stored by a sunny window and an untrained nurse's reading sets an insulin dose. Defines point-of-care testing and the normative status of Annex A, then covers the responsibility of the governing body, service agreements with clinical approval, the person responsible for POCT quality, the training programme, device selection, and where the main text names POCT. A screening clinic in Singapore shows the same model.

What you will be able to do

• Set up service agreements with clinical approval for each POCT location
• Appoint people responsible for POCT quality and for training
• Show where the main text of the standard applies to POCT

Why it matters

A reading from a meter on a ward matters as much to the patient as a result from the analyser, so testing near the patient must stay under control.

Practice: Practice: Point-of-care testing (Annex A) · 3 questions

Begins with a Dubai laboratory that issues a bought pack of generic procedures that staff ignore, against XYZ Hospital's smaller set built from the standard. Shows how to read shall have a procedure, shall have a process and recorded. Then lists the named procedures for resources, before the examination, the examination and reporting, the processes, items to document, and records. Ends with a clause cross-reference and five steps to build the set.

What you will be able to do

• Tell a required procedure from a required process or record
• Separate what the standard requires from what is your choice
• Build a cross-reference from each clause to your documents and records

Why it matters

Documents written for the assessor are filed away, while the set this training course teaches you to build is written by the people who do the work.

Practice: Practice: The procedures and records you need · 3 questions

Opens with a London laboratory that applies for accreditation in a rush, against XYZ Hospital's dated road map. Restates that laboratories are accredited, not certified, then walks through eight phases from the decision to the application. Covers the gap assessment, items that take longest such as external quality assessment, questions for choosing an accreditation body, closing findings at their cause, eight readiness checks, key takeaways and what comes next in this training course.

What you will be able to do

• Draft a dated road map with phases, outputs, owners and dates
• Choose an accreditation body using the questions the course gives
• Check readiness with eight checks and close findings at their cause

Why it matters

Accreditation follows a system that already runs, so months of records behind every requirement matter more than documents written in a rush.

Practice: Practice: Your road map to accreditation · 3 questions