Vijaya Medical Centre Internal Audit 2024

Title Page

Vijaya Medical Centre,14 G Health City, Visakhapatnam
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4 General requirements

4.1 Impartiality

a)Are the Laboratory activities undertaken impartially and structured and managed to safeguard impartiality?
b)Is the laboratory management committed to impartiality?
c)Is the laboratory responsible for the impartiality ?Does it allow commercial, financial or other pressures to compromise impartiality?
d)Does the laboratory monitor its impartiality activities?

4.2 Confidentiality

4.2.1 Management of information

Is the management committed to confidentiality? Is all the information confidential?

4.2.2 Release of information

Does the laboratory release confidential information when required by law or authorized by contractual arrangements?
Is the patient notified of the information released if it's not prohibited by law?
Is information about the patient obtained from sources other than the patient kept confidential by the laboratory?
Is the identity of the source (e.g., complainant, regulator) kept confidential by the laboratory?
Is the identity of the source shared with the patient only if agreed upon by the source?

4.2.3 Personnel responsibility

Do all personnel, including committee members, contractors, and external individuals with access to laboratory information, keep all information obtained or created during laboratory activities confidential?
Is there a requirement for all individuals with access to laboratory information to maintain confidentiality?
Does the laboratory have measures in place to ensure that personnel uphold the confidentiality of information obtained or created during laboratory activities?

4.3 Requirements regarding patients

Does the laboratory provide opportunities for patients and laboratory users to provide helpful information for the selection of examination methods and interpretation of results?
a)Does the laboratory make publicly available information about the examination process, including costs (when applicable) and the expected time for results?
b)Does the laboratory conduct periodic reviews of the examinations offered to ensure they are clinically appropriate and necessary?
c)Does the laboratory disclose incidents that could have resulted in patient harm and maintain records of actions taken to mitigate such incidents?
d)Does the laboratory treat patients, samples, or remains with due care and respect?
e)Does the laboratory obtain informed consent when required?
f)Does the laboratory ensure the ongoing availability and integrity of retained patient samples and records in the event of closure, acquisition, or merger?
g)Does the laboratory make relevant information available to patients and other healthcare providers upon request?
h)Does the laboratory uphold the rights of patients to care that is free from discrimination?

5 Structural and governance requirements

5.1 Legal entity

Does the laboratory have a legal identity?
Does the laboratory have a lab director?

5.2.1 Laboratory director competence

Is the lab director qualified and competent?

5.2.2 Laboratory director responsibilities

Is the laboratory director responsible for implementing the management system, including t risk management?

5.2.3 Delegation of duties

Is the laboratory director allowed to delegate selected duties or responsibilities, or both, to qualified and competent personnel, and is such delegation documented?

5.3 Laboratory activities

5.3.1 General

Has the laboratory specified and documented the range of laboratory activities?

5.3.2 Conformance with requirements

Are laboratory activities carried out in a manner that meets the requirements of ISO 15189:2022?

5.4 Structure and authority

5.4.1 General

a) "Has the laboratory defined its organization and management structure, its place in any parent organization, and the relationships between management, technical operations, and support services?"
b) "Has the laboratory specified the responsibility, authority, lines of communication, and interrelationship of all personnel who manage, perform, or verify work affecting the results of laboratory activities?"
c) "Has the laboratory specified its procedures to ensure the consistent application of its laboratory activities and the validity of the results to the extent necessary?"

5.4.2 Quality management

a) "Is laboratory personnel responsible for the implementation, maintenance, and improvement of the management system?
b)"Is laboratory personnel responsible for identifying deviations from the management system or from the procedures for performing laboratory activities?
c) "Is laboratory personnel responsible for initiating actions to prevent or minimize such deviations?"
d) "Is laboratory personnel responsible for reporting to laboratory management on the performance of the management system and any need for improvement?"
e) "Is laboratory personnel responsible for ensuring the effectiveness of laboratory activities?"

5.5 Objectives and policies

a) "Has laboratory management established and maintained objectives and policies to meet the needs and requirements of its patients and users?"
b)"Has laboratory management established and maintained objectives and policies to commit to good professional practice?"
c) "Has laboratory management established and maintained objectives and policies to provide examinations that fulfill their intended use?"
d) "Has laboratory management established and maintained objectives and policies ?
e) "Are the objectives measurable and consistent with policies, and are they implemented at all levels of the laboratory organization?"
f) "Does laboratory management ensure that the integrity of the management system is maintained when planning and implementing changes?"
g) "Has the laboratory established quality indicators to evaluate performance throughout key aspects of pre-examination, examination, and post-examination

5.6 Risk management

a) "Does the lab have a way to find risks and ways to make patient care better, and do they take actions to deal with those risks and improve things?"
b) "Is the lab director making sure that these ways of finding risks and improving patient care are checked to see if they work and changed if they don't?"

6 Resource requirements

6.1 General

Does the laboratory have the necessary personnel?
Does the laboratory have the necessary facilities?
Does the laboratory have the necessary equipment?
Does the laboratory have the necessary reagents?
Does the laboratory have the necessary consumables?
Does the laboratory have the necessary support services?

6.2 Personnel

6.2.1 General

a) Does the laboratory have enough qualified people for its work?
b) Do all laboratory personnel act fairly, ethically, and competently?
c) Does the laboratory tell its staff how important it is to meet user needs and follow this document?
d) Does the laboratory have a program to introduce new employees to the organization, their job, work conditions, safety rules, and health services?

6.2.2 Competence requirements

a) Does the laboratory define what skills and qualifications are needed for each job?
b) Are all laboratory personnel competent in their assigned tasks?
c) Does the laboratory regularly assess and manage personnel competence?
d) Does the laboratory have documented proof of its personnel's competence?

6.2.3 Authorization

a) Are specific personnel authorized to work on methods and results?
b) Are personnel authorized to review, release, and report results?
c) Are personnel authorized to use laboratory information systems, including patient data and examination results?

6.2.4 Continuing education and professional development

Is there a continuing education program available for personnel involved in managerial and technical processes?
Do all personnel participate in continuing education and regular professional development or professional liaison activities?
Is the suitability of the programs and activities periodically reviewed?

6.2.5 Personnel records

a) Does the laboratory have procedures and records for determining competence requirements?
b) Does the laboratory have procedures and records for position descriptions?
c) Does the laboratory have procedures and records for training?
d) Does the laboratory have procedures and records for authorizing personnel?
e) Does the laboratory have procedures and records for monitoring personnel competence?

6.3 Facilities and environmental conditions

6.3.1 General

Are the facilities and environmental conditions suitable for laboratory activities without causing problems for results or safety?
Does this also apply to places outside the main laboratory where tests are done, including Point-of-Care Testing (POCT)?
Are the requirements for facilities and environmental conditions specified, monitored, and recorded for laboratory activities?

6.3.2 Facility controls

a) Is access controlled for safety, confidentiality, and quality?
b) Are measures in place to prevent contamination and interference?
c) Is there prevention of cross-contamination when necessary?
d) Are safety facilities and devices regularly checked and functional?
e) Are laboratory facilities well-maintained and reliable?

6.3.3 Storage facilities

a) Is there storage space to protect samples, equipment, reagents, consumables, documents, and records?
b) Are patient samples and materials stored to prevent contamination and deterioration?
c) Are storage and disposal facilities suitable for hazardous materials and biological waste based on regulations?

6.3.4 Personnel facilities

Is there access to toilets and drinking water?
Is there storage for personal protective equipment and clothing?
Is there space for personnel activities like meetings, quiet study, and rest areas?

6.3.5 Sample collection facilities

a) Do the sample collection facilities allow for collection without invalidating results or affecting examination quality?
b) Do the facilities consider patient privacy, comfort, and needs, including disabled access and accommodations for accompanying persons?
c) Are there separate areas for patient reception and sample collection?
d) Are first aid materials available for both patients and personnel in the facilities?

6.4 Equipment

6.4.1 General

Does the laboratory have processes to acquire and install equipment?
Does the laboratory test equipment to ensure it meets acceptable criteria?
Does the laboratory have procedures for handling, transporting, and storing equipment?
Does the laboratory have protocols for using and maintaining equipment?
Does the laboratory know how to decommission equipment when needed?
Are these processes in place to ensure equipment works well and stays in good condition?

6.4.2 Equipment requirements

a) Does the laboratory have the equipment it needs?
b) If equipment is used differently than specified, does management ensure compliance with this document?
c) Are all influential equipment items uniquely labeled or marked with a register?
d) Does the laboratory maintain and replace equipment as needed for result quality?

6.4.3 Equipment acceptance procedure

Does the laboratory verify equipment against specified acceptability criteria before using it?
Is equipment used for measurement capable of achieving the required measurement accuracy or measurement uncertainty to provide valid results?

6.4.4 Equipment instructions for use

a) Are there safeguards in place to prevent unintended equipment adjustments that could invalidate results?
b) Is equipment operated only by trained and authorized personnel who are competent?
c) Are instructions for equipment use, including those from the manufacturer, readily available?
d) Is equipment used as specified by the manufacturer, unless validated by the laboratory?

6.4.5 Equipment maintenance and repair

a) Does the laboratory have maintenance programs based on the manufacturer's instructions, and do they record any deviations from these instructions?
b) Is the equipment kept in a safe and working condition, with authorized personnel ensuring electrical safety, emergency stop devices are functional, and hazardous materials are handled and disposed of safely?
c) Is equipment that's not working properly taken out of service, labeled as such, and actions taken when work doesn't meet specified requirements?
d) Does the laboratory decontaminate equipment before servicing, provide space for repairs, and offer appropriate personal protective equipment when needed?

6.4.6 Equipment adverse incident reporting

Are accidents related to specific equipment investigated and reported to the manufacturer, supplier, and authorities when necessary?
Does the laboratory have procedures to respond to manufacturer's recalls or notices, and follow their recommendations?

6.4.7 Equipment records

a) Are records kept for equipment details, including manufacturer and supplier information?
b) Are records maintained for equipment receipt, acceptance testing, and service entry dates?
c) Are there records confirming equipment meets specified criteria?
d) Is the current location of equipment recorded?
e) Are equipment conditions upon receipt documented (e.g., new, used, reconditioned)?
f) Are manufacturer's instructions documented?
g) Is there a preventive maintenance program on record?
h) Are maintenance activities recorded (performed by the laboratory or external service providers)?
i) Are records kept for equipment damage, malfunction, modification, or repair?
j) Are equipment performance records (e.g., calibration reports) documented with dates, times, and results?
k) Is the equipment's status (active, out-of-service, quarantined, retired, or obsolete) documented?

6.5 Equipment calibration and metrological traceability

6.5.1 General

Does the laboratory specify calibration and traceability requirements for consistent reporting of results?
For quantitative methods measuring analytes, are calibration and traceability requirements included in the specifications?
For methods assessing characteristics or qualities instead of specific analytes, are the characteristics and requirements for reproducibility over time specified?

6.5.2 Equipment calibration

a) Do procedures exist for equipment calibration, including following manufacturer's instructions?
b) Are metrological traceability records kept?
c) Are measurements accuracy and system functioning verified at specified intervals?
d) Is the calibration status and re-calibration date recorded?
e) Are correction factors updated and recorded during re-calibration?
f) Are procedures in place for handling calibration issues to minimize risks to service and patients?

6.5.3 Metrological traceability of measurement results

a)Does the laboratory maintain a documented chain of calibrations for measurement traceability?
b)Does the laboratory ensure traceability of its measurement results to the International System of Units (SI) through competent laboratory calibration?
c) Does the laboratory use alternative methods to ensure confidence in results when full traceability isn't possible?
d) For genetic examinations, is traceability to genetic reference sequences established?
e) In qualitative methods, does the laboratory use known materials or previous samples to ensure consistent identification and, when applicable, intensity of the reaction for traceability?

6.6 Reagents and consumables

6.6.1 General

Does the laboratory have processes for managing reagents and consumables, including selection, procurement, reception, storage, and acceptance testing?

6.6.2 Reagents and consumables — Receipt and storage

Does the laboratory store reagents and consumables as per the manufacturers' specifications and monitor environmental conditions when relevant?
When the laboratory is not the receiving facility, does it ensure that the receiving facility can adequately store and handle supplies to prevent damage and deterioration?

6.6.3 Reagents and consumables — Acceptance testing

Are reagents or new examination kit formulations with changes in reagents or procedures, as well as new lots or shipments, verified for performance before use or result release, as needed?
Are consumables that can impact examination quality verified for performance before use?

6.6.4 Reagents and consumables — Inventory management

Does the laboratory have an inventory management system for reagents and consumables?
Does the inventory system separate accepted reagents and consumables from those not yet inspected or accepted for use?

6.6.5 Reagents and consumables — Instructions for use

Are instructions for using reagents and consumables, including manufacturer-provided instructions, readily available in the laboratory?

6.6.6 Reagents and consumables — Adverse incident reporting

Are adverse incidents or accidents directly linked to specific reagents or consumables investigated?
Are these incidents reported to the manufacturer or supplier, or both, when required?
Are relevant authorities informed as needed?
Does the laboratory have procedures for responding to manufacturer's recalls or notices and for implementing recommended actions?

6.6.7 Reagents and consumables — Records

Are records maintained for each reagent and consumable used in examinations?
Do these records include information about the reagent or consumable's identity?
Is manufacturer information, including instructions, name, and batch code or lot number, documented in the records?
Are dates recorded for receipt, condition upon receipt, expiry date, date of first use, and, if applicable, the date the reagent or consumable was taken out of service?
Are there records confirming the initial and ongoing acceptance for use of reagents or consumables?
If the laboratory prepares reagents in-house, do the records include information about the preparation, including the responsible person(s) and preparation dates?

6.7 Service agreements

6.7.1 Agreements with laboratory users

Does the laboratory have a procedure to establish and periodically review agreements for providing laboratory activities?
Does the procedure ensure that requirements are adequately specified?
Does the procedure ensure that the laboratory has the capability and resources to meet the specified requirements?
When applicable, does the laboratory advise the user of the specific activities to be performed by referral laboratories and consultants?
Are laboratory users informed of any changes to an agreement that can affect examination results?
Are records of reviews, including any significant changes, retained?

6.7.2 Agreements with POCT operators

Do service agreements between the laboratory and other parts of the organization using laboratory-supported POCT specify and communicate respective responsibilities and authorities?

6.8 Externally provided products and services

6.8.1 General

Does the laboratory ensure that externally provided products and services intended for incorporation into its own activities are suitable?
Does the laboratory ensure that externally provided products and services, provided in part or in full, directly to the user by the laboratory as received from the external provider, are suitable?
Does the laboratory ensure that externally provided products and services used to support its operation are suitable?
Is collaboration with other organizational departments or functions sometimes necessary to fulfill these requirements?

6.8.2 Referral laboratories and consultants

Does the laboratory communicate its requirements to referral laboratories and consultants for procedures, examinations, reports, and consulting activities?
Does the laboratory communicate its requirements to referral laboratories and consultants for managing critical results?
Does the laboratory communicate its requirements to referral laboratories and consultants regarding personnel qualifications and competence?
Is the referring laboratory responsible for ensuring that examination results from the referral laboratory are provided to the person making the request unless otherwise specified?
Is there a maintained list of all referral laboratories and consultants?

6.8.3 Review and approval of externally provided products and services

Does the laboratory have procedures for defining its requirements for externally provided products and services, and do these procedures include review and approval?
Are there procedures for determining the criteria for qualifying, selecting, evaluating the performance, and re-evaluating external providers?
Are there procedures for handling the referral of samples?
Does the laboratory have procedures to ensure that externally provided products and services meet its established requirements before use or provision to the user?
Are records kept regarding actions taken based on evaluations of external provider performance?

7 Process requirements

7.1 General

Does the laboratory identify and assess potential risks to patient care in its processes?
Are efforts made to mitigate these identified risks?
Is residual risk communicated to users when necessary?
Are the identified risks and mitigation processes monitored and evaluated based on potential harm to patients?
Does the laboratory also identify opportunities to improve patient care?
Is there a framework in place to manage these improvement opportunities?

7.2 Pre-examination processes

7.2.1 General

Does the laboratory have procedures for pre-examination activities, and are these procedures accessible to relevant personnel?

7.2.2 Laboratory information for patients and users

Does the laboratory provide information to its users and patients?
Is the provided information detailed enough to help users understand the laboratory's scope and requirements?
Does the information include the laboratory's location, operating hours, and contact details?
Are procedures for requesting and collecting samples mentioned in the information?
Does the information specify the scope of laboratory activities and expected result availability times?
Is there information about the availability of advisory services?
Are patient consent requirements outlined in the information?
Does the information mention factors that can significantly affect examination performance or result interpretation?
Is there information on the laboratory's complaint process?

7.2.3 Requests for providing laboratory examinations

7.2.3.1 General

Is each examination request considered an agreement by the laboratory?
Does the examination request provide enough information to ensure: Patient and sample traceability?
Identity and contact details of the requester?
Identification of the requested examinations?
Capability to provide clinical and technical advice and interpretation?
Can the examination request information be provided in a format or medium chosen by the laboratory and accepted by the user?
Does the laboratory communicate with users or their representatives when clarification is needed for patient care?

7.2.3.2 Oral requests

Does the laboratory have a procedure for managing oral examination requests, if applicable, which includes sending documented confirmation of the request to the laboratory within a specific timeframe?

7.2.4 Primary sample collection and handling

7.2.4.1 General

Does the laboratory have procedures for collecting and handling primary samples?
Is information available to those responsible for sample collection?
Are deviations from established collection procedures recorded?
Are potential risks and impacts on patient outcomes assessed, recorded, and communicated when there are deviations from collection procedures?
Does the laboratory periodically review sample volume, collection devices, and preservatives to ensure proper sample collection and preservation?

7.2.4.2 Information for pre-collection activities

Does the laboratory provide detailed instructions for sample collection to ensure integrity?
Are there specifications for sample type, amount, and containers provided?
Does the information include guidance on the order of sample collection, if needed?
Are there instructions for special timing of collection, when necessary?
Is relevant clinical information, like drug history, provided?
Are clear instructions given for sample labeling to identify patients and sources when multiple samples are collected?
Are criteria for accepting or rejecting samples for specific tests provided?

7.2.4.3 Patient consent

Does the laboratory obtain the patient's informed consent for all procedures?
Are more detailed explanations and, in some cases, recorded consent required for special or higher-risk procedures?
In emergency situations where consent cannot be obtained, does the laboratory perform necessary procedures in the patient's best interest?

7.2.4.4 Instructions for collection activities

Does the laboratory provide instructions for verifying the patient's identity when collecting primary samples?
Are there instructions for confirming and recording patient compliance with pre-examination requirements (e.g., fasting, medication) when relevant?
Does the laboratory provide instructions for primary sample collection, including details about containers, additives, and the order of collection if needed?
Are there instructions for labeling primary samples to link them unequivocally with the patient?
Are instructions in place for recording the identity of the sample collector, the collection date, and, if relevant, the collection time?
Are there requirements for separating or dividing primary samples when necessary?
Does the laboratory provide instructions for ensuring proper storage and stabilization of collected samples before delivery?
Are there instructions for the safe disposal of materials used during the collection process?

7.2.5 Sample transportation

Does the laboratory provide instructions for packaging samples for transportation?
Does the laboratory provide instructions for ensuring the appropriate time between sample collection and laboratory receipt for requested examinations?
Does the laboratory provide instructions for maintaining the specified temperature during sample handling and transport?
Does the laboratory provide instructions for specifying any requirements to ensure sample integrity, such as using designated preservatives?
c) Does the laboratory establish and periodically evaluate the adequacy of its sample transportation systems?

7.2.6 Sample receipt

7.2.6.1 Sample receipt procedure

Does the laboratory have a procedure for sample receipt that ensures: Unequivocal traceability of samples to uniquely identified patients and, if applicable, anatomical sites?
Are there criteria for accepting and rejecting samples?
Is the date and time of sample receipt recorded when relevant?
Is the identity of the person receiving the sample recorded when relevant?
Are received samples evaluated by authorized personnel to ensure they meet acceptability criteria for the requested examinations?
Are there instructions for handling samples marked as urgent, including special labeling, transport, rapid processing, turnaround times, and reporting criteria?
Does the procedure ensure that all portions of the sample can be traced back to the original sample?

7.2.6.2 Sample acceptance exceptions

a) Does the laboratory have a process that considers the best interests of the patient in receiving care when a sample has been compromised due to:
Incorrect patient or sample identification?
Sample instability due to factors like a delay in transport?
Incorrect storage or handling temperature?
Inappropriate container(s)?
Insufficient sample volume?
b) When a compromised clinically critical or irreplaceable sample is accepted, does the final report indicate the nature of the problem?
c) Does the final report, where applicable, advise caution when interpreting results that can be affected by compromised samples?

7.2.7 Pre-examination handling, preparation, and storage

7.2.7.1 Sample protection

Does the laboratory have procedures and facilities in place to secure patient samples, maintain sample integrity, and prevent loss or damage during handling, preparation, and storage?

7.2.7.2 Criteria for additional examination requests

Do laboratory procedures include time limits for requesting additional examinations on the same sample?

7.2.7.3 Sample stability

Is the time between sample collection and performing the examination specified and monitored, considering the analyte's stability in the primary sample, where applicable?

7.3 Examination processes

7.3.1 General

a) Does the laboratory use validated examination methods for patient testing to ensure clinical accuracy?
b) Do the performance specifications of each examination method align with its intended use and impact on patient care?
c) Are all procedures and relevant documentation kept up to date and readily available to personnel?
d) Do personnel follow established procedures, and is the identity of those performing significant activities in examination processes recorded?
e) Do authorized personnel periodically assess the clinical appropriateness of the examination methods used for incoming requests?

7.3.2 Verification of examination methods

a) Does the laboratory have a procedure to verify that it can properly perform examination methods before introducing them into use, ensuring that the required performance, as specified by the manufacturer or method, can be achieved?
b) Are the performance specifications for the examination method confirmed during the verification process relevant to the intended use of the examination results?
c) Does the laboratory ensure that the extent of the verification of examination methods is sufficient to guarantee the validity of results important for clinical decision making?
d) Do personnel with the appropriate authorization and competence review the verification results and record whether the results meet the specified requirements?
e) If a method is revised by the issuing body, does the laboratory repeat the verification to the extent necessary?
f) Does the laboratory retain records of verification, including:
Performance specifications to be achieved?
Results obtained?
A statement of whether the performance specifications were achieved, and if not, action taken?

7.3.3 Validation of examination methods

a) Does the laboratory validate examination methods from:
Laboratory-designed or developed methods?
Methods used outside their original intended scope?
Validated methods subsequently modified?
b) Is the validation process extensive enough to confirm that the specific requirements for the intended use of the examination have been met, and does it ensure the validity of results relevant to clinical decision making?
c) Do authorized and competent personnel review the validation results and record whether they meet specified requirements?
d) When proposing changes to a validated examination method, is the clinical impact reviewed, and a decision made on whether to implement the modified method?
Are the following records of validation retained:
The validation procedure used?
Specific requirements for the intended use?
Determination of the performance specifications of the method?
Results obtained?
A statement on the validity of the method, describing its fitness for the intended use?

7.3.4 Evaluation of measurement uncertainty (MU)

a) Is the Measurement Uncertainty (MU) evaluated and documented for measured quantity values, compared against performance specifications, and maintained for their intended use, where relevant?
b) Are MU evaluations regularly reviewed?
c) Is the rationale for excluding MU estimation documented for cases where it's not possible or relevant?
d) Is MU information provided to laboratory users upon request?
e) Does the laboratory's response to user inquiries about MU consider other sources of uncertainty, such as biological variation?
f) If a qualitative result relies on a test producing quantitative output data and is based on a threshold (positive/negative), is MU estimated for the output quantity using representative samples?
h) Is MU taken into account when verifying or validating a method, when relevant?

7.3.5 Biological reference intervals and clinical decision limits

a) Are biological reference intervals and clinical decision limits defined, and their basis recorded to reflect the patient population served by the laboratory, while considering the risk to patients?
b) Are biological reference intervals and clinical decision limits periodically reviewed, and are any changes communicated to users?
c) When changes are made to an examination or pre-examination method, does the laboratory review the impact on associated biological reference intervals and clinical decision limits and communicate changes to users when applicable?
d) For examinations that identify the presence or absence of a characteristic, is the biological reference interval the characteristic to be identified, as in the case of genetic examinations?

7.3.6 Documentation of examination procedures

a) Are examination procedures documented to ensure consistency and result validity?
- Yes
- No
- N/A
b) Are procedures written in a language understood by laboratory personnel and available in the right locations?
c) Are abbreviated document contents consistent with the procedure, with full procedures available for reference, and is summarized information updated as needed?
d) Can information from product instructions for use, containing sufficient details, be referenced in procedures?
e) When validated changes are made to an examination procedure that could impact result interpretation, are these changes explained to users?
f) Are all documents related to the examination process subject to document control?

7.3.7 Ensuring the validity of examination results

7.3.7.1 General

Does the laboratory have a procedure for monitoring and recording results in a way that allows the detection of trends and shifts, with the application of statistical techniques when possible, and is this monitoring planned and reviewed?

7.3.7.2 Internal quality control (IQC)

a) Does the laboratory have an IQC procedure to monitor and ensure ongoing validity of examination results for clinical decision making?
Does the IQC procedure take into account the different clinical settings where the examination might be used, considering that performance specifications can vary?
Does the procedure allow for the detection of variation in reagents or calibrators between lots and avoid changing IQC material on the same day/run as reagent or calibrator changes?
Does the laboratory consider using third-party IQC material, either as an alternative or in addition to control material supplied by manufacturers?
b) When selecting IQC material, is consideration given to factors such as stability, similarity to patient samples, reaction to the examination method, clinical relevance, and coverage of the measurement range?
c) If appropriate IQC material is not available, does the laboratory consider alternative methods for IQC, such as trend analysis of patient results, comparison with results from an alternative procedure, or retesting retained patient samples?
d) Is the frequency of IQC based on the stability and robustness of the examination method and the risk of harm to patients from erroneous results?
e) Are IQC data recorded in a way that allows for the detection of trends and shifts, with the application of statistical techniques when applicable?
f) Is IQC data reviewed at regular intervals with defined acceptability criteria, allowing for a meaningful assessment of current performance?
g) Does the laboratory prevent the release of patient results if IQC fails defined acceptability criteria?
Are results rejected and relevant patient samples re-examined when IQC criteria indicate clinically significant errors?
Are results from patient samples examined after the last successful IQC event evaluated?

7.3.7.3 External quality assessment (EQA)

a) Does the laboratory compare its examination results with other labs and participate in EQA programs, including POCT methods?
b) Does the lab have a procedure for joining and participating in EQA programs for the methods it uses?
c) Are EQA samples processed by staff who handle routine procedures?
d) Does the lab select EQA programs that check various processes and provide samples similar to patient samples?
e) When choosing EQA programs, does the lab consider the type of target values offered, such as those set by reference methods, consensus, peer groups, or experts?
f) If suitable EQA programs are unavailable, does the lab use alternative methods to monitor method performance and provide justification and evidence of their effectiveness?
g) Is EQA data regularly reviewed with defined criteria, allowing for a meaningful assessment of current performance?
h) If EQA results fall outside specified criteria, does the lab take appropriate action, including assessing clinical significance for patient samples?
i) If the impact is clinically significant, does the lab review affected patient results, consider amendments, and advise users as needed?

7.3.7.4 Comparability of examination results

Does the laboratory have a procedure to ensure the comparability of results for patient samples when different methods, equipment, or locations are used for the same examination?
b) Does the laboratory record the results of comparability testing and whether the results are acceptable?
c) Does the laboratory periodically review the comparability of results?
d) When differences are identified, does the laboratory evaluate their impact on biological reference intervals and clinical decision limits and take appropriate action?
e) Does the laboratory inform users if there are clinically significant differences in comparability of results?

7.4 Post-examination processes

7.4.1 Reporting of results

7.4.1.1 General

a) Are examination results reported accurately, clearly, and in accordance with specific examination procedure instructions, including all necessary information for interpretation?
b) Does the laboratory have a procedure for notifying users when examination results are delayed, taking into account the impact of the delay on the patient?
c) Is all information associated with issued reports retained in accordance with management system requirements?

7.4.1.2 Result review and release

a) Are results reviewed and authorized before they are released?
b) Does the laboratory ensure that authorized personnel review examination results against IQC, clinical information, and previous results?
c) Are there specified responsibilities and procedures for releasing examination results, including who does it and to whom they are released?

7.4.1.3 Critical result reports

a) Is the user or other authorized person notified promptly when examination results fall within established critical decision limits?
b) Are the actions taken in such cases documented, including the date, time, responsible person, person notified, results conveyed, verification of accuracy of communication, and any difficulties encountered in notification?
c) Does the laboratory have an escalation procedure for laboratory personnel to follow when a responsible person cannot be contacted in such situations?

7.4.1.4 Special considerations for results

a) Is it agreed with the user that results can be reported in a simplified way, with all omitted information readily available?
b) When results are transmitted as a preliminary report, is the final report always forwarded to the user?
c) Are records kept of all results provided orally, including details of verification of accuracy of communication, and are such results always followed by a report?
d) Is special counseling provided when examination results have serious implications for the patient (e.g., for genetic or certain infectious diseases), and is it ensured that these results are not communicated to the patient without the opportunity for adequate counseling?

7.4.1.5 Automated selection, review, release and reporting of results

a) Are the criteria for automated result selection, review, and release specified, approved, and understood by relevant personnel?
b) Are these criteria validated, regularly reviewed, and verified after system changes that may impact their effectiveness and patient care?
c) Can you identify results selected by the automated system for manual review, and is the relevant information retrievable?
d) Is there a process in place to quickly suspend automated processes if needed?

7.4.1.6 Requirements for reports

a) Does each report have patient identification, sample collection date, and report issue date on every page?
b) Is the lab's identity clear in each report?
c) Is the user's name or identifier in the report?
d) Does the report describe the sample type and any specific details?
e) Does the report specify the examinations performed?
f) Does it mention the examination method used?
g) Are examination results and units of measurement included?
h) Are reference intervals, clinical limits, and supporting information provided?
i) Does it indicate examinations for research or development purposes?
j) Are the persons reviewing results and authorizing the report release identified?
k) Does the report indicate any results that should be considered preliminary?
l) Are critical results clearly indicated in the report?
m) Is there a unique identification for all report components, and is it clear where the report ends?

7.4.1.7 Additional information for reports

a) Is the time of sample collection mentioned when needed?
b) Is the time of report release available when necessary, if not in the report?
c) Does the report include examinations from referral labs or consultants without changes and mention the lab's name?
d) Does the report provide interpretation and comments on sample quality, discrepancies in procedures or locations, unit measurement differences, and result trends?

7.4.1.8 Amendments to reported results

a) Is the reason for changing results recorded and included in the revised report when relevant?
b) Are revised results delivered only as an additional document or data transfer, clearly identified as revised, and indicating the date and patient's identity in the original report?
c) Are users made aware of revisions to the results?
d) When issuing a completely new report, is it uniquely identified and does it contain a reference and traceability to the original report it replaces?
e) If the reporting system cannot capture revisions, is a record of such kept?

7.4.2 Post-examination handling of samples

a) Is patient and source identification of the sample maintained after examination?
b) Is the suitability of the sample for additional examination known after examination?
c) Is the sample stored in a manner that optimally preserves its suitability for additional examination?
d) Can the sample be located and retrieved when needed?
e) Is the sample discarded appropriately after examination?

7.5 Nonconforming work

Does the laboratory have specified responsibilities and authorities for managing nonconforming work?
Are immediate and long-term actions determined based on a risk analysis process established by the laboratory?
Does the laboratory halt examinations and withhold reports when there is a risk of harm to patients?
Is an evaluation made regarding the clinical significance of nonconforming work, including an impact analysis on released examination results?
Does the laboratory make a decision on the acceptability of nonconforming work?
Is it ensured that examination results are revised and users are notified when necessary?
Is there a specified responsibility for authorizing the resumption of work after nonconforming work has been addressed?
Does the laboratory implement corrective actions based on the risk of recurrence of nonconforming work?
Does the laboratory retain records of nonconforming work and the actions taken in response to them?

7.6 Control of data and information management

7.6.1 General

Does the laboratory have access to the data and information required to carry out its laboratory activities?

7.6.2 Authorities and responsibilities for information management

Is the responsibility for managing information systems, including maintenance and modifications affecting patient care, clearly specified by the laboratory?

7.6.3 Information systems management

Were the systems validated by the supplier and verified for functionality before being used in the laboratory?
a)Are any changes to the system, including software configuration or modifications, authorized, documented, and validated before implementation?
b)Is documentation for the laboratory information systems available to authorized users, including day-to-day functioning documentation?
c)Are there measures in place to protect the system from unauthorized access and to safeguard data from tampering or loss?
d)Are the systems operated in a way that meets supplier specifications or, for non-computerized systems, safeguards the accuracy of manual recording and transcription?
e)Is the maintenance of systems done to ensure data and information integrity, including recording system failures and taking appropriate actions?
f)Are calculations and data transfers checked systematically?

7.6.4 Downtime plans

Does the laboratory have planned processes in place to maintain operations in the event of failures or downtime in information systems that affect its activities, including automated selection and reporting of results?

7.6.5 Off site management

Is the laboratory ensuring that when its information system(s) are managed and maintained off-site or through an external provider, the provider or operator of the system complies with all applicable requirements of this document?

7.7 Complaints

7.7.1 Process

a) A description of the process for receiving, substantiating, investigating complaints, and deciding on actions to be taken in response?
b) Tracking and recording complaints, including the actions taken to resolve them?
c) Ensuring appropriate action is taken in response to complaints?
Additionally, is the description of the process for handling complaints publicly available?

7.7.2 Receipt of complaint

a) Upon receiving a complaint, does the laboratory confirm whether it relates to its own laboratory activities, and if so, does it take steps to resolve the complaint?
b) Is the laboratory responsible for gathering all necessary information to determine whether the complaint is substantiated?
c) Does the laboratory, whenever possible, acknowledge receipt of the complaint and provide the complainant with the outcome and, if applicable, progress reports?

7.7.3 Resolution of complaint

Does the investigation and resolution of complaints in the laboratory avoid resulting in discriminatory actions?
Are the resolutions of complaints made by persons not involved in the subject of the complaint, or are they reviewed and approved by such individuals?
If resources do not permit individuals not involved in the subject of the complaint, is any alternative approach used to ensure impartiality without compromising it?

7.8 Continuity and emergency preparedness planning

a) Has the laboratory established a planned response to emergency situations, considering the needs and capabilities of all relevant laboratory personnel?
b) Does the laboratory provide information and training as needed to relevant laboratory personnel regarding the planned response to emergency situations?
c) Is the laboratory capable of responding to actual emergency situations?
d) Does the laboratory take appropriate action to prevent or mitigate the consequences of emergency situations based on their magnitude and potential impact?

8 Management system requirements

8.1 General requirements

8.1.1 General

Does the laboratory have a management system in place that includes:
Clearly defined responsibilities?
Defined objectives and policies?
Documented information, as required by sections 8.2, 8.3, and 8.4 of the document?
Actions to address risks and opportunities for improvement as outlined in section 8.5?
A process for continual improvement, as specified in section 8.6?
Procedures for corrective actions as required by section 8.7?
Mechanisms for evaluations and internal audits as described in section 8.8?
Periodic management reviews?

8.1.2 Fulfilment of management system requirements

is the laboratory meeting the requirements of Clause 8.1.1 by establishing, implementing, and maintaining a quality management system (e.g., in accordance with the requirements of ISO 9001) that supports and demonstrates the consistent fulfillment of the requirements of Clauses 4 to 7 and the requirements specified in Clauses 8.2 to 8.9?

8.1.3 Management system awareness

Does the laboratory ensure that individuals working under its control are aware of:
a) Relevant objectives and policies?
b) Their contribution to the effectiveness of the management system and the benefits of improved performance?
c) The consequences of not conforming with the management system requirements?

8.2 Management system documentation

8.2.1 General

Has laboratory management established, documented, and maintained objectives and policies for fulfilling the purposes of this document, and have they ensured that these objectives and policies are acknowledged and implemented at all levels of the laboratory organization?

8.2.2 Competence and quality

Do the objectives and policies established by the laboratory address the competence, quality, and consistent operation of the laboratory?

8.2.3 Evidence of commitment

Does laboratory management provide evidence of commitment to the development and implementation of the management system?
Does laboratory management provide evidence of commitment to continually improving the effectiveness of the management system?

8.2.4 Documentation

Is all relevant documentation included in the management system?
Are all necessary processes included in the management system?
Are all required systems included in the management system?
Are all pertinent records included in the management system?
Does the management system have references or links to connect to the necessary documentation, processes, systems, and records?

8.2.5 Personnel access

Do all personnel involved in laboratory activities have access to the parts of the management system documentation and related information applicable to their responsibilities?
Is there a system in place to ensure that personnel can access the relevant management system documentation and related information?

8.3 Control of management system documents

8.3.1 General

Does the laboratory control internal documents related to the fulfillment of this document?
Does the laboratory control external documents related to the fulfillment of this document?

8.3.2 Control of documents

Are documents uniquely identified?
b) Are documents approved for adequacy before issue by authorized personnel with the expertise and competence to determine adequacy?
c) Are documents periodically reviewed and updated as necessary?
d) Are relevant versions of applicable documents available at points of use, and is their distribution controlled where necessary?
e) Are changes and the current revision status of documents identified?
f) Are documents protected from unauthorized changes, deletion, or removal?
g) Are documents protected from unauthorized access?
h) Is the unintended use of obsolete documents prevented, and is suitable identification applied to them if they are retained for any purpose?
i) Is at least one paper or electronic copy of each obsolete controlled document retained for a specified time period or in accordance with applicable specified requirements?

8.4 Control of records

8.4.1 Creation of records

Has the laboratory established legible records to demonstrate fulfillment of the requirements of this document?
Are records created at the time each activity that affects the quality of an examination is performed?

8.4.2 Amendment of records

Does the laboratory ensure that amendments to records can be traced to previous versions or to original observations?
Is both the original and amended data and files kept, including the date, and where relevant, the time of alteration, an indication of the altered aspects, and the personnel making the alterations?

8.4.3 Retention of records

Are procedures implemented for the identification of laboratory records?
Are procedures implemented for the proper storage of laboratory records?
Are laboratory records protected from unauthorized access?
Are laboratory records protected from unauthorized changes?
Are there procedures in place for the backup of laboratory records?
Are procedures established for the archive and retrieval of laboratory records?
Is there a defined retention time for laboratory records?
b) Retention Times for Records: 8. Are specific retention times specified for laboratory records?
c) Retrievability of Examination Results: 9. Are reported examination results retrievable for as long as necessary or as required?
d) Accessibility and Legibility of Records: 10. Are all laboratory records accessible throughout the entire retention period?
Are laboratory records legible in whichever medium they are kept?
Are laboratory records available for laboratory management review?

8.5 Actions to address risks and opportunities for improvement

8.5.1 Identification of risks and opportunities for improvement

a) Identification of Risks and Opportunities to Prevent or Reduce Undesired Impacts: Does the laboratory identify risks associated with laboratory activities to prevent or reduce undesired impacts and potential failures?
b) Identification of Opportunities for Improvement: 2. Does the laboratory identify opportunities for improvement associated with laboratory activities and take action to achieve improvement?
c) Assurance of Intended Results: 3. Is the laboratory's management system designed to ensure that it achieves its intended results?
d) Mitigation of Risks to Patient Care: 4. Does the laboratory take steps to mitigate risks to patient care associated with its activities?
e) Alignment with Purpose and Objectives: 5. Does the identification of risks and opportunities help the laboratory achieve its purpose and objectives?

8.5.2 Acting on risks and opportunities for improvement

Does the laboratory prioritize identified risks based on their potential impact on laboratory examination results, patient, and personnel safety?
Are actions taken to address risks proportional to their potential impact on laboratory examination results, patient, and personnel safety?
Does the laboratory record decisions made and actions taken on identified risks and opportunities?
Is there an integration of actions on identified risks and improvement opportunities into the laboratory's management system?
Does the laboratory evaluate the effectiveness of actions taken on identified risks and improvement opportunities?

8.6 Improvement

8.6.1 Continual improvement

a) Continual Improvement of the Management System: Does the laboratory continually improve the effectiveness of the management system, including pre-examination, examination, and post-examination processes, in line with its objectives and policies?
b) Identification and Implementation of Improvement Opportunities: 2. Does the laboratory identify and select opportunities for improvement?
Does the laboratory develop, document, and implement necessary actions to address improvement opportunities?
Are improvement activities directed at areas of highest priority based on risk assessments and identified opportunities?
c) Evaluation of Action Effectiveness: 5. Does the laboratory evaluate the effectiveness of the actions taken to address improvement opportunities?
d) Participation in Continual Improvement Activities: 6. Does laboratory management ensure that the laboratory participates in continual improvement activities relevant to patient care?
e) Communication of Improvement Plans and Goals: 7. Does laboratory management communicate its improvement plans and related goals to personnel?

8.6.2 Laboratory patients, user, and personnel feedback

Does the laboratory seek feedback from its patients, users, and personnel?
Is the feedback obtained from patients, users, and personnel analyzed?
Are the results of the feedback analysis used to improve the management system, laboratory activities, and services to users?
Are records of the feedback, including the actions taken, maintained by the laboratory?
Does the laboratory communicate to personnel the actions taken in response to their feedback?

8.7 Nonconformities and corrective actions

8.7.1 Actions when nonconformity occurs

a) Response to Nonconformity:
When a nonconformity occurs, does the laboratory take immediate action to control and correct the nonconformity as applicable?
Does the laboratory address the consequences of the nonconformity, with a particular focus on patient safety, including escalation to the appropriate person?
b) Determination of Nonconformity Cause(s): 3. Does the laboratory determine the cause(s) of the nonconformity?
c) Evaluation of Corrective Action Need: 4. Does the laboratory evaluate the need for corrective action to eliminate the cause(s) of the nonconformity and reduce the likelihood of recurrence or occurrence elsewhere?
Does the laboratory review and analyze the nonconformity during this evaluation?
Does the laboratory determine whether similar nonconformities exist or could potentially occur?
Does the laboratory assess the potential risks and effects if the nonconformity recurs?
d) Implementation of Corrective Action: 8. Does the laboratory implement any action needed based on the evaluation?
e) Review and Evaluation of Corrective Action Effectiveness: 9. Does the laboratory review and evaluate the effectiveness of any corrective action taken?
f) Update of Risks and Opportunities for Improvement: 10. Does the laboratory update risks and opportunities for improvement as needed?
g) Changes to the Management System: 11. Does the laboratory make changes to the management system if necessary?

8.7.2 Corrective action effectiveness

Do corrective actions taken by the laboratory consider the effects of the nonconformities and aim to mitigate the identified cause(s)?

8.7.3 Records of nonconformities and corrective actions

Does the laboratory retain records as evidence of the nature of the nonconformities, their cause(s), and any subsequent actions taken?
b) Retention of Records on Corrective Action Evaluation: 2. Does the laboratory retain records as evidence of the evaluation of the effectiveness of any corrective action?

8.8 Evaluations

8.8.1 General

Does the laboratory conduct evaluations at planned intervals?
Are these evaluations conducted to demonstrate that the management, support, pre-examination, examination, and post-examination processes meet the needs and requirements of patients and laboratory users?
Are these evaluations conducted to ensure conformity to the requirements of the document?

8.8.2 Quality indicators

Is the process of monitoring quality indicators planned by the laboratory?
Does the planning process include establishing objectives, methodology, interpretation, limits, an action plan, and the duration of monitoring?
Are the quality indicators periodically reviewed to ensure their continued appropriateness?

8.8.3 Internal audits

8.8.3.1Does the laboratory conduct internal audits at planned intervals to provide information on whether the management system is:
a) Conformity to Laboratory's Own Requirements: Do the internal audits provide information on whether the management system conforms to the laboratory's own requirements for its management system, including laboratory activities?
b) Conformity to Requirements of This Document: 2. Do the internal audits provide information on whether the management system conforms to the requirements of this document?
c) Effective Implementation and Maintenance: 3. Do the internal audits provide information on whether the management system is effectively implemented and maintained?

8.8.3.2 The laboratory shall plan, establish, implement and maintain an internal audit programme that includes:

a) Priority Given to Patient Risk: Is priority given to assessing risk to patients from laboratory activities during internal audits?
b) Audit Schedule Considerations: 2. Does the audit schedule take into consideration identified risks?
Does the audit schedule consider the outcomes of both external evaluations and previous internal audits?
Does the audit schedule consider the occurrence of nonconformities, incidents, and complaints?
Does the audit schedule consider changes affecting laboratory activities?
c) Specified Audit Objectives, Criteria, and Scope: 6. Are specified audit objectives, criteria, and scope defined for each audit?
d) Selection of Qualified Auditors:
7. Are auditors selected for internal audits trained, qualified, and authorized to assess the performance of the laboratory's management system?
Are auditors, whenever resources permit, independent of the activity to be audited?
e) Objectivity and Impartiality:
9. Does the audit process ensure objectivity and impartiality?
Reporting of Audit Results: Are the results of the internal audits reported to relevant personnel?
g) Implementation of Correction and Corrective Actions:
Is appropriate correction and corrective action implemented without undue delay as a result of audit findings?
h) Retention of Audit Records: Are records retained as evidence of the implementation of the audit program and audit results?

8.9 Management reviews

8.9.1 General

Does laboratory management review its management system at planned intervals to ensure its continuing suitability, adequacy, and effectiveness, including the stated policies and objectives related to the fulfillment of this document?

8.9.2 Review input

a) Status of Actions and Changes:Does the management review consider the status of actions from previous management reviews?
Does the management review consider internal and external changes to the management system?
Does the management review consider changes in the volume and type of laboratory activities?
Does the management review consider the adequacy of resources?
b) Fulfillment of Objectives and Suitability of Policies/Procedures:
5. Does the management review assess the fulfillment of objectives?
Does the management review assess the suitability of policies and procedures?
c) Review of Evaluation Outcomes:
Does the management review consider the outcomes of recent evaluations?
Does the management review consider process monitoring using quality indicators?
Does the management review consider the results of internal audits?
Does the management review consider the analysis of non-conformities and corrective actions?
Does the management review consider assessments by external bodies?
d) Review of Feedback and Complaints:
Does the management review consider patient, user, and personnel feedback and complaints?
e) Quality Assurance of Result Validity:
Does the management review include the evaluation of the quality assurance of result validity?
Effectiveness of Improvements and Actions:
Does the management review assess the effectiveness of any implemented improvements?
Does the management review assess actions taken to address risks and opportunities for improvement?
Performance of External Providers:
Does the management review evaluate the performance of external providers?
Results of Participation in Interlaboratory Comparison Programs: Does the management review consider the results of participation in interlaboratory comparison programs?
i) Evaluation of POCT (Point-of-Care Testing) Activities: Does the management review include the evaluation of POCT activities?
j) Consideration of Other Relevant Factors: Does the management review consider other relevant factors, such as monitoring activities and training?

8.9.3 Review output

Does the output from the management review include decisions and actions related to the effectiveness of the management system and its processes?
Does the output from the management review include decisions and actions related to the improvement of laboratory activities?
Does the output from the management review include decisions and actions related to the provision of required resources?
Does the output from the management review include decisions and actions related to the improvement of services to patients and users?
Does the output from the management review include decisions and actions related to any identified need for change?
Are actions arising from the management review completed within a specified time frame?
Are the conclusions and actions arising from management reviews communicated to laboratory personnel?

6.Resource Requirements

6.1.General

Does the laboratory have the right people, places, tools, chemicals, supplies, and help it needs to do its work?"

6.2.Personnel

6.2.1.General

a) "Does the lab have enough skilled people to do its work?"
b) "Do all lab staff, whether from inside or outside, act fairly, honestly, know what they're doing, and follow the lab's rules?"
c) "Does the lab tell its staff why it's important to meet the needs of users and follow the rules in 15189:2022?
d) "Does the lab coduct induction training to the newly recruited employees?

6.2.2 Competence requirements

a) "Does the lab list what skills and knowledge each job needs, and how people should get those skills?"
b) "Is everyone in the lab trained and skilled enough for their jobs?"
c) "Does the lab have a plan for checking how good its staff are at their jobs, and how often they should be checked?"
d) "Does the lab have records showing that its staff are good at their jobs?"

6.2.3 Authorization

a) "Do they choose, change, and check how they do tests and report results?"
b) "Is there a process for checking and sharing test results?"
c) "Do they have rules for using computers and patient information, like entering and changing data?"

6.2.4 Continuing education and professional development

"Is there an ongoing education program for personnel involved in management and technical processes?"
"Do all personnel participate in continuous education and professional development activities?"
"Is the effectiveness of the programs and activities periodically reviewed?"

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4.1 Impartiality

4.2 Confidentiality

4.2.1 Management of information

4.2.2 Release of information

4.2.3 Personnel responsibility

4.3 Requirements regarding patients

5 Structural and governance requirements

5.1 Legal entity

5.2.1 Laboratory director competence

5.2.2 Laboratory director responsibilities

5.2.3 Delegation of duties

5.3 Laboratory activities

5.3.1 General

5.3.2 Conformance with requirements

5.4 Structure and authority

5.4.1 General

5.4.2 Quality management

5.5 Objectives and policies

5.6 Risk management

6 Resource requirements

6.1 General

6.2 Personnel

6.2.1 General

6.2.2 Competence requirements

6.2.3 Authorization

6.2.4 Continuing education and professional development

6.2.5 Personnel records

6.3 Facilities and environmental conditions

6.3.1 General

6.3.2 Facility controls

6.3.3 Storage facilities

6.3.4 Personnel facilities

6.3.5 Sample collection facilities

6.4 Equipment

6.4.1 General

6.4.2 Equipment requirements

6.4.3 Equipment acceptance procedure

6.4.4 Equipment instructions for use

6.4.5 Equipment maintenance and repair

6.4.6 Equipment adverse incident reporting

6.4.7 Equipment records

6.5 Equipment calibration and metrological traceability

6.5.1 General

6.5.2 Equipment calibration

6.5.3 Metrological traceability of measurement results

6.6 Reagents and consumables

6.6.1 General

6.6.2 Reagents and consumables — Receipt and storage

6.6.3 Reagents and consumables — Acceptance testing

6.6.4 Reagents and consumables — Inventory management

6.6.5 Reagents and consumables — Instructions for use

6.6.6 Reagents and consumables — Adverse incident reporting

6.6.7 Reagents and consumables — Records

6.7 Service agreements

6.7.1 Agreements with laboratory users

6.7.2 Agreements with POCT operators

6.8 Externally provided products and services

6.8.1 General

6.8.2 Referral laboratories and consultants

6.8.3 Review and approval of externally provided products and services

7 Process requirements

7.1 General

7.2 Pre-examination processes

7.2.1 General

7.2.2 Laboratory information for patients and users

7.2.3 Requests for providing laboratory examinations

7.2.3.1 General

7.2.3.2 Oral requests

7.2.4 Primary sample collection and handling

7.2.4.1 General

7.2.4.2 Information for pre-collection activities

7.2.4.3 Patient consent

7.2.4.4 Instructions for collection activities

7.2.5 Sample transportation

7.2.6 Sample receipt