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Accréditation Sans Frontières · ASF Health Standards 9.0

Standard 29 · Laboratory

59 criteria · optional module (declare to apply)

Optional module (declare to apply). 59 criteria, of which 30 non-negotiable. Each criterion is numbered 29.Y, with its classification and verification questions.

Criteria

29.1 Impartiality: No Commercial Pressure on Results

NON-NEGOTIABLE

No staff member's remuneration, performance evaluation, or continued employment is tied, directly or indirectly, to the volume or outcome of specific test results. Laboratory personnel are protected from undue commercial or financial pressure that could influence technical judgement.

VERIFICATION QUESTIONS

  1. Is any part of technical staff compensation linked to test volume, result patterns, or referral relationships?
    Staff pay is not tied to volume or results.
  2. Is there a documented policy explicitly protecting staff who report a quality concern from retaliation?
    Staff who report concerns are protected in writing.
  3. Would a technician who identified a result requiring re-testing feel safe raising it, even if it delays turnaround?
    Staff feel safe raising a result, even when it delays turnaround.

29.2 Conflict of Interest Declared and Reviewed

CORE

Staff and management with influence over testing, purchasing, or reporting decisions declare financial or personal interests that could reasonably affect impartiality, and these declarations are reviewed on a fixed schedule, not only collected once at hiring.

VERIFICATION QUESTIONS

  1. Do current declarations exist for everyone in a position of influence, not just a one-time declaration from years ago?
    Declarations are current for everyone with influence.
  2. Is there a named person or body responsible for reviewing declarations and deciding what action, if any, is needed?
    A named person decides what action a declaration needs.
  3. Where a conflict was identified, is there a record of what mitigation was applied?
    Mitigation for each conflict is recorded.

29.3 Patient Information Is Kept Confidential

NON-NEGOTIABLE

Patient information held by the laboratory is kept confidential, is accessed only by authorised people for a defined purpose, and is disclosed only where the law or the patient's consent allows.

VERIFICATION QUESTIONS

  1. Is access to patient information limited to authorised staff for a defined purpose, with access recorded?
    Unrestricted access makes confidentiality a matter of chance.
  2. Is disclosure of patient information made only where the law or the patient's consent allows, and is each disclosure recorded?
    Disclosure without a record cannot be reviewed.
  3. Are staff trained in confidentiality, and is the training recorded?
    Staff who do not know the rules cannot apply them.

29.4 Users Receive Information on Test Indications and Limitations

CORE

Users of the laboratory receive clear information on the indications and limitations of each examination and on how often it should be requested, so that tests are requested and interpreted correctly.

VERIFICATION QUESTIONS

  1. Is information on the indications and limitations of each examination available to requesting clinicians in writing?
    Tests used outside their indications produce misleading results.
  2. Is the appropriate frequency of requesting each examination communicated where it affects interpretation?
    Repeat testing without need adds error and cost.
  3. Can requesting clinicians obtain advice on test selection and interpretation from qualified laboratory staff?
    Interpretation support is part of the service, not an optional extra. — Clause 5 — Structural and governance requirements —

29.5 Named Accountable Person

NON-NEGOTIABLE

A named individual — the Laboratory Director or an equivalent role — holds documented, final accountability for the quality management system. The name is current, not a vacant title inherited from a predecessor. Financial accountability is named separately, even where the same person holds both roles, and a statement of mission and values exists for the laboratory.

VERIFICATION QUESTIONS

  1. Is there a named, current Laboratory Director or equivalent, not a title left over from someone who has since left?
    A named and current Director, not a title left from a predecessor.
  2. Does that person hold documented authority to stop unsafe testing or release of results?
    Authority to stop unsafe work is written down.
  3. Can staff correctly name this person if asked directly?
    Staff know who holds accountability.
  4. Is financial accountability named separately from quality-system accountability, even if held by the same person?
    Financial and quality accountability are named, even if one person holds both.
  5. Does a statement of mission and values exist that is specific to this laboratory?
    A mission and values statement specific to this laboratory.

29.6 Risk Register, Reviewed on a Schedule

CORE

A risk register identifies specific risks to result accuracy and patient safety across the specimen pathway, with a named owner and review date for each entry, reviewed on a fixed schedule rather than only after an incident.

VERIFICATION QUESTIONS

  1. Does the risk register name specific risks
    not generic entries like "human error" with no detail? — Each risk is specific, not a generic label.
  2. Does each entry have a named owner responsible for it?
    Each risk has an owner.
  3. Is the register reviewed on a fixed schedule, verifiable by actual review dates, not only reactively after something goes wrong?
    The register is reviewed on a schedule, not only after an incident.

29.7 Authority and Responsibilities Are Defined and Documented

NON-NEGOTIABLE

The laboratory's structure, the authority of each role, and the people who may act for another role are defined in writing and are known to staff.

VERIFICATION QUESTIONS

  1. Is there a current organisation chart showing each role, its reporting line, and who is responsible for each function?
    A role that is not written down is one that no one can be held to.
  2. Are the authorities of each role, including who may release results and who may delegate, documented and approved?
    Unclear authority is where unauthorised results get released.
  3. Are the authorities reviewed when staff change or the structure changes, and is the review recorded?
    An outdated structure gives authority to people who no longer hold it. — Clause 6 — Resource requirements —

29.8 External Service and Supply Evaluation

CORE

Reference laboratories, equipment service providers, and critical reagent suppliers are formally evaluated before use and periodically thereafter, against documented criteria relevant to the service each provides.

VERIFICATION QUESTIONS

  1. Is there a documented evaluation on file for the laboratory's current reference laboratory and key equipment service providers?
    Suppliers are evaluated before use.
  2. Are these evaluations repeated on a periodic schedule, not only at the start of the relationship?
    Evaluation continues during the relationship.
  3. Where a provider's performance has been unsatisfactory, is there a record of how the laboratory responded?
    A recorded response to unsatisfactory performance.

29.9 Documented Qualification Before Independent Work

NON-NEGOTIABLE

No staff member performs a laboratory procedure unsupervised until their competence in that specific procedure has been formally assessed and documented, not merely inferred from a general qualification or job title.

VERIFICATION QUESTIONS

  1. For a staff member selected at random, does a documented competence record exist for every procedure they perform unsupervised?
    Competence is evidenced for every procedure performed alone.
  2. Was the competence assessment performed by someone else, not self-certified by the staff member?
    Competence is assessed by someone other than the person being assessed.
  3. Is there a record of the actual date competence was confirmed, not just a start date of employment?
    The date competence was confirmed, not only the start date.

29.10 Competence Reassessed on a Schedule

NON-NEGOTIABLE

Staff competence is formally reassessed at defined intervals — not only at hiring — and immediately following any extended absence, procedural change, or identified performance concern.

VERIFICATION QUESTIONS

  1. Is there a fixed reassessment interval, and does the most recent reassessment date for staff fall within it?
    Competence is reassessed on a fixed interval.
  2. Following a staff member's return from extended leave, was competence reconfirmed before they resumed unsupervised work?
    Competence is rechecked after extended leave.
  3. Where a performance concern was identified, was a targeted reassessment triggered specifically because of it?
    A concern leads to a targeted reassessment.

29.11 Orientation Before First Independent Shift

CORE

Every new staff member completes a documented orientation covering the laboratory's quality management system, safety procedures, and their specific role's SOPs before working an unsupervised shift.

VERIFICATION QUESTIONS

  1. Does a signed orientation record exist for current staff, dated before their first unsupervised shift?
    Orientation is recorded before unsupervised work.
  2. Does orientation cover safety procedures specifically, not only administrative onboarding?
    Orientation covers safety, not only administration.
  3. Can a recently hired staff member describe what their orientation covered?
    Evidence that orientation was understood.

29.12 Training Records Tied to Specific SOPs

CORE

Training records name the specific SOP or procedure version a staff member was trained on, and are updated whenever that SOP is revised, so the laboratory can show at any time exactly which version of a procedure each staff member is currently qualified to perform.

VERIFICATION QUESTIONS

  1. Do training records name the specific SOP and version, not just a general subject area?
    Training is linked to the specific SOP version.
  2. When an SOP was last revised, were affected staff retrained and the record updated before the new version took effect?
    Staff are retrained when an SOP changes.
  3. Can the laboratory produce, for any current staff member, the exact list of SOP versions they are currently qualified on?
    A current, exact list of each person's SOP qualifications.

29.13 Adequate Staffing for Safe Operation

CORE

Staffing levels at all operating hours are sufficient for safe specimen handling, timely result reporting, and compliance with the laboratory's own written procedures, with a documented plan for covering absence.

VERIFICATION QUESTIONS

  1. Does the laboratory have a documented minimum staffing level for each operating shift?
    A written minimum for each shift.
  2. Is there a documented plan for covering unplanned absence that does not rely on an already-fatigued remaining staff member working alone?
    Cover for absence that does not rely on one tired person.
  3. Have critical procedures ever been delayed or skipped due to understaffing, and if so, was this logged as a quality event?
    A recorded case of understaffing affecting critical work.

29.14 Calibration Current on Every Reportable Instrument

NON-NEGOTIABLE

Every instrument used to generate a reportable patient result has a current, traceable calibration record, and no instrument is used past its calibration due date without being formally removed from service first.

VERIFICATION QUESTIONS

  1. For every analyser in use, is its calibration record current, with a traceable certificate or reference standard?
    Calibration is evidenced for each instrument in use.
  2. Is there any instrument past its calibration due date still generating reportable results?
    No instrument is used past its calibration due date.
  3. Where an instrument is taken out of service, is it physically or digitally flagged so staff cannot use it by mistake?
    A taken-out-of-service instrument cannot be used by mistake.

29.15 Preventive Maintenance on a Fixed Schedule

NON-NEGOTIABLE

Every piece of critical equipment is maintained according to the manufacturer's recommended schedule or a validated equivalent, with maintenance records retained and reviewed before each instrument returns to reportable use after service.

VERIFICATION QUESTIONS

  1. Does a maintenance log exist for critical equipment showing the manufacturer's recommended interval was met?
    Maintenance intervals are recorded and met.
  2. After servicing, is there a documented verification step before the instrument returns to reporting patient results?
    A check before the instrument returns to use.
  3. Are maintenance records retained for the full retention period set in criterion 7.7?
    Maintenance records are kept for the required period.

29.16 Reagent Lot Verification Before Use

NON-NEGOTIABLE

Each new reagent lot is verified against the laboratory's own quality control material before being used for reportable patient results, and expired reagents are physically segregated from, and never used in, active testing.

VERIFICATION QUESTIONS

  1. Can the laboratory show lot-verification records for its currently open reagent lots?
    Each open reagent lot is verified before use.
  2. Are expired reagents physically separated from current stock, not just marked and left in the same storage area?
    Expired reagents are kept apart from current stock.
  3. Is reagent storage temperature monitored and logged, with a documented response procedure for excursions?
    Reagent storage temperature is logged and acted on.

29.17 Metrological Traceability to a Recognised Reference

CORE

Calibration of measuring equipment is traceable through an unbroken chain to an internationally recognised reference material or method, documented at each link, not simply asserted by the equipment manufacturer.

VERIFICATION QUESTIONS

  1. Can the laboratory produce documentation showing the traceability chain for a selected instrument back to a recognised reference?
    A documented traceability chain for each instrument.
  2. Where a reference material is used, is its own certificate of traceability on file and current?
    The reference material's own traceability is on file.
  3. Is the traceability chain reviewed whenever equipment or reference materials change?
    The traceability chain is reviewed when equipment changes.

29.18 Equipment Malfunction: Documented Response

CORE

A written procedure governs the laboratory's response to equipment malfunction, including immediate removal from reportable use, assessment of results produced since the last verified-good check, and notification of affected clinicians where results may be unreliable.

VERIFICATION QUESTIONS

  1. Does the malfunction procedure require assessing results produced since the last known-good check, not only results produced after the malfunction was noticed?
    Results since the last good check are reviewed after a malfunction.
  2. Can the laboratory show a recorded example of a clinician being notified after a malfunction affected previously reported results?
    A recorded case of clinicians being told about affected results.
  3. Is the malfunction procedure accessible to staff during an actual event, not only during planned audits?
    The procedure is usable during a real event.

29.19 Personal Protective Equipment, Available and Used

NON-NEGOTIABLE

Appropriate personal protective equipment is available at the point of use for every task requiring it, in adequate supply, and observed to be worn, not merely available but unused under time pressure.

VERIFICATION QUESTIONS

  1. Is PPE worn correctly for the task being performed, as observed at the bench?
    Observed use, not only availability.
  2. Is PPE available at the point of use, not stored somewhere requiring staff to leave the bench to retrieve it?
    PPE is at the point of use, not in a store.
  3. Has PPE ever run out during a shift, and if so, was this logged as a safety event?
    A shortage of PPE is recorded as a safety event.

29.20 Exposure Incident: Documented Response Protocol

NON-NEGOTIABLE

A written protocol governs response to a biological exposure incident — needlestick, splash, spill — including immediate first aid, reporting, and post-exposure medical follow-up, known to staff and accessible at the point of need.

VERIFICATION QUESTIONS

  1. Can staff describe the first steps of the exposure protocol without consulting a document?
    Staff know the first steps without looking them up.
  2. Can the laboratory show a recent recorded exposure incident, and did the actual response match the written protocol?
    A recent recorded case, checked against the protocol.
  3. Is post-exposure medical follow-up accessible, not just named in the policy with no arrangement in place?
    Follow-up is arranged, not only described.

29.21 Information System Access Controlled and Logged

CORE

Access to the laboratory information system is controlled through individual, non-shared user credentials, with access levels matched to role, and a log of who accessed or modified patient data.

VERIFICATION QUESTIONS

  1. Are login credentials individual, or does staff share a single generic login?
    Each user has their own login.
  2. Do access levels differ by role, with results-amendment permission restricted to appropriate staff?
    Access follows role, with amendments restricted.
  3. Is the access log reviewed periodically, not just generated and left unexamined?
    The access log is reviewed. — Replacement text for former laboratory Standard 5 (facilities, environment, waste, suppliers and utilities). Original text lost; this replacement is drafted from ISO 15189:2022 clause 6 (resource requirements) and must be checked against the licensed text —

29.22 Laboratory Accommodation Protects Specimens and Staff

NON-NEGOTIABLE

The laboratory is designed and maintained so that specimens are protected from contamination and damage, and staff work in a safe, controlled environment.

VERIFICATION QUESTIONS

  1. Is the laboratory designed with separate, controlled areas for specimen receipt, processing and reporting?
    Mixing areas allows contamination of specimens and results.
  2. Is access to the laboratory restricted to authorised staff, with the restriction recorded?
    Unauthorised access is a route for specimen tampering and error.
  3. Is the laboratory layout reviewed when workflow changes, and the review recorded?
    A layout built for an earlier workflow causes errors under the new one.

29.23 Environmental Conditions Are Monitored and Recorded

CORE

Temperature, humidity and ventilation that affect specimens, reagents and equipment are monitored, recorded, and acted on when they fall outside the required range.

VERIFICATION QUESTIONS

  1. Are the environmental conditions that affect specimens and reagents defined and monitored on a schedule?
    Conditions not monitored cannot be shown to be correct.
  2. Are out-of-range readings recorded, investigated, and acted on, with the affected results reviewed?
    A reading that is recorded but not acted on protects no one.
  3. Are monitoring devices calibrated on a schedule, with the calibration recorded?
    A monitor that has drifted gives false assurance.

29.24 Laboratory Waste Is Segregated and Disposed of Safely

NON-NEGOTIABLE

Infectious, chemical and sharps waste from the laboratory is segregated at source, stored, transported and disposed of under a documented procedure.

VERIFICATION QUESTIONS

  1. Is laboratory waste segregated at the point of generation by hazard category?
    Mixed waste is a hazard to staff and the public.
  2. Is waste stored, transported, and disposed of under a documented procedure, with the disposal recorded?
    A disposal that cannot be traced cannot be checked.
  3. Are staff trained in waste segregation and handling, and is this training recorded?
    Waste handling is a frequent source of injury.

29.25 Suppliers and External Services Are Qualified and Monitored

CORE

Reagents, consumables and external laboratory services are purchased from suppliers qualified against defined requirements, and their performance is monitored.

VERIFICATION QUESTIONS

  1. Are suppliers and external laboratory services qualified against defined requirements before use?
    An unqualified supplier can introduce a defect that no internal check detects.
  2. Is supplier performance monitored, including the quality of reagents and the timeliness of external results?
    Performance that is not monitored cannot be managed.
  3. Are failures of a supplier recorded, and is the decision to continue using them documented?
    A supplier failure that is ignored is repeated.

29.26 Laboratory Utilities and Failures Are Planned For

NON-NEGOTIABLE

Power, water, and other utility failures that affect laboratory work are identified, back-up arrangements are documented, and the arrangements are tested.

VERIFICATION QUESTIONS

  1. Are the utilities that the laboratory depends on identified, with back-up arrangements documented?
    A laboratory that loses power without a plan loses its results.
  2. Are back-up arrangements, such as generators or alternative testing routes, tested on a defined schedule?
    A back-up that has never been tested may not work when needed.
  3. Are samples and results protected during an utility failure, under a documented procedure?
    Samples lost during a failure cannot be replaced.

29.27 Laboratory Information Is Managed Securely and Accurately

NON-NEGOTIABLE

Laboratory information systems hold accurate, complete and secure records of samples, results and reports, with back-up and recovery arrangements that are tested.

VERIFICATION QUESTIONS

  1. Is the laboratory information system validated before use, and after each change?
    An unvalidated system can produce wrong results without warning.
  2. Are records backed up on a schedule, and is recovery from back-up tested?
    A back-up that has never been restored may not work when needed.
  3. Is the accuracy of data transferred between instruments and the information system checked?
    A transfer error can attach the wrong result to the wrong patient. — Clause 7 — Process requirements —

29.28 Two-Identifier Patient Verification

NON-NEGOTIABLE

Before specimen collection, the patient's identity is verified using at least two independent identifiers — never room number or visual recognition alone — and the verification is actively performed, not merely asked as a rhetorical formality.

VERIFICATION QUESTIONS

  1. During a live collection, are two identifiers checked, not only a name spoken while the patient is expected to confirm passively?
    Verification is performed, not assumed.
  2. Is room number or bed number ever used as one of the two identifiers?
    Room or bed numbers are never used as an identifier.
  3. For a patient unable to confirm identity verbally, is there a documented alternative verification procedure?
    A defined route for a patient who cannot confirm identity.
  4. Is the patient's right to decline specimen collection honoured, with staff able to describe what happens when a patient exercises it?
    The right to decline is honoured.

29.29 Specimen Labelled at the Point of Collection

NON-NEGOTIABLE

Every specimen is labelled in the presence of the patient, immediately following collection, before moving to the next patient or task — never batch-labelled afterwards from memory or a separate list.

VERIFICATION QUESTIONS

  1. Is labelling observed to happen at the bedside or chairside, before the collector moves on?
    Labelling happens at the bedside, before the collector moves on.
  2. Are there any workflows where multiple specimens are collected before any labelling occurs?
    Specimens are labelled one at a time.
  3. Does the label include enough information to re-verify identity independently of the collector's memory?
    The label allows identity to be checked later.

29.30 Rejection Criteria, Applied Consistently

NON-NEGOTIABLE

Written specimen rejection criteria — haemolysis, clotting, insufficient volume, unlabelled or mislabelled specimens, wrong container — are applied consistently regardless of how difficult the specimen was to obtain or who is requesting results urgently.

VERIFICATION QUESTIONS

  1. Can staff describe the rejection criteria without looking them up?
    Staff know the rejection criteria.
  2. Can the laboratory show a recorded example of a specimen being rejected despite clinical pressure to proceed anyway?
    A recorded case of a rejection despite pressure.
  3. Is rejection logged with reason and communicated back to the requesting clinician, not just silently discarded?
    Rejections are logged and explained to the clinician.

29.31 Transport Conditions Preserve Specimen Integrity

NON-NEGOTIABLE

Specimens requiring specific transport conditions — temperature, time limits, light protection — are transported accordingly, with the conditions monitored, not assumed to be met because a general policy exists.

VERIFICATION QUESTIONS

  1. For temperature-sensitive specimens, is the actual transport temperature verified, not just assumed from the container type used?
    Transport temperature is checked, not assumed.
  2. Is time from collection to receipt tracked for time-sensitive analytes?
    Time to receipt is tracked for time-sensitive tests.
  3. Where a specimen arrives outside acceptable transport conditions, is this documented and does it affect result interpretation or trigger rejection?
    Out-of-range arrivals are recorded and assessed.

29.32 Chain of Custody for Forensic or Legal Specimens

CORE

Where the laboratory processes specimens with forensic, legal, or chain-of-custody requirements, a documented, unbroken custody record accompanies the specimen from collection through final disposition, with every handler's signature and timestamp.

VERIFICATION QUESTIONS

  1. Does a chain-of-custody form exist, with every transfer point requiring a signature, not just collection and final testing?
    Every handover is signed.
  2. Are chain-of-custody specimens physically secured differently from routine specimens?
    Legal specimens are secured separately.
  3. Is staff specifically trained on chain-of-custody requirements, distinct from routine specimen handling training?
    Staff are trained for chain of custody.

29.33 Specimen Accessioning Logged in Real Time

CORE

Specimen receipt is logged in the laboratory information system at the time of actual receipt, creating a verifiable, time-stamped record of when the specimen entered the laboratory's custody, not backdated to match the collection time.

VERIFICATION QUESTIONS

  1. Does the accessioning timestamp reflect actual receipt time, verifiable against another independent record such as a courier log?
    The timestamp matches the real time of receipt.
  2. Is there a backlog where specimens sit unaccessioned for a meaningful period before entry?
    No specimens wait unlogged for long.
  3. Can the laboratory produce the accessioning record for any specimen the assessor selects, on request?
    The accessioning record is available on request.

29.34 Urgent/STAT Specimens Prioritised and Tracked

CORE

A written procedure defines how urgent or STAT specimens are flagged, prioritised through processing, and tracked against a defined turnaround-time target, distinct from routine specimen handling.

VERIFICATION QUESTIONS

  1. Is there a visible, physical or digital flagging system that changes how a STAT specimen is handled, not just a label with no operational effect?
    A STAT flag changes how the specimen is handled.
  2. Is STAT turnaround time tracked and reviewed, with a defined target?
    STAT turnaround is tracked against a target.
  3. Where STAT turnaround targets are missed, is this logged and reviewed as a quality event?
    Missed STAT targets are logged and reviewed.

29.35 Specimen Retention Before Discard

STANDARD

Tested specimens are retained for a defined minimum period appropriate to the test type before discard, allowing repeat testing or additional analysis to be requested without recollection.

VERIFICATION QUESTIONS

  1. Does a written retention schedule exist by specimen and test type, not one blanket period applied regardless of test?
    Retention is set by specimen and test type.
  2. Is retained specimen storage condition-appropriate, matching what the specimen requires?
    Retained specimens are stored under the right conditions.
  3. Can the laboratory locate and retrieve a specific retained specimen within its stated retention window?
    A retained specimen can be found within its window.

29.36 Method Validation Before Clinical Use

NON-NEGOTIABLE

Every examination method used for reportable patient results has documented validation or verification data — accuracy, precision, reportable range, reference intervals — completed before the method was first used clinically, not retrospectively assembled.

VERIFICATION QUESTIONS

  1. For a currently used method, does validation data exist with a completion date before the method's first clinical use?
    Validation is completed before clinical use, not after.
  2. Where a manufacturer's validation data is relied upon instead of in-house validation, has the laboratory verified it performs equivalently in its own hands?
    Manufacturer data is verified in the laboratory's own hands.
  3. Are reference intervals appropriate to the actual patient population served, not simply copied from a manufacturer insert?
    Reference intervals suit the patients served.

29.37 Internal Quality Control Run Before Patient Results Released

NON-NEGOTIABLE

Internal quality control is run and reviewed as acceptable before any patient result from that run is released, with a written, followed procedure for what happens when quality control fails.

VERIFICATION QUESTIONS

  1. Can the laboratory show that no patient result was released before quality control for that run was reviewed?
    No result is released before its quality control is reviewed.
  2. When quality control fails, can the laboratory show a recorded example of the correct response being followed
    investigation, correction, re-run — before results were released? — A recorded case of the correct response before release.
  3. Is quality control frequency appropriate to test volume and stability, not merely the minimum the laboratory can get away with?
    QC frequency suits the test volume and stability.

29.38 External Quality Assessment Participation

NON-NEGOTIABLE

The laboratory participates in an external quality assessment or proficiency testing scheme for every discipline it operates where a scheme is available, with results reviewed by the accountable person and unsatisfactory performance investigated.

VERIFICATION QUESTIONS

  1. Does current enrolment and recent participation exist for every operated discipline with an available scheme?
    Current participation in every scheme available.
  2. Is there documented review of each round's results by the accountable person, not just filing the certificate?
    Each round is reviewed by the accountable person.
  3. Where performance was unsatisfactory, was a documented investigation and corrective action completed?
    Unsatisfactory results lead to a recorded investigation.

29.39 Critical Value Communication, Verified Received

NON-NEGOTIABLE

Critical or panic values are communicated directly to a responsible clinician without delay, with verification that the message was received and understood — not left on voicemail or sent by a method with no confirmation of receipt — and the communication is logged.

VERIFICATION QUESTIONS

  1. Is there a written list of what constitutes a critical value for each relevant analyte?
    A written list of critical values per analyte.
  2. Does the communication log show read-back verification or equivalent confirmation of understanding, not just that a call was placed?
    Read-back confirms understanding.
  3. Is there a documented escalation path when the first contact attempt fails to reach a responsible clinician?
    A defined escalation when a clinician cannot be reached.

29.40 Result Amendment Traceable to Original

CORE

Where a released result is amended, the original value, the amended value, the reason, the person making the change, and the date are all retained and visible together — the original is never simply overwritten or deleted.

VERIFICATION QUESTIONS

  1. For an amended result selected at random, is the original value still visible alongside the amendment, not replaced?
    The original value is never lost.
  2. Does the amendment record show who made the change and why?
    Every amendment shows who changed it and why.
  3. Was the ordering clinician notified when a previously released result was amended?
    The ordering clinician is told when a released result changes.

29.41 Result Authorisation Before Release

NON-NEGOTIABLE

Every result is reviewed and authorised by qualified staff before release to the requesting clinician, with the authorisation step distinct from the generation of the raw instrument value and traceable to a named individual.

VERIFICATION QUESTIONS

  1. Is there a documented authorisation step separate from instrument output, attributable to a specific named person?
    Authorisation is a named, separate step.
  2. Where auto-verification rules release results without manual review, are the rules themselves validated and periodically reviewed?
    Auto-verification rules are validated and reviewed.
  3. Can the laboratory show, for any result selected at random, who authorised it and when?
    Any result can be traced to who authorised it and when.

29.42 Report Content Meets a Defined Minimum

NON-NEGOTIABLE

Every report includes, at minimum, patient identification, specimen type and collection date/time, test name, result with units, reference interval, and any flag or interpretive comment needed for safe clinical use.

VERIFICATION QUESTIONS

  1. For a report selected at random, are all required elements present, not just the result value itself?
    Every required element is on the report.
  2. Where a result falls outside the reportable range of the method, is this clearly flagged rather than reported as an exact number?
    Results outside the reportable range are flagged.
  3. Is specimen quality that may affect interpretation
    haemolysis, lipaemia — noted on the report when relevant? — Specimen quality that changes interpretation is shown.

29.43 Report Delivered to the Correct Recipient

NON-NEGOTIABLE

A written procedure confirms the result report reaches the correct requesting clinician or facility, with a check in place to catch and correct misdirected reports before they reach the wrong recipient.

VERIFICATION QUESTIONS

  1. Can the laboratory show a recorded example of a misdirected report being caught and corrected, demonstrating that the check functions?
    A recorded case of a misdirected report being caught.
  2. For electronic delivery, is there confirmation the receiving system accepted the transmission, not just that it was sent?
    Electronic delivery is confirmed as received.
  3. Where a patient has been transferred between facilities, is there a defined process for ensuring pending results follow them?
    Pending results follow a transferred patient.

29.44 Turnaround Time Monitored Against a Target

CORE

Turnaround time from specimen receipt to result release is tracked against a defined target for each major test category, reviewed periodically, with documented action when targets are consistently missed.

VERIFICATION QUESTIONS

  1. Are turnaround targets defined per test category, not one blanket figure applied regardless of complexity?
    Targets are set for each test category.
  2. Is turnaround time data reviewed on a schedule, not just collected and left unexamined?
    Turnaround data is reviewed on a schedule.
  3. Where targets are consistently missed for a category, is there a documented response, not just repeated observation?
    A recorded response to repeated misses.

29.45 Supplementary and Referred Test Results Tracked to Closure

CORE

Tests referred to another laboratory are tracked from referral through to receipt and reporting of the result, with a defined escalation point if the result does not return within an expected timeframe.

VERIFICATION QUESTIONS

  1. Does a log exist of all currently outstanding referred tests, with expected return dates?
    Outstanding referrals are logged with return dates.
  2. Can the laboratory show a recorded example of an overdue referred result being actively followed up, not just passively awaited?
    A recorded case of an overdue referral being chased.
  3. When a referred result finally arrives, does it go through the same authorisation and critical-value process as an in-house result?
    Referred results follow the same checks as in-house results.

29.46 Cumulative/Historical Results Available at Review

CORE

Prior results for the same patient and analyte are available alongside a new result at the point of review, allowing delta-check comparison, so a clinically significant change from a patient's own baseline is not missed.

VERIFICATION QUESTIONS

  1. Is prior-result history visible to the person authorising a new result, not requiring a separate manual lookup they may skip?
    Prior results are visible when a new result is authorised.
  2. Does the system flag a significant delta from the patient's own prior value, not just an absolute reference-range flag?
    Changes from the patient's own baseline are flagged.
  3. Can the laboratory show a recorded case where a delta check caught a potential specimen mix-up or clinically significant change?
    A recorded case where a delta check caught a problem.

29.47 Interpretive Comments Added Where Clinically Needed

STANDARD

Where a result pattern requires clinical interpretation beyond the raw numbers — an unusual combination, a known interference, a testing limitation — qualified staff add an interpretive comment to the report rather than releasing the number alone.

VERIFICATION QUESTIONS

  1. Can the laboratory show examples of interpretive comments added to reports where needed?
    Examples of interpretive comments added when needed.
  2. Is there a defined list of result patterns or situations that trigger a required interpretive comment?
    A defined list of patterns that need a comment.
  3. Are interpretive comments written by staff qualified to make that clinical judgement, not added by whoever happens to be reviewing the result?
    Comments come from qualified staff.

29.48 Patients Are Informed How to Prepare for Testing

CORE

Patients receive clear, written information on how to prepare for each test, including fasting, timing and medicines, before the specimen is collected.

VERIFICATION QUESTIONS

  1. Is preparation information for each test available to patients in writing, in a language they understand?
    A preparation error invalidates the result.
  2. Is the preparation information checked against the laboratory's current test requirements on a schedule?
    Preparation requirements change, and the information must change with them.
  3. Is the patient's preparation confirmed at collection, and is any departure recorded?
    A patient who did not prepare as instructed should be recorded, not silently tested.

29.49 Measurement Uncertainty Is Evaluated for Quantitative Tests

STANDARD

For quantitative examination procedures, measurement uncertainty is evaluated, documented and reviewed, and is made available where it affects interpretation of a result.

VERIFICATION QUESTIONS

  1. Is measurement uncertainty evaluated and documented for each quantitative examination procedure in use?
    A result without an uncertainty estimate cannot be judged against a decision limit.
  2. Is measurement uncertainty reviewed when the method, reagents or equipment change?
    A change can alter the uncertainty of every result that follows.
  3. Is measurement uncertainty available to users where it affects clinical interpretation?
    Users need to know when a difference between two results is within measurement error. — Clause 8 — Management system requirements —

29.50 Document Control: One Current Version

NON-NEGOTIABLE

Every controlled policy, procedure, and SOP exists in exactly one current, identifiable version at the bench. Superseded versions are removed from use, not merely marked obsolete while remaining accessible.

VERIFICATION QUESTIONS

  1. For any SOP selected at random at the bench, is it the current version, verifiable against the master document register?
    The bench copy is the current, controlled version.
  2. Are superseded versions physically or digitally removed from the work area, not just labelled "obsolete"?
    Superseded versions are removed from use.
  3. Is there a single master document register that lists every controlled document and its current version?
    One register lists every controlled document and version.

29.51 Document Approval Before Use

NON-NEGOTIABLE

No policy, procedure, or SOP is used at the bench before it has been formally reviewed and approved by the accountable person or their documented delegate.

VERIFICATION QUESTIONS

  1. Does every controlled document show a named approver and approval date before its effective date?
    Each document shows its approver and date.
  2. Where approval is delegated, is the delegation itself documented and current?
    Delegated approval is documented.
  3. Can the laboratory produce the approval record for any document the assessor selects at random?
    Approval records can be produced on request.

29.52 Retention Schedule Matches Legal Minimum

CORE

A documented retention schedule states how long each record type — patient results, quality control data, equipment maintenance logs, competence records — is kept, and meets or exceeds the applicable national legal minimum.

VERIFICATION QUESTIONS

  1. Does a written retention schedule exist covering every major record type, not just patient results?
    The schedule covers all record types.
  2. Does each retention period meet or exceed the national legal minimum for that record type?
    Each period meets the legal minimum.
  3. Can the laboratory retrieve a record from several years back within the stated retention period, not just recent ones?
    Older records can be retrieved within their period.

29.53 Internal Audit, On a Fixed Schedule

NON-NEGOTIABLE

The full quality management system is internally audited at least once per year against a documented audit schedule, covering every section of the laboratory over a defined cycle, not only the sections most convenient to review.

VERIFICATION QUESTIONS

  1. Does a documented audit schedule exist covering every laboratory section within a defined cycle?
    Audits cover every section on a defined cycle.
  2. Did the most recent audit happen on or near its scheduled date?
    Audits happen on schedule.
  3. Are audit findings recorded in enough detail that someone outside the audit could understand what was checked?
    Findings are recorded clearly enough for others to follow.

29.54 Corrective Action Closes the Root Cause

NON-NEGOTIABLE

Every nonconformance with potential impact on patient results triggers a documented corrective action that identifies the root cause, not only the immediate symptom, and the action is verified as effective after implementation.

VERIFICATION QUESTIONS

  1. For a recent corrective action selected at random, does it name a root cause, or only restate the symptom?
    A named root cause, not a restated symptom.
  2. Was the corrective action's effectiveness checked after a defined interval, not just implemented and assumed to have worked?
    Corrective actions are checked after an interval.
  3. Where the same type of nonconformance has recurred, was that recurrence itself investigated as a sign the original action failed?
    Recurrence is treated as a sign the action failed.

29.55 Preventive Action, Not Only Reactive

CORE

The laboratory identifies potential nonconformances before they occur — from trend data, near-misses, risk register entries, or external quality assessment patterns — and acts on them, not only responding after an actual failure.

VERIFICATION QUESTIONS

  1. Can the laboratory show at least one preventive action taken from trend data or a near-miss, not triggered by an actual failure?
    A preventive action taken before any failure.
  2. Is external quality assessment performance trended over time, not just checked pass/fail each round?
    EQA results are trended, not only pass or fail.
  3. Is there a named person responsible for reviewing trends on a schedule?
    A named person reviews trends.

29.56 Management Review, With Minutes and Actions

CORE

Senior management formally reviews the quality management system at least annually, with documented minutes, inputs covering audits/complaints/nonconformances/external quality assessment, and tracked output actions with owners and dates.

VERIFICATION QUESTIONS

  1. Do management review minutes exist for the most recent cycle, with named attendees?
    Minutes record attendance and the review.
  2. Do the minutes cover the required inputs
    audit results, complaints, nonconformances, external quality assessment performance? — The required inputs are covered.
  3. Are output actions from the previous review traceable to completion, with a named owner for each?
    Actions from each review are tracked to completion.

29.57 Complaints Logged, Investigated, Closed

CORE

Every complaint, from any source — patient, clinician, referring facility — is logged in a single register, investigated, and closed with a documented outcome communicated back to the complainant where contact information exists.

VERIFICATION QUESTIONS

  1. Does a single complaints register exist, or are complaints handled informally by whoever receives them?
    One complaints register.
  2. Is there a documented outcome for each logged complaint, not just a record that it was received?
    Each complaint has a recorded outcome.
  3. Where contact information exists, was the complainant informed of the outcome?
    Complainants are told the outcome where possible.

29.58 User Feedback Is Gathered and Acted On

CORE

Feedback from clinicians, patients and other users of the laboratory is gathered on a defined schedule, analysed, and used to improve the service.

VERIFICATION QUESTIONS

  1. Is feedback from clinicians and other users gathered on a defined schedule?
    A service that does not ask cannot learn what is wrong with it.
  2. Is feedback analysed, and are actions taken and recorded?
    Feedback that is collected and not acted on wastes users' time.
  3. Are the results of the feedback reported back to the users who gave it?
    Users who see no response stop giving feedback.

29.59 Improvement Is Planned, Measured and Reviewed

CORE

The laboratory identifies opportunities to improve its service, sets measurable goals, tracks progress, and reviews the results, rather than only responding to problems.

VERIFICATION QUESTIONS

  1. Are improvement opportunities identified from audits, incidents, feedback and performance data on a defined schedule?
    Improvement that waits for a problem arrives late.
  2. Are improvement goals set with measures and deadlines, and is progress against them recorded?
    A goal without a measure cannot be shown to be met.
  3. Are the results of improvement work reviewed by management, and is the review recorded?
    Improvement that is never reviewed is not managed. ————————————————————

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